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Office of Directorate General of Foreign Trade New Delhi -0
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Para 4.7 Decision
Minutes of the Norms Committee – 3 Meeting No. 10/82-ALC4/2019 dated 29.11.2019 (actually held on 28.11.2019, 20.12.2019 and 26.12.2019) for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri Satyan Sharda, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.
Following members were present:-
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(i) Shri Nirmal Kumar, Dy. Director General of Foreign Trade (ii) Shri Ajay Kumar, Assistant Director
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(iii) Consultant, Technical Expert Pharmaceuticals (iv) Consultant, Technical Expert Chemicals
ONLINE CASES
| Case No.:391/1/83-ALC1/2019 |
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Party Name:UNIJULES LIFE |
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Meet No/Date:10/82- |
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Status: |
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SCIENCES LTD. |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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Lic.No/Date:0310795215 |
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:03/95/040/00001/AM16/ |
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09.04.2015 |
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Case No.:391/1/83-ALC1/2019 |
Case No.:391/1/83-ALC1/2019 |
Party Name:UNIJULES LIFE<br>SCIENCES LTD. |
Party Name:UNIJULES LIFE<br>SCIENCES LTD. |
Party Name:UNIJULES LIFE<br>SCIENCES LTD. |
Party Name:UNIJULES LIFE<br>SCIENCES LTD. |
Party Name:UNIJULES LIFE<br>SCIENCES LTD. |
Party Name:UNIJULES LIFE<br>SCIENCES LTD. |
Party Name:UNIJULES LIFE<br>SCIENCES LTD. |
Party Name:UNIJULES LIFE<br>SCIENCES LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
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HQ File<br>01/83/050/01223/AM19/ |
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RLA File<br>03/95/040/00001/AM16/ |
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Lic.No/Date:0310795215<br>09042015 |
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**Decision:**The Committee c<br>was decided to ratify the ad-hoc<br>b fi hih i l |
onsidered case as per agenda in<br>input output norms under para 4 |
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the presence of the techni<br>.7 of HBP as per details be |
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cal experts and it<br>low or as applied |
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y rm wcever s ower: |
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Export product |
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No. |
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Gadodiamide Injection USP 20 ml<br>vial Net Content of Import Item-<br>Gadodiamide USP-143.33 Kgs & |
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1<br>Numb |
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GADODIAMIDE USP |
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6.027 g/<br>20 ml vial |
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2 |
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CALDIAMIDE SODIUM |
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0.252 g/ |
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Caldiamide<br>Sodium-6.00<br>Kgs.<br>Each ml conaints Gadodiamide 287 |
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<br>20 ml vial |
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mg& Caldiamide Sodium 12mg |
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Gadodiamide Injection USP 15 ml<br>vial,Net Content of Import Item-<br>Gadodiamide<br>USP-58.09<br>Kgs<br>&<br>Caldiamide<br>Sodium-2.50<br>Kgs.<br>Each<br>ml<br>containts<br>Gadodiamide<br>287mg& Caldiamide Sodium 12mg |
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GADODIAMIDE USP |
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4.520 g/<br>15 ml vial |
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CALDIAMIDE SODIUM |
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0.189 g/ |
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15 ml vial |
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Gadodiamide Injection USP 10 ml<br>vial,Net Content of Import Item-<br>Gadodiamide<br>USP-23.36<br>Kgs<br>&<br>Caldiamide<br>Sodium-1.00<br>Kgs.<br>Each<br>ml<br>containts<br>Gadodiamide<br>287mg& Caldiamide Sodium 12mg |
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GADODIAMIDE USP |
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3.157 g/<br>10 ml vial |
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CALDIAMIDE SODIUM |
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0.132 g/<br>10 ml vial |
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RA concerned maytake further necessa |
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ryaction |
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per ab |
ove decision of NC. |
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Case No.:1/13/85-ALC3/2016Party Name:SRIAM LABS<br>PRIVATE LIMITED<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Status:<br>Approved<br>HQ File<br>:01/85/050/00109/AM17/<br>RLA File<br>:09/24/040/00260/AM17/<br>Lic.No/Date:0910064049<br>17.08.2016<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>N1-(2,4-Difluorobenzyl)-4-ethoxy-3-<br>oxobutanamide(ATFD/II)<br>1 kg<br>1<br>2,4 - Difluorobenzylamine<br>0.642 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
Party Name:SRIAM LABS<br>PRIVATE LIMITED |
Party Name:SRIAM LABS<br>PRIVATE LIMITED |
Party Name:SRIAM LABS<br>PRIVATE LIMITED |
Party Name:SRIAM LABS<br>PRIVATE LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
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RLA File<br>:09/24/040/00260/AM17/ |
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Lic.No/Date:0910064049<br>17.08.2016 |
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Qty. |
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Import items |
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1 kg |
1 |
2,4 - Difluorobenzylamine |
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0.642 kg |
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per above decision of NC. |
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Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 2 by firm whichever is lower:
| Case No.:296/15/82- |
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Party Name:MICRO LABS |
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Meet No/Date:10/82- |
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Status: |
| ALC4/2018 |
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LTD |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0710111725 |
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:07/24/040/00082/AM18/ |
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08.06.2017 |
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Case No.:296/15/82-<br>ALC4/2018 |
Party Name:MICRO LABS<br>LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/01753/AM19/ |
RLA File<br>:07/24/040/00082/AM18/ |
Lic.No/Date:0710111725<br>08.06.2017 |
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**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty. per<br>5 ml vial<br>Dorzolamide Hydrochloride and<br>Timolol Maleate Eye Drops, 5 ml<br>vial<br>BP/IP/EP/USP ( Net Contents :<br>DH =22.30 mg/ml and Timolol =<br>6.8 mg) DH=4.25 kg & TML=1.30<br>kgTotal: 5.55kg<br>1 Number<br>1<br>Dorzolamide Hydrochloride<br>BP/IP/EP/USP<br>117.095 mg<br>2<br>Timolol Maleate<br>BP/IP/EP/USP<br>35.70 mg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
3
| Case No.:180/10/82- |
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Party Name:SHREE BANKEY |
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Meet No/Date:10/82- |
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Status: |
| ALC4/2019 |
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BEHARI LAL AROMATICS |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0510403552 |
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| :01/82/050/00754/AM20/ |
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:05/24/040/00176/AM18/ |
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01.08.2017 |
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Case No.:180/10/82-<br>ALC4/2019 |
Case No.:180/10/82-<br>ALC4/2019 |
Party Name:SHREE BANKEY<br>BEHARI LAL AROMATICS |
Party Name:SHREE BANKEY<br>BEHARI LAL AROMATICS |
Party Name:SHREE BANKEY<br>BEHARI LAL AROMATICS |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00754/AM20/ |
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RLA File<br>:05/24/040/00176/AM18/ |
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Lic.No/Date:0510403552<br>01.08.2017 |
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**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 15/82-ALC4/2018 dated 26.07.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CARVACROL<br>1 kg<br>1<br>D-LIMONENE (LIMONENE CITRUS<br>TERPENE, ORANGE TERPENE,<br>BRAZILIAN CITRUS TERPENE,<br>STANDARD CITRUS TERPENE,<br>ORANGE OIL)<br>1.48 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Export product |
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Sl.<br>No. |
Import items |
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CARVACROL |
1 kg |
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D-LIMONENE (LIMONENE CITRUS<br>TERPENE, ORANGE TERPENE,<br>BRAZILIAN CITRUS TERPENE,<br>STANDARD CITRUS TERPENE,<br>ORANGE OIL) |
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1.48 kg |
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RA concerned maytake furthe |
r necessarya |
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ction a |
sper above decision of NC. |
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Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 26.07.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Case No.:134/10/82- |
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Party Name:TAGOOR |
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Meet No/Date:10/82- |
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Status: |
| ALC4/2018 |
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CHEMICALS |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0910065845 |
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| :01/82/050/00421/AM19/ |
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:09/24/040/00506/AM18/ |
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05.01.2018 |
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Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 06/82-ALC4/2018 dated 26.07.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 5
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Sl.<br>No. |
Import items |
Qty. |
| 1 kg |
1 |
Methyl Acrylate |
2.32 kg |
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2 |
Ethyl chloro formate |
2.18 kg |
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2,5 Dichloro Nitro Benzene |
2.27 kg |
RA may take appropriate action as per the decision of Norms Committee.
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| Case No.:311/1/83-ALC1/2019 |
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Party Name:HELIOS |
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Meet No/Date:10/82- |
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Status: |
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PHARMACEUTICALS (DIV. |
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ALC4/2019 |
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Approved |
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OF P.K.T.P. LTD) |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0810144331 |
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| :01/83/050/01143/AM19/ |
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:08/24/040/00348/AM19/ |
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18.01.2019 |
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Case No.:311/1/83-ALC1/2019 |
Party Name:HELIOS<br>PHARMACEUTICALS (DIV.<br>OF P.K.T.P. LTD)<br>RLA File<br>:08/24/040/00348/AM19/ |
Party Name:HELIOS<br>PHARMACEUTICALS (DIV.<br>OF P.K.T.P. LTD)<br>RLA File<br>:08/24/040/00348/AM19/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0810144331<br>18.01.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0810144331<br>18.01.2019 |
Status:<br>Approved |
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HQ File<br>:01/83/050/01143/AM19/ |
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**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Ribatran Tablet<br>(Each tablet will contain not<br>less than 4.2 mg<br>Ribonuclease)<br>4283714 Number<br>1<br>Ribonuclease<br>18.351 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
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Export product |
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Sl.<br>No. |
Import items |
Qty. |
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Ribatran Tablet<br>(Each tablet will contain not<br>less than 4.2 mg<br>Ribonuclease) |
4283714 Number |
1 |
Ribonuclease |
18.351 kg |
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RA maytake appropriate action asper the decision of Norms Committee. |
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Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
5
| Case No.:126/10/82- |
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Party Name:CIPLA LIMITED. |
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Meet No/Date:10/82- |
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Status: |
| ALC4/2019 |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310828562 |
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| :01/82/050/00700/AM20/ |
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:03/94/040/00018/AM20/ |
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24.04.2019 |
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Case No.:126/10/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00700/AM20/ |
RLA File<br>:03/94/040/00018/AM20/ |
Lic.No/Date:0310828562<br>24.04.2019 |
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**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Budesonide Inhalation Suspension<br>0.25mg/2ml Budesonide Respules<br>0.25mg/2ml<br>(Each 2ml contains Budesonide<br>USP 0.25mg)<br>1 Number<br>1<br>Budesonide USP<br>0.2625 mg / 0.25 mg<br>vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on the<br>net weight of empty<br>respules ( Net + 5% )<br>Budesonide Inhalation Suspension<br>0.50mg/2ml Budesonide Respules<br>0.50mg/2ml<br>(Each 2ml contains Budesonide<br>USP 0.50mg)<br>1 Number<br>1<br>Budesonide USP<br>0.525 mg / 0.50 mg<br>vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on the<br>net weight of empty<br>respules ( Net + 5% )<br>Budesonide Inhalation Suspension<br>1mg/2ml<br>Budesonide<br>Respules<br>1mg/2ml<br>(Each 2ml contains Budesonide<br>USP 1mg)<br>1 Number<br>1<br>Budesonide USP<br>1.05 mg / 1 mg vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on the<br>net weight of empty<br>respules ( Net + 5% )<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
6
| Case No.:125/10/82- |
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Party Name:CIPLA LIMITED. |
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Meet No/Date:10/82- |
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Status: |
| ALC4/2019 |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310828993 |
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| :01/82/050/00699/AM20/ |
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:03/94/040/00069/AM20/ |
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14.05.2019 |
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Case No.:125/10/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00069/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved<br> |
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HQ File<br>:01/82/050/00699/AM20/ |
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Lic.No/Date:0310828993<br>14.05.2019 |
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| 8 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>750mg (Pack Size<br>100 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>750mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant,<br>as<br>per<br>packing<br>policy<br>6<br>38/400 FG, CRC HAVING UNIPAC<br>SG-75M LINER PTD. WITH SFYP<br>IN BLACK (REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg<br>Relevant,<br>as<br>per<br>packing<br>policy<br>2<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>750mg (Pack Size<br>500 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>750mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant,<br>as<br>per<br>packing<br>policy<br>6<br>38/400 FG, CRC HAVING UNIPAC<br>SG-75M LINER PTD. WITH SFYP<br>IN BLACK (REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg<br>7<br>950CC WHITE HDPE BOTTLE<br>WITH 53MM NECK DB-22<br>TRIVENI PLASTIC (500 Count)<br>750mg<br>Relevant<br>net to net<br>8<br>53/400 LSC, SCREW CAP HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH 53/400 LSC, SCREW CAP<br>HAVING UNIPAC SG-75M LINER<br>PTD. WITH<br>(500 Count) 750mg |
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Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
7
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Potassium |
1 no. of |
1 |
POTASSIUM CHLORIDE USP |
612.0 mg |
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Chloride<br>Extended Release<br>Capsules 600mg /<br>Potassium Chlor |
capsules |
2<br>3 |
CITRIC ACID (MONOHYDRATE<br>USP)<br>DIBUTYL SEBACATE NF |
8.0 mg<br>9.6 mg |
|
ER Caps USP |
|
4 |
ETHANOL USP 99.9% |
2.62 ml |
|
600mg (Pack Size<br>100 Capsules<br>Each)<br>Each extended |
|
5 |
200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count) |
Relevant,<br>as<br>per |
|
Release Capsule<br>contains: |
|
6 |
750mg / (100 count 600 mg)<br>38/400 FG, CRC HAVING UNIPAC |
packing<br>policy |
|
Potassium |
|
|
SG-75M LINER PTD. WITH SFYP |
|
|
Chloride USP |
|
|
IN BLACK (REXAM CLOSURES) |
|
|
600mg |
|
|
(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg |
|
| Case No.:1/7/85-ALC3/2019 |
|
Party Name:BENZO CHEM |
|
Meet No/Date:10/82- |
|
Status: |
|
|
INDUSTRIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED, |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829436 |
|
|
| :01/85/050/00042/AM20/ |
|
:03/94/040/00147/AM20/ |
|
06.06.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
9
| Export Product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| 2-DIMETHYLAMINO-2- |
1 kg |
1 |
PROPIOPHENONE |
1.408 kg |
| PHENYLBUTAN-1-OL |
|
2 |
SODIUM CYANIDE |
0.599kg |
| (DAFOL) |
|
3 |
PARA FORMALDEHYDE |
0.528 kg |
|
|
4 |
SODIUM BOROHYDRIDE |
0.528 kg |
|
|
5 |
TETRA HYDRO FURAN(THF) |
1.00 kg |
RA concerned may take further necessary action as per above decision of NC.
8
| Case No.:132/10/82- |
|
Party Name:MALWA |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
OXYGEN & INDUSTRIAL |
|
ALC4/2019 |
|
Approved |
|
|
GASES PVT.LTD., |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:5610005640 |
|
|
| :01/82/050/00706/AM20/ |
|
:56/24/040/00008/AM20/ |
|
14.06.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 9/82-ALC4/2019 dated 18.10.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
10
| Export product |
Qty. |
Sl.<br>No |
Import items |
Qty. |
| BIS(4-<br>FLUOROPHENYL)KETONE<br>OR 4,4<br>DIFLUOROBENZOPHENONE |
1 kg |
1 |
FLUOROBENZOYL(4-)CHLORIDE |
1.00 kg |
|
|
2 |
FLUOROBENZENE |
1.10 kg |
|
|
3 |
METHYL ALCOHOL |
0.60 kg |
| Case No.:133/10/82- |
|
Party Name:MALWA |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
OXYGEN & INDUSTRIAL |
|
ALC4/2019 |
|
Approved |
|
|
GASES PVT.LTD., |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:5610005639 |
|
|
| :01/82/050/00707/AM20/ |
|
:56/24/040/00007/AM20/ |
|
14.06.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 9/82-ALC4/2019 dated 18.10.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
11
| Export product |
Qty. |
Sl.<br>No |
Import items |
Qty. |
| BIS(4-<br>FLUOROPHENYL)KETONE<br>OR 4,4<br>DIFLUOROBENZOPHENONE |
1 kg |
1 |
FLUOROBENZOYL(4-)CHLORIDE |
1.00 kg |
|
|
2 |
FLUOROBENZENE |
1.10 kg |
|
|
3 |
METHYL ALCOHOL |
0.60 kg |
| 12 |
Case No.:128/10/82-<br>ALC4/2019 |
Party Name:SRIAM LABS<br>PRIVATE LIMITED<br>RLA File<br>:09/24/040/00200/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00702/AM20/ |
|
Lic.No/Date:0910067789<br>16.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
9
| Case No.:263/6/82- |
|
Party Name:PRASOL |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CHEMICALS PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830795 |
|
|
| :01/82/050/00489/AM20/ |
|
:03/95/040/00453/AM20/ |
|
05.08.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 13 by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| MESITYL OXIDE / METHYL |
1 kg |
1 |
ACETONE |
1.902 kg |
| ISOBUTENYL KETONE / 4- |
|
|
|
|
| METHYL-3-PENTEN-2-ONE |
|
|
|
|
| Case No.:52/7/82- |
|
Party Name:PRASOL |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CHEMICALS PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831102 |
|
|
| :01/82/050/00547/AM20/ |
|
:03/95/040/00513/AM20/ |
|
20.08.2019 |
|
|
Decision: Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 14 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| METHYL ISOBUTYL CARBINOL |
1 kg |
1 |
METHYL ISOBUTYL KETONE |
1.075 kg |
| (MIBC) |
|
|
(MIBK) |
|
Case No.:3/10/82-ALC4/2019 Party Name:ENCEE Meet No/Date:10/82- Status: AROMATICS PVT. LIMITED ALC4/2019 Approved 29.11.2019 HQ File RLA File Lic.No/Date:3210079086 :01/82/050/00577/AM20/ :32/24/040/00036/AM20/ 28.08.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and 15 in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export product Qty. Sl. No. Import items Qty. Enamber / Kephalis / Tetrambrone 1 kg 1 Triethyl Orthoformate 2.400 kg
10
| 16 |
Case No.:1/10/82-ALC4/2019 |
Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0410166026<br>29.08.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00575/AM20/ |
RLA File<br>:04/24/040/00089/AM20/ |
|
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Chennai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chennai.
| Case No.:2/10/82-ALC4/2019 |
|
Party Name:DPB |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ANTIBIOTICS |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831298 |
|
|
| :01/82/050/00576/AM20/ |
|
:03/94/040/00423/AM20/ |
|
29.08.2019 |
|
|
|
Case No.:2/10/82-ALC4/2019 |
Party Name:DPB<br>ANTIBIOTICS |
Party Name:DPB<br>ANTIBIOTICS |
Party Name:DPB<br>ANTIBIOTICS |
Party Name:DPB<br>ANTIBIOTICS |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310831298<br>29.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00576/AM20/ |
RLA File<br>:03/94/040/00423/AM20/ |
|
|
|
|
|
| 17 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and taking<br>cue from SION A-57, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per<br>details below or as applied by firm whichever is lower:<br> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>AMOXYCILLIN CAPSULES 500 MG<br>(EACH<br>CAPSULE<br>CONTAINING<br>AMOXYCILLIN TRIHYDRATE [590<br>MG]<br>EQUIVALENT<br>TO<br>AMOXYCILLIN<br>500<br>MG)<br>NT WT 6490 KGS(110000X10X10)<br>1<br>Number<br>1<br>AMOXYCILLIN TRIHYDRATE<br>OR<br>Its raw material on pro-rata basis as<br>per SION A-57<br>585.28<br>mg/ 500<br>mg<br>capsule<br>AMOXYCILLIN CAPSULES 250MG<br>(EACH<br>CAPSULE<br>CONTAINING<br>AMOXYCILLIN<br>TRIHDRATE<br>[295<br>MG]<br>EQUIVALANT<br>TO<br>AMOXYCILLIN<br>250<br>MG)<br>NT WT 885 KGS(30000X10X10)<br>1<br>Number<br>1<br>AMOXYCILLIN TRIHYDRATE<br>OR<br>Its raw material on pro-rata basis as<br>per SION A-57<br>292.64<br>mg/ 250<br>mg<br>capsule |
|
|
|
|
|
|
|
|
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
1<br>Number |
1 |
AMOXYCILLIN TRIHYDRATE<br>OR<br>Its raw material on pro-rata basis as<br>per SION A-57 |
|
585.28<br>mg/ 500<br>mg<br>capsule |
|
|
|
1<br>Number |
1 |
AMOXYCILLIN TRIHYDRATE<br>OR<br>Its raw material on pro-rata basis as<br>per SION A-57 |
|
292.64<br>mg/ 250<br>mg<br>capsule |
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
11
| 18 |
<br>Case No.:4/10/82-ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00300/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0910067959<br>30.08.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00578/AM20/ |
|
|
|
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
| Case No.:5/10/82-ALC4/2019 |
|
Party Name:AURORE LIFE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067960 |
|
|
| :01/82/050/00579/AM20/ |
|
:09/24/040/00297/AM20/ |
|
30.08.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 19 by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Levetiracetam |
1 kg |
1 |
L-2-Aminobutanamide HCl |
0.95 kg |
|
|
2 |
Methylene Dichloride |
2.26 kg |
Case No.:10/10/82- Party Name:AETHER Meet No/Date:10/82- Status: ALC4/2019 INDUSTRIES LIMITED ALC4/2019 Approved 29.11.2019 HQ File RLA File Lic.No/Date:5210043165 :01/82/050/00584/AM20/ :52/24/040/00026/AM20/ 30.08.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 10/82-ALC4/2018 20 , dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export Product |
Qty. |
Sl. No. |
Import items |
Qty. |
| N-OCTYL-D-<br>GLUCAMINE |
1 kg |
1 |
N-OCTYLAMINE |
0.825 kg |
|
|
2 |
DEXTROSE ANHYDROUS |
0.770 kg |
12
| Case No.:6/10/82-ALC4/2019 |
|
Party Name:NEOGEN |
|
Meet No/Date:10/82- |
|
Status: |
|
|
CHEMICALS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831338 |
|
|
| :01/82/050/00580/AM20/ |
|
:03/95/040/00544/AM20/ |
|
03.09.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 21 by firm whichever is lower:
| Export |
product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
| ETHYL |
2-BROMO ISO BUTYRATE |
1 kg |
1 |
ISOBUTYRIC ACID |
0.65 kg |
|
|
|
2 |
LIQUID BROMINE |
1.15 kg |
|
|
|
3 |
ETHANOL |
0.70 kg |
13
| Case No.:7/10/82-ALC4/2019 |
|
Party Name:PANACEA |
|
Meet No/Date:10/82- |
|
Status: |
|
|
BIOTEC LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411723 |
|
|
| :01/82/050/00581/AM20/ |
|
:05/24/040/00321/AM20/ |
|
03.09.2019 |
|
|
|
Case No.:7/10/82-ALC4/2019 |
Party Name:PANACEA<br>BIOTEC LTD., |
Party Name:PANACEA<br>BIOTEC LTD., |
Party Name:PANACEA<br>BIOTEC LTD., |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0510411723<br>03.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00581/AM20/ |
RLA File<br>:05/24/040/00321/AM20/ |
|
|
|
|
| 22 |
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and taking cue from SION A-412, it was decided to ratify the ad-hoc input output<br>norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty. per<br>tablet<br>CYCLOSPORINE CAPSULE 25 MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 25<br>mg)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>25.50 mg<br>CYCLOSPORINE CAPSULES 50 MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 50<br>mg)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>51.00 mg<br>CYCLOSPORINE CAPSULES 100 MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 100<br>mg)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>102.00 mg<br>PANIMUN BIORAL CAPSULES 25 MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 25<br>MG.)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>25.50 mg<br>PANIMUN BIORAL CAPSULES 50 MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 50<br>MG.)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>51.00 mg<br>PANIMUN BIORAL CAPSULES 100<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 100<br>MG.)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>102.00 mg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
Qty. per<br>tablet |
|
CYCLOSPORINE CAPSULE 25 MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 25<br>mg) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
25.50 mg |
|
CYCLOSPORINE CAPSULES 50 MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 50<br>mg) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
51.00 mg |
|
CYCLOSPORINE CAPSULES 100 MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 100<br>mg) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
102.00 mg |
|
PANIMUN BIORAL CAPSULES 25 MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 25<br>MG.) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
25.50 mg |
|
PANIMUN BIORAL CAPSULES 50 MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 50<br>MG.) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
51.00 mg |
|
PANIMUN BIORAL CAPSULES 100<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP 100<br>MG.) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
102.00 mg |
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and taking cue from SION A-412, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
14
| Case No.:8/10/82-ALC4/2019 |
|
Party Name:NAARI PHARMA |
|
Meet No/Date:10/82- |
|
Status: |
|
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411726 |
|
|
| :01/82/050/00582/AM20/ |
|
:05/24/040/00274/AM20/ |
|
03.09.2019 |
|
|
|
Case No.:8/10/82-ALC4/2019 <br>HQ File<br>:01/82/050/00582/AM20/ |
Party Name:NAARI PHARMA<br>PRIVATE LIMITED<br>RLA File<br>:05/24/040/00274/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0510411726<br>03.09.2019 |
Status:<br>Approved |
| 23 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>07/82-ALC4/2015<br>, dated 24.07.2015, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>19-Norandrostenedione 99%<br>1kg<br>1<br>LACTONE(D)<br>INTERMEDIATE<br>1.40 kg<br>2<br>CHLOROKET,(2-(3-<br>CHLOROPROPYL)-2,5,5-<br>TRIMETHYL-1,3-DIOXANE<br>INTERMEDIATE<br>1.30 kg<br>3<br>Tetrahydrofuran<br>3.50 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 07/82-ALC4/2015 , dated 24.07.2015, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower
| Case No.:9/10/82-ALC4/2019 |
|
Party Name:RAVOOS |
|
Meet No/Date:10/82- |
|
Status: |
|
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067961 |
|
|
| :01/82/050/00583/AM20/ |
|
:09/24/040/00287/AM20/ |
|
03.09.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 24
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| CIPROFLOXACIN |
10000.000 kg |
1 |
Ciprofloxacin Hydrochloride |
2198.24 kg |
| HYDROCHLORIDE TASTE |
|
|
USP |
|
| MASKED PELLETS (Equivalent |
|
|
|
|
| to Ciprofloxacin 250mg) |
|
|
|
|
15
| Case No.:11/10/82-ALC4/2019 |
|
Party Name:VN CREATIVE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
CHEMICALS PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831364 |
|
|
| :01/82/050/00585/AM20/ |
|
:03/95/040/00551/AM20/ |
|
04.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 25 per details given below or as applied by the firm, whichever is less:
| Export product<br>Tonalid |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
1 kg |
1 |
D M B-1 |
0.406 kg |
|
|
2 |
Paracymene |
0.648 kg |
| 26 |
Case No.:12/10/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Transferred |
|
<br>HQ File<br>:01/82/050/00586/AM20/ |
RLA File<br>:03/95/040/00422/AM20/ |
Lic.No/Date:0310831365<br>04.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
| 27 |
Case No.:13/10/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00587/AM20/ |
RLA File<br>:03/95/040/00419/AM20/ |
Lic.No/Date:0310831366<br>04.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
Decision: New Case. The Committee decided to refer the case to Special Committee for further consideration.
16
| Case No.:14/10/82-ALC4/2019 |
|
Party Name:HPL ADDITIVES |
|
Meet No/Date:10/82- |
|
Status: |
|
|
LIMITED(FORMERLY |
|
ALC4/2019 |
|
Approved |
|
|
KNOWN HIGH POLYMER |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411745 |
|
|
| :01/82/050/00588/AM20/ |
|
:05/23/040/00168/AM20/ |
|
04.09.2019 |
|
|
|
Case No.:14/10/82-ALC4/2019 |
Case No.:14/10/82-ALC4/2019 |
Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER |
Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER |
Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER |
Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0510411745<br>04.09.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0510411745<br>04.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00588/AM20/ |
|
RLA File<br>:05/23/040/00168/AM20/ |
|
|
|
|
|
|
| 28 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 8/82-ALC4/2019 dated 20.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>"Benzene Propionic Acid, 3, 5-<br>Bis (1, 1- Dimethyl ethyl)-4-<br>Hydroxy-2-[3-{3,<br>5-Bis<br>(1,<br>1-Dimethyl<br>ethyl)-4-<br>Hydroxyphenyl}-1-Oxopropyl]<br>Hydrazine (Kinox-24)<br>1 kg<br>1<br>2,6 Di Tert Butyl Phenol<br>1.230 kg<br>2<br>Methyl Acrylate<br>0.528 kg<br>3<br>Hydrazine Hydrate 100%<br>0.283 kg<br>4<br>Methanol<br>0.700 kg<br>5<br>Methyl Aceto Acetate<br>0.263 kg<br>6<br>Toluene<br>0.400kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
"Benzene Propionic Acid, 3, 5-<br>Bis (1, 1- Dimethyl ethyl)-4-<br>Hydroxy-2-[3-{3,<br>5-Bis<br>(1,<br>1-Dimethyl<br>ethyl)-4-<br>Hydroxyphenyl}-1-Oxopropyl]<br>Hydrazine (Kinox-24) |
|
1 kg |
1 |
2,6 Di Tert Butyl Phenol |
|
1.230 kg |
|
|
|
|
|
|
2 |
Methyl Acrylate |
|
0.528 kg |
|
|
|
|
|
|
3 |
Hydrazine Hydrate 100% |
|
0.283 kg |
|
|
|
|
|
|
4 |
Methanol |
|
0.700 kg |
|
|
|
|
|
|
5 |
Methyl Aceto Acetate |
|
0.263 kg |
|
|
|
|
|
|
6 |
Toluene |
|
0.400kg |
|
|
|
|
|
|
|
|
|
|
|
| 29 |
Case No.:15/10/82-ALC4/2019 |
Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0910067970<br>05.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00589/AM20/ |
RLA File<br>:09/24/040/00304/AM20/ |
|
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 30 |
Case No.:16/10/82-ALC4/2019 |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0910067973<br>05.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00590/AM20/ |
RLA File<br>:09/24/040/00289/AM20/ |
|
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
17
| Case No.:17/10/82-ALC4/2019 |
|
Party Name:VIVIN DRUGS & |
|
Meet No/Date:10/82- |
|
Status: |
|
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067974 |
|
|
| :01/82/050/00591/AM20/ |
|
:09/24/040/00288/AM20/ |
|
05.09.2019 |
|
|
|
Case No.:17/10/82-ALC4/2019 |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00591/AM20/ |
RLA File<br>:09/24/040/00288/AM20/ |
|
|
|
Lic.No/Date:0910067974<br>05.09.2019 |
|
| 31 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4-AMINO-2-OXO<br>PYRIMIDINYL<br>OXATHIOLANE-2-<br>CARBOXYLIC<br>ACID<br>ISO PROPYL METHYL CYCLO<br>HEXYL ESTER (CEI-II)<br>1 kg<br>1<br>GLYOXYLIC ACID - 50%<br>0.743 kg<br>2<br>2,5 DI HYDROXY 1,4 DITHIANE<br>0.325 kg<br>3<br>CYTOSINE<br>0.428 kg<br>4<br>HEXAMETHYLDISILAZANE<br>0.509 kg<br>5<br>TRIETHYLAMINE<br>0.034 kg<br>6<br>METHYLENE CHLORIDE<br>2.63 kg<br>7<br>L-MENTHOL<br>0.751 kg |
|
|
|
|
|
|
|
|
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
1 kg |
1 |
GLYOXYLIC ACID - 50% |
|
0.743 kg |
|
|
|
|
2 |
2,5 DI HYDROXY 1,4 DITHIANE |
|
0.325 kg |
|
|
|
|
3 |
CYTOSINE |
|
0.428 kg |
|
|
|
|
4 |
HEXAMETHYLDISILAZANE |
|
0.509 kg |
|
|
|
|
5 |
TRIETHYLAMINE |
|
0.034 kg |
|
|
|
|
6 |
METHYLENE CHLORIDE |
|
2.63 kg |
|
|
|
|
7 |
L-MENTHOL |
|
0.751 kg |
|
|
|
|
8 |
TRIPHOSGENE |
|
0.40 kg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
| 32 |
Case No.:18/10/82-ALC4/2019 |
Party Name:CADILA<br>PHARMACEUTICALS LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00592/AM20/ |
RLA File<br>:08/24/040/00175/AM20/ |
Lic.No/Date:0810146100<br>05.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
| 33 |
Case No.:19/10/82-ALC4/2019 |
Party Name:MEHK<br>CHEMICALS PVT. LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00593/AM20/ |
RLA File<br>:03/95/040/00555/AM20/ |
Lic.No/Date:0310831392<br>06.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
18
| Case No.:20/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831396 |
|
|
| :01/82/050/00594/AM20/ |
|
:03/94/040/00442/AM20/ |
|
06.09.2019 |
|
|
|
Case No.:20/10/82-<br>ALC4/2019 |
Case No.:20/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00594/AM20/ |
|
RLA File<br>:03/94/040/00442/AM20/ |
|
|
Lic.No/Date:0310831396<br>06.09.2019 |
|
|
| 34 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>10/82-ALC4/2018<br>, dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Import items<br>Qty.<br>1<br>Acyclovir Ointment USP 5% 15gm<br>( Net. wt. of Acyclovir USP<br>Micronized (Chemo) is 37.500<br>Kgs.)<br>50000.000<br>Pack<br>Acyclovir USP Micronized<br>(Chemo)<br>114.75 kg<br>2<br>Acyclovir Ointment USP 5% 30gm<br>( Net. wt. of Acyclovir USP<br>Micronized (Chemo) is 75.000<br>Kgs.)<br>50000.000<br>Pack<br> <br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
<br>Sl.<br>No. |
Export product |
|
Qty. |
Import items |
|
|
Qty. |
|
1 |
Acyclovir Ointment USP 5% 15gm<br>( Net. wt. of Acyclovir USP<br>Micronized (Chemo) is 37.500<br>Kgs.) |
|
50000.000<br>Pack |
Acyclovir USP Micronized<br>(Chemo) |
|
|
114.75 kg |
|
2 |
Acyclovir Ointment USP 5% 30gm<br>( Net. wt. of Acyclovir USP<br>Micronized (Chemo) is 75.000<br>Kgs.) |
|
50000.000<br>Pack<br> |
|
|
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 10/82-ALC4/2018 , dated 16.10.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
19
| Case No.:21/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831397 |
|
|
| :01/82/050/00595/AM20/ |
|
:03/94/040/00440/AM20/ |
|
06.09.2019 |
|
|
|
Case No.:21/10/82-<br>ALC4/2019<br> <br> |
Case No.:21/10/82-<br>ALC4/2019<br> <br> |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
M<br>A<br>2 |
eet No/Date:10/82-<br>LC4/2019<br>9.11.2019 |
eet No/Date:10/82-<br>LC4/2019<br>9.11.2019 |
St<br>Ap |
St<br>Ap |
atus:<br>proved |
atus:<br>proved |
|
HQ File<br>:01/82/050/00595/AM20/<br> <br>: |
|
RLA File<br>03/94/040/00440/AM20/ |
|
|
|
|
|
|
|
|
L<br>0 |
ic.No/Date:0310831397<br>6.09.2019 |
|
|
|
|
|
| 35 |
**Decision:**The Committee considered the case<br>meeting no. 12/82-ALC4/2018 dated 12.12..2018<br>as per details given below or as applied by the fir |
|
|
|
|
|
|
s as per agenda and in the light of earlier decision taken in<br>, it was decided to ratify norms under Para 4.7 of HBP v1<br>m, whichever is less:<br>ty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>No.<br>ablet<br>1<br>Indapamide EP<br>1.275 mg / tablet<br>No.<br>ablet<br>1<br>Indapamide EP<br>1.275 mg / tablet<br>No<br>1<br>Indaamide EP<br>1275 m / tablet |
|
|
|
|
|
|
|
|
|
|
|
Sl.<br>No. |
Export product |
|
|
|
|
Q |
ty. |
|
Sl.<br>No. |
Import items |
|
|
Qty. |
|
|
|
|
|
1 |
Perindopril and Indapamide<br>4/1.25 mg ( Pack Size 30 T<br>Wt. of Indapamide EP 5.25 |
Tablets<br>abs.) ( Net<br>0 Kgs) |
|
|
|
1 |
No. |
|
1 |
Indapamide EP |
|
|
1.275 |
|
mg / tablet |
|
|
|
|
|
|
|
|
|
T |
ablet |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
Perindopril and Indapamide<br>4/1.25 mg ( Pack Size 90 T<br> |
Tablets<br>abs.) ( Net<br> |
|
|
|
1<br>T |
No.<br>ablet |
|
1 |
Indapamide EP |
|
|
1.275 |
|
mg / tablet |
|
|
|
|
Wt. of Indapamide EP 3.37 |
5 Kgs) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
Perindopril and Indapamide Tablets |
|
|
|
|
1 |
No |
|
1 |
Indaamide EP |
|
|
1275 |
|
m / tablet |
|
|
|
|
<br>4/1.25 mg ( Pack Size 100 Tabs.) ( Net<br>Wt. of Indapamide EP 14.375 Kgs) |
|
|
|
|
.<br>Tablet |
|
|
|
p |
|
|
. g |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
Perindopril and Indapamid<br>2/0.625 mg ( Pack Size 30<br>Wt. of Indapamide EP 2.43 |
e Tablets<br>Tabs.) ( Net<br>8 Kgs) |
|
|
|
1 No.<br>Tablet |
|
|
1 |
In |
|
dapamide EP |
0.6375 |
|
|
mg / tablet |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5 |
Perindopril and Indapamide |
Tablets |
|
|
|
1 No. |
|
|
1 |
In |
|
dapamide EP |
0.6375 |
|
|
mg / tablet |
|
|
|
2/0.625 mg ( Pack Size 20 Tabs.) ( Net<br>Wt. of Indapamide EP 1.375 Kgs) |
|
|
|
|
Tablet |
|
|
|
|
|
|
|
|
|
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|
|
|
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|
RA maytake appropriate action aspe |
|
|
r the d |
|
cision o |
|
|
Norms Committee. |
|
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| 36 |
Case No.:22/10/82-ALC4/2019 |
|
Part<br>IND |
y Nam<br>USTR |
|
e:RELIA<br>IES LIM |
|
|
NCE<br>ITED |
|
|
|
Meet No/Date:10/82-<br>ALC4/2019 |
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Status:<br>Deferred |
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29.11.2019 |
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LiN/Dt0310831402 |
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e<br>:01/82/050/00596/AM20/ |
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c.oae:<br>06.09.2019 |
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**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
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Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 12/82-ALC4/2018 dated 12.12..2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
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Case No.:22/10/82-ALC4/2019 |
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Party Name:RELIANCE |
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Meet No/Date:10/82- |
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Status: |
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INDUSTRIES LIMITED |
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ALC4/2019 |
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Deferred |
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29.11.2019 |
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| 36 |
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HQ File |
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RLA File |
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Lic.No/Date:0310831402 |
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Defer Date: |
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:01/82/050/00596/AM20/ |
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:03/95/040/00516/AM20/ |
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06.09.2019 |
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**Decision:**New Case. The Committee decided to refer the case to Special Committee for further |
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consideration. |
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20
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Case No.:23/10/82-ALC4/2019 |
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Party Name:RELIANCE |
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Meet No/Date:10/82- |
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Status: |
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INDUSTRIES LIMITED |
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ALC4/2019 |
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Deferred |
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29.11.2019 |
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| 37 |
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HQ File |
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RLA File |
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Lic.No/Date:0310831403 |
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Defer Date: |
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:01/82/050/00597/AM20/ |
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:03/95/040/00420/AM20/ |
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06.09.2019 |
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**Decision:**New Case. The Committee decided to refer the case to Special Committee for further |
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consideration. |
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Case No.:24/10/82-ALC4/2019 |
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Party Name:RELIANCE |
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Meet No/Date:10/82- |
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Status: |
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INDUSTRIES LIMITED |
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ALC4/2019 |
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Deferred |
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29.11.2019 |
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| 38 |
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HQ File |
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RLA File |
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Lic.No/Date:0310831405 |
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Defer Date: |
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:01/82/050/00598/AM20/ |
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:03/95/040/00421/AM20/ |
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06.09.2019 |
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**Decision:**New Case. The Committee decided to refer the case to Special Committee for further |
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consideration. |
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| Case No.:25/10/82- |
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Party Name:LUPIN LIMITED |
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Meet No/Date:10/82- |
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Status: |
| ALC4/2019 |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310831413 |
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| :01/82/050/00599/AM20/ |
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:03/95/040/00468/AM20/ |
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06.09.2019 |
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**Decision:**The Committee considered the case |
**Decision:**The Committee considered the case |
**Decision:**The Committee considered the case |
**Decision:**The Committee considered the case |
**Decision:**The Committee considered the case |
**Decision:**The Committee considered the case |
as per |
as per |
agenda in the presence of Technical Experts and |
agenda in the presence of Technical Experts and |
agenda in the presence of Technical Experts and |
agenda in the presence of Technical Experts and |
agenda in the presence of Technical Experts and |
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in |
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the<br>light<br>of<br>earlier<br>decision |
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<br>taken |
by |
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<br>NC |
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<br>in<br>its<br>Meeting |
<br>No. |
3/82-ALC4/2019 |
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, dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under |
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para 4.7 of HBP Vol. I as |
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per |
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details below or as applied by firm whichever is |
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lower: |
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Export product |
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Qty. |
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Sl. |
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Import items |
Qty. |
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No. |
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DOXYCYCLINE FOR ORAL |
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1 Number |
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1 |
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DOXYCYCLINE |
319.32 mg / 60 ml |
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SUSPN. USP 25MG/5ML-60ML |
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MONOHYDRATE |
Bottle |
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(NET WT. 45.000 KGS, WT OF |
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(MICRONIZED) |
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DRUG : 55.800 KGS) |
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DOXYCYCLINE CAPS USP |
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1 Number |
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2 |
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DOXYCYCLINE |
51.7 mg / 50 mg |
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50MG 100s |
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MONOHYDRATE |
tablet |
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(NET WT. 200.00 KGS, WT OF |
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(MICRONIZED) |
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DRUG : 228.00 KGS) |
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DOXYCYCLINE CAPS USP 75 |
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1 Number |
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3 |
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DOXYCYCLINE |
77.55 mg / 75 mg |
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MG 100s |
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MONOHYDRATE |
tablet |
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(NET WT. 105.00 KGS, WT OF |
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(MICRONIZED) |
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DRUG : 119.70 KGS) |
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DOXYCYCLINE CAPS. USP 100 |
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1 Number |
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4 |
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DOXYCYCLINE |
103.4 mg / 100 |
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MG 50s |
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MONOHYDRATE |
mg tablet |
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(NET WT. 2675.000 KGS, WT OF |
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(MICRONIZED) |
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DRUG : 3049.500 KGS) |
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RA concerned maytake further necessaryaction as |
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per above decision of NC. |
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Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
21
| Case No.:26/10/82-ALC4/2019 |
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Party Name:LUPIN LIMITED |
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Meet No/Date:10/82- |
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Status: |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310831418 |
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| :01/82/050/00600/AM20/ |
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:03/95/040/00564/AM20/ |
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06.09.2019 |
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Case No.:26/10/82-ALC4/2019 |
Party Name:LUPIN LIMITED |
Party Name:LUPIN LIMITED |
Party Name:LUPIN LIMITED |
Party Name:LUPIN LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00600/AM20/ |
RLA File<br>:03/95/040/00564/AM20/ |
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Lic.No/Date:0310831418<br>06.09.2019 |
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| 40 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>MAPROTILINE HCL 10MG<br>TABLETS<br>(NET WT.25.000 KGS, WT OF<br>DRUGS;26.750 KGS)<br>1<br>Number<br>1<br>MAPROTILINE<br>HYDROCHLORIDE<br>10.20 mg /<br>10 mg<br>tablet<br>MAPROTILINE HCL 25MG<br>TABLETS<br>(NET WT. 25.000 KGS, WT OF<br>DRUGS :26.750KGS)<br>1<br>Number<br>1<br>MAPROTILINE<br>HYDROCHLORIDE<br>25.50 mg /<br>25 mg<br>tablet<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Qty. |
Sl.<br>No. |
Import items |
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1<br>Number |
1 |
MAPROTILINE<br>HYDROCHLORIDE |
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1<br>Number |
1 |
MAPROTILINE<br>HYDROCHLORIDE |
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RA concerned maytake further necessaryaction asper above decision of NC. |
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| 41 |
Case No.:27/10/82-ALC4/2019 |
Party Name:M/S<br>HIMALAYAN PRODUCTS &<br>INDUSTRIES CORPN.,P.LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00601/AM20/ |
RLA File<br>:61/24/040/00007/AM20/ |
Lic.No/Date:6110001614<br>06.09.2019 |
Defer Date: |
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**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Dehradun. |
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Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Dehradun.
| 42 |
Case No.:28/10/82-ALC4/2019 |
Party Name:SRF LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00602/AM20/ |
RLA File<br>:05/24/040/00296/AM20/ |
Lic.No/Date:0510411778<br>06.09.2019 |
Defer Date: |
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**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhi. |
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Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
22
| Case No.:29/10/82-ALC4/2019 |
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Party Name:STERILE INDIA |
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Meet No/Date:10/82- |
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Status: |
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PRIVATE LIMITED |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0510411779 |
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| :01/82/050/00603/AM20/ |
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:05/24/040/00329/AM20/ |
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06.09.2019 |
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Case No.:29/10/82-ALC4/2019 |
Party Name:STERILE INDIA<br>PRIVATE LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00603/AM20/ |
RLA File<br>:05/24/040/00329/AM20/ |
Lic.No/Date:0510411779<br>06.09.2019 |
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| 43 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Ceftriaxone Sodium Sterile<br>1 kg<br>1<br>Ceftriaxone Sodium (Non Sterile)<br>1.04 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
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| 44 |
Case No.:30/10/82-ALC4/2019 |
Party Name:MANGALAM<br>DRUGS AND ORGANICS<br>LIMITED<br>RLA File<br>:03/95/040/00483/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310831434<br>09.09.2019 |
Status:<br>Deferred<br>Defer Date: |
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<br>HQ File<br>:01/82/050/00604/AM20/ |
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**Decision:**The Committee considered the case as per agenda and it was observed that the quantity of<br>import item No. 1 – Ethoxy Methylene Malonic Acid Ester (EMME) – 82000 kg applied by the firm is not<br>correct . Accordingly, the Committee decided to call the correct quantity of import item No. 1 from the<br>firm. |
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Decision: The Committee considered the case as per agenda and it was observed that the quantity of import item No. 1 – Ethoxy Methylene Malonic Acid Ester (EMME) – 82000 kg applied by the firm is not correct . Accordingly, the Committee decided to call the correct quantity of import item No. 1 from the firm.
| 45 |
<br>Case No.:31/10/82-ALC4/2019 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00605/AM20/ |
RLA File<br>:09/24/040/00307/AM20/ |
Lic.No/Date:0910067982<br>09.09.2019 |
Defer Date: |
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**Decision:**New Case,deferred |
for comments of TE. |
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| 46 |
Case No.:32/10/82-ALC4/2019 |
Party Name:DEEPAK<br>NITRITE LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00606/AM20/ |
RLA File<br>:34/24/040/00111/AM20/ |
Lic.No/Date:3410045437<br>09.09.2019 |
Defer Date: |
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**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Vadodara. |
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Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
23
| 47 |
<br>Case No.:33/10/82-ALC4/2019 |
Party Name:NISARG<br>BIOSCIENCES PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00607/AM20/ |
RLA File<br>:09/24/040/00309/AM20/ |
Lic.No/Date:0910067984<br>11.09.2019 |
Defer Date: |
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**Decision:**New Case,deferred |
for comments of TE. |
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| 48 |
<br>Case No.:34/10/82-ALC4/2019 |
Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00608/AM20/ |
RLA File<br>:09/24/040/00310/AM20/ |
Lic.No/Date:0910067989<br>11.09.2019 |
Defer Date: |
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**Decision:**New Case,deferred |
for comments of TE. |
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| Case No.:35/10/82-ALC4/2019 |
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Party Name:LUPIN LIMITED |
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Meet No/Date:10/82- |
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Status: |
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ALC4/2019 |
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Approved |
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29.11.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310831466 |
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| :01/82/050/00609/AM20/ |
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:03/95/040/00460/AM20/ |
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11.09.2019 |
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Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 49 per details below or as applied by firm whichever is lower:
| Export product<br>BIPERIDEN HYDROCHLORIDE<br>1MG TABLETS<br>(NET WT. 50.00 KGS, WT OF DRUG<br>: 52.00 KGS) |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
1 Number |
1 |
BIPERIDEN<br>HYDROCHLORIDE |
1.02 mg/tablet |
| 50 |
Case No.:36/10/82-ALC4/2019 |
Party Name:HETERO LABS<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00610/AM20/ |
RLA File<br>:09/24/040/00295/AM20/ |
Lic.No/Date:0910067990<br>11.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
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Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
24
| 51 |
Case No.:37/10/82-ALC4/2019 |
Party Name:MANKIND<br>PHARMA LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0510411802<br>11.09.2019<br> |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00611/AM20/ |
RLA File<br>:05/24/040/00336/AM20/ |
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Defer Date: |
|
**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>DrugManufacturingLicence(DML)showingapproved composition. |
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| 52 |
<br>Case No.:38/10/82-ALC4/2019 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310831483<br>11.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00612/AM20/ |
RLA File<br>:03/94/040/00455/AM20/ |
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Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
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| Case No.:39/10/82-ALC4/2019 |
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Party Name:TOPNOTCH |
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Meet No/Date:10/82- |
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Status: |
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CHEMICALS PVT. LTD. |
|
ALC4/2019 |
|
Approved |
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29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831485 |
|
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| :01/82/050/00613/AM20/ |
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:03/95/040/00586/AM20/ |
|
11.09.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 53 by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
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No. |
|
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| ARTEMETHER |
1 kg |
1 |
ARTEMISININ |
1.04 kg |
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2 |
SODIUM BOROHYDRIDE |
0.19 kg |
25
| Case No.:40/10/82-ALC4/2019 |
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Party Name:LUPIN LIMITED |
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Meet No/Date:10/82- |
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Status: |
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ALC4/2019 |
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Approved |
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29.11.2019 |
|
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| HQ File |
|
RLA File |
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Lic.No/Date:0310831486 |
|
|
| :01/82/050/00614/AM20/ |
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:03/95/040/00533/AM20/ |
|
11.09.2019 |
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Case No.:40/10/82-ALC4/2019Party Name:LUPIN LIMITED<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00614/AM20/<br>RLA File<br>:03/95/040/00533/AM20/<br>Lic.No/Date:0310831486<br>11.09.2019 |
Case No.:40/10/82-ALC4/2019Party Name:LUPIN LIMITED<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00614/AM20/<br>RLA File<br>:03/95/040/00533/AM20/<br>Lic.No/Date:0310831486<br>11.09.2019 |
Case No.:40/10/82-ALC4/2019Party Name:LUPIN LIMITED<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00614/AM20/<br>RLA File<br>:03/95/040/00533/AM20/<br>Lic.No/Date:0310831486<br>11.09.2019 |
Case No.:40/10/82-ALC4/2019Party Name:LUPIN LIMITED<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00614/AM20/<br>RLA File<br>:03/95/040/00533/AM20/<br>Lic.No/Date:0310831486<br>11.09.2019 |
Case No.:40/10/82-ALC4/2019Party Name:LUPIN LIMITED<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00614/AM20/<br>RLA File<br>:03/95/040/00533/AM20/<br>Lic.No/Date:0310831486<br>11.09.2019 |
Case No.:40/10/82-ALC4/2019Party Name:LUPIN LIMITED<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00614/AM20/<br>RLA File<br>:03/95/040/00533/AM20/<br>Lic.No/Date:0310831486<br>11.09.2019 |
Case No.:40/10/82-ALC4/2019Party Name:LUPIN LIMITED<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00614/AM20/<br>RLA File<br>:03/95/040/00533/AM20/<br>Lic.No/Date:0310831486<br>11.09.2019 |
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**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
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|
meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms |
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under Para 4.7 of HBP v1 as |
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per details given below or as applied by the firm, whichever is less: |
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| 54 |
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
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|
|
ETIZOLAM TABLETS 0.5MG |
1 Number |
1 |
ETIZOLAM JP |
0.51 mg/0.50 mg tablet |
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(NET WT. 26.200 KGS, WT OF |
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DRUG ; 27.510 KGS) |
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ETIZOLAM TABLETS 1 MG |
1 Number |
1 |
ETIZOLAM JP |
1.02 mg/1 mg tablet |
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(NET WT 21.000 KGS, WT OF |
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DRUGS : 22.050 KGS) |
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RA maytake appropriate action asper the decision of Norms Committee. |
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Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Case No.:41/10/82- |
|
Party Name:JUBILANT |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
GENERICS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411821 |
|
|
| :01/82/050/00615/AM20/ |
|
:05/23/040/00233/AM20/ |
|
12.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 55 per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import Item |
Qty. |
|
|
No. |
|
|
| Amantadine HCl |
1 tablet |
1 |
Amantadine Hydrochloride |
102 mg/ 100 mg tablet |
| Tablet 100mg |
|
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|
|
26
| Case No.:49/10/82-ALC4/2019 |
|
Party Name:PRISM |
|
Meet No/Date:10/82- |
|
Status: |
|
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
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|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045454 |
|
|
| :01/82/050/00623/AM20/ |
|
:34/24/040/00121/AM20/ |
|
12.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 56 per details given below or as applied by the firm, whichever is less:
| Export product<br>LUMEFANTRINE |
Qty. |
Sl.<br>No. |
Import Items |
Qty. |
|
1 kg |
1. |
[DIBUTYLAMINE METHYL]-2,7-DICHLORO-4-<br>FLUOREN METHANOL |
0.8693 kg |
|
|
2. |
PARA CHLORO BENZALDEHYDE |
0.3477 kg |
| 57 |
Case No.:42/10/82-ALC4/2019 |
Party Name:BENZO CHEM<br>INDUSTRIES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00616/AM20/ |
RLA File<br>:03/94/040/00444/AM20/ |
Lic.No/Date:0310831519<br>13.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
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|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 58 |
Case No.:43/10/82-ALC4/2019 |
Party Name:KEVA<br>FRAGRANCES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00617/AM20/ |
RLA File<br>:03/94/040/00462/AM20/ |
Lic.No/Date:0310831524<br>13.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
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|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 59 |
Case No.:44/10/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00618/AM20/ |
RLA File<br>:03/95/040/00477/AM20/ |
Lic.No/Date:0310831537<br>13.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
Decision: New Case. The Committee decided to refer the case to Special Committee for further consideration.
27
|
|
Case No.:45/10/82-ALC4/2019 |
|
Party Name:RELIANCE |
|
Meet No/Date:10/82- |
|
Status: |
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|
|
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 60 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310831538 |
|
Defer Date: |
|
|
:01/82/050/00619/AM20/ |
|
:03/95/040/00325/AM20/ |
|
13.09.2019 |
|
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|
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further |
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|
consideration. |
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|
Case No.:46/10/82-ALC4/2019 |
|
Party Name:RELIANCE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
|
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 61 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310831540 |
|
Defer Date: |
|
|
:01/82/050/00620/AM20/ |
|
:03/95/040/00334/AM20/ |
|
13.09.2019 |
|
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|
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further |
|
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|
|
consideration. |
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|
Case No.:47/10/82-ALC4/2019 |
|
Party Name:RELIANCE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
|
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 62 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310831542 |
|
Defer Date: |
|
|
:01/82/050/00621/AM20/ |
|
:03/95/040/00275/AM20/ |
|
13.09.2019 |
|
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|
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further |
|
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|
consideration. |
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|
Case No.:48/10/82-ALC4/2019Party Name:ENCUBE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ETHICALS PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
29.11.2019 |
|
|
| 63 |
|
HQ File<br>:01/82/050/00622/AM20/<br>RLA File<br>:03/94/040/00395/AM20/ |
|
Lic.No/Date:0310831546<br>13.09.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
|
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|
Case No.:50/10/82-ALC4/2019 |
Party Name:HETERO DRUG<br>LIMITED |
|
|
|
S |
Meet No/Date:10/82-<br>ALC4/2019 |
<br> |
Status:<br>Approved |
|
|
<br>RLA File |
|
|
|
|
<br>29.11.2019 |
<br> |
|
|
HQ File |
|
|
|
|
|
LicNo/Date:091006799 |
|
|
|
<br>:01/82/050/00624/AM20/ |
<br>:09/24/040/00302/AM20/ |
|
|
|
|
.<br>13.09.2019 |
|
|
| 64 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>SOLIFENACIN SUCCINATE<br>1 kg<br>1<br>R-(-)-3-Quiniclidinol<br>0.625 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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|
|
|
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|
|
Qty. |
Sl.<br>No. |
Import items |
|
|
|
|
|
|
|
1 kg |
1 |
R-(-)-3-Quiniclidinol |
|
|
|
|
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
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|
28
|
|
Case No.:51/10/82-ALC4/2019Party Name:ALPHAMED |
|
Meet No/Date:10/82- |
|
|
Status: |
|
|
FORMULATIONS PRIVATE |
|
ALC4/2019 |
|
|
Deferred |
|
|
LIMITED |
|
29.11.2019 |
|
|
|
| 65 |
|
HQ File<br>:01/82/050/00625/AM20/<br>RLA File<br>:09/24/040/00313/AM20/ |
|
Lic.No/Date:0910067997<br>13.09.2019 |
|
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance |
|
|
Authorization is |
|
|
|
|
not available. Hence, it was decided to call for a copy of |
4.07 application of the |
|
subject advance |
|
|
|
|
authorization from RLA,Hyderabad. |
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:52/10/82- |
|
Party Name:STERILE INDIA |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411839 |
|
|
| :01/82/050/00626/AM20/ |
|
:05/24/040/00334/AM20/ |
|
13.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 66 per details given below or as applied by the firm, whichever is less:
| Export product |
|
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
| Meropenem |
Sodium |
Sterile |
1 kg |
1 |
Meropenem Trihydrate (Non |
0.958 kg |
| (Meropenem for |
injection) |
|
|
|
sterile) |
|
| Case No.:53/10/82-ALC4/2019 |
|
Party Name:HETERO DRUGS |
|
Meet No/Date:10/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067998 |
|
|
| :01/82/050/00627/AM20/ |
|
:09/24/040/00296/AM20/ |
|
13.09.2019 |
|
|
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
experts and it |
experts and it |
|
|
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied |
|
|
|
|
|
|
|
|
by firm whichever is lower: |
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| 67 |
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
|
|
|
MONTELUKAST SODIUM |
1 kg |
1 |
2-(2-3S-3,2,7-chloro-2-quinolinyl)- |
1.24 kg |
|
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|
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|
|
ethynylphenyl)-3-hydroxypropyl)- |
|
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|
|
|
|
|
|
phenyl-2-propanol |
|
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|
|
|
2 |
1-(Mercaptomethyl)-1-cyclopropane |
0.40 kg |
|
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|
|
acetic acid |
|
|
|
|
|
|
|
3 |
Acetonitrile |
8.425 kg |
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
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|
29
| Case No.:127/10/82- |
|
Party Name:TITAN |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES PVT. LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831513 |
|
|
| :01/82/050/00701/AM20/ |
|
:03/95/040/00577/AM20/ |
|
13.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 68 meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Export Product |
Qty. |
Sl. No. |
Import items |
Qty. |
| ORLISTAT PELLETS 50% |
1 kg |
1 |
ORLISTAT |
0.50 kg |
| 69 |
Case No.:54/10/82-ALC4/2019 |
Party Name:SANDHYA<br>ORGANIC CHEMICALS<br>PRIVATE LIMITED<br>RLA File<br>:03/95/040/00423/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00628/AM20/ |
|
Lic.No/Date:0310831560<br>16.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 70 |
Case No.:55/10/82-ALC4/2019 |
Party Name:SANDHYA<br>ORGANIC CHEMICALS<br>PRIVATE LIMITED<br>RLA File<br>:03/95/040/00425/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00629/AM20/ |
|
Lic.No/Date:0310831562<br>16.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 71 |
<br>Case No.:56/10/82-ALC4/2019 |
Party Name:CADILA<br>HEALTHCARE LTD<br>RLA File<br>:08/24/040/00172/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00630/AM20/ |
|
Lic.No/Date:0810146177<br>16.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
30
| 72 |
<br>Case No.:57/10/82-ALC4/2019 |
Party Name:CADILA<br>HEALTHCARE LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00631/AM20/ |
RLA File<br>:08/24/040/00173/AM20/ |
Lic.No/Date:0810146178<br>16.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
| Case No.:58/10/82-ALC4/2019 |
|
Party Name:ETERNIS FINE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
CHEMICALS LIMITED, |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831582 |
|
|
| :01/82/050/00632/AM20/ |
|
:03/94/040/00464/AM20/ |
|
16.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 7/82-ALC4/2019 dated 24.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 73
| Export Product |
Qty. |
S. |
Import Items |
Qty. |
|
|
No |
|
|
| COUMARIN |
1 kg |
1 |
SALICYLALDEHYDE |
1.09 kg |
|
|
2 |
ACETIC ANHYDRIDE |
0.91 kg |
|
|
3 |
METHANOL |
0.06 kg |
| 74 |
<br>Case No.:70/10/82-ALC4/2019 |
Party Name:THERAPIVA<br>PRIVATE LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00644/AM20/ |
RLA File<br>:09/24/040/00294/AM20/ |
Lic.No/Date:0910068000<br>16.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
|
|
|
|
|
| 75 |
<br>Case No.:71/10/82-ALC4/2019 |
Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00645/AM20/ |
RLA File<br>:09/24/040/00311/AM20/ |
Lic.No/Date:0910068001<br>16.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
31
| Case No.:177/10/82- |
|
Party Name:ZENITH |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
DYEINTERMEDIATES |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831565 |
|
|
| :01/82/050/00751/AM20/ |
|
:03/95/040/00550/AM20/ |
|
16.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 76
| Export Product |
Qty. |
Sl.<br>No. |
Import Items |
Qty. |
| NAS-5<br>(2-DIAZO-1-NAPHTHOL-5-<br>SULFONIC ACID, SODIUM<br>SALT) |
1 kg |
1 |
SULFO TOBIAS ACID<br>(PURITY 65%) |
1.798 kg |
| Case No.:59/10/82-ALC4/2019 |
|
Party Name:RUMIT LIFE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
CARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831596 |
|
|
| :01/82/050/00633/AM20/ |
|
:03/95/040/00596/AM20/ |
|
17.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 77 per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Betamethasone Dipropionate BP/USP |
1 kg |
1 |
Betamethasone BP/EP/IP/USP |
0.868 kg |
| Case No.:60/10/82- |
|
Party Name:RUMIT LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831597 |
|
|
| :01/82/050/00634/AM20/ |
|
:03/95/040/00595/AM20/ |
|
17.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 78 meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Clobetasol PropionateBP/USP |
1 kg |
1 |
BetamethasoneBP/EP/IP/USP |
1.00kg |
32
| Case No.:61/10/82-ALC4/2019 |
|
Party Name:OLIVE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
HEALTHCARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831598 |
|
|
| :01/82/050/00635/AM20/ |
|
:03/95/040/00587/AM20/ |
|
17.09.2019 |
|
|
|
Case No.:61/10/82-ALC4/2019 |
Party Name:OLIVE<br>HEALTHCARE |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00635/AM20/ |
RLA File<br>:03/95/040/00587/AM20/ |
Lic.No/Date:0310831598<br>17.09.2019 |
|
| 79 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TEMAZEPAM TEVA 10 MG<br>CAPSULES<br>(TOTAL NO OF CAPSULES<br>IS 6000000 AND NET WT OF<br>EXEMPT<br>MATERIALS<br>CONTAIN IN RESULTANT<br>PRODUCT IS 60 KG)<br>1 Number<br>1<br>TEMAZEPAM Ph Eur<br>10.20 mg /<br>10 mg<br>Capsule<br>TEMAZEPAM TEVA 20 MG<br>CAPSULES<br>(TOTAL NO OF CAPSULES<br>IS 3999990 AND NET WT OF<br>EXEMPT<br>MATERIALS<br>CONTAIN IN RESULTANT<br>PRODUCT IS 80 KG)<br>1 Number<br>1<br>TEMAZEPAM Ph Eur<br>20.40 mg /<br>20 mg<br>Capsule<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
33
| Case No.:62/10/82- |
|
Party Name:RECKITT |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
BENCKISER (INDIA) |
|
ALC4/2019 |
|
Approved |
|
|
PRIVATE LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411864 |
|
|
| :01/82/050/00636/AM20/ |
|
:05/24/040/00342/AM20/ |
|
17.09.2019 |
|
|
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
|
|
meeting |
|
no. 8/82-ALC4/2019 dated 20.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as |
|
|
|
|
|
|
|
per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
|
|
|
Sl. |
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
No. |
|
|
|
|
|
|
1 |
DISPRIN REGULAR |
1 Number |
1 |
CALCIUM |
90.00 mg / |
|
|
|
|
|
(ASPIRIN PH. EUR |
|
|
CARBONATE EP |
300 mg tablet |
|
|
|
|
|
300MG) ACETYL |
|
2 |
CITIRIC ACID |
30.00 mg / |
|
|
|
|
|
SALICYLIC ACID 300mg |
|
|
ANHYDROUS F4020 |
300 mg tablet |
|
|
|
|
|
Tablet (ASPIRIN) |
|
3 |
SACCHARIN BASE |
4.50 mg / 300 |
|
| 80 |
|
|
|
|
|
4 |
55Ox<br>TALC EP |
mg tablet<br>6.0 mg / 300 |
|
|
|
|
|
|
|
|
|
mg tablet |
|
|
|
|
2 |
DISPRIN |
1 Number |
1 |
SACCHARIN BASE |
1.00 mg / 300 |
|
|
|
|
|
DIRECTS/MELTS |
|
|
55Ox |
mg tablet |
|
|
|
|
|
(ASPIRIN PH.EUR |
|
2 |
TALC EP |
5.0 mg / 300 |
|
|
|
|
|
300MG) ACETYL |
|
|
|
mg tablet |
|
|
|
|
|
SALICYLIC ACID 300 |
|
|
|
|
|
|
|
|
|
mg Tablet (ASPIRIN) |
|
|
|
|
|
|
|
|
3 |
Disprin EXTRA |
1 Number |
1 |
CITIRIC ACID |
50.00 mg / |
|
|
|
|
|
(ASPIRIN PH.EUR |
|
|
ANHYDROUS F4020 |
500 mg tablet |
|
|
|
|
|
500MG) ACETYL |
|
2 |
SACCHARIN BASE |
7.50 mg / 500 |
|
|
|
|
|
SALICYLIC ACID 500 |
|
|
55Ox |
mg tablet |
|
|
|
|
|
mg Tablet (ASPIRIN) |
|
3 |
CALCIUM |
150.0 mg / |
|
|
|
|
|
|
|
|
CARBONATE EP |
500 mg tablet |
|
|
|
|
|
|
|
4 |
TALC EP |
10.0 mg / 500 |
|
|
|
|
|
|
|
|
|
mg tablet |
|
|
|
RA concerned maytake further necessaryaction asper above |
|
|
|
|
decision of NC. |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 8/82-ALC4/2019 dated 20.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
|
|
|
Case No.:63/10/82-ALC4/2019 |
|
Party Name:RENOWN |
|
Meet No/Date:10/82- |
|
Status: |
|
|
|
|
|
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
PRIVATE LIMITED |
|
29.11.2019 |
|
|
|
|
81 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410045458 |
|
Defer Date: |
|
|
|
|
:01/82/050/00637/AM20/ |
|
:34/24/040/00182/AM20/ |
|
17.09.2019 |
|
|
|
|
|
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:75/10/82-ALC4/2019 |
|
Party Name:DIVIS |
|
Meet No/Date:10/82- |
|
Status: |
|
|
|
|
|
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
|
29.11.2019 |
|
|
|
|
82 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910068002 |
|
Defer Date: |
|
|
|
|
:01/82/050/00649/AM20/ |
|
:09/24/040/00315/AM20/ |
|
17.09.2019 |
|
|
|
|
|
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34
| 83 |
<br>Case No.:64/10/82-ALC4/2019 |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD<br>RLA File<br>:03/94/040/00473/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00638/AM20/ |
|
Lic.No/Date:0310831612<br>18.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
| 84 |
Case No.:65/10/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00534/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00639/AM20/ |
|
Lic.No/Date:0310831632<br>19.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
| 85 |
Case No.:66/10/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00450/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00640/AM20/ |
|
Lic.No/Date:0310831645<br>19.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
|
Case No.:67/10/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/00641/AM20/<br> <br> |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
|
RLA File<br>:03/94/040/00468/AM20/ |
Lic.No/Date:0310831647<br>19.09.2019 |
|
| 86 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Kit Pack of Norgestimate & Ethinyl Estradiol Tablets USP 0.18mg/0.035mg,<br>0.215mg/0.035mg<br>and<br>0.25mg/0.035mg<br>(Pack Size 84 Tabs.) ( Net Wt. of Norgestimate USP is 2.709 Kgs )<br>1 Number<br>Norgestimate & Ethinyl Estradiol Tablets USP 0.25mg/0.035mg (Pack Size 84 Tabs.)<br>( Net Wt. of Norgestimate USP is 9.450 Kgs )<br>1 Number<br>Norgestimate & Ethinyl Estradiol Tablets USP 0.18mg/0.025mg, 0.215mg/0.025mg,<br>0.25mg/0.025mg<br>(Ortho<br>Tri<br>Cyclen-Lo)<br>(Pack Size 84 Tabs.) ( Net Wt. of Norgestimate USP is 9.482 Kgs)<br>1 Number<br>SI.<br>No.<br>Import Items<br>Qty. Allowed for the export of 1 No. Tablet (Quantity in mg)<br>0.18mg<br>/0.035 mg<br>0.215mg<br>/0.035<br>mg<br>0.25mg<br>/0.035 mg<br>0.18mg<br>/0.025<br>mg<br>0.215mg<br>/0.025 mg<br>0.25mg<br>/0.025<br>mg<br>1<br>Norgestimate<br>USP<br>(Micronized)<br>0.1836<br>0.2193<br>0.255<br>0.1836<br>0.2193<br>0.255<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
Case No.:67/10/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/00641/AM20/<br> <br> |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
|
RLA File<br>:03/94/040/00468/AM20/ |
Lic.No/Date:0310831647<br>19.09.2019 |
|
| 86 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Kit Pack of Norgestimate & Ethinyl Estradiol Tablets USP 0.18mg/0.035mg,<br>0.215mg/0.035mg<br>and<br>0.25mg/0.035mg<br>(Pack Size 84 Tabs.) ( Net Wt. of Norgestimate USP is 2.709 Kgs )<br>1 Number<br>Norgestimate & Ethinyl Estradiol Tablets USP 0.25mg/0.035mg (Pack Size 84 Tabs.)<br>( Net Wt. of Norgestimate USP is 9.450 Kgs )<br>1 Number<br>Norgestimate & Ethinyl Estradiol Tablets USP 0.18mg/0.025mg, 0.215mg/0.025mg,<br>0.25mg/0.025mg<br>(Ortho<br>Tri<br>Cyclen-Lo)<br>(Pack Size 84 Tabs.) ( Net Wt. of Norgestimate USP is 9.482 Kgs)<br>1 Number<br>SI.<br>No.<br>Import Items<br>Qty. Allowed for the export of 1 No. Tablet (Quantity in mg)<br>0.18mg<br>/0.035 mg<br>0.215mg<br>/0.035<br>mg<br>0.25mg<br>/0.035 mg<br>0.18mg<br>/0.025<br>mg<br>0.215mg<br>/0.025 mg<br>0.25mg<br>/0.025<br>mg<br>1<br>Norgestimate<br>USP<br>(Micronized)<br>0.1836<br>0.2193<br>0.255<br>0.1836<br>0.2193<br>0.255<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
35
| Case No.:68/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831648 |
|
|
| :01/82/050/00642/AM20/ |
|
:03/94/040/00469/AM20/ |
|
19.09.2019 |
|
|
|
Case No.:68/10/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00642/AM20/ |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD<br>RLA File<br>:03/94/040/00469/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310831648<br>19.09.2019 |
Status:<br>Approved |
| 87 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decisions taken in<br>meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Drospirenone and Ethinyl Estradiol<br>Tablets (YASMIN) 3 mg / 0.03 mg<br>(Pack<br>3<br>x<br>28s)<br>(Net wt of Drospirenone USP<br>(Micronized)is 49.140 Kgs)<br>260000<br>Number<br>1<br>Drospirenone<br>108.50 kg<br>Drospirenone and Ethinyl Estradiol<br>Tablets (YAZ) ( Pack 3 x 28s) 3<br>mg<br>/<br>0.02<br>mg<br>(Net wt of Drospirenone USP<br>(Micronized)is 57.240 Kgs)<br>265000<br>Number<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decisions taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Case No.:69/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831649 |
|
|
| :01/82/050/00643/AM20/ |
|
:03/94/040/00470/AM20/ |
|
19.09.2019 |
|
|
|
Case No.:69/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00643/AM20/ |
RLA File<br>:03/94/040/00470/AM20/ |
Lic.No/Date:0310831649<br>19.09.2019 |
|
| 88 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>3/82-ALC4/2019<br>, dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Lamotrigine<br>Tablets<br>CD<br>25mg (Pack size 100 Tabs.)<br>(Net Wt. of Lamotrigine is<br>400.000 Kgs.)<br>1 Number<br>1<br>Lamotrigine<br>25.50 mg / 25 mg<br>tablet<br>Lamotrigine Tablets CD 5mg<br>(Pack size 100 Tabs.) (Net<br>Wt.<br>of<br>Lamotrigine<br>is<br>100.000Kgs.)<br>1 Number<br>1<br>Lamotrigine<br>5.10 mg / 5 mg<br>tablet<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
36
| 89 |
Case No.:72/10/82-<br>ALC4/2019 |
Party Name:ASTRAL<br>STERITECH PVT. LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00646/AM20/ |
RLA File<br>:34/24/040/00183/AM20/ |
Lic.No/Date:3410045460<br>19.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Vadodara. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
| 90 |
Case No.:73/10/82-ALC4/2019 |
Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD.<br>RLA File<br>:31/82/040/00056/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00647/AM20/ |
|
Lic.No/Date:3110067535<br>19.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Pune. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.
| Case No.:74/10/82-ALC4/2019 |
|
Party Name:BALAJI AMINES |
|
Meet No/Date:10/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067536 |
|
|
| :01/82/050/00648/AM20/ |
|
:31/83/040/00081/AM20/ |
|
19.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 91 per details given below or as applied by the firm, whichever is less:
| Export Product |
Qty. |
Sl.<br>No. |
Import Items |
Qty. |
| GAMMA BUTYROLACTONE |
1 kg |
1. |
1,4 BUTANEDIOL |
1.16 kg |
|
|
2. |
GBL CATAYLYST |
0.001 kg |
37
| 92 |
Case No.:77/10/82-ALC4/2019 |
Party Name:TRANSPEK<br>INDUSTRY LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00651/AM20/ |
RLA File<br>:34/24/040/00184/AM20/ |
Lic.No/Date:3410045472<br>20.09.2019 |
Defer Date: |
|
**Decision:**New Case, deferred for comments of TE. |
|
|
|
| Case No.:86/10/82-ALC4/2019 |
|
Party Name:PI INDUSTRIES |
|
Meet No/Date:10/82- |
|
Status: |
|
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:1310049410 |
|
|
| :01/82/050/00660/AM20/ |
|
:13/24/040/00165/AM20/ |
|
20.09.2019 |
|
|
|
Case No.:86/10/82-ALC4/2019 |
Party Name:PI INDUSTRIES<br>LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:1310049410<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00660/AM20/ |
RLA File<br>:13/24/040/00165/AM20/ |
|
|
| 93 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>HYPE Chemical Name: Methyl<br>1-(3-chloropyridin-2-yl)-3-<br>hydroxymethyl-1H-pyrazole-5-<br>carboxylate<br>1 kg<br>1<br>3-Chloro-2-Hydrazinopyridine<br>0.670 kg<br>2<br>2-methyl-5-ethylpyridine<br>0.0224 kg<br>3<br>Epichlorohydrin<br>0.545 kg<br>4<br>Methyl oxalyl chloride<br>0.672 kg<br>5<br>Tetrahydrofurfuryl alcohol<br>0.320 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
| 94 |
<br>Case No.:129/10/82-<br>ALC4/2019 |
Party Name:TRANSPEK<br>INDUSTRY LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:3410045471<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00703/AM20/ |
RLA File<br>:34/24/040/00187/AM20/ |
|
|
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
| 95 |
<br>Case No.:130/10/82-<br>ALC4/2019 |
Party Name:TRANSPEK<br>INDUSTRY LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:3410045473<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00704/AM20/ |
RLA File<br>:34/24/040/00188/AM20/ |
|
|
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
38
| 96 |
<br>Case No.:131/10/82-<br>ALC4/2019 |
Party Name:TRANSPEK<br>INDUSTRY LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00705/AM20/ |
RLA File<br>:34/24/040/00189/AM20/ |
Lic.No/Date:3410045470<br>20.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
| Case No.:76/10/82-ALC4/2019 |
|
Party Name:IPCA |
|
Meet No/Date:10/82- |
|
Status: |
|
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831729 |
|
|
| :01/82/050/00650/AM20/ |
|
:03/94/040/00487/AM20/ |
|
23.09.2019 |
|
|
|
Case No.:76/10/82-ALC4/2019 |
Party Name:IPCA<br>LABORATORIES LIMITED |
Party Name:IPCA<br>LABORATORIES LIMITED |
Party Name:IPCA<br>LABORATORIES LIMITED |
Party Name:IPCA<br>LABORATORIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00650/AM20/ |
RLA File<br>:03/94/040/00487/AM20/ |
|
|
|
Lic.No/Date:0310831729<br>23.09.2019 |
|
| 97 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 12/82-ALC4/2018 dated 12.12.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>MORANTEL CITRATE<br>1 kg<br>1<br>3-Methyl Thiophene<br>0.33 kg<br>2<br>Acetonitrile<br>0.18 kg<br>3<br>Dimethyl Formamide<br>0.27 kg<br>4<br>Citric Acid<br>0.64 kg<br>5<br>Iso Propyl Alcohol<br>0.225 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
<br>Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
MORANTEL CITRATE |
|
1 kg |
1 |
3-Methyl Thiophene |
|
0.33 kg |
|
|
|
|
2 |
Acetonitrile |
|
0.18 kg |
|
|
|
|
3 |
Dimethyl Formamide |
|
0.27 kg |
|
|
|
|
4 |
Citric Acid |
|
0.64 kg |
|
|
|
|
5 |
Iso Propyl Alcohol |
|
0.225 kg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 12/82-ALC4/2018 dated 12.12.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| 98 |
<br>Case No.:78/10/82-ALC4/2019 |
Party Name:STERLING<br>AUXILIARIES PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00652/AM20/ |
RLA File<br>:03/95/040/00621/AM20/ |
Lic.No/Date:0310831732<br>23.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
| 99 |
<br>Case No.:176/10/82-<br>ALC4/2019 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00750/AM20/ |
RLA File<br>:09/24/040/00322/AM20/ |
Lic.No/Date:0910068026<br>23.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
39
| 100 |
Case No.:79/10/82-<br>ALC4/2019 |
Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00327/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0910068031<br>24.09.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00653/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| Case No.:80/10/82- |
|
Party Name:BRAWN |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411918 |
|
|
| :01/82/050/00654/AM20/ |
|
:05/23/040/00247/AM20/ |
|
24.09.2019 |
|
|
|
Case No.:80/10/82-<br>ALC4/2019 |
Case No.:80/10/82-<br>ALC4/2019 |
Party Name:BRAWN<br>LABORATORIES LTD<br>RLA File<br>:05/23/040/00247/AM20/ |
Party Name:BRAWN<br>LABORATORIES LTD<br>RLA File<br>:05/23/040/00247/AM20/ |
Party Name:BRAWN<br>LABORATORIES LTD<br>RLA File<br>:05/23/040/00247/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00654/AM20/ |
|
|
|
|
Lic.No/Date:0510411918<br>24.09.2019 |
|
|
| 101 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CIPROFLOXACIN<br>TABLETS 500MG<br>(OFF WHITE,<br>ELONGATED,<br>BICONVEX, FLIM<br>COATED TABLET,<br>SCORED ON ONE SIDE)<br>One 500<br>mg tablet<br>1.<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>(FAINTLY YELLOWISH TO<br>LIGHT YELLOW<br>CRYSTALS)<br>555.0 mg/500<br>mg Tablets<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
|
Qty. |
|
|
CIPROFLOXACIN<br>TABLETS 500MG<br>(OFF WHITE,<br>ELONGATED,<br>BICONVEX, FLIM<br>COATED TABLET,<br>SCORED ON ONE SIDE) |
One 500<br>mg tablet |
|
1. |
CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>(FAINTLY YELLOWISH TO<br>LIGHT YELLOW<br>CRYSTALS) |
|
555.0 mg/500<br>mg Tablets |
|
|
RA maytake appropriate action asper the |
|
|
decision of Norms Committee. |
|
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Case No.:81/10/82- |
|
Party |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
Name:SMILAX LABORATORIES |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File :09/24/040/00201/AM20/ |
|
Lic.No/Date:0910068032 |
|
|
| :01/82/050/00655/AM |
|
|
|
24.09.2019 |
|
|
| 20/ |
|
|
|
|
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 102 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| PANTOPRAZOLE SODIUM (OR) |
1 kg |
1 |
Maltol |
0.728 kg |
| PANTOPRAZOLE SODIUM |
|
|
3-HYDROXY-2-METHYL- |
|
| SESQUIHYDRATE |
|
|
4H-PYRAN-4-ONE |
|
|
|
2 |
Acetonitrile |
1.95 kg |
40
| 103 |
Case No.:82/10/82-<br>ALC4/2019 |
Party Name:DANOPHARM<br>CHEMICALS PRIVATE LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00656/AM20/ |
RLA File<br>:03/94/040/00422/AM20/ |
Lic.No/Date:0310831769<br>24.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
Case No.:83/10/82- Party Name:FDC LTD Meet No/Date:10/82- Status: ALC4/2019 ALC4/2019 Approved 29.11.2019 HQ File RLA File Lic.No/Date:0310831779 :01/82/050/00657/AM20/ :03/94/040/00436/AM20/ 25.09.2019
|
Case No.:83/10/82-<br>ALC4/2019 |
Party Name:FDC LTD |
Party Name:FDC LTD |
Party Name:FDC LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00657/AM20/ |
RLA File<br>:03/94/040/00436/AM20/ |
|
|
Lic.No/Date:0310831779<br>25.09.2019 |
|
|
| 104 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>as per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
BRIMONIDINE TARTRATE<br>EYE DROPS 0.2% W/V 5ML |
1<br>Number |
1 |
BRIMONIDINE L-TARTRATE |
|
0.0102<br>gm/vial |
|
|
RA maytake appropriate action |
asper the decision of Norms Committee. |
|
|
|
|
|
41
| Case No.:84/10/82- |
|
Party Name:S KANT |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
HEALTHCARE LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831781 |
|
|
| :01/82/050/00658/AM20/ |
|
:03/95/040/00220/AM20/ |
|
25.09.2019 |
|
|
|
Case No.:84/10/82-<br>ALC4/2019 |
Case No.:84/10/82-<br>ALC4/2019 |
Case No.:84/10/82-<br>ALC4/2019 |
Party Name:S KANT<br>HEALTHCARE LTD |
Party Name:S KANT<br>HEALTHCARE LTD |
Party Name:S KANT<br>HEALTHCARE LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00658/AM20/ |
|
|
RLA File<br>:03/95/040/00220/AM20/ |
|
|
Lic.No/Date:0310831781<br>25.09.2019 |
|
| 105 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>ARTEMETHER<br>560.000 kg<br>1<br>ARTEMISININ<br>582.4 kg<br>2<br>LUMEFANTRINE<br>3360.000 kg<br>1<br>2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN<br>2919.840 kg<br>3<br>ARTEMETHER 20 MG &<br>LUMEFANTRINE 120<br>MG TABLETS<br>4000000.000<br>Number<br>1<br>ARTEMISININ<br>84.864 kg<br>2<br>2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN<br>417.120 kg<br>4<br>ARTEMETHER 20 MG &<br>LUMEFANTRINE 120<br>MG DISPERSIBLE<br>TABLET<br>4000000.000<br>Number<br>1<br>ARTEMISININ<br>84.864 kg<br>2<br>2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN<br>417.120 kg<br>5<br>ARTEMETHER 40 MG &<br>LUMEFANTRINE 240<br>MG TABLETS<br>4000000.000<br>Number<br>1<br>ARTEMISININ<br>169.728 kg<br>2<br>2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN<br>834.240 kg<br>6<br>ARTEMETHER 80 MG &<br>LUMEFANTRINE 480<br>MG TABLETS<br>4000000.000<br>Number<br>1<br>ARTEMISININ<br>339.456 kg<br>2<br>2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN<br>1668.480 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
Sl.<br>No. |
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
|
1 |
ARTEMETHER |
|
560.000 kg |
1 |
ARTEMISININ |
582.4 kg |
|
|
2 |
LUMEFANTRINE |
|
3360.000 kg |
1 |
2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN |
2919.840 kg |
|
|
3 |
ARTEMETHER 20 MG &<br>LUMEFANTRINE 120<br>MG TABLETS |
|
4000000.000<br>Number |
1 |
ARTEMISININ |
84.864 kg |
|
|
|
|
|
|
2 |
2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN |
417.120 kg |
|
|
4 |
ARTEMETHER 20 MG &<br>LUMEFANTRINE 120<br>MG DISPERSIBLE<br>TABLET |
|
4000000.000<br>Number |
1 |
ARTEMISININ |
84.864 kg |
|
|
|
|
|
|
2 |
2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN |
417.120 kg |
|
|
5 |
ARTEMETHER 40 MG &<br>LUMEFANTRINE 240<br>MG TABLETS |
|
4000000.000<br>Number |
1 |
ARTEMISININ |
169.728 kg |
|
|
|
|
|
|
2 |
2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN |
834.240 kg |
|
|
6 |
ARTEMETHER 80 MG &<br>LUMEFANTRINE 480<br>MG TABLETS |
|
4000000.000<br>Number |
1 |
ARTEMISININ |
339.456 kg |
|
|
|
|
|
|
2 |
2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN |
1668.480 kg |
|
|
|
|
|
|
|
|
|
42
| Case No.:85/10/82- |
|
Party Name:S KANT |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
HEALTHCARE LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831782 |
|
|
| :01/82/050/00659/AM20/ |
|
:03/95/040/00219/AM20/ |
|
25.09.2019 |
|
|
|
Case No.:85/10/82-<br>ALC4/2019 |
Case No.:85/10/82-<br>ALC4/2019 |
Case No.:85/10/82-<br>ALC4/2019 |
Party Name:S KANT<br>HEALTHCARE LTD |
Party Name:S KANT<br>HEALTHCARE LTD |
Party Name:S KANT<br>HEALTHCARE LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00659/AM20/ |
|
|
RLA File<br>:03/95/040/00219/AM20/ |
|
|
Lic.No/Date:0310831782<br>25.09.2019 |
|
| 106 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>ARTEMETHER 20 MG &<br>LUMEFANTRINE 120<br>MG TABLETS<br>7500000.000<br>Number<br>1<br>ARTEMISININ<br>159.12 kg<br>2<br>2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN<br>782.100 kg<br>2<br>ARTEMETHER 20 MG &<br>LUMEFANTRINE 120<br>MG DISPERSIBLE<br>TABLET<br>7500000.000<br>Number<br>1<br>ARTEMISININ<br>159.12 kg<br>2<br>2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN<br>782.100 kg<br>3<br>ARTEMETHER 40 MG &<br>LUMEFANTRINE 240<br>MG TABLETS<br>7500000.000<br>Number<br>1<br>ARTEMISININ<br>318.24 kg<br>2<br>2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN<br>1564.200 kg<br>4<br>ARTEMETHER 80 MG &<br>LUMEFANTRINE 480<br>MG TABLETS<br>7500000.000<br>Number<br>1<br>ARTEMISININ<br>636.48 kg<br>2<br>2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN<br>3128.400 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
Sl.<br>No. |
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
|
1 |
ARTEMETHER 20 MG &<br>LUMEFANTRINE 120<br>MG TABLETS |
|
7500000.000<br>Number |
1 |
ARTEMISININ |
159.12 kg |
|
|
|
|
|
|
2 |
2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN |
782.100 kg |
|
|
2 |
ARTEMETHER 20 MG &<br>LUMEFANTRINE 120<br>MG DISPERSIBLE<br>TABLET |
|
7500000.000<br>Number |
1 |
ARTEMISININ |
159.12 kg |
|
|
|
|
|
|
2 |
2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN |
782.100 kg |
|
|
3 |
ARTEMETHER 40 MG &<br>LUMEFANTRINE 240<br>MG TABLETS |
|
7500000.000<br>Number |
1 |
ARTEMISININ |
318.24 kg |
|
|
|
|
|
|
2 |
2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN |
1564.200 kg |
|
|
4 |
ARTEMETHER 80 MG &<br>LUMEFANTRINE 480<br>MG TABLETS |
|
7500000.000<br>Number |
1 |
ARTEMISININ |
636.48 kg |
|
|
|
|
|
|
2 |
2, 7 DICHLORO-A-<br>(DIBUTYLAMINO)<br>METHYL-9H-<br>FLUORENE-4-<br>METHANOL (DBA)<br>99% MIN |
3128.400 kg |
|
|
|
|
|
|
|
|
|
43
| 107 |
Case No.:87/10/82-<br>ALC4/2019 |
Party Name:OPES HEALTH<br>CARE PRIVATE LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00661/AM20/ |
RLA File<br>:08/24/040/00202/AM20/ |
Lic.No/Date:0810146231<br>25.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Ahmedabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
Case No.:90/10/82- Party Name:ASTRAL Meet No/Date:10/82- Status: ALC4/2019 STERITECH PVT. LTD. ALC4/2019 Approved 29.11.2019 HQ File RLA File Lic.No/Date:3410045476 :01/82/050/00664/AM20/ :34/24/040/00197/AM20/ 25.09.2019 Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
Case No.:90/10/82-<br>ALC4/2019 |
Party Name:ASTRAL<br>STERITECH PVT. LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00664/AM20/ |
RLA File<br>:34/24/040/00197/AM20/ |
Lic.No/Date:3410045476<br>25.09.2019 |
|
| 108 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>Oxacillin<br>for<br>Injection<br>USP<br>2<br>gm<br>Each Vials Contains Oxacillin Sodium Equivalent to 2gm Oxacillin.<br>85500<br>Number<br>2<br>Oxacillin<br>for<br>Injection<br>USP<br>10gm.<br>Each Vial Contains Oxaxillin Sodium Equivalent to 10gm Oxacillin.<br>10800<br>Number<br>Sl.<br>No.<br>Import Items<br>Qty.<br>1<br>STERILE OXACILLIN SODIUM (Sterile Bulk)<br>292.95 kg<br>2<br>RUBBER STOPPER (AS PER GENERAL NOTES)<br>Relevant as per packing policy<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
44
| Case No.:91/10/82- |
|
Party Name:ASTRAL |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
STERITECH PVT. LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045477 |
|
|
| :01/82/050/00665/AM20/ |
|
:34/24/040/00198/AM20/ |
|
25.09.2019 |
|
|
|
Case No.:91/10/82-<br>ALC4/2019 |
Party Name:ASTRAL<br>STERITECH PVT. LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00665/AM20/ |
RLA File<br>:34/24/040/00198/AM20/ |
Lic.No/Date:3410045477<br>25.09.2019 |
|
| 109 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>Oxacillin<br>for<br>Injection<br>USP<br>2<br>gm<br>Each Vials Contains Oxacillin Sodium Equivalent to 2gm Oxacillin.<br>85500<br>Number<br>2<br>Oxacillin<br>for<br>Injection<br>USP<br>10gm.<br>Each Vial Contains Oxaxillin Sodium Equivalent to 10gm Oxacillin.<br>10800<br>Number<br>Sl.<br>No.<br>Import Items<br>Qty.<br>1<br>STERILE OXACILLIN SODIUM (Sterile Bulk)<br>292.95 kg<br>2<br>RUBBERSTOPPER(ASPERGENERALNOTES)<br>Relevant as perpacking policy<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
| Case No.:92/10/82- |
|
Party Name:ASTRAL |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
STERITECH PVT. LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045478 |
|
|
| :01/82/050/00666/AM20/ |
|
:34/24/040/00199/AM20/ |
|
25.09.2019 |
|
|
|
Case No.:92/10/82-<br>ALC4/2019 |
Party Name:ASTRAL<br>STERITECH PVT. LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00666/AM20/ |
RLA File<br>:34/24/040/00199/AM20/ |
Lic.No/Date:3410045478<br>25.09.2019 |
|
| 110 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>Oxacillin<br>for<br>Injection<br>USP<br>2<br>gm<br>Each Vials Contains Oxacillin Sodium Equivalent to 2gm Oxacillin.<br>85500<br>Number<br>2<br>Oxacillin<br>for<br>Injection<br>USP<br>10gm.<br>Each Vial Contains Oxaxillin Sodium Equivalent to 10gm Oxacillin.<br>10800<br>Number<br>Sl.<br>No.<br>Import Items<br>Qty.<br>1<br>STERILE OXACILLIN SODIUM (Sterile Bulk)<br>292.95 kg<br>2<br>RUBBER STOPPER (AS PER GENERAL NOTES)<br>Relevant as per packing policy<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
45
| Case No.:93/10/82- |
|
Party Name:ASTRAL |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
STERITECH PVT. LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045479 |
|
|
| :01/82/050/00667/AM20/ |
|
:34/24/040/00200/AM20/ |
|
25.09.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
111
| Sl.<br>No.<br>1<br>2 |
Export Product |
Export Product |
Qty. |
|
Oxacillin<br>for<br>Injection<br>USP<br>2<br>gm<br>Each Vials Contains Oxacillin Sodium Equivalent to 2gm Oxacillin. |
|
85500<br>Number |
|
Oxacillin<br>for<br>Injection<br>USP<br>Each Vial Contains Oxaxillin Sodium Equivalent to 10gm |
10gm.<br>Oxacillin. |
10800<br>Number |
|
|
|
|
| Sl.<br>No. |
Import Items |
Qty. |
|
| 1 |
STERILE OXACILLIN SODIUM (Sterile Bulk) |
292.95 kg |
|
| 2 |
RUBBERSTOPPER(ASPERGENERALNOTES) |
Relevant as perpacking policy |
|
| Case No.:88/10/82- |
|
Party Name:AVA |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CHEMICALS PVT.LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831815 |
|
|
| :01/82/050/00662/AM20/ |
|
:03/94/040/00498/AM20/ |
|
26.09.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 112 meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Exportproduct |
Qty. |
Sl. No. |
Import items |
Qty. |
| EDTA FERRIC SODIUM Fe |
1 kg |
1 |
ETHYLENE DIAMINE |
0.730 kg |
| content 13% ( +/- 0.5) |
|
|
TETRA ACETIC ACID |
|
46
| Case No.:89/10/82- |
|
Party Name:BLISS GVS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831844 |
|
|
| :01/82/050/00663/AM20/ |
|
:03/94/040/00504/AM20/ |
|
26.09.2019 |
|
|
|
Case No.:89/10/82-<br>ALC4/2019 |
Case No.:89/10/82-<br>ALC4/2019 |
Party Name:BLISS GVS<br>PHARMA LIMITED |
Party Name:BLISS GVS<br>PHARMA LIMITED |
Party Name:BLISS GVS<br>PHARMA LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0310831844<br>26.09.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0310831844<br>26.09.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0310831844<br>26.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00663/AM20/ |
|
RLA File<br>:03/94/040/00504/AM20/ |
|
|
|
|
|
|
| 113 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Gsunate - 200 mg / Malavan - 200 mg<br>Artesunate suppositories 200mg ( Net<br>Contain Artesunate 98.04 Kgs)<br>1 Number<br>1<br>Artesunate<br>204.00 mg /<br>200<br>mg<br>suppositories<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
|
Import items |
Qty. |
|
|
|
Gsunate - 200 mg / Malavan - 200 mg<br>Artesunate suppositories 200mg ( Net<br>Contain Artesunate 98.04 Kgs) |
|
1 Number |
1 |
|
Artesunate |
204.00 mg /<br>200<br>mg<br>suppositories |
|
|
|
|
|
|
|
|
|
|
|
| 114 |
<br>Case No.:94/10/82-<br>ALC4/2019 |
Party Name:GOVIND<br>LABORATORIES PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0810146235<br>26.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00668/AM20/ |
RLA File<br>:08/24/040/00207/AM20/ |
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| Case No.:95/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831845 |
|
|
| :01/82/050/00669/AM20/ |
|
:03/94/040/00503/AM20/ |
|
27.09.2019 |
|
|
|
Case No.:95/10/82-<br>ALC4/2019 |
Case No.:95/10/82-<br>ALC4/2019 |
Case No.:95/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310831845<br>27.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00669/AM20/ |
|
|
RLA File<br>:03/94/040/00503/AM20/ |
|
|
|
|
| 115 |
<br>**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output n<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl. No.<br>TELMISARTAN<br>1 kg<br>1<br>2<br>3<br>4<br>RA concerned maytake further necessaryaction a |
|
|
|
|
per agenda in the presence of the technical experts and it<br>orms under para 4.7 of HBP as per details below or as |
|
|
|
|
Export product |
Qty. |
|
Sl. No. |
Import items |
|
Qty. |
|
|
TELMISARTAN |
1 kg |
|
1 |
2N-PROPYL-4-METHYL-6-(1-<br>METHYL- BENZIMIDAZOL-2-<br>YL)BENZIMIDAZOLE |
|
0.763 kg |
|
|
|
|
|
2 |
4-METHYL-2-BIPHENYL<br>CARBOXYLIC ACID METHYL<br>ESTER |
|
0.600 kg |
|
|
|
|
|
3 |
METHANOL |
|
3.69 kg |
|
|
|
|
|
4 |
METHYLENE CHLORIDE |
|
2.20 kg |
|
|
|
|
|
|
sper above decision of NC. |
|
|
47
| Case No.:96/10/82- |
|
Party Name:KAIRAV |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CHEMOFARBE |
|
ALC4/2019 |
|
Deferred |
|
|
INDUSTRIES LTD. |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831860 |
|
Defer Date: |
| :01/82/050/00670/AM20/ |
|
:03/94/040/00484/AM20/ |
|
27.09.2019 |
|
|
116 Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chennai. Further, the Committee considered the case as per online generated agenda and it was decided to call the firm to attend Personal Hearing before Norms Committee alongwith a copy of 4.07 application of subject advance authorization and COA of import item – Acetonitrile (Purity 80%) from foreign supplier.
| Case No.:97/10/82- |
|
Party Name:KAIRAV |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CHEMOFARBE |
|
ALC4/2019 |
|
Deferred |
|
|
INDUSTRIES LTD. |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831861 |
|
Defer Date: |
| :01/82/050/00671/AM20/ |
|
:03/94/040/00485/AM20/ |
|
27.09.2019 |
|
|
117 Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chennai. Further, the Committee considered the case as per online generated agenda and it was decided to call the firm to attend Personal Hearing before Norms Committee alongwith a copy of 4.07 application of subject advance authorization and COA of import item – Acetonitrile (Purity 80%) from foreign supplier.
|
|
Case No.:98/10/82- |
|
Party Name:O C |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
SPECIALITIES PVT.LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 118 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310831873 |
|
Defer Date: |
|
|
:01/82/050/00672/AM20/ |
|
:03/95/040/00625/AM20/ |
|
27.09.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
|
|
Case No.:99/10/82- |
|
Party Name:RELIANCE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 119 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310831889 |
|
Defer Date: |
|
|
:01/82/050/00673/AM20/ |
|
:03/95/040/00567/AM20/ |
|
27.09.2019 |
|
|
|
|
**Decision:**New Case. The |
|
Committee decided to refer the case to Special Committee for further |
|
|
|
|
|
|
consideration. |
|
|
|
|
|
|
|
|
Case No.:100/10/82- |
|
Party Name:AVIK |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
PHARMACEUTICAL LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 120 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310831890 |
|
Defer Date: |
|
|
:01/82/050/00674/AM20/ |
|
:03/94/040/00496/AM20/ |
|
27.09.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
48
| 121 |
Case No.:101/10/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00675/AM20/ |
RLA File<br>:03/95/040/00568/AM20/ |
Lic.No/Date:0310831891<br>27.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
| 122 |
<br>Case No.:102/10/82-<br>ALC4/2019 |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00676/AM20/ |
RLA File<br>:03/94/040/00497/AM20/ |
Lic.No/Date:0310831894<br>27.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 123 |
<br>Case No.:103/10/82-<br>ALC4/2019 |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00677/AM20/ |
RLA File<br>:03/94/040/00494/AM20/ |
Lic.No/Date:0310831896<br>27.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 124 |
Case No.:104/10/82-<br>ALC4/2019 |
Case No.:104/10/82-<br>ALC4/2019 |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00678/AM20/ |
|
RLA File<br>:03/94/040/00493/AM20/ |
|
|
|
Lic.No/Date:0310831897<br>27.09.2019 |
|
|
|
<br>**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output n<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>MOMETASONE FUROATE<br>MICRONIZED EP/BP/USP<br>1 kg<br>RA concerned maytake further necessaryaction a |
|
|
|
per agenda in the presence of the technical experts and it<br>orms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
MOMETASONE FUROATE<br>MICRONIZED EP/BP/USP |
|
1 kg |
1 |
9B, 11B- Epoxy-16A-<br>Methyl pregna-1,4 Diene-<br>17,21- Dihydroxy-3,20-<br>DIONE (8DM) |
|
1.00 kg |
|
|
|
|
|
|
sper above decision of NC. |
|
|
|
|
49
| Case No.:105/10/82- |
|
Party Name:AVIK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICAL LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831898 |
|
|
| :01/82/050/00679/AM20/ |
|
:03/94/040/00492/AM20/ |
|
27.09.2019 |
|
|
|
Case No.:105/10/82-<br>ALC4/2019 |
Case No.:105/10/82-<br>ALC4/2019 |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00679/AM20/ |
|
RLA File<br>:03/94/040/00492/AM20/ |
|
|
|
Lic.No/Date:0310831898<br>27.09.2019 |
|
|
| 125 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CLOBETASOL 17 PROPIONATE<br>EP/BP/USP<br>600 kg<br>1<br>BETAMETHASONE<br>600 kg<br>BETAMETHASONE<br>DIPROPIONATE EP/BP/USP<br>200 kg<br>BETAMETHASONE<br>173.60 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
CLOBETASOL 17 PROPIONATE<br>EP/BP/USP |
|
600 kg |
1 |
BETAMETHASONE |
|
600 kg |
|
|
|
BETAMETHASONE<br>DIPROPIONATE EP/BP/USP |
|
200 kg |
|
BETAMETHASONE |
|
173.60 kg |
|
|
|
|
|
|
|
|
|
|
|
| Case No.:106/10/82- |
|
Party Name:AVIK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICAL LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831899 |
|
|
| :01/82/050/00680/AM20/ |
|
:03/94/040/00495/AM20/ |
|
27.09.2019 |
|
|
|
Case No.:106/10/82-<br>ALC4/2019 |
Case No.:106/10/82-<br>ALC4/2019 |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00680/AM20/ |
|
RLA File<br>:03/94/040/00495/AM20/ |
|
|
|
Lic.No/Date:0310831899<br>27.09.2019 |
|
|
| 126 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>PREDNISOLONE<br>ACETATE<br>MICRONIZED EP/BP/USP<br>1 kg<br>1<br>PREDNISOLONE<br>0.943 kg<br>PREDNISOLONE<br>SODIUM<br>PHOSPHATE EP/BP/USP<br>1 kg<br>1<br>PREDNISOLONE<br>0.839 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
PREDNISOLONE<br>ACETATE<br>MICRONIZED EP/BP/USP |
|
1 kg |
1 |
PREDNISOLONE |
|
0.943 kg |
|
|
|
PREDNISOLONE<br>SODIUM<br>PHOSPHATE EP/BP/USP |
|
1 kg |
1 |
PREDNISOLONE |
|
0.839 kg |
|
|
|
|
|
|
|
|
|
|
|
50
| Case No.:107/10/82- |
|
Party Name:AVIK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICAL LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831900 |
|
|
| :01/82/050/00681/AM20/ |
|
:03/94/040/00491/AM20/ |
|
27.09.2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:107/10/82-<br>ALC4/2019 |
|
Party Name:AVIK<br>PHARMACEUTICAL LTD., |
|
|
|
Meet No/Date:10/82-<br>ALC4/2019 |
|
Status:<br>Approved |
|
HQ File |
|
RLA File |
|
|
|
29.11.2019 |
|
|
|
|
|
|
|
|
|
Lic.No/Date:0310831900 |
|
|
|
:01/82/050/00681/AM20/ |
|
:03/94/040/00491/AM20/ |
|
|
|
27.09.2019 |
|
|
|
**Decision:**The Committee co<br>was decided to ratify the ad-ho |
|
nsidered case as per agenda in the presence of the technical experts and it<br>c input output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
| 127 |
<br>applied by firm whichever is lower:<br> |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
I |
mport items |
Q |
ty. |
|
|
BECLOMETHASONE |
|
1 kg |
1 |
P<br> |
regna 1,4-Dien-9,11-<br> |
0. |
88 kg |
|
|
<br>DIPROPIONATE<br>MICRO<br>(EP/BP/USP) |
NIZED |
|
|
<br> <br> |
poxide-16Beta<br>methyl-17 ALP (DB-<br> |
|
|
|
XI)<br>RA concerned matake further necessaraction aser above decision of NC |
|
|
|
|
XI) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
y y p. |
|
|
|
|
|
|
|
|
| Case No.:108/10/82- |
|
Party Name:BIOLOGICAL E |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068044 |
|
|
| :01/82/050/00682/AM20/ |
|
:09/24/040/00338/AM20/ |
|
27.09.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
128
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| NEOSTIGMINE |
200000.000 |
1 |
NEOSTIGMINE |
2.20 kg |
| METHYLSULFATE INJECTION |
Vials |
|
METHYLSULFATE |
|
| USP 10MG/10ML (1MG/ML) |
|
|
USP |
|
|
|
Case No.:109/10/82- |
|
Party Name:CHIRAG |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
ENTERPRISE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 129 |
|
HQ File<br>:01/82/050/00683/AM20/ |
|
RLA File<br>:24/24/040/00028/AM20/ |
|
Lic.No/Date:2410042868<br>27.09.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Rajkot. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Rajkot.
51
| 130 |
Case No.:110/10/82-<br>ALC4/2019 |
Party Name:GOPINATH<br>CHEM-TECH LTD., |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00684/AM20/ |
RLA File<br>:08/24/040/00190/AM20/ |
Lic.No/Date:0810146246<br>27.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Ahmedabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
| Case No.:111/10/82- |
|
Party Name:S V LABS PVT |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068047 |
|
|
| :01/82/050/00685/AM20/ |
|
:09/24/040/00334/AM20/ |
|
27.09.2019 |
|
|
|
Case No.:111/10/82-<br>ALC4/2019 |
Case No.:111/10/82-<br>ALC4/2019 |
Party Name:S V LABS PVT<br>LTD |
Party Name:S V LABS PVT<br>LTD |
Party Name:S V LABS PVT<br>LTD |
Party Name:S V LABS PVT<br>LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00685/AM20/ |
|
RLA File<br>:09/24/040/00334/AM20/ |
|
|
|
Lic.No/Date:0910068047<br>27.09.2019 |
|
|
| 131 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4-BROMOMETHYL-<br>2CYANOBIPHENYL RX<br>1 kg<br>1<br>DICHLOROMETHANE<br>0.77 kg<br>2<br>2-CYANO-4-METHYL<br>BIPHENYL (OTBN)<br>0.785 kg<br>3<br>METHANOL<br>0.45 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
4-BROMOMETHYL-<br>2CYANOBIPHENYL RX |
|
1 kg |
1 |
DICHLOROMETHANE |
|
0.77 kg |
|
|
|
|
|
|
2 |
2-CYANO-4-METHYL<br>BIPHENYL (OTBN) |
|
0.785 kg |
|
|
|
|
|
|
3 |
METHANOL |
|
0.45 kg |
|
|
|
|
|
|
|
|
|
|
|
| 132 |
Case No.:112/10/82-<br>ALC4/2019 |
Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00686/AM20/ |
RLA File<br>:09/24/040/00318/AM20/ |
Lic.No/Date:0910068049<br>27.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 133 |
<br>Case No.:113/10/82-<br>ALC4/2019 |
Party Name:STERLING<br>AUXILIARIES PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00687/AM20/ |
RLA File<br>:03/95/040/00340/AM20/ |
Lic.No/Date:0310831915<br>30.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
52
| 134 |
<br>Case No.:114/10/82-<br>ALC4/2019 |
Party Name:STERLING<br>AUXILIARIES PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00688/AM20/ |
RLA File<br>:03/95/040/00135/AM20/ |
Lic.No/Date:0310831916<br>30.09.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 135 |
Case No.:115/10/82-<br>ALC4/2019 |
Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00689/AM20/ |
RLA File<br>:31/83/040/00087/AM20/ |
Lic.No/Date:3110067548<br>30.09.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Pune. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.
| Case No.:116/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310831944 |
|
|
| :01/82/050/00690/AM20/ |
|
:03/94/040/00508/AM20/ |
|
01.10.2019 |
|
|
|
Case No.:116/10/82-<br>ALC4/2019 |
Case No.:116/10/82-<br>ALC4/2019 |
Case No.:116/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00690/AM20/ |
|
|
RLA File<br>:03/94/040/00508/AM20/ |
|
|
Lic.No/Date:0310831944<br>01.10.2019 |
|
|
| 136 |
<br>**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output n<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl. No.<br>TELMISARTAN<br>1 kg<br>1<br>2<br>3<br>4<br>RA concerned maytake further necessaryaction a |
|
|
|
|
per agenda in the presence of the technical experts and it<br>orms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
Export product |
Qty. |
|
Sl. No. |
Import items |
|
Qty. |
|
|
|
TELMISARTAN |
1 kg |
|
1 |
2N-PROPYL-4-METHYL-6-(1-<br>METHYL- BENZIMIDAZOL-2-<br>YL)BENZIMIDAZOLE |
|
0.763 kg |
|
|
|
|
|
|
2 |
4-METHYL-2-BIPHENYL<br>CARBOXYLIC ACID METHYL<br>ESTER |
|
0.600 kg |
|
|
|
|
|
|
3 |
METHANOL |
|
3.69 kg |
|
|
|
|
|
|
4 |
METHYLENE CHLORIDE |
|
2.20 kg |
|
|
|
|
|
|
|
sper above decision of NC. |
|
|
|
| 137 |
<br>Case No.:117/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>RLA File<br>:03/94/040/00509/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0310831946<br>01.10.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00691/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
53
| 138 |
Case No.:118/10/82-<br>ALC4/2019 |
Party Name:MOREPEN<br>LABORATORIES LTD.,<br>RLA File<br>:05/24/040/00361/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00692/AM20/ |
|
Lic.No/Date:0510411995<br>01.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhii. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhii.
| Case No.:119/10/82- |
|
Party Name:PANACEA |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
BIOTEC LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510412013 |
|
|
| :01/82/050/00693/AM20/ |
|
:05/24/040/00358/AM20/ |
|
03.10.2019 |
|
|
|
Case No.:119/10/82-<br>ALC4/2019 |
Party Name:PANACEA<br>BIOTEC LTD., |
Party Name:PANACEA<br>BIOTEC LTD., |
Party Name:PANACEA<br>BIOTEC LTD., |
Party Name:PANACEA<br>BIOTEC LTD., |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00693/AM20/ |
RLA File<br>:05/24/040/00358/AM20/ |
|
|
|
Lic.No/Date:0510412013<br>03.10.2019 |
|
|
| 139 |
**Decision:**Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per<br>SION A-412 or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>PANIMUN BIORAL CAPSULES 25<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>25 MG.)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>25.50 mg /<br>25 mg<br>tablet<br>PANIMUN BIORAL CAPSULES 50<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>50 MG.)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>51.00 mg /<br>50 mg<br>tablet<br>PANIMUN BIORAL CAPSULES 100<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>100 MG.)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>102.00 mg<br>/ 100 mg<br>tablet<br>CYCLOSPORINE CAPSULE 25 MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>25 mg)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>25.50 mg /<br>25 mg<br>tablet<br>CYCLOSPORINE CAPSULES 50<br>MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>50 mg)<br>1<br>Number<br>1<br>CYCLOSPORINE USP<br>51.00 mg /<br>50 mg<br>tablet<br>CYCLOSPORINE CAPSULES 100<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>100 mg)<br>16350<br>Number<br>1<br>CYCLOSPORINE USP<br>102.00 mg<br>/ 100 mg<br>tablet<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
|
Qty. |
|
PANIMUN BIORAL CAPSULES 25<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>25 MG.) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
|
|
25.50 mg /<br>25 mg<br>tablet |
|
PANIMUN BIORAL CAPSULES 50<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>50 MG.) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
|
|
51.00 mg /<br>50 mg<br>tablet |
|
PANIMUN BIORAL CAPSULES 100<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>100 MG.) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
|
|
102.00 mg<br>/ 100 mg<br>tablet |
|
CYCLOSPORINE CAPSULE 25 MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>25 mg) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
|
|
25.50 mg /<br>25 mg<br>tablet |
|
CYCLOSPORINE CAPSULES 50<br>MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>50 mg) |
|
1<br>Number |
1 |
CYCLOSPORINE USP |
|
|
51.00 mg /<br>50 mg<br>tablet |
|
CYCLOSPORINE CAPSULES 100<br>MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>100 mg) |
|
16350<br>Number |
1 |
CYCLOSPORINE USP |
|
|
102.00 mg<br>/ 100 mg<br>tablet |
|
RA concerned maytake further necessary |
|
action asper above |
|
decision of NC. |
|
|
|
Decision: Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per SION A-412 or as applied by firm whichever is lower:
54
| 140 |
Case No.:120/10/82-<br>ALC4/2019 |
Party Name:TADIMETY<br>AROMATICS PRIVATE<br>LIMITED<br>RLA File<br>:07/24/040/00141/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00694/AM20/ |
|
Lic.No/Date:0710115523<br>03.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Bangalore. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
| Case No.:121/10/82- |
|
Party Name:HETERO LABS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068055 |
|
|
| :01/82/050/00695/AM20/ |
|
:09/24/040/00351/AM20/ |
|
03.10.2019 |
|
|
Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and in the light of earlier decision taken in meeting no. 2/82-ALC4/2019 dated 21.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
141
|
Export Product |
Qty |
S. |
Import Item |
Qty. |
|
|
|
No. |
|
|
|
Losartan Potassium |
1 kg |
1. |
2-Butyl-4-chloro-5-formyl imidazole |
0.50 kg |
|
|
|
2. |
4-Bromo methyl-2-cyano biphenyl |
0.75 kg |
|
|
|
3. |
Sodium borohydride |
0.048 kg |
|
|
|
4. |
Toluene |
1.45 kg |
|
|
|
5. |
Methanol |
0.85 kg |
| RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
| 142 |
<br>Case No.:122/10/82-<br>ALC4/2019 |
Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00696/AM20/ |
RLA File<br>:03/94/040/00514/AM20/ |
Lic.No/Date:0310832013<br>04.10.2019 |
Defer Date: |
|
**Decision:**Deferred for comments of TE. |
|
|
|
55
|
|
Case No.:123/10/82- |
|
Party Name:YASHO |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 143 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310832030 |
|
Defer Date: |
|
|
:01/82/050/00697/AM20/ |
|
:03/95/040/00677/AM20/ |
|
04.10.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
| Case No.:124/10/82- |
|
Party Name:VIVIMED LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068060 |
|
|
| :01/82/050/00698/AM20/ |
|
:09/24/040/00341/AM20/ |
|
04.10.2019 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in the |
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in the |
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in the |
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in the |
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in the |
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in the |
|
|
light of earlier decision taken by NC in its Meeting No. 6/82-ALC4/2019, dated |
|
|
|
16.08.2019, it was decided |
|
|
|
to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm |
|
|
|
|
|
|
|
whichever is lower: |
|
|
|
|
|
|
|
Export Item |
|
|
|
Qty. |
|
|
|
Losartan Potassium Tablets USP-25 MG-90s |
|
|
|
1 Number |
|
|
|
Losartan Potassium Tablets USP-25Mg-1000s |
|
|
|
1 Number |
|
|
|
Losartan Potassium Tablets USP-50 MG-30s |
|
|
|
1 Number |
|
|
|
Losartan Potassium Tablets USP-50 MG-90s |
|
|
|
1 Number |
|
|
|
Losartan Potassium Tablets USP-50 MG-1000s |
|
|
|
1 Number |
|
|
|
Losartan Potassium Tablets USP-100 MG-30s |
|
|
|
1 Number |
|
| 144 |
|
Losartan Potassium Tablets USP-100 MG-90s |
|
|
|
1 Number |
|
|
|
Losartan Potassium Tablets USP-100 MG-90s |
|
|
|
1 Number |
|
|
|
|
|
|
|
|
|
|
|
Sl.<br>Import items |
Norms Recommended for one Tablet |
|
|
|
|
|
|
No. |
25 Mg Tablet |
50 Mg Tablet<br>100 Mg Tablet |
|
|
|
|
|
1<br>Losartan Potassium (or) Losartan |
25.5 mg |
51 mg |
|
102 mg |
|
|
|
Potasium USP |
|
|
|
|
|
|
|
2<br>Mannitol (Pearlitol 160C) |
101.9 mg |
203.8 mg |
|
407.6 mg |
|
|
|
3<br>Microcrystalline Cellulose (Avicel PH |
40.5 mg |
81.0 mg |
|
162 mg |
|
|
|
102) |
|
|
|
|
|
|
|
4<br>Croscarmellose Sodium (Ac Di Sol) |
7.19 mg |
14.38 mg |
|
<br>28.76 mg |
|
|
|
5<br>Povidone(PLASDONE K-29/32) |
3.61 mg |
7.22 mg |
|
14.44 mg |
|
|
|
6<br>Magnesium Stearate (Mallinckrodt |
1.8 mg |
3.6 mg |
|
7.2 mg |
|
|
|
2257) |
|
|
|
|
|
|
|
7<br>Opadry White (03H28419) |
3.6mg |
7.2 mg |
|
14.4 mg |
|
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
56
|
|
Case No.:134/10/82- |
|
Party Name:YASHO |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 145 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310832068 |
|
Defer Date: |
|
|
:01/82/050/00708/AM20/ |
|
:03/95/040/00678/AM20/ |
|
07.10.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
| Case No.:139/10/82- |
|
Party Name:TIDE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
INDUSTRIES |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045515 |
|
|
| :01/82/050/00713/AM20/ |
|
:34/24/040/00203/AM20/ |
|
07.10.2019 |
|
|
Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and in the light of earlier decision taken in meeting no. 4/82-ALC4/2014 dated 146 03.07.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
|
Export Product |
Qty |
|
S. |
Import Item |
Qty. |
|
|
|
|
No. |
|
|
|
Lauryl Nitrile |
1 kg |
|
1. |
Lauric Acid |
1.22 kg |
| RA maytake appropriate action asper the decision |
|
|
of Norms Committee. |
|
|
|
|
Case No.:140/10/82-<br> |
Party Name:LINK PHARMA<br> |
Meet No/Date:10/82-<br> |
Status:<br> |
| 147 |
ALC4/2019 |
CHEM LIMITED<br>RLA File<br>:34/24/040/00099/AM20/ |
ALC4/2019<br>29.11.2019 |
|
|
<br>HQ File<br>:01/82/050/00714/AM20/ |
|
Lic.No/Date:3410045519<br>07.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Vadodara. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
57
| Case No.:135/10/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832084 |
|
|
| :01/82/050/00709/AM20/ |
|
:03/94/040/00483/AM20/ |
|
09.10.2019 |
|
|
|
Case No.:135/10/82-<br>ALC4/2019 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00483/AM20/ |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00483/AM20/ |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00483/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00709/AM20/ |
|
|
|
Lic.No/Date:0310832084<br>09.10.2019 |
|
|
| 148 |
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower: |
|
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
Rinza sip with Vitamin C<br>(Flavours Orange/ Lemon/<br>Black<br>Currant/<br>Other<br>flavours)<br>&<br>Rinza<br>Sip<br>(Flavours<br>Orange/<br>Lemon/<br>Black<br>currant/<br>Cranberry/ Honey Lemon/<br>Other flavours). Each sachet<br>of 5gm contains Caffeine<br>Anhydrous Powder 30mg.<br>Net content of Caffeine<br>Anhydrous Powder 450 Kgs. |
1 Number<br>Sachet |
1 |
Caffeine Anhydrous Powder |
|
30.3 mg / 5<br>gm sachet |
|
|
Rinza<br>Tablets.<br>Each<br>tablet<br>Contains<br>Caffeine Anhydrous Powder<br>30 mg, Paracetamol BP 500<br>mg. Net Content of Caffeine<br>Anhydrous Powder - 1890<br>Kgs and Paracetamol BP-<br>31500 Kgs |
1 Number<br>Tablet |
1 |
Caffeine Anhydrous Powder |
|
30.60 mg /<br>tablet |
|
|
|
|
2 |
Paracetamol IP/BP |
|
510 mg /<br>tablet |
|
|
Rinza<br>Sip<br>for<br>Children<br>(Flavours Rasp berry/ other<br>flavours).<br>Each sachet of 3gm contains<br>Paracetamol BP - 280mg.<br>Net content-560 Kgs. |
1<br>Number<br>Sachet |
1 |
Paracetamol IP/BP |
|
282.80 mg / 3<br>gm sachet |
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
58
| Case No.:136/10/82- |
|
Party Name:USV PRIVATE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832086 |
|
|
| :01/82/050/00710/AM20/ |
|
:03/95/040/00682/AM20/ |
|
09.10.2019 |
|
|
|
Case No.:136/10/82-<br>ALC4/2019 |
Party Name:USV PRIVATE<br>LIMITED |
Party Name:USV PRIVATE<br>LIMITED |
Party Name:USV PRIVATE<br>LIMITED |
Party Name:USV PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00710/AM20/ |
RLA File<br>:03/95/040/00682/AM20/ |
|
|
|
Lic.No/Date:0310832086<br>09.10.2019 |
|
| 149 |
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts, it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower: |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
Desipramine Hydrochloride Tablets,<br>USP 10 MG<br>(16,000 Bottles x 100 Per Bottles =<br>16,00,000 Tablets) ( Net Content Weight<br>=16.000 Kgs) |
|
1 Number |
1 |
Desipramine HCL |
|
10.20 mg |
|
Desipramine Hydrochloride Tablets,<br>USP 25 MG<br>(6,000 Bottles x 100 Per Bottles =<br>6,00,000 Tablets) ( Net Content Weight<br>= 15.000 Kgs) |
|
1 Number |
1 |
Desipramine HCL |
|
25.50 mg |
|
Desipramine Hydrochloride Tablets,<br>USP 75 MG<br>(1,573 Bottles x 100 Per Bottles =<br>1,57,300 Tablets) ( Net Content Weight<br>= 11.798 Kgs) |
|
1 Number |
1 |
Desipramine HCL |
|
76.50 mg |
|
Desipramine Hydrochloride Tablets,<br>USP 100 MG<br>(3,150 Bottles x 100 Per Bottles =<br>3,15,000 Tablets) ( Net Content Weight<br>=31.500 Kgs) |
|
1 Number |
|
Desipramine HCL |
|
102.00 mg |
|
Desipramine Hydrochloride Tablets,<br>USP 50 MG<br>(6,300 Bottles x 100 Per Bottles =<br>6,30,000 Tablets) ( Net Content Weight<br>=31.500 Kgs) |
|
1 Number |
|
Desipramine HCL |
|
51.00 mg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
59
| Case No.:137/10/82- |
|
Party Name:MALLADI |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
DRUGS & |
|
ALC4/2019 |
|
Approved |
|
|
PHARMACEUTICALS |
|
29.11.2019 |
|
|
|
|
LIMITED |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0410166140 |
|
|
| :01/82/050/00711/AM20/ |
|
:04/24/040/00110/AM20/ |
|
09.10.2019 |
|
|
|
|
ALC4/2019<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00711/AM20/<br>RLA File<br>:04/24/040/00110/AM20/<br>Lic.No/Date:0410166140<br>09.10.2019 |
ALC4/2019<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00711/AM20/<br>RLA File<br>:04/24/040/00110/AM20/<br>Lic.No/Date:0410166140<br>09.10.2019 |
ALC4/2019<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00711/AM20/<br>RLA File<br>:04/24/040/00110/AM20/<br>Lic.No/Date:0410166140<br>09.10.2019 |
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
|
|
|
|
meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as |
|
|
| 150 |
|
per details given below or as applied by the firm, whichever is less: |
|
|
|
|
Export product<br>Qty.<br>Sl.<br>Import items |
Qty. |
|
|
|
No. |
|
|
|
|
N-t-Boc-trans-4-hydroxy-L-<br>1 kg 1<br>Trans-4-hydroxy-l-proline |
0.886 kg |
|
|
|
proline<br>2<br>Di-tertbutyldicarbonate |
1.51 kg |
|
|
|
3<br>Ethyl Acetate |
2.50 kg |
|
|
|
4<br>Caustic soda Flakes |
0.30 kg |
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
Case No.:138/10/82- |
|
Party Name:STERLING |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
AUXILIARIES PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310832108 |
|
Defer Date: |
| 151 |
|
:01/82/050/00712/AM20/ |
|
:03/95/040/00273/AM20/ |
|
09.10.2019 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda |
|
|
|
and it was decided to call |
|
for following |
|
|
information from the firm: |
|
|
|
|
|
|
|
|
(ii)<br>Percentage ofyield on molar basis. |
|
|
|
|
|
|
Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm: (ii) Percentage of yield on molar basis.
| Case No.:141/10/82- |
|
Party Name:AVR ORGANICS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068070 |
|
|
| :01/82/050/00715/AM20/ |
|
:09/24/040/00337/AM20/ |
|
09.10.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
152
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| (1S,4R)-4-AMINO-2- |
1 kg |
1 |
2-Azabicyclo (2,2,1) Hept-5-Ene- |
1.543 kg |
| CYCLOPENTENE-METHANOL |
|
|
3-One(Vincelactam)100% |
|
| HYDROCHLORIDE |
|
2 |
L+Tartaric Acid |
1.358 kg |
|
|
3 |
Sodium Borohydride |
0.420 kg |
60
| Case No.:142/10/82- |
|
Party Name:PANACEA |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
BIOTEC LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510412057 |
|
|
| :01/82/050/00716/AM20/ |
|
:05/24/040/00372/AM20/ |
|
09.10.2019 |
|
|
|
Case No.:142/10/82-<br>ALC4/2019 |
Case No.:142/10/82-<br>ALC4/2019 |
Party Name:PANACEA<br>BIOTEC LTD., |
Party Name:PANACEA<br>BIOTEC LTD., |
Party Name:PANACEA<br>BIOTEC LTD., |
Party Name:PANACEA<br>BIOTEC LTD., |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00716/AM20/ |
|
RLA File<br>:05/24/040/00372/AM20/ |
|
|
|
Lic.No/Date:0510412057<br>09.10.2019 |
|
|
| 153 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TACROLIMUS 1 MG CAPSULES<br>(EACH HARD GELATIN<br>CAPSULE CONTAINS:<br>TACROLIMUS EQUIVALENT<br>TO ANHYDROUS TACROLIMUS<br>1 MG)<br>700000<br>Number<br>1<br>EMPTY HARD<br>GELATIN CAPSULE<br>WHITE<br>Relevant as<br>per Packing<br>Policy<br>TACROLIMUS 1.0 MG<br>CAPSULES<br>(EACH HARD GELATIN<br>CAPSULE CONTAINS:<br>TACROLIMUS EQUIVALENT<br>TO ANHYDROUS TACROLIMUS<br>1.0 MG)TACPAN 1.0 MG<br>CAPSULES<br>300000<br>Number<br>1<br>EMPTY HARD<br>GELATIN CAPSULE<br>WHITE<br>Relevant as<br>per Packing<br>Policy<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
TACROLIMUS 1 MG CAPSULES<br>(EACH HARD GELATIN<br>CAPSULE CONTAINS:<br>TACROLIMUS EQUIVALENT<br>TO ANHYDROUS TACROLIMUS<br>1 MG) |
|
700000<br>Number |
1 |
EMPTY HARD<br>GELATIN CAPSULE<br>WHITE |
|
Relevant as<br>per Packing<br>Policy |
|
|
|
TACROLIMUS 1.0 MG<br>CAPSULES<br>(EACH HARD GELATIN<br>CAPSULE CONTAINS:<br>TACROLIMUS EQUIVALENT<br>TO ANHYDROUS TACROLIMUS<br>1.0 MG)TACPAN 1.0 MG<br>CAPSULES |
|
300000<br>Number |
1 |
EMPTY HARD<br>GELATIN CAPSULE<br>WHITE |
|
Relevant as<br>per Packing<br>Policy |
|
|
|
|
|
|
|
|
|
|
|
| Case No.:143/10/82- |
|
Party Name:AMI ORGANICS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:5210043197 |
|
|
| :01/82/050/00717/AM20/ |
|
:52/24/040/00034/AM20/ |
|
09.10.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 14/82-ALC4/2014 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 154 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
|
Qty. |
|
|
No. |
|
|
|
| TERT- BUTYL 1-PIPERAZINE |
1 kg |
1 |
DI-<br>TERT |
BUTYL |
1.94 kg |
| CARBOXYLATE (1-BOC |
|
|
DICARBONATE |
|
|
| PIPERAZINE) |
|
2 |
PIPERAZINE ANHYDROUS |
|
0.722 kg |
61
| Case No.:144/10/82- |
|
Party Name:DEEPAK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHENOLICS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045525 |
|
|
| :01/82/050/00718/AM20/ |
|
:34/24/040/00196/AM20/ |
|
09.10.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 155 applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| PHENOL |
1 kg |
1 |
BENZENE |
0.87 kg |
| 156 |
Case No.:145/10/82-<br>ALC4/2019 |
Party Name:STERILE INDIA<br>PRIVATE LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00719/AM20/ |
RLA File<br>:05/24/040/00377/AM20/ |
Lic.No/Date:0510412070<br>10.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhi. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
| 157 |
Case No.:146/10/82-<br>ALC4/2019 |
Party Name:RAJASTHAN<br>ANTIBIOTICS LTD<br>RLA File<br>:05/24/040/00357/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00720/AM20/ |
|
Lic.No/Date:0510412071<br>10.10.2019 |
|
|
<br>**Decision:**The Committee considered the case as per agenda and it was decided to call the firm to attend<br>Personal Hearing before Norms Committee alonwigh following documents / information:<br>(i) Drug Manufacturing license (DML) of the export product.<br>(ii) A copyof 4.07 application of subject advance authorization. |
|
|
|
62
| Case No.:148/10/82- |
|
Party Name:DEEPAK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHENOLICS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045527 |
|
|
| :01/82/050/00722/AM20/ |
|
:34/24/040/00072/AM20/ |
|
10.10.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 158 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| PHENOL |
1 kg |
1 |
BENZENE |
0.87 kg |
| Case No.:149/10/82- |
|
Party Name:DEEPAK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHENOLICS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045528 |
|
|
| :01/82/050/00723/AM20/ |
|
:34/24/040/00317/AM19/ |
|
10.10.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 159 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| PHENOL |
1 kg |
1 |
BENZENE |
0.87 kg |
| Case No.:150/10/82- |
|
Party Name:DEEPAK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHENOLICS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045529 |
|
|
| :01/82/050/00724/AM20/ |
|
:34/24/040/00325/AM19/ |
|
10.10.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 160 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| PHENOL |
1 kg |
1 |
BENZENE |
0.87 kg |
63
|
|
Case No.:147/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 161 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310832145 |
|
Defer Date: |
|
|
:01/82/050/00721/AM20/ |
|
:03/94/040/00541/AM20/ |
|
11.10.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
| Case No.:151/10/82- |
|
Party Name:HETERO LABS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068077 |
|
|
| :01/82/050/00725/AM20/ |
|
:09/24/040/00352/AM20/ |
|
11.10.2019 |
|
|
|
|
29.11.2019<br>HQ File<br>:01/82/050/00725/AM20/<br>RLA File<br>:09/24/040/00352/AM20/<br>Lic.No/Date:0910068077<br>11.10.2019 |
29.11.2019<br>HQ File<br>:01/82/050/00725/AM20/<br>RLA File<br>:09/24/040/00352/AM20/<br>Lic.No/Date:0910068077<br>11.10.2019 |
29.11.2019<br>HQ File<br>:01/82/050/00725/AM20/<br>RLA File<br>:09/24/040/00352/AM20/<br>Lic.No/Date:0910068077<br>11.10.2019 |
29.11.2019<br>HQ File<br>:01/82/050/00725/AM20/<br>RLA File<br>:09/24/040/00352/AM20/<br>Lic.No/Date:0910068077<br>11.10.2019 |
29.11.2019<br>HQ File<br>:01/82/050/00725/AM20/<br>RLA File<br>:09/24/040/00352/AM20/<br>Lic.No/Date:0910068077<br>11.10.2019 |
|
|
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical |
|
|
|
|
experts and it |
|
|
|
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
|
| 162 |
|
|
(2S,3S,5S)-2-amino-3-hydroxy-5-(tert |
1 kg |
1 |
L-Phenyl-L-Alanine |
1.64 kg |
|
|
|
|
butylcarbonylamino)-1,6- |
|
2 |
Benzyl Chloride |
0.90 kg |
|
|
|
|
diphenylhexane |
|
3 |
Citric Acid Monohydrate |
2.055 kg |
|
|
|
|
|
|
4 |
Di Tert Butyl Di Carbonate |
0.36 kg |
|
|
|
|
|
|
5 |
ACETONITRILE |
5.89 kg |
|
|
|
|
|
|
6 |
METHANOL |
1.10 kg |
|
|
|
|
|
|
7 |
SODIUM BORO HYDRIDE |
0.45 kg |
|
|
|
|
|
|
8 |
TETRA HYDRO FURAN |
1.00 kg |
|
|
|
|
|
|
9 |
Methane sulfonic acid |
0.95 kg |
|
|
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
64
| Case No.:152/10/82- |
|
Party Name:SUN |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICAL |
|
ALC4/2019 |
|
Approved |
|
|
INDUSTRIES LTD. |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510412089 |
|
|
| :01/82/050/00726/AM20/ |
|
:05/24/040/00380/AM20/ |
|
11.10.2019 |
|
|
|
Case No.:152/10/82-<br>ALC4/2019 |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00726/AM20/ |
RLA File<br>:05/24/040/00380/AM20/ |
|
|
|
Lic.No/Date:0510412089<br>11.10.2019 |
|
| 163 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty. per 5<br>ml vial<br>Dorzolamide and Timolol<br>Ophthalmic Solution, 2.0%w/v +<br>0.5%w/v, 5ml (TIMODOL Sterile<br>Eye Drops) (LOFTEMIDE)<br>(Each ml contains Dorzolamide<br>Hydrochloride equivalent to<br>Dorzolamide 20 mg (Equivalent to<br>1.680Kg of Bulk Drug), and Timolol<br>Maleate equivalent to Timolol 5.0 mg<br>(Equivalent to 0.420 Kg. of Bulk<br>Drug)<br>1<br>Number<br>1<br>Dorzolamide Hydrochloride<br>(Relevant Bulk Drug )<br>117.095<br>mg<br>2<br>Timolol Maleate<br>( Relevant Bulk Drug )<br>35.70 mg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
Qty. |
Sl.<br>No. |
Import items |
|
|
|
|
|
1<br>Number |
1 |
Dorzolamide Hydrochloride<br>(Relevant Bulk Drug ) |
|
|
|
|
|
|
2 |
Timolol Maleate<br>( Relevant Bulk Drug ) |
|
|
|
RA concerned maytake further necessaryaction as |
|
|
|
|
|
|
| 164 |
Case No.:153/10/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00727/AM20/ |
RLA File<br>:03/95/040/00569/AM20/ |
Lic.No/Date:0310832186<br>14.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
| 165 |
Case No.:154/10/82-<br>ALC4/2019 |
Party Name:VISION DRUGS<br>PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00728/AM20/ |
RLA File<br>:09/24/040/00355/AM20/ |
Lic.No/Date:0910068079<br>14.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
65
|
|
Case No.:155/10/82- |
|
Party Name:RELIANCE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 166 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310832193 |
|
Defer Date: |
|
|
:01/82/050/00729/AM20/ |
|
:03/95/040/00662/AM20/ |
|
14.10.2019 |
|
|
|
|
**Decision:**New Case. The |
|
Committee decided to refer the case to Special Committee for further |
|
|
|
|
|
|
consideration. |
|
|
|
|
|
|
|
|
Case No.:156/10/82- |
|
Party Name:RELIANCE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 167 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310832194 |
|
Defer Date: |
|
|
:01/82/050/00730/AM20/ |
|
:03/95/040/00661/AM20/ |
|
14.10.2019 |
|
|
|
|
**Decision:**New Case. The |
|
Committee decided to refer the case to Special Committee for further |
|
|
|
|
|
|
consideration. |
|
|
|
|
|
|
| Case No.:157/10/82- |
|
Party Name:VERGO |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA RESEARCH |
|
ALC4/2019 |
|
Approved |
|
|
LABORATORIES PVT. LTD., |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832202 |
|
|
| :01/82/050/00731/AM20/ |
|
:03/95/040/00573/AM20/ |
|
14.10.2019 |
|
|
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
experts and it |
|
|
|
was decided to ratify the ad-hoc input |
|
output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
|
| 168 |
|
|
LIOTHRONINE SODIUM 5 MCG |
1 |
1 |
LIOTHYRONINE SODIUM |
5.10 MCG |
|
|
|
|
TABLETS |
Number |
|
|
/ 5 MCG |
|
|
|
|
|
|
|
|
TABLET |
|
|
|
|
LIOTHYRONINE SODIUM 10 |
1 |
1 |
LIOTHYRONINE SODIUM |
10.20 |
|
|
|
|
MCG TABLETS |
Number |
|
|
MCG /10 |
|
|
|
|
|
|
|
|
MCG |
|
|
|
|
|
|
|
|
TABLET |
|
|
|
|
LIOTHYRONINE SODIUM 20 |
1 |
1 |
LIOTHYRONINE SODIUM |
20.40 |
|
|
|
|
MCG TABLETS |
Number |
|
|
MCG / 20 |
|
|
|
|
|
|
|
|
MCG |
|
|
|
|
|
|
|
|
TABLET |
|
|
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
66
| 169 |
<br>Case No.:158/10/82-<br>ALC4/2019<br>Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/00732/AM20/<br>RLA File<br>:03/95/040/00589/AM20/<br>Lic.No/Date:0310832227<br>15.10.2019<br>Defer Date:<br>**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
| 170 |
Case No.:159/10/82-<br>ALC4/2019 |
Party Name:U K AROMATICS<br>& CHEMICALS |
<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00733/AM20/ |
RLA File<br>:03/95/040/00700/AM20/ |
Lic.No/Date:0310832236<br>15.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:160/10/82- |
|
Party Name:S M S |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068087 |
|
|
| :01/82/050/00734/AM20/ |
|
:09/24/040/00364/AM20/ |
|
15.10.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 171 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| LEVETIRACETAM |
1 kg |
1 |
(S)+2 AMINO BUTYRAMIDE |
0.95 kg |
|
|
|
HCL |
|
|
|
2 |
METHYLENE CHLORIDE |
2.26 kg |
67
| Case No.:161/10/82- |
|
Party Name:S V LABS PVT |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068090 |
|
|
| :01/82/050/00735/AM20/ |
|
:09/24/040/00358/AM20/ |
|
15.10.2019 |
|
|
|
Case No.:161/10/82-<br>ALC4/2019 |
Case No.:161/10/82-<br>ALC4/2019 |
Party Name:S V LABS PVT<br>LTD |
Party Name:S V LABS PVT<br>LTD |
Party Name:S V LABS PVT<br>LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0910068090<br>15.10.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00735/AM20/ |
|
RLA File<br>:09/24/040/00358/AM20/ |
|
|
|
|
| 172 |
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower: |
|
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
|
Qty. |
|
FCE (SA) |
1 kg |
|
1 |
GLYOXYLIC ACID-50% |
|
0.68 kg |
|
|
|
|
2 |
2,5 DI HYDROXY 1,4 DITHIANE(DIOL) |
|
0.28 kg |
|
|
|
|
3 |
5-FLUORO CYTOSINE |
|
0.44 kg |
|
|
|
|
4 |
HEXAMETHYL DISILAZANE(HMDS) |
|
0.53 kg |
|
|
|
|
5 |
L(-)MENTHOL |
|
0.70 kg |
|
|
|
|
6 |
METHYLENE CHLORIDE STABILIZED<br>WITH AMYLENE 50 PPM(MDC) |
|
3.00 kg |
|
|
|
|
7 |
SODIUM BISULPHATE |
|
0.60 kg |
|
|
|
|
8 |
TRI ETHYL AMINE |
|
0.015 kg |
|
|
|
|
9 |
THIONYL CHLORIDE |
|
0.33 kg |
|
|
|
|
10 |
TOULENE |
|
0.671 kg |
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
| 173 |
Case No.:162/10/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310832255<br>16.10.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00736/AM20/ |
RLA File<br>:03/95/040/00461/AM20/ |
|
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
| 174 |
Case No.:163/10/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310832257<br>16.10.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00737/AM20/ |
RLA File<br>:03/95/040/00684/AM20/ |
|
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
Decision: New Case. The Committee decided to refer the case to Special Committee for further consideration.
68
| Case No.:164/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832260 |
|
|
| :01/82/050/00738/AM20/ |
|
:03/94/040/00560/AM20/ |
|
16.10.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 6/82-ALC4/2018 dated 26.07.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export Product :
175
-
Desonide Cream 0.05% 15gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.188 Kgs) 2. Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs) 3. Desonide Lotion 0.05% 59ml ( Net Wt. of Desonide USP Micronised (Sicor) is 0.738 Kgs) 4. Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 1.475 Kgs)
-
Desonide Ointment 0.05% 15gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.188 Kgs) 6. Desonide Ointment 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)
| SI.<br>No. |
Imort Items<br> <br> |
For the Export of 1 No. Tablet |
For the Export of 1 No. Tablet |
For the Export of 1 No. Tablet |
For the Export of 1 No. Tablet |
For the Export of 1 No. Tablet |
0.05%<br>60gm<br>pack<br>0.0306<br>gm |
|
|
|
0.05%<br>60gm<br>pack |
0.05%<br>59ml<br>pack |
0.05%<br>118ml<br>pack |
0.05%<br>15gm<br>pack |
|
|
|
0.05% |
|
|
|
|
|
|
|
15gm pack |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 1 |
Desonide USP<br>Micronised (Sicor) |
0.00765<br>gm |
0.0306<br>gm |
0.301 gm |
0.602 gm |
0.00765<br>gm |
|
RA may take appropriate action as per the decision of Norms Committee
| Case No.:165/10/82- |
|
Party Name:ALTA |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832261 |
|
|
| :01/82/050/00739/AM20/ |
|
:03/94/040/00517/AM20/ |
|
16.10.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 176 meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1
as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| SODIUM SALICYLATE |
1 kg |
1 |
SALICYLIC ACID |
0.88 kg |
69
| Case No.:166/10/82- |
|
Party Name:YASHO |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832268 |
|
|
| :01/82/050/00740/AM20/ |
|
:03/95/040/00710/AM20/ |
|
17.10.2019 |
|
|
|
|
ALC4/2019<br>INDUSTRIES LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00740/AM20/<br>RLA File<br>:03/95/040/00710/AM20/<br>Lic.No/Date:0310832268<br>17.10.2019 |
ALC4/2019<br>INDUSTRIES LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00740/AM20/<br>RLA File<br>:03/95/040/00710/AM20/<br>Lic.No/Date:0310832268<br>17.10.2019 |
ALC4/2019<br>INDUSTRIES LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00740/AM20/<br>RLA File<br>:03/95/040/00710/AM20/<br>Lic.No/Date:0310832268<br>17.10.2019 |
ALC4/2019<br>INDUSTRIES LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00740/AM20/<br>RLA File<br>:03/95/040/00710/AM20/<br>Lic.No/Date:0310832268<br>17.10.2019 |
ALC4/2019<br>INDUSTRIES LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00740/AM20/<br>RLA File<br>:03/95/040/00710/AM20/<br>Lic.No/Date:0310832268<br>17.10.2019 |
ALC4/2019<br>INDUSTRIES LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00740/AM20/<br>RLA File<br>:03/95/040/00710/AM20/<br>Lic.No/Date:0310832268<br>17.10.2019 |
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
|
|
|
|
|
|
|
meeting no. 9/82-ALC4/2019 dated 18.10.2019, it was decided to ratify norms under Para 4.7 |
|
|
|
of HBP v1 as |
|
|
|
per details given below or as applied |
by the firm, whichever is less: |
|
|
|
|
| 177 |
|
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
|
Qty. |
|
|
|
|
No. |
|
|
|
|
|
COPPER<br>DIBUTYL |
1 kg |
1 |
DI-N- |
|
0.600 kg |
|
|
DITHIOCARBAMATE(CDBC) |
|
|
BUTYLAMINE(DIBUTYLAMINE) |
|
|
|
|
|
|
2 |
CARBON DISULPHIDE |
|
0.360 kg |
|
|
|
|
3 |
COPPER SULPHATE |
|
0.443 kg |
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
| Case No.:167/10/82- |
|
Party Name:RUMIT LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:031083227 |
|
|
| :01/82/050/00741/AM20/ |
|
:03/95/040/00720/AM20/ |
|
7 |
|
|
|
|
|
|
17.10.2019 |
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in 178 its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:Export product Qty. Sl. Import items Qty. No. Hydrocortisone Acetate 1 kg 1 Hydrocortisone 1.00 kg
RA concerned may take further necessary action as per above decision of NC
70
Case No.:168/10/82- Party Name:SHREE GANESH Meet No/Date:10/82- Status: ALC4/2019 REMEDIES LTD. ALC4/2019 Approved 29.11.2019 HQ File RLA File Lic.No/Date:3410045545 :01/82/050/00742/AM20/ :34/24/040/00208/AM20/ 17.10.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2018 , dated 05.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 179 per details below or as applied by firm whichever is lower:
| Export Product |
Qty. |
Sl. No. |
Import items |
Qty. |
| Sorbyl Acetate |
1 kg |
1 |
Sorbic Acid |
0.888 kg |
|
|
2 |
Vitride(Synhydrid) (also<br>chemically known as Sodium bis<br>(2-methoxyethoxy) aluminum<br>hydride) |
Not allowed |
|
Case No.:169/10/82- |
|
Party Name:VEERAL |
|
Meet No/Date:10/82- |
|
Status: |
|
ALC4/2019 |
|
ADDITIVES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
LIMITED |
|
29.11.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310832307 |
|
|
|
:01/82/050/00743/AM20/ |
|
:03/95/040/00716/AM20/ |
|
18.10.2019 |
|
|
180 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:
(i) Percentage yield on molar basis.
(ii) Commercial value of By-product Methanol.
| 181 |
Case No.:170/10/82-<br>ALC4/2019 |
Party Name:VEERAL<br>ADDITIVES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00744/AM20/ |
RLA File<br>:03/95/040/00717/AM20/ |
Lic.No/Date:0310832308<br>18.10.2019 |
Defer Date: |
|
<br>**Decision:**The Committee considered the case as per agenda in the presence of technical<br>was decided to call for following information from the firm:<br>(i)<br>Percentage yield on molar basis.<br>(ii)<br>Commercial value of By-product Methanol. |
|
|
experts and it |
71
| 182 |
<br>Case No.:171/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310832312<br>18.10.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00745/AM20/ |
RLA File<br>:03/94/040/00566/AM20/ |
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| Case No.:172/10/82- |
|
Party Name:FERMENTA |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
BIOTECH LIMITED |
|
ALC4/2019 |
|
Rejected |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832316 |
|
|
| :01/82/050/00746/AM20/ |
|
:03/94/040/00553/AM20/ |
|
18.10.2019 |
|
|
183 Decision: The Committee considered the case as per online generated agenda and it was observed that the import item –DETOX FOC-27 Fish Body Oil Crude having ITC HS – 15042010 comes under Chapter 15 and as per para 4.11 (A) (i) of the FTP 2015-20 , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP.
, the Committee decided to reject the case.
| 184 |
Case No.:173/10/82-<br>ALC4/2019 |
Party Name:BENZO CHEM<br>INDUSTRIES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310832317<br>18.10.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00747/AM20/ |
RLA File<br>:03/94/040/00518/AM20/ |
|
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
72
| Case No.:174/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832319 |
|
|
| :01/82/050/00748/AM20/ |
|
:03/94/040/00539/AM20/ |
|
18.10.2019 |
|
|
|
Case No.:174/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00748/AM20/ |
RLA File<br>:03/94/040/00539/AM20/ |
|
|
|
Lic.No/Date:0310832319<br>18.10.2019 |
|
| 185 |
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Gabapentin Tablets 600mg (Pack<br>Size 100 Tabs.) (Net wt. of<br>Gabapentin USP is 8400.000 Kgs.)<br>1 Pack<br>1<br>Gabapentin USP<br>612 mg / 600 mg tablet<br>Gabapentin Tablets 600mg (Pack<br>Size 500 Tabs.) (Net wt. of<br>Gabapentin is 42000.000 Kgs.)<br>1 Pack<br>1<br>Gabapentin USP<br>612 mg / 600 mg tablet<br>Gabapentin Tablets 800mg (Pack<br>Size 100 Tabs.) (Net wt. of<br>Gabapentin is 9520.000 Kgs.)<br>1 Pack<br>1<br>Gabapentin USP<br>816 mg / 800 mg tablet<br>Gabapentin Tablets 800mg (Pack<br>Size 500 Tabs.) (Net wt. of<br>Gabapentin is 48000.000 Kgs.)<br>1 Pack<br>1<br>Gabapentin USP<br>816 mg / 800 mg tablet<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
|
|
Gabapentin Tablets 600mg (Pack<br>Size 100 Tabs.) (Net wt. of<br>Gabapentin USP is 8400.000 Kgs.) |
|
1 Pack |
1 |
Gabapentin USP |
|
|
|
Gabapentin Tablets 600mg (Pack<br>Size 500 Tabs.) (Net wt. of<br>Gabapentin is 42000.000 Kgs.) |
|
1 Pack |
1 |
Gabapentin USP |
|
|
|
Gabapentin Tablets 800mg (Pack<br>Size 100 Tabs.) (Net wt. of<br>Gabapentin is 9520.000 Kgs.) |
|
1 Pack |
1 |
Gabapentin USP |
|
|
|
Gabapentin Tablets 800mg (Pack<br>Size 500 Tabs.) (Net wt. of<br>Gabapentin is 48000.000 Kgs.) |
|
1 Pack |
1 |
Gabapentin USP |
|
|
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
73
| Case No.:175/10/82- |
|
Party Name:SMS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068111 |
|
|
| :01/82/050/00749/AM20/ |
|
:09/24/040/00369/AM20/ |
|
18.10.2019 |
|
|
|
|
ALC4/2019<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00749/AM20/<br>RLA File<br>:09/24/040/00369/AM20/<br>Lic.No/Date:0910068111<br>18.10.2019 |
ALC4/2019<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00749/AM20/<br>RLA File<br>:09/24/040/00369/AM20/<br>Lic.No/Date:0910068111<br>18.10.2019 |
ALC4/2019<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00749/AM20/<br>RLA File<br>:09/24/040/00369/AM20/<br>Lic.No/Date:0910068111<br>18.10.2019 |
ALC4/2019<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00749/AM20/<br>RLA File<br>:09/24/040/00369/AM20/<br>Lic.No/Date:0910068111<br>18.10.2019 |
ALC4/2019<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00749/AM20/<br>RLA File<br>:09/24/040/00369/AM20/<br>Lic.No/Date:0910068111<br>18.10.2019 |
ALC4/2019<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00749/AM20/<br>RLA File<br>:09/24/040/00369/AM20/<br>Lic.No/Date:0910068111<br>18.10.2019 |
ALC4/2019<br>PHARMACEUTICALS<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00749/AM20/<br>RLA File<br>:09/24/040/00369/AM20/<br>Lic.No/Date:0910068111<br>18.10.2019 |
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it |
|
|
|
|
|
|
|
|
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
Export Product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
|
|
|
|
TENOFOVIR DISOPROXIL |
1 kg |
1 |
(R)-9-[2-(PHOSPHONO |
0.769 kg |
|
|
|
|
FUMARATE |
|
|
METHOXY) PROPYL] |
|
|
|
|
|
|
|
|
ADENINE MONO HYDRATE |
|
|
| 186 |
|
|
|
|
|
(PMPA) |
|
|
|
|
|
|
|
2 |
TRI METHYL CHLORO |
0.070 kg |
|
|
|
|
|
|
|
SILANE |
|
|
|
|
|
|
|
3 |
CHLORO METHYL-2- |
1.3527 kg |
|
|
|
|
|
|
|
ISOPROPYL CARBONATE |
|
|
|
|
|
|
|
4 |
N-METHYL-2- |
1.4478 kg |
|
|
|
|
|
|
|
PYRROLIDONE |
|
|
|
|
|
|
|
5 |
TRI ETHYL AMINE |
0.4477 kg |
|
|
|
|
|
|
6 |
CYCLO HEXANE |
1.444 kg |
|
|
|
|
|
|
7 |
METHYLENE DICHLORIDE |
2.146 kg |
|
|
|
|
|
|
8 |
ISO PROPYL ALCOHOL |
2.113 kg |
|
|
|
|
|
|
9 |
FUMARIC ACID |
0.340 kg |
|
|
|
|
|
|
10 |
METHANOL |
0.548kg |
|
|
|
RA concerned maytake further necessaryaction |
|
|
asper above decision of NC. |
|
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Case No.:178/10/82- |
|
Party Name:SENTISS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510412191 |
|
|
| :01/82/050/00752/AM20/ |
|
:05/24/040/00404/AM20/ |
|
21.10.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 187 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Mydrimax Eye Drops 5ml Vial |
1 Number |
1 |
Tropicamide |
40.8 mg / 5 ml vial |
| (Each ml Containing 8 mg |
|
|
|
|
| Tropicamide) |
|
|
|
|
74
| 188 |
Case No.:179/10/82-<br>ALC4/2019 |
Party Name:PANACEA<br>BIOTEC LTD.,<br>RLA File<br>:05/24/040/00410/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00753/AM20/ |
|
Lic.No/Date:0510412195<br>21.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA, New Delhi. Further, it was decided to forward a copy of that application to DBT<br>for obtainingits comments. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi. Further, it was decided to forward a copy of that application to DBT for obtaining its comments.
| Case No.:181/10/82- |
|
Party Name:PRISM |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045550 |
|
|
| :01/82/050/00755/AM20/ |
|
:34/24/040/00214/AM20/ |
|
21.10.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 189 per details given below or as applied by the firm, whichever is less:
| Export product<br>LUMEFANTRINE |
Qty. |
Sl.<br>No. |
Import Items |
|
1 kg |
1. |
[DIBUTYLAMINE METHYL]-2,7-DICHLORO-4-<br>FLUOREN METHANOL |
| Case No.:182/10/82- |
|
Party Name:AMI LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045554 |
|
|
| :01/82/050/00756/AM20/ |
|
:34/24/040/00216/AM20/ |
|
22.10.2019 |
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in 190 its 1/82-ALC4/2019 meeting dated 03.06.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Benfotiamine |
1 kg |
1 |
Thiamine Hydrochloride |
0.922 kg |
RA concerned may take further necessary action as per above decision of NC
75
| Case No.:183/10/82- |
|
Party Name:AMI LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045555 |
|
|
| :01/82/050/00757/AM20/ |
|
:34/24/040/00215/AM20/ |
|
22.10.2019 |
|
|
|
Case No.:183/10/82-<br>ALC4/2019 |
Party Name:AMI LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00757/AM20/ |
RLA File<br>:34/24/040/00215/AM20/ |
Lic.No/Date:3410045555<br>22.10.2019 |
|
| 191 |
<br>**Decision:**The Committee considered case as per agenda and as per earlier decision taken by NC in<br>its 1/82-ALC4/2019 meeting dated 03.06.2019, it was decided to ratify the ad-hoc input output norms<br>under para 4.7 of HBP as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Benfotiamine<br>1 kg<br>1<br>Thiamine Hydrochloride<br>0.922 kg<br>RA concerned maytake further necessaryaction asper above decision of NC |
|
|
|
| Case No.:184/10/82- |
|
Party Name:CHROMO |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES INDIA PVT |
|
ALC4/2019 |
|
Approved |
|
|
LTD. |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068121 |
|
|
| :01/82/050/00758/AM20/ |
|
:09/24/040/00370/AM20/ |
|
22.10.2019 |
|
|
|
Case No.:184/10/82-<br>ALC4/2019 |
Party Name:CHROMO<br>LABORATORIES INDIA PVT<br>LTD.<br>RLA File<br>:09/24/040/00370/AM20/ |
Party Name:CHROMO<br>LABORATORIES INDIA PVT<br>LTD.<br>RLA File<br>:09/24/040/00370/AM20/ |
Party Name:CHROMO<br>LABORATORIES INDIA PVT<br>LTD.<br>RLA File<br>:09/24/040/00370/AM20/ |
Party Name:CHROMO<br>LABORATORIES INDIA PVT<br>LTD.<br>RLA File<br>:09/24/040/00370/AM20/ |
<br>Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00758/AM20/ |
|
|
|
|
Lic.No/Date:0910068121<br>22.10.2019 |
|
| 192 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>VORICONAZOLE<br>1 kg<br>1<br>4-Chloro-6-ethyl-5-fluoro<br>pyrimidine<br>3.30 kg<br>2<br>Methylene Chloride<br>9.32 kg<br>3<br>Methanol<br>8.03 kg<br>4<br>Tetrahydrofuran<br>2.89kg<br>5<br>L(-)Camphor Sulphonic Acid<br>1.01 kg<br>6<br>Acetone<br>2.00 kg |
|
|
|
|
|
|
|
|
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
1 kg |
1 |
4-Chloro-6-ethyl-5-fluoro<br>pyrimidine |
|
3.30 kg |
|
|
|
|
2 |
Methylene Chloride |
|
9.32 kg |
|
|
|
|
3 |
Methanol |
|
8.03 kg |
|
|
|
|
4 |
Tetrahydrofuran |
|
2.89kg |
|
|
|
|
5 |
L(-)Camphor Sulphonic Acid |
|
1.01 kg |
|
|
|
|
6 |
Acetone |
|
2.00 kg |
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
76
| Case No.:185/10/82- |
|
Party Name:ARENE LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068123 |
|
|
| :01/82/050/00759/AM20/ |
|
:09/24/040/00372/AM20/ |
|
22.10.2019 |
|
|
|
Case No.:185/10/82-<br>ALC4/2019 |
Party Name:ARENE LIFE<br>SCIENCES LIMITED |
Party Name:ARENE LIFE<br>SCIENCES LIMITED |
Party Name:ARENE LIFE<br>SCIENCES LIMITED |
Party Name:ARENE LIFE<br>SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00759/AM20/ |
RLA File<br>:09/24/040/00372/AM20/ |
|
|
|
Lic.No/Date:0910068123<br>22.10.2019 |
|
| 193 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>DARUNAVIR/DARUNAVIR<br>ETHANOLATE/DARUNAVIR<br>AMORPHOUS<br>1 kg<br>1<br>(2S,3S)-1,2-epoxy-(Boc<br>amino)-4-phenylbutane<br>0.73 kg<br>2<br>Isobutyl amine<br>0.63 kg<br>3<br>(3aS,4S,6aR)-4-methoxy-<br>tetrahydrofuro[3,4-b]furan-<br>2(3H)-one<br>0.55 kg<br>4<br>Tetrahydrofuran<br>1.60 kg<br>5<br>Potassium borohydride<br>0.25 kg<br>6<br>Methylene dichloride<br>4.15 kg |
|
|
|
|
|
|
|
|
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
1 kg |
1 |
(2S,3S)-1,2-epoxy-(Boc<br>amino)-4-phenylbutane |
|
0.73 kg |
|
|
|
|
2 |
Isobutyl amine |
|
0.63 kg |
|
|
|
|
3 |
(3aS,4S,6aR)-4-methoxy-<br>tetrahydrofuro[3,4-b]furan-<br>2(3H)-one |
|
0.55 kg |
|
|
|
|
4 |
Tetrahydrofuran |
|
1.60 kg |
|
|
|
|
5 |
Potassium borohydride |
|
0.25 kg |
|
|
|
|
6 |
Methylene dichloride |
|
4.15 kg |
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
| 194 |
Case No.:186/10/82-<br>ALC4/2019 |
Party Name:DEEPAK<br>NITRITE LIMITED<br>RLA File<br>:34/24/040/00173/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00760/AM20/ |
|
Lic.No/Date:3410045560<br>22.10.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Vadodara. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
| Case No.:187/10/82- |
|
Party Name:DEEPAK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHENOLICS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045564 |
|
|
| :01/82/050/00761/AM20/ |
|
:34/24/040/00212/AM20/ |
|
23.10.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 195 applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| PHENOL |
1 kg |
1 |
BENZENE |
0.87 kg |
77
| 196 |
Case No.:188/10/82-<br>ALC4/2019 |
Party Name:SPC LIFE<br>SCIENCES PVT. LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00762/AM20/ |
RLA File<br>:34/24/040/00143/AM20/ |
Lic.No/Date:3410045565<br>23.10.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Vadodara. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
| 197 |
Case No.:189/10/82-<br>ALC4/2019 |
Party Name:MENTHA &<br>ALLIED PRODUCTS<br>PRIVATE LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00763/AM20/ |
RLA File<br>:05/24/040/00375/AM20/ |
Lic.No/Date:0510412231<br>23.10.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhii. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhii.
| Case No.:190/10/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832384 |
|
|
| :01/82/050/00764/AM20/ |
|
:03/94/040/00574/AM20/ |
|
23.10.2019 |
|
|
|
Case No.:190/10/82-<br>ALC4/2019 |
Case No.:190/10/82-<br>ALC4/2019 |
Case No.:190/10/82-<br>ALC4/2019 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00574/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0310832384<br>23.10.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0310832384<br>23.10.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00764/AM20/ |
|
|
|
|
|
|
| 198 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 8/82-ALC4/2019 dated 20.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 5<br>MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 37.392 Kgs (ii) 290.756 Kgs (iii) 602.153<br>Kgs (iv) 307.358 Kgs.<br>1 Number<br>2<br>OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10<br>MG. Each tablet contains (i) Oxybutynin Chloride USP- 10 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 53.913 Kgs (ii) 209.614 Kgs (iii) 435.455<br>Kgs (iv) 221.582 Kgs.<br>1 Number<br>3<br>OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15<br>MG. Each tablet contains (i) Oxybutynin Chloride USP - 15 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 81.02 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 17.391 Kgs (ii) 45.077 Kgs (iii) 93.935<br>Kgs (iv)47.651 Kgs.<br>1 Number |
|
|
|
|
|
|
|
<br> |
|
|
|
|
|
|
|
|
Sl.<br>No. |
Export Product |
|
|
Qty. |
|
|
|
1 |
OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 5<br>MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 37.392 Kgs (ii) 290.756 Kgs (iii) 602.153<br>Kgs (iv) 307.358 Kgs. |
|
|
1 Number |
|
|
|
2 |
OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10<br>MG. Each tablet contains (i) Oxybutynin Chloride USP- 10 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 53.913 Kgs (ii) 209.614 Kgs (iii) 435.455<br>Kgs (iv) 221.582 Kgs. |
|
|
1 Number |
|
|
|
3 |
OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15<br>MG. Each tablet contains (i) Oxybutynin Chloride USP - 15 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 81.02 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 17.391 Kgs (ii) 45.077 Kgs (iii) 93.935<br>Kgs (iv)47.651 Kgs. |
|
|
1 Number |
|
|
|
|
|
|
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 8/82-ALC4/2019 dated 20.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
78
|
Sl.<br>No.<br>Import Items<br>For export of 1 Number of Tablet<br>5 mg<br>10 mg<br>15 mg<br>1<br>OXYBUTYNIN CHLORIDE USP<br>5.10 mg<br>10.20 mg<br>15.30 mg<br>2<br>EASTMAN (TM) CELLULOSE ACETATE (CA<br>398-10NF/EP)<br>32.40 mg<br>32.40 mg<br>32.40 mg<br>3<br>SENTRY POLYOX WSR N80 FP NF<br>80.52 mg<br>80.77 mg<br>81.02 mg<br>4<br>SENTRY POLYOX WSR 303 NF<br>41.10 mg<br>41.10 mg<br>41.10 mg<br>RA maytake appropriate action asper the decision of Norms Committee. |
Sl.<br>No. |
Import Items |
For export of 1 Number of Tablet |
For export of 1 Number of Tablet |
For export of 1 Number of Tablet |
|
|
|
|
5 mg |
10 mg |
15 mg |
|
|
1 |
OXYBUTYNIN CHLORIDE USP |
5.10 mg |
10.20 mg |
15.30 mg |
|
|
2 |
EASTMAN (TM) CELLULOSE ACETATE (CA<br>398-10NF/EP) |
32.40 mg |
32.40 mg |
32.40 mg |
|
|
3 |
SENTRY POLYOX WSR N80 FP NF |
80.52 mg |
80.77 mg |
81.02 mg |
|
|
4 |
SENTRY POLYOX WSR 303 NF |
41.10 mg |
41.10 mg |
41.10 mg |
| 199 |
Case No.:191/10/82-<br>ALC4/2019 |
Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD. |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00765/AM20/ |
RLA File<br>:03/94/040/00526/AM20/ |
Lic.No/Date:0310832396<br>23.10.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:192/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832414 |
|
|
| :01/82/050/00766/AM20/ |
|
:03/94/040/00589/AM20/ |
|
24.10.2019 |
|
|
|
Case No.:192/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310832414<br>24.10.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00766/AM20/ |
RLA File<br>:03/94/040/00589/AM20/ |
|
|
|
|
|
| 200 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>GLIMEPIRIDE<br>1 kg<br>1<br>4-[2-(3-ETHYL-4-METHYL-2-<br>OXO-3-PYRROLINE-1-<br>CARBOXAMIDO)-<br>ETHYL]BENZENE<br>SULFONAMIDE<br>0.80 kg<br>2<br>METHANOL<br>4.56 kg<br>3<br>TOLUENE<br>1.24 kg |
|
|
|
|
|
|
|
|
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
1 kg |
1 |
4-[2-(3-ETHYL-4-METHYL-2-<br>OXO-3-PYRROLINE-1-<br>CARBOXAMIDO)-<br>ETHYL]BENZENE<br>SULFONAMIDE |
|
0.80 kg |
|
|
|
|
2 |
METHANOL |
|
4.56 kg |
|
|
|
|
3 |
TOLUENE |
|
1.24 kg |
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
79
| Case No.:193/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832415 |
|
|
| :01/82/050/00767/AM20/ |
|
:03/94/040/00588/AM20/ |
|
24.10.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 201 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| SOLIFENACIN SUCCINATE |
1 kg |
1<br>2 |
(R)-3-QUINUCLIDINOL<br>TETRAHYDROFURAN(THF) |
0.625 kg<br>2.36 kg |
| 202 |
<br>Case No.:194/10/82-<br>ALC4/2019 |
Party Name:NATURAL AND<br>ESSENTIAL OILS PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00768/AM20/ |
RLA File<br>:07/24/040/00158/AM20/ |
Lic.No/Date:0710115596<br>24.10.2019 |
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| Case No.:199/10/82- |
|
Party Name:PI INDUSTRIES |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:1310049428 |
|
Defer Date: |
| :01/82/050/00773/AM20/ |
|
:13/24/040/00168/AM20/ |
|
24.10.2019 |
|
|
203 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete chemical name / description of the import item.
(ii) Certificate of Analysis (CoA) of the import item from foreign supplier.
(iii) Percentage assay of import and export items.
(iv) Process involved and percentage yield on molar basis.
80
| Case No.:195/10/82- |
|
Party Name:SMILAX |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068133 |
|
|
| :01/82/050/00769/AM20/ |
|
:09/24/040/00377/AM20/ |
|
25.10.2019 |
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms 204 under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| PANTOPRAZOLE BASE |
1 kg |
1 |
Maltol |
0.728 kg |
|
|
|
(3-HYDROXY-2-METHYL- |
|
|
|
|
4H-PYRAN-4-ONE) |
|
RA concerned may take further necessary action as per above decision of NC
| Case No.:196/10/82- |
|
Party Name:STYRAX |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2610012884 |
|
|
| :01/82/050/00770/AM20/ |
|
:26/24/040/00009/AM20/ |
|
28.10.2019 |
|
|
|
|
ALC4/2019<br>PHARMA PRIVATE<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00770/AM20/<br>RLA File<br>:26/24/040/00009/AM20/<br>Lic.No/Date:2610012884<br>28.10.2019 |
ALC4/2019<br>PHARMA PRIVATE<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00770/AM20/<br>RLA File<br>:26/24/040/00009/AM20/<br>Lic.No/Date:2610012884<br>28.10.2019 |
ALC4/2019<br>PHARMA PRIVATE<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00770/AM20/<br>RLA File<br>:26/24/040/00009/AM20/<br>Lic.No/Date:2610012884<br>28.10.2019 |
ALC4/2019<br>PHARMA PRIVATE<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00770/AM20/<br>RLA File<br>:26/24/040/00009/AM20/<br>Lic.No/Date:2610012884<br>28.10.2019 |
ALC4/2019<br>PHARMA PRIVATE<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00770/AM20/<br>RLA File<br>:26/24/040/00009/AM20/<br>Lic.No/Date:2610012884<br>28.10.2019 |
ALC4/2019<br>PHARMA PRIVATE<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00770/AM20/<br>RLA File<br>:26/24/040/00009/AM20/<br>Lic.No/Date:2610012884<br>28.10.2019 |
ALC4/2019<br>PHARMA PRIVATE<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00770/AM20/<br>RLA File<br>:26/24/040/00009/AM20/<br>Lic.No/Date:2610012884<br>28.10.2019 |
ALC4/2019<br>PHARMA PRIVATE<br>LIMITED<br>ALC4/2019<br>29.11.2019<br>Approved<br>HQ File<br>:01/82/050/00770/AM20/<br>RLA File<br>:26/24/040/00009/AM20/<br>Lic.No/Date:2610012884<br>28.10.2019 |
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
|
|
|
|
|
|
|
|
|
meeting no. 06/82-ALC4/2019 |
|
dated 16.08.2019, it was decided to ratify norms under Para |
|
|
|
4.7 of HBP v1 |
|
|
|
as per details given below or as |
|
applied by the |
|
firm, whichever is less: |
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. |
Import items |
|
Qty. |
|
|
|
|
|
|
No. |
|
|
|
|
|
|
5-(4-amino-2-oxo-<br>pyrimidinyl)-oxathiolane-2- |
|
1 kg |
1 |
GLYOXALIC ACID 50% |
|
0.746 kg |
| 205 |
|
|
carboxylic acid-isopropyl-<br>methyl-cyclohexyl ester or<br>CHE |
|
|
2<br>3 |
2,5-DIHYDROXY-1,4-DIATHINE<br>DI METHYL FORMAMIDE |
|
0.327 kg<br>0.260 kg |
|
|
|
|
|
|
|
(DMF) |
|
|
|
|
|
|
|
|
4 |
CYTOSINE |
|
0.434 kg |
|
|
|
|
|
|
5 |
HEXA METHYL DISILAZANE |
|
0.708 kg |
|
|
|
|
|
|
|
(HMDS) |
|
|
|
|
|
|
|
|
6 |
METHYLENE DI CHLORIDE |
|
2.630 kg |
|
|
|
|
|
|
|
(MDC) |
|
|
|
|
|
|
|
|
7 |
L-MENTHOL (FRESH / |
|
0.751 kg |
|
|
|
|
|
|
|
RECOVERY) |
|
|
|
|
|
|
|
|
8 |
TRI ETHYL AMINE (TEA) |
|
0.034 kg |
|
|
|
|
|
|
9 |
TRIPHOSGENE |
|
0.40 kg |
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
81
| Case No.:197/10/82- |
|
Party Name:VIVIN DRUGS & |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Deferred |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068135 |
|
Defer Date: |
| :01/82/050/00771/AM20/ |
|
:09/24/040/00362/AM20/ |
|
28.10.2019 |
|
|
|
Case No.:197/10/82-<br>ALC4/2019 |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Party Name:VIVIN DRUGS &<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00771/AM20/ |
RLA File<br>:09/24/040/00362/AM20/ |
|
|
|
Lic.No/Date:0910068135<br>28.10.2019 |
Defer Date: |
|
| 206 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
|
Qty. |
|
4-AMINO-2-OXO<br>PYRIMIDINYL<br>OXATHIOLANE-2-<br>CARBOXYLIC<br>ACID<br>ISO PROPYL METHYL CYCLO<br>HEXYL ESTER (CEI-II) |
|
1 kg |
1 |
GLYOXYLIC ACID - 50% |
|
|
0.743 kg |
|
|
|
|
2 |
2,5 DI HYDROXY 1,4 DITHIANE |
|
|
0.325 kg |
|
|
|
|
3 |
CYTOSINE |
|
|
0.428 kg |
|
|
|
|
4 |
HEXAMETHYLDISILAZANE |
|
|
0.509 kg |
|
|
|
|
5 |
TRIETHYLAMINE |
|
|
0.034 kg |
|
|
|
|
6 |
METHYLENE CHLORIDE |
|
|
2.63 kg |
|
|
|
|
7 |
L-MENTHOL |
|
|
0.751 kg |
|
|
|
|
8 |
TRIPHOSGENE |
|
|
0.40 kg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
| 207 |
Case No.:198/10/82-<br>ALC4/2019 |
Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00376/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00772/AM20/ |
|
Lic.No/Date:0910068138<br>28.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
82
| Case No.:200/10/82- |
|
Party Name:PORUS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068142 |
|
|
| :01/82/050/00774/AM20/ |
|
:09/24/040/00381/AM20/ |
|
30.10.2019 |
|
|
|
Case No.:200/10/82-<br>ALC4/2019 |
Party Name:PORUS<br>LABORATORIES PVT LTD |
Party Name:PORUS<br>LABORATORIES PVT LTD |
Party Name:PORUS<br>LABORATORIES PVT LTD |
Party Name:PORUS<br>LABORATORIES PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00774/AM20/ |
RLA File<br>:09/24/040/00381/AM20/ |
|
|
|
Lic.No/Date:0910068142<br>30.10.2019 |
|
|
| 208 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
2-Phenyl-3,3-bis(4-hydroxy<br>phenyl)phthalimide (PPP-BP) |
|
1 kg |
1 |
PTHALIC ANHYDRIDE |
|
0.927 kg |
|
|
|
|
|
2 |
PHENOL |
|
1.145 kg |
|
|
|
|
|
3 |
ZINC CHLORIDE |
|
0.104 kg |
|
|
|
|
|
4 |
ANILINE |
|
0.596 kg |
|
|
|
|
|
5 |
METHANOL |
|
0.715 kg |
|
|
|
|
|
6 |
ACTIVATED CARBON |
|
0.100 kg |
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
| Case No.:201/10/82- |
|
Party Name:PORUS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068143 |
|
|
| :01/82/050/00775/AM20/ |
|
:09/24/040/00382/AM20/ |
|
30.10.2019 |
|
|
|
Case No.:201/10/82-<br>ALC4/2019 |
Party Name:PORUS<br>LABORATORIES PVT LTD |
Party Name:PORUS<br>LABORATORIES PVT LTD |
Party Name:PORUS<br>LABORATORIES PVT LTD |
Party Name:PORUS<br>LABORATORIES PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00775/AM20/ |
RLA File<br>:09/24/040/00382/AM20/ |
|
|
|
Lic.No/Date:0910068143<br>30.10.2019 |
|
|
| 209 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
2-Phenyl-3,3-bis(4-hydroxy<br>phenyl)phthalimide (PPP-BP) |
|
1 kg |
1 |
PTHALIC ANHYDRIDE |
|
0.927 kg |
|
|
|
|
|
2 |
PHENOL |
|
1.145 kg |
|
|
|
|
|
3 |
ZINC CHLORIDE |
|
0.104 kg |
|
|
|
|
|
4 |
ANILINE |
|
0.596 kg |
|
|
|
|
|
5 |
METHANOL |
|
0.715 kg |
|
|
|
|
|
6 |
ACTIVATED CARBON |
|
0.100 kg |
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
83
| Case No.:202/10/82- |
|
Party Name:NECTAR |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIFESCIENCES LIMITED, |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2210016277 |
|
|
| :01/82/050/00776/AM20/ |
|
:22/24/040/00086/AM16/ |
|
30.10.2019 |
|
|
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
**Decision:**The Committee considered case as per agenda in the presence of the technical |
experts and it |
|
|
|
was decided to ratify the ad-hoc |
|
|
input |
output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
|
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
Cefpodoxime Proxetil |
1 kg |
1 |
|
7-ACA |
0.8378 kg |
|
| 210 |
|
|
|
|
2 |
|
Methane Sulfonicacid |
1.626 kg |
|
|
|
|
|
|
3 |
|
Methanol |
1.635 kg |
|
|
|
|
|
|
4 |
|
S-2 Benzothiazolyl-2-Amino-2-(methoxyimino)-4- |
0.8378 kg |
|
|
|
|
|
|
|
|
tiazolyl acetate(MAEM) |
|
|
|
|
|
|
|
5 |
|
Triethylamine(TEA) |
0.260 kg |
|
|
|
|
|
|
6 |
|
Toluene |
0.263 kg |
|
|
|
|
|
|
7 |
|
N,N-Dimethyl Acetamide |
0.665 kg |
|
|
|
|
|
|
8 |
|
TMG |
0.223 kg |
|
|
|
|
|
|
9 |
|
Ethyl acetate |
1.842 kg |
|
|
|
|
|
|
10 |
|
Activated carbon |
0.100 kg |
|
|
|
|
|
|
11 |
|
Acetone |
1.863 kg |
|
|
|
|
|
|
12 |
|
Cyclohexane |
3.572 kg |
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
| Case No.:203/10/82- |
|
Party Name:MEDICO |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
REMEDIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832498 |
|
|
| :01/82/050/00777/AM20/ |
|
:03/95/040/00685/AM20/ |
|
30.10.2019 |
|
|
|
|
29.11.2019<br>HQ File<br>:01/82/050/00777/AM20/<br>RLA File<br>:03/95/040/00685/AM20/<br>Lic.No/Date:0310832498<br>30.10.2019 |
29.11.2019<br>HQ File<br>:01/82/050/00777/AM20/<br>RLA File<br>:03/95/040/00685/AM20/<br>Lic.No/Date:0310832498<br>30.10.2019 |
29.11.2019<br>HQ File<br>:01/82/050/00777/AM20/<br>RLA File<br>:03/95/040/00685/AM20/<br>Lic.No/Date:0310832498<br>30.10.2019 |
29.11.2019<br>HQ File<br>:01/82/050/00777/AM20/<br>RLA File<br>:03/95/040/00685/AM20/<br>Lic.No/Date:0310832498<br>30.10.2019 |
29.11.2019<br>HQ File<br>:01/82/050/00777/AM20/<br>RLA File<br>:03/95/040/00685/AM20/<br>Lic.No/Date:0310832498<br>30.10.2019 |
|
|
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical |
|
|
|
|
experts and it |
|
|
|
was decided to ratify the ad-hoc input |
|
output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
| 211 |
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
|
|
|
CIPROFLOXACIN TABLETS USP |
1 |
1 |
CIPROFLOXACIN |
555.0 mg / |
|
|
|
|
500mg (NET CONTENTS OF |
Number |
|
HYDROCHLORIDE |
500 mg |
|
|
|
|
INPUTS IN 10000000 TABLETS |
|
|
|
Tablets |
|
|
|
|
ARE 5800 KG) |
|
|
|
|
|
|
|
|
CIPROFLOXACIN TABLETS USP |
1 |
1 |
CIPROFLOXACIN |
277.50 mg |
|
|
|
|
250mg (NET CONTENTS OF |
Number |
|
HYDROCHLORIDE |
/ 250 mg |
|
|
|
|
INPUTS IN 5000000 TABLETS |
|
|
|
Tablets |
|
|
|
|
ARE 1450KG) |
|
|
|
|
|
|
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
84
| Case No.:204/10/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832503 |
|
|
| :01/82/050/00778/AM20/ |
|
:03/94/040/00548/AM20/ |
|
30.10.2019 |
|
|
==> picture [453 x 437] intentionally omitted <==
----- Start of picture text -----<br>
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 8/82-ALC4/2019 dated 20.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Sl. Export Product Qty.<br>No.<br>1 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 5 1 Number<br>MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 27.826 Kgs (ii) 216.375 Kgs (iii) 448.110<br>Kgs (iv) 228.73 Kgs.<br>212 2 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10 1 Number<br>MG. Each tablet contains (i) Oxybutynin Chloride USP- 10 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 120 Kgs (ii) 466.56 Kgs (iii) 969.24 Kgs<br>(iv) 493.20 Kgs.<br>3 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15 1 Number<br>MG. Each tablet contains (i) Oxybutynin Chloride USP - 15 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 81.02 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 69.566 Kgs (ii) 180.314 Kgs (iii) 375.746<br>Kgs (iv) 190.609 Kgs.<br>Sl. Import Items For export of 1 Number of Tablet<br>No. 5 mg 10 mg 15 mg<br>1 OXYBUTYNIN CHLORIDE USP 5.10 mg 10.20 mg 15.30 mg<br>2 EASTMAN (TM) CELLULOSE ACETATE (CA 32.40 mg 32.40 mg 32.40 mg<br>398-10NF/EP)<br>3 SENTRY POLYOX WSR N80 FP NF 80.52 mg 80.77 mg 81.02 mg<br>4 SENTRY POLYOX WSR 303 NF 41.10 mg 41.10 mg 41.10 mg<br>RA may take appropriate action as per the decision of Norms Committee.<br>----- End of picture text -----<br>
85
| Case No.:205/10/82- |
|
Party Name:LUPIN LIMITED |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832505 |
|
|
| :01/82/050/00779/AM20/ |
|
:03/95/040/00747/AM20/ |
|
30.10.2019 |
|
|
213
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| TRIHEXYPHENIDYL HCL TABLETS JP |
1 |
1 |
TRIHEXYPHENIDYL |
2.04 mg/ 2 |
| 2MG |
Tablet |
|
HCL JP |
mg tablet |
| (NET WT. 54.00 KGS, WT OF DRUGS : |
|
|
|
|
| 56.160 KGS) |
|
|
|
|
| 214 |
Case No.:206/10/82-<br>ALC4/2019 |
Party Name:USV PRIVATE<br>LIMITED<br>RLA File<br>:03/95/040/00697/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
<br>HQ File<br>:01/82/050/00780/AM20/ |
|
Lic.No/Date:0310832511<br>30.10.2019 |
|
|
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to ratify the ad-hoc norms under para 4.7 of HBP as perSION A-412or as applied by firm<br>whichever is lower. |
|
|
|
| 215 |
Case No.:207/10/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00781/AM20/ |
RLA File<br>:03/95/040/00630/AM20/ |
Lic.No/Date:0310832521<br>30.10.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
Decision: New Case. The Committee decided to refer the case to Special Committee for further consideration.
86
| 216 |
Case No.:208/10/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00782/AM20/ |
RLA File<br>:03/95/040/00641/AM20/ |
Lic.No/Date:0310832525<br>30.10.2019<br> |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer th |
|
e case to Special Committe |
e for further |
|
consideration. |
|
|
|
|
|
Case No.:209/10/82- |
|
Party Name:RELIANCE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 217 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310832526 |
|
Defer Date: |
|
|
:01/82/050/00783/AM20/ |
|
:03/95/040/00642/AM20/ |
|
30.10.2019 |
|
|
|
|
**Decision:**New Case. The |
|
Committee decided to refer the case to Special Committee for further |
|
|
|
|
|
|
consideration. |
|
|
|
|
|
|
| Case No.:211/10/82- |
|
Party Name:DR. REDDYS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068156 |
|
|
| :01/82/050/00785/AM20/ |
|
:09/24/040/00392/AM20/ |
|
01.11.2019 |
|
|
|
|
:01/82/050/00785/AM20/<br>:09/24/040/00392/AM20/<br>01.11.2019 |
:01/82/050/00785/AM20/<br>:09/24/040/00392/AM20/<br>01.11.2019 |
:01/82/050/00785/AM20/<br>:09/24/040/00392/AM20/<br>01.11.2019 |
:01/82/050/00785/AM20/<br>:09/24/040/00392/AM20/<br>01.11.2019 |
:01/82/050/00785/AM20/<br>:09/24/040/00392/AM20/<br>01.11.2019 |
|
|
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier |
|
|
|
|
decision taken in |
|
|
|
meeting no. 9/82-ALC4/2019 dated 18.10.2019, it was |
|
|
|
decided to ratify norms under Para |
4.7 of HBP v1 as |
|
|
|
per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
| 218 |
|
|
Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
|
|
|
|
Valsartan |
1 kg |
1 |
N-(2-Cyanobiphenyl-4-Methyl) |
1.267 kg |
|
|
|
|
|
|
|
(L) Valine Methyl Ester HCl |
|
|
|
|
|
|
|
2 |
Methylene Chloride |
2.47 kg |
|
|
|
|
|
|
3 |
Ethyl Acetate |
9.64 kg |
|
|
|
|
|
|
4 |
n-Heptane 98% |
3.33 kg |
|
|
|
|
|
|
5 |
Methanol |
0.40 kg |
|
|
|
|
|
|
6 |
Sodium Azide |
0.69kg |
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 9/82-ALC4/2019 dated 18.10.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
|
|
Case No.:210/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 219 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310832575 |
|
Defer Date: |
|
|
:01/82/050/00784/AM20/ |
|
:03/94/040/00607/AM20/ |
|
04.11.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
87
| 220 |
Case No.:212/10/82-<br>ALC4/2019 |
Party Name:PORUS<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00786/AM20/ |
RLA File<br>:09/24/040/00394/AM20/ |
Lic.No/Date:0910068157<br>04.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:213/10/82- |
|
Party Name:PORUS |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068158 |
|
Defer Date: |
| :01/82/050/00787/AM20/ |
|
:09/24/040/00393/AM20/ |
|
04.11.2019 |
|
|
221 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete chemical name of the export item. (ii) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.
| 222 |
Case No.:214/10/82-<br>ALC4/2019 |
Party Name:GRANDEUR<br>PHARMA PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00788/AM20/ |
RLA File<br>:05/23/040/00251/AM20/ |
Lic.No/Date:0510412350<br>05.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhi. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
88
| Case No.:215/10/82- |
|
Party Name:KLJ |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PLASTICIZERS LIMITED. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510412352 |
|
|
| :01/82/050/00789/AM20/ |
|
:05/23/040/00306/AM20/ |
|
05.11.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
223
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
DI - ISO BUTYL PHTHALATE |
1 kg |
1 |
PHTHALIC ANHYDRIDE |
0.56 kg |
|
(DIBP) |
|
2 |
ISO BUTANOL |
0.56 kg |
|
(PACKED IN 2,554 NOS. OF HM- |
|
3 |
HDPE GRANULES |
Relevant |
|
HDPE DRUMS MADE OF HDPE |
|
|
(TOTAL WEIGHT = |
as per |
|
GRANULES (21,709.000 KGS. |
|
|
22,794.450 KGS.) |
Packing |
|
WITHOUT WASTAGE)) (EACH |
|
|
|
policy |
|
DRUM SHALL WEIGHT 8.5 KG |
|
|
|
|
|
AND STORAGE CAPACITY |
|
|
|
|
|
235.000KGS.) |
|
|
|
|
| Case No.:216/10/82- |
|
Party Name:SUN |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICAL |
|
ALC4/2019 |
|
Approved |
|
|
INDUSTRIES LTD. |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510412357 |
|
|
| :01/82/050/00790/AM20/ |
|
:05/24/040/00440/AM20/ |
|
05.11.2019 |
|
|
224
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
| Export product<br>Volini Gel 30gm (Each tube<br>contains 1.50gm of Racementhol)<br>equivalent to 3007.500 Kg of bulk<br>drug. |
Qty. |
Sl.<br>No. |
Import items |
Qty. allowed |
|
Nos. |
1. |
Racementhol |
1.53 gm /30 gm<br>tube |
RA concerned may take further necessary action as per above decision of NC
| 225 |
Case No.:217/10/82-<br>ALC4/2019 |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD.<br>RLA File<br>:05/24/040/00439/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00791/AM20/ |
|
Lic.No/Date:0510412361<br>05.11.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhi. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
89
| Case No.:218/10/82- |
|
Party Name:STERILE INDIA |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510412362 |
|
|
| :01/82/050/00792/AM20/ |
|
:05/24/040/00449/AM20/ |
|
05.11.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 226 per details given below or as applied by the firm, whichever is less:
| Export product |
Export product |
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
| Piperacillin |
Sodium |
and |
1 Kg. |
1 |
PIPERACILLIN ACID |
0.891 kg |
| Tazobactam<br>(8:1) |
Sodium |
Sterile |
|
2 |
TAZOBACTAM ACID |
0.109 kg |
| 227 |
Case No.:219/10/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00793/AM20/ |
RLA File<br>:03/95/040/00667/AM20/ |
Lic.No/Date:0310832613<br>06.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
| 228 |
Case No.:220/10/82-<br>ALC4/2019 |
Party Name:CHEMECA<br>DRUGS PRIVATE LIMITED<br>RLA File<br>:09/24/040/00401/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00794/AM20/ |
|
Lic.No/Date:0910068162<br>06.11.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
90
| Case No.:221/10/82- |
|
Party Name:WEXFORD |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES P LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710115656 |
|
|
| :01/82/050/00795/AM20/ |
|
:07/24/040/00166/AM20/ |
|
07.11.2019 |
|
|
|
|
ALC4/2019<br>LABORATORIES P LTD<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00795/AM20/<br>RLA File<br>:07/24/040/00166/AM20/<br>Lic.No/Date:0710115656<br>07.11.2019 |
ALC4/2019<br>LABORATORIES P LTD<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00795/AM20/<br>RLA File<br>:07/24/040/00166/AM20/<br>Lic.No/Date:0710115656<br>07.11.2019 |
ALC4/2019<br>LABORATORIES P LTD<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00795/AM20/<br>RLA File<br>:07/24/040/00166/AM20/<br>Lic.No/Date:0710115656<br>07.11.2019 |
ALC4/2019<br>LABORATORIES P LTD<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00795/AM20/<br>RLA File<br>:07/24/040/00166/AM20/<br>Lic.No/Date:0710115656<br>07.11.2019 |
ALC4/2019<br>LABORATORIES P LTD<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00795/AM20/<br>RLA File<br>:07/24/040/00166/AM20/<br>Lic.No/Date:0710115656<br>07.11.2019 |
Approved |
|
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical |
|
|
|
|
experts and it |
|
|
|
was decided to ratify the ad-hoc input |
|
output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
|
| 229 |
|
|
Vancomycin Hydrochloride for |
1 |
1 |
VANCOMYCIN HCL USP |
1076.52 |
|
|
|
|
Injection USP 1 G (WEIGHT |
Number |
|
STERILE |
mg / 1 gm |
|
|
|
|
7.85KG) |
|
|
|
injection |
|
|
|
|
Vancomycin Hydrochloride for |
1 |
1 |
VANCOMYCIN HCL USP |
538.26 |
|
|
|
|
Injection USP 500 MG (WEIGHT |
Number |
|
STERILE |
mg/ 500 |
|
|
|
|
15.7 KG) |
|
|
|
mg |
|
|
|
|
|
|
|
|
injection |
|
|
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
| Case No.:222/10/82- |
|
Party Name:FDC LTD |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832635 |
|
|
| :01/82/050/00796/AM20/ |
|
:03/94/040/00556/AM20/ |
|
07.11.2019 |
|
|
|
|
ALC4/2019<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00796/AM20/<br>RLA File<br>:03/94/040/00556/AM20/<br>Lic.No/Date:0310832635<br>07.11.2019 |
ALC4/2019<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00796/AM20/<br>RLA File<br>:03/94/040/00556/AM20/<br>Lic.No/Date:0310832635<br>07.11.2019 |
ALC4/2019<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00796/AM20/<br>RLA File<br>:03/94/040/00556/AM20/<br>Lic.No/Date:0310832635<br>07.11.2019 |
ALC4/2019<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00796/AM20/<br>RLA File<br>:03/94/040/00556/AM20/<br>Lic.No/Date:0310832635<br>07.11.2019 |
ALC4/2019<br>ALC4/2019<br>29.11.2019<br>HQ File<br>:01/82/050/00796/AM20/<br>RLA File<br>:03/94/040/00556/AM20/<br>Lic.No/Date:0310832635<br>07.11.2019 |
Approved |
|
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical |
|
|
|
|
experts and it |
|
|
|
was decided to ratify the ad-hoc input |
|
output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
| 230 |
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
|
|
|
|
CHLORAMPHENICOL EYE |
549200 |
1 |
CHLORAMPHENICOL |
29.07 kg |
|
|
|
|
DROPS 0.5% W/V OF 10 ML ( |
Vials |
|
(MICRONIZED) |
|
|
|
|
|
CHLORAFAST EYE DROPS 10 |
|
|
|
|
|
|
|
|
ML & CLOROGEN EYE DROPS 10 |
|
|
|
|
|
|
|
|
ML) |
|
|
|
|
|
|
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
91
| 231 |
Case No.:223/10/82-<br>ALC4/2019 |
Party Name:MAPAEX<br>CONSUMER HEALTHCARE<br>PRIVATE LIMITED<br>RLA File<br>:56/24/040/00018/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00797/AM20/ |
|
Lic.No/Date:5610005722<br>07.11.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Indore. |
|
|
|
| Case No.:224/10/82- |
|
Party Name:SWATI |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
MENTHOL & ALLIED |
|
ALC4/2019 |
|
Approved |
|
|
CHEMICALS LTD., |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510412433 |
|
|
| :01/82/050/00798/AM20/ |
|
:05/24/040/00442/AM20/ |
|
08.11.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 232 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Terpineol Extra Pure |
1 kg |
1 |
Alpha Pinene |
1.00 kg |
| Case No.:225/10/82- |
|
Party Name:YASHO |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832689 |
|
|
| :01/82/050/00799/AM20/ |
|
:03/95/040/00759/AM20/ |
|
11.11.2019 |
|
|
233
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| YAPOX CL 30/10 " |
1 kg |
1 |
HYDROQUINONE |
0.579 kg |
| HYDROQUINONE BIS"( 2 |
|
|
|
|
| HYDROXY ETHYL ETHER) |
|
2 |
ETHYLENE CARBONATE |
0.934 kg |
92
| Case No.:226/10/82- |
|
Party Name:YASHO |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832692 |
|
|
| :01/82/050/00800/AM20/ |
|
:03/95/040/00760/AM20/ |
|
11.11.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 234
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| YAPOX CL 30/10 " |
1 kg |
1 |
HYDROQUINONE |
0.579 kg |
| HYDROQUINONE BIS"( 2 |
|
|
|
|
| HYDROXY ETHYL ETHER) |
|
2 |
ETHYLENE CARBONATE |
0.934 kg |
| 235 |
Case No.:227/10/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00801/AM20/ |
RLA File<br>:03/95/040/00734/AM20/ |
Lic.No/Date:0310832693<br>11.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee decided to refer the case to Special Committee for further<br>consideration. |
|
|
|
Decision: New Case. The Committee decided to refer the case to Special Committee for further consideration.
93
| Case No.:228/10/82- |
|
Party Name:WOCKHARDT |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832696 |
|
|
| :01/82/050/00802/AM20/ |
|
:03/95/040/00772/AM20/ |
|
11.11.2019 |
|
|
|
Case No.:228/10/82-<br>ALC4/2019 |
Case No.:228/10/82-<br>ALC4/2019 |
Party Name:WOCKHARDT<br>LIMITED |
Party Name:WOCKHARDT<br>LIMITED |
Party Name:WOCKHARDT<br>LIMITED |
Party Name:WOCKHARDT<br>LIMITED |
Party Name:WOCKHARDT<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br> <br> |
Meet No/Date:10/82-<br>ALC4/2019<br> <br> |
Status:<br>Approved |
Status:<br>Approved |
|
|
|
<br>RLA File<br>:03/95/040/00772/AM20/ |
|
|
|
|
<br>29.11.2019<br><br>Lic.No/Date:0310832696<br>11.11.2019 |
|
|
|
|
HQ File<br>:01/82/050/00802/AM20/ |
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| 236 |
**Decision:**The Committee co<br>was decided to ratify the ad-h |
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nsidered case as per agenda in t<br>c input output norms under par |
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he presence of the technical<br>a 47 of HBP as per detail |
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experts and it<br>s below or as |
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<br>applied by firm whichever is lower:<br>Export product<br>Qty. |
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. |
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Qty. |
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Sl.<br>No. |
Import items |
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Qty. |
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FUROSEMIDE<br>IN |
JECTION |
|
USP |
7 |
257 Packs |
1 |
FUROSEMIDE US |
P |
3.991 kg |
|
|
<br>10MG/ML,2ML<br>VI<br>PACK)<br>EACH<br>CONTAINS 20 MG<br>USP<br>(Total 181425 Vial<br>Content of FUROSE<br>3.901 KGS)<br>FUROSEMIDE<br>IN<br>10MG/ML,4ML<br>VI<br>PACK)<br>EACH<br>CONTAINS 40 MG<br> |
AL<br>(25<br>2ML<br>FUROSE<br>s and Tota<br>MIDE USP |
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VIAL |
co |
ntaining |
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VIAL |
2 |
5 vials each |
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MIDE |
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l Net<br> |
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upto |
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JECTION<br>AL<br>(25<br>4ML<br>FUROSE |
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USP<br>VIAL |
7<br> |
44 Packs<br>tii |
1 |
FUROSEMIDE U |
P |
8.188 kg |
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<br>VIAL |
c<br>2 |
nanng<br>vials each |
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<br>MIDE |
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USP<br>(Total 186100 Vials and Total Net<br> |
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Content of FUROSEMIDE USP upto<br>8.002 KGS)<br>FUROSEMIDE<br>INJECTION<br>USP |
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3429 Packs |
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1 |
FUROSEMIDE USP |
|
943 k |
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<br> <br>10MG/ML, 10ML VIAL (2<br>PACK)<br>EACH<br>10ML<br>CONTAINS 100 MG FURO |
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<br> <br>5 VIAL<br>VIAL<br>SEMIDE |
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<br>containing<br>25 vials each |
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. g |
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USP<br>(Total 85725 Vials and T<br> |
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otal Net<br> |
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Content of FUROSEMIDE USP upto<br>9.001 KGS)<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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| Case No.:229/10/82- |
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Party Name:DEEPAK |
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Meet No/Date:10/82- |
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Status: |
| ALC4/2019 |
|
PHENOLICS LIMITED |
|
ALC4/2019 |
|
Approved |
|
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|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045591 |
|
|
| :01/82/050/00803/AM20/ |
|
:34/24/040/00217/AM20/ |
|
11.11.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 237 applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| PHENOL |
1 kg |
1 |
BENZENE |
0.87 kg |
94
| Case No.:230/10/82- |
|
Party Name:RUMIT LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832720 |
|
|
| :01/82/050/00804/AM20/ |
|
:03/95/040/00775/AM20/ |
|
13.11.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 238 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| CLOBETASOL PROPIONATE<br>BP/USP |
1 kg |
1 |
BETAMETHASONE<br>IP/BP/USP/EP |
1.00 kg |
| Case No.:231/10/82- |
|
Party Name:RUMIT LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832721 |
|
|
| :01/82/050/00805/AM20/ |
|
:03/95/040/00777/AM20/ |
|
13.11.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 239 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| BETAMETHASONE DI |
1 kg |
1 |
BETAMETHASONE |
0.868 kg |
| PROPIONATE BP/USP |
|
|
IP/BP/USP/EP |
|
| Case No.:232/10/82- |
|
Party Name:RUMIT LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832722 |
|
|
| :01/82/050/00806/AM20/ |
|
:03/95/040/00776/AM20/ |
|
13.11.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 240 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| CLOBETASOL PROPIONATE<br>BP/USP |
1 kg |
1 |
BETAMETHASONE<br>IP/BP/USP/EP |
1.00 kg |
95
| Case No.:233/10/82- |
|
Party Name:RUMIT LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832724 |
|
|
| :01/82/050/00807/AM20/ |
|
:03/95/040/00778/AM20/ |
|
13.11.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 241 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| BETAMETHASONE DI |
1 kg |
1 |
BETAMETHASONE |
0.868 kg |
| PROPIONATE BP/USP |
|
|
IP/BP/USP/EP |
|
96
| Case No.:234/10/82- |
|
Party Name:J.B. |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CHEMICALS & |
|
ALC4/2019 |
|
Approved |
|
|
PHARMACEUTICALS |
|
29.11.2019 |
|
|
|
|
LIMITED |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832727 |
|
|
| :01/82/050/00808/AM20/ |
|
:03/94/040/00620/AM20/ |
|
13.11.2019 |
|
|
|
Case No.:234/10/82-<br>ALC4/2019 |
Case No.:234/10/82-<br>ALC4/2019 |
Case No.:234/10/82-<br>ALC4/2019 |
Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED |
Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved<br> |
|
HQ File<br>:01/82/050/00808/AM20/ |
|
|
RLA File<br>:03/94/040/00620/AM20/ |
|
Lic.No/Date:0310832727<br>13.11.2019 |
|
|
|
| 242 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 8/82-ALC4/2019 dated 20.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>10<br>mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR<br>303 NF- 100 mg. Net content (i) 161.741 Kgs (ii) 480.371 Kgs (iii)<br>2880.607 Kgs (iv) 1617.41 Kgs.<br>1 Number<br>2<br>GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>5<br>mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303<br>NF- 50 mg. Net content (i) 59.131 Kgs (ii) 241.252 Kgs (iii) 1053.114<br>Kgs (iv) 591.305 Kgs.<br>1 Number<br>3<br>GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>2.5<br>mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303<br>NF- 50 mg. Net content (i) 18.261 Kgs (ii) 149.009 Kgs (iii) 650.451<br>Kgs (iv) 365.217 Kgs.<br>1 Number<br>Sl.<br>No.<br>Import Items<br>For export of 1 Number of Tablet<br>2.5 mg<br>5.0 mg<br>10.0 mg<br>1<br>GLIPIZIDE USP<br>2.55 mg<br>5.10 mg<br>10.20 mg<br>2<br>EASTMAN (TM) CELLULOSE ACETATE<br>(CA 398-10NF/EP)<br>20.40 mg<br>20.40 mg<br>29.70 mg<br>3<br>SENTRY POLYOX WSR N80 FP NF<br>89.05 mg<br>89.05 mg<br>178.10 mg<br>4<br>SENTRY POLYOX WSR 303 NF<br>50.00 mg<br>50.00 mg<br>100.00 mg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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<br>Sl.<br>No.<br>1<br>2<br>3 |
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|
Export Product |
|
|
|
|
Qty. |
|
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|
|
GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>10<br>mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR<br>303 NF- 100 mg. Net content (i) 161.741 Kgs (ii) 480.371 Kgs (iii)<br>2880.607 Kgs (iv) 1617.41 Kgs. |
|
|
|
|
1 Number |
|
|
|
|
GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>5<br>mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303<br>NF- 50 mg. Net content (i) 59.131 Kgs (ii) 241.252 Kgs (iii) 1053.114<br>Kgs (iv) 591.305 Kgs. |
|
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|
1 Number |
|
|
|
|
GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>2.5<br>mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303<br>NF- 50 mg. Net content (i) 18.261 Kgs (ii) 149.009 Kgs (iii) 650.451<br>Kgs (iv) 365.217 Kgs. |
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1 Number |
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|
Sl.<br>No. |
Import Items |
|
For export of 1 Number of Tablet |
|
|
|
|
|
|
|
|
|
2.5 mg |
|
5.0 mg |
|
10.0 mg |
|
|
1 |
GLIPIZIDE USP |
|
2.55 mg |
|
5.10 mg |
|
10.20 mg |
|
|
2 |
EASTMAN (TM) CELLULOSE ACETATE<br>(CA 398-10NF/EP) |
|
20.40 mg |
|
20.40 mg |
|
29.70 mg |
|
|
3 |
SENTRY POLYOX WSR N80 FP NF |
|
89.05 mg |
|
89.05 mg |
|
178.10 mg |
|
|
4 |
SENTRY POLYOX WSR 303 NF |
|
50.00 mg |
|
50.00 mg |
|
100.00 mg |
|
|
|
|
|
|
|
|
|
|
97
| Case No.:235/10/82- |
|
Party Name:SUVEN LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068176 |
|
Defer Date: |
| :01/82/050/00809/AM20/ |
|
:09/24/040/00407/AM20/ |
|
13.11.2019 |
|
|
243 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:
(i) Complete chemical name of export product. (ii) Stepwise complete and balanced chemical reactions showing molecular weight and % yield on molar basis. (iii) Technical justification for the yields at various steps.
| Case No.:236/10/82- |
|
Party Name:SUVEN LIFE |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068177 |
|
|
| :01/82/050/00810/AM20/ |
|
:09/24/040/00406/AM20/ |
|
13.11.2019 |
|
|
|
Case No.:236/10/82-<br>ALC4/2019 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br> <br>Lic.No/Date:0910068177<br>13.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00810/AM20/ |
RLA File<br>:09/24/040/00406/AM20/ |
|
|
|
|
|
| 244 |
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower: |
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
1-[2-[5-METHYL-3-<br>(TRIFLUOROMETHYL)-1H-<br>PYRAZOL-1-YL] ACETYL]<br>PIPERIDINE-4-CARBOTHIOAMIDE |
|
1 kg |
1 |
4-CYANO PYRIDINE |
|
0.524 kg |
|
|
|
|
2 |
TERTIARY BUTANOL |
|
0.488 kg |
|
|
|
|
3 |
N,N-DIMETHYL FORMAMIDE<br>(DMF) |
|
2.890 kg |
|
|
|
|
4 |
ETHYL TRIFLUORO ACETATE |
|
0.708 kg |
|
|
|
|
5 |
ACETONE |
|
0.315 kg |
|
|
|
|
6 |
HYDRAZINE HYDRATE(80%) |
|
0.398 kg |
|
|
|
|
7 |
METHYL TERTIARY BUTYL<br>ETHER |
|
2.88 kg |
|
RA concerned maytake further necessaryaction as |
|
|
per above decision of NC. |
|
|
|
98
Case No.:237/10/82- Party Name:SRINI Meet No/Date:10/82- Status: ALC4/2019 PHARMACEUTICALS ALC4/2019 Approved PRIVATE LIMITED 29.11.2019 HQ File RLA File Lic.No/Date:0910068178 :01/82/050/00811/AM20/ :09/24/040/00385/AM20/ 13.11.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2018 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
|
|
Decision: |
Decision: |
Decision: |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
The Committee considered the case as per agenda in the presence of Technical Experts and |
|
|
in |
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the |
light<br>of |
earlier |
|
<br>decision |
|
taken<br>by<br>NC<br>in<br>its<br>Meeting |
|
No. |
|
3/82-ALC4/2018 |
|
|
|
, dated 05.07.2019, it |
|
|
|
was decided to ratify the |
|
|
|
|
ad-hoc input output norms under para 4.7 |
|
|
of HBP Vol. I |
as |
|
|
per |
|
details |
below or as applied by firm whichever is lower: |
|
|
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|
|
|
|
|
|
| 245 |
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Export |
product |
|
|
Qty. |
Sl. No. |
|
Import items |
|
|
Qty. |
|
|
|
|
|
FLUVOXAMINE |
|
|
1 kg |
|
1 |
|
1-CHLORO-4-METHOXY BUTANE |
|
|
1.01 kg |
|
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|
MALEATE |
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|
2 |
|
4-(TRIFLUORO<br>METHYL) |
|
|
0.93 kg |
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BENZONITRILE |
|
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3 |
|
TETRA HYDROFURAN |
|
|
1.9845 kg |
|
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|
|
4 |
|
2-CHLOROETHYLAMINE HCL |
|
|
0.48 kg |
|
|
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|
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|
|
5 |
|
SODIUM HYDROXIDE MICRO |
|
|
1.313 kg |
|
|
|
|
|
|
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|
|
PEARLS |
|
|
|
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|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
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|
Case No.:238/10/82- |
|
Party Name:ATUL LIMITED |
|
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
29.11.2019 |
|
|
| 246 |
|
HQ File<br>:01/82/050/00812/AM20/ |
|
RLA File<br>:08/24/040/00258/AM20/ |
|
|
Lic.No/Date:0810146544<br>13.11.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Ahmedabad. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
|
|
Case No.:239/10/82- |
|
Party Name:INDOCO |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
REMEDIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 247 |
|
HQ File<br>:01/82/050/00813/AM20/ |
|
RLA File<br>:03/94/040/00587/AM20/ |
|
Lic.No/Date:0310832731<br>13.11.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
|
|
Case No.:240/10/82- |
|
|
Party Name:RELIANCE |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
29.11.2019 |
|
|
| 248 |
|
HQ File |
|
|
RLA File |
|
Lic.No/Date:0310832770 |
|
Defer Date: |
|
|
:01/82/050/00814/AM20/ |
|
|
:03/95/040/00707/AM20/ |
|
14.11.2019 |
|
|
|
|
**Decision:**New Case. |
The Committee decided to refer the case to Special Committee for further |
|
|
|
|
|
|
|
|
consideration. |
|
|
|
|
|
|
|
99
| 249 |
Case No.:241/10/82-<br>ALC4/2019 |
Party Name:SMILAX<br>LABORATORIES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00815/AM20/ |
RLA File<br>:09/24/040/00411/AM20/ |
Lic.No/Date:0910068182<br>14.11.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:242/10/82- |
|
Party Name:MANGALAM |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
DRUGS AND ORGANICS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832757 |
|
|
| :01/82/050/00816/AM20/ |
|
:03/95/040/00731/AM20/ |
|
14.11.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 250 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| PIPERAQUINE PHOSPHATE |
1 kg |
1 |
ETHOXY METHYLENE |
1.30 kg |
|
|
|
MALONIC ACID ESTER(EMME) |
|
|
|
2 |
PIPERAZINE ANHYDROUS |
0.832 kg |
| 251 |
Case No.:243/10/82-<br>ALC4/2019 |
Party Name:U K AROMATICS<br>& CHEMICALS |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00817/AM20/ |
RLA File<br>:03/95/040/00795/AM20/ |
Lic.No/Date:0310832762<br>14.11.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
100
| 252 |
<br>Case No.:244/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00818/AM20/ |
RLA File<br>:03/94/040/00636/AM20/ |
Lic.No/Date:0310832767<br>14.11.2019 |
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 253 |
<br>Case No.:245/10/82-<br>ALC4/2019 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00819/AM20/ |
RLA File<br>:09/24/040/00414/AM20/ |
Lic.No/Date:0910068184<br>14.11.2019 |
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 254 |
Case No.:246/10/82-<br>ALC4/2019 |
Party Name:NISARG<br>BIOSCIENCES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00820/AM20/ |
RLA File<br>:09/24/040/00403/AM20/ |
Lic.No/Date:0910068187<br>14.11.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:248/10/82- |
|
Party Name:NEOGEN |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
CHEMICALS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832778 |
|
|
| :01/82/050/00822/AM20/ |
|
:03/95/040/00786/AM20/ |
|
14.11.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 255 applied by firm whichever is lower:
| Export product |
Export product |
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
| ETHYL |
2-BROMO |
ISO |
1 kg |
1 |
ISOBUTYRIC ACID |
0.65 kg |
| BUTYRATE |
|
|
|
2 |
LIQUID BROMINE |
1.15 kg |
|
|
|
|
3 |
ETHANOL |
0.70 kg |
101
| 256 |
<br>Case No.:249/10/82-<br>ALC4/2019 |
Party Name:YASHO<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00791/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00823/AM20/ |
|
Lic.No/Date:0310832783<br>14.11.2019 |
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 257 |
Case No.:250/10/82-<br>ALC4/2019 |
Party Name:MANGALAM<br>ORGANICS LIMITED<br>FORMERLY DUJODWALA<br>PRODU |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br>Lic.No/Date:0310832785<br>14.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00824/AM20/ |
RLA File<br>:03/95/040/00702/AM20/ |
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:251/10/82- |
|
Party Name:VERGO |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA RESEARCH |
|
ALC4/2019 |
|
Approved |
|
|
LABORATORIES PVT. |
|
29.11.2019 |
|
|
|
|
LTD., |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832786 |
|
|
| :01/82/050/00825/AM20/ |
|
:03/95/040/00800/AM20/ |
|
14.11.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 258 meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Export Product |
Qty. |
Sl.No. |
Import items |
Qty. |
| Colchicine, 500MCG Tablets |
1 Number |
1 |
Colchicine Ph.Eur |
510 mcg/<br>500mcg<br>tablet |
| 259 |
<br>Case No.:252/10/82-<br>ALC4/2019 |
Party Name:CLARIANT<br>INDIA LIMITED<br>RLA File<br>:03/94/040/00639/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00826/AM20/ |
|
Lic.No/Date:0310832792<br>14.11.2019 |
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
102
| 260 |
Case No.:247/10/82-<br>ALC4/2019 |
Party Name:VEKO CARE<br>PRIVATE LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00821/AM20/ |
RLA File<br>:31/83/040/00104/AM20/ |
Lic.No/Date:3110067591<br>15.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Pune. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.
| 261 |
Case No.:253/10/82-<br>ALC4/2019 |
Party Name:VINS<br>BIOPRODUCTS LTD`<br>RLA File<br>:09/24/040/00410/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019<br> <br><br>Lic.No/Date:0910068189<br>15.11.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00827/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 262 |
<br>Case No.:254/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00828/AM20/ |
RLA File<br>:03/94/040/00628/AM20/ |
Lic.No/Date:0310832799<br>15.11.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 263 |
Case No.:255/10/82-<br>ALC4/2019 |
Party Name:PORUS<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00829/AM20/ |
RLA File<br>:09/24/040/00421/AM20/ |
Lic.No/Date:0910068191<br>15.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 264 |
Case No.:256/10/82-<br>ALC4/2019 |
Party Name:MEDREICH<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00830/AM20/ |
RLA File<br>:07/24/040/00171/AM20/ |
Lic.No/Date:0710115694<br>15.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Bangalore. |
|
|
|
103
| Case No.:257/10/82- |
|
Party Name:NEW |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
ALLIANCE DYE-CHEM |
|
ALC4/2019 |
|
Approved |
|
|
PVT. LTD., |
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:031083283 |
|
|
| :01/82/050/00831/AM20/ |
|
:03/95/040/00807/AM20/ |
|
7 |
|
|
|
|
|
|
18.11.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2019, dated 21.06.2019, it was 265 decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
|
|
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
No. |
|
|
| DISODIUM |
EDTA |
ZINC |
[ZN |
1 kg |
1 |
ETHYLENE DIAMINE |
0.685 kg |
| CONTENT 15% (+/- 0.5%)] |
|
|
|
|
|
TETRA ACETIC ACID |
|
|
|
|
|
|
|
(EDTA) |
|
|
|
Case No.:258/10/82- |
|
Party Name:WEXFORD |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
LABORATORIES P LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
29.11.2019 |
|
|
| 266 |
|
HQ File<br>:01/82/050/00832/AM20/ |
|
RLA File<br>:07/24/040/00178/AM20/ |
|
Lic.No/Date:0710115700<br>18.11.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Bangalore. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
|
|
Case No.:259/10/82- |
|
Party Name:NISARG |
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
BIOSCIENCES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
29.11.2019 |
|
|
| 267 |
|
HQ File<br>:01/82/050/00833/AM20/ |
|
RLA File<br>:09/24/040/00424/AM20/ |
|
Lic.No/Date:0910068197<br>18.11.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Hyderabad. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
104
| Case No.:260/10/82- |
|
Party Name:J N P |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
PRODUCTS |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045617 |
|
|
| :01/82/050/00834/AM20/ |
|
:34/24/040/00254/AM20/ |
|
18.11.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of HBP v1 268 as per details given below or as applied by the firm, whichever is less:
| Export Product |
Qty. |
Sl.<br>No. |
Import items |
Qty.<br>1.222 kg<br>0.500 kg |
| Para Amino Phenol |
1 kg |
1 |
Para Nitro Chloro Benzene |
|
|
|
2 |
Caustic Soda Lye |
|
| 269 |
Case No.:261/10/82-<br>ALC4/2019 |
Party Name:AVIEUM LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00835/AM20/ |
RLA File<br>:31/83/040/00101/AM20/ |
Lic.No/Date:3110067594<br>18.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Pune. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.
| 270 |
Case No.:262/10/82-<br>ALC4/2019 |
Party Name:REYAANSH<br>HEALTHCARE |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00836/AM20/ |
RLA File<br>:03/95/040/00757/AM20/ |
Lic.No/Date:0310832850<br>18.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 271 |
Case No.:263/10/82-<br>ALC4/2019 |
Party Name:STERLING<br>AUXILIARIES PVT LTD |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00837/AM20/ |
RLA File<br>:03/95/040/00812/AM20/ |
Lic.No/Date:0310832853<br>19.11.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
105
| Case No.:264/10/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832883 |
|
|
| :01/82/050/00838/AM20/ |
|
:03/94/040/00623/AM20/ |
|
19.11.2019 |
|
|
|
Case No.:264/10/82-<br>ALC4/2019 |
Case No.:264/10/82-<br>ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00838/AM20/ |
|
RLA File<br>:03/94/040/00623/AM20/ |
|
|
Lic.No/Date:0310832883<br>19.11.2019 |
|
|
| 272 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
|
<br>Export product |
Qty. |
|
Sl. No. |
Import items |
|
Qty. |
|
|
CILOSTAZOL |
1 Kg. |
|
1 |
5-(4-CHLOROBUTYL)-1-<br>CYCLOHEXYL 1H TETRAZOLE |
|
0.88 kg |
|
|
|
|
|
2 |
6-HYDROXY-2 OXO-1,2,3,4-<br>TETRAHYDROQUINOLINONE |
|
0.59 kg |
|
|
|
|
|
3 |
METHANOL |
|
4.00 kg |
|
|
|
|
|
4 |
TOLUENE |
|
0.30 kg |
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
| Case No.:265/10/82- |
|
Party Name:BIOLOGICAL E |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910068200 |
|
|
| :01/82/050/00839/AM20/ |
|
:09/24/040/00397/AM20/ |
|
19.11.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 273 meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Exportproduct |
Qty. |
Sl. No. |
<br>Import items |
Qty. |
| DAPTOMYCIN FOR INJCTION<br>500 MG PER VIAL |
1 Number |
1 |
DAPTOMYCIN |
550 mg / 10<br>ml vial |
| 274 |
Case No.:266/10/82-<br>ALC4/2019 |
Party Name:OPTIMUS<br>DRUGS PRIVATE LIMITED<br>RLA File<br>:09/24/040/00412/AM20/ |
Meet No/Date:10/82-<br>ALC4/2019<br>29.11.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00840/AM20/ |
|
Lic.No/Date:0910068203<br>19.11.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
106
|
|
Case No.:267/10/82- |
|
|
Party Name:AVIEUM LIFE |
|
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
|
SCIENCES PRIVATE |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
LIMITED |
|
|
29.11.2019 |
|
|
| 275 |
|
HQ File<br>:01/82/050/00841/AM20/ |
|
|
RLA File<br>:31/83/040/00108/AM20/ |
|
|
Lic.No/Date:3110067598<br>19.11.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
|
not available. Hence, it was |
decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Pune. |
|
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.
|
|
Case No.:268/10/82- |
|
|
Party Name:JODAS EXPOIM |
|
|
Meet No/Date:10/82- |
|
Status: |
|
|
ALC4/2019 |
|
|
PVT.LTD |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
|
29.11.2019 |
|
|
| 276 |
|
HQ File<br>:01/82/050/00842/AM20/ |
|
|
RLA File<br>:09/24/040/00365/AM20/ |
|
|
Lic.No/Date:0910068207<br>20.11.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
|
not available. Hence, it was |
decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Pune. |
|
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.
| Case No.:269/10/82- |
|
Party Name:ASTEC |
|
Meet No/Date:10/82- |
|
Status: |
| ALC4/2019 |
|
LIFESCIENCES LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
29.11.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310832904 |
|
|
| :01/82/050/00843/AM20/ |
|
:03/94/040/00599/AM20/ |
|
20.11.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 277 meeting no. 9/82-ALC4/2018 dated 18.09.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Exportproduct |
Qty. |
Sl. No. |
Import items |
Qty. |
| DEXTRINOL |
1 kg |
1 |
CROTONIC ACID |
0.849 kg |
|
|
2 |
BUTADIENE |
0.629 kg |
107
MANUAL CASES
|
Case No. |
Case No. |
B- 01 |
B- 01 |
B- 01 |
B- 01 |
|
Meeting No. |
|
10/AM20 |
|
|
|
|
Date |
|
29.11.2019 |
|
|
|
|
Firm’s Name |
|
M/s Ascent Finechem Pvt. Ltd. |
|
|
|
|
HQ F. No. |
|
01/82/050/01116/AM14/DES-III |
|
|
|
|
|
|
01/82/050/00174/AM16/DES-III |
|
|
|
|
|
|
01/82/050/00539/AM17/DES-III |
|
|
|
|
|
|
01/82/050/00699/AM13/DES-III |
|
|
|
|
RLA F. No. |
|
08/24/040/00415/AM14 |
|
|
|
|
|
|
08/24/040/00397/AM15 |
|
|
|
|
|
|
08/24/040/00104/AM17 |
|
|
|
|
|
|
08/24/040/00160/AM13 |
|
|
|
|
Advance Authorization No. and Date |
|
0810127686 dated 03.01.2014 |
|
|
|
|
|
|
0810134800 dated 13.03.2015 |
|
|
|
|
|
|
0810138218 dated 28.06.2016 |
|
|
|
|
|
|
0810114398 dated 21.08.2012 |
|
|
|
|
Subject |
|
Request of M/s Ascent Finechem Pvt. Ltd. Ahmedabad for<br>enhancement of norms in adhoc norms fixed against Advance<br>Authorization No. 0810127696 dated 03.01.2014, 0810134800<br>dated 13.03.2015, 0810138218 dated 28.06.2016 and 0810114398<br>dated 21.08.2012. |
|
|
|
|
**Decision:**The Committee considered the request of firm for enhancement of norms in respect of advance<br>authorization Nos. 0810127686 dated 03.01.2014, 0810138218 dated 28.06.2006 and 0810114398 dated<br>21.08.2012 and it was decided to reject the request of firm. Further, the Committee decided to fix following<br>adhoc norms in respect of advance authorization No. 0810134800 dated 13.03.2015:<br>Exportproduct<br> Qty.<br>Sl. No.<br>Import items<br>Qty.<br>RASPBERRY KETONE/ 4-(4-<br>HYDROXYPHYENYL)<br>BUTANE - 2 - ONE WHITE<br>CRYSTALLINE POWDER<br>1 kg<br>1<br>p-HYDROXY<br>BENZALDEHYDE<br>(LIGHT<br>YELLOW<br>CRYSTALLINE<br>POWDER),<br>PARA<br>HYDROXY<br>BENZALDEHYDE,<br>4-<br>HYDROXY<br>BENZALDEHYDE<br>1.69 kg<br>2<br>ACETONE<br>(COLORLESS<br>LIQUID)<br>0.802 kg<br>3<br>G2PAC<br>ASSEMBLY<br>700<br>LITER / 250 KGS (35 inch x<br>35 inch x 35 inch polyprpelene<br>woven<br>fabric<br>bags)<br>Relevant as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Exportproduct |
Qty. |
|
Sl. No. |
Import items |
Qty. |
|
RASPBERRY KETONE/ 4-(4-<br>HYDROXYPHYENYL)<br>BUTANE - 2 - ONE WHITE<br>CRYSTALLINE POWDER |
1 kg |
|
1 |
p-HYDROXY<br>BENZALDEHYDE<br>(LIGHT<br>YELLOW<br>CRYSTALLINE<br>POWDER),<br>PARA<br>HYDROXY<br>BENZALDEHYDE,<br>4-<br>HYDROXY<br>BENZALDEHYDE |
1.69 kg |
|
|
|
|
2 |
ACETONE<br>(COLORLESS<br>LIQUID) |
0.802 kg |
|
|
|
|
3 |
G2PAC<br>ASSEMBLY<br>700<br>LITER / 250 KGS (35 inch x<br>35 inch x 35 inch polyprpelene<br>woven<br>fabric<br>bags) |
Relevant as per<br>packing policy |
|
RA concerned may take further necessary action as per |
|
|
|
above decision of NC. |
|
108
| Case No. |
B- 02 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Alchem International Ltd. |
| HQ F. No. |
01/82/050/01457/AM15/DES-III |
|
01/82/050/00562/AM15/DES-III |
|
01/82/050/00191/AM15/DES-III |
| RLA F. No. |
05/23/040/00449/AM15 |
|
05/23/040/00053/AM15 |
|
05/23/040/00413/AM14 |
| Advance Authorization No. and Date |
0510392602 dated 29.12.2014 |
|
0510388783 dated 18.06.2014 |
|
0510376990 dated 24.01.2014 |
| Subject |
Request of M/s Alchem International Ltd. New Delhi for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization Nos. 0510392602 dated. 19.12.2014, 0510388783<br>dated. 18.06.2014, 0510376990 dated 24.01.2014 |
| Decision:The Committee considered t<br>experts and it was decided torejectthe ca |
he request of firm enhancement of norms in the presence of technical<br>se maintaining the status quo. |
| Case No. |
B- 03 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Eurolife Healthcare Pvt. Ltd. |
| HQ F. No. |
01/82/050/00323/AM14/DES-III |
|
01/82/050/00571/AM16/DES-III |
| RLA F. No. |
03/94/040/00981/AM13 |
|
03/94/040/01086/AM15 |
| Advance Authorization No. and Date |
0310728713 dated 19.03.2013 |
|
0310794964 dated 27.03.2015 |
| Subject |
Request of M/s Eurolife Healthcare Pvt. Ltd. Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization<br>No.<br>0310728713<br>dated<br>19.03.2013<br>and<br>0310794964 dated 27.03.2015 |
| Decision:The Committee considered the request of firm in the presence of technical experts and it was<br>observed that the reply given by the firm is not as per the DL issued earlier. Further, the import items include<br>large quantity of LDPE Granules, Craft Paper and other packing materials.<br>In view of above, the Committee decided to call the firm for attendingPersonal Hearingbefore<br>Norms Committee alongwith sample of import item. |
|
109
| Case No. |
Case No. |
B- 04 |
|
|
|
|
| Meeting No. |
|
10/AM20 |
|
|
|
|
| Date |
|
29.11.2019 |
|
|
|
|
| Firm’s Name |
|
M/s Adishank Chemicals Pvt. Ltd., Mumbai |
|
|
|
|
| HQ F. No. |
|
01/82/050/00422/AM15/DES-III |
|
|
|
|
| RLA F. No. |
|
03/94/040/01140/AM14 |
|
|
|
|
| Advance Authorization No. and Date |
|
0310777786 dated 09.04.2014 |
|
|
|
|
| Subject |
|
Request of M/s Adhishank Chemicals Pvt. |
|
Ltd Mumbai, for |
|
|
|
|
fixation of adhoc norms against Advance |
|
Authorization |
|
No. |
|
|
0310777786 dated 09.04.2014 |
|
|
|
|
| **Decision:**The Committee considered the request of firm in the presence of technical experts and it |
|
|
|
|
|
was |
| decided to fix following adhoc norms: |
|
|
|
|
|
|
|
Export product |
Qty.<br>Sl. |
Import items |
|
Qty. |
|
|
|
No. |
|
|
|
|
|
DI ISO DECYL PHENYL |
1 kg<br>1 |
Phenol |
|
0.54 kg |
|
|
PHOSPHITE (DDPP) |
2 |
Phosphorous Trichloride |
|
0.33 kg |
|
|
|
3 |
Isodecyl Alcohol |
|
0.745 kg |
|
| RA concerned may take further necessary |
|
action as per above decision of NC. |
|
|
|
|
| Case No. |
B- 05 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Survival Technologies Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/00258/AM18/DES-III |
| RLA F. No. |
03/95/040/00034/AM18 |
| Advance Authorization No. and Date |
0310812810 dated 26.04.2017 |
| Subject |
Request of M/s Survival Technologies Pvt. Ltd., Mumbai for |
|
enhancement in the quantity of import items of adhoc norms |
|
fixed against Advance Authorization No. 0310812810 dated |
|
26.04.2017 |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical |
|
| experts andit was decided to reject the casemaintaining the status quo. |
|
| Case No. |
B- 06 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Survival Technologies Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/00796/AM16/DES-III |
| RLA F. No. |
03/95/040/00065/AM16 |
| Advance Authorization No. and Date |
0310795759 Dated:07.05.2015 |
| Subject |
Request of M/s Survival Technologies Pvt. Ltd., Mumbai for |
|
revision of norms fixed against Advance Authorization No. |
|
0310795759 dated 07.05.2015 |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical |
|
| experts and it was decided torejectthe case maintaining the status quo. |
|
110
| Case No. |
B- 07 |
|
| Meeting No. |
10/AM20 |
|
| Date |
29.11.2019 |
|
| Firm’s Name |
M/s Survival Technologies Pvt. Ltd., Mumbai |
|
| HQ F. No. |
01/82/050/00114/AM18/DES-III |
01/82/050/01085/AM17/DES-III |
| RLA F. No. |
03/95/040/00921/AM17 |
03/95/040/00639/AM17 |
| Advance Authorization No. and Date |
0310811465 dated 27.02.2017 |
0310809216 dated 22.11.2016 |
| Subject |
Request of M/s Survival Technologies Pvt. Ltd., Mumbai for |
|
|
enhancement in the quantity of import items of adhoc norms fixed |
|
|
against Advance Authorization Nos. 0310811465 dated 27.02.2017 |
|
|
and 0310809216 dated 22.11.2016 |
|
| **Decision:**The Committee considered the request of firm enhancement of |
|
norms in the presence of technical |
| experts and it was decided torejectthe case maintaining the status quo. |
|
|
| Case No. |
Case No. |
B- 08 |
|
|
| Meeting No. |
|
10/AM20 |
|
|
| Date |
|
29.11.2019 |
|
|
| Firm’s Name |
|
M/s Ogene Systems India Ltd., Hyderabad |
|
|
| HQ F. No. |
|
01/82/050/00936/AM15/DES-III |
|
|
| RLA F. No. |
|
09/24/040/00669/AM14 |
|
|
| Advance Authorization No. and Date |
|
0910059697 dated 03.04.2014 |
|
|
| Subject |
|
Request of M/s Ogene Systems India Pvt. Ltd., Hyderabad for |
|
|
|
|
fixation of input output norms against Advance Authorization |
|
|
|
|
No. 0910059697 dated 03.04.2014 |
|
|
| **Decision:**The Committee considered the request of firm in the presence of technical experts and it |
|
|
|
was |
| decided to fix following adhoc norms: |
|
|
|
|
|
Export product |
Qty.<br>Sl.<br>Import items |
Qty. |
|
|
|
No. |
|
|
|
2-Ethyl-3,4-Ethylenedioxy thiophene |
1 kg<br>1<br>Diethyl Thioglycolate |
2.50 kg |
|
|
(Ethyl EDOT) |
2<br>1,2,-Butanediol |
2.50 kg |
|
|
|
3<br>Diethyl Oxalate |
2.00 kg |
|
|
|
4<br>Dimethyl formamide |
1.00 kg |
|
|
|
5<br>Ethylene dichloride |
2.50 kg |
|
|
|
6<br>Methanol |
2.00 kg |
|
|
|
7<br>Sodium methoxide solution |
4.46 kg |
|
| RA concerned may take further necessary |
|
action as per above decision of NC. |
|
|
111
| Case No. |
B- 09 |
B- 09 |
| Meeting No. |
10/AM20 |
|
| Date |
29.11.2019 |
|
| Firm’s Name |
M/s Ogene Systems India Ltd., Hyderabad |
|
| HQ F. No. |
01/82/050/00246/AM17 /DES-III |
01/82/050/00181/AM18/DES-III |
| RLA F. No. |
09/24/040/00620/AM16 |
09/24/040/00535/AM17 |
| Advance Authorization<br>No. and Date |
0910063151 dated 22.01.2016 |
0910064554 dated 05.01.2017 |
| Subject |
Request of M/s Ogene Systems India Ltd., Hyderabad for enhancement in the<br>quantity of Import Items in respect of adhoc norms fixed against Advance<br>Authorization Nos. 0910059697 dated 03.04.201410064554 dated 05.01.2017 |
|
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
|
| Case No. |
B- 10 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s ARENE LIFE SCIENCES LIMITED, Hyderabad |
| HQ F. No. |
01/82/050/01462/AM16/DES-III |
| RLA F. No. |
09/24/040/040/00571/AM16 |
| Advance Authorization No. and Date |
0910063114 dated 08.01.2016 |
| Subject |
Request of M/s ARENE LIFE SCIENCES LIMITED,<br>Hyderabad for correction in the description of Export Product<br>in respect of norms fixed against Advance Authorization No.<br>0910063114 dated 08.01.2016 |
| Decision:The Committee considered the request of the firm for correction in the description of Export<br>Product in the presence of technical experts and it was decided to amend the description of Export Product to<br>read as“SAQUINAVIR MESYLATE”.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
112
|
Case No. |
Case No. |
Case No. |
B- 11 |
B- 11 |
B- 11 |
B- 11 |
|
Meeting No. |
|
|
10/AM20 |
|
|
|
|
Date |
|
|
29.11.2019 |
|
|
|
|
Firm’s Name |
|
|
M/s Alembic Pharmaceuticals Limited, Vadodara |
|
|
|
|
HQ F. No. |
|
|
01/82/050/00527/AM17/DES-III |
|
|
|
|
RLA F. No. |
|
|
34/24/040/00021/AM17 |
|
|
|
|
Advance Authorization No. and Date |
|
|
3410042142 dated 05.05.2016 |
|
|
|
|
Subject |
|
|
Request of M/s Alembic Pharmaceuticals Ltd, Vododara for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 3410042142<br>dated 05.05.2016. |
|
|
|
|
**Decision:**The Committee considered the request of<br>decided to revise the norms as under: |
|
|
|
|
the firm in the presence of technical experts and it was<br>Import Items<br>Qty.<br>(in mg)<br>CANDESARTAN CILEXETIL Ph. Eur.<br>87.694<br>LACTOSE MONOHYDRATE<br>(GRANULAC 200)<br>702.212<br>CORN STARCH<br>108.533<br>CARBOXYMETHYLCELLULOSE<br>CALCIUM<br>19.943<br>HYDROXYPROPYL CELLULOSE<br>(HPC L)<br>34.188<br>POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF)<br>45.584<br>PIGMENT BLEND PB-24880 PINK<br>2.713<br>CANDESARTAN CILEXETIL Ph. Eur.<br>94.076<br>LACTOSE MONOHYDRATE<br>(GRANULAC 200)<br>680.542<br>CARBOXYMETHYL CELLULOSE<br>CALCIUM<br>21.394<br>HYDROXYPROPYL CELLULOSE<br>(HPC L)<br>36.676<br>POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF)<br>48.901<br>PIGMENT BLEND PB-24880 PINK<br>2.911<br>CANDESARTAN CILEXETIL Ph. Eur.<br>49.336<br>LACTOSE MONOHYDRATE<br>(GRANULAC 200)<br>716.837<br>CARBOXYMETHYLCELLULOSE<br>CALCIUM<br>22.439<br>HYDROXYPROPYL CELLULOSE<br>(HPC L)<br>38.467<br>POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF)<br>51.29<br>CANDESARTAN CILEXETIL Ph. Eur.<br>4.08<br>LACTOSE MONOHYDRATE<br>(GRANULAC 200)<br>32.35<br>CORN STARCH<br>5.00<br>CARBOXYMETHYLCELLULOSE<br>CALCIUM<br>0.919<br>HYDROXYPROPYL CELLULOSE<br>(HPC L)<br>1.575<br>POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF)<br>2.1<br>PIGMENT BLEND PB-24880PINK<br>0.125 |
|
|
Sl.<br>No. |
Export Product |
Qty. |
|
Sl.<br>No. |
Import Items |
Qty.<br>(in mg) |
|
1 |
CANDESARTAN<br>CILEXETIL 8.68%<br>MIXED GRANULES |
1 Gram |
|
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
87.694 |
|
|
|
|
|
2 |
LACTOSE MONOHYDRATE<br>(GRANULAC 200) |
702.212 |
|
|
|
|
|
3 |
CORN STARCH |
108.533 |
|
|
|
|
|
4 |
CARBOXYMETHYLCELLULOSE<br>CALCIUM |
19.943 |
|
|
|
|
|
5 |
HYDROXYPROPYL CELLULOSE<br>(HPC L) |
34.188 |
|
|
|
|
|
6 |
POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF) |
45.584 |
|
|
|
|
|
7 |
PIGMENT BLEND PB-24880 PINK |
2.713 |
|
2 |
CANDESARTAN<br>CILEXETIL 9.31%<br>MIXED GRANULES |
1 Gram |
|
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
94.076 |
|
|
|
|
|
2 |
LACTOSE MONOHYDRATE<br>(GRANULAC 200) |
680.542 |
|
|
|
|
|
3 |
CARBOXYMETHYL CELLULOSE<br>CALCIUM |
21.394 |
|
|
|
|
|
4 |
HYDROXYPROPYL CELLULOSE<br>(HPC L) |
36.676 |
|
|
|
|
|
5 |
POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF) |
48.901 |
|
|
|
|
|
6 |
PIGMENT BLEND PB-24880 PINK |
2.911 |
|
3 |
CANDESARTAN<br>CILEXETIL 4.88%<br>MIXED GRANULES |
1 Gram |
|
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
49.336 |
|
|
|
|
|
2 |
LACTOSE MONOHYDRATE<br>(GRANULAC 200) |
716.837 |
|
|
|
|
|
3 |
CARBOXYMETHYLCELLULOSE<br>CALCIUM |
22.439 |
|
|
|
|
|
4 |
HYDROXYPROPYL CELLULOSE<br>(HPC L) |
38.467 |
|
|
|
|
|
5 |
POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF) |
51.29 |
|
4 |
CANDESARTAN 4<br>MG TAB. |
1 Number |
|
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
4.08 |
|
|
|
|
|
2 |
LACTOSE MONOHYDRATE<br>(GRANULAC 200) |
32.35 |
|
|
|
|
|
3 |
CORN STARCH |
5.00 |
|
|
|
|
|
4 |
CARBOXYMETHYLCELLULOSE<br>CALCIUM |
0.919 |
|
|
|
|
|
5 |
HYDROXYPROPYL CELLULOSE<br>(HPC L) |
1.575 |
|
|
|
|
|
6 |
POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF) |
2.1 |
|
|
|
|
|
7 |
PIGMENT BLEND PB-24880PINK |
0.125 |
113
|
|
|
|
8 |
MAGNESIUM STEARATE |
0.525 |
|
|
5 |
CANDESARTAN 8<br>MG TAB. |
1 Number |
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
8.16 |
|
|
|
|
|
2 |
LACTOSE MONOHYDRATE<br>(GRANULAC 200) |
64.70 |
|
|
|
|
|
3 |
CORN STARCH |
10.00 |
|
|
|
|
|
4 |
CARBOXYMETHYLCELLULOSE<br>CALCIUM |
1.837 |
|
|
|
|
|
5 |
HYDROXYPROPYL CELLULOSE<br>(HPC L) |
3.15 |
|
|
|
|
|
6 |
POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF) |
4.20 |
|
|
|
|
|
7 |
PIGMENT BLEND PB-24880 PINK |
0.25 |
|
|
|
|
|
8 |
MAGNESIUM STEARATE |
1.05 |
|
|
6 |
CANDESARTAN 16<br>MG TAB. |
1 Number |
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
16.32 |
|
|
|
|
|
2 |
LACTOSE MONOHYDRATE<br>(GRANULAC 200) |
129.40 |
|
|
|
|
|
3 |
CORN STARCH |
20.00 |
|
|
|
|
|
4 |
CARBOXYMETHYLCELLULOSE<br>CALCIUM |
3.675 |
|
|
|
|
|
5 |
HYDROXYPROPYL CELLULOSE<br>(HPC L) |
6.30 |
|
|
|
|
|
6 |
POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF) |
8.40 |
|
|
|
|
|
7 |
PIGMENT BLEND PB-24880 PINK |
0.50 |
|
|
|
|
|
8 |
MAGNESIUM STEARATE |
2.10 |
|
|
7 |
CANDESARTAN 32<br>MG TAB. |
1 Number |
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
32.64 |
|
|
|
|
|
2 |
LACTOSE MONOHYDRATE<br>(GRANULAC 200) |
258.80 |
|
|
|
|
|
3 |
CORN STARCH |
40.00 |
|
|
|
|
|
4 |
CARBOXYMETHYLCELLULOSE<br>CALCIUM |
7.35 |
|
|
|
|
|
5 |
HYDROXYPROPYL CELLULOSE<br>(HPC L) |
12.60 |
|
|
|
|
|
6 |
POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF) |
16.80 |
|
|
|
|
|
7 |
PIGMENT BLEND PB-24880 PINK |
1.00 |
|
|
|
|
|
8 |
MAGNESIUM STEARATE |
4.20 |
|
|
8 |
CANDESARTAN<br>HCTZ 16/12.5 MG<br>TAB. |
1 Number |
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
16.32 |
|
|
|
|
|
2 |
LACTOSE MONOHYDRATE<br>(GRANULAC 200) |
116.90 |
|
|
|
|
|
3 |
CARBOXYMETHYLCELLULOSE<br>CALCIUM |
3.675 |
|
|
|
|
|
4 |
HYDROXYPROPYL CELLULOSE<br>(HPC L) |
6.30 |
|
|
|
|
|
5 |
POLYETHYLENE GLYCOL 8000<br>(POLYGLYKOL 8000 PF) |
8.40 |
|
|
|
|
|
6 |
PIGMENT BLEND PB-24880 PINK |
0.50 |
|
|
|
|
|
7 |
HYDROCHLOROTHIAZIDE |
12.75 |
|
|
|
|
|
8 |
CARBOXYMETHYLCELLULOSE<br>CALCIUM |
2.625 |
|
|
|
|
|
9 |
MAGNESIUM STEARATE |
2.10 |
|
|
9 |
CANDESARTAN<br>HCTZ 32/12.5 MG<br>TAB. |
1 Number |
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
32.64 |
|
|
|
|
|
2 |
LACTOSE MONOHYDRATE<br>(GRANULAC 200) |
233.80 |
|
|
|
|
|
3 |
CARBOXYMETHYLCELLULOSE<br>CALCIUM |
7.35 |
|
|
|
|
|
4 |
HYDROXYPROPYL CELLULOSE<br>(HPCL) |
12.60 |
|
114
|
|
|
|
5 |
POLYETHYLENE GLYCOL 8000 |
16.80 |
|
|
|
|
|
|
(POLYGLYKOL 8000 PF) |
|
|
|
|
|
|
6 |
PIGMENT BLEND PB-24880 PINK |
1.00 |
|
|
|
|
|
7 |
HYDROCHLOROTHIAZIDE |
12.75 |
|
|
|
|
|
8 |
CARBOXYMETHYLCELLULOSE |
5.25 |
|
|
|
|
|
|
CALCIUM |
|
|
|
|
|
|
9 |
MAGNESIUM STEARATE |
4.20 |
|
|
10 |
CANDESARTAN |
1 Number |
1 |
CANDESARTAN CILEXETIL Ph. Eur. |
32.64 |
|
|
|
HCTZ 32/25 MG TAB. |
|
2 |
LACTOSE MONOHYDRATE |
233.80 |
|
|
|
|
|
|
(GRANULAC 200) |
|
|
|
|
|
|
3 |
CARBOXYMETHYLCELLULOSE |
7.35 |
|
|
|
|
|
|
CALCIUM |
|
|
|
|
|
|
4 |
HYDROXYPROPYL CELLULOSE |
12.60 |
|
|
|
|
|
|
(HPC L) |
|
|
|
|
|
|
5 |
POLYETHYLENE GLYCOL 8000 |
16.80 |
|
|
|
|
|
|
(POLYGLYKOL 8000 PF) |
|
|
|
|
|
|
6 |
PIGMENT BLEND PB-24880 PINK |
1.00 |
|
|
|
|
|
7 |
HYDROCHLOROTHIAZIDE |
25.50 |
|
|
|
|
|
8 |
CARBOXYMETHYLCELLULOSE |
5.25 |
|
|
|
|
|
|
CALCIUM |
|
|
|
|
|
|
9 |
MAGNESIUM STEARATE |
4.20 |
|
| RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
|
| Case No. |
Case No. |
|
B- 12 |
|
|
|
|
| Meeting No. |
|
|
10/AM20 |
|
|
|
|
| Date |
|
|
29.11.2019 |
|
|
|
|
| Firm’s Name |
|
|
M/s Brawn |
Laboratories Ltd, CLA, New Delhi |
|
|
|
| HQ F. No. |
|
|
01/82/050/02198/AM19/DES-III |
|
|
|
|
| RLA F. No. |
|
|
05/23/040/00388/AM19 |
|
|
|
|
| Advance Authorization No. and Date |
|
|
0510409001 dated 20.12.2018 |
|
|
|
|
| Subject |
|
|
Request of |
|
M/s Brawn Laboratories Ltd, CLA, New Delhi |
|
|
|
|
|
for revision/correction in adhoc norms |
|
|
fixed against |
|
|
|
|
Advance Authorization No. 0510409001 dated 20.12.2018 |
|
|
|
|
| **Decision:**The Committee considered the request of |
|
|
|
|
the firm in the presence of technical experts and it |
|
|
| was decided to revise the norms as under: |
|
|
|
|
|
|
|
|
Exportproduct |
Qty.<br>S.No |
|
|
Import items |
Qty. |
|
|
DOXYCYCLINECAPSULES |
1 No.<br>1. |
|
|
DOXYCYCLINE HYCLATE |
117.70 |
|
|
100MG |
Capsule |
|
|
B.P. |
mg/100 mg |
|
|
(HARD GELATINE CAPSULES |
|
|
|
(YELLOW HYGROSCOPIC |
Capsule |
|
|
CONTAINING YELLOW |
|
|
|
CRYSTALLINE POWDER_)_ |
|
|
|
GRANULAR POWDER). THE |
|
|
|
|
|
|
|
NET WEIGHT OF |
|
|
|
|
|
|
|
DOXYCYLINE HYCLATE |
|
|
|
|
|
|
|
B.P.SHOULD BE 2000 Kgs. IN |
|
|
|
|
|
|
|
EXPORT PRODUCT |
|
|
|
|
|
|
| RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
|
|
115
|
Case No. |
B- 13 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s Brawn Laboratories Ltd, CLA, New Delhi |
|
HQ F. No. |
01/82/050/00009/AM20/DES-III |
|
RLA F. No. |
05/23/040/00580/AM19 |
|
Advance Authorization No. and Date |
0510410163 dated 05.04.2019 |
|
Subject |
Request of M/s Brawn Laboratories Ltd, CLA for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 051040163 dated 05.04.2019 |
|
Decision:The Committee considered the request of the firm in the presence of technical experts and it<br>was decided to revise the norms as under:<br> <br>Exportproduct<br>Qty.<br>S.No<br>Import items<br>Qty.<br>AZITHROMYCINTABLETS<br>250MG<br>(WHITE,ROUND,<br>BICONVEX, FLIM COATED<br>TABLETS)<br>1 Number<br>1.<br>AZITHROMYCIN<br>DIHYDRATE USP<br>(WHITE OR ALMOST<br>WHITE POWDER))<br>267.256 mg/250<br>mgTablet<br>AZITHROMYCINTABLETS<br>500MG<br>(WHITE, ELONGATED,<br>BICONVEX,SCORED ON<br>ONE SIDE, FILM COATED<br>TABLETS)<br>1 Number<br>2.<br>AZITHROMYCIN<br>DIHYDRATE USP<br>(WHITE OR ALMOST<br>WHITE POWDER)<br>534.512mg/500<br>mgTablet<br>RA concerned may take further necessary action as per above decision of NC. |
|
116
|
Case No. |
B- 14 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s Indian Immunologicals Ltd., Hyderabad |
|
HQ F. No. |
01/82/050/01322/AM17**/**DES-III |
|
RLA F. No. |
09/24/040/00475/AM17 |
|
Advance Authorization No. and Date |
0910064483 dated 14.12.2016 |
|
Subject |
Request of M/s Indian Immunologicals Ltd, Hyderabad for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0910064483 dated 14.12.2016 |
| <br> <br> |
Decision:The Committee considered the request of the firm in the presence of technical experts and on the<br>basis of comments of DBT and earlier decision taken in meeting no. 13/AM15 dated 26.12.2014, it was<br>decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>ABHAYARAB 0.5 ML<br>(HUMAN RABIES VACCINE)<br>WITH DISPOSABLE SYRINGE<br>AND DILUENT 1 DOSE/1<br>VIAL<br>1000<br>vials<br>1.<br>TRYPAN BLUE<br>0.001gm<br>2<br>ADULT BOVINE SERUM 0.2<br>MICRON<br>0.76 Ltr<br>3<br>L-GLUTAMINE<br>0.0547gm<br>4<br>MINIMUM ESSENTIAL MEDIUM<br>WITH PEPTONE<br>0.413kg<br>5<br>POLYMIXIN B SULPHATE<br>0.396gm<br>6<br>KANAMYCIN SULPHATE<br>4.37gm<br>7<br>NEOMYCIN SULPHATE<br>3.216gm<br>8<br>HUMAN SERUM ALBUMIN 20%<br>0.84Ltr<br>9<br>2ML VIAL CLEAR INJECTION<br>F13<br>1100 Nos<br>10<br>13MM FLIP- OFF SEAL 3769<br>(ALUMINIUM SEAL)<br>1100 Nos<br>11<br>RUBBER STOPPER V50 4023 / 50<br>GREY EPP RSSIL 1/4A<br>1100 Nos<br>12<br>THIMERSOL/THIOMERSAL<br>0.15gm<br>13<br>ROLLER BOTTLE PETG 5x ST<br>IND WRAP 1/12 4200 CM2 662006<br>– 0430<br>14.08<br>14<br>SYRINGES-2ML WITH NEEDLE<br>24 GUAGE<br>1000.8 Nos<br>RA concerned may take further necessary action as per above decision of NC. |
|
117
| Case No. |
B- 15 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Pab Organics Pvt. Ltd, Vadodara |
| HQ F. No. |
01/82/050/00698/AM16/DES-III |
| RLA F. No. |
34/24/040/00173/AM15 |
| Advance Authorization No. and Date |
3410040608 dated 09.10.2014 |
| Subject |
Request of M/s PAB Organics Pvt. Ltd, Vadodara for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 3410040608 dated 09.10.2014 |
| Decision:The Committee considered the request of the firm for correction in the description of Export<br>Product in the presence of technical experts and it was decided to amend the description of Export Product to<br>read as“2, 3 DICHLORO BENZOYL CYANIDE (2,3 DICHLORO BENZOYL NITRILE)”.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
Case No. |
Case No. |
B- 16 |
B- 16 |
B- 16 |
B- 16 |
| Meeting No. |
|
|
10/AM20 |
|
|
|
| Date |
|
|
29.11.2019 |
|
|
|
| Firm’s Name |
|
|
M/s Pab Organics Pvt. Ltd., Vodadara |
|
|
|
| HQ F. No. |
|
|
01/82/050/00493/AM14/DES-III |
|
|
|
| RLA F. No. |
|
|
34/24/040/00085/AM14 |
|
|
|
| Advance Authorization No. and Date |
|
|
3410037541 dated 31.07.2013 |
|
|
|
| Subject |
|
|
Request of M/s Pab Organics Pvt. Ltd., Vodadara for fixation of<br>adhoc norms against Advance Authorization No. 3410037541<br>dated 31.07.2013 |
|
|
|
| **Decision:**The Committee considered the request of firm in the presence of technical<br>decided to fix following adhoc norms:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>(±)-3-(Carbamoyl Methyl)-5-<br>Methylhexanoic Acid<br>1 kg<br>1<br>2-Cyanoacetamide<br>2<br>Isovaleraldehyde<br>3<br>UREA (Ammonium Carbamide)<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
request of firm in the presence of technical |
|
experts and it was<br>Qty.<br>1.40 kg<br>0.72 kg<br>0.90 kg |
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
(±)-3-(Carbamoyl Methyl)-5-<br>Methylhexanoic Acid |
1 kg |
|
1 |
2-Cyanoacetamide |
1.40 kg |
|
|
|
|
2 |
Isovaleraldehyde |
0.72 kg |
|
|
|
|
3 |
UREA (Ammonium Carbamide) |
0.90 kg |
118
|
Case No. |
B- 17 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s PCL Oil & Solvents Ltd, CLA, New Delhi |
|
HQ F. No. |
01/82/050/00409/AM18/DES-III<br>01/82/050/00410/AM18/DES-III |
|
RLA F. No. |
05/24/040/040/00098/AM18<br>05/24/040/00097/AM18 |
|
Advance Authorization No. and Date |
0510403003 dated 01.06.2017<br>0510403001 dated 01.06.2017 |
|
Subject |
Request of M/s PCL Oil & Solvents Ltd, CLA, New Delhi for<br>revision of norms fixed against Advance Authorization No.<br>0510403003 dated 01.06.2017 and 051003001 dated 01.06.2017 |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and after<br>taking cue from SION A-3151, it was decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>PLASTICIZER (PVC) (DINP)<br>1kg<br>1<br>PHTHALIC ANHYDRIDE<br>0.372 kg<br>2<br>ISO NONANOL<br>0.726 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
Case No. |
B- 18 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s Ravoos Laboratories Ltd., Hyderabad |
|
HQ F. No. |
01/82/050/00375/AM20/DES-III |
|
RLA F. No. |
09/24/040/040/00183/AM20 |
|
Advance Authorization No. and Date |
0910067761 dated 09.07.2019 |
|
Subject |
Request of M/s Ravoos Laboratories Ltd, Hyderabad for<br>correction in the description of Import Item in respect of adhoc<br>norms fixed against Advance Authorization No. 0910067761<br>dated 09.07.2019. |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Exportproduct<br>Qty.<br>Sl. No.<br>Import item<br>Qty.<br>Azithromycin Dihydrate Taste Masked<br>Granules 7.5% w/w / Azithromycin<br>TasteMasked Granules 7.5% w/w<br>20000 kg<br>1<br>Azithromycin IP/USP<br>1578.125 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
119
|
Case No. |
B- 19 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s Vindhya Organics Private Limited, Hyderabad |
|
HQ F. No. |
01/82/050/02072/AM19/DES-III |
|
RLA F. No. |
09/24/040/00371/AM18 |
|
Advance Authorization No. and Date |
0910066816 dated 09.11.2018 |
|
Subject |
Request of M/s Vindhya Organics Pvt Ltd, Hyderabad for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0910066816 dated 09.11.2018. |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No<br>Import items<br>Qty.<br>AFC ABACAVIR (ABV) I<br>1 kg<br>1.<br>2-AZABICYCLO (2.2.1) HEPT-5-EN-3-<br>ONE; (VINCELACTAM)<br>1.226 kg<br>2<br>N-(2-AMINO-4, 6-DICHLORO-5-<br>PYRIMIDINYL) FORMAMIDE<br>0.764 kg<br>3<br>SODIUM BOROHYDRIDE POWDER<br>0.226 kg<br>4<br>D(-) TARTARIC ACID<br>0.78 kg<br>5<br>L + TARTARIC ACID<br>1.079 kg<br>6<br>METHANOL<br>4.53 kg<br>7<br>ISOPROPYL ALCOHOL<br>4.40 kg<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
| Case No. |
B- 20 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s GLOBAL CALCIUM PRIVATE LIMITED., Bangalore |
| HQ F. No. |
01/82/050/00220/AM20/DES-III |
| RLA F. No. |
07/24/040/040/00048/AM20 |
| Advance Authorization No. and Date |
0710114983 dated 29.05.2019 |
| Subject |
Request of M/s GLOBAL CALCIUM PRIVATE LIMITED.,<br>Bangalore for correction in the description of Import Item in<br>respect of norms fixed against Advance Authorization No.<br>0710114983 dated 29.05.2019 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to call for following information from the firm:<br>(i)<br>Details of Oral Grade indicating impurities profile alongwith COA. |
|
120
| Case No. |
B- 21 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Global Calcium Private Limited., Bangalore |
| HQ F. No. |
01/82/050/01076/AM17/DES-III |
| RLA F. No. |
07/24/040/00386/AM16 |
| Advance Authorization No. and Date |
0710109429 dated 23.02.2016 |
| Subject |
Request of M/s Global Calcium Pvt. Ltd., Bangalore for revision<br>of adhoc norms fixed against Advance Authorization No.<br>0710109429 dated 23.02.2016 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to call for following information from the firm:<br>(i)<br>Production / Consumption Data for last two years for each export product duly certified by<br>Superintendent GST. |
|
| Case No. |
B- 22 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Global Calcium Private Limited., Bangalore |
| HQ F. No. |
01/82/050/01480/AM17/DES-III |
| RLA F. No. |
07/24/040/00218/AM17 |
| Advance Authorization No. and Date |
0710110528 dated 19.10.2016 |
| Subject |
Request of M/s Global Calcium Pvt. Ltd., Bangalore for revision<br>of adhoc norms fixed against Advance Authorization No.<br>0710110528 dated 19.10.2016 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to call for following information from the firm:<br>(i)<br>Manufacturing process, chemistry and material balance, % of yield of reaction for Export Product<br>No. 3–Calcium Glubionate. |
|
(i) Manufacturing process, chemistry and material balance, % of yield of reaction for Export Product No. 3 – Calcium Glubionate.
121
|
Case No. |
B- 23 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s Malwa Oxygen & Industrial Gases Pvt Ltd, Indore |
|
HQ F. No. |
01/82/050/00088/AM19/DES-III |
|
RLA F. No. |
56/24/040/00034/AM18 |
|
Advance Authorization No. and Date |
5610005293 dated 02.01.2018 |
|
Subject |
Request of M/s Malwa Oxygen & Industrial Gases Pvt. Ltd,<br>Indore for fixation of adhoc norms against Advance<br>Authorization No. 5610005293 dated 02.01.2018 |
|
**Decision:**The Committee considered the case as per agenda and after deliberation, it was decided to fix<br>following adhoc norms:<br>Export product<br>Qty.<br>Sl.<br>**No **<br>Import items<br>Qty.<br>BIS(4-<br>FLUROPHENYL)KETONE OR<br>4,4<br>DIFLUOROBENZOPHENONE<br>1 kg<br>1<br>FLUOROBENZOYL (4-) CHLORIDE<br>1.00 kg<br>2<br>FLUOROBENZENE<br>1.10 kg<br>3<br>METHYLE ALCOHOL<br>0.60 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
Case No. |
B- 24 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s Malwa Oxygen & Industrial Gases Pvt Ltd, Indore |
|
HQ F. No. |
01/82/050/00092/AM19/DES-III |
|
RLA F. No. |
56/24/040/00026/AM18 |
|
Advance Authorization No. and Date |
5610005271 dated 12.12.2017 |
|
Subject |
Request of M/s Malwa Oxygen & Industrial Gases Pvt. Ltd,<br>Indore for fixation of adhoc norms against Advance<br>AuthorizationNo. 5610005271 dated 12.12.2017 |
|
**Decision:**The Committee considered the case as per agenda and after deliberation, it was decided to fix<br>following adhoc norms:<br>Export product<br>Qty.<br>Sl.<br>**No **<br>Import items<br>Qty.<br>BIS(4-<br>FLUROPHENYL)KETONE OR<br>4,4<br>DIFLUOROBENZOPHENONE<br>1 kg<br>1<br>FLUOROBENZOYL (4-) CHLORIDE<br>1.00 kg<br>2<br>FLUOROBENZENE<br>1.10 kg<br>3<br>METHYLE ALCOHOL<br>0.60 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
122
|
Case No. |
B- 25 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s Shree Bankey Bihari Lal Flavors, CLA, New Delhi |
|
HQ F. No. |
01/82/050/00006/AM19/DES-III |
|
RLA F. No. |
05/24/040/00597/AM18 |
|
Advance Authorization No. and Date |
0510405729 dated 27.02.2018 |
|
Subject |
Request of M/s Shree Bankey Bihari Lal Flavors, CLA,<br>New Delhi for allowing import item No. 2 - ISO PROPYL<br>ALCOHOL in respect of adhoc norms fixed against<br>Advance Authorization No. 0510405729 dated 27.02.2018 |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it<br>was decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No<br>Import items<br>Qty.<br>Menthol/ Dl Menthol<br>1 kg<br>1.<br>Meta - Cresol<br>Above 98.5% Pure<br>0.97 kg<br>2<br>Iso Propyl Alcohol<br>0.554 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
B- 26 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| HQ F. No. |
01/82/162/00033/AM20/DES-III |
| Subject: |
Request of M/s Bharat Parenterals Limited, Vadodara for<br>regularization of export product description mismatch<br>between advance authorization and shipping bill towards<br>fulfilment of Export Obligation of advance authorization<br>No. 3410041411 dated 29.07.2015 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and from<br>the Drug Manufacturing Licence (DML) and Certificate of Analysis (COA) furnished by the firm, it was<br>observed that Phenicol is the brand name of the Chloramphenicol Capsules BP 250 mg. Hence, the<br>Committee after deliberation decided that the export product Chloramphenicol Capsules BP 250 mg and<br>Phenicol is one and the same thing.<br>RA concerned may take further necessary action as per above decision of NC. |
|
123
|
Case No. |
B- 27 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
|
HQ F. No. |
01/82/050/01440/AM16/DES-III |
|
RLA F. No. |
03/94/040/00403/AM16 |
|
Advance Authorization No. and Date |
0310798726 dated 08.09.2015 |
|
Subject |
Request of M/s J.B. Chemicals & Pharmaceuticals Ltd, Mumbai<br>for revision of norms of adhoc norms fixed against Advance<br>Authorization No. 0310798726 dated 08.09.2015 |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Sl. No. Export product<br>Qty.<br>Import items as per<br>Qty.<br>(in gm for 100<br>lozenges)<br>1.<br>Difflam Blackcurrant Sugar Free<br>Lozenges, Each lozenge contains<br>Pholcodine<br>5.50<br>mg,<br>Benzydamine Hydrchloride 1.50 mg,<br>Cetylpyridinium Chloride 1.33 mg,<br>Isomalt ST-M 2141.64 mg.<br>100<br>lozenges<br>1.<br>Pholcodine<br>0.561<br>2.<br>Benzydamine<br>hydrochloride<br>0.153<br>3.<br>Cetylpyridinium Chloride<br>0.1356<br>4.<br>Isomalt ST-M<br>214.164<br>2.<br>DURO-TUSS dry cough lozenges<br>sugar free orange. Each lozenge<br>contains<br>Pholcodine<br>5.50<br>mg,<br>Cetylpyridinium Chloride 1.33 mg,<br>Isomalt ST-M 2141.64 mg.<br>100<br>lozenges<br>1.<br>Pholcodine<br>0.561<br>2.<br>Cetylpyridinium Chloride<br>0.1356<br>3.<br>Isomalt ST-M<br>214.164<br>3.<br>DURO-TUSS dry cough lozenges<br>sugar<br>free<br>lemon.Each<br>lozenge<br>contains<br>Pholcodine<br>5.50<br>mg,<br>Cetylpyridinium Chloride 1.33 mg,<br>Isomalt ST-M 2141.64 mg. Net<br>Content<br>Pholcodine<br>6.923<br>Kgs,<br>Cetylpyridinium Chloride 1.674 Kgs,<br>Isomalt ST-M 2695.794 Kgs<br>100<br>lozenges<br>1.<br>Pholcodine<br>0.561<br>2.<br>Cetylpyridinium Chloride<br>0.1356<br>3.<br>Isomalt ST-M<br>214.164<br>4.<br>Difflam<br>Lozenges<br>Raspberry/Eucalyptus<br>&<br>Menthol/Honey<br>&<br>Lemon/Orange/Double Mint Sugar<br>Free. Each Lozenges contains<br>Benzydamine Hydrochloride 3.00<br>mg, Cetylpyridinium Chloride 1.33<br>mg, Isomalt ST-M 2141.64 mg.<br>100<br>lozenges<br>1.<br>Benzydamine<br>hydrochloride<br>0.306<br>2.<br>Cetylpyridinium Chloride<br>0.1356<br>3.<br>Isomalt ST-M<br>214.164<br>5.<br>Cetylpyridinium<br>Chloride<br>and<br>Benzydamine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free.<br>Each<br>Lozenges<br>contains<br>Cetylpyridinium Chloride 1.00 mg,<br>Isomalt ST-M 2591.86 mg<br>100<br>lozenges<br>1.<br>Cetylpyridinium Chloride<br>0.102<br>2.<br>Isomalt ST-M<br>249.526<br>RA concerned may take further necessary action as per above decision of NC. |
|
124
|
Case No. |
Case No. |
B- 28 |
B- 28 |
B- 28 |
B- 28 |
|
Meeting No. |
|
10/AM20 |
|
|
|
|
Date |
|
29.11.2019 |
|
|
|
|
Firm’s Name |
|
M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
|
|
|
|
HQ F. No. |
|
01/82/050/00423/AM16/DES-III |
|
|
|
|
RLA F. No. |
|
03/94/040/01084/AM15 |
|
|
|
|
Advance Authorization No. and Date |
|
0310793953 dated 18.02.2015 |
|
|
|
|
Subject |
|
Request of M/s J.B. Chemicals & Pharmaceuticals Ltd, Mumbai<br>for revision of norms in respect of adhoc norms fixed against<br>Advance Authorization No. 0310793953 dated 18.02.2015 |
|
|
|
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Import Items<br>Qty.<br>(in gm for 100<br>lozenges)<br>1.<br>DIFFLAM Sugar Free Lozenges<br>Flavors Raspberry/Eucalyptus &<br>Menthol/Honey &<br>Lemon/Orange/Double Mint- Each<br>Lozenges contains Isomalt ST-<br>M2141.64 mg, Benzydamine<br>Hydrochloride 3.00 mg,<br>Cetylpyridinium chloride 1.33<br>mg.Isomalt 2141.64 mg<br>100 lozenges<br>Benzydamine Hydrochloride<br>0.306<br>Cetylpyridinium Chloride<br>0.1356<br>Isomalt ST-M<br>214.164<br>2.<br>DIFFLAM AAA Sugar Free<br>Lozenges Flavors Eucalyptus &<br>Menthol/Honey & Lemon/ Black<br>Current/Berry<br>Each Lozenges contains Isomalt ST-<br>M2141.64 mg, Benzydamine<br>Hydrochloride 3.00 mg. Isomalt<br>2141.64 mg<br>100 lozenges<br>Benzydamine Hydrochloride<br>0.306<br>Isomalt ST-M<br>214.164<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
|
Sl.<br>No. |
Export Product |
|
Qty. |
Import Items |
Qty.<br>(in gm for 100<br>lozenges) |
|
1. |
DIFFLAM Sugar Free Lozenges<br>Flavors Raspberry/Eucalyptus &<br>Menthol/Honey &<br>Lemon/Orange/Double Mint- Each<br>Lozenges contains Isomalt ST-<br>M2141.64 mg, Benzydamine<br>Hydrochloride 3.00 mg,<br>Cetylpyridinium chloride 1.33<br>mg.Isomalt 2141.64 mg |
|
100 lozenges |
Benzydamine Hydrochloride |
0.306 |
|
|
|
|
|
Cetylpyridinium Chloride |
0.1356 |
|
|
|
|
|
Isomalt ST-M |
214.164 |
|
2. |
DIFFLAM AAA Sugar Free<br>Lozenges Flavors Eucalyptus &<br>Menthol/Honey & Lemon/ Black<br>Current/Berry<br>Each Lozenges contains Isomalt ST-<br>M2141.64 mg, Benzydamine<br>Hydrochloride 3.00 mg. Isomalt<br>2141.64 mg |
|
100 lozenges |
Benzydamine Hydrochloride |
0.306 |
|
|
|
|
|
Isomalt ST-M |
214.164 |
|
RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
125
|
Case No. |
B-29 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
|
HQ F. No. |
01/82/050/01625/AM16/DES-III<br>01/82/050/01612/AM16/DES-III<br>01/82/050/01615/AM16/DES-III<br>01/82/050/01613/AM16/DES-III |
|
RLA F. No. |
03/94/040/ 00816/AM16<br>03/94/040/ 00814/AM16<br>03/94/040/00815/AM16<br>03/94/040/00817/AM16 |
|
Advance Authorization No. and Date |
0310801629 dated 07.01.2016<br>0310801603 dated 06.01.2016<br>0310801571 dated 05.01.2016<br>0310801604 dated 06.01.2016 |
|
Subject |
Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumbai<br>for revision of norms in respect of adhoc norms fixed against<br>Advance Authorization Nos. 0310801629 dated 07.01.2016,<br>0310801603 dated 06.01.2016, 0310801571 dated 05.01.2016 &<br>0310801604 dated 06.01.2016. |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Export product<br>Qty.<br>Import items<br>Qty.<br>(in gm for 100<br>lozenges)<br>Difflam Sugar Free Lozenges<br>Flavours Raspberry/Eucalyptus &<br>Menthol/Honey &<br>Lemon/Orange/Double Mint<br>Flavours<br>Each lozenge contains Benzydamine<br>Hydrchloride 3.00 mg,<br>Cetylpyridinium Chloride 1.33 mg,<br>Isomalt ST-M 2591.86 mg<br>100 lozenges<br>Benzydamine Hydrochloride<br>0.306<br>Cetylpyridinium Chloride<br>0.1356<br>Isomalt ST-M<br>214.164<br>Difflam AAA Sugar Free Lozenges<br>Flavours /Eucalyptus &<br>Menthol/Honey & Lemon/Black<br>Currant/Berry.<br>Each lozenge contains Benzydamine<br>Hydrchloride 3.00 mg, Isomalt ST-M<br>2591.86 mg<br>100 lozenges<br>Benzydamine Hydrochloride<br>0.306<br>Isomalt ST-M<br>214.164<br>RA concerned may take further necessary action as per above decision of NC. |
|
126
|
Case No. |
Case No. |
B- 30 |
B- 30 |
B- 30 |
B- 30 |
|
Meeting No. |
|
10/AM20 |
|
|
|
|
Date |
|
29.11.2019 |
|
|
|
|
Firm’s Name |
|
M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
|
|
|
|
HQ F. No. |
|
01/82/050/00114/AM17/DES-III<br>01/82/050/01590/AM16/DES-III<br>01/82/050/01610/AM16/DES-III |
|
|
|
|
RLA F. No. |
|
03/94/040/ 01086/AM16<br>03/94/040/ 00552/AM16<br>03/94/040/00800/AM16 |
|
|
|
|
Advance Authorization No. and Date |
|
0310803470 dated 21.03.2016<br>0310799930 dated 02.11.2015<br>0310801515 dated 04.01.2016 |
|
|
|
|
Subject |
|
Request of M/s J.B. Chemicals & Pharmaceuticals Ltd, Mumbai<br>for revision of norms in respect of adhoc norms fixed against<br>Advance Authorization No. 0310803470 dated 21.03.2016,<br>0310799930 dated 02.11.2015and 0310801515 dated 04.01.2016. |
|
|
|
|
**Decision:**The Committee considered the request<br>decided to revise the norms as under: |
|
|
of the firm in the |
presence of technical experts and it was<br>Import items<br>Qty.<br>(in gm for 100<br>lozenges)<br>Benzocaine<br>1.224<br>Benzocaine<br>1.020<br>Benzocaine<br>0.1275<br> NC. |
|
|
Sl.<br>No. |
Export product |
|
Qty. |
Import items |
Qty.<br>(in gm for 100<br>lozenges) |
|
1 |
Sugar based medicated lozenges; medi-keel<br>A throat lozenges/medi-keel A throat<br>lozenge black current/honey & lemon. Each<br>lozenges contains benzocaine 12mg |
|
100 lozenges |
Benzocaine |
1.224 |
|
2 |
Benzocaine and cetylpyridinium chloride<br>anesthetic throat lozenges each lozenges<br>contains benzocaine 10mg |
|
100 lozenges |
Benzocaine |
1.020 |
|
3 |
Benzocaine and cetylpyridinium chloride<br>and dextromethorphan hydrobromide<br>anesthetic throat lozenges. Each lozenges<br>contains benzocaine 1.25mg. |
|
100 lozenges |
Benzocaine |
0.1275 |
|
RAconcernedmay takefurther necessary actionas perabove decisionof |
|
|
|
NC. |
|
127
| Case No. |
B- 31 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
| HQ F. No. |
01/82/050/00163/AM20/DES-III |
| RLA F. No. |
03/94/040/00115/AM20 |
| Advance Authorization No. and Date |
0310829085 dated 16.05.2019 |
| Subject |
Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai<br>for enhancement in the wastage in respect of adhoc norms fixed<br>against Advance Authorization No. 0310829085 dated 16.05.2019 |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 32 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Astec Lifesciences Ltd., Mumbai |
| HQ F. No. |
01/82/050/00371/AM17/DES-III<br>01/82/050/01089/AM16/DES-III |
| RLA F. No. |
03/94/040/00132/AM17<br>03/94/040/00879/AM15 |
| Advance Authorization No. and Date |
0310805494 dated 15.06.2016<br>0310798319 dated 20.08.2015 |
| Subject |
Request of M/s ASTEC LIFESCIENCES LTD ,Mumbai for<br>enhancement in the quantity of import itsms in respect of norms<br>fixed against Advance Authorization Nos. 0310805494 dated<br>15.06.2016 and 0310798319 dated 20.08.2015 |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
128
| Case No. |
B- 33 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Astec Lifesciences Ltd., Mumbai |
| HQ F. No. |
01/82/050/01090/AM16/DES-III |
| RLA F. No. |
03/94/040/00878/AM15 |
| Advance Authorization No. and Date |
0310798205 dated 17.08.2015 |
| Subject |
Request of M/s ASTEC LIFESCIENCES LTD ,Mumbai for<br>revision of norms in respect of norms fixed against Advance<br>Authorization No. 0310798205 dated. 17.08.2015 |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintainingthe statusquo. |
|
| Case No. |
B- 34 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Balaji Amines Ltd., Pune |
| HQ F. No. |
01/82/050/01225/AM17/DES-III<br>01/82/050/00504/AM19/DES-III |
| RLA F. No. |
31/83/040/00089/AM17<br>31/83/040/00020/AM19 |
| Advance Authorization No. and Date |
3110066521 dated 29.12.2016 and<br>3110067057 dated 21.05.2018 |
| Subject |
Request of M/s Balaji Amines Ltd., Pune for enhancement<br>in the quantity of import item in respect of adhoc norms<br>fixed against Advance Authorization No. 3110066521 dated<br>29.12.2016 and 3110067057 dated 21.05.2018 |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
129
| Case No. |
B- 35 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Cropnosys (India) Private Limited., Mumbai |
| HQ F. No. |
01/82/050/00087/AM18/DES-III |
| RLA F. No. |
03/94/040/00466/AM16 |
| Advance Authorization No. and Date |
0310811611 dated 03.03.2017 |
| Subject |
Request of M/s Cropnosys India Pvt. Ltd., Mumbai for<br>enhancement in the quantity of Import Item in respect of norms<br>fixed against Advance Authorization No. 0310811611 dated<br>03.03.2017 |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 36 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Divi’s Laboratoties Limited, Hyderabad |
| HQ F. No. |
01/82/050/02271/AM19/DES-III<br>01/82/050/02571/AM19/DES-III |
| RLA F. No. |
09/24/040/040/00509/AM19<br>09/24/040/040/00587/AM19 |
| Advance Authorization No. and Date |
0910067057 dated 11.01.2019<br>0910067281 dated 15.03.2019 |
| Subject |
Request<br>of<br>M/s<br>Divi’Laboratories<br>Ltd,<br>Hydrabad<br>for<br>enhancement in the quantity of import item No. 1 DL-<br>NAPROXEN in respect of adhoc norms fixed against Advance<br>Authorization No. 0910067057 dated 11.01.2019and 0910067281<br>dated 15.03.2019. |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 37 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Panacea Biotec Ltd., New Delhi |
| HQ F. No. |
01/82/050/00171/AM20/DES-III |
| RLA F. No. |
05/24/040/ 00086/AM20 |
| Advance Authorization No. and Date |
0510410569 dated 14.05.2019 |
| Subject |
Request of M/s Panacea Biotaec Ltd, CLA, New Delhi for<br>enhancement of norms fixed against Advance Authorization<br>No. 0510410569 dated 14.05.2019 |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
130
| Case No. |
B- 38 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Paramount Aromachem Private Limited, New Delhi |
| HQ F. No. |
01/82/050/01283/AM17/DES-III |
| RLA F. No. |
05/24/040/00399/AM17 |
| Advance Authorization No. and Date |
0510400599 dated 02.12.2016 |
| Subject |
Request of M/s Paramount Aromachem Private Limited,<br>New Delhi for enhancement in the quantity of Import Item –<br>in respect of adhoc norms fixed against Advance<br>Authorization No. 0510400599 dated 02.12.2016 |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 39 |
B- 39 |
| Meeting No. |
10/AM20 |
|
| Date |
29.11.2019 |
|
| Firm’s Name |
M/s Survival Technologies Pvt. Ltd., Mumbai |
|
| HQ F. No. |
01/82/050/00754/AM17/DES-III |
01/82/050/01382/AM16/DES-III |
| RLA F. No. |
03/95/040/00410/AM17 |
03/95/040/00491/AM16/ |
| Advance Authorization No. and<br>Date |
0310808209 dated 30.09.2016 |
0310799292 dated 08.10.2015 |
| Subject |
Request of M/s Survival Technologies Pvt. Ltd., Mumbai for<br>enhancement in the quantity of Import Item No. 2 - Dichloromethane /<br>Methylene Di-chloride / Methylene chloride in respect of adhoc norms<br>fixed against Advance Authorization Nos. 0310808209 dated<br>30.09.2016 and 0310799292 dated 08.10.2015 |
|
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
|
| Case No. |
B- 40 |
B- 40 |
| Meeting No. |
10/AM20 |
|
| Date |
29.11.2019 |
|
| Firm’s Name |
M/s Survival Technologies Pvt. Ltd., Mumbai |
|
| HQ F. No. |
01/82/050/01812/AM16/DES-III |
01/82/050/00753/AM17/DES-III |
| RLA F. No. |
03/95/040/00798/AM16 |
03/95/040/00490/AM17 |
| Advance Authorization No. and<br>Date |
0310801923 dated 20.01.2016 |
0310808208 dated 30.09.2016 |
| Subject |
Request of M/s Survival Technologies Pvt. Ltd., Mumbai for<br>enhancement in the quantity of Import Items of adhoc norms fixed<br>against Advance Authorization Nos. 0310801923 dated 20.01.2016 and<br>0310808208 dated 30.09.2016 |
|
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
|
131
| Case No. |
B- 41 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Survival Technologies Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/01395/AM16/DES-III |
| RLA F. No. |
03/95/040/00525/AM16 |
| Advance Authorization No. and Date |
0310799704 dated 28.10.2015 |
| Subject |
Request of M/s Survival Technologies Pvt. Ltd., Mumbai for<br>enhancement in the quantity of Import Items in respect of adhoc<br>norms fixed against Advance Authorization No. 0310799704<br>dated 28.10.2015 |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 42 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Uma Enterprises Ltd, Ahmedabad |
| HQ F. No. |
01/82/050/01800/AM16/DES-III<br>01/82/050/00717/AM17/DES-III<br>01/82/050/02433/AM19/DES-III<br>01/82/050/02444/AM19/DES-III<br>01/82/050/02445/AM19/DES-III |
| RLA F. No. |
08/24/040/00396/AM16<br>08/24/040/00099/AM17<br>08/24/040/00189/AM16<br>08/24/040/00287/AM16<br>08/24/040/00322/AM16 |
| Advance Authorization No. and Date |
0810137202 dated 15.02.2016<br>0810138154 dated 10.06.2016<br>0810136151 dated 05.10.2015<br>0810136677 dated 07.12.2015<br>0810136786 dated 28.12.2015 |
| Subject |
Request of M/s Uma Enterprises Ltd, Ahmedabad for<br>enhancement in the quantity of import items in respect of adhoc<br>norms fixed against Advance Authorization Nos. 0810137202<br>dated 15.02.2016, 0810138154 dated 10.06.2016, 0810136151<br>dated 05.10.2015, 0810136677 dated 07.12.2015 and 0810136786<br>dated 28.12.2015. |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
132
| Case No. |
B- 43 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Clean Science and Technology Private Limited, Pune |
| HQ F. No. |
01/82/162/00035/AM20/DES-III |
| Advance Authorization No. and Date |
Not issued yet |
| Subject |
Request of M/s Clean Science and Technology Private Limited,<br>Pune for fixation of norms for the export product Ascorbyl<br>Palmitate (ITC HS Code – 29362700) under Para 4.06 of HBP Vol. I<br>(2015-20) |
| **Decision:**Deferred for comments of TE. |
|
|
|
| Case No. |
B- 44 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Blue Circle Organics Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/00556/AM16/DES-III |
| RLA F. No. |
03/94/040/01197/AM15 |
| Advance Authorization No. and Date |
0310795139 dated 07.04.2015 |
| Subject |
Request of M/s Blue Circle Organics P Ltd Mumbai, for fixation of<br>adhoc norms against Advance Authorization No. 0310795139 dated<br>07.04.2015. |
| **Decision:**The Committee considered the request of firm in the presence of technical experts and it was decided to<br>fix following adhoc norms:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>5-HYDROXYISOPHTHALIC ACID<br>1 kg<br>1<br>MONOSODIUM-5-<br>SULFOISOPHTHALATE<br>1.82 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
B- 45 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Kopran Ltd., Mumbai |
| HQ F. No. |
01/82/050/01199/AM15/DES-III<br>01/82/050/01200/AM15/DES-III |
| RLA F. No. |
03/94/040/00545/AM15<br>03/94/040/00547/AM15 |
| Advance Authorization No. and Date |
0310788934 dated 09.09.2014<br>0310789054 dated 11.09.2014 |
| Subject |
Request of M/s Kopran Limited, Mumbai for fixation of adhoc<br>norms against Advance Authorization Nos. 0310788934 dated<br>09.09.2014 and 0310789054 dated 11.09.2014 and |
| **Decision:**Deferred for comments of TE. |
|
133
| Case No. |
B- 46 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Micro Orgo-Chem, Mumbai |
| HQ F. No. |
01/82/050/00382/AM19/DES-III |
| RLA F. No. |
03/95/040/00102/AM18 |
| Advance Authorization No. and Date |
0310819584 dated 07.03.2018 |
| Subject |
Request of M/s Micro Orgo-Chem, Mumbai for enhancement in<br>the quantity of import item in respect of adhoc norms fixed<br>against<br>Advance<br>Authorization<br>No.<br>0310819584<br>dated<br>07.03.2018 |
| Decision:The Committee considered the request of firm for enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 47 |
B- 47 |
| Meeting No. |
10/AM20 |
|
| Date |
29.11.2019 |
|
| Firm’s Name |
M/s Reannon Pharmaceuticals, Mumbai |
|
| HQ F. No. |
01/82/050/01251/AM15/DES-III |
|
| RLA F. No. |
03/95/040/00325/AM15 |
|
| Advance Authorization No. and Date |
0310786993 dated 17.07.2014 |
|
| Subject |
Request of M/s Reannon Pharmaceuticals, Mumbai for fixation<br>of adhoc norms against Advance Authorization No. 0310786993<br>dated 17.07.2014 |
|
| **Decision:**The Committee considered the request of firm in the presence of technical<br>decided to fix following adhoc norms:<br> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>RENONTRIKAL INJECTIION<br>(APROTININ 10000 IU )<br>LYOPHILIZED INJECTION<br>(EACH COMBIPACK<br>CONTAINS 10 VIALS OF<br>APROTININ +10 AMPOULS OF<br>SODIUM CHLORIDE 0.09%<br>INJECTION) EACH<br>LYOPHILIZED VIAL CONTAINS<br>APROTININ 10,000 IU,EACH<br>AMPOULE CONTAINS SODIUM<br>CHLORIDE BP 0.9% W/V<br>WATER FOR INJECTION BP q.s.<br>1 Million vials<br>1<br>APPROTININE<br>RA concerned may take further necessary action as per above decision of NC. |
|
experts and it was<br>Qty.<br>2.244 kg /<br>million vials |
134
|
Case No. |
Case No. |
B- 48 |
B- 48 |
B- 48 |
B- 48 |
|
Meeting No. |
|
10/AM20 |
|
|
|
|
Date |
|
29.11.2019 |
|
|
|
|
Firm’s Name |
|
M/s Vins Bioproducts Limited, Hyderabad |
|
|
|
|
HQ F. No. |
|
01/82/050/01743/AM16/DES-III |
|
|
|
|
RLA F. No. |
|
09/24/040/00442/AM16 |
|
|
|
|
Advance Authorization No. and Date |
|
0910062831 dated 03.11.2015 |
|
|
|
|
Subject |
|
Request of M/s Vins Bioproducts Limited, Hyderabad for<br>enhancement in the quantity of Import Item in respect of<br>adhoc norms fixed against Advance Authorization No.<br>0910062831 dated 03.11.2015 |
|
|
|
|
**Decision:**The Committee considered the request of the firm and on the basis of written comments<br>(formula) furnished by Department of Biotechnology vide their OM dated 13.11.2019, it was decided to<br>revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TETANUS ANTITOXIN<br>IHS/BP 1500IU/ML (IN THE<br>FORM OF PFS/VIALS 1 ML<br>EACH)<br>695500.000<br>vials<br>1<br>TETANUS ANTITOXIN<br>3000IU/ ML<br>483.410<br>Litres<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
TETANUS ANTITOXIN<br>IHS/BP 1500IU/ML (IN THE<br>FORM OF PFS/VIALS 1 ML<br>EACH) |
695500.000<br>vials |
|
1 |
TETANUS ANTITOXIN<br>3000IU/ ML |
483.410<br>Litres |
|
RAconcernedmay takefurther necessary actionas |
|
|
|
|
|
|
Case No. |
Case No. |
B- 49 |
B- 49 |
B- 49 |
B- 49 |
|
Meeting No. |
|
10/AM20 |
|
|
|
|
Date |
|
29.11.2019 |
|
|
|
|
Firm’s Name |
|
M/s Vins Bioproducts Limited, Hyderabad |
|
|
|
|
HQ F. No. |
|
01/82/050/00207/AM15/DES-III |
|
|
|
|
RLA F. No. |
|
09/24/040/00362/AM14 |
|
|
|
|
Advance Authorization No. and Date |
|
0910058863 dated 08.01.2014 |
|
|
|
|
Subject |
|
Request of M/s Vins Bioproducts Limited, Hyderabad for<br>fixation of adhoc norms against Advance Authorization No.<br>0910058863 dated 08.01.2014 |
|
|
|
|
**Decision:**The Committee considered the request of the firm and on the basis of written comments<br>(formula) furnished by Department of Biotechnology vide their OM dated 13.11.2019, it was decided to fix<br>following adhoc norms:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TETANUS ANTITOXIN IHS<br>1500IU/MLVIALS<br>459735.000<br>Vials<br>1<br>TETANUS ANTITOXIN 2500<br>IU / ML<br>383.449<br>Litres<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
TETANUS ANTITOXIN IHS<br>1500IU/MLVIALS |
459735.000<br>Vials |
|
1 |
TETANUS ANTITOXIN 2500<br>IU / ML |
383.449<br>Litres |
|
RA concerned may take further necessary action as |
|
|
|
|
|
135
|
Case No. |
Case No. |
B- 50 |
B- 50 |
B- 50 |
B- 50 |
|
Meeting No. |
|
10/AM20 |
|
|
|
|
Date |
|
29.11.2019 |
|
|
|
|
Firm’s Name |
|
M/s Vins Bioproducts Limited, Hyderabad |
|
|
|
|
HQ F. No. |
|
01/82/050/01300/AM15/DES-III |
|
|
|
|
RLA F. No. |
|
09/24/040/00290/AM15 |
|
|
|
|
Advance Authorization No. and Date |
|
0910061111 dated 16.10.2014 |
|
|
|
|
Subject |
|
Request of M/s Vins Bioproducts Limited, Hyderabad for<br>enhancement in the quantity of Import Item in respect of<br>adhoc norms fixed against Advance Authorization No.<br>0910061111 dated 16.10.2014 |
|
|
|
|
**Decision:**The Committee considered the request of the firm and on the basis of written comments<br>(formula) furnished by Department of Biotechnology vide their OM dated 13.11.2019, it was decided to<br>revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TETANUS ANTITOXIN<br>IHS/BP 1500IU/ML (IN THE<br>FORM OF PFS/VIALS 1 ML<br>EACH)<br>470000.000<br>vials<br>1<br>TETANUS ANTITOXIN<br>2500IU / ML<br>392.000<br>Litres<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
TETANUS ANTITOXIN<br>IHS/BP 1500IU/ML (IN THE<br>FORM OF PFS/VIALS 1 ML<br>EACH) |
470000.000<br>vials |
|
1 |
TETANUS ANTITOXIN<br>2500IU / ML |
392.000<br>Litres |
|
RAconcernedmay takefurther necessary actionas |
|
|
|
|
|
| Case No. |
B- 51 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Vins Bioproducts Limited, Hyderabad |
| HQ F. No. |
01/82/050/00119/AM16/DES-III |
| RLA F. No. |
09/24/040/00652/AM15 |
| Advance Authorization No. and Date |
0910061882 dated 15.04.2015 |
| Subject |
Request of M/s Vins Bioproducts Limited, Hyderabad for |
|
enhancement in the quantity of Import Item in respect of |
|
adhoc norms fixed against Advance Authorization No. |
|
0910061882 dated 15.04.2015 |
Decision: The Committee considered the request of the firm and on the basis of written comments (formula) furnished by Department of Biotechnology vide their OM dated 13.11.2019, it was decided to revise the norms as under:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| TETANUS ANTITOXIN<br>IHS/BP 1500IU/ML (IN THE<br>FORM OF PFS/VIALS 1 ML<br>EACH) |
590000.000<br>vials |
1 |
TETANUS ANTITOXIN<br>3000IU/ ML |
408.00<br>Litres |
RA concerned may take further necessary action as per above decision of NC.
136
| Case No. |
B- 52 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Satyadeva Pharmaceuticals Pvt. Ltd, Hyderabad |
| HQ F. No. |
01/82/050/01070/AM18/DES-III |
| RLA F. No. |
09/24/040/00337/AM18 |
| Advance Authorization No. and Date |
0910065537 dated 05.10.2017 |
| Subject |
Request of M/s Satyadeva Pharmaceuticals Pvt. Ltd, Hyderabad<br>for fixation of adhoc norms against Advance Authorization No.<br>0910065537 dated 05.10.2017 |
| **Decision:**Deferred for comments of TE. |
|
|
Case No. |
B- 53 |
|
Meeting No. |
10/AM20 |
|
Date |
29.11.2019 |
|
Firm’s Name |
M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
|
HQ F. No. |
01/82/050/00058/AM16/DES-III |
|
RLA F. No. |
03/94/040/00932/AM15 |
|
Advance Authorization No. and Date |
0310792548 dated 01.01.2015 |
|
Subject |
Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai<br>for review of norms fixed against Advance Authorization No.<br>0310792548 dated 01.01.2015. |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items as per<br>Qty.<br>(in gm for<br>100<br>lozenges)<br>1<br>Boots Sore Throat Relife Lozenges<br>Blackcurrant Sugar Free.<br>Each Lozenges contains Isomalt ST-M<br>2141.64mg, Amylmetacrysol 0.6mg. Net<br>content-Isomalt ST-M<br>6098kgs,Amylmetacrysol 1.708kgs<br>100<br>lozenges<br>1.<br>Pholcodine<br>0.561<br>2.<br>Benzydamine<br>hydrochloride<br>0.153<br>3.<br>Cetylpyridinium<br>Chloride<br>0.1356<br>4.<br>Isomalt ST-M<br>214.164<br>2<br>Duro-Tuss Chesty Sugar Free Lozenges<br>Lemon/Eucalyptus & Menthol<br>Each Lozenges contains Isomalt ST-M<br>2141.64mg, Cetylpyridinium Chloride<br>1.33mg. Net Content Isomalt ST-M<br>5488kgs, Cetylpyridinium Chloride<br>3.408kgs<br>100<br>lozenges<br>1.<br>Pholcodine<br>5.61 mg<br>2.<br>Cetylpyridinium<br>Chloride<br>0.1356<br>3.<br>Isomalt ST-M<br>214.64<br>3<br>Septolete Lozenges / Septolete Extra<br>Lozenges / Septolete Ultra Lozenges /<br>Septolete Omni Lozenges / Septolete<br>Total Lozenges / Septolete Duo<br>Lozenges / Septabene Lozenges Each<br>Lozenges contains Cetypyridinium<br>Chloride EP 1.00 MG, Isomalt ST-M<br>2579.550 MG, Net content<br>Cetypyridinium Chloride 7.688 Kgs.,<br>Isomalt ST-M 19840.135Kgs.<br>100<br>lozenges<br>1.<br>Cetylpyridinium<br>Chloride<br>0.102<br>2.<br>Isomalt ST-M<br>249.526<br>RA concerned may take further necessary action as per above decision of NC. |
|
137
| Case No. |
B- 54 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Aarti Organic, Ahmedabad |
| HQ F. No. |
01/82/050/00873/AM12/DES-III |
|
01/82/050/01358/AM11/DES-III |
| RLA F. No. |
08/24/040/00121/AM12 |
|
08/24/040/01286/AM11 |
| Advance Authorization No. and Date |
0810103178 dated 05.09.2011<br>0810094954 dated 27.12.2010 |
| Subject |
Request of M/s Aarti Organic, Ahmedabad for review of norms<br>fixed against Advance Authorization No. 0810103178 dated<br>05.09.2011 & 0810094954 dated 27.12.2010 |
| **Decision:**The Committee considered the request of firm in the presence of technical experts and it was decided<br>to fix following adhoc norms:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4-Amino 4-Nitro Diphenyl Amine 2<br>Sulphonic Acid(4 NADPSA)<br>1 kg<br>1<br>Para Nitro Aniline<br>0.50 kg<br>2<br>Para Nitro Chloro Benzene<br>0.62 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
B- 55 |
| Meeting No. |
10/AM20 |
| Date |
29.11.2019 |
| Firm’s Name |
M/s Global Calcium Pvt. Ltd., Bangalore |
| HQ F. No. |
01/82/050/00314/AM16/DES-III |
| RLA F. No. |
07/24/040/040/00393/AM15 |
| Advance Authorization No. and Date |
0710108142 dated 01.05.2015 |
| Subject |
Request of M/s Global Calcium Pvt. Ltd., Bangalore for<br>revision of adhoc norms fixed against Advance Authorization<br>No. 0710108142 dated 01.05.2015 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to call for following information from the firm:<br>(i)<br>Details of Oral Grade indicating impurities profile alongwith COA. |
|
138
OUT OF AGENDA CASES
Correction Cases:
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Case No. |
B-01 |
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Meeting No. |
10/AM20 |
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Date |
29.112019 |
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Firm’s Name |
M/s Ami Lifesciences Pvt. Ltd., Vadodara |
|
HQ F. No. |
01/82/050/01286/AM19/DES-III |
|
RLA F. No. |
34/24/040/00113/AM19 |
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Advance Authorization No. and Date |
3410044289 dated 29.06.2018 |
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Subject |
Request of M/s Ami Lifesciences Pvt Ltd, Vododara for<br>review of norms fixed against Advance Authorization No.<br>3410044289 dated 29.06.2018 |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it<br>was decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No<br>Import items<br>Qty.<br>Benfotiamine<br>1 kg<br>1<br>Thiamine Hydrochloride<br>0.922 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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139
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Case No. |
B-02 |
|
Meeting No. |
10/AM20 |
|
Date |
29.112019 |
|
Firm’s Name |
M/s Ami Lifesciences Pvt. Ltd., Vadodara |
|
HQ F. No. |
01/82/050/01297/AM19/DES-III<br>01/82/050/02597/AM19/DES-III<br>01/82/050/02598/AM19/DES-III<br>01/82/050/00104/AM20/DES-III<br>01/82/050/00105/AM20/DES-III |
|
RLA F. No. |
34/24/040/00019/AM19<br>34/24/040/00372/AM19<br>34/24/040/00374/AM19<br>34/24/040/00043/AM20<br>34/24/040/00044/AM20 |
|
Advance Authorization No. and Date |
3410044121 dated 01.05.2018<br>3410044955 dated 07.03.2019<br>3410044956 dated 07.03.2019<br>3410045104 dated 01.05.2019<br>3410045105 dated 01.05.2019 |
|
Subject |
Request of M/s Ami Life sciences Pvt Ltd, Vododara for<br>review of norms fixed against Advance Authorization Nos.<br>3410044121 dated 01.05.2018, 3410044955 dated 07.03.2019,<br>3410044956 dated 07.03.2019, 3410045104 dated 01.05.2019<br>and 3410045105 dated 01.05.2019 |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it<br>was decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No<br>Import items<br>Qty.<br>Benfotiamine<br>1 kg<br>1<br>Thiamine Hydrochloride<br>0.922 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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140
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Case No. |
B- 03 |
|
Meeting No. |
10/AM20 |
|
Date |
29.112019 |
|
Firm’s Name |
M/s Cipla Ltd., Mumbai |
|
HQ F. No. |
01/82/050/01233/AM19/DES-III |
|
RLA F. No. |
03/94/040/00321/AM19 |
|
Advance Authorization No. and Date |
0310822432 dated 19.07.2018 |
|
Subject |
Request of M/s Cipla Ltd, Mumbai for revision/correction in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization<br>No.<br>0310822432 dated 19.07.2018 |
|
**Decision:**The Committee considered the request of firm in the presence of technical experts and it was decided<br>to revise the norms as under:<br>Export Product: Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 62.5mg in 75 ml,<br>100 ml and 150 ml<br>S.No.<br>Import Item<br>For export of 1000 No. pack<br>75 ml<br>100 ml<br>150 ml<br>1.<br>Amoxycillin Trihydrate<br>4.200 kg<br>5.649 kg<br>8.274 kg<br>2.<br>CLAVULANATE POTASSIUM WITH SILICON<br>DIOXIDE 1:1<br>2.3444 kg<br>3.126 kg<br>4.6888 kg<br>3.<br>SILICONE DIOXIDE(SYLOID 244FP)<br>1.50 kg<br>2.00 kg<br>3.00 kg<br>4.<br>115CC HDPE BOTTLES 75 ML (250/62.5)<br>Relevant as per packing policy<br>5.<br>185 CC HDPE BOTTLES 100 ML (250/62.5)<br>6.<br>225 CC HDPE BOTTLES 150 ML (250/62.5)<br>7<br>28-400 WHITE CLIC LOC CAP WITH PRINTED<br>FSM-1<br>8<br>Cap 28/400 WHT CRC W/FS M-I WITH<br>INDUCTION SEALING<br>RA concerned may take further necessary action as per above decision of NC. |
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141
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B- 04 |
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10/AM20 |
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29.112019 |
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| Firm |
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’s Name |
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M/s Cadila Healthcare L |
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imited, Ahmedabad |
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| HQ F. No. |
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F N |
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01/82/050/00281/AM20/ |
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ESIII |
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| RLA F. No. |
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08/24/040/00094/AM20 |
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| Advance Authorization No. and Date |
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0810145530 dated 18.06.2019 |
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| Subject |
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Request of M/s Cadila Healthcare Ltd, Ahmadabad for revision<br>of norms in respect of adhoc norms fixed against Advance<br>Authorization No. 0810145530 dated 18.06.2019 |
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<br> |
<br>Author |
<br>ization |
p<br>No. 0810145530 dated 18.06.2019 |
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v |
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| **Decision:**The Committee considered the request of firm in the presence of technical experts and it was decided<br>to revise the norms as under:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>ISOSORBIDE<br>DINITRATE<br>TABLETS<br>USP<br>5<br>MG<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE USP EQUIVALENT<br>TO ISOSORBIDE DINITRATE USP-NET WT. 15.980 KGS)<br>1 Number<br>2<br>ISOSORBIDE<br>DINITRATE<br>TABLETS<br>USP<br>10<br>MG<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE USP EQUIVALENT<br>TO ISOSORBIDE DINITRATE USP-NET WT. 92.790 KGS)<br>1 Number<br>3<br>ISOSORBIDE<br>DINITRATE<br>TABLETS<br>USP<br>20<br>MG<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE USP EQUIVALENT<br>TO ISOSORBIDE DINITRATE USP-NET WT. 212.812 KGS)<br>1 Number<br>4<br>ISOSORBIDE<br>DINITRATE<br>TABLETS<br>USP<br>30<br>MG<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE USP EQUIVALENT<br>TO ISOSORBIDE DINITRATE USP-NET WT. 153.162 KGS)<br>1 Number<br>5<br>ISOSORBIDE<br>DINITRATE<br>TABLETS<br>USP<br>40<br>MG<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE USP EQUIVALENT<br>TO ISOSORBIDE DINITRATE USP-NET WT. 12.420 KGS)<br>1 Number<br>Sl.<br>No.<br>Import Items<br>For export of 1 Number of tablet<br>(Quantity in mg )<br>5 mg<br>10<br>mg<br>20<br>mg<br>30<br>mg<br>40 mg<br>1<br>DILUTED ISOSORBIDE DINITRATE USP<br>12.75<br>25.50<br>51.00<br>76.50 102.00<br>2<br>LACTOSE MONOHYDRATE NF<br>48.16<br>96.55<br>71.00<br>46.43<br>88.39<br>3<br>SODIUM STARCH GLYCOLATE TYPE A NF/JP<br>5.23<br>10.45<br>10.45<br>10.45<br>4.375<br>4<br>MICROCRYSTALLINE CELLULOSE (AVICEL PH<br>200) NF/PH.EUR<br>11.00<br>22.00<br>22.00<br>22.00<br>52.50<br>5<br>MAGNESIUM STEARATE PH.EUR/NF/JP<br>1.10<br>2.20<br>2.20<br>2.20<br>3.50<br>RA concerned may take further necessary action as per above decision of NC. |
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on: |
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The Committee considered the r |
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equest |
of firm |
in the presence of technical experts an |
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d it was decid |
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<br>se the n |
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<br>orms as under: |
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Sl.<br>No. |
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Exp |
ort Product |
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Qty. |
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1 |
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<br> |
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<br> <br> <br> |
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ISO<br>(AC<br> |
SORBIDE<br>DINITRATE<br>TIVE INGREDIENT : DILUT<br> |
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<br>ED ISO<br> |
TAB<br>SORB<br> |
ETS<br>USP<br>5<br>M<br>IDE DINITRATE USP EQUIVALEN<br> |
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<br>T |
1 Number |
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TO |
SOSORBIDE DINITRATE US |
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P-NE |
T WT. |
15.980 KGS) |
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2 |
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ISO<br> |
SORBIDE<br>DINITRATE<br> |
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<br> |
TABL<br> |
ETS<br>USP<br>10<br>M<br> |
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G<br> |
1 Number |
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(AC<br>TO I |
TIVE INGREDIENT : DILUT<br>SOSORBIDE DINITRATE US |
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D IS<br>P-NE |
SORB<br>T WT. |
DE DINITRATE USP EQUIVALEN<br>92.790 KGS) |
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3 |
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ISO |
ORBIDE<br>DINITRATE |
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TAB |
ETS<br>SP<br>20<br>M |
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1 Nb |
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<br>(AC<br>TO I |
<br> <br>TIVE INGREDIENT : DILUT<br>SOSORBIDE DINITRATE US |
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<br>ED ISO<br>P-NE |
<br>SORB<br>T WT |
<br>U<br> <br> <br>IDE DINITRATE USP EQUIVALEN<br>212812 KGS |
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<br>T |
umer |
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. ) |
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4 |
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ISO |
ORBIDE<br>DINITRATE |
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TAB |
ETS<br>USP<br>30<br>M |
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1 Nb |
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<br>(AC<br>TO I |
<br> <br> <br> <br> <br> <br>TIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE USP EQUIVALENT<br>SOSORBIDE DINITRATE USP-NET WT. 153.162 KGS) |
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<br>SORB<br>T WT |
<br> <br> <br> <br>IDE DINITRATE USP EQUIVALEN<br>153162 KGS) |
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<br>T |
ume |
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5 |
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ISO |
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1 Number |
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Sl.<br>No. |
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Import Items |
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For export of 1 Number of tablet<br>(Quantity in mg ) |
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5 mg |
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10<br>mg |
20<br>mg |
30<br>mg |
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40 mg |
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1 |
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DILUTED ISOSORBIDE DINITRATE USP |
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12.75 |
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25.50 |
51.00 |
76.50 |
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102.00 |
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2 |
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LACTOSE MONOHYDRATE NF |
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48.16 |
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96.55 |
71.00 |
46.43 |
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88.39 |
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3 |
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SODIUM STARCH GLYCOLATE TYPE A NF/JP |
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5.23 |
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10.45 |
10.45 |
10.45 |
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4.375 |
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4 |
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MICROCRYSTALLINE CELLULOSE (AVICEL PH<br>200) NF/PH.EUR |
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11.00 |
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22.00 |
22.00 |
22.00 |
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52.50 |
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5 |
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MAGNESIUM STEARATE PH.EUR/NF/JP |
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1.10 |
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2.20 |
2.20 |
2.20 |
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3.50 |
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142
| Case No. |
B- 05 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Glenmark Pharmaceuticals Ltd., Mumbai |
| HQ F. No. |
01/82/050/00556/AM20/DES-III |
| RLA F. No. |
03/94/040/00421/AM20 |
| Advance Authorization No. and Date |
0310831222 dated 26.08.2019 |
| Subject |
Request of M/s Glenmark Life Sciences, Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310831222 dated 26.08.2019 |
| Decision:The Committee considered the request of the firm for correction in the description of Import Item<br>No. 2 in the presence of technical experts and it was decided to amend the description of Import Item No. 2 to read<br>as“6-HYDROXY-2 OXO-1,2,3,4-TETRAHYDROQUINOLINE”.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
Decision: The Committee considered the request of the firm for correction in the description of Import Item No. 2 in the presence of technical experts and it was decided to amend the description of Import Item No. 2 to read as “6-HYDROXY-2 OXO-1,2,3,4-TETRAHYDROQUINOLINE” .
|
Case No. |
B- 06 |
|
Meeting No. |
10/AM20 |
|
Date |
29.112019 |
|
Firm’s Name |
M/s Glenmark Pharmaceuticals Ltd., Mumbai |
|
HQ F. No. |
01/82/050/00439/AM20/DES-III |
|
RLA F. No. |
03/94/040/00323/AM20 |
|
Advance Authorization No. and Date |
0310830525 dated 24.07.2019 |
|
Subject |
Request of M/s Glenmark Life Sciences, Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310830525 dated 24.07.2019 |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>OLMESARTAN<br>MEDOXOMIL<br> <br>1 kg<br>1.<br>4-(1-HYDROXY-1-METHYL ETHYL)-2-<br>PROPYL-1H-IMIDAZOLE 5-<br>CARBOXYLIC ACID ETHYL ESTER<br>0.70 kg<br>2<br>5-(4-BROMOMETHYL BIPHENYL-2-YL)-<br>1-TRITYL-1H-TETRAZOLE<br>5-(4-BROMOMETHYL) (1,-<br>BROMOMETHYLIPHENYL)-2YL<br>TRIPHENYL-1-H TETRAZOLE<br>1.25 kg<br>3<br>4-CHLOROMETHYL-5-METHYL 1,3-<br>DIOXOLEN-2-ONE<br>0.4654 kg<br>4<br>METHYLENE CHLORIDE(MDC)<br>3.50 Litre<br>5<br>TOLUENE<br>2.50 Litre<br>6<br>DIMETHYL FORMAMIDE (DMF)<br>1.50 Litre<br> <br>RA concerned may take further necessary action as per above decision of NC. |
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143
|
Case No. |
B- 07 |
|
Meeting No. |
10/AM20 |
|
Date |
29.112019 |
|
Firm’s Name |
M/s Glenmark Pharmaceuticals Ltd., Mumbai |
|
HQ F. No. |
01/82/050/00517/AM20/DES-III |
|
RLA F. No. |
03/94/040/00375/AM20 |
|
Advance Authorization No. and Date |
0310830915 dated 09.08.2019 |
|
Subject |
Request of M/s Glenmark Life Sciences, Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310830915 dated 09.08.2019 |
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CILOSTAZOL<br> <br>1 kg<br>1.<br>5-(4-CHLOROBUTYL)-1-CYCLOHEXYL<br>1H<br>TETRAZOLE<br>0.88 kg<br>2<br>6-HYDROXY-2<br>OXO-1,2,3,4-<br>TETRAHYDROQUINOLINE<br>0.59 kg<br>3<br>METHANOL<br>4.00 kg<br>4<br>TOLUENE<br>0.30 kg<br> <br>RA concerned may take further necessary action as per above decision of NC. |
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| Case No. |
Case No. |
Case No. |
B- 08 |
B- 08 |
B- 08 |
B- 08 |
B- 08 |
| Meeting No. |
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10/AM20 |
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| Date |
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29.112019 |
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| Firm’s Name |
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M/s Glenmark Pharmaceuticals Ltd., Mumbai |
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| HQ F. No. |
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01/82/050/00397/AM20/DES-III |
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| RLA F. No. |
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03/94/040/00311/AM20 |
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| Advance Authorization No. and Date |
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0310830410 dated 18.07.2019 |
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| Subject |
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Request of M/s GLENMARK PHARMACEUTICALS LTD.,<br>Mumbai for revision of norms in respect of norms fixed against<br>Advance Authorization No. 0310830410 dated 18.07.2019 |
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|
| Decision:The Committee considered the request of the firm in the presence of<br>decided to revise the norms as under:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>1<br>Mupirocin Ointment USP 2%<br>(Pack Size 22gms)<br>1 pack<br>1<br>Mupirocin USP<br>2<br>Supiroban 15gm Ointment ZA<br>(Pack Size 15gms)<br>1 pack<br>1<br>Mupirocin USP<br>3<br>Supiroban 14gm zulu Ointment<br>(Pack Size 14gms)<br>1 pack<br>1<br>Mupirocin USP<br>4<br>Supiroban 50gm Ointment<br>(Pack Size 50gms)<br>1 pack<br>1<br>Mupirocin USP<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
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request of the firm in the presence of |
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technical experts and it was<br>Qty.<br>0.4488 gm/22 gm pack<br>0.306 gm/15 gm pack<br>0.2856 mg/14 gm pack<br>1.02 gm / 50 gm pack |
|
Sl.<br>No. |
Export product |
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Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
1 |
Mupirocin Ointment USP 2%<br>(Pack Size 22gms) |
|
1 pack |
1 |
Mupirocin USP |
0.4488 gm/22 gm pack |
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2 |
Supiroban 15gm Ointment ZA<br>(Pack Size 15gms) |
|
1 pack |
1 |
Mupirocin USP |
0.306 gm/15 gm pack |
|
3 |
Supiroban 14gm zulu Ointment<br>(Pack Size 14gms) |
|
1 pack |
1 |
Mupirocin USP |
0.2856 mg/14 gm pack |
|
4 |
Supiroban 50gm Ointment<br>(Pack Size 50gms) |
|
1 pack |
1 |
Mupirocin USP |
1.02 gm / 50 gm pack |
144
| Case No. |
Case No. |
Case No. |
Case No. |
B- 09 |
B- 09 |
B- 09 |
B- 09 |
| Meeting No. |
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10/AM20 |
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| Date |
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29.112019 |
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| Firm’s Name |
|
|
|
M/s Global Calcium Pvt. Ltd., Bangalore |
|
|
|
| HQ F. No. |
|
|
|
01/82/050/01075/AM17/DES-III |
|
|
|
| RLA F. No. |
|
|
|
07/24/040/00255/AM16 |
|
|
|
| Advance Authorization No. and Date |
|
|
|
0710109043 dated 13.11.2015 |
|
|
|
| Subject |
|
|
|
Request of M/s GLOBAL CALCIUM PRIVATE LIMITED.,<br>Bangalore for revision of norms in respect of adhoc norms fixed<br>against<br>Advance<br>Authorization<br>No.<br>0710114983<br>dated<br>29.05.2019 |
|
|
|
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Sl. No. Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>CALCIUM LACTATE<br>GLUCONATE<br>1 kg<br>1.<br>CALCIUM GLUCONATE - ORAL<br>GRADE<br>0.686 kg<br>2.<br>CALCIUM CARBONATE<br>0.310 kg<br>3<br>LACTIC ACID - ANY GRADE<br>0.560 kg<br>2<br>FERROUS LACTATE<br>1 kg<br>1.<br>LACTIC ACID-ANY GRADE<br>1.028 kg<br>3<br>MAGNESIUM LACTATE<br>1 kg<br>1.<br>LACTIC ACID-ANY GRADE<br>1.19 kg<br>4<br>ZINC LACTATE<br>1 kg<br>1.<br>LACTIC ACID-ANY GRADE<br>0.990 kg<br>5<br>MAGNESIUM LACTATE<br>GLUCONATE<br>1 kg<br>1<br>LACTIC ACID-ANY GRADE<br>0.390 kg<br>2<br>**GLUCONO DELTA LACTONE **<br>0.766 kg<br>6<br>CALCIUM LACTATE<br>1 kg<br>1<br>LACTIC ACID- ANY GRADE<br>0.95 kg<br>2<br>CALCIUM CARBONATE<br>0.49 kg<br> <br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
the firm in the presence of technical experts and it was |
|
|
Sl. No. |
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
1 |
CALCIUM LACTATE<br>GLUCONATE |
1 kg |
|
1. |
CALCIUM GLUCONATE - ORAL<br>GRADE |
0.686 kg |
|
|
|
|
|
2. |
CALCIUM CARBONATE |
0.310 kg |
|
|
|
|
|
3 |
LACTIC ACID - ANY GRADE |
0.560 kg |
|
2 |
FERROUS LACTATE |
1 kg |
|
1. |
LACTIC ACID-ANY GRADE |
1.028 kg |
|
3 |
MAGNESIUM LACTATE |
1 kg |
|
1. |
LACTIC ACID-ANY GRADE |
1.19 kg |
|
4 |
ZINC LACTATE |
1 kg |
|
1. |
LACTIC ACID-ANY GRADE |
0.990 kg |
|
5 |
MAGNESIUM LACTATE<br>GLUCONATE |
1 kg |
|
1 |
LACTIC ACID-ANY GRADE |
0.390 kg |
|
|
|
|
|
2 |
**GLUCONO DELTA LACTONE ** |
0.766 kg |
|
6 |
CALCIUM LACTATE |
1 kg |
|
1 |
LACTIC ACID- ANY GRADE |
0.95 kg |
|
|
|
|
|
2 |
CALCIUM CARBONATE |
0.49 kg |
|
|
|
|
|
as perabove decisionofNC. |
|
|
145
| Case No. |
B- 10 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Global Calcium Pvt. Ltd., Bangalore |
| HQ F. No. |
01/82/050/00056/AM17/DES-III |
| RLA F. No. |
07/24/040/00123/AM16 |
| Advance Authorization No. and Date |
0710108886 dated 13.10.2015 |
| Subject |
Request of M/s GLOBAL CALCIUM PRIVATE LIMITED,<br>Bangalore for correction/revision of norms in respect of adhoc<br>norms fixed against Advance Authorization No. 0710108886<br>dated 13.10.2015 |
| Decision:The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Exportproduct<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>CALCIUM LACTOBIONATE<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.172 kg<br>2.<br>LACTOSE<br>1.16 kg<br>CALCIUM<br>BROMOLACTOBIONATE<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.360 kg<br>2.<br>LACTOSE<br>1.021 kg<br>3.<br>HYDROBROMIC ACID<br>0.510 kg<br>CALCIUM GLUBIONATE<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.259kg<br>2.<br>LACTOSE<br>0.829 kg<br>3.<br>CALCIUM<br>GLUCONATE<br>-<br>ORALGRADE<br>0.430 kg<br>LACTOBIONIC ACID<br>1 kg<br>1.<br>CALCIUM CARBONATE<br>0.234 kg<br>2.<br>LACTOSE<br>1.58 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
B- 11 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Global Calcium Pvt. Ltd., Bangalore |
| HQ F. No. |
01/82/050/00158/AM19/DES-III |
| RLA F. No. |
07/24/040/00273/AM18 |
| Advance Authorization No. and Date |
0710112638 dated 04.01.2018 |
| Subject |
Request of M/s GLOBAL CALCIUM PRIVATE LIMITED,<br>Bangalore for correction/revision of norms in respect of norms<br>fixed against Advance Authorization No. 0710112638 dated<br>04.01.2018 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to call for following information from the firm:<br>(i)<br>Particular Grade of all the Export Products.<br>(ii)<br>Specific grade of Citric Acid and Magnesium Carbonate imported. |
|
146
| Case No. |
B- 12 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Global Calcium Pvt. Ltd., Bangalore |
| HQ F. No. |
01/82/050/00508/AM20/DES-III |
| RLA F. No. |
07/24/040/00095/AM20 |
| Advance Authorization No. and Date |
0710115189 dated 19.07.2019 |
| Subject |
Request of M/s Global Calcium Pvt. Ltd., Bangalore for<br>correction / revision in the description of import item in respect<br>of Advance Authorization No. 0710115189 dated 19.07.2019 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to call for following information from the firm:<br>(i)<br>Complete specification of oral grade including impurity profile with COA. |
|
| Case No. |
B- 13 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Jubilant Life Sciences, CLA, New Delhi |
| HQ F. No. |
01/82/050/00034/AM20/DES-III<br>01/82/050/00170/AM20/DES-III |
| RLA F. No. |
05/23/040/00566/AM19<br>05/23/040/00530/AM19 |
| Advance Authorization No. and Date |
0510410180 dated 09.04.2019<br>0510410582 dated 14.05.2019 |
| Subject |
Request of M/s Jubilant Life Sciences, CLA, New Delhi for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization Nos. 0510410180 dated 09.04.2019 and 0510410582<br>dated 14.05.2019 |
| **Decision:**Deferred for comments of TE. |
|
| Case No. |
B- 14 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Jubilant Life Sciences, CLA, New Delhi |
| HQ F. No. |
01/82/050/02173/AM19/DES-III |
| RLA F. No. |
05/23/040/00243/AM19 |
| Advance Authorization No. and Date |
0510408887 dated 13.12.2018 |
| Subject |
Request of M/s Jubilant Life Sciences, CLA, New Delhi for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0510408887 dated 13.12.2018 |
| **Decision:**Deferred for comments of TE. |
|
147
| Case No. |
Case No. |
Case No. |
Case No. |
B- 15 |
B- 15 |
B- 15 |
B- 15 |
B- 15 |
| Meeting No. |
|
|
|
10/AM20 |
|
|
|
|
| Dat |
e |
|
|
29.112019 |
|
|
|
|
| Fir<br> |
m’s Name<br> |
|
|
M/s Mylan Laboratories<br>as M/s Matrix Laboratori<br> |
|
Limited, Hyderabad (Form<br>es Ltd, Hyderabad)<br> |
|
erly known |
| HQ |
F. No. |
|
|
01/82/050/00712/AM10/D |
|
ES-III |
|
|
| RL |
A F. No. |
|
|
09/24/040/00130/AM10 |
|
|
|
|
| Ad |
Ahii N d D |
|
|
0910038699 dd 24072 |
|
09 |
|
|
|
vance utorzaton o. an at |
|
|
ate .. |
|
|
|
|
| Sub |
ject |
|
|
Request of M/s Mylan |
|
Laboratories Limited, |
|
Hyderabad |
|
|
|
|
<br>(Formerly known as M/s Matrix Laboratories Ltd, Hyderabad)<br>for revision/correction in adhoc norms fixed against Advance<br> |
|
|
|
|
|
|
|
|
Authorization No. 091 |
0038699 dated 24.07.2009 |
|
|
|
| De<br>dec<br>(<br>( |
**cision:**The Committee con<br>ided to call for following infor |
sidered the request of firm in t<br>mation from the firm:<br>cation at the time of applying f<br>rts and export against the abov |
|
|
he presence of technical e<br>or above licences.<br>e licences. |
|
xperts and it was |
|
|
i)<br> Complete set of appli<br>ii)<br>Details of actual impo |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Case No. |
Case No. |
Case No. |
B- 16 |
B- 16 |
B- 16 |
B- 16 |
|
|
|
10/AM20 |
|
|
|
| Me |
eting No. |
|
10/AM20 |
|
|
|
| Dat |
e |
|
29.112019 |
|
|
|
| Fir |
m’s Name |
|
M/s Nagarjuna Agri |
chem Ltd., Hyderabad |
|
|
| HQ |
F. No. |
|
01/82/050/00912/AM |
15/DES-III |
|
|
| <br>RL |
<br>A F. No. |
|
09/24/040/00376/AM |
<br>15 |
|
|
| Ad |
vance Authorization No. and Dat |
e |
0910061106 dated 16 |
.10.2014 |
|
|
| Sub |
ject |
|
Request of M/s N<br> |
agarjuna Agrichem Lt<br> |
d., Hyderabad f<br> |
|
|
|
|
|
|
|
|
| Decision:The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to call for following information from the firm:<br>(i)<br>Complete technical details as per Appendix 4E. |
|
|
|
|
|
|
| Case No. |
B- 17 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s O C Specialities Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/00564/AM20/DES-III |
| RLA F. No. |
03/95/040/00528/AM20 |
| Advance Authorization No. and Date |
0310831252 dated 27.08.2019 |
| Subject |
Request of M/s O C Specialties Pvt Ltd, Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310831252 dated 27.08.2019 |
| **Decision:**The Committee considered the request of firm and it was decided to approve the request of firm with<br>the following directions to RLA, Mumbai:<br>“If concentration of import item No. 4 - HYDRAZINE HYDRATE is increased, RA may reduced the quantity of<br>import item No. 4 on inverse basis, i.e. higher the concentration, lower will be the quantity of import item No. 4.” |
|
148
| Case No. |
B- 18 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Oriental Aromatics Ltd., Mumbai |
| HQ F. No. |
01/82/050/02577/AM19/DES-III |
| RLA F. No. |
03/95/040/02577/AM19 |
| Advance Authorization No. and Date |
0310827770 dated 18.03.2019 |
| Subject |
Request of M/s ORIENTAL AROMATICS LTD, Mumbai for<br>amendment in the description of export product and import<br>item No. 2 in respect of adhoc norms fixed against Advance<br>Authorization No. 0310827770 dated 18.03.2019 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Allyl Caproate (AB15012)<br>1 kg<br>1<br>Caproic Acid<br>0.826 kg<br>2<br>Allyl Alcohol<br>0.413 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
Case No. |
Case No. |
B- 19 |
B- 19 |
B- 19 |
B- 19 |
|
Meeting No. |
|
10/AM20 |
|
|
|
|
Date |
|
29.112019 |
|
|
|
|
Firm’s Name |
|
M/s Posy Pharmachem Pvt. Ltd., Ahmedabad |
|
|
|
|
HQ F. No. |
|
01/82/050/01564/AM19/DES-III<br>01/82/050/01730/AM19/DES-III<br>01/82/050/02246/AM19/DES-III |
|
|
|
|
RLA F. No. |
|
08/24/040/00229/AM19<br>08/24/040/00377/AM16<br>08/24/040/00253/AM19 |
|
|
|
|
Advance Authorization No. and Date |
|
0810143768 dated 26.10.2018<br>0810137117 dated 03.02.2016<br>0810144202 dated 02.01.2019 |
|
|
|
|
Subject |
|
Request<br>of<br>M/s<br>POSY<br>PHARMACHEM<br>PVT.<br>LTD,<br>Ahmedabad for revision of norms in respect of norms fixed<br>against<br>Advance<br>Authorization<br>Nos.<br>0810143768<br>dated<br>26.10.2018, 0810144202 dated 02.01.2019 and 0810137117 dated<br>03.02.2016 |
|
|
|
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br>Exportproduct<br> Qty.<br>Sl. No.<br>Import items<br>Qty.<br>SODIUM CITRATE BP/USP<br>1 kg<br>1<br>CITRIC ACID MONOHYDRATE<br>0.736 kg<br>2.<br>CAUSTIC SODA FLAKES /<br>PEARLS<br>0.421 kg<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
|
Exportproduct |
Qty. |
|
Sl. No. |
Import items |
Qty. |
|
SODIUM CITRATE BP/USP |
1 kg |
|
1 |
CITRIC ACID MONOHYDRATE |
0.736 kg |
|
|
|
|
2. |
CAUSTIC SODA FLAKES /<br>PEARLS |
0.421 kg |
|
RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
|
|
|
149
| Case No. |
B- 20 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s S M Herbals Pvt Ltd, CLA, New Delhi |
| HQ F. No. |
01/82/050/00608/AM13/DES-III |
| RLA F. No. |
05/24/040/00147/AM13 |
| Advance Authorization No. and Date |
0510330512 dated 25.07.2012 |
| Subject |
Request of M/s S M Herbals Pvt. Ltd., CLA, New Delhi for<br>review of norms in respect of adhoc norms fixed against Advance<br>Authorization No. 0510330512 dated 25.07.2012 |
| Decision:The Committee considered the request of firm for amendment in the description of Import Item and<br>enhancement of norms. The Committee after deliberation decided to amend the description of import item to read<br>as<br>“Crude<br>Camptothecin<br>(CHEMICAL)<br>HPLC Purity NLT 90%”.<br> The request of firm for enhancement of norms is rejected.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
B- 21 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s S M Herbals Pvt Ltd, CLA, New Delhi |
| HQ F. No. |
01/82/050/00842/AM14/DES-III |
| RLA F. No. |
05/24/040/00239/AM14 |
| Advance Authorization No. and Date |
0510367886 dated 08.10.2013 |
| Subject |
Request of M/s S M Herbals Pvt. Ltd., CLA, New Delhi for<br>review of norms in respect of adhoc norms fixed against Advance<br>Authorization No. 0510367886 dated 08.10.2013 |
| Decision:The Committee considered the request of firm for amendment in the description of Import Item and<br>enhancement of norms. The Committee after deliberation decided to amend the description of import item to read<br>as<br>“Quinoline<br>Based<br>Alkaloid-Camptothecin<br>(Chemical)<br>HPLC Purity NLT 90%”.<br> The request of firm for enhancement of norms is rejected.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
150
| Case No. |
B- 22 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s UPL Ltd., Mumbai |
| HQ F. No. |
01/82/050/01082/AM17/DES-III |
| RLA F. No. |
03/95/040/00622/AM17 |
| Advance Authorization No. and Date |
0310809222 dated 22.11.2018 |
| Subject |
Request of M/s UPL Ltd., Mumbai for correction / revision in<br>respect of adhoc norms fixed against Advance Authorization No.<br>0310809222 dated 22.11.2016 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to revise the norms as under:<br> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Tris Tri Decyl Phosphite (TTDP)<br>1 kg<br>1<br>Yellow Phosphorus<br>0.067 kg<br>2<br>Methanol<br>0.209 kg<br>3<br>Safol 23 (C12/13 Alcohol)<br>0.931 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
151
EARLIER REJECTED CASES IN WHICH NORMS ARE YET TO BE FIXED:
| Case No. |
B- 01 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Arjun Chemicals Pvt. Ltd., Chennai |
| HQ F. No. |
01/82/050/01281/AM17/DES-III<br>01/82/050/00302/AM18/DES-III |
| RLA F. No. |
04/24/040/00170/AM17<br>04/24/040/00202/AM17 |
| Advance Authorization No. and Date |
0410162725 dated 18.01.2017<br>0410162954 dated 04.04.2017 |
| Subject |
Request of M/s Arjun Chemicals Pvt Ltd, Chennai for fixation of<br>adhoc norms against Advance Authorization Nos. 0410162725<br>dated 18.01.2017 and 0410162954 dated 04.04.2017 |
| **Decision:**The Committee considered the request of firm in the presence of technical experts and it was decided<br>to fix following adhoc norms:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>KEYDIME -AKD<br>Alkyl Ketene Dimer Emulsion<br>(containing 10% solid content)<br>1 kg<br>1.<br>Alkyl Ketene Dimer AKD<br>0.100 kg<br>2.<br>Solbond<br>SBC<br>40S<br>Cationic Potato Starch<br>0.007 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
B- 02 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Almelo Priavate Limited, Hyderabad |
| HQ F. No. |
01/82/050/00620/AM17/DES-III |
| RLA F. No. |
09/24/040/00056/AM17 |
| Advance Authorization No. and Date |
0910063626 dated 17.05.2016 |
| Subject |
Request of M/s ALMELO Pvt. Limited, Hyderabad for fixation<br>of adhoc norms against Advance Authorization No. 0910063626<br>dated 17.05.2016. |
| **Decision:**Deferred for comments of TE. |
|
| Case No. |
B- 03 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Inchem Laboratories Pvt. Ltd., Hyderabad |
| HQ F. No. |
01/82/050/00910/AM14/DES-III |
| RLA F. No. |
09/24/040/00287/AM14 |
| Advance Authorization No. and Date |
0910057785 dated 01.10.2013 |
| Subject |
Request of M/s Inchem Laboratories Pvt Ltd., Hyderabad for<br>fixation of adhoc norms against Advance Authorization No.<br>0910057785 dated 01.10.2013 |
| **Decision:**Deferred for comments of TE. |
|
152
| Case No. |
B- 04 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Inchem Laboratories Pvt. Ltd., Hyderabad |
| HQ F. No. |
01/82/050/01493/AM12/DES-III |
| RLA F. No. |
09/24/040/00579/AM12 |
| Advance Authorization No. and Date |
0910051360 dated 21.02.2012 |
| Subject |
Request of M/s Inchem Laboratories Pvt Ltd., Hyderabad for<br>fixation of adhoc norms against Advance Authorization No.<br>0910051360 dated 21.02.2012 |
| **Decision:**Deferred for comments of TE. |
|
|
|
| Case No. |
B- 05 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Inchem Laboratories Private Limited., Hyderabad |
| HQ F. No. |
01/82/050/01275/AM12/DES-III |
| RLA F. No. |
09/24/040/00413/AM12 |
| Advance Authorization No. and Date |
0910050238 dated 15.12.2011 |
| Subject |
Request of M/s Inchem Laboratories Pvt. Ltd., Hyderabad for<br>fixation of adhoc norms against Advance Authorization No.<br>0910050238 dated 15.12.2011 |
| **Decision:**Deferred for comments of TE. |
|
| Case No.<br>B- 06<br>Meeting No.<br>10/AM20<br>Date<br>29.112019<br>Firm’s Name<br>M/s Sun Pharmaceutical Industries Ltd., New Delhi (earlier<br>known as M/s Ranbaxy Labs Ltd., New Delhi)<br>HQ F. No.<br>01/82/050/00303/AM16/DES-III<br>RLA F. No.<br>05/24/040/00503/AM15<br>Advance Authorization No. and Date<br>0510393026 dated 29.01.2015<br>Subject<br>Request of M/s Sun Pharmaceutical Industries Ltd., New<br>Delhi (earlier known as M/s Ranbaxy Labs Ltd., New Delhi)<br>for fixation of the input output norms fixed by NC-3 against<br>Advance Authorization No. 0510393026 dated 29.01.2015<br>**Decision:**Deferred for comments of TE. |
|
| Case No. |
B- 06 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Sun Pharmaceutical Industries Ltd., New Delhi (earlier<br>known as M/s Ranbaxy Labs Ltd., New Delhi) |
| HQ F. No. |
01/82/050/00303/AM16/DES-III |
| RLA F. No. |
05/24/040/00503/AM15 |
| Advance Authorization No. and Date |
0510393026 dated 29.01.2015 |
| Subject |
Request of M/s Sun Pharmaceutical Industries Ltd., New<br>Delhi (earlier known as M/s Ranbaxy Labs Ltd., New Delhi)<br>for fixation of the input output norms fixed by NC-3 against<br>Advance Authorization No. 0510393026 dated 29.01.2015 |
| **Decision:**Deferred for comments of TE. |
|
153
| Case No. |
B- 07 |
B- 07 |
| Meeting No. |
10/AM20 |
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| Date |
29.112019 |
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| Firm’s Name |
M/s Sun Pharmaceutical Industries Ltd., New Delhi<br>(earlier known as M/s Ranbaxy Labs Ltd., New Delhi) |
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| HQ F. No. |
01/82/050/00858/AM13/DES-III |
01/82/050/00347/AM13/DES-III |
| RLA F. No. |
05/24/040/00252/AM13 |
05/24/040/00061/AM13 |
| Advance<br>Authorization No.<br>and Date |
0510337284 dt. 16.10.2012 |
0510325945 dt. 25.05.2012 |
| Subject |
Request of M/s Sun Pharmaceutical Industries Ltd., New Delhi (earlier known as<br>M/s Ranbaxy Labs Ltd., New Delhi) for fixation of the input output norms against<br>Advance Authorization Nos. 0510337284 dated 16.10.2012 and 0510325945 dated<br>23.05.2012 |
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| **Decision:**Deferredforcomments of TE. |
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|
| Case No. |
B- 08 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s SRINI PHARMACEUTICALS PRIVATE LIMITED,<br>Hyderabad |
| HQ F. No. |
01/82/050/00226/AM14/DES-III<br>01/82/050/00684/AM15/DES-III |
| RLA F. No. |
09/24/040/00017/AM14<br>09/24/040/00139/AM15 |
| Advance Authorization No. and Date |
0910055800 dated 19.04.2013<br>0910060467 dated 17.06.2014 |
| Subject |
Request of M/s Srini Pharmaceuticals Pvt Ltd, Hyderabad for<br>fixation of adhoc norms against Advance Authorization No.<br>0910055800 dated 19.04.2013 and 0910060467 dated 17.06.2014 |
| **Decision:**Deferred for comments of TE. |
|
| Case No. |
B- 09 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Sentiss Pharma Private Limited, New Delhi |
| HQ F. No. |
01/82/050/01678/AM16/DES-III |
| RLA F. No. |
05/24/040/00499/AM16 |
| Advance Authorization No. and Date |
0510397256 dated 08.01.2016 |
| Subject |
Request of M/s Sentiss Pharma Private Limited, New Delhi<br>for fixation of adhoc norms fixed by NC -3 against Advance<br>Authorization No. 0510397256 dated 08.01.2016 |
| **Decision:**Deferred for comments of TE. |
|
154
| Case |
No. |
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No. |
No. |
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B- 10 |
B- 10 |
B- 10 |
B- 10 |
B- 10 |
B- 10 |
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ting No. |
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10/AM20 |
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| Date<br> |
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29.112019<br> |
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| Firm |
’s Name |
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M/s Stericat Gustrings P |
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vt. Ltd., New Delhi |
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F. No. |
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01/82/050/00294/AM14/ |
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DES-III |
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F N |
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05/24/040/00091/AM14 |
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. o. |
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| Adv |
ance Authorization No. and Date |
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0510358000 dated 25.06.2013 |
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| Subj |
ect |
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Request of M/s Stericat Gustrings Pvt. Ltd., New Delhi, f<br>fixation of adhoc norms against Advance Authorization N<br>0510358000 dated 25.06.2013 |
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or<br>o. |
| Dec<br>to fi<br>Sl.<br>No<br>1 |
isi<br>x |
**on:**The Committee considered the r<br>following adhoc norms: |
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equest o |
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f firm in t |
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he presence of technical exper |
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ts and it was d |
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ecid |
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<br>. |
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Export product |
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Qt |
y. |
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Sl. |
Import items |
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Qty. |
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<br>No. |
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Sterile Surgical sutures USP/ EP<br>( Monofilament Polydioxanone) wit<br>or without Needle packed in 140<br>Boxes.<br>containing packing material:<br>Sterilisation Paper : 1.00 Kg, Triple<br>Kraft Paper :1.47 Kg, Aluminium F<br>: 2.26 Kg, Polyster Film : 0.93 Kg |
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<br>h<br> <br>oil |
<br>12<br>Me |
60.000 |
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1 |
Monofilament |
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1.01 M |
eter<br>in<br> |
/ |
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ter |
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Polydioxanone Threa |
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d . |
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Meter |
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<br>TC : DIAMETER 0.0 |
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<br>7 |
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content |
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TO 0.61MM +/-10%. |
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export |
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2 |
Sterilisation Paper fo |
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r |
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<br>Releva |
<br>nt as<br>king |
<br> |
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<br>outer pouch, 60 GSM |
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<br>/ |
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per pac |
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M2 in Rolls |
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policy |
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3 |
Triple Kraft Paper in |
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Releva |
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<br> |
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Rolls / Reel 152 GSM<br>&-10% |
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+ |
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4 |
Aluminium Foil<br>(Laminated) Jumbo Rolls<br> |
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Relevant as<br>per packing<br>policy |
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| 2 |
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90 mm or Multiple in<br>pouch form |
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policy |
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5 |
Polyster Film for Outer<br>Pouch 55 GSM + & - |
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Relevant as<br>per packing |
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<br> |
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10% |
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<br>policy |
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Sterile Surgical sutures USP/ EP (<br>Braided Coated Synthetic made of<br>Polyglycolic Acid or PGA+PLA)with<br>or without Needle<br> |
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341253.000<br>Meter |
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1 |
Braided Coated Synthetic<br>Twine (Thread) made of<br>Polyglycolic Acid or<br>PGA+PLA. TC :<br> |
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1.01 Meter<br>Meter<br>content in<br>export |
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/ |
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packed in 40377 Boxes.<br>packing material: Sterilis<br> |
containing<br>ation Paper :<br> |
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DIAMETER 0.0<br>0.64MM +/-10% |
4 TO<br> |
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<br> |
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278.78 Kg, Triple Kraft<br>Kg, Aluminium Foil : 65<br>Polyster Film :269.18 Kg |
aper :423.00<br>3.73 Kg,<br>, |
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2 |
Sterilisation Pap<br>outer pouch, 60<br>M2 in Rolls |
er for<br>GSM / |
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Relevant as<br>per packing<br>policy |
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3 |
Triple Kraft Pap<br>Rolls / Reel 152<br>&-10% |
er in<br>GSM + |
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Relevant as<br>per packing<br>policy |
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<br> |
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4 |
Aluminium Foil<br> |
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Relevant as<br> |
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(Laminated) Jumbo Rolls<br>90 mm r Mltil in |
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per packing<br>li |
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| 3 |
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o upe<br>pouch form |
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5 |
Polyster Film for Outer<br>Pouch 55 GSM + & -<br>10% |
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Relevant as<br>per packing<br>policy |
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Sterile Surgical sutures USP/ EP (<br>Monofilament Nylon) with or without<br>Needle packed in 28675 Boxes. |
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267851.000<br>Meter |
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1 |
Monofilament Nylon<br>Thread. TC :<br>DIAMETER 0.02 TO |
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1.01 Meter /<br>Meter<br>content in |
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155
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containing packing material:<br>Sterilisation Paper : 198.00 Kg, Triple |
containing packing material:<br>Sterilisation Paper : 198.00 Kg, Triple |
containing packing material:<br>Sterilisation Paper : 198.00 Kg, Triple |
containing packing material:<br>Sterilisation Paper : 198.00 Kg, Triple |
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0.599MM +/-10% |
0.599MM +/-10% |
export |
export |
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2 |
Sterilisation Paper for |
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Relevant as<br>per packing<br>policy |
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Kraft Paper :300.40 Kg, Al<br>Foil : 464.26 Kg, Polyster F<br>191.17 Kg, Needle 135000. |
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uminium<br>ilm :<br>00 Nos |
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<br>outer pouch, 60 GSM /<br>M2 in Rolls |
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per packing<br>policy |
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3 |
Triple Kraft Paper in<br> |
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Relevant as<br> |
<br> |
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Rolls / Reel 152 GSM +<br>&-10% |
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per packing<br>policy |
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4 |
Aluminium Foil |
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Relevant a |
<br> |
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<br>(Laminated) Jumbo Rolls<br>90 mm or Multiple in<br>pouch form |
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<br>per packing<br>policy |
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5 |
Polyster Film for Outer<br>Pouch 55 GSM + & -<br> |
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Relevant as<br>per packing<br>policy |
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10% |
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policy |
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6 |
Atraumatic Needled<br>Sutures, with or without<br>Suture TC of relevant |
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Not allowe |
d |
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.<br>length and specification |
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| 4 |
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Sterile Surgical sutures US |
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P/ EP ( |
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35910.000 |
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1 |
Monofilament |
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1.01 Meter |
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<br>Monofilament Polypropylene) with or<br>without Needle packed in 3850 Boxes.<br>containing packing material:<br> |
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Polypropylene Thread .<br>TC : DIAMETER<br>0.02MM TO 0.599MM<br> |
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Meter<br>content in<br>export |
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Sterilisation Paper : 26.58 Kg, Triple<br>Kraft Paper :40.33 Kg, Aluminium<br>Foil : 6233 K Polster Film : 2566 |
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+/-10%. |
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2 |
Sterilisation Paper for<br>t h 60 GSM / |
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Relevant as<br>per packing<br>policy |
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. g, y<br>Kg, Needle 15000.00 Nos. |
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. |
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ouer pouc,<br>M2 in Rolls |
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per pacng<br>policy |
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3 |
Triple Kraft Paper in<br>Rolls / Reel 152 GSM +<br>&-10% |
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Relevant as<br>per packing |
<br> |
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<br>policy |
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4 |
Aluminium Foil<br> |
|
Relevant as<br> |
<br> |
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(Laminated) Jumbo Rolls<br>90 mm or Multiple in<br>pouch form |
|
per packing<br>policy |
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5 |
Polyster Film for Outer<br> |
|
Relevant as<br> |
<br> |
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Pouch 55 GSM + & -<br>1 |
|
per packing<br>li |
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0% |
|
pocy |
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6 |
Atraumatic<br>Needl<br>ih ih |
ed<br> |
Net to Net<br>ih |
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Sutures, wt or wt<br>Suture TC of releva<br>lh d ifii |
ut<br>nt<br> |
(wtout<br>wastage) |
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engt an speccato |
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| 5 |
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Sterile Surgical sutur<br>Braided Silk) with or |
es USP/ EP<br>without N |
|
( |
1 |
22730.000 |
1 |
Braided Silk Twine |
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101 Meter |
/ |
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<br>eedle |
<br> |
<br>Meter |
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<br>(Thread). TC: |
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.<br>Meter |
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<br>packed in 11920 Boxes.<br>containing packing material: |
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<br>DIAMETER 0.04 TO<br>0.699MM +/-10% |
|
content in<br>export |
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Sterilisation Paper :82.30 Kg, Triple<br>Kraft Paper :124.87 Kg, Aluminium<br> |
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2 |
Sterilisation Paper for<br>outer pouch, 60 GSM /<br> |
|
Relevant as<br>per packing<br>policy |
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Foil : 193.00 Kg, Polyster F<br>Kg |
|
ilm : 79.46 |
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M2 in Rolls |
|
policy |
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3 |
Triple Kraft Paper in<br>Rolls / Reel 152 GSM +<br>&-10% |
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Relevant as<br>per packing<br>policy |
<br> |
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4 |
<br>Aluminium Foil<br>(Laminated) Jumbo Rolls |
|
<br>Relevant as<br>per packing |
<br> |
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90 mm or Multiple in<br>pouch form |
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<br>policy |
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5 |
Polyster Film for Outer<br> |
|
Relevant as<br> |
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Pouch 55 GSM + & -<br>10% |
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| 6 |
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Sterile Surgical sutures USP/ EP (<br>Braided Polyester) with or without |
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|
19213.000<br>Meter |
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1 |
Braided Polyester Twine<br>(Thread) TC: |
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1.01 Meter /<br>Meter |
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156
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Needle packed in 1718 Boxes.<br>containing packing material:<br>Sterilisation Paper : 11.86 Kg, Triple<br>Kraft Paper :18.00 Kg, Aluminium<br>Foil : 27.81 Kg, Polyster Film : 11.45<br>Kg |
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DIAMETER 0.04 TO<br>0.699MM +/-10% |
content in<br>export |
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2 |
Sterilisation Paper for<br>outer pouch, 60 GSM /<br>M2 in Rolls |
Relevant as<br>per packing<br>policy |
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3 |
Triple Kraft Paper in<br>Rolls / Reel 152 GSM +<br>&-10% |
Relevant as<br>per packing<br>policy |
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4 |
Aluminium Foil<br>(Laminated) Jumbo Rolls<br>90 mm or Multiple in<br>pouch form |
Relevant as<br>per packing<br>policy |
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5 |
Polyster Film for Outer<br>Pouch 55 GSM + & -<br>10% |
Relevant as<br>per packing<br>policy |
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7 |
Sterile Surgical sutures USP/ EP (<br>Monofilament Poliglecaprone 25) with<br>or without Needle packed in 900<br>Boxes.<br>containing packing material:<br>Sterilisation Paper : 6.21 Kg, Triple<br>Kraft Paper :9.42 Kg, Aluminium Foil<br>: 14.57 Kg, Polyster Film : 6.00 Kg |
8700.000<br>Meter |
1 |
Monofilament<br>Poliglecaprone 25<br>Thread.TC: DIAMETER<br>0.10 TO 0.699MM +/-<br>10% |
1.01 Meter /<br>Meter<br>content in<br>export |
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2 |
Sterilisation Paper for<br>outer pouch, 60 GSM /<br>M2 in Rolls |
Relevant as<br>per packing<br>policy |
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3 |
Triple Kraft Paper in<br>Rolls / Reel 152 GSM +<br>&-10% |
Relevant as<br>per packing<br>policy |
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4 |
Aluminium Foil<br>(Laminated) Jumbo Rolls<br>90 mm or Multiple in<br>pouch form |
Relevant as<br>per packing<br>policy |
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|
5 |
Polyster Film for Outer<br>Pouch 55 GSM + & -<br>10% |
Relevant as<br>per packing<br>policy |
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8 |
Sterile Surgical sutures USP/ EP<br>(Catgut Chromic & Plain) with or<br>without Needle packed in 19420<br>Boxes.<br>containing packing material:<br>Sterilisation Paper : 134.00 Kg, Triple<br>Kraft Paper :203.45 Kg, Aluminium<br>Foil : 314.42 Kg, Polyster Film :<br>129.46 Kg |
201936.000<br>Meter |
1 |
Catgut Twine<br>(Thread).TC:<br>DIAMETER 0.10 TO<br>0.799MM +/-10% |
Not<br>allowed,<br>since not<br>covered<br>under<br>chapter 42 |
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2 |
Sterilisation Paper for<br>outer pouch, 60 GSM /<br>M2 in Rolls |
Relevant as<br>per packing<br>policy |
|
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|
3 |
Triple Kraft Paper in<br>Rolls / Reel 152 GSM +<br>&-10% |
Relevant as<br>per packing<br>policy |
|
|
|
|
4 |
Aluminium Foil<br>(Laminated) Jumbo Rolls<br>90 mm or Multiple in<br>pouch form |
Relevant as<br>per packing<br>policy |
|
|
|
|
5 |
Polyster Film for Outer<br>Pouch 55 GSM + & -<br>10% |
Relevant as<br>per packing<br>policy |
|
9 |
Monofilament Polypropylene Mesh in<br>Various size |
136.000<br>Sq. Meter |
1 |
Polypropylene Surgical<br>Mesh in Rolls or Pre cut<br>Length TC: ROLLS OR<br>PRE CUT LENGTH. |
Relevant as<br>per packing<br>policy |
|
RA concerned may take further necessary action a |
|
s per above decision |
|
of NC. |
|
157
| Case No. |
B- 11 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Rhodia Speciality Chemicals India Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/00069/AM19/DES-III |
| RLA F. No. |
03/95/040/00976/AM18 |
| Advance Authorization No. and Date |
0310819042 dated 08.02.2018 |
| Subject |
Request of M/s Rhodia Speciality Chemicals India Pvt. Ltd.,<br>Mumbai for fixation of adhoc norms against Advance<br>Authorization No. 0310819042 dated 08.02.2018 |
| **Decision:**The Committee considered the request of firm in the presence of technical experts and it was decided<br>to fix following adhoc norms:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Bricorr Flow (Tetrakis<br>(Hydroxymethyl) Phosphonium<br>Sulphate (2 : 1) (containing 71.5%<br>Tolcide PS70a)<br>1000.000<br>MT<br>1.<br>Bricorr<br>70a<br>/<br>Tolcide<br>PS<br>70a<br>(Hydroxy<br>Methyl<br>Phosphorium<br>SulphateDose)<br>715.00 MT<br>2.<br>Ascorbic acid<br>Not<br>allowed<br>under<br>para<br>4.07<br>RA concerned may take further necessary action as per above decision of NC. |
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| Case No. |
B- 12 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Vovantis Laboratories Private Limited., Vadodara |
| HQ F. No. |
01/82/050/00532/AM17/DES-III |
| RLA F. No. |
34/24/040/00290/AM16 |
| Advance Authorization No. and Date |
3410042021 dated 30.03.2016 |
| Subject |
Request of M/s Vovantis Laboratories Private Limited,<br>Vadodara for fixation of adhoc norms against Advance<br>Authorization No. 3410042021 dated 30.03.2016 |
| **Decision:**Deferred for comments of TE. |
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158
| Case No. |
B- 13 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Verve Human Care Laboratories, Dehradun |
| HQ F. No. |
01/82/050/00921/AM19/DES-III |
| RLA F. No. |
61/24/040/00002/AM19 |
| Advance Authorization No. and Date |
6110001506 dated 07.05.2018 |
| Subject |
Request of M/s Verve Human care Laboratories., Dehradun for<br>fixation of adhoc norms against Advance Authorization No.<br>6110001506 dated 07.05.2018 |
| **Decision:**Deferred for comments of TE. |
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| Case No. |
B- 14 |
B- 14 |
| Meeting No. |
10/AM20 |
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| Date |
29.112019 |
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| Firm’s Name |
M/s Yasho Industries Ltd., Mumbai |
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| HQ F. No. |
01/82/050/01160/AM18/DES-III |
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| RLA F. No. |
03/95/040/00782/AM18 |
|
| Advance Authorization No. and Date |
0310817908 dated 19.12.2017 |
|
| Subject |
Request of M/s Yasho Industries Ltd., Mumbai for fixation of<br>adhoc norms against Advance Authorization No. 0310817908<br>dated 19.12.2017 |
|
| **Decision:**The Committee considered the request of firm in the presence of technical<br>decided to fix following adhoc norms:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Methyl Eugenol<br>1 kg<br>1<br>CloveLeafOil<br>RA concerned may take further necessary action as per above decision of NC. |
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experts and it was<br>Qty.<br>1.137kg |
159
| C |
ase No. |
ase No. |
B- 15 |
B- 15 |
B- 15 |
B- 15 |
B- 15 |
B- 15 |
B- 15 |
B- 15 |
B- 15 |
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eeting No. |
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10/AM20 |
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ate |
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29.112019 |
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irm’s Name |
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M/s Lumis Biotech Pvt. Ltd, Mumbai |
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Q F. No. |
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01/82/050/01332/AM04/DES-III |
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01/82/050/00572/AM05/DES-III |
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LA F. No. |
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03/24/040/02013/AM04 |
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03/24/040/02527/AM04 |
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dvance Authorization No. and Date |
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0310248050 dated 19.01.2004 |
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0310272452 dated 03.06.2004 |
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f<br>0 |
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ubject |
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Request of M/s Lumis Biotech Pvt. Ltd, Mumbai for fixation o<br>adhoc norms against Advance Authorization No. 031024805<br>dated 19.01.2004 and 0310272452 dated 03.06.2004 |
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| <br> <br>f<br> |
**ecision:**The Committee considered the request of the firm and on the basis of written comments furnished b<br>Department of Biotechnology vide their OM No. BT/IL/05/003/2019-PID dated 03.12.2019, it was decided to fi<br>ollowing adhoc norms:<br> |
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Export product |
Qty. |
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Sl.<br> |
Import items |
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Qty. |
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No. |
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LUMIZYME NC 7XG |
1 kg |
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1 |
INDIAGE NEUTRA G |
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0.4545 kg |
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2 |
DENIMAX 399S |
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0.5555 kg |
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Note: The above norms are subjec<br> |
t to fulfilment of terms and conditions mentioned in the NOC<br> |
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issued by the GEAC for this advance a |
thorization time to time. |
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or Advance Authorization No. 031027 |
452 dated 03.06.2004 |
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Export product |
Qty. |
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Sl.<br>No. |
Import items |
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Qty. |
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NEUTRA COOL 2X |
1 kg |
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1 |
INDIAGE SUPER GX PLUS |
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0.40 kg |
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2 |
DENIMAX XT |
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<br>0.05 kg |
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3 |
DENIMA |
X 399S |
0.05 kg |
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LBL AC CONC |
1 k |
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1 |
INDIAGE |
MAXL |
0.30 kg |
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LUMIPOL SUPER |
<br>1 k |
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<br> |
1 |
INDIAGE |
MAXL |
<br>0.47 kg |
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2 |
DENIMA |
X 991L |
<br>0.231 kg |
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Note: The above norms are subject to f |
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ulfilment of terms and |
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<br>conditions mentioned in the NO |
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<br>issued by the GEAC for this advance authori |
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<br>zation time to time. |
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160
| Case No. |
B- 16 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Cipla Ltd., Mumbai |
| HQ F. No. |
F. No. 01/82/050/00972/AM17/DES-III<br>F. No. 01/82/050/00285/AM18/DES-III<br>F. No. 01/82/050/00610/AM18/DES-III<br>F. No. 01/82/050/00127/AM19/DES-III |
| RLA F. No. |
03/94/040/00617/AM17<br>03/94/040/01181/AM17<br>03/94/040/00295/AM18<br>03/94/040/00822/AM18 |
| Advance Authorization No. and Date |
0310808312 dated 06.10.2016<br>0310812323 dated 03.04.2017<br>0310814908 dated 31.07.2017<br>0310818765 dated 30.01.2018 |
| Subject |
Request of M/s Cipla Ltd, Mumbai for fixation of adhoc norms<br>against Advance Authorization Nos. 0310808312 dated<br>06.10.2016, 0310812323 dated 03.04.2017, 0310814908 dated<br>31.07.2017 and 0310818765 dated 30.01.2018 |
| **Decision:**Deferred for comments of TE. |
|
| Case No. |
B- 17 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Spansules Formulations, Hyderabad |
| HQ F. No. |
01/82/050/00482/AM19/DES-III |
| RLA F. No. |
09/24/040/00351/AM18 |
| Advance Authorization No. and Date |
0910065592 dated 25.10.2017 |
| Subject |
Request of M/s Spansules Formulations., Hyderabad for fixation<br>of adhoc norms against Advance Authorization No. 0910065592<br>dated 25.10.2017 |
| **Decision:**The Committee considered the request of firm in the presence of technical experts and it was decided<br>to fix following adhoc norms:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Thiamine Mononitrate, Riboflavin,<br>Nicotimamide, Pyridoxine Hcl, Calcium<br>Pantothenate and Ascorbic Acid Pallets<br>Blend (each 480 mg of blended pellets<br>contains Thiamine Mono Nitrate NLT 24<br>mg, Riboflavin NLT 12 mg, Pyridoxine<br>Hcl NLT 12 mg and Ascorbic Acid NLT<br>240 mg)<br>1 kg<br>1<br>ASCORBIC ACID<br>0.500 kg<br>2<br>THIAMINE MONONITRATE<br>0.050 kg<br>3<br>RIBOFLAVIN<br>0.025 kg<br>4<br>PYRIDOXINE<br>HYDROCLORIDE<br>0.025 kg<br>Note: RA shall verify the composition of actual export as given above with the shipping bill at the<br>time of redemption. |
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161
| Case No. |
Case No. |
Case No. |
B- 17 |
B- 17 |
B- 17 |
B- 17 |
| Meeting No. |
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10/AM20 |
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| Date |
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29.112019 |
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| Firm |
’s Name |
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M/s Techno Drugs & I |
ntermediates (P) Ltd., Mu |
mbai |
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| HQ |
F. No. |
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01/83/050/00503/AM17 |
/DES-III |
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| RLA |
F. No. |
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03/95/040/00486/AM17 |
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| Adv |
ance Authorization No. and Date |
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0310392619 dated 02.08 |
.2006 |
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| Sub |
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or<br>o. |
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ect |
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Request of M/s Techno Drugs & Intermediates, Mumbai f<br>fixation of adhoc norms against Advance Authorization N<br>0310392619 dated 02.08.2006 |
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| Dec |
**ision:**The Committee considered the request of firm in the presence of technical experts and it was decid |
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162
Enhancement Cases:
| Case No. |
B- 01 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Alkaloids Corporation, Kolkata |
| HQ F. No. |
01/82/050/01356/AM17/DES-III |
| RLA F. No. |
02/24/040/00216/AM17 |
| Advance Authorization No. and Date |
0210207287 dated 27.01.2017 |
| Subject |
Request of M/s Alkaloids Corporation, Kolkata for<br>enhancement in the quantity of import items in respect of<br>norms fixed against Advance Authorization No. 0210207287<br>dated 27.01.2017 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 02 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Arihantanam Lifecare Pvt. Ltd., Surat |
| HQ F. No. |
01/82/050/00424/AM20/DES-III |
| RLA F. No. |
52/24/040/00018/AM19 |
| Advance Authorization No. and Date |
5210042636 dated 09.05.2018 |
| Subject |
Request of M/s Arihantanam Life care Pvt Ltd, Surat for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 5210042636<br>dated 09.05.2018. |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 03 |
B- 03 |
| Meeting No. |
10/AM20 |
|
| Date |
29.112019 |
|
| Firm’s Name |
M/s AVA Chemicals Private Limited, Mumbai |
|
| HQ F. No. |
01/82/050/00864/AM18/DES-III |
01/82/050/00668/AM19/DES-III |
| RLA F. No. |
03/94/040/00467/AM18 |
03/94/040/00146/AM19 |
| Advance Authorization<br>No. and Date |
0310815663 dated 11.09.2017 |
0310821149 dated 22.05.2018 |
| Subject |
Request of M/s AVA Chemicals Private Limited, Mumbai for<br>enhancement in the quantity of import item in respect of adhoc norms<br>fixed against Advance Authorization Nos. 0310815663 dated 11.09.2017<br>and 0310821149 dated 22.05.2018 |
|
| Decision:The Committee considered the request of firm enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
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163
| Case No. |
B- 04 |
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| Meeting No. |
10/AM20 |
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| Date |
29.112019 |
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| Firm’s Name |
M/s AVA Chemicals Private Limted, Mumbai |
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| HQ F. No. |
01/82/050/01010/AM18/DES-III |
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01/82/050/01374/AM19/DES-III |
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01/82/050/01342/AM19/DES-III |
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01/82/050/02395/AM19/DES-III |
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| RLA F. No. |
03/94/040/00589/AM18 |
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03/94/040/00507/AM19 |
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03/94/040/00544/AM19 |
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03/94/040/01014/AM19 |
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| Advance Authorization No. and Date |
0310816816 dated 06.11.2017 |
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0310823801 dated 17.09.2018 |
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0310823938 dated 24.09.2018 |
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0310827270 dated 25.02.2019 |
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| Subject |
Request of AVA Chemicals Private Limted, Mumbai for |
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|
enhancement in the quantity of import item in respect |
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|
of |
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adhoc norms fixed against against |
advance Authorization |
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No.<br>0310816816<br>dated<br>06.11.2017,0310823801 |
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dated |
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17.09.2018,0310823938 dated 24.09.2018 and 0310827270 |
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dated 25.02.2019 |
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| **Decision:**The Committee considered the request of firm enhancement of norms in the presence |
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of |
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| technicalexperts andit was decided to reject the casemaintaining the status quo. |
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| Case No. |
B- 05 |
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| Meeting No. |
10/AM20 |
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| Date |
29.112019 |
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| Firm’s Name |
M/s Balaji Amines Ltd., Pune |
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| HQ F. No. |
01/82/050/00914/AM19/DES-III |
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01/82/050/00756/AM18/DES-III |
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| RLA F. No. |
31/83/040/00062/AM19 |
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31/83/040/00090/AM18 |
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| Advance Authorization No. and Date |
3110067125 dated 24.07.2018 |
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|
3110066899 dated 02.11.2017 |
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| Subject |
Request of M/s Balaji Amines Ltd, Pune for enhancement |
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|
in the |
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quantity of Import Item No. 3 in respect of adhoc norms fixed |
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against<br>Advance<br>Authorization |
No.<br>3110067125 |
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dated |
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24.07.2018 and 3110066889 dated 02.11.2017. |
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| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical |
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| experts and it was decided torejectthe case maintaining the status quo. |
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164
| Case No. |
B- 06 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Chirag Enterprise, Rajkot |
| HQ F. No. |
01/82/050/01529/AM19/DES-III |
| RLA F. No. |
24/24/040/00046/AM18 |
| Advance Authorization No. and Date |
2410042384 dated 19.03.2018 |
| Subject |
Request of M/s Chirag Enterprise, Rajkot for enhancement in<br>the quantity of import items in respect of norms fixed against<br>Advance Authorization No. 2410042384 dated 19.03.2018 |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts andit was decided to reject the casemaintaining the status quo. |
|
| Case No. |
B- 07 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Cadila Healthcare Limited, Ahmedabad |
| HQ F. No. |
01/82/050/00200/AM20/DES-III |
| RLA F. No. |
08/24/040/00072/AM20 |
| Advance Authorization No. and Date |
0810145358 dated 24.05.2019 |
| Subject |
Request of M/s Cadila Healthcare Ltd, Ahmadabad for<br>enhancement of wastage in respect of adhoc norms fixed against<br>Advance Authorization No. 0810145358 dated 24.05.2019 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
165
| Case No. |
B- 08 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Eternis Fine Chemicals Ltd, Mumbai |
| HQ F. No. |
01/82/050/00782/AM19/DES-III |
| RLA F. No. |
03/94/040/01053/AM18 |
| Advance Authorization No. and Date |
0310819947 dated 20.03.2018 |
| Subject |
Request of M/s Eternis Fine Chemicals Ltd, Mumbai for<br>enhancement in the quantity of import item No. 2 - 5%<br>Rhodium On Alumina Catalyst in respect of adhoc norms<br>fixed against Advance Authorization No. 0310819947<br>dated 20.03.2018 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 09 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Global Calcium Pvt. Ltd., Bangalore |
| HQ F. No. |
01/82/050/00688/AM15/DES-III |
| RLA F. No. |
07/24/040/00323/AM14 |
| Advance Authorization No. and Date |
0710101055 dated 02.01.2014 |
| Subject |
Request of M/s Global Calcium Pvt Ltd, Bangalore for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 0710101055<br>dated 02.01.2014 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 10 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Global Calcium Pvt. Ltd., Bangalore |
| HQ F. No. |
01/82/050/00501/AM20/DES-III<br>01/82/050/00500/AM20/DES-III |
| RLA F. No. |
07/24/040/00224/AM19<br>07/24/040/00026/AM19 |
| Advance Authorization No. and Date |
0710114343 dated 31.12.2018<br>0710113317 dated 22.05.2018 |
| Subject |
Request of M/s Global Calcium Pvt. Ltd., Bangalore for<br>enhancement in the quantity of mport item in respect of<br>Advance Authorization No. 0710114343 dated 31.12.2018 and<br>0710113317 dated 22.05.2018 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
166
| Case No. |
B- 11 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Global Calcium Pvt. Ltd., Bangalore |
| HQ F. No. |
01/82/050/00909/AM19/DES-III<br>01/82/050/00493/AM19/DES-III<br>01/82/050/01986/AM19/DES-III<br>01/82/050/00323/AM20/DES-III |
| RLA F. No. |
07/24/040/00331/AM17<br>07/24/040/00279/AM18<br>07/24/040/00145/AM19<br>07/24/040/00063/AM20 |
| Advance Authorization No. and Date |
0710110965 dated 13.01.2017<br>0710112728 dated 23.01.2018<br>0710113898 dated 25.09.2018<br>0710115110 dated 27.06.2019 |
| Subject |
Request of M/s Global Calcium Pvt Ltd, Bangalore for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 0710110965<br>dated 13.01.2017, 0710112728 dated 23.01.2018, 0710113898<br>dated 25.09.2018 and 0710115110 dated 27.06.2019 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 12 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Global Calcium Pvt. Ltd., Bangalore |
| HQ F. No. |
01/82/050/00507/AM20/DES-III |
| RLA F. No. |
07/24/040/00032/AM20 |
| Advance Authorization No. and Date |
0710114937 dated 22.05.2019 |
| Subject |
Request of M/s Global Calcium Pvt. Ltd., Bangalore for revision<br>of norms in respect of Advance Authorization No. 0710114937<br>dated 22.05.2019 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
167
| Case No. |
B- 13 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Inchem Laboratories Pvt. Ltd., Hyderabad |
| HQ F. No. |
01/82/050/01513/AM15/DES-III |
|
01/82/050/00124/AM15/DES-III |
| RLA F. No. |
09/24/040/00105/AM13 |
|
09/24/040/00416/AM14 |
| Advance Authorization No. and Date |
0910052851 dated 31.05.2012 |
|
0910058483 dated 06.12.2013 |
| Subject |
Request of M/s Inchem Laboratories Ltd, Hyderabad for |
|
enhancement in the quantity of import items in respect of adhoc |
|
norms fixed against Advance Authorization No. 0910052851 |
|
dated 31.05.2012 and 0910058483 dated 06.12.2013. |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical |
|
| experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
|
B- 14 |
| Meeting No. |
|
10/AM20 |
| Date |
|
29.112019 |
| Firm’s Name |
|
M/s India Glycols Limited, New Delhi |
| HQ F. No. |
|
01/82/050/00846/AM19/DES-III |
| RLA F. No. |
|
05/23/040/00485/AM18 |
| Advance Authorization |
|
0510405825 dated 09.03.2018 |
| No. and Date |
|
|
| Subject |
|
Request of M/s India Glycols Limited, New Delhi for enhancement in the |
|
|
quantity of Import Item No. 2 – Silver Catalyst in respect of adhoc norms |
|
|
fixed against Advance Authorization No. 0510405825 dated 09.03.2018 |
| **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it |
|
|
| was decided to call for following information from the firm: |
|
|
| (i) |
Catalogue of import item No. 2 – Silver Catalyst from the supplier |
|
| (ii) |
Percentage activity of Silver Catalyst. |
|
| (iii) |
Recovery / regeneration of Silver Catalyst. |
|
| (iv) |
Production Consumption Data duly certified by GST/ Chartered Engineer. |
|
| (v) |
Percentage of yield at every stage on molar basis. |
|
| Case No. |
B- 15 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Jubilant Life Sciences, CLA, New Delhi |
| HQ F. No. |
01/82/050/00061/AM15/DES-III |
| RLA F. No. |
05/23/040/00506/AM14 |
| Advance Authorization No. and Date |
0510382053 dated 18.03.2014 |
| Subject |
Request of M/s Jubilant Life Sciences, CLA, New Delhi for |
|
revision/correction in adhoc norms fixed against Advance |
|
Authorization No. 0510382053 dated 18.03.2014 |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical |
|
| experts and it was decided torejectthe case maintaining the status quo. |
|
168
| Case No. |
B- 16 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Kairav Chemofarbe Industries Ltd, Mumbai |
| HQ F. No. |
01/82/050/00108/AM19/DES-III |
| RLA F. No. |
03/94/040/00838/AM18 |
| Advance Authorization No. and Date |
0310818810 dated 31.01.2018 |
| Subject |
Request of M/s Kairav Chemofarbe Industries Ltd, Mumbai for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 0310818810<br>dated 31.01.2018 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 17 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Kairav Chemofarbe Industries Ltd, Mumbai |
| HQ F. No. |
01/82/050/01819/AM16/DES-III |
| RLA F. No. |
03/94/040/ 00859/AM16 |
| Advance Authorization No. and Date |
0310802380 dated 09.02.2016 |
| Subject |
Request of M/s Kairav Chemofarbe Industries Ltd, Mumbai for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 0310802380<br>dated 09.02.2016. |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 18 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Kairav Chemofarbe Industries Ltd, Mumbai |
| HQ F. No. |
01/82/050/01035/AM18/DES-III |
| RLA F. No. |
03/94/040/00582/AM18 |
| Advance Authorization No. and Date |
0310816608 dated 30.10.2017 |
| Subject |
Request of M/s Kairav Chemofarbe Industries Ltd, Mumbai for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 0310816608<br>dated 30.10.2017 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
169
| Case No. |
B- 19 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s KLJ Plasticizers Limited, New Delhi |
| HQ F. No. |
01/82/050/00308/AM20/DES-III |
|
01/82/050/02301/AM19/DES-III |
| RLA F. No. |
05/23/040/00125/AM20 |
|
05/23/040/00475/AM19 |
| Advance Authorization No. and Date |
0510411049 dated 25.06.2019 |
|
0510409477 dated 25.01.2019 |
| Subject |
Request of M/s KLJ PLASTICIZERS LIMITED, NEW |
|
DELHI for enhancement in the quantity of import item No. |
|
2 - SABUTOL in respect of adhoc norms fixed against |
|
Advance Authorization Nos. 0510411049 dated 25.06.2019 |
|
and 0510409477 dated 25.01.2019. |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of |
|
| technical experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 20 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Mangalam Organics Ltd, Mumbai |
| HQ F. No. |
01/82/050/02048/AM19/DES-III |
| RLA F. No. |
03/95/040/00598/AM19 |
| Advance Authorization No. and Date |
0310824494 dated 17.10.2018 |
| Subject |
Request of M/s Mangalam Organics Ltd, Mumbai for |
|
enhancement in the quantity of import item in respect of |
|
adhoc norms fixed against Advance Authorization No. |
|
0310824494 dated 17.10.2018. |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of |
|
| technical experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 21 |
|
|
| Meeting No. |
10/AM20 |
|
|
| Date |
29.112019 |
|
|
| Firm’s Name |
M/s Navin Fluorine International Limited, Mumbai |
|
|
| HQ F. No. |
01/82/050/00765/AM17/DES-III |
|
|
| RLA F. No. |
03/95/040/00437/AM17 |
|
|
| Advance Authorization No. and Date |
0310807709 dated 08.09.2016 |
|
|
| Subject |
Request of M/s Navin Fluorine |
International Limited, Mumbai |
|
|
for enhancement in the quantity of import item in respect of |
|
|
|
adhoc<br>norms<br>fixed<br>against |
Advance<br>Authorization |
No. |
|
0310807709 dated 08.09.2016. |
|
|
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical |
|
|
|
| experts andit was decided to reject the casemaintaining the status quo. |
|
|
|
170
| Case No. |
B- 22 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Rishabh Metals & Chemicals Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/00794/AM19/DES-III |
| RLA F. No. |
03/95/040/00018/AM19 |
| Advance Authorization No. and Date |
0310821129 dated 22.05.2018 |
| Subject |
Request of M/s Rishabh Metals & Chemicals Pvt. Ltd.,<br>Mumbai for enhancement in the quantity of Import Item<br>No. 1 – DICYANDIAMIDE 99.5% MIN in respect of adhoc<br>norms fixed against Advance Authorization No. 0310821129<br>dated 22.05.2018 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 23 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Survival Technologies Pvt. Ltd, Mumbai. |
| HQ F. No. |
01/82/050/00955/AM18/DES-III |
| RLA F. No. |
03/95/040/ 00707/AM18 |
| Advance Authorization No. and Date |
0310817452 dated 30.11.2017 |
| Subject |
Request of M/s Survival Technologies Pvt. Ltd, Mumbai for |
|
enhancement in the quantity of import items in respect of adhoc |
|
norms fixed against Advance Authorization No. 0310817452 |
|
dated 30.11.2017 |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical |
|
| experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 24 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Sentiss Pharma Private Limited, New Delhi |
| HQ F. No. |
01/82/050/00876/AM19/DES-III |
| RLA F. No. |
05/24/040/00187/AM19 |
| Advance Authorization No. and Date |
0510407060 dated 03.07.2018 |
| Subject |
Request of M/s Sentiss Pharma Private Limited, New Delhi |
|
for enhancement in wastage against adhoc norms fixed |
|
against Advance Authorization No. 0510407060 dated |
|
03.07.2018 |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of |
|
| technical experts and it was decided torejectthe case maintaining the status quo. |
|
171
| Case No. |
B- 25 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Synnat Pharma Pvt. Ltd., Kolkata |
| HQ F. No. |
01/82/050/00749/AM18/DES-III |
| RLA F. No. |
02/24/040/00108/AM18 |
| Advance Authorization No. and Date |
0210207903 dated 24.10.2017 |
| Subject |
Request of M/s Synnat Pharma Pvt Ltd, Kolkata for<br>enhancement in the quantity of import item in respect of<br>adhoc norms fixed against Advance Authorization No.<br>0210207903 dated 24.10.2017 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of<br>technical experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 26 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s SMS Pharmaceuticals Ltd, Hyderabad |
| HQ F. No. |
01/82/050/00197/AM16/DES-III |
| RLA F. No. |
09/24/040/ 00566/AM15 |
| Advance Authorization No. and Date |
0910061534 dated 16.01.2015 |
| Subject |
Request of M/s SMS PHARMACEUTICALS LTD, Hyderabad<br>for enhancement in the quantity of import items in respect of<br>norms fixed against Advance Authorization No. 0910061534 dt.<br>16.01.2015 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 27 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s SMS Pharmaceuticals Ltd, Hyderabad |
| HQ F. No. |
01/82/050/02207/AM19/DES-III<br>01/82/050/02194/AM19/DES-III<br>01/82/050/01058/AM19/DES-III |
| RLA F. No. |
09/24/040/ 00590/AM18<br>09/24/040/ 00609/AM18<br>09/24/040/00201/AM19 |
| Advance Authorization No. and Date |
0910066497 dated 20.07.2018<br>0910066022 dated 01.03.2018<br>0910066501 dated 24.07.2018 |
| Subject |
Request of M/s SMS Pharmaceuticals Ltd, Hyderabad for<br>enhancement in the quantity of import item No 2 in respect of<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization<br>No.<br>0910066497 dated 20.07.2018, 0910066022 dated 01.03.2018 and<br>0910066501 dated 24.07.2018 |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts andit was decided to reject the casemaintaining the status quo. |
|
172
| Case No. |
B- 28 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s SRINI PHARMACEUTICALS PRIVATE LIMITED,<br>Hyderabad |
| HQ F. No. |
01/82/050/00986/AM19/DES-III |
| RLA F. No. |
09/24/040/00036/AM19 |
| Advance Authorization No. and Date |
0910066244 dated 18.05.2018 |
| Subject |
Request of M/s SRINI PHARMACEUTICALS PRIVATE<br>LIMITED, Hyderabad for enhancement in the quantity of<br>import items in respect of norms fixed against Advance<br>Authorization No. 0910066244 dt. 18.05.2018 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 29 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s SRINI PHARMACEUTICALS PRIVATE LIMITED,<br>Hyderabad |
| HQ F. No. |
01/82/050/00219/AM19/DES-III |
| RLA F. No. |
09/24/040/00459/AM18 |
| Advance Authorization No. and Date |
0910065758 dated 19.12.2017 |
| Subject |
Request of M/s SRINI PHARMACEUTICALS PRIVATE<br>LIMITED, Hyderabad for enhancement in the quantity of<br>import items in respect of norms fixed against Advance<br>Authorization No. 0910065758 dated 19.12.2017 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 30 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s SRINI PHARMACEUTICALS PRIVATE LIMITED,<br>Hyderabad |
| HQ F. No. |
01/82/050/00217/AM19/DES-III<br>01/82/050/01317/AM17/DES-III |
| RLA F. No. |
09/24/040/00430/AM18<br>09/24/040/00348/AM17 |
| Advance Authorization No. and Date |
0910065723 dated 07.12.2017<br>0910064196 dated 28.09.2016 |
| Subject |
Request of M/s SRINI PHARMACEUTICALS PRIVATE<br>LIMITED, Hyderabad for enhancement in the quantity of<br>import items in respect of norms fixed against Advance<br>Authorization Nos. 0910065723 dt. 07.12.2017 and 0910064196<br>dt. 28.09.2016. |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
173
| Case No. |
B- 31 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s SRINI PHARMACEUTICALS PRIVATE LIMITED,<br>Hyderabad |
| HQ F. No. |
01/82/050/00426/AM19/DES-III |
| RLA F. No. |
09/24/040/00477/AM18 |
| Advance Authorization No. and Date |
0910065816 dated 02.01.2018 |
| Subject |
Request of M/s SRINI PHARMACEUTICALS PRIVATE<br>LIMITED, Hyderabad for enhancement in the quantity of<br>import items in respect of norms fixed against Advance<br>Authorization No.0910065816 dt. 02.01.2018 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
| Case No. |
B- 32 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s SRINI PHARMACEUTICALS PRIVATE LIMITED,<br>Hyderabad |
| HQ F. No. |
01/82/050/01074/AM18/DES-III |
| RLA F. No. |
09/24/040/ 00309/AM18 |
| Advance Authorization No. and Date |
0910065528 dated 29.09.2017 |
| Subject |
Request of M/s SRINI PHARMACEUTICALS PRIVATE<br>LIMITED, Hyderabad for enhancement in the quantity of<br>import items in respect of adhoc norms fixed against Advance<br>Authorization No. 0910065528 dt. 29.09.2017 |
| **Decision:**The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts andit was decided to reject the casemaintaining the status quo. |
|
| Case No. |
B- 33 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s SRINI PHARMACEUTICALS PRIVATE LIMITED,<br>Hyderabad |
| HQ F. No. |
01/82/050/01170/AM10/DES-III |
| RLA F. No. |
09/24/040/00478/AM10 |
| Advance Authorization No. and Date |
0910041061 dated 25.02.2010 |
| Subject |
Request of M/s SRINI PHARMACEUTICALS PRIVATE<br>LIMITED, Hyderabad for enhancement in the quantity of<br>import items in respect of norms fixed against Advance<br>Authorization No. 0910041061 dated 25.02.2010 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintaining the status quo. |
|
174
|
Case No. |
Case No. |
B- 34 |
B- 34 |
B- 34 |
B- 34 |
|
Meeting No. |
|
10/AM20 |
|
|
|
|
Date |
|
29.112019 |
|
|
|
|
Firm’s Name |
|
M/s S. Kant Healthcare Ltd, Mumbai |
|
|
|
|
HQ F. No. |
|
01/82/050/01457/AM13/DES-III<br>01/82/050/01095/AM13/DES-III<br>01/82/050/01093/AM13/DES-III<br>01/82/050/01070/AM13/DES-III<br>01/82/050/00337/AM14/DES-III<br>01/87/050/00156/AM14/DES-III |
|
|
|
|
RLA F. No. |
|
03/95/040/00565/AM13<br>03/95/040/00701/AM13<br>03/95/040/00702/AM13<br>03/95/040/00670/AM13<br>03/95/040/00706/AM13<br>03/95/040/00707/AM13 |
|
|
|
|
Advance Authorization No. and Date |
|
0310714576 dated 07.11.2012,<br>0310717631 dated 19.12.2012,<br>0310717633 dated 19.12.2012,<br>0310716370 dated 05.12.2012,<br>0310734892 dated 20.05.2013 and<br>0310734894 dated 20.05.2013 |
|
|
|
|
Subject |
|
Request of M/s S. Kant Healthcare Ltd, Mumbai for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 0310714576<br>dated 07.11.2012, 0310717631 dated 19.12.2012, 0310717633<br>dated 19.12.2012, 0310716370 dated 05.12.2012, 0310734892<br>dated 20.05.2013 and 0310734894 dated 20.05.2013 |
|
|
|
|
Decision:The Committee considered the request of the firm in the presence of technical experts and it was<br>noted that NC was allowing 1.50 kg quantity of import item- Artemisinin against 1 kg export of Artemether till<br>2010 and reduced the same to 1.235 kg in 2012-13 and further to 1.04 kg in recently approved norms in March<br>2019.<br>The above licences pertain to period 2012-13 and 2013-14, at that time the norms prevailing were 1.4925 kg<br>as per Production Consumption Certificate duly certified by Supdt. GST & Central Excise, Range III, Vapi II.<br>In line with GST & Central Excise Certificate of the licensing period, the Committee decided to revise<br>the norms of export productARTEMETHERas under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>ARTEMETHER<br>1 kg<br>1.<br>ARTEMISININ<br>1.4925 kg<br>Rest of the earlier Minutes would remain unchanged. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
ARTEMETHER |
1 kg |
|
1. |
ARTEMISININ |
1.4925 kg |
|
Rest of the earlier Minutes would remain unchanged. |
|
|
|
|
|
|
Note: The above revision is only for regularization and closure purpose. Rest of the earlier Minutes<br>would remain unchanged. No further import will be allowed against these advance authorizations. No<br>repeat licence will be issued based on above. RA concerned may take further necessary action as per<br>above decision of NC. |
|
|
|
|
|
175
| Case No. |
B- 35 |
B- 35 |
| Meeting No. |
10/AM20 |
|
| Date |
29.112019 |
|
| Firm’s Name |
M/s Trion Chemicals Pvt. Ltd., Ahmedabad |
|
| HQ F. No. |
01/82/050/00367/AM18/DES-III |
01/82/050/00968/AM18/DES-III |
| RLA F. No. |
08/24/040/00530/AM17 |
08/24/040/00247/AM18 |
| Advance<br>Authorization No.<br>and Date |
0810140332 dt. 23.05.2017 |
0810141409 dt. 29.11.2017 |
| Subject |
Request of M/s Trion Chemicals Pvt. Ltd., Ahmedabad for enhancement in the<br>quantity of Import Items in respect of adhoc norms fixed against Advance<br>Authorization Nos. 0810140332 dated 23.05.2017 and 0810141409 dated 29.11.2017 |
|
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and it was decided torejectthe case maintainingthe statusquo. |
|
|
| Case No. |
B- 36 |
| Meeting No. |
10/AM20 |
| Date |
29.112019 |
| Firm’s Name |
M/s Zytex Biotech Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/01153/AM18/DES-III |
| RLA F. No. |
03/95/040/00688/AM18 |
| Advance Authorization No. and Date |
0310817180 dated 21.11.2017 |
| Subject |
Request of M/s Zytex Biotech Pvt. Ltd., Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310817180 dated 21.11.2017 |
| Decision:The Committee considered the request of firm enhancement of norms in the presence of technical<br>experts and on the basis of comments furnished by Department of Biotechnology vide their OM No.<br>BT/IL/05/383/2013-PID, dated 16.09.2019, it was decided torejectthe case maintaining the status quo. |
|
Meeting ended with thanks to Chair.
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