1
Office of Directorate General of Foreign Trade New Delhi -0
-----------------------------------------------------------------------------Para 4.7 Decision
Minutes of the Norms Committee – 3 Meeting No. 5/82-ALC4/2019 dated 02.08.2019 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
MEETING NUMBER : 5/82-ALC4/2019 MEETING DATE : 02.08.2019
| Case No.:6/16/82-ALC4/2012 |
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Party Name:STELLENCE |
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Meet No/Date:5/82- |
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Status: |
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PHARMSCIENCE PVT LTD |
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ALC4/2019 |
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Approved |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0710088213 |
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| :01/82/050/00442/AM13/ |
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:07/24/040/00062/AM13/ |
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16.05.2012 |
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Case No.:6/16/82-ALC4/2012 |
Party Name:STELLENCE<br>PHARMSCIENCE PVT LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00442/AM13/ |
RLA File<br>:07/24/040/00062/AM13/ |
Lic.No/Date:0710088213<br>16.05.2012 |
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| 1 |
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence<br>of 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:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>7-DEHYDROCHOLESTROL<br>1 kg<br>1<br>CHOLEST-5-EN-3-OL(KID)<br>2.01 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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| Case No.:27/21/82- |
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Party Name:STELLENCE |
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Meet No/Date:5/82- |
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Status: |
| ALC4/2012 |
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PHARMSCIENCE PVT LTD |
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ALC4/2019 |
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Approved |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0710089972 |
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| :01/82/050/00657/AM13/ |
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:07/24/040/00183/AM13/ |
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31.07.2012 |
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Decision: The Committee considered case as per agenda and deliberated on the matter in the presence 2 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.<br>No. |
Import items |
Qty. |
| 4 CHLORO 4 FLOURO<br>BUTYROPHENONE |
1 kg |
1 |
FLOUROBENZENE |
2.20 kg |
RA concerned may take further necessary action as per above decision of NC.
2
| Case No.:19/7/82-ALC4/2014 |
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Party Name:COVALENT |
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Meet No/Date:5/82- |
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Status: |
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LABORATORIES PRIVATE |
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ALC4/2019 |
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Approved |
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LIMITED |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0910056083 |
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| :01/82/050/00663/AM15/ |
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:09/24/040/00325/AM13/ |
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21.05.2013 |
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Case No.:19/7/82-ALC4/2014 |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00663/AM15/ |
RLA File<br>:09/24/040/00325/AM13/ |
Lic.No/Date:0910056083<br>21.05.2013 |
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| 3 |
**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 per<br>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>CEFPODOXIME PROXETIL<br>1 kg<br>1<br>7 Amino Cephalosporonic Acid (7<br>ACA)<br>0.8378 kg<br>2<br>2- Mercapto- Benzothiazol- 2-<br>Aminothiazole- 4yl- Methoxyimino<br>Acetate (MAEM)<br>0.8378 kg<br>3<br>Alpha-Chloroethyl Isopropyl<br>Carbonate (CEIPC)<br>0.550 kg<br>4<br>1,1,3,3, - tetramethyl Guanidine<br>(TMG)<br>0.223 kg<br>5<br>Methanol<br>1.51 kg<br>6<br>Methylene Chloride<br>2.32 kg<br>7<br>Acetone<br>2.50 kg<br>8<br>Tetra Hydro Furan<br>1.56 kg<br>9<br>Sodium Iodide<br>0.28 kg<br>10<br>Activated Carbon<br>0.100 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Decision: The 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 details below or as applied by firm whichever is lower:
3
| Case No.:34/5/82-ALC4/2015 |
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Party Name:ASCENT |
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Meet No/Date:5/82- |
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Status: |
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FINECHEM PVT. LTD., |
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ALC4/2019 |
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Approved |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0810134800 |
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| :01/82/050/00174/AM16/ |
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:08/24/040/00397/AM15/ |
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13.03.2015 |
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Case No.:34/5/82-ALC4/2015 |
Party Name:ASCENT<br>FINECHEM PVT. LTD., |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00174/AM16/ |
RLA File<br>:08/24/040/00397/AM15/ |
Lic.No/Date:0810134800<br>13.03.2015 |
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| 4 |
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence<br>of 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:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>RASPBERRY KETONE/ 4-(4-<br>HYDROXYPHYENYL) BUTANE<br>- 2 - ONE WHITE CRYSTALLINE<br>POWDER<br>1 kg<br>1<br>p-HYDROXY<br>BENZALDEHYDE LIGHT<br>YELLOW CRYSTALLINE<br>POWDER<br>1.69 kg<br>2<br>ACETONE COLORLESS<br>LIQUID<br>0.802 kg<br>3<br>G2PAC ASSEMBLY 700<br>LITER / 250 KGS 35 inch x<br>35 inch x 35 inch<br>polypropylene woven fabric<br>bags<br>700 LITER / 250 KGS 35<br>inch x 35 inch x 35 inch<br>polyprpelene woven fabric<br>bags<br>Net to Net<br>with<br>accountability<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Decision: The 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 details below or as applied by firm whichever is lower:
| Case No.:137/14/82- |
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Party Name:HPL ADDITIVES |
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Meet No/Date:5/82- |
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Status: |
| ALC4/2015 |
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LIMITED(FORMERLY |
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ALC4/2019 |
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Approved |
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KNOWN HIGH POLYMER |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0510395972 |
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| :01/82/050/01273/AM16/ |
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:05/23/040/00275/AM16/ |
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19.10.2015 |
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Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 5 meeting no. 3/82-ALC4/2019 dated 05.07.2019, 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. |
Import items |
Qty. |
| Azodicarbonamide |
1 kg |
Hydrazine Hydrate(100%) |
0.548 kg |
|
|
Technical Grade Urea |
1.316 kg |
RA may take appropriate action as per the decision of Norms Committee.
4
| Case No.:75/1/82-ALC1/2016 |
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Party Name:BLISS GVS |
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Meet No/Date:5/82- |
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Status: |
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PHARMA LTD. |
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ALC4/2019 |
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Approved |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310802382 |
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| :01/82/050/01849/AM16/ |
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:03/94/040/00948/AM16/ |
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09.02.2016 |
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Case No.:75/1/82-ALC1/2016 |
Case No.:75/1/82-ALC1/2016 |
Part |
Name:BLISS GVS |
Name:BLISS GVS |
Name:BLISS GVS |
Name:BLISS GVS |
Name:BLISS GVS |
Meet No/Date:5/82- |
Meet No/Date:5/82- |
Meet No/Date:5/82- |
Status: |
Status: |
d |
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<br>PHA |
<br>RMA LTD. |
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<br>ALC4/2019 |
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<br>Approve |
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<br>02.08.2019 |
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il |
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i122 |
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HQ Fe<br>01/82/050/01849/AM16/ |
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RL<br>03/ |
Fe<br>4/040/00948/AM16/ |
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Lc.No/Date:0308038<br>09022016 |
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**Decision:**The Committee conside<br> |
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red case as per agenda and deliberated on the matter in the presence<br> |
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the technical experts and it was decide<br>details below or as applied by firm whi |
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d to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>chever is lower: |
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| 6 |
Export product |
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Qty. |
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Sl.<br>No. |
Import items |
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Qty. |
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RECTICIN-100 Suppositories Net<br> |
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490200<br> |
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1 |
Indomethacin BP |
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50.000 kg |
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Content of import item used -<br> |
* |
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Number |
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Indomethacin BP 49.02 Kgs |
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INDOMETACINA 100mg Su<br>Net Content of import item us<br>Indomethacin BP 49.02 Kgs |
ppositories<br>ed - * |
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490200<br>Number |
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1 |
Indomethacin BP |
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50.000 kg |
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GMETH Suppositories Net C<br>import item used - * Indomet<br>49.02 Kgs |
ontent of<br>hacin BP |
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49200<br>Number |
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1 |
Indomethacin BP |
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50.000 kg |
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Indogen S Suppositories Net |
Content of |
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490200 |
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1 |
Indomethacin BP |
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50.000 kg |
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import item used - * Indomethacin BP<br>49.02 Kgs |
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Number |
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RA concerned maytake further necessaryaction asper above decision of NC. |
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Decision: The 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 details below or as applied by firm whichever is lower:
5
| Case No.:42/7/82-ALC4/2016 |
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Party Name:ALEMBIC |
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Meet No/Date:5/82- |
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Status: |
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PHARMACEUTICALS LTD |
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ALC4/2019 |
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Approved |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:3410042036 |
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| :01/82/050/00216/AM17/ |
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:34/24/040/00325/AM16/ |
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07.04.2016 |
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Decision: The Committee considered the cases as per agenda in the presence of technical experts and 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
-
IRBESARTAN AND HYDROCHLOROTHIAZIDE 150/12.5 MG TAB. (Irbesartan HCTZ 150/12.5mg)
- (Net content of active ingredients = 673.44 kgs)
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IRBESARTAN AND HYDROCHLOROTHIAZIDE 300/12.5 MG Tab. (Irbesartan HCTZ 300/12.5 mg)
(Net content of active ingredients = 4183.20 kgs)
- 7 3. IRBESARTAN AND HYDROCHLOROTHIAZIDE 300/25 MG TAB. ( Irbesartan HCTZ 30/25 mg) (Net content of active ingredients = 1530.40 kgs)
| Sl. |
Import Items |
For export of 1 Number of Tablet |
For export of 1 Number of Tablet |
(Qty. in mg) |
| No. |
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150 / 12.5 mg |
300 / 12.5 mg |
300 / 25.0 mg |
| 1 |
Irbesartan Ph. Eur. (CEP |
153.00 |
306.00 |
306.00 |
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Grade) |
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| 2 |
Lactose Monohydrate |
105.90 |
211.80 |
211.80 |
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( Granulac-200) |
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| 3 |
Croscarmellose Sodium |
12.00 |
24.00 |
24.00 |
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( Ac Di Sol) |
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| 4 |
Hydrochlorothiazide |
12.75 |
12.75 |
25.50 |
| 5 |
Lactose Monohydrate |
5.00 |
10.00 |
10.00 |
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( Granulac-200) |
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| 6 |
Croscarmellose Sodium |
Not matching with |
Not matching with |
Not matching with |
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( Granulac-200) |
MBF |
MBF |
MBF |
| 7 |
Magnesium Stearate |
2.25 |
4.50 |
4.50 |
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Case No.:382/4/82-ALC4/2017 |
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Party Name:ELPPE |
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Meet No/Date:5/82- |
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Status: |
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CHEMICALS PRIVATE |
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ALC4/2019 |
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Deferred |
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LIMITED |
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02.08.2019 |
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| 8 |
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HQ File |
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RLA File |
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Lic.No/Date:0310812684 |
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Defer Date |
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:01/82/050/00390/AM18/ |
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:03/94/040/00036/AM18/ |
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24.04.2017 |
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**Decision:**Deferred for comments of TE. |
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| 9 |
Case No.:220/1/82-ALC4/2019 |
Party Name:AETHER<br>INDUSTRIES LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Lic.No/Date:5210043009<br>25.03.2019 |
Status:<br>Deferred<br>Defer Date |
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HQ File<br>:01/82/050/02615/AM19/ |
RLA File<br>:52/24/040/00097/AM19/ |
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**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Surat. |
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Decision: 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, Surat.
6
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Case No.:222/1/82- |
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Party Name:ANLON |
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Meet No/Date:5/82- |
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Status: |
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ALC4/2019 |
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HEALTHCARE |
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ALC4/2019 |
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Deferred |
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PRIVATELIMITED |
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02.08.2019 |
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| 10 |
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HQ File |
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RLA File |
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Lic.No/Date:2410042706 |
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Defer Date |
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:01/82/050/02617/AM19/ |
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:24/24/040/00062/AM19/ |
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25.03.2019 |
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**Decision:**Deferred for comments of TE. |
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Case No.:223/1/82- |
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Party Name:ANLON |
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Meet No/Date:5/82- |
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Status: |
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ALC4/2019 |
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HEALTHCARE |
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ALC4/2019 |
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Deferred |
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PRIVATELIMITED |
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02.08.2019 |
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| 11 |
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HQ File |
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RLA File |
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Lic.No/Date:2410042707 |
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Defer Date |
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:01/82/050/02618/AM19/ |
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:24/24/040/00063/AM19/ |
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25.03.2019 |
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**Decision:**Deferred for comments of TE. |
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| Case No.:219/1/82-ALC4/2019 |
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Party Name:GLENMARK |
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Meet No/Date:5/82- |
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Status: |
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PHARMACEUTICALS LTD., |
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ALC4/2019 |
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Approved |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310827889 |
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| :01/82/050/02614/AM19/ |
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:03/94/040/01122/AM19/ |
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26.03.2019 |
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Case No.:219/1/82-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., |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD., |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD., |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
Status:<br>Approved |
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HQ File |
RLA |
File |
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Lic.No/Date:0310827889 |
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:01/82/050/02614/AM19/ |
:03/9 |
4/040/01122/AM19/ |
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26.03.2019 |
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**Decision:**The Committee consid |
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ered case as er aenda in the resence of technical exerts and it was |
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<br>decided to ratif the ad-hoc input outp |
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p g p p<br>t norms under para 47 of HBP as per details below or as applied b |
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y<br>firm whichever is lower:- |
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y |
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Export product |
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Qty. |
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Sl. |
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Import items |
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Qty. |
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<br>No. |
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Indomethacin Capsule USP 25mg<br>(Per Pack 100 Tabs.) (Net wt. of |
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1 No. |
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1 |
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Indomethacin USP |
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25.50 mg/25 mg capsule |
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| 12 |
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<br> <br>Indomethacin USP is 125.000 Kgs) |
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Indomethacin Capsule USP 25m |
g |
1 N |
o |
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1 |
Indomethacin USP |
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2550 mg |
/25 mg capsule |
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<br>(Per Pack 1000 Tabs.) (Net wt.<br>Indomethacin USP is 500.000 K |
<br>of<br>gs) |
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Indomethacin Capsule USP 50m<br>(Per Pack 100 Tabs.) (Net wt. o |
g<br>f |
1 N |
o. |
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1 |
Indomethacin USP |
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51.00 mg |
/50 mg capsul |
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<br>Indomethacin USP is 35.000 Kgs) |
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|
|
|
Indomethacin Capsule USP 50mg<br>(Per Pack 500 Tabs.) (Net wt. of<br>Indomethacin USP is 400.000 Kgs) |
|
1 No. |
|
1 |
|
Indomethacin USP<br> |
|
51.00 mg/50 mg capsule |
|
|
|
|
|
RA concerned maytake further necessaryaction |
|
|
|
asper above decision of NC. |
|
|
|
|
|
|
|
7
| 13 |
Case No.:224/1/82-<br>ALC4/2019 |
Party Name:SAINOR<br>LABORATORIES PVT LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02619/AM19/ |
RLA File<br>:09/24/040/00647/AM19/ |
Lic.No/Date:0910067319<br>26.03.2019 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad. |
|
|
|
Decision: 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.
| 14 |
Case No.:225/1/82-<br>ALC4/2019 |
Party Name:SAINOR<br>LABORATORIES PVT LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02620/AM19/ |
RLA File<br>:09/24/040/00646/AM19/ |
Lic.No/Date:0910067320<br>26.03.2019 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad. |
|
|
|
Decision: 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.:226/1/82-ALC4/2019 |
|
Party Name:BRAWN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
BIOTECH LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410051 |
|
|
| :01/82/050/02621/AM19/ |
|
:05/23/040/00567/AM19/ |
|
26.03.2019 |
|
|
|
Case No.:226/1/82-ALC4/2019 |
Party Name:BRAWN<br>BIOTECH LTD. |
Party Name:BRAWN<br>BIOTECH LTD. |
Party Name:BRAWN<br>BIOTECH LTD. |
Party Name:BRAWN<br>BIOTECH LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02621/AM19/ |
RLA File<br>:05/23/040/00567/AM19/ |
|
|
|
Lic.No/Date:0510410051<br>26.03.2019 |
|
|
| 15 |
<br>**Decision:**The Committee considered case a<br>was decided to ratify the ad-hoc input output norm<br>applied by firm whichever is lower:-<br>Export product<br>Qty.<br>AZITHROMYCIN CAPSULE<br>USP 250 MG<br>(HARD GELATIN CAPSULES<br>CONTAINING WHITE<br>GRANULAR POWDER)<br>1 Number<br>AZITHROMYCIN CAPSULE<br>USP 500 MG<br>(HARD GELATIN CAPSULES<br>CONTAINING WHITE<br>GRANULAR POWDER)<br>1 Number<br>AZITHROMYCIN SYRUP 200<br>MG/5 ML - 30 ML<br>(PINKISH WHITE GRANULAR<br>POWDER FORMING PINK<br>COLOURED SUSPENSION ON<br>RECONSTITUTION)<br>1 Number<br>RA concerned maytake further necessaryaction as |
|
|
s per agenda in the presence of technical experts and it<br>s under para 4.7 of HBP as per details below or as<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>AZITHROMYCIN<br>DIHYDRATE USP<br>(WHITE OR ALMOST<br>WHITE POWDER)<br>267.256 mg / 250<br>mg capsule<br>2<br>AZITHROMYCIN<br>DIHYDRATE USP<br>(WHITE OR ALMOST<br>WHITE POWDER)<br>534.512 mg / 500<br>mg capsule<br>3<br>AZITHROMYCIN<br>DIHYDRATE USP<br>(WHITE OR ALMOST<br>WHITE POWDER)<br>1320.56 mg / 30 ml<br>bottle<br> per above decision of NC. |
|
|
|
|
|
|
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
|
1 Number |
1 |
AZITHROMYCIN<br>DIHYDRATE USP<br>(WHITE OR ALMOST<br>WHITE POWDER) |
|
267.256 mg / 250<br>mg capsule |
|
|
|
|
1 Number |
2 |
AZITHROMYCIN<br>DIHYDRATE USP<br>(WHITE OR ALMOST<br>WHITE POWDER) |
|
534.512 mg / 500<br>mg capsule |
|
|
|
|
1 Number |
3 |
AZITHROMYCIN<br>DIHYDRATE USP<br>(WHITE OR ALMOST<br>WHITE POWDER) |
|
1320.56 mg / 30 ml<br>bottle |
|
|
|
|
|
per above decision of NC. |
|
|
|
|
8
|
Case No.:227/1/82-ALC4/2019 |
|
Party Name:GULBRANDSEN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
CHEMICALS PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
02.08.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410044999 |
|
Defer Date |
|
:01/82/050/02622/AM19/ |
|
:34/24/040/00392/AM19/ |
|
26.03.2019 |
|
|
16 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information:
(i) Complete 4E with all technical detail s, molecular weight and stoichiometric balance etc. (ii) Generic name of the export product.
| Case No.:228/1/82-ALC4/2019 |
|
Party Name:SPC LIFE |
|
Meet No/Date:5/82- |
|
Status: |
|
|
SCIENCES PVT. LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045001 |
|
|
| :01/82/050/02623/AM19/ |
|
:34/24/040/00331/AM19/ |
|
26.03.2019 |
|
|
Decision: The 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 details below or as applied by firm whichever is lower: 17
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 3-DI<br>METHYL<br>AMINO<br>PROPYL<br>CHLORIDE<br>HYDROCHLORIDE<br>65%<br>SOLUTION |
1 kg |
1 |
1-BROMO-3-<br>CHLOROPROPANE |
0.72 kg |
| Case No.:243/1/82-ALC4/2019 |
|
Party Name:CHEMCON |
|
Meet No/Date:5/82- |
|
Status: |
|
|
SPECIALITY CHEMICALS |
|
ALC4/2019 |
|
Approved |
|
|
PVT LTD |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045000 |
|
|
| :01/82/050/00149/AM20/ |
|
:34/24/040/00391/AM19/ |
|
26.03.2019 |
|
|
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 under 18 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. |
| CHLOROMETHYL<br>ISOPROPYL CARBONATE<br>(CMIC) |
1 kg |
1 |
METHYL<br>CHLOROFORMATE(MCF) |
0.943 kg |
RA concerned may take further necessary action as per above decision of NC
9
| Case No.:230/1/82-ALC4/2019 |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:5/82- |
|
Status: |
|
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310827966 |
|
|
| :01/82/050/02625/AM19/ |
|
:03/94/040/01077/AM19/ |
|
28.03.2019 |
|
|
Decision: The Committee considered the cases as per agenda in the presence of technical experts and 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
-
OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 5 MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 13.333 Kgs (ii) 103.681 Kgs (iii) 214.723 Kgs (iv) 109.601 Kgs.
-
OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10 MG. Each tablet contains (i) Oxybutynin Chloride USP- 10 mg
- (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 57.50 Kgs (ii) 223.56 Kgs (iii) 464.428 Kgs (iv) 236.325 Kgs.
19
-
OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15 MG. Each tablet contains (i) Oxybutynin Chloride USP - 15 mg
- (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 81.02 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 33.335 Kgs (ii) 86.403 Kgs (iii) 180.051 Kgs (iv) 91.337 Kgs.
| Sl.<br>No. |
Import Items |
For export of 1 Number of |
For export of 1 Number of |
Tablet |
|
|
5 mg |
10 mg |
15 mg |
| 1 |
OXYBUTYNIN<br>CHLORIDE USP |
5.10 mg |
10.20 mg |
15.30 mg |
|
|
|
|
|
| 2 |
EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP) |
32.40 mg |
32.40 mg |
32.40 mg |
| 3 |
SENTRY POLYOX WSR<br>N80 FP NF |
80.52 mg |
80.77 mg |
81.02 mg |
| 4 |
SENTRY POLYOX WSR<br>303 NF |
41.10 mg |
41.10 mg |
41.10 mg |
10
| Case No.:231/1/82- |
|
Party Name:INCHEM |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067335 |
|
|
| :01/82/050/02626/AM19/ |
|
:09/24/040/00639/AM19/ |
|
28.03.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision 20 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:
| Export Product |
Qty. |
Sl. No. |
Import items |
Qty. |
| Ractopamine hcl |
1 kg |
1 |
Amino acetonitrile hcl |
0.85 kg |
|
|
2 |
4 -(4 - Hydroxy phenyl)- 2 -butanone |
0.70 kg |
| Case No.:232/1/82- |
|
Party Name:NAVIN |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
FLUORINE |
|
ALC4/2019 |
|
Approved |
|
|
INTERNATIONAL LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310827981 |
|
|
| :01/82/050/02627/AM19/ |
|
:03/95/040/01210/AM19/ |
|
28.03.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 21 meeting no. 5/82-ALC4/2018 dated 25.07.2018, 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 |
Qty. |
Sl. No. |
Import items |
Qty. |
| Refrigerant Gas HFO 1234yf (2,3,3,3<br>Tetra Fluoro Prop-l-ene) |
1 kg |
1 |
Hexa Fluoro Propylene |
1.60 kg |
| Case No.:233/1/82- |
|
Party Name:EMCURE |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067352 |
|
|
| :01/82/050/02628/AM19/ |
|
:31/83/040/00193/AM19/ |
|
28.03.2019 |
|
|
Decision: The 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 details below or as applied by firm whichever is lower:
22
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Drug<br>Formulations<br>Injections(ampules/ vials upto<br>10 ML) TRANEXAMIC ACID<br>INJECTION 1000 MG/10 ML<br>EACH<br>VIAL<br>OF<br>10ML<br>CONTAINS<br>TRANEXAMIC<br>ACID<br>1000<br>MG<br>[NET<br>WEIGHT 282.96 KGS] |
1 Number |
1 |
TRANEXAMIC ACID<br>USP (INJECTABLE<br>GRADE) |
1100 mg / 10 ml<br>vial |
11
| 23 |
<br>Case No.:234/1/82-ALC4/2019 |
Party Name:NEOGEN<br>CHEMICALS LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02629/AM19/ |
RLA File<br>:03/95/040/00788/AM18/ |
Lic.No/Date:0310828002<br>28.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:235/1/82-ALC4/2019 |
|
Party Name:SHREE GANESH |
|
Meet No/Date:5/82- |
|
Status: |
|
|
REMEDIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045006 |
|
|
| :01/82/050/02630/AM19/ |
|
:34/24/040/00399/AM19/ |
|
28.03.2019 |
|
|
|
Case No.:235/1/82-ALC4/2019 |
Party Name:SHREE GANESH<br>REMEDIES LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/02630/AM19/ |
RLA File<br>:34/24/040/00399/AM19/ |
Lic.No/Date:3410045006<br>28.03.2019 |
|
| 24 |
<br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence<br>of 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:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Di Methyl Amino Propyl Chloride<br>Hydrochloride-65% Solution in Water<br>(DMPC-65%)<br>1 kg<br>1<br>1-Bromo-3-Chloro Propane<br>0.72 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
| 25 |
Case No.:2/1/82-ALC4/2019 |
Party Name:AMI ORGANICS<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00002/AM20/ |
RLA File<br>:52/24/040/00102/AM19/ |
Lic.No/Date:5210043013<br>29.03.2019 |
|
|
<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>15/82-ALC4/2018<br>, dated 22.03.2019, 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>1-PHENYL OXINDOLE<br>1 kg<br>1<br>DIPHENYL<br>AMINE(Diphenyl<br>amine-99.6%MIN.)<br>1.20 kg<br>2<br>CHLOROACETYL CHLORIDE<br>0.81 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
12
| 26 |
<br>Case No.:3/1/82-ALC4/2019 |
Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD.<br>RLA File<br>:03/94/040/01102/AM19/ |
|
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00003/AM20/ |
|
|
Lic.No/Date:0310828018<br>29.03.2019 |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
| 27 |
<br>Case No.:4/1/82-ALC4/2019 <br> <br> <br>HQ File<br>:01/82/050/00004/AM20/<br> <br>: |
Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
|
Status:<br>Deferred |
|
|
|
RLA File<br>03/94/040/01101/AM19/ |
Lic.No/Date:0310828030<br>29.03.2019 |
|
Defer Date |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
Case No.:6/1/82-ALC4/2019 Party Name:SOMU ORGANO Meet No/Date:5/82- Status: CHEM PVT.LTD., ALC4/2019 Approved 02.08.2019 HQ File RLA File Lic.No/Date:0710114735 :01/82/050/00006/AM20/ :07/24/040/00308/AM19/ 01.04.2019 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. 15/82-ALC4/2018 28 , dated 22.03.2019, 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. Import items Qty. No. 1,3-CYCLOHEXANEDIONE 1 kg 1 RESORCINOL 1.196 kg
Case No.:7/1/82-ALC4/2019 Party Name:SAGA Meet No/Date:5/82- Status: LABORATORIES ALC4/2019 Approved 02.08.2019 HQ File RLA File Lic.No/Date:0810144895 :01/82/050/00007/AM20/ :08/24/040/00444/AM19/ 02.04.2019 Decision: The 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 29 details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| DIFLAH<br>500<br>(Diosmin<br>and<br>Hesperidin Tablets 500mg) |
1 Number |
1 |
DIOSMIN+HESPIRIDINE<br>9:1 |
510.0 mg<br>/500 mg<br>tablet |
13
| Case No.:8/1/82-ALC4/2019 |
|
Party Name:KOPRAN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
RESEARCH |
|
ALC4/2019 |
|
Approved |
|
|
LABORATORIES LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828072 |
|
|
| :01/82/050/00008/AM20/ |
|
:03/94/040/01064/AM19/ |
|
02.04.2019 |
|
|
Decision: The Committee considered the cases as per agenda 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: 30
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| MEROPENEM<br>FOR<br>INJECTION<br>(MEROPENEM<br>BUFFERED<br>STERILE) |
1 kg |
1 |
MEROPENEM<br>NON-<br>STERILE<br>(MEROPENEM<br>TRIHYDRATE<br>NON-<br>STERILE) |
0.958 kg |
| 31 |
<br>Case No.:13/1/82-ALC4/2019 |
Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD<br>RLA File<br>:31/83/040/00296/AM19/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00013/AM20/ |
|
Lic.No/Date:3110067362<br>02.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:18/1/82-ALC4/2019 |
|
Party Name:VERGO |
|
Meet No/Date:5/82- |
|
Status: |
|
|
PHARMA RESEARCH |
|
ALC4/2019 |
|
Approved |
|
|
LABORATORIES PVT. LTD., |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828109 |
|
|
| :01/82/050/00018/AM20/ |
|
:03/95/040/01239/AM19/ |
|
02.04.2019 |
|
|
Decision: The 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 details below or as applied by firm whichever is lower: 32
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Alverine Citrate 60mg Hard |
1 Number |
1 |
Alverine Citrate |
61.2 mg/ 60 mg |
|
Capsules |
|
|
|
tablet |
|
Alverine Citrate 120mg Hard |
1 Number |
1 |
Alverine Citrate |
122.4 mg/ 120 mg |
|
Capsules |
|
|
|
tablet |
| RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
14
| Case No.:19/1/82-ALC4/2019 |
|
Party Name:VERGO |
|
Meet No/Date:5/82- |
|
Status: |
|
|
PHARMA RESEARCH |
|
ALC4/2019 |
|
Approved |
|
|
LABORATORIES PVT. LTD., |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828110 |
|
|
| :01/82/050/00019/AM20/ |
|
:03/95/040/01240/AM19/ |
|
02.04.2019 |
|
|
Decision: The 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 33 details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Mebeverine Tablets 135mg |
1 Number |
1 |
Mebeverine HCL |
137.70 mg/<br>135 mg tablet |
| Case No.:21/1/82-ALC4/2019 |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828102 |
|
|
| :01/82/050/00021/AM20/ |
|
:03/94/040/00963/AM19/ |
|
02.04.2019 |
|
|
|
Case No.:21/1/82-ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00021/AM20/ |
RLA File<br>:03/94/040/00963/AM19/ |
Lic.No/Date:0310828102<br>02.04.2019 |
|
| 34 |
<br>**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 per<br>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>(mg / tablet)<br>Efavirenz 600mg, Emtricitabine<br>200mg, Tenofovir Disoproxil<br>Fumarate 300mg Tablets Odimune<br>Tablets<br>Each Tablet contains: Efavirenz<br>600mg, Tenofovir Disoproxil<br>Fumarate 300mg, Emtricitabine<br>200mg Tablets<br>1 Number<br>1<br>Efavirenz<br>602.20<br>2<br>Emtricitabine<br>200.74<br>3<br>Tenofovir Disoproxil<br>Fumarate<br>301.10<br>4<br>Croscarmellose Sodium<br>(AC-DI-SOL) NF<br>124.40<br>5<br>Microcrystalline Cellulose<br>NF (Avicel PH 101)<br>235.77<br>6<br>Magnesium Stearate NF<br>(Vegetable Grade)<br>15.60<br>7<br>Hydroxy Propyl Cellulose<br>NF (Klucel LF)<br>38.40<br>8<br>Silica Gel bags 2 GM<br>Stripax R/F<br>Relevant<br>packing<br>material net to<br>net<br>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 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:
| 35 |
<br>Case No.:23/1/82-ALC4/2019 |
Party Name:HUBERGROUP<br>INDIA PRIVATE LIMITED.<br>RLA File<br>:03/94/040/01143/AM19/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00023/AM20/ |
|
Lic.No/Date:0310828106<br>02.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
15
| 36 |
Case No.:24/1/82-<br>ALC4/2019 |
Party<br>Name:SMILAX LABORATORIE<br>S LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00024/AM20/ |
RLA File<br>:09/24/040/00651/AM19/ |
Lic.No/Date:0910067357<br>02.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:10/1/82-ALC4/2019 |
|
Party Name:VIVIN DRUGS & |
|
Meet No/Date:5/82- |
|
Status: |
|
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067362 |
|
|
| :01/82/050/00010/AM20/ |
|
:09/24/040/00593/AM19/ |
|
03.04.2019 |
|
|
|
Case No.:10/1/82-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:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00010/AM20/ |
RLA File<br>:09/24/040/00593/AM19/ |
|
|
|
Lic.No/Date:0910067362<br>03.04.2019 |
|
| 37 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 14/82-ALC4/2019 dated 14.02.2019, 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 concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
| 38 |
Case No.:11/1/82-ALC4/2019 |
Party Name:VASUDHA<br>PHARMA CHEM LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00011/AM20/ |
RLA File<br>:09/24/040/00620/AM19/ |
Lic.No/Date:0910067361<br>03.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
16
| Case No.:22/1/82-ALC4/2019 |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828142 |
|
|
| :01/82/050/00022/AM20/ |
|
:03/94/040/01142/AM19/ |
|
03.04.2019 |
|
|
|
Case No.:22/1/82-ALC4/2019 |
Case No.:22/1/82-ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00022/AM20/ |
|
RLA File<br>:03/94/040/01142/AM19/ |
Lic.No/Date:0310828142<br>03.04.2019 |
|
|
| 39 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 4/82-ALC4/2019 dated 19.07.2019, 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>Exportproduct<br> Qty.<br>Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray / Dymista<br>Nasal Spray (Pack 120MD)<br>Each Spray delivers: Azelastine Hydrochloride BP 137mcg Fluticasone<br>Propionate 50mcg<br>1 Number<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Azelastine Hydrochloride<br>16.44 mg<br>2<br>Fluticasone Propionate<br>6.00 mg<br>3<br>140 mcl pumps<br>Net + 1 %<br>4<br>25ml USP type 1 amber glass vial<br>Net + 1 %<br>5<br>Nasal actuator<br>Net + 1 %<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Exportproduct |
|
|
|
Qty. |
|
|
Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray / Dymista<br>Nasal Spray (Pack 120MD)<br>Each Spray delivers: Azelastine Hydrochloride BP 137mcg Fluticasone<br>Propionate 50mcg |
|
|
|
1 Number |
|
|
|
|
|
|
|
|
|
Sl. No. |
Import items |
|
|
Qty. |
|
|
1 |
Azelastine Hydrochloride |
|
|
16.44 mg |
|
|
2 |
Fluticasone Propionate |
|
|
6.00 mg |
|
|
3 |
140 mcl pumps |
|
|
Net + 1 % |
|
|
4 |
25ml USP type 1 amber glass vial |
|
|
Net + 1 % |
|
|
5 |
Nasal actuator |
|
|
Net + 1 % |
|
|
RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 4/82-ALC4/2019 dated 19.07.2019, 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.:26/1/82-ALC4/2019 |
|
Party Name:PACT LABS |
|
Meet No/Date:5/82- |
|
Status: |
|
|
P.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067368 |
|
|
| :01/82/050/00026/AM20/ |
|
:31/83/040/00001/AM20/ |
|
03.04.2019 |
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 40 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>2 FLOURO ANISOLE |
Qty. |
Sl. No. |
Import items |
Qty. |
|
1 kg |
1 |
2 FLUORO PHENOL Purity 99.5%<br>Min |
0.935 kg |
RA concerned may take further necessary action as per above decision of NC
| 41 |
Case No.:12/1/82-<br>ALC4/2019 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00012/AM20/ |
RLA File<br>:09/24/040/00661/AM19/ |
Lic.No/Date:0910067365<br>04.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
17
|
|
Case No.:14/1/82- |
|
Party Name:CLEAN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ALC4/2019 |
|
SCIENCE AND |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
TECHNOLOGY PVT.LTD. |
|
02.08.2019 |
|
|
| 42 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3110067371 |
|
Defer Date |
|
|
:01/82/050/00014/AM20/ |
|
:31/83/040/00299/AM19/ |
|
04.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:9/1/82-ALC4/2019 |
|
Party Name:BRAWN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410163 |
|
|
| :01/82/050/00009/AM20/ |
|
:05/23/040/00580/AM19/ |
|
05.04.2019 |
|
|
|
|
**Decision:**The Committee |
**Decision:**The Committee |
considered case as per |
considered case as per |
considered case as per |
agenda in the presence of |
technical experts and it |
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. |
|
|
|
| 43 |
|
|
AZITHROMYCIN TABLETS |
|
1 Number |
1 |
AZITHROMYCIN |
267.256 mg / 250 |
|
|
|
|
250MG |
|
|
|
DIHYDRATE USP |
mg capsule |
|
|
|
|
(WHITE,ROUND, BICONVEX, |
|
|
|
(WHITE OR ALMOST |
|
|
|
|
|
FLIM COATED TABLETS) |
|
|
|
WHITE POWDER) |
|
|
|
|
|
AZITHROMYCIN TABLETS |
|
1 Number |
2 |
AZITHROMYCIN |
534.512 mg / 500 |
|
|
|
|
500MG |
|
|
|
DIHYDRATE USP |
mg capsule |
|
|
|
|
(WHITE, ELONGATED, |
|
|
|
(WHITE OR ALMOST |
|
|
|
|
|
BICONVEX,SCORED ON ONE |
|
|
|
WHITE POWDER) |
|
|
|
|
|
SIDE, FILM COATED |
|
|
|
|
|
|
|
|
|
TABLETS) |
|
|
|
|
|
|
|
|
RA concerned may take further necessary action as |
|
|
|
per above decision of NC. |
|
|
|
Decision: The Committee considered case as per agenda in the presence of 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.:20/1/82- |
|
Party Name:THINQ |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ALC4/2019 |
|
PHARMA-CRO LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
02.08.2019 |
|
|
| 44 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310828192 |
|
Defer Date |
|
|
:01/82/050/00020/AM20/ |
|
:03/95/040/01366/AM19/ |
|
05.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:25/1/82- |
|
Party Name:SAINOR |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ALC4/2019 |
|
LABORATORIES PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
02.08.2019 |
|
|
| 45 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067371 |
|
Defer Date |
|
|
:01/82/050/00025/AM20/ |
|
:09/24/040/00659/AM19/ |
|
05.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
18
| 46 |
<br>Case No.:27/1/82-<br>ALC4/2019<br> <br> <br> <br>HQ File<br>:01/82/050/00027/AM20/<br> <br> |
Party Name:CLEAN<br>SCIENCE AND<br>TECHNOLOGY PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
|
RLA File<br>:31/83/040/00168/AM19/ |
Lic.No/Date:3110067373<br>05.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:28/1/82-ALC4/2019 |
|
Party Name:RAJASTHAN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ANTIBIOTICS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410174 |
|
|
| :01/82/050/00028/AM20/ |
|
:05/24/040/00744/AM19/ |
|
08.04.2019 |
|
|
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 47 per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Vancomycin HCL (Sterile Powder) |
1 kg |
1 |
VANCOMYCIN HCL<br>USP (NON-STERILE) |
1.01 kg |
| Case No.:29/1/82-ALC4/2019 |
|
Party Name:RAJASTHAN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ANTIBIOTICS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410175 |
|
|
| :01/82/050/00029/AM20/ |
|
:05/24/040/00684/AM19/ |
|
08.04.2019 |
|
|
|
Case No.:29/1/82-ALC4/2019 |
Party Name:RAJASTHAN<br>ANTIBIOTICS LTD<br>RLA File<br>:05/24/040/00684/AM19/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Lic.No/Date:0510410175<br>08.04.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00029/AM20/ |
|
|
|
| 48 |
<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>15/82-ALC4/2018<br>, dated 22.03.2019, 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>Meropenem for Injection<br>1 kg<br>1<br>Meropenem trihydrate Non<br>Sterile<br>0.958 kg<br>2<br>Sodium Carbonate (non-<br>Sterile)<br>0.160 kg<br>3<br>Acetone<br>1.265 kg<br>4<br>Methanol<br>1.375 kg<br>5<br>Activated Carbon<br>0.0182 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. 15/82-ALC4/2018 , dated 22.03.2019, 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:
19
| Case No.:30/1/82-ALC4/2019 |
|
Party Name:RAJASTHAN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ANTIBIOTICS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410176 |
|
|
| :01/82/050/00030/AM20/ |
|
:05/24/040/00675/AM19/ |
|
08.04.2019 |
|
|
|
Case No.:30/1/82-ALC4/2019 <br>HQ File<br>:01/82/050/00030/AM20/ |
Party Name:RAJASTHAN<br>ANTIBIOTICS LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
|
RLA File<br>:05/24/040/00675/AM19/ |
Lic.No/Date:0510410176<br>08.04.2019 |
|
| 49 |
**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 per<br>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>Ampicillin Sodium Sterile<br>1 kg<br>1<br>Ampicillin Trihydrate<br>1.20 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
| Case No.:34/1/82-ALC4/2019 |
|
Party Name:JUBILANT LIFE |
|
Meet No/Date:5/82- |
|
Status: |
|
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410180 |
|
|
| :01/82/050/00034/AM20/ |
|
:05/23/040/00566/AM19/ |
|
09.04.2019 |
|
|
|
Case No.:34/1/82-ALC4/2019 |
Party Name:JUBILANT LIFE<br>SCIENCES LIMITED<br>RLA File<br>:05/23/040/00566/AM19/ |
Party Name:JUBILANT LIFE<br>SCIENCES LIMITED<br>RLA File<br>:05/23/040/00566/AM19/ |
Party Name:JUBILANT LIFE<br>SCIENCES LIMITED<br>RLA File<br>:05/23/040/00566/AM19/ |
Party Name:JUBILANT LIFE<br>SCIENCES LIMITED<br>RLA File<br>:05/23/040/00566/AM19/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00034/AM20/ |
|
|
|
|
Lic.No/Date:0510410180<br>09.04.2019 |
|
|
| 50 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 3/82-ALC4/2019 dated 05.07.2019, 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. No.<br>Import items<br>Qty.<br>Piperidine (Min Purity 99%)<br>1 kg<br>1<br>Ruthenium Alumina<br>Catalyst (Ruthenium 5 %)<br>0.00196 kg<br>2<br>Alumina Silicate Catalyst<br>0.01896 kg<br>3<br>Denatured Ethyl Alcohol<br>2.242 kg<br>4<br>Propionaldehyde<br>No details<br>5<br>Methanol<br>1.441 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
|
Qty. |
|
|
Piperidine (Min Purity 99%) |
|
1 kg |
1 |
Ruthenium Alumina<br>Catalyst (Ruthenium 5 %) |
|
0.00196 kg |
|
|
|
|
|
2 |
Alumina Silicate Catalyst |
|
0.01896 kg |
|
|
|
|
|
3 |
Denatured Ethyl Alcohol |
|
2.242 kg |
|
|
|
|
|
4 |
Propionaldehyde |
|
No details |
|
|
|
|
|
5 |
Methanol |
|
1.441 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. 3/82-ALC4/2019 dated 05.07.2019, 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:
20
| Case No.:35/1/82- |
|
Party Name:BALAJI AMINES |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067375 |
|
|
| :01/82/050/00035/AM20/ |
|
:31/83/040/00295/AM19/ |
|
09.04.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 3/82-ALC4/2019 dated 05.07.2019, 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: 51
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| N-METHYL-2-<br>PYRROLIDONE |
1 kg |
1 |
METHANOL |
0.370 kg |
|
|
2 |
AMMONIA ANHYDROUS |
0.160 kg |
|
|
3 |
1,4 BUTANEDIOL |
1.044 kg |
|
|
4 |
METHYLAMINE CATALYST |
0.00080 kg |
|
|
5 |
GBL CATALYST |
0.00075 kg |
21
| Case No.:37/1/82-ALC4/2019 |
|
Party Name:CADILA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
HEALTHCARE LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810144979 |
|
|
| :01/82/050/00037/AM20/ |
|
:08/24/040/00449/AM19/ |
|
10.04.2019 |
|
|
|
ase No:37/1/82-ALC4/2019 |
Party Name:CADILA |
Party Name:CADILA |
Party Name:CADILA |
Party Name:CADILA |
Meet No/Date:5/82- |
Meet No/Date:5/82- |
Meet No/Date:5/82- |
Status: |
| <br> <br>: |
. |
<br>HEALTHCARE LTD<br>RLA File<br>:08/24/040/00449/AM19/ |
|
|
|
<br>ALC4/2019<br>02.08.2019<br>Lic.No/Date:0810144979<br>10.04.2019 |
|
|
<br>Approved |
|
HQ File<br>01/82/050/00037/AM20/ |
|
|
|
|
|
|
|
|
| 52<br> <br> <br>p |
**Decision:**The Committee con |
sidered the cases as per agenda a |
|
|
|
nd in the light of earlier dec |
|
|
ision 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 as<br>er 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>ACYCLOVIR TABLETS<br>USP 400 MG<br>1 Number<br>1<br>ACYCLOVIR USP<br>408.00 mg / 400<br>mg tablet<br>2<br>MICRO CRYSTALLINE<br>CELLULOSE NF 101<br>(COMPRECEL M101D+)<br>27.6 mg / 400 mg<br>tablet<br>3<br>MICRO CRYSTALLINE<br>CELLULOSE NF 102<br> <br>8.0 mg / 400 mg<br>tablet |
|
|
|
|
|
|
|
|
|
|
Qty. |
|
Sl. |
Import items |
|
Qty. |
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
1 Number |
|
1 |
ACYCLOVIR USP |
|
4<br>m |
08.00 mg / 400<br>g tablet |
|
|
|
|
|
2 |
MICRO CRYSTALLINE<br>CELLULOSE NF 101<br>(COMPRECEL M101D+) |
|
2<br>ta |
7.6 mg / 400 mg<br>blet |
|
|
|
|
|
3 |
MICRO CRYSTALLINE<br>CELLULOSE NF 102<br> |
|
8.0 mg / 400 mg<br>tablet |
|
|
|
|
|
|
|
(COMPRECEL M102D+) |
|
|
|
|
|
|
|
|
4 |
MAGNESIUM STEARATE<br>NF |
|
5.25 mg / 400 mg<br>tblt |
|
|
|
ACYCLOVIR TABLETS |
|
|
|
|
|
ae |
|
|
|
|
|
|
5 |
SODIUM<br>GLYCOL |
STARCH<br>ATE NF |
21.0<br>tablet |
|
mg / 400 mg<br> |
|
|
1 Number |
|
1 |
ACYCLO |
VIR USP |
816.0 |
|
0 mg / 800<br>blet |
|
USP 800 MG |
|
|
|
|
|
<br>mg ta |
|
|
|
|
|
|
2 |
MICRO |
CRYSTALLINE |
55.20 |
|
mg / 800 |
|
RA maytake appropriate action a |
|
|
|
CELLULOSE NF 101<br>(COMPRECEL M101D+) |
|
mg tablet |
|
|
|
|
|
|
3 |
MICRO CRYSTALLINE<br>CELLULOSE NF 102<br> |
|
1<br>m |
6.00 mg / 800<br>g tablet |
|
|
|
|
|
|
(COMPRECEL M102D+) |
|
|
|
|
|
|
|
|
4 |
MAGNESIUM STEARATE<br> |
|
1<br> |
0.50 mg / 800<br> |
|
|
|
|
|
|
NF |
|
m |
g tablet |
|
|
|
|
|
5 |
SODIUM STARCH<br>GLYCOLATE NF |
|
4<br>m |
2.00 mg / 800<br>g tablet |
|
|
|
sper the deci |
sion of N |
|
orms Committee. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22
| Case No.:38/1/82-ALC4/2019 |
|
Party Name:CADILA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
HEALTHCARE LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810144980 |
|
|
| :01/82/050/00038/AM20/ |
|
:08/24/040/00448/AM19/ |
|
10.04.2019 |
|
|
|
|
**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 |
**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. 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: |
|
|
|
|
|
|
|
|
|
|
|
Export Product |
|
|
|
|
|
|
|
|
|
|
|
Norms<br>recommended<br>for |
|
OMEPRAZOLE |
|
DELAYED |
|
RELEASE |
CAPSULE |
USP |
|
|
|
10 mg, 20 mg and 40 mg |
|
|
|
|
|
|
|
|
|
|
|
|
Sl.<br>Import Items |
|
Norms for 1 million |
|
capsule (Qty. In kg) |
|
|
|
|
|
|
|
No. |
|
10 mg capsule |
|
20 mg capsule |
|
40 mg capsule |
|
|
| 53 |
|
|
1<br>5-METHOXY 2- |
|
8.6417 |
|
17.283 |
|
34.566 |
|
|
|
|
|
MERCAPTO |
|
|
|
|
|
|
|
|
|
|
|
BENZAMIDAZOLE |
|
|
|
|
|
|
|
|
|
|
|
2<br>2-CHLOROMETHYL-3,5 |
|
10.2288 |
|
20.457 |
|
40.915 |
|
|
|
|
|
HYDROCHLORIDE |
|
|
|
|
|
|
|
|
|
|
|
3<br>HYPROMELLOSE 3 CPS |
|
4.68 |
|
9.36 |
|
18.6 |
|
|
|
|
|
2910 USP |
|
|
|
|
|
|
|
|
|
|
|
4<br>HYPROMELLOSE |
|
8.555 |
|
17.110 |
|
31.0 |
|
|
|
|
|
PHTHALATE NF |
|
|
|
|
|
|
|
|
|
|
|
5<br>SUGAR SPHERES NF |
|
47.50 |
|
95.0 |
|
190.0 |
|
|
|
|
|
(PHARMA-SPHERES, |
710- |
|
|
|
|
|
|
|
|
|
|
850 MICRON) |
|
|
|
|
|
|
|
|
|
|
|
6<br>TALC PH.E/USP/JP |
|
5.00 |
|
10.00 |
|
20.00 |
|
|
|
|
|
7<br>TRIETHYL CITRATE NF |
|
1.285 |
|
2.570 |
|
4.65 |
|
|
|
|
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. 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.:39/1/82- |
|
Party Name:TIDE |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
02.08.2019 |
|
|
| 54 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410045044 |
|
Defer Date |
|
|
:01/82/050/00039/AM20/ |
|
:34/24/040/00009/AM20/ |
|
11.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:41/1/82- |
|
Party Name:ORTIN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ALC4/2019 |
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
02.08.2019 |
|
|
| 55 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067389 |
|
Defer Date |
|
|
:01/82/050/00041/AM20/ |
|
:09/24/040/00650/AM19/ |
|
15.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
23
| 56 |
<br>Case No.:42/1/82-ALC4/2019 |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00042/AM20/ |
RLA File<br>:05/23/040/00015/AM20/ |
Lic.No/Date:0510410233<br>15.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 57 |
<br>Case No.:43/1/82-ALC4/2019 |
Party Name:HEMA DYE<br>CHEM PVT. LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00043/AM20/ |
RLA File<br>:03/94/040/01141/AM19/ |
Lic.No/Date:0310828400<br>16.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 58 |
Case No.:47/1/82-ALC4/2019 |
Party Name:SYMBIOSIS<br>PHARMACEUTICALS.PRIVATE<br>LIMITED. |
<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/00047/AM20/ |
RLA File<br>:33/24/040/00002/AM20/ |
Lic.No/Date:3310030527<br>16.04.2019 |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Panipat. |
|
|
|
Decision: 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, Panipat.
| Case No.:44/1/82-ALC4/2019 |
|
Party Name:ALIVIRA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ANIMAL HEALTH LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828406 |
|
|
| :01/82/050/00044/AM20/ |
|
:03/94/040/00017/AM20/ |
|
18.04.2019 |
|
|
|
Case No.:44/1/82-ALC4/2019 |
Party Name:ALIVIRA<br>ANIMAL HEALTH LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00044/AM20/ |
RLA File<br>:03/94/040/00017/AM20/ |
Lic.No/Date:0310828406<br>18.04.2019 |
|
| 59 |
<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 04.05.2018, 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>CLOZASOLE 3400 (NET CONTENT OF<br>IMPORT ITEM TETRAMSOLE HCl IN<br>EXPORT QTY = 10800 KGS)<br>(Tetramisole 2000 mgBolus)<br>1 Number<br>1<br>TETRAMISOLE HCL<br>2040 mg / 2<br>gm Bolus<br>CLOZASOLE 900 (NET CONTENT OF<br>IMPORT ITEM TETRAMSOLE HCl IN<br>EXPORT QTY = 2430 KGS)<br>(Tetramisole 450 mgBolus)<br>1 Number<br>1<br>TETRAMISOLE HCL<br>459 mg /<br>450 mg<br>Bolus<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
24
| 60 |
Case No.:49/1/82-ALC4/2019 |
Party Name:COVALENT<br>LABORATORIES PRIVATE |
Meet No/Date:5/82-<br>ALC4/2019 |
Status:<br>Deferred |
|
|
LIMITED |
02.08.2019 |
|
|
HQ File<br>:01/82/050/00049/AM20/ |
RLA File<br>:09/24/040/00020/AM20/ |
Lic.No/Date:0910067394<br>23.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 61 |
Case No.:50/1/82-ALC4/2019 |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br> |
Meet No/Date:5/82-<br>ALC4/2019<br> |
Status:<br>Deferred |
|
|
LIMITED |
02.08.2019 |
|
|
HQ File<br>:01/82/050/00050/AM20/ |
RLA File<br>:09/24/040/00019/AM20/ |
Lic.No/Date:0910067395<br>23.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:54/1/82-ALC4/2019 |
|
Party Name:ALTA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828483 |
|
|
| :01/82/050/00054/AM20/ |
|
:03/94/040/00060/AM20/ |
|
23.04.2019 |
|
|
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 62 per details given below or as applied by the firm, whichever is less:
| Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 1 kg |
1 |
PARA HYDROXY BENZOIC ACID |
0.969 kg |
|
2 |
METHANOL |
0.500 kg |
| Case No.:55/1/82-ALC4/2019 |
|
Party Name:ALTA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828485 |
|
|
| :01/82/050/00055/AM20/ |
|
:03/94/040/00058/AM20/ |
|
23.04.2019 |
|
|
|
|
:01/82/050/00055/AM20/<br>:03/94/040/00058/AM20/<br>23.04.2019 |
|
|
|
|
|
**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: |
|
|
|
| 63 |
|
|
|
|
|
|
|
Export product<br>Qty.<br>Sl.<br>Import items |
|
Qty. |
|
|
|
No. |
|
|
|
|
|
PROPYL PARABEN<br>1 kg<br>1<br>PARA HYDROXY BENZOIC ACID |
|
0.85 kg |
|
|
|
2<br>N-PROPANOL |
|
0.500 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:
25
| Case No.:56/1/82-ALC4/2019 |
|
Party Name:ALTA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828504 |
|
|
| :01/82/050/00056/AM20/ |
|
:03/94/040/00059/AM20/ |
|
23.04.2019 |
|
|
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. 15/82-ALC4/2018 64 , dated 22.03.2019, 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. Import items Qty. No. SODIUM SALICYLATE 1 kg 1 SALICYLIC ACID 0.88 kg
Case No.:57/1/82- Party Name:AVA Meet No/Date:5/82- Status: ALC4/2019 CHEMICALS PVT.LTD., ALC4/2019 Deferred 02.08.2019 HQ File RLA File Lic.No/Date:0310828516 Defer Date :01/82/050/00057/AM20/ :03/94/040/00044/AM20/ 23.04.2019 65 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information: (i) Exact specifications of export product. (ii) % yield and molecular weight. (iii) Material balance. Case No.:58/1/82-ALC4/2019 Party Name:AVA Meet No/Date:5/82- Status: CHEMICALS PVT.LTD., ALC4/2019 Deferred 02.08.2019 HQ File RLA File Lic.No/Date:0310828518 Defer Date :01/82/050/00058/AM20/ :03/94/040/00043/AM20/ 23.04.2019 66 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information: (i) Exact specifications of export product. (ii) % yield and molecular weight. (iii) Material balance.
26
| Case No.:59/1/82-ALC4/2019 |
|
Party Name:LUPIN LIMITED |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828484 |
|
|
| :01/82/050/00059/AM20/ |
|
:03/95/040/01322/AM19/ |
|
23.04.2019 |
|
|
|
|
**Decision:**The Committee considered the case as per |
**Decision:**The Committee considered the case as per |
**Decision:**The Committee considered the case as per |
**Decision:**The Committee considered the case as per |
agenda |
agenda |
in |
the presence of Technical Experts and |
the presence of Technical Experts and |
the presence of Technical Experts and |
the presence of Technical Experts and |
|
|
in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by |
|
|
<br>NC |
|
<br>in |
its |
<br>Meeting |
|
No.<br>15/82-ALC4/2018 |
|
|
|
, dated 22.03.2019, 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: |
|
|
|
|
|
|
|
|
|
|
| 67 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Export product |
Qty. |
|
Sl. |
|
Import items |
|
|
Qty. |
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
|
|
ETIZOLAM TABLETS 0.5MG |
1 Number |
|
1 |
|
ETIZOLAM JP |
|
|
0.51 mg / 0.50 mg tablet |
|
|
|
|
(NET WT.15.00 KGS, WEIGHT |
|
|
|
|
|
|
|
|
|
|
|
|
OF DURGS : 15.750 KGS) |
|
|
|
|
|
|
|
|
|
|
|
|
ETIZOLAM TABLETS 1 MG |
1 Number |
|
1 |
|
ETIZOLAM JP |
|
|
1.02 mg /1 mg tablet |
|
|
|
|
(NET WT 15.00 KGS, WEIGHT |
|
|
|
|
|
|
|
|
|
|
|
|
OF DRUGS : 15.750 KGS) |
|
|
|
|
|
|
|
|
|
|
|
|
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. 15/82-ALC4/2018 , dated 22.03.2019, 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:
|
|
Case No.:60/1/82-ALC4/2019 |
|
Party Name:MANKIND |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
PHARMA LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
02.08.2019 |
|
|
| 68 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0510410328 |
|
Defer Date |
|
|
:01/82/050/00060/AM20/ |
|
:05/24/040/00024/AM20/ |
|
23.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:61/1/82-ALC4/2019 |
|
Party Name:KUMAR |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ORGANIC PRODUCTS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED, |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114795 |
|
|
| :01/82/050/00061/AM20/ |
|
:07/24/040/00008/AM20/ |
|
24.04.2019 |
|
|
|
|
Case No.:61/1/82-ALC4/2019Party Name:KUMAR<br>ORGANIC PRODUCTS<br>LIMITED,<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00061/AM20/<br>RLA File<br>:07/24/040/00008/AM20/<br>Lic.No/Date:0710114795<br>24.04.2019 |
Case No.:61/1/82-ALC4/2019Party Name:KUMAR<br>ORGANIC PRODUCTS<br>LIMITED,<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00061/AM20/<br>RLA File<br>:07/24/040/00008/AM20/<br>Lic.No/Date:0710114795<br>24.04.2019 |
Case No.:61/1/82-ALC4/2019Party Name:KUMAR<br>ORGANIC PRODUCTS<br>LIMITED,<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00061/AM20/<br>RLA File<br>:07/24/040/00008/AM20/<br>Lic.No/Date:0710114795<br>24.04.2019 |
Case No.:61/1/82-ALC4/2019Party Name:KUMAR<br>ORGANIC PRODUCTS<br>LIMITED,<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00061/AM20/<br>RLA File<br>:07/24/040/00008/AM20/<br>Lic.No/Date:0710114795<br>24.04.2019 |
Case No.:61/1/82-ALC4/2019Party Name:KUMAR<br>ORGANIC PRODUCTS<br>LIMITED,<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00061/AM20/<br>RLA File<br>:07/24/040/00008/AM20/<br>Lic.No/Date:0710114795<br>24.04.2019 |
|
|
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of |
|
|
|
|
| 69 |
|
the technical experts and 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: |
|
|
|
|
|
|
Export product<br>Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
|
|
|
ZINC PYRITHIONE ASSAY 50%<br>1 kg |
1 |
2, CHLOROPYRIDINE, ASSAY |
0.502 kg |
|
|
|
|
|
85% |
|
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
27
|
Case No.:62/1/82-ALC4/2019 |
Party Name:KEVA |
Meet No/Date:5/82- |
Status: |
| 70 |
|
<br>FRAGRANCES PRIVATE<br>LIMITED |
<br>ALC4/2019<br>02.08.2019<br>Lic.No/Date:0310828561<br>24.04.2019 |
<br>Deferred<br>Defer Date |
|
HQ File<br>:01/82/050/00062/AM20/ |
RLA File<br>:03/94/040/00052/AM20/ |
|
|
|
|
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information:<br>(i) Complete 4E with all technical details,molecular weight and stoichiometric balance etc. |
idered the case as per agenda in t |
he presence of technical exp |
erts and it |
| 71 |
Case No.:63/1/82-ALC4/2019 |
Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00063/AM20/ |
RLA File<br>:31/83/040/00004/AM20/ |
Lic.No/Date:3110067389<br>24.04.2019 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Pune. |
|
|
|
Decision: 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.:64/1/82-ALC4/2019 |
|
Party Name:AURORE LIFE |
|
Meet No/Date:5/82- |
|
Status: |
|
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067402 |
|
|
| :01/82/050/00064/AM20/ |
|
:09/24/040/00594/AM19/ |
|
24.04.2019 |
|
|
|
|
**Decision:**The Committee |
**Decision:**The Committee |
**Decision:**The Committee |
considered case as per agenda and in the presence |
considered case as per agenda and in the presence |
of the technical |
of the technical |
|
|
experts, 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. |
|
|
|
| 72 |
|
|
Amlodipine |
1 kg |
1 |
Phthalic Anhydride |
0.752 kg |
|
|
|
|
Besylate |
|
2 |
Mono ethanol Amine |
0.308 kg |
|
|
|
|
|
|
3 |
Ethyl-4-chloro aceto acetate |
0.858 kg |
|
|
|
|
|
|
4 |
Ortho Chloro Benzyl dehyde |
0.670 kg |
|
|
|
|
|
|
5 |
Methyl Aceto Acetate |
1.00 kg |
|
|
|
|
|
|
6 |
Benzone Sulpone Acid |
0.463 kg |
|
|
|
|
|
|
7 |
Methanol |
0.36 kg |
|
|
|
|
|
|
8 |
Toulene |
2.40 kg |
|
|
|
|
|
|
9 |
Morpholine |
0.090 kg |
|
|
|
|
|
|
10 |
Isopropyl Alcohol (IPA) |
1.00 kg |
|
|
|
RA concerned may |
|
take appropriate action asper the decision of Norms Committee. |
|
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, 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.:65/1/82- |
|
Party Name:AURORE LIFE |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ALC4/2019 |
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
02.08.2019 |
|
|
| 73 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067403 |
|
Defer Date |
|
|
:01/82/050/00065/AM20/ |
|
:09/24/040/00008/AM20/ |
|
24.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
28
| 74 |
Case No.:66/1/82-ALC4/2019 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00066/AM20/ |
RLA File<br>:09/24/040/00013/AM20/ |
Lic.No/Date:0910067405<br>24.04.2019 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad. |
|
|
|
Decision: 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.
| 75 |
<br>Case No.:67/1/82-ALC4/2019 |
Party Name:AUROBINDO<br>PHARMA LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00067/AM20/ |
RLA File<br>:09/24/040/00025/AM20/ |
Lic.No/Date:0910067414<br>24.04.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 76 |
Case No.:75/1/82-ALC4/2019 |
Party Name:LABORATE<br>PHARMACEUTICAL INDIA<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00075/AM20/ |
RLA File<br>:33/24/040/00003/AM20/ |
Lic.No/Date:3310030529<br>24.04.2019 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Panpiat. |
|
|
|
Decision: 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, Panpiat.
| Case No.:82/1/82- |
|
Party Name:MEDREICH |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114798 |
|
|
| :01/82/050/00082/AM20/ |
|
:07/24/040/00009/AM20/ |
|
24.04.2019 |
|
|
|
Case No.:82/1/82-<br>ALC4/2019 |
Party Name:MEDREICH<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00082/AM20/ |
RLA File<br>:07/24/040/00009/AM20/ |
Lic.No/Date:0710114798<br>24.04.2019 |
|
| 77 |
<br>**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 per<br>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>Rosuvastatin 10mg & Ezetimibe<br>10mg Tablets [6117600 No.]<br>[61.176+61.176=122.352 KG]<br>1 Number<br>1<br>ROSUVASTATIN<br>CALCIUM<br>10.625 mg / 10 mg<br>tablet<br>Rosuvastatin 20mg & Ezetimibe<br>10 mg Tablets [12000000 No.]<br>[240+120=360 KG]<br>1 Number<br>1<br>ROSUVASTATIN<br>CALCIUM<br>21.25 mg / 20 mg<br>tablet<br>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 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:
29
|
|
Case No.:68/1/82- |
|
Party Name:SRF LIMITED |
|
Meet No/Date:5/82- |
|
Status: Deferred |
|
|
ALC4/2019 |
|
|
|
ALC4/2019 |
|
|
|
|
|
|
|
|
02.08.2019 |
|
|
| 78 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0510410372 |
|
Defer Date |
|
|
:01/82/050/00068/AM20/ |
|
:05/24/040/00438/AM19/ |
|
25.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:69/1/82-ALC4/2019 |
|
Party Name:SAVLA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
CHEMICALS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828605 |
|
|
| :01/82/050/00069/AM20/ |
|
:03/95/040/00053/AM20/ |
|
25.04.2019 |
|
|
Decision: The 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 79 details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| HIGH PURITY METHYL<br>TERTIARY BUTYL ETHER<br>99.8% |
900000 kg |
1 |
METHYL TERTIARY<br>BUTYL ETHER (MTBE) |
900000 kg |
|
|
Case No.:74/1/82-ALC4/2019 |
|
Party Name:SUN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
PHARMACEUTICAL |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
INDUSTRIES LTD. |
|
02.08.2019 |
|
|
| 80 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0510410387 |
|
Defer Date |
|
|
:01/82/050/00074/AM20/ |
|
:05/24/040/00029/AM20/ |
|
26.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:76/1/82-ALC4/2019 |
|
Party Name:VERVE HUMAN |
|
Meet No/Date:5/82- |
|
Status: |
|
|
CARE LABORATORIES |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410398 |
|
|
| :01/82/050/00076/AM20/ |
|
:05/24/040/00001/AM20/ |
|
26.04.2019 |
|
|
Decision: The 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 81 details below or as applied by firm whichever is lower:
| Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 84000 Number |
1 |
Bupivacaine HCL |
8.82 kg |
30
|
|
Case No.:79/1/82-ALC4/2019Party Name:AVA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
CHEMICALS PVT.LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
02.08.2019 |
|
|
|
|
HQ File<br>RLA File |
|
Lic.No/Date:0310828628 |
|
Defer Date |
|
|
:01/82/050/00079/AM20/<br>:03/94/040/00045/AM20/ |
|
26.04.2019 |
|
|
| 82 |
|
**Decision:**The Committee considered the case as per agenda in |
the presence of technical experts and it |
|
|
|
|
|
was decided to call for following information: |
|
|
|
|
|
|
(i)<br>Exact specifications of export product. |
|
|
|
|
|
|
(ii)<br>% yield and molecular weight. |
|
|
|
|
|
|
(iii)<br>Material balance. |
|
|
|
|
Case No.:80/1/82-ALC4/2019 Party Name:AVA Meet No/Date:5/82- Status: CHEMICALS PVT.LTD., ALC4/2019 Deferred 02.08.2019 HQ File RLA File Lic.No/Date:0310828629 Defer Date :01/82/050/00080/AM20/ :03/94/040/00046/AM20/ 26.04.2019 83 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information: (i) Exact specifications of export product. (ii) % yield and molecular weight. (iii) Material balance.
Case No.:83/1/82-ALC4/2019 Party Name:CAPLIN POINT Meet No/Date:5/82- Status: LABORATORIES LIMITED ALC4/2019 Approved 02.08.2019 HQ File RLA File Lic.No/Date:0410165522 :01/82/050/00083/AM20/ :04/24/040/00019/AM20/ 29.04.2019 Decision: The 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 84 details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Lincomycin Injection USP 600 mg / |
1 Vial |
1 |
Lincomycin Hydrochloride |
719.26 mg |
| 2ml - 2mlvial |
|
|
USP |
/2mlvial |
31
|
|
Case No.:84/1/82-ALC4/2019 |
|
Party Name:SHIVA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
PHARMACHEM LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
02.08.2019 |
|
|
| 85 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410045091 |
|
Defer Date |
|
|
:01/82/050/00084/AM20/ |
|
:34/24/040/00032/AM20/ |
|
29.04.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:85/1/82-ALC4/2019 |
|
Party Name:ASCENT |
|
Meet No/Date:5/82- |
|
Status: |
|
|
FINECHEM PVT. LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810145127 |
|
|
| :01/82/050/00085/AM20/ |
|
:08/24/040/00026/AM20/ |
|
30.04.2019 |
|
|
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. 7/82-ALC4/2018 , dated 24.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 86 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| N-(3-AMINOPROPYL) |
1 kg |
1 |
Imidazole |
0.68 kg |
| IMIDAZOLE WHITE OR OFF<br>WHITE<br>CRYSTAL |
|
2 |
SODIUM METHOXIDE POWDER |
1.00 kg |
|
|
3 |
ACRYLONITRILE |
0.466 kg |
| Case No.:87/1/82-ALC4/2019 |
|
Party Name:S V LABS PVT |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067427 |
|
|
| :01/82/050/00087/AM20/ |
|
:09/24/040/00032/AM20/ |
|
30.04.2019 |
|
|
|
|
Case No.:87/1/82-ALC4/2019Party Name:S V LABS PVT<br>LTD<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00087/AM20/<br>RLA File<br>:09/24/040/00032/AM20/<br>Lic.No/Date:0910067427<br>30.04.2019 |
Case No.:87/1/82-ALC4/2019Party Name:S V LABS PVT<br>LTD<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00087/AM20/<br>RLA File<br>:09/24/040/00032/AM20/<br>Lic.No/Date:0910067427<br>30.04.2019 |
Case No.:87/1/82-ALC4/2019Party Name:S V LABS PVT<br>LTD<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00087/AM20/<br>RLA File<br>:09/24/040/00032/AM20/<br>Lic.No/Date:0910067427<br>30.04.2019 |
Case No.:87/1/82-ALC4/2019Party Name:S V LABS PVT<br>LTD<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00087/AM20/<br>RLA File<br>:09/24/040/00032/AM20/<br>Lic.No/Date:0910067427<br>30.04.2019 |
Case No.:87/1/82-ALC4/2019Party Name:S V LABS PVT<br>LTD<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00087/AM20/<br>RLA File<br>:09/24/040/00032/AM20/<br>Lic.No/Date:0910067427<br>30.04.2019 |
Case No.:87/1/82-ALC4/2019Party Name:S V LABS PVT<br>LTD<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00087/AM20/<br>RLA File<br>:09/24/040/00032/AM20/<br>Lic.No/Date:0910067427<br>30.04.2019 |
Case No.:87/1/82-ALC4/2019Party Name:S V LABS PVT<br>LTD<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00087/AM20/<br>RLA File<br>:09/24/040/00032/AM20/<br>Lic.No/Date:0910067427<br>30.04.2019 |
|
|
**Decision:**The 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 |
|
|
|
details below or as applied by firm whichever is lower: |
|
|
|
|
|
|
| 87 |
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
|
|
|
|
CYCLOHEXYL ESTER (CEI) |
1 kg |
1 |
GLYOXYALIC ACID (50%) |
0.746 kg |
|
|
|
|
|
|
2 |
2,5 DIHYDROXY-1,4 |
0.327 kg |
|
|
|
|
|
|
|
DITHIANE (DIOL) |
|
|
|
|
|
|
|
3 |
CYTOSINE |
0.434 kg |
|
|
|
|
|
|
4 |
HEXAMETHYL |
0.348 kg |
|
|
|
|
|
|
|
DISILAZANE (HMDS) |
|
|
|
|
|
|
|
5 |
L-MENTHOL |
0.736 kg |
|
|
|
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 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:
32
|
|
Case No.:94/1/82-ALC4/2019Party Name:RAJASTHAN |
Case No.:94/1/82-ALC4/2019Party Name:RAJASTHAN |
Meet No/Date:5/82- |
|
|
Status: |
Status: |
|
|
|
|
ANTIBIOTICS LTD |
ALC4/2019 |
|
|
Approved |
|
|
|
|
|
|
02.08.2019 |
|
|
|
|
|
|
|
HQ File<br>RLA File |
|
Lic.No/Date:0510410426 |
|
|
|
|
|
|
|
:01/82/050/00094/AM20/<br>:05/24/040/00023/AM20/ |
|
30.04.2019 |
|
|
|
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and |
|
|
|
|
|
|
|
|
|
in |
the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC |
in<br>its<br>Meeting<br>No. |
7/82-ALC4/2018 |
|
|
|
|
| 88 |
|
, dated 24.08.2018, 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<br>Qty.<br>Sl.<br>Import items |
|
|
|
|
Qty. |
|
|
|
|
No. |
|
|
|
|
|
|
|
|
|
Ceftriaxone Sodium (sterile)<br>1 kg<br>1<br>Ceftriaxone Sodium (non-sterile) |
|
|
|
|
1.04 kg |
|
|
|
RA concerned maytake further necessaryaction asper above |
|
decision of NC. |
|
|
|
|
|
|
|
Case No.:86/1/82-ALC4/2019 |
|
|
Party Name:ASCENT |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
|
FINECHEM PVT. LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
02.08.2019 |
|
|
| 89 |
|
HQ File<br>:01/82/050/00086/AM20/ |
|
|
RLA File<br>:08/24/040/00005/AM20/ |
|
Lic.No/Date:0810145144<br>01.05.2019 |
|
Defer Date |
|
|
**Decision:**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: 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.:88/1/82-ALC4/2019 |
|
Party Name:SMS |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
LIFESCIENCES INDIA |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
02.08.2019 |
|
|
| 90 |
|
HQ File<br>:01/82/050/00088/AM20/ |
|
RLA File<br>:09/24/040/00037/AM20/ |
|
Lic.No/Date:0910067429<br>01.05.2019 |
|
Defer Date |
|
|
**Decision:**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: 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.
33
| Case No.:89/1/82-ALC4/2019 |
|
Party Name:AURORE LIFE |
|
Meet No/Date:5/82- |
|
Status: |
|
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067431 |
|
|
| :01/82/050/00089/AM20/ |
|
:09/24/040/00617/AM19/ |
|
01.05.2019 |
|
|
|
Case No.:89/1/82-ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00089/AM20/ |
RLA File<br>:09/24/040/00617/AM19/ |
|
|
Lic.No/Date:0910067431<br>01.05.2019 |
|
|
| 91 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 13/82-ALC4/2018 dated 14.01.2019, 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>Piroctone Olamine<br>1 kg<br>1<br>3,3-dimethylacrylic acid<br>0.84 kg<br>2<br>3,5,5-trimethlhexonyl chloride<br>1.30 kg<br>3<br>Hydroxylamine HCl<br>0.73 kg<br>4<br>Potassium Carbonate<br>0.90 kg<br>5<br>Methylene Chloride<br>0.50 kg<br>6<br>Toulene<br>0.25kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
Piroctone Olamine |
1 kg |
1 |
3,3-dimethylacrylic acid |
|
0.84 kg |
|
|
|
|
2 |
3,5,5-trimethlhexonyl chloride |
|
1.30 kg |
|
|
|
|
3 |
Hydroxylamine HCl |
|
0.73 kg |
|
|
|
|
4 |
Potassium Carbonate |
|
0.90 kg |
|
|
|
|
5 |
Methylene Chloride |
|
0.50 kg |
|
|
|
|
6 |
Toulene |
|
0.25kg |
|
|
RA maytake appropriate action a |
sper 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. 13/82-ALC4/2018 dated 14.01.2019, 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.:93/1/82-ALC4/2019 |
|
Party Name:ALCON |
|
Meet No/Date:5/82- |
|
Status: |
|
|
BIOSCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828700 |
|
|
| :01/82/050/00093/AM20/ |
|
:03/94/040/00082/AM20/ |
|
01.05.2019 |
|
|
Decision: The 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 92 details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| SODIUM SACCHARIN 40-80<br>MESH TECHNICALGRADE |
1 kg |
1 |
SODIUM SACCHARIN 8-80<br>MESH RAWMATERIAL |
1.01 kg |
| 93 |
Case No.:96/1/82-ALC4/2019 |
Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00096/AM20/ |
RLA File<br>:31/83/040/00012/AM20/ |
Lic.No/Date:3110067403<br>01.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 94 |
Case No.:97/1/82-ALC4/2019 |
Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00097/AM20/ |
RLA File<br>:31/83/040/00013/AM20/ |
Lic.No/Date:3110067404<br>01.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
34
| Case No.:98/1/82-ALC4/2019 |
|
Party Name:VISION DRUGS |
|
Meet No/Date:5/82- |
|
Status: |
|
|
PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067433 |
|
|
| :01/82/050/00098/AM20/ |
|
:09/24/040/00592/AM19/ |
|
02.05.2019 |
|
|
|
Case No.:98/1/82-ALC4/2019 |
Party Name:VISION DRUGS<br>PVT LTD |
Party Name:VISION DRUGS<br>PVT LTD |
Party Name:VISION DRUGS<br>PVT LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00098/AM20/ |
RLA File<br>:09/24/040/00592/AM19/ |
|
|
Lic.No/Date:0910067433<br>02.05.2019 |
|
|
| 95 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 13/82-ALC4/2018 dated 14.01.2019, 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>Piroctone Olamine<br>1 kg<br>1<br>3,3-dimethylacrylic acid<br>0.84 kg<br>2<br>3,5,5-trimethlhexonyl chloride<br>1.30 kg<br>3<br>Hydroxylamine HCl<br>0.73 kg<br>4<br>Potassium Carbonate<br>0.90 kg<br>5<br>Methylene Chloride<br>0.50 kg<br>6<br>Toulene<br>0.25kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
Piroctone Olamine |
1 kg |
1 |
3,3-dimethylacrylic acid |
|
0.84 kg |
|
|
|
|
2 |
3,5,5-trimethlhexonyl chloride |
|
1.30 kg |
|
|
|
|
3 |
Hydroxylamine HCl |
|
0.73 kg |
|
|
|
|
4 |
Potassium Carbonate |
|
0.90 kg |
|
|
|
|
5 |
Methylene Chloride |
|
0.50 kg |
|
|
|
|
6 |
Toulene |
|
0.25kg |
|
|
RA maytake appropriate action a |
sper 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. 13/82-ALC4/2018 dated 14.01.2019, 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.:99/1/82-ALC4/2019 |
|
Party Name:DIVIS |
|
Meet No/Date:5/82- |
|
Status: |
|
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
PRIVATE LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067437 |
|
|
| :01/82/050/00099/AM20/ |
|
:09/24/040/00009/AM20/ |
|
02.05.2019 |
|
|
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. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 96 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Alpha-(2-Methyl Amine) Ethyl<br>Benzene Methanol |
1 kg |
1 |
Benzaldehyde |
1.72 kg |
|
|
2 |
Palladium |
0.002 kg |
|
|
3 |
Paraformaldehyde |
0.40 kg |
|
|
4 |
Acetophenone |
1.63kg |
| 97 |
Case No.:102/1/82-ALC4/2019 |
Party Name:SV<br>PLASTOCHEM PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00102/AM20/ |
RLA File<br>:31/83/040/00006/AM20/ |
Lic.No/Date:3110067406<br>02.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
35
| 98 |
Case No.:103/1/82-ALC4/2019 |
Party Name:SV<br>PLASTOCHEM PVT.LTD.<br>RLA File<br>:31/83/040/00005/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00103/AM20/ |
|
Lic.No/Date:3110067407<br>02.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 99 |
Case No.:100/1/82-<br>ALC4/2019 |
Party Name:ETERNIS FINE<br>CHEMICALS LIMITED,<br>RLA File<br>:03/94/040/00029/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br>Lic.No/Date:0310828779<br>03.05.2019 |
Status: Deferred |
|
HQ File<br>:01/82/050/00100/AM20/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 100 |
<br>Case No.:101/1/82-<br>ALC4/2019<br>Party Name:JODAS EXPOIM<br>PVT.LTD<br>HQ File<br>:01/82/050/00101/AM20/<br>RLA File<br>:05/23/040/00048/AM20/<br>**Decision:**Deferred for comments of TE. |
Party Name:JODAS EXPOIM<br>PVT.LTD |
<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred<br> <br>Defer Date |
|
|
RLA File<br>:05/23/040/00048/AM20/ |
Lic.No/Date:0510410475<br>03.05.2019 |
|
|
|
|
|
|
36
| Case No.:110/1/82-ALC4/2019 |
|
Party Name:COVALENT |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067448 |
|
|
| :01/82/050/00110/AM20/ |
|
:09/24/040/00031/AM20/ |
|
07.05.2019 |
|
|
|
Case No.:110/1/82-ALC4/2019 |
Case No.:110/1/82-ALC4/2019 |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00110/AM20/ |
|
RLA File<br>:09/24/040/00031/AM20/ |
|
|
Lic.No/Date:0910067448<br>07.05.2019 |
|
| 101 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 15/82-ALC4/2019 dated 22.03.2019, 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. |
|
<br>CefpodoximProxetil |
1 kg |
|
1 |
D-7-AMINO CEPHALOSPORANIC ACID<br>(D-7-ACA) |
|
0.810 kg |
|
|
|
|
2 |
2- Mercapto- Benzothiazol- 2- Aminothiazole-<br>4yl-Methoxyimino Acetate (MAEM) |
|
0.8378 kg |
|
|
|
|
3 |
Dimethyl Carbonate(DMC) |
|
1.422 kg |
|
|
|
|
4 |
1,1,3,3,- tetramethyl Guanidine(TMG) |
|
0.189 kg |
|
|
|
|
5 |
Methanol |
|
4.00 kg |
|
|
|
|
6 |
Methane sulfonic acid |
|
1.626 kg |
|
|
|
|
7 |
Acetone |
|
1.41 kg |
|
|
|
|
8 |
Trimethyl orthoformate(TMOF) |
|
0.80 kg |
|
|
|
|
9 |
Dimethyl Acetamide(DMAC) |
|
2.35 kg |
|
|
|
|
10 |
Toluene |
|
2.22 kg |
|
|
|
|
11 |
Activated Carbon |
|
0.100 kg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
| 102 |
<br>Case No.:135/1/82-<br>ALC4/2019 |
Party Name:SV<br>PLASTOCHEM PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00135/AM20/ |
RLA File<br>:31/83/040/00087/AM19/ |
Lic.No/Date:3110067409<br>07.05.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 103 |
<br>Case No.:136/1/82-ALC4/2019 |
Party Name:SV<br>PLASTOCHEM PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00136/AM20/ |
RLA File<br>:31/83/040/00113/AM18/ |
Lic.No/Date:3110067410<br>07.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 104 |
Case No.:106/1/82-ALC4/2019 |
Party Name:PRACHEM<br>LABORATORIES |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00106/AM20/ |
RLA File<br>:08/24/040/00003/AM20/ |
Lic.No/Date:0810145205<br>08.05.2019 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Ahmedabad. |
|
|
|
37
| 105 |
Case No.:107/1/82-ALC4/2019 |
Party Name:SHANKUS<br>PHARMACEUTICALS<br>RLA File<br>:08/24/040/00040/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00107/AM20/ |
|
Lic.No/Date:0810145203<br>08.05.2019 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Ahmedabad. |
|
|
|
| Case No.:108/1/82- |
|
Party Name:SYNNAT |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0210209153 |
|
|
| :01/82/050/00108/AM20/ |
|
:02/24/040/00009/AM20/ |
|
08.05.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or 106 as applied by firm whichever is lower:
| Export Product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Papaverine<br>Hydrochloride<br>BP/Ph.Eur/USP/JP |
1 kg |
1 |
Papaverine Crude Content<br>95% |
1.05 kg |
| 107 |
<br>Case No.:111/1/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/00111/AM20/<br> <br> |
Party Name:SAINOR<br>LABORATORIES PVT LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
|
RLA File<br>:09/24/040/00057/AM20/ |
Lic.No/Date:0910067455<br>08.05.2019 |
<br>Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad. |
|
|
|
Decision: 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.
38
| Case No.:119/1/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:5/82- |
|
Status: |
|
|
PHARMACEUTICALS LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828859 |
|
|
| :01/82/050/00119/AM20/ |
|
:03/94/040/00065/AM20/ |
|
08.05.2019 |
|
|
|
Case No.:119/1/82-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:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00119/AM20/ |
RLA File<br>:03/94/040/00065/AM20/ |
|
|
|
Lic.No/Date:0310828859<br>08.05.2019 |
|
|
| 108 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 13/82-ALC4/2018 dated 14.01.2019, 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. |
|
|
<br>Indomethacin Capsule USP 25mg<br>(Per Pack 100 Tabs.) (Net wt. of<br>Indomethacin USP is 500.000 Kgs) |
|
1 Pack |
1 |
Indomethacin USP |
|
25.50 mg/25 mg<br>capsule |
|
|
Indomethacin Capsule USP 25mg<br>(Per Pack 1000 Tabs.) (Net wt. of<br>Indomethacin USP is 1250.000<br>Kgs) |
|
1 Pack |
|
Indomethacin USP |
|
25.50 mg/25 mg<br>capsule |
|
|
Indomethacin Capsule USP 50mg<br>(Per Pack 100 Tabs.) (Net wt. of<br>Indomethacin USP is 105.000 Kgs) |
|
1 Pack |
|
Indomethacin USP |
|
51.00 mg/50 mg<br>capsule |
|
|
Indomethacin Capsule USP 50mg<br>(Per Pack 500 Tabs.) (Net wt. of<br>Indomethacin USP is 1125.000<br>Kgs) |
|
1 Pack |
|
Indomethacin USP<br> |
|
51.00 mg/50 mg<br>capsule |
|
|
RA maytake appropriate action asper |
|
the decision |
of Norms Committee. |
|
|
|
|
| 109 |
Case No.:129/1/82-ALC4/2019 |
Party Name:N S CHEMICALS |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00129/AM20/ |
RLA File<br>:03/95/040/00012/AM20/ |
Lic.No/Date:0310828854<br>08.05.2019 |
Defer Date |
|
<br>**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information:<br>(i) CoA of import item from foreign supplier.<br>(ii) Testingreport of exportproduct. |
|
|
|
| 110 |
<br>Case No.:113/1/82-ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00113/AM20/ |
RLA File<br>:09/24/040/00011/AM20/ |
Lic.No/Date:0910067466<br>09.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 111 |
Case No.:117/1/82-ALC4/2019 |
Party Name:ADISHANK<br>CHEMICALS PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019 |
Status:<br>Approved |
39
|
|
|
|
02.08.2019 |
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828912 |
| :01/82/050/00117/AM20/ |
|
:03/94/040/00006/AM20/ |
|
09.05.2019 |
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 3/82-ALC4/2019 dated 05.07.2019, 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. |
|
|
| DI<br>PHENYL |
ISO |
DECYL |
PHOSPHITE |
1 kg |
1. |
Phenol |
0.557 kg |
| (DPDP) |
|
|
|
|
2. |
2 -Propyl Heptanol |
0.386 kg |
| Case No.:118/1/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828889 |
|
|
| :01/82/050/00118/AM20/ |
|
:03/94/040/00081/AM20/ |
|
09.05.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and 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:
112
| Export Product |
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
| Difluprednate |
Ophthalmic |
1 Number |
1 |
Difluprednate |
0.00255 gm / 5 ml pack |
| Emulsion |
0.05% |
|
|
|
|
| Each<br>ml |
contains<br>: |
|
|
|
|
| Difluprednate |
0.05%, Sorbic |
|
|
|
|
| acid NF0.1% |
|
|
|
|
|
| Case No.:130/1/82- |
|
Party Name:GLOBE |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
TROTTERS PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828909 |
|
|
| :01/82/050/00130/AM20/ |
|
:03/94/040/00106/AM20/ |
|
09.05.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision 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:
113
|
Export Product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
Cefotaxime Sodium Sterile |
1 kg |
1 |
cefotaxime acid |
0.989kg |
|
|
|
2 |
triethyl amine |
0.178 kg |
|
|
|
3 |
sod-2-ethylhexanoate |
0.44 kg |
|
|
|
4 |
ethyl acetate |
2.233 kg |
|
|
|
5 |
methanol meOH |
0.40 kg |
|
|
|
6 |
ethylenediaminetetraacetic acid |
0.013 kg |
|
|
|
7 |
activated carbon |
0.014 kg |
40
| Case No.:131/1/82-ALC4/2019 |
|
Party Name:ZIM |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828917 |
|
|
| :01/82/050/00131/AM20/ |
|
:03/95/040/00121/AM20/ |
|
09.05.2019 |
|
|
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. 7/82-ALC4/2015 114 , 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:
| Export product |
Qty. |
Import items |
Qty. |
| Nicardipine Hydrochloride SR Pellets<br>50 mg |
1kg |
Nicardipine HCL JP / USP |
0.2196 kg |
|
|
Case No.:140/1/82-ALC4/2019 |
|
Party Name:MALWA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
OXYGEN & INDUSTRIAL |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
GASES PVT.LTD., |
|
02.08.2019 |
|
|
| 115 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:5610005605 |
|
Defer Date |
|
|
:01/82/050/00140/AM20/ |
|
:56/24/040/00035/AM19/ |
|
09.05.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:141/1/82-ALC4/2019 |
|
Party Name:MALWA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
OXYGEN & INDUSTRIAL |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
GASES PVT.LTD., |
|
02.08.2019 |
|
|
| 116 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:5610005606 |
|
Defer Date |
|
|
:01/82/050/00141/AM20/ |
|
:56/24/040/00034/AM19/ |
|
09.05.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
41
| Case No.:274/1/82-ALC4/2019 |
|
Party Name:STYRAX LIFE |
|
Meet No/Date:5/82- |
|
Status: |
|
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2610012877 |
|
|
| :01/82/050/00180/AM20/ |
|
:26/24/040/00003/AM20/ |
|
09.05.2019 |
|
|
|
Case No.:274/1/82-ALC4/2019 |
Case No.:274/1/82-ALC4/2019 |
Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00180/AM20/ |
|
RLA File<br>:26/24/040/00003/AM20/ |
|
|
Lic.No/Date:2610012877<br>09.05.2019 |
|
| 117 |
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and 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>4/82-ALC4/2018<br>, dated 19.06.2018, 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: |
|
|
|
|
|
|
|
Export product |
Qty. |
|
Sl. No. |
Import items |
|
Qty. |
|
5-(4-AMINO-2-OXO-<br>PYRIMIDINYL)-<br>OXATYHIOLANE-2-<br>CARBOXYLIC<br>ACID-<br>ISOPROPYL-METHYL-<br>CYCLOHEXYL<br>ESTER<br>OR CHE |
1kg |
|
1 |
GLYOXALIC ACID 50% |
|
0.746 kg |
|
|
|
|
2 |
2,5-DIHYDROXY-1,4-DIATHINE |
|
0.327 kg |
|
|
|
|
3 |
TOLUENE |
|
1.56 kg |
|
|
|
|
4 |
DI METHYL FORMAMIDE (DMF) |
|
0.26 kg |
|
|
|
|
5 |
CYTOSINE |
|
0.434 kg |
|
|
|
|
6 |
HEXA METHYL DISILAZANE<br>(HMDS) |
|
0.708 kg |
|
|
|
|
7 |
METHYLENE DI CHLORIDE (MDC) |
|
2.63 kg |
|
|
|
|
8 |
L-MENTHOL (FRESH / RECOVERY) |
|
0.751 kg |
|
|
|
|
9 |
TRI ETHYL AMINE (TEA) |
|
0.67 kg |
|
|
|
|
10 |
TRIPHOSGINE |
|
0.50 kg |
|
RA concerned maytake further necessaryaction a |
|
|
|
sper above decision of NC. |
|
|
| 118 |
Case No.:109/1/82-ALC4/2019 |
Party Name:SAURAV<br>CHEMICALS LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00109/AM20/ |
RLA File<br>:22/24/040/00011/AM20/ |
Lic.No/Date:2210016146<br>10.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:114/1/82- |
|
Party Name:GLAND |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067489 |
|
|
| :01/82/050/00114/AM20/ |
|
:09/24/040/00040/AM20/ |
|
10.05.2019 |
|
|
Decision: The 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 details below or as applied by firm whichever is lower:
119
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Metoprolol Tartrate Injection<br>1mg/ml, 5ml Vial |
1 Number |
1 |
Metoprolol Tartrate |
5.50 mg/5ml vial |
|
|
2 |
Glass Vials |
Relevant<br>as<br>per<br>Packing policy |
|
|
3 |
Rubber Stoppers |
Relevant<br>as<br>per<br>Packing policy |
|
|
4 |
Flip off Seals |
Relevant<br>as<br>per<br>Packing policy |
42
| Case No.:115/1/82- |
|
Party Name:GLAND |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:091006749 |
|
|
| :01/82/050/00115/AM20/ |
|
:09/24/040/00041/AM20/ |
|
0 |
|
|
|
|
|
|
10.05.2019 |
|
|
|
Case No.:115/1/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00115/AM20/ |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
|
RLA File<br>:09/24/040/00041/AM20/ |
Lic.No/Date:091006749<br>0<br>10.05.2019 |
|
| 120 |
**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:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Ganciclovir for Injection USP<br>500mg/vial, 10ml Vial<br>1 Number<br>1<br>Ganciclovir USP<br>550 mg/10ml vial<br>2<br>Glass Vials<br>Relevant<br>as<br>per<br>Packing policy<br>3<br>Rubber Stoppers<br>Relevant<br>as<br>per<br>Packing policy<br>4<br>Flip off Seals<br>Relevant<br>as<br>per<br>Packing policy<br>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 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.:116/1/82- |
|
Party Name:ZENITH |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
DYEINTERMEDIATES |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828945 |
|
|
| :01/82/050/00116/AM20/ |
|
:03/95/040/00016/AM20/ |
|
10.05.2019 |
|
|
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 and 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 121 less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| NAS-5 |
1 kg |
1 |
TOBIAS ACID |
1.618 kg |
| (2-DIAZO-1-NAPTHOL-5- |
|
|
(PURITY MIN. 97%) |
|
| SULFONIC ACID, SODIUM SALT) |
|
|
|
|
43
|
|
Case No.:134/1/82-ALC4/2019Party Name:STERILE INDIA<br>Meet No/Date:5/82- |
Case No.:134/1/82-ALC4/2019Party Name:STERILE INDIA<br>Meet No/Date:5/82- |
Case No.:134/1/82-ALC4/2019Party Name:STERILE INDIA<br>Meet No/Date:5/82- |
|
|
Status: |
Status: |
|
|
|
|
|
PRIVATE LIMITED<br>ALC4/2019 |
|
|
Approved |
|
|
|
|
|
|
02.08.2019 |
|
|
|
|
|
|
|
HQ File |
|
RLA File<br>Lic.No/Date:3310030540 |
|
|
|
|
|
|
|
:01/82/050/00134/AM20/ |
|
:33/24/040/00004/AM20/<br>10.05.2019 |
|
|
|
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and |
|
|
|
|
|
|
|
| 122 |
|
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>, dated 24.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 |
|
|
7/82-ALC4/2018<br>of HBP Vol. I as |
|
|
|
<br> |
|
|
per details below or as applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
|
Export product |
Qty.<br>Sl.No.<br>Import items |
|
|
|
Qty. |
|
|
|
|
Ceftriaxone Sodium Sterile |
<br>1 kg<br>1<br>Ceftriaxone Sodium (Non Sterile) |
|
|
|
1.04 kg |
|
|
|
RA concerned maytake further |
|
necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
Case No.:137/1/82-ALC4/2019 |
|
Party Name:ANLON |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
HEALTHCARE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
PRIVATELIMITED |
|
02.08.2019 |
|
|
| 123 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:2410042746 |
|
Defer Date |
|
|
:01/82/050/00137/AM20/ |
|
:24/24/040/00004/AM20/ |
|
10.05.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:138/1/82-ALC4/2019 |
|
Party Name:ANLON |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
HEALTHCARE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
PRIVATELIMITED |
|
02.08.2019 |
|
|
| 124 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:2410042747 |
|
Defer Date |
|
|
:01/82/050/00138/AM20/ |
|
:24/24/040/00005/AM20/ |
|
10.05.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:139/1/82-<br>Party Name:MAMTA |
|
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
ALC4/2019<br>POLYCOATS |
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
|
|
02.08.2019 |
|
|
|
|
|
HQ File<br>RLA File |
|
|
Lic.No/Date:341004513 |
|
|
|
|
|
:01/82/050/00139/AM20/<br>:34/24/040/00048/AM20/ |
|
|
0 |
|
|
|
|
|
|
|
|
10.05.2019 |
|
|
|
| 125 |
|
**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 |
|
|
|
|
|
|
|
|
per details below or as applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
Export product<br>Qty.<br>Sl. |
|
Import items |
|
|
Qty. |
|
|
|
No. |
|
|
|
|
|
|
|
|
Tri Butyl Citrate (Citrate Esters)<br>1 kg<br>1 |
|
Citric Acid |
|
|
0.5614 kg |
|
|
|
RA concerned maytake further necessaryaction asper above |
|
decision of NC. |
|
|
|
|
44
| Case No.:112/1/82- |
|
Party Name:LANTECH |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067504 |
|
|
| :01/82/050/00112/AM20/ |
|
:09/24/040/00067/AM20/ |
|
13.05.2019 |
|
|
|
Case No.:112/1/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00112/AM20/ |
Party Name:LANTECH<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
|
RLA File<br>:09/24/040/00067/AM20/ |
Lic.No/Date:0910067504<br>13.05.2019 |
|
| 126 |
<br>**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:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>5-(4-Amino-2-oxo-1(2H)-<br>pyrimidinyl)-1,3-oxathiolane-2-<br>carboxylic acid 5-methyl-2-(1-<br>methylethyl) cyclohexyl ester<br>1 kg<br>1<br>Glyoxalic acid (50%)<br>0.746 kg<br>2<br>Menthol (L-Menthol)<br>0.751 kg<br>3<br>2,5-Dihydroxy-1,4-dithiane<br>0.327 kg<br>4<br>Toluene<br>0.50 kg<br>5<br>Cyclohexane<br>0.79 kg<br>6<br>Hexanes<br>1.13 kg<br>7<br>Methylene dichloride<br>2.87 kg<br>8<br>Cytosine<br>0.434 kg<br>9<br>Hexamethyldisilazane<br>0.708 kg<br>10<br>Triphosgene<br>0.50 kg<br>11<br>Triethylamine<br>0.53 kg<br>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 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.:132/1/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828961 |
|
|
| :01/82/050/00132/AM20/ |
|
:03/94/040/00105/AM20/ |
|
13.05.2019 |
|
|
Decision: The 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 details below or as applied by firm whichever is lower:
127
|
Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
|
CILOSTAZOL |
1 Kg. |
1 |
5-(4-CHLOROBUTYL)-1- |
0.88 kg |
|
|
|
|
CYCLOHEXYL 1H TETRAZOLE |
|
|
|
|
2 |
6-HYDROXY-2 OXO-1,2,3,4- |
0.59 kg |
|
|
|
|
TETRAHYDROQUINOLINONE |
|
|
|
|
3 |
METHANOL |
4.00 litres |
|
|
|
4 |
TOLUENE |
0.30 litres |
45
| Case No.:133/1/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828962 |
|
|
| :01/82/050/00133/AM20/ |
|
:03/94/040/00104/AM20/ |
|
13.05.2019 |
|
|
|
Case No.:133/1/82-ALC4/2019 |
Case No.:133/1/82-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:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00133/AM20/ |
|
RLA File<br>:03/94/040/00104/AM20/ |
|
|
Lic.No/Date:0310828962<br>13.05.2019 |
|
|
| 128 |
**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. No. |
Import items |
|
Qty. |
|
|
<br>OLMESARTAN<br>MEDOXOMIL |
1 Kg. |
|
1 |
4-(1-HYDROXY-1-METHYL<br>ETHYL)-2-PROPYL-1H-IMIDAZOLE<br>5-CARBOXYLIC ACID ETHYL<br>ESTER |
|
0.70 kg |
|
|
|
|
|
2 |
5-(4-BROMOMETHYL) (1,-<br>BROMOMETHYLIPHENYL)-2YL<br>TRIPHENYL-1-H TETRAZOLE |
|
1.35 kg |
|
|
|
|
|
3 |
4-CHLOROMETHYL-5-METHYL 1,3-<br>DIOXOLEN-2-ONE |
|
0.47 kg |
|
|
|
|
|
4 |
METHYLENE CHLORIDE(MDC) |
|
4.78 litres |
|
|
|
|
|
5 |
TOLUENE |
|
2.45 litres |
|
|
|
|
|
6 |
DIMETHYL FORMAMIDE(DMF) |
|
1.76 litres |
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
| 129 |
<br>Case No.:250/1/82-ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00156/AM20/ |
RLA File<br>:09/24/040/00042/AM20/ |
Lic.No/Date:0910067505<br>13.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
46
| Case No.:255/1/82- |
|
Party Name:J.B. |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
CHEMICALS & |
|
ALC4/2019 |
|
Approved |
|
|
PHARMACEUTICALS |
|
02.08.2019 |
|
|
|
|
LIMITED |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828984 |
|
|
| :01/82/050/00161/AM20/ |
|
:03/94/040/00107/AM20/ |
|
13.05.2019 |
|
|
|
Case No.:255/1/82-<br>ALC4/2019<br> <br> |
Case No.:255/1/82-<br>ALC4/2019<br> <br> |
Party Name:J.B.<br>CHEMICALS & |
Party Name:J.B.<br>CHEMICALS & |
Meet No/Date:5/82-<br>ALC4/2019 |
Meet No/Date:5/82-<br>ALC4/2019 |
Meet No/Date:5/82-<br>ALC4/2019 |
Status:<br>Approved |
Status:<br>Approved |
Status:<br>Approved |
|
<br> <br> <br> <br>HQ File<br> |
|
<br>PHARMACEUTICALS<br>LIMITED |
|
<br>02<br>Li |
<br>.08.2019 |
|
|
|
|
|
|
|
RLA File<br>03/94/040/00107/AM20/ |
|
|
c.No/Date:0310828984 |
|
|
|
|
|
<br>:01/82/050/00161/AM20/<br> <br>: |
|
|
|
<br>13 |
<br>.05.2019 |
|
|
|
|
|
**Decision:**The Committee co |
|
nsidered case as per agenda and d |
|
|
eliberated on the matter in t |
|
|
he presence of |
|
|
<br>the technical experts and it was decided to ratify the ad-hoc |
|
|
|
<br>inp |
<br>ut output norms under para |
|
|
<br>4.7 of HBP as |
|
|
per details below or as applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
|
Sl |
E Pd |
|
|
Sl |
|
I I |
|
|
|
|
.<br>No. |
xport rouct |
|
Qty. |
<br>N |
.<br>o. |
mport tem |
|
|
Qty |
|
1 |
Benzydamine Hydroch<br>Cetylpyridinium Chlori |
loride And<br>de Anti-<br>es Sugar Free |
1 Number |
1 |
|
Benzydamine<br>Hydrochloride |
|
|
3.06 mg |
|
|
<br>Inflammatory<br>And Antiseptic Lozeng |
|
|
2 |
|
<br>Cetylpyridinium<br>Chloride |
|
|
1.33 mg |
|
|
and all other flavours. Each lozenge<br>contains (i) Benzydamine<br>Hydrochloride- 3mg (ii)<br>Cetlridinium Chloride- 133m |
|
|
3 |
|
Isomalt ST-M |
|
|
2282 mg |
|
|
ypy .g<br>(iii) Isomalt ST-M - 2282mg. Net<br>content (i) 73.34 Kgs (ii) 32.514 Kgs |
|
|
|
|
|
|
|
|
| 130 |
|
<br>(iii) 55787.306 Kgs. |
|
|
|
|
|
|
|
|
|
2 |
Benzydamine Hydroch<br>Dichlorobenzyl Alcoho |
loride, 2,4-<br>l And<br>de<br>mmatory,<br>Sr Fr |
1 Number |
4 |
|
Benzydamine<br>Hydrochloride |
|
|
3.06 mg |
|
|
Lidocaine Hydrochlori<br>Anaesthetic, Anti-Infla<br>AntiBtril Ln |
|
|
5 |
|
Isomalt ST-M |
|
|
2282<br>mg |
|
|
-acea ozeges uga ee.<br>Each lozenge contains (i)<br>Benzydamine Hydrochloride - 3mg<br>(ii) Isomalt ST-M- 2282mg. Net |
|
|
|
|
|
|
|
|
|
|
content (i) 39.973 Kgs. (ii) 30406.39<br>Kgs. |
|
|
|
|
|
|
|
|
|
3 |
Benzydamine Hydroch<br>Inflammatory Lozenge<br>Each lozenge contains<br>Benzdamine Hdroch |
loride Anti-<br>s Sugar Free.<br>(i)<br>loride- 3m |
1 Number |
6 |
|
Benzydamine<br>Hydrochloride |
|
|
3.06 mg |
|
|
|
|
|
7 |
|
Isomalt ST-M |
|
|
2282 mg |
|
|
y y<br>(ii) Isomalt ST-M - 228<br>content (i) 20.02 Kgs. ( |
g<br>2mg. Net<br>ii) 15228.534 |
|
|
|
|
|
|
|
|
|
<br>Kgs. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
Cetylpyridinium Chloride And<br>Bromhexine Hydrochloride<br>Antisetic Lozenes Suar Free and |
|
1 Number |
8 |
|
Cetylpyridinium<br>Chloride |
|
|
1.33 mg |
|
|
|
|
|
9 |
|
Isomalt ST-M |
|
|
2282 m |
|
|
p g<br>all other flavours.<br>Each lozenge contains<br>Cetylpyridinium Chlori |
g<br>(i)<br>de - 1.33mg<br>2 mg. Net<br>ii) 3214.06 |
|
|
|
|
|
|
g |
|
|
(ii) Isomalt ST-M - 228<br>content (i) 1.873 Kgs. (<br> |
|
|
|
|
|
|
|
|
|
|
Kgs. |
|
|
|
|
|
|
|
|
|
5 |
Cetylpyridinium Chloride And<br>Benzydamine Hydrochloride<br>Antiseptic Lozenges Suger Free. |
|
1 Number |
10 |
|
Cetylpyridinium<br>Chloride |
|
|
1 mg |
|
|
<br>Each lozenge contains (i)<br>Cetylpyridinium Chloride- 1mg (ii)<br>Isomalt ST-M - 2282mg. Net content<br>(i) 1.406 Kgs (ii) 3209.514 Kgs. |
|
|
11 |
|
Isomalt ST-M |
|
|
2282 mg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
|
47
| Case No.:248/1/82- |
|
Party Name:COVALENT |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067509 |
|
|
| :01/82/050/00154/AM20/ |
|
:09/24/040/00047/AM20/ |
|
14.05.2019 |
|
|
|
Case No.:248/1/82-<br>ALC4/2019<br> <br> <br> <br>HQ File<br>:01/82/050/00154/AM20/<br> <br> |
Case No.:248/1/82-<br>ALC4/2019<br> <br> <br> <br>HQ File<br>:01/82/050/00154/AM20/<br> <br> |
Case No.:248/1/82-<br>ALC4/2019<br> <br> <br> <br>HQ File<br>:01/82/050/00154/AM20/<br> <br> |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
Status:<br>Approved |
|
|
|
|
RLA File<br>:09/24/040/00047/AM20/ |
|
Lic.No/Date:0910067509<br>14.05.2019 |
|
|
| 131 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and 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>1/82-ALC4/2019<br>, dated 03.06.2019, 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> <br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Item Name.<br>Qty.<br>Cefdinir<br>1kg<br>1<br>7-Phenylacetamideo-3-Chloromethyl<br>Cephalosporonic Acid Para Methoxybenzyl Ester<br>(GCLE)<br>2.263 kg<br>2<br>Triphenyl Phosphine<br>1.234 kg<br>3<br>ethyl-(Z)-2-hydroxylamino-2-(2-aminthiazole-4-y)<br>acetate (EHATA)<br>1.397 kg<br>4<br>Methylene Chloride<br>14.87 kg<br>5<br>Tetra Hydro Furan<br>2.06 kg<br>6<br>Methanol<br>4.12 kg<br>7<br>Activated Carbon<br>0.055 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
Export Product |
Qty. |
Sl.<br>No. |
Import Item Name. |
|
|
Qty. |
|
|
Cefdinir |
1kg |
1 |
7-Phenylacetamideo-3-Chloromethyl<br>Cephalosporonic Acid Para Methoxybenzyl Ester<br>(GCLE) |
|
|
2.263 kg |
|
|
|
|
2 |
Triphenyl Phosphine |
|
|
1.234 kg |
|
|
|
|
3 |
ethyl-(Z)-2-hydroxylamino-2-(2-aminthiazole-4-y)<br>acetate (EHATA) |
|
|
1.397 kg |
|
|
|
|
4 |
Methylene Chloride |
|
|
14.87 kg |
|
|
|
|
5 |
Tetra Hydro Furan |
|
|
2.06 kg |
|
|
|
|
6 |
Methanol |
|
|
4.12 kg |
|
|
|
|
7 |
Activated Carbon |
|
|
0.055 kg |
|
|
|
|
necessaryaction asper above decision of NC. |
|
|
|
|
| 132 |
<br>Case No.:251/1/82-ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00043/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/00157/AM20/ |
|
Lic.No/Date:0910067519<br>14.05.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:261/1/82- |
|
Party Name:SANDHYA |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
ORGANIC CHEMICALS |
|
ALC4/2019 |
|
Approved |
|
|
PVT.LTD. |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828995 |
|
|
| :01/82/050/00167/AM20/ |
|
:03/95/040/01388/AM19/ |
|
14.05.2019 |
|
|
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 133 details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| DIPHENYL<br>ISODECYL<br>PHOSPHITE (DPDP) |
1 kg |
1 |
PHENOL |
0.557 kg |
|
|
2 |
ISODECYL ALCOHOL |
0.386 kg |
|
|
3 |
YELLOW PHOSPHORUS |
0.087 kg |
48
| Case No.:262/1/82-ALC4/2019 |
|
Party Name:SANDHYA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ORGANIC CHEMICALS |
|
ALC4/2019 |
|
Approved |
|
|
PVT.LTD. |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828997 |
|
|
| :01/82/050/00168/AM20/ |
|
:03/95/040/01387/AM19/ |
|
14.05.2019 |
|
|
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: 134
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 2 ETHYLHEXYL DIPHENYL<br>PHOSPHITE (2 EHDP) |
1 kg |
1 |
YELLOW PHOSPHORUS |
0.087 kg |
|
|
2 |
PHENOL |
0.570 kg |
|
|
3 |
2 ETHYLHEXANOL |
0.386 kg |
| 135 |
Case No.:263/1/82-ALC4/2019 |
Party Name:JUBILANT LIFE<br>SCIENCES LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00169/AM20/ |
RLA File<br>:05/23/040/00018/AM20/ |
Lic.No/Date:0510410573<br>14.05.2019 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information:<br>(i) Complete 4E with all technical details,molecular weight and stoichiometric balance etc. |
|
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information:
| Case No.:264/1/82-ALC4/2019 |
|
Party Name:JUBILANT LIFE |
|
Meet No/Date:5/82- |
|
Status: |
|
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410582 |
|
|
| :01/82/050/00170/AM20/ |
|
:05/23/040/00530/AM19/ |
|
14.05.2019 |
|
|
|
Case No.:264/1/82-ALC4/2019 |
Party Name:JUBILANT LIFE<br>SCIENCES LIMITED |
Party Name:JUBILANT LIFE<br>SCIENCES LIMITED |
Party Name:JUBILANT LIFE<br>SCIENCES LIMITED |
Party Name:JUBILANT LIFE<br>SCIENCES LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00170/AM20/ |
RLA File<br>:05/23/040/00530/AM19/ |
|
|
|
Lic.No/Date:0510410582<br>14.05.2019 |
|
|
| 136 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 3/82-ALC4/2019 dated 05.07.2019, 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. No. |
Import items |
|
Qty. |
|
|
Piperidine (Min Purity 99%) |
|
1 kg |
1 |
Ruthenium Alumina Catalyst<br>(Ruthenium 5 %) |
|
0.00196 kg |
|
|
|
|
|
2 |
Alumina Silicate Catalyst |
|
0.01896 kg |
|
|
|
|
|
3 |
Denatured Ethyl Alcohol |
|
2.242 kg |
|
|
|
|
|
4 |
Methanol |
|
1.441 kg |
|
|
|
|
|
5 |
Propionaldehyde |
|
No details |
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
49
| Case No.:265/1/82- |
|
Party Name:PANACEA |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
BIOTEC LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410569 |
|
|
| :01/82/050/00171/AM20/ |
|
:05/24/040/00086/AM20/ |
|
14.05.2019 |
|
|
|
Case No.:265/1/82-<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:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00171/AM20/ |
RLA File<br>:05/24/040/00086/AM20/ |
|
|
|
Lic.No/Date:0510410569<br>14.05.2019 |
|
| 137 |
**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>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>PANIMUN BIORAL CAPSULES 25<br>MG.<br>EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>25 MG.<br>6000<br>Number<br>1<br>CYCLOSPORINE USP<br>0.153 kg<br>PANIMUN BIORAL CAPSULES 50<br>MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>50 MG.)<br>235980<br>Number<br>2<br>CYCLOSPORINE USP<br>12.00 kg<br>PANIMUN BIORAL CAPSULES 100<br>MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>100 MG.)<br>208860<br>Number<br>3<br>CYCLOSPORINE USP<br>21.304 kg<br>CYCLOSPORINE CAPSULE 25 MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>25 mg)<br>90000<br>Number<br>4<br>CYCLOSPORINE USP<br>2.30 kg<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. |
|
6000<br>Number |
1 |
CYCLOSPORINE USP |
|
0.153 kg |
|
PANIMUN BIORAL CAPSULES 50<br>MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>50 MG.) |
|
235980<br>Number |
2 |
CYCLOSPORINE USP |
|
12.00 kg |
|
PANIMUN BIORAL CAPSULES 100<br>MG.<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>100 MG.) |
|
208860<br>Number |
3 |
CYCLOSPORINE USP |
|
21.304 kg |
|
CYCLOSPORINE CAPSULE 25 MG<br>(EACH SOFT GELATIN CAPSULE<br>CONTAINS: CYCLOSPORINE USP<br>25 mg) |
|
90000<br>Number |
4 |
CYCLOSPORINE USP |
|
2.30 kg |
|
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 details below or as applied by firm whichever is lower:
| Case No.:266/1/82-ALC4/2019 |
|
Party Name:SENTISS |
|
Meet No/Date:5/82- |
|
Status: |
|
|
PHARMA PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410568 |
|
|
| :01/82/050/00172/AM20/ |
|
:05/24/040/00060/AM20/ |
|
14.05.2019 |
|
|
|
Case No.:266/1/82-ALC4/2019 |
Party Name:SENTISS<br>PHARMA PVT.LTD.<br>RLA File<br>:05/24/040/00060/AM20/ |
Party Name:SENTISS<br>PHARMA PVT.LTD.<br>RLA File<br>:05/24/040/00060/AM20/ |
Party Name:SENTISS<br>PHARMA PVT.LTD.<br>RLA File<br>:05/24/040/00060/AM20/ |
Party Name:SENTISS<br>PHARMA PVT.LTD.<br>RLA File<br>:05/24/040/00060/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00172/AM20/ |
|
|
|
|
Lic.No/Date:0510410568<br>14.05.2019 |
|
|
| 138 |
**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. |
|
|
TIZOPTAN (BIMATOPROST 0.03%<br>AND TIMOLOL 0.5% OPHTHALMIC<br>SOLUTION) 3ML |
|
1 No. |
1 |
BIMATOPROST |
|
0.90 mg/3 ml vial |
|
|
BIMATAN EYE DROPS<br>(BIMATOPROST OPHTHALMIC<br>SOLUTION 0.03% 2.5ML) |
|
1 No. |
1 |
BIMATOPROST |
|
0.75 mg/2.5 ml vial |
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
50
| 139 |
Case No.:249/1/82-ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00155/AM20/ |
RLA File<br>:09/24/040/00071/AM20/ |
Lic.No/Date:0910067527<br>15.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 140 |
Case No.:252/1/82-<br>ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00158/AM20/ |
RLA File<br>:09/24/040/00069/AM20/ |
Lic.No/Date:0910067532<br>15.05.2019 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information:<br>(i)<br>COA of import item “Bacitracin” from Foreign Supplier showing potencyin IU / mg. |
|
|
|
| 141 |
Case No.:253/1/82-<br>ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Rejected |
|
HQ File<br>:01/82/050/00159/AM20/ |
RLA File<br>:09/24/040/00068/AM20/ |
Lic.No/Date:0910067533<br>15.05.2019 |
|
|
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was observed that as per DML furnished permission has been given by CDSCO for export of 1300 vials<br>against product licence for export of 9000 vials.<br>In view of above,the Committee decided torejectthe case. |
|
|
|
| Case No.:254/1/82- |
|
Party Name:AMITEX AGRO |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
PRODUCT PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829061 |
|
|
| :01/82/050/00160/AM20/ |
|
:03/94/040/00102/AM20/ |
|
15.05.2019 |
|
|
Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of 142 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. No. |
Import items |
Qty. |
| Standard Sunflower Lecithin Liquid |
200 kg |
1 |
Crude Sunflower Lecithin<br>Liquid |
200 kg |
51
| 143 |
Case No.:267/1/82-ALC4/2019 |
Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/00173/AM20/ |
RLA File<br>:31/83/040/00017/AM20/ |
Lic.No/Date:3110067419<br>15.05.2019 |
|
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Pune. |
|
|
|
Decision: 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.:256/1/82-ALC4/2019 |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:5/82- |
|
Status: |
|
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829068 |
|
|
| :01/82/050/00162/AM20/ |
|
:03/94/040/00072/AM20/ |
|
16.05.2019 |
|
|
Decision: The Committee considered the cases as per agenda in the presence of technical experts and 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
-
GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet contains (i) Glipizide USP- 10 mg
- (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii) Sentry Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 281.25 Kgs (ii) 835.313 Kgs (iii) 5009.063 Kgs (iv) 2812.50 Kgs.
-
GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet contains (i) Glipizide USP- 5 mg
-
(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP
-
144 NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 104.167 Kgs (ii) 425.001 Kgs (iii) 1855.214 Kgs (iv) 1041.67 Kgs.
- GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet contains (i) Glipizide USP- 2.5 mg
(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 31.25 Kgs (ii) 255 Kgs (iii) 1113.126 Kgs (iv) 625.001 Kgs.
| Sl.<br>No. |
Import Items |
For export of 1 Number of |
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)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP) |
20.40 mg |
20.40 mg |
29.70 mg |
| 3 |
SENTRY POLYOX WSR<br>N80 FP NF |
89.05 mg |
89.05 mg |
178.10 mg |
| 4 |
SENTRY POLYOX WSR<br>303 NF |
50.00 mg |
50.00 mg |
100.00 mg |
52
| Case No.:257/1/82-ALC4/2019 |
|
Party Name:J.B. CHEMICALS |
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Meet No/Date:5/82- |
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Status: |
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& PHARMACEUTICALS |
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ALC4/2019 |
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Approved |
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LIMITED |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310829085 |
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:03/94/040/00115/AM20/ |
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16.05.2019 |
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Case No.:257/1/82-ALC4/2019 |
Case No.:257/1/82-ALC4/2019 |
Case No.:257/1/82-ALC4/2019 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br> <br> <br>Lic.No/Date:0310829085<br>16.05.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br> <br> <br>Lic.No/Date:0310829085<br>16.05.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00163/AM20/ |
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RLA File<br>:03/94/040/00115/AM20/ |
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| 145 |
<br>**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:<br>Sl. No.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Item<br>Qty<br>1<br>Benzocaine and<br>Cetylpyridinium Chloride<br>Anaesthetic Throat Lozenges.<br>Flavours Black Current, Honey<br>Lemon & Other Flavours. Each<br>Lozenge Contains 12mg<br>Benzocaine. Net content of<br>Benzocaine-90.066 Kgs.<br>1 Number<br>1<br>Benzocaine<br>12.24 mg<br>2<br>Benzocaine and<br>Cetylpyridinium Chloride<br>Anaesthetic Throat Lozenges.<br>Flavours Black Current and<br>Lime & Lemon and Other<br>Flavours. Each Lozenge<br>contains 10mg Benzocaine. Net<br>content of Benzocaine - 17.341<br>Kgs.<br>1 Number<br>2<br>Benzocaine<br>10.2 mg<br>3<br>Benzocaine, Cetylpyridinium<br>Chloride And<br>Dextromethorphan<br>Hydrobromide Anaesthetic<br>Throat Lozenges.<br>Each Lozenge Contains 1.25mg<br>Benzocaine. Net content of<br>Benzocaine-8.696 Kgs.<br>1 Number<br>3<br>Benzocaine<br>1.275 mg<br>4<br>Life Brand Sore Throat & Nasal<br>Congestion Relief Extra<br>Strength<br>(Flavours Cherry/Honey &<br>Lemon/Other flavours) Sugar<br>Free Lozenges. Each Lozenge<br>Contains Bezocaine 15 mg &<br>Isomalt ST-M 2700 Mg. Net<br>Content Benzocaine 4.054 Kgs.<br>And Isomalt ST-M - 729.734<br>Kgs.<br>1 Number<br>4<br>Benzocaine<br>15.30 mg<br>5<br>Isomalt ST-M<br>2700 mg<br>5<br>Personnelle Oral Anesthetic<br>Sore Throat Lozenges Extra<br>Strenght Sugar Free<br>(Flavours Cherry/Honey<br>Lemon/Other flavours) Each<br>Lozenge Contains Bezocaine 15<br>mg & Isomalt ST-M 2700 Mg.<br>Net Content Benzocaine 2.703<br>Kgs. and Isomalt ST-M -<br>486.562 Kgs.<br>1 Number<br>6<br>Benzocaine<br>15.30 mg<br>7<br>Isomalt ST-M<br>2700 mg |
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Sl. No. |
Export Product |
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Qty. |
Sl. No. |
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Import Item |
Qty |
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1 |
Benzocaine and<br>Cetylpyridinium Chloride<br>Anaesthetic Throat Lozenges.<br>Flavours Black Current, Honey<br>Lemon & Other Flavours. Each<br>Lozenge Contains 12mg<br>Benzocaine. Net content of<br>Benzocaine-90.066 Kgs. |
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1 Number |
1 |
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Benzocaine |
12.24 mg |
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2 |
Benzocaine and<br>Cetylpyridinium Chloride<br>Anaesthetic Throat Lozenges.<br>Flavours Black Current and<br>Lime & Lemon and Other<br>Flavours. Each Lozenge<br>contains 10mg Benzocaine. Net<br>content of Benzocaine - 17.341<br>Kgs. |
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1 Number |
2 |
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Benzocaine |
10.2 mg |
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3 |
Benzocaine, Cetylpyridinium<br>Chloride And<br>Dextromethorphan<br>Hydrobromide Anaesthetic<br>Throat Lozenges.<br>Each Lozenge Contains 1.25mg<br>Benzocaine. Net content of<br>Benzocaine-8.696 Kgs. |
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1 Number |
3 |
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Benzocaine |
1.275 mg |
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4 |
Life Brand Sore Throat & Nasal<br>Congestion Relief Extra<br>Strength<br>(Flavours Cherry/Honey &<br>Lemon/Other flavours) Sugar<br>Free Lozenges. Each Lozenge<br>Contains Bezocaine 15 mg &<br>Isomalt ST-M 2700 Mg. Net<br>Content Benzocaine 4.054 Kgs.<br>And Isomalt ST-M - 729.734<br>Kgs. |
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1 Number |
4 |
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Benzocaine |
15.30 mg |
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5 |
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Isomalt ST-M |
2700 mg |
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5 |
Personnelle Oral Anesthetic<br>Sore Throat Lozenges Extra<br>Strenght Sugar Free<br>(Flavours Cherry/Honey<br>Lemon/Other flavours) Each<br>Lozenge Contains Bezocaine 15<br>mg & Isomalt ST-M 2700 Mg.<br>Net Content Benzocaine 2.703<br>Kgs. and Isomalt ST-M -<br>486.562 Kgs. |
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1 Number |
6 |
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Benzocaine |
15.30 mg |
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7 |
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Isomalt ST-M |
2700 mg |
53
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6<br>Option +Oral Lozenges Sore<br>Throat & Nasal Congestion<br>Relief Extra Strenght<br>Flavours Cherry/Honey Lemon<br>/Other flavours. Each Lozenge<br>Contains Bezocaine 15 mg &<br>Isomalt ST-M 2700 Mg. Net<br>Content Benzocaine 4.054 Kgs.<br>And Isomalt ST-M - 729.734<br>Kgs.<br>8<br>Benzocaine<br>9<br>Isomalt ST-M<br>Items at Sl.Nos.1,2,3,4,6<br>& 8 (Benzocaine) are<br>drugs and is covered<br>under P.C.No.9dt:<br>30.06.2003 read with<br>P.C.No.15,dt:17.09.2003<br>RA maytake appropriate action asper the decision of Norms Committee. |
6 |
Option +Oral Lozenges Sore<br>Throat & Nasal Congestion<br>Relief Extra Strenght<br>Flavours Cherry/Honey Lemon<br>/Other flavours. Each Lozenge<br>Contains Bezocaine 15 mg &<br>Isomalt ST-M 2700 Mg. Net<br>Content Benzocaine 4.054 Kgs.<br>And Isomalt ST-M - 729.734<br>Kgs. |
Option +Oral Lozenges Sore<br>Throat & Nasal Congestion<br>Relief Extra Strenght<br>Flavours Cherry/Honey Lemon<br>/Other flavours. Each Lozenge<br>Contains Bezocaine 15 mg &<br>Isomalt ST-M 2700 Mg. Net<br>Content Benzocaine 4.054 Kgs.<br>And Isomalt ST-M - 729.734<br>Kgs. |
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8 |
8 |
Benzocaine |
Benzocaine |
15.30 mg |
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9 |
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Isomalt ST-M<br>Items at Sl.Nos.1,2,3,4,6<br>& 8 (Benzocaine) are<br>drugs and is covered<br>under P.C.No.9dt:<br>30.06.2003 read with<br>P.C.No.15,dt:17.09.2003 |
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<br> <br>2700 mg |
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| 146 |
<br>Case No.:268/1/82-<br>ALC4/2019 |
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Party Name:CLEAN<br>SCIENCE AND<br>TECHNOLOGY PVT.LTD. |
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Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
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Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00174/AM20/ |
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RLA File<br>:31/83/040/00019/AM20/ |
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Lic.No/Date:3110067424<br>16.05.2019 |
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<br>Defer Date |
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**Decision:**Deferred for comments of TE. |
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| 147 |
<br>Case No.:269/1/82-ALC4/2019 |
Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00175/AM20/ |
RLA File<br>:31/83/040/00021/AM20/ |
Lic.No/Date:3110067425<br>16.05.2019 |
Defer Date |
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**Decision:**Deferred for comments of TE. |
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| 148 |
<br>Case No.:270/1/82-ALC4/2019 |
Party Name:VISION DRUGS<br>PVT LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00176/AM20/ |
RLA File<br>:09/24/040/00048/AM20/ |
Lic.No/Date:0910067541<br>17.05.2019 |
Defer Date |
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**Decision:**Deferred for comments of TE. |
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54
Case No.:271/1/82- Party Name:ORCH Meet No/Date:5/82- Status: ALC4/2019 LABORATORIES INDIA ALC4/2019 Approved PVT LTD 02.08.2019 HQ File RLA File Lic.No/Date:0910067543 :01/82/050/00177/AM20/ :09/24/040/00039/AM20/ 17.05.2019 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. 15/82-ALC4/2018 , dated 22.03.2019, 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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Case No.:271/1/82-<br>ALC4/2019 |
Party Name:ORCH<br>LABORATORIES INDIA<br>PVT LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00177/AM20/ |
RLA File<br>:09/24/040/00039/AM20/ |
Lic.No/Date:0910067543<br>17.05.2019 |
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| 149 |
<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>15/82-ALC4/2018<br>, dated 22.03.2019, 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>4-AMINO-2-OXO-<br>PYRIMIDINYL-<br>OXATHIOLANE-2-<br>CARBOXYLIC ACID-<br>ISOPROPYL-METHYL-<br>CYCLOHEXYLESTER (CHE)<br>1 kg<br>1<br>Glyoxylic Acid 50%<br>0.746 kg<br>2<br>L(-)menthol(Fresh/Recovery)<br>0.751 kg<br>3<br>Cyclohexane<br>0.790 kg<br>4<br>2,5-Dihydroxy-1,4-Dithiane<br>0.327 kg<br>5<br>Cytosine<br>0.434 kg<br>6<br>Hexamethyl Disilazane<br>0.708 kg<br>7<br>Methylene Dichloride<br>3.00 kg<br>8<br>Triphosgene<br>0.50 kg<br>9<br>n-Hexane<br>1.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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| 150 |
Case No.:276/1/82-<br>ALC4/2019 |
Party Name:PIRAMAL<br>ENTERPRISES LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status: Deferred |
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<br>HQ File<br>:01/82/050/00182/AM20/ |
RLA File<br>:03/95/040/00143/AM20/ |
Lic.No/Date:0310829108<br>17.05.2019 |
Defer Date |
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**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information:<br>(i)<br>Master Batch Formula for each export item to be furnished. . |
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| 151 |
Case No.:272/1/82-ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00077/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00178/AM20/ |
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Lic.No/Date:0910067546<br>20.05.2019 |
Defer Date |
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**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Bangalore. |
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55
| Case No.:273/1/82-ALC4/2019 |
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Party Name:GLAND |
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Meet No/Date:5/82- |
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Status: |
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PHARMA LIMITED |
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ALC4/2019 |
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Approved |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0910067548 |
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| :01/82/050/00179/AM20/ |
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:09/24/040/00076/AM20/ |
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20.05.2019 |
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Case No.:273/1/82-ALC4/2019 |
Case No.:273/1/82-ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED |
Party Name:GLAND<br>PHARMA LIMITED |
Party Name:GLAND<br>PHARMA LIMITED |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00179/AM20/ |
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RLA File<br>:09/24/040/00076/AM20/ |
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Lic.No/Date:0910067548<br>20.05.2019 |
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| 152 |
<br>**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:<br> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Esmolol Hydrochloride in Sodium<br>Chloride Injection 2000 mg per<br>100ml (20mg per ml) single dose<br>bags<br>14822.000<br>Number<br>1<br>Esmolol Hydrochloride<br>60.00 kg<br>Esmolol Hydrochloride in Sodium<br>Chloride Injection 2500 mg per<br>250ml (10mg per ml) single dose<br>bags<br>11000.000<br>Number<br>2<br>Flexible bags<br>Relevant as per<br>packing policy<br>3<br>Twist off port stoppers<br>Relevant as per<br>packing policy<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Export product |
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Qty. |
Sl.<br>No. |
Import items |
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Qty. |
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Esmolol Hydrochloride in Sodium<br>Chloride Injection 2000 mg per<br>100ml (20mg per ml) single dose<br>bags |
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14822.000<br>Number |
1 |
Esmolol Hydrochloride |
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60.00 kg |
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Esmolol Hydrochloride in Sodium<br>Chloride Injection 2500 mg per<br>250ml (10mg per ml) single dose<br>bags |
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11000.000<br>Number |
2 |
Flexible bags |
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Relevant as per<br>packing policy |
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3 |
Twist off port stoppers |
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Relevant as per<br>packing policy |
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| 153 |
<br>Case No.:275/1/82-<br>ALC4/2019 |
Party Name:SUNSHIELD<br>CHEMICALS LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00181/AM20/ |
RLA File<br>:03/95/040/00149/AM20/ |
Lic.No/Date:0310829140<br>20.05.2019 |
<br>Defer Date |
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**Decision:**Deferred for comments of TE. |
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56
| Case No.:277/1/82- |
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Party Name:CADILA |
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Meet No/Date:5/82- |
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Status: |
| ALC4/2019 |
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HEALTHCARE LTD |
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ALC4/2019 |
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Approved |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0810145319 |
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| :01/82/050/00183/AM20/ |
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:08/24/040/00053/AM20/ |
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21.05.2019 |
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Case No.:277/1/82-<br>ALC4/2019 |
Case No.:277/1/82-<br>ALC4/2019 |
Case No.:277/1/82-<br>ALC4/2019 |
Case No.:277/1/82-<br>ALC4/2019 |
Party Name:CADILA<br>HEALTHCARE LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00183/AM20/ |
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RLA File<br>:08/24/040/00053/AM20/ |
Lic.No/Date:0810145319<br>21.05.2019 |
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| 154 |
**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:<br> <br>Sl. No.<br>Export Product<br>Qty.<br>1<br>CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4<br>GRAMS<br>(60X9G<br>PCH<br>PACK)<br>(EACH POUCH OF 9 GRAMS CONTAIN 4 GRAMS OF<br>CHOLESTYRAMINE<br>RESIN<br>USP)<br>(ACTIVE<br>INGREDIENT:<br>CHOLESTYRAMINE RESIN USP-NET WT. 56158.560 KGS)<br>1 Number<br>2<br>CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4<br>GRAMS<br>(1X378G<br>JAR<br>PACK)<br>(EACH JAR OF 378 GRAMS EQUVIVALENT TO 42 POUCHES OF<br>9 GRAMS AND EACH POUCH OF 9 GRAMS CONTAIN 4 GRAMS<br>OF CHOLESTYRAMINE RESIN USP) (ACTIVE INGREDIENT:<br>CHOLESTYRAMINE RESIN USP-NET WT. 11278.512 KGS)<br>1 Number<br>3<br>CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT<br>POWDER<br>4<br>GRAMS<br>(60X5.5G<br>PCH<br>PACK)<br>(EACH POUCH OF 5.5 GRAMS CONTAIN 4 GRAMS OF<br>CHOLESTYRAMINE<br>RESIN<br>USP)<br>(ACTIVE<br>INGREDIENT:<br>CHOLESTYRAMINE RESIN USP-NET WT. 23996.160 KGS)<br>1 Number<br>4<br>CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT<br>POWDER<br>4<br>GRAMS<br>(1X231G<br>JAR<br>PACK)<br>(EACH JAR OF 231 GRAMS EQUVIVALENT TO 42 POUCHES OF<br>5.5 GRAMS AND EACH POUCH OF 5.5 GRAMS CONTAIN 4<br>GRAMS<br>OF<br>CHOLESTYRAMINE<br>RESIN<br>USP)<br>(ACTIVE<br>INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT.<br>9679.152 KGS)<br>1 Number<br>S.NO.<br>Import Items<br>For export of 1 Pouch of<br>9 gm<br>5.5 gm<br>1<br>CHOLESTYRAMINE RESIN USP<br>4.08 gm<br>4.08 gm<br>2<br>SUCROSE NF (COMPRESSUC PS)<br>4.461 gm<br>Nil<br>3<br>MANNITOL USP (PEARLITOL SD 200)<br>Nil<br>1.1575 gm<br>4<br>ANHYDROUS CITRIC ACID USP (POWDER GRADE)<br>0.100 gm<br>0.060 gm<br>5<br>PROPYLENEGLYCOL ALGINATENF(KELCOLOIDS)<br>0.225 gm<br>0.050 gm<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Sl. No. |
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Export Product |
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Qty. |
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1 |
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CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4<br>GRAMS<br>(60X9G<br>PCH<br>PACK)<br>(EACH POUCH OF 9 GRAMS CONTAIN 4 GRAMS OF<br>CHOLESTYRAMINE<br>RESIN<br>USP)<br>(ACTIVE<br>INGREDIENT:<br>CHOLESTYRAMINE RESIN USP-NET WT. 56158.560 KGS) |
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1 Number |
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2 |
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CHOLESTYRAMINE FOR ORAL SUSPENSION USP POWDER 4<br>GRAMS<br>(1X378G<br>JAR<br>PACK)<br>(EACH JAR OF 378 GRAMS EQUVIVALENT TO 42 POUCHES OF<br>9 GRAMS AND EACH POUCH OF 9 GRAMS CONTAIN 4 GRAMS<br>OF CHOLESTYRAMINE RESIN USP) (ACTIVE INGREDIENT:<br>CHOLESTYRAMINE RESIN USP-NET WT. 11278.512 KGS) |
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1 Number |
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3 |
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CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT<br>POWDER<br>4<br>GRAMS<br>(60X5.5G<br>PCH<br>PACK)<br>(EACH POUCH OF 5.5 GRAMS CONTAIN 4 GRAMS OF<br>CHOLESTYRAMINE<br>RESIN<br>USP)<br>(ACTIVE<br>INGREDIENT:<br>CHOLESTYRAMINE RESIN USP-NET WT. 23996.160 KGS) |
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1 Number |
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4 |
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CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT<br>POWDER<br>4<br>GRAMS<br>(1X231G<br>JAR<br>PACK)<br>(EACH JAR OF 231 GRAMS EQUVIVALENT TO 42 POUCHES OF<br>5.5 GRAMS AND EACH POUCH OF 5.5 GRAMS CONTAIN 4<br>GRAMS<br>OF<br>CHOLESTYRAMINE<br>RESIN<br>USP)<br>(ACTIVE<br>INGREDIENT: CHOLESTYRAMINE RESIN USP - NET WT.<br>9679.152 KGS) |
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1 Number |
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S.NO. |
Import Items |
|
|
|
For export |
of 1 Pouch of |
|
|
|
|
|
|
|
|
|
9 gm |
|
5.5 gm |
|
|
|
1 |
CHOLESTYRAMINE RESIN USP |
|
|
|
4.08 gm |
|
4.08 gm |
|
|
|
2 |
SUCROSE NF (COMPRESSUC PS) |
|
|
|
4.461 gm |
|
Nil |
|
|
|
3 |
MANNITOL USP (PEARLITOL SD 200) |
|
|
|
Nil |
|
1.1575 gm |
|
|
|
4 |
ANHYDROUS CITRIC ACID USP (POWDER GRADE) |
|
|
|
0.100 gm |
|
0.060 gm |
|
|
|
5 |
PROPYLENEGLYCOL ALGINATENF(KELCOLOIDS) |
|
|
|
0.225 gm |
|
0.050 gm |
|
|
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 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:
57
| Case No.:290/1/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:031082915 |
|
|
| :01/82/050/00196/AM20/ |
|
:03/94/040/00113/AM20/ |
|
6 |
|
|
|
|
|
|
21.05.2019 |
|
|
Decision: The 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 155 as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| AMIODARONE HCL |
1 kg |
1 |
2-BUTYL-3-(3,5-<br>DIIODO-4-HYDROXY<br>BENZOYL) |
0.9135 kg |
|
|
2 |
TOLUENE |
2.70 litres |
| 156 |
Case No.:291/1/82-ALC4/2019 |
Case No.:291/1/82-ALC4/2019 |
Case No.:291/1/82-ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred<br>Defer Date |
|
HQ File<br>:01/82/050/00197/AM20/ |
|
|
RLA File<br>:03/94/040/00112/AM20/ |
|
Lic.No/Date:0310829157<br>21.05.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 157 |
Case No.:293/1/82-ALC4/2019 |
|
|
Party Name:PRISM<br>INDUSTRIES LIMITED |
|
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00199/AM20/ |
|
|
RLA File<br>:34/24/040/00052/AM20/ |
|
Lic.No/Date:3410045164<br>21.05.2019 |
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 3/82-ALC4/2019 dated 05.07.2019, 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>LUMEFANTRINE<br>1 kg<br>1.<br>[DIBUTYLAMINE METHYL]-2,7-DICHLORO-4-<br>FLUOREN METHANOL<br>0.8693 kg<br>2.<br>PARA CHLORO BENZALDEHYDE<br>0.3477 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
|
Import Items |
|
Qty. |
|
LUMEFANTRINE |
1 kg |
1. |
|
[DIBUTYLAMINE METHYL]-2,7-DICHLORO-4-<br>FLUOREN METHANOL |
|
0.8693 kg |
|
|
|
2. |
|
PARA CHLORO BENZALDEHYDE |
|
0.3477 kg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
58
| Case No.:278/1/82-ALC4/2019 |
|
Party Name:S V LABS PVT |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067560 |
|
|
| :01/82/050/00184/AM20/ |
|
:09/24/040/00079/AM20/ |
|
22.05.2019 |
|
|
|
Case No.:278/1/82-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:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00184/AM20/ |
RLA File<br>:09/24/040/00079/AM20/ |
|
|
|
Lic.No/Date:0910067560<br>22.05.2019 |
|
| 158 |
**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. |
|
CYCLOHEXYL ESTER (CEI) |
|
1 kg |
1 |
GLYOXYLIC ACID |
|
0.743 kg |
|
|
|
|
2 |
2,5 DI HYDROXY 1,4 DITHIANE<br>(DIOL) |
|
0.325 kg |
|
|
|
|
3 |
CYTOSINE |
|
0.428 kg |
|
|
|
|
4 |
HEXAMETHYL DISILAZANE<br>(HMDS) |
|
0.698 kg |
|
|
|
|
5 |
L(-)MENTHOL |
|
0.751 kg |
|
|
|
|
6 |
TRIPHOSGENE |
|
0.40 kg |
|
|
|
|
7 |
METHYLENE CHLORIDE<br>STABILIZED WITH AMYLENE<br>50 PPM (MDC) |
|
2.63 kg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
| Case No.:279/1/82-ALC4/2019 |
|
Party Name:SMILAX |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067559 |
|
|
| :01/82/050/00185/AM20/ |
|
:09/24/040/00082/AM20/ |
|
22.05.2019 |
|
|
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. 15/82-ALC4/2018 159 , dated 22.03.2019, 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:
| Exportproduct |
Qty. |
Sl. No. |
Import items |
Qty. |
| Atorvastatin Calcium |
1 kg |
1 |
(4R,6R)-Tert-Butyl-6-Cyanomethyl- |
0.708 kg |
|
|
|
2,2-Dimethyl-1,3-Dioxane-4-Acetate |
|
|
|
|
(ATS-8) |
|
59
| 160 |
Case No.:280/1/82-ALC4/2019 |
Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED<br>RLA File<br>:09/24/040/00084/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00186/AM20/ |
|
Lic.No/Date:0910067561<br>22.05.2019 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Hyderabad. |
|
|
|
Decision: 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.:281/1/82- |
|
Party Name:MERCK |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829201 |
|
|
| :01/82/050/00187/AM20/ |
|
:03/95/040/00154/AM20/ |
|
22.05.2019 |
|
|
|
Case No.:281/1/82-<br>ALC4/2019 |
Party Name:MERCK<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00187/AM20/ |
RLA File<br>:03/95/040/00154/AM20/ |
Lic.No/Date:0310829201<br>22.05.2019 |
|
| 161 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision<br>taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of<br>HBP v1 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>Thiamine Disulfide<br>1 kg<br>1<br>Thiamine HCL<br>1.4199kg<br>2<br>Sodium Hydroxide Pellets<br>0.4605 kg<br>3<br>Potassium Hexacyanoferate III<br>GR<br>0.0022 kg<br>4<br>Hydrochloric Acid Fuming37%<br>0.3356 kg<br>5<br>Hydrogen Peroxide Solution 35%<br>extrapure<br>0.2157 kg<br>6<br>Acetone<br>0.6023 Litre<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 decision 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:
60
| Case No.:282/1/82- |
|
Party Name:J.B. |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
CHEMICALS & |
|
ALC4/2019 |
|
Approved |
|
|
PHARMACEUTICALS |
|
02.08.2019 |
|
|
|
|
LIMITED |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829196 |
|
|
| :01/82/050/00188/AM20/ |
|
:03/94/040/00120/AM20/ |
|
22.05.2019 |
|
|
Decision: The Committee considered the cases as per agenda in the presence of technical experts and 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
-
OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 5 MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg
- (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 13.333 Kgs (ii) 103.681 Kgs (iii) 214.723 Kgs (iv) 109.601 Kgs.
-
OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10 MG. Each tablet contains (i) Oxybutynin Chloride USP- 10 mg
-
(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80
-
162 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 57.50 Kgs (ii) 223.56 Kgs (iii) 464.428 Kgs (iv) 236.325 Kgs.
-
OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15 MG. Each tablet contains (i) Oxybutynin Chloride USP - 15 mg
- (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 81.02 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 33.335 Kgs (ii) 86.403 Kgs (iii) 180.051 Kgs (iv) 91.337 Kgs.
| Sl.<br>No. |
Import Items |
For export of 1 Number of |
For export of 1 Number of |
Tablet |
|
|
5 mg |
10 mg |
15 mg |
| 1 |
OXYBUTYNIN<br>CHLORIDE USP |
5.10 mg |
10.20 mg |
15.30 mg |
| 2 |
EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP) |
32.40 mg |
32.40 mg |
32.40 mg |
| 3 |
SENTRY POLYOX WSR<br>N80 FP NF |
80.52 mg |
80.77 mg |
81.02 mg |
| 4 |
SENTRY POLYOX WSR<br>303 NF |
41.10 mg |
41.10 mg |
41.10 mg |
61
| 163 |
<br>Case No.:283/1/82-ALC4/2019 |
Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00189/AM20/ |
RLA File<br>:03/95/040/00158/AM20/ |
Lic.No/Date:0310829176<br>22.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 164 |
<br>Case No.:284/1/82-ALC4/2019 |
Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00190/AM20/ |
RLA File<br>:03/95/040/00156/AM20/ |
Lic.No/Date:0310829177<br>22.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 165 |
<br>Case No.:285/1/82-ALC4/2019 |
Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00191/AM20/ |
RLA File<br>:03/95/040/00157/AM20/ |
Lic.No/Date:0310829190<br>22.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 166 |
<br>Case No.:286/1/82-ALC4/2019 |
Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00192/AM20/ |
RLA File<br>:03/95/040/00160/AM20/ |
Lic.No/Date:0310829199<br>22.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 167 |
<br>Case No.:287/1/82-ALC4/2019 |
Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00193/AM20/ |
RLA File<br>:03/95/040/00161/AM20/ |
Lic.No/Date:0310829200<br>22.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 168 |
<br>Case No.:288/1/82-ALC4/2019 |
Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00194/AM20/ |
RLA File<br>:03/95/040/00159/AM20/ |
Lic.No/Date:0310829205<br>22.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
62
| Case No.:289/1/82-ALC4/2019 |
|
Party Name:SANDHYA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
ORGANIC CHEMICALS |
|
ALC4/2019 |
|
Approved |
|
|
PRIVATE LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829197 |
|
|
| :01/82/050/00195/AM20/ |
|
:03/95/040/00133/AM20/ |
|
22.05.2019 |
|
|
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. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 169 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| TRIS (TRIDECYL) PHOSPHITE |
1 kg |
1 |
PHENOL |
0.05 kg |
|
|
2 |
TRIDECYL ALCOHOL |
0.975 kg |
|
|
3 |
PHOSPHORUS TRICHLORIDE |
0.229 kg |
| Case No.:292/1/82-ALC4/2019 |
|
Party Name:ASIATIC DRUGS |
|
Meet No/Date:5/82- |
|
Status: |
|
|
&PHARMACEUTICALS PVT. |
|
ALC4/2019 |
|
Approved |
|
|
LTD. |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410660 |
|
|
| :01/82/050/00198/AM20/ |
|
:05/23/040/00043/AM20/ |
|
22.05.2019 |
|
|
|
Case No.:292/1/82-ALC4/2019<br>HQ File<br>:01/82/050/00198/AM20/ |
Case No.:292/1/82-ALC4/2019<br>HQ File<br>:01/82/050/00198/AM20/ |
Case No.:292/1/82-ALC4/2019<br>HQ File<br>:01/82/050/00198/AM20/ |
Party Name:ASIATIC DRUGS<br>&PHARMACEUTICALS PVT.<br>LTD.<br>RLA File<br>:05/23/040/00043/AM20/ |
Party Name:ASIATIC DRUGS<br>&PHARMACEUTICALS PVT.<br>LTD.<br>RLA File<br>:05/23/040/00043/AM20/ |
Party Name:ASIATIC DRUGS<br>&PHARMACEUTICALS PVT.<br>LTD.<br>RLA File<br>:05/23/040/00043/AM20/ |
Party Name:ASIATIC DRUGS<br>&PHARMACEUTICALS PVT.<br>LTD.<br>RLA File<br>:05/23/040/00043/AM20/ |
Party Name:ASIATIC DRUGS<br>&PHARMACEUTICALS PVT.<br>LTD.<br>RLA File<br>:05/23/040/00043/AM20/ |
<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
<br>Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
|
|
|
|
|
|
|
|
Lic.No/Date:0510410660<br>22.05.2019 |
|
|
| 170 |
<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>15/82-ALC4/2018<br>, dated 22.03.2019, 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> <br> <br> <br> <br> |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Export product |
|
|
Qty. |
Sl.<br>No. |
Imp |
rt items |
|
|
Qty. |
|
|
Ampicillin Trihydrate (F<br>APA Route) |
rom 6- |
|
1 kg |
1 |
6-A<br>APA |
mino penicillanic acid (6-<br>) |
|
|
0.596 kg |
|
|
|
|
|
|
2 |
<br>D-(-<br>(PG |
<br>)-Alpha phenyl glycine base<br>base) |
|
|
0.417 kg |
|
3<br>Immobilized amidase(HIT-ABC)<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
3 |
Immobilized amidase(HIT-ABC) |
|
|
|
0.0018 kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63
| Case No.:296/1/82- |
|
Party Name:ADCOCK |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
INGRAM LTD, |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114945 |
|
|
| :01/82/050/00202/AM20/ |
|
:07/24/040/00035/AM20/ |
|
23.05.2019 |
|
|
|
Case No.:296/1/82-<br>ALC4/2019 |
Party Name:ADCOCK<br>INGRAM LTD, |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00202/AM20/ |
RLA File<br>:07/24/040/00035/AM20/ |
Lic.No/Date:0710114945<br>23.05.2019 |
|
| 171 |
<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>15/82-ALC4/2018<br>, dated 22.03.2019, 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. No.<br>Import items<br>Qty.<br>Neulin 125mg Tablets -<br>(Theophylline 125mg<br>+Guar gum 4.375mg)<br>(Theop-2500.000 +GUAR<br>GUM 87.500 KGS) (No. of<br>Tablets - 20000000) BP /<br>EP / USP / PH.EUR<br>1 no. of<br>Neulin<br>Tablet<br>1.<br>Theophylline BP / EP / USP / PH.EUR Anhydrous<br>Powder<br>127.5 mg<br>2.<br>Guar Gum IH (BP / EP / USP / PH.EUR)<br>4.375 mg<br>Neulin 200mg Tablets -<br>(Theophylline 200mg +<br>Guar gum 7.00mg)<br>(Theop-2500.000 +GUAR<br>GUM 87.500 KGS) (No. of<br>Tablets -12500000) BP /<br>EP / USP / PH.EUR<br>1 no. of<br>Neulin<br>tablet<br>1<br>Theophylline BP / EP / USP / PH.EUR Anhydrous<br>Powder<br>204.0 mg<br>2<br>Guar Gum IH (BP / EP / USP / PH.EUR)<br>7.00 mg<br>Neulin 250mg Tablets -<br>(Theophylline 250mg +<br>Guar gum 8.750mg)<br>(Theop-2500.000 +GUAR<br>GUM 87.500 KGS) (No. of<br>Tablets - 10000000) BP /<br>EP / USP / PH.EUR<br>1 no. of<br>Neulin<br>tablet<br>1<br>Theophylline BP / EP / USP / PH.EUR Anhydrous<br>Powder<br>255.0 mg<br>2<br>Guar Gum IH (BP / EP / USP / PH.EUR)<br>8.75 mg<br>Neulin 300mg Tablets -<br>(Theophylline 300mg +<br>Guar gum 10.5mg)<br>(Theop-3000.000 +GUAR<br>GUM 105.00 KGS) (No. of<br>Tablets - 10000000) BP /<br>EP / USP / PH.EUR<br>1 no. of<br>Neulin<br>tablet<br>1<br>Theophylline BP / EP / USP / PH.EUR Anhydrous<br>Powder<br>306.0 mg<br>2<br>Guar Gum IH (BP / EP / USP / PH.EUR)<br>10.5 mg<br>RA concerned maytake further necessaryaction asper 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. 15/82-ALC4/2018 , dated 22.03.2019, 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:
64
| Case No.:294/1/82- |
|
Party Name:CADILA |
|
Meet No/Date:5/82- |
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Status: |
| ALC4/2019 |
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HEALTHCARE LTD |
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ALC4/2019 |
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Approved |
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02.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0810145358 |
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| :01/82/050/00200/AM20/ |
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:08/24/040/00072/AM20/ |
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24.05.2019 |
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Case No.:294/1/82-<br>ALC4/2019 |
Case No.:294/1/82-<br>ALC4/2019 |
Case No.:294/1/82-<br>ALC4/2019 |
Party Name:CADILA<br>HEALTHCARE LTD |
Party Name:CADILA<br>HEALTHCARE LTD |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00200/AM20/ |
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RLA File<br>:08/24/040/00072/AM20/ |
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Lic.No/Date:0810145358<br>24.05.2019 |
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| 172 |
<br>**Decision:**The Committee considered the cases as per agenda in the presence of technical experts and it<br>was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,<br>whichever is less:<br>Export Product<br>Sl. No.<br>Export Product<br>Qty.<br>1<br>NYSTATIN TOPICAL POWDER USP 1,00,000 UNITS PER GRAM<br>(15 GRAM BOTTLE)<br>(EACH GRAM CONTAINS 22.730 MG OF NYSTATIN<br>MICRONIZED USP) (ACTIVE INGREDIENT : NYSTATIN<br>MICRONIZED USP-NET WT. 133.062 KGS)<br>1 Number<br>2<br>NYSTATIN TOPICAL POWDER USP 1,00,000 UNITS PER GRAM<br>(30 GRAM BOTTLE)<br>(EACH GRAM CONTAINS 22.730 MG OF NYSTATIN<br>MICRONIZED USP) (ACTIVE INGREDIENT : NYSTATIN<br>MICRONIZED USP-NET WT. 125.288 KGS)<br>1 Number<br>3<br>NYSTATIN TOPICAL POWDER USP 1,00,000 UNITS PER GRAM<br>(60 GRAM BOTTLE)<br>(EACH GRAM CONTAINS 22.730 MG OF NYSTATIN<br>MICRONIZED USP) (ACTIVE INGREDIENT : NYSTATIN<br>MICRONIZED USP-NET WT. 375.229 KGS)<br>1 Number<br>Sl.<br>No.<br>Import Items<br>For export of 1 No. of Pack<br>15 gm<br>30 gm<br>60 gm<br>1<br>NYSTATIN MICRONIZED USP<br>0.3444 gm<br>0.6887 gm<br>1.377 gm<br>2<br>TALC USP<br>14.659 gm<br>29.318 gm<br>58.636 gm<br>RA maytake appropriate action asper the decision of Norms Committee. |
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Sl. No. |
Export Product |
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Qty. |
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1 |
NYSTATIN TOPICAL POWDER USP 1,00,000 UNITS PER GRAM<br>(15 GRAM BOTTLE)<br>(EACH GRAM CONTAINS 22.730 MG OF NYSTATIN<br>MICRONIZED USP) (ACTIVE INGREDIENT : NYSTATIN<br>MICRONIZED USP-NET WT. 133.062 KGS) |
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1 |
Number |
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2 |
NYSTATIN TOPICAL POWDER USP 1,00,000 UNITS PER GRAM<br>(30 GRAM BOTTLE)<br>(EACH GRAM CONTAINS 22.730 MG OF NYSTATIN<br>MICRONIZED USP) (ACTIVE INGREDIENT : NYSTATIN<br>MICRONIZED USP-NET WT. 125.288 KGS) |
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1 |
Number |
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3 |
NYSTATIN TOPICAL POWDER USP 1,00,000 UNITS PER GRAM<br>(60 GRAM BOTTLE)<br>(EACH GRAM CONTAINS 22.730 MG OF NYSTATIN<br>MICRONIZED USP) (ACTIVE INGREDIENT : NYSTATIN<br>MICRONIZED USP-NET WT. 375.229 KGS) |
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1 |
Number |
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Sl.<br>No. |
Import Items |
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For export of 1 No. |
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of Pack |
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15 gm |
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30 gm |
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60 gm |
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1 |
NYSTATIN MICRONIZED USP |
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0.3444 gm |
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0.6887 gm |
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1.377 gm |
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2 |
TALC USP |
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14.659 gm |
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29.318 gm |
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58.636 gm |
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65
| Case No.:295/1/82- |
|
Party Name:CADILA |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
HEALTHCARE LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810145359 |
|
|
| :01/82/050/00201/AM20/ |
|
:08/24/040/00061/AM20/ |
|
24.05.2019 |
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|
Case No.:295/1/82- |
Case No.:295/1/82- |
Case No.:295/1/82- |
Case No.:295/1/82- |
Party Name:CADILA |
Party Name:CADILA |
Meet No/Date:5/82- |
Meet No/Date:5/82- |
Meet No/Date:5/82- |
Meet No/Date:5/82- |
Status: |
Status: |
|
<br>ALC4/2019<br>HQ File |
|
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|
<br>HEALTHCARE LTD |
|
<br>ALC4/2019<br>02.08.2019 |
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<br>Approved |
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RLA File |
|
Lic.No/Date:081014535 |
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9 |
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<br>:01/82/050/00201/AM20/ |
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<br>:08/24/040/00061/AM20/ |
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<br>24.05.2019 |
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**Decision:**The Committee |
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|
onsidered case as per agenda an |
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d deliberated |
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n the matter |
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in |
the presence of |
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<br>the technical experts and it was decided to ratify the ad-hoc input output n<br>per details below or as applied by firm whichever is lower:<br> |
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<br>orms under para 4.7 of HBP as |
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Sl. No. |
Export Product |
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Qty. |
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1 |
CISATRACURIUM<br>BESYLATE<br>INJECTION<br>USP<br> <br> <br> <br> |
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8519.000 Vials |
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10MG/5ML<br>(ACTIVE INGR<br>USP - NET W<br>MATERIAL IN<br>8519) |
(5ML<br>X<br>EDIENT : CISATRACURIUM<br>T. 0.085 KGS) & (RELEVENT<br>FINISHED FORM - NET |
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1VIAL)<br>BESYLATE<br>PACKING<br>VIALS/NOS. |
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2 |
<br>CISATRACURI<br>10MG/5ML |
UM<br>BESYLATE<br>INJECT<br>(5ML<br>X |
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ION<br>USP<br>10VIAL) |
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87160.000 |
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Vials |
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(ACTIVE INGREDIENT : CISATRACURIUM BESYLATE<br>USP - NET WT. 0.872 KGS) & (RELEVENT PACKING<br>MATERIAL IN FINISHED FORM - NET VIALS/NOS.<br>87160) |
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<br> <br> <br> |
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3 |
CISATRACURIUM<br>BESYLATE<br>INJECTION<br>USP<br>200MG/20ML<br>(20ML<br>X<br>1VIAL)<br>(ACTIVE INGREDIENT : CISATRACURIUM BESYLATE |
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10230.000 Vials |
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| 173 |
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<br>USP - NET W<br>MATERIAL IN<br>10230) |
<br>T. 2.046 KGS) & (RELEVENT<br>FINISHED FORM - NET |
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<br>PACKING<br>VIALS/NOS. |
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4 |
CISATRACURI<br>200MG/20ML<br> |
UM<br>BESYLATE<br>INJECT<br>(20ML<br>X<br> |
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ION<br>USP<br>10VIAL)<br> |
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88500.000 |
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Vials |
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(ACTIVE INGREDIENT : CISATRACURIUM BESYLATE<br>USP - NET WT. 17.700 KGS) & (RELEVENT PACKING<br>MATERIAL IN FINISHED FORM - NET VIALS/NOS.<br>88500) |
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Sl. No.<br>Import items<br>1<br>CISATRACURIUM BESYLATE USP<br>(THIS LICENCE IS ISSUED AS PER POLICY CIRCULAR NO.<br>9 DTD. 30.06.2003 AND POLICY CIRCULAR NO. 15 DTD.<br>17.09.2003 AND AS PER PARA 4.07 OF HBP 2015-20<br>SUBLECT TO FIXATION OF NORMS BY ALC, NEW DELHI)<br>2<br>6 ML CLEAR USP TYPE I TUBULAR GLASS VIALS<br>(AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED<br>PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 5%)<br>3<br>20 ML USP TYPE I CLEAR MOLDED GLASS VIALS<br>(AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED<br>PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 5%)<br>4<br>20 MM OMNIFLEX PLUS RUBBER STOPPER<br>(AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED<br>PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 1%)<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Qty.<br>29.15 kg<br>Relevant as per<br>packing policy<br>Relevant as per<br>packing policy<br>Relevant as per<br>packing policy |
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Sl. No. |
Import items |
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Qty. |
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1 |
CISATRACURIUM BESYLATE USP<br>(THIS LICENCE IS ISSUED AS PER POLICY CIRCULAR NO.<br>9 DTD. 30.06.2003 AND POLICY CIRCULAR NO. 15 DTD.<br>17.09.2003 AND AS PER PARA 4.07 OF HBP 2015-20<br>SUBLECT TO FIXATION OF NORMS BY ALC, NEW DELHI) |
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29.15 kg |
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2 |
6 ML CLEAR USP TYPE I TUBULAR GLASS VIALS<br>(AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED<br>PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 5%) |
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Relevant as per<br>packing policy |
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3 |
20 ML USP TYPE I CLEAR MOLDED GLASS VIALS<br>(AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED<br>PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 5%) |
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Relevant as per<br>packing policy |
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4 |
20 MM OMNIFLEX PLUS RUBBER STOPPER<br>(AS PER GENERAL NOTE FOR CHEMICAL AND ALLIED<br>PRODUCTS POINT NO. 5, WASTAGE ALLOWED @ 1%) |
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Relevant as per<br>packing policy |
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Decision: The 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 details below or as applied by firm whichever is lower:
66
| Case No.:297/1/82-ALC4/2019 |
|
Party Name:ADCOCK |
|
Meet No/Date:5/82- |
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Status: |
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|
INGRAM LTD, |
|
ALC4/2019 |
|
Approved |
|
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|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114948 |
|
|
| :01/82/050/00203/AM20/ |
|
:07/24/040/00034/AM20/ |
|
24.05.2019 |
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|
Case No.:297/1/82-ALC4/2019 |
Case No.:297/1/82-ALC4/2019 |
Party Name:ADCOCK<br>INGRAM LTD |
Party Name:ADCOCK<br>INGRAM LTD |
Party Name:ADCOCK<br>INGRAM LTD |
Party Name:ADCOCK<br>INGRAM LTD |
Party Name:ADCOCK<br>INGRAM LTD |
Party Name:ADCOCK<br>INGRAM LTD |
Party Name:ADCOCK<br>INGRAM LTD |
Party Name:ADCOCK<br>INGRAM LTD |
Meet No/Date:5/82-<br>ALC4/2019 |
Meet No/Date:5/82-<br>ALC4/2019 |
Status:<br>Approved |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00203/AM20/ |
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,<br>RLA File<br>:07/24/040/00034/AM20/ |
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<br>02.08.2019 |
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Lic.No/Date:0710114<br>24.05.2019 |
948 |
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**Decision:**The Committee<br>the<br>light<br>of<br>earlier<br>d |
considered the case as per agend<br>ecision<br>taken<br>by<br>NC<br>in |
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a in the presence of Techni<br> <br>its<br>Meeting<br>No<br> |
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cal Experts and in<br>15/82-ALC4/2018 |
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| 174 |
<br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br> <br>.<br> <br>, dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7<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>SYNDOL TABLETS -<br>(Paracetamol 450mg + Caffeine<br>30mg +<br>Doxylamine Succinate 5mg +<br>Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632mg) (Para -<br>13500.000+Caff -900.000+<br>Doxy-150.000+Codeine -<br>300.000 Colour Yellow 14037-<br>48.960 KGS) (No. of Tablets<br>30000000) BP/EP/USP/PH.EUR<br>1<br>million<br>tablets<br>1.<br>DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade<br>2.<br>CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR<br>3.<br>COLOUR YELLOW 14037 IH |
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<br>of HBP Vol. I as |
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Qt |
y. |
Sl.<br>No. |
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Impo |
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rt items |
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Qty. |
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1<br>mil<br>tb |
lion<br>t |
1. |
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DOX<br>USP |
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YLAMINE SUCCINATE<br>/Ph. Eur Grade |
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5.10 kg |
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2 |
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COD |
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ENE PHOSPHATE BP / |
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102 k |
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a |
es |
. |
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<br>EP / |
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<br>USP / PH.EUR |
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. g |
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3. |
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COL |
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OUR YELLOW 14037 IH |
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1.632 kg |
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ADCO DOL TABLETS -<br>(Paracetamol 450mg+Codeine<br> |
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1<br>million |
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1. |
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DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade |
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5.10 kg |
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Phosphate 10mg+Caffeine<br>45mg+<br>Doxylamine Succinate<br>5mg+Colour Yellow Lake- |
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tablets |
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2. |
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CO<br>EP |
DIENE PHOSPHATE BP /<br>/ USP / PH.EUR |
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10.2 kg |
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3. |
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CO |
LOUR YELLOW 14037 IH |
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2.43 kg |
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<br>4.56mg+ Colour Yellow WS<br>2.43mg)(Para- |
- |
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4. |
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CO<br>YE |
LOUR QUINOLINE<br>LLOW WS (SPECTRACO |
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L) |
4.56 kg |
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45000.000+Codeine-<br>1000.000+Caff-4500.000+Doxy-<br>500.000 Colour Yellow Lake-<br>456.000 Colour Yellow WS-<br>243000 KGSN f Tblt |
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. )(o. o aes<br>100000000)BP/EP/USP/PH.EUR |
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RA concerned maytake further |
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necessaryaction asper above deci |
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sion of NC. |
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67
| Case No.:298/1/82- |
|
Party Name:ADCOCK |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
INGRAM LTD, |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114950 |
|
|
| :01/82/050/00204/AM20/ |
|
:07/24/040/00036/AM20/ |
|
24.05.2019 |
|
|
|
Case No.:298/1/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00204/AM20/ |
Party Name:ADCOCK<br>INGRAM LTD, |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved<br> |
|
|
RLA File<br>:07/24/040/00036/AM20/ |
Lic.No/Date:0710114950<br>24.05.2019 |
|
| 175 |
<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>15/82-ALC4/2018<br>, dated 22.03.2019, 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. No.<br>Import items<br>Qty.<br>Neulin 125mg Tablets -<br>(Theophylline 125mg<br>+Guar gum 4.375mg)<br>(Theop-2500.000 +GUAR<br>GUM 87.500 KGS) (No. of<br>Tablets - 20000000) BP /<br>EP / USP / PH.EUR<br>1 no. of Neulin<br>Tablet<br>1.<br>Theophylline BP / EP / USP / PH.EUR<br>Anhydrous Powder<br>127.5 mg<br>2.<br>Guar Gum IH (BP / EP / USP / PH.EUR)<br>4.375 mg<br>Neulin 200mg Tablets -<br>(Theophylline 200mg +<br>Guar gum 7.00mg)<br>(Theop-2500.000 +GUAR<br>GUM 87.500 KGS) (No. of<br>Tablets -12500000) BP /<br>EP / USP / PH.EUR<br>1 no. of Neulin<br>tablet<br>1<br>Theophylline BP / EP / USP / PH.EUR<br>Anhydrous Powder<br>204.0 mg<br>2<br>Guar Gum IH (BP / EP / USP / PH.EUR)<br>7.00 mg<br>Neulin 250mg Tablets -<br>(Theophylline 250mg +<br>Guar gum 8.750mg)<br>(Theop-2500.000 +GUAR<br>GUM 87.500 KGS) (No. of<br>Tablets - 10000000) BP /<br>EP / USP / PH.EUR<br>1 no. of Neulin<br>tablet<br>1<br>Theophylline BP / EP / USP / PH.EUR<br>Anhydrous Powder<br>255.0 mg<br>2<br>Guar Gum IH (BP / EP / USP / PH.EUR)<br>8.75 mg<br>Neulin 300mg Tablets -<br>(Theophylline 300mg +<br>Guar gum 10.5mg)<br>(Theop-3000.000 +GUAR<br>GUM 105.00 KGS) (No. of<br>Tablets - 10000000) BP /<br>EP / USP / PH.EUR<br>1 no. of Neulin<br>tablet<br>1<br>Theophylline BP / EP / USP / PH.EUR<br>Anhydrous Powder<br>306.0 mg<br>2<br>Guar Gum IH (BP / EP / USP / PH.EUR)<br>10.5 mg<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. 15/82-ALC4/2018 , dated 22.03.2019, 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:
| 176 |
<br>Case No.:299/1/82-ALC4/2019 |
Party Name:RUBICON<br>RESEARCH PVT. LTD.,<br>RLA File<br>:03/95/040/00103/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00205/AM20/ |
|
Lic.No/Date:0310829246<br>24.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
68
|
|
Case No.:300/1/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
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|
|
|
|
02.08.2019 |
|
|
| 177 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310829263 |
|
Defer Date |
|
|
:01/82/050/00206/AM20/ |
|
:03/94/040/00133/AM20/ |
|
27.05.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
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|
Case No.:301/1/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:5/82- |
|
Status: |
|
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|
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
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|
|
02.08.2019 |
|
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| 178 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310829265 |
|
Defer Date |
|
|
:01/82/050/00207/AM20/ |
|
:03/94/040/00134/AM20/ |
|
27.05.2019 |
|
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|
|
**Decision:**Deferred for comments of TE. |
|
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|
| Case No.:302/1/82- |
|
Party Name:BRAWN |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410722 |
|
|
| :01/82/050/00208/AM20/ |
|
:05/23/040/00088/AM20/ |
|
27.05.2019 |
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|
|
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
ALC4/2019<br>LABORATORIES LTD<br>ALC4/2019<br>02.08.2019<br>Approved<br>HQ File<br>:01/82/050/00208/AM20/<br>RLA File<br>:05/23/040/00088/AM20/<br>Lic.No/Date:0510410722<br>27.05.2019 |
|
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|
|
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of |
|
|
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|
|
|
|
|
|
|
|
|
the technical experts and it was decided to ratify the ad-hoc input |
|
|
|
|
|
|
|
output norms under |
para 4.7 of HBP as |
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|
|
per details below or as applied by firm |
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whichever is lower: |
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|
179 |
|
|
Export product |
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|
Qty.<br>Sl. No. |
|
|
Import items |
Qty. |
|
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|
|
|
CEFADROXIL CAPSULES 500 |
|
|
|
1 Number<br>1 |
|
|
CEFADROXIL |
535.244 mg |
|
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|
MG |
|
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|
|
MONOHYDRATE |
/ capsule |
|
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|
(HARD GELATIN CAPSULE |
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USP |
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CONTAINING WHITE |
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(WHITE TO OFF |
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CRYSTALLINE POWDER) |
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WHITE |
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CRYSTALLINE |
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POWDER) |
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RA concerned maytake further necessaryaction asper above decision of NC. |
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|
Case No.:303/1/82-ALC4/2019 |
|
|
Party |
|
Name:CLEAN SCIENCE |
|
|
Meet No/Date:5/82- |
|
|
Status: |
|
|
|
|
|
|
|
|
AND |
|
TECHNOLOGY |
|
|
ALC4/2019 |
|
|
Deferred |
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|
PVT.LTD. |
|
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|
02.08.2019 |
|
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180 |
|
HQ File<br>:01/82/050/00209/AM20/ |
|
|
RLA File<br>:31/83/040/00032/AM20/ |
|
|
|
|
Lic.No/Date:3110067429<br>28.05.2019 |
|
|
Defer Date |
|
|
|
|
|
**Decision:**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 |
|
|
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from RLA,Pune. |
|
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|
69
Case No.:304/1/82- Party Name:VERGO Meet No/Date:5/82- Status: ALC4/2019 PHARMA RESEARCH ALC4/2019 Approved LABORATORIES PVT. LTD., 02.08.2019 HQ File RLA File Lic.No/Date:0310829291 :01/82/050/00210/AM20/ :03/95/040/00182/AM20/ 28.05.2019 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. 15/82-ALC4/2018 181 , dated 22.03.2019, 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.<br>No. |
Import Item |
Qty. |
| Amantadine HCL<br>capsules 100 mg |
1capsule |
1 |
Amantadine Hydrochloride |
102 mg/ capsule |
| 182 |
Case No.:305/1/82-ALC4/2019 |
Party Name:RUMIT<br>CHEMISYNTH PRIVATE<br>LIMITED<br>RLA File<br>:03/95/040/00196/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00211/AM20/ |
|
Lic.No/Date:0310829292<br>28.05.2019 |
Defer Date |
|
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>from RLA,Mumbai. |
|
|
|
Decision: 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.:306/1/82- |
|
Party Name:VERGO |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA RESEARCH |
|
ALC4/2019 |
|
Approved |
|
|
LABORATORIES PVT. LTD., |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829293 |
|
|
| :01/82/050/00212/AM20/ |
|
:03/95/040/00183/AM20/ |
|
28.05.2019 |
|
|
Decision: The Committee considered the cases as per agenda 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 183 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 |
|
510 mcg/ |
|
|
|
|
Colchicine Ph.Eur |
500mcg |
|
|
|
|
|
tablet |
| RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
| 184 |
<br>Case No.:307/1/82-ALC4/2019 |
Party Name:ATUL LIMITED,<br>RLA File<br>:08/24/040/00073/AM20/ |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00213/AM20/ |
|
Lic.No/Date:0810145379<br>28.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
70
|
|
Case No.:308/1/82-ALC4/2019 |
|
Party Name:ATUL LIMITED, |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
02.08.2019 |
|
|
| 185 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0810145380 |
|
Defer Date |
|
|
:01/82/050/00214/AM20/ |
|
:08/24/040/00074/AM20/ |
|
28.05.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:311/1/82-ALC4/2019 |
|
Party Name:GLAND |
|
Meet No/Date:5/82- |
|
Status: |
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067595 |
|
|
| :01/82/050/00217/AM20/ |
|
:09/24/040/00090/AM20/ |
|
28.05.2019 |
|
|
Decision: The Committee considered the cases as per agenda 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:
Export Product : 1. Adenosine Injection Prefilled Syringe 3mg/ml, 2ml in a PFS 2. Adenosine Injection Prefilled Syringe 3mg/ml, 4ml in a PFS 186
| Sl. |
|
Quantity |
Quantity |
| No. |
Import Item Name. |
3mg/ml, 2ml in a |
3mg/ml, 4ml in a |
|
|
PFS USP |
PFS USP |
| 1 |
Adenosine |
0.0066 gm/ vial |
0.0132 gm/ vial |
| 2 |
Barrel Syringes |
Relevant, as per |
Relevant, as per |
| 3 |
V-OVS 10.6 Tip Caps |
packing policy |
packing policy |
| 4 |
Plunger Stoppers |
|
|
| 5 |
Plunger Rods |
|
|
| Case No.:312/1/82- |
|
Party Name:MEDREICH |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114969 |
|
|
| :01/82/050/00218/AM20/ |
|
:07/24/040/00027/AM20/ |
|
28.05.2019 |
|
|
Decision: The 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 details below or as applied by firm whichever is lower:
187
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Rosuvastatin 10mg & Ezetimibe |
241.176 kg |
1 |
ROSUVASTATIN |
575.000 kg |
|
10mg Tablets [24117600 No.] |
|
|
CALCIUM |
|
|
Rosuvastatin 20mg & Ezetimibe |
300.000 kg |
|
|
|
|
10mg Tablets [15000000 No.] |
|
|
|
|
71
| Case No.:309/1/82- |
|
Party Name:ASHISH LIFE |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
SCIENCE PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829306 |
|
|
| :01/82/050/00215/AM20/ |
|
:03/94/040/00130/AM20/ |
|
29.05.2019 |
|
|
|
Case No.:309/1/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00215/AM20/ |
Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD. |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
|
RLA File<br>:03/94/040/00130/AM20/ |
Lic.No/Date:0310829306<br>29.05.2019 |
|
| 188 |
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence<br>of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP<br>as 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>BENZYL PENICILLIN FOR<br>INJECTION<br>(EACH VIAL CONTAINS<br>BENZYL PENICILLIN<br>SODIUM EQ. TO BENZYL<br>PENICILLIN 5000000 I.U.)<br>(3000MG)<br>208600.000<br>Number<br>1<br>BENZYL<br>PENICILIN<br>SODIUM<br>700.320 kg<br>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 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:
| 189 |
Case No.:310/1/82-ALC4/2019 |
Party Name:YASHO<br>INDUSTRIES LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00216/AM20/ |
RLA File<br>:03/95/040/00188/AM20/ |
Lic.No/Date:0310829319<br>29.05.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
72
|
Case No.:313/1/82-ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00219/AM20/ |
RLA File<br>:09/24/040/00094/AM20/ |
Lic.No/Date:0910067596<br>29.05.2019 |
|
| 190 |
**Decision:**The Committee considered the request of the firm for revision in adhoc norms in the presence<br>of technical experts and after deliberation, it was decided to revise the adhoc norms as under:<br>Export Product<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>Levoleucovorin Injection 175mg/17.5ml Vial<br>1 Number<br>2<br>Levoleucovorin Injection 250mg/25ml Vial<br>1 Number<br>S.NO.<br>Import Items<br>Norms recommended for 1 No. Injection<br>Qty.<br>(for175mg/17.5ml Vial)<br>Qty.<br>(for250mg/25ml Vial)<br>1<br>Levoleucovorin Calcium<br>233.49 mg / 17.5 ml vial<br>333.56 mg / 25 ml vial<br>2<br>Glass Vials<br>Relevant, as per packing policy<br>3<br>Rubber Stoppers<br>4<br>Flip Off Seals<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
Case No.:313/1/82-ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00219/AM20/ |
RLA File<br>:09/24/040/00094/AM20/ |
Lic.No/Date:0910067596<br>29.05.2019 |
|
| 190 |
**Decision:**The Committee considered the request of the firm for revision in adhoc norms in the presence<br>of technical experts and after deliberation, it was decided to revise the adhoc norms as under:<br>Export Product<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>Levoleucovorin Injection 175mg/17.5ml Vial<br>1 Number<br>2<br>Levoleucovorin Injection 250mg/25ml Vial<br>1 Number<br>S.NO.<br>Import Items<br>Norms recommended for 1 No. Injection<br>Qty.<br>(for175mg/17.5ml Vial)<br>Qty.<br>(for250mg/25ml Vial)<br>1<br>Levoleucovorin Calcium<br>233.49 mg / 17.5 ml vial<br>333.56 mg / 25 ml vial<br>2<br>Glass Vials<br>Relevant, as per packing policy<br>3<br>Rubber Stoppers<br>4<br>Flip Off Seals<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
73
| Case No.:314/1/82- |
|
Party Name:GLOBAL |
|
Meet No/Date:5/82- |
|
Status: |
| ALC4/2019 |
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114983 |
|
|
| :01/82/050/00220/AM20/ |
|
:07/24/040/00048/AM20/ |
|
29.05.2019 |
|
|
|
Case No.:314/1/82-<br>ALC4/2019<br> <br> <br> <br>HQ File<br>:01/82/050/00220/AM20/<br> <br> |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
|
RLA File<br>:07/24/040/00048/AM20/ |
Lic.No/Date:0710114983<br>29.05.2019 |
|
| 191 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 2/82-ALC4/2019 dated 21.06.2019, 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>CALCIUM GLUCONATE (EP FOR<br>INJECTION/JP/USP)<br>1 kg<br>1<br>CALCIUM<br>GLUCONATE<br>1.09 kg<br>CALCIUM BOROGLUCONATE<br>1 kg<br>1<br>CALCIUM<br>GLUCONATE<br>0.946 kg<br>CALCIUM GLUBIONATE(FOR<br>INJECTION) / CALCIUM<br>GLUBIONATE<br>1 kg<br>1<br>CALCIUM<br>GLUCONATE<br>0.430 kg<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 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:
| Case No.:315/1/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:5/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114984 |
|
|
| :01/82/050/00221/AM20/ |
|
:07/24/040/00049/AM20/ |
|
29.05.2019 |
|
|
|
Case No.:315/1/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00221/AM20/ |
RLA File<br>:07/24/040/00049/AM20/ |
|
|
Lic.No/Date:0710114984<br>29.05.2019 |
|
| 192 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 2/82-ALC4/2018 dated 16.05.2018, 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: |
|
|
|
|
|
|
Export product |
Qty. |
Sl. No. |
Import items |
|
Qty. |
|
<br>MAGNESIUM CITRATE<br>(USP/ NONAHYDRATE<br>Eur.Ph/ ANHYDROUS<br>Eur.Ph/ DODECAHYDRATE<br>Eur.Ph) |
1 kg |
1 |
CITRIC ACID - ANY GRADE |
|
1.001 kg |
|
|
|
2 |
MAGNESIUM CARBONATE -<br>ANY GRADE |
|
0.730 kg |
|
CALCIUM CITRATE(USP) |
1 kg |
1 |
CITRIC ACID - ANY GRADE |
|
0.816 kg |
|
|
|
2 |
Calcium Carbonate |
|
0.708 kg |
|
ZINC CITRATE(USP) |
1 kg |
1 |
CITRIC ACID - ANY GRADE |
|
0.880 kg |
|
POTASSIUM<br>CITRATE(BP/Eur.Ph/USP) |
1 kg |
1 |
CITRIC ACID - ANY GRADE |
|
0.859 kg |
|
RA maytake appropriate action |
asper the |
decision of Norms Committee. |
|
|
|
74
| Case No.:316/1/82-ALC4/2019 |
|
Party Name:COVALENT |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067597 |
|
|
| :01/82/050/00222/AM20/ |
|
:09/24/040/00091/AM20/ |
|
30.05.2019 |
|
|
|
Case No.:316/1/82-ALC4/2019 |
Case No.:316/1/82-ALC4/2019 |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00222/AM20/ |
|
RLA File<br>:09/24/040/00091/AM20/ |
|
|
|
Lic.No/Date:0910067597<br>30.05.2019 |
|
| 193 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken<br>in meeting no. 1/82-ALC4/2019 dated 03.06.2019, 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. No.<br>Import items<br>Qty.<br>Cefuroxime<br>Axetil<br>Amorphous<br>1 kg<br>1<br>D-7-AMINO CEPHALOSPORANIC<br>ACID (D-7-ACA)<br>0.752 kg<br>2<br>Cholorosulphonyl Isocynate<br>0.53 kg<br>3<br>(Z)-2-Methoxy Imino (Furyl-2-YL)<br>Acetic Acid Ammonium Salt (SMIA)<br>0.700 kg<br>4<br>Dimethyl Acetamide<br>1.94 kg<br>5<br>Methylene Chloride<br>2.87 kg<br>6<br>Acetone<br>0.175 kg<br>7<br>Methanol<br>3.05 kg<br>8<br>Activated Carbon<br>0.100kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl. No. |
Import items |
|
Qty. |
|
|
Cefuroxime<br>Axetil<br>Amorphous |
|
1 kg |
1 |
D-7-AMINO CEPHALOSPORANIC<br>ACID (D-7-ACA) |
|
0.752 kg |
|
|
|
|
|
2 |
Cholorosulphonyl Isocynate |
|
0.53 kg |
|
|
|
|
|
3 |
(Z)-2-Methoxy Imino (Furyl-2-YL)<br>Acetic Acid Ammonium Salt (SMIA) |
|
0.700 kg |
|
|
|
|
|
4 |
Dimethyl Acetamide |
|
1.94 kg |
|
|
|
|
|
5 |
Methylene Chloride |
|
2.87 kg |
|
|
|
|
|
6 |
Acetone |
|
0.175 kg |
|
|
|
|
|
7 |
Methanol |
|
3.05 kg |
|
|
|
|
|
8 |
Activated Carbon |
|
0.100kg |
|
|
|
|
per the decision of Norms Committee. |
|
|
|
|
| Case No.:317/1/82-ALC4/2019 |
|
Party Name:COVALENT |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067598 |
|
|
| :01/82/050/00223/AM20/ |
|
:09/24/040/00092/AM20/ |
|
30.05.2019 |
|
|
|
Case No.:317/1/82-ALC4/2019 |
Case No.:317/1/82-ALC4/2019 |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:5/82-<br>ALC4/2019<br>02.08.2019<br> <br><br>Lic.No/Date:0910067598<br>30.05.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00223/AM20/ |
|
RLA File<br>:09/24/040/00092/AM20/ |
|
|
|
|
| 194 |
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision<br>taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of<br>HBP v1 as per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
<br>Export product |
Qty. |
|
Sl.<br>No. |
Import items |
|
Qty. |
|
Cefixime |
1 kg |
|
1 |
7-Phenylacetamideo-3-Chloromethyl<br>Cephalosporonic<br>Acid<br>Para<br>Methoxybenzyl Ester (GCLE) |
|
1.4219 kg |
|
|
|
|
2 |
Triphenyl Phosphine |
|
0.775 kg |
|
|
|
|
3 |
Activated Carbon |
|
0.05 kg |
|
|
|
|
4 |
Dimethyl Formamide |
|
2.80 kg |
|
|
|
|
5 |
Methylene Chloride |
|
10.00 kg |
|
|
|
|
6 |
Mica Ester |
|
0.82 kg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
75
| Case No.:318/1/82-ALC4/2019 |
|
Party Name:PORUS |
|
Meet No/Date:5/82- |
|
Status: |
|
|
LABORATORIES PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
02.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067601 |
|
|
| :01/82/050/00224/AM20/ |
|
:09/24/040/00085/AM20/ |
|
30.05.2019 |
|
|
|
|
**Decision:**The Committee considered the case as |
**Decision:**The Committee considered the case as |
**Decision:**The Committee considered the case as |
**Decision:**The Committee considered the case as |
**Decision:**The Committee considered the case as |
per agenda in the presence of Technical Experts and |
per agenda in the presence of Technical Experts and |
per agenda in the presence of Technical Experts and |
per agenda in the presence of Technical Experts and |
per agenda in the presence of Technical Experts and |
per agenda in the presence of Technical Experts and |
|
|
in<br>the<br>light<br>of<br>earlier |
decision |
|
<br>taken |
<br>by |
NC<br>in<br>its<br>Meeting |
|
No. |
<br>15/82-ALC4/2018 |
|
|
|
|
, dated 22.03.2019, 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: |
|
|
|
|
|
|
|
|
|
|
| 195 |
|
Export product |
|
|
Qty. |
Sl. |
|
Import items |
|
|
Qty. |
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
|
2-Phenyl-3,3-bis(4-hydroxy |
|
|
1 kg |
1 |
|
PTHALIC ANHYDRIDE |
|
|
0.927 kg |
|
|
|
phenyl)phthalimide (PPP-BP) |
|
|
|
2 |
|
PHENOL |
|
|
1.145 kg |
|
|
|
|
|
|
|
3 |
|
ZINC CHLORIDE |
|
|
0.104 kg |
|
|
|
|
|
|
|
4 |
|
ANILINE |
|
|
0.596 kg |
|
|
|
|
|
|
|
5 |
|
METHANOL |
|
|
0.715 kg |
|
|
|
|
|
|
|
6 |
|
ACTIVATEDCARBON |
|
|
0.100kg |
|
|
|
RA concerned maytake further |
necessaryaction asper |
|
|
|
above decision of NC. |
|
|
|
|
|
|
|
Case No.:319/1/82-ALC4/2019 |
|
Party Name:RAVESHIA |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
ORGANICS LLP |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
02.08.2019 |
|
|
| 196 |
|
HQ File<br>:01/82/050/00225/AM20/ |
|
RLA File<br>:03/95/040/00204/AM20/ |
|
Lic.No/Date:0310829355<br>30.05.2019 |
|
Defer Date |
|
|
**Decision:**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: 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.:320/1/82-ALC4/2019 |
|
Party Name:DEEPAK |
|
Meet No/Date:5/82- |
|
Status: |
|
|
|
|
PHENOLICS LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
02.08.2019 |
|
|
| 197 |
|
HQ File<br>:01/82/050/00226/AM20/ |
|
RLA File<br>:34/24/040/00036/AM20/ |
|
Lic.No/Date:3410045179<br>30.05.2019 |
|
Defer Date |
|
|
**Decision:**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. |
|
|
|
|
|
|
Decision: 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.
76
MANUAL CASES
|
Case No. |
B-1 |
|
Meeting No. |
05/AM20 |
|
Date |
02.08.2019 |
|
Firm’s Name |
M/s Amines & Plasticizers Limited. |
|
HQ F. No. |
01/82/050/00498/AM19/DES-III |
|
RLA F. No. |
03/94/040/01041/AM18 |
|
Advance Authorization No. and Date |
0310819908 dt. 19.03.2018 |
|
Subject |
Request of M/s Amines & Plasticizers Limited. for correction in<br>the quantity of import item No. 3 in respect of adhoc norms<br>fixed against Advance Authorization No. 0310819908 dt.<br>19.03.2018 |
| <br> <br> <br> <br> |
**Decision:**The Committee considered the request of the firm for correction in the quantity of import item<br>No. 3 in the presence of technical experts and it was decided to revise the quantity of Import Item No. 3 as<br>under:<br>Import Item No. 3<br>Qty.<br>From<br>To<br>FORMIC ACID<br>0.245 g<br>0.245 kg<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 quantity of import item No. 3 in the presence of technical experts and it was decided to revise the quantity of Import Item No. 3 as under:
| Case No. |
B-2 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Aarti Industries, Mumbai |
| HQ F. No. |
01/82/050/00584/AM16/ DES-III |
| RLA F. No. |
03/94/040/01132/AM15 |
| Advance Authorization No. and Date |
0310794412 dated 09.03.2015 |
| Subject |
Request of M/s Aarti Industries Limited, Mumbai for fixation of |
|
adhoc norms against Advance Authorization No. 0310794412 |
|
dated 09.03.2015 |
Decision: The Committee considered the request of the firm for fixation of adhoc norms in the presence of technical experts and the Committee after deliberation decided to fix following adhoc norms:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Benazepril Hcl |
1 kg |
1 |
(R)-2-HYDROXY-4-PHENYLBUTANOIC ACID ETHYL<br>ESTER |
0.684 kg |
|
|
2 |
T-BUTYL-3S-AMINO-2,3,4,5-TETRAHYDRO-L-H-(1)-<br>BENAZEPIN-2-ONE-L-ACETATE |
0.808 kg |
77
|
Case No. |
Case No. |
B-3 |
B-3 |
B-3 |
B-3 |
|
Meeting No. |
|
05/AM20 |
|
|
|
|
Date |
|
02.08.2019 |
|
|
|
|
Firm’s Name |
|
M/s Aarti Industries, Mumbai |
|
|
|
|
HQ F. No. |
|
01/82/050/00411/AM16/ DES-III |
|
|
|
|
RLA F. No. |
|
03/94/040/00882/AM15 |
|
|
|
|
Advance Authorization No. and Date |
|
0310792412 dated 29.12.2014 |
|
|
|
|
Subject |
|
Request of M/s Aarti Industries Limited, Mumbai for fixation of<br>adhoc norms against Advance Authorization No. 0310792412<br>dated 29.12.2014 |
|
|
|
|
**Decision:**The Committee considered the request of the firm for fixation of adhoc nor<br>technical experts and after deliberation decided to fix following adhoc norms: |
|
|
|
|
ms in the presence of<br>Qty.<br>100000.000 kg |
|
Export product |
Qty. |
|
Sl.<br>No. |
Import item |
Qty. |
|
Ortho Phenylene Diamine |
100000.000 kg |
|
1 |
Crude Ortho Phenylene Diamine |
100000.000 kg |
|
RA concerned may take further necessary action |
|
|
as per above decision of NC. |
|
|
| Case No. |
B-4 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s AVA Chemicals Pvt. Ltd., Mumbai |
| HQ F. No. |
01/82/050/01368/AM19/DES-III |
| RLA F. No. |
03/94/040/00548/AM19 |
| Advance Authorization No. and Date |
0310824039 dated 27.09.2018 |
| Subject |
Request of M/s AVA Chemicals Pvt. Ltd., Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310824039 dated 27.09.2018 |
| 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“EDTA TETRA AMMONIUM - LIQUID ASSAY MIN 40% ”<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
78
|
Case No. |
B-5 |
|
Meeting No. |
05/AM20 |
|
Date |
02.08.2019 |
|
Firm’s Name |
M/s Arihant Siddhar Laboratories Pvt. Ltd. |
|
HQ F. No. |
01/82/050/01476/AM17/DES-III |
|
RLA F. No. |
31/83/040/00162/AM17 |
|
Advance Authorization No. and Date |
3110066602 dt. 28.02.2017 |
|
Subject |
Request of M/s Arihant Siddhar Laboratories Pvt. Ltd, Pune for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 3110066602 dated 28.02.2017 |
|
**Decision:**The Committee considered the request of the firm for revision in adhoc norms in the presence of<br>technical experts and after deliberation, it was decided to revise the adhoc norms as under:<br>Exportproduct<br>Qty.<br>Sl. No.<br>Import item<br>Qty.<br>Florfenicol 20% W/v Oral Suspension<br>1 Litre<br>1.<br>Florfenicol<br>0.206 kg<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
| Case No. |
B-6 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Aurobindo Pharma Limited. |
| HQ F. No. |
01/82/050/01464/AM19/DES-III |
| RLA F. No. |
09/24/040/00079/AM19 |
| Advance Authorization No. and Date |
0910066273 dt. 25.05.2018 |
| Subject |
Request of M/s Aurobindo Pharma Limited. correction in the<br>quantity of import items in respect of adhoc norms fixed against<br>Advance Authorization No. 0910066273 dt. 25.05.2018. |
| Decision:The Committee considered the request of the firm for inclusion of import item No. 5 -Amberlite<br>Resin IRA-67in the presence of technical experts and it was observed that the import item No. 5 -Amberlite<br>Resin IRA-67is a consumable, not a raw material. Hence, it was decided torejectthe request of firm<br>maintaining the status quo.<br>RA concerned may take appropriate action as per the decision of Norms Committee. |
|
79
| Case No. |
Case No. |
Case No. |
B-7 |
B-7 |
B-7 |
B-7 |
| Meeting No. |
|
|
05/AM20 |
|
|
|
| Date |
|
|
02.08.2019 |
|
|
|
| Firm’s Name |
|
|
M/s Balaji Amines Limited. |
|
|
|
| HQ F. No. |
|
|
01/82/050/00067/AM16/DES-III |
|
|
|
| RLA F. No. |
|
|
31/83/040/00272/AM15 |
|
|
|
| Advance Authorization No. and Date |
|
|
3110065386 dt. 21.04.2015 |
|
|
|
| Subject |
|
|
Request of M/s Balaji Amines Limited. correction in the<br>quantity of import items in respect of adhoc norms fixed against<br>Advance Authorization No. 3110065386 dt. 21.04.2015. |
|
|
|
| **Decision:**The Committee considered the request of the firm for revision in adhoc norms in<br>technical experts and after deliberation, it was decided to revise the adhoc norms as under:<br> <br>EXPORT PRODUCT<br>QTY.<br>Sl.<br>No.<br>IMPORT ITEMS<br>N-METHYL-2-PYRROLIDONE<br>1 kg<br>1<br>METHANOL<br>2<br>AMMONIA ANHYDROUS<br>3<br>GAMMA BUTYROLACTONE<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
the presence of<br>QTY.<br>0.377 kg<br>0.164 kg<br>0.965 kg |
|
EXPORT PRODUCT |
QTY. |
|
Sl.<br>No. |
IMPORT ITEMS |
QTY. |
|
N-METHYL-2-PYRROLIDONE |
1 kg |
|
1 |
METHANOL |
0.377 kg |
|
|
|
|
2 |
AMMONIA ANHYDROUS |
0.164 kg |
|
|
|
|
3 |
GAMMA BUTYROLACTONE |
0.965 kg |
|
|
|
|
as per above decision of NC. |
|
|
| Case No. |
B-8 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Eternis Fine Chemicals Limited. |
| HQ F. No. |
01/82/050/00782/AM19/DES-III |
| RLA F. No. |
03/94/040/01053/AM18 |
| Advance Authorization No. and Date |
0310819947 dt. 20.03.2018 |
| Subject |
Request of M/s Eternis Fine Chemicals Limited. correction in<br>the description of Import Item No. 2 in respect of adhoc norms<br>fixed against Advance Authorization No. 0310819947 dt.<br>20.03.2018. |
| 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<br>read as“5% RHODIUM ON ALUMINA CATALYST”.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
80
|
Case No. |
Case No. |
B-9 |
B-9 |
B-9 |
B-9 |
|
Meeting No. |
|
05/AM20 |
|
|
|
|
Date |
|
02.08.2019 |
|
|
|
|
Firm’s Name |
|
M/s Fresenius Kabi Oncology Limited, New Delhi |
|
|
|
|
HQ F. No. |
|
01/82/050/00413/AM18/DES-III |
|
|
|
|
RLA F. No. |
|
05/23/040/00086/AM18 |
|
|
|
|
Advance Authorization No. and Date |
|
0510402751 dated 30.05.2017 |
|
|
|
|
Subject |
|
Request of M/s Fresenius Kabi Oncology Limited, New Delhi<br>for revision of norms in respect of adhoc norms fixed by NC-3<br>against Advance Authorization No. 0510402751 dated<br>30.05.2017 |
|
|
|
|
**Decision:**The Committee considered the request of the firm for revision in adhoc norms in the presence of<br>technical experts and after deliberation, it was decided to revise the adhoc norms as under:<br>For Export of 1 Number of Paclitaxel Injection<br>S.NO.<br>Import Items<br>Norms recommended for 1 No. Injection<br>300 mg / 50 ml<br>150 mg / 25 ml<br>30 mg / 5 ml<br>1<br>Paclitaxel.<br>White to almost white crystalline<br>powder.<br>315.00 mg<br>157.50 mg<br>33.00 mg<br>2<br>Ethanol Absolute suitable for use as<br>excipient EMPROVE (R) exp Ph EUR,<br>BP, JP, USP.<br>USP.<br>19.65 mg<br>9.825 mg<br>1.965 mg<br>3<br>Rubber Stoppers for Pharmaceutical<br>Article Use 20mm TEF 2 1888 GRY<br>SIL LEV3 WESTAR RS OR<br>Rubber Stoppers for Pharmaceutical<br>Article Use WPS S10-F451 4432/50G<br>B240 WESTARS/SP06.<br>Relevant as per<br>packing policy<br>Relevant as per<br>packing policy<br>Relevant as per<br>packing policy<br>4<br>Glass Bottles Antibiotique 50 Clear<br>Glass Tupe- 1, Neck Finish<br>ISO83620200.<br>Moulded Glass Bottle 50ml capacity.<br>Relevant as per<br>packing policy<br>Relevant as per<br>packing policy<br>Relevant as per<br>packing policy<br>5<br>6ml ISO clear Type 1 Tubular Glass<br>Vial 20mm crimp neck, VCDIN6R.<br>Tubular Glass Bottle 6ml capacity.<br>Nil<br>Nil<br>Relevant as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
S.NO. |
Import Items |
|
Norms recommended for 1 No. Injection |
|
|
|
|
|
|
300 mg / 50 ml |
150 mg / 25 ml |
30 mg / 5 ml |
|
1 |
Paclitaxel.<br>White to almost white crystalline<br>powder. |
|
315.00 mg |
157.50 mg |
33.00 mg |
|
2 |
Ethanol Absolute suitable for use as<br>excipient EMPROVE (R) exp Ph EUR,<br>BP, JP, USP.<br>USP. |
|
19.65 mg |
9.825 mg |
1.965 mg |
|
3 |
Rubber Stoppers for Pharmaceutical<br>Article Use 20mm TEF 2 1888 GRY<br>SIL LEV3 WESTAR RS OR<br>Rubber Stoppers for Pharmaceutical<br>Article Use WPS S10-F451 4432/50G<br>B240 WESTARS/SP06. |
|
Relevant as per<br>packing policy |
Relevant as per<br>packing policy |
Relevant as per<br>packing policy |
|
4 |
Glass Bottles Antibiotique 50 Clear<br>Glass Tupe- 1, Neck Finish<br>ISO83620200.<br>Moulded Glass Bottle 50ml capacity. |
|
Relevant as per<br>packing policy |
Relevant as per<br>packing policy |
Relevant as per<br>packing policy |
|
5 |
6ml ISO clear Type 1 Tubular Glass<br>Vial 20mm crimp neck, VCDIN6R.<br>Tubular Glass Bottle 6ml capacity. |
|
Nil |
Nil |
Relevant as per<br>packing policy |
|
RA concerned may take further necessary action as |
|
|
per above decision of NC. |
|
|
81
| Case No. |
Case No. |
Case No. |
Case No. |
B-10 |
B-10 |
B-10 |
B-10 |
B-10 |
B-10 |
B-10 |
B-10 |
B-10 |
B-10 |
| Me |
eting No. |
|
|
05/AM20 |
|
|
|
|
|
|
|
|
|
| Da |
te |
|
|
02.08.2019 |
|
|
|
|
|
|
|
|
|
| Fir<br> |
m’s Name<br> |
|
|
M/s Fresenius Kabi O<br> |
|
|
ncology Limited.<br> |
|
|
|
|
|
|
| HQ |
F. No. |
|
|
01/82/050/01502/AM1 |
|
|
6/DES-III |
|
|
|
|
|
|
| RL |
A F. No. |
|
|
05/23/040/00244/AM1 |
|
|
6 |
|
|
|
|
|
|
| <br>Ad |
<br>vance Authorization No. and Date |
|
|
<br>0510397137 dt. 30.12.2015 |
|
|
|
|
|
|
|
|
|
| Su |
bject |
|
|
Request of M/s Fresenius Kabi Oncology Limited. correction in<br>the quantity of import items in respect of adhoc norms fixed<br>against Advance Authorization No. 0510397137 dt. 30.12.2015. |
|
|
|
|
|
|
|
|
|
| De<br>tec |
**cision:**The Committee considered the request of the firm for revision in adhoc norms in the presence of<br>hnical experts and after deliberation, it was decided to revise the adhoc norms as under: |
|
|
|
|
|
|
|
|
|
|
|
|
| Imort Item |
|
|
|
|
Norms recommended for 1 No Injection |
|
|
|
|
|
|
|
|
|
|
|
|
|
Norms recommended for 1 No Injection |
|
|
|
|
|
|
|
|
| <br>1 |
p |
|
|
|
|
|
. |
|
|
|
|
|
|
|
|
|
|
|
600<br>mg / |
300<br>mg |
/ |
260<br>mg / |
150<br>mg / |
10<br>m<br>16<br>ml |
0<br>g / |
30 mg<br>/ 5 ml |
|
|
|
|
|
|
100 ml |
50 m |
l |
43.4<br>ml |
25 ml |
|
.07<br> |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
. Paclitaxel |
|
|
|
630<br>mg |
315<br>mg |
|
273<br>mg |
157<br>mg |
10<br>m |
5<br> |
33 mg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| <br>it<br>p<br>2<br>3<br> |
OR<br>s raw materials as per norms g<br> |
|
iven below on |
|
|
|
|
|
|
|
|
|
|
|
ro rata basis: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
KOLLIPHOR ELP.<br>Used as excipient. |
|
|
53<br>gms |
26.5<br>gms |
<br> |
23.0<br>gms |
13.25<br>gms |
8.<br>gm |
851<br>s |
2.65<br>gms |
|
|
|
ETHANOL<br>ABSOLUTE<br>SUITABLE<br>FOR USE AS EXCIPIENT EMPROVE<br>EXP<br>PH<br>EUR,<br>BP,JP,USP.<br>Used as excipient. |
|
|
<br>39.3<br>gms |
<br>19.65<br>gms |
|
<br>17.056<br>gms |
<br>9.825<br>gms |
<br>6.563<br>gms |
|
<br>1.965<br>gms |
|
|
|
RUBBER<br>STOPPERS<br>FOR |
|
|
|
|
|
|
|
|
|
|
|
| 4 |
|
<br> <br> <br>PHARMACEUTICAL ARTICLES USE<br>20MM TFE 2 1888 GRY SIL LEV3 |
|
|
|
|
|
|
|
|
|
|
|
| 5<br>6 |
|
WESTAR<br>Rubber Stoppers 20mm<br>bottles. |
RS.<br>dia for glass |
|
|
|
|
|
|
|
|
|
|
|
|
GLASS<br>BOTTLES<br> |
ANTIBIOTIQUE |
|
|
|
|
|
|
|
|
|
|
|
|
<br> <br> <br>100, CLEAR GLASS<br>FINISH<br> |
<br>TYPE 1, NECK<br>ISO836220,0.<br> |
|
|
|
|
|
|
|
|
|
|
|
|
Moulded glass bottle 100 |
ml capacity. |
|
Relevant as per packing policy |
|
|
|
|
|
|
|
|
|
|
GLASS BOTTLES ANTIBIOTIQUE 50,<br>CLEAR GLASS TYPE 1, NECK FINISH<br>ISO83620200<br>Moulded glass bottle 50 ml capacity. |
|
|
|
|
|
|
|
|
|
|
|
| 7<br>8 |
|
20 ML CLEAR TYPE 1 TUBULAR<br>GLASS VIAL, 20MM CRIMP NECK,<br>VC020-20C<br>OR GLASS BOTTLES ANTIBIOTIQUE<br>50, CLEAR GLASS TYPE 1, NECK<br>FINISH ISO83620200. |
|
|
|
|
|
|
|
|
|
|
|
|
|
6 ML ISO CLEAR TYPE 1 TUBULAR<br>GLASS VIAL 20 MM CRIMP NECK,<br>VCDIN6R.<br>Tubular glass bottles 6 ml capacity. |
|
|
|
|
|
|
|
|
|
|
|
82
|
Norms for 1 kg export of Paclitaxel |
Norms for 1 kg export of Paclitaxel |
Qty.<br>20.00 kg<br>0.100 kg<br>1.12 kg<br>1722.00 kg |
|
Sl. No. |
Import Items |
Qty. |
|
1 |
SILICA GEL.<br>Moisture content: NMT 6%. |
20.00 kg |
|
2 |
CERROUS CHLORIDE ANHYDROUS.<br>Assay: NLT 95%. |
0.100 kg |
|
3 |
2-(PMP)-N-Bz-4-Ph-OXAZOLIDINE CARBOXYLIC ACID.<br>Assay: NLT 98% |
1.12 kg |
|
4 |
TAXUS BACCATTA LEAVES.<br>D/L Ratio: NLT 0.1 |
1722.00 kg |
|
RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
|
| Case No. |
B-11 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Fermenta Biotech Ltd, Mumbai |
| HQ F. No. |
01/82/050/01106/AM10/DES-III |
| RLA F. No. |
09/24/040/00817/AM17 |
| Advance Authorization No. and Date |
0310809743 dated 13.12.2016 |
| Subject |
Request<br>of<br>M/s<br>Fermenta<br>Biotech<br>Ltd,<br>Mumbai<br>for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310809743 dated 13.12.2016 |
| **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“**CHOLECALCIFEROL (VITAMIN D3) BP/USP/ EP/PH EUR”.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
83
|
Case No. |
B-12 |
|
Meeting No. |
05/AM20 |
|
Date |
02.08.2019 |
|
Firm’s Name |
M/s Fresenius Kabi Oncology Limited. |
|
HQ F. No. |
01/82/050/00520/AM17/DES-III |
|
RLA F. No. |
05/23/040/00038/AM17 |
|
Advance Authorization No. and Date |
0510398377 dt. 04.05.2016 |
|
Subject |
Request of M/s Fresenius Kabi Oncology Limited. correction in<br>the quantity of import items in respect of adhoc norms fixed<br>against Advance Authorization No. 0510398377 dt. 04.05.2016. |
|
**Decision:**The Committee considered the request of the firm for revision in adhoc norms in the presence of<br>technical experts and after deliberation, it was decided to revise the adhoc norms as under:<br>Export Product<br>Gemcitabine Injections 200mg<br>Gemcitabine Injections 1gm<br>Gemcitabine Injections 1.4gm<br>Gemcitabine Injections 2gm<br>S.NO<br>.<br>Import Items<br>Norms recommended for 1 No. Injection<br>200 mg /vial<br>1gm /vial<br>1.4 gm/ vial<br>2 gm / vial<br>1<br>2-Deoxy-2,-difluoro-D-ribofuranose-3,5-<br>dibenzoate-1-methanesulphonate<br>(T-8).<br>White crystalline powder.Assay: NLT90.0%<br>1.08 gm<br>5.40 gm<br>7.60 gm<br>10.80 gm<br>2<br>N-Acetyl<br>cytosine.<br>White or off white crystalline powder. Assay:<br>NLT98.0%<br>0.77 gm<br>3.84 gm<br>5.38 gm<br>7.69 gm<br>3<br>VCDIN10R , 10 ml ISO Clear Type 1 Tubular<br>Glass<br>Vial<br>20<br>mm<br>crimp<br>neck.<br>Glass Vial , tubular Capacity-10 ml.<br>Relevant, As per packing policy.<br>4<br>Rubber Stopper for Pharmaceuticals Use S 87 I<br>Lyotec 4432-50GS3WESTARRS1MPK SP01<br>OR<br>Rubber Stoppers for Pharmaceutical Use S 87 J<br>4405-50/GREY EPP RS SIL 1 4A<br>5<br>Glass Bottles Antibiotique 50 ,Clear Glass Type<br>1<br>Neck<br>Finish<br>ISO83620200.<br>Moulded GlassBottle 50mlCapacity<br>RA concerned may take further necessary action as per above decision of NC. |
|
84
|
Case No. |
Case No. |
B-13 |
B-13 |
B-13 |
B-13 |
|
Meeting No. |
|
05/AM20 |
|
|
|
|
Date |
|
02.08.2019 |
|
|
|
|
Firm’s Name |
|
M/s Fresenius Kabi Oncology Limited. |
|
|
|
|
HQ F. No. |
|
01/82/050/01419/AM19/DES-III |
|
|
|
|
RLA F. No. |
|
05/23/040/00279/AM19 |
|
|
|
|
Advance Authorization No. and Date |
|
0510407939 dt. 28.09.2018 |
|
|
|
|
Subject |
|
Request of M/s Fresenius Kabi Oncology Limited. correction in<br>the quantity of import items in respect of adhoc norms fixed<br>against Advance Authorization No. 0510407939 dt. 28.09.2018. |
|
|
|
|
**Decision:**The Committee considered<br>technical experts and after deliberation, it<br>Export Product<br>Gemcitabine Injections 200mg<br>Gemcitabine Injections 1gm<br>Gemcitabine Injections 1.4gm<br>Gemcitabine Injections 2gm |
|
|
|
|
|
|
S.NO. |
Import Items |
Norms recommended for 1 No. Injection |
|
|
|
|
|
|
200 mg/vial |
1gm /vial |
1.4 gm/ vial |
2 gm / vial |
|
1 |
2-Deoxy-2,-difluoro-D-<br>ribofuranose-3,5-dibenzoate-1-<br>methanesulphonate<br>(T-8).<br>White crystalline powder. Assay:<br>NLT 90.0% |
1.08 gm |
5.40 gm |
7.60 gm |
10.80 gm |
|
2 |
N-Acetyl<br>cytosine.<br>White or off white crystalline<br>powder. Assay: NLT 98.0% |
0.77 gm |
3.84 gm |
5.38 gm |
7.69 gm |
|
3 |
VCDIN10R , 10 ml ISO Clear<br>Type 1 Tubular Glass Vial 20<br>mm<br>crimp<br>neck.<br>Glass Vial , tubular Capacity - 10<br>ml. |
Relevant, as per packing policy. |
|
|
|
|
4 |
Rubber<br>Stopper<br>for<br>Pharmaceuticals Use S 87 I<br>Lyotec<br>4432-<br>50GS3WESTARRS1MPK SP01<br>OR<br>Rubber<br>Stoppers<br>for<br>Pharmaceutical Use S 87 J 4405-<br>50/GREY EPP RS SIL 1 4A |
|
|
|
|
|
5 |
Glass Bottles Antibiotique 50<br>,Clear Glass Type 1 Neck Finish<br>ISO83620200.<br>Moulded Glass Bottle 50 ml<br>Capacity |
|
|
|
|
|
6 |
VCT050-20CT-50ml Clear Type<br>1 Tubular Glass Vial 20 mm<br>crimpneck68X42.5X1.5MM. |
|
|
|
|
|
7 |
Glass Bottles 01500 30 039<br>Antibiotique 100 Clear Glass<br>Type<br>1<br>Neck<br>Finish<br>ISO836220.0 Pack with 88 Vials. |
|
|
|
|
85
|
Case No. |
Case No. |
B-14 |
B-14 |
B-14 |
B-14 |
|
Meeting No. |
|
05/AM20 |
|
|
|
|
Date |
|
02.08.2019 |
|
|
|
|
Firm’s Name |
|
M/s FDC Limited |
|
|
|
|
HQ F. No. |
|
01/82/050/00980/AM16/DES-III |
|
|
|
|
RLA F. No. |
|
03/94/040/00220/AM16 |
|
|
|
|
Advance Authorization No. and Date |
|
0310796950 dt. 30.06.2015. |
|
|
|
|
Subject |
|
Request of M/s FDC Limited. correction in the quantity of<br>import items in respect of adhoc norms fixed against Advance<br>Authorization No. 0310796950 dt. 30.06.2015. |
|
|
|
|
**Decision:**The Committee considered the request of firm for issuance of clarification whether export of<br>different vials that is 10 ml packs and 5 ml packs can be accepted towards EO fulfilment for redemption of EO<br>and the Committee after deliberation decided to clarify that “for 5 ml vial, RA may workout wastage on pro-rata<br>basis taking into account following adhoc norms fixed for 10 ml vial:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Gentamicin<br>Ear/Eye<br>Drops, 0.3% w/v, 10 ml<br>vials<br>2,50,000 vials<br>1<br>Gentamicin Sulphate<br>5.73 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl. No. |
Import items |
Qty. |
|
Gentamicin<br>Ear/Eye<br>Drops, 0.3% w/v, 10 ml<br>vials |
2,50,000 vials |
|
1 |
Gentamicin Sulphate |
5.73 kg |
|
RA concerned may take further necessary action |
|
|
as per above decision of NC. |
|
|
| Case No. |
B-15 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Jubilant Life Sciences Limited. |
| HQ F. No. |
01/82/050/01291/AM12/DES-III |
| RLA F. No. |
05/23/040/00382/AM12 |
| Advance Authorization No. and Date |
0510314518 dt. 13.01.2012 |
| Subject |
Typing error to be rectified in the Minutes of Meeting No.<br>15/AM19 dated 26.04.2019 |
| Decision:The Committee considered the request of the firm for following corrections in the Minutes of<br>Meeting No. 15/AM19 dated 26.04.2019 (Case No. B-39):<br>(i)<br>Firm’s name was wrongly mentioned in the Minutes of Meeting No. 15/AM19 dated<br>26.04.2019 (Case No. B-39) asM/s. Jubilant Generics Limited.Accordingly, the firm has<br>requested to correct it to read asM/s. Jubilant Life Sciences Limited.<br>(ii)<br>Licence No. was wrongly mentioned in the subject of the Minutes in the Minutes of Meeting<br>No. 15/AM19 dated 26.04.2019(Case No. B-39) as0510393616 dated 18.03.2015.<br>Accordingly, the firm has requested to correct it to read as0510314518 dated 13.01.2012.<br>The Committee after deliberation decided to make following corrections in the Minutes of Meeting No.<br>15/AM19 dated 26.04.2019 (Case No. B-39) :<br>(i)<br>Firm’s name may be read as M/s Jubilant Life Sciences Limited.<br>(ii)<br>Licence No. in the subject may be read as 0510314518 dated 13.01.2012.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
86
| Case No. |
B-16 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Jubilant Life Sciences Limited. |
| HQ F. No. |
01/82/050/02221/AM19/DES-III |
| RLA F. No. |
05/23/040/00302/AM19 |
| Advance Authorization No. and Date |
0510409073 dt. 26.12.2018 |
| Subject |
Request of M/s Jubilant Life Sciences Limited. correction in the<br>quantity of import items in respect of adhoc norms fixed against<br>Advance Authorization No. 0510409073 dt. 26.12.2018. |
| **Decision:**Deferred for comments of TE. |
|
| Case No. |
B-17 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Jubilant Life Sciences Limited. |
| HQ F. No. |
01/82/050/00431/AM17/DES-III |
| RLA F. No. |
05/23/040/00172/AM17 |
| Advance Authorization No. and Date |
0510398972 dt. 04.07.2016 |
| Subject |
Typing error to be rectified in the Minutes of Meeting No.<br>15/AM19 dated 26.04.2019 |
| Decision:The Committee considered the request of the firm for following corrections in the Minutes of<br>Meeting No. 15/AM19 dated 26.04.2019 (Case No. B-38):<br>(i)<br>Firm’s name was wrongly mentioned in the Minutes of Meeting No. 15/AM19 dated<br>26.04.2019 (Case No. B-38) asM/s. Jubilant Generics Limited.Accordingly, the firm has<br>requested to correct it to read asM/s. Jubilant Life Sciences Limited.<br>(ii)<br>Licence No. was wrongly mentioned in the subject of the Minutes in the Minutes of Meeting<br>No. 15/AM19 dated 26.04.2019(Case No. B-38) as0510393616 dated 18.03.2015.<br>Accordingly, the firm has requested to correct it to read as0510398972 dated 04.07.2016.<br>(iii)<br>Correction in the description of Import Item No. 3.<br>The Committee after deliberation decided to make following corrections in the Minutes of Meeting No.<br>15/AM19 dated 26.04.2019 (Case No. B-38) :<br>(i)<br>Firm’s name may be read asM/s Jubilant Life Sciences Limited.<br>(ii)<br>Licence No. in the subject may be read as0510398972 dated 04.07.2016.<br>(iii)<br>Description of Import Item No. 3 may be amended to read asCatalyst (CP7191) (Alumino<br>Silicate Catalyst).<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
87
|
|
|
|
|
|
| Ca |
se No. |
|
B-18 |
|
|
| M |
eting No. |
|
05/AM20 |
|
|
| <br>Da |
<br>te |
|
<br>02.08.2019 |
|
|
| Fir |
m’s Name |
|
M/s J.B. Khokhani & |
CO. |
|
| HQ |
F. No. |
|
01/82/050/00786/AM19/DES-III |
|
|
| RL |
A F. No. |
|
03/94/040/01085/AM18 |
|
|
| Ad |
vance Authorization No. and Date |
|
0310820175 dt. 28.03.2018 |
|
|
| Su |
bject |
|
Request of M/s J.B. Khokhani & CO. correction in the quantity<br>of import items in respect of adhoc norms fixed against Advance<br> |
|
|
|
|
|
Authorization No. 0310820175 dt. 28.03.2018. |
|
|
| De<br>No<br>Im<br> <br>Re<br>RA |
**cision:**The Committee cons<br>. 1 - Erythromycin Thiocyana<br>port Item No. 2 - Isopropanol in |
idered the request of the firm fo<br>te (on 100% Activity Basis) an<br>the presence of technical expert |
|
r enhancement in the quant<br>d correction in the unit o<br>s. |
ity of import item<br>f measurement of |
|
The Committee after |
deliberation took following decis |
|
ions: |
|
|
(i)<br>The quantity of import item No. 1 - Erythromycin Thiocyanate (on 100% Activity Basis) may<br>not be enhanced and<br>(ii)<br>The quantity of import item No. 2 – Isopropanol may be corrected to read as 0.78 Litre.<br>st of the earlier Minutes would remain unchanged.<br>concerned may take further necessary action as per above decision of NC. |
|
|
|
|
| Case No. |
B-19 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Kopalle Pharma Chemicals Pvt. Ltd. |
| HQ F. No. |
01/82/050/00450/AM19/DES-III |
| RLA F. No. |
09/24/040/00456/AM18 |
| Advance Authorization No. and Date |
0910065827 dt. 03.01.2018 |
| Subject |
Request of M/s Kopalle Pharma Chemicals Pvt. Ltd. correction<br>in the quantity of import items in respect of adhoc norms fixed<br>against Advance Authorization No. 0910065827 dt. 03.01.2018. |
| 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“AMLODIPINE BESYLATE”.<br>Rest of the earlier Minutes would remain unchanged.<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
88
| C |
ase No. |
B-20 |
|
Meeting No. |
05/AM20 |
| D |
ate |
02.08.2019 |
| F |
irm’s Name |
M/s Lupin Limited. |
| H |
Q F. No. |
01/82/050/00610/AM19/DES-III |
| R |
LA F. No. |
03/95/040/00928/AM18 |
| A |
dvance Authorization No. and Date |
0310821182 dt. 23.05.2018 |
| S |
ubject |
Request of M/s Lupin Limited. correction in the quantity of<br>import items in respect of adhoc norms fixed against Advance<br>Authorization No. 0310821182 dt. 23.05.2018. |
| D<br>I<br>r<br>R<br>R |
**ecision:**The Committee considered the request of the firm for correction in the Unit of Measurement of<br>mport Item No. 1-Sodium Rifa Sin the presence of technical experts and after deliberation, it was decided to<br>evise the quantity of Import Item No. 1 -Sodium Rifa Sas under:<br>Import Item No. 1<br>Qty.<br>From<br>To<br>Sodium Rifa S<br>30844.800 kg<br>30844.800 kg Activity<br>est of the earlier Minutes would remain unchanged.<br>A concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
Case No. |
Case No. |
B-21 |
B-21 |
B-21 |
B-21 |
| Meeting No. |
|
|
05/AM20 |
|
|
|
| Date |
|
|
02.08.2019 |
|
|
|
| Firm’s Name |
|
|
M/s Lupin Limited. |
|
|
|
| HQ F. No. |
|
|
01/82/050/00681/AM18 /DES-III |
|
|
|
| RLA F. No. |
|
|
03/95/040/00341/AM18 |
|
|
|
| Advance Authorization No. and Date |
|
|
0310815236 dt. 18.08.2017 |
|
|
|
| Subject |
|
|
Request of M/s Lupin Limited. correction in the quantity of<br>import items in respect of adhoc norms fixed against Advance<br>Authorization No. 0310815236 dt. 18.08.2017 |
|
|
|
| **Decision:**The Committee considered the request of the firm for revision in adhoc norms in<br>technical experts and after deliberation, it was decided to revise the adhoc norms as under:<br> <br>EXPORT PRODUCT<br>QTY.<br>Sl.<br>No.<br>IMPORT ITEMS<br>RIFAMPICIN 150MG TABS +<br>ISONIAZID 75MG TABS<br>(NET WT : 15750 KGS, WT.<br>OF DRUG : 16065.00 KGS)<br>70000000.000<br>Number<br>1<br>SODIUM RIFA S<br>2<br>CHLOROFORM<br>3<br>ACETIC ACID<br>4<br>PIPERAZINE ANHYDROUS<br>5<br>METHYLENE CHLORIDE<br>6<br>ISOPROPYL ALCOHOL<br>7<br>DIMETHYL FORMAMIDE<br>8<br>TERTIARY BUTYL AMINE<br>9<br>ACETONE<br>10<br>ISONIAZID<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
the presence of<br>QTY.<br>10281.600<br>kg Activity<br>7079.310 kg<br>1713.600 kg<br>1285.200 kg<br>9992.430 kg<br>5462.100 kg<br>8032.500 kg<br>1606.500 kg<br>6104.700 kg<br>5355.000 kg |
|
EXPORT PRODUCT |
QTY. |
|
Sl.<br>No. |
IMPORT ITEMS |
QTY. |
|
RIFAMPICIN 150MG TABS +<br>ISONIAZID 75MG TABS<br>(NET WT : 15750 KGS, WT.<br>OF DRUG : 16065.00 KGS) |
70000000.000<br>Number |
|
1 |
SODIUM RIFA S |
10281.600<br>kg Activity |
|
|
|
|
2 |
CHLOROFORM |
7079.310 kg |
|
|
|
|
3 |
ACETIC ACID |
1713.600 kg |
|
|
|
|
4 |
PIPERAZINE ANHYDROUS |
1285.200 kg |
|
|
|
|
5 |
METHYLENE CHLORIDE |
9992.430 kg |
|
|
|
|
6 |
ISOPROPYL ALCOHOL |
5462.100 kg |
|
|
|
|
7 |
DIMETHYL FORMAMIDE |
8032.500 kg |
|
|
|
|
8 |
TERTIARY BUTYL AMINE |
1606.500 kg |
|
|
|
|
9 |
ACETONE |
6104.700 kg |
|
|
|
|
10 |
ISONIAZID |
5355.000 kg |
|
|
|
|
as per above decision of NC. |
|
|
89
|
Case No. |
B-22 |
|
Meeting No. |
05/AM20 |
|
Date |
02.08.2019 |
|
Firm’s Name |
M/s Lee Pharma Limited. |
|
HQ F. No. |
01/82/050/01203/AM16/DES-III |
|
RLA F. No. |
09/24/040/00360/AM16 |
|
Advance Authorization No. and Date |
0910062631 dt. 18.09.2015 |
|
Subject |
Request of M/s Lee Pharma Limited. For revision / correction<br>in respect of adhoc norms fixed against Advance Authorization<br>No. 0910062631 dt. 18.09.2015. |
| <br> <br> |
**Decision:**The Committee considered the request of the firm for revision in adhoc norms in the presence of<br>technical experts and after deliberation, it was decided to revise the description of Import Items as under:<br>Import Item No.<br>Description of Import Item<br>From<br>To<br>1<br>R)-3-(Carbamoylmethyl)-5-<br>Methylhexanoic Acid<br>(R)-3-(2-AMINO-2-OXOETHYL)-5-<br>METHYLHEXANOIC ACID<br>2<br>Isobutanol<br>ISOPROPYL ALCOHOL<br>RA concerned may take further necessary action as per above decision of NC. |
|
| Case No. |
B-23 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Mylan Laboratories Limited, Hyderabad (Formerly known<br>as M/s Matrix Laboratories Ltd, Hyderabad) |
| HQ F. No. |
01/82/050/00712/AM10/DES-III |
| RLA F. No. |
09/24/040/00130/AM10 |
| Advance Authorization No. and Date |
0910038699 dated 24.07.2009 |
| Subject |
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. 0910038699 dated 24.07.2009 |
| Decision:The Committee considered the request of the firm for enhancement of norms in the presence of<br>technical experts and it was noted the norms given by the Committee were appropriate and therefore there is no<br>need to enhance the quantity of import item. Hence, it was decided torejectthe request of firm maintaining the<br>status quo.<br>RA concerned may take appropriate action as per the decision of Norms Committee. |
|
90
| Case No. |
B-24 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Malladi Drugs & Pharmaceuticals Limited |
| HQ F. No. |
01/82/162/00010/AM19/DES-III |
| Subject |
Request of M/s Malladi Drugs & Pharmaceuticals Limited. |
|
(SION Amendment)correction in the quantity of import items |
|
in respect of adhoc norms fixed |
| **Decision:**The Committee considered the request of the firm for amendment in the description of Export |
|
| Product of SION A-3551 in the presence |
of technical experts and after deliberation it was decided to call for |
| following information: |
|
| “Production Consumption Data for the last five years duly certified by Central Taxes & GST Authorities. |
|
| Case is Deferred. |
|
| <br> |
Case No.<br>B-25<br>Meeting No.<br>05/AM20 |
Case No.<br>B-25<br>Meeting No.<br>05/AM20 |
|
|
05/AM20 |
|
Date |
02.08.2019 |
|
Firm’s Name |
M/s NOCIL Ltd., Mumbai |
|
HQ F. No. |
01/82/050/00059/AM18/DES-III |
|
RLA F. No. |
03/95/040/00861/AM17 |
|
Advance Authorization No. and Date |
0310811898 dated 17.03.2017 |
|
Subject |
Request<br>of<br>M/s<br>NOCIL<br>Limited,<br>Mumbai<br>for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310811898 dated 17.03.2017 |
| <br> <br> |
**Decision:**The Committee considered the request of the firm for correction in the quantity of import item<br>No. 3 in the presence of technical experts and after deliberation, it was decided to revise the quantity of Import<br>Item No. 3 as under:<br>Import Item No. 3<br>Qty.<br>From<br>To<br>CAUSTIC POTASH FLAKES (Potassium<br>Hydroxide) (KOH)<br>0.020 kg<br>0.233 kg<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 quantity of import item No. 3 in the presence of technical experts and after deliberation, it was decided to revise the quantity of Import Item No. 3 as under:
91
| Case No. |
B-26 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Sentiss Pharma Pvt. Ltd. |
| HQ F. No. |
01/82/050/00616/AM17/DES-III |
| RLA F. No. |
05/24/040/00624/AM16 |
| Advance Authorization No. and Date |
0510398507 dt. 17.05.2016 |
| Subject |
Request of M/s Sentiss Pharma Pvt. Ltd. correction in the<br>quantity of import items in respect of adhoc norms fixed against<br>Advance Authorization No. 0510398507 dt. 17.05.2016. |
| **Decision:**The Committee considered the request of the firm for revision in adhoc norms in the presence of<br>technical experts and after deliberation, it was decided to revise the adhoc norms as under:<br> <br>EXPORT PRODUCT<br>QTY.<br>Sl.<br>No.<br>IMPORT ITEMS<br>QTY.<br>OFTAHIST<br>(Olopatadine<br>Eye<br>Solution 0.1% vial of 5ml) (Net<br>content of Bulk Drug=83.250 Gms)<br>1 No. Pack<br>1<br>Olopatadine HCL<br>5.65 mg / 5 ml vial<br>Visallergol Eye Drops 0.2%, 2.5ml<br>(Net<br>content<br>of<br>bulk<br>drug<br>Olopatadine HCL=86.391gms)<br>1 No. Pack<br>2<br>Olopatadine HCL<br>5.65 mg / 2.5 ml vial<br>RA concerned may take further necessary action as per above decision of NC. |
|
92
|
Case No. |
Case No. |
Case No. |
B-27 |
B-27 |
B-27 |
|
Meeting No. |
|
|
05/AM20 |
|
|
|
Date |
|
|
02.08.2019 |
|
|
|
Firm’s Name |
|
|
M/s SMB Corporation of India, Mumbai |
|
|
|
HQ F. No. |
|
|
01/82/050/01605/AM16/DES-III |
|
|
|
RLA F. No. |
|
|
03/95/040/00738/AM16 |
|
|
|
Advance Authorization No. and Date |
|
|
0310801409 dt. 30.12.2015 |
|
|
|
Subject |
|
|
Request of M/s SMB Corporation of India, Mumbai for<br>correction in the adhoc norms fixed against Advance<br>Authorization No. 0310801409 dt. 30.12.2015 |
|
|
|
**Decision:**The Committee considered the<br>technical experts and after deliberation, it was |
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
|
Import items |
Qty. |
|
INTRAUTERINE<br>CONTRACEPTIVE<br>DEVICE COPPER T<br>380A |
1 Number |
1 |
|
COPPER<br>WIRE<br>(OF<br>HIGH<br>CONDUCTIVITY99.99% PURE COPPER) |
0.0002 kg |
|
|
|
2 |
|
HDPE GRANULES |
0.00099kg |
|
|
|
3 |
|
POUCHES (MADE OF COATED PAPER<br>LAMINATE<br>WITH<br>POLYESTER/POLYETHELENE POUCHES) |
Net + 10% |
|
|
|
4 |
|
COPPER<br>TUBING<br>(OF<br>HIGH<br>CONDUCTIVITY99.99% PURE COPPER) |
0.0001656<br>kg |
|
|
|
5 |
|
POLYPROPYLENE GRANULES (GAMMA<br>RADIATION<br>STABILISED<br>POLYPROPYLENE) |
0.00165 kg |
|
|
|
6 |
|
COMPOUND<br>OF<br>LDPE<br>RESIN<br>AND<br>BARIUM SULPHATE<br>(GRANULES) |
0.00049 kg |
|
RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
93
|
Case No. |
B-28 |
B-28 |
B-28 |
|
Meeting No. |
05/AM20 |
|
|
|
Date |
02.08.2019 |
|
|
|
Firm’s Name |
M/s Shree Ganesh Remedies Limited, Vadodara |
|
|
|
HQ F. No. |
01/82/050/00705/AM16/DES-III |
|
|
|
RLA F. No. |
34/24/040/00024/AM16 |
|
|
|
Advance Authorization No. and Date |
3410041261 dated 28.05.2015 |
|
|
|
Subject |
Request of M/s Shree Ganesh Remedies Limited, Vadodara for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 3410041261<br>dated 28.05.2015 |
|
|
| <br> <br> <br> |
**Decision:**The Committee considered the request of the firm for enhancement in the quantity of import item<br>in the presence of technical experts and after deliberation, it was decided to revise the quantity of Import Item as<br>under:<br>Import Item<br>Qty.<br>From<br>To<br>1-Bromo-3-Chloro Propane<br>0.684 kg<br>0.720 kg<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
Import Item |
|
Qty. |
|
|
|
|
From |
To |
|
1-Bromo-3-Chloro Propane |
|
0.684 kg |
0.720 kg |
|
Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of |
|
|
|
Decision: The Committee considered the request of the firm for enhancement in the quantity of import item in the presence of technical experts and after deliberation, it was decided to revise the quantity of Import Item as under:
|
Case No. |
B-29 |
|
Meeting No. |
05/AM20 |
|
Date |
02.08.2019 |
|
Firm’s Name |
M/s Sunshield Chemicals Ltd. |
|
HQ F. No. |
01/82/050/00062/AM18/DES-III |
|
RLA F. No. |
03/95/040/00964/AM17 |
|
Advance Authorization No. and Date |
0310811691 dt. 08.03.2017 |
|
Subject |
Request of M/s Sunshield Chemicals Ltd. correction in the<br>quantity of import items in respect of adhoc norms fixed against<br>Advance Authorization No. 0310811691 dt. 08.03.2017. |
| <br> <br> <br> <br> |
**Decision:**The Committee considered the request of the firm for correction in the Unit of Measurement of<br>Export Product in the presence of technical experts and after deliberation, it was decided to revise the quantity<br>of Export Product as under:<br>Import Item<br>Qty.<br>From<br>To<br>CDPA(CUMYLATED DI PHENYL AMINE)<br>1 Litre<br>1 kg<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
94
| Case No. |
B-30 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Supriya Lifescience Ltd., Mumbai |
| HQ F. No. |
01/ 82/162/00044/AM16/DES-III<br>01/ 82/162/00045/AM16/DES-III<br>01/ 82/162/00046/AM16/DES-III<br>01/ 82/162/00047/AM16/DES-III |
| RLA F. No. |
03/95/040/01085/AM15<br>03/95/040/00988/AM15<br>03/95/040/00815/AM15<br>03/95/040/00801/AM15 |
| Subject |
Request of M/s Supriya Life Sciences Ltd, Mumbai for<br>revision/correction in respect of adhoc norms fixed under Para<br>4.4.2 of HBO Vol. I |
| 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 after deliberation, it was decided to amend the description of<br>Export Product to read as“Methyl Cobalamin JP (Mecobalamin)”<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-31 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Unitech International Ltd, Mumbai |
| HQ F. No. |
01/82/050/01121/AM19/DES-III<br>01/82/050/01139/AM19/DES-III<br>01/82/050/01109/AM19/DES-III<br>01/82/050/01136/AM19/DES-III |
| RLA F. No. |
03/95/040/00155/AM19<br>03/95/040/00236/AM19<br>03/95/040/00449/AM19<br>03/95/040/00722/AM19 |
| Advance Authorization No. and Date |
0310821282 dated 29.05.2018<br>0310822254 dated 11.07.2018<br>0310823340 dated 28.08.2018<br>0310824473 dated 16.10.2018 |
| Subject |
Request of M/s Unitech International Ltd, Mumbai for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310821282 dated 29.05.2018, 0310822254<br>dated 11.07.2018, 0310823340 dated 28.08.2018 and 0310824473<br>dated 16.10.2018 |
| Decision:The Committee considered the request of the firm for deletion of net content in the description of<br>Export Product in the presence of technical experts and after deliberation, it was decided to amend the<br>description of Export Product to read as“Esters of Methacrylic Acid - Crude Methyl Methacrylate<br>Monomer”.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
95
| Case No. |
B-32 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Unitech International Ltd. |
| HQ F. No. |
01/82/050/01132/AM19/DES-III |
| RLA F. No. |
03/95/040/00031/AM19 |
| Advance Authorization No. and Date |
0310821095 dt. 18.05.2018 |
| Subject |
Request of M/s Unitech International Ltd. correction in the<br>quantity of import items in respect of adhoc norms fixed against<br>Advance Authorization No. 0310821095 dt. 18.05.2018. |
| Decision:The Committee considered the request of the firm for deletion of net content in the description of<br>Export Product in the presence of technical experts and after deliberation, it was decided to amend the<br>description of Export Product to read as“Esters of Methacrylic Acid - Regenerated Methyl Methacrylate<br>Monomer (Purity Less than 99%).”<br>Rest of the earlier Minutes would remain unchanged.<br>RAconcernedmay takefurther necessary actionas perabove decisionofNC. |
|
96
| Case No. |
B-33 |
| Meeting No. |
05/AM20 |
| Date |
02.08.2019 |
| Firm’s Name |
M/s Yasho Industries Ltd, Mumbai |
| HQ F. No. |
01/ 82/050/01648/AM19/DES-III<br>01/ 82/050/01613/AM16/DES-III<br>01/ 82/050/01616/AM19/DES-III |
| RLA F. No. |
03/95/040/00655/AM19<br>03/95/040/00659/AM19<br>03/95/040/00662/AM19 |
| Advance Authorization No. and Date |
0310824061 dated 28.09.2018<br>0310824062 dated 28.09.2018<br>0310824104 dated 01.10.2018 |
| Subject |
Request of M/s Yasho Industries Ltd, Mumbai for allowing<br>Ascorbic Acid in respect of adhoc norms fixed against Advance<br>Authorization<br>No.<br>0310824061<br>dated<br>28.09.2018,<br>No.<br>0310824062<br>dated<br>28.09.2018and<br>No.0310824104<br>dated<br>01.10.2018 |
| **Decision:**The Committee noted that earlier in the above mentioned three authorisations, the Committee in its<br>Meeting No. 15/82-ALC-4/2018 dated 22.03.2019, while ratifying the ad-hoc norms under Para 4.07 of HBP,<br>had disallowed the import of ‘Ascorbic Acid’ as one of the import items required for the production of<br>‘Ascorbyl Palmitate’. Against this decision, the party had submitted the review petition which was considered<br>by the Committee in the present Meeting. The representatives of the party appeared before the Committee and<br>requested for review of the earlier decision of the Committee on the ground that the item ‘Ascorbic Acid’ is also<br>required for the production of their export product ‘Ascorbyl Palmitate’ and the same was also allowed by the<br>RA while issuing the Advance Authorisation.<br>The Committee considered the matter and drew the attention of the representatives of party to para<br>4.11 (A) (ix) of theFTP 2015-20according to which Vitamins except for use in pharmaceutical industry are<br>ineligible for import on self- declaration basis under para 4.07 of the FTP and explained that since their export<br>product ‘Ascorbyl Palmitate’ was found to be not a pharmaceutical product but a food additive, import item<br>‘Ascorbic Acid’ was disallowed as one of the inputs in respect of the above mentioned three authorisations. The<br>Committee, therefore, maintained its earlier decision of disallowing import item ‘Ascorbic Acid’ in respect of<br>the above mentioned three authorisations. |
|
Meeting ended with thanks to Chair.
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