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Office of Directorate General of Foreign Trade New Delhi -0
-----------------------------------------------------------------------------Para 4.7 Decision
Minutes of the Norms Committee – 3 Meeting No. 8/82-ALC4/2019 dated 20.09.2019 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:-
(i) Shri Nirmal Kumar, Dy. Director General of Foreign Trade (ii) Shri Ajay Kumar, Assistant Director (iii) Consultant, Technical Expert Pharmaceuticals (iv) Consultant, Technical Expert Chemicals
MEETING NUMBER : 8/82-ALC4/2019 MEETING DATE : 20.09.2019
ONLINE CASES
| Case No.:27/2/82-ALC4/2010 |
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Party Name:ARJUN |
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Meet No/Date:8/82- |
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Status: |
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CHEMICALS PVT. LTD., |
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ALC4/2019 |
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Approved |
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20.09.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0410111329 |
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:04/24/040/00279/AM10/ |
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04.02.2010 |
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Case No.:27/2/82-ALC4/2010 |
Case No.:27/2/82-ALC4/2010 |
Party Name:ARJUN<br>CHEMICALS PVT. LTD., |
Party Name:ARJUN<br>CHEMICALS PVT. LTD., |
Party Name:ARJUN<br>CHEMICALS PVT. LTD., |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/01261/AM10/ |
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RLA File<br>:04/24/040/00279/AM10/ |
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Lic.No/Date:0410111329<br>04.02.2010 |
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**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output nor<br>by firm whichever is lower: |
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per agenda in the presence of the technical experts and it<br>ms under para 4.7 of HBP as per details below or as applied<br>Import items<br>Qty.<br>Alkyl Ketene Dimer (C16-70%), C18-<br>30%)AKD WAX<br>0.100 kg<br>Emcat<br>E6L<br>-<br>ZS<br>Cationic Potato Starch<br>0.007 kg<br>GUM<br>ROSIN<br>ABEITIC ACID<br>0.136 kg<br>FUMARIC ACID<br>0.005 kg<br>BEWOTEN<br>C410<br>CATIONIC POLYMER<br>0.0293 kg<br>asper above decision of NC. |
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Export product |
Qty. |
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Sl.<br>No. |
Import items |
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Qty. |
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KEYDIME<br>–AKD<br>ALKYL<br>KETENE<br>DIMER – EMULSION |
1 kg |
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1 |
Alkyl Ketene Dimer (C16-70%), C18-<br>30%)AKD WAX |
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0.100 kg |
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2 |
Emcat<br>E6L<br>-<br>ZS<br>Cationic Potato Starch |
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0.007 kg |
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COMPOSIZE<br>NEUTRAL<br>SIZING<br>ROSIN |
1 kg |
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1 |
GUM<br>ROSIN<br>ABEITIC ACID |
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0.136 kg |
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2 |
FUMARIC ACID |
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0.005 kg |
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3 |
BEWOTEN<br>C410<br>CATIONIC POLYMER |
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0.0293 kg |
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RA concerned maytake further necessaryaction |
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asper above decision of NC. |
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Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
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| 2 |
Case No.:6/11/85-ALC3/2016 |
Party Name:GELTEC<br>PRIVATE LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
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HQ File<br>:01/85/050/00103/AM17/ |
RLA File<br>:03/94/040/00502/AM17/ |
Lic.No/Date:0310807611<br>06.09.2016 |
Defer Date |
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**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 20.06.2019 has furnished its reply. Deferred for comments of TE. |
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Case No.:335/12/82- |
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Party Name:MEDREICH |
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Meet No/Date:8/82- |
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Status: |
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ALC4/2018 |
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LIMITED |
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ALC4/2019 |
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Deferred |
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20.09.2019 |
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HQ File |
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RLA File |
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Lic.No/Date:0710110453 |
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Defer Date |
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:01/82/050/00962/AM19/ |
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:07/24/040/00216/AM17/ |
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23.09.2016 |
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3 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Drug Manufacturing license (DML).
(ii) Size and number of bottles to be exported.
| Case No.:283/12/82- |
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Party Name:GLOBAL |
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Meet No/Date:8/82- |
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Status: |
| ALC4/2018 |
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CALCIUM PRIVATE |
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ALC4/2019 |
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Approved |
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LIMITED, |
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20.09.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0710111675 |
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| :01/82/050/00910/AM19/ |
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:07/24/040/00053/AM18/ |
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29.05.2017 |
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Case No.:283/12/82-<br>ALC4/2018 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED, |
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:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00910/AM19/ |
RLA File<br>:07/24/040/00053/AM18/ |
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Lic.No/Date:0710111675<br>29.05.2017 |
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**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output nor<br>by firm whichever is lower:<br>Export product<br>Qty.<br>CALCIUM GLUCONATE -<br>MONOHYDRATE - ORAL GRADE<br>1 kg<br>CALCIUM GLUCONATE -<br>ANHYDROUS - ORAL GRADE<br>1 kg |
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per agenda in the presence of the technical experts and it<br>ms under para 4.7 of HBP as per details below or as applied<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>GLUCONO DELTA LACTONE<br>0.97 kg<br>2<br>CALCIUM CARBONATE<br>0.2738 kg<br>1<br>GLUCONO DELTA LACTONE<br>1.01 kg<br>2<br>CALCIUM CARBONATE<br>0.284 kg<br>asper above decision of NC. |
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Qty. |
Sl.<br>No. |
Import items |
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Qty. |
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1 kg |
1 |
GLUCONO DELTA LACTONE |
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0.97 kg |
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2 |
CALCIUM CARBONATE |
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0.2738 kg |
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1 kg |
1 |
GLUCONO DELTA LACTONE |
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1.01 kg |
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2 |
CALCIUM CARBONATE |
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0.284 kg |
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RA concerned maytake further necessaryaction |
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asper above decision of NC. |
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Case No.:109/12/82- |
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Party Name:VIVIMED LABS |
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Meet No/Date:8/82- |
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Status: |
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ALC4/2017 |
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LIMITED |
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ALC4/2019 |
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Deferred |
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20.09.2019 |
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| 5 |
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HQ File<br>:01/82/050/01064/AM18/ |
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RLA File<br>:09/24/040/00181/AM18/ |
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Lic.No/Date:0910065247<br>06.07.2017 |
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Defer Date |
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**Decision:**The Representative of the firm attended the PH on scheduled date and submitted requisite |
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documents supporting the manufacture of the export product. Since, the process involves numerous stages, |
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more time is required for examiningthe case. |
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Decision: The Representative of the firm attended the PH on scheduled date and submitted requisite documents supporting the manufacture of the export product. Since, the process involves numerous stages, more time is required for examining the case.
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Case No.:297/12/82- |
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Party Name:GLOBAL |
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Meet No/Date:8/82- |
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Status: |
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ALC4/2018 |
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CALCIUM PRIVATE |
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ALC4/2019 |
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Deferred |
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LIMITED, |
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20.09.2019 |
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| 6 |
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HQ File |
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RLA File |
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Lic.No/Date:0710111984 |
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Defer Date |
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:01/82/050/00924/AM19/ |
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:07/24/040/00129/AM18/ |
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08.08.2017 |
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**Decision:**Deferred for comments of TE. |
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| 7 |
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Deferred |
Deferred |
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Case No.:116/12/82-<br>ALC4/2017 |
P<br>L |
arty Name:VIVIMED LABS<br>IMITED |
<br>Mee<br>ALC |
t No/Date:8/82-<br>4/2019 |
Status:<br> <br>Defer D |
Deferred |
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<br>HQ File |
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20.0<br>Lic. |
9.2019 |
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LA File |
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No/Date:0910065373 |
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ate |
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<br> <br>:01/82/050/01071/AM18/<br>:09/24/040/00234/AM18/<br>23.08.2017<br>**Decision:**The Representative of the firm attended the PH on scheduled date and submitted requisite<br>documents supporting the manufacture of the export product. Since, the process involves numerous stages, |
:09/24/040/00234/AM18/ |
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23.08.2017 |
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<br>more time is required for examiningthe case. |
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Decision: The Representative of the firm attended the PH on scheduled date and submitted requisite documents supporting the manufacture of the export product. Since, the process involves numerous stages, more time is required for examining the case.
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Deferred<br>e |
Deferred<br>e |
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Case No.:134/12/82-<br>ALC4/2017 |
Pa<br>LI |
rty Name:VIVIMED LABS<br>MITED<br> <br> |
Meet<br>ALC4 |
No/Date:8/82-<br>/2019<br>.2019<br> <br>o/Date:0910065372<br> |
Status: |
Deferred |
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<br>HQ File |
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<br>LA File<br> |
20.09 |
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R |
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Lic.N |
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Defer Dat |
e |
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<br> <br>:01/82/050/01089/AM18/<br>:09/24/040/00233/AM18/<br>23.08.2017<br>**Decision:**The Representative of the firm attended the PH on scheduled date and submitted requisite<br>documents supporting the manufacture of the export product. Since, the process involves numerous stages, |
:09/24/040/00233/AM18/<br> |
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23.08.2017 |
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<br>more time is required for examiningthe case. |
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Decision: The Representative of the firm attended the PH on scheduled date and submitted requisite documents supporting the manufacture of the export product. Since, the process involves numerous stages, more time is required for examining the case.
| <br>Case No.:131/12/82-<br>ALC4/2017<br>Party Name:VIVIMED LABS<br>LIMITED<br>Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Status: Deferred<br>HQ File<br>:01/82/050/01086/AM18/<br>RLA File<br>:09/24/040/00238/AM18/<br>Lic.No/Date:0910065396<br>28.08.2017<br>Defer Date<br>**Decision:**The Representative of the firm attended the PH on scheduled date and submitted requisite<br>documents supporting the manufacture of the export product. Since, the process involves numerous stages,<br>more time is required for examiningthe case. |
Party Name:VIVIMED LABS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status: Deferred |
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RLA File<br>:09/24/040/00238/AM18/ |
Lic.No/Date:0910065396<br>28.08.2017 |
<br>Defer Date |
Decision: The Representative of the firm attended the PH on scheduled date and submitted requisite documents supporting the manufacture of the export product. Since, the process involves numerous stages, more time is required for examining the case.
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Case No.:132/12/82-<br>ALC4/2017 |
Party Name:VIVIMED LABS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status: Deferred |
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<br>HQ File<br>:01/82/050/01087/AM18/ |
RLA File<br>:09/24/040/00235/AM18/ |
Lic.No/Date:0910065398<br>28.08.2017 |
<br>Defer Date |
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**Decision:**The Representative of the firm attended the PH on scheduled date and submitted requisite<br>documents supporting the manufacture of the export product. Since, the process involves numerous stages,<br>more time is required for examiningthe case. |
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Decision: The Representative of the firm attended the PH on scheduled date and submitted requisite documents supporting the manufacture of the export product. Since, the process involves numerous stages, more time is required for examining the case.
| 11 |
Case No.:141/12/82-<br>ALC4/2017 |
Party Name:VIVIMED LABS<br>LIMITED<br> <br> <br> <br>RLA File<br>:09/24/040/00236/AM18/<br> <br> |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br>Lic.No/Date:0910065397<br>28.08.2017<br> |
Status: Deferred |
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<br>HQ File<br>:01/82/050/01096/AM18/ |
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Defer Date |
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**Decision:**The Representative of the firm attended the PH on scheduled date and submitted requisite<br>documents supporting the manufacture of the export product. Since, the process involves numerous stages,<br>more time is required for examiningthe case. |
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Decision: The Representative of the firm attended the PH on scheduled date and submitted requisite documents supporting the manufacture of the export product. Since, the process involves numerous stages, more time is required for examining the case.
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Case No.:177/12/82-<br>ALC4/2017 |
Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00273/AM18/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br> <br>Defer Date |
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<br>HQ File<br>:01/82/050/01132/AM18/ |
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Lic.No/Date:0910065450<br>11.09.2017 |
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**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 28.06.2019 has furnished its reply. Deferred for comments of TE. |
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Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 28.06.2019 has furnished its reply. Deferred for comments of TE.
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Case No.:112/12/82-<br>ALC4/2017 |
Party Name:SATYA<br>DEEPTHA<br>PHARMACEUTICALS LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Withdrawn |
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<br>HQ File<br>:01/82/050/01067/AM18/ |
RLA File<br>:09/24/040/00303/AM18/ |
Lic.No/Date:0910065453<br>14.09.2017 |
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<br>Decision:The Committee considered the case as per Agenda and it was noted that NC-3 in its Meeting<br>No. 4/82-ALC4/2019 dated 19.07.2019 has already rejected this case, however this case has come up in this<br>meeting due to misupdation.<br>In view of above,the Committee decided towithdrawthe case. |
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Case No.:198/4/82-ALC4/2018 |
Party Name:SAPTAGIR<br>CAMPHOR LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00198/AM19/ |
RLA File<br>:09/24/040/00293/AM18/ |
Lic.No/Date:0910065468<br>15.09.2017 |
Defer Date |
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<br>**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i) Percentage yield on molar basis at every stage.<br>(ii) Chemical reactions with molecular weights of all the chemicals involved in the reaction. |
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| Case No.:79/12/82-ALC4/2017 |
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Party Name:CIPLA LIMITED. |
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Meet No/Date:8/82- |
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Status: |
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ALC4/2019 |
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Deferred |
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20.09.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310816778 |
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Defer Date |
| :01/82/050/01034/AM18/ |
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:03/94/040/00496/AM18/ |
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02.11.2017 |
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15 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:
(i) Qty. of import items in each actuation. (ii) Number of Actuation per ml of Topical Solution. (iii) Qty. of each actuation or metered dose.
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Case No.:51/12/82-ALC4/2017 |
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Party Name:D. K. PHARMA |
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Meet No/Date:8/82- |
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Status: |
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LAB |
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ALC4/2019 |
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Rejected |
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20.09.2019 |
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HQ File |
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RLA File |
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Lic.No/Date:0310816992 |
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:01/82/050/01006/AM18/ |
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:03/94/040/00603/AM18/ |
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13.11.2017 |
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16 Decision: The Committee considered the case as per agenda and it was observed that the import item – DETOX FOC-27 Fish Body Oil having ITC HS – 15042010 comes under Chapter 15 and as per para 4.11 (A) (ix) of the FTP 2015-20 , all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self- declaration basis under para 4.07 of the FTP. In view of above, the Committee decided to reject the case.
| Case No.:234/4/82-ALC4/2018 |
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Party Name:VIVIMED LIFE |
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Meet No/Date:8/82- |
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Status: |
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SCIENCES PRIVATE |
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ALC4/2019 |
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Deferred |
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LIMITED |
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20.09.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0910065686 |
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Defer Date |
| :01/82/050/00234/AM19/ |
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:09/24/040/00396/AM18/ |
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24.11.2017 |
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Decision: The Committee considered the case as per online agenda in the presence of technical experts 17 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, followed by Final Reminder on 05.09.2019:
- (i) Copy of valid DML for each export product.
(ii) Master Batch Formula for each export product. (iii) Imports applied for each export items viz – 2.5 mg, 5mg and 10 mg tablets separately.
Reply awaited from the firm.
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Case No.:236/4/82-<br>ALC4/2018 |
Party Name:VIVIMED LABS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status: Deferred |
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<br>HQ File<br>:01/82/050/00236/AM19/ |
RLA File<br>:09/24/040/00403/AM18/ |
Lic.No/Date:0910065688<br>24.11.2017 |
<br>Defer Date |
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**Decision:**The Representative of the firm attended the PH on scheduled date and submitted requisite<br>documents supporting the manufacture of the export product. Since, the process involves numerous stages,<br>more time is required for examiningthe case. |
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Decision: The Representative of the firm attended the PH on scheduled date and submitted requisite documents supporting the manufacture of the export product. Since, the process involves numerous stages, more time is required for examining the case.
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Case No.:243/4/82-<br>ALC4/2018 |
Party Name:VIVIMED LABS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status: Deferred |
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<br>HQ File<br>:01/82/050/00243/AM19/ |
RLA File<br>:09/24/040/00404/AM18/ |
Lic.No/Date:0910065687<br>24.11.2017 |
<br>Defer Date |
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**Decision:**The Representative of the firm attended the PH on scheduled date and submitted requisite<br>documents supporting the manufacture of the export product. Since, the process involves numerous stages,<br>more time is required for examiningthe case. |
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Decision: The Representative of the firm attended the PH on scheduled date and submitted requisite documents supporting the manufacture of the export product. Since, the process involves numerous stages, more time is required for examining the case.
Case No.:240/12/82- Party Name:HERBOCHEM Meet No/Date:8/82- Status: ALC4/2017 INDUSTRIES ALC4/2019 Deferred 20.09.2019 HQ File RLA File Lic.No/Date:0610038759 Defer Date :01/82/050/01195/AM18/ :06/24/040/00041/AM18/ 14.12.2017 20 Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 4/82-ALC4/2019 dated 19.07.2019 and reminder dated 04.09.2019: (i) CoA of import item indicating percentage composition of Mentha Arvensis Oil. In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
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| Case No.:241/12/82- |
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Party Name:HERBOCHEM |
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Meet No/Date:8/82- |
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Status: |
| ALC4/2017 |
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INDUSTRIES |
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ALC4/2019 |
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Deferred |
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20.09.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0610038783 |
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Defer Date |
| :01/82/050/01196/AM18/ |
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:06/24/040/00044/AM18/ |
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10.01.2018 |
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21 Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 4/82-ALC4/2019 dated 19.07.2019 and reminder dated 04.09.2019: (i) CoA of import item indicating percentage composition of Mentha Arvensis Oil. In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
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Case No.:12/4/82-ALC4/2018 |
Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00012/AM19/ |
RLA File<br>:03/95/040/00810/AM18/ |
Lic.No/Date:0310818490<br>15.01.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda and it was decided to call<br>information from the firm:<br>(i) Percentageyield on molar basis at everystage. |
|
|
for following |
Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
| 23 |
Case No.:165/10/82-<br>ALC4/2018 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0910065915<br>20.01.2018 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/00452/AM19/ |
RLA File<br>:09/24/040/00438/AM18/ |
|
|
|
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 10.07.2019 has furnished its reply. Deferred for comments of TE. |
|
|
|
8
| Case No.:188/10/82- |
|
Party Name:SATYADEVA |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
PHARMACEUTICALS PVT |
|
ALC4/2019 |
|
Approved |
|
|
LTD |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910065921 |
|
|
| :01/82/050/00475/AM19/ |
|
:09/24/040/00504/AM18/ |
|
24.01.2018 |
|
|
|
Case No.:188/10/82-<br>ALC4/2018 |
Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD<br>RLA File<br>:09/24/040/00504/AM18/ |
Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD<br>RLA File<br>:09/24/040/00504/AM18/ |
Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD<br>RLA File<br>:09/24/040/00504/AM18/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00475/AM19/ |
|
|
|
Lic.No/Date:0910065921<br>24.01.2018 |
|
|
| 24 |
**Decision:**The Representative of the firm appeared for PH<br>case. The Committee after deliberation decided to ratify norm<br>given below or as applied by the firm, whichever is less: |
|
|
|
|
|
|
|
Export Product |
Qty |
Sl.<br>No. |
Import Items |
|
Qty |
|
|
(2S,3S,5S)-2-Amino-3-<br>Hydroxy-5-(1-Tetra hydro<br>pyramid-2-only)-3-Methyl<br>butanoyl)<br>Amino-1,6-diphenyl<br>Hexane-s-pyro<br>glutamate(THP) |
1 kg |
1 |
DAH-II |
|
1.13 kg |
|
|
|
|
2 |
1,2 DIMETHOXYETHANE |
|
6.74 kg |
|
|
|
|
3 |
SODIUM BOROHYDRIDE |
|
0.406 kg |
|
|
|
|
4 |
METHANE SULFONIC ACID<br>(OR)METHANESULPHONIC ACID |
|
1.57 kg |
|
|
|
|
5 |
ISOPROPYL ALCOHOL |
|
1.27 kg |
|
|
|
|
6 |
Triethanolamine(99%) |
|
1.167 kg |
|
|
|
|
7 |
N.N-DIMETHYL ACETAMIDE (OR)<br>DIMETHYL ACETAMIDE |
|
1.60 kg |
|
|
|
|
8 |
L-VALINE |
|
0.630 kg |
|
|
|
|
9 |
MCF(Methyl chloroformate) |
|
1.00 kg |
|
|
|
|
10 |
MDC(Methylene Dichloride) |
|
3.25 kg |
|
|
|
|
11 |
ACRYLONITRILE |
|
0.30 kg |
|
|
|
|
12 |
METHANOL |
|
3.30 kg |
|
|
|
|
13 |
METHYL TETR-BUTYL ETHER<br>(OR)TERTIARY BUTYL METHYL<br>ETHER |
|
2.45 kg |
|
|
|
|
14 |
N,N-CARBONYL DIMIDAZOLE |
|
0.443 kg |
|
|
|
|
15 |
AMMONIUMFORMATE |
|
0.500 kg |
|
|
|
|
16 |
DIMETHYL FORMAMIDE |
|
3.95 kg |
|
|
|
|
17 |
L-PYROGLUTAMIC ACID |
|
0.295 kg |
|
|
|
|
18 |
AMMONIUM CHLORIDE |
|
2.00 kg |
|
|
|
|
19 |
PALLADIUM SPONGE (99.95%<br>MIN) |
|
0.001 kg |
|
|
RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Decision: The Representative of the firm appeared for PH before Norms Committee and explained its case. The Committee after deliberation 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.:187/10/82-<br>ALC4/2018 |
Party Name:NISARG<br>BIOSCIENCES PVT LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00474/AM19/ |
RLA File<br>:09/24/040/00497/AM18/ |
Lic.No/Date:0910065945<br>31.01.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda<br>information from the firm:<br>(i) Exact chemical name of the exportproduct. |
|
and it was decided to call for following |
|
9
| 26 |
<br>Case No.:132/10/82-<br>ALC4/2018 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00516/AM18/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00419/AM19/ |
|
Lic.No/Date:0910065954<br>01.02.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 27 |
Case No.:130/10/82-<br>ALC4/2018 |
Party Name:NISARG<br>BIOSCIENCES PVT LTD |
Party Name:NISARG<br>BIOSCIENCES PVT LTD |
Party Name:NISARG<br>BIOSCIENCES PVT LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00417/AM19/ |
RLA File<br>:09/24/040/00496/AM18/ |
|
|
Lic.No/Date:0910065956<br>02.02.2018 |
|
|
|
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 2/82-ALC4/2018 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:<br>Export Product<br>Qty<br>Sl.<br>No.<br>Import Items<br>Qty<br>REVERSACOL OXFORD<br>BLUE<br>1 kg<br>1<br>2,3,3-TRIMETHYL INDOLENINE<br>1.33 kg<br>2<br>1-NITROSO 2-NAPHTHOL<br>1.73 kg |
|
|
|
|
|
|
|
Export Product |
Qty |
Sl.<br>No. |
Import Items |
|
Qty |
|
|
REVERSACOL OXFORD<br>BLUE |
1 kg |
1 |
2,3,3-TRIMETHYL INDOLENINE |
|
1.33 kg |
|
|
|
|
2 |
1-NITROSO 2-NAPHTHOL |
|
1.73 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. 2/82-ALC4/2018 dated 16.05.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as 27 per details given below or as applied by the firm, whichever is less:
RA may take appropriate action as per the decision of Norms Committee.
| 28 |
<br>Case No.:131/10/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/00418/AM19/<br> <br>: |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br> <br>Defer Date |
|
|
RLA File<br>09/24/040/00561/AM18/ |
Lic.No/Date:0910065961<br>02.02.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 29 |
Case No.:135/10/82-<br>ALC4/2018 |
Party Name:NISARG<br>BIOSCIENCES PVT LTD<br>RLA File<br>:09/24/040/00498/AM18/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00422/AM19/ |
|
Lic.No/Date:0910065963<br>02.02.2018 |
Defer Date |
|
<br>**Decision:**The Committee considered the case as per agenda<br>information from the firm:<br>(i) Percentage yield on molar basis at every stage.<br>(ii) Exact chemical name of the exportproduct. |
|
and it was decided to call for following |
|
10
| 30 |
<br>Case No.:140/10/82-<br>ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00427/AM19/ |
RLA File<br>:09/24/040/00527/AM18/ |
Lic.No/Date:0910065968<br>06.02.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 31 |
Case No.:142/4/82-ALC4/2018 |
Party Name:HERBOCHEM<br>INDUSTRIES |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00142/AM19/ |
RLA File<br>:06/24/040/00047/AM18/ |
Lic.No/Date:0610038810<br>07.02.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 08.07.2019 has furnished its reply. Deferred for comments of TE. |
|
|
|
Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 08.07.2019 has furnished its reply. Deferred for comments of TE.
| 32 |
<br>Case No.:166/10/82-<br>ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00453/AM19/ |
RLA File<br>:09/24/040/00528/AM18/ |
Lic.No/Date:0910065973<br>07.02.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
Case No.:80/10/82- |
|
Party Name:CORAL |
|
Meet No/Date:8/82- |
|
Status: |
|
ALC4/2018 |
|
LABORATORIES LTD., |
|
ALC4/2019 |
|
Withdrawn |
|
|
|
|
|
20.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310819212 |
|
|
|
:01/82/050/00367/AM19/ |
|
:03/94/040/00938/AM18/ |
|
16.02.2018 |
|
|
33 Decision: The Committee considered the case as per Agenda and it was noted that NC-3 in its Meeting No. 4/82-ALC4/2019 dated 19.07.2019 has already rejected this case, however this case has come up in this meeting due to misupdation.
, the Committee decided to withdraw the case.
11
| Case No.:82/10/82-ALC4/2018 |
|
Party Name:FRESENIUS KABI |
|
Meet No/Date:8/82- |
|
Status: |
|
|
INDIA PRIVATE LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310819230 |
|
Defer Date |
| :01/82/050/00369/AM19/ |
|
:03/94/040/00911/AM18/ |
|
19.02.2018 |
|
|
34 Decision: The Representative of the firm attended the PH on scheduled date alongwith the sample of packing material and explained its case. The Committee after deliberation decided to call for following information:
(i) Exact name of the export product. (ii) Product wise content of each import item.
| Case No.:93/10/82-ALC4/2018 |
|
Party Name:YASHO |
|
Meet No/Date:8/82- |
|
Status: |
|
|
INDUSTRIES PVT.LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310819263 |
|
Defer Date |
| :01/82/050/00380/AM19/ |
|
:03/95/040/01007/AM18/ |
|
20.02.2018 |
|
|
35 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.
(ii) Chemical structure of finished product with molecular weight.
| 36 |
<br>Case No.:47/13/82-<br>ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01025/AM19/ |
RLA File<br>:09/24/040/00587/AM18/ |
Lic.No/Date:0910066003<br>20.02.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
12
| Case No.:140/4/82- |
|
Party Name:RECKITT |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
BENCKISER (INDIA) |
|
ALC4/2019 |
|
Approved |
|
|
PRIVATE LIMITED |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510405700 |
|
|
| :01/82/050/00140/AM19/ |
|
:05/24/040/00592/AM18/ |
|
21.02.2018 |
|
|
|
Case No.:140/4/82-<br>ALC4/2018 |
Case No.:140/4/82-<br>ALC4/2018 |
Party Name:RECKITT<br>BENCKISER (INDIA)<br>PRIVATE LIMITED |
Party Name:RECKITT<br>BENCKISER (INDIA)<br>PRIVATE LIMITED |
Party Name:RECKITT<br>BENCKISER (INDIA)<br>PRIVATE LIMITED |
Party Name:RECKITT<br>BENCKISER (INDIA)<br>PRIVATE LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00140/AM19/ |
|
RLA File<br>:05/24/040/00592/AM18/ |
|
|
|
Lic.No/Date:0510405700<br>21.02.2018 |
|
|
| 37 |
**Decision:**The Committee considered the case a<br>deliberation, it was decided to ratify the adhoc nor<br>applied by firm whichever is lower: |
|
|
|
s per agenda in the presence of technical experts and after<br>ms under para 4.7 of HBP Vol. I as per details below or as<br>Sl. No.<br>Import items<br>Qty.<br>1<br>CITIRIC ACID<br>ANHYDROUS F4020<br>30.00 mg /<br>300 mgtablet<br>2<br>SACCHARIN BASE<br>55Ox<br>4.50 mg / 300<br>mgtablet<br>3<br>CALCIUM<br>CARBONATE EP<br>90.0 mg / 300<br>mgtablet<br>4<br>ALUMINIUM FOIL<br>Relevant as<br>per packing<br>policy<br>5<br>TALC EP<br>6.0 mg / 300<br>mgtablet<br>2<br>SACCHARIN BASE<br>55Ox<br>1.00 mg / 300<br>mgtablet<br>4<br>ALUMINIUM FOIL<br>Relevant as<br>per packing<br>policy<br>5<br>TALC EP<br>5.0 mg / 300<br>mgtablet<br>1<br>CITIRIC ACID<br>ANHYDROUS F4020<br>50.00 mg /<br>500 mgtablet<br>2<br>SACCHARIN BASE<br>55Ox<br>7.50 mg / 500<br>mgtablet<br>3<br>CALCIUM<br>CARBONATE EP<br>150.0 mg /<br>500 mgtablet<br>4<br>ALUMINIUM FOIL<br>Relevant as<br>per packing<br>policy<br>5<br>TALC EP<br>10.0 mg / 500<br>mgtablet<br>per above decision of NC. |
|
|
|
|
|
Sl.<br>No. |
Export product |
|
Qty. |
Sl. No. |
Import items |
|
Qty. |
|
|
1 |
Disprin Regular<br>(ASPIRIN PH.EUR<br>300MG) ACETYL<br>SALICYLIC ACID 300<br>mg Tablet (ASPIRIN) |
|
1 Number |
1 |
CITIRIC ACID<br>ANHYDROUS F4020 |
|
30.00 mg /<br>300 mgtablet |
|
|
|
|
|
|
2 |
SACCHARIN BASE<br>55Ox |
|
4.50 mg / 300<br>mgtablet |
|
|
|
|
|
|
3 |
CALCIUM<br>CARBONATE EP |
|
90.0 mg / 300<br>mgtablet |
|
|
|
|
|
|
4 |
ALUMINIUM FOIL |
|
Relevant as<br>per packing<br>policy |
|
|
|
|
|
|
5 |
TALC EP |
|
6.0 mg / 300<br>mgtablet |
|
|
2 |
Dispirn Direct and Melts<br>(ASPIRIN PH.EUR<br>300MG) ACETYL<br>SALICYLIC ACID 300<br>mg Tablet (ASPIRIN) |
|
1 Number |
2 |
SACCHARIN BASE<br>55Ox |
|
1.00 mg / 300<br>mgtablet |
|
|
|
|
|
|
4 |
ALUMINIUM FOIL |
|
Relevant as<br>per packing<br>policy |
|
|
|
|
|
|
5 |
TALC EP |
|
5.0 mg / 300<br>mgtablet |
|
|
3 |
Disprin Extra (ASPIRIN<br>PH.EUR 500MG)<br>ACETYL SALICYLIC<br>ACID 500 mg Tablet<br>(ASPIRIN) |
|
1 Number |
1 |
CITIRIC ACID<br>ANHYDROUS F4020 |
|
50.00 mg /<br>500 mgtablet |
|
|
|
|
|
|
2 |
SACCHARIN BASE<br>55Ox |
|
7.50 mg / 500<br>mgtablet |
|
|
|
|
|
|
3 |
CALCIUM<br>CARBONATE EP |
|
150.0 mg /<br>500 mgtablet |
|
|
|
|
|
|
4 |
ALUMINIUM FOIL |
|
Relevant as<br>per packing<br>policy |
|
|
|
|
|
|
5 |
TALC EP |
|
10.0 mg / 500<br>mgtablet |
|
|
RA concerned may take further necessary action as |
|
|
|
per above decision of NC. |
|
|
|
|
Decision: The Committee considered the case as per agenda in the presence of technical experts and after deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
13
|
|
Case No.:186/13/82- |
|
Party Name:SONGWON |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
SPECIALTY CHEMICALS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
INDIA PVT. LTD. |
|
20.09.2019 |
|
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410043908 |
|
Defer Date |
| 38 |
|
:01/82/050/01164/AM19/ |
|
:34/24/040/00341/AM18/ |
|
22.02.2018 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda |
|
|
and it was decided to call for following |
|
|
|
|
|
information from the firm: |
|
|
|
|
|
|
|
|
(i) Percentageyield on molar basis at everystage. |
|
|
|
|
|
|
Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
|
|
Case No.:286/4/82-ALC4/2018 |
Party Name:SURVIVAL |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
TECHNOLOGIES PVT.LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
20.09.2019 |
|
|
|
|
HQ File |
RLA File |
|
Lic.No/Date:0310819412 |
|
Defer Date |
| 39 |
|
:01/82/050/00286/AM19/<br>:03/95/040/00993/AM18/<br>26.02.2018<br>**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) Justification for low yield. |
|
|
|
|
|
|
|
Case No.:125/13/82- |
|
Party Name:ORTIN |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 40 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066054 |
|
Defer Date |
|
|
:01/82/050/01103/AM19/ |
|
:09/24/040/00611/AM18/ |
|
12.03.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
14
| Case No.:72/10/82-ALC4/2018 |
|
Party Name:O C |
|
Meet No/Date:8/82- |
|
Status: |
|
|
SPECIALITIES PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310819894 |
|
|
| :01/82/050/00359/AM19/ |
|
:03/95/040/01114/AM18/ |
|
16.03.2018 |
|
|
|
Case No.:72/10/82-ALC4/2018 |
Case No.:72/10/82-ALC4/2018 |
Party Name:O C<br>SPECIALITIES PVT.LTD. |
Party Name:O C<br>SPECIALITIES PVT.LTD. |
Party Name:O C<br>SPECIALITIES PVT.LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0310819894<br>16.03.2018 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00359/AM19/ |
|
RLA File<br>:03/95/040/01114/AM18/ |
|
|
|
|
| 41 |
<br>**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output norm<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>2,3 DICHLORO<br>PYRIDINE<br>1 kg<br>1<br>2<br>3<br>4 |
|
|
|
per agenda in the presence of the technical experts and it<br>s under para 4.7 of HBP as per details below or as applied<br>Import items<br>Qty.<br>3-AMINO PYRIDINE<br>1.00 kg<br>HYDROGEN<br>PEROXIDE<br>(50<br>%<br>CONCENTRATION)<br>0.637 kg<br>SODIUM NITRITE<br>0.687 kg<br>CAUSTIC SODA LYE (SODIUM<br>HYDOXIDE LYE)<br>6.12 kg<br>sper above decision of NC. |
|
|
|
|
Qty. |
|
Sl.<br>No. |
Import items |
|
|
|
|
1 kg |
|
1 |
3-AMINO PYRIDINE |
|
|
|
|
|
|
2 |
HYDROGEN<br>PEROXIDE<br>(50<br>%<br>CONCENTRATION) |
|
|
|
|
|
|
3 |
SODIUM NITRITE |
|
|
|
|
|
|
4 |
CAUSTIC SODA LYE (SODIUM<br>HYDOXIDE LYE) |
|
|
|
RA concerned maytake further necessaryaction a |
|
|
|
sper above decision of NC. |
|
|
| 42 |
<br>Case No.:33/13/82-<br>ALC4/2018 |
Party Name:VISWAAT<br>CHEMICALS LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01011/AM19/ |
RLA File<br>:03/95/040/01027/AM18/ |
Lic.No/Date:0310819857<br>16.03.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 43 |
Case No.:127/13/82-<br>ALC4/2018 |
Party Name:SPANSULES<br>FORMULATIONS |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01105/AM19/ |
RLA File<br>:09/24/040/00619/AM18/ |
Lic.No/Date:0910066066<br>20.03.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide e-mail<br>dated 03.09.2019 has furnished its reply. Deferred for comments of TE. |
|
|
|
| Case No.:258/12/82- |
|
Party Name:SYNTHO |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
CHIRALS PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
LIMITED |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066087 |
|
Defer Date |
| :01/82/050/00885/AM19/ |
|
:09/24/040/00669/AM18/ |
|
26.03.2018 |
|
|
44 Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 4/82-ALC4/2019 dated 19.07.2019 and reminder dated 03.09.2019:
(i) Production / Consumption data of last 3 years for item of export and import (applied ). (ii) Catalogue of import item. In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.
15
|
|
Case No.:126/13/82- |
|
Party Name:OPTRIX |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
20.09.2019 |
|
|
| 45 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066086 |
|
Defer Date |
|
|
:01/82/050/01104/AM19/ |
|
:09/24/040/00639/AM18/ |
|
26.03.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:44/10/82-ALC4/2018 |
|
Party Name:JUBILANT |
|
Meet No/Date:8/82- |
|
Status: |
|
|
GENERICS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510406024 |
|
|
| :01/82/050/00331/AM19/ |
|
:05/23/040/00490/AM18/ |
|
28.03.2018 |
|
|
|
|
Decision: |
Decision: |
The Committee considered the cases as per agenda and in the light of earlier decision taken in |
The Committee considered the cases as per agenda and in the light of earlier decision taken in |
The Committee considered the cases as per agenda and in the light of earlier decision taken in |
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: |
|
|
|
|
|
Exportproduct |
|
|
Qty. |
|
|
|
|
Valacyclovir Film Coated Tablet 500 mg |
|
|
1 Number |
|
|
|
|
Valacyclovir Film Coated Tablet 1000 mg |
|
|
1 Number |
|
|
|
|
|
|
|
|
|
|
|
|
Sl. No. |
Import items |
For export of 1 No. |
Tablet |
|
| 46 |
|
|
|
|
(Quantityin mg/ tablet)<br>500 mg/ tablet<br>1000 mg/ tablet |
|
|
|
|
|
1 |
Valacyclovir Hydrochloride USP |
600.48 |
1174.51 |
|
|
|
|
|
Monohydrate |
|
|
|
|
|
|
2 |
Microcrystalline Cellulose USNF (Avicel PH |
152.50 |
305.00 |
|
|
|
|
|
101) |
|
|
|
|
|
|
3 |
Crospovidone USNF(Polyplasdone XL) |
7.00 |
14.00 |
|
|
|
|
4 |
Hypromellose(Pharmacoat615)USP |
31.00 |
62.00 |
|
|
|
|
5 |
OpadryBlue(13B50647) |
22.50 |
45.00 |
|
|
|
|
6 |
Magnesium Stearate(MF-2-V-Vegetable) |
3.50 |
7.00 |
|
|
|
|
7 |
CLOSURE PP 38mm CRC-MOLD-RITE |
Relevant as per |
Relevant as per |
|
|
|
|
|
|
PackingPolicy |
PackingPolicy |
|
|
|
|
8 |
CLOSURE PP 53mm RS MOLD-RITE |
Relevant as per |
Relevant as per |
|
|
|
|
|
|
PackingPolicy |
PackingPolicy |
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 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:
| 47 |
Case No.:320/10/82-<br>ALC4/2018 |
Party Name:HETERO LABS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
HQ File<br>:01/82/050/00607/AM19/ |
RLA File<br>:09/24/040/00666/AM18/ |
Lic.No/Date:0910066105<br>28.03.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
16
| Case No.:122/12/82- |
|
Party Name:NEON |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310820210 |
|
|
| :01/82/050/00749/AM19/ |
|
:03/95/040/00877/AM18/ |
|
02.04.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
48
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
CISATRACURIUM |
1 Number |
1 |
CISATRACURIUM BESYLATE |
29.444 mg |
|
BESYLATE INJECTION |
|
|
|
/ 10 ml vial |
|
USP-2MG/ML-10ML |
|
|
|
|
|
2455 Nos. of Ampoules-- |
|
|
|
|
|
2MG/ML-10ML |
|
|
|
|
RA concerned may take further necessary action as per above decision of NC.
| Case No.:123/12/82- |
|
Party Name:NEON |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
LABORATORIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310820208 |
|
|
| :01/82/050/00750/AM19/ |
|
:03/95/040/00709/AM18/ |
|
02.04.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
49
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| CISATRACURIUM |
1 Number |
1 |
CISATRACURIUM BESYLATE |
29.444 mg |
| BESYLATE INJECTION |
|
|
|
/ 10 ml vial |
| USP-2MG/ML-10ML |
|
|
|
|
| 2455 Nos. of Ampoules-- |
|
|
|
|
| 2MG/ML-10ML |
|
|
|
|
|
|
Case No.:5/10/82-ALC4/2018 |
|
Party Name:DCM SHRIRAM |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
INDUSTRIES LTD, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0510406067 |
|
Defer Date |
| 50 |
|
:01/82/050/00292/AM19/ |
|
:05/23/040/00515/AM18/ |
|
09.04.2018 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda |
|
|
and it was decided to call for following |
|
|
|
|
|
information from the firm: |
|
|
|
|
|
|
|
|
(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % |
|
|
|
|
|
|
|
|
ofyield on molar basis at everystage. |
|
|
|
|
|
|
17
| 51 |
<br>Case No.:261/12/82-<br>ALC4/2018 |
Party Name:AKTINOS<br>HEALTHCARE PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00668/AM18/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00888/AM19/ |
|
Lic.No/Date:0910066131<br>11.04.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 52 |
Case No.:232/10/82-<br>ALC4/2018 |
Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD<br>RLA File<br>:31/83/040/00171/AM18/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00519/AM19/ |
|
Lic.No/Date:3110067030<br>12.04.2018 |
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) Exact chemical name of the exportproduct. |
|
|
|
| 53 |
<br>Case No.:156/13/82-<br>ALC4/2018 |
Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED<br>RLA File<br>:09/24/040/00654/AM18/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01134/AM19/ |
|
Lic.No/Date:0910066137<br>12.04.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:320/13/82- |
|
Party Name:GULBRANDSEN |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410044039 |
|
|
| :01/82/050/01298/AM19/ |
|
:34/24/040/00006/AM19/ |
|
16.04.2018 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 8/82-ALC4/2015 dated 16.09.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as 54 per details given below or as applied by the firm, whichever is less:
| Export Product |
Qty |
Sl.<br>No. |
Import Items |
Qty |
| Tetra Butyl Tin (TBT) |
1 kg |
1 |
Tin Ingots |
0.364 kg |
|
|
2 |
Aluminium Grit/Granules |
0.119 kg |
|
|
3 |
Butene-1 |
0.869kg |
RA may take appropriate action as per the decision of Norms Committee.
18
| 55 |
<br>Case No.:122/13/82-<br>ALC4/2018 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01100/AM19/ |
RLA File<br>:09/24/040/00024/AM19/ |
Lic.No/Date:0910066156<br>18.04.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 56 |
<br>Case No.:153/12/82-<br>ALC4/2018 |
Party Name:ETERNIS FINE<br>CHEMICALS LIMITED, |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00780/AM19/ |
RLA File<br>:03/94/040/00055/AM19/ |
Lic.No/Date:0310820647<br>25.04.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 57 |
<br>Case No.:121/13/82-<br>ALC4/2018 |
Party Name:VIVIMED LABS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01099/AM19/ |
RLA File<br>:09/24/040/00044/AM19/ |
Lic.No/Date:0910066198<br>04.05.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 58 |
<br>Case No.:225/10/82-<br>ALC4/2018 |
Party Name:DR J<br>PHARMACHEM PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00512/AM19/ |
RLA File<br>:31/83/040/00014/AM19/ |
Lic.No/Date:3110067038<br>07.05.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:272/10/82- |
|
Party Name:DORF KETAL |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS INDIA |
|
ALC4/2019 |
|
Approved |
|
|
PRIVATE LIMITED |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310820805 |
|
|
| :01/82/050/00559/AM19/ |
|
:03/94/040/00090/AM19/ |
|
07.05.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 59
| Export product<br>Chemical Name: Tetrakis<br>(2-Ethylhexyl)<br>Titanate,<br>Trade<br>Name:<br>TYZOR<br>TOT |
Qty. |
Sl.<br>No. |
Import items |
|
1 kg |
1 |
Tetra Isopropyl Titanate (Brand Name<br>:TYZOR TPT) |
|
|
2 |
2 ETHYL HEXANOL (2-EHA) |
19
| 60 |
Case No.:247/10/82-<br>ALC4/2018 |
Party Name:GOPINATH<br>CHEM-TECH LTD., |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00534/AM19/ |
RLA File<br>:08/24/040/00391/AM18/ |
Lic.No/Date:0810142536<br>09.05.2018 |
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. |
|
|
|
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.
| 61 |
<br>Case No.:107/13/82-<br>ALC4/2018 |
Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01085/AM19/ |
RLA File<br>:09/24/040/00006/AM19/ |
Lic.No/Date:0910066210<br>09.05.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 62 |
Case No.:250/10/82-<br>ALC4/2018 |
Party Name:AETHER<br>INDUSTRIES LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00537/AM19/ |
RLA File<br>:52/24/040/00016/AM19/ |
Lic.No/Date:5210042638<br>10.05.2018 |
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,Surat. |
|
|
|
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.
| 63 |
Case No.:196/12/82-<br>ALC4/2018 |
Party Name:SHREE BANKEY<br>BEHARI LAL FLAVORS |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00823/AM19/ |
RLA File<br>:05/24/040/00067/AM19/ |
Lic.No/Date:0510406412<br>10.05.2018 |
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) Certified production consumption data for item 3.<br>(ii)Justification for lowyield. |
|
|
|
| 64 |
<br>Case No.:93/12/82-ALC4/2018 |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD., |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00720/AM19/ |
RLA File<br>:03/94/040/00104/AM19/ |
Lic.No/Date:0310820963<br>14.05.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
20
| 65 |
<br>Case No.:120/13/82-<br>ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01098/AM19/ |
RLA File<br>:09/24/040/00614/AM18/ |
Lic.No/Date:0910066236<br>15.05.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 66 |
<br>Case No.:18/13/82-ALC4/2018 |
Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00996/AM19/ |
RLA File<br>:09/24/040/00067/AM19/ |
Lic.No/Date:0910066242<br>18.05.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 67 |
Case No.:168/12/82-<br>ALC4/2018 |
Party Name:MANGALAM<br>ORGANICS LIMITED<br>FORMERLY DUJODWALA<br>PRODU |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00795/AM19/ |
RLA File<br>:03/95/040/01140/AM18/ |
Lic.No/Date:0310821107<br>21.05.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and %<br>ofyield on molar basis at everystage. |
|
|
|
|
Case No.:216/10/82- |
|
Party Name:DEEPAK |
|
Meet No/Date:8/82- |
|
Status: |
|
ALC4/2018 |
|
NOVOCHEM |
|
ALC4/2019 |
|
Deferred |
|
|
|
TECHNOLOGIES LTD |
|
20.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:3110067060 |
|
Defer Date |
|
:01/82/050/00503/AM19/ |
|
:31/83/040/00005/AM19/ |
|
23.05.2018 |
|
|
68 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Percentage yield on molar basis at every stage.
(ii) Exact chemical name of the export product.
| 69 |
Case No.:190/12/82-<br>ALC4/2018 |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00817/AM19/ |
RLA File<br>:05/24/040/00098/AM19/ |
Lic.No/Date:0510406572<br>23.05.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i) DrugManufacturinglicense(DML)of the exportproduct. |
|
|
|
21
| Case No.:105/13/82- |
|
Party Name:NAGARJUNA |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
AGRICHEM LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066269 |
|
Defer Date |
| :01/82/050/01083/AM19/ |
|
:09/24/040/00085/AM19/ |
|
24.05.2018 |
|
|
70 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage. (ii) Requirement and recovery of solvents at each stage of manufacturing process.
| Case No.:194/12/82- |
|
Party Name:JUBILANT |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
GENERICS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510406614 |
|
|
| :01/82/050/00821/AM19/ |
|
:05/23/040/00087/AM19/ |
|
25.05.2018 |
|
|
|
Case No.:194/12/82-<br>ALC4/2018 |
Case No.:194/12/82-<br>ALC4/2018 |
Party Name:JUBILANT<br>GENERICS LTD |
Party Name:JUBILANT<br>GENERICS LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00821/AM19/ |
|
RLA File<br>:05/23/040/00087/AM19/ |
|
Lic.No/Date:0510406614<br>25.05.2018 |
|
|
|
| 71 |
**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>Valacyclovir Film Coated Tablet 500 mg<br>1 Number<br>Valacyclovir Film Coated Tablet 1000 mg<br>1 Number<br>Sl. No.<br>Import items<br>For export of 1 No. Tablet<br>(Quantityin mg/ tablet)<br>500 mg/ tablet<br>1000 mg/ tablet<br>1<br>Valacyclovir Hydrochloride USP Monohydrate<br>600.48<br>1174.51<br>2<br>Microcrystalline Cellulose USNF (Avicel PH<br>101)<br>152.50<br>305.00<br>3<br>Crospovidone USNF(Polyplasdone XL)<br>7.00<br>14.00<br>4<br>Hypromellose(Pharmacoat615)USP<br>31.00<br>62.00<br>5<br>OpadryBlue(13B50647)<br>22.50<br>45.00<br>6<br>Magnesium Stearate(MF-2-V-Vegetable)<br>3.50<br>7.00<br>7<br>CLOSURE PP 38mm CRC-MOLD-RITE<br>Relevant as per<br>PackingPolicy<br>Relevant as per<br>PackingPolicy<br>8<br>CLOSURE PP 53mm RS MOLD-RITE<br>Relevant as per<br>PackingPolicy<br>Relevant as per<br>PackingPolicy<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
Exportproduct |
|
|
|
|
|
Qty. |
|
|
Valacyclovir Film Coated Tablet 500 mg |
|
|
|
|
|
1 Number |
|
|
Valacyclovir Film Coated Tablet 1000 mg |
|
|
|
|
|
1 Number |
|
|
|
|
|
|
|
|
|
|
|
Sl. No. |
Import items |
|
For export of 1 No. Tablet<br>(Quantityin mg/ tablet) |
|
|
|
|
|
|
|
|
500 mg/ tablet |
|
1000 mg/ tablet |
|
|
|
1 |
Valacyclovir Hydrochloride USP Monohydrate |
|
600.48 |
|
1174.51 |
|
|
|
2 |
Microcrystalline Cellulose USNF (Avicel PH<br>101) |
|
152.50 |
|
305.00 |
|
|
|
3 |
Crospovidone USNF(Polyplasdone XL) |
|
7.00 |
|
14.00 |
|
|
|
4 |
Hypromellose(Pharmacoat615)USP |
|
31.00 |
|
62.00 |
|
|
|
5 |
OpadryBlue(13B50647) |
|
22.50 |
|
45.00 |
|
|
|
6 |
Magnesium Stearate(MF-2-V-Vegetable) |
|
3.50 |
|
7.00 |
|
|
|
7 |
CLOSURE PP 38mm CRC-MOLD-RITE |
|
Relevant as per<br>PackingPolicy |
|
Relevant as per<br>PackingPolicy |
|
|
|
8 |
CLOSURE PP 53mm RS MOLD-RITE |
|
Relevant as per<br>PackingPolicy |
|
Relevant as per<br>PackingPolicy |
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 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:
22
| Case No.:114/12/82- |
|
Party Name:STERLING |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
AUXILIARIES PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310821255 |
|
|
| :01/82/050/00741/AM19/ |
|
:03/95/040/00875/AM18/ |
|
28.05.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
72
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| STERO N-HEPD (EX) |
1 kg |
1 |
PIPERIDINE |
0.8236 kg |
| (Piperidine Ethanol) |
|
2 |
ETHYLENE OXIDE |
0.4264 kg |
| Sterol 1300 ( ISO TRI |
1 kg |
1 |
ISO TRI DECANOL(ITDA)/EXXAL13 |
0.980 kg |
| DECANOL) |
|
2 |
ISO DECANOL |
0.02 kg |
| Case No.:293/10/82- |
|
Party Name:SATYADEVA |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
PHARMACEUTICALS PVT |
|
ALC4/2019 |
|
Approved |
|
|
LTD |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066289 |
|
|
| :01/82/050/00580/AM19/ |
|
:09/24/040/00102/AM19/ |
|
31.05.2018 |
|
|
|
|
**Decision:**The Representative of the firm |
**Decision:**The Representative of the firm |
**Decision:**The Representative of the firm |
**Decision:**The Representative of the firm |
appeared for PH before Norms Committee and explained |
appeared for PH before Norms Committee and explained |
appeared for PH before Norms Committee and explained |
its |
|
|
case. The Committee after deliberation 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. |
|
|
|
|
|
|
|
(2S,3S,5S)-2-Amino-3- |
1 kg |
1 |
|
DAH-II |
1.13 kg |
|
|
|
|
Hydroxy-5-(1-Tetra hydro |
|
2 |
|
1,2 DIMETHOXYETHANE |
6.74 kg |
|
|
|
|
pyramid-2-only)-3-Methyl |
|
3 |
|
SODIUM BOROHYDRIDE |
0.406 kg |
|
|
|
|
butanoyl) |
|
4 |
|
METHANE SULFONIC ACID |
1.57 kg |
|
|
|
|
Amino-1,6-diphenyl |
|
|
|
(OR)METHANESULPHONIC ACID |
|
|
|
|
|
Hexane-s-pyro |
|
5 |
|
ISOPROPYL ALCOHOL |
1.27 kg |
|
| 73 |
|
|
glutamate(THP) |
|
6 |
|
Triethanolamine(99%) |
1.167 kg |
|
|
|
|
|
|
7 |
|
N.N-DIMETHYL ACETAMIDE (OR) |
1.60 kg |
|
|
|
|
|
|
|
|
DIMETHYL ACETAMIDE |
|
|
|
|
|
|
|
8 |
|
L-VALINE |
0.630 kg |
|
|
|
|
|
|
9 |
|
MCF(Methyl chloroformate) |
1.00 kg |
|
|
|
|
|
|
10 |
|
MDC(Methylene Dichloride) |
3.25 kg |
|
|
|
|
|
|
11 |
|
ACRYLONITRILE |
0.30 kg |
|
|
|
|
|
|
12 |
|
METHANOL |
3.30 kg |
|
|
|
|
|
|
13 |
|
METHYL TETR-BUTYL ETHER |
2.45 kg |
|
|
|
|
|
|
|
|
(OR)TERTIARY BUTYL METHYL |
|
|
|
|
|
|
|
|
|
ETHER |
|
|
|
|
|
|
|
14 |
|
N,N-CARBONYL DIMIDAZOLE |
0.443 kg |
|
|
|
|
|
|
15 |
|
AMMONIUMFORMATE |
0.500 kg |
|
|
|
|
|
|
16 |
|
DIMETHYL FORMAMIDE |
3.95 kg |
|
|
|
|
|
|
17 |
|
L-PYROGLUTAMIC ACID |
0.295 kg |
|
|
|
|
|
|
18 |
|
AMMONIUM CHLORIDE |
2.00 kg |
|
|
|
|
|
|
19 |
|
PALLADIUM SPONGE (99.95% |
0.001 kg |
|
|
|
|
|
|
|
|
MIN) |
|
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
Decision: The Representative of the firm appeared for PH before Norms Committee and explained its case. The Committee after deliberation 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:
23
| 74 |
<br>Case No.:39/13/82-ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01017/AM19/ |
RLA File<br>:09/24/040/00082/AM19/ |
Lic.No/Date:0910066291<br>01.06.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:277/10/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310821558 |
|
Defer Date |
| :01/82/050/00564/AM19/ |
|
:03/94/040/00208/AM19/ |
|
08.06.2018 |
|
|
75 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:
(i) Qty. of import items in each actuation. (ii) Number of Actuation per ml of Topical Solution. (iii) Number of metered doses in one unit pack.
| 76 |
<br>Case No.:279/10/82-<br>ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00566/AM19/ |
RLA File<br>:03/94/040/00207/AM19/ |
Lic.No/Date:0310821556<br>08.06.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 77 |
<br>Case No.:81/12/82-ALC4/2018 |
Party Name:KOPRAN<br>RESEARCH LABORATORIES<br>LTD. |
<br>Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00708/AM19/ |
RLA File<br>:03/94/040/00194/AM19/ |
Lic.No/Date:0310821554<br>08.06.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 78 |
<br>Case No.:59/13/82-ALC4/2018 |
Party Name:VIVIMED LABS<br>LIMITED<br>RLA File<br>:09/24/040/00106/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:0910066318<br>11.06.2018<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01037/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
24
| Case No.:55/12/82-ALC4/2018 |
|
Party Name:SURVIVAL |
|
Meet No/Date:8/82- |
|
Status: |
|
|
TECHNOLOGIES PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310821614 |
|
|
| :01/82/050/00682/AM19/ |
|
:03/95/040/00220/AM19/ |
|
12.06.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
79
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| 1,1-CARBONYLDIIMIDAZOLE / |
1 kg |
1 |
IMIDAZOLE |
1.31 kg |
| N,N CARBONYL DIIMIDAZOLE |
|
2 |
TRIPHOSGENE |
1.20 kg |
|
|
3 |
TRI-N-BUTYLAMINE |
0.80 kg |
|
|
4 |
TETRAHYDROFURAN |
1.80 kg |
| 80 |
Case No.:56/12/82-ALC4/2018 |
Party Name:SANJIVANI<br>PARANTERAL LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
HQ File<br>:01/82/050/00683/AM19/ |
RLA File<br>:03/95/040/00227/AM19/ |
Lic.No/Date:0310821651<br>13.06.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:273/10/82- |
|
Party Name:DORF-KETAL |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS INDIA |
|
ALC4/2019 |
|
Approved |
|
|
PVT.LTD. |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310821762 |
|
|
| :01/82/050/00560/AM19/ |
|
:03/94/040/00224/AM19/ |
|
19.06.2018 |
|
|
|
Case No.:273/10/82-<br>ALC4/2018 |
Case No.:273/10/82-<br>ALC4/2018 |
Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. |
Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. |
Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00560/AM19/ |
|
RLA File<br>:03/94/040/00224/AM19/ |
|
|
Lic.No/Date:0310821762<br>19.06.2018 |
|
| 81 |
**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output nor<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>TETRA-N-PROPYL<br>ZIRCONATE (<br>CONTAINING TETRA-<br>N-PROPYL<br>ZIRCONATE75% AND<br>N-PROPYL ALCOHOL<br>25%)<br>1 kg<br>1<br>2<br>3<br>RA concerned maytake further necessaryaction |
|
|
|
per agenda in the presence of the technical experts and it<br>ms under para 4.7 of HBP as per details below or as applied<br>Import items<br>Qty.<br>ZIRCONIUM TETRACHLORIDE<br>0.533 kg<br>N-PROPYL ALCOHOL / NPA /<br>NORMAL PROPANOL<br>0.829 kg<br>HEPTANE<br>0.10 kg<br>asper above decision of NC. |
|
|
|
|
Qty. |
|
Sl.<br>No. |
Import items |
|
|
|
|
1 kg |
|
1 |
ZIRCONIUM TETRACHLORIDE |
|
|
|
|
|
|
2 |
N-PROPYL ALCOHOL / NPA /<br>NORMAL PROPANOL |
|
|
|
|
|
|
3 |
HEPTANE |
|
|
|
|
|
|
|
asper above decision of NC. |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
25
| Case No.:278/10/82- |
|
Party Name:DORF-KETAL |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS INDIA |
|
ALC4/2019 |
|
Approved |
|
|
PVT.LTD. |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310821761 |
|
|
| :01/82/050/00565/AM19/ |
|
:03/94/040/00223/AM19/ |
|
19.06.2018 |
|
|
|
Case No.:278/10/82-<br>ALC4/2018 |
Case No.:278/10/82-<br>ALC4/2018 |
Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. |
Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. |
Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0310821761<br>19.06.2018 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00565/AM19/ |
|
RLA File<br>:03/94/040/00223/AM19/ |
|
|
|
|
| 82 |
<br>**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output nor<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>TETRA-N-BUTYL<br>ZIRCONATE<br>(<br>CONTAINING TETRA-<br>N-BUTYL ZIRCONATE<br>86%<br>AND<br>N-BUTYL<br>ALCOHOL 14%)<br>1 kg<br>1<br>2<br>3<br>RA concerned maytake further necessaryaction |
|
|
|
per agenda in the presence of the technical experts and it<br>ms under para 4.7 of HBP as per details below or as applied<br>Import items<br>Qty.<br>ZIRCONIUM TETRACHLORIDE<br>0.538 kg<br>N-BUTYL ALCOHOL / NBA /<br>NORMAL BUTANOL<br>0.839 kg<br>HEPTANE<br>0.10 kg<br>asper above decision of NC. |
|
|
|
|
Qty. |
|
Sl.<br>No. |
Import items |
|
|
|
|
1 kg |
|
1 |
ZIRCONIUM TETRACHLORIDE |
|
|
|
|
|
|
2 |
N-BUTYL ALCOHOL / NBA /<br>NORMAL BUTANOL |
|
|
|
|
|
|
3 |
HEPTANE |
|
|
|
|
|
|
|
asper above decision of NC. |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Case No.:175/12/82- |
|
Party Name:NECTAR |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
LIFESCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2210015928 |
|
|
| :01/82/050/00802/AM19/ |
|
:22/24/040/00028/AM19/ |
|
22.06.2018 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 06/82-ALC4/2019 dated 16.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 83
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Cefazolin Sodium Sterile |
1 kg |
1 |
Cefazolin Acid |
0.989 kg |
|
|
2 |
Acetone |
0.515 kg |
|
|
3 |
Activated Carbon |
0.020 kg |
RA may take appropriate action as per the decision of Norms Committee.
| 84 |
<br>Case No.:35/13/82-ALC4/2018 |
Party Name:VIVIMED LABS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01013/AM19/ |
RLA File<br>:09/24/040/00136/AM19/ |
Lic.No/Date:0910066375<br>22.06.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
26
| 85 |
<br>Case No.:71/13/82-ALC4/2018 |
Party Name:VIVIMED LABS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01049/AM19/ |
RLA File<br>:09/24/040/00134/AM19/ |
Lic.No/Date:0910066374<br>22.06.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 86 |
<br>Case No.:76/13/82-ALC4/2018 |
Party Name:VIVIMED LABS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01054/AM19/ |
RLA File<br>:09/24/040/00135/AM19/ |
Lic.No/Date:0910066376<br>22.06.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 87 |
Case No.:274/10/82-<br>ALC4/2018 |
Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00561/AM19/ |
RLA File<br>:03/95/040/00235/AM19/ |
Lic.No/Date:0310821895<br>25.06.2018 |
Defer Date |
|
<br>**Decision:**The Committee considered the case as per agenda and it was decided to call<br>information from the firm:<br>(i) Percentage yield on molar basis at every stage.<br>(ii) Material balance of the entire process.<br>(iii) Stoichiometric balance and balanced chemical reactions. |
|
|
for following |
| 88 |
<br>Case No.:185/13/82-<br>ALC4/2018 |
Party Name:SPC LIFE<br>SCIENCES PVT. LTD.<br>RLA File<br>:34/24/040/00109/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:3410044282<br>26.06.2018 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01163/AM19/ |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 89 |
<br>Case No.:117/13/82-<br>ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD<br>RLA File<br>:09/24/040/00150/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0910066395<br>27.06.2018 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01095/AM19/ |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
27
| Case No.:214/12/82- |
|
Party Name:HPL ADDITIVES |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
LIMITED(FORMERLY |
|
ALC4/2019 |
|
Approved |
|
|
KNOWN HIGH POLYMER |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510407023 |
|
|
| :01/82/050/00841/AM19/ |
|
:05/23/040/00024/AM19/ |
|
29.06.2018 |
|
|
|
Case No.:214/12/82-<br>ALC4/2018 |
Case No.:214/12/82-<br>ALC4/2018 |
Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER |
Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER |
Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER |
Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00841/AM19/ |
|
RLA File<br>:05/23/040/00024/AM19/ |
|
|
|
Lic.No/Date:0510407023<br>29.06.2018 |
|
|
| 90 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Kinox-24<br>Benzene<br>Propionic<br>Acid, 3, 5-Bis (1, 1- Dimethyl<br>ethyl)-4-Hydroxy-2-[3-{3, 5-Bis<br>(1,<br>1-Dimethyl<br>ethyl)-4-<br>Hydroxyphenyl}-1-Oxopropyl]-<br>Hydrazine<br>1 kg<br>1<br>2,6 Di Tert Butyl Phenol<br>1.230 kg<br>2<br>Methyl Acrylate<br>0.528 kg<br>3<br>Hydrazine Hydrate 100%<br>0.283 kg<br>4<br>Methanol<br>0.700 kg<br>5<br>Methyl Aceto Acetate<br>0.263 kg<br>6<br>Toluene<br>0.400 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
case as<br>output n |
per agenda and in the presence of the technical experts and it<br>orms under para 4.7 of HBP as per details below or as applied |
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
Kinox-24<br>Benzene<br>Propionic<br>Acid, 3, 5-Bis (1, 1- Dimethyl<br>ethyl)-4-Hydroxy-2-[3-{3, 5-Bis<br>(1,<br>1-Dimethyl<br>ethyl)-4-<br>Hydroxyphenyl}-1-Oxopropyl]-<br>Hydrazine |
|
1 kg |
1 |
2,6 Di Tert Butyl Phenol |
|
1.230 kg |
|
|
|
|
|
|
2 |
Methyl Acrylate |
|
0.528 kg |
|
|
|
|
|
|
3 |
Hydrazine Hydrate 100% |
|
0.283 kg |
|
|
|
|
|
|
4 |
Methanol |
|
0.700 kg |
|
|
|
|
|
|
5 |
Methyl Aceto Acetate |
|
0.263 kg |
|
|
|
|
|
|
6 |
Toluene |
|
0.400 kg |
|
|
|
|
|
|
|
|
|
|
|
| 91 |
<br>Case No.:221/12/82-<br>ALC4/2018 |
Party Name:IOL CHEMICALS<br>AND PHARMACEUTICALS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00848/AM19/ |
RLA File<br>:30/24/040/00017/AM19/ |
Lic.No/Date:3010104375<br>29.06.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
28
| Case No.:249/13/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310822175 |
|
|
| :01/82/050/01227/AM19/ |
|
:03/94/040/00298/AM19/ |
|
06.07.2018 |
|
|
|
Case No.:249/13/82-<br>ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01227/AM19/ |
RLA File<br>:03/94/040/00298/AM19/ |
Lic.No/Date:0310822175<br>06.07.2018 |
|
| 92 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export Product<br> <br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 5<br>MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 104.167 Kgs (ii) 810.003 Kgs (iii)<br>1677.505 Kgs(iv)856.253 Kgs.<br>1 Number<br>2<br>OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10<br>MG. Each tablet contains (i) Oxybutynin Chloride USP- 10 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 208.334 Kgs (ii) 810.003 Kgs (iii)<br>1682.714 Kgs(iv)856.253 Kgs.<br>1 Number<br>3<br>OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 15<br>MG. Each tablet contains (i) Oxybutynin Chloride USP - 15 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 81.02 mg (iv) Sentry Polyox WSR 303<br>NF- 41.10 mg. Net content (i) 104.167 Kgs (ii) 270.002 Kgs (iii)<br>562.643 Kgs(iv)285.419Kgs.<br>1 Number<br>Sl.<br>No.<br>Import Items<br>For export of 1 Number of Tablet<br>5 mg<br>10 mg<br>15 mg<br>1<br>OXYBUTYNIN CHLORIDE USP<br>5.10 mg<br>10.20 mg<br>15.30 mg<br>2<br>EASTMAN (TM) CELLULOSE ACETATE (CA<br>398-10NF/EP)<br>32.40 mg<br>32.40 mg<br>32.40 mg<br>3<br>SENTRY POLYOX WSR N80 FP NF<br>80.52 mg<br>80.77 mg<br>81.02 mg<br>4<br>SENTRY POLYOX WSR 303 NF<br>41.10 mg<br>41.10 mg<br>41.10 mg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
29
| 93 |
<br>Case No.:247/12/82-<br>ALC4/2018 |
Party Name:MOREPEN<br>LABORATORIES LTD., |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00874/AM19/ |
RLA File<br>:05/24/040/00203/AM19/ |
Lic.No/Date:0510407132<br>09.07.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:250/13/82- |
|
Party Name:BDR |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
INTERNATIONAL PVT. |
|
20.09.2019 |
|
|
|
|
LTD. |
|
|
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310822211 |
|
|
| :01/82/050/01228/AM19/ |
|
:03/94/040/00285/AM19/ |
|
10.07.2018 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 94 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Colistimethate Sodium for<br>Injection BP 1 Million<br>International Unitsper vial 10ml |
1 Number |
1 |
Colistimethate Sodium for<br>Injection BP |
96.63 mg/<br>vial |
| Case No.:96/12/82-ALC4/2018 |
|
Party Name:STERLING |
|
Meet No/Date:8/82- |
|
Status: |
|
|
AUXILIARIES PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310822247 |
|
Defer Date |
| :01/82/050/00723/AM19/ |
|
:03/95/040/00332/AM19/ |
|
11.07.2018 |
|
|
Decision: The Committee considered the case as per online agenda in the presence of technical experts 95 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, followed by Final Reminder on 05.09.2019:
(i) Complete technical details as per Appendix 4E alongwith stoichiometric chemical equation and molecular weight.
Reply awaited from the firm.
30
| Case No.:93/13/82-ALC4/2018 |
|
Party Name:PORUS |
|
Meet No/Date:8/82- |
|
Status: |
|
|
LABORATORIES PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066447 |
|
Defer Date |
| :01/82/050/01071/AM19/ |
|
:09/24/040/00172/AM19/ |
|
12.07.2018 |
|
|
96 Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019 followed by Final Reminder on 05.09.2019:
(i) Complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage of yield on molar basis from the firm. Reply awaited from the firm.
| Case No.:311/13/82- |
|
Party Name:GULBRANDSEN |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410044328 |
|
|
| :01/82/050/01289/AM19/ |
|
:34/24/040/00139/AM19/ |
|
12.07.2018 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 97 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| P 1062 |
1 kg |
1 |
CYANURIC CHLORIDE |
0.515 kg |
| (1,3-Benzenediol, 4-[4,6-bis(2,4-<br>dimethylphenyl)-1,3,5-triazin-2- |
|
2 |
RESORCINOL |
0.307 kg |
| yl]-) |
|
|
|
|
RA may take appropriate action as per the decision of Norms Committee
|
|
Case No.:91/13/82-ALC4/2018 |
|
Party Name:SUVEN LIFE |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 98 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066455 |
|
Defer Date |
|
|
:01/82/050/01069/AM19/ |
|
:09/24/040/00177/AM19/ |
|
13.07.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:98/13/82-ALC4/2018 |
|
Party Name:SUVEN LIFE |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 99 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066454 |
|
Defer Date |
|
|
:01/82/050/01076/AM19/ |
|
:09/24/040/00176/AM19/ |
|
13.07.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
31
| 100 |
Case No.:100/13/82-<br>ALC4/2018 |
Party Name:RA CHEM<br>PHARMA LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01078/AM19/ |
RLA File<br>:09/24/040/00188/AM19/ |
Lic.No/Date:0910066457<br>13.07.2018 |
|
|
**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i) DrugManufacturingLicense(DML)of the exportproduct showingapproved composition. |
|
|
|
Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
| Case No.:237/10/82- |
|
Party Name:CLEAN SCIENCE |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
AND TECHNOLOGY |
|
ALC4/2019 |
|
Approved |
|
|
PVT.LTD. |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067115 |
|
|
| :01/82/050/00524/AM19/ |
|
:31/83/040/00050/AM19/ |
|
16.07.2018 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and taking cue from SION A-74, 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: 101
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Anisole |
1 kg |
1 |
Phenol |
1.007 kg |
|
|
2 |
Di-Methyl Sulphate |
0.770 kg |
|
|
3 |
Caustic Soda Lye |
0.486 kg |
RA may take appropriate action as per the decision of Norms Committee
|
Case No.:189/13/82- |
|
Party Name:YASH RASAYAN |
|
Meet No/Date:8/82- |
|
Status: |
|
ALC4/2018 |
|
& CHEMICALS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
20.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410044333 |
|
Defer Date |
|
:01/82/050/01167/AM19/ |
|
:34/24/040/00114/AM19/ |
|
16.07.2018 |
|
|
102 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage.
32
| Case No.:99/12/82- |
|
Party Name:YASHO |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310822345 |
|
|
| :01/82/050/00726/AM19/ |
|
:03/95/040/00349/AM19/ |
|
17.07.2018 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 103 applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| COPPER<br>DIBUTYL<br>DITHIOCARBAMATE(CDBC) |
1 kg |
1 |
DI-N-<br>BUTYLAMINE(DIBUTYLAMINE) |
0.600 kg |
|
|
2 |
CARBON DISULPHIDE |
0.360 kg |
|
|
3 |
COPPER SULPHATE |
0.443 kg |
RA may take appropriate action as per the decision of Norms Committee
| 104 |
<br>Case No.:300/13/82-<br>ALC4/2018 |
Party Name:ATHENA DRUG<br>DELIVERY SOLUTIONS<br>PRIVATE LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01278/AM19/ |
RLA File<br>:03/94/040/00312/AM19/ |
Lic.No/Date:0310822337<br>17.07.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 105 |
Case No.:87/13/82-ALC4/2018 |
Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00148/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01065/AM19/ |
|
Lic.No/Date:0910066481<br>19.07.2018 |
|
|
<br>**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i) Drug Manufacturing License (DML) of the export product showing approved composition.<br>(ii) Master Batch Formula(MBF)of each exportproduct. |
|
|
|
| 106 |
Case No.:255/12/82-<br>ALC4/2018 |
Party Name:ESKAG<br>PHARMA PRIVATE<br>LIMITED, |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:0210208597<br>20.07.2018<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00882/AM19/ |
RLA File<br>:02/24/040/00064/AM19/ |
|
Defer Date |
|
**Decision:**The Committee considered the case as per agenda and it was decided to call for following<br>information from the firm:<br>(i)<br>DrugManufacturingLicense(DML)of the exportproduct showingapproved composition. |
|
|
|
33
| Case No.:263/13/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310822486 |
|
|
| :01/82/050/01241/AM19/ |
|
:03/94/040/00341/AM19/ |
|
20.07.2018 |
|
|
|
Case No.:263/13/82-<br>ALC4/2018 |
Case No.:263/13/82-<br>ALC4/2018 |
Case No.:263/13/82-<br>ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01241/AM19/ |
|
|
RLA File<br>:03/94/040/00341/AM19/ |
|
Lic.No/Date:0310822486<br>20.07.2018 |
|
|
|
|
| 107 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>10<br>mg<br>(ii) Eastman (TM) Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR<br>303 NF- 100 mg. Net content (i) 201.667 Kgs (ii) 598.951 Kgs (iii)<br>3591.689Kgs(iv)2016.67 Kgs.<br>1 Number<br>2<br>GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>5<br>mg<br>(ii) Eastman (TM) Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303<br>NF- 50 mg. Net content (i) 83.333 Kgs (ii) 340.001 Kgs (iii) 1484.17<br>Kgs(iv)833.335 Kgs.<br>1 Number<br>3<br>GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>2.5<br>mg<br>(ii) Eastman (TM) Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303<br>NF- 50 mg. Net content (i) 53.333 Kgs (ii) 435.254 Kgs (iii) 1899.971<br>Kgs(iv)1066.80 Kgs.<br>1 Number<br>Sl.<br>No.<br>Import Items<br>For export of 1 Number of Tablet<br>2.5 mg<br>5.0 mg<br>10.0 mg<br>1<br>GLIPIZIDE USP<br>2.55 mg<br>5.10 mg<br>10.20 mg<br>2<br>EASTMAN (TM) CELLULOSE ACETATE<br>(CA 398-10NF/EP)<br>20.40 mg<br>20.40 mg<br>29.70 mg<br>3<br>SENTRY POLYOX WSR N80 FP NF<br>89.05 mg<br>89.05 mg<br>178.10 mg<br>4<br>SENTRY POLYOX WSR 303 NF<br>50.00 mg<br>50.00 mg<br>100.00 mg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
|
|
|
|
|
<br>Sl.<br>No.<br>1<br>2<br>3 |
|
|
|
|
|
|
|
|
|
|
|
Export Product |
|
|
|
|
Qty. |
|
|
|
|
|
GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>10<br>mg<br>(ii) Eastman (TM) Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR<br>303 NF- 100 mg. Net content (i) 201.667 Kgs (ii) 598.951 Kgs (iii)<br>3591.689Kgs(iv)2016.67 Kgs. |
|
|
|
|
1 Number |
|
|
|
|
|
GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>5<br>mg<br>(ii) Eastman (TM) Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303<br>NF- 50 mg. Net content (i) 83.333 Kgs (ii) 340.001 Kgs (iii) 1484.17<br>Kgs(iv)833.335 Kgs. |
|
|
|
|
1 Number |
|
|
|
|
|
GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet<br>contains<br>(i)<br>Glipizide<br>USP-<br>2.5<br>mg<br>(ii) Eastman (TM) Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii)<br>Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR 303<br>NF- 50 mg. Net content (i) 53.333 Kgs (ii) 435.254 Kgs (iii) 1899.971<br>Kgs(iv)1066.80 Kgs. |
|
|
|
|
1 Number |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sl.<br>No. |
Import Items |
|
For export of 1 Number |
|
|
|
of Tablet |
|
|
|
|
|
|
2.5 mg |
|
5.0 mg |
|
10.0 mg |
|
|
|
1 |
GLIPIZIDE USP |
|
2.55 mg |
|
5.10 mg |
|
10.20 mg |
|
|
|
2 |
EASTMAN (TM) CELLULOSE ACETATE<br>(CA 398-10NF/EP) |
|
20.40 mg |
|
20.40 mg |
|
29.70 mg |
|
|
|
3 |
SENTRY POLYOX WSR N80 FP NF |
|
89.05 mg |
|
89.05 mg |
|
178.10 mg |
|
|
|
4 |
SENTRY POLYOX WSR 303 NF |
|
50.00 mg |
|
50.00 mg |
|
100.00 mg |
|
|
|
|
|
|
|
|
|
|
|
|
34
|
Case No.:248/13/82- |
Case No.:248/13/82- |
Party Name:FDC LTD |
Party Name:FDC LTD |
|
|
Meet No/Date:8/82- |
|
|
Status: |
|
|
ALC4/2018 |
|
|
|
|
|
ALC4/2019 |
|
|
Approved |
|
|
|
|
|
|
|
|
20.09.2019 |
|
|
|
|
|
HQ File |
|
RLA File |
|
|
|
Lic.No/Date:0310822498 |
|
|
|
|
|
:01/82/050/01226/AM19/ |
|
:03/94/040/00323/AM19/ |
|
|
|
23.07.2018 |
|
|
|
|
|
**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: |
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
|
|
Qty. |
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
|
|
Gentamicin Ear/Eye Drops |
5ML,<br>1 Number |
1 |
GENTAMICIN |
|
|
18.375 mg / 5 |
|
|
|
|
|
0.3% w/v |
|
|
SULPHATE |
|
|
ml |
|
|
|
|
|
Gentamicin Ear/Eye Drops |
<br>1 Number |
1 |
GENTAMICIN |
|
|
36.75 mg / 10 |
|
|
|
|
|
10ML,0.3% w/v |
|
|
SULPHATE |
|
|
ml |
|
|
|
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: 108
|
|
Case No.:34/13/82-ALC4/2018 |
|
Party Name:NITIKA |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
PHARMACEUTICAL |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
SPECIALITIES PVT. LTD. |
|
20.09.2019 |
|
|
| 109 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:5010002462 |
|
Defer Date |
|
|
:01/82/050/01012/AM19/ |
|
:50/24/040/00013/AM19/ |
|
24.07.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:78/13/82-ALC4/2018 |
|
Party Name:SMS |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
LIFESCIENCES INDIA |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
20.09.2019 |
|
|
| 110 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066505 |
|
Defer Date |
|
|
:01/82/050/01056/AM19/ |
|
:09/24/040/00205/AM19/ |
|
24.07.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:323/13/82- |
|
Party Name:ALEMBIC |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 111 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410044364 |
|
Defer Date |
|
|
:01/82/050/01301/AM19/ |
|
:34/24/040/00140/AM19/ |
|
25.07.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
35
Case No.:324/13/82- Party Name:GULBRANDSEN Meet No/Date:8/82- Status: ALC4/2018 CHEMICALS PVT LTD ALC4/2019 Approved 20.09.2019 HQ File RLA File Lic.No/Date:3410044367 :01/82/050/01302/AM19/ :34/24/040/00150/AM19/ 27.07.2018 Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 7/82-ALC4/2019 dated 06.09.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 112 per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Ethyl Aluminium Sesqui Chloride<br>(EASC) |
1 kg |
1 |
ALUMINIUM GRIT/GRANULES |
0.14 kg |
| Case No.:239/13/82- |
|
Party Name:KEVA |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
FRAGRANCES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
LIMITED |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310822723 |
|
Defer Date |
| :01/82/050/01217/AM19/ |
|
:03/94/040/00390/AM19/ |
|
31.07.2018 |
|
|
113 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 name of the export product. |
| (ii) |
Crude to finished product. |
| (iii) |
Past production consumption data. |
| 114 |
<br>Case No.:77/13/82-ALC4/2018 |
Party Name:ORTIN<br>LABORATORIES LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01055/AM19/ |
RLA File<br>:09/24/040/00211/AM19/ |
Lic.No/Date:0910066546<br>03.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
36
| Case No.:266/13/82- |
|
Party Name:DORF-KETAL |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS INDIA |
|
ALC4/2019 |
|
Approved |
|
|
PVT.LTD. |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310822847 |
|
|
| :01/82/050/01244/AM19/ |
|
:03/94/040/00399/AM19/ |
|
03.08.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
115
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
TETRA-N-BUTYL |
1 kg |
1 |
ZIRCONIUM TETRACHLORIDE |
0.538 kg |
|
ZIRCONATE<br>(CONTAINING TETRA-N- |
|
2 |
N-BUTYL ALCOHOL / NBA /<br>NORMAL BUTANOL |
0.839 kg |
|
BUTYL ZIRCONATE 86%<br>AND N-BUTYL ALCOHOL |
|
3 |
HEPTANE |
0.10 kg |
|
14%) |
|
|
|
|
| Case No.:267/13/82- |
|
Party Name:DORF-KETAL |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
CHEMICALS INDIA |
|
ALC4/2019 |
|
Approved |
|
|
PVT.LTD. |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310822848 |
|
|
| :01/82/050/01245/AM19/ |
|
:03/94/040/00400/AM19/ |
|
03.08.2018 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
116
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
TETRA-N-PROPYL |
1 kg |
1 |
ZIRCONIUM TETRACHLORIDE |
0.533 kg |
|
ZIRCONATE (CONTAINING<br>TETRA-N-PROPYL |
|
2 |
N-PROPYL ALCOHOL / NPA /<br>NORMAL PROPANOL |
0.829 kg |
|
ZIRCONATE 75% AND N-<br>PROPYL ALCOHOL 25%) |
|
3 |
HEPTANE |
0.10 kg |
37
| Case No.:25/13/82-ALC4/2018 |
|
Party Name:SUN |
|
Meet No/Date:8/82- |
|
Status: |
|
|
PHARMACEUTICAL |
|
ALC4/2019 |
|
Approved |
|
|
INDUSTRIES LTD. |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510407451 |
|
|
| :01/82/050/01003/AM19/ |
|
:05/24/040/00266/AM19/ |
|
06.08.2018 |
|
|
|
Case No.:25/13/82-ALC4/2018 |
Case No.:25/13/82-ALC4/2018 |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/01003/AM19/ |
|
RLA File<br>:05/24/040/00266/AM19/ |
|
|
Lic.No/Date:0510407451<br>06.08.2018 |
|
|
| 117 |
<br>**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output n<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Pentoxifylline<br>1 kg<br>1<br>2<br>3<br>4<br>5<br>6<br>RA concerned maytake further necessaryaction |
|
|
|
per agenda in the presence of the technical experts and it<br>orms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
Qty. |
|
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
1 kg |
|
1 |
Theobromine |
|
0.84 kg |
|
|
|
|
|
2 |
Chlorohexan-2-One / 6-Chloro-2-<br>Hexanone |
|
0.72 kg |
|
|
|
|
|
3 |
Dimethyl Formamide |
|
0.75 kg |
|
|
|
|
|
4 |
Pottasium Carbonate |
|
0.43 kg |
|
|
|
|
|
5 |
Methanol |
|
0.75 kg |
|
|
|
|
|
6 |
Acticarbone |
|
0.0117 kg |
|
|
|
|
|
|
asper above decision of NC. |
|
|
|
| 118 |
<br>Case No.:11/13/82-ALC4/2018 |
Party Name:SRI<br>VYJAYANTHI LABS PVT<br>LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00989/AM19/ |
RLA File<br>:26/24/040/00007/AM19/ |
Lic.No/Date:2610012846<br>07.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:172/13/82- |
|
Party Name:TIDE |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
INDUSTRIES |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410044399 |
|
Defer Date |
| :01/82/050/01150/AM19/ |
|
:34/24/040/00094/AM19/ |
|
08.08.2018 |
|
|
119 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 chemical name of the export product.
(ii) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.
38
120
|
Case No.:134/13/82- |
|
Party Name:YASHO |
|
Meet No/Date:8/82- |
|
Status: |
|
ALC4/2018 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
20.09.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310822942 |
|
Defer Date |
|
:01/82/050/01112/AM19/ |
|
:03/95/040/00445/AM19/ |
|
09.08.2018 |
|
|
Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:
(i) Percentage yield on molar basis at every stage.
(ii) Chemical reactions with molecular weights of all the chemicals involved in the reaction.
| 121 |
<br>Case No.:234/13/82-<br>ALC4/2018 |
Party Name:LASENOR INDIA<br>PRIVATE LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01212/AM19/ |
RLA File<br>:50/24/040/00015/AM19/ |
Lic.No/Date:5010002465<br>09.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 122 |
<br>Case No.:133/13/82-<br>ALC4/2018 |
Party Name:RUBICON<br>RESEARCH PVT. LTD., |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01111/AM19/ |
RLA File<br>:03/95/040/00417/AM19/ |
Lic.No/Date:0310822983<br>10.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
39
| Case No.:305/13/82- |
|
Party Name:J.B. CHEMICALS |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
& PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310823011 |
|
|
| :01/82/050/01283/AM19/ |
|
:03/94/040/00418/AM19/ |
|
13.08.2018 |
|
|
|
|
|
|
|
|
|
|
|
Case No.:305/13/82-<br>ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS |
|
|
Meet No/Date:8/82-<br>ALC4/2019 |
|
Status:<br>Approved |
|
|
LIMITED<br>RLA File |
|
|
20.09.2019 |
|
|
|
HQ File |
|
|
|
Lic.No/Date:0310823011 |
|
|
|
:01/82/050/01283/AM19/ |
:03/94/040/00418/AM19/ |
|
|
13.08.2018 |
|
|
|
**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 b |
y firm whichever is lower: |
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import it |
ems |
Q |
ty. |
|
Rinza sip with Vitamin C<br>(Flavours Orange/ Lemon/ |
79487180<br>Number |
1 |
Caffeine |
Anhydrous Powder |
2 |
408.466 kg |
|
Black<br>Currant/<br>Other<br>flavours)<br>&Rinza<br>Sip<br>(Flavours<br>Orange/<br>Lemon/<br>Black<br>currant/ Craneberry/ Honey<br>Lemon/<br>Other<br>flavours).<br>Eh h f 5 i |
Sachet |
|
|
|
|
|
|
ac sacet o gm contans<br>Caffeine Anhydrous Powder<br>30mg.<br>Net<br>contains<br>of |
|
|
|
|
|
|
| 123 |
<br> <br> <br> <br> <br>Caffeine Anhydrous Powder<br>2384.62 Kgs. |
|
|
|
|
|
|
|
Rinza Tablet. Each tablet<br> <br> |
23460420<br> |
1 |
Caffeine |
Anhydrous Powder |
7 |
17.886 kg |
|
contains<br>Caffeine<br>Anhydrous Powder 30 mg,<br> |
Number<br>Tablet |
2 |
Paraceta |
mol IP/BP |
1 |
1964.814 kg |
|
and Paracetamol BP 500 mg.<br>Net Content of Caffeine<br>Anhydrous Powder - 703.81<br>Kgs and Paracetamol IP/ |
|
|
|
|
|
|
|
<br>BP- 11730.21 Kgs |
|
|
|
|
|
|
|
Rinza<br>Sip<br>for<br>Children<br>(Flavours Raspberry/ other<br>flavours). Each sachet of 3<br>gm<br>contains<br>Paracetamol<br>IP/BP<br>-<br>280mg.<br>Net contains of Paracetamol<br>IP/BP- 4807.69Kgs. |
17170330<br>Number<br>Sachet |
1 |
Paracetamol IP/BP |
|
4855.766 kg |
|
|
Ittensy<br>Caffeine<br>Coffee<br>Flavour<br>Lozenges.<br>Each<br>lozenge contains Caffeine<br>Anhydrous Powder- 30mg.<br>Net contains of Caffeine<br>Anhydrous<br>Powder<br>-<br>1015.63 Kgs. |
33854184<br>Number<br>Lozenges |
1 |
Caffeine Anhydrous Powder |
|
1035.94 kg |
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
40
| 124 |
<br>Case No.:89/13/82-ALC4/2018 |
Party Name:SUVEN LIFE<br>SCIENCES LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01067/AM19/ |
RLA File<br>:09/24/040/00227/AM19/ |
Lic.No/Date:0910066569<br>16.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 125 |
<br>Case No.:151/13/82-<br>ALC4/2018 |
Party Name:STERLING<br>AUXILIARIES PVT LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01129/AM19/ |
RLA File<br>:03/95/040/00489/AM19/ |
Lic.No/Date:0310823127<br>20.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 126 |
Case No.:326/13/82-<br>ALC4/2018 |
Party Name:BALAJI AMINES<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01304/AM19/ |
RLA File<br>:31/83/040/00082/AM19/ |
Lic.No/Date:3110067147<br>20.08.2018 |
Defer Date |
|
**Decision:**The Committee considered the case as per agenda<br>information from the firm:<br>(i) Percentageyield on molar basis at everystage. |
|
and it was decided to call for following |
|
| 127 |
<br>Case No.:142/13/82-<br>ALC4/2018 |
Party Name:PALADIN<br>PAINTS AND CHEMICALS<br>PVT. LTD.,<br>RLA File<br>:03/95/040/00456/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:0310823254<br>24.08.2018<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01120/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 128 |
<br>Case No.:209/13/82-<br>ALC4/2018 |
Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01187/AM19/ |
RLA File<br>:31/83/040/00081/AM19/ |
Lic.No/Date:3110067162<br>24.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
41
| 129 |
<br>Case No.:86/13/82-ALC4/2018 |
Party Name:RAKSHIT<br>PHARMACEUTICALS LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01064/AM19/ |
RLA File<br>:09/24/040/00239/AM19/ |
Lic.No/Date:0910066593<br>27.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 130 |
<br>Case No.:150/13/82-<br>ALC4/2018 |
Party Name:STERLING<br>AUXILIARIES PVT LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01128/AM19/ |
RLA File<br>:03/95/040/00413/AM19/ |
Lic.No/Date:0310823301<br>27.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 131 |
<br>Case No.:164/13/82-<br>ALC4/2018 |
Party Name:SARNA<br>CHEMICALS PVT LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01142/AM19/ |
RLA File<br>:52/24/040/00044/AM19/ |
Lic.No/Date:5210042742<br>27.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 132 |
<br>Case No.:368/13/82-<br>ALC4/2018 |
Party Name:DANOPHARM<br>CHEMICALS PRIVATE LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01346/AM19/ |
RLA File<br>:03/94/040/00340/AM19/ |
Lic.No/Date:0310823354<br>28.08.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 133 |
<br>Case No.:369/13/82-<br>ALC4/2018 |
Party Name:DANOPHARM<br>CHEMICALS PRIVATE LTD.<br>RLA File<br>:03/94/040/00413/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:0310823358<br>28.08.2018<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01347/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
42
| Case No.:85/13/82-ALC4/2018 |
|
Party Name:S V LABS PVT |
|
Meet No/Date:8/82- |
|
Status: |
|
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910066602 |
|
|
| :01/82/050/01063/AM19/ |
|
:09/24/040/00246/AM19/ |
|
29.08.2018 |
|
|
|
|
LTD<br>ALC4/2019<br>20.09.2019<br>Approved<br>HQ File<br>:01/82/050/01063/AM19/<br>RLA File<br>:09/24/040/00246/AM19/<br>Lic.No/Date:0910066602<br>29.08.2018 |
LTD<br>ALC4/2019<br>20.09.2019<br>Approved<br>HQ File<br>:01/82/050/01063/AM19/<br>RLA File<br>:09/24/040/00246/AM19/<br>Lic.No/Date:0910066602<br>29.08.2018 |
LTD<br>ALC4/2019<br>20.09.2019<br>Approved<br>HQ File<br>:01/82/050/01063/AM19/<br>RLA File<br>:09/24/040/00246/AM19/<br>Lic.No/Date:0910066602<br>29.08.2018 |
LTD<br>ALC4/2019<br>20.09.2019<br>Approved<br>HQ File<br>:01/82/050/01063/AM19/<br>RLA File<br>:09/24/040/00246/AM19/<br>Lic.No/Date:0910066602<br>29.08.2018 |
LTD<br>ALC4/2019<br>20.09.2019<br>Approved<br>HQ File<br>:01/82/050/01063/AM19/<br>RLA File<br>:09/24/040/00246/AM19/<br>Lic.No/Date:0910066602<br>29.08.2018 |
LTD<br>ALC4/2019<br>20.09.2019<br>Approved<br>HQ File<br>:01/82/050/01063/AM19/<br>RLA File<br>:09/24/040/00246/AM19/<br>Lic.No/Date:0910066602<br>29.08.2018 |
LTD<br>ALC4/2019<br>20.09.2019<br>Approved<br>HQ File<br>:01/82/050/01063/AM19/<br>RLA File<br>:09/24/040/00246/AM19/<br>Lic.No/Date:0910066602<br>29.08.2018 |
|
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it |
|
|
|
|
|
|
|
|
|
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
| 134 |
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
|
|
|
Cyclohexyl<br>Ester |
1 kg |
|
1 |
Glyoxyllic acid(50 %) |
0.726 kg |
|
|
|
|
Rx |
|
|
2 |
L(-)Menthol |
0.663 kg |
|
|
|
|
|
|
|
3 |
2,5 Dihydroxy-1,4 Dithiane(Diol) |
0.312 kg |
|
|
|
|
|
|
|
4 |
METHYLENE CHLORIDE(MDC) |
2.63 kg |
|
|
|
|
|
|
|
5 |
Triphosgene |
0.40 kg |
|
|
|
|
|
|
|
6 |
HEXAMETHYL DISILAZANE(HMDS) |
0.286 kg |
|
|
|
|
|
|
|
7 |
Cytosine |
0.395 kg |
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
Case No.:147/13/82- |
|
Party Name:NAPROD LIFE |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
SCIENCES PVT. LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 135 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310823401 |
|
Defer Date |
|
|
:01/82/050/01125/AM19/ |
|
:03/95/040/00537/AM19/ |
|
29.08.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:84/13/82-ALC4/2018 |
|
Party Name:SRINI |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
PRIVATE LIMITED |
|
20.09.2019 |
|
|
| 136 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066620 |
|
Defer Date |
|
|
:01/82/050/01062/AM19/ |
|
:09/24/040/00251/AM19/ |
|
03.09.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:88/13/82-ALC4/2018 |
|
Party Name:SATYADEVA |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
PHARMACEUTICALS PVT |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LTD |
|
20.09.2019 |
|
|
| 137 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066623 |
|
Defer Date |
|
|
:01/82/050/01066/AM19/ |
|
:09/24/040/00247/AM19/ |
|
03.09.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
43
|
|
Case No.:230/13/82- |
|
Party Name:KAIRAV |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
CHEMOFARBE INDUSTRIES |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LTD. |
|
20.09.2019 |
|
|
| 138 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310823513 |
|
Defer Date |
|
|
:01/82/050/01208/AM19/ |
|
:03/94/040/00403/AM19/ |
|
04.09.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:435/13/82- |
|
Party Name:DCM SHRIRAM |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
INDUSTRIES LTD, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 139 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0510407689 |
|
Defer Date |
|
|
:01/82/050/01413/AM19/ |
|
:05/23/040/00242/AM19/ |
|
05.09.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:227/13/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMACEUTICALS LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 140 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310823648 |
|
Defer Date |
|
|
:01/82/050/01205/AM19/ |
|
:03/94/040/00518/AM19/ |
|
07.09.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:429/13/82- |
|
Party Name:CADILA |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
HEALTHCARE LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 141 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0810143413 |
|
Defer Date |
|
|
:01/82/050/01407/AM19/ |
|
:08/24/040/00131/AM19/ |
|
07.09.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:94/13/82-ALC4/2018Party Name:VIVIMED LABS<br>Meet No/Date:8/82- |
|
Status: |
|
|
LIMITED<br>ALC4/2019 |
|
Deferred |
|
|
20.09.2019 |
|
|
|
|
HQ File<br>RLA File<br>Lic.No/Date:0910066645 |
|
Defer Date |
|
|
:01/82/050/01072/AM19/<br>:09/24/040/00273/AM19/<br>10.09.2018 |
|
|
| 142 |
|
Decision: The Committee considered the case as per online agenda in the presence of technical experts |
|
|
|
|
and it was noted that the firm still has not furnished the following information asked for by NC-3 in its |
|
|
|
|
Meeting No. 13/82-ALC4/2018 dated 14.01.2019, followed by Final Reminder on 05.09.2019: |
|
|
|
|
(i)<br>Percentage of yield at every stage with stoichiometric balance. |
|
|
|
|
Replyawaited from the firm. |
|
|
44
| 143 |
<br>Case No.:108/13/82-<br>ALC4/2018 |
Party Name:SHREE BANKEY<br>BEHARI LAL FLAVORS |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01086/AM19/ |
RLA File<br>:05/24/040/00324/AM19/ |
Lic.No/Date:0510407757<br>12.09.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 144 |
<br>Case No.:180/13/82-<br>ALC4/2018 |
Party Name:SARNA<br>CHEMICALS PVT LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:5210042764<br>14.09.2018 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01158/AM19/ |
RLA File<br>:52/24/040/00050/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 145 |
<br>Case No.:400/13/82-<br>ALC4/2018 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01378/AM19/ |
RLA File<br>:03/94/040/00504/AM19/ |
Lic.No/Date:0310823779<br>17.09.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 146 |
<br>Case No.:176/13/82-<br>ALC4/2018 |
Party Name:VOVANTIS<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:3410044518<br>26.09.2018 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01154/AM19/ |
RLA File<br>:34/24/040/00145/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 147 |
<br>Case No.:213/13/82-<br>ALC4/2018 |
Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01191/AM19/ |
RLA File<br>:31/83/040/00094/AM19/ |
Lic.No/Date:3110067177<br>26.09.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 148 |
<br>Case No.:365/13/82-<br>ALC4/2018 |
Party Name:ELPPE<br>CHEMICALS PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01343/AM19/ |
RLA File<br>:03/94/040/00551/AM19/ |
Lic.No/Date:0310823993<br>26.09.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
45
|
|
Case No.:447/13/82- |
|
Party Name:AETHER |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 149 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:5210042774 |
|
Defer Date |
|
|
:01/82/050/01425/AM19/ |
|
:52/24/040/00031/AM19/ |
|
27.09.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:450/13/82- |
|
Party Name:AETHER |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 150 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:5210042776 |
|
Defer Date |
|
|
:01/82/050/01428/AM19/ |
|
:52/24/040/00048/AM19/ |
|
27.09.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:112/13/82- |
|
Party Name:VARAHI |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
PHARMA PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
20.09.2019 |
|
|
| 151 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:6610000013 |
|
Defer Date |
|
|
:01/82/050/01090/AM19/ |
|
:66/24/040/00004/AM19/ |
|
03.10.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:52/13/82-ALC4/2018 |
|
Party Name:S V LABS PVT |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 152 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066711 |
|
Defer Date |
|
|
:01/82/050/01030/AM19/ |
|
:09/24/040/00301/AM19/ |
|
04.10.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:56/13/82-ALC4/2018 |
|
Party Name:S M S |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 153 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910066717 |
|
Defer Date |
|
|
:01/82/050/01034/AM19/ |
|
:09/24/040/00321/AM19/ |
|
04.10.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:442/13/82- |
|
Party Name:MOREPEN |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ALC4/2018 |
|
LABORATORIES LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 154 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0510407973 |
|
Defer Date |
|
|
:01/82/050/01420/AM19/ |
|
:05/24/040/00367/AM19/ |
|
04.10.2018 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
46
| 155 |
<br>Case No.:454/13/82-<br>ALC4/2018 |
Party Name:IND-SWIFT<br>LABORATORIES LTD., |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01432/AM19/ |
RLA File<br>:22/24/040/00058/AM19/ |
Lic.No/Date:2210015989<br>05.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 156 |
<br>Case No.:438/13/82-<br>ALC4/2018 |
Party Name:HPL ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER<br>RLA File<br>:05/23/040/00284/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:0510408013<br>08.10.2018<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01416/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 157 |
<br>Case No.:224/13/82-<br>ALC4/2018 |
Party Name:ASTRAL<br>STERITECH PVT. LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01202/AM19/ |
RLA File<br>:34/24/040/00225/AM19/ |
Lic.No/Date:3410044573<br>10.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 158 |
<br>Case No.:168/13/82-<br>ALC4/2018 |
Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01146/AM19/ |
RLA File<br>:34/24/040/00232/AM19/ |
Lic.No/Date:3410044578<br>11.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 159 |
<br>Case No.:169/13/82-<br>ALC4/2018 |
Party Name:SPC LIFE<br>SCIENCES PVT. LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01147/AM19/ |
RLA File<br>:34/24/040/00211/AM19/ |
Lic.No/Date:3410044586<br>12.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 160 |
<br>Case No.:322/13/82-<br>ALC4/2018 |
Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01300/AM19/ |
RLA File<br>:24/24/040/00033/AM19/ |
Lic.No/Date:2410042548<br>24.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
47
| 161 |
<br>Case No.:424/13/82-<br>ALC4/2018 |
Party Name:DEEPAK<br>NITRITE LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019 |
|
<br>HQ File<br>:01/82/050/01402/AM19/ |
RLA File<br>:34/24/040/00144/AM19/ |
Lic.No/Date:3410044635<br>25.10.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 162 |
<br>Case No.:426/13/82-<br>ALC4/2018 |
Party Name:DEEPAK<br>NITRITE LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01404/AM19/ |
RLA File<br>:34/24/040/00208/AM19/ |
Lic.No/Date:3410044636<br>25.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:453/13/82- |
|
Party Name:HESTER |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
BIOSCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810143739 |
|
Defer Date |
| :01/82/050/01431/AM19/ |
|
:08/24/040/00231/AM19/ |
|
25.10.2018 |
|
|
163 Decision: The application of the firm was forwarded to DBT for obtaining its comments. DBT vide its e-mail dated 15.07.2019 requested to call for following information from the firm:
(i) Breakup total no. of vials of different doses to be exported.
(ii) QA approved batch manufacturing record showing issuance and reconciliation of material for manufacturing vaccine.
| Case No.:232/13/82- |
|
Party Name:DEEPAK |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2018 |
|
NOVOCHEM |
|
ALC4/2019 |
|
Deferred |
|
|
TECHNOLOGIES LTD |
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067218 |
|
Defer Date |
| :01/82/050/01210/AM19/ |
|
:31/83/040/00114/AM19/ |
|
29.10.2018 |
|
|
164 Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019: (i) It has been observed that the chemistry given by the firm is not clear, since the firm has stated that that the raw material shown as phenol while import is of OCP 50. Accordingly, the firm was requested vide e-mail dated 05.09.2019 to furnish exact chemical name of OCP 50 along with manufacturing process and all technical details starting from OCP 50.
| 165 |
<br>Case No.:183/13/82-<br>ALC4/2018 |
Party Name:PHAROSE<br>REMEDIES LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01161/AM19/ |
RLA File<br>:30/24/040/00032/AM19/ |
Lic.No/Date:3010104485<br>31.10.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
48
| 166 |
<br>Case No.:363/13/82-<br>ALC4/2018 |
Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00699/AM19/ |
Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00699/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01341/AM19/ |
|
|
Lic.No/Date:0310824906<br>05.11.2018 |
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
| 167 |
<br>Case No.:362/13/82-<br>ALC4/2018 |
Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00683/AM19/ |
|
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
|
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01340/AM19/ |
|
|
Lic.No/Date:0310824929<br>06.11.2018 |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
| 168 |
<br>Case No.:351/13/82-<br>ALC4/2018 |
Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00682/AM19/ |
|
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
|
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/01329/AM19/ |
|
|
Lic.No/Date:0310824972<br>12.11.2018 |
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
| 169 |
Case No.:427/13/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/01405/AM19/ |
Party Name:GULBRANDSEN<br>CHEMICALS PVT LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
|
Status:<br>Approved |
|
|
|
RLA File<br>:34/24/040/00264/AM19/ |
Lic.No/Date:3410044694<br>14.11.2018 |
|
|
|
|
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 8/82-ALC4/2015 dated 16.09.2015, 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>Tetra Butyl Tin (TBT)<br>1 kg.<br>1<br>Tin Ingots<br>0.364 kg<br>2<br>Aluminium Grit/Granules<br>0.119 kg<br>3<br>Butene-1<br>0.869kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
| 170 |
<br>Case No.:463/13/82-<br>ALC4/2018 |
Party Name:INDIA GLYCOLS<br>LTD.,<br>RLA File<br>:05/23/040/00359/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01441/AM19/ |
|
Lic.No/Date:0510408634<br>26.11.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
49
| 171 |
<br>Case No.:242/1/82-ALC4/2019 |
Party Name:MALWA<br>OXYGEN & INDUSTRIAL<br>GASES PVT.LTD.,<br>RLA File<br>:56/24/040/00028/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/00148/AM20/ |
|
Lic.No/Date:5610005519<br>29.11.2018 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 172 |
<br>Case No.:466/13/82-<br>ALC4/2018 |
Party Name:DCM SHRIRAM<br>INDUSTRIES LTD, |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:0510408809<br>06.12.2018<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/01444/AM19/ |
RLA File<br>:05/23/040/00376/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 173 |
<br>Case No.:240/1/82-ALC4/2019 |
Party Name:BENZO CHEM<br>INDUSTRIES PRIVATE<br>LIMITED,<br>RLA File<br>:03/94/040/00756/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00146/AM20/ |
|
Lic.No/Date:0310825931<br>26.12.2018 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 174 |
<br>Case No.:144/1/82-ALC4/2019 |
Party Name:VIRCHOW<br>BIOTECH PV T LTD.,<br>RLA File<br>:09/24/040/00484/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02539/AM19/ |
|
Lic.No/Date:0910067053<br>09.01.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:190/1/82- |
|
Party Name:MICRO LABS |
|
Meet No/Date:8/82- |
|
Status: |
| ALC4/2019 |
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710114616 |
|
|
| :01/82/050/02585/AM19/ |
|
:07/24/040/00283/AM19/ |
|
04.03.2019 |
|
|
|
Case No.:190/1/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/02585/AM19/<br> <br>: |
Party Name:MICRO LABS<br>LTD |
Party Name:MICRO LABS<br>LTD |
Party Name:MICRO LABS<br>LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Approved<br> |
|
|
RLA File<br>07/24/040/00283/AM19/ |
|
|
Lic.No/Date:0710114616<br>04.03.2019 |
|
| 175 |
<br>**Decision:**The Committee considered case as per<br>was decided to ratify the ad-hoc input output norm<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>CLINDAMYCIN 75 MG<br>CAPSULES<br>BP/EP/IP/USP(2000000 Nos.)<br>1 Number<br>CLINDAMYCIN 150 MG<br>CAPSULES<br>BP/EP/IP/USP(2000000 Nos.)<br>1 Number<br>CLINDAMYCIN 300 MG<br>CAPSULES<br>BP/EP/IP/USP(2000000 Nos.)<br>1 Number |
|
|
|
|
|
|
|
|
Qty. |
Sl.<br>No. |
Import items |
|
|
|
|
1 Number |
1 |
CLINDAMYCIN<br>HYDROCHLORIDE<br>BP/EP/IP/USP |
|
|
|
|
1 Number |
1 |
CLINDAMYCIN<br>HYDROCHLORIDE<br>BP/EP/IP/USP |
|
|
|
|
1 Number |
1 |
CLINDAMYCIN<br>HYDROCHLORIDE<br>BP/EP/IP/USP |
|
|
RA concerned maytake further necessaryaction asper above |
|
|
|
decision of NC. |
|
50
| 176 |
Case No.:191/1/82-ALC4/2019 |
Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0710114617<br>04.03.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02586/AM19/ |
RLA File<br>:07/24/040/00282/AM19/ |
|
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,Bangalore. |
|
|
|
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, Bangalore.
| 177 |
<br>Case No.:192/1/82-ALC4/2019 |
Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PVT.LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:3110067342<br>05.03.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02587/AM19/ |
RLA File<br>:31/83/040/00182/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 178 |
<br>Case No.:201/1/82-ALC4/2019 |
Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02596/AM19/ |
RLA File<br>:34/24/040/00370/AM19/ |
Lic.No/Date:3410044950<br>05.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 179 |
<br>Case No.:143/1/82-ALC4/2019 |
Party Name:TINA ORGANICS<br>PRIVATE LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02538/AM19/ |
RLA File<br>:05/24/040/00695/AM19/ |
Lic.No/Date:0510409855<br>06.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 180 |
<br>Case No.:194/1/82-ALC4/2019 |
Party Name:SARNA<br>CHEMICALS PVT LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02589/AM19/ |
RLA File<br>:52/24/040/00090/AM19/ |
Lic.No/Date:5210042986<br>06.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 181 |
<br>Case No.:142/1/82-ALC4/2019 |
Party Name:AVA<br>CHEMICALS PVT.LTD., |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02537/AM19/ |
RLA File<br>:03/94/040/01029/AM19/ |
Lic.No/Date:0310827515<br>07.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
51
| 182 |
<br>Case No.:145/1/82-ALC4/2019 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02540/AM19/ |
RLA File<br>:03/94/040/01066/AM19/ |
Lic.No/Date:0310827513<br>07.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 183 |
<br>Case No.:174/1/82-<br>ALC4/2019 |
Party Name:BIOLOGICAL E<br>LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status: Deferred |
|
<br>HQ File<br>:01/82/050/02569/AM19/ |
RLA File<br>:09/24/040/00588/AM19/ |
Lic.No/Date:0910067245<br>07.03.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 184 |
<br>Case No.:149/1/82-ALC4/2019 |
Party Name:SRIAM LABS<br>PRIVATE LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02544/AM19/ |
RLA File<br>:09/24/040/00604/AM19/ |
Lic.No/Date:0910067252<br>11.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 185 |
<br>Case No.:150/1/82-ALC4/2019 |
Party Name:ALKALI<br>METALS LTD.,<br>RLA File<br>:09/24/040/00561/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:0910067258<br>11.03.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02545/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 186 |
<br>Case No.:152/1/82-ALC4/2019 |
Party Name:BENZO CHEM<br>INDUSTRIES PRIVATE<br>LIMITED, |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02547/AM19/ |
RLA File<br>:03/94/040/00854/AM19/ |
Lic.No/Date:0310827603<br>11.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 187 |
<br>Case No.:156/1/82-ALC4/2019 |
Party Name:NEOGEN<br>CHEMICALS LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02551/AM19/ |
RLA File<br>:03/95/040/01222/AM19/ |
Lic.No/Date:0310827621<br>12.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
52
| 188 |
<br>Case No.:159/1/82-ALC4/2019 |
Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02554/AM19/ |
RLA File<br>:09/24/040/00600/AM19/ |
Lic.No/Date:0910067264<br>12.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 189 |
<br>Case No.:160/1/82-ALC4/2019 |
Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0310827639<br>12.03.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02555/AM19/ |
RLA File<br>:03/94/040/00693/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 190 |
<br>Case No.:161/1/82-ALC4/2019 |
Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02556/AM19/ |
RLA File<br>:09/24/040/00621/AM19/ |
Lic.No/Date:0910067270<br>13.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 191 |
Case No.:166/1/82-ALC4/2019 |
Party Name:ENAL DRUGS<br>PVT LTD., |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0910067274<br>13.03.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02561/AM19/ |
RLA File<br>:09/24/040/00614/AM19/ |
|
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.
| 192 |
<br>Case No.:167/1/82-ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02562/AM19/ |
RLA File<br>:09/24/040/00612/AM19/ |
Lic.No/Date:0910067275<br>13.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 193 |
<br>Case No.:169/1/82-<br>ALC4/2019 |
Party Name:RUSAN<br>PHARMA LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02564/AM19/ |
RLA File<br>:03/95/040/01315/AM19/ |
Lic.No/Date:0310827685<br>13.03.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
53
| 194 |
<br>Case No.:170/1/82-ALC4/2019 |
Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/01071/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02565/AM19/ |
|
Lic.No/Date:0310827686<br>13.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 195 |
Case No.:197/1/82-ALC4/2019 |
Party Name:STERILE INDIA<br>PRIVATE LIMITED<br>RLA File<br>:33/24/040/00019/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02592/AM19/ |
|
Lic.No/Date:3310030518<br>13.03.2019 |
|
|
**Decision:**The Committee<br>available. Hence, it was decided<br>from RLA,Panipat. |
noted that the 4.07 application of subject Advance Authorization is not<br>to call for a copy of 4.07 application of the subject advance authorization |
|
|
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.
| 196 |
<br>Case No.:171/1/82-<br>ALC4/2019 |
Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br> <br> <br>2<br>RLA File<br>:04/24/040/00243/AM19/<br> <br>1 |
Meet No/Date:8/82-<br>ALC4/2019<br>0.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02566/AM19/ |
|
Lic.No/Date:0410165319<br>4.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 197 |
<br>Case No.:175/1/82-ALC4/2019 |
Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:04/24/040/00244/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0410165324<br>14.03.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02570/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 198 |
<br>Case No.:198/1/82-<br>ALC4/2019<br>P<br>P<br>I<br>HQ File<br>:01/82/050/02593/AM19/<br> <br>: |
arty Name:LABORATE<br>HARMACEUTICAL<br>NDIA LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
|
RLA File<br>33/24/040/00020/AM19/ |
Lic.No/Date:3310030519<br>14.03.2019 |
<br>Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
54
| 199 |
<br>Case No.:204/1/82-ALC4/2019 |
Party Name:DEEPAK<br>PHENOLICS LIMITED<br>RLA File<br>:34/24/040/00353/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02599/AM19/ |
|
Lic.No/Date:3410044969<br>14.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 200 |
<br>Case No.:177/1/82-<br>ALC4/2019<br> <br>I<br>HQ File<br>:01/82/050/02572/AM19/<br> <br>: |
Party Name:RELIANCE<br>NDUSTRIES LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
|
RLA File<br>03/95/040/01062/AM19/ |
Lic.No/Date:0310827733<br>15.03.2019 |
<br>Defer<br>Date:19.07.2019 |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| Case No.:178/1/82-ALC4/2019 |
|
Party Name:VIJAYASRI |
|
Meet No/Date:8/82- |
|
Status: |
|
|
ORGANICS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067282 |
|
|
| :01/82/050/02573/AM19/ |
|
:09/24/040/00560/AM19/ |
|
15.03.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 201 applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| SUCROFERRIC |
1 kg |
1 |
FERRIC CHLORIDE SOLUTION HIGH PURITY |
2.40 kg |
| OXYHYDROXIDE |
|
|
(containing11% to 13% Ferric Chloride) |
|
|
|
2 |
ISO PROPYL ALCOHOL |
1.00 kg |
| 202 |
<br>Case No.:179/1/82-ALC4/2019 |
Party Name:SHANKUS<br>PHARMACEUTICALS<br>RLA File<br>:08/24/040/00430/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:0810144782<br>18.03.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02574/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 203 |
<br>Case No.:180/1/82-ALC4/2019 |
Party Name:VINDHYA<br>ORGANICS PVT LTD<br>RLA File<br>:09/24/040/00628/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02575/AM19/ |
|
Lic.No/Date:0910067284<br>18.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
55
| 204 |
Case No.:181/1/82-<br>ALC4/2019 |
Party Name:DINAKARA<br>LIFE SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02576/AM19/ |
RLA File<br>:09/24/040/00571/AM19/ |
Lic.No/Date:0910067285<br>18.03.2019 |
<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.
| 205 |
<br>Case No.:182/1/82-ALC4/2019 |
Party Name:ORIENTAL<br>AROMATICS LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0310827770<br>18.03.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02577/AM19/ |
RLA File<br>:03/95/040/01319/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 206 |
<br>Case No.:184/1/82-ALC4/2019 |
Party Name:KLJ<br>PLASTICIZERS LIMITED. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02579/AM19/ |
RLA File<br>:05/23/040/00562/AM19/ |
Lic.No/Date:0510409975<br>19.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 207 |
<br>Case No.:185/1/82-ALC4/2019 |
Party Name:MANGALAM<br>ORGANICS LIMITED<br>(FORMERLY DUJODWALA |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br>Lic.No/Date:0310827775<br>19.03.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02580/AM19/ |
RLA File<br>:03/95/040/00899/AM19/ |
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 208 |
<br>Case No.:187/1/82-ALC4/2019 |
Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02582/AM19/ |
RLA File<br>:09/24/040/00619/AM19/ |
Lic.No/Date:0910067297<br>19.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 209 |
<br>Case No.:188/1/82-ALC4/2019 |
Party Name:VASUDHA<br>PHARMA CHEM LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred<br>Defer Date |
|
<br>HQ File<br>:01/82/050/02583/AM19/ |
RLA File<br>:09/24/040/00629/AM19/ |
Lic.No/Date:0910067299<br>19.03.2019 |
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
56
| Case No.:189/1/82-ALC4/2019 |
|
Party Name:DR. REDDYS |
|
Meet No/Date:8/82- |
|
Status: |
|
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
20.09.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067300 |
|
|
| :01/82/050/02584/AM19/ |
|
:09/24/040/00626/AM19/ |
|
19.03.2019 |
|
|
|
|
**Decision:**The Committee considered case as per agenda in |
**Decision:**The Committee considered case as per agenda in |
**Decision:**The Committee considered case as per agenda in |
the presence of the technical experts and it |
the presence of the technical experts and it |
|
| 210 |
|
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: |
|
|
|
|
|
|
|
|
Exportproduct |
Qty.<br>Sl. No. |
Import items |
Qty. |
|
|
|
|
Nise Gel 20g Tubes (Each tube |
1 Number<br>1 |
Capsaicin |
5.10 mg / 20 mg |
|
|
|
|
contains 5mg of Capsaicin) |
|
|
tube |
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
Case No.:200/1/82-ALC4/2019 |
|
Party Name:AETHER |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
20.09.2019 |
|
|
| 211 |
|
HQ File<br>:01/82/050/02595/AM19/ |
|
RLA File<br>:52/24/040/00085/AM19/ |
|
Lic.No/Date:5210043000<br>19.03.2019 |
|
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,Surat. |
|
|
|
|
|
|
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.
|
|
Case No.:205/1/82-ALC4/2019 |
|
Party Name:ALEOR |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
DERMACEUTICALS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
20.09.2019 |
|
|
| 212 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410044985 |
|
Defer Date |
|
|
:01/82/050/02600/AM19/ |
|
:34/24/040/00396/AM19/ |
|
19.03.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:206/1/82-ALC4/2019 |
|
Party Name:ALEOR |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
DERMACEUTICALS |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
20.09.2019 |
|
|
| 213 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410044986 |
|
Defer Date |
|
|
:01/82/050/02601/AM19/ |
|
:34/24/040/00397/AM19/ |
|
19.03.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:207/1/82-ALC4/2019 |
|
Party Name:ELPPE |
|
Meet No/Date:8/82- |
|
Status: |
|
|
|
|
CHEMICALS PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
20.09.2019 |
|
|
| 214 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310827824 |
|
Defer Date |
|
|
:01/82/050/02602/AM19/ |
|
:03/94/040/01100/AM19/ |
|
20.03.2019 |
|
|
|
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
57
| 215 |
<br>Case No.:208/1/82-ALC4/2019 |
Party Name:DR. ACHARYA<br>LABORATORIES PVT. LTD., |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02603/AM19/ |
RLA File<br>:03/94/040/01091/AM19/ |
Lic.No/Date:0310827825<br>20.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 216 |
<br>Case No.:209/1/82-ALC4/2019 |
Party Name:V.D.H.<br>ORGANICS PVT. LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02604/AM19/ |
RLA File<br>:05/24/040/00722/AM19/ |
Lic.No/Date:0510410009<br>20.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 217 |
<br>Case No.:210/1/82-ALC4/2019 |
Party Name:V.D.H.<br>ORGANICS PVT. LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02605/AM19/ |
RLA File<br>:05/24/040/00721/AM19/ |
Lic.No/Date:0510410010<br>20.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 218 |
Case No.:211/1/82-ALC4/2019 |
Party Name:PORUS<br>LABORATORIES PVT LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02606/AM19/ |
RLA File<br>:09/24/040/00633/AM19/ |
Lic.No/Date:0910067303<br>20.03.2019 |
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.
| 219 |
<br>Case No.:212/1/82-ALC4/2019 |
Party Name:LUPIN LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02607/AM19/ |
RLA File<br>:03/95/040/01323/AM19/ |
Lic.No/Date:0310827848<br>20.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 220 |
<br>Case No.:214/1/82-ALC4/2019 |
Party Name:DEEPAK<br>PHENOLICS LIMITED<br>RLA File<br>:34/24/040/00327/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:3410044990<br>20.03.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02609/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
58
| 221 |
<br>Case No.:213/1/82-ALC4/2019 |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02608/AM19/ |
RLA File<br>:09/24/040/00635/AM19/ |
Lic.No/Date:0910067312<br>21.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 222 |
<br>Case No.:215/1/82-ALC4/2019 |
Party Name:BEST VALUE<br>CHEM PVT. LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02610/AM19/ |
RLA File<br>:34/24/040/00389/AM19/ |
Lic.No/Date:3410044991<br>22.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 223 |
<br>Case No.:216/1/82-ALC4/2019 |
Party Name:BEST VALUE<br>CHEM PVT. LTD. |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02611/AM19/ |
RLA File<br>:34/24/040/00390/AM19/ |
Lic.No/Date:3410044992<br>22.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 224 |
<br>Case No.:217/1/82-ALC4/2019 |
Party Name:PRACHI<br>PHARMACEUTICALS PVT<br>LTD |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02612/AM19/ |
RLA File<br>:03/95/040/01344/AM19/ |
Lic.No/Date:0310827870<br>22.03.2019 |
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
| 225 |
<br>Case No.:218/1/82-ALC4/2019 |
Party Name:PRACHI<br>PHARMACEUTICALS PVT<br>LTD<br>RLA File<br>:03/95/040/01345/AM19/ |
Meet No/Date:8/82-<br>ALC4/2019<br>20.09.2019<br> <br><br>Lic.No/Date:0310827871<br>22.03.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/02613/AM19/ |
|
|
Defer Date |
|
**Decision:**Deferred for comments of TE. |
|
|
|
59
MANUAL CASES
|
Case No. |
B-1 |
|
Meeting No. |
8/AM20 |
|
Date |
20.09.2019 |
|
Firm’s Name |
M/s Arene Lifesciences Limited, Hyderabad |
|
HQF. No. |
01/82/050/00077/AM15/DES-III |
|
RLA F. No. |
09/24/040/00536/AM14 |
|
Advance Authorization No. and Date |
0910059285 dated 14.02.2014 |
|
Subject |
Request of M/s Arene Lifesciences Limited, Hyderabad for<br>fixation of adhoc norms against Advance Authorization No.<br>0910059285 dated 14.02.2014 |
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and after<br>deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br> <br>Exportproduct<br> Qty.<br>Sl. No.<br>Import items<br>Qty.<br>EFAVIRENZ<br>1 kg<br>1<br>4-CHLORO-2-TRIFLURO<br>ACETYLANILINE<br>HYDROCHLORIDE<br>1.18 kg<br>2<br>CYCLOPROPYL ACETYLENE<br>0.343 kg<br>3<br>TRI FLURO ETHANOL<br>0.327 kg<br>4<br>TETRAHYDROFURAN<br>3.33 kg<br>5<br>CITRIC ACID MONO HYDRATE<br>0.788 kg<br>6<br>TOLUENE<br>1.63 kg<br>7<br>METHANOL<br>6.14 kg<br>8<br>TRIPHOSGENE<br>0.431 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
Case No. |
B-2 |
|
Meeting No. |
8/AM20 |
|
Date |
20.09.2019 |
|
Firm’s Name |
M/s Global Calcium Private Limited, Bangalore |
|
HQF. No. |
01/82/050/00672/AM18/DES-III |
|
RLA F. No. |
07/24/040/00393/AM17 |
|
Advance Authorization No. and Date |
0710111246 dated 07.03.2017 |
|
Subject |
Request of M/s Global Calcium Private Limited, Bangalore for<br>amendment in the description of import item against Advance<br>Authorization No. 0710111246 dated 07.03.2017 |
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and after<br>deliberation, it was decided to amend the description of Import Item to read as Calcium Gluconate.<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
|
60
Case No. B-3 Meeting No. 8/AM20 Date 20.09.2019 Firm’s Name M/s Krishna Antioxidants Pvt. Ltd., Mumbai HQ F. No. 01/82/050/01528/AM19/DES-III RLA F. No. 03/94/040/00043/AM19 Advance Authorization No. and Date 0310820723 dated 27.04.2018 Subject Request of M/s Krishna Antioxidants Pvt. Ltd., Mumbai for enhancement in the quantity of Import Item No. 2 - ISO DECYL ALCOHOL in respect of adhoc norms fixed against Advance Authorization No. 0310820723 dated 27.04.2018 Decision: The Committee considered the request of the firm in the presence of technical experts and after deliberation, it was decided to revise the quantity of Import Item No. 2 as under:
| Subject<br>Request of M/s Krishna Antioxidants Pvt. Ltd., Mumbai for<br>enhancement in the quantity of Import Item No. 2 - ISO<br>DECYL ALCOHOL in respect of adhoc norms fixed against<br>Advance Authorization No. 0310820723 dated 27.04.2018 |
Subject<br>Request of M/s Krishna Antioxidants Pvt. Ltd., Mumbai for<br>enhancement in the quantity of Import Item No. 2 - ISO<br>DECYL ALCOHOL in respect of adhoc norms fixed against<br>Advance Authorization No. 0310820723 dated 27.04.2018 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and after |
|
| deliberation, it was decided to revise the quantity of Import Item No. 2 as under: |
|
| Import Item No. 2<br>Qty. |
|
| From<br>To |
|
| ISO DECYL ALCOHOL<br>0.386 kg<br>0.430 kg |
|
| Rest of the earlier Minutes would remain unchanged. |
|
| RA concerned maytake further necessaryaction asper above decision of NC. |
|
| Case No. |
B-4 |
| Meeting No. |
8/AM20 |
| Date |
20.09.2019 |
| Firm’s Name |
M/s Lantech Pharmaceuticals Limited, Hyderabad |
| HQF. No. |
01/82/050/00172/AM16/DES-III |
| RLA F. No. |
09/24/040/00011/AM16 |
| Advance Authorization No. and Date |
0910061900 dated 20.04.2015 |
| Subject |
Request of M/s Lantech Pharmaceuticals Ltd Hydrabad, for |
|
fixation of adhoc norms against Advance Authorization No. |
|
0910061900 dated 20.04.2015 |
| Subject<br>Request of M/s Lantech Pharmaceuticals Ltd Hydrabad, for<br>fixation of adhoc norms against Advance Authorization No.<br>0910061900 dated 20.04.2015 |
Subject<br>Request of M/s Lantech Pharmaceuticals Ltd Hydrabad, for<br>fixation of adhoc norms against Advance Authorization No.<br>0910061900 dated 20.04.2015 |
Subject<br>Request of M/s Lantech Pharmaceuticals Ltd Hydrabad, for<br>fixation of adhoc norms against Advance Authorization No.<br>0910061900 dated 20.04.2015 |
Subject<br>Request of M/s Lantech Pharmaceuticals Ltd Hydrabad, for<br>fixation of adhoc norms against Advance Authorization No.<br>0910061900 dated 20.04.2015 |
Subject<br>Request of M/s Lantech Pharmaceuticals Ltd Hydrabad, for<br>fixation of adhoc norms against Advance Authorization No.<br>0910061900 dated 20.04.2015 |
Subject<br>Request of M/s Lantech Pharmaceuticals Ltd Hydrabad, for<br>fixation of adhoc norms against Advance Authorization No.<br>0910061900 dated 20.04.2015 |
Subject<br>Request of M/s Lantech Pharmaceuticals Ltd Hydrabad, for<br>fixation of adhoc norms against Advance Authorization No.<br>0910061900 dated 20.04.2015 |
| **Decision:**The Committee considered the case as per agenda in the presence of technical experts and after |
|
|
|
|
|
|
| deliberation, it was decided to ratify |
|
the adhoc norms |
|
under para 4.7 of HBP Vol. I as per details below or as |
|
|
| applied by firm whichever is |
lower: |
|
|
|
|
|
| Export product |
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
|
| (1S,4S,5S)-4-Bromo-6- |
|
1 kg |
1 |
3-Cyclohexene-1-Carboxylic acid |
3.30 kg |
|
| oxabicyclo [3.2.1] octan-7-one |
|
|
2 |
R-(+)-1-Phenylethylamine |
2.75 kg |
|
| (PACKED<br>IN |
51 |
|
3 |
Methylene Dichloride |
3.00 kg |
|
| CONTAINERS) |
|
|
4 |
Ethyl Acetate |
6.33 kg |
|
|
|
|
5 |
Flexible Containers |
Relevant as per |
|
|
|
|
|
|
packing policy |
|
61
|
Case No. |
Case No. |
B-5 |
B-5 |
B-5 |
|
Meeting No. |
|
8/AM20 |
|
|
|
Date |
|
20.09.2019 |
|
|
|
Firm’s Name |
|
M/s Lantech Pharmaceuticals Ltd., Hyderabad |
|
|
|
HQF. No. |
|
01/82/050/00111/AM16/DES-III |
|
|
|
RLA F. No. |
|
09/24/040/00647/AM15 |
|
|
|
Advance Authorization No. and Date |
|
0910061664 dated 04.03.2015 |
|
|
|
Subject |
|
Request of M/s Lantech Pharmaceuticals Ltd, Hyderabad for<br>enhancement in the quantity of import items in respect of adhoc<br>norms fixed against Advance Authorization No. 0910061664<br>dated 04.03.2015 |
|
|
| <br> <br> <br> |
**Decision:**The Committee considered the request of the firm in the presence of technical experts and after<br>deliberation, it was decided to revise the quantity of following Import Items as under:<br>Sl. No.<br>Import Items<br>Qty.<br>From<br>To<br>1<br>3-Cyclohexene-1-Carboxylic acid<br>1.773 kg<br>3.30 kg<br>2<br>R(+)-Phenyl ethylamine<br>1.353 kg<br>2.75 kg<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
Sl. No. |
Import Items |
|
Qty. |
|
|
|
|
|
From |
To |
|
1 |
3-Cyclohexene-1-Carboxylic acid |
|
1.773 kg |
3.30 kg |
|
2 |
R(+)-Phenyl ethylamine |
|
1.353 kg |
2.75 kg |
|
Rest of the earlier Minutes would remain unchanged.<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
Case No. |
Case No. |
B-6 |
B-6 |
B-6 |
|
Meeting No. |
|
8/AM20 |
|
|
|
Date |
|
20.09.2019 |
|
|
|
Firm’s Name |
|
M/s Lantech Pharmaceuticals Ltd., Hyderabad |
|
|
|
HQF. No. |
|
01/82/050/01474/AM19/DES-III |
|
|
|
RLA F. No. |
|
09/24/040/00121/AM19 |
|
|
|
Advance Authorization No. and Date |
|
0910066337 dated 14.06.2018 |
|
|
|
Subject |
|
Request of M/s Lantech Pharmaceuticals Ltd, Hyderabad for<br>enhancement in the quantity of import items in respect of adhoc<br>norms fixed against Advance Authorization No. 0910066337<br>dated 14.06.2018 |
|
|
| <br> <br> <br> |
**Decision:**The Committee considered the request of the firm in the presence of technical experts and after<br>deliberation, it was decided to revise the quantity of following Import Items as under:<br>Sl. No.<br>Import Items<br>Qty.<br>From<br>To<br>1<br>3-Cyclohexene-1-Carboxylic acid<br>1.773 kg<br>3.30 kg<br>2<br>R(+)-Phenyl ethylamine<br>1.353 kg<br>2.75 kg<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
Sl. No. |
Import Items |
|
Qty. |
|
|
|
|
|
From |
To |
|
1 |
3-Cyclohexene-1-Carboxylic acid |
|
1.773 kg |
3.30 kg |
|
2 |
R(+)-Phenyl ethylamine |
|
1.353 kg |
2.75 kg |
|
Rest of the earlier Minutes would remain unchanged.<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
62
|
Case No. |
Case No. |
B-7 |
B-7 |
B-7 |
B-7 |
|
Meeting No. |
|
8/AM20 |
|
|
|
|
Date |
|
20.09.2019 |
|
|
|
|
Firm’s Name |
|
M/s Mahima Life Sciences Pvt. Ltd., New Delhi |
|
|
|
|
HQF. No. |
|
01/82/050/00907/AM17/DES-III |
|
|
|
|
RLA F. No. |
|
05/24/040/00229/AM17 |
|
|
|
|
Advance Authorization<br>No. and Date |
|
0510399749 dated 16.09.2016 |
|
|
|
|
Subject |
|
Request of M/s Mahima Life Sciences Pvt. Ltd., New Delhi for fixation of<br>adhoc norms against Advance Authorization No. 0510399749 dated 16.09.2016 |
|
|
|
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and after<br>deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>METHYL<br>PREDNISOLONE<br>1 kg<br>1<br>11 BETA 17 ALPHA DIHYDROXY 6 ALPHA-<br>METHYLPREGNA 1 4 DIENE 3 20 DIONE<br>1.313 kg<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
METHYL<br>PREDNISOLONE |
1 kg |
|
1 |
11 BETA 17 ALPHA DIHYDROXY 6 ALPHA-<br>METHYLPREGNA 1 4 DIENE 3 20 DIONE |
1.313 kg |
|
RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Case No. |
Case No. |
B-8 |
B-8 |
B-8 |
B-8 |
|
Meeting No. |
|
8/AM20 |
|
|
|
|
Date |
|
20.09.2019 |
|
|
|
|
Firm’s Name |
|
M/s MSN Laboratories Private Limited,Hyderabad |
|
|
|
|
HQF. No. |
|
01/82/050/01351/AM16/DES-III |
|
|
|
|
RLA F. No. |
|
09/24/040/00423/AM16 |
|
|
|
|
Advance Authorization No. and Date |
|
0910062790 dated 28.10.2015 |
|
|
|
|
Subject |
|
Request of M/s MSN Laboratories Private Limited, Hyderabad<br>for fixation of adhoc norms against Advance Authorization No.<br>0910062790 dated 28.10.2015 |
|
|
|
|
**Decision:**The Committee considered the case as<br>deliberation, it was decided to ratify the adhoc norm<br>applied by firm whichever is lower: |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. |
|
EPLERENONE |
1 kg |
|
1 |
11-Alpha Hydroxycanrenone |
2.61 kg |
|
RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
63
|
Case No. |
Case No. |
B-9 |
B-9 |
B-9 |
|
Meeting No. |
|
8/AM20 |
|
|
|
Date |
|
20.09.2019 |
|
|
|
Firm’s Name |
|
M/s Orbit Lifescience Pvt. Ltd.,Mumbai |
|
|
|
HQF. No. |
|
01/82/050/00308/AM17/DES-III |
|
|
|
RLA F. No. |
|
03/95/040/00069/AM17 |
|
|
|
Advance Authorization No. and Date |
|
0310804944 dated 24.05.2016 |
|
|
|
Subject |
|
Request of M/s Orbit Lifescience Pvt. Ltd., Mumbai for revision<br>of adhoc norms fixed against Advance Authorization No.<br>0310804944 dated 24.05.2016 |
|
|
|
**Decision:**The Committee considered the request of firm in the presence of<br>deliberation, it was decided to revise the quantity of following import items: |
|
|
technical experts and after<br>Qty.<br>From<br>To<br>1.872 kg<br>2.700 kg<br>0.672 kg<br>1.00 kg<br>1.596 kg<br>1.900 kg<br>(Sterile / Technical). |
|
|
Import<br>Item No. |
Import Items |
|
Qty. |
|
|
|
|
|
From |
To |
|
3 |
P-NITROBENXL-6-(1-HYDROXYETHYL)-1-<br>AZBICYCLO(3.2.)HEPTANE-3,7-DIONE-2-CARBOXYLATE/BCK |
|
1.872 kg |
2.700 kg |
|
4 |
CYSTEAMINE HYDROCHLORIDE |
|
0.672 kg |
1.00 kg |
|
5 |
DI PHENYL CHLOROPHOSPHATE(DPCP) |
|
1.596 kg |
1.900 kg |
|
The above revision is subject to following conditions:<br>(i)<br>Actual imports already made against the export of 4440 kg of Imipenum<br>(ii)<br>No further imports will be permitted against this licence.<br>(iii)<br>This is only for redemption purpose.<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-10 |
| Meeting No. |
8/AM20 |
| Date |
20.09.2019 |
| HQF. No. |
01/82/162/00008/AM19/DES-III |
| Subject: |
Request of M/s PCL Oil & Solvents Ltd., New Delhi for<br>clarification in respect of item of Export – PVC Plasticizer /<br>Plasticizer / Di-Isononyl Phthalate (DINP) |
| **Decision:**The Committee considered the request of firm in the presence of technical experts and it was<br>observed that Plasticizer is a chemical compounded added to a synthetic resin to produce or promote<br>plasticity and flexibility and to reduce brittleness.<br> Plasticizers for plastics are additives, most commonly Phthalate Esters in PVC Applications.<br>Almost 90% of Plasticizers are used in PVC for improved flexibility.<br>In view of above, it is clarified that Di-Isononyl Phthalate (DINP) is one of the PVC Plasticizers<br>the norms for which are fixed at SION No. A-3151. |
|
64
| Case No. |
B-11 |
| Meeting No. |
8/AM20 |
| Date |
20.09.2019 |
| HQF. No. |
01/82/162/00007/AM19/DES-III |
| Subject: |
Request of M/s PCL Oil & Solvents Ltd., New Delhi for<br>clarification in respect of item of Export – PVC Plasticizer /<br>Plasticizer / DOP (Di Octyl Phthalate) |
| **Decision:**The Committee considered the request of firm in the presence of technical experts and it was<br>observed that Plasticizer is a chemical compounded added to a synthetic resin to produce or promote<br>plasticity and flexibility and to reduce brittleness.<br> Plasticizers for plastics are additives, most commonly Phthalate Esters in PVC Applications.<br>Almost 90% of Plasticizers are used in PVC for improved flexibility.<br>In view of above, it is clarified that Di-Octyl Phthalate (DOP) is one of the PVC Plasticizer, the<br>norms for which are fixed at SION No. A-1303. |
|
65
|
Case No. |
Case No. |
B-12 |
B-12 |
B-12 |
B-12 |
|
Meeting No. |
|
8/AM20 |
|
|
|
|
Date |
|
20.09.2019 |
|
|
|
|
Firm’s Name |
|
M/s Reckitt Benckiser Healthcare India Limited, New Delhi |
|
|
|
|
HQF. No. |
|
01/82/050/01369/AM15/DES-III |
|
|
|
|
RLA F. No. |
|
05/24/040/00279/AM15 |
|
|
|
|
Advance Authorization No. and Date |
|
0510391259dated 22.09.2014 |
|
|
|
|
Subject |
|
Request of M/s Reckitt Benckiser Healthcare India Pvt. Ltd.,<br>New Delhi for fixation of adhoc norms in respect of Advance<br>Authorization No. 0510391259 dated 22.09.2014 |
|
|
|
|
**Decision:**The Committee considered the case as<br>deliberation, it was decided to ratify the adhoc norms<br>applied by firm whichever is lower: |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty.<br>(ingrams) |
|
Mucinex Fast Max Cold, Flu &<br>Sore Throat Liquid |
1 kg |
|
1 |
Xanthan Gum Ph.Eur,USP,IH |
1.00 |
|
|
|
|
2 |
Propyl Gallate,USNF |
1.818 |
|
|
|
|
3 |
Magnasweet 110 |
6.909 |
|
|
|
|
4 |
Red Fruits |
0.818 |
|
|
|
|
5 |
FD&C Blue 1 |
0.025 |
|
|
|
|
6 |
FD&C Red 40 |
0.005 |
|
|
|
|
7 |
SORBITOL SOLUTION<br>(70PERCENT) USP (D-<br>sorbitol/Sorbitol 70PERCENT) |
136.364 |
|
|
|
|
8 |
PROPYLENE GLYCOL USP |
272.727 |
|
|
|
|
9 |
GLYCERIN USP |
181.818 |
|
|
|
|
10 |
ANHYDROUS CITRIC ACID USP<br>(Citric acid) |
1.155 |
|
|
|
|
11 |
SODIUM BENZOATE NF |
2.00 |
|
|
|
|
12 |
SUCRALOSE NF |
1.818 |
|
|
|
|
13 |
EDTA DISODIUM USP (Disodium<br>(ethylenedinitrolo) tetraacetate<br>dihydrate) |
0.455 |
|
|
|
|
14 |
Venus 24MM(Plastic Closures) |
Relevant as<br>per packing<br>policy |
|
|
|
|
15 |
Square M/Wash O/C Blue HT<br>(Plastic Closures) |
|
|
|
|
|
16 |
Mucinex-6P Multipage Cold & Flu<br>(Paper Labels) |
|
|
RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
66
| Cas |
e No. |
|
B-13 |
B-13 |
B-13 |
B-13 |
B-13 |
B-13 |
|
|
|
|
| Mee |
ting No. |
|
8/AM20 |
|
|
|
|
|
|
|
|
|
| Dat<br> |
e<br> |
|
20.09.2019<br> |
|
|
|
|
|
|
|
|
|
| Firm |
’s Name |
|
M/s Reckitt Benckiser He |
|
|
|
|
|
althcare India Limited, N |
|
ew Delhi |
|
| HQ |
F. No. |
|
01/82/050/00334/AM15/DE |
|
|
|
|
|
S-III |
|
|
|
| RLA |
F N |
|
05/24/040/00053/AM15 |
|
|
|
|
|
|
|
|
|
|
. o. |
|
|
|
|
|
|
|
|
|
|
|
| Adv |
ance Authorization No. and Date |
|
0510386224 dated 09.05.2014 |
|
|
|
|
|
|
|
|
|
| Sub |
ject |
|
Request of M/s Reckitt Benckiser Healthcare India Pvt. Ltd.,<br>New Delhi for fixation of adhoc norms in respect of Advance<br>Authorization No. 0510386224 dated 09.05.2014 |
|
|
|
|
|
|
|
|
|
| Deci<br>delib<br>appl |
**sion:**The Committee considered the case as per agenda in the presence of technical experts and after<br>eration, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as<br>ied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
|
|
| <br>Export product |
|
|
|
|
|
|
|
|
|
Qty. |
|
|
|
|
Qty. |
|
Sl. |
Import items |
|
|
|
|
Qty. |
|
|
| Mu<br>So<br>( 1 |
|
|
|
No. |
|
|
|
|
|
(i |
ngrams) |
|
|
cinex Fast Max Cold, Flu &<br>re<br>Throat<br>Liquid<br> |
1 kg |
|
1 |
Xanthan Gum |
|
|
Ph.Eur,USP,IH |
|
1. |
00 |
|
|
|
|
|
2 |
Propyl Gallate |
|
|
,USNF |
|
1. |
818 |
|
|
|
|
|
|
|
|
|
|
|
6. |
|
|
|
,46,56,420 Milileter(ML) ) |
|
|
3 |
Magnasweet |
|
|
10 |
|
|
909 |
|
|
|
|
|
4 |
Red Fruits |
|
|
|
|
0. |
818 |
|
|
|
|
|
5 |
FD&C Blue 1 |
|
|
|
|
0 |
025 |
|
|
|
|
|
<br>6 |
<br>FD&C Red 40 |
|
|
|
|
.<br>0.005 |
|
|
|
|
|
|
7 |
<br> <br> |
SORBITOL SOLUTION<br>(70PERCENT) USP (D-<br>sorbitol/Sorbitol 70PERCENT) |
|
|
|
136.364 |
|
|
|
|
|
|
8 |
|
PROPY |
LENE GLYCOL USP |
|
|
2 |
72.727 |
|
|
|
|
|
9 |
|
GLYC |
ERIN USP |
|
|
1 |
81.818 |
|
|
|
|
|
10 |
<br> |
ANHY |
DROUS CITRIC ACID USP |
|
|
1. |
155 |
|
|
|
|
|
|
|
(Citric |
acid) |
|
|
|
|
|
|
|
|
|
11 |
|
SODIU |
M BENZOATE NF |
|
|
2. |
00 |
|
|
|
|
|
12 |
|
SUCR |
ALOSE NF |
|
|
1 |
818 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13 |
<br> <br> |
EDTA |
DISODIUM USP (Disodium |
|
|
0. |
455 |
|
|
|
|
|
|
|
<br>(ethyle |
<br>nedinitrolo) tetraacetate |
|
|
|
|
|
|
|
|
|
|
|
<br>dihydra |
<br>te) |
|
|
|
|
|
|
|
|
|
14 |
|
Venus |
24MM(Plastic Closures) |
|
|
R<br>p |
elevant as<br>er packing |
|
|
|
|
|
15 |
|
Square |
M/Wash O/C Blue HT |
|
|
|
|
|
|
|
|
|
|
<br> |
<br>(Plastic |
<br>Closures) |
|
|
<br>p |
<br>olicy |
|
|
|
|
|
16 |
|
Mucinex- 6P Multipage Cold & Flu |
|
|
|
|
|
|
| (Paper Labels)<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
(Paper Labels) |
|
|
|
|
|
|
|
67
|
Case No. |
Case No. |
B-14 |
B-14 |
B-14 |
B-14 |
|
Meeting No. |
|
8/AM20 |
|
|
|
|
Date |
|
20.09.2019 |
|
|
|
|
Firm’s Name |
|
M/s Reckitt Benckiser Healthcare India Limited, New Delhi |
|
|
|
|
HQF. No. |
|
01/82/050/00335/AM15/DES-III |
|
|
|
|
RLA F. No. |
|
05/24/040/00021/AM15 |
|
|
|
|
Advance Authorization No. and Date |
|
0510386223 dated 09.05.2014 |
|
|
|
|
Subject |
|
Request of M/s Reckitt Benckiser Healthcare India Pvt. Ltd.,<br>New Delhi for fixation of adhoc norms in respect of Advance<br>Authorization No. 0510386223 dated 09.05.2014 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and after<br>deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(ingrams)<br>Mucinex Fast-Max DM Max<br>Liquid<br>( 19,17,00,480 Milileter(ML) )<br>1 kg<br>1<br>Xanthan Gum Ph.Eur,USP,IH<br>1.00<br>2<br>Propyl Gallate,USNF<br>1.818<br>3<br>Magnasweet 110<br>6.909<br>4<br>Orange Wonf Flavour<br>0.909<br>5<br>CherryBerryFlavour<br>2.272<br>6<br>FD&C Red 40<br>0.059<br>7<br>SORBITOL SOLUTION (70percent)<br>USP(D-sorbitol/Sorbitol 70percent)<br>136.364<br>8<br>PROPYLENE GLYCOL USP<br>272.727<br>9<br>GLYCERIN USP<br>181.818<br>10<br>ANHYDROUS CITRIC ACID USP<br>(Citric acid)<br>1.614<br>11<br>SODIUM BENZOATE NF<br>2.00<br>12<br>SUCRALOSE NF<br>1.818<br>13<br>EDTA DISODIUM USP (Disodium<br>(ethylenedinitrolo)tetraacetate<br>dihydrate)<br>0.455<br>14<br>Venus 24MM(Plastic Closures)<br>Relevant as<br>per packing<br>policy<br>15<br>Square M/Wash O/C Blue HT<br>(Plastic Closures)<br>16<br>Mucinex- 4P Multipage DM Adult<br>(Paper Labels)<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty.<br>(ingrams) |
|
Mucinex Fast-Max DM Max<br>Liquid<br>( 19,17,00,480 Milileter(ML) ) |
1 kg |
|
1 |
Xanthan Gum Ph.Eur,USP,IH |
1.00 |
|
|
|
|
2 |
Propyl Gallate,USNF |
1.818 |
|
|
|
|
3 |
Magnasweet 110 |
6.909 |
|
|
|
|
4 |
Orange Wonf Flavour |
0.909 |
|
|
|
|
5 |
CherryBerryFlavour |
2.272 |
|
|
|
|
6 |
FD&C Red 40 |
0.059 |
|
|
|
|
7 |
SORBITOL SOLUTION (70percent)<br>USP(D-sorbitol/Sorbitol 70percent) |
136.364 |
|
|
|
|
8 |
PROPYLENE GLYCOL USP |
272.727 |
|
|
|
|
9 |
GLYCERIN USP |
181.818 |
|
|
|
|
10 |
ANHYDROUS CITRIC ACID USP<br>(Citric acid) |
1.614 |
|
|
|
|
11 |
SODIUM BENZOATE NF |
2.00 |
|
|
|
|
12 |
SUCRALOSE NF |
1.818 |
|
|
|
|
13 |
EDTA DISODIUM USP (Disodium<br>(ethylenedinitrolo)tetraacetate<br>dihydrate) |
0.455 |
|
|
|
|
14 |
Venus 24MM(Plastic Closures) |
Relevant as<br>per packing<br>policy |
|
|
|
|
15 |
Square M/Wash O/C Blue HT<br>(Plastic Closures) |
|
|
|
|
|
16 |
Mucinex- 4P Multipage DM Adult<br>(Paper Labels) |
|
|
RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
68
|
Case No. |
Case No. |
B-15 |
B-15 |
B-15 |
B-15 |
|
Meeting No. |
|
8/AM20 |
|
|
|
|
Date |
|
20.09.2019 |
|
|
|
|
Firm’s Name |
|
M/s Reckitt Benckiser Healthcare India Limited, New Delhi |
|
|
|
|
HQF. No. |
|
01/82/050/00730/AM15/DES-III |
|
|
|
|
RLA F. No. |
|
05/24/040/00205/AM15 |
|
|
|
|
Advance Authorization No. and Date |
|
0510390158 dated 06.08.2014 |
|
|
|
|
Subject |
|
Request of M/s Reckitt Benckiser Healthcare India Pvt. Ltd.,<br>New Delhi for fixation of adhoc norms in respect of Advance<br>Authorization No. 0510390158 dated 06.08.2014 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and after<br>deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(ingrams)<br>Mucinex Fast-Max Night Time<br>Cold & Flu Liquid<br>1 kg<br>1<br>Xanthan Gum Ph.Eur,USP,IH<br>1.00<br>2<br>PROPYLENE GLYCOL USP<br>272.727<br>3<br>Magnasweet 110<br>6.909<br>4<br>Propyl Gallate,USNF<br>1.818<br>5<br>Red Fruits<br>0.818<br>6<br>FD&C Blue 1<br>0.025<br>7<br>FD&C Red 40<br>0.005<br>8<br>SORBITOL<br>SOLUTION<br>(70<br>PERCENT) USP (D-sorbitol/Sorbitol<br>70 PERCENT)<br>136.364<br>9<br>GLYCERIN USP<br>181.818<br>10<br>ANHYDROUS CITRIC ACID USP<br>(Citric acid)<br>1.155<br>11<br>SODIUM BENZOATE NF<br>2.00<br>12<br>SUCRALOSE NF<br>1.818<br>13<br>EDTA DISODIUM USP (Disodium<br>(ethylenedinitrolo)tetraacetate<br>dihydrate)<br>0.455<br>14<br>Venus 24MM(Plastic Closures)<br>Relevant as<br>per packing<br>policy<br>15<br>Square M/Wash O/C Blue HT<br>(Plastic Closures)<br>16<br>RBL-LABEL MUCINEX 180 ML<br>FRONT(Paper Labels)<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty.<br>(ingrams) |
|
Mucinex Fast-Max Night Time<br>Cold & Flu Liquid |
1 kg |
|
1 |
Xanthan Gum Ph.Eur,USP,IH |
1.00 |
|
|
|
|
2 |
PROPYLENE GLYCOL USP |
272.727 |
|
|
|
|
3 |
Magnasweet 110 |
6.909 |
|
|
|
|
4 |
Propyl Gallate,USNF |
1.818 |
|
|
|
|
5 |
Red Fruits |
0.818 |
|
|
|
|
6 |
FD&C Blue 1 |
0.025 |
|
|
|
|
7 |
FD&C Red 40 |
0.005 |
|
|
|
|
8 |
SORBITOL<br>SOLUTION<br>(70<br>PERCENT) USP (D-sorbitol/Sorbitol<br>70 PERCENT) |
136.364 |
|
|
|
|
9 |
GLYCERIN USP |
181.818 |
|
|
|
|
10 |
ANHYDROUS CITRIC ACID USP<br>(Citric acid) |
1.155 |
|
|
|
|
11 |
SODIUM BENZOATE NF |
2.00 |
|
|
|
|
12 |
SUCRALOSE NF |
1.818 |
|
|
|
|
13 |
EDTA DISODIUM USP (Disodium<br>(ethylenedinitrolo)tetraacetate<br>dihydrate) |
0.455 |
|
|
|
|
14 |
Venus 24MM(Plastic Closures) |
Relevant as<br>per packing<br>policy |
|
|
|
|
15 |
Square M/Wash O/C Blue HT<br>(Plastic Closures) |
|
|
|
|
|
16 |
RBL-LABEL MUCINEX 180 ML<br>FRONT(Paper Labels) |
|
|
RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
69
|
Case No. |
Case No. |
B-16 |
B-16 |
B-16 |
B-16 |
|
Meeting No. |
|
8/AM20 |
|
|
|
|
Date |
|
20.09.2019 |
|
|
|
|
Firm’s Name |
|
M/s Reckitt Benckiser Healthcare India Limited, New Delhi |
|
|
|
|
HQF. No. |
|
01/82/050/00336/AM15/DES-III |
|
|
|
|
RLA F. No. |
|
05/24/040/00020/AM15 |
|
|
|
|
Advance Authorization No. and Date |
|
0510386217 dated 09.05.2014 |
|
|
|
|
Subject |
|
Request of M/s Reckitt Benckiser Healthcare India Pvt. Ltd.,<br>New Delhi for fixation of adhoc norms in respect of Advance<br>Authorization No. 0510386217 dated 09.05.2014 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and after<br>deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(ingrams)<br>Mucinex<br>Fast-Max<br>Severe<br>Congestion & Cough Liquid<br>( 20,44,79,640 Milileter(ML) )<br>1 kg<br>1<br>SORBITOL SOLUTION (70percent)<br>USP(D-sorbitol/Sorbitol 70percent)<br>136.36<br>2<br>PROPYLENE GLYCOL USP<br>272.73<br>3<br>GLYCERIN USP<br>181.82<br>4<br>Xanthan Gum Ph.Eur,USP,IH<br>1.00<br>5<br>ANHYDROUS CITRIC ACID USP<br>(Citric acid)<br>1.61<br>6<br>Propyl Gallate,USNF<br>1.82<br>7<br>SODIUM BENZOATE NF<br>2.00<br>8<br>SUCRALOSE NF<br>1.82<br>9<br>Magnasweet 110<br>6.91<br>10<br>Red Fruits<br>0.82<br>11<br>EDTA DISODIUM USP (Disodium<br>(ethylenedinitrolo)tetraacetate<br>dihydrate)<br>0.45<br>12<br>FD&C Blue 1<br>0.03<br>13<br>FD&C Red 40<br>0.005<br>14<br>Venus 24MM(Plastic Closures)<br>Relevant as<br>per packing<br>policy<br>15<br>Square M/Wash O/C Blue HT<br>(Plastic Closures)<br>16<br>Mucinex-<br>4P<br>Multipage<br>Severe<br>Cough(Paper Labels)<br>RA concerned may take further necessary action as per above decision of NC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty.<br>(ingrams) |
|
Mucinex<br>Fast-Max<br>Severe<br>Congestion & Cough Liquid<br>( 20,44,79,640 Milileter(ML) ) |
1 kg |
|
1 |
SORBITOL SOLUTION (70percent)<br>USP(D-sorbitol/Sorbitol 70percent) |
136.36 |
|
|
|
|
2 |
PROPYLENE GLYCOL USP |
272.73 |
|
|
|
|
3 |
GLYCERIN USP |
181.82 |
|
|
|
|
4 |
Xanthan Gum Ph.Eur,USP,IH |
1.00 |
|
|
|
|
5 |
ANHYDROUS CITRIC ACID USP<br>(Citric acid) |
1.61 |
|
|
|
|
6 |
Propyl Gallate,USNF |
1.82 |
|
|
|
|
7 |
SODIUM BENZOATE NF |
2.00 |
|
|
|
|
8 |
SUCRALOSE NF |
1.82 |
|
|
|
|
9 |
Magnasweet 110 |
6.91 |
|
|
|
|
10 |
Red Fruits |
0.82 |
|
|
|
|
11 |
EDTA DISODIUM USP (Disodium<br>(ethylenedinitrolo)tetraacetate<br>dihydrate) |
0.45 |
|
|
|
|
12 |
FD&C Blue 1 |
0.03 |
|
|
|
|
13 |
FD&C Red 40 |
0.005 |
|
|
|
|
14 |
Venus 24MM(Plastic Closures) |
Relevant as<br>per packing<br>policy |
|
|
|
|
15 |
Square M/Wash O/C Blue HT<br>(Plastic Closures) |
|
|
|
|
|
16 |
Mucinex-<br>4P<br>Multipage<br>Severe<br>Cough(Paper Labels) |
|
|
RA concerned may take further necessary action as per above decision of NC. |
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70
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| Ca |
se No. |
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B-17 |
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| Me |
eting No. |
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8/AM20 |
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| Da |
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te |
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20.09.2019 |
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| Fir |
m’s Name |
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M/s Reckitt Benckiser H |
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ealthcare India Limited, N |
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ew Delhi |
| H |
F No |
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01/82/050/00369/AM17/D |
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ES-III |
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| RL |
. .<br>A F. No. |
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<br>05/24/040/00128/AM17 |
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| Ad |
vance Authorization No. and Date |
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0510398826 dated 16.06.2016 |
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| Su |
bject |
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Request of M/s Reckitt Benckiser Healthcare India Pvt. Ltd., |
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<br>New Delhi for fixation of adhoc norms in respect of Advance<br>Authorization No. 0510398826 dated 16.06.2016 |
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| De<br>del<br>app<br>S<br>N<br>1 |
**cision:**The Committee consi<br>iberation, it was decided to ratify<br>lied by firm whichever is lower: |
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dered the case as per agenda<br>the adhoc norms under para |
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in t<br>4.7 |
he presence of technical ex<br>of HBP Vol. I as per detail |
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perts and after<br>s below or as |
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ty.<br>mg/tablet) |
|
l.<br>o. |
|
Export product |
|
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|
|
Qty. |
|
Sl.<br>No. |
Im |
port items |
Q<br>( |
|
|
|
|
|
Disprin Cardiocare (ASPIRIN<br>BP<br>100MG)<br>ACETYL<br>SALICYLIC<br>ACID<br>100mg |
|
|
|
|
1 Number |
|
1 |
SACCHARIN BASE<br>55Ox |
|
0.300<br>44.30 |
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2 |
GLYCINE EP |
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Tablet (ASPIRIN) |
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4 |
Aluminium Foil |
|
Relevant<br>as<br>per<br>packing<br> |
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| 2<br>3<br>4 |
|
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policy<br>4.50<br>3000 |
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Disprin<br>Regular<br>(ASPIRIN<br>PH.EUR<br>300MG)<br>ACETYL<br>SALICYLIC ACID 300 mg<br>Tablet (ASPIRIN) |
|
PIRIN<br>ETYL<br>0 mg |
|
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1 Number |
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1 |
S<br>55 |
ACCHARIN BASE<br>Ox |
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3 |
CITIRIC<br>ACID<br>ANHYDROUS F4020 |
TIRIC<br>ACID |
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<br> <br>NHYDROUS F4020 |
|
.<br>Relevant<br>as |
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4 |
A |
luminium Foil |
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per<br>packing<br>policy<br>1.00<br>133.00<br>Relevant<br>as<br>per<br>packing<br>policy<br>7.50<br>50.00 |
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Dispirn<br>Direct<br>and<br>Melts<br>(ASPIRIN PH.EUR 300MG)<br>ACETYL SALICYLIC ACID |
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1 Number |
|
1 |
SACCHARIN<br>BASE<br>55Ox |
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2 |
GLYCINE EP |
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300 mg Tablet (ASPI |
RIN) |
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4 |
Aluminium Foil |
|
Relevant<br>a<br>per<br>packin |
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policy |
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Disprin<br>Extra |
(ASPIRI |
|
N |
|
1 Nu |
mber |
1 |
SACCHARIN BASE |
|
7.50 |
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|
PH.EUR<br>500MG)<br>ACETYL<br>SALICYLIC ACID 500 mg<br> |
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55Ox |
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3 |
CITIRIC<br>ACID<br> |
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| Tablet (ASPIRIN)<br>ANHYDROUS F4020<br>4<br>Aluminium Foil<br>RA concerned may take further necessary action as per above decision of NC. |
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Tablet (ASPIRIN) |
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ANHYDROUS F4020 |
|
Relevant<br>as<br>per<br>packing<br>policy |
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4 |
Aluminium Foil |
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71
Case No. B-18 Meeting No. 8/AM20 Date 20.09.2019 Firm’s Name M/s Reckitt Benckiser Healthcare India Limited, New Delhi HQ F. No. 01/82/050/01149/AM15/DES-III RLA F. No. 05/24/040/00304/AM15 Advance Authorization No. and Date 0510391511 dated 09.10.2014 Subject Request of M/s Reckitt Benckiser Healthcare India Pvt. Ltd., New Delhi for enhancement in the quantity of import items in respect of adhoc norms fixed against Advance Authorization No. 0510391511 dated 09.10.2014 Decision: The Committee considered the case as per agenda in the presence of technical experts and after deliberation, it was decided to revise the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
(ingrams) |
| Mucinex Fast-Max DM Max |
1 kg |
1 |
Xanthan Gum Ph.Eur,USP,IH |
1.00 |
| Liquid |
|
2 |
Propyl Gallate,USNF |
1.818 |
|
|
3 |
Magnasweet 110 |
6.909 |
|
|
4 |
Orange Wonf Flavour |
0.909 |
|
|
5 |
CherryBerryFlavour |
2.272 |
|
|
6 |
FD&C Red 40 |
0.059 |
|
|
7 |
SORBITOL SOLUTION (70 |
136.364 |
|
|
|
percent) USP (D-sorbitol/Sorbitol 70 |
|
|
|
|
percent) |
|
|
|
8 |
PROPYLENE GLYCOL USP |
272.727 |
|
|
9 |
GLYCERIN USP |
181.818 |
|
|
10 |
ANHYDROUS CITRIC ACID USP |
1.614 |
|
|
|
(Citric acid) |
|
|
|
11 |
SODIUM BENZOATE NF |
2.00 |
|
|
12 |
SUCRALOSE NF |
1.818 |
|
|
13 |
EDTA DISODIUM USP (Disodium |
0.455 |
|
|
|
(ethylenedinitrolo)tetraacetate |
|
|
|
|
dihydrate) |
|
|
|
14 |
Venus 24MM(Plastic Closures) |
Relevant as |
|
|
15 |
Square M/Wash O/C Blue HT |
per packing |
|
|
|
(Plastic Closures) |
policy |
|
|
16 |
Mucinex- 4P Multipage DM Adult |
|
|
|
|
(Paper Labels) |
|
72
|
Case No. |
B-19 |
B-19 |
B-19 |
B-19 |
B-19 |
|
Meeting No. |
8/AM20 |
|
|
|
|
|
Date |
20.09.2019 |
|
|
|
|
|
Firm’s Name |
M/s Strides Shasun Ltd, Chennai |
|
|
|
|
|
HQF. No. |
01/82/050/00138/AM15/DES-III |
|
|
|
|
|
RLA F. No. |
04/24/040/00226/AM14 |
|
|
|
|
|
Advance Authorization<br>No. and Date |
0410154220 dated 13.01.2014 |
|
|
|
|
|
Subject |
Request of M/s Strides Shasun Ltd., Chennai for fixation of adhoc norms<br>against Advance Authorization No. 0410154220 dated 13.01.2014 |
|
|
|
|
|
**Decision:**The Committee considered the request of the firm in the presence of technical experts and after<br>deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty. per 25<br>mgtablet<br>METOPROLOL TARTRATE<br>TABLETS USP 25 MG<br>1 Tablet<br>1<br>METOPROLOL TARTRATE<br>25.50 mg<br>2<br>STEAR O WET (Magnesium<br>Stearate/SLS)<br>1.49 mg<br>3<br>AVICEL<br>102<br>(MICRO<br>CRYSTALLINE<br>CELLULOSE.Nf,Ph.Eur,J.P)<br>75.20 mg<br>4<br>ACDISOL<br>SD-711<br>(CROSS<br>CARMELLOSE<br>SODIUM<br>Nf,Ph.Eur,J.P)<br>11.917 mg<br>5<br>CLOSURE<br>38MM<br>CRC[PACKING MATERIAL].<br>Relevant as<br>per packing<br>policy<br>6<br>Plastic Bottles<br>Relevant as<br>per packing<br>policy<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty. / 100 mg<br>tablet<br>METOPROLOL TARTRATE<br>TABLETS USP 100MG NET<br>API CONTENT PER<br>TABLET: 102MG<br>INCLUDING WASTAGE<br>1 Number<br>1<br>METOPROLOL TARTRATE<br>102.0 mg<br>2<br>STEAR O WET (MAGNESIUM<br>STEARATE / SLS)<br>4.20 mg<br>3<br>AVICEL<br>102<br>(MICRO<br>CRYSTALLINE<br>SODIUM<br>NF.PH.EUR.J.P)<br>190.80 mg<br>4<br>ACDISOL<br>SD<br>711<br>(CROSS<br>CARMELLOSE<br>SODIUM<br>NF.PH.EUR.J.P)<br>33.60 mg<br>5<br>CLOSURE<br>53MM<br>CT<br>(PACKING MATERIAL)<br>Relevant as<br>per packing<br>policy<br>6<br>Plastic Bottles<br>Relevant as<br>per packing<br>policy<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
Qty. per 25<br>mgtablet |
|
METOPROLOL TARTRATE<br>TABLETS USP 25 MG |
|
1 Tablet |
1 |
METOPROLOL TARTRATE |
25.50 mg |
|
|
|
|
2 |
STEAR O WET (Magnesium<br>Stearate/SLS) |
1.49 mg |
|
|
|
|
3 |
AVICEL<br>102<br>(MICRO<br>CRYSTALLINE<br>CELLULOSE.Nf,Ph.Eur,J.P) |
75.20 mg |
|
|
|
|
4 |
ACDISOL<br>SD-711<br>(CROSS<br>CARMELLOSE<br>SODIUM<br>Nf,Ph.Eur,J.P) |
11.917 mg |
|
|
|
|
5 |
CLOSURE<br>38MM<br>CRC[PACKING MATERIAL]. |
Relevant as<br>per packing<br>policy |
|
|
|
|
6 |
Plastic Bottles |
Relevant as<br>per packing<br>policy |
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
Qty. / 100 mg<br>tablet |
|
METOPROLOL TARTRATE<br>TABLETS USP 100MG NET<br>API CONTENT PER<br>TABLET: 102MG<br>INCLUDING WASTAGE |
|
1 Number |
1 |
METOPROLOL TARTRATE |
102.0 mg |
|
|
|
|
2 |
STEAR O WET (MAGNESIUM<br>STEARATE / SLS) |
4.20 mg |
|
|
|
|
3 |
AVICEL<br>102<br>(MICRO<br>CRYSTALLINE<br>SODIUM<br>NF.PH.EUR.J.P) |
190.80 mg |
|
|
|
|
4 |
ACDISOL<br>SD<br>711<br>(CROSS<br>CARMELLOSE<br>SODIUM<br>NF.PH.EUR.J.P) |
33.60 mg |
|
|
|
|
5 |
CLOSURE<br>53MM<br>CT<br>(PACKING MATERIAL) |
Relevant as<br>per packing<br>policy |
|
|
|
|
6 |
Plastic Bottles |
Relevant as<br>per packing<br>policy |
|
RA concerned maytake further necessaryaction |
|
|
asper above decision of NC. |
|
|
73
| Case No. |
B-20 |
| Meeting No. |
8/AM20 |
| Date |
20.09.2019 |
| Firm’s Name |
M/s Strides Shasun Ltd, Chennai |
| HQF. No. |
01/82/050/00339/AM16/DES-III |
| RLA F. No. |
04/24/040/00040/AM16 |
| Advance Authorization<br>No. and Date |
0410160570 dated 21.05.2015 |
| Subject |
Request of M/s Strides Shasun Ltd., Chennai for fixation of adhoc norms<br>against Advance Authorization No. 0410160570 dated 21.05.2015 |
| **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in the<br>light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2019, dated 21.06.2019, it was decided to<br>ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is<br>lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>GABAPENTIN<br>TABLETS USP<br>600MG<br>1 Number<br>1<br>GABAPENTIN USP<br>612.00 mg / tablet<br>2<br>MANNITOL (PEARLITOL 100SD)<br>USP/NF<br>91.5 mg /tablet<br>3<br>COPOVIDONE / PLASDONE S-<br>630 USP/NF/PH.EUR<br>30.0 mg / tablet<br>4<br>KOLLIPHOR P 407 MICRO /<br>POLOXAMER (LUTROL M 127)<br>NF<br>1.00 mg/ tablet<br>5<br>MAGENSIUM<br>STEARATE<br>VEG.EP/USP/NF<br>2.00 mg/ tablet<br>6<br>HYDROXY<br>PROPYL<br>CELLULOSE<br>NF/PH.EUR<br>(KLUCEL - EF PH)<br>30.00 mg/ tablet<br>7<br>LOW SUBSTITUTED HYDROXY<br>PROPYL CELLULOSE USP NF.JP<br>10.00 mg/ tablet<br>RA concerned may take further necessary action as per above decision of NC. |
|
74
|
Case No. |
Case No. |
B-21 |
B-21 |
B-21 |
B-21 |
|
Meeting No. |
|
8/AM20 |
|
|
|
|
Date |
|
20.09.2019 |
|
|
|
|
Firm’s Name |
|
M/s Strides Shasun Ltd, Chennai |
|
|
|
|
HQF. No. |
|
01/82/050/00340/AM16/DES-III |
|
|
|
|
RLA F. No. |
|
04/24/040/00038/AM16 |
|
|
|
|
Advance Authorization<br>No. and Date |
|
0410159569 dated 21.05.2015 |
|
|
|
|
Subject |
|
Request of M/s Strides Shasun Ltd., Chennai for fixation of adhoc norms<br>against Advance Authorization No. 0410160569 dated 21.05.2015 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in the<br>light of earlier decision taken by NC in its Meeting No. 2/82-ALC4/2019, dated 21.06.2019, it was decided to<br>ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is<br>lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty. Allowed in<br>mg/tablet<br>GABAPENTIN<br>TABLETS USP<br>800MG<br>1 Number<br>1<br>GABAPENTIN USP<br>816.0<br>2<br>MANNITOL (PEARLITOL 100SD)<br>USP/NF<br>120.0<br>3<br>COPOVIDONE / PLASDONE S-<br>630 USP/NF/PH.EUR<br>40.0<br>4<br>KOLLIPHOR P 407 MICRO /<br>POLOXAMER (LUTROL M127)<br>NF<br>10.00<br>5<br>MAGENSIUM STEARATE<br>VEG.EP/USP/NF<br>10.00<br>6<br>HYDROXY PROPYL<br>CELLULOSE NF/PH.EUR<br>(KLUCEL - EF PH)<br>60.00<br>7<br>LOW SUBSTITUTED HYDROXY<br>PROPYL CELLULOSE USP NF.JP<br>20.00<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
Qty. Allowed in<br>mg/tablet |
|
GABAPENTIN<br>TABLETS USP<br>800MG |
1 Number |
|
1 |
GABAPENTIN USP |
816.0 |
|
|
|
|
2 |
MANNITOL (PEARLITOL 100SD)<br>USP/NF |
120.0 |
|
|
|
|
3 |
COPOVIDONE / PLASDONE S-<br>630 USP/NF/PH.EUR |
40.0 |
|
|
|
|
4 |
KOLLIPHOR P 407 MICRO /<br>POLOXAMER (LUTROL M127)<br>NF |
10.00 |
|
|
|
|
5 |
MAGENSIUM STEARATE<br>VEG.EP/USP/NF |
10.00 |
|
|
|
|
6 |
HYDROXY PROPYL<br>CELLULOSE NF/PH.EUR<br>(KLUCEL - EF PH) |
60.00 |
|
|
|
|
7 |
LOW SUBSTITUTED HYDROXY<br>PROPYL CELLULOSE USP NF.JP |
20.00 |
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
75
| Case No. |
Case No. |
|
B-22 |
|
|
|
|
|
|
| Meeting No. |
|
|
8/AM20 |
|
|
|
|
|
|
| Date |
|
|
20.09.2019 |
|
|
|
|
|
|
| Firm’s Name |
|
|
M/s Strides Shasun Ltd, Chennai |
|
|
|
|
|
|
| HQF. No. |
|
|
01/82/050/01089/AM15/DES-III |
|
|
|
|
|
|
| RLA F. No. |
|
|
04/24/040/00172/AM15 |
|
|
|
|
|
|
| Advance Authorization |
|
|
0410159540 dated 08.10.2014 |
|
|
|
|
|
|
| No. and Date |
|
|
|
|
|
|
|
|
|
| Subject |
|
|
Request |
of M/s Strides Shasun Ltd, Chennai for fixation of adhoc norms |
|
|
|
|
|
|
|
|
against Advance Authorization |
|
|
No. 0410159540 dated 08.10.2014 |
|
|
|
| **Decision:**The Committee considered the request of the |
|
|
|
|
|
firm in the presence of technical experts and after |
|
|
|
| deliberation, it was decided to ratify |
|
|
|
the adhoc norms under |
|
para 4.7 of |
HBP Vol. I as per details below or as |
|
|
| applied by firm whichever |
|
|
is lower: |
|
|
|
|
|
|
|
Export product |
Qty. |
|
Sl. |
Import items |
|
|
Qty. per 25 mg |
|
|
|
|
|
No. |
|
|
|
tablet |
|
|
METOPROLOL |
1 Tablet |
|
1. |
METOPROLOL TARTRATE |
|
|
25.50 mg |
|
|
TARTRATE |
|
|
2. |
STEAR<br>O |
WET |
(MAGNESIUM |
1.49 mg |
|
|
TABLETS USP 25 |
|
|
|
STEARATE/SLS) |
|
|
|
|
|
MG |
|
|
3. |
AVICEL 102 |
(MICRO |
CRYSTALLINE |
75.20 mg |
|
|
|
|
|
|
CELLULOSE.Nf,Ph.Eur,J.P) |
|
|
|
|
|
|
|
|
4. |
ACDISOL |
SD-711 |
<br>(CROSS |
11.917 mg |
|
|
|
|
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CARMELLOSE SODIUM Nf,Ph.Eur,J.P) |
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5. |
CLOSURE |
38MM |
CRC[PACKING |
Relevant as per |
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MATERIAL] |
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packing policy |
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6. |
75CC/38 MM |
HDPE PLASTIC BOTTLE |
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Relevant as per |
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[PACKING MATERIAL]. |
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packing policy |
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RA concerned maytake |
further necessaryaction asper above decision of NC. |
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| Case No. |
Case No. |
B-23 |
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| Meeting No. |
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8/AM20 |
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| Date |
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20.09.2019 |
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| Firm’s Name |
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M/s Strides Shasun Limited, Chennai |
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| HQF. No. |
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01/82/050/01086/AM15/DES-III |
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| RLA F. No. |
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04/24/040/00187/AM15 |
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| Advance Authorization |
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0410159552 dated 09.10.2014 |
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| No. and Date |
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| Subject |
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Request of M/s Shasun Pharmaceuticals Ltd, Chennai |
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for fixation of adhoc |
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norms against Advance Authorization No. 0410159552 dated 09.10.2014 |
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| **Decision:**The Committee considered the request of the firm in the presence of |
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technical experts and after |
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| deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or |
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as |
| applied by firm whichever |
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is lower: |
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Export product |
Qty.<br>Sl. |
Import items |
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Qty. |
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No. |
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NYSTATIN TABLETS USP 500000<br>1 Number<br>1. |
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NYSTATIN USP |
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85.87 mg / tablet |
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UNITS ( 84.187 MG) |
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RA concerned may take further necessary action as per above decision of NC. |
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76
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Case No. |
B-24 |
B-24 |
B-24 |
B-24 |
B-24 |
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Meeting No. |
14/AM 19 |
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Date |
14.02.2019 |
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Firm’s Name |
M/s Sentiss Pharma Pvt.Ltd,New Delhi |
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HQF. No. |
01/82/050/01456/AM17/DES-III |
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RLA F. No. |
05/24/040/00600/AM17 |
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Advance Authorization No. and Date |
0510401782 dated 23.02.2017 |
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Subject |
Request of M/s Sentiss Pharma Pvt.Ltd , New Delhi for<br>review<br>of<br>adhoc<br>norms<br>fixed<br>against<br>Advanced<br>Authorization No. 0510401782 dated 23.02.2017 |
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**Decision:**The Committee considered the request of the firm in the presence of technical experts and after<br>deliberation, it was decided to ratify the adhoc norms of Export Product No. 2 under para 4.7 of HBP Vol. I<br>as per details below or as applied by firm whichever is lower:<br>Export product No. 2<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Visallergol Eye Drops 0.2%, 2.5ml (Net<br>content of bulk drug Olopatadine HCL =<br>609.506 Gms)<br>1 Pack<br>1.<br>Olopatadine HCL<br>5.65 mg per pack<br>Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
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Export product No. 2 |
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Qty. |
Sl.<br>No. |
Import items |
Qty. |
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Visallergol Eye Drops 0.2%, 2.5ml (Net<br>content of bulk drug Olopatadine HCL =<br>609.506 Gms) |
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1 Pack |
1. |
Olopatadine HCL |
5.65 mg per pack |
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Rest of the earlier Minutes would remain unchanged.<br>RA concerned may take further necessary action as per above decision of NC. |
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77
| Case No. |
B-25 |
| MeetingNo. |
8/AM20 |
| Date |
20.09.2019 |
| Firm’s Name |
M/s S. Kant Healthcare Ltd,Mumbai |
| HQ F. No. |
01/82/050/01457/AM13/DES-III<br>01/82/050/01095/AM13/DES-III<br>01/82/050/01093/AM13/DES-III<br>01/82/050/01070/AM13/DES-III<br>01/82/050/00337/AM14/DES-III<br>01/87/050/00156/AM14/DES-III |
| RLA F. No. |
03/95/040/00565/AM13<br>03/95/040/00701/AM13<br>03/95/040/00702/AM13<br>03/95/040/00670/AM13<br>03/95/040/00706/AM13<br>03/95/040/00707/AM13 |
| Advance Authorization No. and Date |
0310714576 dated 07.11.2012,<br>0310717631 dated 19.12.2012,<br>0310717633 dated 19.12.2012,<br>0310716370 dated 05.12.2012,<br>0310734892 dated 20.05.2013 and<br>0310734894 dated 20.05.2013 |
| Subject |
Request of M/s S. Kant Healthcare Ltd, Mumbai for revision in<br>the quantity of import item in respect of adhoc norms fixed<br>against<br>Advance<br>Authorization<br>No.<br>0310714576<br>dated<br>07.11.2012, 0310717631 dated 19.12.2012, 0310717633 dated<br>19.12.2012, 0310716370 dated 05.12.2012, 0310734892 dated<br>20.05.2013 and 0310734894 dated 20.05.2013 |
| **Decision:**The Committee considered the request of the firm in the presence of technical experts and it was<br>decided to call for the duly certified Central Excise Data for the period 2012-13 and 2013-14 mentioning these<br>advance authorization Nos. |
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78
| Case No. |
B-26 |
B-26 |
| Meeting No. |
8/AM20 |
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| Date |
20.09.2019 |
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| Firm’s Name |
M/s Theon Pharmaceuticals Ltd.,Chandigarh |
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| HQF. No. |
01/82/050/00290/AM17/DES-III |
01/82/050/00293/AM17/DES-III |
| RLA F. No. |
22/24/040/00111/AM16 |
22/24/040/00121/AM16 |
| Advance Authorization No. and Date |
2210015421 dated 26.02.2016 |
2210015426 dated 04.03.2016 |
| Subject |
Request of M/s Theon Pharmaceuticals Ltd., Chandigarh for<br>amendment in the adhoc norms by NC-3 against Advance<br>Authorization Nos. 2210015421 dated 26.02.2016 and 2210015426<br>dated 04.03.2016 |
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| **Decision:**The Committee considered the request of the firm in the presence of technical experts and after<br>deliberation, it was decided to revise the adhoc norms as per SION A-3648.<br>RA maywork-out thequantityof inputs onpro-rata basis. |
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| Case No. |
B-27 |
| Meeting No. |
8/AM20 |
| Date |
20.09.2019 |
| 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 considered the case as per agenda in the presence of technical experts and after<br>deliberation,it was decided to allow import of Ascorbic Acid – 0.500 kgonlyfor regularizationpurpose. |
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79
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Case No. |
B-28 |
|
Meeting No. |
8/AM20 |
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Date |
20.09.2019 |
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Firm’s Name |
M/s Malwa Oxygen & Industrial Gases Pvt Ltd, Indore |
|
HQ F. No. |
01/82/050/00623/AM17/DES-III<br>01/82/050/00366/AM18/DES-III<br>01/82/050/00360/AM18/DES-III<br>01/82/050/00465/AM18/DES-III<br>01/82/050/01062/AM18//DES-III<br>01/82/050/00927/AM19/DES-III<br>01/82/050/00933/AM19/DES-III |
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RLA F. No. |
56/24/040/00015/AM17<br>56/24/040/00045/AM17<br>56/24/040/00004/AM18<br>56/24/040/00007/AM18<br>56/24/040/00028/AM18<br>56/24/040/00019/AM18<br>56/24/040/00048/AM18 |
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Advance Authorization No. and Date |
5610004949 dated 12.07.2016<br>5610005103 dated 22.03.2017<br>5610005123 dated 24.04.2017<br>5610005139 dated 18.05.2017<br>5610005253 dated 26.10.2017<br>5610005252 dated 26.10.2017<br>5610005395 dated 08.05.2018 |
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Subject |
Request of M/s Malwa Oxygen & Industrial Gases Pvt Ltd,<br>Indore for revision/correction in adhoc norms fixed against<br>Advance Authorization Nos. 5610004949 dated 12.07.2016,<br>5610005103 dated 22.03.2017, 5610005123 dated 24.04.2017,<br>5610005139 dated 18.05.2017, 5610005253 dated 26.10.2017,<br>5610005252 dated 26.10.2017 and 5610005395 dated 08.05.2018 |
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**Decision:**The Committee considered the case as per agenda and after deliberation, it was decided to revise<br>the norms as under:<br>Export product<br>Qty.<br>Sl.<br>**No **<br>Import items<br>Qty.<br>BIS(4-<br>FLUROPHENYL)KETONE OR<br>4,4<br>DIFLUOROBENZOPHENONE<br>1 kg<br>1<br>FLUOROBENZOYL(4-)CHLORIDE<br>1.00 kg<br>2<br>FLUOROBENZENE<br>1.10 kg<br>3<br>METHYLE ALCOHOL<br>0.60 kg<br>RA concerned may take further necessary action as per above decision of NC. |
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80
Case No. B-29 Meeting No. 8/AM20 Date 20.09.2019 Firm’s Name M/s Malwa Oxygen & Industrial Gases Pvt Ltd, Indore HQ F. No. 01/82/050/00816/AM19/DES-III RLA F. No. 56/24/040/00009/AM19 Advance Authorization No. and Date 5610005415 dated 17.05.2018 Subject Request of M/s Malwa Oxygen & Industrial Gases Pvt. Ltd, Indore for fixation of adhoc norms against Advance Authorization No. 5610005415 dated 17.05.2018
Decision: The Committee considered the request of the firm in the presence of technical experts and after deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
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No. |
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|
| 1,4-BIS (4-HYDROXYBENZOYL) |
1 kg |
1 |
TEREPHTHALOYL CHLORIDE |
1.1 kg |
| BENZENE |
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2 |
FLUORO BENZENE |
2.84 kg |
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3 |
METHANOL |
4.00 kg |
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4 |
CUPROUS CHLORIDE |
0.10 kg |
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5 |
ALUMINIUM CHLORIDE |
1.55 kg |
Case No. B-30 Meeting No. 8/AM20 Date 20.09.2019 Firm’s Name M/s Malwa Oxygen & Industrial Gases Pvt Ltd, Indore HQ F. No. 01/82/050/00806/AM19/DES-III RLA F. No. 56/24/040/00008/AM19 Advance Authorization No. and Date 5610005414 dated 17.05.2018 Subject Request of M/s Malwa Oxygen & Industrial Gases Pvt. Ltd, Indore for fixation of adhoc norms against Advance Authorization No. 5610005414 dated 17.05.2018
Decision: The Committee considered the request of the firm in the presence of technical experts and after deliberation, it was decided to ratify the adhoc norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 1,3-BIS (4-HYDROXYBENZOYL)<br>BENZENE |
1 kg |
1 |
ISOPHTHALOYL CHLORIDE |
1.1 kg |
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2 |
FLUORO BENZENE |
2.84 kg |
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3 |
METHANOL |
4.00 kg |
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4 |
CUPROUS CHLORIDE |
0.10 kg |
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|
5 |
ALUMINIUM CHLORIDE |
1.55 kg |
| RA concerned may take further necessary action as per above decision of NC. |
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Meeting ended with thanks to Chair.
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