1
Office of Directorate General of Foreign Trade New Delhi -0
-----------------------------------------------------------------------------Para 4.7 Decision
Minutes of the Norms Committee – 3 Meeting No. 6/82-ALC4/2019 dated 16.08.2019 (actually held on 23.08.2019) for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri Satyan Sharda, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.
Following members were present:-
- (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
The committee went through the minutes of earlier meeting No. 4/82-ALC4/2019 dated 19.07.2019 and 5/82-ALC4/2019 dated 12.08.2019 and approved the same.
MEETING NUMBER : 6/82-ALC4/2019 MEETING DATE : 16.08.2019
(actually held on 23.08.2019)
| Case No.:141/6/82-ALC4/2019 |
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Party Name:COVALENT |
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Meet No/Date:6/82- |
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Status: |
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LABORATORIES PRIVATE |
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ALC4/2019 |
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Approved |
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LIMITED |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0910038898 |
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| :01/82/050/00367/AM20/ |
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:09/24/040/00108/AM10/ |
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12.08.2009 |
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Case No.:141/6/82-ALC4/2019 |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00367/AM20/ |
RLA File<br>:09/24/040/00108/AM10/ |
Lic.No/Date:0910038898<br>12.08.2009 |
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| 1 |
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>5/82-ALC4/2019<br>, dated 02.08.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CEFPODOXIME PROXETIL<br>1 kg<br>1<br>7 Amino Cephalosporonic Acid (7<br>ACA)<br>0.8378 kg<br>2<br>2- Mercapto- Benzothiazol- 2-<br>Aminothiazole- 4yl- Methoxyimino<br>Acetate (MAEM)<br>0.8378 kg<br>3<br>Alpha-Chloroethyl Isopropyl<br>Carbonate (CEIPC)<br>0.550 kg<br>4<br>1,1,3,3, - tetramethyl Guanidine<br>(TMG)<br>0.223 kg<br>5<br>Methanol<br>1.51 kg<br>6<br>Methylene Chloride<br>2.32 kg<br>7<br>Acetone<br>2.50 kg<br>8<br>Tetra Hydro Furan<br>1.56 kg<br>9<br>Sodium Iodide<br>0.28 kg<br>10<br>Activated Carbon<br>0.100 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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Decision: The Committee considered 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. 5/82-ALC4/2019 , dated 02.08.2019, 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:
2
| Case No.:225/6/82-ALC4/2019 |
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Party Name:KARNATAKA |
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Meet No/Date:6/82- |
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Status: |
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ANTIBIOTICS & |
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ALC4/2019 |
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Approved |
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PHARMACEUTICALS LTD., |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0710086623 |
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| :01/82/050/00451/AM20/ |
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:07/24/040/00480/AM12/ |
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28.02.2012 |
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Case No.:225/6/82-ALC4/2019Party Name:KARNATAKA<br>ANTIBIOTICS &<br>PHARMACEUTICALS LTD.,<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>HQ File<br>:01/82/050/00451/AM20/<br>RLA File<br>:07/24/040/00480/AM12/<br>Lic.No/Date:0710086623<br>28.02.2012 |
Case No.:225/6/82-ALC4/2019Party Name:KARNATAKA<br>ANTIBIOTICS &<br>PHARMACEUTICALS LTD.,<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>HQ File<br>:01/82/050/00451/AM20/<br>RLA File<br>:07/24/040/00480/AM12/<br>Lic.No/Date:0710086623<br>28.02.2012 |
Case No.:225/6/82-ALC4/2019Party Name:KARNATAKA<br>ANTIBIOTICS &<br>PHARMACEUTICALS LTD.,<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>HQ File<br>:01/82/050/00451/AM20/<br>RLA File<br>:07/24/040/00480/AM12/<br>Lic.No/Date:0710086623<br>28.02.2012 |
Case No.:225/6/82-ALC4/2019Party Name:KARNATAKA<br>ANTIBIOTICS &<br>PHARMACEUTICALS LTD.,<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>HQ File<br>:01/82/050/00451/AM20/<br>RLA File<br>:07/24/040/00480/AM12/<br>Lic.No/Date:0710086623<br>28.02.2012 |
Case No.:225/6/82-ALC4/2019Party Name:KARNATAKA<br>ANTIBIOTICS &<br>PHARMACEUTICALS LTD.,<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>HQ File<br>:01/82/050/00451/AM20/<br>RLA File<br>:07/24/040/00480/AM12/<br>Lic.No/Date:0710086623<br>28.02.2012 |
Status:<br>Approved |
Status:<br>Approved |
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**Decision:**The Committee considered case as per agenda in the presence of the technical |
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experts and it |
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was decided to ratify the ad-hoc input output norms under |
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para 4.7 of HBP as per details below or as applied |
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by firm whichever is lower: |
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| 2 |
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Exportproduct |
Qty. |
Sl. No. |
Import items |
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Qty. |
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AMIKACIN<br>SULPHATE |
1 Number |
1 |
AMIKACIN SULPHATE USP |
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715.81 mg |
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INJECTION<br>USP |
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/ 2 ml vial |
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500MG/2ML |
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EACH<br>VIAL |
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CONTAINS:AMIKACIN |
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500MG EQUIVALENT TO |
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AMIKACIN<br>SULPHATE |
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USP |
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RA concerned maytake further necessaryaction asper above decision of NC. |
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Decision: The Committee considered case as per agenda 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.:140/6/82-ALC4/2019 |
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Party Name:INCHEM |
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Meet No/Date:6/82- |
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Status: |
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LABORATORIES PRIVATE |
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ALC4/2019 |
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Approved |
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LIMITED |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0910057229 |
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| :01/82/050/00366/AM20/ |
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:09/70/040/00077/AM14/ |
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19.08.2013 |
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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 3 by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
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No. |
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| Sodium Valproate |
1 kg |
1 |
N-Propyl Bromide |
2.91 kg |
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2 |
Diethyl Malonate |
1.45 kg |
RA concerned may take further necessary action as per above decision of NC.
3
| Case No.:226/6/82-ALC4/2019 |
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Party Name:MYLAN |
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Meet No/Date:6/82- |
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Status: |
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LABORATORIES LIMITED |
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ALC4/2019 |
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Approved |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0910059463 |
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| :01/82/050/00452/AM20/ |
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:09/24/040/00615/AM14/ |
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28.02.2014 |
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Case No.:226/6/82-ALC4/2019 |
Case No.:226/6/82-ALC4/2019 |
Party Name:MYLAN<br>LABORATORIES LIMITED |
Party Name:MYLAN<br>LABORATORIES LIMITED |
Party Name:MYLAN<br>LABORATORIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
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HQ File<br>:01/82/050/00452/AM20/ |
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RLA File<br>:09/24/040/00615/AM14/ |
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Lic.No/Date:0910059463<br>28.02.2014 |
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| 4 |
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts and<br>it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>OLMESARTAN<br>MEDOXOMIL<br>1 kg<br>1<br>Ethyl Ester of 4-(Hydroxy-1-<br>Methylethyl)-2-Propylimidazole-5-<br>Carboxylic Acid (Imidazole Ester)<br>(or) 1H-Imidazole-4-Carboxylic Acid,<br>5-(1-Hydroxy-1-Methylethyl)-2-Propyl<br>Ethyl Ester<br>0.70 kg<br>2<br>Potassium carbonate<br>0.50 kg<br>3<br>Acetonitrile<br>2.00 kg<br>4<br>Isopropyl alcohol<br>4.20 kg<br>5<br>4-chloro methyl-5-methyl-2-oxo-1,3-<br>dioxolene (or) 4-chloromethyl-5-<br>methyl-1,3-dioxolen-2-one<br>0.426 kg<br>6<br>Methanol<br>2.60 kg<br>7<br>CECA carbon (Activated Carbon<br>(ENOPC))<br>0.100 kg<br>8<br>Toluene<br>2.40 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
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agenda and in the presence of the technical experts and<br>rms under para 4.7 of HBP as per details below or as |
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Export product |
Qty. |
Sl.<br>No. |
Import items |
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Qty. |
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OLMESARTAN<br>MEDOXOMIL |
1 kg |
1 |
Ethyl Ester of 4-(Hydroxy-1-<br>Methylethyl)-2-Propylimidazole-5-<br>Carboxylic Acid (Imidazole Ester)<br>(or) 1H-Imidazole-4-Carboxylic Acid,<br>5-(1-Hydroxy-1-Methylethyl)-2-Propyl<br>Ethyl Ester |
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0.70 kg |
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2 |
Potassium carbonate |
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0.50 kg |
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3 |
Acetonitrile |
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2.00 kg |
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4 |
Isopropyl alcohol |
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4.20 kg |
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5 |
4-chloro methyl-5-methyl-2-oxo-1,3-<br>dioxolene (or) 4-chloromethyl-5-<br>methyl-1,3-dioxolen-2-one |
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0.426 kg |
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6 |
Methanol |
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2.60 kg |
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7 |
CECA carbon (Activated Carbon<br>(ENOPC)) |
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0.100 kg |
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8 |
Toluene |
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2.40 kg |
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sper the decision of Norms Committee |
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| Case No.:269/6/82-ALC4/2019 |
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Party Name:BIOCON |
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Meet No/Date:6/82- |
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Status: |
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LIMITED, |
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ALC4/2019 |
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Approved |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0710103216 |
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| :01/82/050/00495/AM20/ |
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:07/24/040/00482/AM14/ |
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26.03.2014 |
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Decision: The Committee considered case as per agenda in the presence of the technical experts and it 5 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
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No. |
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| ACARBOSE PH.EUR BULK DRUG |
1200 kg |
1 |
ACARBOSE BULK DRUG |
1200 kg |
4
| Case No.:139/6/82- |
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Party Name:PCL OIL & |
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Meet No/Date:6/82- |
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Status: |
| ALC4/2019 |
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SOLVENTS LTD., |
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ALC4/2019 |
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Approved |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0510393090 |
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| :01/82/050/00365/AM20/ |
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:05/24/040/00030/AM15/ |
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05.02.2015 |
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Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 6 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| PVC Plasticizer( DOP ) |
1 kg |
1 |
PHTHALIC ANHYDRIDE |
0.400 kg |
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2 |
2 ETHYLHEXANOL (OCTANOL) |
0.700 kg |
| Case No.:196/6/82- |
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Party Name:PCL OIL & |
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Meet No/Date:6/82- |
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Status: |
| ALC4/2019 |
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SOLVENTS LTD., |
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ALC4/2019 |
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Approved |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0510393538 |
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| :01/82/050/00422/AM20/ |
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:05/24/040/00585/AM15/ |
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12.03.2015 |
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Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 7 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| PVC Plasticizer( DOP ) |
1 kg |
1 |
PHTHALIC ANHYDRIDE |
0.400 kg |
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2 |
2 ETHYLHEXANOL(OCTANOL) |
0.700kg |
| Case No.:197/6/82- |
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Party Name:PCL OIL & |
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Meet No/Date:6/82- |
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Status: |
| ALC4/2019 |
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SOLVENTS LTD., |
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ALC4/2019 |
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Approved |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0510393589 |
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| :01/82/050/00423/AM20/ |
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:05/24/040/00482/AM15/ |
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16.03.2015 |
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Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 8 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| PVC Plasticizer( DOP ) |
1 kg |
1 |
PHTHALIC ANHYDRIDE |
0.400 kg |
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2 |
2 ETHYLHEXANOL (OCTANOL) |
0.700 kg |
5
| 9 |
Case No.:173/6/82-ALC4/2019 |
Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00301/AM16/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
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HQ File<br>:01/82/050/00399/AM20/ |
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Lic.No/Date:0310797781<br>29.07.2015 |
Defer Date: |
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**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was observed that the import quantity worked out by the firm in the subject Advance Authorization does not<br>match with the export obligation shown in the application. Such details are confusing in all the export items.<br>The firm maybe,at first instance,advice toget the license amended from RA. |
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Decision: The Committee considered the case as per agenda in the presence of technical experts and it was observed that the import quantity worked out by the firm in the subject Advance Authorization does not match with the export obligation shown in the application. Such details are confusing in all the export items. The firm may be, at first instance, advice to get the license amended from RA.
| Case No.:174/6/82- |
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Party Name:CIPLA LIMITED. |
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Meet No/Date:6/82- |
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Status: |
| ALC4/2019 |
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ALC4/2019 |
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Approved |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310805840 |
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| :01/82/050/00400/AM20/ |
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:03/94/040/00241/AM17/ |
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30.06.2016 |
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Case No.:174/6/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00400/AM20/ |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
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RLA File<br>:03/94/040/00241/AM17/ |
Lic.No/Date:0310805840<br>30.06.2016 |
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| 10 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated 14.01.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Potassium<br>Chloride<br>Extended<br>Release<br>Capsules<br>750mg<br>/<br>Potassium Chlor ER<br>Caps<br>USP<br>750mg(Pack Size 90<br>Capsules<br>Each)<br>Each<br>extended<br>Release<br>Capsule<br>contains:<br>Potassium<br>Chloride USP 750mg<br>1 No. of<br>Capsule<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant,<br>as per<br>packing<br>policy<br>6<br>38/400 FG, CRC HAVING UNIPAC<br>SG-75M LINER PTD. WITH SFYP<br>IN BLACK (REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg / (100<br>count) 600mg<br>Relevant,<br>as<br>per<br>packing<br>policy<br>2<br>Potassium<br>Chloride<br>Extended<br>Release<br>Capsules<br>750mg<br>/<br>Potassium Chlor ER<br>Caps<br>USP<br>750mg<br>(Pack<br>Size<br>100<br>Capsules<br>Each)<br>Each<br>extended<br>Release<br>Capsule<br>contains:<br>Potassium<br>Chloride USP 750mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant,<br>as<br>per<br>packing<br>policy<br>6<br>38/400 FG, CRC HAVING UNIPAC<br>SG-75M LINER PTD. WITH SFYP<br>IN BLACK (REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg / (100<br>count) 600mg<br>Relevant,<br>as<br>per<br>packing<br>policy |
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Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
6
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3 |
Potassium<br>Chloride<br>Extended<br>Release<br>Capsules<br>750mg<br>/<br>Potassium Chlor ER<br>Caps<br>USP<br>750mg<br>(Pack<br>Size<br>500<br>Capsules<br>Each)<br>Each<br>extended<br>Release<br>Capsule<br>contains:<br>Potassium<br>Chloride USP 750mg |
1 no. of<br>capsules |
1 |
POTASSIUM CHLORIDE USP |
765.0 mg |
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2 |
CITRIC ACID (MONOHYDRATE<br>USP) |
10.0 mg |
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3 |
DIBUTYL SEBACATE NF |
12.0 mg |
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4 |
ETHANOL USP 99.9% |
2.62 ml |
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5 |
200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg) |
Relevant,<br>as<br>per<br>packing<br>policy |
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6 |
38/400 FG, CRC HAVING UNIPAC<br>SG-75M LINER PTD. WITH SFYP<br>IN BLACK (REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg / (100<br>count) 600mg |
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7 |
950CC WHITE HDPE BOTTLE<br>WITH 53MM NECK DB-22<br>TRIVENI PLASTIC (500 Count)<br>750mg |
Relevant<br>net to net |
|
|
|
|
|
8 |
53/400 LSC, SCREW CAP HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH 53/400 LSC, SCREW CAP<br>HAVING UNIPAC SG-75M LINER<br>PTD. WITH<br>(500 Count) 750mg |
|
|
|
4 |
Potassium<br>Chloride<br>Extended<br>Release<br>Capsules<br>600mg<br>/<br>Potassium Chlor ER<br>Caps<br>USP<br>600mg<br>(Pack<br>Size<br>100<br>Capsules<br>Each)<br>Each<br>extended<br>Release<br>Capsule<br>contains:<br>Potassium<br>Chloride USP 600mg |
1 no. of<br>capsules |
1 |
POTASSIUM CHLORIDE USP |
612.0 mg |
|
|
|
|
|
2 |
CITRIC ACID (MONOHYDRATE<br>USP) |
8.0 mg |
|
|
|
|
|
3 |
DIBUTYL SEBACATE NF |
9.6 mg |
|
|
|
|
|
4 |
ETHANOL USP 99.9% |
2.62 ml |
|
|
|
|
|
5 |
200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg) |
Relevant,<br>as<br>per<br>packing<br>policy |
|
|
|
|
|
6 |
38/400 FG, CRC HAVING UNIPAC<br>SG-75M LINER PTD. WITH SFYP<br>IN BLACK (REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg / (100<br>count) 600mg |
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|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
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|
|
7
| Case No.:175/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310805842 |
|
|
| :01/82/050/00401/AM20/ |
|
:03/94/040/00242/AM17/ |
|
30.06.2016 |
|
|
|
Case No.:175/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00401/AM20/ |
RLA File<br>:03/94/040/00242/AM17/ |
Lic.No/Date:0310805842<br>30.06.2016 |
|
| 11 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated 14.01.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Quantity allowed<br>in mg/tablet<br>Telmisartan and Amlodipine Tablets<br>40/10mg Each uncoated tablets<br>contains : Telmisartan 40 mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg/<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg<br>1<br>Number<br>1<br>Telmisartan<br>Granules<br>68.034<br>2<br>Amlodipine<br>Besilate<br>10.20<br>Telmisartan and Amlodipine Tablets<br>80/10mg Each uncoated tablets<br>contains : Telmisartan 80 mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg<br>1<br>Number<br>1<br>Telmisartan<br>Granules<br>136.067<br>2<br>Amlodipine<br>Besilate<br>10.20<br>Telmisartan and Amlodipine Tablets<br>40/5mg Each uncoated tablets<br>contains : Telmisartan 40 mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg<br>1<br>Number<br>1<br>Telmisartan<br>Granules<br>68.034<br>2<br>Amlodipine<br>Besilate<br>5.10<br>Telmisartan and Amlodipine Tablets<br>80/5mg Each uncoated tablets<br>contains : Telmisartan 80 mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP5mg<br>1<br>Number<br>1<br>Telmisartan<br>Granules<br>136.067<br>2<br>Amlodipine<br>Besilate<br>5.10<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
8
| Case No.:176/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310805843 |
|
|
| :01/82/050/00402/AM20/ |
|
:03/94/040/00247/AM17/ |
|
30.06.2016 |
|
|
|
Case No.:176/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00402/AM20/ |
RLA File<br>:03/94/040/00247/AM17/ |
Lic.No/Date:0310805843<br>30.06.2016 |
|
| 12 |
<br>**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. 13/82-ALC4/2018, dated 14.01.2019, it was decided<br>to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Quantity<br>allowed in<br>mg/tablet<br>Telmisartan and Amlodipine<br>Tablets 40/10mg Each uncoated<br>tablets contains : Telmisartan 40<br>mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg/<br>Amlodipine Besilate equivalent<br>to Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan Granules<br>68.034<br>2<br>Amlodipine Besilate<br>10.20<br>Telmisartan and Amlodipine<br>Tablets 80/10mg Each uncoated<br>tablets contains : Telmisartan 80<br>mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent<br>to Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan Granules<br>136.067<br>2<br>Amlodipine Besilate<br>10.20<br>Telmisartan and Amlodipine<br>Tablets 40/5mg Each uncoated<br>tablets contains : Telmisartan 40<br>mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg<br>Amlodipine Besilate equivalent<br>to Amlodipine USP 5mg<br>1 Number<br>1<br>Telmisartan Granules<br>68.034<br>2<br>Amlodipine Besilate<br>5.10<br>Telmisartan and Amlodipine<br>Tablets 80/5mg Each uncoated<br>tablets contains : Telmisartan 80<br>mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent<br>toAmlodipine USP5mg<br>1 Number<br>1<br>Telmisartan Granules<br>136.067<br>2<br>Amlodipine Besilate<br>5.10<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
9
| 13 |
Case No.:177/6/82-ALC4/2019 |
Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00254/AM17/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00403/AM20/ |
|
Lic.No/Date:0310805844<br>30.06.2016 |
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) Copy of Master Batch Formula duly authenticated by Quality Control Incharge for each export item<br>showingthe net weight of each input in the export items. |
|
|
|
(i) Copy of Master Batch Formula duly authenticated by Quality Control Incharge for each export item showing the net weight of each input in the export items.
| Case No.:178/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310805888 |
|
|
| :01/82/050/00404/AM20/ |
|
:03/94/040/00266/AM17/ |
|
01.07.2016 |
|
|
|
Case No.:178/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00404/AM20/ |
RLA File<br>:03/94/040/00266/AM17/ |
Lic.No/Date:0310805888<br>01.07.2016 |
|
| 14 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Budesonide Inhalation Suspension<br>0.25mg/2ml Budesonide Respules<br>0.25mg/2ml<br>(Each 2ml contains Budesonide<br>USP 0.25mg)<br>1 Number<br>1<br>Budesonide USP<br>0.2625 mg / 0.25<br>mg vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% )<br>Budesonide Inhalation Suspension<br>0.50mg/2ml Budesonide Respules<br>0.50mg/2ml<br>(Each 2ml contains Budesonide<br>USP 0.50mg)<br>1 Number<br>1<br>Budesonide USP<br>0.525 mg / 0.50<br>mg vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% )<br>Budesonide Inhalation Suspension<br>1mg/2ml Budesonide Respules<br>1mg/2ml<br>(Each 2ml contains Budesonide<br>USP 1mg)<br>1 Number<br>1<br>Budesonide USP<br>1.05 mg / 1 mg<br>vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% )<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
10
|
|
Case No.:179/6/82-ALC4/2019Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
16.08.2019 |
|
|
| 15 |
|
HQ File<br>:01/82/050/00405/AM20/<br>RLA File<br>:03/94/040/00257/AM17/ |
|
Lic.No/Date:0310805901<br>04.07.2016 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:180/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310809333 |
|
|
| :01/82/050/00406/AM20/ |
|
:03/94/040/00756/AM17/ |
|
25.11.2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 15 |
C |
ase No.:179/6/82-ALC4/2019 |
Party |
Name:CIP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LA LIM |
|
ITED. |
|
Meet No/Date:6/82-<br>ALC4/2019<br>16082019 |
|
Status:<br>Deferred |
|
|
|
|
|
|
|
|
|
|
|
.. |
|
|
|
|
H<br>:0 |
Q File<br>1/82/050/00405/AM20/ |
RLA<br>:03/94 |
File<br>/040/002 |
|
7/AM1 |
|
/ |
|
Lic.No/Date:0310805901<br>04072016 |
|
Defer Date: |
|
|
|
|
|
|
|
|
|
|
|
.. |
|
|
|
|
D<br>no<br>au |
**ecision:**New Case. The Committee<br>t available. Hence, it was decided<br>thorization from RLA,Mumbai. |
|
noted th<br>to call |
|
at the 4.0<br>for a co |
|
7 application of subject Advance A<br>py of 4.07 application of the su |
|
|
|
uthorization is<br>bject advance |
|
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|
|
C<br>A |
ase No.:180/6/82-<br>LC4/2019<br> |
Party N |
ame:CIP |
|
LA LIMI |
|
TED.<br> |
|
Meet No/Date:6/82-<br>LC4/2019<br> <br> |
|
Status:<br>Aroved |
|
|
|
|
|
|
|
|
|
<br>1 |
|
<br>6.08.2019<br> |
|
pp |
|
|
HQ File<br>:01/82/050/00406/AM20/<br> <br> |
|
RLA File<br>03/94/040/00756/AM17/<br> <br> |
|
|
|
|
|
|
Lic.No/Date:0310809333<br>5112016 |
|
|
|
|
<br> |
|
<br> |
|
|
|
|
|
|
.. |
|
|
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>b fi hih i l |
|
|
|
|
|
|
|
|
|
|
|
|
| 16 |
y rm wcever s ower:<br>Export Product<br>Qty.<br>Budesonide Inhalation Suspension<br>0.25mg/2ml Budesonide Respules<br>0.25mg/2ml<br>(Each 2ml contains Budesonide USP<br>0.25mg)<br>1<br>Number<br>Budesonide Inhalation Suspension<br>1 |
|
|
|
|
|
|
|
|
|
|
llowed<br>/ 0.25 |
|
|
|
Export Product |
|
|
Qty. |
|
Sl.<br>No. |
|
Impo |
rt items |
Quantity a |
llowed |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Budesonide Inhalation Suspe<br>0.25mg/2ml Budesonide Resp |
nsion<br>ules |
|
1<br>Number |
|
1 |
|
Bude |
sonide USP |
0.2625 mg<br>mg vial |
/ 0.25 |
|
|
|
<br>0.25mg/2ml<br>(Each 2ml contains Budesonide USP<br>0.25mg) |
|
|
|
|
2 |
|
PURELL PE<br>1840H<br>GRANULES |
|
<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% ) |
|
|
|
|
Budesonide Inhalation Suspension |
|
|
1 |
|
1 |
|
Budesonide USP |
|
0.525 mg / 0.50 |
|
|
|
|
0.50mg/2ml Budesonide Respules<br>0.50mg/2ml<br> |
|
|
Number |
|
|
|
|
|
mg vial |
|
|
|
|
|
|
|
|
|
2 |
|
PURELL PE<br> |
|
Relevant, as per<br> |
|
|
|
|
(Each 2ml contains Budesoni<br>0.50mg) |
e USP |
|
|
|
|
|
1840<br>GRA |
H<br>NULES |
Packing P<br>the net wei<br>empty resp<br>Net + 5% |
olicy on<br>ght of<br>ules (<br> |
|
|
|
Budesonide Inhalation Suspe<br>1mg/2ml Budesonide Respule |
nsion<br>s |
|
1<br>Number |
|
1 |
|
Bude |
sonide USP |
<br>1.05 mg /<br>vial |
<br>1 mg |
|
|
|
1mg/2ml<br>(Each 2ml contains Budesonide USP<br>1 |
|
|
|
|
2 |
|
PUR<br>1840<br> |
ELL PE<br>H<br> |
Relevant, as per<br>Packing Policy on<br> |
|
|
|
mg)<br>GRANULES<br>the net weight of<br>empty respules (<br>Net + 5% )<br>RA concerned maytake further necessaryaction asper above decision of NC. |
mg) |
|
|
|
|
|
|
GRANULES |
|
the net weight of<br>empty respules (<br>Net + 5% ) |
|
|
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:
11
| Case No.:181/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310811828 |
|
|
| :01/82/050/00407/AM20/ |
|
:03/94/040/01100/AM17/ |
|
15.03.2017 |
|
|
|
Case No.:181/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/01100/AM17/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00407/AM20/ |
|
Lic.No/Date:0310811828<br>15.03.2017 |
|
| 17 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated 14.01.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>750mg(Pack Size<br>90 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>750mg<br>1 No. of<br>Capsule<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID<br>(MONOHYDRATE USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE<br>BOTTLE WITH 38MM NECK<br>DB-02 TRIVENI PLASTIC<br>(100 Count) 750mg / (100 count<br>600 mg)<br>Relevant, as per<br>packing policy<br>6<br>38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK<br>(REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg<br>/ (100 count) 600mg<br>Relevant, as<br>per packing<br>policy<br>2<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>750mg (Pack Size<br>100 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>750mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID<br>(MONOHYDRATE USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE<br>BOTTLE WITH 38MM NECK<br>DB-02 TRIVENI PLASTIC<br>(100 Count) 750mg / (100 count<br>600 mg)<br>Relevant, as<br>per packing<br>policy<br>6<br>38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK<br>(REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg<br>/ (100 count) 600mg<br>Relevant, as<br>per packing<br>policy<br>3<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID<br>(MONOHYDRATE USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml |
|
|
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
12
|
750mg (Pack Size<br>500 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>750mg<br>5<br>200CC WHITE HDPE<br>BOTTLE WITH 38MM NECK<br>DB-02 TRIVENI PLASTIC<br>(100 Count) 750mg / (100 count<br>600 mg)<br>Relevant, as<br>per packing<br>policy<br>6<br>38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK<br>(REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg<br>/ (100 count) 600mg<br>7<br>950CC WHITE HDPE<br>BOTTLE WITH 53MM NECK<br>DB-22 TRIVENI PLASTIC<br>(500 Count) 750mg<br>Relevant net to<br>net<br>8<br>53/400 LSC, SCREW CAP<br>HAVING UNIPAC SG-75M<br>LINER PTD. WITH 53/400<br>LSC, SCREW CAP HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH<br>(500 Count) 750mg<br>4<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 600mg /<br>Potassium Chlor<br>ER Caps USP<br>600mg (Pack Size<br>100 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>600mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>612.0 mg<br>2<br>CITRIC ACID<br>(MONOHYDRATE USP)<br>8.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>9.6 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE<br>BOTTLE WITH 38MM NECK<br>DB-02 TRIVENI PLASTIC<br>(100 Count) 750mg / (100 count<br>600 mg)<br>Relevant, as<br>per packing<br>policy<br>6<br>38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK<br>(REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg<br>/ (100 count) 600mg<br>RA maytake appropriate action asper the decision of Norms Committee. |
RA may take appropriate action as per the decision of Norms Committee.
13
| Case No.:182/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310812686 |
|
|
| :01/82/050/00408/AM20/ |
|
:03/94/040/00016/AM18/ |
|
24.04.2017 |
|
|
|
Case No.:182/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00408/AM20/ |
RLA File<br>:03/94/040/00016/AM18/ |
Lic.No/Date:0310812686<br>24.04.2017 |
|
| 18 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Quantity allowed<br>Budesonide Inhalation Suspension<br>0.25mg/2ml<br>Budesonide Respules<br>0.25mg/2ml<br>(Each 2ml contains Budesonide USP<br>0.25mg)<br>1<br>Number<br>1<br>Budesonide USP<br>0.2625 mg / 0.25<br>mg vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% )<br>Budesonide Inhalation Suspension<br>0.50mg/2ml<br>Budesonide Respules<br>0.50mg/2ml<br>(Each 2ml contains Budesonide USP<br>0.50mg)<br>1<br>Number<br>1<br>Budesonide USP<br>0.525 mg / 0.50<br>mg vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% )<br>Budesonide Inhalation Suspension<br>1mg/2ml<br>Budesonide<br>Respules<br>1mg/2ml<br>(Each 2ml contains Budesonide USP<br>1mg)<br>1<br>Number<br>1<br>Budesonide USP<br>1.05 mg / 1 mg<br>vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% )<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
14
| Case No.:183/6/82-ALC4/2019 |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310813088 |
|
|
| :01/82/050/00409/AM20/ |
|
:03/94/040/00057/AM18/ |
|
05.05.2017 |
|
|
|
Case No.:183/6/82-ALC4/2019 |
Case No.:183/6/82-ALC4/2019 |
Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00057/AM18/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00409/AM20/ |
|
|
Lic.No/Date:0310813088<br>05.05.2017 |
|
|
| 19 |
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in the light of earlier decision taken by NC in its Meeting No. 4/82-ALC4/2019<br>, dated 16.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Exportproduct<br> Qty.<br>Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray / Dymista Nasal<br>Spray (Pack 120MD)<br>Each Spray delivers: Azelastine Hydrochloride BP 137mcg Fluticasone Propionate<br>50mcg<br>1 Number<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Azelastine Hydrochloride<br>16.44 mg<br>2<br>Fluticasone Propionate<br>6.00 mg<br>3<br>140MCL PUMPS<br>Net + 1 %<br>4<br>25ML USP TYPE I AMBER GLASS VIAL.<br>5<br>NASAL ACTUATOR<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
Exportproduct |
|
|
|
Qty. |
|
|
Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray / Dymista Nasal<br>Spray (Pack 120MD)<br>Each Spray delivers: Azelastine Hydrochloride BP 137mcg Fluticasone Propionate<br>50mcg |
|
|
|
1 Number |
|
|
|
|
|
|
|
|
|
Sl. No. |
Import items |
|
|
Qty. |
|
|
1 |
Azelastine Hydrochloride |
|
|
16.44 mg |
|
|
2 |
Fluticasone Propionate |
|
|
6.00 mg |
|
|
3 |
140MCL PUMPS |
|
|
Net + 1 % |
|
|
4 |
25ML USP TYPE I AMBER GLASS VIAL. |
|
|
|
|
|
5 |
NASAL ACTUATOR |
|
|
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
| Case No.:184/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310813385 |
|
|
| :01/82/050/00410/AM20/ |
|
:03/94/040/00118/AM18/ |
|
18.05.2017 |
|
|
|
Case No.:184/6/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00410/AM20/ |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
|
RLA File<br>:03/94/040/00118/AM18/ |
Lic.No/Date:0310813385<br>18.05.2017 |
|
| 20 |
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated 14.01.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Quantity<br>allowed in<br>mg/tablet<br>Telmisartan and Amlodipine<br>Tablets 40/10mg Each uncoated<br>tablets contains : Telmisartan 40<br>mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg/<br>Amlodipine Besilate equivalent<br>to Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan Granules<br>68.034<br>2<br>Amlodipine Besilate<br>10.20<br>Telmisartan and Amlodipine<br>Tablets 80/10mg Each uncoated<br>tablets contains : Telmisartan 80<br>mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent<br>to Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan Granules<br>136.067<br>2<br>Amlodipine Besilate<br>10.20 |
|
|
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
15
|
Telmisartan and Amlodipine<br>Tablets 40/5mg Each uncoated<br>tablets contains : Telmisartan 40<br>mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg<br>Amlodipine Besilate equivalent<br>to Amlodipine USP 5mg<br>1 Number<br>1<br>Telmisartan Granules<br>68.034<br>2<br>Amlodipine Besilate<br>5.10<br>Telmisartan and Amlodipine<br>Tablets 80/5mg Each uncoated<br>tablets contains : Telmisartan 80<br>mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent<br>toAmlodipine USP5mg<br>1 Number<br>1<br>Telmisartan Granules<br>136.067<br>2<br>Amlodipine Besilate<br>5.10<br>RA maytake appropriate action asper the decision of Norms Committee. |
| Case No.:137/6/82- |
|
Party Name:S M S |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910065087 |
|
|
| :01/82/050/00363/AM20/ |
|
:09/24/040/00097/AM18/ |
|
23.05.2017 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 21 per details below or as applied by firm whichever is lower:
| Export Product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| EFAVIRENZ |
1 kg |
1 |
(S)-5-Chloro-Alpha-(Cyclo Propyl<br>Ethynyl)-2-Amino-Alpha-(Tri Fluoro<br>Methyl) Benzene Methanol |
0.987 kg |
|
|
2 |
TRIPHOSGENE |
0.431 kg |
16
| Case No.:185/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310813599 |
|
|
| :01/82/050/00411/AM20/ |
|
:03/94/040/00161/AM18/ |
|
26.05.2017 |
|
|
|
Case No.:185/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00411/AM20/ |
RLA File<br>:03/94/040/00161/AM18/ |
Lic.No/Date:0310813599<br>26.05.2017 |
|
| 22 |
<br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per<br>details below or as applied by firm whichever is lower:<br>A. For 1 Number of Export Item<br>Sl. No.<br>Export Product<br>Qty. in mg<br>Abacavir<br>Sulfate<br>Lamivudine<br>1<br>Abacavir Sulfate and Lamivudine Dispersible Tablets<br>60/30mg<br>Abacavir<br>Sulfate<br>and<br>Lamivudine Tablets for Oral Suspension 60/30mg Abamune<br>-L Baby Tablets<br>61.20<br>30.60<br>2<br>Abacavir<br>and<br>Lamivudine<br>Tablets<br>600/300<br>mg<br>Abacavir Sulfate 600mg and Lamivudine 300mg Tablet<br>612.0<br>306.0<br>B. Norms for 1 kg Abacavir Sulfate<br>Sl. No.<br>Import Item<br>Qty.<br>1<br>Formamido Amino Dichloro Pyrimidine (FADCP)<br>1.042 kg<br>2<br>Methylene Chloride<br>3.00 kg<br>3<br>Cyclopropyl Amine<br>0.19 kg<br>C. Norms for 1 kg Lamivudine<br>Sl. No.<br>Import Item<br>Qty.<br>1<br>(1 R, 2 S, 5 R)- MENTHYL-5S-(CYTOSINE-1 -YL)-1,3-<br>OXATHIOLANE- 2R-CARBOXYLATE / CME<br>COMPOUND"<br>2.19 kg<br>2<br>SODIUM BOROHYDRIDE<br>0.48 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
17
| Case No.:186/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310813761 |
|
|
| :01/82/050/00412/AM20/ |
|
:03/94/040/00190/AM18/ |
|
05.06.2017 |
|
|
|
Case No.:186/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00190/AM18/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00412/AM20/ |
|
Lic.No/Date:0310813761<br>05.06.2017 |
|
| 23 |
<br>**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. 13/82-ALC4/2018, dated 14.01.2019, it was decided<br>to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>750mg(Pack Size<br>90 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>750mg<br>1 No. of<br>Capsule<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant, as<br>per packing<br>policy<br>6<br>38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK (REXAM<br>CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg<br>Relevant, as<br>per packing<br>policy<br>2<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>750mg (Pack Size<br>100 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>750mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant, as<br>per packing<br>policy<br>6<br>38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK (REXAM<br>CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg<br>Relevant, as<br>per packing<br>policy<br>3<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>750mg (Pack Size<br>500 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant, as<br>per packing<br>policy<br>6<br>38/400 FG, CRC HAVING |
|
|
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
18
|
|
|
contains:<br>Potassium<br>Chloride USP<br>750mg |
contains:<br>Potassium<br>Chloride USP<br>750mg |
|
|
UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK (REXAM<br>CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg |
UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK (REXAM<br>CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg |
UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK (REXAM<br>CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg |
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7 |
950CC WHITE HDPE BOTTLE<br>WITH 53MM NECK DB-22<br>TRIVENI PLASTIC (500 Count)<br>750mg |
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|
Relevant net<br>to net |
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8 |
53/400 LSC, SCREW CAP<br>HAVING UNIPAC SG-75M<br>LINER PTD. WITH 53/400 LSC,<br>SCREW CAP HAVING UNIPAC<br>SG-75M LINER PTD. WITH<br>(500 Count) 750mg |
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4 |
Potassium<br>Chloride<br>Extended Release<br>Capsules 600mg /<br>Potassium Chlor<br>ER Caps USP<br>600mg (Pack Size<br>100 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>600mg |
|
1 no. of<br>capsules |
1 |
POTASSIUM CHLORIDE USP |
|
|
612.0 mg |
|
|
|
|
|
|
|
2 |
CITRIC ACID (MONOHYDRATE<br>USP) |
|
|
8.0 mg |
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|
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|
3 |
DIBUTYL SEBACATE NF |
|
|
9.6 mg |
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4 |
ETHANOL USP 99.9% |
|
|
2.62 ml |
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5 |
200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg) |
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|
Relevant, as<br>per packing<br>policy |
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6 |
38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK (REXAM<br>CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg |
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RA may |
take appropriate action asper the |
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decision of Norms Committee. |
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| 24 |
Case No.:192/6/82-<br>ALC4/2019 |
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Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00235/AM18/ |
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Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
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Status:<br>Approved |
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HQ File<br>:01/82/050/00418/AM20/ |
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Lic.No/Date:0310814259<br>27.06.2017 |
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<br>**Decision:**The Committee considered case as per agenda and deliberated on<br>technical experts and it was decided to ratify the ad-hoc input output norm<br>details below or as applied by firm whichever is lower:<br>A. For 1 Number of Export Item<br>Sl. No.<br>Export Product<br>1<br>Abacavir<br>and<br>Lamivudine<br>Tablets<br>600/300<br>mg<br>AbacavirSulfate 600mg andLamivudine 300mgTablet<br>B. Norms for 1 kg Abacavir Sulfate<br>Sl. No.<br>Import Item<br>1<br>Formamido Amino Dichloro Pyrimidine (FADCP)<br>2<br>Methylene Chloride<br>3<br>Cyclopropyl Amine |
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the matter in<br>s under para |
the presence of the<br>4.7 of HBP as per<br>in mg<br>Lamivudine<br>306.0 |
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Sl. No. |
|
Export Product |
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Qty. |
in mg |
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Abacavir<br>Sulfate |
Lamivudine |
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1 |
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Abacavir<br>and<br>Lamivudine<br>Tablets<br>600/300<br>mg<br>AbacavirSulfate 600mg andLamivudine 300mgTablet |
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612.0 |
306.0 |
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Sl. No. |
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Import Item |
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Qty. |
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1 |
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Formamido Amino Dichloro Pyrimidine (FADCP) |
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1.042 kg |
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2 |
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Methylene Chloride |
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3.00 kg |
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3 |
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Cyclopropyl Amine |
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0.19 kg |
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19
C. Norms for 1 kg Lamivudine
| Sl. No. |
Import Item |
Qty. |
| 1 |
(1 R, 2 S, 5 R)- MENTHYL-5S-(CYTOSINE-1 -YL)-1,3-<br>OXATHIOLANE- 2R-CARBOXYLATE / CME<br>COMPOUND" |
2.19 kg |
| 2 |
SODIUM BOROHYDRIDE |
0.48 kg |
| Case No.:187/6/82- |
|
Party Name:CIPLA LIMITED. |
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Meet No/Date:6/82- |
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Status: |
| ALC4/2019 |
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|
ALC4/2019 |
|
Approved |
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16.08.2019 |
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| HQ File |
|
RLA File |
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Lic.No/Date:0310814909 |
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|
| :01/82/050/00413/AM20/ |
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:03/94/040/00372/AM18/ |
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31.07.2017 |
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Case No.:187/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED.<br>RLA File<br>:03/94/040/00372/AM18/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00413/AM20/ |
|
Lic.No/Date:0310814909<br>31.07.2017 |
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| 25 |
<br>**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. 13/82-ALC4/2018, dated 14.01.2019, it was decided<br>to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER<br>Caps<br>USP<br>750mg(Pack Size<br>90<br>Capsules<br>Each)<br>Each<br>extended<br>Release<br>Capsule<br>contains:<br>Potassium<br>Chloride<br>USP<br>750mg<br>1 No. of<br>Capsule<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID<br>(MONOHYDRATE USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant, as<br>per packing<br>policy<br>6<br>38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK<br>(REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg<br>Relevant, as<br>per<br>packing<br>policy<br>2<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER<br>Caps<br>USP<br>750mg (Pack Size<br>100<br>Capsules<br>Each)<br>Each<br>extended<br>Release<br>Capsule<br>contains:<br>Potassium<br>Chloride<br>USP<br>750mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID<br>(MONOHYDRATE USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant, as<br>per<br>packing<br>policy<br>6<br>38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK<br>(REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg<br>Relevant, as<br>per<br>packing<br>policy |
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|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
20
|
|
3 |
Potassium<br>Chloride |
1 no. of<br>capsules |
1 no. of<br>capsules |
1 |
POTASSIUM CHLORIDE USP |
POTASSIUM CHLORIDE USP |
765.0 mg |
765.0 mg |
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Extended Release<br>Capsules 750mg /<br>Potassium Chlor |
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2 |
CITRIC ACID<br>(MONOHYDR |
ATE USP) |
10.0 m |
g |
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3 |
DIBUTYL SEB |
ACATE NF |
12.0 m |
g |
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|
ER<br>Caps<br>USP<br>750mg (Pack Size<br>500<br>Cl |
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4 |
ETHANOL US |
P 99.9% |
2.62 m |
l |
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5 |
200CC WHITE<br> |
HDPE BOTTLE<br> |
Releva |
nt, as<br> |
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<br>apsues<br>Each) |
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WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count) |
|
per<br>packing<br>policy |
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Each<br>extended<br>Release<br>Capsule<br> |
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<br>750mg / (100 count 600 mg) |
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6 |
38/400 FG, CRC HAVING |
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contains:<br>Potassium<br>Chloride<br>USP<br>750m |
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UNIPAC SG-7<br>WITH SFYP IN<br>(REXAM CLO<br> |
5M LINER PTD.<br>BLACK<br>SURES)<br> |
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g |
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(90 Count ) (10<br>(100 count) 600 |
Count) 750mg /<br>mg |
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7 |
950CC WHITE |
HDPE BOTTLE |
Releva |
nt net to |
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<br>WITH 53MM NECK DB-22 |
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<br>net |
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TRIVENI PLASTIC (500 Count)<br>750mg |
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8 |
53/400 LSC, S<br>HAVING UNIP<br>LINER PTD. W<br>SCREW CAP H |
REW CAP<br>AC SG-75M<br>ITH 53/400 LSC,<br>AVING |
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<br>UNIPAC SG-7<br>WITH |
<br>5M LINER PTD. |
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(500 Count) 750mg |
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4 |
Potassium<br>Chloride<br>Extended Release |
1 no. of<br>capsules |
|
1 |
POTASSIUM CHLORIDE USP |
|
612.0 mg |
|
|
|
|
|
|
|
|
2 |
CITRIC ACID<br> |
|
8.0 mg |
|
|
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|
|
<br>Capsules 600mg /<br>Potassium Chlor<br>ER<br>Caps<br>USP |
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|
(MONOHYDR |
ATE USP) |
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3 |
DIBUTYL SEB |
ACATE NF |
9.6 mg |
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4 |
ETHANOL US |
P 99.9% |
2.62 m |
l |
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|
|
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600mg (Pack Size<br>100<br>Capsules<br> |
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|
5 |
200CC WHITE<br>WITH 38MM N |
HDPE BOTTLE<br>ECK DB-02 |
Releva<br>per |
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|
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|
|
Each)<br>Each<br>extended<br>Release<br>Capsule<br>contains:<br>Potassium<br>Chloride<br>USP<br>600mg |
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|
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<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg) |
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|
6 |
38/400 FG, CRC HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH SFYP IN BLACK<br>(REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg |
|
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|
|
21
| Case No.:188/6/82-ALC4/2019 |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310816515 |
|
|
| :01/82/050/00414/AM20/ |
|
:03/94/040/00553/AM18/ |
|
25.10.2017 |
|
|
|
|
Case No.:188/6/82-ALC4/2019Party Name:CIPLA LIMITED.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00414/AM20/<br>RLA File<br>:03/94/040/00553/AM18/<br>Lic.No/Date:0310816515<br>25.10.2017 |
Case No.:188/6/82-ALC4/2019Party Name:CIPLA LIMITED.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00414/AM20/<br>RLA File<br>:03/94/040/00553/AM18/<br>Lic.No/Date:0310816515<br>25.10.2017 |
Case No.:188/6/82-ALC4/2019Party Name:CIPLA LIMITED.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00414/AM20/<br>RLA File<br>:03/94/040/00553/AM18/<br>Lic.No/Date:0310816515<br>25.10.2017 |
|
|
**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. 4/82-ALC4/2019 |
|
|
|
|
, dated 16.07.2019, 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: |
|
|
|
|
Exportproduct |
Qty. |
|
| 26 |
|
Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray / Dymista |
1 Number |
|
|
|
Nasal Spray (Pack 120MD) |
|
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|
|
Each Spray delivers: Azelastine Hydrochloride BP 137mcg Fluticasone |
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Propionate 50mcg |
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|
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|
|
Sl. No.<br>Import items |
Qty. |
|
|
|
1<br>Azelastine Hydrochloride |
16.44 mg |
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|
|
2<br>Fluticasone Propionate |
6.00 mg |
|
|
|
3<br>140MCL PUMPS |
Net + 1 % |
|
|
|
4<br>25ML USP TYPE I AMBER GLASS VIAL. |
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|
5<br>NASAL ACTUATOR . |
|
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|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
| Case No.:190/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310817507 |
|
|
| :01/82/050/00416/AM20/ |
|
:03/94/040/00652/AM18/ |
|
05.12.2017 |
|
|
|
|
Decision: |
Decision: |
The Committee considered the case as per agenda in the presence of Technical Experts and in the |
The Committee considered the case as per agenda in the presence of Technical Experts and in the |
The Committee considered the case as per agenda in the presence of Technical Experts and in the |
The Committee considered the case as per agenda in the presence of Technical Experts and in the |
The Committee considered the case as per agenda in the presence of Technical Experts and in the |
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided |
|
|
|
|
|
|
|
|
|
to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm |
|
|
|
|
|
|
|
|
|
whichever is lower: |
|
|
|
|
|
|
|
|
|
|
Sl. |
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
No. |
|
|
No. |
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|
| 27 |
|
|
1 |
Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor |
1 No. of<br>Capsule |
1<br>2<br>3 |
POTASSIUM CHLORIDE USP<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>DIBUTYL SEBACATE NF |
765.0 mg<br>10.0 mg<br>12.0 mg |
|
|
|
|
|
ER Caps USP |
|
4 |
ETHANOL USP 99.9% |
2.62 ml |
|
|
|
|
|
750mg(Pack Size |
|
5 |
200CC WHITE HDPE BOTTLE |
Relevant, |
|
|
|
|
|
90 Capsules |
|
|
WITH 38MM NECK DB-02 |
as per |
|
|
|
|
|
Each) |
|
|
TRIVENI PLASTIC (100 Count) |
packing |
|
|
|
|
|
Each extended |
|
|
750mg / (100 count 600 mg) |
policy |
|
|
|
|
|
Release Capsule |
|
6 |
38/400 FG, CRC HAVING UNIPAC |
Relevant, |
|
|
|
|
|
contains: |
|
|
SG-75M LINER PTD. WITH SFYP |
as |
|
|
|
|
|
Potassium |
|
|
IN BLACK (REXAM CLOSURES) |
per |
|
|
|
|
|
Chloride USP |
|
|
(90 Count ) (100 Count) 750mg / |
packing |
|
|
|
|
|
750mg |
|
|
(100 count) 600mg |
policy |
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
22
|
2<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>750mg (Pack Size<br>100 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>750mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant,<br>as<br>per<br>packing<br>policy<br>6<br>38/400 FG, CRC HAVING UNIPAC<br>SG-75M LINER PTD. WITH SFYP<br>IN BLACK (REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg<br>Relevant,<br>as<br>per<br>packing<br>policy<br>3<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 750mg /<br>Potassium Chlor<br>ER Caps USP<br>750mg (Pack Size<br>500 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>750mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>765.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>10.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>12.0 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant,<br>as<br>per<br>packing<br>policy<br>6<br>38/400 FG, CRC HAVING UNIPAC<br>SG-75M LINER PTD. WITH SFYP<br>IN BLACK (REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg<br>7<br>950CC WHITE HDPE BOTTLE<br>WITH 53MM NECK DB-22<br>TRIVENI PLASTIC (500 Count)<br>750mg<br>Relevant<br>net to net<br>8<br>53/400 LSC, SCREW CAP HAVING<br>UNIPAC SG-75M LINER PTD.<br>WITH 53/400 LSC, SCREW CAP<br>HAVING UNIPAC SG-75M LINER<br>PTD. WITH<br>(500 Count) 750mg<br>4<br>Potassium<br>Chloride<br>Extended Release<br>Capsules 600mg /<br>Potassium Chlor<br>ER Caps USP<br>600mg (Pack Size<br>100 Capsules<br>Each)<br>Each extended<br>Release Capsule<br>contains:<br>Potassium<br>Chloride USP<br>600mg<br>1 no. of<br>capsules<br>1<br>POTASSIUM CHLORIDE USP<br>612.0 mg<br>2<br>CITRIC ACID (MONOHYDRATE<br>USP)<br>8.0 mg<br>3<br>DIBUTYL SEBACATE NF<br>9.6 mg<br>4<br>ETHANOL USP 99.9%<br>2.62 ml<br>5<br>200CC WHITE HDPE BOTTLE<br>WITH 38MM NECK DB-02<br>TRIVENI PLASTIC (100 Count)<br>750mg / (100 count 600 mg)<br>Relevant,<br>as<br>per<br>packing<br>policy<br>6<br>38/400 FG, CRC HAVING UNIPAC<br>SG-75M LINER PTD. WITH SFYP<br>IN BLACK (REXAM CLOSURES)<br>(90 Count ) (100 Count) 750mg /<br>(100 count) 600mg<br>RA maytake appropriate action asper the decision of Norms Committee. |
23
| Case No.:227/6/82-ALC4/2019 |
|
Party Name:AMI ORGANICS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PVT LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:5210042448 |
|
|
| :01/82/050/00453/AM20/ |
|
:52/24/040/00047/AM18/ |
|
05.12.2017 |
|
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm 28 whichever is lower:
| Export Product |
Qty. |
S. |
Import Product |
Qty. |
|
|
No. |
|
|
| 3,4 DI HYDROXY 5 |
1 kg |
1 |
VANILLINE- 99.5 % min |
1.588 kg |
| NITRO BENZAL<br>DEHYDE-99% min |
|
2 |
DI METHYL FORMAMIDE - 99.5% |
3.17 kg |
Case No.:189/6/82- Party Name:CIPLA LIMITED. Meet No/Date:6/82- Status: ALC4/2019 ALC4/2019 Approved 16.08.2019 HQ File RLA File Lic.No/Date:0310818040 :01/82/050/00415/AM20/ :03/94/040/00614/AM18/ 27.12.2017
|
Case No.:189/6/82-<br>ALC4/2019<br>Party Name:CIPLA LIMITED. Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00415/AM20/<br>RLA File<br>:03/94/040/00614/AM18/<br>Lic.No/Date:0310818040<br>27.12.2017 |
Case No.:189/6/82-<br>ALC4/2019<br>Party Name:CIPLA LIMITED. Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00415/AM20/<br>RLA File<br>:03/94/040/00614/AM18/<br>Lic.No/Date:0310818040<br>27.12.2017 |
Case No.:189/6/82-<br>ALC4/2019<br>Party Name:CIPLA LIMITED. Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00415/AM20/<br>RLA File<br>:03/94/040/00614/AM18/<br>Lic.No/Date:0310818040<br>27.12.2017 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
|
|
|
Lic.No/Date:0310818040<br>27.12.2017 |
|
|
| 29 |
**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. 13/82-ALC4/2018, dated 14.01.2019, it was decided<br>to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Quantity<br>allowed in<br>mg/tablet<br>Telmisartan and Amlodipine Tablets<br>40/10mg Each uncoated tablets contains<br>:<br>Telmisartan<br>40<br>mg<br>Telmisartan<br>40<br>mg<br>equivalent<br>to<br>Telmisartan<br>granules<br>67.36mg/<br>Amlodipine<br>Besilate<br>equivalent<br>to<br>Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan Granules<br>68.034<br>2<br>Amlodipine Besilate<br>10.20<br>Telmisartan and Amlodipine Tablets<br>80/10mg Each uncoated tablets contains<br>:<br>Telmisartan<br>80<br>mg<br>Telmisartan<br>80<br>mg<br>equivalent<br>to<br>Telmisartan<br>granules<br>134.72mg<br>Amlodipine<br>Besilate<br>equivalent<br>to<br>Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan Granules<br>136.067<br>2<br>Amlodipine Besilate<br>10.20<br>Telmisartan and Amlodipine Tablets<br>40/5mg Each uncoated tablets contains :<br>Telmisartan<br>40<br>mg<br>Telmisartan<br>40<br>mg<br>equivalent<br>to<br>Telmisartan<br>granules<br>67.36mg<br>Amlodipine<br>Besilate<br>equivalent<br>to<br>Amlodipine USP 5mg<br>1 Number<br>1<br>Telmisartan Granules<br>68.034<br>2<br>Amlodipine Besilate<br>5.10<br>Telmisartan and Amlodipine Tablets<br>1 Number<br>1<br>TelmisartanGranules<br>136.067 |
|
|
|
|
|
|
Export Product |
Qty. |
Sl.<br>No. |
Import items |
Quantity<br>allowed in<br>mg/tablet |
|
|
Telmisartan and Amlodipine Tablets<br>40/10mg Each uncoated tablets contains<br>:<br>Telmisartan<br>40<br>mg<br>Telmisartan<br>40<br>mg<br>equivalent<br>to<br>Telmisartan<br>granules<br>67.36mg/<br>Amlodipine<br>Besilate<br>equivalent<br>to<br>Amlodipine USP 10mg |
1 Number |
1 |
Telmisartan Granules |
68.034 |
|
|
|
|
2 |
Amlodipine Besilate |
10.20 |
|
|
Telmisartan and Amlodipine Tablets<br>80/10mg Each uncoated tablets contains<br>:<br>Telmisartan<br>80<br>mg<br>Telmisartan<br>80<br>mg<br>equivalent<br>to<br>Telmisartan<br>granules<br>134.72mg<br>Amlodipine<br>Besilate<br>equivalent<br>to<br>Amlodipine USP 10mg |
1 Number |
1 |
Telmisartan Granules |
136.067 |
|
|
|
|
2 |
Amlodipine Besilate |
10.20 |
|
|
Telmisartan and Amlodipine Tablets<br>40/5mg Each uncoated tablets contains :<br>Telmisartan<br>40<br>mg<br>Telmisartan<br>40<br>mg<br>equivalent<br>to<br>Telmisartan<br>granules<br>67.36mg<br>Amlodipine<br>Besilate<br>equivalent<br>to<br>Amlodipine USP 5mg |
1 Number |
1 |
Telmisartan Granules |
68.034 |
|
|
|
|
2 |
Amlodipine Besilate |
5.10 |
|
|
Telmisartan and Amlodipine Tablets |
1 Number |
1 |
TelmisartanGranules |
136.067 |
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
24
80/5mg Each uncoated tablets contains : 2 Amlodipine Besilate 5.10 Telmisartan 80 mg Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to Amlodipine USP 5mg
| 30 |
Case No.:228/6/82-ALC4/2019 |
Party Name:AMI ORGANICS<br>PVT LTD. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00454/AM20/ |
RLA File<br>:52/24/040/00059/AM18/ |
Lic.No/Date:5210042473<br>01.01.2018 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Surat. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Surat.
| Case No.:250/6/82-ALC4/2019 |
|
Party Name:MELOG |
|
Meet No/Date:6/82- |
|
Status: |
|
|
SPECIALITY CHEMICALS |
|
ALC4/2019 |
|
Approved |
|
|
PVT. LTD. |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310818189 |
|
|
| :01/82/050/00476/AM20/ |
|
:03/95/040/00823/AM18/ |
|
03.01.2018 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 3/82-ALC4/2019 dated 05.07.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 31 per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| MR-3<br>(2,4,6-TRI<br>[(2,4-<br>DIHYDROXY<br>3<br>METHYL)<br>PHENYL]1,3,5-TRIAZINE |
1 kg |
1 |
2 METHYL RESORCINOL |
1.140 kg |
|
|
2 |
CYANURIC CHLORIDE |
0.479 kg |
|
|
3 |
SULFOLANE |
1.80 kg |
| Case No.:224/6/82-ALC4/2019 |
|
Party Name:SHREE GANESH |
|
Meet No/Date:6/82- |
|
Status: |
|
|
REMEDIES PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410043947 |
|
|
| :01/82/050/00450/AM20/ |
|
:34/24/040/00340/AM18/ |
|
09.03.2018 |
|
|
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 32 per details given below or as applied by the firm, whichever is less:
| Export product |
|
|
|
|
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
No. |
|
|
| Di<br>Methyl |
Amino |
<br>Propyl |
Chloride |
|
1 kg |
1 |
1-Bromo-3-Chloro Propane |
0.72 kg |
| Hydrochloride-65% |
|
solution |
in |
water |
|
|
|
|
| (DMPC 65%) |
|
|
|
|
|
|
|
|
25
| Case No.:198/6/82-ALC4/2019 |
|
Party Name:ARIHANTANAM |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIFECARE PVT. LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:5210042636 |
|
|
| :01/82/050/00424/AM20/ |
|
:52/24/040/00018/AM19/ |
|
09.05.2018 |
|
|
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. 15/82-ALC4/2018 33 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export product Qty. Sl. Import items Qty. No. ARTEMETHER 1 kg 1 ARTEMISININ 1.04 kg
| Case No.:200/6/82- |
|
Party Name:GULBRANDSEN |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
CHEMICALS PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410044185 |
|
|
| :01/82/050/00426/AM20/ |
|
:34/24/040/00366/AM18/ |
|
29.05.2018 |
|
|
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. 9/82-ALC4/2018 34 , dated 18.09.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| 30% DEZ in Toluene |
1 kg |
1 |
Aluminium Grit / Granules |
0.10 kg |
|
|
2 |
Zinc Chloride |
0.414 kg |
| Case No.:222/6/82- |
|
Party Name:NOCIL LIMITED |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310823440 |
|
|
| :01/82/050/00448/AM20/ |
|
:03/95/040/00482/AM19/ |
|
30.08.2018 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decisions taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019 and 5/AM20 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: 35
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| N-(Cyclohexylthio-)<br>phthalimide<br>Our<br>Brand<br>Name<br>:-<br>PILGARD PVI |
1 kg |
1 |
Phthalic Anyhdride (PAN) |
0.603 kg |
|
|
2 |
DICYCLOHEXYL DISULPHIDE (DCDS) |
0.486 kg |
|
|
3 |
CAUSTIC POTASH FLAKES (Potassium<br>Hydroxide) (KOH) |
0.233 kg |
26
|
Case No.:201/6/82-ALC4/2019 |
|
Party Name:DEEPAK NITRITE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
16.08.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:3410044637 |
|
|
|
:01/82/050/00427/AM20/ |
|
:34/24/040/00257/AM18/ |
|
25.10.2018 |
|
|
36 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.
| Case No.:202/6/82- |
|
Party Name:TIDE |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
INDUSTRIES |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410044740 |
|
|
| :01/82/050/00428/AM20/ |
|
:34/24/040/00276/AM19/ |
|
06.12.2018 |
|
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided 37 to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Aldehyde C-12 MNA |
1 kg |
1 |
C-11 Alcohol |
1.92 kg |
| Case No.:138/6/82-ALC4/2019 |
|
Party Name:KLJ |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PLASTICIZERS LIMITED. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510409721 |
|
|
| :01/82/050/00364/AM20/ |
|
:05/23/040/00513/AM19/ |
|
21.02.2019 |
|
|
38
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 8/82-ALC4/2018 meeting dated 31.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| KANATOL - 8080 |
1 kg |
1 |
TERE PHTHALIC ACID |
0.447 kg |
|
|
2 |
2-ETHYL HEXANOL |
0.740 kg |
|
|
3 |
HDPE GRANULES |
Relevant as per |
|
|
|
|
packing policy |
RA concerned may take further necessary action as per above decision of NC
27
| Case No.:195/6/82-ALC4/2019 |
|
Party Name:SUPRIYA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIFESCIENCE LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310827249 |
|
|
| :01/82/050/00421/AM20/ |
|
:03/95/040/01203/AM19/ |
|
22.02.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 39 by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| RACTOPAMINE Hcl |
1 kg |
1 |
OCTOPAMINE Hcl |
0.833 kg |
|
|
2 |
RASPBERRY KETONE |
0.700 kg |
|
|
3 |
PALLADIUM ON CHARCOAL 5% |
0.015 kg |
| 40 |
Case No.:136/6/82-ALC4/2019 |
Party Name:ENCUBE<br>ETHICALS PVT LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310827548<br>08.03.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00362/AM20/ |
RLA File<br>:03/94/040/01057/AM19/ |
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| Case No.:133/6/82-ALC4/2019 |
|
Party Name:ORIENTAL |
|
Meet No/Date:6/82- |
|
Status: |
|
|
AROMATICS LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310827769 |
|
Defer Date: |
| :01/82/050/00359/AM20/ |
|
:03/95/040/01320/AM19/ |
|
18.03.2019 |
|
|
41 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) Percentage wastage from crude to finished item.
| Case No.:135/6/82-ALC4/2019 |
|
Party Name:NEOGEN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CHEMICALS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310827841 |
|
|
| :01/82/050/00361/AM20/ |
|
:03/95/040/00745/AM16/ |
|
20.03.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 15/82-ALC4/2018 dated 22.03.2019, it was decided to ratify norms under Para 4.7 of 42 HBP v1 as per details given below or as applied by the firm, whichever is less:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
N-DECYL BROMIDE (1- |
1 kg |
1 |
DECYL ALCOHOL (1-DECANOL, N- |
0.794 kg |
|
Bromodecane) |
|
|
DECYL ALCOHOL) |
|
|
|
|
2 |
HYDROBROMIC ACID 48% |
0.848 kg |
|
|
|
|
|
|
| RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
28
| Case No.:132/6/82-ALC4/2019 |
|
Party Name:NEOGEN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CHEMICALS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310827961 |
|
|
| :01/82/050/00358/AM20/ |
|
:03/95/040/00907/AM15/ |
|
27.03.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 43 per details below or as applied by firm whichever is lower:
| Export product<br>6-BROMOHEXYLTRIMETHYL<br>AMMONIUM BROMIDE |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
1 kg |
1 |
1,6 HEXANDIOL |
1.233 kg |
|
|
2 |
HYDROBROMIC ACID 48% |
3.53 kg |
| 44 |
Case No.:172/6/82-ALC4/2019 |
Party Name:CARENOW<br>MEDICAL PVT LTD, |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00398/AM20/ |
RLA File<br>:32/24/040/00062/AM19/ |
Lic.No/Date:3210078903<br>01.04.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee considered the case as per agenda in the presence of technical<br>experts and it was decided to forward a copyof application to DIPP for obtainingits comments. |
|
|
|
Decision: New Case. The Committee considered the case as per agenda in the presence of technical experts and it was decided to forward a copy of application to DIPP for obtaining its comments.
29
| Case No.:191/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828058 |
|
|
| :01/82/050/00417/AM20/ |
|
:03/94/040/01149/AM19/ |
|
01.04.2019 |
|
|
|
Case No.:191/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00417/AM20/ |
RLA File<br>:03/94/040/01149/AM19/ |
Lic.No/Date:0310828058<br>01.04.2019 |
|
| 45 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated 14.01.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Quantity<br>allowed in<br>mg/tablet<br>Telmisartan and Amlodipine Tablets<br>40/10mg Each uncoated tablets<br>contains : Telmisartan 40 mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg/<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan Granules<br>68.034<br>2<br>Amlodipine Besilate<br>10.20<br>Telmisartan and Amlodipine Tablets<br>80/10mg Each uncoated tablets<br>contains : Telmisartan 80 mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg<br>1 Number<br>1<br>Telmisartan Granules<br>136.067<br>2<br>Amlodipine Besilate<br>10.20<br>Telmisartan and Amlodipine Tablets<br>40/5mg Each uncoated tablets<br>contains : Telmisartan 40 mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg<br>1 Number<br>1<br>Telmisartan Granules<br>68.034<br>2<br>Amlodipine Besilate<br>5.10<br>Telmisartan and Amlodipine Tablets<br>80/5mg Each uncoated tablets<br>contains : Telmisartan 80 mg<br>Telmisartan 80 mg equivalent to<br>Telmisartan granules 134.72mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP5mg<br>1 Number<br>1<br>Telmisartan Granules<br>136.067<br>2<br>Amlodipine Besilate<br>5.10<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
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. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
30
| 46 |
<br>Case No.:131/6/82-ALC4/2019 |
Party Name:MALWA<br>OXYGEN & INDUSTRIAL<br>GASES PVT.LTD., |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:5610005601<br>06.05.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00357/AM20/ |
RLA File<br>:56/24/040/00037/AM19/ |
|
|
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
| 47 |
<br>Case No.:134/6/82-ALC4/2019 |
Party Name:MALWA<br>OXYGEN & INDUSTRIAL<br>GASES PVT.LTD., |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:5610005600<br>06.05.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00360/AM20/ |
RLA File<br>:56/24/040/00002/AM20/ |
|
|
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
| 48 |
Case No.:194/6/82-ALC4/2019 |
Party Name:ETERNIS FINE<br>CHEMICALS LIMITED, |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310828815<br>07.05.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00420/AM20/ |
RLA File<br>:03/94/040/00023/AM20/ |
|
|
|
<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) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and %<br>ofyield at everystage. |
|
|
|
| Case No.:251/6/82- |
|
Party Name:INDO AMINES |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310828974 |
|
|
| :01/82/050/00477/AM20/ |
|
:03/94/040/00097/AM20/ |
|
13.05.2019 |
|
|
|
Case No.:251/6/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00477/AM20/ |
Party Name:INDO AMINES<br>LIMITED<br> <br> <br> |
Party Name:INDO AMINES<br>LIMITED<br> <br> <br> |
Party Name:INDO AMINES<br>LIMITED<br> <br> <br> |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310828974<br>13.05.2019 |
Status:<br>Approved |
|
|
RLA File<br>:03/94/040/00097/AM20/<br> <br> |
|
|
|
|
| 49 |
<br>**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. 13/82-ALC4/2018, dated 14.01.2019, it was decided<br>to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm<br>whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>COCO AMINE DISTILLED<br>(Purity 99.5%)<br>1 kg<br>1<br>COCO AMINE DISTILLED (PURITY<br>98%)<br>1.02 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
COCO AMINE DISTILLED<br>(Purity 99.5%) |
1 kg |
1 |
COCO AMINE DISTILLED (PURITY<br>98%) |
|
1.02 kg |
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
31
| Case No.:252/6/82-ALC4/2019 |
|
Party Name:SPC LIFE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
SCIENCES PVT. LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045166 |
|
|
| :01/82/050/00478/AM20/ |
|
:34/24/040/00053/AM20/ |
|
21.05.2019 |
|
|
|
Case No.:252/6/82-ALC4/2019 |
Party Name:SPC LIFE<br>SCIENCES PVT. LTD. |
Party Name:SPC LIFE<br>SCIENCES PVT. LTD. |
Party Name:SPC LIFE<br>SCIENCES PVT. LTD. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:3410045166<br>21.05.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00478/AM20/ |
RLA File<br>:34/24/040/00053/AM20/ |
|
|
|
|
| 50 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 3/82-ALC4/2019 dated 05.07.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CHLOROHEXAN-2-ONE<br>1 kg<br>1<br>1-BROMO-3-CHLOROPROPANE<br>CLEAR LIQUID<br>2.05 kg<br>2<br>METHYL ACETO ACETATE<br>CLEAR COLOURLESS TO LIGHT<br>YELLOW LIQUID<br>1.65 kg<br>3<br>SODIUM METHOXIDE<br>WHITE POWDER<br>1.25 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
<br>Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
CHLOROHEXAN-2-ONE |
1 kg |
1 |
1-BROMO-3-CHLOROPROPANE<br>CLEAR LIQUID |
|
2.05 kg |
|
|
|
2 |
METHYL ACETO ACETATE<br>CLEAR COLOURLESS TO LIGHT<br>YELLOW LIQUID |
|
1.65 kg |
|
|
|
3 |
SODIUM METHOXIDE<br>WHITE POWDER |
|
1.25 kg |
|
RA maytake appropriate action a |
sper the |
decision of Norms Committee. |
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 3/82-ALC4/2019 dated 05.07.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| 51 |
<br>Case No.:1/6/82-ALC4/2019<br> <br> <br> <br> <br>HQ File<br>:01/82/050/00227/AM20/<br> <br> |
Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br> <br> <br> <br>RLA File<br>:04/24/040/00048/AM20/<br> <br> |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
|
|
Lic.No/Date:0410165665<br>31.05.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Chennai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chennai.
| 52 |
<br>Case No.:2/6/82-ALC4/2019 |
Party Name:VISION DRUGS<br>PVT LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0910067615<br>31.05.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00228/AM20/ |
RLA File<br>:09/24/040/00093/AM20/ |
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
32
| Case No.:3/6/82-ALC4/2019 |
|
Party Name:OPTIMUS DRUGS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067616 |
|
|
| :01/82/050/00229/AM20/ |
|
:09/24/040/00104/AM20/ |
|
31.05.2019 |
|
|
-
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018
-
53 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| RIFAXIMIN Ph.Eur |
1kg |
1 |
RIFAMYCIN-O |
1.52 kg |
|
|
Case No.:4/6/82-ALC4/2019 |
|
Party Name:DIVIS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 54 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067620 |
|
Defer Date: |
|
|
:01/82/050/00230/AM20/ |
|
:09/24/040/00101/AM20/ |
|
31.05.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
| Case No.:5/6/82-ALC4/2019 |
|
Party Name:DIVIS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067621 |
|
|
| :01/82/050/00231/AM20/ |
|
:09/24/040/00100/AM20/ |
|
31.05.2019 |
|
|
|
|
Case No.:5/6/82-ALC4/2019Party Name:DIVIS<br>LABORATORIES LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>HQ File<br>:01/82/050/00231/AM20/<br>RLA File<br>:09/24/040/00100/AM20/<br>Lic.No/Date:0910067621<br>31.05.2019 |
Case No.:5/6/82-ALC4/2019Party Name:DIVIS<br>LABORATORIES LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>HQ File<br>:01/82/050/00231/AM20/<br>RLA File<br>:09/24/040/00100/AM20/<br>Lic.No/Date:0910067621<br>31.05.2019 |
Case No.:5/6/82-ALC4/2019Party Name:DIVIS<br>LABORATORIES LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>HQ File<br>:01/82/050/00231/AM20/<br>RLA File<br>:09/24/040/00100/AM20/<br>Lic.No/Date:0910067621<br>31.05.2019 |
Status:<br>Approved<br> |
Status:<br>Approved<br> |
Status:<br>Approved<br> |
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier |
|
|
decision taken in |
|
|
|
|
meeting no. 10/82-ALC4/2018 dated 16.10.2018, it was decided to ratify norms under Para |
|
|
4.7 of HBP v1 as |
|
|
|
|
per details given below or as applied by the firm, whichever is less: |
|
|
|
|
|
| 55 |
|
Export product<br>Qty. |
Sl. |
Import items |
|
Qty. |
|
|
|
|
No. |
|
|
|
|
|
|
B-WING (L-VALINE CYCLIC<br>1 kg |
1 |
L-VALINE |
|
1.837 kg |
|
|
|
UREA) |
2 |
METHYL CHLORO FORMATE |
|
2.25 kg |
|
|
|
|
3 |
ACRYLONITRILE |
|
0.95 kg |
|
|
|
|
4 |
CAUSTIC POTASH FLAKES |
|
4.055 kg |
|
|
|
|
5 |
METHYLENE CHLORIDE |
|
2.25 kg |
|
|
|
|
6 |
ISO PROPYL ALCOHOL |
|
0.92 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. 10/82-ALC4/2018 dated 16.10.2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
33
| Case No.:6/6/82-ALC4/2019 |
|
Party Name:BIOLOGICAL E |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067622 |
|
|
| :01/82/050/00232/AM20/ |
|
:09/24/040/00102/AM20/ |
|
03.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and 56 it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
|
DAPTOMYCIN FOR INJCTION<br>500 MG PER VIAL |
1 Number |
1 |
DAPTOMYCIN |
550 mg / 5 ml<br>vial |
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
| 57 |
Case No.:7/6/82-ALC4/2019 |
Party Name:BIOLOGICAL E<br>LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00233/AM20/ |
RLA File<br>:09/24/040/00062/AM20/ |
Lic.No/Date:0910067623<br>03.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee considered the case as per agenda in the presence of technical<br>experts and it was decided to forward a copyof application to DBT for obtainingits comments. |
|
|
|
Decision: New Case. The Committee considered the case as per agenda in the presence of technical experts and it was decided to forward a copy of application to DBT for obtaining its comments.
| Case No.:8/6/82-ALC4/2019 |
|
Party Name:PANACEA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
BIOTEC LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510410795 |
|
|
| :01/82/050/00234/AM20/ |
|
:05/24/040/00130/AM20/ |
|
03.06.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 58
| Exportproduct |
|
Qty. |
Sl. No. |
Import items |
Qty. |
| ALPHADOL |
CAPSULES |
3000000 Number |
1 |
ALFACALCIDOL |
1.050 gram |
| (EACH<br>SOFT |
GELATIN |
|
|
|
|
| CAPSULE |
CONTAINS: |
|
|
|
|
| ALFACALCIDOL |
0.25 MCG) |
|
|
|
|
The Committee allowed the above norms on one time basis and no repeat norms is allowed. RA concerned may take further necessary action as per above decision of NC.
| 59 |
Case No.:9/6/82-ALC4/2019 |
Party Name:RAJASTHAN<br>ANTIBIOTICS LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00235/AM20/ |
RLA File<br>:05/24/040/00108/AM20/ |
Lic.No/Date:0510410798<br>03.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhi. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
34
|
|
Case No.:10/6/82-ALC4/2019 |
|
Party Name:ADCOCK |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
INGRAM LTD, |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 60 |
|
HQ File<br>:01/82/050/00236/AM20/ |
|
RLA File<br>:07/24/040/00039/AM20/ |
|
Lic.No/Date:0710115001<br>03.06.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Bangalore. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
| Case No.:11/6/82-ALC4/2019 |
|
Party Name:NECTAR |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIFESCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2210016174 |
|
|
| :01/82/050/00237/AM20/ |
|
:22/24/040/00017/AM20/ |
|
03.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 61 by firm whichever is lower:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Cefazolin Sodium Sterile |
1 kg |
1 |
Cefazolin Acid |
0.989 kg |
|
|
|
2 |
Acetone |
0.515 kg |
|
|
|
3 |
Activated Carbon |
0.020 kg |
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
| Case No.:12/6/82-ALC4/2019 |
|
Party Name:BALAJI AMINES |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067438 |
|
|
| :01/82/050/00238/AM20/ |
|
:31/83/040/00040/AM20/ |
|
03.06.2019 |
|
|
|
|
Case No.:12/6/82-ALC4/2019Party Name:BALAJI AMINES<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00238/AM20/<br>RLA File<br>:31/83/040/00040/AM20/<br>Lic.No/Date:3110067438<br>03.06.2019 |
Case No.:12/6/82-ALC4/2019Party Name:BALAJI AMINES<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00238/AM20/<br>RLA File<br>:31/83/040/00040/AM20/<br>Lic.No/Date:3110067438<br>03.06.2019 |
Case No.:12/6/82-ALC4/2019Party Name:BALAJI AMINES<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00238/AM20/<br>RLA File<br>:31/83/040/00040/AM20/<br>Lic.No/Date:3110067438<br>03.06.2019 |
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
|
|
|
|
meeting no. 12/82-ALC4/2018 dated 12.12..2018, it was decided to ratify norms under Para 4.7 of HBP v1 |
|
|
| 62 |
|
as per details given below or as applied by the firm, whichever is less: |
|
|
|
|
Export Product<br>Qty.<br>Sl.<br>Import Items |
Qty. |
|
|
|
No |
|
|
|
|
GAMMA BUTYROLACTONE<br>1 kg<br>1.<br>1,4 BUTANEDIOL |
1.16 kg |
|
|
|
2.<br>GBL CATAYLYST |
0.001 kg |
|
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
35
| Case No.:13/6/82-ALC4/2019 |
|
Party Name:ALEMBIC |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045187 |
|
|
| :01/82/050/00239/AM20/ |
|
:34/24/040/00081/AM20/ |
|
04.06.2019 |
|
|
|
|
Case No.:13/6/82-ALC4/2019Party Name:ALEMBIC<br>PHARMACEUTICALS LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00239/AM20/<br>RLA File<br>:34/24/040/00081/AM20/<br>Lic.No/Date:3410045187<br>04.06.2019 |
Case No.:13/6/82-ALC4/2019Party Name:ALEMBIC<br>PHARMACEUTICALS LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00239/AM20/<br>RLA File<br>:34/24/040/00081/AM20/<br>Lic.No/Date:3410045187<br>04.06.2019 |
Case No.:13/6/82-ALC4/2019Party Name:ALEMBIC<br>PHARMACEUTICALS LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00239/AM20/<br>RLA File<br>:34/24/040/00081/AM20/<br>Lic.No/Date:3410045187<br>04.06.2019 |
Case No.:13/6/82-ALC4/2019Party Name:ALEMBIC<br>PHARMACEUTICALS LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00239/AM20/<br>RLA File<br>:34/24/040/00081/AM20/<br>Lic.No/Date:3410045187<br>04.06.2019 |
Case No.:13/6/82-ALC4/2019Party Name:ALEMBIC<br>PHARMACEUTICALS LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00239/AM20/<br>RLA File<br>:34/24/040/00081/AM20/<br>Lic.No/Date:3410045187<br>04.06.2019 |
Case No.:13/6/82-ALC4/2019Party Name:ALEMBIC<br>PHARMACEUTICALS LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00239/AM20/<br>RLA File<br>:34/24/040/00081/AM20/<br>Lic.No/Date:3410045187<br>04.06.2019 |
Case No.:13/6/82-ALC4/2019Party Name:ALEMBIC<br>PHARMACEUTICALS LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00239/AM20/<br>RLA File<br>:34/24/040/00081/AM20/<br>Lic.No/Date:3410045187<br>04.06.2019 |
|
|
**Decision:**The Committee considered case as per agenda and as per earlier decision taken by NC in its |
|
|
|
|
|
|
|
|
13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under |
|
|
|
|
|
|
|
|
para 4.7 of HBP as per details below or as applied by |
|
|
firm whichever is lower:- |
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
| 63 |
|
|
|
|
No. |
|
|
|
|
|
|
Temazepam Caps Usp 7.5 mg (net |
1 Number |
1 |
Temazepam USP |
7.65 mg /7.5 mg tablet |
|
|
|
|
content of active ingredients = 5.625 |
|
|
|
|
|
|
|
|
kgs) |
|
|
|
|
|
|
|
|
Temazepam Caps Usp 15 mg (net |
1 Number |
2 |
Temazepam USP |
15.30 mg /15 mg tablet |
|
|
|
|
content of active ingredients = 180 |
|
|
|
|
|
|
|
|
kgs) |
|
|
|
|
|
|
|
|
Temazepam Caps Usp 30 mg (net |
1 Number |
3 |
Temazepam USP |
30.6 mg /30 mg tablet |
|
|
|
|
content of active ingredients = 468 |
|
|
|
|
|
|
|
|
kgs) |
|
|
|
|
|
|
|
RA concerned maytake further necessaryaction asper above decision of NC |
|
|
|
|
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
|
|
Case No.:14/6/82-ALC4/2019 |
|
Party Name:GLENMARK LIFE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 64 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310829437 |
|
Defer Date: |
|
|
:01/82/050/00240/AM20/ |
|
:03/94/040/00176/AM20/ |
|
06.06.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
| Case No.:15/6/82-ALC4/2019 |
|
Party Name:GLENMARK LIFE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829438 |
|
|
| :01/82/050/00241/AM20/ |
|
:03/94/040/00177/AM20/ |
|
06.06.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 65 meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
| VILDAGLIPTIN |
1 kg |
1 |
3-Amino-1-adamantanol |
36
| Case No.:16/6/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829440 |
|
|
| :01/82/050/00242/AM20/ |
|
:03/94/040/00178/AM20/ |
|
06.06.2019 |
|
|
|
Case No.:16/6/82-ALC4/2019 |
Case No.:16/6/82-ALC4/2019 |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00242/AM20/ |
|
RLA File<br>:03/94/040/00178/AM20/ |
|
Lic.No/Date:0310829440<br>06.06.2019 |
|
|
|
| 66 |
**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output norm<br>by firm whichever is lower: |
|
|
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>Qty.<br>Import items<br>Qty.<br>80000.000 Pack<br>Alclometasone<br>Dipropionate USP<br>5.317 kg<br>50000.000 Pack<br>40000.000 Pack<br>50000.000 Pack<br>45000.000 Pack<br>30000.000 Pack<br>sper above decision of NC. |
|
|
|
|
|
Sl.<br>No. |
Export product |
|
Qty. |
|
Import items |
|
Qty. |
|
1 |
Alclometasone<br>Dipropionate<br>USP<br>Cream<br>0.05%<br>15gm<br>( Pack Size 15gm) |
|
80000.000 Pack |
|
Alclometasone<br>Dipropionate USP |
|
5.317 kg |
|
2 |
Alclometasone<br>Dipropionate<br>USP<br>Cream 0.05% 45gm ( Pack Size 45gm) |
|
50000.000 Pack |
|
|
|
|
|
3 |
Alclometasone<br>Dipropionate<br>USP<br>Cream 0.05% 60gm ( Pack Size 60gm) |
|
40000.000 Pack |
|
|
|
|
|
4 |
Alclometasone Dipropionate Ointment<br>0.05% 15gm ( Pack Size 15gm) |
|
50000.000 Pack |
|
|
|
|
|
5 |
Alclometasone Dipropionate Ointment<br>0.05% 45gm ( Pack Size 45gm) |
|
45000.000 Pack |
|
|
|
|
|
6 |
Alclometasone Dipropionate Ointment<br>0.05% 60gm ( Pack Size 60gm) |
|
30000.000 Pack |
|
|
|
|
|
RA concerned maytake further necessaryaction a |
|
|
sper 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:
37
| Case No.:17/6/82-ALC4/2019 |
|
Party Name:AARTI DRUGS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829443 |
|
|
| :01/82/050/00243/AM20/ |
|
:03/94/040/00036/AM20/ |
|
06.06.2019 |
|
|
|
|
Case No.:17/6/82-ALC4/2019Party Name:AARTI DRUGS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00243/AM20/<br>RLA File<br>:03/94/040/00036/AM20/<br>Lic.No/Date:0310829443<br>06.06.2019 |
Case No.:17/6/82-ALC4/2019Party Name:AARTI DRUGS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00243/AM20/<br>RLA File<br>:03/94/040/00036/AM20/<br>Lic.No/Date:0310829443<br>06.06.2019 |
Case No.:17/6/82-ALC4/2019Party Name:AARTI DRUGS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00243/AM20/<br>RLA File<br>:03/94/040/00036/AM20/<br>Lic.No/Date:0310829443<br>06.06.2019 |
Case No.:17/6/82-ALC4/2019Party Name:AARTI DRUGS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00243/AM20/<br>RLA File<br>:03/94/040/00036/AM20/<br>Lic.No/Date:0310829443<br>06.06.2019 |
Case No.:17/6/82-ALC4/2019Party Name:AARTI DRUGS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00243/AM20/<br>RLA File<br>:03/94/040/00036/AM20/<br>Lic.No/Date:0310829443<br>06.06.2019 |
Case No.:17/6/82-ALC4/2019Party Name:AARTI DRUGS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00243/AM20/<br>RLA File<br>:03/94/040/00036/AM20/<br>Lic.No/Date:0310829443<br>06.06.2019 |
Case No.:17/6/82-ALC4/2019Party Name:AARTI DRUGS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00243/AM20/<br>RLA File<br>:03/94/040/00036/AM20/<br>Lic.No/Date:0310829443<br>06.06.2019 |
|
|
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in |
|
|
|
|
|
|
|
|
meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as |
|
|
|
|
|
|
|
|
per details given below or as applied |
|
|
by the firm, whichever is less: |
|
|
|
|
|
|
Exportproduct |
Qty. |
Sl. No. |
Import items |
Qty. |
|
| 67 |
|
|
Diclofenac Sodium |
1 kg |
1.<br>2. |
Acetic Acid<br>Methanol |
1.25 kg<br>1.00 kg |
|
|
|
|
|
|
3. |
2,6 Dichlorophenol |
1.521 kg |
|
|
|
|
|
|
4. |
Toluene |
1.995 kg |
|
|
|
|
|
|
5. |
Potassium Carbonate |
1.00 kg |
|
|
|
|
|
|
6. |
Aniline |
1.198 kg |
|
|
|
|
|
|
7. |
Sodium Methoxide |
0.795 kg |
|
|
|
|
|
|
8. |
Sodium Hydroxide Flakes |
0.285 kg |
|
|
|
|
|
|
9. |
Isopropyl Alcohol |
2.040 kg |
|
|
|
|
|
|
10. |
Dimethyl Formamide |
0.469 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. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
|
|
Case No.:18/6/82-ALC4/2019 |
|
Party Name:SMILAX |
|
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
LABORATORIES LIMITED |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
16.08.2019 |
|
|
| 68 |
|
HQ File<br>:01/82/050/00244/AM20/ |
|
RLA File<br>:09/24/040/00103/AM20/ |
|
|
Lic.No/Date:0910067628<br>06.06.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Hyderabad. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
|
|
Case No.:19/6/82-ALC4/2019 |
|
Party Name:S V LABS PVT |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 69 |
|
HQ File<br>:01/82/050/00245/AM20/ |
|
RLA File<br>:09/24/040/00086/AM20/ |
|
Lic.No/Date:0910067629<br>06.06.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Hyderabad. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
38
| Case No.:20/6/82-ALC4/2019 |
|
Party Name:SHREE JAYA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES PVT LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067630 |
|
|
| :01/82/050/00246/AM20/ |
|
:09/24/040/00096/AM20/ |
|
06.06.2019 |
|
|
|
Case No.:20/6/82-ALC4/2019 |
Case No.:20/6/82-ALC4/2019 |
Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. |
Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. |
Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00246/AM20/ |
|
RLA File<br>:09/24/040/00096/AM20/ |
|
|
Lic.No/Date:0910067630<br>06.06.2019 |
|
|
| 70 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts and<br>it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>5-DIFLUOROMETHOXY-<br>2MERCAPTO-1H-<br>BENZIMIDAZOLE<br>1 kg<br>1<br>ACETONITRIL<br>0.17 kg<br>2<br>CHLOROFORM<br>0.18 kg<br>3<br>SODA ASH<br>3.03 kg<br>4<br>PARACETMOL<br>1.435 kg<br>5<br>CARBON DI SULFIDE<br>0.70 kg<br>6<br>FREON GAS<br>0.715 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
5-DIFLUOROMETHOXY-<br>2MERCAPTO-1H-<br>BENZIMIDAZOLE |
1 kg |
1 |
ACETONITRIL |
|
0.17 kg |
|
|
|
|
|
2 |
CHLOROFORM |
|
0.18 kg |
|
|
|
|
|
3 |
SODA ASH |
|
3.03 kg |
|
|
|
|
|
4 |
PARACETMOL |
|
1.435 kg |
|
|
|
|
|
5 |
CARBON DI SULFIDE |
|
0.70 kg |
|
|
|
|
|
6 |
FREON GAS |
|
0.715 kg |
|
|
|
|
sper the decision of Norms Committee |
|
|
|
|
|
| Case No.:21/6/82-ALC4/2019 |
|
Party Name:SHREE JAYA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES PVT LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067631 |
|
|
| :01/82/050/00247/AM20/ |
|
:09/24/040/00097/AM20/ |
|
06.06.2019 |
|
|
|
Case No.:21/6/82-ALC4/2019 |
Case No.:21/6/82-ALC4/2019 |
Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. |
Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. |
Party Name:SHREE JAYA<br>LABORATORIES PVT LTD. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00247/AM20/ |
|
RLA File<br>:09/24/040/00097/AM20/ |
|
|
Lic.No/Date:0910067631<br>06.06.2019 |
|
|
| 71 |
<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>2-HYDROXY METHYL-<br>3,5-DIMETHYL 4-<br>METHOXY PYRIDINE<br>HYDROCHLORIDE<br>1 kg<br>1<br>3,5 LUTIDINE<br>1.04 kg<br>2<br>CHLOROFORM<br>3.20 kg<br>3<br>METHYLENE DICHLORIDE<br>2.00 kg<br>4<br>AMMONIUM PER SULPHATE<br>1.80 kg<br>5<br>ISO PROPYL ALCOHOL<br>1.00 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
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. |
|
|
|
2-HYDROXY METHYL-<br>3,5-DIMETHYL 4-<br>METHOXY PYRIDINE<br>HYDROCHLORIDE |
1 kg |
1 |
3,5 LUTIDINE |
|
1.04 kg |
|
|
|
|
|
2 |
CHLOROFORM |
|
3.20 kg |
|
|
|
|
|
3 |
METHYLENE DICHLORIDE |
|
2.00 kg |
|
|
|
|
|
4 |
AMMONIUM PER SULPHATE |
|
1.80 kg |
|
|
|
|
|
5 |
ISO PROPYL ALCOHOL |
|
1.00 kg |
|
|
|
|
sper the decision of Norms Committee |
|
|
|
|
|
39
| Case No.:22/6/82-ALC4/2019 |
|
Party Name:AARTI DRUGS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829454 |
|
|
| :01/82/050/00248/AM20/ |
|
:03/94/040/00937/AM19/ |
|
06.06.2019 |
|
|
|
Case No.:22/6/82-ALC4/2019 |
Party Name:AARTI DRUGS<br>LIMITED<br>RLA File<br>:03/94/040/00937/AM19/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310829454<br>06.06.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00248/AM20/ |
|
|
|
| 72 |
<br>**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in<br>meeting no. 3/82-ALC4/2019 dated 05.07.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Ciprofloxacin Hydrochloride 1 kg<br>1<br>Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-5 Fluorobenzoyl) Acrylate<br>1.294 kg<br>2<br>Caustic Soda Flakes<br>0.35 kg<br>3<br>Toluene<br>0.123 kg<br>4<br>Anhydrous Piperazine<br>0.39 kg<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 3/82-ALC4/2019 dated 05.07.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| 73 |
Case No.:23/6/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00015/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310829466<br>07.06.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00249/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 74 |
Case No.:24/6/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00250/AM20/ |
RLA File<br>:03/95/040/00021/AM20/ |
Lic.No/Date:0310829479<br>07.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 75 |
<br>Case No.:25/6/82-ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00251/AM20/ |
RLA File<br>:09/24/040/00098/AM20/ |
Lic.No/Date:0910067641<br>07.06.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
40
| Case No.:26/6/82-ALC4/2019 |
|
Party Name:MSN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067642 |
|
|
| :01/82/050/00252/AM20/ |
|
:09/24/040/00113/AM20/ |
|
07.06.2019 |
|
|
-
Decision: The Committee considered case as per agenda in the presence of the technical experts and it
-
76 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. |
Sl. No. |
Import items |
Qty. |
| Exemestane Tablets 25 mg |
1 Number |
1 |
EXEMESTANE |
25.50 mg/ 25 mgtablet |
|
|
Case No.:27/6/82-ALC4/2019 |
|
Party Name:AARTI DRUGS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 77 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310829511 |
|
Defer Date: |
|
|
:01/82/050/00253/AM20/ |
|
:03/94/040/01134/AM19/ |
|
10.06.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:28/6/82-ALC4/2019 |
|
Party Name:O C |
|
Meet No/Date:6/82- |
|
Status: |
|
|
SPECIALITIES PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829526 |
|
|
| :01/82/050/00254/AM20/ |
|
:03/95/040/00227/AM20/ |
|
10.06.2019 |
|
|
|
|
Case No.:28/6/82-ALC4/2019Party Name:O C<br>SPECIALITIES PVT.LTD.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00254/AM20/<br>RLA File<br>:03/95/040/00227/AM20/<br>Lic.No/Date:0310829526<br>10.06.2019 |
Case No.:28/6/82-ALC4/2019Party Name:O C<br>SPECIALITIES PVT.LTD.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00254/AM20/<br>RLA File<br>:03/95/040/00227/AM20/<br>Lic.No/Date:0310829526<br>10.06.2019 |
Case No.:28/6/82-ALC4/2019Party Name:O C<br>SPECIALITIES PVT.LTD.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00254/AM20/<br>RLA File<br>:03/95/040/00227/AM20/<br>Lic.No/Date:0310829526<br>10.06.2019 |
Case No.:28/6/82-ALC4/2019Party Name:O C<br>SPECIALITIES PVT.LTD.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00254/AM20/<br>RLA File<br>:03/95/040/00227/AM20/<br>Lic.No/Date:0310829526<br>10.06.2019 |
Case No.:28/6/82-ALC4/2019Party Name:O C<br>SPECIALITIES PVT.LTD.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00254/AM20/<br>RLA File<br>:03/95/040/00227/AM20/<br>Lic.No/Date:0310829526<br>10.06.2019 |
Case No.:28/6/82-ALC4/2019Party Name:O C<br>SPECIALITIES PVT.LTD.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00254/AM20/<br>RLA File<br>:03/95/040/00227/AM20/<br>Lic.No/Date:0310829526<br>10.06.2019 |
Case No.:28/6/82-ALC4/2019Party Name:O C<br>SPECIALITIES PVT.LTD.<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00254/AM20/<br>RLA File<br>:03/95/040/00227/AM20/<br>Lic.No/Date:0310829526<br>10.06.2019 |
|
|
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it |
|
|
|
|
|
|
|
|
was decided to ratify the |
|
ad-hoc input output norms under para 4.7 of HBP as per details below or as applied |
|
|
|
|
|
|
by firm whichever is lower: |
|
|
|
|
|
|
| 78 |
|
|
|
|
|
|
|
|
|
|
|
Exportproduct |
Qty. |
Sl. No. |
Import items |
Qty. |
|
|
|
|
2,3 DICHLORO |
1 kg |
1 |
3 AMINO PYRIDINE |
1.00 kg |
|
|
|
|
PYRIDINE |
|
2 |
HYDROGEN PEROXIDE |
0.637 kg |
|
|
|
|
|
|
|
(50 % CONCENTRATION) |
|
|
|
|
|
|
|
3 |
SODIUM NITRITE |
0.687 kg |
|
|
|
|
|
|
4 |
CAUSTIC SODA LYE (SODIUM HYDOXIDE |
6.33 kg |
|
|
|
|
|
|
|
LYE) |
|
|
|
|
RA concerned maytake |
|
further necessaryaction asper above decision of NC. |
|
|
|
|
41
Case No.:29/6/82-ALC4/2019 Party Name:ONEIRO Meet No/Date:6/82- Status: CHEMICALS PVT LTD ALC4/2019 Approved 16.08.2019 HQ File RLA File Lic.No/Date:3410045199 :01/82/050/00255/AM20/ :34/24/040/00082/AM20/ 10.06.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 79 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 4,5,6,7-TETRAHYDRO THIENO<br>(3,2,C)<br>PYRIDINE<br>HYDROCHLORIDE |
1 kg |
1 |
Thiophene 2 Ethylamine |
0.87 kg |
|
|
2 |
Methanol |
1.49 kg |
|
|
3 |
Methyene Chloride |
0.79 kg |
| 80 |
Case No.:30/6/82-ALC4/2019 |
Party Name:TIDE<br>INDUSTRIES |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00256/AM20/ |
RLA File<br>:34/24/040/00083/AM20/ |
Lic.No/Date:3410045200<br>10.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Vadodara. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
| 81 |
Case No.:31/6/82-ALC4/2019 |
Party Name:GITANJALI<br>CHEMICALS PVT LTD<br>RLA File<br>:03/94/040/01070/AM19/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310829535<br>11.06.2019<br> |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00257/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
42
| Case No.:32/6/82-ALC4/2019 |
|
Party Name:GLAND PHARMA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067648 |
|
|
| :01/82/050/00258/AM20/ |
|
:09/24/040/00111/AM20/ |
|
11.06.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
82
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Tigecycline Powder for |
396826 |
1 |
Tigecycline |
21.82 kg |
|
Solution for |
Number |
2 |
Glass Vials |
Relevant |
|
Infusion,(Lyophilized) |
|
3 |
Rubber Stoppers |
as per |
|
50mg/vial, 5ml Vial |
|
4 |
Flip off Seals |
Packing |
|
|
|
|
|
Policy |
| 83 |
<br>Case No.:36/6/82-ALC4/2019 |
Party Name:NOVEL<br>NUTRIENTS PVT LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00262/AM20/ |
RLA File<br>:07/24/040/00056/AM20/ |
Lic.No/Date:0710115041<br>11.06.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 84 |
<br>Case No.:33/6/82-ALC4/2019 |
Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD.<br>RLA File<br>:03/94/040/00197/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310829569<br>12.06.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00259/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 85 |
Case No.:34/6/82-ALC4/2019 |
Party Name:DIPS<br>BIOSCIENCE PVT.LTD. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00260/AM20/ |
RLA File<br>:03/94/040/00199/AM20/ |
Lic.No/Date:0310829573<br>12.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
43
| 86 |
Case No.:35/6/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00225/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310829588<br>12.06.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00261/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:37/6/82-ALC4/2019 |
|
Party Name:CLEAN SCIENCE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
AND TECHNOLOGY |
|
ALC4/2019 |
|
Approved |
|
|
PVT.LTD. |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067445 |
|
|
| :01/82/050/00263/AM20/ |
|
:31/83/040/00042/AM20/ |
|
12.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 87 by firm whichever is lower:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Guaiacol |
1 kg |
1 |
Phenol |
1.012 kg |
|
|
|
2 |
Methanol |
0.39 kg |
|
|
|
3 |
Hydrogen Peroxide PURITY 60% |
0.687 kg |
|
|
|
4 |
Acetone(Solvent) |
0.14 kg |
| RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
| 88 |
Case No.:38/6/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00223/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310829590<br>12.06.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00264/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 89 |
Case No.:39/6/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00222/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310829591<br>12.06.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00265/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
44
| 90 |
Case No.:40/6/82-ALC4/2019 |
Party Name:NECTAR<br>LIFESCIENCES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00266/AM20/ |
RLA File<br>:22/24/040/00101/AM19/ |
Lic.No/Date:2210016183<br>12.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 91 |
Case No.:41/6/82-ALC4/2019 |
Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00267/AM20/ |
RLA File<br>:09/24/040/00107/AM20/ |
Lic.No/Date:0910067652<br>12.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
Case No.:43/6/82-ALC4/2019 Party Name:SARACA Meet No/Date:6/82- Status: LABORATORIES LTD ALC4/2019 Approved 16.08.2019 HQ File RLA File Lic.No/Date:0910067656 :01/82/050/00269/AM20/ :09/24/040/00117/AM20/ 12.06.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 92 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import Items |
Qty. |
| GABAPENTIN |
1 kg |
1 |
1,1 CYCLOHEXANE DI ACETIC ACID<br>MONOAMIDE (CAM) |
1.630 kg |
45
| Case No.:46/6/82-ALC4/2019 |
|
Party Name:PI INDUSTRIES |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:1310049313 |
|
|
| :01/82/050/00272/AM20/ |
|
:13/24/040/00151/AM20/ |
|
12.06.2019 |
|
|
|
|
Case No.:46/6/82-ALC4/2019Party Name:PI INDUSTRIES<br>LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00272/AM20/<br>RLA File<br>:13/24/040/00151/AM20/<br>Lic.No/Date:1310049313<br>12.06.2019 |
Case No.:46/6/82-ALC4/2019Party Name:PI INDUSTRIES<br>LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00272/AM20/<br>RLA File<br>:13/24/040/00151/AM20/<br>Lic.No/Date:1310049313<br>12.06.2019 |
Case No.:46/6/82-ALC4/2019Party Name:PI INDUSTRIES<br>LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00272/AM20/<br>RLA File<br>:13/24/040/00151/AM20/<br>Lic.No/Date:1310049313<br>12.06.2019 |
Case No.:46/6/82-ALC4/2019Party Name:PI INDUSTRIES<br>LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00272/AM20/<br>RLA File<br>:13/24/040/00151/AM20/<br>Lic.No/Date:1310049313<br>12.06.2019 |
Case No.:46/6/82-ALC4/2019Party Name:PI INDUSTRIES<br>LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00272/AM20/<br>RLA File<br>:13/24/040/00151/AM20/<br>Lic.No/Date:1310049313<br>12.06.2019 |
Case No.:46/6/82-ALC4/2019Party Name:PI INDUSTRIES<br>LTD<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00272/AM20/<br>RLA File<br>:13/24/040/00151/AM20/<br>Lic.No/Date:1310049313<br>12.06.2019 |
|
|
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts and |
|
|
|
|
|
|
|
it |
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
| 93 |
|
|
|
|
No. |
|
|
|
|
|
HYPE Chemical Name: Methyl |
1 kg |
1 |
3-Chloro-2-Hydrazinopyridine |
0.670 kg |
|
|
|
1-(3-chloropyridin-2-yl)-3- |
|
|
|
|
|
|
|
hydroxymethyl-1H-pyrazole-5- |
|
2 |
2-methyl-5-ethyl pyridine |
0.0224 kg |
|
|
|
carboxylate |
|
3 |
Epichlorohydrin |
0.545 kg |
|
|
|
|
|
4 |
Methyl oxalyl chloride |
0.672 kg |
|
|
|
|
|
5 |
Tetrahydrofurfuryl alcohol |
0.320 kg |
|
|
RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
| Case No.:47/6/82-ALC4/2019 |
|
Party Name:PI INDUSTRIES |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:1310049314 |
|
|
| :01/82/050/00273/AM20/ |
|
:13/24/040/00150/AM20/ |
|
12.06.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 94 by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| 2-methyl-1-methylthio-2-<br>propanamine (SAA) |
1 kg |
1 |
2-Amino-2-Methyl-1-Propanol (AMP) |
0.865 kg |
46
| Case No.:48/6/82-ALC4/2019 |
|
Party Name:PI INDUSTRIES |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:1310049315 |
|
|
| :01/82/050/00274/AM20/ |
|
:13/24/040/00149/AM20/ |
|
12.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 95 by firm whichever is lower:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| 2-CYANIMINO 1,3<br>THIAZOLIDIN (CIT) |
1 kg |
1 |
Cysteamine Hydrochloride 95% Min |
1.04 kg |
|
|
2 |
Dimethyl N-Cyanodithioimino<br>Carbonate (CCITM) |
1.28 kg |
RA may take appropriate action as per the decision of Norms Committee
| Case No.:193/6/82-ALC4/2019 |
|
Party Name:ALKYL AMINES |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CHEMICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829582 |
|
|
| :01/82/050/00419/AM20/ |
|
:03/94/040/00001/AM20/ |
|
12.06.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in 96 meeting no. 12/82-ALC4/2018 dated 12.12..2018, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Export product<br>2ETHYLHEXYLAMINE |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
1 kg |
1 |
2ETHYLHEXANOL |
1.011 kg |
| 97 |
<br>Case No.:44/6/82-ALC4/2019 |
Party Name:DIVIS<br>LABORATORIES LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00270/AM20/ |
RLA File<br>:09/24/040/00118/AM20/ |
Lic.No/Date:0910067663<br>13.06.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 98 |
Case No.:45/6/82-ALC4/2019 |
Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0910067664<br>13.06.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00271/AM20/ |
RLA File<br>:09/24/040/00114/AM20/ |
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
47
| Case No.:58/6/82-ALC4/2019 |
|
Party Name:WINDLAS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
HEALTH CARE PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:6110001597 |
|
|
| :01/82/050/00284/AM20/ |
|
:61/24/040/00001/AM20/ |
|
13.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 99 by firm whichever is lower:
| Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 1 Number |
1 |
PIROXICAM |
10.2 mg / 10<br>mg capsule |
| 1 Number |
1 |
PIROXICAM |
20.4 mg / 20<br>mg capsule |
| Case No.:59/6/82-ALC4/2019 |
|
Party Name:WINDLAS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
HEALTH CARE PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:6110001598 |
|
|
| :01/82/050/00285/AM20/ |
|
:61/24/040/00002/AM20/ |
|
13.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it 100 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
|
Acyclovir Capsules 200 mg |
1 Number |
1 |
Acyclovir |
204 mg / 200 |
|
Anti Viral Drug |
|
|
|
mg capsule |
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
| 101 |
Case No.:42/6/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00268/AM20/ |
RLA File<br>:03/95/040/00110/AM20/ |
Lic.No/Date:0310829637<br>14.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 102 |
Case No.:49/6/82-ALC4/2019 |
Party Name:DHANUKA<br>LABORATORIES LTD<br> <br> <br> <br>RLA File<br>:05/23/040/00104/AM20/<br> <br> |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0510410949<br>14.06.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00275/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhi. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
48
|
|
Case No.:50/6/82-ALC4/2019 |
|
Party Name:VISION DRUGS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 103 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067669 |
|
Defer Date: |
|
|
:01/82/050/00276/AM20/ |
|
:09/24/040/00121/AM20/ |
|
14.06.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
|
|
Case No.:51/6/82-ALC4/2019Party Name:SYNNAT |
Case No.:51/6/82-ALC4/2019Party Name:SYNNAT |
|
|
|
|
Meet No/Date:6/82- |
Meet No/Date:6/82- |
|
|
|
Status: |
|
|
|
|
PHARMA PRIVATE |
|
|
|
|
ALC4/2019 |
|
|
|
|
Approved |
|
|
|
|
LIMITED |
|
|
|
|
16.08.2019 |
|
|
|
|
|
|
|
|
HQ File<br>RLA File |
|
|
|
|
|
Lic.No/Date:0210209260 |
|
|
|
|
|
|
|
|
:01/82/050/00277/AM20/<br>:02/24/040/00044/AM20/ |
|
|
|
|
|
17.06.2019 |
|
|
|
|
|
|
|
|
**Decision:**The Committee considered the case as |
|
per agenda in the presence of Technical Experts and |
|
|
|
|
|
|
|
|
|
|
|
|
in |
<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by |
NC |
|
in |
|
its<br>Meeting |
No. |
<br>15/82-ALC4/2018 |
|
|
|
|
| 104 |
|
, dated 22.03.2019, it was decided to ratify the ad-hoc input |
|
|
|
output norms under para |
|
|
|
4.7 of |
|
|
HBP Vol. I as |
|
|
|
per details below or as applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Export Product<br>Qty.<br>Sl. |
|
Import |
|
|
items |
|
|
|
Qty. |
|
|
|
|
|
No. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noscapine BP USP Ph.Eur JP CP /<br>1 kg<br>1 |
|
Noscapine Crude Content 95% |
|
|
|
|
|
|
1.10 kg |
|
|
|
|
|
Noscapine Hydrochloride BP Ph.Eur |
|
|
|
|
|
|
|
|
|
|
|
|
|
RA concerned maytake further necessaryaction asper |
|
above decision of NC. |
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:52/6/82-ALC4/2019Party Name:DECCAN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
NUTRACEUTICALS PVT |
|
ALC4/2019 |
|
Deferred |
|
|
LTD |
|
16.08.2019 |
|
|
|
|
HQ File<br>RLA File |
|
Lic.No/Date:0210209261 |
|
Defer Date: |
| 105 |
|
:01/82/050/00278/AM20/<br>:02/24/040/00042/AM20/ |
|
17.06.2019 |
|
|
|
|
**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) Certificate of Analysis(CoA)of import item from foreign supplier. |
|
|
|
|
49
| 106 |
Case No.:53/6/82-ALC4/2019 |
Party Name:KAIRAV<br>CHEMOFARBE INDUSTRIES<br>LTD.<br>RLA File<br>:03/94/040/00201/AM20/ |
<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00279/AM20/ |
|
Lic.No/Date:0310829703<br>17.06.2019 |
|
|
<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) Certificate of Analysis ( CoA) of import item from foreign supplier.<br>(ii) Certificate of Analysis(CoA)of exportproduct. |
|
|
|
| 107 |
<br>Case No.:54/6/82-ALC4/2019 |
Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0910067671<br>18.06.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00280/AM20/ |
RLA File<br>:09/24/040/00130/AM20/ |
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Defer Date: |
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**Decision:**New Case,deferred for comments of TE. |
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| Case No.:55/6/82-ALC4/2019 |
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Party Name:CADILA |
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Meet No/Date:6/82- |
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Status: |
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HEALTHCARE LTD |
|
ALC4/2019 |
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Approved |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0810145530 |
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| :01/82/050/00281/AM20/ |
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:08/24/040/00094/AM20/ |
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18.06.2019 |
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|
==> picture [453 x 331] intentionally omitted <==
----- Start of picture text -----<br>
Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as<br>per details below or as applied by firm whichever is lower:<br>Sl. No. Export Product Qty.<br>1 ISOSORBIDE DINITRATE TABLETS USP 5 MG 1 Number<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE<br>USP EQUIVALENT TO ISOSORBIDE DINITRATE USP - NET WT.<br>15.980 KGS)<br>2 ISOSORBIDE DINITRATE TABLETS USP 10 MG 1 Number<br>108<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE<br>USP EQUIVALENT TO ISOSORBIDE DINITRATE USP - NET WT.<br>92.790 KGS)<br>3 ISOSORBIDE DINITRATE TABLETS USP 20 MG 1 Number<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE<br>USP EQUIVALENT TO ISOSORBIDE DINITRATE USP - NET WT.<br>212.812 KGS)<br>4 ISOSORBIDE DINITRATE TABLETS USP 30 MG 1 Number<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE<br>USP EQUIVALENT TO ISOSORBIDE DINITRATE USP - NET WT.<br>153.162 KGS)<br>5 ISOSORBIDE DINITRATE TABLETS USP 40 MG 1 Number<br>(ACTIVE INGREDIENT : DILUTED ISOSORBIDE DINITRATE<br>USP EQUIVALENT TO ISOSORBIDE DINITRATE USP - NET WT.<br>12.420 KGS)<br>S.NO. Import Items For export of 1 Number of tablet ( Quantity in mg )<br>----- End of picture text -----<br>
50
|
|
|
5 mg |
10 mg |
20 mg |
30 mg |
40 mg |
|
1 |
DILUTED ISOSORBIDE<br>DINITRATE USP |
12.75 |
25.00 |
50.00 |
75.00 |
100.00 |
|
2 |
LACTOSE<br>MONOHYDRATE NF |
48.16 |
96.55 |
71.00 |
46.43 |
88.39 |
|
3 |
SODIUM STARCH<br>GLYCOLATE TYPE A NF/JP |
5.23 |
10.45 |
10.45 |
10.45 |
4.375 |
|
4 |
MICROCRYSTALLINE<br>CELLULOSE (AVICEL PH<br>200) NF/PH.EUR |
11.00 |
22.00 |
22.00 |
22.00 |
52.50 |
|
5 |
MAGNESIUM STEARATE<br>PH.EUR/NF/JP |
1.10 |
2.20 |
2.20 |
2.20 |
3.50 |
|
RA concerned maytake further necessaryaction asper above decision of NC. |
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| 109 |
<br>Case No.:56/6/82-ALC4/2019 |
Party Name:SOLARA<br>ACTIVE PHARMA<br>SCIENCES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0410165732<br>18.06.2019 |
Status:<br>Deferred |
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<br>HQ File<br>:01/82/050/00282/AM20/ |
RLA File<br>:04/24/040/00050/AM20/ |
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Defer Date: |
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**Decision:**New Case,deferred for comments of TE. |
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| Case No.:57/6/82-ALC4/2019 |
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Party Name:YASHO |
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Meet No/Date:6/82- |
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Status: |
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INDUSTRIES LIMITED |
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ALC4/2019 |
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Approved |
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16.08.2019 |
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| HQ File |
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RLA File |
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Lic.No/Date:0310829756 |
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| :01/82/050/00283/AM20/ |
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:03/95/040/00269/AM20/ |
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18.06.2019 |
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Decision: The Committee considered case as per agenda and in the presence of the technical experts, it 110 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
Export product |
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Sl. |
Import items |
Qty. |
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Qty. |
No. |
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|
|
ZINC DIACRYLATE(QUREACC ZDA) |
1 kg |
1 |
ACRYLIC ACID |
0.744 kg |
|
|
|
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2 |
ZINC OXIDE |
0.425 kg |
|
| RA maytake appropriate action asper the decision of Norms Committee. |
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| 111 |
Case No.:60/6/82-ALC4/2019 |
Party Name:TIDE<br>INDUSTRIES |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:3410045217<br>18.06.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00286/AM20/ |
RLA File<br>:34/24/040/00101/AM20/ |
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Defer Date: |
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**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Vadodara. |
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Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
51
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Case No.:61/6/82-ALC4/2019 |
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Party Name:ASTRAL |
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Meet No/Date:6/82- |
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Status: |
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STERITECH PVT. LTD. |
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ALC4/2019 |
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Deferred |
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16.08.2019 |
|
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| 112 |
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HQ File<br>:01/82/050/00287/AM20/ |
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RLA File<br>:34/24/040/00102/AM20/ |
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Lic.No/Date:3410045218<br>19.06.2019 |
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Defer Date: |
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|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
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not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
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authorization from RLA,Vadodara. |
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Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
|
|
Case No.:62/6/82-ALC4/2019 |
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Party Name:DR. REDDYS |
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Meet No/Date:6/82- |
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Status: |
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|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Deferred |
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|
16.08.2019 |
|
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| 113 |
|
HQ File |
|
RLA File |
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Lic.No/Date:0910067680 |
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Defer Date: |
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:01/82/050/00288/AM20/ |
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:09/24/040/00122/AM20/ |
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19.06.2019 |
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**Decision:**New Case,deferred for comments of TE. |
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| Case No.:63/6/82-ALC4/2019 |
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Party Name:AARTI DRUGS |
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Meet No/Date:6/82- |
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Status: |
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LIMITED |
|
ALC4/2019 |
|
Approved |
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|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829807 |
|
|
| :01/82/050/00289/AM20/ |
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:03/94/040/00880/AM19/ |
|
20.06.2019 |
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|
**Decision:**The Committee considered |
**Decision:**The Committee considered |
the cases as per agenda and in the light of earlier |
the cases as per agenda and in the light of earlier |
the cases as per agenda and in the light of earlier |
decision taken in |
decision taken in |
|
|
meeting no. 3/82-ALC4/2019 dated 05.07.2019, |
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|
it was decided to ratify norms under Para |
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4.7 of HBP v1 as |
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per details given below or as applied by the firm, whichever is less: |
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| 114 |
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Export product |
Qty. |
Sl. |
Import items |
|
Qty. |
|
|
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|
No. |
|
|
|
|
|
|
Ciprofloxacin Hydrochloride |
1 kg |
1 |
Ethyl 3 Cyclopropylamino-2(2,4 |
|
1.294 kg |
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|
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|
|
|
Dichloro-5 Fluorobenzoyl) Acrylate |
|
|
|
|
|
|
|
2 |
Caustic Soda Flakes |
|
0.35 kg |
|
|
|
|
|
3 |
Sulphuric Acid (98%) |
|
Not importable |
|
|
|
|
|
4 |
Toluene |
|
0.123 kg |
|
|
|
|
|
5 |
Anhydrous Piperazine |
|
0.39 kg |
|
|
|
RA maytake appropriate action |
asper the decision of Norms Committee. |
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| Case No.:64/6/82-ALC4/2019 |
|
Party Name:PRO-LIFE BIO- |
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Meet No/Date:6/82- |
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Status: |
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|
CHEMICAL INDUSTRIES |
|
ALC4/2019 |
|
Approved |
|
|
(P)LTD. |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829817 |
|
|
| :01/82/050/00290/AM20/ |
|
:03/95/040/00215/AM20/ |
|
20.06.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision 115 taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
| Export Product |
Qty. |
Sl.No. |
Import items |
Qty. |
| 1-METHYLAMINO-4-<br>BROMO ANTHRAQUINONE |
1 kg |
1 |
1-<br>NITROANTHRAQUINONE |
1.234 kg |
52
| 116 |
Case No.:65/6/82-ALC4/2019 |
Party Name:SMS<br>PHARMACEUTICALS<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00291/AM20/ |
RLA File<br>:09/24/040/00144/AM20/ |
Lic.No/Date:0910067683<br>20.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:66/6/82-ALC4/2019 |
|
Party Name:CLEAN SCIENCE |
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Meet No/Date:6/82- |
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Status: |
|
|
AND TECHNOLOGY |
|
ALC4/2019 |
|
Approved |
|
|
PVT.LTD. |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067449 |
|
|
| :01/82/050/00292/AM20/ |
|
:31/83/040/00044/AM20/ |
|
20.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 117 applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Guaiacol |
1 kg |
1 |
Phenol |
1.012 kg |
|
|
|
2 |
Methanol |
0.39 kg |
|
|
|
3 |
Hydrogen Peroxide PURITY 60% |
0.687 kg |
|
|
|
4 |
Acetone(Solvent) |
0.14 kg |
| RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
| 118 |
Case No.:67/6/82-ALC4/2019 |
Party Name:ASTRAL<br>STERITECH PVT. LTD. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00293/AM20/ |
RLA File<br>:34/24/040/00100/AM20/ |
Lic.No/Date:3410045222<br>20.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Vadodara. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Vadodara.
53
| Case No.:68/6/82-ALC4/2019 |
|
Party Name:THINQ PHARMA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CRO LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829823 |
|
|
| :01/82/050/00294/AM20/ |
|
:03/95/040/00274/AM20/ |
|
21.06.2019 |
|
|
|
|
**Decision:**The Committee considered |
**Decision:**The Committee considered |
the cases as per agenda and in the light of earlier decision taken in |
the cases as per agenda and in the light of earlier decision taken in |
the cases as per agenda and in the light of earlier decision taken in |
the cases as per agenda and in the light of earlier decision taken in |
the cases as per agenda and in the light of earlier decision taken in |
the cases as per agenda and in the light of earlier decision taken in |
|
|
meeting no. 3/82-ALC4/2019 dated 05.07.2019, it was decided to ratify norms under Para 4.7 |
|
|
|
|
|
of HBP v1 as |
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|
|
per details given below or as applied by the firm, |
|
|
whichever is less: |
|
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|
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| 119 |
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|
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Export product |
Qty. |
Sl. |
Import items |
|
Qty. |
|
|
|
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|
|
No. |
|
|
|
|
|
|
|
G-101 (All Trans Retinoic Acid,1- |
1 kg |
1 |
Tretinoin (All Trans Retinoic |
|
1.00 kg |
|
|
|
|
Hydroxy-3,3-dimethyl-2-Butanone |
|
|
Acid) |
|
|
|
|
|
|
Ester) |
|
2 |
1-Chloro Pinacolone |
|
0.469 kg |
|
|
|
|
|
|
3 |
Cesium Carbonate |
|
1.135 kg |
|
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
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|
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| Case No.:69/6/82-ALC4/2019 |
|
Party Name:ALTA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829833 |
|
|
| :01/82/050/00295/AM20/ |
|
:03/94/040/00239/AM20/ |
|
21.06.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 120 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| SODIUM SALICYLATE |
1 kg |
1 |
SALICYLIC ACID |
0.88 kg |
| Case No.:70/6/82-ALC4/2019 |
|
Party Name:ALTA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829834 |
|
|
| :01/82/050/00296/AM20/ |
|
:03/94/040/00240/AM20/ |
|
21.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 121 applied by firm whichever is less:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| METHYL SALICYLATE |
1 kg |
1 |
SALICYLIC ACID |
0.955 kg |
|
|
2 |
METHANOL |
0.244 kg |
RA concerned may take further necessary action as per above decision of NC
54
| Case No.:73/6/82-ALC4/2019 |
|
Party Name:NATURAL AND |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ESSENTIAL OILS PVT LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710115086 |
|
|
| :01/82/050/00299/AM20/ |
|
:07/24/040/00072/AM20/ |
|
21.06.2019 |
|
|
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 122 applied by firm whichever is lower:
| Export Product |
Qty. |
Qty. |
Sl.No. |
Sl.No. |
Import items |
Import items |
Qty. |
| Caffeine |
1 |
0020 kg |
1 |
|
Crude<br>(decaff<br>coffee) |
Caffeine<br>eination from green<br>Purity53.38% |
17600 kg |
| Coffee Extracts |
6 |
150 kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Case No.:71/6/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829872 |
|
|
| :01/82/050/00297/AM20/ |
|
:03/94/040/00225/AM20/ |
|
24.06.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
123
|
Case No:71/6/82-ALC4/2019 |
Case No:71/6/82-ALC4/2019 |
Case No:71/6/82-ALC4/2019 |
Part Name:GLENMARK |
Part Name:GLENMARK |
Part Name:GLENMARK |
Part Name:GLENMARK |
Meet No/Date:6/82- |
Meet No/Date:6/82- |
Meet No/Date:6/82- |
Meet No/Date:6/82- |
Status: |
Status: |
Status: |
Status: |
|
.<br>HQ File |
|
|
y<br>PHARMACEUTICALS LTD |
|
|
|
<br>A<br>1 |
<br>LC4/2019<br>6.08.2019 |
|
|
<br>Ap |
|
<br>proved |
|
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|
RLA File<br>:03/94/040/00225/AM20/ |
|
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|
L |
cNo/Date:0310829872 |
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<br>:01/82/050/00297/AM20/ |
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<br>2 |
.<br>4.06.2019 |
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DiinTh C |
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itt idd th |
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d d i th liht f |
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li dii |
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| 123 |
**ecso:**e ommee consere<br>taken in meeting no. 1/82-ALC4/2019 dated 03.06<br>HBP v1 as per details given below or as applied by<br>Export Product<br>Q<br>Omeprazole DR Capsules USP 10mg (Pack size<br>1 |
|
|
|
|
|
cases as per agena an n e g o ea<br>.2019, it was decided to ratify norms unde<br>the firm, whichever is less: |
|
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|
|
er ecson<br>r Para 4.7 of<br>ty.<br>0089.21 kg |
|
|
|
Export Product |
|
|
|
Q |
ty. |
Sl. No. |
|
Import items |
|
|
Q |
ty. |
|
|
|
Om |
eprazole DR Capsules USP 10mg (Pac |
|
k size |
1 |
20000.000 |
1 |
|
Sugar Spheres |
|
|
6 |
0089.21 kg |
|
|
|
<br>30<br>( |
<br> <br>Net wt. of Sugar Spheres 18 |
|
<br>tabs)<br>- 20 |
P |
acks |
|
|
<br>18 - 20<br>(SURINERTS |
<br>) |
|
|
|
|
|
|
(S<br>NF |
URINERTS)<br>(SUGAR<br>SPHERES<br>(850-1000)) is 144.000 Kgs) |
|
USP- |
|
|
|
|
(SUGAR<br>SPHERES<br>USP-NF(850-<br>1000)) |
|
|
|
|
|
|
|
|
|
|
|
|
4800.000<br>acks |
|
|
|
|
|
|
|
|
|
|
Om<br>10<br>( |
eprazole DR Capsules USP 10mg (Pac<br>0<br>Net wt. of Sugar Spheres 18 |
|
k size<br>tabs)<br>- 20 |
6<br>P |
|
|
|
|
|
|
|
|
|
|
|
<br>(S<br>NF |
<br>URINERTS)<br>(SUGAR<br>SPHERES<br>(850-1000))is 259.200 Kgs) |
|
<br>USP- |
|
80000.000<br> |
|
|
|
|
|
|
|
|
|
|
Om<br> |
eprazole DR Capsules USP 20mg (Pac<br> |
|
k size<br> |
1<br> |
|
|
|
|
|
|
|
|
|
|
|
30<br>(<br>(S<br>NF |
<br>Net wt. of Sugar Spheres 18<br>URINERTS)<br>(SUGAR<br>SPHERES<br>(850-1000))is 432000 Ks) |
|
tabs)<br>- 20<br>USP- |
P |
acks |
|
|
|
|
|
|
|
|
|
|
|
.g |
|
|
|
06000.000<br>acks |
|
|
|
|
|
|
|
|
|
|
Om<br>10<br>( |
eprazole DR Capsules USP 20mg (Pac<br>0<br>Net wt. of Sugar Spheres 18 |
|
k size<br>tabs)<br>- 20 |
3<br>P |
|
|
|
|
|
|
|
|
|
|
|
(S<br>NF |
URINERTS)<br>(SUGAR<br>SPHERES<br>(850-1000))is 2448.000 Kgs) |
|
USP- |
|
58300.000<br> |
|
|
|
|
|
|
|
|
|
|
Om<br> |
eprazole DR Capsules USP 20mg (Pac<br> |
|
k size<br> |
2<br> |
|
|
|
|
|
|
|
|
|
|
|
10<br>(<br>(S<br>NF |
0<br>Net wt. of Sugar Spheres 18<br>URINERTS)<br>(SUGAR<br>SPHERES<br>(850-1000))is 20664.000 Kgs) |
|
tabs)<br>- 20<br>USP- |
P |
acks |
|
|
|
|
|
|
|
|
|
|
Omeprazole DR Capsules USP 40mg (Pack size |
|
|
|
3 |
50000.000 |
|
|
|
|
|
|
|
|
|
|
30<br>tabs)<br>( Net wt. of Sugar Spheres 18 - 20<br>(SURINERTS)<br>(SUGAR<br>SPHERES<br>USP-<br>NF(850-1000))is 892.500 Kgs) |
|
|
|
Packs |
|
|
|
|
|
|
|
|
|
55
Omeprazole DR Capsules USP 40mg (Pack size 746668.000 90 tabs) Packs ( Net wt. ofSugar Spheres 18 - 20 (SURINERTS) (SUGAR SPHERES USPNF(850-1000)) is 5712.010 Kgs) Omeprazole DR Capsules USP 40mg (Pack size 275000.000 100 tabs) Packs ( Net wt. of Sugar Spheres 18 - 20 (SURINERTS) (SUGAR SPHERES USPNF(850-1000)) is 2337.500 Kgs) Omeprazole DR Capsules USP 40mg (Pack size 320000.000 1000 tabs) Packs ( Net wt. of Sugar Spheres 18 - 20 (SURINERTS) (SUGAR SPHERES USPNF(850-1000)) is 27200.000 Kgs)
|
|
Case No.:72/6/82-ALC4/2019 |
|
Party Name:BENZO CHEM |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
INDUSTRIES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
16.08.2019 |
|
|
| 124 |
|
HQ File<br>:01/82/050/00298/AM20/ |
|
RLA File<br>:03/94/040/00210/AM20/ |
|
Lic.No/Date:0310829874<br>24.06.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
|
|
Case No.:74/6/82-ALC4/2019 |
|
Party Name:AURORE LIFE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
16.08.2019 |
|
|
| 125 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067684 |
|
Defer Date: |
|
|
:01/82/050/00300/AM20/ |
|
:09/24/040/00147/AM20/ |
|
24.06.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
|
|
Case No.:75/6/82-ALC4/2019 |
|
Party Name:NAARI PHARMA |
|
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
PRIVATE LIMITED |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
16.08.2019 |
|
|
| 126 |
|
HQ File<br>:01/82/050/00301/AM20/ |
|
RLA File<br>:05/24/040/00172/AM20/ |
|
|
Lic.No/Date:0510411026<br>24.06.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from CLA,New Delhi. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
|
|
Case No.:76/6/82-ALC4/2019 |
|
Party Name:ORTIN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 127 |
|
HQ File<br>:01/82/050/00302/AM20/ |
|
RLA File<br>:09/24/040/00132/AM20/ |
|
Lic.No/Date:0910067687<br>24.06.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from CLA,New Delhi. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
56
|
|
Case No.:77/6/82-ALC4/2019 |
|
Party Name:ORTIN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 128 |
|
HQ File<br>:01/82/050/00303/AM20/ |
|
RLA File<br>:09/24/040/00133/AM20/ |
|
Lic.No/Date:0910067688<br>24.06.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Hyderabad. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:78/6/82-ALC4/2019 |
|
Party Name:INDO AMINES |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829884 |
|
|
| :01/82/050/00304/AM20/ |
|
:03/94/040/00179/AM20/ |
|
25.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it 129 was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| TALLOW AMINE |
1 kg |
1 |
C16 18 FATTY ACID |
1.57 kg |
|
|
2 |
NI-CATALYST OR NICKEL METAL |
0.001 kg |
|
|
Case No.:79/6/82-ALC4/2019 |
|
Party Name:DR. ACHARYA |
|
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
LABORATORIES PVT. LTD., |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
16.08.2019 |
|
|
| 130 |
|
HQ File<br>:01/82/050/00305/AM20/ |
|
RLA File<br>:03/94/040/00249/AM20/ |
|
|
Lic.No/Date:0310829897<br>25.06.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
|
|
Case No.:80/6/82-ALC4/2019Party Name:DINAKARA LIFE |
Case No.:80/6/82-ALC4/2019Party Name:DINAKARA LIFE |
Case No.:80/6/82-ALC4/2019Party Name:DINAKARA LIFE |
|
Meet No/Date:6/82- |
Meet No/Date:6/82- |
|
Status: |
Status: |
|
|
|
SCIENCES PRIVATE |
|
|
|
ALC4/2019 |
|
|
Approved |
|
|
|
|
LIMITED |
|
|
|
16.08.2019 |
|
|
|
|
|
|
|
HQ File<br>RLA File |
|
|
|
Lic.No/Date:0910067692 |
|
|
|
|
|
|
|
:01/82/050/00306/AM20/<br>:09/24/040/00150/AM20/ |
|
|
|
25.06.2019 |
|
|
|
|
|
|
|
**Decision:**The Committee considered case as per agenda and |
|
|
|
in |
the presence of the technical experts |
|
|
|
|
| 131 |
|
and it was decided to ratify the ad-hoc input output norms |
|
under para 4.7 of HBP as per details |
|
|
|
|
|
below or as |
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. No. |
|
|
Import items |
|
|
Qty. |
|
|
|
1-(2,4-Difluoro<br>Phenyl)-2-(1H-1,2,4- |
1 kg |
1 |
|
|
1,3-Difluoro Benzene. |
|
|
0.60 kg |
|
|
|
triazole-1-yl)<br>Ethanone<br>(Ethanone |
|
|
|
|
|
|
|
|
|
|
|
Derivative) |
|
|
|
|
|
|
|
|
|
|
|
RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
57
|
Case No.:81/6/82-ALC4/2019 |
Party Name:VN CREATIVE |
Party Name:VN CREATIVE |
Meet No/Date:6/82- |
Meet No/Date:6/82- |
Status: |
| 132 |
|
<br>CHEMICALS PRIVATE<br>LIMITED<br>RLA File |
|
<br>ALC4/2019<br>16.08.2019 |
|
<br>Deferred |
|
HQ File<br>:01/82/050/00307/AM20/ |
|
|
Lic.No/Date:03108299 |
15 |
Defer Date: |
|
|
<br>:03/95/040/00232/AM20/ |
|
<br>25.06.2019 |
|
|
|
**Decision:**New Case The Co |
mmittee noted that the 407 ap |
lication of subject Advanc |
|
e Authorization is |
|
|
. .<br>not available. Hence, it was decided to call for a copy o |
|
<br>f 4.07 application of the |
|
<br>subject advance |
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
Case No.:82/6/82-ALC4/2019 Party Name:KLJ Meet No/Date:6/82- Status: PLASTICIZERS LIMITED. ALC4/2019 Approved 16.08.2019 HQ File RLA File Lic.No/Date:0510411049 :01/82/050/00308/AM20/ :05/23/040/00125/AM20/ 25.06.2019
|
|
|
**Decision:**The Committee considered case as per |
**Decision:**The Committee considered case as per |
**Decision:**The Committee considered case as per |
**Decision:**The Committee considered case as per |
**Decision:**The Committee considered case as per |
agenda |
agenda |
and in the presence of the technical experts |
and in the presence of the technical experts |
and in the presence of the technical experts |
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 SION A-1291 or as |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
|
|
|
133 |
|
|
Export product |
|
|
Qty. |
|
Sl. |
Import items |
Qty. |
|
|
|
|
|
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
|
|
DI-BUTYL PHTHALATE (GRADE-M) |
|
|
1 kg |
|
1 |
PHTHALIC |
0.56 kg |
|
|
|
|
|
|
|
(DBP-M) |
|
|
|
|
|
ANHYDRIDE |
|
|
|
|
|
|
|
|
(PACKED IN 2554 NOS. OF |
|
HM-HDPE |
|
|
2 |
SABUTOL |
0.56 kg |
|
|
|
|
|
|
|
DRUMS MADE OF HDPE GRANULES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,709.000 KGS. WITHOUT |
|
|
|
|
3 |
HDPE GRANULES |
Relevant as per |
|
|
|
|
|
|
|
WASTAGE)) (EACH DRUM SHALL |
|
|
|
|
|
(TOTAL WEIGHT = |
packing policy |
|
|
|
|
|
|
|
WEIGHT 8.5 KG AND STORAGE |
|
|
|
|
|
22,794.450 KGS.) |
|
|
|
|
|
|
|
|
CAPACITY 235.000 KGS.) |
|
|
|
|
|
|
|
|
|
|
|
|
|
RA maytake appropriate action |
|
asper the decision of Norms |
|
|
|
|
Committee |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:83/6/82-ALC4/2019 |
|
|
Party Name:THINQ PHARMA<br>Meet No/Date:6/82- |
|
|
|
|
|
|
Status: |
|
|
|
|
|
|
|
CRO LIMITED |
|
|
|
ALC4/2019 |
|
|
Deferred |
|
|
|
|
|
|
|
|
|
|
|
16.08.2019 |
|
|
|
|
|
134 |
|
HQ File<br>:01/82/050/00309/AM20/ |
|
|
RLA File<br>:03/95/040/00279/AM20/ |
|
|
|
Lic.No/Date:0310829925<br>26.06.2019 |
|
|
Defer Date: |
|
|
|
|
**Decision:**New Case. The Committee noted |
|
|
|
that the |
4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a |
|
|
|
|
|
copy |
of 4.07 application of the subject advance |
|
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:84/6/82-ALC4/2019 |
|
Party Name:RELIANCE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 135 |
|
HQ File<br>:01/82/050/00310/AM20/ |
|
RLA File<br>:03/95/040/00142/AM20/ |
|
Lic.No/Date:0310829937<br>26.06.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
58
| Case No.:85/6/82-ALC4/2019 |
|
Party Name:SOLARA ACTIVE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMA SCIENCES |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0410165773 |
|
|
| :01/82/050/00311/AM20/ |
|
:04/24/040/00060/AM20/ |
|
27.06.2019 |
|
|
|
Case No.:85/6/82-ALC4/2019 |
Case No.:85/6/82-ALC4/2019 |
Party Name:SOLARA ACTIVE<br>PHARMA SCIENCES<br>LIMITED |
Party Name:SOLARA ACTIVE<br>PHARMA SCIENCES<br>LIMITED |
Party Name:SOLARA ACTIVE<br>PHARMA SCIENCES<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00311/AM20/ |
|
RLA File<br>:04/24/040/00060/AM20/ |
|
|
Lic.No/Date:0410165773<br>27.06.2019 |
|
| 136 |
<br>**Decision:**The Committee considered case as per<br>and it was decided to ratify the ad-hoc input output no<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>IBUPROFEN USP<br>1 kg<br>1<br>2<br>3<br>4<br>5<br>6<br>7<br>RA maytake appropriate action asper the decision of |
|
|
|
agenda and in the presence of the technical experts<br>rms under para 4.7 of HBP as per details below or as |
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
IBUPROFEN USP |
1 kg |
1 |
ISO BUTYL BENZENE (IBB) |
|
0.887 kg |
|
|
|
|
2 |
ACETYL CHLORIDE |
|
0.588 kg |
|
|
|
|
3 |
SODIUM METAL |
|
0.219 kg |
|
|
|
|
4 |
MANOCHLORO ACETIC ACID |
|
0.919 kg |
|
|
|
|
5 |
ISO-PROPYL ALCOHOL |
|
0.250 kg |
|
|
|
|
6 |
ISO-PROPYL ALCOHOL |
|
0.250 kg |
|
|
|
|
7 |
SODIUM DICHROMATE |
|
0.630 kg |
|
|
|
sper the decision of |
|
Norms Committee |
|
|
| Case No.:86/6/82-ALC4/2019 |
|
Party Name:GLAND |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067703 |
|
|
| :01/82/050/00312/AM20/ |
|
:09/24/040/00153/AM20/ |
|
27.06.2019 |
|
|
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 137 applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Metronidazole Injection USP<br>500mg (5mg/ml), 100ml Bag |
1 Number |
1 |
Metronidazole USP |
525 mg/ 100 ml bag |
|
|
2 |
Injection Port |
Relevant Net +1%<br>with accountability |
|
|
3 |
Twist off port stoppers |
|
59
| Case No.:87/6/82-ALC4/2019 |
|
Party Name:BRAWN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411076 |
|
|
| :01/82/050/00313/AM20/ |
|
:05/23/040/00121/AM20/ |
|
27.06.2019 |
|
|
|
|
**Decision:**The Committee considered the case as per agenda in the |
**Decision:**The Committee considered the case as per agenda in the |
**Decision:**The Committee considered the case as per agenda in the |
**Decision:**The Committee considered the case as per agenda in the |
**Decision:**The Committee considered the case as per agenda in the |
presence |
of |
Technical Experts and |
Technical Experts and |
Technical Experts and |
|
|
in<br>the<br>light<br>of |
earlier |
<br>decision |
taken |
by<br>NC<br>in<br>its |
Meeting |
No. |
|
3/82-ALC4/2019 |
|
|
|
, dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 |
|
|
|
|
|
|
|
of HBP Vol. I as |
|
|
|
per details below or as |
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
| 138 |
|
Export product |
|
Qty. |
Sl. |
Import items |
|
|
Qty. |
|
|
|
|
|
|
|
No. |
|
|
|
|
|
|
|
|
CIPROFLOXACIN |
|
One 500 |
1. |
CIPROFLOXACIN |
|
|
555.0 mg / |
|
|
|
|
TABLETS 500MG |
|
mg tablet |
|
HYDROCHLORIDE USP |
|
|
500 |
mg |
|
|
|
(OFF WHITE, |
|
|
|
(FAINTLY YELLOWISH TO |
|
|
Tablets |
|
|
|
|
ELONGATED, |
|
|
|
LIGHT YELLOW |
|
|
|
|
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|
BICONVEX, FLIM |
|
|
|
CRYSTALS) |
|
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|
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|
COATED TABLET, |
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|
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|
|
SCORED ON ONE SIDE) |
|
|
|
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|
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|
|
RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
|
|
|
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
|
|
|
Case No.:88/6/82-ALC4/2019 |
|
Party Name:DIVIS |
|
|
Meet No/Date:6/82- |
|
|
|
Status: |
|
|
|
|
|
|
LABORATORIES LTD |
|
|
ALC4/2019 |
|
|
|
Deferred |
|
|
|
|
|
|
|
|
|
16.08.2019 |
|
|
|
|
|
|
139 |
|
HQ File |
|
RLA File |
|
|
Lic.No/Date:0910067706 |
|
|
|
Defer Date: |
|
|
|
|
:01/82/050/00314/AM20/ |
|
:09/24/040/00151/AM20/ |
|
|
27.06.2019 |
|
|
|
|
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:89/6/82-ALC4/2019 |
Party Name:AURORE LIFE |
|
|
Meet No/Date:6/82- |
|
|
Status: |
|
|
|
|
|
|
|
SCIENCES PRIVATE |
|
|
ALC4/2019 |
|
|
Deferred |
|
|
|
|
|
|
|
LIMITED |
|
|
16.08.2019 |
|
|
|
|
|
|
|
140 |
|
HQ File |
RLA File |
|
|
Lic.No/Date:0910067709 |
|
|
Defer Date: |
|
|
|
|
|
|
:01/82/050/00315/AM20/ |
:09/24/040/00157/AM20/ |
|
|
27.06.2019 |
|
|
|
|
|
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Case No.:90/6/82-ALC4/2019 |
Party Name:RELIANCE |
|
|
Meet No/Date:6/82- |
|
|
Status: |
|
|
|
|
|
|
|
INDUSTRIES LIMITED |
|
|
ALC4/2019 |
|
|
Deferred |
|
|
|
|
|
|
|
|
|
|
16.08.2019 |
|
|
|
|
|
|
|
141 |
|
HQ File<br>:01/82/050/00316/AM20/ |
RLA File<br>:03/95/040/00268/AM20/ |
|
|
Lic.No/Date:0310829959<br>27.06.2019 |
|
|
Defer Date: |
|
|
|
|
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60
| 142 |
Case No.:91/6/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00317/AM20/ |
RLA File<br>:03/95/040/00190/AM20/ |
Lic.No/Date:0310829960<br>27.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
|
|
|
|
|
| 143 |
Case No.:92/6/82-ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00318/AM20/ |
RLA File<br>:03/95/040/00267/AM20/ |
Lic.No/Date:0310829964<br>27.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
| 144 |
Case No.:93/6/82-ALC4/2019 |
Party Name:CONCORD<br>BIOTECH LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00319/AM20/ |
RLA File<br>:08/24/040/00101/AM20/ |
Lic.No/Date:0810145581<br>27.06.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Ahmedabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
61
| Case No.:95/6/82-ALC4/2019 |
|
Party Name:RECKITT |
|
Meet No/Date:6/82- |
|
Status: |
|
|
BENCKISER HEALTHCARE |
|
ALC4/2019 |
|
Approved |
|
|
INDIA PRIVATE LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411088 |
|
|
| :01/82/050/00321/AM20/ |
|
:05/24/040/00196/AM20/ |
|
27.06.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
145
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Cepacol Extra Strength<br>Lozenges Cherry |
1 Number<br>tablet<br>(Lozenges) |
1 |
ISOMALT ST-M |
1822.00 mg / tablet |
|
|
2 |
Lycasin 80/55 (Maltitol) |
456.00 mg / tablet |
|
|
3 |
D&C red no. 33 |
0.055 mg / tablet |
|
|
4 |
FD&C Red no. 40 |
0.073 mg / tablet |
|
|
5 |
Benzocaine USP |
15.30 mg / tablet |
|
|
6 |
Wild Cherry Flavour TAK<br>040489 |
12.71 mg / tablet |
|
|
7 |
Cherry Bark FL NAT TAK<br>054757 |
4.90 mg /tablet |
|
|
8 |
Intensate Cool Flavour<br>TAK052848 |
4.70 mg / tablet |
| Case No.:96/6/82-ALC4/2019 |
|
Party Name:GLAND |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067713 |
|
|
| :01/82/050/00322/AM20/ |
|
:09/24/040/00158/AM20/ |
|
27.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 146
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Milrinone Lactate Injection<br>1mg/ml, 50ml Vial |
1 Number |
1 |
Milrinone |
52.5 mg / 50 ml vial |
|
|
2 |
Glass Vials |
Relevant as per<br>packing Policy |
|
|
3 |
Rubber Stoppers |
|
|
|
4 |
Flipoff Seals |
|
62
| Case No.:97/6/82-ALC4/2019 |
|
Party Name:GLOBAL |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CALCIUM PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710115110 |
|
|
| :01/82/050/00323/AM20/ |
|
:07/24/040/00063/AM20/ |
|
27.06.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 147 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| MAGNESIUM<br>PIDOLATE(Eur.Ph) |
1 kg |
1. |
L-PYROGLUTAMIC ACID |
0.90 kg |
| CALCIUM PIDOLATE |
1 kg |
1. |
L-PYROGLUTAMIC ACID |
0.82 kg |
| Case No.:94/6/82-ALC4/2019 |
|
Party Name:T& T PHARMA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310829994 |
|
|
| :01/82/050/00320/AM20/ |
|
:03/95/040/00300/AM20/ |
|
28.06.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 148
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
LUMICAR ( Pilocarpine HCL |
36000Number |
1 |
PILOCARPINE HCL BP |
14.70 kg |
|
eye drop BP 4% ) (Each 10 ml |
|
|
|
|
|
bottle contains Pilocarpine |
|
|
|
|
|
HCL BP0.4gm) |
|
|
|
|
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
63
| Case No.:98/6/82-ALC4/2019 |
|
Party Name:RECKITT |
|
Meet No/Date:6/82- |
|
Status: |
|
|
BENCKISER HEALTHCARE |
|
ALC4/2019 |
|
Approved |
|
|
INDIA PRIVATE LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411091 |
|
|
| :01/82/050/00324/AM20/ |
|
:05/24/040/00199/AM20/ |
|
28.06.2019 |
|
|
|
Case No.:98/6/82-ALC4/2019 |
Party Name:RECKITT<br>BENCKISER HEALTHCARE<br>INDIA PRIVATE LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00324/AM20/ |
RLA File<br>:05/24/040/00199/AM20/ |
Lic.No/Date:0510411091<br>28.06.2019 |
|
| 149 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>15/82-ALC4/2018<br>, dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Cepacol Extra<br>Strength Lozenges-<br>Honey Lemon<br>1 Number<br>1<br>ISOMALT ST-M<br>2313.35 mg /<br>tablet<br>2<br>D&C YELLOW NO. 10<br>0.44 mg / tablet<br>3<br>FD&C YELLOW NO. 6<br>0.007 mg/ tablet<br>4<br>BENZOCAINE USP<br>15.30 mg / tablet<br>5<br>HONEY & LEMON FLAVOUR<br>TAK 042202<br>6.444 mg / tablet<br>6<br>INTENSATE COOL FLAV TAK<br>052848<br>4.70 mg / tablet<br>7<br>MOUTHFEEL ENHANCER<br>TAK 053628<br>2.30 mg / tablet<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Case No.:99/6/82-ALC4/2019 |
|
Party Name:RECKITT |
|
Meet No/Date:6/82- |
|
Status: |
|
|
BENCKISER HEALTHCARE |
|
ALC4/2019 |
|
Approved |
|
|
INDIA PRIVATE LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411103 |
|
|
| :01/82/050/00325/AM20/ |
|
:05/24/040/00202/AM20/ |
|
01.07.2019 |
|
|
|
Case No.:99/6/82-ALC4/2019 |
Party Name:RECKITT<br>BENCKISER HEALTHCARE<br>INDIA PRIVATE LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00325/AM20/ |
RLA File<br>:05/24/040/00202/AM20/ |
Lic.No/Date:0510411103<br>01.07.2019 |
|
| 150 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>15/82-ALC4/2018<br>, dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Cepacol Extra Strength<br>Lozenges-Sore throat<br>& Cough Mixed Berry<br>1 Number<br>1<br>ISOMALT ST-M<br>2320.080 mg / tablet<br>2<br>FD&C Red No. 40<br>0.259 mg / tablet<br>3<br>Spectracol Dual FD&C<br>Blue No. 1<br>0.001 mg / tablet<br>4<br>Benzocaine USP<br>8.1864 mg / tablet<br>5<br>Berry Flavour TAK<br>041362<br>8.152 mg / tablet<br>6<br>Intensate Masking TAK<br>041943<br>4.485 mg / tablet<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
64
| Case No.:100/6/82-ALC4/2019 |
|
Party Name:STYRAX |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMA PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2610012878 |
|
|
| :01/82/050/00326/AM20/ |
|
:26/24/040/00004/AM20/ |
|
01.07.2019 |
|
|
|
Case No.:100/6/82-ALC4/2019 |
Case No.:100/6/82-ALC4/2019 |
Party Name:STYRAX<br>PHARMA PRIVATE<br>LIMITED |
Party Name:STYRAX<br>PHARMA PRIVATE<br>LIMITED |
Party Name:STYRAX<br>PHARMA PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00326/AM20/ |
|
RLA File<br>:26/24/040/00004/AM20/ |
|
|
Lic.No/Date:2610012878<br>01.07.2019 |
|
| 151 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts<br>and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>5-(4-AMINO-2-OXO-<br>PYRIMIDINYL)-<br>OXATHIOLANE-2-<br>CARBOXYLIC ACID-<br>ISOPROPYL-METHYL-<br>CYCLOHEXYL ESTER OR<br>CHE<br>1 kg<br>1<br>GLYOXALIC ACID 50%<br>0.746 kg<br>2<br>2,5-DIHYDROXY-1,4-DIATHINE<br>0.327 kg<br>3<br>DI METHYL FORMAMIDE(DMF)<br>0.260kg<br>4<br>CYTOSINE<br>0.434 kg<br>5<br>HEXA METHYL DISILAZANE<br>(HMDS)<br>0.708 kg<br>6<br>METHYLENE DI CHLORIDE (MDC)<br>2.630 kg<br>7<br>L-MENTHOL (FRESH /<br>RECOVERY)<br>0.751 kg<br>8<br>TRI ETHYL AMINE (TEA)<br>0.034 kg<br>9<br>TRIPHOSGENE<br>0.40 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
5-(4-AMINO-2-OXO-<br>PYRIMIDINYL)-<br>OXATHIOLANE-2-<br>CARBOXYLIC ACID-<br>ISOPROPYL-METHYL-<br>CYCLOHEXYL ESTER OR<br>CHE |
1 kg |
1 |
GLYOXALIC ACID 50% |
|
0.746 kg |
|
|
|
|
2 |
2,5-DIHYDROXY-1,4-DIATHINE |
|
0.327 kg |
|
|
|
|
3 |
DI METHYL FORMAMIDE(DMF) |
|
0.260kg |
|
|
|
|
4 |
CYTOSINE |
|
0.434 kg |
|
|
|
|
5 |
HEXA METHYL DISILAZANE<br>(HMDS) |
|
0.708 kg |
|
|
|
|
6 |
METHYLENE DI CHLORIDE (MDC) |
|
2.630 kg |
|
|
|
|
7 |
L-MENTHOL (FRESH /<br>RECOVERY) |
|
0.751 kg |
|
|
|
|
8 |
TRI ETHYL AMINE (TEA) |
|
0.034 kg |
|
|
|
|
9 |
TRIPHOSGENE |
|
0.40 kg |
|
|
|
sper the |
decision |
of Norms Committee |
|
|
65
| Case No.:101/6/82-ALC4/2019 |
|
Party Name:STYRAX LIFE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:2610012879 |
|
|
| :01/82/050/00327/AM20/ |
|
:26/24/040/00005/AM20/ |
|
01.07.2019 |
|
|
|
Case No.:101/6/82-ALC4/2019 |
Case No.:101/6/82-ALC4/2019 |
Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00327/AM20/ |
|
RLA File<br>:26/24/040/00005/AM20/ |
|
|
Lic.No/Date:2610012879<br>01.07.2019 |
|
| 152 |
<br>**Decision:**The Committee considered case as per<br>and it was decided to ratify the ad-hoc input output no<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>5-(4-AMINO-2-OXO-<br>PYRIMIDINYL)-<br>OXATHIOLANE-2-<br>CARBOXYLIC ACID-<br>ISOPROPYL-METHYL-<br>CYCLOHEXYL ESTER OR<br>CHE<br>1 kg<br>1<br>2<br>3<br>4<br>5<br>6<br>7<br>8<br>9<br>RA maytake appropriate action asper the decision of |
|
|
|
agenda and in the presence of the technical experts<br>rms under para 4.7 of HBP as per details below or as |
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
5-(4-AMINO-2-OXO-<br>PYRIMIDINYL)-<br>OXATHIOLANE-2-<br>CARBOXYLIC ACID-<br>ISOPROPYL-METHYL-<br>CYCLOHEXYL ESTER OR<br>CHE |
1 kg |
1 |
GLYOXALIC ACID 50% |
|
0.746 kg |
|
|
|
|
2 |
2,5-DIHYDROXY-1,4-DIATHINE |
|
0.327 kg |
|
|
|
|
3 |
DI METHYL FORMAMIDE<br>(DMF) |
|
0.260 kg |
|
|
|
|
4 |
CYTOSINE |
|
0.434 kg |
|
|
|
|
5 |
HEXA METHYL DISILAZANE<br>(HMDS) |
|
0.708 kg |
|
|
|
|
6 |
METHYLENE DI CHLORIDE<br>(MDC) |
|
2.630 kg |
|
|
|
|
7 |
L-MENTHOL (FRESH /<br>RECOVERY) |
|
0.751 kg |
|
|
|
|
8 |
TRI ETHYL AMINE (TEA) |
|
0.034 kg |
|
|
|
|
9 |
TRIPHOSGENE |
|
0.40 kg |
|
|
|
sper the decision of |
|
Norms Committee |
|
|
| Case No.:102/6/82-ALC4/2019 |
|
Party Name:RAJASTHAN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ANTIBIOTICS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411121 |
|
|
| :01/82/050/00328/AM20/ |
|
:05/24/040/00200/AM20/ |
|
02.07.2019 |
|
|
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 153 applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Ampicillin Sodium Sterile+<br>Sulbactam Sodium Sterile |
3600 kg |
1 |
Ampicillin Trihydrate |
2880 kg |
|
(Ratio:2x1, 2400+1200 KG) |
|
2 |
Sulbactam Sodium Sterile |
1200 kg |
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
66
| 154 |
Case No.:103/6/82-<br>ALC4/2019 |
Party<br>Name:SMILAX LABORATORIES<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
HQ File<br>:01/82/050/00329/AM20/ |
RLA File :09/24/040/00146/AM20/ |
Lic.No/Date:0910067735<br>02.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
| Case No.:104/6/82-ALC4/2019 |
|
Party Name:CHROMO |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES INDIA PVT |
|
ALC4/2019 |
|
Approved |
|
|
LTD. |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067737 |
|
|
| :01/82/050/00330/AM20/ |
|
:09/24/040/00143/AM20/ |
|
02.07.2019 |
|
|
|
Case No.:104/6/82-ALC4/2019 |
Case No.:104/6/82-ALC4/2019 |
Party Name:CHROMO<br>LABORATORIES INDIA PVT<br>LTD. |
Party Name:CHROMO<br>LABORATORIES INDIA PVT<br>LTD. |
Party Name:CHROMO<br>LABORATORIES INDIA PVT<br>LTD. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00330/AM20/ |
|
RLA File<br>:09/24/040/00143/AM20/ |
|
|
Lic.No/Date:0910067737<br>02.07.2019 |
|
| 155 |
**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output n<br>applied by firm whichever is lower: |
|
|
|
per agenda in the presence of the technical experts and it<br>orms under para 4.7 of HBP as per details below or as |
|
|
|
Export product |
Qty. |
|
Sl.<br>No. |
Import items |
|
Qty. |
|
Candesartan<br>Cilexetil<br>100%<br>BG<br>condition<br>imposed. |
1 kg |
|
1 |
3-Nitrophthalic Acid |
|
1.352 kg |
|
|
|
|
2 |
4-Bromomethyl-2-cyanobiphenyl |
|
1.66 kg |
|
|
|
|
3 |
Hydrazine Hydrate |
|
1.65 kg |
|
|
|
|
4 |
1-Chloro Ethyl Cyclohexyl Carbonate |
|
0.672 kg |
|
|
|
|
5 |
Tetra Ethyl Ortho Carbonate |
|
1.19kg |
|
|
|
|
6 |
Trityl Chloride |
|
1.216 kg |
|
|
|
|
7 |
Potassium Carbonate |
|
3.096 kg |
|
|
|
|
8 |
Sodium Azide |
|
1.68 kg |
|
|
|
|
9 |
Acetone |
|
11.00 kg |
|
|
|
|
10 |
Dimethyl Formamide |
|
3.32 kg |
|
|
|
|
11 |
Methanol |
|
8.55 kg |
|
|
|
|
12 |
Methylene Chloride |
|
21.75 kg |
|
RA concerned maytake further necessaryaction |
|
|
|
asper above decision of NC. |
|
|
67
| Case No.:105/6/82-ALC4/2019 |
|
Party Name:HETERO LABS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067738 |
|
|
| :01/82/050/00331/AM20/ |
|
:09/24/040/00160/AM20/ |
|
02.07.2019 |
|
|
|
|
Case No.:105/6/82-ALC4/2019Party Name:HETERO LABS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00331/AM20/<br>RLA File<br>:09/24/040/00160/AM20/<br>Lic.No/Date:0910067738<br>02.07.2019 |
Case No.:105/6/82-ALC4/2019Party Name:HETERO LABS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00331/AM20/<br>RLA File<br>:09/24/040/00160/AM20/<br>Lic.No/Date:0910067738<br>02.07.2019 |
Case No.:105/6/82-ALC4/2019Party Name:HETERO LABS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00331/AM20/<br>RLA File<br>:09/24/040/00160/AM20/<br>Lic.No/Date:0910067738<br>02.07.2019 |
Case No.:105/6/82-ALC4/2019Party Name:HETERO LABS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00331/AM20/<br>RLA File<br>:09/24/040/00160/AM20/<br>Lic.No/Date:0910067738<br>02.07.2019 |
Case No.:105/6/82-ALC4/2019Party Name:HETERO LABS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00331/AM20/<br>RLA File<br>:09/24/040/00160/AM20/<br>Lic.No/Date:0910067738<br>02.07.2019 |
Case No.:105/6/82-ALC4/2019Party Name:HETERO LABS<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00331/AM20/<br>RLA File<br>:09/24/040/00160/AM20/<br>Lic.No/Date:0910067738<br>02.07.2019 |
|
|
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts |
|
|
|
|
|
|
|
and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details |
|
|
|
|
below or as |
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
| 156 |
|
|
|
|
No. |
|
|
|
|
|
2-CHLORO-N-(2-CHLORO-4- |
1 kg |
1 |
2-CHOLORO NICLOTINIC ACID |
0.71 kg |
|
|
|
METHYL-3-PYRIDINYL)-3- |
|
2 |
THIONYL CHLORIDE |
0.90 kg |
|
|
|
PYRIDINE CARBOXAMIDE |
|
3 |
N N DI METHYL FORMAMIDE |
0.040 kg |
|
|
|
|
|
4 |
3-AMINO 2-CHLORO-4-METHYL |
0.540 kg |
|
|
|
|
|
|
PYRIDINE |
|
|
|
|
|
|
5 |
TETRA BUTYL AMMONIUM |
0.197 kg |
|
|
|
|
|
|
BROMIDE |
|
|
|
|
|
|
6 |
TOLUENE |
3.65 kg |
|
|
|
|
|
7 |
METHANOL |
0.087 kg |
|
|
RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
| Case No.:106/6/82-ALC4/2019 |
|
Party Name:VIVIMED LIFE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
SCIENCES PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067740 |
|
|
| :01/82/050/00332/AM20/ |
|
:09/24/040/00155/AM20/ |
|
03.07.2019 |
|
|
|
|
Case No.:106/6/82-ALC4/2019Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00332/AM20/<br>RLA File<br>:09/24/040/00155/AM20/<br>Lic.No/Date:0910067740<br>03.07.2019 |
Case No.:106/6/82-ALC4/2019Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00332/AM20/<br>RLA File<br>:09/24/040/00155/AM20/<br>Lic.No/Date:0910067740<br>03.07.2019 |
Case No.:106/6/82-ALC4/2019Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00332/AM20/<br>RLA File<br>:09/24/040/00155/AM20/<br>Lic.No/Date:0910067740<br>03.07.2019 |
Case No.:106/6/82-ALC4/2019Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00332/AM20/<br>RLA File<br>:09/24/040/00155/AM20/<br>Lic.No/Date:0910067740<br>03.07.2019 |
Case No.:106/6/82-ALC4/2019Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00332/AM20/<br>RLA File<br>:09/24/040/00155/AM20/<br>Lic.No/Date:0910067740<br>03.07.2019 |
|
|
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in |
|
|
|
|
|
|
the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated |
|
|
14.01.2019, it was |
|
|
|
decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by |
|
|
|
|
|
|
firm whichever is lower: |
|
|
|
|
|
|
Export Product: |
|
|
|
|
|
|
Losartan Potassium Tablets USP (Losartan) 25 Mg, 50 Mg, 100 Mg |
|
|
|
|
| 157 |
|
Sl.<br>No.<br>Import items |
Norms Recommended for one Tablet<br>25 Mg Tablet<br>50 Mg Tablet<br>100 Mg Tablet |
|
|
|
|
|
1<br>Losartan Potassium (or) Losartan |
25.5 mg |
51 mg |
102 mg |
|
|
|
Potasium USP |
|
|
|
|
|
|
2<br>Mannitol (Pearlitol 160C) |
101.9 mg |
203.8 mg |
407.6 mg |
|
|
|
3<br>Microcrystalline Cellulose (Avicel PH |
40.5 mg |
81.0 mg |
162 mg |
|
|
|
102) |
|
|
|
|
|
|
4<br>Croscarmellose Sodium (Ac Di Sol) |
7.19 mg |
14.38 mg |
28.76 mg |
|
|
|
5<br>Povidone(PLASDONE K-29/32) |
3.61 mg |
7.22 mg |
14.44 mg |
|
|
|
6<br>Magnesium Stearate (Mallinckrodt |
1.8 mg |
3.6 mg |
7.2 mg |
|
|
|
2257) |
|
|
|
|
|
|
7<br>Opadry White (03H28419) |
3.6mg |
7.2 mg |
14.4 mg |
|
|
|
RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
68
|
|
Case No.:107/6/82- |
|
Party Name:VIVIMED LIFE |
|
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
SCIENCES PRIVATE |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
|
16.08.2019 |
|
|
| 158 |
|
HQ File<br>:01/82/050/00333/AM20/ |
|
RLA File<br>:09/24/040/00156/AM20/ |
|
|
Lic.No/Date:0910067741<br>03.07.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Hyderabad. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
|
|
Case No.:108/6/82- |
|
Party Name:FRESENIUS |
|
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
KABI ONCOLOGY LIMITED |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
16.08.2019 |
|
|
| 159 |
|
HQ File<br>:01/82/050/00334/AM20/ |
|
RLA File<br>:05/23/040/00129/AM20/ |
|
|
Lic.No/Date:0510411135<br>03.07.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from CLA,New Delhi. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
| Case No.:109/6/82-ALC4/2019 |
|
Party Name:BRAWN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411137 |
|
|
| :01/82/050/00335/AM20/ |
|
:05/23/040/00131/AM20/ |
|
03.07.2019 |
|
|
|
|
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts |
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts |
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts |
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts |
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts |
|
|
and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
| 160 |
|
|
|
No. |
|
|
|
|
ACICLOVIR<br>TABLETS |
1 Number |
1 |
ACICLOVIR BP |
204.0 mg / |
|
|
BP<br>200<br>MG |
|
|
WHITE OR ALMOST WHITE |
200 mg tablet |
|
|
WHITE ROUND FLAT |
|
|
CRYSTALLINE POWDER |
|
|
|
SCORED ON ONE SIDE |
|
|
|
|
|
|
UNCOATED TABLETS |
|
|
|
|
|
|
ACICLOVIR<br>TABLETS |
1 Number |
1 |
ACICLOVIR BP |
408.0 mg / |
|
|
BP<br>400<br>MG |
|
|
WHITE OR ALMOST WHITE |
400 mg tablet |
|
|
WHITE ROUND FLAT |
|
|
CRYSTALLINE POWDER |
|
|
|
SCORED ON ONE SIDE |
|
|
|
|
|
|
UNCOATED TABLETS |
|
|
|
|
|
|
RA maytake appropriate action |
asper the decision of Norms Committee |
|
|
|
69
| 161 |
Case No.:110/6/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00266/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310830037<br>03.07.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00336/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 162 |
Case No.:111/6/82-ALC4/2019 |
Case No.:111/6/82-ALC4/2019 |
Party Name:BDR<br>PHARMACEUTICALS<br>INTERNATIONAL PRIVATE<br>LIMITED |
Party Name:BDR<br>PHARMACEUTICALS<br>INTERNATIONAL PRIVATE<br>LIMITED |
Party Name:BDR<br>PHARMACEUTICALS<br>INTERNATIONAL PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00337/AM20/ |
|
RLA File<br>:03/94/040/00263/AM20/ |
|
|
Lic.No/Date:0310830039<br>03.07.2019 |
|
|
|
<br>**Decision:**The Committee considered case as per<br>and it was decided to ratify the ad-hoc input output no<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Leflunomide 6.66% DCG<br>500 kg<br>1<br>RA maytake appropriate action asper the decision of |
|
|
|
agenda and in the presence of the technical experts<br>rms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
Leflunomide 6.66% DCG |
500 kg |
1 |
Leflunomide |
|
33.633 kg |
|
|
|
|
asper the decision of |
|
Norms Committee |
|
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts 162 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:
| 163 |
<br>Case No.:112/6/82-ALC4/2019 |
Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00338/AM20/ |
RLA File<br>:08/24/040/00112/AM20/ |
Lic.No/Date:0810145626<br>03.07.2019 |
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
70
| Case No.:113/6/82-ALC4/2019 |
|
Party Name:BODAL |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CHEMICALS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810145627 |
|
|
| :01/82/050/00339/AM20/ |
|
:08/24/040/00111/AM20/ |
|
03.07.2019 |
|
|
|
|
Case No.:113/6/82-ALC4/2019Party Name:BODAL<br>CHEMICALS LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00339/AM20/<br>RLA File<br>:08/24/040/00111/AM20/<br>Lic.No/Date:0810145627<br>03.07.2019 |
Case No.:113/6/82-ALC4/2019Party Name:BODAL<br>CHEMICALS LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00339/AM20/<br>RLA File<br>:08/24/040/00111/AM20/<br>Lic.No/Date:0810145627<br>03.07.2019 |
Case No.:113/6/82-ALC4/2019Party Name:BODAL<br>CHEMICALS LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00339/AM20/<br>RLA File<br>:08/24/040/00111/AM20/<br>Lic.No/Date:0810145627<br>03.07.2019 |
Case No.:113/6/82-ALC4/2019Party Name:BODAL<br>CHEMICALS LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00339/AM20/<br>RLA File<br>:08/24/040/00111/AM20/<br>Lic.No/Date:0810145627<br>03.07.2019 |
Case No.:113/6/82-ALC4/2019Party Name:BODAL<br>CHEMICALS LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00339/AM20/<br>RLA File<br>:08/24/040/00111/AM20/<br>Lic.No/Date:0810145627<br>03.07.2019 |
Case No.:113/6/82-ALC4/2019Party Name:BODAL<br>CHEMICALS LIMITED<br>Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00339/AM20/<br>RLA File<br>:08/24/040/00111/AM20/<br>Lic.No/Date:0810145627<br>03.07.2019 |
|
|
|
**Decision:**The Committee considered case as per agenda and in the presence of the technical experts |
|
|
|
|
|
|
|
|
and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
|
|
|
applied by firm whichever is lower: |
|
|
|
|
|
|
| 164 |
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
|
|
|
SULFO PARA BASE |
1 kg |
1 |
ANILINE OIL |
0.500 kg |
|
|
|
|
ESTER (SULFO VINYL<br>SULPHONE ESTER) |
|
2<br>3 |
ACETIC ACID(GLACIAL)<br>SULPHUR |
0.400 kg<br>0.927 kg |
|
|
|
|
|
|
4 |
CAUSTIC SODA FLAKES / LYE |
0.832 kg |
|
|
|
|
|
|
5 |
ETHYLENE OXIDE |
0.241 kg |
|
|
|
|
|
|
6 |
SODA ASH |
0.170 kg |
|
|
|
|
|
|
7 |
POTASSIUM CHLORIDE |
0.588 kg |
|
|
|
RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
Case No.:114/6/82-ALC4/2019 |
|
Party Name:TITAN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
LABORATORIES PVT. LTD. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 165 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310830043 |
|
Defer Date: |
|
|
:01/82/050/00340/AM20/ |
|
:03/95/040/00318/AM20/ |
|
03.07.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:115/6/82-ALC4/2019 |
|
Party Name:ELPPE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
CHEMICALS PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
16.08.2019 |
|
|
| 166 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310830047 |
|
Defer Date: |
|
|
:01/82/050/00341/AM20/ |
|
:03/94/040/00266/AM20/ |
|
03.07.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:117/6/82- |
|
Party Name:SYNTHO |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
CHIRALS PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
16.08.2019 |
|
|
| 167 |
|
HQ File<br>:01/82/050/00343/AM20/ |
|
RLA File<br>:09/24/040/00172/AM20/ |
|
Lic.No/Date:0910067749<br>03.07.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Hyderabad. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
71
| Case No.:118/6/82-ALC4/2019 |
|
Party Name:DEEPAK |
|
Meet No/Date:6/82- |
|
Status: |
|
|
NITRITE LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045252 |
|
|
| :01/82/050/00344/AM20/ |
|
:34/24/040/00056/AM20/ |
|
03.07.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 168 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| 2- ETHYL HEXYL |
1 kg |
1 |
2-ETHYL HEXANOL |
0.748 kg |
| NITRATE |
|
2 |
NITRIC ACID |
Not allowed |
|
|
3 |
SULPHURIC ACID |
Not allowed |
|
|
4 |
SODA ASH |
Not allowed |
| 169 |
Case No.:116/6/82-<br>ALC4/2019 |
Party Name:LUPIN LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00342/AM20/ |
RLA File<br>:03/95/040/00301/AM20/ |
Lic.No/Date:0310830087<br>04.07.2019 |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
72
| Case No.:119/6/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830091 |
|
|
| :01/82/050/00345/AM20/ |
|
:03/94/040/00261/AM20/ |
|
04.07.2019 |
|
|
|
Case No.:119/6/82-ALC4/2019 |
Case No.:119/6/82-ALC4/2019 |
Case No.:119/6/82-ALC4/2019 |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Party Name:GLENMARK<br>PHARMACEUTICALS LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310830091<br>04.07.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310830091<br>04.07.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00345/AM20/ |
|
|
RLA File<br>:03/94/040/00261/AM20/ |
|
|
|
|
| 170 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts<br>and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Clobetasol Propionate Cream USP 0.05%<br>(Pack Size 15gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.750 Kgs)<br>100000<br>Packs<br>1<br>CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED)<br>17.07 kg<br>2<br>Clobetasol Propionate Cream USP 0.05%<br>(Pack size 30gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.300 Kgs)<br>20000<br>Packs<br>3<br>Clobetasol Propionate Cream USP 0.05%<br>(Pack size 45 gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.450 Kgs)<br>20000<br>Packs<br>4<br>Clobetasol Propionate Cream USP 0.05%<br>(Pack size 60gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.600 Kgs)<br>20000<br>Packs<br>5<br>Clobetasol Propionate Ointment USP<br>0.05% (Pack size 15gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.150 Kgs)<br>20000<br>Packs<br>6<br>Clobetasol Propionate Ointment USP<br>0.05% (Pack size 30gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.750 Kgs)<br>50000<br>Packs<br>7<br>Clobetasol Propionate Ointment USP<br>0.05% (Pack size 45gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.900 Kgs)<br>40000<br>Packs<br>8<br>Clobetasol Propionate Ointment USP<br>0.05% (Pack size 60gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.600 Kgs)<br>20000<br>Packs<br>9<br>Clobetasol Propionate Spray 0.05% (Pack<br>size 59ml)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 1.180 Kgs)<br>40000<br>Packs<br>10<br>Clobetasol Propionate Spray 0.05% (Pack<br>size 125ml)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 1.250 Kgs)<br>20000<br>Packs<br>11<br>Clobetasol Prop. Top Sol USP, 0.05%<br>25ml<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.625 Kgs)<br>50000<br>Packs |
|
|
|
|
|
|
|
|
|
Sl.<br>No. |
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
Qty. |
|
|
1 |
Clobetasol Propionate Cream USP 0.05%<br>(Pack Size 15gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.750 Kgs) |
|
100000<br>Packs |
1 |
CLOBETASOL<br>PROPIONATE<br>USP<br>(MICRONIZED) |
17.07 kg |
|
|
2 |
Clobetasol Propionate Cream USP 0.05%<br>(Pack size 30gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.300 Kgs) |
|
20000<br>Packs |
|
|
|
|
|
3 |
Clobetasol Propionate Cream USP 0.05%<br>(Pack size 45 gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.450 Kgs) |
|
20000<br>Packs |
|
|
|
|
|
4 |
Clobetasol Propionate Cream USP 0.05%<br>(Pack size 60gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.600 Kgs) |
|
20000<br>Packs |
|
|
|
|
|
5 |
Clobetasol Propionate Ointment USP<br>0.05% (Pack size 15gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.150 Kgs) |
|
20000<br>Packs |
|
|
|
|
|
6 |
Clobetasol Propionate Ointment USP<br>0.05% (Pack size 30gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.750 Kgs) |
|
50000<br>Packs |
|
|
|
|
|
7 |
Clobetasol Propionate Ointment USP<br>0.05% (Pack size 45gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.900 Kgs) |
|
40000<br>Packs |
|
|
|
|
|
8 |
Clobetasol Propionate Ointment USP<br>0.05% (Pack size 60gm)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.600 Kgs) |
|
20000<br>Packs |
|
|
|
|
|
9 |
Clobetasol Propionate Spray 0.05% (Pack<br>size 59ml)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 1.180 Kgs) |
|
40000<br>Packs |
|
|
|
|
|
10 |
Clobetasol Propionate Spray 0.05% (Pack<br>size 125ml)<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 1.250 Kgs) |
|
20000<br>Packs |
|
|
|
|
|
11 |
Clobetasol Prop. Top Sol USP, 0.05%<br>25ml<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.625 Kgs) |
|
50000<br>Packs |
|
|
|
73
|
12<br>Clobetasol Prop. Top Sol USP, 0.05%<br>50ml<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.500 Kgs)<br>20000<br>Packs<br>13<br>Clobetasol Pro Shampoo, 0.05 % 118ml<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 1.180 Kgs)<br>20000<br>Packs<br>14<br>Clobetasol Propionate Foam 0.05% 50gm<br>( Net. wt. of Net. wt. of Clobetasol<br>Propionate USP (Micronized) is 2.500<br>Kgs.)<br>100000<br>Packs<br>15<br>Clobetasol Propionate Foam 0.05%<br>100gm<br>( Net. wt. of Clobetasol Propionate USP<br>(Micronized) is 5.000 Kgs.)<br>100000<br>Packs<br>RA maytake appropriate action asper the decision of Norms Committee |
12 |
Clobetasol Prop. Top Sol USP, 0.05%<br>50ml<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.500 Kgs) |
20000<br>Packs |
|
|
|
|
|
13 |
Clobetasol Pro Shampoo, 0.05 % 118ml<br>(Net Weight of Clobetasol Propionate<br>USP (Micronized) 1.180 Kgs) |
20000<br>Packs |
|
|
|
|
|
14 |
Clobetasol Propionate Foam 0.05% 50gm<br>( Net. wt. of Net. wt. of Clobetasol<br>Propionate USP (Micronized) is 2.500<br>Kgs.) |
100000<br>Packs |
|
|
|
|
|
15 |
Clobetasol Propionate Foam 0.05%<br>100gm<br>( Net. wt. of Clobetasol Propionate USP<br>(Micronized) is 5.000 Kgs.) |
100000<br>Packs |
|
|
|
|
|
|
|
|
|
|
|
| 171 |
<br>Case No.:120/6/82-ALC4/2019 |
Party Name:YASHO<br>INDUSTRIES LIMITED<br>RLA File<br>:03/95/040/00322/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00346/AM20/ |
|
Lic.No/Date:0310830094<br>04.07.2019 |
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 172 |
<br>Case No.:121/6/82-<br>ALC4/2019 |
Party Name:YASHO<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310830121<br>05.07.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00347/AM20/ |
RLA File<br>:03/95/040/00331/AM20/ |
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 173 |
Case No.:122/6/82-<br>ALC4/2019 |
Party Name:PROLIFE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310830123<br>05.07.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00348/AM20/ |
RLA File<br>:03/95/040/00329/AM20/ |
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
74
| Case No.:123/6/82-ALC4/2019 |
|
Party Name:OLIVE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
HEALTHCARE |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830125 |
|
|
| :01/82/050/00349/AM20/ |
|
:03/95/040/00317/AM20/ |
|
05.07.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 174
| Export product<br>TEMAZEPAM TEVA 10<br>MG CAPSULES<br>TEMAZEPAM TEVA 20<br>MG CAPSULES |
Qty.<br>6000000<br>Number<br>3999990<br>Number |
Sl.<br>No.<br>1 |
Import items<br>TEMAZEPAM Ph Eur |
Qty.<br>142.80 kg |
| Case No.:124/6/82-ALC4/2019 |
|
Party Name:VERVE HUMAN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CARE LABORATORIES |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411161 |
|
|
| :01/82/050/00350/AM20/ |
|
:05/24/040/00177/AM20/ |
|
05.07.2019 |
|
|
| 175 |
Case No.:124/6/82-ALC4/2019 |
Case No.:124/6/82-ALC4/2019 |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Party Name:VERVE HUMAN<br>CARE LABORATORIES |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00350/AM20/ |
|
RLA File<br>:05/24/040/00177/AM20/ |
|
|
Lic.No/Date:0510411161<br>05.07.2019 |
|
|
|
<br>**Decision:**The Committee considered case as per<br>and it was decided to ratify the ad-hoc input output no<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Inj. Adrenaline 1mg/ml,1ml<br>Amp ( Adrenaline acid<br>tartrate BP 1.8mg eq.<br>Adrenaline base 1mg /ml,<br>1ml Amp)<br>405000<br>Number<br>1<br>RA maytake appropriate action asper the decision of |
|
|
|
agenda and in the presence of the technical experts<br>rms under para 4.7 of HBP as per details below or as |
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
Inj. Adrenaline 1mg/ml,1ml<br>Amp ( Adrenaline acid<br>tartrate BP 1.8mg eq.<br>Adrenaline base 1mg /ml,<br>1ml Amp) |
405000<br>Number |
1 |
Adrenaline Acid Bitartrate |
|
0.802 kg |
|
|
|
|
asper the decision of |
|
Norms Committee. |
|
|
|
175
75
| Case No.:125/6/82-ALC4/2019 |
|
Party Name:SOHAN |
|
Meet No/Date:6/82- |
|
Status: |
|
|
HEALTHCARE PVT. LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067465 |
|
|
| :01/82/050/00351/AM20/ |
|
:31/83/040/00052/AM20/ |
|
05.07.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 176 per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| METFORMIN |
1 kg |
1 |
DICYANDIAMIDE (DCDA) |
0.567 kg |
| HYDROCHLORIDE BP/EP |
|
|
WHITE POWDER |
|
| WHITE CRYSTLLINE POWDER |
|
|
|
|
| Case No.:126/6/82- |
|
Party Name:SENTISS |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
PHARMA PVT.LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411169 |
|
|
| :01/82/050/00352/AM20/ |
|
:05/24/040/00216/AM20/ |
|
05.07.2019 |
|
|
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 177 applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Dancil Eye & Ear Drops .3% 5ml |
1 Pack |
1 |
Ofloxacin |
0.0153 gm / 5 ml pack |
| 178 |
<br>Case No.:127/6/82-<br>ALC4/2019 |
Party Name:APNAR<br>PHARMA PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00353/AM20/ |
RLA File<br>:34/24/040/00098/AM20/ |
Lic.No/Date:3410045258<br>05.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
| 179 |
<br>Case No.:128/6/82-<br>ALC4/2019 |
Party Name:PANACEA<br>BIOTEC LTD., |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00354/AM20/ |
RLA File<br>:05/24/040/00217/AM20/ |
Lic.No/Date:0510411176<br>08.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
76
| Case No.:129/6/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830153 |
|
|
| :01/82/050/00355/AM20/ |
|
:03/94/040/00277/AM20/ |
|
08.07.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 180
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| Lidocaine Ointment USP |
125000 Number |
1 |
LIDOCAINE USP |
225.93 kg |
| 5%(Pack Size 35.44gms) |
|
|
|
|
| Lidocaine Ointment USP |
135000 Number |
1 |
LIDOCAINE USP |
344.25 kg |
| 5% (Pack Size 50gms) |
|
|
|
|
|
|
Case No.:130/6/82- |
|
Party Name:ACME |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
GENERICS LLP |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 181 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:2210016194 |
|
Defer Date: |
|
|
:01/82/050/00356/AM20/ |
|
:22/24/040/00026/AM20/ |
|
08.07.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:142/6/82-ALC4/2019 |
|
Party Name:LANTECH |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067759 |
|
|
| :01/82/050/00368/AM20/ |
|
:09/24/040/00177/AM20/ |
|
09.07.2019 |
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
182
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| N,N-CARBONYL |
1 kg |
1 |
Imidazole |
1.31 kg |
| DIIMIDAZOLE |
|
2 |
Triphosgene |
1.20 kg |
|
|
3 |
Tributylamine |
1.78 kg |
|
|
4 |
Toluene |
2.20 kg |
77
| Case No.:143/6/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830168 |
|
|
| :01/82/050/00369/AM20/ |
|
:03/94/040/00279/AM20/ |
|
09.07.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts 183 and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
|
AZELAIC ACID GEL 15% |
250000 Packs |
1 |
Azelaic Acid |
1912.50 kg |
|
(Pack Size 50 Grams) |
|
|
|
|
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
Case No.:144/6/82-ALC4/2019 |
|
Party Name:LACTOSE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
(INDIA) LTD., |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
16.08.2019 |
|
|
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310830184 |
|
|
|
:01/82/050/00370/AM20/ |
|
:03/95/040/00296/AM20/ |
|
09.07.2019 |
|
|
184 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) Certificate of Analysis ( CoA) of import item from foreign supplier.
(ii) Certificate of Analysis ( CoA) of export item from the party.
|
|
Case No.:145/6/82- |
|
Party Name:MAHARSHI |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
PHARMA CHEM PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
16.08.2019 |
|
|
| 185 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0810145666 |
|
Defer Date: |
|
|
:01/82/050/00371/AM20/ |
|
:08/24/040/00114/AM20/ |
|
09.07.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
| 186 |
<br>Case No.:146/6/82-<br>ALC4/2019<br>Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED<br>HQ File<br>:01/82/050/00372/AM20/<br>RLA File<br>:08/24/040/00115/AM20/<br>**Decision:**New Case,deferred for comments of TE. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0810145667<br>09.07.2019 |
Status:<br>Deferred<br>Defer Date: |
78
| Case No.:149/6/82-ALC4/2019 |
|
Party Name:RAVOOS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LABORATORIES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067761 |
|
|
| :01/82/050/00375/AM20/ |
|
:09/24/040/00183/AM20/ |
|
09.07.2019 |
|
|
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 187 applied by firm whichever is lower:
| Exportproduct |
Qty. |
Sl. No. |
Import items |
Qty. |
| Azithromycin Dihydrate Taste |
20000 kg |
1 |
Azithromycin Dihydrate |
1604 kg |
| Masked Granules 7.5% w/w / |
|
|
|
|
| Azithromycin Taste Masked |
|
|
|
|
| Granules 7.5% w/w. |
|
|
|
|
|
|
Case No.:150/6/82- |
|
Party Name:MAHARSHI |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
PHARMA CHEM PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
16.08.2019 |
|
|
| 188 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0810145668 |
|
Defer Date: |
|
|
:01/82/050/00376/AM20/ |
|
:08/24/040/00116/AM20/ |
|
09.07.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:151/6/82- |
|
Party Name:MAHARSHI |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
PHARMA CHEM PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
16.08.2019 |
|
|
| 189 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0810145669 |
|
Defer Date: |
|
|
:01/82/050/00377/AM20/ |
|
:08/24/040/00117/AM20/ |
|
09.07.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:147/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 190 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310830195 |
|
Defer Date: |
|
|
:01/82/050/00373/AM20/ |
|
:03/94/040/00281/AM20/ |
|
10.07.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
| 191 |
Case No.:148/6/82-<br>ALC4/2019 |
Party Name:THINQ PHARMA<br>CRO LIMITED<br> <br> <br> <br>RLA File<br>:03/95/040/00338/AM20/<br> <br> |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0310830207<br>10.07.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00374/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
79
| Case No.:152/6/82- |
|
Party Name:JUBILANT |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
GENERICS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0510411213 |
|
|
| :01/82/050/00378/AM20/ |
|
:05/23/040/00152/AM20/ |
|
10.07.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 192 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export product Qty. Sl. Import Item Qty. No. Amantadine HCl 1 tablet 1 Amantadine Hydrochloride 102 mg/ 100 mg tablet Tablet 100mg
| Case No.:153/6/82-ALC4/2019 |
|
Party Name:GLAND |
|
Meet No/Date:6/82- |
|
Status: |
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067774 |
|
|
| :01/82/050/00379/AM20/ |
|
:09/24/040/00195/AM20/ |
|
11.07.2019 |
|
|
193
| 193 |
Case No.:153/6/82-ALC4/2019 |
Case No.:153/6/82-ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00195/AM20/ |
Party Name:GLAND<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00195/AM20/ |
Party Name:GLAND<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00195/AM20/ |
Party Name:GLAND<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00195/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00379/AM20/ |
|
|
|
|
|
Lic.No/Date:0910067774<br>11.07.2019 |
|
|
|
<br>**Decision:**The Committee considered case as per agenda and in the presence<br>and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP a<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Chlorothiazide<br>Sodium<br>for<br>Injection, USP 500mg/vial, 20ml<br>Vial<br>USP<br>1 Number<br>1<br>Chlorothiazide<br>USP<br>2<br>Glass Vials<br>3<br>Rubber Stoppers<br>4<br>Flip off Seals<br>RA maytake appropriate action asper the decision of Norms Committee. |
|
|
|
|
|
|
of the technical experts<br>s per details below or as<br>Qty.<br>525 mg / 20 ml vial<br>Relevant<br>as<br>per<br>Packing Policy |
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
Chlorothiazide<br>Sodium<br>for<br>Injection, USP 500mg/vial, 20ml<br>Vial<br>USP |
|
1 Number |
1 |
Chlorothiazide<br>USP |
|
525 mg / 20 ml vial |
|
|
|
|
|
|
2 |
Glass Vials |
|
Relevant<br>as<br>per<br>Packing Policy |
|
|
|
|
|
|
3 |
Rubber Stoppers |
|
|
|
|
|
|
|
|
4 |
Flip off Seals |
|
|
|
|
|
|
|
|
of Norms Committee. |
|
|
|
|
| 194 |
<br>Case No.:154/6/82-<br>ALC4/2019 |
Party Name:INDO AMINES<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310830244<br>12.07.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00380/AM20/ |
RLA File<br>:03/94/040/00122/AM20/ |
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
80
| 195 |
Case No.:155/6/82-<br>ALC4/2019 |
Party Name:ORIENTAL<br>AROMATICS LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310830246<br>12.07.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00381/AM20/ |
RLA File<br>:03/95/040/00335/AM20/ |
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 196 |
Case No.:156/6/82-<br>ALC4/2019 |
Party Name:ORIENTAL<br>AROMATICS LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310830257<br>12.07.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00382/AM20/ |
RLA File<br>:03/95/040/00356/AM20/ |
|
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 197 |
<br>Case No.:157/6/82-<br>ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0910067778<br>12.07.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00383/AM20/ |
RLA File<br>:09/24/040/00187/AM20/ |
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
Case No.:158/6/82- Party Name:SYNNAT Meet No/Date:6/82- Status: ALC4/2019 PHARMA PRIVATE ALC4/2019 Approved LIMITED 16.08.2019 HQ File RLA File Lic.No/Date:0210209307 :01/82/050/00384/AM20/ :02/24/040/00056/AM20/ 12.07.2019 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 198 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export Product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| Noscapine BP USP Ph.Eur JP CP /<br>NoscapineHydrochlorideBP Ph.Eur |
1 kg |
1 |
Noscapine Crude Content 95% |
1.10 kg |
81
| Case No.:159/6/82- |
|
Party Name:SOMU ORGANO |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
CHEM PVT.LTD., |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0710115163 |
|
|
| :01/82/050/00385/AM20/ |
|
:07/24/040/00088/AM20/ |
|
12.07.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018, dated 22.03.2019, it was 199 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. |
| 1,3-CYCLOHEXANEDIONE |
1 kg |
1 |
RESORCINOL |
1.196 kg |
| 200 |
<br>Case No.:162/6/82-<br>ALC4/2019 |
Party Name:ANG<br>LIFESCIENCES INDIA LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00388/AM20/ |
RLA File<br>:30/24/040/00064/AM20/ |
Lic.No/Date:3010104756<br>12.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 201 |
Case No.:160/6/82-<br>ALC4/2019 |
Party Name:ORIENTAL<br>AROMATICS LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00386/AM20/ |
RLA File<br>:03/95/040/00363/AM20/ |
Lic.No/Date:0310830298<br>15.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:161/6/82-ALC4/2019 |
|
Party Name:INDO AMINES |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830304 |
|
|
| :01/82/050/00387/AM20/ |
|
:03/94/040/00292/AM20/ |
|
15.07.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts 202 and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| TETRA BUTYL UREA / IAL TBU /<br>1,1,3,3-TETRABUTYLUREA |
1 kg |
1 |
DINBUTYL AMINE |
1.00kg |
|
|
2 |
TRIPHOSGENE |
0.319 kg |
82
| 203 |
Case No.:163/6/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00389/AM20/ |
RLA File<br>:03/95/040/00294/AM20/ |
Lic.No/Date:0310830351<br>16.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 204 |
Case No.:164/6/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00390/AM20/ |
RLA File<br>:03/95/040/00293/AM20/ |
Lic.No/Date:0310830352<br>16.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 205 |
Case No.:165/6/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00391/AM20/ |
RLA File<br>:03/95/040/01002/AM19/ |
Lic.No/Date:0310830355<br>16.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
Case No.:166/6/82-ALC4/2019 Party Name:BALAJI AMINES Meet No/Date:6/82- Status: LIMITED ALC4/2019 Approved 16.08.2019 HQ File RLA File Lic.No/Date:3110067474 :01/82/050/00392/AM20/ :31/83/040/00061/AM20/ 16.07.2019
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 12/82-ALC4/2018 dated 12.12..2018, it was decided to ratify norms under Para 4.7 of HBP v1 206 as per details given below or as applied by the firm, whichever is less:
| Export Product |
Qty. |
Sl. |
Import Items |
Qty. |
|
|
No. |
|
|
| GAMMA BUTYROLACTONE |
1 kg |
1. |
1,4 BUTANEDIOL |
1.16 kg |
|
|
2. |
GBL CATAYLYST |
0.001 kg |
83
| Case No.:167/6/82-ALC4/2019 |
|
Party Name:BALAJI AMINES |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067475 |
|
|
| :01/82/050/00393/AM20/ |
|
:31/83/040/00060/AM20/ |
|
16.07.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
207
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| N-METHYL-2-PYRROLIDONE |
1 kg |
1 |
METHANOL |
0.370 kg |
|
|
2 |
AMMONIA ANHYDROUS |
0.160 kg |
|
|
3 |
1,4 BUTANEDIOL |
1.044 kg |
|
|
4 |
METHYLAMINE CATALYST |
0.00080 kg |
|
|
5 |
GBL CATALYST |
0.00075 kg |
| Case No.:168/6/82-ALC4/2019 |
|
Party Name:BALAJI AMINES |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067476 |
|
|
| :01/82/050/00394/AM20/ |
|
:31/83/040/00062/AM20/ |
|
16.07.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 208 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| Export product |
Qty. |
Sl. No. |
Import items |
Qty. |
| N-ETHYL-2- |
1 kg |
1 |
GAMMA BUTYROLACTONE |
0.72 kg |
| PYRROLIDONE |
|
2 |
MONOETHYLAMINE 70% |
0.533 kg |
|
|
|
SOLUTION |
|
84
| Case No.:204/6/82-ALC4/2019 |
|
Party Name:ZENITH |
|
Meet No/Date:6/82- |
|
Status: |
|
|
DYEINTERMEDIATES |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830334 |
|
|
| :01/82/050/00430/AM20/ |
|
:03/95/040/00306/AM20/ |
|
16.07.2019 |
|
|
Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 5/82-ALC4/2019 dated 02.08.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as 209 per details given below or as applied by the firm, whichever is less:
| Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
No. |
|
|
| NAS-5 |
1 kg |
1 |
TOBIAS ACID |
1.618 kg |
| (2-DIAZO-1-NAPTHOL-5- |
|
|
(PURITY MIN. 97%) |
|
| SULFONIC ACID, SODIUM SALT) |
|
|
|
|
| 210 |
Case No.:169/6/82-<br>ALC4/2019 |
Party Name:PRACHEM<br>LABORATORIES<br> <br> <br> <br>RLA File<br>:08/24/040/00123/AM20/<br> <br> |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br> <br><br>Lic.No/Date:0810145731<br>17.07.2019<br> |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00395/AM20/ |
|
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Ahmedabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
| 211 |
Case No.:170/6/82-<br>ALC4/2019 |
Party Name:RUBICON<br>RESEARCH PVT. LTD., |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00396/AM20/ |
RLA File<br>:03/95/040/00251/AM20/ |
Lic.No/Date:0310830404<br>18.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
85
| Case No.:171/6/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830410 |
|
|
| :01/82/050/00397/AM20/ |
|
:03/94/040/00311/AM20/ |
|
18.07.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 13/82-ALC4/2018, dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
212
| Sl.<br>No. |
Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 1 |
Mupirocin Ointment USP 2%<br>(Pack Size 22gms) |
1 pack |
1 |
Mupirocin USP |
0.4488 gm/22<br>gm pack |
| 2 |
Supiroban 15gm Ointment ZA<br>(Pack Size 15gms) |
1 pack |
1 |
Mupirocin USP |
0.306 gm/15<br>gm pack |
| 3 |
Supiroban 14gm zulu Ointment<br>(Pack Size 14gms) |
1 pack |
1 |
Mupirocin USP |
0.2856 mg/14<br>gm pack |
| 4 |
Supiroban 50gm Ointment (Pack<br>Size 50gms) |
1 pack |
1 |
Mupirocin USP |
0.51 gm/50<br>gm pack |
| 213 |
<br>Case No.:203/6/82-<br>ALC4/2019 |
Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:3410045298<br>18.07.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00429/AM20/ |
RLA File<br>:34/24/040/00069/AM20/ |
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| Case No.:206/6/82-ALC4/2019 |
|
Party Name:WINDLAS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
HEALTH CARE PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:6110001607 |
|
|
| :01/82/050/00432/AM20/ |
|
:61/24/040/00005/AM20/ |
|
18.07.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts 214 and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
Export product |
Qty. |
Sl. |
Import items |
Qty. |
|
|
|
No. |
|
|
|
Acyclovir Capsules 200 mg |
1 Number |
1 |
Acyclovir |
204 mg / 200 mg Tablet |
|
AntiViral Drug |
|
|
|
|
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
86
| 215 |
<br>Case No.:199/6/82-ALC4/2019 |
Party Name:CIRON DRUGS &<br>PHARMACEUTICALS P.<br>LTD., |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00425/AM20/ |
RLA File<br>:03/94/040/00312/AM20/ |
Lic.No/Date:0310830435<br>19.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| Case No.:205/6/82-ALC4/2019 |
|
Party Name:BODAL |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CHEMICALS LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0810145761 |
|
|
| :01/82/050/00431/AM20/ |
|
:08/24/040/00128/AM20/ |
|
22.07.2019 |
|
|
|
Case No.:205/6/82-ALC4/2019 |
Case No.:205/6/82-ALC4/2019 |
Party Name:BODAL<br>CHEMICALS LIMITED |
Party Name:BODAL<br>CHEMICALS LIMITED |
Party Name:BODAL<br>CHEMICALS LIMITED |
Party Name:BODAL<br>CHEMICALS LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00431/AM20/ |
|
RLA File<br>:08/24/040/00128/AM20/ |
|
|
|
Lic.No/Date:0810145761<br>22.07.2019 |
|
|
| 216 |
<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<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>SULFO PARA BASE ESTER<br>(SULFO VINYL SULPHONE<br>ESTER)<br>1 kg<br>1<br>ANILINE OIL<br>0.500 kg<br>2<br>ACETIC ACID(GLACIAL)<br>0.400 kg<br>3<br>SULPHUR<br>0.927 kg<br>4<br>CAUSTIC SODA FLAKES / LYE<br>0.832 kg<br>5<br>ETHYLENE OXIDE<br>0.241 kg<br>6<br>SODA ASH<br>0.170 kg<br>7<br>POTASSIUM CHLORIDE<br>0.588 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
|
Export product |
|
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
|
SULFO PARA BASE ESTER<br>(SULFO VINYL SULPHONE<br>ESTER) |
|
1 kg |
1 |
ANILINE OIL |
|
0.500 kg |
|
|
|
|
|
|
2 |
ACETIC ACID(GLACIAL) |
|
0.400 kg |
|
|
|
|
|
|
3 |
SULPHUR |
|
0.927 kg |
|
|
|
|
|
|
4 |
CAUSTIC SODA FLAKES / LYE |
|
0.832 kg |
|
|
|
|
|
|
5 |
ETHYLENE OXIDE |
|
0.241 kg |
|
|
|
|
|
|
6 |
SODA ASH |
|
0.170 kg |
|
|
|
|
|
|
7 |
POTASSIUM CHLORIDE |
|
0.588 kg |
|
|
|
|
|
|
|
Norms Committee |
|
|
|
| 217 |
Case No.:209/6/82-ALC4/2019 |
Case No.:209/6/82-ALC4/2019 |
Party Name:WINDLAS<br>HEALTH CARE PRIVATE<br>LIMITED |
Party Name:WINDLAS<br>HEALTH CARE PRIVATE<br>LIMITED |
Party Name:WINDLAS<br>HEALTH CARE PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00435/AM20/ |
|
RLA File<br>:61/24/040/00004/AM20/ |
|
|
Lic.No/Date:6110001608<br>22.07.2019 |
|
|
|
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts and<br>it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Amiloride HCI Tablet 5 mg<br>antikaliuretic diuretic agent<br>1 Number<br>1<br>Amiloride Hydrochloride<br>5.10 mg / 5<br>mg Tablet<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl. No. |
Import items |
|
Qty. |
|
|
|
Amiloride HCI Tablet 5 mg<br>antikaliuretic diuretic agent |
1 Number |
1 |
Amiloride Hydrochloride |
|
5.10 mg / 5<br>mg Tablet |
|
|
|
|
asper the decision of Norms Committee |
|
|
|
|
|
87
| Case No.:207/6/82- |
|
Party Name:PRACHI |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS PVT |
|
ALC4/2019 |
|
Approved |
|
|
LTD |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830498 |
|
|
| :01/82/050/00433/AM20/ |
|
:03/95/040/00406/AM20/ |
|
23.07.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 218 , 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. Import items Qty. No. THIAMINE HYDRO CHLORIDE 1 kg 1 THIAMINE MONONITRATE 1.02 kg RA concerned may take further necessary action as per above decision of NC.
| 219 |
<br>Case No.:208/6/82-ALC4/2019 |
Party Name:VISION DRUGS<br>PVT LTD<br>RLA File<br>:09/24/040/00210/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00434/AM20/ |
|
Lic.No/Date:0910067812<br>23.07.2019 |
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 220 |
Case No.:210/6/82-<br>ALC4/2019 |
Party Name:HETERO LABS<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00436/AM20/ |
RLA File<br>:09/24/040/00212/AM20/ |
Lic.No/Date:0910067817<br>23.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 221 |
<br>Case No.:244/6/82-<br>ALC4/2019 |
Party Name:JODAS EXPOIM<br>PVT.LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00470/AM20/ |
RLA File<br>:09/24/040/00193/AM20/ |
Lic.No/Date:0910067814<br>23.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
88
| 222 |
Case No.:211/6/82-<br>ALC4/2019 |
Party Name:ANWITA DRUGS<br>& CHEMICALS PVT LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00437/AM20/ |
RLA File<br>:09/24/040/00214/AM20/ |
Lic.No/Date:0910067818<br>24.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| 223 |
Case No.:212/6/82-<br>ALC4/2019 |
Party Name:HETERO LABS<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00438/AM20/ |
RLA File<br>:09/24/040/00211/AM20/ |
Lic.No/Date:0910067819<br>24.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:213/6/82-ALC4/2019 |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
|
|
LIFE SCIENCES LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830525 |
|
|
| :01/82/050/00439/AM20/ |
|
:03/94/040/00323/AM20/ |
|
24.07.2019 |
|
|
|
Case No.:213/6/82-ALC4/2019 |
Case No.:213/6/82-ALC4/2019 |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Party Name:GLENMARK<br>LIFE SCIENCES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00439/AM20/ |
|
RLA File<br>:03/94/040/00323/AM20/ |
|
|
Lic.No/Date:0310830525<br>24.07.2019 |
|
| 224 |
<br>**Decision:**The Committee considered case as per agenda and in the presence of the technical experts and<br>it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>OLMESARTAN<br>MEDOXOMIL<br>1 kg<br>1<br>4-(1-HYDROXY-1-METHYL<br>ETHYL)-2-PROPYL-1H-<br>IMIDAZOLE 5-CARBOXYLIC<br>ACID ETHYL ESTER<br>0.70 kg<br>2<br>5-(4-BROMOMETHYL<br>BIPHENYL-2-YL)-1-TRITYL-1H-<br>TETRAZOLE<br>5-(4-BROMOMETHYL) (1,-<br>BROMOMETHYLIPHENYL)-2YL<br>TRIPHENYL-1-H TETRAZOLE<br>1.35 kg<br>3<br>4-CHLOROMETHYL-5-METHYL<br>1,3-DIOXOLEN-2-ONE<br>0.4654 kg<br>4<br>METHYLENE CHLORIDE (MDC)<br>3.50 kg<br>5<br>TOLUENE<br>2.50 kg<br>6<br>DIMETHYL FORMAMIDE (DMF)<br>1.50 kg<br>RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
|
|
Export product |
Qty. |
Sl.<br>No. |
Import items |
|
Qty. |
|
|
OLMESARTAN<br>MEDOXOMIL |
1 kg |
1 |
4-(1-HYDROXY-1-METHYL<br>ETHYL)-2-PROPYL-1H-<br>IMIDAZOLE 5-CARBOXYLIC<br>ACID ETHYL ESTER |
|
0.70 kg |
|
|
|
|
2 |
5-(4-BROMOMETHYL<br>BIPHENYL-2-YL)-1-TRITYL-1H-<br>TETRAZOLE<br>5-(4-BROMOMETHYL) (1,-<br>BROMOMETHYLIPHENYL)-2YL<br>TRIPHENYL-1-H TETRAZOLE |
|
1.35 kg |
|
|
|
|
3 |
4-CHLOROMETHYL-5-METHYL<br>1,3-DIOXOLEN-2-ONE |
|
0.4654 kg |
|
|
|
|
4 |
METHYLENE CHLORIDE (MDC) |
|
3.50 kg |
|
|
|
|
5 |
TOLUENE |
|
2.50 kg |
|
|
|
|
6 |
DIMETHYL FORMAMIDE (DMF) |
|
1.50 kg |
|
|
|
asper the decision of |
|
Norms Committee |
|
|
89
| 225 |
<br>Case No.:214/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00440/AM20/ |
RLA File<br>:03/94/040/00324/AM20/ |
Lic.No/Date:0310830527<br>24.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 226 |
Case No.:215/6/82-<br>ALC4/2019 |
Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00441/AM20/ |
RLA File<br>:31/83/040/00047/AM20/ |
Lic.No/Date:3110067483<br>24.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Pune. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.
| 227 |
Case No.:216/6/82-<br>ALC4/2019 |
Party Name:ORIENTAL<br>AROMATICS LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00442/AM20/ |
RLA File<br>:03/95/040/00413/AM20/ |
Lic.No/Date:0310830547<br>24.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| 228 |
Case No.:217/6/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00443/AM20/ |
RLA File<br>:03/95/040/00387/AM20/ |
Lic.No/Date:0310830566<br>25.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
90
| Case No.:218/6/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830585 |
|
|
| :01/82/050/00444/AM20/ |
|
:03/94/040/00335/AM20/ |
|
25.07.2019 |
|
|
|
Case No.:218/6/82- |
Case No.:218/6/82- |
Case No.:218/6/82- |
Party Name:GLENMARK |
Party Name:GLENMARK |
Party Name:GLENMARK |
Party Name:GLENMARK |
Party Name:GLENMARK |
Meet No/Date:6/82- |
Meet No/Date:6/82- |
Meet No/Date:6/82- |
Meet No/Date:6/82- |
Status: |
Status: |
|
<br>ALC4/2019 |
|
|
<br>PHARMACEUTICALS LTD |
|
|
|
|
<br>A<br>1 |
<br>LC4/2019<br>6.08.2019 |
|
|
<br>A |
<br>pproved |
|
HQ File |
|
|
RLA File<br>:03/94/040/00335/AM20/ |
|
|
|
|
L |
ic.No/Date:0310830585 |
|
|
|
|
|
<br>:01/82/050/00444/AM20/ |
|
|
|
|
|
|
|
<br>2 |
<br>5.07.2019 |
|
|
|
|
|
**Decision:**The Committee c |
|
|
onsidered case as per agenda and |
|
|
|
|
|
in the presence of the tech |
|
|
|
nical experts |
|
<br>and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sl.<br>No.<br> |
Export product<br> |
|
|
|
Qty<br> |
|
Sl.<br>No.<br> |
|
Import items |
|
|
Qty.<br> |
|
|
1 |
Mometasone Furoate<br>(Pack 10gms) (Net Wt<br>Furoate Micronized 0. |
Ointment 0.10%<br>. of Mometasone<br>180 Kgs.) |
|
|
18000<br>Packs |
|
1 |
|
Mometasone<br>Furoate Micronized |
|
|
50.287 kg |
|
|
2 |
Mometasone Furoate |
Ointment 0.10%<br>. of Mometasone<br>270 Kgs.) |
|
|
18000 |
|
|
|
|
|
|
|
|
|
|
<br>(Pack 15gms) (Net Wt<br>Furoate Micronized 0. |
|
|
|
<br>Packs |
|
|
|
|
|
|
|
|
|
3 |
Mometasone Furoate Ointment 0.10%<br>/Momate Ointment 0.10% (Pack 20gms)<br>(Net Wt. of Mometasone Furoate<br>Micronized 0.280 Kgs.) |
|
|
|
14000<br>Packs |
|
|
|
|
|
|
|
|
|
4 |
Mometasone Furoate Ointment<br>(Pack 30gms) (Net Wt. of Mom<br> |
|
0.10%<br>etasone<br> |
|
10<br>Pa |
0000<br>cks |
|
|
|
|
|
|
|
|
|
Furoate Micronized 3.000 Kgs.) |
|
|
|
|
|
|
|
|
|
|
|
|
|
5 |
Mometasone Furoate Ointment<br> |
|
0.10%<br> |
|
90<br> |
000<br> |
|
|
|
|
|
|
|
|
|
(pack 45gms) (Net Wt. of Mometasone<br>Furoate Micronized 4.050 Kgs.) |
|
|
|
Packs |
|
|
|
|
|
|
|
|
|
6 |
Mmtn Frt Ointmnt 010% |
|
|
|
8100 |
|
|
|
|
|
|
|
| 229 |
|
|
oeasoe uoae e .<br>(Pack 50gms) (Net Wt. of Mometasone<br>Furoate Micronized 0.405 Kgs.) |
|
|
|
<br>Packs |
|
|
|
|
|
|
|
|
|
7 |
<br>Mometasone Furoate<br>(pack 60gms) (Net Wt<br>Furoate Micronized 0. |
<br>Ointment 0.10%<br>. of Mometasone<br>570 Kgs.) |
|
|
9500<br>Packs |
|
|
|
|
|
|
|
|
|
8 |
Mometasone Furoate<br>(pack 100gms) (Net W<br> |
Ointment 0.10%<br>t. of Mometasone<br> |
|
|
19000<br>Packs |
|
|
|
|
|
|
|
|
|
|
Furoate Micronized 1. |
900 Kgs.) |
|
|
|
|
|
|
|
|
|
|
|
|
9 |
Mometasone Furoate Tropical Solution<br>USP 0.1% (Lotion) (Pack 30ml) (Net Wt.<br>of Mometasone Furoate Micronized 0.360 |
|
|
|
12000<br>Packs |
|
|
|
|
|
|
|
|
|
|
Kgs.) |
|
|
|
|
|
|
|
|
|
|
|
|
|
10 |
Mometasone Furoate Tropical Solution<br>USP 0.1% (Lotion) (Pack 60ml) (Net Wt.<br>of Mometasone Furoate Micronized 0.396<br>Kgs.) |
|
|
|
6600<br>Packs |
|
|
|
|
|
|
|
|
|
11 |
Mometasone Furoate Cream 0.1% (Pack<br>10gms) (Net Wt. of Mometasone Furoate<br>Micronized 0.210 Kgs.) |
|
|
|
21000<br>Packs |
|
|
|
|
|
|
|
|
|
12 |
Mometasone Furoate Cream 0.1% (Pack<br>15gms) (Net Wt. of Mometasone Furoate<br>Micronized 1.050 Kgs.) |
|
|
|
70000<br>Packs |
|
|
|
|
|
|
|
|
|
13 |
Mometasone Furoate Cream 0.1% (Pack<br>20gms) (Net Wt. of Mometasone Furoate<br>Micronized 0.100 Kgs.) |
|
|
|
5000<br>Packs |
|
|
|
|
|
|
|
|
|
14 |
Mometasone Furoate Cream 0.1%<br>/Metactiv Cream 0.10% (Pack 30gms)<br>(Net Wt. of Mometasone Furoate<br>Micronized 2.130 Kgs.) |
|
|
|
71000<br>Packs |
|
|
|
|
|
|
|
91
|
15<br>Mometasone Furoate Cream 0.1% (Pack<br>45gms) (Net Wt. of Mometasone Furoate<br>Micronized 1.800 Kgs.)<br>40000<br>Packs<br>16<br>Mometasone Furoate Cream 0.1% (Pack<br>50gms) (Net Wt. of Mometasone Furoate<br>Micronized 3.000 Kgs.)<br>60000<br>Packs<br>17<br>Mometasone Furoate Cream 0.1% (Pack<br>60gms) (Net Wt. of Mometasone Furoate<br>Micronized 0.900 Kgs.)<br>15000<br>Packs<br>18<br>Mometasone Furoate Cream 0.1% (Pack<br>100gms) (Net Wt. of Mometasone<br>Furoate Micronized 28.700 Kgs.)<br>287000<br>Packs<br>RA maytake appropriate action asper the decision of Norms Committee |
15 |
Mometasone Furoate Cream 0.1% (Pack<br>45gms) (Net Wt. of Mometasone Furoate<br>Micronized 1.800 Kgs.) |
40000<br>Packs |
|
|
|
|
|
16 |
Mometasone Furoate Cream 0.1% (Pack<br>50gms) (Net Wt. of Mometasone Furoate<br>Micronized 3.000 Kgs.) |
60000<br>Packs |
|
|
|
|
|
17 |
Mometasone Furoate Cream 0.1% (Pack<br>60gms) (Net Wt. of Mometasone Furoate<br>Micronized 0.900 Kgs.) |
15000<br>Packs |
|
|
|
|
|
18 |
Mometasone Furoate Cream 0.1% (Pack<br>100gms) (Net Wt. of Mometasone<br>Furoate Micronized 28.700 Kgs.) |
287000<br>Packs |
|
|
|
|
|
|
|
|
|
|
|
| Case No.:219/6/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830586 |
|
|
| :01/82/050/00445/AM20/ |
|
:03/94/040/00337/AM20/ |
|
25.07.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
Export product Qty. Kit Pack of Norgestimate& Ethinyl Estradiol Tablets USP 0.18mg/0.035mg, 1 Number 0.215mg/0.035mg and0.25mg/0.035mg (Pack Size 84 Tabs.) ( Net Wt. of Norgestimate USP is 0.677 Kgs ) Norgestimate& Ethinyl Estradiol Tablets USP 0.25mg/0.035mg (Pack Size84Tabs.)( 1 Number 230 Net Wt. of Norgestimate USP is 1.575 Kgs,) Norgestimate& Ethinyl Estradiol Tablets USP 0.18mg/0.025mg, 0.215mg/0.025mg, 1 Number 0.25mg/0.025mg(Ortho Tri Cyclen-Lo) (Pack Size 84 Tabs.) (Net Wt. of Norgestimate USP is 2.086 Kgs.)
|
SI. |
Import Items |
Qty. Allowed for the export of 1 No. Tablet (Quantity in mg) |
Qty. Allowed for the export of 1 No. Tablet (Quantity in mg) |
Qty. Allowed for the export of 1 No. Tablet (Quantity in mg) |
Qty. Allowed for the export of 1 No. Tablet (Quantity in mg) |
Qty. Allowed for the export of 1 No. Tablet (Quantity in mg) |
Qty. Allowed for the export of 1 No. Tablet (Quantity in mg) |
|
No. |
|
0.18mg |
0.215mg |
0.25mg |
0.18mg |
0.215mg |
0.25 mg |
|
|
|
/0.035 mg |
/0.035 |
/0.035 mg |
/0.025 |
/0.025 mg |
/0.025 |
|
|
|
|
mg |
|
mg |
|
mg |
|
1 |
Norgestimate |
|
0.2193 |
0.255 |
|
0.2193 |
0.255 |
|
|
USP |
0.1836 |
|
|
0.1836 |
|
|
|
|
(Micronized) |
|
|
|
|
|
|
| RA may |
|
take appropriate action asper |
|
the decision |
of Norms Committee |
|
|
|
92
|
|
Case No.:220/6/82- |
|
Party Name:BHARAT |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
SERUMS & VACCINES LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 231 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310830591 |
|
Defer Date: |
|
|
:01/82/050/00446/AM20/ |
|
:03/94/040/00313/AM20/ |
|
25.07.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:221/6/82- |
|
Party Name:ALPHAMED |
|
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
FORMULATIONS PRIVATE |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
|
16.08.2019 |
|
|
| 232 |
|
HQ File<br>:01/82/050/00447/AM20/ |
|
RLA File<br>:09/24/040/00222/AM20/ |
|
|
Lic.No/Date:0910067834<br>25.07.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Hyderabad. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
|
|
Case No.:229/6/82- |
|
Party Name:NISARG |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
BIOSCIENCES PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 233 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067836 |
|
Defer Date: |
|
|
:01/82/050/00455/AM20/ |
|
:09/24/040/00221/AM20/ |
|
25.07.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
| Case No.:223/6/82- |
|
Party Name:LITMUS |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
ORGANICS PRIVATE |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830619 |
|
|
| :01/82/050/00449/AM20/ |
|
:03/95/040/00271/AM20/ |
|
26.07.2019 |
|
|
Decision: The Committee considered case as per agenda and in the presence of the technical experts 234 and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
|
Export product |
|
Qty. |
Sl. No. |
Import items |
Qty. |
|
TRIETHYL |
PHOSPHONO |
1 kg |
1 |
TRIETHYL PHOSPHITE |
0.823 kg |
|
ACETATE |
|
|
|
|
|
| RA maytake appropriate action asper the decision of Norms Committee |
|
|
|
|
|
|
93
| 235 |
<br>Case No.:230/6/82-<br>ALC4/2019 |
Party Name:GLAND<br>PHARMA LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0910067838<br>26.07.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00456/AM20/ |
RLA File<br>:09/24/040/00224/AM20/ |
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 236 |
Case No.:231/6/82-<br>ALC4/2019 |
Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0910067841<br>26.07.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00457/AM20/ |
RLA File<br>:09/24/040/00215/AM20/ |
|
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
| Case No.:232/6/82- |
|
Party Name:SARACA |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
LABORATORIES LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0910067842 |
|
|
| :01/82/050/00458/AM20/ |
|
:09/24/040/00218/AM20/ |
|
26.07.2019 |
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 237 per details below or as applied by firm whichever is lower:
| Export Product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| GABAPENTIN |
1 kg |
1 |
1,1 CYCLOHEXANE DI<br>ACETIC ACID MONOAMIDE<br>(CAM) |
1.630 kg |
| 238 |
<br>Case No.:233/6/82-<br>ALC4/2019 |
Party Name:BRAWN<br>LABORATORIES LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0510411373<br>26.07.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00459/AM20/ |
RLA File<br>:05/23/040/00169/AM20/ |
|
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
94
| 239 |
<br>Case No.:234/6/82-<br>ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00460/AM20/ |
RLA File<br>:09/24/040/00226/AM20/ |
Lic.No/Date:0910067843<br>26.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 240 |
<br>Case No.:235/6/82-<br>ALC4/2019 |
Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00461/AM20/ |
RLA File<br>:09/24/040/00225/AM20/ |
Lic.No/Date:0910067844<br>26.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 241 |
Case No.:236/6/82-<br>ALC4/2019 |
Party Name:ACME<br>GENERICS LLP |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00462/AM20/ |
RLA File<br>:22/24/040/00031/AM20/ |
Lic.No/Date:2210016214<br>26.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Chandigarh. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chandigarh.
| 242 |
Case No.:237/6/82-<br>ALC4/2019 |
Party Name:ACME<br>GENERICS LLP |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00463/AM20/ |
RLA File<br>:22/24/040/00030/AM20/ |
Lic.No/Date:2210016215<br>26.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Chandigarh. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Chandigarh.
95
| Case No.:239/6/82- |
|
Party Name:ALEOR |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
DERMACEUTICALS |
|
ALC4/2019 |
|
Approved |
|
|
LIMITED |
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3410045317 |
|
|
| :01/82/050/00465/AM20/ |
|
:34/24/040/00135/AM20/ |
|
26.07.2019 |
|
|
|
Case No.:239/6/82-<br>ALC4/2019 |
Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:3410045317<br>26.07.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00465/AM20/ |
RLA File<br>:34/24/040/00135/AM20/ |
|
|
| 243 |
<br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>3/82-ALC4/2018<br>, dated 05.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Import items<br>Qty.<br>1<br>Clobetasol Propionate Cream ,<br>0.05% 15 gm<br>(net content of active ingredients =<br>315.465 gm)<br>1 Number<br>Clobetasol<br>Propionate USP (<br>Micronized)<br>7.65 mg / 15 gm<br>pack<br>2<br>Clobetasol Propionate Cream ,<br>0.05% 30 gm<br>(net content of active ingredients =<br>639.345gm)<br>1 Number<br>Clobetasol<br>Propionate USP (<br>Micronized)<br>15.30 mg / 30<br>gm pack<br>3<br>Clobetasol Propionate Cream ,<br>0.05% 45 gm<br>(net content of active ingredients =<br>257.333 gm)<br>1 Number<br>Clobetasol<br>Propionate USP (<br>Micronized)<br>22.95 mg / 45<br>gm/pack<br>4<br>Clobetasol Propionate Cream ,<br>0.05% 60 gm<br>(net content of active ingredients<br>=2230.980 gm)<br>1 Number<br>Clobetasol<br>Propionate USP (<br>Micronized)<br>30.60 mg / 60<br>gm pack<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2018 , dated 05.06.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
| 244 |
<br>Case No.:240/6/82-<br>ALC4/2019 |
Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED<br>RLA File<br>:34/24/040/00136/AM20/ |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:3410045318<br>26.07.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00466/AM20/ |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
96
| Case No.:241/6/82- |
|
Party Name:BALAJI AMINES |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
LIMITED |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:3110067485 |
|
|
| :01/82/050/00467/AM20/ |
|
:31/83/040/00068/AM20/ |
|
26.07.2019 |
|
|
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms 245 under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
| Export Product |
Qty. |
Sl. No. |
Import items |
Qty. |
| N-METHYL-2-<br>PYRROLIDONE |
1 kg |
1. |
METHANOL |
0.37 kg |
|
|
2 |
AMMONIA ANHYDROUS |
0.16 kg |
|
|
3 |
GAMMA BUTYROLACTONE |
0.90 kg |
RA concerned may take further necessary action as per above decision of NC
| 246 |
<br>Case No.:238/6/82-<br>ALC4/2019 |
Party Name:WOCKHARDT<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00464/AM20/ |
RLA File<br>:03/95/040/00426/AM20/ |
Lic.No/Date:0310830632<br>29.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
| 247 |
Case No.:242/6/82-<br>ALC4/2019 |
Party Name:PANACEA<br>BIOTEC LTD., |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00468/AM20/ |
RLA File<br>:05/24/040/00250/AM20/ |
Lic.No/Date:0510411383<br>29.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from CLA,New Delhi. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from CLA, New Delhi.
| 248 |
<br>Case No.:243/6/82-<br>ALC4/2019 |
Party Name:MAHAVIR<br>SYNTHESIS PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00469/AM20/ |
RLA File<br>:52/24/040/00023/AM20/ |
Lic.No/Date:5210043127<br>29.07.2019 |
Defer Date: |
|
**Decision:**New Case,deferred for comments of TE.. |
|
|
|
97
| 249 |
Case No.:245/6/82-<br>ALC4/2019 |
Party Name:RELIANCE<br>INDUSTRIES LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00471/AM20/ |
RLA File<br>:03/95/040/00327/AM20/ |
Lic.No/Date:0310830678<br>30.07.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:246/6/82- |
|
Party Name:CIPLA LIMITED. |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
|
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830686 |
|
|
| :01/82/050/00472/AM20/ |
|
:03/94/040/00332/AM20/ |
|
30.07.2019 |
|
|
|
Case No.:246/6/82-<br>ALC4/2019 |
Party Name:CIPLA LIMITED. |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Approved |
|
HQ File<br>:01/82/050/00472/AM20/ |
RLA File<br>:03/94/040/00332/AM20/ |
Lic.No/Date:0310830686<br>30.07.2019 |
|
| 250 |
<br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Budesonide Inhalation Suspension<br>0.25mg/2ml Budesonide Respules<br>0.25mg/2ml<br>(Each 2ml contains Budesonide<br>USP 0.25mg)<br>1 Number<br>1<br>Budesonide USP<br>0.2625 mg / 0.25<br>mg vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% )<br>Budesonide Inhalation Suspension<br>0.50mg/2ml Budesonide Respules<br>0.50mg/2ml<br>(Each 2ml contains Budesonide<br>USP 0.50mg)<br>1 Number<br>1<br>Budesonide USP<br>0.525 mg / 0.50<br>mg vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% )<br>Budesonide Inhalation Suspension<br>1mg/2ml Budesonide Respules<br>1mg/2ml<br>(Each 2ml contains Budesonide<br>USP 1mg)<br>1 Number<br>1<br>Budesonide USP<br>1.05 mg / 1 mg<br>vial<br>2<br>PURELL PE<br>1840H<br>GRANULES<br>Relevant, as per<br>Packing Policy on<br>the net weight of<br>empty respules (<br>Net + 5% )<br>RA concerned maytake further necessaryaction asper above decision of NC. |
|
|
|
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
98
| Case No.:247/6/82-ALC4/2019 |
|
Party Name:SUNSHIELD |
|
Meet No/Date:6/82- |
|
Status: |
|
|
CHEMICALS LTD. |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830692 |
|
|
| :01/82/050/00473/AM20/ |
|
:03/95/040/00236/AM20/ |
|
30.07.2019 |
|
|
Decision: The Committee considered case as per agenda and and in the presence of the technical experts, it was decided to ratify the ad-hoc input output norms as per earlier decision taken by NC in its 4/82-ALC4/2018 meeting dated 19.06.2018 under para 4.7 of HBP as per details below or as applied by 251 firm whichever is lower:
| Export Product` |
|
Qty. |
Sl. |
Import Items |
Qty. |
|
|
|
No. |
|
|
| OCTYLATED DI-PHENYLAMINE |
1 kg |
|
1. |
DI-PHENYLAMINE |
0.405 kg |
| ~~(~~ODPA) |
|
|
2. |
DI-ISO BUTYLENE |
0.632 kg |
|
|
Case No.:249/6/82-ALC4/2019 |
|
Party Name:AUROBINDO |
|
Meet No/Date:6/82- |
|
Status: |
|
|
|
|
PHARMA LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 252 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067851 |
|
Defer Date: |
|
|
:01/82/050/00475/AM20/ |
|
:09/24/040/00232/AM20/ |
|
30.07.2019 |
|
|
|
|
**Decision:**New Case,deferred |
|
for comments of TE. |
|
|
|
|
|
|
Case No.:248/6/82- |
|
Party Name:HUBERGROUP |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDIA PRIVATE LIMITED. |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 253 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310830713 |
|
Defer Date: |
|
|
:01/82/050/00474/AM20/ |
|
:03/94/040/00346/AM20/ |
|
31.07.2019 |
|
|
|
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
|
|
|
|
|
Case No.:253/6/82- |
|
Party Name:RELIANCE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 254 |
|
HQ File<br>:01/82/050/00479/AM20/ |
|
RLA File<br>:03/95/040/00381/AM20/ |
|
Lic.No/Date:0310830728<br>01.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
99
| 255 |
Case No.:254/6/82-<br>ALC4/2019 |
Party Name:POLYGEL<br>INDUSTRIES PVT.LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0310830745<br>01.08.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00480/AM20/ |
RLA File<br>:03/95/040/00373/AM20/ |
|
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
| Case No.:255/6/82- |
|
Party Name:GLENMARK |
|
Meet No/Date:6/82- |
|
Status: |
| ALC4/2019 |
|
PHARMACEUTICALS LTD |
|
ALC4/2019 |
|
Approved |
|
|
|
|
16.08.2019 |
|
|
| HQ File |
|
RLA File |
|
Lic.No/Date:0310830747 |
|
|
| :01/82/050/00481/AM20/ |
|
:03/94/040/00341/AM20/ |
|
01.08.2019 |
|
|
256
Decision: The Committee considered case as per agenda and as per earlier decision taken by NC in its 13/82-ALC4/2018 meeting dated 14.01.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
| Sl.<br>No. |
Export product |
Qty. |
Sl.<br>No. |
Import items |
Qty. |
| 1 |
Ursodiol Tablets USP 250mg<br>(Pack Size 100 Tabs.) |
1 tablet |
1 |
Ursodiol USP |
255 mg / 250 mg<br>tablet |
| 2 |
Ursodiol Tablets USP 500mg<br>(PackSize100Tabs.) |
1 tablet |
1 |
Ursodiol USP |
510 mg / 500 mg<br>tablet |
RA concerned may take further necessary action as per above decision of NC
| 257 |
Case No.:256/6/82-<br>ALC4/2019 |
Party Name:WEXFORD<br>LABORATORIES P LTD |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00482/AM20/ |
RLA File<br>:07/24/040/00100/AM20/ |
Lic.No/Date:0710115236<br>01.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Bangalore. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Bangalore.
| 258 |
Case No.:257/6/82-<br>ALC4/2019 |
Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019<br>Lic.No/Date:0910067855<br>01.08.2019 |
Status:<br>Deferred<br>Defer Date: |
|
<br>HQ File<br>:01/82/050/00483/AM20/ |
RLA File<br>:09/24/040/00229/AM20/ |
|
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Hyderabad. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
100
|
|
Case No.:258/6/82- |
|
Party Name:NISARG |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
BIOSCIENCES PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 259 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067858 |
|
Defer Date: |
|
|
:01/82/050/00484/AM20/ |
|
:09/24/040/00236/AM20/ |
|
01.08.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:264/6/82- |
|
|
Party Name:DEEPAK |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
|
NOVOCHEM |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
TECHNOLOGIES LTD |
|
16.08.2019 |
|
|
| 260 |
|
HQ File<br>:01/82/050/00490/AM20/ |
|
|
RLA File<br>:31/83/040/00051/AM20/ |
|
Lic.No/Date:3110067490<br>02.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was |
decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Pune. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Pune.
|
|
Case No.:265/6/82- |
|
Party Name:GOVIND |
|
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
LABORATORIES PVT. LTD., |
|
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
|
16.08.2019 |
|
|
| 261 |
|
HQ File<br>:01/82/050/00491/AM20/ |
|
RLA File<br>:08/24/040/00145/AM20/ |
|
|
Lic.No/Date:0810145905<br>02.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
|
authorization from RLA,Ahmedabad. |
|
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Ahmedabad.
|
|
Case No.:259/6/82- |
|
Party Name:VISION DRUGS |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
PRIVATE LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 262 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067863 |
|
Defer Date: |
|
|
:01/82/050/00485/AM20/ |
|
:09/24/040/00240/AM20/ |
|
05.08.2019 |
|
|
|
|
**Decision:**New Case,deferred |
for comments of TE. |
|
|
|
|
|
|
|
Case |
|
Party Name:VINDHYA |
|
Meet No/Date:6/82- |
|
Status: |
|
|
260/6/82-ALC4/2019 |
|
ORGANICS PVT LTD |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 263 |
|
HQ File<br>:01/82/050/00486/AM20/ |
|
RLA File<br>:09/24/040/00239/AM20/ |
|
Lic.No/Date:0910067864<br>05.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Hyderabad. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Hyderabad.
101
|
|
Case No.:261/6/82- |
|
Party Name:SUVEN LIFE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 264 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067865 |
|
Defer Date: |
|
|
:01/82/050/00487/AM20/ |
|
:09/24/040/00242/AM20/ |
|
05.08.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:262/6/82- |
|
Party Name:SUVEN LIFE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
SCIENCES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 265 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0910067866 |
|
Defer Date: |
|
|
:01/82/050/00488/AM20/ |
|
:09/24/040/00244/AM20/ |
|
05.08.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
|
|
Case No.:263/6/82- |
|
Party Name:PRASOL |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
CHEMICALS PRIVATE |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
LIMITED |
|
16.08.2019 |
|
|
| 266 |
|
HQ File<br>:01/82/050/00489/AM20/ |
|
RLA File<br>:03/95/040/00453/AM20/ |
|
Lic.No/Date:0310830795<br>05.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance |
|
|
|
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
|
|
Case No.:266/6/82- |
|
Party Name:RELIANCE |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 267 |
|
HQ File<br>:01/82/050/00492/AM20/ |
|
RLA File<br>:03/95/040/00326/AM20/ |
|
Lic.No/Date:0310830799<br>05.08.2019 |
|
Defer Date: |
|
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is |
|
|
|
|
|
|
|
|
not available. Hence, it was decided to call for a copy of |
|
|
4.07 application of the subject advance |
|
|
|
|
|
authorization from RLA,Mumbai. |
|
|
|
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
|
|
Case No.:267/6/82- |
|
Party Name:YASHO |
|
Meet No/Date:6/82- |
|
Status: |
|
|
ALC4/2019 |
|
INDUSTRIES LIMITED |
|
ALC4/2019 |
|
Deferred |
|
|
|
|
|
|
16.08.2019 |
|
|
| 268 |
|
HQ File |
|
RLA File |
|
Lic.No/Date:0310830804 |
|
Defer Date: |
|
|
:01/82/050/00493/AM20/ |
|
:03/95/040/00457/AM20/ |
|
05.08.2019 |
|
|
|
|
**Decision:**New Case,deferred for comments of TE. |
|
|
|
|
|
|
102
| 269 |
Case No.:268/6/82-<br>ALC4/2019 |
Party Name:CHEMIESYNTH<br>(VAPI)LTD., |
Meet No/Date:6/82-<br>ALC4/2019<br>16.08.2019 |
Status:<br>Deferred |
|
<br>HQ File<br>:01/82/050/00494/AM20/ |
RLA File<br>:03/94/040/00363/AM20/ |
Lic.No/Date:0310830809<br>05.08.2019 |
Defer Date: |
|
**Decision:**New Case. The Committee noted that the 4.07 application of subject Advance Authorization is<br>not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance<br>authorization from RLA,Mumbai. |
|
|
|
Decision: New Case. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization from RLA, Mumbai.
Meeting ended with thanks to Chair.
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