DGFT Minutes
In force — no superseding record on file.
Case No. A 7
M/s. Fermenta Biotech Limited Norms Committee Meeting No.28/AM13 F.No. 01/82/162/128/AM 13/DES III Meeting Date:10.01.2013 Adv. Lic. No. & Date Decision: It was decided to call from the firm the production and consumption data duly certified by Central Excise Authority. The case was deferred for 7.2.2013.
Case No. B 433
M/s. PCL Oil & Solvents Limited, New Delhi Norms Committee Meeting No.28/AM13 F.No. 01/82/162/917/AM 13/DES III Meeting Date:10.01.2013 RA File No. 05/27/040/00083/AM 13 RA File No. 05/27/040/00454/AM 13 RA File NO. 05/27/040/00455/AM 13 Adv. Lic. No. & Date Decision: It was decided to defer the case for 7.2.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals.
Case No. B 434
M/s. Aqua Pharma Chemicals (P) Ltd. Norms Committee Meeting No.28/AM13 F.No. 01/82/162/442/AM 13 DES III F. NO. 01/82/162/443/AM 13 DES III F. NO 01/82/162/444/AM 13 DES III F. No. 01/82/162/445/AM 13 DES III F. No. 01/82/162/446/AM 13 DES III Meeting Date:10.01.2013 Adv. Lic. No. & Date Decision: It was decided to defer the case for 7.2.2013 for comments of Department of Chemicals and Petrochemicals. Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 28/82ALC4/2012 MEETING DATE : 10.01.2013 The Meeting No. 28/82 in the year 201213 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 10.01.2013 under the Chairmanship of, Shri Mukesh Bhatnagar, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi.. Following members were present: 1. Shri V.K. Tyagi, Sr. Advisor, Department of Pharmaceutical 2. Shri R.C. Meena, Deputy Director General of Foreign Trade
Case No. B 435
M/s. Metropolitan Eximchem Limited Norms Committee Meeting No.28/AM13 F.No. 01/82/50/00244/AM 13/DES III F.No. 01/82/50/01062/AM 12/DES III Meeting Date:10.01.2013 RLA F. No. 03/95/040/00002/AM 13 RLA F. No. 03/95/040/00643/AM 12 Adv. Lic. No. & Date 0310690688 dated 13.4.2012 0310664714 dated 14.11.2012 Decision: It was decided to defer the case for 7.2.2013 for comments of Department of Chemicals and Petrochemicals.
Case No. B 436
M/s. Medchl Chem. & Pharma Limited Norms Committee Meeting No.28/AM13 F.No. 01/82/50/01760/AM 11 F. NO. 01/82/50/0911/Am 11 F.No 01/82/50/01258/AM 11 Meeting Date:10.01.2013 RLA F. No. 09/24/40/00539/AM 11 RLA F. No. 09/24/40/00231/AM 12 RLA F. No. 09/24/40/00324/AM 11 Adv. Lic. No. & Date 0910045802 dated 4.3.2011 0910047496 dated 29.8.2011 0910044428 dated 24.11.2010 Decision: It was decided to defer the case for 7.2.2013 for comments of Department of Pharmaceuticals. 1
Case No.:48/22/82ALC4/2010
Party Name:AUCTUS PHARMA LIMITED Meet No/Date:28/82ALC4/2012 10.01.2013 Status:Case Approved HQ File :01/82/050/00701/AM11/ RLA File :09/24/040/00535/AM10/ Lic.No/Date:0910041595 08.04.2010 Defer Date: Decision :In the light of earlier decision taken in meeting no. 22/82 dated 30.8.2011, 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 Export Qty. Sl.No. Import items Qty. allowed 1(2,4Difluoro Phenyl)2(1H 1,2,4Triazole1yl) Ethanone (Ethanone derivate) 1 kg. 1. 1,3Difluoro Benzene 0.914 kg 2. 4Amino1,2,4 Triazole 0.667 kg 3. Methylene Chloride 1.60 kg 4. Acetonitrile 4.00 kg RA may take appropriate action as per the decision of Norms Committee.
2
Case No.:10/28/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 10.01.2013 Status:Case Deferred HQ File :01/82/050/00892/AM11/ RLA File :09/24/040/00273/AM11/ Lic.No/Date:0910043757 30.09.2010 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of Department of Pharmaceuticals. 3
Case No.:55/41/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/01403/AM11/ RLA File :09/24/040/00298/AM11/ Lic.No/Date:0910043877 11.10.2010 Defer Date: Decision : The firm has requested for giving them higher norms for vials, stoppers, Seals than available in the HBP v1 as their company is approved by the USFDA in India. On the basis of batch log sheets provided by the company, a comparative data as per Central Excise & Batch Log Sheets was examined by the Department of Pharmaceuticals. In exercise of powers conferred under Para 4.10 of HBP v 1, the Committee decided to ratify norms under Para 4.7 of HBP v1 on the basis of the lower of the percentage of the actual used(in accordance with the comparative statement provided by Department of Pharmaceuticals), as per details given below: Export product Export Qty. Sl.No. Import items Qty. allowed Heparin Sodium Injection USP, 1000 IU/ml, 1ml Vial 1 ml vial 1. Heparin Sodium USP 6.341 mg 2. Vial glass 7.85% 3. Rubber Stoppers Rubber 8.99% 4. Seals Plastic 5.91% 5. Sodium Chloride BP Net to net basis 6. Benzyl Alcohol BP 7. Sodium Hydroxide USP 8. Hydrochloric Acid USP 9. Tubing Plastic 10. Filters Plastic 11 Anti Factor Xa Test Kits Kits 12 Anti Factor Ha Test Kits Kits 13 Analytical Columns Kits 14 Analytical Guard Columns Kits Heparin Sodium Injection USP 1000 IU/ml, 2 ml Vial USP 1 vial 1 Heparin Sodium USP 12.682 mg 2 Vial glass 7.57% 3 Rubber Stoppers Rubber 7.41% 4
14 Analytical Guard Columns Kits Heparin Sodium Injection USP 1000 IU/ml, 2 ml Vial USP 1 vial 1 Heparin Sodium USP 12.682 mg 2 Vial glass 7.57% 3 Rubber Stoppers Rubber 7.41% 4 Seals Plastic 4.21% 5 Sodium Chloride BP Net to net basis 6 Benzyl Alcohol BP 7 Sodium Hydroxide USP 8 Hydrochloric Acid USP
8 Hydrochloric Acid USP 9 Tubing Plastic 10 Filters Plastic 11 Anti Factor Xa Test Kits Kits 12 Anti Factor Ha Test Kits Kits 13 Analytical Columns Kits 14 Analytical Guard Columns Kits Heparin Sodium Injection USP 1000 IU/ml, 10 ml vial 1 vial 1 Heparin Sodium USP 63.41 mg 2 Vial glass 7.80% 3 Rubber Stoppers Rubber 9.18% 4 Seals Plastic 6.93% 5 Sodium Chloride BP Net to net basis 6 Benzyl Alcohol BP 7 Sodium Hydroxide USP 8 Hydrochloric Acid USP 9 Tubing Plastic 10 Filters Plastic 11 Anti Factor Xa Test Kits Kits 12 Anti Factor Ha Test Kits Kits 13 Analytical Columns Kits 14 Analytical Guard Columns Kits Heparin Sodium Injection USP, 1000 IU/ml, 30 ml vial USP 1 vial 1 Heparin Sodium USP 181.755 mg 2 Vial glass 7.198% 3 Rubber Stoppers Rubber 8.088% 4 Seals Plastic 5.33% 5 Sodium Chloride BP Net to net basis 6 Benzyl Alcohol BP 7 Sodium Hydroxide USP 8 Hydrochloric Acid USP 9 Tubing Plastic 10 Filters Plastic 11 Anti Factor Xa Test Kits Kits 12 Anti Factor Ha Test Kits Kits 13 Analytical Columns Kits 14 Analytical Guard Columns Kits Heparin Sodium Injection USP, 5000 IU/ml, 1 ml vial USP 1 vial 1
i Factor Xa Test Kits Kits 12 Anti Factor Ha Test Kits Kits 13 Analytical Columns Kits 14 Analytical Guard Columns Kits Heparin Sodium Injection USP, 5000 IU/ml, 1 ml vial USP 1 vial 1 Heparin Sodium USP 31.705 mg
5000 U/ , a US 2 Vial glass 4.79% 3 Rubber Stoppers Rubber 5.28% 4 Seals Plastic 4.02% 5 Sodium Chloride BP Net to net basis 6 Benzyl Alcohol BP 7 Sodium Hydroxide USP 8 Hydrochloric Acid USP 9 Tubing Plastic Filters Plastic Anti Factor Xa Test Kits Kits Anti Factor Ha Test Kits Kits Analytical Columns Kits Analytical Guard Columns Kits RA may take appropriate action as per the decision of Norms Committee. These higher norms for packing material shall be permissible only in respect of exports to the USA and will not be applicable on repeat basis. 4
Case No.:63/40/82ALC4/2010
Party Name:EMAMI LIMITED, 10.01.2013 HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Defer Date:07.02.2013 Decision :It was decided to give a final reminder to the firm to furnish the information sought by DC(MSME) vide their letter dated 12.9.2012 within 15 days failing which their case would be closed. The case was deferred for 7.2.2013. 5
Case No.:53/47/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD 10.01.2013 HQ File :01/82/050/01643/AM11/ RLA File :09/24/040/00519/AM11/ Lic.No/Date:0910045550 14.02.2011 Defer Date:07.02.2013 6
Case No.:5/4/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 10.01.2013 HQ File :01/82/050/00056/AM12/ RLA File :03/95/040/00949/AM11/ Lic.No/Date:0310620143 08.03.2011 Defer Date:07.02.2013 Decision :It was decided to remind Department of Biotechnology to furnish their comments at the earliest. The case was deferred for 7.2.2013 for comments of Department of Biotechnology.
Case No :19/10/82 ALC4/2011
Party Name:PLANET HERBS LIFE SCIENCES Meet No/Date:28/82 ALC4/2012 Status:Case Deferred
7
Case No.:19/10/82ALC4/2011
Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 10.01.2013 HQ File :01/82/050/00278/AM12/ RLA File :61/24/040/00097/AM11/ Lic.No/Date:6110000608 03.05.2011 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of DC(MSME). 8
Case No.:18/11/82ALC4/2011
10.01.2013 HQ File :01/82/050/00332/AM12/ RLA File :09/24/040/00080/AM12/ Lic.No/Date:0910046973 02.06.2011 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of Department of Chemicals and Petrochemicals. 9
Case No.:19/11/82ALC4/2011
10.01.2013 HQ File :01/82/050/00333/AM12/ RLA File :09/24/040/00079/AM12/ Lic.No/Date:0910046974 02.06.2011 Defer Date:07.02.2013 10
Case No.:25/19/82ALC4/2011
10.01.2013 HQ File :01/82/050/00539/AM12/ RLA File :09/24/040/00085/AM12/ Lic.No/Date:0910046996 06.06.2011 Defer Date:07.02.2013 11
Case No.:27/16/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD 10.01.2013 HQ File :01/82/050/00485/AM12/ RLA File :34/24/040/00039/AM12/ Lic.No/Date:3410030563 10.06.2011 Defer Date:07.02.2013 12
Case No.:35/19/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 10.01.2013 HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 Defer Date:07.02.2013
Case No.:97/22/82ALC4/2012
Party Name:ALEMBIC PHARMACEUTICALS LTD 10.01.2013
13 0.0 . 0 3 HQ File :01/82/050/00800/AM13/ RLA File :34/24/040/00058/AM12/ Lic.No/Date:3410030822 05.07.2011 Defer Date:07.02.2013 14
Case No.:3/17/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 10.01.2013 Status:Case Approved HQ File :01/82/050/00498/AM12/ RLA File :05/24/040/00124/AM12/ Lic.No/Date:0510296379 12.07.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/534/2012PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Imipenem Ph. Eur Sterile (bulk Drug/Pharmacopeal Grade) 1 kg 1. (3R,4R)4Acetoxy3((R) (TertButyldimethylsilyloxy) Ethyl2Ezetidinone 4.967 kg 2. Dimethyl Aminopyridine 0.03 kg 3. Acetone 9.55 kg 4. Acetonitirile 1.35 kg 5. Activated Carbon 0.100 kg 6. Cysteamine Hydrochloride 1.12 kg 7. Diphenyl Chlorophosphate 3.53 kg 8. Isopropyl Alcohol 15.67 kg 9. Methane Sulfonic Acid 0.73 kg 10. Methanol 10.23 kg 11. Methylene Chloride 22.36 kg 12. N,NDiisopropyl Ethylamine 5.08 kg 13. NMethyl Morpholine 0.57 kg 14 Palladium Sponge 12.5 gm/kg 15. Tetrahydrofuran 3.13 kg 16. Toluene 6.22 kg 17 Triethylamine 2.931 kg 18 Trimethyl Chlorosilane 3.00 kg 15
Case No.:25/26/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 10.01.2013 HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic.No/Date:0310646711 05.08.2011 Defer Date:07.02.2013 Decision : It was decided to remind the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula immediately failing which their case would be closed. The case was deferred for 7.2.2013.
Case No.:39/31/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 10.01.2013
16 0.0 . 0 3 HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date:07.02.2013 Decision :It was decided to give final reminder to the firm to furnish the following information within 15 days failing which their case would be closed: Complete chemical reaction showing utilization of each inputs, their Mol. Wt. and % yield on molar basis. Details of recylation of Step 1 product. Details step II reactions showing actual utilisation of Iodine and KI in the process as the export product formula does not contain Iodine. Past production visavis actual consumption of all inputs duly certified by Central Excise Authorities. The case was deferred for 7.2.2013. 17
Case No.:89/42/82ALC4/2011
10.01.2013 HQ File :01/82/050/01124/AM12/ RLA File :09/24/040/00276/AM12/ Lic.No/Date:0910048679 08.09.2011 Defer Date:07.02.2013 18
Case No.:16/35/82ALC4/2011
Party Name:HIRAN ORGOCHEM LIMITED 10.01.2013 HQ File :01/82/050/00943/AM12/ RLA File :03/94/040/00474/AM12/ Lic.No/Date:0310657248 30.09.2011 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following information within 15 days failing which their case would be closed: Stepwise complete and balanced chemical reaction showing Mol. Wt. of each input and output items. % yield on molar basis for each step. Requirement and recovery of solvent at each step. The case was deferred for 7.2.2013. 19
Case No.:14/41/82ALC4/2011
Party Name:MEDREICH LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/01015/AM12/ RLA File :07/24/040/00254/AM12/ Lic.No/Date:0710083012 04.10.2011 Defer Date: Decision :In the light of earlier decision taken in meeting no. 26/AM 13 dated 13.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Sustained Release Capsules of Ferrous Sulphate with Folic Acid (Fefol 270 mg/0 3 mg) 1 no. of capsules 1. Ferrous Sulfate Pellets 18/25 324.0 mg 2. Folic Acid Pellets 18/25 90.0 mg 3. Non Pareil Seeds 20/25 19.34 mg
(Fefol 270 mg/0.3 mg) g 20
Case No.:9/35/82ALC4/2011
Party Name:UNITED BIOTECH PVT.LTD. 10.01.2013 HQ File :01/82/050/00936/AM12/ RLA File :05/24/040/00226/AM12/ Lic.No/Date:0510304974 11.10.2011 Defer Date:07.02.2013 21
Case No.:5/31/82ALC4/2011
Party Name:TITAN LABORATORIES PVT. LTD. 10.01.2013 Status:Case Approved HQ File :01/82/050/00831/AM12/ RLA File :03/95/040/00570/AM12/ Lic.No/Date:0310659395 13.10.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/547/2012PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Flurbiprofen SR Pellets 88.9% 1 kg 1 Flurbiprofen 0.898 kg 2. Polyvinylpyrolidone USP, NF,EP, JP (PVPK30) 3. Eudragit RS 100 (Ammonio Methacrylate Copolymer) 22
Case No.:3/45/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 10.01.2013 HQ File :01/82/050/01180/AM12/ RLA File :03/94/040/00691/AM12/ Lic.No/Date:0310664617 14.11.2011 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula immediately otherwise their case would be closed. The case was deferred for 7.2.2013. 23
Case No.:5/45/83ALC1/2011
Party Name:SPAN DIAGNOSTICS LTD 10.01.2013 HQ File :01/83/050/00780/AM12/ RLA File :52/24/040/00033/AM12/ Lic.No/Date:5210037002 15.11.2011 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of Department of Biotechnology. 24
Case No.:31/49/82ALC4/2011
Party Name:SMILAX LABORATORIES LIMITED 10.01.2013 HQ File :01/82/050/01340/AM12/ RLA File :09/24/040/00332/AM12/ Lic No/Date:0910049719 Defer
24 HQ File :01/82/050/01340/AM12/ RLA File :09/24/040/00332/AM12/ Lic.No/Date:0910049719 16.11.2011 Defer Date:07.02.2013 25
Case No.:7/27/85ALC3/2011
Party Name:BELOOR BAYIR BIOTECH LTD, 10.01.2013 HQ File :01/85/050/00151/AM12/ RLA File :07/24/040/00317/AM12/ Lic.No/Date:0710084045 18.11.2011 Defer Date:07.02.2013 Decision :It was decided to remind the firm to clarify whether the items are drug item. If yes, furnish a copy of Drug Manufacturing License. If not a drug item, elaborate under which ITC(HS) code the firm is claiming the norms. It was also decided to send a copy of application to Department of Biotechnology for their comments. 26
Case No.:2/39/82ALC4/2011
Party Name:BILCARE LIMITED 10.01.2013 HQ File :01/82/050/00994/AM12/ RLA File :31/83/040/00167/AM12/ Lic.No/Date:3110051868 13.12.2011 Defer Date:24.01.2013 Decision :It was decided to call the firm for Personal Hearing on 24.1.2013. The case was deferred for 24.1.2013. 27
Case No.:23/45/82ALC4/2011
Party Name:SUTURES INDIA PRIVATE LIMITED, 10.01.2013 HQ File :01/82/050/01200/AM12/ RLA File :07/24/040/00341/AM12/ Lic.No/Date:0710084630 13.12.2011 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of Department of Industrial Policy and Promotion. 28
Case No.:24/46/82ALC4/2011
Party Name:ASHISH LIFE SCIENCE PVT.LTD. 10.01.2013 HQ File :01/82/050/01240/AM12/ RLA File :03/94/040/00737/AM12/ Lic.No/Date:0310670672 14.12.2011 Defer Date:07.02.2013 29
Case No.:59/46/82ALC4/2011
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 10.01.2013 HQ File :01/82/050/01275/AM12/ RLA File :09/24/040/00413/AM12/ Lic.No/Date:0910050238 15.12.2011 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33. The case was deferred for 7.2.2013.
30
Case No.:11/3/82ALC4/2012
10.01.2013 HQ File :01/82/050/00015/AM13/ RLA File :09/24/040/00460/AM12/ Lic.No/Date:0910050479 29.12.2011 Defer Date:07.02.2013 31
Case No.:41/1/82ALC4/2012
10.01.2013 HQ File :01/82/050/01483/AM12/ RLA File :09/24/040/00459/AM12/ Lic.No/Date:0910050480 29.12.2011 Defer Date:07.02.2013 32
Case No.:43/21/82ALC4/2012
10.01.2013 HQ File :01/82/050/00673/AM13/ RLA File :09/24/040/00458/AM12/ Lic.No/Date:0910050481 29.12.2011 Defer Date:07.02.2013 33
Case No.:18/1/82ALC4/2012
Party Name:RA CHEM PHARMA LIMITED 10.01.2013 HQ File :01/82/050/01460/AM12/ RLA File :09/24/040/00493/AM12/ Lic.No/Date:0910050772 13.01.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following details/clarifications within 15 days failing which their case would be closed: The chemistry of Step III and IV do not match with the material balance. Yields of Step III and IV are not given 34
Case No.:35/3/82ALC4/2012
10.01.2013 HQ File :01/82/050/00039/AM13/ RLA File :09/24/040/00532/AM12/ Lic.No/Date:0910051038 31.01.2012 Defer Date:07.02.2013 35
Case No.:39/3/82ALC4/2012
10.01.2013 HQ File :01/82/050/00043/AM13/ RLA File :09/24/040/00528/AM12/ Lic.No/Date:0910051037 31 01 2012 Defer Date:07 02 2013
31.01.2012 Date:07.02.2013 36
Case No.:28/3/82ALC4/2012
10.01.2013 HQ File :01/82/050/00032/AM13/ RLA File :09/24/040/00527/AM12/ Lic.No/Date:0910051095 02.02.2012 Defer Date:07.02.2013 37
Case No.:26/1/82ALC4/2012
Party Name:METROCHEM API PVT. LTD. 10.01.2013 HQ File :01/82/050/01468/AM12/ RLA File :09/24/040/00480/AM12/ Lic.No/Date:0910051119 06.02.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following information within 15 days failing which their case would be closed: Complete and balanced chemical reactions showing mol. wt. of each reactant and output product. % yield on molar basis for each step of manufacturing process Material balance for entire process. 38
Case No.:55/1/82ALC4/2012
Party Name:ARCH PHARMALABS LTD 10.01.2013 HQ File :01/82/050/01497/AM12/ RLA File :03/94/040/00996/AM12/ Lic.No/Date:0310681891 14.02.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following information within 15 days failing which their case would be closed: % yield on molar basis for each step. Molar requirement of each import item Copy of technical literature in support of yields envisaged. 39
Case No.:67/1/82ALC4/2012
Party Name:CHEMSPEC CHEMICALS PVT LTD 10.01.2013 HQ File :01/82/050/01509/AM12/ RLA File :03/94/040/01007/AM12/ Lic.No/Date:0310682171 15.02.2012 Defer Date:07.02.2013 Decision :It was decided to give a final reminder to the firm to furnish the following information within 15 days failing which their case would be closed:
Complete description of export product. Complete technical details from the applicant firm as per Appendix 33 of the application proforma. 40
Case No.:35/1/82ALC4/2012
Party Name:SPECTRUM LIFE SCIENCES PRIVATE LIMITED 10.01.2013 HQ File :01/82/050/01477/AM12/ RLA File :04/24/040/00309/AM12/ Lic.No/Date:0410133868 16.02.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing license otherwise their case would be closed. The case was deferred for 7.2.2013. 41
Case No.:51/1/82ALC4/2012
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 10.01.2013 HQ File :01/82/050/01493/AM12/ RLA File :09/24/040/00579/AM12/ Lic.No/Date:0910051360 21.02.2012 Defer Date:07.02.2013 Decision :It was decided to give a final reminder to the firm to furnish the technical details as per Appendix 33. Accordingly, the case was deferred for 07.02.2013. 42
Case No.:26/4/82ALC4/2012
10.01.2013 HQ File :01/82/050/00106/AM13/ RLA File :03/94/040/01048/AM12/ Lic.No/Date:0310683210 23.02.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following details: % yield on molar basis for each step. Molar requirement of each import item. Copy of technical literature in support of yield envisaged. 43
Case No.:88/4/82ALC4/2012
10.01.2013 HQ File :01/82/050/00168/AM13/ RLA File :09/24/040/00601/AM12/ Lic.No/Date:0910051490 28.02.2012 Defer Date:07.02.2013
Case No.:60/49/82ALC4/2011
10 01 2013
44 10.01.2013 HQ File :01/82/050/01369/AM12/ RLA File :03/94/040/00125/AM12/ Lic.No/Date:0310683824 29.02.2012 Defer Date:07.02.2013 Decision :The case was deferred for 7.2.2013 for comments of Department of Pharmaceuticals. 45
Case No.:30/4/82ALC4/2012
10.01.2013 HQ File :01/82/050/00110/AM13/ RLA File :03/94/040/01096/AM12/ Lic.No/Date:0310684923 05.03.2012 Defer Date:07.02.2013 46
Case No.:33/4/82ALC4/2012
10.01.2013 HQ File :01/82/050/00113/AM13/ RLA File :03/94/040/01099/AM12/ Lic.No/Date:0310684919 05.03.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following technical details within 15 days failing which thier case would be closed: Whether step III shown in the reaction scheme is part of the manufacturing activity in the present export. Technical justification along with revised scheme to be forwarded Material balance for the entire process. % conversion yield on molar basis for each step to be furnished. 47
Case No.:34/4/82ALC4/2012
10.01.2013 HQ File :01/82/050/00114/AM13/ RLA File :03/94/040/01077/AM12/ Lic.No/Date:0310684930 05.03.2012 Defer Date:07.02.2013 48
Case No.:1/4/82ALC4/2012
Party Name:BELCO PHARMA 10.01.2013 HQ File :01/82/050/00081/AM13/ RLA File :05/23/040/00485/AM12/ Lic.No/Date:0510319713 06.03.2012 Defer Date:07.02.2013
Case No.:28/4/82ALC4/2012
10.01.2013
49 HQ File :01/82/050/00108/AM13/ RLA File :03/94/040/01102/AM12/ Lic.No/Date:0310684966 06.03.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following information within 15 days failing which their case would be closed: Whether Step III shown in the reaction scheme is part of the manufacturing activity in the present export. Technical justification along with revised scheme Material balance for the entire process. % conversion yield on molar basis for each step. 50
Case No.:29/4/82ALC4/2012
10.01.2013 HQ File :01/82/050/00109/AM13/ RLA File :03/94/040/01104/AM12/ Lic.No/Date:0310684961 06.03.2012 Defer Date:07.02.2013 51
Case No.:31/4/82ALC4/2012
10.01.2013 HQ File :01/82/050/00111/AM13/ RLA File :03/94/040/01101/AM12/ Lic.No/Date:0310684973 06.03.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following information immediately: i) Technical justification for applying import of pNitrophenyl2 (furfurylsulfinyl) Acetate, as the process given by the firm does not justify its use to the process/reaction. ii) Details of solvents applied like Methanol and Ethyl Acetate regarding its requirement and recovery in the process. 52
Case No.:41/4/82ALC4/2012
10.01.2013 HQ File :01/82/050/00121/AM13/ RLA File :03/94/040/01105/AM12/ Lic.No/Date:0310684976 06.03.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following information immediately: i) Technical justification for applying import of pNitrophenyl2 (furfurylsulfinyl) Acetate, as the process given by the firm does not justify its use to the process/reaction. ii) Details of solvents applied like Methanol and Ethyl Acetate regarding its requirement and recovery in the process.
53
Case No.:61/4/82ALC4/2012
Party Name:ANUGRAHA CHEMICALS 10.01.2013 HQ File :01/82/050/00141/AM13/ RLA File :07/24/040/00489/AM12/ Lic.No/Date:0710086840 07.03.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the full information about the item they are exporting and also a copy of Drug Manufacturing License. 54
Case No.:3/7/82ALC4/2012
Party Name:SIFLON DRUGS 10.01.2013 Status:Case Approved HQ File :01/82/050/00187/AM13/ RLA File :09/24/040/00591/AM12/ Lic.No/Date:0910051650 09.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/569/2012PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Rafoxanide BP Vet 1 kg 1 Iodine 0.50 kg 55
Case No.:41/11/82ALC4/2012
Party Name:EMCURE PHARMACEUTICALS LTD. 10.01.2013 HQ File :01/82/050/00308/AM13/ RLA File :31/83/040/00227/AM12/ Lic.No/Date:3110053321 09.03.2012 Defer Date:07.02.2013 56
Case No.:59/3/82ALC4/2012
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 10.01.2013 HQ File :01/82/050/00063/AM13/ RLA File :05/23/040/00483/AM12/ Lic.No/Date:0510319858 12.03.2012 Defer Date:24.01.2013 Decision :It was decided to call the firm for personal hearing on 24.1.2013. The case was deferred for 24.1.12013. 57
Case No.:28/11/82ALC4/2012
Party Name:PERKIN LABORATORIES 10.01.2013 HQ File :01/82/050/00295/AM13/ RLA File :09/24/040/00517/AM12/ Lic.No/Date:0910051719 13.03.2012 Defer Date:07.02.2013 Decision :It was decided to defer the case for 07.02.2013 for comments of Department of Pharmaceuticals.
58
Case No.:71/3/82ALC4/2012
Party Name:FORACE POLYMERS (P) LTD. 10.01.2013 HQ File :01/82/050/00075/AM13/ RLA File :05/23/040/00502/AM12/ Lic.No/Date:0510320188 15.03.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the following information immediately: Manufacturing process indicating stage wise wastage of each raw material for the export item separately. Consumption of raw material both imported and indigenous with corresponding production of each export item separately for the past 3 years duly certified by the concerned Central Excise/Chartered Accountant. 59
Case No.:12/8/82ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/00204/AM13/ RLA File :09/24/040/00594/AM12/ Lic.No/Date:0910051799 16.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/528/2012PI(Norms) dated 21.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Artesunate 1kg 1. Artemisinin 0.9259 kg 2. Sodium Borohydride 0.150 kg 3. Methanol 1.429 kg 4. Tetra Hydrofuran 0.974 kg 5. 4Dimethyl Amino Pyridine 0.073 kg 60
Case No.:38/8/82ALC4/2012
10.01.2013 Status:Case Approved HQ File :01/82/050/00230/AM13/ RLA File :09/24/040/00603/AM12/ Lic.No/Date:0910051798 16.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/532/2012PI(Norms) dated 26.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Montelukast Sodium 1 kg 1. 2(2(3(S)(3(2(7Chloro2 quinolinyl)ethenyl)phenyl)3 hydroxypropyl)phenyl)2propanol 1.424 kg 2. 1(Mercaptomethyl)cyclopropane acetic acid 0.60 kg 3. L(+) Tartaric Acid 0.643 kg 4. N,NDi isopropyl ethylamine 0.30 kg 5. Toluene 4.97 kg 6 Acetonitrile 7 09 kg
Acetonitrile 7.09 kg 7. Isopropyl ether 1.00 kg 8. Nmethyl2pyrrolidone Not shown in reaction scheme 9. Methylene Chloride 9.56 kg 10. Acetone 2.13 kg 11. Methanol 3.90 kg 61
Case No.:39/11/82ALC4/2012
10.01.2013 HQ File :01/82/050/00306/AM13/ RLA File :09/24/040/00600/AM12/ Lic.No/Date:0910051800 16.03.2012 Defer Date:07.02.2013 62
Case No.:43/11/82ALC4/2012
10.01.2013 HQ File :01/82/050/00310/AM13/ RLA File :09/24/040/00595/AM12/ Lic.No/Date:0910051797 16.03.2012 Defer Date:07.02.2013 63
Case No.:40/8/82ALC4/2012
Party Name:ADCOCK INGRAM LTD, 10.01.2013 HQ File :01/82/050/00232/AM13/ RLA File :07/24/040/00520/AM12/ Lic.No/Date:0710087119 20.03.2012 Defer Date:07.02.2013 Decision :It was decided to defer the case for 07.02.2013 for comments of Department of Pharmaceuticals. 64
Case No.:63/3/82ALC4/2012
Party Name:PARABOLIC DRUGS LTD., 10.01.2013 HQ File :01/82/050/00067/AM13/ RLA File :05/24/040/00447/AM12/ Lic.No/Date:0510320617 21.03.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the technical as per Appendix 33 within 15 days failing which their case would be closed. The case was deferred for 7.2.2013. 65
Case No.:75/4/82ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 10.01.2013 HQ File :01/82/050/00155/AM13/ RLA File :08/24/040/00292/AM12/ Lic.No/Date:0810110000 22.03.2012 Defer Date:07.02.2013
66
Case No.:76/4/82ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 10.01.2013 HQ File :01/82/050/00156/AM13/ RLA File :08/24/040/00301/AM12/ Lic.No/Date:0810110001 22.03.2012 Defer Date:07.02.2013 67
Case No.:77/4/82ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 10.01.2013 Status:Case Approved HQ File :01/82/050/00157/AM13/ RLA File :08/24/040/00304/AM12/ Lic.No/Date:0810109993 22.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/531/2012PI(Norms) dated 21.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Atorvastatin Condensation product 1 kg 1 Methyl Isobutyl Acetate 0.981 kg 2. Toluene 1.08 kg 3. Thiazole Base 0.120 kg 4. Acetone 1.77 kg 5. IPA (Iso Propyl Alcohol) 5.97 kg 6. (4R,CIS)1,1Dimethylethyl6 Cynomethyl2,2Dimethyl1,3 Dioxane4Acetate 0.763 kg 7. Methanol 1.63 68
Case No.:10/8/82ALC4/2012
Party Name:SUVEN LIFE SCIENCES LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/00202/AM13/ RLA File :09/24/040/00647/AM12/ Lic.No/Date:0910051921 28.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/546/2012PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed (RCisNMethylNPropanoic acid tetrahydropapaverine)besylate(R CisPAMQ) 1 kg 1. Homoveratrylamine 3.00 kg 2. Homoveratric acid 3.25 kg 3. Phosporous Oxychloride 2.63 kg 4. Methyl Benzene Sulfonate 4.13 kg 5. RuCl[(S,S)TSDPEN(P Cymene)] – Catalyst 0.100 kg
69
Case No.:29/8/82ALC4/2012
Party Name:AGIO PHARMACEUTICALS LTD 10.01.2013 Status:Case Approved HQ File :01/82/050/00221/AM13/ RLA File :03/94/040/01171/AM12/ Lic.No/Date:0310688368 28.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/545/2012PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Bendaz 10% Suspension (1000 ml) Albendasole Oral Suspension 10% w/v each ml contains Albendazole USP 100 mg 1 no.of Bottle 1. Albendazole USP/BP/EP/CP 0.102 kg/Bottle Bendaz 2.5% Suspension (1000 ml) Albendasole Oral Suspension 2.5% w/v Each ml contains Alebendazole USP 25.5 mg 1 no. of Bottle 1. 0.0255 kg/Bottle Bendaz 600 mg Albendazole Bolus 600 mg 1 Bolus 1. 612 mg/Bolus Bendaz 1500 mg Albendazole Bolus 1500 mg 1 Bolus 1. 1530 mg/Bolus Bendaz 2500 mg Albendazole Bolus 2500 mg 1 Bolus 1. 2550 mg/Bolus Bendaz Plus 900 (Albendazole and Oxyclozanide Tablets 600/300 mg) Each uncoated tablet contains Albendazole USP 600 mg Oxyclozanide BP (Vet) 300 mg 1 tablet 1. 612 mg/Tablets Bendaz Plus 535 (Albendazole and Oxyclozamide Tablets 360/175 mg) Each uncoated Tablet contains Albendazole USP 360 mg Oxyclozanide BP (Vet) 175 mg 1 tablet 1 367.2 mg/Tablet
Case No.:7/8/82ALC4/2012
Party Name:SUVEN LIFE SCIENCES LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/00199/AM13/ RLA File :09/24/040/00642/AM12/ Lic.No/Date:0910051920 28.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/570/2012PI(Norms) dated 27.12.2012, it
70 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/570/2012 PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Pamabrom USP 1 kg 1. Theophylline 1.00 kg 2. 2Amino2Methyl Propanol 0.54 kg 71
Case No.:9/11/82ALC4/2012
Party Name:CHEMCON SPECIALITY CHEMICALS P LTD 10.01.2013 HQ File :01/82/050/00276/AM13/ RLA File :34/24/040/00298/AM12/ Lic.No/Date:3410033741 29.03.2012 Defer Date:07.02.2013 72
Case No.:1/2/82ALC4/2012
10.01.2013 HQ File :01/82/050/00001/AM13/ RLA File :03/95/040/00970/AM12/ Lic.No/Date:0310688849 30.03.2012 Defer Date:07.02.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 25011/558/2012PI(Norms) dated 27.12.2012, it was decided to call from the firm a copy of Master Batch formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 7.2.2013. 73
Case No.:13/8/82ALC4/2012
10.01.2013 Status:Case Approved HQ File :01/82/050/00205/AM13/ RLA File :05/24/040/00470/AM12/ Lic.No/Date:0510321504 30.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/538/2012PI(Norms) dated 27.12.2012, 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: S. No Export Item Norms allowed for tablets Atorvastatin Calcium 1. Atorvastatin Calcium Tablets 10 mg 10.2 mg/tablets 2. Atorvastatin Calcium Tablets 20 mg 20.4 mg/tablets 3. Atorvastatin Calcium Tablets 40 mg 40.8 mg/tablets 4. Atorvastatin Calcium Tablets 80 mg 81.6 mg/tablets S. No Import Item Quantity Allowed kg/kg 1. ASC 3 (4RCIS)1,1DIMETHYL ETHYL6CYANO METHYL 2,2DIMETHYL1,3DIOXANE4ACETATE 0.733 2. ACTIVATED CARBON 0.047 3. CYCLOHEXANE 0.235 4. DKT 34FLUOROALPHA (2METHYL1OXOPROPYL)) GAMAOXONBETADIPHENYL BENZENE BUTANAMIDE} 1.15
ISOPROPYL ALCOHOL 0.58 6 METHANOL 2.82 7 METHYLTBUTYLETHER 1.36 8 NHEPTANE 0.83 9 TETRAHYDROFURAN 1.10 10 TOLUENE 1.46 74
Case No.:2/2/82ALC4/2012
10.01.2013 HQ File :01/82/050/00002/AM13/ RLA File :03/95/040/01032/AM12/ Lic.No/Date:0310688856 30.03.2012 Defer Date:07.02.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 35011/554/2012PI(Norms) dated 27.12.2012, it was decided to call from the firm a copy of Master Batch formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 7.2.2013. 75
Case No.:3/2/82ALC4/2012
10.01.2013 HQ File :01/82/050/00003/AM13/ RLA File :03/95/040/01037/AM12/ Lic.No/Date:0310688874 30.03.2012 Defer Date:07.02.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 35011/553/2012PI(Norms) dated 27.12.2012, it was decided to call from the firm a copy of Master Batch formula duly certified by Quality Control Incharge. The case was deferred for 7.2.2013. 76
Case No.:4/7/82ALC4/2012
Party Name:PROMED EXPORTS PVT.LTD. 10.01.2013 HQ File :01/82/050/00188/AM13/ RLA File :05/24/040/00471/AM12/ Lic.No/Date:0510321506 30.03.2012 Defer Date:07.02.2013 77
Case No.:34/8/82ALC4/2012
10.01.2013 Status:Case Approved HQ File :01/82/050/00226/AM13/ RLA File :22/24/040/00002/AM13/ Lic.No/Date:2210012699 09.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/544/2012PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Ceftiazidime for Injection 1 kg 1. Ceftazidime Pentahydrate Sterile (unbuffered) 0.928 kg 2. Sodium Carbonate 0.082 kg 3. Aluminium Bottle Anodized with Tear Relevant, as
off alu cap & chlorobutyl plug per packing policy 78
Case No.:48/11/82ALC4/2012
Party Name:VIHITA CHEM PVT.LTD. 10.01.2013 HQ File :01/82/050/00315/AM13/ RLA File :34/24/040/00282/AM12/ Lic.No/Date:3410033798 10.04.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the requisite information within 15 days failing which their case would be closed. The case was deferred for 7.2.2013. 79
Case No.:1/11/82ALC4/2012
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. 10.01.2013 HQ File :01/82/050/00268/AM13/ RLA File :03/94/040/01138/AM12/ Lic.No/Date:0310690368 11.04.2012 Defer Date:07.02.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately failing which their case would be closed. The case was deferred for 7.2.2013. 80
Case No.:38/16/82ALC4/2012
Party Name:BRILLIANT BIO PHARMA LIMITED 10.01.2013 HQ File :01/82/050/00474/AM13/ RLA File :09/24/040/00664/AM12/ Lic.No/Date:0910052111 11.04.2012 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of Department of Biotechnology. 81
Case No.:3/11/82ALC4/2012
Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 10.01.2013 HQ File :01/82/050/00270/AM13/ RLA File :03/94/040/00007/AM13/ Lic.No/Date:0310690582 12.04.2012 Defer Date:07.02.2013 82
Case No.:32/13/82ALC4/2012
10.01.2013 HQ File :01/82/050/00367/AM13/ RLA File :22/24/040/00003/AM13/ Lic.No/Date:2210012707 12.04.2012 Defer Date:07.02.2013
Case No.:50/3/83ALC1/2012
(FORMERLY NICHOLAS PIRAMAL) 10 01 2013
83 10.01.2013 HQ File :01/83/050/00053/AM13/ RLA File :03/95/040/01118/AM12/ Lic.No/Date:0310690527 12.04.2012 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of Department of Biotechnology. 84
Case No.:19/9/82ALC4/2012
10.01.2013 Status:Case Approved HQ File :01/82/050/00264/AM13/ RLA File :03/95/040/00963/AM12/ Lic.No/Date:0310690704 13.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/539/2012PI(Norms) dated 26.12.2012, 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 Sl.No. Import items Qty. allowed for export of 1 no. of Tablets Cilostazol Tablets 50 mg 100 mg 1. Cilostazol 51.0 102.0 2. Microcrystalline cellulose NF Avicel PH 102 20.0 40.0 3. Povidone USP (PVP K 30) 3.0 6.0 4. Corn Starch NF 16.75 33.50 5. Crospovidone NF 5.0 10.0 6. Magnesium Stearate NF/BP 0.75 1.50 7. Bottle HDPE 60 CC White 33/400 Neck (DPG) Relevant, as per packing policy 8. Plastic CR Closur PP 33/400/FS MI(Green) Relevant, as per packing policy 85
Case No.:8/7/82ALC4/2012
10.01.2013 Status:Case Approved HQ File :01/82/050/00192/AM13/ RLA File :03/95/040/01046/AM12/ Lic.No/Date:0310690715 13.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/541/2012PI(Norms) dated 26.12.2012, 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 Item: Diltiazem HCL Tablets 30 mg, 60 mg, 90 mg and 120 mg S.No Import item For Export of 1 no. of Tablets 30 mg 60 mg 90 mg 120 mg 1. Dilitazem HCL USP 30.6 mg 61.2 mg 91.8 mg 122.4 mg 2. Lactose Monohydrate NF/BP (200 Mesh) 139.0 mg 278.0 mg 417.0 mg 556.0 mg 3. Bottle HDPE 60 CC white 33/400 Neck (DPG) Relevant, as per packing policy.
( ) 4. Plastic CR Closur PP 33400/FS M1(Green) 5. Bottle HDPE 250 CC White 53/400 Neck (DPG) 6. Plastic RS Closur PP 53400/FS ML Liner 7. Bottle HDPE 100 CC White 38/400 NECK(DPG) 8 Plastic CR Closur PP 38400/FS MI(Green) 9 Bottle HDPE 500 CC White 53/400 Neck (DPG) 10. Plastic RS Closur PP 53400/FS MI Liner 11. Bottle HDPE 150 CC white 38/400 Neck (DPG) 12. Plastic CR Closur PP 38400/FS MI(Green) 86
Case No.:10/11/82ALC4/2012
Party Name:AMI LIFESCIENCES P LTD 10.01.2013 HQ File :01/82/050/00277/AM13/ RLA File :34/24/040/00012/AM13/ Lic.No/Date:3410033877 16.04.2012 Defer Date:07.02.2013 87
Case No.:47/8/82ALC4/2012
10.01.2013 Status:Case Approved HQ File :01/82/050/00239/AM13/ RLA File :05/24/040/00011/AM13/ Lic.No/Date:0510322536 19.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/533/2012PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Imipenem Technical (Crude) (Bulk Drug/pharmacopeal Grade) 1 kg 1. (3R,4R)4ACETOXY3((R)(TERT BUTYLDIMETHYLSILYLOXY)ETHYL2 AZETIDINONE 3.44 kg 2 4 DIMETHYL AMINOPYRIDINE 0.021 kg 3 ACETONITRILE 0 768 kg
3 ACETONITRILE 0.768 kg 4 ACETONE 10.975 kg 5 CYCLOHEXANE 14.22 kg 6 CYSTEAMINE HYDROCHLORIDE 0.78 kg 7 DIPHENYL CHLOROPHOSPHATE 2.44 kg 8 N,NDIISOPROPYL ETHYLAMINE 3.52 kg 9 FORMIC ACID 3.15 kg 10 ISOPROPYL ALCOHOL 0.505 kg 11 METHYLENE CHLORIDE 14.269 kg 12 METHANOL 1.37 kg 13 METHANE SULFONIC ACID 0.51 kg 14 NMETHYL MORPHOLINE 0.39 kg 15 PALLADIUM SPONGE 8.65 gm/kg 16 TETRAHYDROFURAN 2.768 gm/kg 17 TOLUENE 2.526 kg 18 TRIETHYLAMINE 2.03 kg 88
Case No.:48/8/82ALC4/2012
10.01.2013 Status:Case Approved HQ File :01/82/050/00240/AM13/ RLA File :05/24/040/00014/AM13/ Lic.No/Date:0510322537 19.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/533/2012PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Imipenem Sterile (Bulk Drug/Pharmacopeal Grade) 1 kg 1 (3R,4R)4ACETOXY3((R)(TERT BUTYLDIMETHYLSILYLOXY)ETHYL2 AZETIDINONE 4.967 kg 2 DIMETHYL AMINOPYRIDINE 0.03 kg 3 ACETONITRILE 1.35 kg 4 ACETONE 9.55 kg 5 ACTIVATED CARBON 0.100 kg 6 CYSTEAMINE HYDROCHLORIDE 1.12 kg 7 DIPHENYL CHLOROPHOSPHATE 3.53 kg 8 N,NDIISOPROPYL ETHYLAMINE 5.08 kg 9 ISOPROPYL ALCOHOL 15.67 kg 10 METHYLENE CHLORIDE 22.36 kg 11 METHANOL 10.23 kg 12 METHANE SULFONIC ACID 0.73 kg 13 NMETHYL MORPHOLINE 0.57 kg 14 PALLADIUM SPONGE 12.5 gm/kg 15 TETRAHYDROFURAN 3.13 kg/kg 16 TOLUENE 6.22 kg 17 TRIMETHYL CHLOROSILANE 2.931 kg 18 TRIETHYLAMINE 3.00 kg
89
Case No.:2/5/82ALC4/2012
Party Name:TITAN LABORATORIES PVT. LTD. 10.01.2013 Status:Case Approved HQ File :01/82/050/00174/AM13/ RLA File :03/95/040/00048/AM13/ Lic.No/Date:0310691572 20.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/564/2012PI(Norms) dated 21.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Trimebutine Maleate DC Granules 50% 1 kg 1. Trimebutine Maleate BP/EP/USP/JP 505gm/kg 2. Lactose 460 gm/kg 90
Case No.:18/11/82ALC4/2012
10.01.2013 HQ File :01/82/050/00285/AM13/ RLA File :22/24/040/00001/AM13/ Lic.No/Date:2210012759 24.04.2012 Defer Date:07.02.2013 91
Case No.:40/11/82ALC4/2012
10.01.2013 Status:Case Approved HQ File :01/82/050/00307/AM13/ RLA File :22/24/040/00005/AM13/ Lic.No/Date:2210012763 25.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/544/2012PI(Norms) dated 27.12.2012, 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 Export Qty. Sl.No. Import items Qty. allowed Ceftiazidine for Injection “ The export product shall account for 109 Nos. aluminium Bottle anodized with Tear of Alu & Chlorobutyl plug” 1 kg 1. Ceftazidime Pentahydrate Sterile (UnBuffered) 0.928 kg 2. Sodium Carbonate 0.082 kg 3. Aluminium Bottles Anodized with Tear off alucap & chlorobutyl plug Relevant, as per packing policy 92
Case No.:10/28/82ALC4/2012
10.01.2013 HQ File :01/82/050/00977/AM13/ RLA File :09/24/040/00339/AM13/ Lic.No/Date:0910054180 29.10.2012 Defer Date:07.02.2013 304
Case No.:2/28/82ALC4/2012
Party Name:POLYGON CHEMICALS 10.01.2013 HQ File :01/82/050/00969/AM13/ RLA File :08/24/040/00258/AM13/ Lic.No/Date:0810115970 29.10.2012 Defer Date:07.02.2013 305
Case No.:3/28/82ALC4/2012
Party Name:POLYGON CHEMICALS 10.01.2013 HQ File :01/82/050/00970/AM13/ RLA File :08/24/040/00262/AM13/ Lic.No/Date:0810115971 29.10.2012 Defer Date:07.02.2013 306
Case No.:31/28/82ALC4/2012
Party Name:MSN LABORATORIES LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/00998/AM13/ RLA File :09/24/040/00363/AM13/ Lic.No/Date:0910054179 29.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export Product Export Quantity S.No Import Product Quantity Allowed Ezetimibe 1 kg 1. ®2MethylCBS Oxazaborolidine 0.057 kg 2. Borane dimethyl sulfide 0.424 kg 3. Bistrimethylsilyl acetamide 1.07 kg 4. (S)+4 Phenyl2 Oxazolidinone 0.93 kg
307
Case No.:45/26/82ALC4/2012
Party Name:PAYAL POLYPLAST PVT.LTD., 10.01.2013 HQ File :01/82/050/00953/AM13/ RLA File :05/24/040/00255/AM13/ Lic.No/Date:0510337699 29.10.2012 Defer Date:07.02.2013 308
Case No.:5/28/82ALC4/2012
Party Name:AUCTUS PHARMA LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/00972/AM13/ RLA File :09/24/040/00365/AM13/ Lic.No/Date:0910054182 29.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 15.11.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg (2R.5R)5Hydroxy[1,3] Oxathiolane2carboxylic acid, 2S Isopropyl5R Methyl1R Cyclohexyl Ester (ECE) 1 kg 1. 2,5Dihydroxy1,4diathiane 0.30 2. Glyoxalic Acid 0.3585 3. Toluene 0.60 4. nHexane 1.01 309
Case No.:8/28/82ALC4/2012
Party Name:MSN LABORATORIES LIMITED 10.01.2013 HQ File :01/82/050/00975/AM13/ RLA File :09/24/040/00379/AM13/ Lic.No/Date:0910054186 29.10.2012 Defer Date:07.02.2013 310
Case No.:2/24/82ALC4/2012
Party Name:LAKE CHEMICALS PRIVATE LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/00806/AM13/ RLA File :07/24/040/00296/AM13/ Lic.No/Date:0710091635 30.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 47/82 dated 22.2.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export product Export Qty. Sl.No. Import items Qty. allowed Midazolam Hcl 1 Kg. 1. 2Aminomethyl 7chloro2,3 Dihydro 5(2Flurophenyul)1H1,4 Benzodiazepine Di maleate 4.59 kg/kg 2. Triethyl ortho acetate 3.42 kg/kg
311
Case No.:3/24/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 10.01.2013 HQ File :01/82/050/00807/AM13/ RLA File :09/24/040/00332/AM13/ Lic.No/Date:0910054196 30.10.2012 Defer Date:07.02.2013 312
Case No.:36/28/82ALC4/2012
Party Name:PI INDUSTRIES LTD., 10.01.2013 HQ File :01/82/050/01003/AM13/ RLA File :13/24/040/00035/AM13/ Lic.No/Date:1310041436 30.10.2012 Defer Date:07.02.2013 313
Case No.:43/28/82ALC4/2012
Party Name:METROPOLITAN EXIMCHEM LTD. 10.01.2013 HQ File :01/82/050/01010/AM13/ RLA File :03/95/040/00561/AM13/ Lic.No/Date:0310713820 30.10.2012 Defer Date:07.02.2013 314
Case No.:47/28/82ALC4/2012
Party Name:YASHO INDUSTRIES PVT.LTD. 10.01.2013 HQ File :01/82/050/01014/AM13/ RLA File :03/95/040/00580/AM13/ Lic.No/Date:0310713891 30.10.2012 Defer Date:07.02.2013 315
Case No.:52/28/82ALC4/2012
Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 10.01.2013 Status:Case Approved HQ File :01/82/050/01019/AM13/ RLA File :22/24/040/00038/AM13/ Lic.No/Date:2210013370 30.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 46/82 dated 14.2.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export product Exp. Qty. Sl.No. Import items Qty. allowed Ampicillin Trihydrate through 6APA through Enzyme Route 1 Kg. 1. 6Amino Penicillinic Acid (6APA) 0.568 kg 2. Formidase (Enzyme) 5 gm 3. D() Alpha Phenyl Glycine Base 4. Methanol 0.020kg
316
Case No.:53/28/82ALC4/2012
Party Name:INDSWIFT LABORATORIES LTD., 10.01.2013 Status:Case Approved HQ File :01/82/050/01020/AM13/ RLA File :22/24/040/00040/AM13/ Lic.No/Date:2210013369 30.10.2012 Defer Date: Decision :In the light of earlier decision taken in meeting no. 47/82 dated 21.2.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export product Exp. Qty. Sl.No. Import items Qty. allowed Atorvastatin Calcium 1 Kg. 1. Methyl Isobutyryl Acetate 1.646 kg 2. Beta Ananine 0.100 kg 3. Sodium Meta Bisulphite 0.037 kg 4. Para Fluoro Benzaldehyde 0.70 kg 5. 3Ethyl5(2Hydroxy Ethyl)4Methyl Thiazolium Bromide 0.262 kg 6. Isopropyl Alcohol 8.375 kg 7. (4RCis)1,1Dimethylethyl6 Cyanomethyl2,2Dimethyl12Dioxane4 Acetate (ATS8) 1.003 kg 8. Tert. Butyl Methyl Ether 4.151 kg 317
Case No.:9/28/82ALC4/2012
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 10.01.2013 HQ File :01/82/050/00976/AM13/ RLA File :09/24/040/00374/AM13/ Lic.No/Date:0910054204 30.10.2012 Defer Date:07.02.2013 318
Case No.:37/28/82ALC4/2012
Party Name:DEEPAK NITRITE LIMITED 10.01.2013 HQ File :01/82/050/01004/AM13/ RLA File :34/24/040/00015/AM13/ Lic.No/Date:3410035376 31.10.2012 Defer Date:07.02.2013 319
Case No.:38/28/82ALC4/2012
Party Name:DEEPAK NITRITE LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/01005/AM13/ RLA File :34/24/040/00064/AM13/ Lic.No/Date:3410035377 31.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 44/82 dated 31.1.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details
Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Ethyl Hexyl Nitrate 1 Kg. 1. 2Ethyl Hexanol 0.765 kg 320
Case No.:4/24/82ALC4/2012
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 10.01.2013 HQ File :01/82/050/00808/AM13/ RLA File :09/24/040/00362/AM13/ Lic.No/Date:0910054208 31.10.2012 Defer Date:07.02.2013 321
Case No.:45/28/82ALC4/2012
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 10.01.2013 Status:Case Approved HQ File :01/82/050/01012/AM13/ RLA File :03/95/040/00515/AM13/ Lic.No/Date:0310713981 31.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export Product Export Qty. Sl.No. Import items Qty. allowed Artemether 1 Kg. 1. Artemisinin 1.50 kg 2. Sodium Borohydride 0.188 kg 322
Case No.:7/24/82ALC4/2012
Party Name:SHIVA PHARMACHEM LTD, 10.01.2013 HQ File :01/82/050/00811/AM13/ RLA File :34/24/040/00168/AM13/ Lic.No/Date:3410035379 31.10.2012 Defer Date:07.02.2013 323
Case No.:39/28/82ALC4/2012
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 10.01.2013 HQ File :01/82/050/01006/AM13/ RLA File :34/24/040/00184/AM13/ Lic.No/Date:3410035411 01.11.2012 Defer Date:07.02.2013 324
Case No.:8/24/82ALC4/2012
Party Name:ALKEM LABORATORIES LTD., 10.01.2013 HQ File :01/82/050/00812/AM13/ RLA File :03/94/040/00668/AM13/ Lic.No/Date:0310714062 01.11.2012 Defer Date:07.02.2013
325
Case No.:46/28/82ALC4/2012
Party Name:ZENITH DYEINTERMEDIATES LIMITED Meet No/Date:28/82ALC4/2012 10.01.2013 HQ File :01/82/050/01013/AM13/ RLA File :03/95/040/00571/AM13/ Lic.No/Date:0310714165 02.11.2012 Defer Date:07.02.2013 326
Case No.:48/28/82ALC4/2012
Party Name:YASHO INDUSTRIES PVT.LTD. 10.01.2013 HQ File :01/82/050/01015/AM13/ RLA File :03/95/040/00594/AM13/ Lic.No/Date:0310714182 02.11.2012 Defer Date:07.02.2013 327
Case No.:22/26/82ALC4/2012
Party Name:RELIANCE INDUSTRIES LTD. 10.01.2013 HQ File :01/82/050/00930/AM13/ RLA File :03/95/040/00370/AM13/ Lic.No/Date:0310714238 05.11.2012 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of Petrochemical division of Department of Chemicals and Petrochemicals. 328
Case No.:33/28/82ALC4/2012
Party Name:DHARUHERA PHARMACEUTICALS PVT LTD 10.01.2013 HQ File :01/82/050/01000/AM13/ RLA File :05/23/040/00264/AM13/ Lic.No/Date:0510338287 05.11.2012 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of Department of Pharmaceuticals 329
Case No.:41/28/82ALC4/2012
Party Name:PREGNA INTERNATIONAL LTD. 10.01.2013 HQ File :01/82/050/01008/AM13/ RLA File :03/95/040/00444/AM13/ Lic.No/Date:0310714240 05.11.2012 Defer Date:07.02.2013 Decision :It was decided to defer the case for 7.2.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals. 330
Case No.:7/28/82ALC4/2012
Party Name:MELZER CHEMICALS PVT. LTD 10.01.2013 HQ File :01/82/050/00974/AM13/ RLA File :31/83/040/00134/AM13/ Lic.No/Date:3110056196 05.11.2012 Defer Date:07.02.2013
331
Case No.:35/28/82ALC4/2012
Party Name:UNITED BIOTECH PVT.LTD. 10.01.2013 HQ File :01/82/050/01002/AM13/ RLA File :05/24/040/00280/AM13/ Lic.No/Date:0510338316 06.11.2012 Defer Date:07.02.2013 332
Case No.:34/28/82ALC4/2012
10.01.2013 HQ File :01/82/050/01001/AM13/ RLA File :05/24/040/00283/AM13/ Lic.No/Date:0510338695 08.11.2012 Defer Date:07.02.2013 333
Case No.:4/28/82ALC4/2012
Party Name:POSY PHARMACHEM PVT. LTD. 10.01.2013 HQ File :01/82/050/00971/AM13/ RLA File :08/24/040/00242/AM13/ Lic.No/Date:0810116296 12.11.2012 Defer Date:07.02.2013 334
Case No.:26/28/82ALC4/2012
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 10.01.2013 HQ File :01/82/050/00993/AM13/ RLA File :04/24/040/00126/AM13/ Lic.No/Date:0410141071 16.11.2012 Defer Date:07.02.2013 335
Case No.:27/28/82ALC4/2012
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 10.01.2013 HQ File :01/82/050/00994/AM13/ RLA File :04/24/040/00160/AM13/ Lic.No/Date:0410141072 16.11.2012 Defer Date:07.02.2013 336
Case No.:3/26/82ALC4/2012
Party Name:SHIVA PHARMACHEM LTD, 10.01.2013 HQ File :01/82/050/00911/AM13/ RLA File :34/24/040/00205/AM13/ Lic.No/Date:3410035547 26.11.2012 Defer Date:07.02.2013
337
Case No.:47/26/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 10.01.2013 HQ File :01/82/050/00955/AM13/ RLA File :09/24/040/00375/AM13/ Lic.No/Date:0910054404 29.11.2012 Defer Date:07.02.2013 338
Case No.:61/28/82ALC4/2012
10.01.2013 HQ File :01/82/050/01028/AM13/ RLA File :09/24/040/00436/AM13/ Lic.No/Date:0910054444 05.12.2012 Defer Date:07.02.2013 339
Case No.:1/28/82ALC4/2012
Party Name:ANUPAM RASAYAN (INDIA) LTD 10.01.2013 HQ File :01/82/050/00968/AM13/ RLA File :52/24/040/00038/AM13/ Lic.No/Date:5210039286 19.12.2012 Defer Date:07.02.2013 340
Case No.:40/28/82ALC4/2012
Party Name:HETERO LABS LIMITED 10.01.2013 HQ File :01/82/050/01007/AM13/ RLA File :09/24/040/00447/AM13/ Lic.No/Date:0910054591 20.12.2012 Defer Date:07.02.2013 341
Case No.:54/28/82ALC4/2012
10.01.2013 HQ File :01/82/050/01021/AM13/ RLA File :22/24/040/00053/AM13/ Lic.No/Date:2210013461 20.12.2012 Defer Date:07.02.2013 342
Case No.:55/28/82ALC4/2012
Party Name:ADVANCE PETROCHEMICALS LIMITED 10.01.2013 HQ File :01/82/050/01022/AM13/ RLA File :08/24/040/00337/AM13/ Lic.No/Date:0810117116 26.12.2012 Defer Date:07.02.2013 343
Case No.:56/28/82ALC4/2012
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:28/82ALC4/2012 Status:Case
3 3
Case No.:56/ 8/8
C / 0 a ty Na e: NU O O S . eet No/ ate: 8/8 C / 0 10.01.2013 Status:Case Approved HQ File :01/82/050/01023/AM13/ RLA File :05/23/040/00397/AM13/ Lic.No/Date:0510341753 27.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting No. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export product Exp. Qty. Sl.No. Import items Qty. allowed Kg/kg GCTA Powder Ikg 1, GCLE 1.282 2. Triphenyl Phosphine 0.726 3. 4Methyl5Formyl Thiazol 0.769 4. Propane1ol 2.40 5. Chloroform 4.27 6. Sodium Iodide 0.41 7. Methanol 1.918 8. Potassium Meta Bisulphite 2.353 344
Case No.:57/28/82ALC4/2012
Party Name:DHANUKA LABORATORIES LTD. 10.01.2013 Status:Case Approved HQ File :01/82/050/01024/AM13/ RLA File :05/23/040/00395/AM13/ Lic.No/Date:0510341758 27.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting No. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export product Exp. Qty. Sl.No. Import items Qty. allowed Kg/kg GCTA Powder Ikg 1, GCLE 1.282 2. Triphenyl Phosphine 0.726 3. 4Methyl5Formyl Thiazol 0.769 4. Propane1ol 2.40 5. Chloroform 4.27 6. Sodium Iodide 0.41 7. Methanol 1.918 8. Potassium Meta Bisulphite 2.353 345
Case No.:58/28/82ALC4/2012
Party Name:DHANUKA LABORATORIES LTD. 10.01.2013 Status:Case Approved HQ File :01/82/050/01025/AM13/ RLA File :05/23/040/00392/AM13/ Lic.No/Date:0510341764 27.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting No. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export product Exp. Sl.No. Import items Qty. allowed
p p p Qty. p y Kg/kg GCTA Powder Ikg 1, GCLE 1.282 2. Triphenyl Phosphine 0.726 3. 4Methyl5Formyl Thiazol 0.769 4. Propane1ol 2.40 5. Chloroform 4.27 6. Sodium Iodide 0.41 7. Methanol 1.918 8. Potassium Meta Bisulphite 2.353 346
Case No.:59/28/82ALC4/2012
Party Name:DHANUKA LABORATORIES LTD. 10.01.2013 Status:Case Approved HQ File :01/82/050/01026/AM13/ RLA File :05/23/040/00393/AM13/ Lic.No/Date:0510341768 27.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting No. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export product Exp. Qty. Sl.No. Import items Qty. allowed Kg/kg GCTA Powder Ikg 1, GCLE 1.282 2. Triphenyl Phosphine 0.726 3. 4Methyl5Formyl Thiazol 0.769 4. Propane1ol 2.40 5. Chloroform 4.27 6. Sodium Iodide 0.41 7. Methanol 1.918 8. Potassium Meta Bisulphite 2.353 347
Case No.:60/28/82ALC4/2012
Party Name:DHANUKA LABORATORIES LTD. 10.01.2013 Status:Case Approved HQ File :01/82/050/01027/AM13/ RLA File :05/23/040/00394/AM13/ Lic.No/Date:0510341771 27.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting No. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details Export product Exp. Qty. Sl.No. Import items Qty. allowed Kg/kg GCTA Powder Ikg 1, GCLE 1.282 2. Triphenyl Phosphine 0.726 3. 4Methyl5Formyl Thiazol 0.769 4. Propane1ol 2.40 5. Chloroform 4.27 6 Sodium Iodide 0 41
Outside Agenda No. 1 M/s. Ashish Life Sciences Pvt. Ltd. Norms Committee Meeting No.28/AM13 F.No. 01/60/162/352/AM 13/EFGC(PRC) Meeting Date:10.01.2013 RLA File No. 03/81/040/00150/AM 10 Adv. Lic. No. & Date 0310537518 dated 14.9.2009 Decision: This is regarding the request of the firm for switching over from SION 412 and 1945 to SION 207 for regularization purpose. The issue was discussed in the meeting in detail and it was decided that RA may decide this case as per SION if the firm has valid Drug Manufacturing License for the new export product. 6. Sodium Iodide 0.41 7. Methanol 1.918 8. Potassium Meta Bisulphite 2.353 348
Case No.:62/28/82ALC4/2012
Party Name:UNIMARK REMEDIES LIMITED., 10.01.2013 HQ File :01/82/050/01029/AM13/ RLA File :03/95/040/00718/AM13/ Lic.No/Date:0310718680 31.12.2012 Defer Date: 7.2.2013 Decision : It was decided to defer the case for 7.2.2013 for comments of Department of Pharmaceuticals. 349
Case No.:63/28/82ALC4/2012
Party Name:UNIMARK REMEDIES LIMITED., 10.01.2013 HQ File :01/82/050/01030/AM13/ RLA File :03/95/040/00719/AM13/ Lic.No/Date:0310718683 31.12.2012 Defer Date: 7.2.2013 Decision : It was decided to defer the case for 7.2.2013 for comments of Department of Pharmaceuticals. 350
Case No.:64/28/82ALC4/2012
Party Name:GOPINATH CHEMTECH LTD., 10.01.2013 HQ File :01/82/050/01031/AM13/ RLA File :08/24/040/00340/AM13/ Lic.No/Date:0810117249 01.01.2013 Defer Date:07.02.2013 351
Case No.:65/28/82ALC4/2012
Party Name:UNITED BIOTECH PVT.LTD. 10.01.2013 HQ File :01/82/050/01032/AM13/ RLA File :05/24/040/00375/AM13/ Lic.No/Date:0510342192 01.01.2013 Defer Date:07.02.2013
p p Date:14.01.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer
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