IN FORCE Advance Authorisation

DGFT Minutes

Reliability

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Case No. B 457

M/s. Ruby Fragrance Pvt Limited Vickramasigapuram (TN) Norms Committee Meeting No.30/AM13 F.No 01/82/050/00966/AM 12/DES III F. No. 01/82/050/00295/AM 12/DES III Meeting Date:07.02.2013 35/24/040/0045/AM 12 35/24/040/00025/AM 12 Adv. Lic. No. & Date 3510035931 dated 25.5.2011 and 3510034005 dated 25.5.2011 Decision: It was decided to defer the case for 7.3.2013 for comments of Department of Chemicals and Petrochemicals.

Case No. B 458

M/s. Encee Aromatics Pvt. Ltd. F.No 01/82/162/00020/AM 10/DES III Decision: It was decided to remind the Chemcexil to furnish All Industry Data for fixation of norms. The case was deferred for 7.3.2013.

Case No. B 459

M/s.Cipla Limited, Mumbai F.No 01/82/050/00624/AM 13/DES III 03/94/040/00342/AM 13/ZALC 0310703951 dated 3.8.2012 Decision: The case was discussed in the meeting and technical member from Department of Ph ti l h l ifi d th t th h b tifi d f th i t di t f “L fl i Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision

MEETING NUMBER : 30/82ALC4/2012 MEETING DATE : 07.02.2013 The Meeting No. 30/82 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 07.02.2013 under the Chairmanship of, Shri Mukesh Bhatnagar, Addl DGFT in Room No.4, Udyog Bhawan, New Delhi.. Following members were present: 1. Shri D.N. Mathur. Advisor, Department of Pharmaceutical 2. Shri S.K. Aggarwal, Assistant Director, DC(MSME) 3. Shri R.C. Meena, Deputy Director General of Foreign Trade

Pharmaceuticals has clarified that the norms have been ratified for the intermediate of “Levofloxacin Hemihydrate”. However, it was decided to amend the UOM for the quantity allowed from kg/kg to kg/1000 No. of Levofloxacin tablets. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 460

M/s. Smruthi Organics Limited F. No 01/83/050/01087/AM 04/DES III F. No. 01/83/050/0001/AM 03/DES III F. No. 01/83/050/01350/AM 03/DES III F. No. 01/83/050/00975/AM 04/DES III 31/24/040/00195/AM 04 31/24/040/00082/AM 02 31/24/040/00322/AM 03 31/24/040/00173/AM 04 31/24/040/00016/AM 04 3110013489 dated 2.12.2003 3110006244 dated 20.2.2002 3110009528 dated 13.01.2003 3110013121 dated 4.11.2003 3110010812 dated 28.4.2003 Decision: It was decided to reject the request of the firm as these relate to norms ratified in year 2002,2003 & 2004.

Case No. B 461

M/s. Solvay Specialities India Pvt. Ltd., Panoli, Distt. Bharuch, Gujarat. F.No. 01/82/162/01074/AM 12/DES III 03/95/040/00596/AM 12/ZALC 0310668224 dated 30.11.2011 Decision: It was decided to defer the case for 7.3.2013 for comments of Department of Chemicals and Petrochemicals.

Case No. B 462

M/s. Medchl Chem. & Pharma Limited F.No 01/82/050/017606/AM 11/DES III F. No. 01/82/050/00911/AM 11/DES III F. No. 01/82/50/01258/AM 11/DES III 09/24/40/00539/AM 11 09/24/40/00231/AM 12 09/24/40/00324/AM 11 Adv Lic No & Date 3510035931 dated 25 5 2011 and 3510034005 dated

3510035931 dated 25.5.2011 and 3510034005 dated 25.5.2011 Decision: It was decided to defer the case for 7.3.2013 for comments of Department of Pharmaceuticals.

Case No. B 463

M/s. Metropolitan Eximchem Limited F.No 01/82/050/00244/AM 13/DES III F. No. 01/82/050/1062/AM 12/DES III 03/95/040/00002/AM 13 03/95/040/00643/AM 12 0310690688 dated 13.4.2012 0310664714 dated 14.11.2012 Decision: It was decided to defer the case for 7.3.2013 for comments of Department of Chemicals and Petrochemicals.

Case No. B 464

M/s. Aqua Pharm Chemicals (Pvt. ) Limited F.No 01/82/162/442/AM 13 F. No. 01/82/162/443/AM 13 F. No 01/82/162/444/AM 13 F. No 01/82/162/445/AM 13 F. No 01/82/162/446/AM 13 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/159/2011/Ch. II dated 28.1.2013, it was decided to ratify norms under Para 6.8(e) of FTP, as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Diethylene Tri amine Penta (Methylene Phosphonic) Acid, Partial Ammonium Salt (36%) 1 kg 1. Diethylene Triamine (DETA) 0.060 kg 2. Liquor Ammonia (25%) 0.272 kg 3. Phosphorous Trichloride Or Phosphorous Acid 0.400 kg 0.239 kg Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg)

Hydroxy Ethylidene Diphosphonic Acid also known as phsophonic acid, (1 Hydroxyethylidene) Bis or Etidronic Acid) (CAS No. 2809214) Aquacid 105 EX, Aquacid 105 NS, Maxinol 42 1 kg 1. Acetic Acid 0.669 2. Phosphorous Trichloride 0.806 3. Hydrogen Peroxide 0.013 Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Diethylene Tri Amine Penta (Methylene Phosphonic) Acid, Partial Ammonium Salt (47%) Aquacid 1062 EX 1 kg 1. Diethylene Triamine (DETA) 0.083 kg 2. Liquor Ammonia 0.214 kg 3. Phosphorous Trichloride Or Phsophorous Acid 0.587 kg Or 0.350 kg Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Aquacid 1054 PG Tetra sodium Salt of 1 Hydroxyethlidene11

osphorous Trichloride Or Phsophorous Acid 0.587 kg Or 0.350 kg Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Aquacid 1054 PG Tetra sodium Salt of 1 Hydroxyethlidene11 Diphosphonic Acid (92%) Granulated Powder 1 kg 1. Tetra Sodium Salt of 1 Hydroxy Ethylidene 1,1 Diphosphonic Acid (92%) 0.500 kg 2. 1 Hydroxy Ethylidene 1,1 Diphosphonic Acid (60%) 0.527 kg 3. Caustic Soda Lye 0.492 kg 4. Phosphorous Acid 0.006 kg Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Aquacid 1014 EX 2 Ph h b 1 1 kg 1. 1Phosphonobutane1,2,4 Tricarboxylic Acid (50%) 0.640kg

2Phosphonobutane1, 2,4Tricarboxylic Acid, Tetra Sodium Salt (43%) 2. Caustic Soda Lye 0.375 kg Development Commissioner may take appropriate action as per the decision of Norms Committee.

Case No. B 465

M/s. PCL Oil and Solvents Limited, New Delhi F.No 01/82/162/917/AM 13 DES III 05/27/040/00083/AM 13 05/27/040/00454/AM 13 05/27/040/00455/AM 13 Decision: It was decided to defer the case for 7.3.2013 for comments of Petrochemicals division of Department of Chemicals and Petrochemicals.

Case No. C 57

M/s. Encee Aromatics Pvt. Ltd. F.No 01/82/162/00008/AM 13/DES III Decision: It was decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authority. The case was deferred for 7.3.2013.

Case No. C 58

M/s. Fermenta Biotech Limited F.No 01/82/162/128/AM 13/DES III Decision: It was decided to remind the firm to furnish the production and consumption data duly certified by Central Excise Authority. The case was deferred for 7.3.2013. 1

Case No.:71/15/82ALC4/2010

Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:30/82ALC4/2012 07.02.2013 Status:Case Deferred HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date:07.03.2013 Decision :It was decided to defer the case for 7.3.2013 for comments of Department of Pharmaceuticals.

Case No :10/28/82ALC4/2010

Party Name:VIVIMED LABS LIMITED Meet No/Date:30/82ALC4/2012 Status:Case Deferred

Case No.:10/28/82ALC4/2010

Party Name:VIVIMED LABS LIMITED 07.02.2013 HQ File :01/82/050/00892/AM11/ RLA File :09/24/040/00273/AM11/ Lic.No/Date:0910043757 30.09.2010 Defer Date:07.03.2013 Decision :It was decided to defer the case for 7.3.2013 for comments of Department of Chemicals and Petrochemicals. 3

Case No.:63/40/82ALC4/2010

Party Name:EMAMI LIMITED, 07.02.2013 HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Defer Date:07.03.2013 Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 4

Case No.:53/47/82ALC4/2010

Party Name:NEULAND LABORATORIES LTD 07.02.2013 HQ File :01/82/050/01643/AM11/ RLA File :09/24/040/00519/AM11/ Lic.No/Date:0910045550 14.02.2011 Defer Date:07.03.2013 Decision :It was decided to defer the case for 07.03.2013 for comments of Department of Pharmaceuticals. 5

Case No.:5/4/82ALC4/2011

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 07.02.2013 HQ File :01/82/050/00056/AM12/ RLA File :03/95/040/00949/AM11/ Lic.No/Date:0310620143 08.03.2011 Defer Date:07.03.2013 Decision :It was decided to defer the case for 07.03.2013 for comments of Department of Biotechnology. 6

Case No.:19/10/82ALC4/2011

Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 07.02.2013 HQ File :01/82/050/00278/AM12/ RLA File :61/24/040/00097/AM11/ Lic.No/Date:6110000608 03.05.2011 Defer Date:07.03.2013 Decision :It was decided to defer the case for 07.03.2013 for comments of DC(MSME). 7

Case No.:18/11/82ALC4/2011

07.02.2013 HQ File :01/82/050/00332/AM12/ RLA File :09/24/040/00080/AM12/ Lic.No/Date:0910046973 02.06.2011 Defer Date:07.03.2013 Decision :It was decided to defer the case for 07.03.2013 for comments of Department of Chemicals and Petrochemicals.

Case No.:19/11/82ALC4/2011

07.02.2013

8 07.0 . 0 3 HQ File :01/82/050/00333/AM12/ RLA File :09/24/040/00079/AM12/ Lic.No/Date:0910046974 02.06.2011 Defer Date:07.03.2013 9

Case No.:25/19/82ALC4/2011

07.02.2013 HQ File :01/82/050/00539/AM12/ RLA File :09/24/040/00085/AM12/ Lic.No/Date:0910046996 06.06.2011 Defer Date:07.03.2013 10

Case No.:27/16/82ALC4/2011

Party Name:ALEMBIC PHARMACEUTICALS LTD 07.02.2013 Status:Case Approved HQ File :01/82/050/00485/AM12/ RLA File :34/24/040/00039/AM12/ Lic.No/Date:3410030563 10.06.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/604/2012PI(Norms) dated 6.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Candesartan Cilexetil 1 kg 1 2ETHOXY1[2{1 H TETARZOLE5YL} BIPHENYL 4YL)METHYL] BENZIMIDAZOLE7 CARBOXYLIC ACID ( EBCIII ) 1.35 2 TRIETHYLAMINE 0.31 3 ACETONE 4.32 4 METHANOL 4.58 5 METHYLENE CHLORIDE ( OR DICHLOROMETHANE) 6.88 6 1CHLOROETHYL CYCLOHEXYL CARBONATE 0.49 7 DIMETHYL FORMAMIDE 0.83 8 CYCLOHEXANE 2.06 RA may take appropriate action as per the decision of Norms Committee. 11

Case No.:35/19/82ALC4/2011

Party Name:NECTAR LIFESCIENCES LIMITED, 07.02.2013 HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 Defer

11 HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 Defer Date:07.03.2013 12

Case No.:97/22/82ALC4/2012

Party Name:ALEMBIC PHARMACEUTICALS LTD 07.02.2013 HQ File :01/82/050/00800/AM13/ RLA File :34/24/040/00058/AM12/ Lic.No/Date:3410030822 05.07.2011 Defer Date:07.03.2013 13

Case No.:25/26/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 07.02.2013 HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic.No/Date:0310646711 05.08.2011 Defer Date:07.03.2013 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula within 15 days failing which their case would be closed. The case was deferred for 7.3.2013. 14

Case No.:39/31/82ALC4/2011

Party Name:SAURAV CHEMICALS LTD, 07.02.2013 HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date:07.03.2013 Decision :It was decided to remind the firm to furnish the information within 15 days failing which thier 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 reaction showing actual utilization 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 Authority. The case was deferred for 7.3.2013. 15

Case No.:89/42/82ALC4/2011

07.02.2013 HQ File :01/82/050/01124/AM12/ RLA File :09/24/040/00276/AM12/ Lic.No/Date:0910048679 08.09.2011 Defer Date:07.03.2013 Decision :It was decided to defer the case for 07.03.2013 for comments of Department of Chemicals and Petrochemicals 16

Case No.:16/35/82ALC4/2011

Party Name:HIRAN ORGOCHEM LIMITED 07.02.2013 HQ File :01/82/050/00943/AM12/ RLA File :03/94/040/00474/AM12/ Lic.No/Date:0310657248 30.09.2011 Defer Date:07.03.2013 Decision :It was decided to remind the firm to furnish the following information within 15 days failing which their case would be closed:

16 Stepwise complete and balanced chemical reaction showing Mol. Wt. of each input and output item. % yield on molar basis for each step. Requirement and recovery of solvent at each step. The case was deferred for 7.3.2013. 17

Case No.:9/35/82ALC4/2011

Party Name:UNITED BIOTECH PVT.LTD. 07.02.2013 HQ File :01/82/050/00936/AM12/ RLA File :05/24/040/00226/AM12/ Lic.No/Date:0510304974 11.10.2011 Defer Date:07.03.2013 18

Case No.:3/45/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 07.02.2013 HQ File :01/82/050/01180/AM12/ RLA File :03/94/040/00691/AM12/ Lic.No/Date:0310664617 14.11.2011 Defer Date:07.03.2013 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula within 15 days failing which their case would be closed. The case was deferred for 7.3.2013. 19

Case No.:5/45/83ALC1/2011

Party Name:SPAN DIAGNOSTICS LTD 07.02.2013 HQ File :01/83/050/00780/AM12/ RLA File :52/24/040/00033/AM12/ Lic.No/Date:5210037002 15.11.2011 Defer Date:07.03.2013 Decision :The firm has submitted a copy of reply in response to the Deficiency letter issued by Department of Biotechnology. The case was deferred for comments of Department of Biotechnology. 20

Case No.:31/49/82ALC4/2011

Party Name:SMILAX LABORATORIES LIMITED 07.02.2013 HQ File :01/82/050/01340/AM12/ RLA File :09/24/040/00332/AM12/ Lic.No/Date:0910049719 16.11.2011 Defer Date:07.03.2013 21

Case No.:7/27/85ALC3/2011

Party Name:BELOOR BAYIR BIOTECH LTD, 07.02.2013 HQ File :01/85/050/00151/AM12/ RLA File :07/24/040/00317/AM12/ Lic.No/Date:0710084045 18.11.2011 Defer Date:07.03.2013 Decision :It was decided to remind the firm to clarify whether the items are drug items. 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 The case was deferred for 7 3 2013

item, elaborate under which ITC(HS) code the firm is claiming the norms. The case was deferred for 7.3.2013. 22

Case No.:23/45/82ALC4/2011

Party Name:SUTURES INDIA PRIVATE LIMITED, 07.02.2013 HQ File :01/82/050/01200/AM12/ RLA File :07/24/040/00341/AM12/ Lic.No/Date:0710084630 13.12.2011 Defer Date:07.03.2013 Decision :It was decided to defer the case for 07.03.2013 for comments of Department of Industrial Policy and Promotion. 23

Case No.:24/46/82ALC4/2011

Party Name:ASHISH LIFE SCIENCE PVT.LTD. 07.02.2013 HQ File :01/82/050/01240/AM12/ RLA File :03/94/040/00737/AM12/ Lic.No/Date:0310670672 14.12.2011 Defer Date:07.03.2013 24

Case No.:59/46/82ALC4/2011

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 07.02.2013 HQ File :01/82/050/01275/AM12/ RLA File :09/24/040/00413/AM12/ Lic.No/Date:0910050238 15.12.2011 Defer Date:07.03.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33 within 15 days failing which their case would be closed. The case was deferred for 7.3.2013. 25

Case No.:11/3/82ALC4/2012

07.02.2013 HQ File :01/82/050/00015/AM13/ RLA File :09/24/040/00460/AM12/ Lic.No/Date:0910050479 29.12.2011 Defer Date:07.03.2013 26

Case No.:41/1/82ALC4/2012

07.02.2013 HQ File :01/82/050/01483/AM12/ RLA File :09/24/040/00459/AM12/ Lic.No/Date:0910050480 29.12.2011 Defer Date:07.03.2013 27

Case No.:43/21/82ALC4/2012

07.02.2013 HQ File :01/82/050/00673/AM13/ RLA File :09/24/040/00458/AM12/ Lic.No/Date:0910050481 29.12.2011 Defer Date:07.03.2013 D i i It d id d t d f th f 07 03 2013 f t f D t t f Ch i l d P t h i l

Case No.:18/1/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 07.02.2013 HQ File :01/82/050/01460/AM12/ RLA File :09/24/040/00493/AM12/ Lic.No/Date:0910050772 13.01.2012 Defer Date:07.03.2013 Decision :It was decided to remind the firm to furnish the following details/clarification 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 29

Case No.:35/3/82ALC4/2012

07.02.2013 HQ File :01/82/050/00039/AM13/ RLA File :09/24/040/00532/AM12/ Lic.No/Date:0910051038 31.01.2012 Defer Date:07.03.2013 30

Case No.:39/3/82ALC4/2012

07.02.2013 HQ File :01/82/050/00043/AM13/ RLA File :09/24/040/00528/AM12/ Lic.No/Date:0910051037 31.01.2012 Defer Date:07.03.2013 31

Case No.:28/3/82ALC4/2012

07.02.2013 HQ File :01/82/050/00032/AM13/ RLA File :09/24/040/00527/AM12/ Lic.No/Date:0910051095 02.02.2012 Defer Date:07.03.2013 32

Case No.:26/1/82ALC4/2012

Party Name:METROCHEM API PVT. LTD. 07.02.2013 HQ File :01/82/050/01468/AM12/ RLA File :09/24/040/00480/AM12/ Lic.No/Date:0910051119 06.02.2012 Defer Date:07.03.2013 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 reaction showing mol wt of each reactant and output product

Complete and balanced chemical reaction showing mol. wt. of each reactant and output product. % yield on molar basis for each step of manufacturing process. Material balance for entire process. 33

Case No.:55/1/82ALC4/2012

Party Name:ARCH PHARMALABS LTD 07.02.2013 HQ File :01/82/050/01497/AM12/ RLA File :03/94/040/00996/AM12/ Lic.No/Date:0310681891 14.02.2012 Defer Date:07.03.2013 Decision :It was decided to given a final reminder to 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. 34

Case No.:67/1/82ALC4/2012

Party Name:CHEMSPEC CHEMICALS PVT LTD 07.02.2013 HQ File :01/82/050/01509/AM12/ RLA File :03/94/040/01007/AM12/ Lic.No/Date:0310682171 15.02.2012 Defer Date:07.03.2013 Decision :The reply received from the firm was sent to both Department of Pharmaceuticals and Department of Chemicals and Petrochemicals. The case was deferred for 7.3.2013 35

Case No.:35/1/82ALC4/2012

Party Name:SPECTRUM LIFE SCIENCES PRIVATE LIMITED 07.02.2013 HQ File :01/82/050/01477/AM12/ RLA File :04/24/040/00309/AM12/ Lic.No/Date:0410133868 16.02.2012 Defer Date:07.03.2013 Decision :It was decided to give a final reminder to the firm to furnish a copy of Drug Manufacturing License failing which their case would be closed: 36

Case No.:51/1/82ALC4/2012

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 07.02.2013 HQ File :01/82/050/01493/AM12/ RLA File :09/24/040/00579/AM12/ Lic.No/Date:0910051360 21.02.2012 Defer Date:07.03.2013 Decision :It was decided to give a final reminder to the firm to furnish the technical details as per Appendix 33 within 15 days failing which their case would be closed. The case was deferred for 7.3.2013.

Case No.:26/4/82ALC4/2012

07.02.2013 HQ File :01/82/050/00106/AM13/ RLA File :03/94/040/01048/AM12/ Lic.No/Date:0310683210 23.02.2012 Defer Date:07.03.2013 Decision :It was decided to give a final reminder to the firm to furnish the following information immediately failing which their case would be closed: Molar requirement of each import item. Copy of technical literature in support of yield envisaged. 38

Case No.:88/4/82ALC4/2012

07.02.2013 HQ File :01/82/050/00168/AM13/ RLA File :09/24/040/00601/AM12/ Lic.No/Date:0910051490 28.02.2012 Defer Date:07.03.2013 39

Case No.:60/49/82ALC4/2011

07.02.2013 HQ File :01/82/050/01369/AM12/ RLA File :03/94/040/00125/AM12/ Lic.No/Date:0310683824 29.02.2012 Defer Date:07.03.2013 40

Case No.:30/4/82ALC4/2012

07.02.2013 HQ File :01/82/050/00110/AM13/ RLA File :03/94/040/01096/AM12/ Lic.No/Date:0310684923 05.03.2012 Defer Date:07.03.2013 41

Case No.:33/4/82ALC4/2012

07.02.2013 HQ File :01/82/050/00113/AM13/ RLA File :03/94/040/01099/AM12/ Lic.No/Date:0310684919 05.03.2012 Defer Date:07.03.2013 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.: 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.

Material balance for the entire process. % conversion yield on molar basis for each step to be furnished. 42

Case No.:34/4/82ALC4/2012

07.02.2013 HQ File :01/82/050/00114/AM13/ RLA File :03/94/040/01077/AM12/ Lic.No/Date:0310684930 05.03.2012 Defer Date:07.03.2013 43

Case No.:1/4/82ALC4/2012

Party Name:BELCO PHARMA 07.02.2013 HQ File :01/82/050/00081/AM13/ RLA File :05/23/040/00485/AM12/ Lic.No/Date:0510319713 06.03.2012 Defer Date:07.03.2013 44

Case No.:28/4/82ALC4/2012

07.02.2013 HQ File :01/82/050/00108/AM13/ RLA File :03/94/040/01102/AM12/ Lic.No/Date:0310684966 06.03.2012 Defer Date:07.03.2013 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: 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. 45

Case No.:29/4/82ALC4/2012

07.02.2013 HQ File :01/82/050/00109/AM13/ RLA File :03/94/040/01104/AM12/ Lic.No/Date:0310684961 06.03.2012 Defer Date:07.03.2013

Case No.:31/4/82ALC4/2012

07.02.2013 HQ Fil 01/82/050/00111/AM13/ RLA Fil 03/94/040/01101/AM12/ Li N /D 0310684973 D f

46 HQ File :01/82/050/00111/AM13/ RLA File :03/94/040/01101/AM12/ Lic.No/Date:0310684973 06.03.2012 Defer Date:07.03.2013 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: 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. Details of solvents applied like Methanol and Ethyl Acetate regarding its requirement and recovery in the process. 47

Case No.:41/4/82ALC4/2012

07.02.2013 HQ File :01/82/050/00121/AM13/ RLA File :03/94/040/01105/AM12/ Lic.No/Date:0310684976 06.03.2012 Defer Date:07.03.2013 Decision :It was decided to give final reminder to the firm to furnish the following information within 15 days failing which thier case would be closed: 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. Details of solvents applied like Methanol and Ethyl Acetate regarding its requirement and recovery in the process. 48

Case No.:61/4/82ALC4/2012

Party Name:ANUGRAHA CHEMICALS 07.02.2013 HQ File :01/82/050/00141/AM13/ RLA File :07/24/040/00489/AM12/ Lic.No/Date:0710086840 07.03.2012 Defer Date:07.03.2013 49

Case No.:41/11/82ALC4/2012

Party Name:EMCURE PHARMACEUTICALS LTD. 07.02.2013 Status:Case Approved HQ File :01/82/050/00308/AM13/ RLA File :31/83/040/00227/AM12/ Lic.No/Date:3110053321 09.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/601/2012PI(Norms) dated 6.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Tablets/Capsules Ci fl i T bl t 1 500 1. Ciprofloxacin HCL (Relevant B lk D ) 555.0mg /500 mg T bl t

Ciprofloxacin Tablets USP 500 MG (each film coated tablet contains ciprofloxacin HCL USP equivalent to Ciprofloxacin 500 mg) mg tablet Bulk Drug) Tablets 50

Case No.:28/11/82ALC4/2012

Party Name:PERKIN LABORATORIES 07.02.2013 Status:Case Approved HQ File :01/82/050/00295/AM13/ RLA File :09/24/040/00517/AM12/ Lic.No/Date:0910051719 13.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/623/2012PI(Norms) dated 6.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Ketorolac Tromethamine 1 kg 1. Pyrrole 1.25 2. Isopropenyl Acetate 1.02 3. Dimethyl Sulphoxide 2.80 4. DMF 1.822 5. Potassium Carbonate 4.96 6. DiEthyl Malonate 2.732 7. Tromethamine 0.40 51

Case No.:71/3/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 07.02.2013 HQ File :01/82/050/00075/AM13/ RLA File :05/23/040/00502/AM12/ Lic.No/Date:0510320188 15.03.2012 Defer Date:07.03.2013 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: 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 in the past three years duly certified by the concerned Central Excise/Chartered Accountant. The case was deferred for 7.3.2013.

e case was de e ed o 7.3. 0 3. 52

Case No.:39/11/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 07.02.2013 HQ File :01/82/050/00306/AM13/ RLA File :09/24/040/00600/AM12/ Lic.No/Date:0910051800 16.03.2012 Defer Date:07.03.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/609/2012PI(Norms) dated 6.2.2013, it was decided to call from the firm the following information: Complete technical details as per Appendix 33; Past production visavis actual consumption of raw materials duly certified by Central Excise Authorities. 53

Case No.:43/11/82ALC4/2012

07.02.2013 Status:Case Approved HQ File :01/82/050/00310/AM13/ RLA File :09/24/040/00595/AM12/ Lic.No/Date:0910051797 16.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/609/2012PI(Norms) dated 6.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Pregabalin 1 kg 1 BENZYL2BROMOACETATE 11.20 ISOVALERALDEHYDE 5.317 POTASSIUM CARBONATE 11.20 TETRA HYDRO FURAN 6.87 METHANOL 19.17 TRIETHYLAMINE 0.880 TRIETHYL PHOSPHITE 8.96 ISO PROPYL ALCOHOL 0.96 lit/kg 54

Case No.:40/8/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 07.02.2013 HQ File :01/82/050/00232/AM13/ RLA File :07/24/040/00520/AM12/ Lic.No/Date:0710087119 20 03 2012 Defer Date: 7 3 2013

20.03.2012 7.3.2013 Decision : It was decided to defer the case for 7.3.2013 for comments of Department of Pharmaceuticals. 55

Case No.:63/3/82ALC4/2012

Party Name:PARABOLIC DRUGS LTD., 07.02.2013 HQ File :01/82/050/00067/AM13/ RLA File :05/24/040/00447/AM12/ Lic.No/Date:0510320617 21.03.2012 Defer Date:07.03.2013 Decision :It was decided to give a final reminder to the firm to furnish the technical details as per Appendix 33 within 15 days failing which their case would be closed. The case was deferred for 7.3.2013. 56

Case No.:75/4/82ALC4/2012

Party Name:CADILA HEALTHCARE LTD., 07.02.2013 HQ File :01/82/050/00155/AM13/ RLA File :08/24/040/00292/AM12/ Lic.No/Date:0810110000 22.03.2012 Defer Date:07.03.2013 57

Case No.:76/4/82ALC4/2012

Party Name:CADILA HEALTHCARE LTD., 07.02.2013 HQ File :01/82/050/00156/AM13/ RLA File :08/24/040/00301/AM12/ Lic.No/Date:0810110001 22.03.2012 Defer Date:07.03.2013 58

Case No.:9/11/82ALC4/2012

Party Name:CHEMCON SPECIALITY CHEMICALS P LTD 07.02.2013 HQ File :01/82/050/00276/AM13/ RLA File :34/24/040/00298/AM12/ Lic.No/Date:3410033741 29.03.2012 Defer Date:07.03.2013 59

Case No.:1/2/82ALC4/2012

07.02.2013 HQ File :01/82/050/00001/AM13/ RLA File :03/95/040/00970/AM12/ Lic.No/Date:0310688849 30.03.2012 Defer Date:07.03.2013 Decision :It was decided to give a final reminder to the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 7.3.2013.

Case No.:2/2/82ALC4/2012

07.02.2013

60 HQ File :01/82/050/00002/AM13/ RLA File :03/95/040/01032/AM12/ Lic.No/Date:0310688856 30.03.2012 Defer Date:07.03.2013 Decision :It was decided to give a final reminder to the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 7.3.2013. 61

Case No.:3/2/82ALC4/2012

07.02.2013 HQ File :01/82/050/00003/AM13/ RLA File :03/95/040/01037/AM12/ Lic.No/Date:0310688874 30.03.2012 Defer Date:07.03.2013 Decision :It was decided to give a final reminder to the firm to furnish a copy of master batch formula duly certified by Quality Control Incharge, otherwise their case would be closed. The case was deferred for 7.3.2013. 62

Case No.:4/7/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 07.02.2013 HQ File :01/82/050/00188/AM13/ RLA File :05/24/040/00471/AM12/ Lic.No/Date:0510321506 30.03.2012 Defer Date:07.03.2013 63

Case No.:48/11/82ALC4/2012

Party Name:VIHITA CHEM PVT.LTD. 07.02.2013 HQ File :01/82/050/00315/AM13/ RLA File :34/24/040/00282/AM12/ Lic.No/Date:3410033798 10.04.2012 Defer Date:07.03.2013 Decision :It was decided to give a final reminder to the firm to furnish the requisite information, without any further delay else their case would be closed. 64

Case No.:1/11/82ALC4/2012

Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. 07.02.2013 HQ File :01/82/050/00268/AM13/ RLA File :03/94/040/01138/AM12/ Lic.No/Date:0310690368 11.04.2012 Defer Date:07.03.2013 Decision :It was decided to give a final reminder to the firm to furnish the requisite information, without any further delay, else their case would be closed. 65

Case No.:38/16/82ALC4/2012

Party Name:BRILLIANT BIO PHARMA LIMITED 07.02.2013 HQ File :01/82/050/00474/AM13/ RLA File :09/24/040/00664/AM12/ Lic.No/Date:0910052111 11.04.2012 Defer Date:07.03.2013 Decision :It was decided to defer the case for 7.3.2013 for comments of Department of Biotechnology.

Case No.:3/11/82ALC4/2012

Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 07.02.2013 HQ File :01/82/050/00270/AM13/ RLA File :03/94/040/00007/AM13/ Lic.No/Date:0310690582 12.04.2012 Defer Date:07.03.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/598/2012PI(Norms) dated 7.2.2013, it was decided to call from the firm complete technical details as per Appendix 33. The case was deferred for 7.3.2013. 67

Case No.:32/13/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 07.02.2013 Status:Case Approved HQ File :01/82/050/00367/AM13/ RLA File :22/24/040/00003/AM13/ Lic.No/Date:2210012707 12.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/597/2012PI(Norms) dated 6.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Tazobactam Sodium Sterile “The export product shall account for 44 Nos. Aluminium Bottle Anodized with tear of alu & chlorobutyl plug” 1 kg 1. Tazobactam Acid 1.00 2. Sodium Bicarbonate 0.33 3. Aluminium Bottle Anodized with Tear off alu cap & cholorbutyl plug Relevant, as per packing policy 68

Case No.:50/3/83ALC1/2012

07.02.2013 HQ File :01/83/050/00053/AM13/ RLA File :03/95/040/01118/AM12/ Lic.No/Date:0310690527 12.04.2012 Defer Date:07.03.2013 Decision :It was decided to defer the case for 7.3.2013 for comments of Department of Biotechnology. 69

Case No.:10/11/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 07.02.2013 HQ File :01/82/050/00277/AM13/ RLA File :34/24/040/00012/AM13/ Lic.No/Date:3410033877 16.04.2012 Defer Date:07.03.2013

Case No.:18/11/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 07.02.2013 HQ File :01/82/050/00285/AM13/ RLA File :22/24/040/00001/AM13/ Lic.No/Date:2210012759 24.04.2012 Defer Date:07.03.2013 71

Case No.:34/11/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 07.02.2013 Status:Case Approved HQ File :01/82/050/00301/AM13/ RLA File :07/24/040/00031/AM13/ Lic.No/Date:0710087924 27.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/600/2012PI(Norms) dated 6.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Neulin 125 mg tablets Theophylline 125 mg+Guar gum 4.375 mg 1 no. of Neulin Tablet 1. Theophylline BP/EP/USP Ph. EUR Anhydrous powder 127.5 mg 2. Guar Gum, 1 H (BP/EP/USP/PH. EUR) 4.375 mg Neulin 200 mg tablets Theophylline 200 mg+ Guar Gum 7.00 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 204.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 7.00 mg Neulin 250 mg tablets Theophylline 250 mg+ Guar Gum 8.750 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 255.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 8.75 mg Neulin 300 mg tablets Theophylline 300 mg+ Guar Gum 10.5 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 306.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 10.5 mg 72

Case No.:2/14/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 07.02.2013 Status:Case Rejected HQ File :01/82/050/00379/AM13/ RLA File :03/94/040/00006/AM13/ Lic.No/Date:0310693056 Defer Date:

7 Q 01.05.2012 Decision :It was decided to close the case as the firm has not furnished the information despite repeated reminders. 73

Case No.:3/14/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 07.02.2013 Status:Case Rejected HQ File :01/82/050/00380/AM13/ RLA File :03/94/040/00053/AM13/ Lic.No/Date:0310692961 01.05.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished the information despite repeated reminders. 74

Case No.:14/14/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 07.02.2013 HQ File :01/82/050/00391/AM13/ RLA File :03/94/040/00070/AM13/ Lic.No/Date:0310693809 08.05.2012 Defer Date:07.03.2013 Decision :It was decided to call from the firm the technical details as per Appendix 33 . The case was deferred for 7.3.2013. 75

Case No.:27/11/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 07.02.2013 HQ File :01/82/050/00294/AM13/ RLA File :34/24/040/00027/AM13/ Lic.No/Date:3410034073 08.05.2012 Defer Date:07.03.2013 76

Case No.:5/20/83ALC1/2012

Party Name:VIMAL DRUGS PRIVATE LIMITED 07.02.2013 HQ File :01/83/050/00351/AM13/ RLA File :09/24/040/00049/AM13/ Lic.No/Date:0910052504 08.05.2012 Defer Date:07.03.2013 77

Case No.:24/13/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 07.02.2013 Status:Case Approved HQ File :01/82/050/00359/AM13/ RLA File :07/24/040/00052/AM13/ Lic.No/Date:0710088126 09.05.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/600/2012PI(Norms) dated 6.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed AluTab 600 mg tablets – Aluminium 1 no. of tablet 1. Dried Aluminium Hydroxide Gel S100 BP/USP/EP/PH.EUR 612 mg

Hydroxide 600 mg+ Microcrystalline Cellulose 60 mg 2. Microcrystalline Cellulose NF/BP/EP.USP/PH. EUR/JP 60.0 mg 78

Case No.:21/14/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 07.02.2013 HQ File :01/82/050/00398/AM13/ RLA File :05/23/040/00037/AM13/ Lic.No/Date:0510324671 14.05.2012 Defer Date:07.03.2013 Decision :The reply received from the firm was sent to Department of Industrial Policy and Promotion. The case was deferred for 7.3.2013 for comments of Department of Industrial Policy and Promotion. 79

Case No.:30/13/82ALC4/2012

Party Name:HALDIA PETROCHEMICALS LTD. 07.02.2013 HQ File :01/82/050/00365/AM13/ RLA File :02/24/040/00029/AM13/ Lic.No/Date:0210177518 14.05.2012 Defer Date:07.03.2013 80

Case No.:10/9/82ALC4/2012

07.02.2013 HQ File :01/82/050/00255/AM13/ RLA File :03/95/040/00094/AM13/ Lic.No/Date:0310694706 15.05.2012 Defer Date:07.03.2013 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: A copy of Master Batch Formula duly certified by Quality Control Incharge. Copy of DML alongwith list of approved items. The case was deferred for 7.3.2013 81

Case No.:11/9/82ALC4/2012

07.02.2013 Status:Case Approved HQ File :01/82/050/00256/AM13/ RLA File :03/95/040/00093/AM13/ Lic.No/Date:0310694735 15.05.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/612/2012PI(Norms) dated 7.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Sterile Polygeline S l ti I f i f 500 ml k 1. Polygeline, Polypeptides of d d d t ti C li k d 18.375 gm/500 ml k

Solutions, Infusion for intravenous Administration (Plasma Expander) pack degraded getatin, Crosslinked via urea bridges (Gelatin) pack 2. Polypropylene (Purell RP 270 G) Relevant, as per packing policy 3. 4180 PP Inso CAPS Relevant, as per packing policy 82

Case No.:2/9/83ALC1/2012

07.02.2013 HQ File :01/83/050/00176/AM13/ RLA File :03/95/040/00092/AM13/ Lic.No/Date:0310694716 15.05.2012 Defer Date:07.02.2013 Decision :It was decided to give a final reminder to the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula, else their case would be closed. The case was deferred for 7.2.2013. 83

Case No.:15/9/82ALC4/2012

07.02.2013 Status:Case Approved HQ File :01/82/050/00260/AM13/ RLA File :03/95/040/00089/AM13/ Lic.No/Date:0310694925 16.05.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/612/2012PI(Norms) dated 7.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Sterile Polygeline Solutions, Infusion for intravenous Administration (Plasma Expander) 500 ml pack 1. Polygeline, Polypeptides of degraded getatin, Crosslinked via urea bridges (Gelatin) 18.375 gm/500 ml pack 2. Polypropylene (Purell RP 270 G) Relevant, as per packing policy 3. 4180 PP Inso CAPS Relevant, as per packing policy

Case No.:16/9/82ALC4/2012

07.02.2013 Status:Case Approved HQ File :01/82/050/00261/AM13/ RLA File :03/95/040/00090/AM13/ Lic.No/Date:0310694936 16.05.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No 35011/612/2012 PI(Norms) dated 7 2 2013 it

84 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/612/2012PI(Norms) dated 7.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Sterile Polygeline Solutions, Infusion for intravenous Administration (Plasma Expander) 500 ml pack 1. Polygeline, Polypeptides of degraded getatin, Crosslinked via urea bridges (Gelatin) 18.375 gm/500 ml pack 2. Polypropylene (Purell RP 270 G) Relevant, as per packing policy 3. 4180 PP Inso CAPS Relevant, as per packing policy 85

Case No.:6/16/82ALC4/2012

Party Name:STELLENCE PHARMSCIENCE PVT LTD 07.02.2013 HQ File :01/82/050/00442/AM13/ RLA File :07/24/040/00062/AM13/ Lic.No/Date:0710088213 16.05.2012 Defer Date:07.03.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/611/2012PI(Norms) dated 76.2.2013, it was decided to call from the firm the technical details as per Appendix 33. The case was deferred for 7.3.2013. 86

Case No.:4/13/82ALC4/2012

Party Name:ATUL LIMITED, 07.02.2013 HQ File :01/82/050/00339/AM13/ RLA File :08/24/040/00048/AM13/ Lic.No/Date:0810111728 17.05.2012 Defer Date:07.03.2013 87

Case No.:50/28/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 07.02.2013 HQ File :01/82/050/01017/AM13/ RLA File :03/95/040/00523/AM13/ Lic.No/Date:0310713233 19.10.2012 Defer Date:07.03.2013 246

Case No.:42/28/82ALC4/2012

Party Name:ZIM LABORATORIES LTD. 07.02.2013 HQ File :01/82/050/01009/AM13/ RLA File :03/95/040/00542/AM13/ Lic.No/Date:0310713482 23.10.2012 Defer Date:07.03.2013 247

Case No.:51/28/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 07.02.2013 HQ File :01/82/050/01018/AM13/ RLA File :03/95/040/00495/AM13/ Lic.No/Date:0310713489 23.10.2012 Defer Date:07.03.2013 248

Case No.:12/28/82ALC4/2012

07.02.2013 HQ File :01/82/050/00979/AM13/ RLA File :09/24/040/00335/AM13/ Lic.No/Date:0910054160 25.10.2012 Defer Date:07.03.2013

Case No.:16/28/82ALC4/2012

Party Name:CADILA PHARMACEUTICALS LTD. 07.02.2013

249 HQ File :01/82/050/00983/AM13/ RLA File :08/24/040/00259/AM13/ Lic.No/Date:0810115897 25.10.2012 Defer Date:07.03.2013 250

Case No.:49/28/82ALC4/2012

Party Name:S M B CORPORATION OF INDIA 07.02.2013 HQ File :01/82/050/01016/AM13/ RLA File :03/95/040/00568/AM13/ Lic.No/Date:0310713614 25.10.2012 Defer Date:07.03.2013 Decision :It was decided to defer the case for 7.3.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals. 251

Case No.:6/28/82ALC4/2012

07.02.2013 HQ File :01/82/050/00973/AM13/ RLA File :09/24/040/00352/AM13/ Lic.No/Date:0910054161 25.10.2012 Defer Date:07.03.2013 252

Case No.:1/24/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 07.02.2013 HQ File :01/82/050/00805/AM13/ RLA File :09/24/040/00371/AM13/ Lic.No/Date:0910054177 29.10.2012 Defer Date:07.03.2013 253

Case No.:10/28/82ALC4/2012

07.02.2013 HQ File :01/82/050/00977/AM13/ RLA File :09/24/040/00339/AM13/ Lic.No/Date:0910054180 29.10.2012 Defer Date:07.03.2013 254

Case No.:2/28/82ALC4/2012

Party Name:POLYGON CHEMICALS 07.02.2013 HQ File :01/82/050/00969/AM13/ RLA File :08/24/040/00258/AM13/ Lic.No/Date:0810115970 29.10.2012 Defer Date:07.03.2013 255

Case No.:3/28/82ALC4/2012

Party Name:POLYGON CHEMICALS 07.02.2013 HQ File :01/82/050/00970/AM13/ RLA File :08/24/040/00262/AM13/ Lic.No/Date:0810115971 Defer

29.10.2012 Date:07.03.2013 256

Case No.:45/26/82ALC4/2012

Party Name:PAYAL POLYPLAST PVT.LTD., 07.02.2013 HQ File :01/82/050/00953/AM13/ RLA File :05/24/040/00255/AM13/ Lic.No/Date:0510337699 29.10.2012 Defer Date:07.03.2013 257

Case No.:8/28/82ALC4/2012

Party Name:MSN LABORATORIES LIMITED 07.02.2013 HQ File :01/82/050/00975/AM13/ RLA File :09/24/040/00379/AM13/ Lic.No/Date:0910054186 29.10.2012 Defer Date:07.03.2013 258

Case No.:3/24/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 07.02.2013 HQ File :01/82/050/00807/AM13/ RLA File :09/24/040/00332/AM13/ Lic.No/Date:0910054196 30.10.2012 Defer Date:07.03.2013 259

Case No.:36/28/82ALC4/2012

Party Name:PI INDUSTRIES LTD., 07.02.2013 HQ File :01/82/050/01003/AM13/ RLA File :13/24/040/00035/AM13/ Lic.No/Date:1310041436 30.10.2012 Defer Date:07.03.2013 260

Case No.:43/28/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 07.02.2013 HQ File :01/82/050/01010/AM13/ RLA File :03/95/040/00561/AM13/ Lic.No/Date:0310713820 30.10.2012 Defer Date:07.03.2013 261

Case No.:47/28/82ALC4/2012

Party Name:YASHO INDUSTRIES PVT.LTD. 07.02.2013 HQ File :01/82/050/01014/AM13/ RLA File :03/95/040/00580/AM13/ Lic.No/Date:0310713891 30.10.2012 Defer Date:07.03.2013

262

Case No.:9/28/82ALC4/2012

Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 07.02.2013 HQ File :01/82/050/00976/AM13/ RLA File :09/24/040/00374/AM13/ Lic.No/Date:0910054204 30.10.2012 Defer Date:07.03.2013 263

Case No.:37/28/82ALC4/2012

Party Name:DEEPAK NITRITE LIMITED 07.02.2013 HQ File :01/82/050/01004/AM13/ RLA File :34/24/040/00015/AM13/ Lic.No/Date:3410035376 31.10.2012 Defer Date:07.03.2013 264

Case No.:4/24/82ALC4/2012

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 07.02.2013 HQ File :01/82/050/00808/AM13/ RLA File :09/24/040/00362/AM13/ Lic.No/Date:0910054208 31.10.2012 Defer Date:07.03.2013 265

Case No.:7/24/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 07.02.2013 HQ File :01/82/050/00811/AM13/ RLA File :34/24/040/00168/AM13/ Lic.No/Date:3410035379 31.10.2012 Defer Date:07.03.2013 266

Case No.:39/28/82ALC4/2012

Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 07.02.2013 HQ File :01/82/050/01006/AM13/ RLA File :34/24/040/00184/AM13/ Lic.No/Date:3410035411 01.11.2012 Defer Date:07.03.2013 267

Case No.:8/24/82ALC4/2012

Party Name:ALKEM LABORATORIES LTD., 07.02.2013 Status:Case Approved HQ File :01/82/050/00812/AM13/ RLA File :03/94/040/00668/AM13/ Lic.No/Date:0310714062 01.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/591/2012PI(Norms) dated 6.2.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Meropenem for injection 1 gm USP (Each vial contains Meropenem Trihydrate USP equivalent to Anhydrous Meropenem 1 gm. Also contains Sodium Carbonate (Sodium 90.2 mg) 1 no. of Injection 1. Meropenem USP for Injection (Meropenem Buffered sterile) 1196.667 mg Meropenem for injection 500 mg (each vial contains Meropenem Trihydrate USP equivalent to Anhydrous Meropenem 500 mg. Also contains Sodium Carbonate (Sodium 45.1 mg) 1 no. of injection 1 Meropenem USP for Injection (Meropenem Buffered sterile) 597.778 mg 268

Case No.:46/28/82ALC4/2012

Party Name:ZENITH DYEINTERMEDIATES LIMITED Meet No/Date:30/82ALC4/2012 07.02.2013 HQ File :01/82/050/01013/AM13/ RLA File :03/95/040/00571/AM13/ Lic.No/Date:0310714165 02.11.2012 Defer Date:07.03.2013 269

Case No.:48/28/82ALC4/2012

Party Name:YASHO INDUSTRIES PVT.LTD. 07.02.2013 HQ File :01/82/050/01015/AM13/ RLA File :03/95/040/00594/AM13/ Lic.No/Date:0310714182 02.11.2012 Defer Date:07.03.2013 270

Case No.:22/26/82ALC4/2012

Party Name:RELIANCE INDUSTRIES LTD. 07.02.2013 HQ File :01/82/050/00930/AM13/ RLA File :03/95/040/00370/AM13/ Lic.No/Date:0310714238 05.11.2012 Defer Date:07.03.2013

Decision :It was decided to defer the case for 7.3.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals. 271

Case No.:33/28/82ALC4/2012

Party Name:DHARUHERA PHARMACEUTICALS PVT LTD 07.02.2013 HQ File :01/82/050/01000/AM13/ RLA File :05/23/040/00264/AM13/ Lic.No/Date:0510338287 05.11.2012 Defer Date:07.03.2013 272

Case No.:41/28/82ALC4/2012

Party Name:PREGNA INTERNATIONAL LTD. 07.02.2013 HQ File :01/82/050/01008/AM13/ RLA File :03/95/040/00444/AM13/ Lic.No/Date:0310714240 05.11.2012 Defer Date:07.03.2013 Decision :It was decided to defer the case for 7.3.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals. 273

Case No.:7/28/82ALC4/2012

Party Name:MELZER CHEMICALS PVT. LTD 07.02.2013 HQ File :01/82/050/00974/AM13/ RLA File :31/83/040/00134/AM13/ Lic.No/Date:3110056196 05.11.2012 Defer Date:07.03.2013 274

Case No.:35/28/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 07.02.2013 HQ File :01/82/050/01002/AM13/ RLA File :05/24/040/00280/AM13/ Lic.No/Date:0510338316 06.11.2012 Defer Date:07.03.2013 275

Case No.:34/28/82ALC4/2012

07.02.2013 HQ File :01/82/050/01001/AM13/ RLA File :05/24/040/00283/AM13/ Lic.No/Date:0510338695 08.11.2012 Defer Date:07.03.2013 276

Case No.:4/28/82ALC4/2012

Party Name:POSY PHARMACHEM PVT. LTD. 07.02.2013 HQ File :01/82/050/00971/AM13/ RLA File :08/24/040/00242/AM13/ Lic.No/Date:0810116296 12.11.2012 Defer Date:07.03.2013

277

Case No.:26/28/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 07.02.2013 HQ File :01/82/050/00993/AM13/ RLA File :04/24/040/00126/AM13/ Lic.No/Date:0410141071 16.11.2012 Defer Date:07.03.2013 278

Case No.:27/28/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 07.02.2013 HQ File :01/82/050/00994/AM13/ RLA File :04/24/040/00160/AM13/ Lic.No/Date:0410141072 16.11.2012 Defer Date:07.03.2013 279

Case No.:3/26/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 07.02.2013 HQ File :01/82/050/00911/AM13/ RLA File :34/24/040/00205/AM13/ Lic.No/Date:3410035547 26.11.2012 Defer Date:07.03.2013 280

Case No.:47/26/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 07.02.2013 HQ File :01/82/050/00955/AM13/ RLA File :09/24/040/00375/AM13/ Lic.No/Date:0910054404 29.11.2012 Defer Date:07.03.2013 281

Case No.:61/28/82ALC4/2012

07.02.2013 HQ File :01/82/050/01028/AM13/ RLA File :09/24/040/00436/AM13/ Lic.No/Date:0910054444 05.12.2012 Defer Date:07.03.2013 282

Case No.:1/28/82ALC4/2012

Party Name:ANUPAM RASAYAN (INDIA) LTD 07.02.2013 HQ File :01/82/050/00968/AM13/ RLA File :52/24/040/00038/AM13/ Lic.No/Date:5210039286 19.12.2012 Defer Date:07.03.2013

283

Case No.:40/28/82ALC4/2012

Party Name:HETERO LABS LIMITED 07.02.2013 HQ File :01/82/050/01007/AM13/ RLA File :09/24/040/00447/AM13/ Lic.No/Date:0910054591 20.12.2012 Defer Date:07.03.2013 284

Case No.:54/28/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 07.02.2013 HQ File :01/82/050/01021/AM13/ RLA File :22/24/040/00053/AM13/ Lic.No/Date:2210013461 20.12.2012 Defer Date:07.03.2013 285

Case No.:55/28/82ALC4/2012

Party Name:ADVANCE PETROCHEMICALS LIMITED 07.02.2013 HQ File :01/82/050/01022/AM13/ RLA File :08/24/040/00337/AM13/ Lic.No/Date:0810117116 26.12.2012 Defer Date:07.03.2013 286

Case No.:62/28/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 07.02.2013 HQ File :01/82/050/01029/AM13/ RLA File :03/95/040/00718/AM13/ Lic.No/Date:0310718680 31.12.2012 Defer Date:07.03.2013 287

Case No.:63/28/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 07.02.2013 HQ File :01/82/050/01030/AM13/ RLA File :03/95/040/00719/AM13/ Lic.No/Date:0310718683 31.12.2012 Defer Date:07.03.2013 288

Case No.:64/28/82ALC4/2012

Party Name:GOPINATH CHEMTECH LTD., 07.02.2013 HQ File :01/82/050/01031/AM13/ RLA File :08/24/040/00340/AM13/ Lic.No/Date:0810117249 01.01.2013 Defer Date:07.03.2013

Case No :65/28/82ALC4/2012

Party Name:UNITED BIOTECH PVTLTD Meet No/Date:30/82ALC4/2012 Status:Case Deferred

Outside Agenda No. 1 M/s. Actavis Pharma Manufacturing Pvt. Ltd. F.No 01/82/050/00336/AM 13/DES III 04/24/040/00328/AM 12 Ad Li N & D t 0410136360 d t d 14 5 2012 289

Case No.:65/28/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 07.02.2013 HQ File :01/82/050/01032/AM13/ RLA File :05/24/040/00375/AM13/ Lic.No/Date:0510342192 01.01.2013 Defer Date:07.03.2013 290

Case No.:1/30/82ALC4/2012

Party Name:ADVANCE PETROCHEMICALS LIMITED 07.02.2013 HQ File :01/82/050/01037/AM13/ RLA File :08/24/040/00356/AM13/ Lic.No/Date:0810117592 16.01.2013 Defer Date:07.03.2013 291

Case No.:2/30/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 07.02.2013 HQ File :01/82/050/01038/AM13/ RLA File :05/24/040/00389/AM13/ Lic.No/Date:0510343975 23.01.2013 Defer Date:07.03.2013 Decision :It was decided to defer the case for 7.3.2013 for comments of Department of Pharmaceuticals 292

Case No.:3/30/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 07.02.2013 HQ File :01/82/050/01039/AM13/ RLA File :05/24/040/00393/AM13/ Lic.No/Date:0510343986 23.01.2013 Defer Date:07.03.2013 293

Case No.:4/30/82ALC4/2012

Party Name:MEDREICH LIMITED 07.02.2013 HQ File :01/82/050/01040/AM13/ RLA File :07/24/040/00448/AM13/ Lic.No/Date:0710093283 23.01.2013 Defer Date:07.03.2013

0410136360 dated 14.5.2012 Decision: It was decided to call from the firm a copy of Certificate of Analysis for the export product issued after May 2012. The case was deferred for 7.3.2013. Outside Agenda No. 2 M/s. Hetero Drugs Limited F.No 01/82/50/01462/AM 12/DES III 09/24/040/00515/AM 12 0910050977 dated 25.1.2012 Decision: It was decided to amend the description of export product from “Zidovudine (Purity 100.2%)” as ratified in Meeting no 16/82 dated 16.8.2012 to “Zidovudine (Purity 99.5%)”. RA may take appropriate action as per the decision of Norms Committee. Date:11.02.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer

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DGFT Minutes

Case No. B 457

Case No. B 458

Case No. B 459

Para 4.7 Decision

Case No. B 460

Case No. B 461

Case No. B 462

Case No. B 463

Case No. B 464

Case No. B 465

Case No. C 57

Case No. C 58

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