IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2012-11-15

DGFT Committee Minutes

Document text

Case No. B 376

M/s. Medreich Limited Norms Committee Meeting No.24/AM13 F.No. 01/82/50/0070/AM 08 F. No 01/82/50/00178/AM 08 Meeting Date:16.11.2012 RA F. No. 07/24/40/00205/AM 08 RA F. No. 07/24/40/00404/AM 08 Adv. Lic. No. & Date 0710052078 dated 20.6.2007 0710053240 dated 10.9.2007 Decision: The firm was requested to appear before the Committee for personal hearing. However, the firm through email has requested for some other date as they were not able to get production and consumption data from Central Excise Department. It was decided to call the firm for PH on 29.12.2012. The case was deferred for 29.12.2012.

Case No. B 377

M/s. Medreich Limited F.No. 01/82/50/00798/AM 11 F. No 01/82/50/00457/AM 11 F. No. 01/82/50/00863/AM 11 Meeting Date:1.11.2012 RA F. No. 07/24/40/00200/AM 11 RA F. No. 07/24/40/00072/AM 11 RA F. No. 07/24/40/00222/AM 11 0710073911 dated 30.8.2010 0710072323 dated 18.6.2010 0710074194 dated 16.9.2010 D i i Th fi t d t b f th C itt f l h i Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 24/82ALC4/2012 MEETING DATE : 15.11.2012 The Meeting No. 24/82 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 scheduled to be held on 15.11.2012 but was actually held on 16.11.2012 under the Chairmanship of, Shri Mukesh Bhatnagar, Addl DGFT in Room No.4, Udyog Bhawan, New Delhi. Following members were present: 1. Shri S.K. Aggarwal, Jt. Development Commissioner, DC(MSME) 2. Shri D.N. Mathur, Consultant, Department of Pharmaceutical 3. Shri Jasbir Singh, Consultant, Department of Chemicals and Petrochemicals.

Decision: The firm was requested to appear before the Committee for personal hearing. However, the firm through email has requested for some other date as they were not able to get production and consumption data from Central Excise Department. It was decided to call the firm for PH on 27.12.2012. The case was deferred for 27.12.2012

Case No. B 378

M/s. Jubilant Lifesciences Limited F.No. 01/82/50/00248/AM 10/DES III RA F. No. 05/24/40/00146/AM 10 0510244396 dated 24.6.2009 Decision: The firm was requested to appear before the Committee for personal hearing. However, no one appear before the Committee. It was decided to call the firm for PH on 27.12.2012. The case was deferred for 27.12.2012.

Case No. B 379

M/s. Jubilant Lifesciences Limited F.No. 01/82/50/01593/AM 11/DES III RA F. No. 05/23/040/00138/AM 11 0510272117 dated 6.9.2010 Decision: The firm was requested to appear before the Committee for personal hearing. However, no one appear before the Committee. It was decided to call the firm for PH on 27.12.2012. The case was deferred for 27.12.2012.

Case No. B 380

M/s. Medchl Chem. & Pharma Limited F.No. 01/82/50/01760/AM 11 F. No. 01/82/50/00911/AM 11 F.No. 01/82/50/01258/AM 11 RA F. No. 09/24/40/00539/AM 11 RA F. No. 09/24/40/00231/AM 12 RA F.No. 09/24/40/00324/AM 11 0910045802 dated 4.3.2011 0910048496 dated 29.8.2011 0910044428 dated 24.11.2010 Decision: The firm was requested to appear before the Committee for personal hearing. However, the firm through email has expressed their inability to attend the meeting as their representative was hospitalized due to malaria fever. It was decided to call the firm for PH on 29.11.2012. Accordingly, the case was deferred for 29.11.2012. C N B 381 M/ R h E t I di Li it d d M/

Case No. B 381

M/s. Rohan Exports India Limited and M/s. Mahesh Raj Chemicals Limited F.No. 01/83/162/00654/AM 12/DES III Decision: It was decided to defer the case for 13.12.2012 for comments of Department of Chemicals and Petrochemicals.

Case No. B 382

M/s. PCL Oil & Solvents Limited, New Delhi F.No. RA F. No. 05/27/040/00083/AM 13 RA F. No. 05/27/040/00454/AM 13 RA F. No 05/27/040/00455/AM 13 Decision: It was decided to defer the case for 13.12.2012 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals.

Case No. B 383

M/s. Elpee Chemical Pvt. Ltd. F.No. 01/82/50/01100/AM 12/DES III RA F. No. 03/94/40/766/AM 12 0310669818 dated 9.12.2011 Decision: It was decided to enhance the quantity of “Isophthalic Acid” from 0.908 kg to 1 kg. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 384

M/s. Chiral Bioscience Limited F.No. 01/82/50/00970/AM 09/DES III F. No. 01/82/50/01618/AM 11/DES III F. No. 01/82/050/01415/AM 11/DES III RA F. No. 09/24/040/00120/AM 09 RA F. No. 09/24/040/00162/AM 11 RA F. No. 09/24/040/00005/AM 11 0910034444 dated 26.7.2008 0910043817 dated 6.10.2010 0910042381 dated 17.6.2010 Decision: Shri L. Rameshwar Reddy, Managing Director of the firm appeared before the Committee. After discussions on the issue of delay in representing their case to DGFT HQs, he has stated that they were taking up the matter with the Hyderabad office since 2000. Committee requested them to submit the copies of same to this office for perusal. He assured that the same would be submitted within day or two. The case was deferred for 27.12.2012 for comments of Department of Pharmaceuticals.

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Case No. B 386

M/s. Chiral Bioscience Limited F.No. 01/82/50/00113/AM 11/DES III RA F. No. 09/24/040/00413/AM 10 0910040795 dated 2.2.2010 Decision: Shri L. Rameshwar Reddy, Managing Director of the firm appeared before the Committee. After discussions on the issue of delay in representing their case to DGFT HQs, he has stated that they were taking up the matter with the Hyderabad office since 2000. Committee requested them to submit the copies of same to this office for perusal. He assured that the same would be submitted within day or two. The case was deferred for 27.12.2012 for comments of Department of Pharmaceuticals.

Case No. B 385

M/s. Chiral Bioscience Limited F.No. 01/82/162/00163/AM 13/DES III RA F. No. 09/24/040/00102/AM 10 0910038495 dated 8.7.2009 Decision: Shri L. Rameshwar Reddy, Managing Director of the firm appeared before the Committee. After discussions on the issue of delay in representing their case to DGFT HQs, he has stated that they were taking up the matter with the Hyderabad office since 2000. Committee requested them to submit the copies of same to this office for perusal. He assured that the same would be submitted within day or two. The case was deferred for 27.12.2012 for comments of Department of Pharmaceuticals.

Case No. C 51

M/s. Shasun Pharmaceuticals Limited F.No. 01/82/162/00261/AM 12/DES III Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/471/2012PI(Norms) dated 22.10.2012, it was decided to ratify norms under

Para 4.4.2 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 Gabapentin 1 kg 1. Cyclohexane 1,1diacelic acid Monamide 1.63 kg 2. Liquid Bromine 2.06 kg 3. Acetone 2.33 kg 4. Tributylamine 0.90 kg 5. Isopropryl Alcohol 1.17

Case No C 50

M/s Encee Aromatics Pvt Ltd

Case No. C 50

M/s. Encee Aromatics Pvt. Ltd. F.No. 01/82/162/00745/AM 12/DES III Decision: It was decided to call from the firm certificate from the Central Excise Authority certifying yearwise production and corresponding consumption of raw material for the last three years. Accordingly the case was deferred for 27.12.2012.

Case No. C 51

M/s. Camlin Fine Chemicals Limited F.No. 01/82/162/00922/AM 12 DES III Decision: It was decided to defer the case for 13.12.2012 for comments of Department of Chemicals and Petrochemicals. 1

Case No.:39/24/82ALC4/2012

Party Name:CENTURY PHARMACEUTICALS LTD. Meet No/Date:24/82ALC4/2012 15.11.2012 Status:Case Approved HQ File :01/82/050/00843/AM13/ RLA File :34/24/040/00030/AM11/ Lic.No/Date:3410027211 11.06.2010 Defer Date: Decision : In the light of earlier decision taken in meeting No. 48/82 dated 1.3.2011, 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 9Deoxo9AAza9A Hemoerythromycin A (Azithromycin Amine) 1 kg 1. Erythromycin Thiocyanate 1.64 KGA 2

Case No.:57/40/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/01256/AM11/ RLA File :09/24/040/00237/AM11/ Lic.No/Date:0910043987 20.10.2010 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/474/2012PI(Norms) dated 16.11.2012, 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 kg/kg Sevelamer Carbonate 1 kg 1. Polyallylamine HCL Solution (50%) 2.70 2. Epichlorohydrin 0.144 3. Cyclohexane 2.36 4. Isopropyl alcohol 4.73

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

Party Name:EMAMI LIMITED, 15.11.2012 Status:Case Deferred HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the information sought by DC(MSME) vide thier letter dated 12.9.2012 within 15 days failing which the case would be closed. Accordingly, the case was deferred for 13.12.2012. 4

Case No.:56/40/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/01255/AM11/ RLA File :09/24/040/00236/AM11/ Lic.No/Date:0910044022 26.10.2010 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/475/2012PI(Norms) dated 16.11.2012, 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 kg/kg Colesevelam HCL 1 kg 1. Polyallylamine Hcl Solution (50%) 2.26 2. Epichlorohydrin 0.12 3 Cyclohexane 1.975 4. Isopropyl alcohol 3.959 5. Methanol 2.13 5

Case No.:25/40/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/01224/AM11/ RLA File :09/24/040/00238/AM11/ Lic.No/Date:0910044429 25.11.2010 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/473/2012PI(Norms) dated 16.11.2012, 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 kg/kg Sevelamer Hcl 1 kg 1. Polyallylamine HCL Solution (50%) 2.70 2. Epichlorohydrin 0.144 3. Cyclohexane 2.36 4. Isopropyl alcohol 4.73

Case No.:24/47/82ALC4/2010

Party Name:AUROBINDO PHARMA LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/01614/AM11/ RLA File :09/24/040/00404/AM11/ Lic.No/Date:0910044631 10.12.2010 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/469/2012PI(Norms) dated 17.10.2012, 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 kg/kg Atazanavir Sulfate 1 kg 1 NMethyl2Pyrrolidone 1.54 2 Acetone 10.89 3. Methanol 1.65 4. Isopropyl Alcohol 4.01 5. Methylene Chloride 7.95 6. (2R)[(1S)TertButoxycarbonyl) Amino2Phenyethyl) Oxirane 0.49 7. 4(2Pyridinyl) Benzaldehyde 0.528 8. LTertLeucine 0.554 7

Case No.:23/4/82ALC4/2011

Party Name:PADMINI AROMATICS PVT. LTD 15.11.2012 Status:Case Rejected HQ File :01/82/050/00074/AM12/ RLA File :07/24/040/00352/AM11/ Lic.No/Date:0710075977 13.12.2010 Defer Date: Decision :It was decided to reject the case as the firm has not furnished informatin despite repeated reminders. 8

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

Party Name:NEULAND LABORATORIES LTD 15.11.2012 HQ File :01/82/050/01643/AM11/ RLA File :09/24/040/00519/AM11/ Lic.No/Date:0910045550 14.02.2011 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Department of Pharmaceuticals.

Case No.:32/6/82ALC4/2011

15.11.2012 Status:Case Approved HQ File :01/82/050/00150/AM12/ RLA File :09/24/040/00037/AM12/ Lic.No/Date:0910046439 21.04.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/477/2012PI(Norms) dated 17.10.2012, 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:

9 y p g pp y , Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg Clindamycin Hydrochloride 1 kg 1. Lincomycin Hydrochloride Monohydrate 1.43 2. N,N Dimethylformamide 1.42 3. Isopropyl Alcohol 2.13 4. Acetone 8.10 5. Activated Carbon 0.06 6. Steam/Thermal Coal As per fuel policy 10

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

Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 15.11.2012 HQ File :01/82/050/00278/AM12/ RLA File :61/24/040/00097/AM11/ Lic.No/Date:6110000608 03.05.2011 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of DC(MSME). 11

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

Party Name:ALEMBIC PHARMACEUTICALS LTD 15.11.2012 HQ File :01/82/050/00485/AM12/ RLA File :34/24/040/00039/AM12/ Lic.No/Date:3410030563 10.06.2011 Defer Date:13.12.2012 Decision :The reply has been received from the firm and the same was forwarded to Department of Pharmaceuticals. It was decided to defer the case for 13.12.2012 for comments of Department of Pharmaceuticals. 12

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

Party Name:NECTAR LIFESCIENCES LIMITED, 15.11.2012 HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 Defer Date:13.12.2012 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals. Accordingly, the case was deferred for 13.12.2012 for comments of Department of Pharmaceuticals. 13

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

Party Name:ALEMBIC PHARMACEUTICALS LTD 15.11.2012 HQ File :01/82/050/00800/AM13/ RLA File :34/24/040/00058/AM12/ Lic.No/Date:3410030822 05.07.2011 Defer Date:13.12.2012

Case No :3/17/82 ALC4/2011

Party Name:RANBAXY LABORATORIES LTD Meet No/Date:24/82 ALC4/2012 Status:Case Deferred

Case No.:3/17/82ALC4/2011

Party Name:RANBAXY LABORATORIES LTD 15.11.2012 HQ File :01/82/050/00498/AM12/ RLA File :05/24/040/00124/AM12/ Lic.No/Date:0510296379 12.07.2011 Defer Date:13.12.2012 15

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

Party Name:ENCUBE ETHICALS PVT LTD 15.11.2012 HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic.No/Date:0310646711 05.08.2011 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish Drug Manufacturing License and Master Batch Formula. Accordingly, the case was deferred for 13.12.2012. 16

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

Party Name:SAURAV CHEMICALS LTD, 15.11.2012 HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately failing which the case would be closed. Accordingly, the case was deferred for 13.12.2012. 17

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

Party Name:VIVIMED LABS LIMITED 15.11.2012 HQ File :01/82/050/01124/AM12/ RLA File :09/24/040/00276/AM12/ Lic.No/Date:0910048679 08.09.2011 Defer Date:13.12.2012 Decision : Shri Veeranna Seelamsethi, Sr. Manager, Materials appeared before the Committee and after discussion, the firm was requested to furnish following information:  Colour index and hue number of the product to be exported.  Yields stepwise supported with authenticated technical literature.  Production consumption data duly certified by Central Excise Authority.  Details regarding recovery of solvents. Shri Seelamsetti has assured that the information would be submitted in a weeks' time. The case was deferred for 13.12.2012.

Case No.:17/28/82ALC4/2011

Party Name:RUSAN PHARMA LTD. Status:Case

18 y 15.11.2012 Approved HQ File :01/82/050/00787/AM12/ RLA File :03/95/040/00471/AM12/ Lic.No/Date:0310656673 28.09.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/118/2012PI(Norms) dated 4.7.2012, 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 kg/kg Nalbuphine Hydrochloride Pharma Grade 1 kg 1. Noroxymorphone Pharma Grade 1.24 19

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

Party Name:HIRAN ORGOCHEM LIMITED 15.11.2012 HQ File :01/82/050/00943/AM12/ RLA File :03/94/040/00474/AM12/ Lic.No/Date:0310657248 30.09.2011 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 20

Case No.:14/41/82ALC4/2011

Party Name:MEDREICH LIMITED 15.11.2012 HQ File :01/82/050/01015/AM12/ RLA File :07/24/040/00254/AM12/ Lic.No/Date:0710083012 04.10.2011 Defer Date:13.12.2012 Decision :The firm was called for Personal Hearing. However, the firm has requested for some another date for PH as they are unable to get the production consumption data. It was decided to call the firm for PH on 13.12.2012. Accordingly, the case was deferred for 13.12.2012. 21

Case No.:26/35/82ALC4/2011

Party Name:INDOFIL INDUSTRIES LTD. 15.11.2012 HQ File :01/82/050/00953/AM12/ RLA File :03/94/040/00606/AM12/ Lic.No/Date:0310658741 11.10.2011 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Department of Chemicals and Petrochemicals. 22

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

Party Name:UNITED BIOTECH PVT.LTD. 15.11.2012 HQ File :01/82/050/00936/AM12/ RLA File :05/24/040/00226/AM12/ Lic.No/Date:0510304974 11.10.2011 Defer Date:13.12.2012 Decision :The reply received from the firm has been sent to Department of Pharmaceuticals. The case was deferred for 13.12.2012 for comments of Department of Pharmaceuticals.

Case No.:5/31/82ALC4/2011

Party Name:TITAN LABORATORIES PVT. LTD. 15.11.2012 HQ File :01/82/050/00831/AM12/ RLA File :03/95/040/00570/AM12/ Lic.No/Date:0310659395 13.10.2011 Defer Date:13.12.2012 24

Case No.:54/31/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/00880/AM12/ RLA File :03/94/040/00647/AM12/ Lic.No/Date:0310660797 19.10.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/81/2012PI(Norms) dated 12.11.2012, 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 Fusidic Acid Cream 15 gm tube Tech. Spec. Labelled content Fusidic Acid 2% W.W; Brand Amigermol Cream or any other 1 no. of tube of Fusidic Acid Cream 2% w/w 1. Fusidic Acid Micronized 0.306 gm 2. While Soft Paraffin (Petroleum Jelly) 0.840 gm 3. Liquid Paraffin (Mineral Oil Kyadol) 1.665 gm 4. Empty Aluminium Tuble 15 gm printed Relevant, as per packing policy. Fusidic Acid 30 gm Tuble Tech. Spec. Labelled content Fusidic Acid 2% W.W; Brand Amigermol Cream or any other 1 no. of tube of Fusidic Acid Cream 2% w/w 1. Fusidic Acid Mirconized 0.612 gm 2. White Soft Paraffin (Petroleum Jelly) 1.68 gm 3. Liquid Paraffin (Mineral Oil Kyadol) 3.33 gm 4. Empty Aluminum Tube 30 gm printed. Relevant, as per packing policy Sodium Fusidate Ointment 30 gm tuble Tech. Spec. Labelled Content Sodium Fusidate 2% W/W Brand Amigermol Pomada or any other 1 no. of tube of Sodium Fusidate Ointment 2% w/w, 30 gm tube 1. Sodium Fusidate Micronized 0.612 gm 2. White Soft Paraffin 23.7 gm 3. Wool Fat (Medilam Ultra) 1.38 gm 4. Liquid Paraffin 4.20 gm 5. Empty Aluminium Tube 10 gm printed Relevant, as per packing policy 25

Case No.:28/41/82ALC4/2011

Party Name:LIV MEDICA PRODUCTS PVT. LTD. 15.11.2012 HQ File :01/82/050/01029/AM12/ RLA File :04/24/040/00210/AM12/ Lic.No/Date:0410130168 09.11.2011 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Department of Industrial Policy and Promotion.

Case No :3/45/82 ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:24/82 ALC4/2012 Status:Case Deferred

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

Party Name:ENCUBE ETHICALS PVT LTD 15.11.2012 HQ File :01/82/050/01180/AM12/ RLA File :03/94/040/00691/AM12/ Lic.No/Date:0310664617 14.11.2011 Defer Date:13.12.2012 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula immediately. Accordingly, the case was deferred for 13.12.2012. 27

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

Party Name:SPAN DIAGNOSTICS LTD 15.11.2012 HQ File :01/83/050/00780/AM12/ RLA File :52/24/040/00033/AM12/ Lic.No/Date:5210037002 15.11.2011 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Department of Biotechnology. 28

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

Party Name:SMILAX LABORATORIES LIMITED 15.11.2012 HQ File :01/82/050/01340/AM12/ RLA File :09/24/040/00332/AM12/ Lic.No/Date:0910049719 16.11.2011 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 13.12.2012. 29

Case No.:27/49/82ALC4/2011

Party Name:ANDHRA ORGANICS LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/01336/AM12/ RLA File :09/24/040/00344/AM12/ Lic.No/Date:0910049777 18.11.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/324/2012PI(Norms) dated 10.09.2012, 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 kg/kg 4(NAcetyl) AminoN(5 Methyl3Isoxazoly) Benzenesulfonamide 1 kg 1. Methanol 1.66 2. Methanol 0.269 3. Oxalic Acid 0.833 4. Hydroxyl Amine Sulphate 0.666 5. Acetone 0.541 6. Pyridine 0.083 7. Aniline 0.708 8. Methylene Chloride 0.833

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

Party Name:BELOOR BAYIR BIOTECH LTD, 15.11.2012 HQ File :01/85/050/00151/AM12/ RLA File :07/24/040/00317/AM12/ Lic.No/Date:0710084045 Defer

30 Q 18.11.2011 Date:13.12.2012 Decision :It was decided to call from the firm the following clarification: Whether the items are drug item. if yes, kindly furnish the Drug Manufacturing License. If not a drug item, kindly elaborate under which ITC(HS) code they are claiming the norms. The case was deferred for 13.12.2012. 31

Case No.:29/49/82ALC4/2011

15.11.2012 Status:Case Approved HQ File :01/82/050/01338/AM12/ RLA File :09/24/040/00379/AM12/ Lic.No/Date:0910049906 24.11.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/334/2012PI(Norms) dated 13.9.2012, 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 kg/kg Fosinopril Sodium 1 kg 1. (Trans)4CyclohexylLProline 0.552 2. 1,3 Dicyclohexyl Carbodiimide 0.55 3. 4Phenyl1Butene 3.06 4. Acetone 1.61 5. Acetonitrile 1.28 6. Isopropyl Alcohol 2.81 7. LCinchonidine 0.2379 8. Methanol 2.65 9. Methyl Isobutyl ketone 4.19 10 Methylene Chloride 16.57 11 Triethylamine 0.276 12 Trimethylchlorosilane 3.301

Case No.:54/46/82ALC4/2011

15.11.2012 Status:Case Approved HQ File :01/82/050/01270/AM12/ RLA File :09/24/040/00398/AM12/ Lic.No/Date:0910050048 05.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/320/2012PI(Norms) dated 10.9.2012, 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 kg/kg Abacavir Sulfate 1 kg 1. FADCP[N(2Amino4,6Dichloro5 Pyrimidinyl) Formamide] 1.042

32 Pyrimidinyl)Formamide] 2. Triethyl Orthoformate 0.69 3. Cyclopropylamine 0.19 4. Vincelactam 2.50 5. D() Tartaric Acid 1.45 6. Sodium Borohydrate 0.681 7. Activated Carbon 0.100 8. Iso Propyl Alcohol 3.78 9. Methanol 10.36 10 Methelene Chloride 3.55 11 Steam/Thermal Coal As per fuel policy 33

Case No.:34/49/82ALC4/2011

15.11.2012 Status:Case Approved HQ File :01/82/050/01343/AM12/ RLA File :09/24/040/00358/AM12/ Lic.No/Date:0910050099 08.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/320/2012PI(Norms) dated 10.9.2012, 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 kg/kg Ampicillin Anhydrous 1 kg 1. 6APA 0.692 2. D() Alpha Phenyl Glycine Base (PG Base) 0.500 3. Ethyl Aceto Acetate (EAA) 0.4146 4. Pivaloyl Chloride 0.42 5. Diethylamine 0.233 6. Potassium Carbonate 0.235 7. Triethylamine 0.023 8. Methylene Chloride 0.737 9. Isopropyl Alcohol 1.21 10. Coal As per fuel policy 34

Case No.:2/39/82ALC4/2011

Party Name:BILCARE LIMITED 15.11.2012 HQ File :01/82/050/00994/AM12/ RLA File :31/83/040/00167/AM12/ Lic.No/Date:3110051868 13.12.2011 Defer Date:13.12.2012 Decision :The case is being examined on file. Therefore, it was deferred for 13.12.2012.

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

Party Name:SUTURES INDIA PRIVATE LIMITED, 15.11.2012 HQ File :01/82/050/01200/AM12/ RLA File :07/24/040/00341/AM12/ Lic.No/Date:0710084630 13.12.2011 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Department of Industrial Policy and Promotion. 36

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

Party Name:ASHISH LIFE SCIENCE PVT.LTD. 15.11.2012 HQ File :01/82/050/01240/AM12/ RLA File :03/94/040/00737/AM12/ Lic.No/Date:0310670672 14.12.2011 Defer Date:13.12.2012 37

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

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/01275/AM12/ RLA File :09/24/040/00413/AM12/ Lic.No/Date:0910050238 15.12.2011 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the details as per Appendix 33, Accordingly, the case was deferred for 13.12.2012. 38

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

15.11.2012 HQ File :01/82/050/00673/AM13/ RLA File :09/24/040/00458/AM12/ Lic.No/Date:0910050481 29.12.2011 Defer Date:13.12.2012 Decision : Shri Veeranna Seelamsethi, Sr. Manager, Materials appeared before the Committee and after discussion, the firm was requested to Shri Seelamsetti has assured that the information would be submitted in a weeks' time. The case was deferred for 13.12.2012.

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

Party Name:RA CHEM PHARMA LIMITED 15.11.2012 HQ File :01/82/050/01460/AM12/ RLA File :09/24/040/00493/AM12/ Lic No/Date:0910050772 Defer

39 HQ File :01/82/050/01460/AM12/ RLA File :09/24/040/00493/AM12/ Lic.No/Date:0910050772 13.01.2012 Defer Date:13.12.2012 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/376/2012PI(Norms) dated 28.9.2012, it was decided to call from the firm the following technical details/justification: The chemistry of step III and IV do not match with the material balance. Yields of Step III and IV are not given. Accordingly, the case was deferred for 13.12.2012. 40

Case No.:69/1/82ALC4/2012

15.11.2012 HQ File :01/82/050/01511/AM12/ RLA File :09/24/040/00496/AM12/ Lic.No/Date:0910050771 13.01.2012 Defer Date:13.12.2012 Decision : Shri Veeranna Seelamsethi, Sr. Manager, Materials appeared before the Committee and after discussion, the firm was requested to Shri Seelamsetti has assured that the information would be submitted in a weeks' time. The case was deferred for 13.12.2012. 41

Case No.:21/1/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/01463/AM12/ RLA File :09/24/040/00447/AM12/ Lic.No/Date:0910050799 17.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/350/2012PI(Norms) dated 10.9.2012, 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 kg/kg Mirtazapine 1 kg 1. 1(3Hydroxymethylpyridyl2)2 Phenyl4MethylPiperazine 1.306 2. Activated Carbon 0.069 3. Cyclohexane 4.19 4. Di isopropyl Ether 0.582 5. Methanol 0.716

Methylene Chloride 3.357 42

Case No.:52/49/82ALC4/2011

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/01361/AM12/ RLA File :08/24/040/00239/AM12/ Lic.No/Date:0810108117 25.01.2012 Defer Date: Decision : : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/57/2012Ch. II dated 16.11.2012, 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 Methyl Tri Octyl Ammonium Chloride 1 kg 1. Tri Octyl Amine 0.815 kg 2. Iso Propyl Alcohol 0.350 litre 43

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

15.11.2012 HQ File :01/82/050/00039/AM13/ RLA File :09/24/040/00532/AM12/ Lic.No/Date:0910051038 31.01.2012 Defer Date:13.12.2012 Decision : Shri Veeranna Seelamsethi, Sr. Manager, Materials appeared before the Committee and after discussion, the firm was requested to Shri Seelamsetti has assured that the information would be submitted in a weeks' time. The case was deferred for 13.12.2012. 44

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

15.11.2012 HQ File :01/82/050/00043/AM13/ RLA File :09/24/040/00528/AM12/ Lic.No/Date:0910051037 31.01.2012 Defer Date:13.12.2012 Decision : Shri Veeranna Seelamsethi, Sr. Manager, Materials appeared before the Committee and after discussion, the firm was requested to

44 Shri Seelamsetti has assured that the information would be submitted in a weeks' time. The case was deferred for 13.12.2012. 45

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

15.11.2012 HQ File :01/82/050/00032/AM13/ RLA File :09/24/040/00527/AM12/ Lic.No/Date:0910051095 02.02.2012 Defer Date:13.12.2012 Decision : Shri Veeranna Seelamsethi, Sr. Manager, Materials appeared before the Committee and after discussion, the firm was requested to Shri Seelamsetti has assured that the information would be submitted in a weeks' time. The case was deferred for 13.12.2012. 46

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

Party Name:METROCHEM API PVT. LTD. 15.11.2012 HQ File :01/82/050/01468/AM12/ RLA File :09/24/040/00480/AM12/ Lic.No/Date:0910051119 06.02.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 47

Case No.:51/46/82ALC4/2011

Party Name:RELIANCE INDUSTRIES LTD. 15.11.2012 HQ File :01/82/050/01267/AM12/ RLA File :03/95/040/00867/AM12/ Lic.No/Date:0310680799 08.02.2012 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals.

Case No.:40/1/82ALC4/2012

Party Name:MEDREICH LIMITED

48 15.11.2012 HQ File :01/82/050/01482/AM12/ RLA File :07/24/040/00455/AM12/ Lic.No/Date:0710086215 10.02.2012 Defer Date:13.12.2012 Decision :The firm was called for Personal Hearing. However, the firm has requested for some other date for PH as they are unable to get the production consumption data. It was decided to call the firm for PH on 13.12.2012. 49

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

Party Name:ARCH PHARMALABS LTD 15.11.2012 HQ File :01/82/050/01497/AM12/ RLA File :03/94/040/00996/AM12/ Lic.No/Date:0310681891 14.02.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 50

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

Party Name:CHEMSPEC CHEMICALS PVT LTD 15.11.2012 HQ File :01/82/050/01509/AM12/ RLA File :03/94/040/01007/AM12/ Lic.No/Date:0310682171 15.02.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 51

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

Party Name:SPECTRUM LIFE SCIENCES PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/01477/AM12/ RLA File :04/24/040/00309/AM12/ Lic.No/Date:0410133868 16.02.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish Drug Manufacturing License for the export product. Accordingly, the case was deferred for 13.12.2012 52

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

15.11.2012 Status:Case Approved HQ File :01/82/050/01470/AM12/ RLA File :03/94/040/01016/AM12/ Lic.No/Date:0310682483 17.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/285/2012PI(Norms) dated 10.9.2012, 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 kg/kg N(2Butyl3(p(3 (dibutylamino) propoxy) benzoyl)5benzofuranyl) methanesulfonamide (Dronedarone hydrochloride) 1 kg 1. 2nButyl 3(4methoxy benzoyl) 5 nitrobenzofuran 1.556 2. N(3Cholorophenyl)dibutylamine 0.944

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

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/01493/AM12/ RLA File :09/24/040/00579/AM12/ Lic.No/Date:0910051360 21.02.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33. Accordingly, the case was deferred for 13.12.2012. 54

Case No.:58/1/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/01500/AM12/ RLA File :09/24/040/00564/AM12/ Lic.No/Date:0910051391 22.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/383/2012PI(Norms) dated 28.9.2012, 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 kg/kg Ractopamine HCL 1 kg 1 4(4Hyroxy Phenyl)2Butanone 1.063 2. 4HydroxyAlpha Bromo Acetophenone 1.063 3. Methanol 3.91 4. Ethyl Acetate 4.11 5. Toluene 1.28 6. Acetone 0.33 55

Case No.:7/49/82ALC4/2011

Party Name:EMCURE PHARMACEUTICALS LTD. 15.11.2012 Status:Case Approved HQ File :01/82/050/01316/AM12/ RLA File :31/83/040/00236/AM12/ Lic.No/Date:3110053141 24.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/521/2012PI(Norms) dated 12.11.2012, 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 kg/kg Sevelamer HCL (Relevant Bulk Drug) 1 kg 1. Allyl Amine HCL Solution (60%) 2.25

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

15.11.2012

56 5. . 0 HQ File :01/82/050/01369/AM12/ RLA File :03/94/040/00125/AM12/ Lic.No/Date:0310683824 29.02.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 57

Case No.:65/3/82ALC4/2012

Party Name:SHASUN PHARMACEUTICALS LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00069/AM13/ RLA File :04/24/040/00322/AM12/ Lic.No/Date:0410134302 01.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/15/2012PI(Norms) dated 13.6.2012, 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 Metoprolol Tartrate Tablets 25 mg 1 number 1. Metoprolol Tartrate 25.5 mg 2. Magnesium Stearate 1.53 mg 58

Case No.:61/1/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/01503/AM12/ RLA File :05/24/040/00429/AM12/ Lic.No/Date:0510319400 02.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/351/2012PI(Norms) dated 13.9.2012, 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 kg/kg Orlistat (Pharmaceuticals formulations/Standard Grade) 1 kg 1 (S)()2,2 bis(diphenylphosphino)1,1 binaphthyl 0.0166 2. 2 Methoxy Propane 13.10 3. Acetone 0.95 4. Activated Carbon 0.100 5. Dicyclohexyl Carbodiimide 1.189 6 Diisobutyl Aluminium hydride 10.76 7 Dimethyl Formamide 0.194 8. Ethyl Acetate 0.40 9. Formic Acid 0.643 10 Lithium Hexamethyldisilazide 2.865 11 LLeucine 0.921 12 Meldrum Acid 2.985 13. Methanol 19.70 14 Methylene Chloride 11.08

y 15 Palladium Sponge 0.00618 16 Pivaloyl Chloride 0.848 17 Tetrachlorobis(PCymene) Diruthenium (II) 0.0083 18 Tetrahydrofuran 3.97 19 Toluene 21.305 20 Triethylamine 0.780 59

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

15.11.2012 HQ File :01/82/050/00110/AM13/ RLA File :03/94/040/01096/AM12/ Lic.No/Date:0310684923 05.03.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012 60

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

15.11.2012 HQ File :01/82/050/00113/AM13/ RLA File :03/94/040/01099/AM12/ Lic.No/Date:0310684919 05.03.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 13.12.2012. 61

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

15.11.2012 HQ File :01/82/050/00114/AM13/ RLA File :03/94/040/01077/AM12/ Lic.No/Date:0310684930 05.03.2012 Defer Date: 13.12.2012 Decision : It was decided to defer the case for 13.12.2012 for comments of Department of Pharmaceuticals. 62

Case No.:71/4/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 15.11.2012 Status:Case Approved HQ File :01/82/050/00151/AM13/ RLA File :07/24/040/00492/AM12/ Lic.No/Date:0710086777 05.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/459/2012PI(Norms) dated 31.10.2012, 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 kg/kg Calcium Carbonate 1250 mg+Glycine 535.7 mg tablets 1000 tablets 1 Glycine USP/BP Not shown in DML 2. Calcium Carbonate Dense BP/USP 1.25 kg

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

Party Name:BELCO PHARMA 15.11.2012 HQ File :01/82/050/00081/AM13/ RLA File :05/23/040/00485/AM12/ Lic.No/Date:0510319713 06.03.2012 Defer Date:13.12.2012 64

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

15.11.2012 HQ File :01/82/050/00108/AM13/ RLA File :03/94/040/01102/AM12/ Lic.No/Date:0310684966 06.03.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 65

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

15.11.2012 HQ File :01/82/050/00109/AM13/ RLA File :03/94/040/01104/AM12/ Lic.No/Date:0310684961 06.03.2012 Defer Date: 13.12.2012 Decision : It was decided to defer the case for 13.12.2012 for comments of Department of Pharmaceuticals. 66

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

15.11.2012 HQ File :01/82/050/00111/AM13/ RLA File :03/94/040/01101/AM12/ Lic.No/Date:0310684973 06.03.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 67

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

15.11.2012 HQ File :01/82/050/00121/AM13/ RLA File :03/94/040/01105/AM12/ Lic.No/Date:0310684976 06.03.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012.

Case No.:86/4/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00166/AM13/ RLA File :09/24/040/00569/AM12/ Lic.No/Date:0910051621 06.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/517/2012PI(Norms) dated 14.11.2012, 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:

68 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 kg/kg Hydroxymethylene Diphosphonic Acid, Disodium Salt (HmDp) 1 kg 1. Clodronate Disodium Tetrahydrate 3.82 69

Case No.:6/3/82ALC4/2012

Party Name:ONEIRO CHEMICALS LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/00010/AM13/ RLA File :34/24/040/00267/AM12/ Lic.No/Date:3410033486 07.03.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 23/82 dated 7.9.2010, 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 4,5,6,7‐Tetrahydro (3,2,C) Thiono Pyridine Hcl 1 Kg. 1. Thephen‐2‐Ethylamine 1.13 kg 2. Methanol 1.956 kg 3. Methylene Chloride 1.03 kg 70

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

Party Name:ANUGRAHA CHEMICALS 15.11.2012 HQ File :01/82/050/00141/AM13/ RLA File :07/24/040/00489/AM12/ Lic.No/Date:0710086840 07.03.2012 Defer Date:13.12.2012 Decision :It was decided to call from the firm the full information about the item they are exporting and also a copy of Drug Manufacturing License. Accordingly, the case was deferred for 13.12.2012. 71

Case No.:60/4/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00140/AM13/ RLA File :09/24/040/00606/AM12/ Lic.No/Date:0910051644 08.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/522/2012PI(Norms) dated 12.11.2012, 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 kg/kg Clonazepam 1 kg 1. 2Amino5Nitro2Chloro Benzophenone 1.33 2. Bromo Acetyl Bromide 1.18

Case No.:3/7/82ALC4/2012

Party Name:SIFLON DRUGS 15.11.2012 HQ File :01/82/050/00187/AM13/ RLA File :09/24/040/00591/AM12/ Lic.No/Date:0910051650 09.03.2012 Defer Date:13.12.2012 73

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

Party Name:EMCURE PHARMACEUTICALS LTD. 15.11.2012 HQ File :01/82/050/00308/AM13/ RLA File :31/83/040/00227/AM12/ Lic.No/Date:3110053321 09.03.2012 Defer Date:13.12.2012 74

Case No.:59/3/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 15.11.2012 HQ File :01/82/050/00063/AM13/ RLA File :05/23/040/00483/AM12/ Lic.No/Date:0510319858 12.03.2012 Defer Date:13.12.2012 Decision :The firm was called for PH. However, no representative of the firm appeared before the Committee. It was decided to call the firm for PH on 13.12.2012. Accordingly, the case was deferred for 13.12.2012. 75

Case No.:2/7/82ALC4/2012

Party Name:XL LABORATORIES PVT LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/00186/AM13/ RLA File :05/24/040/00412/AM12/ Lic.No/Date:0510319982 13.03.2012 Defer Date: Decision : In line with SION A 412, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by them, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg Ornitox (LOrnithineL Aspartate Granules) 1 number 1. LOrnithineLAspartate 999.90 76

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

Party Name:PERKIN LABORATORIES 15.11.2012 HQ File :01/82/050/00295/AM13/ RLA File :09/24/040/00517/AM12/ Lic.No/Date:0910051719 13.03.2012 Defer Date:13.12.2012

Case No.:38/11/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/00305/AM13/ RLA File :09/24/040/00501/AM12/ Lic.No/Date:0910051737 14.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/511/2012PI(Norms) dated 14.11.2012, 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 kg/kg NexiumTM HP Multipack (composition of each pack: Nexium TN 20 mg tablets 14 nos., Clarithromycin in 500 mg Tabs – 14 Nos., Amoxycillin 500 mg Capsules – 28 Nos. As per purchase order) 1 pack 1. Nexium TM 20 mg Tablets (Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate equivalent to Esomerprazole 20 mg) 14.0 Nos. 2. 6 APA 9.167 gm 3. D()PHydroxy Phenyl Glycine base 7.667 gm 4. Methyl Aceto Acetate 5.833 gm 5. Methanol 4.667 gm 6. Triethylamine 0.333 gm 7 Methylene Chloride 5.333 gm 8 Isopropyl Alcohol 6.833 gm 9. N, NDimethyl Acetamide 1.50 gm 10 Pivaloyl Chloride 5.333 gm 78

Case No.:50/4/82ALC4/2012

Party Name:MEHTA API PVT LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/00130/AM13/ RLA File :03/95/040/01050/AM12/ Lic.No/Date:0310686182 14.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/457/2012PI(Norms) dated 18.10.2012, 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 kg/kg Azithromycin/Azithromycin Dihyrate EP/BP/USP 1 kg 1 Azithromycin Amine having purity NMT 94% 1.07

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

Party Name:FORACE POLYMERS (P) LTD.

79 y ( ) 15.11.2012 HQ File :01/82/050/00075/AM13/ RLA File :05/23/040/00502/AM12/ Lic.No/Date:0510320188 15.03.2012 Defer Date:13.12.2012 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. Accordingly, the case was deferred for 13.12.2012. 80

Case No.:12/8/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 15.11.2012 HQ File :01/82/050/00204/AM13/ RLA File :09/24/040/00594/AM12/ Lic.No/Date:0910051799 16.03.2012 Defer Date:13.12.2012 81

Case No.:38/8/82ALC4/2012

15.11.2012 HQ File :01/82/050/00230/AM13/ RLA File :09/24/040/00603/AM12/ Lic.No/Date:0910051798 16.03.2012 Defer Date:13.12.2012 82

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

15.11.2012 HQ File :01/82/050/00306/AM13/ RLA File :09/24/040/00600/AM12/ Lic.No/Date:0910051800 16.03.2012 Defer Date:13.12.2012 83

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

15.11.2012 HQ File :01/82/050/00310/AM13/ RLA File :09/24/040/00595/AM12/ Lic.No/Date:0910051797 16.03.2012 Defer Date:13.12.2012

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

15.11.2012

84 HQ File :01/82/050/00232/AM13/ RLA File :07/24/040/00520/AM12/ Lic.No/Date:0710087119 20.03.2012 Defer Date:13.12.2012 85

Case No.:17/4/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00097/AM13/ RLA File :03/94/040/01117/AM12/ Lic.No/Date:0310687376 21.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/483/2012PI(Norms) dated 12.11.2012, 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 kg/kg Cilostazol 1 kg 1. [5(4Chlorobutyl)1Cyclohexyl1H Tetrazole] {CBT Cilostazol} 0.88 2. 5Hydroxy3,4Dihydroquinolinone [HCS Cilostazol] 0.59 3. Methanol 1.03 4. Isopropyl Alcohol 2.90 86

Case No.:35/8/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00227/AM13/ RLA File :09/24/040/00632/AM12/ Lic.No/Date:0910051839 21.03.2012 Defer Date: Decision : In line with the written comments received from Department of Pharmaceuticals vide their OM No. 35011/434/2012PI(Norms) dated 3.10.2012, 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 kg/kg Valacyclovir Hydrochloride 1 kg 1 CarbobenxyloxyLValine (CBZL Valine) 1.1824 2. N,N’ Dicyclohexyl Carbodiimide (DCC) 1.387 3. 4Dimethyl amine pyridine (DMAP) 0.028 4. Acyclovir 0.78 5. Dimethyl Sulfoxide (DMSO) 7.45 87

Case No.:4/8/82ALC4/2012

Party Name:HETERO LABS LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00196/AM13/ RLA File :09/24/040/00631/AM12/ Lic.No/Date:0910051837 Defer Date:

21.03.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/493/2012PI(Norms) dated 17.10.2012, 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 kg/kg Ezetimibe 1 kg 1. Para hydroxyl benzaldehyde 1.48 2. Para fluoro aniline 1.35 3. Tetra butyl ammonium fluoride 0.09 4. Glutaric anhydride 1.45 5. Fluoro benzene 1.93 6. N, NDicyclohexyl carbodiimide 1.18 7 4Dimethyl amino pyridine 0.17 8 NOBis trimethylsilyl acetamide 1.07 9 Dimethyl sulfide borane 0.424 10 ®Methyl Oxazaborolidine inToluene 1 M (on 100% Active basis) 0.057 11 Tert. Butyl alcohol 4.69 88

Case No.:62/3/82ALC4/2012

Party Name:PARABOLIC DRUGS LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00066/AM13/ RLA File :05/24/040/00085/AM12/ Lic.No/Date:0510320612 21.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/481/2012PI(Norms) dated 14.11.2012, 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 kg/kg Cefpodoxime Proxetil 1 kg 1. 7Amino Cephalosporanic Acid (7 ACA) 0.956 2. Boron Triflouride 0.614 3. Methanol 1.70 4. Sulfolane 1.29 5. Methylene Chloride 4.29 6 2Mecraptoben zothiazoly (z)22(2 Aminothiazole4YL)2Methoxyimino Acetate (MAEM) 0.956 7. EnoCarbon 0.100 8. Acetone 0.54 9. N,N Dimethyl Acetamide 2.02 10 18Crown6Ether 0.022 11 Chloro Ethyl Isopropyl Carbonate 0.55 12. Sodium Iodide 0.39

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

Party Name:PARABOLIC DRUGS LTD., 15.11.2012 HQ File :01/82/050/00067/AM13/ RLA File :05/24/040/00447/AM12/ Lic.No/Date:0510320617 21.03.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33. Accordingly, the case was deferred for 13.12.2012. 90

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

Party Name:CADILA HEALTHCARE LTD., 15.11.2012 HQ File :01/82/050/00155/AM13/ RLA File :08/24/040/00292/AM12/ Lic.No/Date:0810110000 22.03.2012 Defer Date:13.12.2012 91

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

15.11.2012 HQ File :01/82/050/00156/AM13/ RLA File :08/24/040/00301/AM12/ Lic.No/Date:0810110001 22.03.2012 Defer Date:13.12.2012 92

Case No.:77/1/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 15.11.2012 Status:Case Approved HQ File :01/82/050/01519/AM12/ RLA File :03/95/040/00865/AM11/ Lic.No/Date:0310687522 22.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/509/2012PI(Norms) dated 14.11.2012, 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 kg/kg Montelukast Sodium 1 kg 1. MNTVI{2(2(3(S)3(2(7Chloro2 Quinnolinyl)Ethenyl)3 Hydroxypropyl)Phenyl)2Propanol 1.438 2. Diisopropylethylamine 0.557 3. Methane Sulfonyl Chloride 0.474 4. Toluene 4.466 5. Acetonitrile 1.545 6. MCAVI(side chain) 1 (Mercaptomethyl)Cyclopropane Acetic Acid 0.600 7. Sodium Methoxide 0.670 8. Activated Carbon 0.100 9. Ethyl Acetate 10.811 10 Hexane 7.145 11 Methanol 2.528

12 Di Methyl Formamide 0.891 13. NHeptane 1.262 93

Case No.:77/4/82ALC4/2012

15.11.2012 HQ File :01/82/050/00157/AM13/ RLA File :08/24/040/00304/AM12/ Lic.No/Date:0810109993 22.03.2012 Defer Date:13.12.2012 94

Case No.:78/1/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 15.11.2012 Status:Case Approved HQ File :01/82/050/01520/AM12/ RLA File :03/95/040/00719/AM12/ Lic.No/Date:0310687530 22.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/510/2012PI(Norms) dated 14.11.2012, 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 kg/kg Lisinopril/Lisinopril Dihydrate 1 kg 1. N6Trifluoro AcetylLLysine 1.231 2. Potassium Carbonate 0.789 3. Benzyl Chloroformate 1.30 4. Toluene 1.55 5. Ethyl Acetate 4.25 6. NHexane 1.45 7. LProline Benzyl Ester HCL 1.266 8. Triethalamine 0.536 9. Pivaloyl Chloride 0.584 10 Methanol 6.34 11 Raney Nickle catalyst 0.100 12 Methylene Dichloride 3.49 13 Ethyl2Oxo4Phenyl Butyrate 0.85 14 Iso Propyl Alcohol 1.92 15 Activated Carbon 0.060 95

Case No.:78/4/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/00158/AM13/ RLA File :08/24/040/00303/AM12/ Lic.No/Date:0810109994 22.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/523/2012PI(Norms) dated 14.11.2012, 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 kg/kg Atorvastatin Calcium 1 kg 1. (4R,CIS)1,1Dimethylethyl6 Cyanomethyl2,2Dimethyl1,3 Dioxane4Acetate 0.733 2. Tetrahydrofuran 0.80 3. Iso Propyl Alcohol 1.16 4. Methanol 6.42 96

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

15.11.2012 Status:Case Approved HQ File :01/82/050/00162/AM13/ RLA File :08/24/040/00302/AM12/ Lic.No/Date:0810110002 22.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/451/2012PI(Norms) dated 22.10.201214.11.2012, 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 S.No Import item For Export of 1 million Tablets (Qty in kg) Losartan Potassium 25 mg 50 mg 100 mg 1. Toulene 36.72 73.44 146.88 2. 1Triethyl5[4’ (Bromomethyl) {1,1’ Biphenyl}4yl] 1 HTetrazole 37.23 74.46 148.92 3. 2Butyl4Chloro5Formyl Imidazole (BFCI) 12.75 25.50 51.0 4. Aceto Nitrile 81.60 163.20 326.40 5. Methylene Chloride (MDC) 43.605 87.21 174.42 6. NHeptane 31.62 63.24 126.48 7. Lactose Monohydrate NF 43.00 86.00 172.00 8. Microcrystalline Cellulose NF (Avicel PH 102) 5.0 10.0 20.0 9. Low substituted hyroxypropyl Cellulose 2.50 5.0 10.0 10. Magnesium Stearate NF 1.00 2.00 4.00 11. Bottles & Caps (packing materials in finished form) 1. 60 CC while HDPE bottle Relevant, as per packing policy. 12. 11 b. CRC white cap 33 mm pulp liner 13. 11 c. 150 cc white HDPE bottle 14. 11 d. white continuous (Thread 38 MM cap) 15 11 e 400 CC White HDPE bottle

bottle 16 11 f. NCRC white cap 53 MM pulp liner 17 11 g 750 CC white HDPE bottle 18 11 h. 300 CC WH HDPE Bottle 19. 11 i. NCRC WH Cap 45 MM 97

Case No.:81/4/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/00161/AM13/ RLA File :08/24/040/00306/AM12/ Lic.No/Date:0810110029 23.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/485/2012PI(Norms) dated 12.11.2012, 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: Norms allowed for export of Lamotrignie ( 1 no. of Tablet) Qty. in mg S.No Import item 25 mg tabs 100 mg tabs 150 mg tabs 200 mg tabs 1. Lamotrigine 25.5 mg 102 mg 153 mg 204 mg 2. Microcrystalline Cellulose (Avicel PH 101) 30 mg 120 mg 180 mg 240 mg 3 Lactose Monohydrate 15 mg 60 mg 90 mg 120 mg 4. Bottles & Caps Relevant, as per packing policy Norms for 1 kg Lamotrigine S.No Import Item Qty allowed (kg/kg) 1. 2,3 Dichloro Benzoyl Nitrile 1.222 2 Amino Guanidine Bicarbonate 1.222 3 Di Methyl Sulphoxide 0.70 4. Methanol 2.80 98

Case No.:4/11/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/00271/AM13/ RLA File :09/24/040/00634/AM12/ Lic.No/Date:0910051870 26.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/512/2012PI(Norms) dated 14.11.2012, 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

p p y p y kg/kg Lopinavir 1 kg 1 LPhenyl Alanine 0.710 2. LValine 0.761 3. Thionyl Chloride 0.299 4. Methane Sulphonic Acid 1.867 5. Monoglyme 6.69 6. nHeptane 4.348 7 Trifluoro Acetic Acid 1.816 8. Iodine 0.001 9 Potassium Carbonate (Anhydrous) 1.368 10 Sodium Boro Hydride 0.819 11 LPyro Glutamic Acid 0.316 12. N,NCarbonyl Di Imidazole 0.647 13 Activated Carbon 0.100 14 Acetonitrile 0.195 15 Dimethyl Formamide 2.496 16. Isopropyl Alcohol 6.603 17 Methanol 13.184 18 Methylene Chloride 8.457 19 Tetrahydrofuran 9.034 20 Steam/Thermal Coal As per fuel policy 99

Case No.:90/4/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00170/AM13/ RLA File :05/24/040/00468/AM12/ Lic.No/Date:0510321002 26.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/487/2012PI(Norms) dated 14.11.2012, 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 kg/kg Atorvastatin Calcium 1 kg 1. 4Fluoroalpha[2methyl1 Oxopropyl]gammaoxoN(Beta) Diphenyl Benzene Butanamide 1.15 2. (4RCis)1,1Dimethylethyl6 Cyanomethyl2,2Dimethyl1,3 Dioxane4Acetate 0.733 3. Methylene Chloride 4.48 4. Diisopropyl ether 3.90 100

Case No.:91/4/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD., 15.11.2012 Status:Case Approved

pp HQ File :01/82/050/00171/AM13/ RLA File :05/24/040/00469/AM12/ Lic.No/Date:0510321003 26.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/488/2012PI(Norms) dated 14.11.2012, 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 kg/kg Montelukast Sodium 1 kg 1. (S)(E)2[2[3[2(7Chloro2 Quinolinyl)Ethenylphenyl]3 Hydroxypropyl]Phenyl]2Propanol 1.424 2. Methanol 12.12 3. N,NDiisopropylethylamine 0.30 4. Tetrahydrofuran 3.62 5. Acetonitrile 3.39 6. 2[1(Mercaptomethyl) Cyclopropyl] Acetic Acid 0.60 101

Case No.:10/8/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 15.11.2012 HQ File :01/82/050/00202/AM13/ RLA File :09/24/040/00647/AM12/ Lic.No/Date:0910051921 28.03.2012 Defer Date:13.12.2012 102

Case No.:17/11/82ALC4/2012

15.11.2012 HQ File :01/82/050/00284/AM13/ RLA File :09/24/040/00646/AM12/ Lic.No/Date:0910051917 28.03.2012 Defer Date:13.12.2012 Decision : Shri Veeranna Seelamsethi, Sr. Manager, Materials appeared before the Committee and after discussion, the firm was requested to Shri Seelamsetti has assured that the information would be submitted in a weeks' time. The case was deferred for 13.12.2012. 103

Case No :29/8/82ALC4/2012

Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:24/82ALC4/2012 Status:Case Deferred

103

Case No.:29/8/82ALC4/2012

Party Name:AGIO PHARMACEUTICALS LTD 15.11.2012 HQ File :01/82/050/00221/AM13/ RLA File :03/94/040/01171/AM12/ Lic.No/Date:0310688368 28.03.2012 Defer Date:13.12.2012 104

Case No.:7/8/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 15.11.2012 HQ File :01/82/050/00199/AM13/ RLA File :09/24/040/00642/AM12/ Lic.No/Date:0910051920 28.03.2012 Defer Date:13.12.2012 105

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

Party Name:CHEMCON SPECIALITY CHEMICALS P LTD 15.11.2012 HQ File :01/82/050/00276/AM13/ RLA File :34/24/040/00298/AM12/ Lic.No/Date:3410033741 29.03.2012 Defer Date:13.12.2012 106

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

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 15.11.2012 HQ File :01/82/050/00001/AM13/ RLA File :03/95/040/00970/AM12/ Lic.No/Date:0310688849 30.03.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula. Accordingly, the case was deferred for 13.12.2012. 107

Case No.:13/8/82ALC4/2012

15.11.2012 HQ File :01/82/050/00205/AM13/ RLA File :05/24/040/00470/AM12/ Lic.No/Date:0510321504 30.03.2012 Defer Date:13.12.2012 108

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

15.11.2012 HQ File :01/82/050/00002/AM13/ RLA File :03/95/040/01032/AM12/ Lic.No/Date:0310688856 30.03.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula. Accordingly, the case was deferred for 13.12.2012.

109

Case No.:27/16/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/00463/AM13/ RLA File :09/24/040/00671/AM12/ Lic.No/Date:0910052024 30.03.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/43/2011Ch. II dated 1.11.2012, 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 kg/kg 2Methoxy Methyl Benzene 1,4Diamine (MBB) 1 kg 1. 2Chloro Benzyl Chloride or Ortho Chloro Benzyl Chloride 3.328 kg 2. Toluene 2.850 kg 3. Methanol 2.565 kg 4. Tetra Ethyl Ammonium Bromide (TBAB) 2.600 kg 5. Benzyl Amine 3.974 kg 110

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

15.11.2012 HQ File :01/82/050/00003/AM13/ RLA File :03/95/040/01037/AM12/ Lic.No/Date:0310688874 30.03.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula. Accordingly, the case was deferred for 13.12.2012. 111

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

Party Name:PROMED EXPORTS PVT.LTD. 15.11.2012 HQ File :01/82/050/00188/AM13/ RLA File :05/24/040/00471/AM12/ Lic.No/Date:0510321506 30.03.2012 Defer Date:13.12.2012 112

Case No.:34/16/82ALC4/2012

15.11.2012 HQ File :01/82/050/00470/AM13/ RLA File :09/24/040/00658/AM12/ Lic.No/Date:0910052048 04.04.2012 Defer Date:15.11.2012 113

Case No.:34/8/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 15.11.2012 HQ File :01/82/050/00226/AM13/ RLA File :22/24/040/00002/AM13/ Lic.No/Date:2210012699 Defer

09.04.2012 Date:13.12.2012 114

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

Party Name:VIHITA CHEM PVT.LTD. 15.11.2012 HQ File :01/82/050/00315/AM13/ RLA File :34/24/040/00282/AM12/ Lic.No/Date:3410033798 10.04.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012 115

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

Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. 15.11.2012 HQ File :01/82/050/00268/AM13/ RLA File :03/94/040/01138/AM12/ Lic.No/Date:0310690368 11.04.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 116

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

Party Name:BRILLIANT BIO PHARMA LIMITED 15.11.2012 HQ File :01/82/050/00474/AM13/ RLA File :09/24/040/00664/AM12/ Lic.No/Date:0910052111 11.04.2012 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Department of Biotechnology. 117

Case No.:6/7/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 15.11.2012 Status:Case Approved HQ File :01/82/050/00190/AM13/ RLA File :05/23/040/00526/AM12/ Lic.No/Date:0510322039 11.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/500/2012PI(Norms) dated 18.10.2012, 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 kg/kg Cefixime USP/IP/BP 1 kg 1. 7Phenylacetamideo3Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 1.555 2. Tri Phenyl Phosphine 1.20 3. Acetone 1.18 4. N,N Dimethyl Formamide 4.00 5. Dichloromethane 4.98 6. Phenol 1.12 7. Methanol 6.16 8. Activated Carbon 0.100 9 Triethyl amine 0 34

Triethyl amine 0.34 10 Mica Ester 1.112 11 Tetra Hydrofuran 2.40 118

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

Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 15.11.2012 HQ File :01/82/050/00270/AM13/ RLA File :03/94/040/00007/AM13/ Lic.No/Date:0310690582 12.04.2012 Defer Date:13.12.2012 119

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

Party Name:NECTAR LIFESCIENCES LIMITED, 15.11.2012 HQ File :01/82/050/00367/AM13/ RLA File :22/24/040/00003/AM13/ Lic.No/Date:2210012707 12.04.2012 Defer Date:13.12.2012 120

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

15.11.2012 HQ File :01/83/050/00053/AM13/ RLA File :03/95/040/01118/AM12/ Lic.No/Date:0310690527 12.04.2012 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Department of Biotechnology. 121

Case No.:19/9/82ALC4/2012

15.11.2012 HQ File :01/82/050/00264/AM13/ RLA File :03/95/040/00963/AM12/ Lic.No/Date:0310690704 13.04.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and also Master Batch Formula. Accordingly, the case was deferred for 13.12.2012. 122

Case No.:8/7/82ALC4/2012

15.11.2012 HQ File :01/82/050/00192/AM13/ RLA File :03/95/040/01046/AM12/ Lic.No/Date:0310690715 13.04.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and also Master Batch Formula. Accordingly, the case was deferred for 13.12.2012. 123 C 10/11/ 2 A C4/2012 A SC C S / 24/82 A C4/2012 St t C D f d

123

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

Party Name:AMI LIFESCIENCES P LTD 15.11.2012 HQ File :01/82/050/00277/AM13/ RLA File :34/24/040/00012/AM13/ Lic.No/Date:3410033877 16.04.2012 Defer Date:13.12.2012 124

Case No.:47/8/82ALC4/2012

15.11.2012 HQ File :01/82/050/00239/AM13/ RLA File :05/24/040/00011/AM13/ Lic.No/Date:0510322536 19.04.2012 Defer Date:13.12.2012 125

Case No.:48/8/82ALC4/2012

15.11.2012 HQ File :01/82/050/00240/AM13/ RLA File :05/24/040/00014/AM13/ Lic.No/Date:0510322537 19.04.2012 Defer Date:13.12.2012 126

Case No.:2/5/82ALC4/2012

Party Name:TITAN LABORATORIES PVT. LTD. 15.11.2012 HQ File :01/82/050/00174/AM13/ RLA File :03/95/040/00048/AM13/ Lic.No/Date:0310691572 20.04.2012 Defer Date:13.12.2012 127

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

Party Name:NECTAR LIFESCIENCES LIMITED, 15.11.2012 HQ File :01/82/050/00285/AM13/ RLA File :22/24/040/00001/AM13/ Lic.No/Date:2210012759 24.04.2012 Defer Date:13.12.2012 128

Case No.:40/11/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 15.11.2012 HQ File :01/82/050/00307/AM13/ RLA File :22/24/040/00005/AM13/ Lic.No/Date:2210012763 25.04.2012 Defer Date:13.12.2012 129

Case No.:26/10/83ALC1/2012

Party Name:SPAN DIAGNOSTICS LTD 15 11 2012

15.11.2012 HQ File :01/83/050/00206/AM13/ RLA File :52/24/040/00001/AM13/ Lic.No/Date:5210038307 26.04.2012 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Department of Biotechnology. 130

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

15.11.2012 HQ File :01/82/050/00301/AM13/ RLA File :07/24/040/00031/AM13/ Lic.No/Date:0710087924 27.04.2012 Defer Date:13.12.2012 131

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

Party Name:ENCUBE ETHICALS PVT LTD 15.11.2012 HQ File :01/82/050/00379/AM13/ RLA File :03/94/040/00006/AM13/ Lic.No/Date:0310693056 01.05.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information without any further delay, failing which their case would be closed. Accordingly, the case was deferred for 13.12.2012. 132

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

Party Name:ENCUBE ETHICALS PVT LTD 15.11.2012 HQ File :01/82/050/00380/AM13/ RLA File :03/94/040/00053/AM13/ Lic.No/Date:0310692961 01.05.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information without any further delay failing which their case would be closed. Accordingly, the case was deferred for 13.12.2012. 133

Case No.:23/16/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/00459/AM13/ RLA File :09/24/040/00043/AM13/ Lic.No/Date:0910052448 02.05.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/43/2011Ch. II dated 1.11.2012, 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 kg/kg Jarocol Blue 2 1 kg 1 Crude Jarocol Blue2 or HC Blue 2 1.220 kg 134

Case No.:27/13/82ALC4/2012

Party Name:EMCURE PHARMACEUTICALS LTD. 15.11.2012 Status:Case Approved Q il 01/82/0 0/00362/A 13/ A il 31/83/040/0001 /A 13/ i / 31100 4091 f

HQ File :01/82/050/00362/AM13/ RLA File :31/83/040/00015/AM13/ Lic.No/Date:3110054091 07.05.2012 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/521/2012PI(Norms) dated 12.11.2012, 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 kg/kg Sevelamer Hydrochloride (Relevant Bulk Drug) 1 kg 1. Allyl Amine Hydrochloride Solution (60%) (Chemical) 2.25 135

Case No.:5/16/82ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED 15.11.2012 Status:Deffered HQ File :01/82/050/00441/AM13/ RLA File :07/24/040/00041/AM13/ Lic.No/Date:0710088058 07.05.2012 Defer Date:13.12.2012 Decision : It was decided to defer the case for 13.12.2012 for comments of Department of Pharmaceuticals. 136

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

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/00391/AM13/ RLA File :03/94/040/00070/AM13/ Lic.No/Date:0310693809 08.05.2012 Defer Date:13.12.2012 137

Case No.:20/11/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/00287/AM13/ RLA File :08/24/040/00039/AM13/ Lic.No/Date:0810111430 08.05.2012 Defer Date: Decision : : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/57/2012Ch. II dated 16.11.2012, 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 Methyl Tri Octyl Ammonium Chloride 1 kg 1 Tri Octyl Amine 0.815 2. Iso Propyl Alcohol 0.350 litre 138

Case No.:21/11/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 15.11.2012 HQ File :01/82/050/00288/AM13/ RLA File :08/24/040/00282/AM12/ Lic.No/Date:0810111431 08.05.2012 Defer Date:13.12.2012

Decision : : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/57/2012Ch. II dated 16.11.2012, 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 kg/kg Methyl Triphenyl Phosphonium Bromide 1 kg 1. Triphenyl Phosphine 0.850 2. Methyl Ethyl Ketone 0.270 139

Case No.:22/11/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 15.11.2012 HQ File :01/82/050/00289/AM13/ RLA File :08/24/040/00012/AM13/ Lic.No/Date:0810111429 08.05.2012 Defer Date:13.12.2012 Decision : : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/57/2012Ch. II dated 16.11.2012, 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 kg/kg Ethyl Triphenyl Phosphonium Bromide 1 kg 1. Triphenyl Phosphine 0.785 2. Ethyl Bromide 0.230 140

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

Party Name:AMI LIFESCIENCES P LTD 15.11.2012 HQ File :01/82/050/00294/AM13/ RLA File :34/24/040/00027/AM13/ Lic.No/Date:3410034073 08.05.2012 Defer Date:13.12.2012 141

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

Party Name:VIMAL DRUGS PRIVATE LIMITED 15.11.2012 HQ File :01/83/050/00351/AM13/ RLA File :09/24/040/00049/AM13/ Lic.No/Date:0910052504 08.05.2012 Defer Date:13.12.2012 142

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

15.11.2012 HQ File :01/82/050/00359/AM13/ RLA File :07/24/040/00052/AM13/ Lic.No/Date:0710088126 09.05.2012 Defer Date:13.12.2012

143

Case No.:57/11/82ALC4/2012

Party Name:INTERMED, 15.11.2012 HQ File :01/82/050/00324/AM13/ RLA File :04/24/040/00004/AM13/ Lic.No/Date:0410136242 09.05.2012 Defer Date:13.12.2012 144

Case No.:17/18/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/00512/AM13/ RLA File :09/24/040/00047/AM13/ Lic.No/Date:0910052581 10.05.2012 Defer Date: Decision : : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/43/2011Ch. II dated 1.11.2012, 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 kg/kg Phenyl Benzimidazole Sulphonic Acid – PBSA or (Vivsonic/Suntech817) 1 kg 1. OPhenylene Diamine 0.662 2. Caustic Soda (NAOH) 0.840 3. Benzaldehyde 0.728 4. Acetic Acid 3.000 5. Methanol 0.266 RA may take appropriate action as per the decision of Norms Committee. 145

Case No.:13/11/82ALC4/2012

15.11.2012 HQ File :01/82/050/00280/AM13/ RLA File :05/24/040/00045/AM13/ Lic.No/Date:0510324687 14.05.2012 Defer Date:13.12.2012 146

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

Party Name:FORACE POLYMERS (P) LTD. 15.11.2012 HQ File :01/82/050/00398/AM13/ RLA File :05/23/040/00037/AM13/ Lic.No/Date:0510324671 14.05.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 13.12.2012. 147

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

Party Name:HALDIA PETROCHEMICALS LTD. 15.11.2012 HQ File :01/82/050/00365/AM13/ RLA File :02/24/040/00029/AM13/ Lic.No/Date:0210177518 14.05.2012 Defer Date:13.12.2012

Decision :It was decided to defer the case for 13.12.2012 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 148

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

15.11.2012 HQ File :01/82/050/00255/AM13/ RLA File :03/95/040/00094/AM13/ Lic.No/Date:0310694706 15.05.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula. Accordingly, the case was deferred for 13.12.2012. 149

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

15.11.2012 HQ File :01/82/050/00256/AM13/ RLA File :03/95/040/00093/AM13/ Lic.No/Date:0310694735 15.05.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula. Accordingly, the case was deferred for 13.12.2012. 150

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

15.11.2012 HQ File :01/83/050/00176/AM13/ RLA File :03/95/040/00092/AM13/ Lic.No/Date:0310694716 15.05.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula. Accordingly, the case was deferred for 13.12.2012. 151

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

15.11.2012 HQ File :01/82/050/00261/AM13/ RLA File :03/95/040/00090/AM13/ Lic.No/Date:0310694936 16.05.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License and Master Batch Formula. Accordingly, the case was deferred for 13.12.2012. 152

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

Party Name:STELLENCE PHARMSCIENCE PVT LTD 15.11.2012 HQ File :01/82/050/00442/AM13/ RLA File :07/24/040/00062/AM13/ Lic.No/Date:0710088213 16.05.2012 Defer Date:13.12.2012

Case No.:35/14/82ALC4/2012

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 15.11.2012

153 PHARMACEUTICALS LTD. 15.11.2012 HQ File :01/82/050/00412/AM13/ RLA File :03/94/040/00801/AM12/ Lic.No/Date:0310695056 17.05.2012 Defer Date:13.12.2012 154

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

Party Name:ATUL LIMITED, 15.11.2012 HQ File :01/82/050/00339/AM13/ RLA File :08/24/040/00048/AM13/ Lic.No/Date:0810111728 17.05.2012 Defer Date:13.12.2012 155

Case No.:21/16/82ALC4/2012

15.11.2012 HQ File :01/82/050/00457/AM13/ RLA File :09/24/040/00071/AM13/ Lic.No/Date:0910052683 18.05.2012 Defer Date:13.12.2012 156

Case No.:22/16/82ALC4/2012

15.11.2012 HQ File :01/82/050/00458/AM13/ RLA File :09/24/040/00041/AM13/ Lic.No/Date:0910052681 18.05.2012 Defer Date:13.12.2012 157

Case No.:29/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00406/AM13/ RLA File :03/94/040/00705/AM12/ Lic.No/Date:0310695318 18.05.2012 Defer Date:13.12.2012 158

Case No.:29/16/82ALC4/2012

15.11.2012 HQ File :01/82/050/00465/AM13/ RLA File :09/24/040/00067/AM13/ Lic.No/Date:0910052682 18.05.2012 Defer Date:13.12.2012 159

Case No.:30/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00407/AM13/ RLA File :03/94/040/00706/AM12/ Lic.No/Date:0310695305 Defer

159 Q e :0 /8 /050/00 07/ 3/ e :03/9 /0 0/00706/ / c.No/ ate:03 0695305 18.05.2012 e e Date:13.12.2012 160

Case No.:31/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00408/AM13/ RLA File :03/94/040/00807/AM12/ Lic.No/Date:0310695310 18.05.2012 Defer Date:13.12.2012 161

Case No.:32/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00409/AM13/ RLA File :03/94/040/00802/AM12/ Lic.No/Date:0310695307 18.05.2012 Defer Date:13.12.2012 162

Case No.:33/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00410/AM13/ RLA File :03/94/040/00815/AM12/ Lic.No/Date:0310695316 18.05.2012 Defer Date:13.12.2012 163

Case No.:15/13/82ALC4/2012

Party Name:NIFTY LABS PVT LTD., 15.11.2012 HQ File :01/82/050/00350/AM13/ RLA File :09/24/040/00077/AM13/ Lic.No/Date:0910052708 21.05.2012 Defer Date:13.12.2012 164

Case No.:18/9/82ALC4/2012

Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 15.11.2012 HQ File :01/82/050/00263/AM13/ RLA File :03/94/040/00111/AM13/ Lic.No/Date:0310695465 21.05.2012 Defer Date:13.12.2012 165

Case No.:27/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00404/AM13/ RLA File :03/94/040/00804/AM12/ Lic.No/Date:0310695480 21.05.2012 Defer Date:13.12.2012

166

Case No.:28/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00405/AM13/ RLA File :03/94/040/00805/AM12/ Lic.No/Date:0310695474 21.05.2012 Defer Date:13.12.2012 167

Case No.:3/16/82ALC4/2012

15.11.2012 HQ File :01/82/050/00439/AM13/ RLA File :07/24/040/00075/AM13/ Lic.No/Date:0710088327 21.05.2012 Defer Date:13.12.2012 168

Case No.:32/16/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/00468/AM13/ RLA File :09/24/040/00082/AM13/ Lic.No/Date:0910052715 21.05.2012 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/515/2012PI(Norms) dated 14.11.2012, 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 kg/kg Florfenicol 1 kg 1. Fluoroamine 0.761 2. Carbon Enoanticromos (Activated Carbon) 0.024 3. Methyl Alcohol (Methanol) 1.693 169

Case No.:36/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00413/AM13/ RLA File :03/94/040/00811/AM12/ Lic.No/Date:0310695482 21.05.2012 Defer Date:13.12.2012 170

Case No.:39/16/82ALC4/2012

15.11.2012 HQ File :01/82/050/00475/AM13/ RLA File :07/24/040/00071/AM13/ Lic.No/Date:0710088326 21.05.2012 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13 12 2012 for comments of Department of Pharmaceuticals

171

Case No.:21/9/82ALC4/2012

Party Name:EMCURE PHARMACEUTICALS LTD. 15.11.2012 HQ File :01/82/050/00266/AM13/ RLA File :31/83/040/00026/AM13/ Lic.No/Date:3110054379 22.05.2012 Defer Date:13.12.2012 172

Case No.:31/16/82ALC4/2012

Party Name:HETERO LABS LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00467/AM13/ RLA File :09/24/040/00084/AM13/ Lic.No/Date:0910052721 22.05.2012 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/513/2012PI(Norms) dated 15.11.2012, 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 kg/kg Saquinavir Mesylate 1 kg 1 LPhenyl Alanine 1.151 2. Methyl chloro formate 0.8689 3. Bromo chloro methane 0.900 4. Trimethyl silyl chloride 0.722 5. Tetrahydrofuran 1.072 6. Sodium borohydride 0.033 7. (3S,4aS,8aS)NTert. Butyl DecahydroIsoquinoline3 Carboxamide 0.5983 8. Quinaldic Acid 0.4778 9. LAspargine monohydrate 0.421 10 Pivaloyl chloride 0.531 11. Methane sulfonic acid 0.338 173

Case No.:11/13/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 15.11.2012 HQ File :01/82/050/00346/AM13/ RLA File :05/24/040/00048/AM13/ Lic.No/Date:0510325611 23.05.2012 Defer Date:13.12.2012 174

Case No.:6/13/82ALC4/2012

Party Name:BHARAT PARENTERALS LTD, 15.11.2012 HQ File :01/82/050/00341/AM13/ RLA File :34/24/040/00045/AM13/ Lic.No/Date:3410034190 23.05.2012 Defer Date:13.12.2012

175

Case No.:4/16/82ALC4/2012

15.11.2012 HQ File :01/82/050/00440/AM13/ RLA File :07/24/040/00078/AM13/ Lic.No/Date:0710088441 24.05.2012 Defer Date:13.12.2012 176

Case No.:55/14/82ALC4/2012

Party Name:ANUH PHARMA LTD. 15.11.2012 HQ File :01/82/050/00432/AM13/ RLA File :03/94/040/00094/AM13/ Lic.No/Date:0310696080 24.05.2012 Defer Date:13.12.2012 177

Case No.:7/13/82ALC4/2012

15.11.2012 HQ File :01/82/050/00342/AM13/ RLA File :08/24/040/00062/AM13/ Lic.No/Date:0810111893 24.05.2012 Defer Date:13.12.2012 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 35011/404/2012PI(Norms) dated 3.10.2012, it was decided to call from the firm the following technical details: Import details for each export item. Master Batch Formula for each export product duly certified by Quality Control Incharge. Accordingly, the case was deferred for 13.12.2012. 178

Case No.:10/14/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 15.11.2012 HQ File :01/82/050/00387/AM13/ RLA File :05/24/040/00062/AM13/ Lic.No/Date:0510325995 25.05.2012 Defer Date:13.12.2012 179

Case No.:12/13/82ALC4/2012

15.11.2012 HQ File :01/82/050/00347/AM13/ RLA File :05/24/040/00061/AM13/ Lic.No/Date:0510325945 25.05.2012 Defer Date:13.12.2012 C N 38/14/82 ALC4/2012 P N CALYX CHEMICALS & M N /D 24/82 ALC4/2012 St t C D f d

180

Case No.:38/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00415/AM13/ RLA File :03/94/040/00026/AM13/ Lic.No/Date:0310696238 25.05.2012 Defer Date:13.12.2012 181

Case No.:50/11/82ALC4/2012

Party Name:ALKEM LABORATORIES LTD., 15.11.2012 HQ File :01/82/050/00317/AM13/ RLA File :03/94/040/00054/AM13/ Lic.No/Date:0310696260 25.05.2012 Defer Date:13.12.2012 182

Case No.:37/14/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 15.11.2012 HQ File :01/82/050/00414/AM13/ RLA File :03/94/040/00143/AM13/ Lic.No/Date:0310696330 28.05.2012 Defer Date:13.12.2012 183

Case No.:9/14/82ALC4/2012

15.11.2012 HQ File :01/82/050/00386/AM13/ RLA File :05/24/040/00063/AM13/ Lic.No/Date:0510326034 28.05.2012 Defer Date:13.12.2012 184

Case No.:46/16/82ALC4/2012

15.11.2012 HQ File :01/82/050/00482/AM13/ RLA File :07/21/040/00128/AM13/ Lic.No/Date:0710088534 30.05.2012 Defer Date:13.12.2012 185

Case No.:51/14/82ALC4/2012

Party Name:AGIO PHARMACEUTICALS LTD 15.11.2012 HQ File :01/82/050/00428/AM13/ RLA File :03/94/040/01186/AM12/ Lic.No/Date:0310696799 30.05.2012 Defer Date:13.12.2012

Case No.:59/11/82ALC4/2012

Party Name:JINDAL DRUGS LIMITED 15 11 2012 Status:Case Approved

186 15.11.2012 Approved HQ File :01/82/050/00326/AM13/ RLA File :03/94/040/00027/AM13/ Lic.No/Date:0310697012 31.05.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/106/2011Ch. II dated 26.10.2012, 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 kg/kg Pure Cineole 1 kg 1. Eucalyptol Oil 1.05 187

Case No.:46/14/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 15.11.2012 HQ File :01/82/050/00423/AM13/ RLA File :03/94/040/00188/AM13/ Lic.No/Date:0310697620 06.06.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 188

Case No.:61/11/82ALC4/2012

Party Name:KOPRAN LIMITED 15.11.2012 HQ File :01/82/050/00328/AM13/ RLA File :03/94/040/00162/AM13/ Lic.No/Date:0310697570 06.06.2012 Defer Date:13.12.2012 189

Case No.:18/14/82ALC4/2012

Party Name:ASTRIX LABORATORIES LTD., 15.11.2012 HQ File :01/82/050/00395/AM13/ RLA File :09/24/040/00088/AM13/ Lic.No/Date:0910052978 12.06.2012 Defer Date:13.12.2012 190

Case No.:53/16/82ALC4/2012

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 15.11.2012 HQ File :01/82/050/00489/AM13/ RLA File :04/24/040/00049/AM13/ Lic.No/Date:0410137249 12.06.2012 Defer Date:13.12.2012 191

Case No.:54/16/82ALC4/2012

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 15.11.2012 HQ File :01/82/050/00490/AM13/ RLA File :04/24/040/00015/AM13/ Lic.No/Date:0410137244 12.06.2012 Defer Date:13.12.2012 D i i It d id d t d f th f 13 12 2012 f t f D t t f Ph ti l

192

Case No.:50/14/82ALC4/2012

Party Name:AARTI INDUSTRIES LIMITED 15.11.2012 HQ File :01/82/050/00427/AM13/ RLA File :03/94/040/00187/AM13/ Lic.No/Date:0310698861 15.06.2012 Defer Date:13.12.2012 193

Case No.:8/16/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 15.11.2012 HQ File :01/82/050/00444/AM13/ RLA File :22/24/040/00011/AM13/ Lic.No/Date:2210013017 15.06.2012 Defer Date:13.12.2012 194

Case No.:3/12/82ALC4/2012

Party Name:BILCARE LIMITED 15.11.2012 HQ File :01/82/050/00333/AM13/ RLA File :31/83/040/00057/AM13/ Lic.No/Date:3110054717 18.06.2012 Defer Date:13.12.2012 Decision :The case is being examined on file. The case was deferred for 13.12.2012. 195

Case No.:45/14/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 15.11.2012 HQ File :01/82/050/00422/AM13/ RLA File :03/95/040/00081/AM13/ Lic.No/Date:0310699034 18.06.2012 Defer Date:13.12.2012 196

Case No.:39/14/82ALC4/2012

Party Name:CIPLA LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00416/AM13/ RLA File :03/94/040/00225/AM13/ Lic.No/Date:0310699167 19.06.2012 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/505/2012PI(Norms) dated 18.10.2012, 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 Travoprost 0.004%/Travoprost Ophthalmic Solution 0.004% (Each pack 2.5 ml) Each ml contains Travoprost 0.04 mg 1000 vials 1. Travoprost 105 mg T t 1000 i l 1 T t 210

Travoprost 0.004%/Travoprost Ophthalmic Solution 0.004% (Each pack 5 ml) Each ml contains Travoprost 0.04 mg 1000 vials 1. Travoprost 210 mg 197

Case No.:11/16/82ALC4/2012

Party Name:NEULAND LABORATORIES LTD 15.11.2012 HQ File :01/82/050/00447/AM13/ RLA File :09/24/040/00141/AM13/ Lic.No/Date:0910053093 20.06.2012 Defer Date:13.12.2012 198

Case No.:40/14/82ALC4/2012

Party Name:CIPLA LIMITED 15.11.2012 HQ File :01/82/050/00417/AM13/ RLA File :03/94/040/00224/AM13/ Lic.No/Date:0310699235 20.06.2012 Defer Date:13.12.2012 199

Case No.:28/13/82ALC4/2012

Party Name:MELZER CHEMICALS PVT. LTD 15.11.2012 HQ File :01/82/050/00363/AM13/ RLA File :31/83/040/00060/AM13/ Lic.No/Date:3110054836 26.06.2012 Defer Date:13.12.2012 Decision :Department of Chemicals and Petrochemicals vide thier letter No. 14010/72/2012ch. II dated 26th September, 2012 has requested the firm to furnish the following information: Manufacturing process in brief. Balanced chemical reaction showing all the reactants, product and by product with thier molecular formula and molecular weight. Complete material balance with the formation of isomers. Stagewise % yield on molecular weight basis in respect of each reactant along with justification supported with authentic/printed technical literature. Production of export item for the past 3 years and corresponding consumption of each input duly certified by Chartered Accountant. It was decided to remind the firm to furnish the above information. Accordingly, the case was deferred for 13.12.2012. 200

Case No.:109/18/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 15.11.2012 HQ File :01/82/050/00604/AM13/ RLA File :05/23/040/00491/AM12/ Lic.No/Date:0510328334 27.06.2012 Defer Date:13.12.2012 D i i I d id d d f h f 13 12 2012 f f D f Ph i l

201

Case No.:31/13/82ALC4/2012

Party Name:PALADIN PAINTS AND CHEMICALS PVT. LTD., 15.11.2012 HQ File :01/82/050/00366/AM13/ RLA File :03/95/040/00055/AM13/ Lic.No/Date:0310699970 27.06.2012 Defer Date:13.12.2012 Decision :It was decided to remind the firm to furnish the requisite information immediately. Accordingly, the case was deferred for 13.12.2012. 202

Case No.:32/18/82ALC4/2012

Party Name:PMC RUBBER CHEMICALS INDIA PRIVATE LIMITED, 15.11.2012 Status:Case Approved HQ File :01/82/050/00527/AM13/ RLA File :02/24/040/00060/AM13/ Lic.No/Date:0210179279 03.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/101/2010Ch. II 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 Accitard RE N (Cyclohexyl ) thio Phthalimide 1 kg 1. PVI N(Cyclohexylthio Phthalimide) 1.050 kg 2. Toluene 0.210 kg 203

Case No.:10/16/82ALC4/2012

15.11.2012 HQ File :01/82/050/00446/AM13/ RLA File :05/24/040/00116/AM13/ Lic.No/Date:0510328831 04.07.2012 Defer Date:13.12.2012 204

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

Party Name:FDC LTD 15.11.2012 HQ File :01/82/050/00452/AM13/ RLA File :03/94/040/00208/AM13/ Lic.No/Date:0310701169 06.07.2012 Defer Date:13.12.2012

Case No.:14/16/82ALC4/2012

Party Name:JINDAL DRUGS LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00450/AM13/ RLA File :03/94/040/00194/AM13/ Lic No/Date:0310701336 Defer Date:

205 HQ File :01/82/050/00450/AM13/ RLA File :03/94/040/00194/AM13/ Lic.No/Date:0310701336 09.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/106/2011Ch. II dated 26.10.2012, 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 kg/kg Pure Cineole 1 kg 1. Eucalyptol Oil 1.05 206

Case No.:69/18/82ALC4/2012

Party Name:SMILAX LABORATORIES LIMITED 15.11.2012 HQ File :01/82/050/00564/AM13/ RLA File :09/24/040/00156/AM13/ Lic.No/Date:0910053216 09.07.2012 Defer Date:13.12.2012 207

Case No.:6/18/82ALC4/2012

Party Name:PI INDUSTRIES LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00501/AM13/ RLA File :13/24/040/00019/AM13/ Lic.No/Date:1310040328 11.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 15022/31/2006Ch. II dated 1.10.2012, 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 kg/kg MIPD Ketal (1E)1(2, 5, 5 Trimetlhyl1,3Dioxane2yl) (Propane1, 2Dione1(O methyl oxime) 1 kg 1 Acetyl Acetone 0.578 2. Methyl Tertiary Butyl Ether (MTBE HP 99.9 PCT) 0.583 3. Di Methyl Formamide 0.300 4. Neo Pentyl Glycol (NPG) 0.503 5. Potassium Carbonate Granule 0.950 6. Sodium Nitrite 0.412 7. Toluene 0.273 8. Methanol 0.258 208

Case No.:57/14/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00434/AM13/ RLA File :31/83/040/00075/AM13/ Lic.No/Date:3110055038 19.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/22/2011Ch. II dated

208 g p 15.11.2012, 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 kg/kg NEthyl2 Pyrrolidone 1 kg 1. Gamma Butyrolactone 0.818 2. Monoethyl Amine (70% Solution) 0.612 209

Case No.:58/14/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00435/AM13/ RLA File :31/83/040/00073/AM13/ Lic.No/Date:3110055046 19.07.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2008Ch. II dated 14.9.2009, 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 kg/kg NMethyl2Pyrrolidone 1 kg 1. Methanol 0.377 2. Gamma Butyrolactone 0.965 3. Ammonia 0.164 210

Case No.:20/24/82ALC4/2012

Party Name:DECCAN NUTRACEUTICALS PVT LTD 15.11.2012 HQ File :01/82/050/00824/AM13/ RLA File :31/83/040/00058/AM13/ Lic.No/Date:3110055158 27.07.2012 Defer Date:13.12.2012 Decision :It was decided to call from the firm the full description of the export product along with copy of relevant pharmacopeia. Accordingly, the case was deferred for 13.12.2012. 211

Case No.:27/21/82ALC4/2012

Party Name:STELLENCE PHARMSCIENCE PVT LTD 15.11.2012 HQ File :01/82/050/00657/AM13/ RLA File :07/24/040/00183/AM13/ Lic.No/Date:0710089972 31.07.2012 Defer Date:13.12.2012 212

Case No.:15/20/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/00626/AM13/ RLA File :03/94/040/00336/AM13/ Lic.No/Date:0310703768 01.08.2012 Defer Date:13.12.2012

213

Case No.:16/20/82ALC4/2012

15.11.2012 HQ File :01/82/050/00627/AM13/ RLA File :05/24/040/00150/AM13/ Lic.No/Date:0510331127 01.08.2012 Defer Date:13.12.2012 214

Case No.:17/20/82ALC4/2012

15.11.2012 HQ File :01/82/050/00628/AM13/ RLA File :05/24/040/00148/AM13/ Lic.No/Date:0510331126 01.08.2012 Defer Date:15.11.2012 215

Case No.:18/20/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 15.11.2012 HQ File :01/82/050/00629/AM13/ RLA File :09/24/040/00223/AM13/ Lic.No/Date:0910053402 01.08.2012 Defer Date:13.12.2012 216

Case No.:20/22/82ALC4/2012

Party Name:HETERO LABS LIMITED 15.11.2012 HQ File :01/82/050/00723/AM13/ RLA File :09/24/040/00225/AM13/ Lic.No/Date:0910053420 03.08.2012 Defer Date:13.12.2012 217

Case No.:29/24/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00833/AM13/ RLA File :09/24/040/00172/AM13/ Lic.No/Date:0910053421 03.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/426/2012PI(Norms) dated 1.10.2012, 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 kg/kg (2R.5R)5Hydroxy[1,3] Oxathiolane2carboxylic acid, 2S Isopropyl5R Methyl1R Cyclohexyl Ester (ECE) 1 kg 1. 2,5Dihydroxy1,4diathiane 0.30 2. Cyclohexane 1.104 3. Glyoxalic Acid 0.3585 4 Toluene 0 60

Toluene 0.60 5. nHexane 218

Case No.:18/24/82ALC4/2012

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00822/AM13/ RLA File :09/24/040/00226/AM13/ Lic.No/Date:0910053441 06.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2008Ch. II dated 20.11.2009, 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 kg/kg Brosalidox L 1 kg 1 Propylene Glycol (Liquid) 0.895 2. 5Bromo5Nitro1,3Dioxane 0.100 219

Case No.:38/24/82ALC4/2012

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00842/AM13/ RLA File :09/24/040/00228/AM13/ Lic.No/Date:0910053440 06.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2008Ch. II dated 1.7.2009, 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 kg/kg Allantoin (Powder) 1 kg 1. Glyoxylic Acid 50% (Liquid) 1.28 220

Case No.:44/16/82ALC4/2012

Party Name:SUPREET CHEMICALS PVT.LTD. 15.11.2012 HQ File :01/82/050/00480/AM13/ RLA File :03/95/040/00324/AM13/ Lic.No/Date:0310704113 06.08.2012 Defer Date:13.12.2012 221

Case No.:47/16/82ALC4/2012

Party Name:PARAMOUNT PHARMA 15.11.2012 HQ File :01/82/050/00483/AM13/ RLA File :05/24/040/00178/AM13/ Lic.No/Date:0510331427 07.08.2012 Defer Date:13.12.2012

222

Case No.:48/16/82ALC4/2012

Party Name:PARAMOUNT PHARMA 15.11.2012 HQ File :01/82/050/00484/AM13/ RLA File :05/24/040/00179/AM13/ Lic.No/Date:0510331428 07.08.2012 Defer Date:13.12.2012 223

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

Party Name:AUCTUS PHARMA LIMITED 15.11.2012 HQ File :01/82/050/00725/AM13/ RLA File :09/24/040/00206/AM13/ Lic.No/Date:0910053463 09.08.2012 Defer Date:13.12.2012 224

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

15.11.2012 HQ File :01/82/050/00729/AM13/ RLA File :09/24/040/00243/AM13/ Lic.No/Date:0910053480 10.08.2012 Defer Date:13.12.2012 Decision : Shri Veeranna Seelamsethi, Sr. Manager, Materials appeared before the Committee and after discussion, the firm was requested to Shri Seelamsetti has assured that the information would be submitted in a weeks' time. The case was deferred for 13.12.2012. 225

Case No.:44/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00747/AM13/ RLA File :03/94/040/00347/AM13/ Lic.No/Date:0310704825 10.08.2012 Defer Date:13.12.2012 226

Case No.:24/22/82ALC4/2012

Party Name:HETERO LABS LIMITED 15.11.2012 HQ File :01/82/050/00727/AM13/ RLA File :09/24/040/00174/AM13/ Lic.No/Date:0910053519 Defer

16.08.2012 Date:13.12.2012 227

Case No.:65/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00768/AM13/ RLA File :03/94/040/00380/AM13/ Lic.No/Date:0310705390 16.08.2012 Defer Date:13.12.2012 228

Case No.:66/22/82ALC4/2012

Party Name:ALKYL AMINES CHEMICALS LTD 15.11.2012 HQ File :01/82/050/00769/AM13/ RLA File :03/94/040/00104/AM12/ Lic.No/Date:0310705336 16.08.2012 Defer Date:13.12.2012 Decision : Department of Chemicals and Petrochemicals vide their letter No. 14010/85/2012Ch. III dated 9.11.2012 has requested the firm to furnish the following information: Chemical reactions with molecular and structural formulae and molecular weights. Stagewise percentage yields. Complete material balance. CA certificate certifying the production of export item achieved by the firm for the last three years and corresponding consumption of different raw materials/of each input. Details of byproduct/coproducts formed in the above production with quantities and values certified by CA. Authentic technical literature in support of norms applied for import. It was decided to remind the firm to furnish the above information. Accordingly, the case was deferred for 13.12.2012. 229

Case No.:68/22/82ALC4/2012

Party Name:GITANJALI CHEMICALS PVT LTD 15.11.2012 HQ File :01/82/050/00771/AM13/ RLA File :03/94/040/00209/AM13/ Lic.No/Date:0310705334 16.08.2012 Defer Date:13.12.2012 230

Case No.:25/22/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 15.11.2012 HQ File :01/82/050/00728/AM13/ RLA File :09/24/040/00250/AM13/ Lic.No/Date:0910053546 17.08.2012 Defer Date:13.12.2012

231

Case No.:27/22/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 15.11.2012 HQ File :01/82/050/00730/AM13/ RLA File :09/24/040/00249/AM13/ Lic.No/Date:0910053547 17.08.2012 Defer Date:13.12.2012 232

Case No.:1/20/82ALC4/2012

Party Name:SUNSHIELD CHEMICALS LTD. 15.11.2012 Status:Case Approved HQ File :01/82/050/00612/AM13/ RLA File :03/95/040/00261/AM13/ Lic.No/Date:0310705885 22.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2008Ch. II dated 15.11.2012, 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 kg/kg Ethoxylated Amine (Surfactant) 1 kg 1. Tallow Amine 0.193 2. Ethylene Oxide 0.741 233

Case No.:36/22/82ALC4/2012

Party Name:CIPLA LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00739/AM13/ RLA File :03/94/040/00401/AM13/ Lic.No/Date:0310706125 23.08.2012 Defer Date: Decision : In line with SION A 1972, 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 Doxycip 20% powder/Doxycyline Oral Powder 20% w/w (per pack 100 grams) Each 100 gm contains Doxycyline Hyclate 20 grams 1 pack 1. Doxycyline Hyclate 20.20 gm 234

Case No.:32/22/82ALC4/2012

Party Name:SYMBIOTEC PHARMALAB LTD., 15.11.2012 HQ File :01/82/050/00735/AM13/ RLA File :56/24/040/00017/AM13/ Lic.No/Date:5610000974 24.08.2012 Defer Date:13.12.2012

235

Case No.:32/24/82ALC4/2012

15.11.2012 HQ File :01/82/050/00836/AM13/ RLA File :09/24/040/00248/AM13/ Lic.No/Date:0910053559 24.08.2012 Defer Date:13.12.2012 Decision :It was decided to defer the case for 13.12.2012 for comments of Departmentof Pharmaceuticals. 236

Case No.:33/24/82ALC4/2012

15.11.2012 HQ File :01/82/050/00837/AM13/ RLA File :09/24/040/00247/AM13/ Lic.No/Date:0910053560 24.08.2012 Defer Date:13.12.2012 237

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

Party Name:SUVEN LIFE SCIENCES LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00817/AM13/ RLA File :09/24/040/00267/AM13/ Lic.No/Date:0910053575 27.08.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 19 dated 6.9.2012, it was decided to ratify norms under Para 4.7of 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 NBenzyl 3(S)Hydroxy Pyrrolidine (BHP) 1 kg 1. LMalic Acid 2.69 kg 2. Benzyl Amine 2.28 kg 3. Tetrahydro Furan 3.77 kg 4. Sodium Boro Hydride 2.26 kg 5. RMandelic Acid 1.60 kg 238

Case No.:37/22/82ALC4/2012

Party Name:FDC LTD 15.11.2012 HQ File :01/82/050/00740/AM13/ RLA File :03/94/040/00374/AM13/ Lic.No/Date:0310706515 27.08.2012 Defer Date:13.12.2012 239

Case No.:41/24/82ALC4/2012

Party Name:DISTO PHARMACEUTICALS PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/00845/AM13/ RLA File :09/24/040/00256/AM13/ Lic.No/Date:0910053578 27.08.2012 Defer Date:13.12.2012 D i i It d id d t d f th f 13 12 2012 f t f D t t f Ph ti l

240

Case No.:5/22/82ALC4/2012

Party Name:SANOFI INDIA LIMITED 15.11.2012 HQ File :01/82/050/00708/AM13/ RLA File :03/95/040/00318/AM13/ Lic.No/Date:0310706473 27.08.2012 Defer Date:13.12.2012 241

Case No.:3/20/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 15.11.2012 HQ File :01/82/050/00614/AM13/ RLA File :05/24/040/00201/AM13/ Lic.No/Date:0510332840 28.08.2012 Defer Date:13.12.2012 242

Case No.:30/24/82ALC4/2012

Party Name:MSN LABORATORIES LIMITED 15.11.2012 HQ File :01/82/050/00834/AM13/ RLA File :09/24/040/00271/AM13/ Lic.No/Date:0910053602 28.08.2012 Defer Date:13.12.2012 243

Case No.:12/24/82ALC4/2012

Party Name:HETERO LABS LIMITED 15.11.2012 HQ File :01/82/050/00816/AM13/ RLA File :09/24/040/00275/AM13/ Lic.No/Date:0910053624 29.08.2012 Defer Date:13.12.2012 244

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

15.11.2012 HQ File :01/82/050/00828/AM13/ RLA File :09/24/040/00220/AM13/ Lic.No/Date:0910053621 29.08.2012 Defer Date:13.12.2012 245

Case No.:26/24/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 15.11.2012 HQ File :01/82/050/00830/AM13/ RLA File :09/24/040/00246/AM13/ Lic.No/Date:0910053623 29.08.2012 Defer Date:13.12.2012

p 246

Case No.:28/24/82ALC4/2012

15.11.2012 HQ File :01/82/050/00832/AM13/ RLA File :09/24/040/00274/AM13/ Lic.No/Date:0910053628 29.08.2012 Defer Date:13.12.2012 247

Case No.:35/24/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 15.11.2012 HQ File :01/82/050/00839/AM13/ RLA File :09/24/040/00245/AM13/ Lic.No/Date:0910053622 29.08.2012 Defer Date:13.12.2012 248

Case No.:30/22/82ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/00733/AM13/ RLA File :07/24/040/00237/AM13/ Lic.No/Date:0710090496 30.08.2012 Defer Date:13.12.2012 249

Case No.:31/24/82ALC4/2012

Party Name:S M S PHARMACEUTICALS LTD 15.11.2012 Status:Case Approved HQ File :01/82/050/00835/AM13/ RLA File :09/24/040/00272/AM13/ Lic.No/Date:0910053636 30.08.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 3.4.2012, 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 Efavirenz 1 kg 1. (S)5ChloroAlpha (Cyclopropylethynyl)2AminoAlpha (Trifluoromethyl) Benzene Methanol 0.987 kg 2 Tri Phosgene 0.448 kg 250

Case No.:4/20/82ALC4/2012

15.11.2012 HQ File :01/82/050/00615/AM13/ RLA File :05/24/040/00323/AM12/ Lic.No/Date:0510333154 30.08.2012 Defer Date:13.12.2012

251

Case No.:23/22/82ALC4/2012

Party Name:INTAS PHARMACEUTICALS LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00726/AM13/ RLA File :08/24/040/00173/AM13/ Lic.No/Date:0810114691 31.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their O.M No. 35011/472/2012PI(Norms) dated 16.11.2012, 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 kg/kg Gemcitabine HCL 1 kg 1 Trimethylsilyl triflate 8.358 2. Vitride 3.05 3. Di Benzoyl Lactum 5.14 4. Methanol 6.27 5. Isopropyl Alcohol 6.20 6. N 4 Acetyl Cytosine 6.70 7. Tetra Hydrofuran 4.70 252

Case No.:34/24/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00838/AM13/ RLA File :09/24/040/00280/AM13/ Lic.No/Date:0910053638 31.08.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 10 dated 7.6.2011, 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 Doxofylline 1kg. 1. Theophylline 1.17kg 2. Chloro acetaldehyde dimethyl acetal 0.81kg 3. Potassium carbonate 0.89kg 4. Methanol 0.63kg 5. Dimethyl formamide 0.56kg 253

Case No.:23/24/82ALC4/2012

Party Name:TRIGON CHEMICALS PVT. LTD. 15.11.2012 HQ File :01/82/050/00827/AM13/ RLA File :31/83/040/00098/AM13/ Lic.No/Date:3110055637 03.09.2012 Defer Date:13.12.2012 254

Case No.:28/22/82ALC4/2012

Party Name:AURO LAB 15.11.2012 Status:Case Approved

HQ File :01/82/050/00731/AM13/ RLA File :35/24/040/00009/AM 13 Lic.No/Date:3510039223 dated4.9.2012 Defer Date: Decision : In the light of written comments received from Department of Industrial Policy and Promotion vide tier note dated 16.11.2012, 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 Hydroxy Propyl Methyl Cellulose Ophthalmic Solution USP 2.0% W/V 2 ML PFS 75000 pieces 1. HYPAK SCF 2.25 ML RF PRTCF M 27 Glass Syringe Barrels Net to net 2. HYPAK PR 2.25 ML PP SYRINGE PLUNGER ROD Net to net 3. HYPAK NSCF 13ML PH701/50C BLACK SI 1000(Syringe Plunger stopper) Net to net 4. Pouch size 7.5x25 Net to net 255

Case No.:15/24/82ALC4/2012

Party Name:HETERO LABS LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00819/AM13/ RLA File :09/24/040/00290/AM13/ Lic.No/Date:0910053657 04.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 18/82 dated 30.8.2012, 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 Levetiracetam 1 kg 1 S(+) 2amino Butyramide HCL 0.95 kg 2. Methylene chloride 3.65 kg 3. Acetone 0.87 kg 256

Case No.:25/24/82ALC4/2012

Party Name:THERMAX LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00829/AM13/ RLA File :31/83/040/00083/AM13/ Lic.No/Date:3110055658 04.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/78/2010Ch. II dated 26.6.2012, 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 Exp. Qty. Sl.No. Import items Qty. allowed Biocide1 (Brand Name Biomin 2750) 1 kg 1. Tertrakis Hydroxymethyl Phosphonium 0.484 kg

Phosphonium Sulphate –THPS 75% Biocide 2 (Brand Name Biomin 4020) 1 kg 1. Myristyl Dimethyl Amine/Tertiary Amine 0.065 kg 2. Gluteraldehyde 0.415 kg 257

Case No.:42/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00745/AM13/ RLA File :03/94/040/00116/AM13/ Lic.No/Date:0310707575 04.09.2012 Defer Date:13.12.2012 258

Case No.:43/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00746/AM13/ RLA File :03/94/040/00101/AM13/ Lic.No/Date:0310707592 04.09.2012 Defer Date:13.12.2012 259

Case No.:45/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00748/AM13/ RLA File :03/94/040/00115/AM13/ Lic.No/Date:0310707571 04.09.2012 Defer Date:13.12.2012 260

Case No.:52/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00755/AM13/ RLA File :03/94/040/00114/AM13/ Lic.No/Date:0310707589 04.09.2012 Defer Date:13.12.2012 261

Case No.:53/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00756/AM13/ RLA File :03/94/040/00137/AM13/ Lic.No/Date:0310707577 04.09.2012 Defer Date:13.12.2012

Case No.:54/22/82ALC4/2012

262 y 15.11.2012 HQ File :01/82/050/00757/AM13/ RLA File :03/94/040/00110/AM13/ Lic.No/Date:0310707578 04.09.2012 Defer Date:13.12.2012 263

Case No.:55/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00758/AM13/ RLA File :03/94/040/00117/AM13/ Lic.No/Date:0310707585 04.09.2012 Defer Date:13.12.2012 264

Case No.:56/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00759/AM13/ RLA File :03/94/040/00034/AM13/ Lic.No/Date:0310707587 04.09.2012 Defer Date:13.12.2012 265

Case No.:6/20/82ALC4/2012

Party Name:PARABOLIC DRUGS LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00617/AM13/ RLA File :05/24/040/00024/AM13/ Lic.No/Date:0510333659 04.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting No. 3/82 dated 17.4.2012, 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 Cefixime Trihydrate 1 Kg. 1. Acetone 1.205 kg 2. Activated Carbon 1.00 kg 3. G.C.L.E. 1.555 kg 4. Methanol 6.50 kg 5 Methylene Chloride 7.30 kg 6. Triphenyl Phosphine 1.22 kg 7. 2Mercaptobenzothiazoyl(Z)2 (2Aminothiazoyl4yl)2 (Mica Ester) 0.82 kg

Case No.:60/22/82ALC4/2012

15.11.2012

266 HQ File :01/82/050/00763/AM13/ RLA File :03/94/040/00105/AM13/ Lic.No/Date:0310707569 04.09.2012 Defer Date:13.12.2012 267

Case No.:10/22/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 15.11.2012 HQ File :01/82/050/00713/AM13/ RLA File :09/24/040/00281/AM13/ Lic.No/Date:0910053672 05.09.2012 Defer Date:13.12.2012 268

Case No.:40/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00743/AM13/ RLA File :03/94/040/00109/AM13/ Lic.No/Date:0310707803 05.09.2012 Defer Date:13.12.2012 269

Case No.:44/24/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 15.11.2012 HQ File :01/82/050/00848/AM13/ RLA File :09/24/040/00251/AM13/ Lic.No/Date:0910053668 05.09.2012 Defer Date:13.12.2012 270

Case No.:62/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00765/AM13/ RLA File :03/94/040/00429/AM13/ Lic.No/Date:0310707808 05.09.2012 Defer Date:13.12.2012 271

Case No.:78/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00781/AM13/ RLA File :03/94/040/00430/AM13/ Lic.No/Date:0310707806 05.09.2012 Defer Date:13.12.2012 272

Case No.:79/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00782/AM13/ RLA File :03/94/040/00104/AM13/ Lic.No/Date:0310707802 05 09 2012 Defer D 13 12 2012

05.09.2012 Date:13.12.2012 273

Case No.:80/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00783/AM13/ RLA File :03/94/040/00118/AM13/ Lic.No/Date:0310707813 05.09.2012 Defer Date:13.12.2012 274

Case No.:48/22/82ALC4/2012

Party Name:S. D. FINE CHEM LTD. 15.11.2012 HQ File :01/82/050/00751/AM13/ RLA File :03/95/040/00353/AM13/ Lic.No/Date:0310707898 06.09.2012 Defer Date:13.12.2012 275

Case No.:58/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00761/AM13/ RLA File :03/94/040/00113/AM13/ Lic.No/Date:0310707983 06.09.2012 Defer Date:13.12.2012 276

Case No.:59/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00762/AM13/ RLA File :03/94/040/00119/AM13/ Lic.No/Date:0310707975 06.09.2012 Defer Date:13.12.2012 277

Case No.:61/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00764/AM13/ RLA File :03/94/040/00106/AM13/ Lic.No/Date:0310707970 06.09.2012 Defer Date:13.12.2012 278

Case No.:81/22/82ALC4/2012

Party Name:BHARAT CHEMICALS 15.11.2012 HQ File :01/82/050/00784/AM13/ RLA File :03/94/040/00433/AM13/ Lic.No/Date:0310707963 06.09.2012 Defer Date:13.12.2012

279

Case No.:83/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00786/AM13/ RLA File :03/94/040/00498/AM11/ Lic.No/Date:0310707992 06.09.2012 Defer Date:13.12.2012 280

Case No.:86/22/82ALC4/2012

Party Name:AVA CHEMICALS PVT.LTD., 15.11.2012 HQ File :01/82/050/00789/AM13/ RLA File :03/94/040/00307/AM13/ Lic.No/Date:0310708058 06.09.2012 Defer Date:13.12.2012 281

Case No.:87/22/82ALC4/2012

Party Name:AVA CHEMICALS PVT.LTD., 15.11.2012 HQ File :01/82/050/00790/AM13/ RLA File :03/94/040/00308/AM13/ Lic.No/Date:0310708059 06.09.2012 Defer Date:13.12.2012 282

Case No.:11/24/82ALC4/2012

Party Name:ANUS LABORATORIES LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00815/AM13/ RLA File :09/24/040/00138/AM13/ Lic.No/Date:0910053730 07.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 17/82 dated 27.7.2010, 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 Sodium Methoxide Solution 30% 1 Kg. 1. Methanol 0.622 kg 2. CS Flakes 0.050 kg 283

Case No.:21/24/82ALC4/2012

Party Name:TORRENT PHARMACEUTICALS LTD. 15.11.2012 HQ File :01/82/050/00825/AM13/ RLA File :08/24/040/00196/AM13/ Lic.No/Date:0810114835 07.09.2012 Defer Date:13.12.2012

Case No.:46/22/82ALC4/2012

Party Name:LUPIN LIMITED Meet No/Date:24/82ALC4/2012 Status:Case Deferred

284

Case No.:46/22/82 ALC4/2012

Party Name:LUPIN LIMITED Meet No/Date:24/82 ALC4/2012 15.11.2012 HQ File :01/82/050/00749/AM13/ RLA File :03/95/040/00306/AM13/ Lic.No/Date:0310708068 07.09.2012 Defer Date:13.12.2012 285

Case No.:57/22/82ALC4/2012

Party Name:AARTI INDUSTRIES LIMITED 15.11.2012 Status:Case Approved HQ File :01/82/050/00760/AM13/ RLA File :03/94/040/00443/AM13/ Lic.No/Date:0310708086 07.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/137/2011Ch. II dated 16.11.2012, 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 Exp. Qty. Sl.No. Import items Qty. allowed 2,4 Difluoro Nitro Benzene (2,4 DFNB) 1 kg 1. Meta Dichloro Benzene 1.33 kg 2. Potassium Fluoride (KF) 0.810 kg 3. Sulfolane 0.100 kg 286

Case No.:76/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00779/AM13/ RLA File :03/94/040/00437/AM13/ Lic.No/Date:0310708094 07.09.2012 Defer Date:13.12.2012 287

Case No.:77/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00780/AM13/ RLA File :03/94/040/00436/AM13/ Lic.No/Date:0310708090 07.09.2012 Defer Date:13.12.2012 288

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

15.11.2012 HQ File :01/82/050/00785/AM13/ RLA File :03/94/040/00017/AM11/ Lic.No/Date:0310708089 07.09.2012 Defer Date:13.12.2012

289

Case No.:17/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00720/AM13/ RLA File :08/24/040/00199/AM13/ Lic.No/Date:0810114964 10.09.2012 Defer Date:13.12.2012 290

Case No.:47/22/82ALC4/2012

Party Name:YASHO INDUSTRIES PVT.LTD. 15.11.2012 Status:Case Approved HQ File :01/82/050/00750/AM13/ RLA File :03/95/040/00433/AM13/ Lic.No/Date:0310708266 10.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 17.11.2012, 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 Exp. Qty. Sl.No. Import items Qty. allowed Yantq 2020 (20% Solution Tertiary Butyl Hydroquinone) 1 kg 1. Hydroquinone 0.282 kg 2. Tertiary Butanol 0.208 kg 3. Propylene Glycol 0.700 kg 291

Case No.:85/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00788/AM13/ RLA File :03/94/040/00136/AM13/ Lic.No/Date:0310708279 10.09.2012 Defer Date:13.12.2012 292

Case No.:11/22/82ALC4/2012

Party Name:HONEST BIOVET PVT. LTD 15.11.2012 HQ File :01/82/050/00714/AM13/ RLA File :08/24/040/00208/AM13/ Lic.No/Date:0810115029 12.09.2012 Defer Date:13.12.2012 293

Case No.:12/22/82ALC4/2012

Party Name:HONEST BIOVET PVT. LTD 15.11.2012 HQ File :01/82/050/00715/AM13/ RLA File :08/24/040/00206/AM13/ Lic.No/Date:0810115027 12.09.2012 Defer Date:13.12.2012 294

Case No.:13/22/82ALC4/2012

Party Name:HONEST BIOVET PVT. LTD

15.11.2012 HQ File :01/82/050/00716/AM13/ RLA File :08/24/040/00207/AM13/ Lic.No/Date:0810115028 12.09.2012 Defer Date:13.12.2012 295

Case No.:14/22/82ALC4/2012

Party Name:ATUL LIMITED, 15.11.2012 Status:Case Approved HQ File :01/82/050/00717/AM13/ RLA File :08/24/040/00209/AM13/ Lic.No/Date:0810115071 12.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 49/82 dated 6.3.2012, it was decided to ratify norms under Para 4.7of HBP v1 as per details Export product Exp. Qty. Sl.No. Import items Qty. allowed Reactive Diluent Lapox 1 Kg. 1. Epichlorohydrin 0.920 kg 2. Phenol 0.941 kg 296

Case No.:42/24/82ALC4/2012

Party Name:AVON ORGANICS LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00846/AM13/ RLA File :09/24/040/00268/AM13/ Lic.No/Date:0910053777 12.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 16/82 dated 16.8.2012, it was decided to ratify norms under Para 4.7of HBP v1 as per details Export product Exp. Qty. Sl.No. Import items Qty. allowed Valacyclovir Hydrochloride 1 kg 1. Acyclovir 0.78 kg 2. NBenzyloxy CarbonylLValine (CBZ LValine) 1.182 kg 3. Dicyclohexyl Carbodimide (DCC) 1.387 kg 4. 4Dimethyl Amino Pyridine (DMAP) 0.028 kg 5. Dimethyl Formamide 3.36 kg 297

Case No.:50/22/82ALC4/2012

Party Name:SARNA CHEMICALS PVT.LTD. 15.11.2012 HQ File :01/82/050/00753/AM13/ RLA File :52/24/040/00014/AM13/ Lic.No/Date:5210038997 12.09.2012 Defer Date:13.12.2012 298

Case No.:51/22/82ALC4/2012

Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 15.11.2012 Status:Case Approved HQ Fil 01/82/050/00754/AM13/ RLA Fil 52/24/040/00018/AM13/ Li N /D 5210038998 D f D

HQ File :01/82/050/00754/AM13/ RLA File :52/24/040/00018/AM13/ Lic.No/Date:5210038998 12.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/45/2010Ch. II dated 12.6.2012, 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 Exp. Qty. Sl.No. Import items Qty. allowed 4(2Chloro Ethylsulfonyl) Butyric Acid 1 kg 1. Gamma Butyrolactone 0.651 kg 2. 2 Mercapto Ethanol 0.691 kg 299

Case No.:70/22/82ALC4/2012

Party Name:CIPLA LIMITED 15.11.2012 HQ File :01/82/050/00773/AM13/ RLA File :03/94/040/00488/AM13/ Lic.No/Date:0310708792 12.09.2012 Defer Date:13.12.2012 300

Case No.:75/22/82ALC4/2012

Party Name:CIPLA LIMITED 15.11.2012 HQ File :01/82/050/00778/AM13/ RLA File :03/94/040/00499/AM13/ Lic.No/Date:0310708794 12.09.2012 Defer Date:13.12.2012 301

Case No.:15/22/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 15.11.2012 HQ File :01/82/050/00718/AM13/ RLA File :05/23/040/00208/AM13/ Lic.No/Date:0510334566 13.09.2012 Defer Date:13.12.2012 302

Case No.:63/22/82ALC4/2012

Party Name:UNIMAX CHEMICALS PVT LTD. 15.11.2012 HQ File :01/82/050/00766/AM13/ RLA File :03/95/040/00421/AM13/ Lic.No/Date:0310708895 13.09.2012 Defer Date:13.12.2012

303

Case No.:96/22/82ALC4/2012

Party Name:ACTGEN PHARMA PVT. LTD. 15.11.2012 HQ File :01/82/050/00799/AM13/ RLA File :03/94/040/00476/AM13/ Lic.No/Date:0310708985 13.09.2012 Defer Date:13.12.2012 304

Case No.:14/24/82ALC4/2012

Party Name:HETERO LABS LIMITED 15.11.2012 HQ File :01/82/050/00818/AM13/ RLA File :09/24/040/00306/AM13/ Lic.No/Date:0910053810 14.09.2012 Defer Date:13.12.2012 305

Case No.:22/24/82ALC4/2012

Party Name:TORRENT PHARMACEUTICALS LTD. 15.11.2012 Status:Case Approved HQ File :01/82/050/00826/AM13/ RLA File :08/24/040/00212/AM13/ Lic.No/Date:0810115144 14.09.2012 Defer Date: Decision : In line with SION A 412, 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 Moxonidine Tablets Moxonidine Heumann 0.2 mg Filmtabletten (Pack Size 30, 50 & 100 Tablets) Each film coated tablet contains: Moxonidine Ph. Eur. 0.2mg Colours: Titanium Dioxide and Red Oxide of Iron, Excipient q.s. Net content of active ingredient Moxonidine should not be less than 2.5 kgs in export product 12500000 numbers Moxonidine 340.13 kg Moxonidine Tablets Moxonidine Heumann 0.3 mg Filmtabletten (Pack Size 30, 50 & 100 Tablets) Each film coated tablet 8333333 numbers Moxonidine 226.75 kg

Each film coated tablet contains: Moxonidine Ph. Eur. 0.3mg Colours: Titanium Dioxide and Red Oxide of Iron, Excipient q.s. Net content of active ingredient Moxonidine should not be less than 2.5 kgs in export product Moxonidine Tablets Moxonidine Heumann 0.4 mg Filmtabletten (Pack Size 30, 50 & 100 Tablets) Each film coated tablet contains: Moxonidine Ph. Eur. 0.4mg Colours: Titanium Dioxide and Red Oxide of Iron, Excipient q.s. Net content of active ingredient Moxonidine should not be less than 2.0 kgs in export product 5000000 numbers Moxonidine 136.05 kg 306

Case No.:91/22/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 15.11.2012 HQ File :01/82/050/00794/AM13/ RLA File :22/24/040/00032/AM13/ Lic.No/Date:2210013277 14.09.2012 Defer Date:13.12.2012 307

Case No.:7/22/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00710/AM13/ RLA File :09/24/040/00300/AM13/ Lic.No/Date:0910053820 17.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No 35011/508/2012 PI(Norms) dated 18 10 2012 it

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/508/2012PI(Norms) dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by them, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed BWing (LValine Cyclic Urea) 1 kg 1. LValine 1.837 kg 2. Acrylonitrile 0.95 kg 3. Methyl Chloro Formate 2.25 kg 308

Case No.:17/24/82ALC4/2012

15.11.2012 Status:Case Approved HQ File :01/82/050/00821/AM13/ RLA File :09/24/040/00229/AM13/ Lic.No/Date:0910053848 18.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 14/82 dated 31.7.2012, 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 kg/kg Cefotaxime Sodium Sterile 1 kg 1. Cefotaxime Acid 0.989 2. Ethyl Acetate 3.16 3. Methanol 0.44 4. Triethylamine (TEA) 0.178 5 Activated Carbon/Carbon Enoanticromos 0.031 6. Sod2Ethyl Hexanoate 0.44 7. Methyl Iso Butyl Ketone 0.25 8. Aluminium Canisters with inner & Outer Lids (with eaquel Plugs/Caps) [20 Ltrs.(10Kg Capacity) /14 Ltrs (5kg Capacity) / 12.5 Ltrs (5kg Capacity)] Relevant, as per packing policy 309

Case No.:49/24/82ALC4/2012

Party Name:KUDOS CHEMIE LTD., 15.11.2012 HQ File :01/82/050/00853/AM13/ RLA File :22/24/040/00034/AM13/ Lic.No/Date:2210013301 19.09.2012 Defer Date:13.12.2012

19.09.2012 Date:13.12.2012 310

Case No.:89/22/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 15.11.2012 HQ File :01/82/050/00792/AM13/ RLA File :22/24/040/00035/AM13/ Lic.No/Date:2210013297 19.09.2012 Defer Date:13.12.2012 311

Case No.:90/22/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 15.11.2012 HQ File :01/82/050/00793/AM13/ RLA File :22/24/040/00033/AM13/ Lic.No/Date:2210013300 19.09.2012 Defer Date:13.12.2012 312

Case No.:10/24/82ALC4/2012

Party Name:VASISTA LIFE SCIENCES PVT LTD 15.11.2012 HQ File :01/82/050/00814/AM13/ RLA File :09/24/040/00308/AM13/ Lic.No/Date:0910053881 21.09.2012 Defer Date:13.12.2012 313

Case No.:1/22/82ALC4/2012

15.11.2012 HQ File :01/82/050/00704/AM13/ RLA File :05/24/040/00231/AM13/ Lic.No/Date:0510335607 25.09.2012 Defer Date:13.12.2012 314

Case No.:16/24/82ALC4/2012

Party Name:OGENE SYSTEMS INDIA PVT. LTD. 15.11.2012 HQ File :01/82/050/00820/AM13/ RLA File :09/24/040/00312/AM13/ Lic.No/Date:0910053896 25 09 2012 Defer Date:13 12 2012

25.09.2012 Date:13.12.2012 315

Case No.:51/24/82ALC4/2012

Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 15.11.2012 Status:Case Approved HQ File :01/82/050/00855/AM13/ RLA File :05/23/040/00244/AM13/ Lic.No/Date:0510335613 25.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O no. 14010/7/2011Ch. II dated 16.11.2012, 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 kg/kg 1,3 Dibromo 5,5 Dimethyl Hydantoin 1 kg 1. Acetone Cyanohydrin 0.437 2. Ammonium Bicarbonate 0.436 3. Liquid Bromine 0.621 316

Case No.:43/24/82ALC4/2012

15.11.2012 HQ File :01/82/050/00847/AM13/ RLA File :09/24/040/00288/AM13/ Lic.No/Date:0910053905 26.09.2012 Defer Date:13.12.2012 317

Case No.:37/24/82ALC4/2012

15.11.2012 HQ File :01/82/050/00841/AM13/ RLA File :09/24/040/00289/AM13/ Lic.No/Date:0910053917 27.09.2012 Defer Date:13.12.2012 318

Case No.:47/24/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 15.11.2012 Status:Case Approved HQ File :01/82/050/00851/AM13/ RLA File :05/23/040/00249/AM13/ Lic.No/Date:0510335912 27.09.2012 Defer Date: D i i I th li ht f li d i i t k i ti 20/82 d t d 20 9 2012 it d id d t tif d P 4 7 f HBP 1 d t il

Decision : In the light of earlier decision taken in meeting no. 20/82 dated 20.9.2012, 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 Cefdinir Powder 1 kg 1. 7Phenylacetamideo3 Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 2.44 kg 2. Triphenyl Phosphine 2.037 kg 3. Sodium Iodide 0.11 kg 4. Phenol 2.42 kg 5. Methylene Chloride 22.59 kg 6. Tetra Hydro Furan (THF) 4.36 kg 7. Methanol 7.94 kg 8. Formaldehyde 2,.74 kg 9. CAEM 1.82 kg 10. Triethylamine 0.155 kg 11. nButyl Acetate 2.98 kg 319

Case No.:48/24/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 15.11.2012 HQ File :01/82/050/00852/AM13/ RLA File :05/23/040/00248/AM13/ Lic.No/Date:0510335908 27.09.2012 Defer Date:13.12.2012 320

Case No.:36/24/82ALC4/2012

Party Name:MSN PHARMACHEM PRIVATE LIMITED Meet No/Date:24/82ALC4/2012 15.11.2012 HQ File :01/82/050/00840/AM13/ RLA File :09/24/040/00324/AM13/ Lic.No/Date:0910053933 28.09.2012 Defer Date:13.12.2012 321

Case No.:19/24/82ALC4/2012

Party Name:ARJUN CHEMICALS PVT. LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00823/AM13/ RLA File :04/24/040/00137/AM13/ Lic.No/Date:0410140229 04.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/150/2011/Ch. II dated 18 4 2012 it d id d t tif d 4 7 f HBP 1 d t il i b l li d b th fi hi h i l

18.4.2012, 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 KeydimeAKD (Alkyl Ketene DimerEmulsion) 1 kg 1. Alkyl Ketene Dimer AKD Wax 0.100 kg 2. Solbond C40S (Emcal E6LZS) Cationic Potato Starch 0.070 kg 322

Case No.:3/22/82ALC4/2012

Party Name:ULTRATECH INDIA LTD. 15.11.2012 HQ File :01/82/050/00706/AM13/ RLA File :03/95/040/00310/AM13/ Lic.No/Date:0310711590 04.10.2012 Defer Date:13.12.2012 323

Case No.:45/24/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 15.11.2012 HQ File :01/82/050/00849/AM13/ RLA File :05/23/040/00260/AM13/ Lic.No/Date:0510336434 04.10.2012 Defer Date:13.12.2012 324

Case No.:46/24/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 15.11.2012 HQ File :01/82/050/00850/AM13/ RLA File :05/23/040/00256/AM13/ Lic.No/Date:0510336433 04.10.2012 Defer Date:13.12.2012 325

Case No.:50/24/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 15.11.2012 HQ File :01/82/050/00854/AM13/ RLA File :05/23/040/00255/AM13/ Lic.No/Date:0510336432 04.10.2012 Defer Date:13.12.2012 326

Case No.:52/24/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 15.11.2012 HQ File :01/82/050/00856/AM13/ RLA File :05/23/040/00253/AM13/ Lic.No/Date:0510336431 04.10.2012 Defer Date:15.11.2012

327

Case No.:55/24/82ALC4/2012

Party Name:AMI ORGANICS PVT LTD. 15.11.2012 HQ File :01/82/050/00859/AM13/ RLA File :52/24/040/00026/AM13/ Lic.No/Date:5210039071 05.10.2012 Defer Date:13.12.2012 328

Case No.:33/22/82ALC4/2012

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/00736/AM13/ RLA File :09/24/040/00295/AM13/ Lic.No/Date:0910053985 08.10.2012 Defer Date:13.12.2012 329

Case No.:40/24/82ALC4/2012

15.11.2012 HQ File :01/82/050/00844/AM13/ RLA File :08/24/040/00148/AM13/ Lic.No/Date:0810115662 08.10.2012 Defer Date:13.12.2012 330

Case No.:56/24/82ALC4/2012

Party Name:AMI ORGANICS PVT LTD. 15.11.2012 HQ File :01/82/050/00860/AM13/ RLA File :52/24/040/00029/AM13/ Lic.No/Date:5210039086 09.10.2012 Defer Date:13.12.2012 331

Case No.:57/24/82ALC4/2012

Party Name:AMI ORGANICS PVT LTD. 15.11.2012 HQ File :01/82/050/00861/AM13/ RLA File :52/24/040/00028/AM13/ Lic.No/Date:5210039089 09.10.2012 Defer Date:13.12.2012 332

Case No.:53/24/82ALC4/2012

Party Name:V.D.H. ORGANICS PVT. LTD 15.11.2012 HQ File :01/82/050/00857/AM13/ RLA File :05/24/040/00250/AM13/ Lic.No/Date:0510337065 11.10.2012 Defer Date:13.12.2012

333

Case No.:27/24/82ALC4/2012

Party Name:TORRENT PHARMACEUTICALS LTD. 15.11.2012 HQ File :01/82/050/00831/AM13/ RLA File :08/24/040/00241/AM13/ Lic.No/Date:0810115743 12.10.2012 Defer Date:13.12.2012 334

Case No.:54/24/82ALC4/2012

15.11.2012 HQ File :01/82/050/00858/AM13/ RLA File :05/24/040/00252/AM13/ Lic.No/Date:0510337284 16.10.2012 Defer Date:13.12.2012 335

Case No.:9/24/82ALC4/2012

Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED 15.11.2012 HQ File :01/82/050/00813/AM13/ RLA File :02/24/040/00119/AM13/ Lic.No/Date:0210183299 17.10.2012 Defer Date:13.12.2012 336

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

15.11.2012 HQ File :01/82/050/00805/AM13/ RLA File :09/24/040/00371/AM13/ Lic.No/Date:0910054177 29.10.2012 Defer Date:13.12.2012 337

Case No.:2/24/82ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/00806/AM13/ RLA File :07/24/040/00296/AM13/ Lic.No/Date:0710091635 30.10.2012 Defer Date:13.12.2012

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

1 11 2012

338 15.11.2012 HQ File :01/82/050/00807/AM13/ RLA File :09/24/040/00332/AM13/ Lic.No/Date:0910054196 30.10.2012 Defer Date:13.12.2012 339

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

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 15.11.2012 HQ File :01/82/050/00808/AM13/ RLA File :09/24/040/00362/AM13/ Lic.No/Date:0910054208 31.10.2012 Defer Date:13.12.2012 340

Case No.:5/24/82ALC4/2012

Party Name:ASCENT FINECHEM PVT. LTD., 15.11.2012 Status:Case Approved HQ File :01/82/050/00809/AM13/ RLA File :08/24/040/00268/AM13/ Lic.No/Date:0810116019 31.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/1/2012Ch. II dated 4.7.2012, 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 N(3Aminopropyl) Imidazole Clear colourless to Pale Yellow Liquid 1 kg 1. Imidazole (white to offwhite crystals) 0.889 kg 341

Case No.:6/24/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 15.11.2012 Status:Case Approved HQ File :01/82/050/00810/AM13/ RLA File :34/24/040/00167/AM13/ Lic.No/Date:3410035378 31.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no 40/82 dated 4.1.2011, 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 nValeryl Chloride 1 Kg. 1. nValeric Acid 0.891 kg 342

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

Party Name:SHIVA PHARMACHEM LTD, 15.11.2012 HQ File :01/82/050/00811/AM13/ RLA File :34/24/040/00168/AM13/ Lic.No/Date:3410035379 31.10.2012 Defer Date:13.12.2012

3 . 0. 0 ate: 3. . 0 343

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

Party Name:ALKEM LABORATORIES LTD., 15.11.2012 HQ File :01/82/050/00812/AM13/ RLA File :03/94/040/00668/AM13/ Lic.No/Date:0310714062 01.11.2012 Defer Date:13.12.2012 Date:20.11.2012 Place:New Delhi Lalita Maini Foreign Trade Development Officer

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Para 4.7 Decision(DRAFT)

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Para 4.4.2 of HBP v1 as per details given below or as applied by the firm, whichever is less:

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