IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2010-02-23

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 48/82‐ALC4/2009 MEETING DATE : 23.02.2010 The Meeting No.48/82 in the year 2009‐10 to consider the cases under Duty Exemption Scheme (Chapter‐4) of Foreign Trade Policy, 2004‐09 pertaining to products falling in Chapter 29 and 30 was held on 23.02.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Shaish Kumar, IA, DIPP 2. Shri D.N. Mathur, Dy. IA, Department of Pharmaceuticals 3. Shri Rajinder Pal Singh, Dy. DGFT 4. Shri Shyam Lal, FTDO

Case No. B‐470

M/S Yasho Industries Pvt. Ltd. Norms Committee Meeting No. 48/10 File No. 01/83/050/00646/AM08 File No. 01/83/050/01077/AM07 Meeting Date 23.02.2010 RAF No. 03/95/040/00281/AM08 RAF No. 03/95/040/01183/AM07 Adv. Lic. No. 0310433842 dated 25.06.2007 Adv. Lic. No. 0310413968 dated 29.12.2006 Committee decided to defer case for 23.03.2010 for comments of Department of C&PC.

Case No. B‐471

M/S J.S. Chemicals File No. 01/82/050/01179/AM09 RAF No. 52/24/040/00019/AM09 Adv. Lic. No. 5210024577 dated 21.10.2008 Committee decided to defer case for 23.03.2010 for comments of Department of C&PC.

Case No. A‐218

M/S BDR Pharma International Pvt. Ltd. File No. 01/82/162/01037/AM10 RAF No. 03/94/040/00509/AM07 Adv. Lic. No. 0310396799 dated 28.08.2006 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/158/2009‐PI‐(Norms) dated 07.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Atorvastatin 1 Kg. 1. (4R‐Cis)‐1,1‐Dimethyl Ethyl‐6‐Cyanomethyl‐2, 1.00 kg

Calcium Dimethyl 1,3‐Dioxane‐4‐Acetane RA concerned may take further necessary action as per above decision of NC.

Case No. A‐219

M/S Cipla Ltd. File No. 01/82/162/01038/AM10 RAF No. 03/94/040/00072/AM09 Adv. Lic. No. 0310469561 dated 25.04.2008 Committee considered case as per agenda and in light of earlier decision taken in 24/82 meeting held on 21.09.2005 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Etoposide 1 Kg. 1. 4‐Dimethyl Epipodophyllotoxin 1.39 kg

Case No. A‐220

M/S Gitanjali Chemicals Pvt. Ltd. File No. 01/82/162/01033/AM10 RAF No. 03/94/040/01276/AM09 Adv. Lic. No. 0310465769 dated 19.03.2008 Committee decided to defer case for 23.03.2010 for comments of Department of C&PC.

Case No. A‐221

M/S KDL Biotech Ltd. File No. 01/82/162/01039/AM10 RAF No. 03/94/040/00007/AM07 Adv. Lic. No. 0310385508 dated 20.06.2006 Committee considered case as per agenda and observed that there is no details of import and export items in the application. It was, therefore, decided to examine the case on file.

Case No. A‐222

M/S Biostadt India Ltd. File No. 01/82/162/01034/AM10 RAF No. 03/94/040/00259/AM09 Adv. Lic. No. 0310473370 dated 05.06.2008 Committee considered case as per agenda and decided to call for NOC/comments from Ministry of Environment and Forests. The case will be treated as closed 奱�ll the NOC/comments are received from Ministry of E&F.

Case No. A‐223

M/S Cipla Ltd. File No. 01/82/162/01035/AM10�

RAF No. 03/94/040/01218/AM08 Adv. Lic. No. 0310463174 dated 28.02.2008 Committee considered case as per agenda and in light of earlier decision taken in 15/82 meeting held on 07.07.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Lamivudine 1 Kg. 1. (1’R’,2’S,5’R)‐Menthyl‐5S‐(Cytosine‐1”‐YL)‐1,3‐ oxathiolane‐2R‐carboxylate/CME Compound 2.19 kg 1

Case No.:36/6/83‐ALC1/2008

Party Name:H.K.FINECHEM LIMITED Meet No/Date:48/82‐ALC4/2009 23.02.2010 Status:Case Deferred HQ File :01/83/050/00146/AM09/ RLA File :08/24/040/00149/AM08/ Lic.No/Date:0810067303 21.09.2007 Defer Date:23.03.2010 Decision :Committee considered case as per agenda and observed that the reply received form the firm has been forwarded to Department of C&PC for examination and comments. It was decoded to examine the case on file with reference to sensitiveness of import item. Accordingly, case was deferred for 23.03.2010. 2

Case No.:1/3/82‐ALC4/2009

Party Name:AARTI INDUSTRIES LIMITED 23.02.2010 Status:Case Approved HQ File :01/82/050/00013/AM10/ RLA File :03/94/040/01069/AM09/ Lic.No/Date:0310514552 03.04.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/154/2009‐PI‐III dated 26.10.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Perindropril Erbumine 1 Kg. 1. Octahydro indole‐2‐carboxylic acid 1.00 kg 2. L‐norvaline 1.60 kg 3

Case No.:8/4/82‐ALC4/2009

Party Name:METROPOLITAN EXIMCHEM LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00029/AM10/ RLA File :03/95/040/01007/AM09/ Lic.No/Date:0310516119 17.04.2009 Defer Date:23.03.2010 Decision :Committee decided to defer case for 23.03.2010 for comments of Department of C&PC.

Case No.:2/9/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.02.2010 Status:Case Approved HQ File :01/82/050/00115/AM10/ RLA File :05/24/040/00091/AM10/ Lic.No/Date:0510241724 19.05.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 22/82 meeting held on 04.10.2007 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Oseltamivir Phosphate 1 Kg. 1. Shikimid Acid 4.25 kg 2. 2,2 Dimethoxy Propane 0.043 kg 3. Toluene 5.73 kg 4. Triethylamine 3.32 kg 5. Methylene Chloride 13.52 kg 6. Acetone 6.58 kg 7. Methanol 2.41 kg 8. Dimethyl Formamide 1.57 kg 9. 3‐Pentanone 14.239 kg 10. Triflic Acid 0.204 kg 11. Cyclohexane 6.86 kg 12. Triethyl Silane 3.00 kg 13. Triphenyl Phosphine 7.703 kg 14. Activated Carbon 0.100 kg 15. Tetrahydrofuran 2.77 kg 5

Case No.:13/13/82‐ALC4/2009

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 23.02.2010 Status:Case Deferred HQ File :01/82/050/00153/AM10/ RLA File :03/95/040/00994/AM09/ Lic.No/Date:0310523242 09.06.2009 Defer Date:23.03.2010 Decision :Committee decided to defer case for 23.03.2010 for comments of Department of C&PC. 6

Case No.:14/21/82‐ALC4/2009

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 23.02.2010 Status:Case Approved HQ File :01/82/050/00441/AM10/ RLA File :22/24/040/00012/AM10/ Lic.No/Date:2210009104 15.07.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/182/2009‐PI‐(Norms) dated 04.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate 1 Kg. 1. 6‐Amino Penicillanic Acid 0.568 kg 2. Oxilasa (Enzyme) 5.00 gm. 3. D(‐) P‐Hydroxy Phenyl Glycine Methylester 0.608 kg 7

Case No.:5/22/82‐ALC4/2009

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 23.02.2010 Status:Case Approved HQ File :01/82/050/00462/AM10/ RLA File :22/24/040/00016/AM10/ Lic.No/Date:2210009103 15.07.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/182/2009‐PI‐(Norms) dated 04.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate 1 Kg. 1. 6‐Amino Penicillanic Acid 0.568 kg 2. Oxilasa (Enzyme) 5.00 gm. 3. D(‐) P‐Hydroxy Phenyl Glycine Methylester 0.608 kg 8

Case No.:32/22/82‐ALC4/2009

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 23.02.2010 Status:Case Deferred HQ File :01/82/050/00489/AM10/ RLA File :07/24/040/00165/AM10/ Lic.No/Date:0710066086 21.07.2009 Defer Date:23.03.2010 Decision : Committee decided to defer case for 23.03.2010 for comments of Department of C&PC. 9

Case No.:54/48/82‐ALC4/2009

Party Name:STERLING AUXILIARIES PVT LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/01117/AM10/ RLA File :03/95/040/00254/AM10/ Lic.No/Date:0310530172 22.07.2009 Defer Date:23.03.2010 10

Case No.:7/36/82‐ALC4/2009

Party Name:IND‐SWIFT LABORATORIES LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/00732/AM10/ RLA File :22/24/040/00019/AM10/ Lic.No/Date:2210009119 Defer

22.07.2009 Date:23.03.2010 Decision : Committee decided to defer case for 23.03.2010 for comments of Department of Pharmaceuticals. 11

Case No.:26/21/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00453/AM10/ RLA File :09/24/040/00112/AM10/ Lic.No/Date:0910038897 12.08.2009 Defer Date:23.03.2010 12

Case No.:27/21/82‐ALC4/2009

Party Name:GITANJALI CHEMICALS PVT LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00454/AM10/ RLA File :03/94/040/00225/AM10/ Lic.No/Date:0310533516 12.08.2009 Defer Date:23.03.2010 13

Case No.:33/22/82‐ALC4/2009

Party Name:PRIVI ORGANICS LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00490/AM10/ RLA File :03/95/040/00310/AM10/ Lic.No/Date:0310534394 20.08.2009 Defer Date:23.03.2010 14

Case No.:32/48/82‐ALC4/2009

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 23.02.2010 Status:Case Approved HQ File :01/82/050/01095/AM10/ RLA File :03/95/040/00312/AM10/ Lic.No/Date:0310534937 24.08.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 12/10 meeting held on 16.06.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Artemether 1 Kg. 1. Artemisinin 1.50 kg 2. Sodium Borohydride 0.188 kg 3. Methanol 1.00 kg 15

Case No.:4/24/82‐ALC4/2009

Party Name:CIPLA LIMITED 23.02.2010 Status:Case Deferred

HQ File :01/82/050/00501/AM10/ RLA File :03/94/040/00454/AM10/ Lic.No/Date:0310535251 26.08.2009 Defer Date:23.03.2010 16

Case No.:6/24/82‐ALC4/2009

Party Name:KLJ PLASTICIZERS LTD, 23.02.2010 Status:Case Deferred HQ File :01/82/050/00503/AM10/ RLA File :05/24/040/00242/AM10/ Lic.No/Date:0510248395 26.08.2009 Defer Date:23.03.2010 17

Case No.:8/24/82‐ALC4/2009

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00505/AM10/ RLA File :31/24/040/00409/AM08/ Lic.No/Date:3110039743 27.08.2009 Defer Date:23.03.2010 18

Case No.:8/36/82‐ALC4/2009

Party Name:SURYA MEDICARE LTD., 23.02.2010 Status:Case Approved HQ File :01/82/050/00733/AM10/ RLA File :22/24/040/00022/AM10/ Lic.No/Date:2210009214 27.08.2009 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Ce䬀riaxone Sodium Sterile 1 Kg. 1. Ce䬀riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate (EDTA) 0.01 kg 4. Eno Carbon 51.66 gm 19

Case No.:9/24/82‐ALC4/2009

Party Name:LIFE LINE INDUSTRIES LIMITED 23.02.2010 Status:Case Deferred HQ File :01/82/050/00506/AM10/ RLA File :03/95/040/00328/AM10/ Lic.No/Date:0310535518 27.08.2009 Defer Date:23.03.2010 Decision :Committee decided to defer case for 23.03.2010 for reply form firm.

Case No.:10/24/82‐ALC4/2009

Party Name:AARTI INDUSTRIES LIMITED 23.02.2010 Status:Case Approved HQ File :01/82/050/00507/AM10/ RLA File :03/94/040/00399/AM10/ Lic.No/Date:0310535665 28.08.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 6/82 meeting held on 12.05.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Capecitabine 1 Kg. 1. 1,2,3‐Triacetoxy‐5‐Deoxy‐Ribose 1.11 kg 2. 5‐Fluorocytosine 0.553 kg 3. N‐Pentylchloroformate 1.12 kg 21

Case No.:14/24/82‐ALC4/2009

Party Name:ASTRIX LABORATORIES LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/00511/AM10/ RLA File :09/24/040/00168/AM10/ Lic.No/Date:0910039133 28.08.2009 Defer Date:23.03.2010 22

Case No.:15/24/82‐ALC4/2009

Party Name:ASTRIX LABORATORIES LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/00512/AM10/ RLA File :09/24/040/00171/AM10/ Lic.No/Date:0910039134 28.08.2009 Defer Date:23.03.2010 23

Case No.:16/24/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 23.02.2010 Status:Case Deferred HQ File :01/82/050/00513/AM10/ RLA File :09/24/040/00200/AM10/ Lic.No/Date:0910039135 28.08.2009 Defer Date:23.03.2010 24

Case No.:19/24/82‐ALC4/2009

Party Name:PANACEA BIOTEC LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/00516/AM10/ RLA File :05/24/040/00299/AM10/ Lic.No/Date:0510248628 28.08.2009 Defer

Date:23.03.2010 Decision : Committee decided to defer case for 23.03.2010 for comments of Department of Bio‐technology. 25

Case No.:27/24/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00524/AM10/ RLA File :09/24/040/00196/AM10/ Lic.No/Date:0910039221 01.09.2009 Defer Date:23.03.2010 26

Case No.:28/24/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00525/AM10/ RLA File :09/24/040/00199/AM10/ Lic.No/Date:0910039222 01.09.2009 Defer Date:23.03.2010 27

Case No.:29/24/82‐ALC4/2009

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 23.02.2010 Status:Case Deferred HQ File :01/82/050/00526/AM10/ RLA File :09/24/040/00208/AM10/ Lic.No/Date:0910039223 01.09.2009 Defer Date:23.03.2010 28

Case No.:32/24/82‐ALC4/2009

Party Name:UNI SANKYO LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00529/AM10/ RLA File :09/24/040/00190/AM10/ Lic.No/Date:0910039228 01.09.2009 Defer Date:23.03.2010 29

Case No.:33/24/82‐ALC4/2009

Party Name:INDIA GLYCOLS LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00530/AM10/ RLA File :05/23/040/00019/AM10/ Lic.No/Date:0510248771 02.09.2009 Defer Date:23.03.2010 30

Case No.:11/36/82‐ALC4/2009

Party Name:NECTAR LIFESCIENCES LIMITED, 23.02.2010 Status:Case Approved HQ File :01/82/050/00736/AM10/ RLA File :22/24/040/00026/AM10/ Lic.No/Date:2210009216

09.09.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Ce䬀riaxone Sodium Sterile 1 Kg. 1. Ce䬀riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate (EDTA) 0.01 kg 4. Eno Carbon 51.66 gm 31

Case No.:10/36/82‐ALC4/2009

Party Name:NECTAR LIFESCIENCES LIMITED, 23.02.2010 Status:Case Approved HQ File :01/82/050/00735/AM10/ RLA File :22/24/040/00024/AM10/ Lic.No/Date:2210009249 10.09.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Ce䬀riaxone Sodium Sterile 1 Kg. 1. Ce䬀riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate (EDTA) 0.01 kg 4. Eno Carbon 51.66 gm 32

Case No.:4/26/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/00536/AM10/ RLA File :03/94/040/00486/AM10/ Lic.No/Date:0310536937 10.09.2009 Defer Date:23.03.2010 33

Case No.:7/26/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 23.02.2010 Status:Case Deferred

HQ File :01/82/050/00539/AM10/ RLA File :03/94/040/00383/AM10/ Lic.No/Date:0310537073 10.09.2009 Defer Date:23.03.2010 34

Case No.:9/36/82‐ALC4/2009

Party Name:NECTAR LIFESCIENCES LIMITED, 23.02.2010 Status:Case Deferred HQ File :01/82/050/00734/AM10/ RLA File :22/24/040/00023/AM10/ Lic.No/Date:2210009248 10.09.2009 Defer Date:23.03.2010 35

Case No.:9/26/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00541/AM10/ RLA File :03/95/040/00346/AM10/ Lic.No/Date:0310537187 11.09.2009 Defer Date:23.03.2010 36

Case No.:7/27/82‐ALC4/2009

Party Name:LUPIN LIMITED 23.02.2010 Status:Case Approved HQ File :01/82/050/00549/AM10/ RLA File :03/95/040/00362/AM10/ Lic.No/Date:0310537610 14.09.2009 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/168/2009‐PI‐(Norms) dated 11.02.2010 and decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed Sterile Ce䬀riaxone Sodium‐ (Non‐Infringing) 1. Ethyl Acetate 2.181 kg 2. Methylene Chloride 2.00 kg 3. Sodium Hydrosulphite 0.0049 kg 4. 7 ACA 0.668 kg 5. 2,5 Dihydro‐6‐Hydroxy‐3‐Mercapto‐ 2‐Methyl‐5‐Oxo‐1,2,4‐Triazene 0.360 kg 6 Boron Trifluoride Gas 0.611 kg 7. Acetonitrile 2.60 kg 8. Acetone 11.50 kg 9. Activated Carbon 0.100 kg 10. Tetra Hydrofuran 1.23 kg 11 Formic Acid 3.158 kg

Hexamethyl Disilazane 0.54 kg 13. Triethylamine 0.514 kg 14. Phasphorous Pentachloride 0.474 kg 15. Isopropyl Alcohol 0.400 kg 16. Thiourea 0.180 kg 17. Trimethyl Chlorosilane 0.079 kg 18. Sodium 2‐Ethyl Hexanoate 0.684 kg 19. 4‐Bromo‐2‐Methoxyimino‐3‐Oxo Butyric Acid (Bromic Acid) 0.485 kg 20. Relevant Aluminium Containers of 20 Ltrs Capacity with caps & Plus As per packing policy 37

Case No.:11/27/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00553/AM10/ RLA File :03/94/040/00493/AM10/ Lic.No/Date:0310537793 15.09.2009 Defer Date:23.03.2010 Decision : Committee decided to defer case for 23.03.2010 for reply from firm. 38

Case No.:3/28/82‐ALC4/2009

Party Name:STERLING BIOTECH LTD. 23.02.2010 Status:Case Approved HQ File :01/82/050/00563/AM10/ RLA File :34/24/040/00082/AM10/ Lic.No/Date:3410025128 18.09.2009 Decision : Committee considered case as per agenda and taking 95% yield and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed 2 Chloro 4 Methyl Sulfonyl Benzoic Acid 1 Kg. 1. Calcium Acetate As applied 2. Cobalt‐II‐Acetate‐4‐Hydrate As applied 3. Manganese‐II‐Acetate As applied 4. 2‐Chl‐4‐methylsulfonyltoluene 0.92 kg 39

Case No.:4/28/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/00564/AM10/ RLA File :05/24/040/00307/AM10/ Lic.No/Date:0510249607 18.09.2009 Defer Date:23.03.2010

Case No.:5/28/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/00565/AM10/ RLA File :05/24/040/00308/AM10/ Lic.No/Date:0510249608 18.09.2009 Defer Date:23.03.2010 41

Case No.:6/28/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/00566/AM10/ RLA File :05/24/040/00275/AM10/ Lic.No/Date:0510249610 18.09.2009 Defer Date:23.03.2010 42

Case No.:9/28/82‐ALC4/2009

Party Name:EMCURE PHARMACEUTICALS LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00569/AM10/ RLA File :31/24/040/00110/AM10/ Lic.No/Date:3110040034 23.09.2009 Defer Date:23.03.2010 43

Case No.:69/48/82‐ALC4/2009

Party Name:CHEMIESYNTH (VAPI)LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/01132/AM10/ RLA File :03/94/040/00450/AM10/ Lic.No/Date:0310539253 24.09.2009 Defer Date:23.03.2010 44

Case No.:6/34/82‐ALC4/2009

Party Name:STAR ORECHEM INTERNATIONAL PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00651/AM10/ RLA File :50/24/040/00004/AM10/ Lic.No/Date:5010000149 25.09.2009 Defer Date:23.03.2010 45

Case No.:51/48/82‐ALC4/2009

Party Name:RATNAGIRI CHEMICALS PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01114/AM10/ RLA File :03/95/040/00416/AM10/ Lic.No/Date:0310539888 30.09.2009 Defer

Date:23.03.2010 46

Case No.:1/30/82‐ALC4/2009

23.02.2010 Status:Case Approved HQ File :01/82/050/00602/AM10/ RLA File :05/24/040/00330/AM10/ Lic.No/Date:0510250359 06.10.2009 Decision :Withdrawn as the case has already been approved by NC in 44/82 meeting held on 27.01.2010. 47

Case No.:8/30/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/00609/AM10/ RLA File :03/94/040/00577/AM10/ Lic.No/Date:0310541231 09.10.2009 Defer Date:23.03.2010 Decision :Committee decided to call the firm for personal hearing along with a declaration declaring that 1,1,1,2, Tetrafluoroethane (HFA 134A Propellant) is not a ODS gas. Accordingly, case was deferred for 23.03.2010. 48

Case No.:9/30/82‐ALC4/2009

Party Name:EMCURE PHARMACEUTICALS LTD. 23.02.2010 HQ File :01/82/050/00610/AM10/ RLA File :31/24/040/00123/AM10/ Lic.No/Date:3110040264 09.10.2009 49

Case No.:47/39/83‐ALC1/2009

Party Name:SPAN DIAGNOSTICS LTD 23.02.2010 HQ File :01/83/050/00754/AM10/ RLA File :52/24/040/00016/AM10/ Lic.No/Date:5210028576 13.10.2009 Decision : Committee decided to defer case for 23.03.2010 for comments of Department of Bio‐technology. 50

Case No.:49/34/83‐ALC1/2009

Party Name:SPAN DIAGNOSTICS LTD 23.02.2010 Status:Case Deferred HQ File :01/83/050/00634/AM10/ RLA File :52/24/040/00014/AM10/ Lic.No/Date:5210028574 13.10.2009 Defer Date:23.03.2010 Decision : Committee decided to defer case for 23.03.2010 for comments of Department of Bio‐technology. 51

Case No.:50/34/83‐ALC1/2009

Party Name:SPAN DIAGNOSTICS LTD 23.02.2010 Status:Case Deferred

HQ File :01/83/050/00635/AM10/ RLA File :52/24/040/00015/AM10/ Lic.No/Date:5210028575 13.10.2009 Defer Date:23.03.2010 Decision : Committee decided to defer case for 23.03.2010 for comments of Department of Bio‐technology. 52

Case No.:5/32/82‐ALC4/2009

Party Name:SUVEN LIFE SCIENCES LIMITED 23.02.2010 Status:Case Approved HQ File :01/82/050/00619/AM10/ RLA File :09/71/040/00080/AM10/ Lic.No/Date:0910039588 14.10.2009 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms as per SION A‐1284 or as applied by firm whichever is lower. 53

Case No.:3/32/82‐ALC4/2009

Party Name:AICO LABORATORIES INDIA LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00617/AM10/ RLA File :08/24/040/00176/AM10/ Lic.No/Date:0810083625 15.10.2009 Defer Date:23.03.2010 Decision :Committee considered case as per agenda and observed that the import and export are chemically same. It was, therefore, decided to call for copy of shipping bills and bills of entries from the firm as already decided in other four case of the firm on file. Accordingly, case was deferred for 23.02.2010. 54

Case No.:14/32/82‐ALC4/2009

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/00628/AM10/ RLA File :07/24/040/00246/AM10/ Lic.No/Date:0710067616 16.10.2009 Defer Date:23.03.2010 55

Case No.:40/48/82‐ALC4/2009

Party Name:RELIANCE INDUSTRIES LTD. 23.02.2010 Status:Case Approved HQ File :01/82/050/01103/AM10/ RLA File :03/95/040/00445/AM10/ Lic.No/Date:0310541786 23.10.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by PC Division vide their O.M. No.46011/20/2008‐PC.II dated 23.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import item Qty. allowed Propylene 1 MT. 1. Naphtha 1.2359 MT

Case No.:52/48/82‐ALC4/2009

Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01115/AM10/ RLA File :03/94/040/00538/AM10/ Lic.No/Date:0310541878 23.10.2009 Defer Date:23.03.2010 57

Case No.:9/32/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/00623/AM10/ RLA File :03/94/040/00580/AM10/ Lic.No/Date:0310541570 23.10.2009 Defer Date:23.03.2010 Decision : Committee decided to call the firm for personal hearing along with a declaration declaring that 1,1,1,2, Tetrafluoroethane (HFA 134A Propellant) is not a ODS gas. Accordingly, case was deferred for 23.03.2010. 58

Case No.:36/48/82‐ALC4/2009

Party Name:G AMPHRAY LABORATORIES, 23.02.2010 Status:Case Approved HQ File :01/82/050/01099/AM10/ RLA File :03/94/040/00614/AM10/ Lic.No/Date:0310543005 28.10.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 44/82 meeting held on 27.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Piperazine Adipate BP/USP 1 Kg. 1. Diethyl diamine Piperazine 0.380 kg 2. Adipic Acid 0.675 kg 59

Case No.:35/48/82‐ALC4/2009

Party Name:GALAXY SURFACTANTS LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/01098/AM10/ RLA File :03/94/040/00129/AM10/ Lic.No/Date:0310543281 29.10.2009 Defer Date:23.03.2010 60

Case No.:64/48/82‐ALC4/2009

23.02.2010 Status:Case Approved Lic.No/Date:0310543282

HQ File :01/82/050/01127/AM10/ RLA File :03/94/040/00629/AM10/ 29.10.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 9/82 meeting held on 27.05.2008 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Sulfamethazine & Trimethoprim Oral Powder/Cobalt Powder 1 pack of 100 gm 1. Sulfamethazine USP 20.20 gm/pack 2. Trimethoprim USP 4.04 gm/pack Sulfamethazine & Trimethoprim Oral Powder/Cobalt Powder 1 pack of 1.00 kg 1. Sulfamethazine USP 202 gm/pack 2. Trimethoprim USP 40.4 gm/pack 61

Case No.:18/34/82‐ALC4/2009

Party Name:SHIVA PHARMACHEM PVT. LTD, 23.02.2010 Status:Case Deferred HQ File :01/82/050/00663/AM10/ RLA File :34/24/040/00120/AM10/ Lic.No/Date:3410025485 30.10.2009 Defer Date:23.03.2010 62

Case No.:19/34/82‐ALC4/2009

Party Name:SHIVA PHARMACHEM PVT. LTD, 23.02.2010 HQ File :01/82/050/00664/AM10/ RLA File :34/24/040/00118/AM10/ Lic.No/Date:3410025488 30.10.2009 63

Case No.:21/34/82‐ALC4/2009

Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00666/AM10/ RLA File :03/94/040/00612/AM10/ Lic.No/Date:0310543424 30.10.2009 Defer Date:23.03.2010 64

Case No.:22/34/82‐ALC4/2009

Party Name:SCITECH SPECIALITIES PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00667/AM10/ RLA File :03/95/040/00470/AM10/ Lic.No/Date:0310543476 30.10.2009 Defer Date:23.03.2010

Case No.:65/48/82‐ALC4/2009

23.02.2010 Status:Case Approved HQ File :01/82/050/01128/AM10/ RLA File :03/94/040/00634/AM10/ Lic.No/Date:0310543537 30.10.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/127/2009‐PI‐(Norms) dated 11.02.2010 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Fipronil 9.7% w/v 3x0.67 ml 1 ml 1. Fipronil 97.97 mg Fipronil 9.7% w/v 3x1.34 ml 1 ml 1. Fipronil 97.97 mg Fipronil Spray 0.25% w/v 100 ml 100 ml 1. Fipronil 0.2525 gm Fipronil Spray 0.25% w/v, 250 ml 250 ml 1. Fipronil 0.63125 gm 66

Case No.:44/48/82‐ALC4/2009

Party Name:AVA CHEMICALS PVT.LTD., 23.02.2010 HQ File :01/82/050/01107/AM10/ RLA File :03/94/040/00475/AM10/ Lic.No/Date:0310543630 03.11.2009 67

Case No.:25/34/82‐ALC4/2009

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00670/AM10/ RLA File :31/24/040/00132/AM10/ Lic.No/Date:3110040444 04.11.2009 Defer Date:23.03.2010 68

Case No.:26/34/82‐ALC4/2009

Party Name:ANUPAM RASAYAN (INDIA) LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00671/AM10/ RLA File :52/24/040/00017/AM10/ Lic.No/Date:5210028666 04.11.2009 Defer Date:23.03.2010

Case No.:33/48/82‐ALC4/2009

Party Name:GLENMARK GENERICS LIMITED 23.02.2010 Status:Case Approved HQ File :01/82/050/01096/AM10/ RLA File :03/94/040/00632/AM10/ Lic.No/Date:0310543856 04.11.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 32/82 meeting held on 11.12.2007 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Bupropion Hydrochloride BP 1 kg 1. M‐Chloropropiophenone 0.85 kg 2. Methylene Chloride/MDC/Methylene Dichloride 2.00 kg 3. Methanol 1.00 kg 70

Case No.:27/34/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 23.02.2010 Status:Case Deferred HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Defer Date:23.03.2010 71

Case No.:29/34/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.02.2010 Status:Case Approved HQ File :01/82/050/00674/AM10/ RLA File :05/24/040/00352/AM10/ Lic.No/Date:0510251928 05.11.2009 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/150/2009‐PI (Norms) dated 01.02.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate 500 mg & Clavulanate Potassium + Microcrystalline Cellulose (1:1) (250 + 125 mg Tablet 1No.. 1. Amoxycillin Trihydrate (OR) 255 mg/tablet Its raw materials as per revised SION A‐57 2. Potassium Lavulanate + Microcrystalline Cellulose (1:1) 303.45 mg/tablet Amoxycillin Trihydrate 500 mg + Potassium 1 No. 1. Amoxycillin Trihydrate (OR) 510 mg/tablet Its raw materials as per revised SION A‐57

Calavulanate 125 mg + Microcrystalline Cellulose (1:1) Tablet p 2. Potassium Lavulanate + Microcrystalline Cellulose (1:1) 303.45 mg/tablet Amoxycillin Trihydrate 750 mg + Potassium Calavulanate 125 mg + Microcrystalline Cellulose (1:1) Tablet 1 No. 1. Amoxycillin Trihydrate (OR) 765 mg/tablet Its raw materials as per revised SION A‐57 2. Potassium Lavulanate + Microcrystalline Cellulose (1:1) 303.45 mg/tablet 72

Case No.:31/34/82‐ALC4/2009

Party Name:NAPROD LIFE SCIENCES PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00676/AM10/ RLA File :03/95/040/00096/AM10/ Lic.No/Date:0310544100 05.11.2009 Defer Date:23.03.2010 73

Case No.:32/34/82‐ALC4/2009

Party Name:PREGNA INTERNATIONAL LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00677/AM10/ RLA File :03/95/040/00286/AM10/ Lic.No/Date:0310544168 05.11.2009 Defer Date:23.03.2010 Decision : Committee decided to defer case for 23.03.2010 for comments of Department of C&PC, PC Div.. 74

Case No.:33/34/82‐ALC4/2009

Party Name:PREGNA INTERNATIONAL LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00678/AM10/ RLA File :03/95/040/00285/AM10/ Lic.No/Date:0310544171 05.11.2009 Defer Date:23.03.2010 Decision : Committee decided to defer case for 23.03.2010 for comments of Department of C&PC, PC Div.. 75

Case No.:34/34/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/00679/AM10/ RLA File :05/24/040/00291/AM10/ Lic.No/Date:0510252005 06.11.2009 Defer Date:23.03.2010 76

Case No.:35/34/82‐ALC4/2009

23.02.2010

HQ File :01/82/050/00680/AM10/ RLA File :05/24/040/00337/AM10/ Lic.No/Date:0510252006 06.11.2009 77

Case No.:44/34/82‐ALC4/2009

Party Name:DELTA FINOCHEM PVT.LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00689/AM10/ RLA File :03/94/040/00556/AM10/ Lic.No/Date:0310544608 09.11.2009 Defer Date:23.03.2010 78

Case No.:45/34/82‐ALC4/2009

Party Name:OMKAR SPECIALITY CHEMICALS PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00690/AM10/ RLA File :03/95/040/00486/AM10/ Lic.No/Date:0310544624 09.11.2009 Defer Date:23.03.2010 79

Case No.:70/48/82‐ALC4/2009

Party Name:CHEMPRO EXPORTS (INDIA) 23.02.2010 Status:Case Deferred HQ File :01/82/050/01133/AM10/ RLA File :03/94/040/00613/AM10/ Lic.No/Date:0310544665 09.11.2009 Defer Date:23.03.2010 80

Case No.:39/48/82‐ALC4/2009

Party Name:RELIANCE LIFE SCIENCES PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01102/AM10/ RLA File :03/95/040/00475/AM10/ Lic.No/Date:0310544816 10.11.2009 Defer Date:23.03.2010 81

Case No.:63/48/82‐ALC4/2009

23.02.2010 Status:Case Approved HQ File :01/82/050/01126/AM10/ RLA File :03/94/040/00668/AM10/ Lic.No/Date:0310545021 12.11.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 9/82 meeting held on 27.05.2008 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed

Sulfamethazine & Trimethoprim Oral Powder/Cobalt Powder 1 pack of 100 gm 1. Sulfamethazine USP 20.20 gm/pack 2. Trimethoprim USP 4.04 gm/pack 82

Case No.:6/36/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.02.2010 HQ File :01/82/050/00731/AM10/ RLA File :05/24/040/00363/AM10/ Lic.No/Date:0510252688 16.11.2009 83

Case No.:14/36/82‐ALC4/2009

Party Name:KAJAY REMEDIES PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00739/AM10/ RLA File :03/94/040/00571/AM10/ Lic.No/Date:0310545944 17.11.2009 Defer Date:23.03.2010 84

Case No.:15/36/82‐ALC4/2009

Party Name:K.PATEL CHEMO PHARMA PVT LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00740/AM10/ RLA File :03/94/040/00620/AM10/ Lic.No/Date:0310545949 17.11.2009 Defer Date:23.03.2010 85

Case No.:17/36/82‐ALC4/2009

Party Name:METROPOLITAN EXIMCHEM LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00742/AM10/ RLA File :03/95/040/00512/AM10/ Lic.No/Date:0310546022 17.11.2009 Defer Date:23.03.2010 86

Case No.:18/36/82‐ALC4/2009

Party Name:SHALINA LABORATORIES PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00743/AM10/ RLA File :03/95/040/00441/AM10/ Lic.No/Date:0310546039 17.11.2009 Defer Date:23.03.2010

Case No.:61/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01124/AM10/ RLA File :03/94/040/00605/AM10/ Lic.No/Date:0310546153 17.11.2009 Defer Date:23.03.2010 88

Case No.:62/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01125/AM10/ RLA File :03/94/040/00698/AM10/ Lic.No/Date:0310546317 18.11.2009 Defer Date:23.03.2010 89

Case No.:60/48/82‐ALC4/2009

23.02.2010 Status:Case Approved HQ File :01/82/050/01123/AM10/ RLA File :03/94/040/00715/AM10/ Lic.No/Date:0310546752 20.11.2009 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms as per SION A‐1945 with 1% wastage. 90

Case No.:47/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01110/AM10/ RLA File :03/94/040/00599/AM10/ Lic.No/Date:0310547381 25.11.2009 Defer Date:23.03.2010 91

Case No.:45/48/82‐ALC4/2009

Party Name:GALAXY SURFACTANTS LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/01108/AM10/ RLA File :03/94/040/00637/AM10/ Lic.No/Date:0310547805 26.11.2009 Defer Date:23.03.2010 92

Case No.:50/48/82‐ALC4/2009

Party Name:S.KANT HEALTHCARE LTD. 23.02.2010 Status:Case Approved HQ File :01/82/050/01113/AM10/ RLA File :03/95/040/00551/AM10/ Lic.No/Date:0310548313

30.11.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 32/82 meeting held on 03.11.2009 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Artemether 1 Kg 1. Artemisinin 1.50 kg Artesunate 1 kg. 1. Artemisinin 0.9259 kg. Dihydro Artemisinin 1 Kg. 1. Artemisinin 1.12 kg 93

Case No.:66/48/82‐ALC4/2009

23.02.2010 Status:Case Approved HQ File :01/82/050/01129/AM10/ RLA File :03/94/040/00702/AM10/ Lic.No/Date:0310548853 03.12.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 28/82 meeting held on 13.11.2007 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Beclate Nasal Spray/Ciplametazon Nasal Spray (50 MCG/200 MD) 1 No. 1. Beclomethasone Dipropionate 3700 gms 2. 63 mcl Aerosol Vasve As per packing policy 3. 19 ml Aluminium Can As per packing policy 4. Actuators with Dust Covers/Caps Fi܂ng to 19 ml Aluminium Can As per packing policy 94

Case No.:67/48/82‐ALC4/2009

23.02.2010 Status:Case Approved HQ File :01/82/050/01130/AM10/ RLA File :03/94/040/00758/AM10/ Lic.No/Date:0310548949 03.12.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/153/2009‐PI‐(Norms) dated 19.01.2010 and in consultation with technical authority present in meeting, decided to revise norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty allowed Telmisartan and Amlodipine Tablet 40/10 mg Each uncoated tablet contains: Telmisartan Granules 67.36 mg equivalent 10,60,000 Nos 1. Telmisartan Granules 897.313 kg 2. Amlodipine Besilate 60.190 kg

to Telmisartan 40 mg, Amlodipine USP 10 mg Telmisartan and Amlodipine Tablet 80/10 mg Each uncoated tablet contains: Telmisartan Granules 134.72 mg equivalent to Telmisartan 80 mg, Amlodipine USP 10 mg 19,99,995 Nos. Telmisartan and Amlodipine Tablet 40/5 mg Each uncoated tablet contains: Telmisartan Granules 67.36 mg equivalent to Telmisartan 40 mg, Amlodipine USP 5 mg 20,00,000 Nos. Telmisartan and Amlodipine Tablet 80/5 mg Each uncoated tablet contains: Telmisartan Granules 134.72 mg equivalent to Telmisartan 80 mg, Amlodipine USP 5 mg 30,00,000 Nos. RA concerned may take further necessary action as per above decision of NC 95

Case No.:71/48/82‐ALC4/2009

Party Name:CENTAUR PHARMACEUTICALS PVT. LTD., 23.02.2010 Status:Case Approved HQ File :01/82/050/01134/AM10/ RLA File :03/94/040/00740/AM10/ Lic.No/Date:0310548862 03.12.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 49/82 meeting held on 24.02.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Chloracetamido‐2‐Chloro‐5‐Nitro Benzaphenone (Chloroacetamido compound) 1 Kg. 1. 2‐Amino‐5‐Nitro 2‐ Chloro Benzophenone 0.820 kg 96

Case No.:38/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01101/AM10/ RLA File :03/94/040/00598/AM10/ Lic.No/Date:0310549279 04.12.2009 Defer Date:23.03.2010

Case No.:42/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01105/AM10/ RLA File :03/94/040/00597/AM10/ Lic.No/Date:0310549287 04.12.2009 Defer Date:23.03.2010 98

Case No.:43/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01106/AM10/ RLA File :03/94/040/00596/AM10/ Lic.No/Date:0310549266 04.12.2009 Defer Date:23.03.2010 99

Case No.:48/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01111/AM10/ RLA File :03/94/040/00476/AM10/ Lic.No/Date:0310549284 04.12.2009 Defer Date:23.03.2010 100

Case No.:41/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01104/AM10/ RLA File :03/94/040/00531/AM10/ Lic.No/Date:0310549545 07.12.2009 Defer Date:23.03.2010 101

Case No.:49/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01112/AM10/ RLA File :03/94/040/00501/AM10/ Lic.No/Date:0310549541 07.12.2009 Defer Date:23.03.2010 102

Case No.:46/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01109/AM10/ RLA File :03/94/040/00685/AM10/ Lic.No/Date:0310550099 09.12.2009 Defer Date:23.03.2010

103

Case No.:1/40/82‐ALC4/2009

Party Name:ANUPAM RASAYAN (INDIA) LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00816/AM10/ RLA File :52/24/040/00023/AM10/ Lic.No/Date:5210029109 15.12.2009 Defer Date:23.03.2010 104

Case No.:3/40/82‐ALC4/2009

Party Name:BALAJI AMINES LIMITED 23.02.2010 HQ File :01/82/050/00818/AM10/ RLA File :31/24/040/00180/AM10/ Lic.No/Date:3110041089 15.12.2009 105

Case No.:11/40/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.02.2010 Status:Case Approved HQ File :01/82/050/00826/AM10/ RLA File :05/24/040/00406/AM10/ Lic.No/Date:0510254670 16.12.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/150/2009‐PI‐(Norms) dated 01.02.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Imipenem/Imipenem Crude 1 Kg. 1. (3R,4R)‐4‐Acetoxy‐3(R)‐(Tert‐ Butyldimethylsilyloxy)‐Ethyl‐2‐Azetidinone 6.52 kg 2 4 Dimethyl Aminopyridine 0.04 kg 3. Acetone 15.86 kg 4. Acetonitrile 1.11 kg 5. Cyclohexane 20.55 kg 6. Cysteamine Hydrochloride 1.12 kg 7. Diphenyl Chlorophosphate 3.53 kg 8. Formic Acid 4.56 kg 9. Isopropyl Alcohol 0.73 kg 10. Methane Sulfonic Acid 1.11 kg 11. Methanol 1.98 kg 12. Methylene Acetoacetate 3.26 kg 13. Methylene Chloride 20.62 kg 14. N,N‐Diisopropyl Ethylamine 5.08 kg 15. N‐Methyl Morholine 0.57 kg

Palladium 0.0125 kg 17. P‐Nitrobenzyl Alcohol 4.29 kg 18. Poly(4‐Vinyl Pyridine) Cross Linked with 2% Divinyl Benzene 0.85 kg 19. Rhodium Octanoate (Dimer) 0.010 kg 20. Tetrahydrofuran 4.00 kg 21. Toluene 3.65 kg 22. Triethylamine 4.60 kg 106

Case No.:13/40/82‐ALC4/2009

Party Name:ANUH PHARMA LTD. 23.02.2010 Status:Case Approved HQ File :01/82/050/00828/AM10/ RLA File :03/94/040/00545/AM10/ Lic.No/Date:0310551165 16.12.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 10/08 meeting held on 10.07.2007 and 11/82 meeting held on 20.07.2007 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Erythromycin Propionate 1 Kg. 1. Erythromycin Thiocyanate 0.900 KGA 107

Case No.:14/40/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 23.02.2010 HQ File :01/82/050/00829/AM10/ RLA File :03/94/040/00513/AM10/ Lic.No/Date:0310551191 16.12.2009 Decision : Committee decided to defer case for 23.03.2010 for comments of Department of MSME. 108

Case No.:4/40/82‐ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00819/AM10/ RLA File :09/24/040/00257/AM10/ Lic.No/Date:0910040253 16.12.2009 Defer Date:23.03.2010 109

Case No.:57/48/82‐ALC4/2009

23.02.2010 Status:Case Approved

HQ File :01/82/050/01120/AM10/ RLA File :03/94/040/00792/AM10/ Lic.No/Date:0310551139 16.12.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/223/2009‐PI‐(Norms) dated 22.02.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Stavudine Capsule 15 mg [Stavudine = 15.3 mg/Capsule] 1 No. 1. 5‐Methyl Uridine 2.597 kg/kg of Stavudine Stavudine Capsule 20 mg [Stavudine = 20.4 mg/Capsule] 1 No. 2. N‐Methyl Morpholine 1.23 kg/kg of Stavudine Stavudine Capsule 30 mg [Stavudine = 30.6 mg/Capsule] 1 No. 3. Methane Sulfonyl Chloride 2.40 kg/kg of Stavudine Stavudine Capsule 40 mg [Stavudine = 40.8 mg/Capsule] 1 No. 4. Dimethyl Formamide 12.74 kg/kg of Stavudine 110

Case No.:58/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01121/AM10/ RLA File :03/94/040/00782/AM10/ Lic.No/Date:0310551036 16.12.2009 Defer Date:23.03.2010 111

Case No.:9/40/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.02.2010 HQ File :01/82/050/00824/AM10/ RLA File :05/24/040/00404/AM10/ Lic.No/Date:0510254651 16.12.2009 112

Case No.:16/40/82‐ALC4/2009

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 23.02.2010 Status:Case Deferred HQ File :01/82/050/00831/AM10/ RLA File :09/24/040/00384/AM10/ Lic.No/Date:0910040330 17.12.2009 Defer Date:23.03.2010 113

Case No.:17/40/82‐ALC4/2009

Party Name:SALICYLATES & CHEMICALS PRIVATE Status:Case

LIMITED 23.02.2010 Deferred HQ File :01/82/050/00832/AM10/ RLA File :09/24/040/00382/AM10/ Lic.No/Date:0910040331 17.12.2009 Defer Date:23.03.2010 114

Case No.:72/48/82‐ALC4/2009

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.02.2010 Status:Case Approved HQ File :01/82/050/01135/AM10/ RLA File :03/94/040/00796/AM10/ Lic.No/Date:0310551321 17.12.2009 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/9/2005/Ch.II dated 22.05.2005 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Astrolide in Diethyl Phthalate/Isopropyl Myristate/Benzyl Benzoate Main Total Astrolide content: 62.5% minium 1 Kg. 1. Alpha Methyl Styrene 0.500 kg 2. Isoamylene 0.380 kg 3. Propylene Oxide 0.280 kg 4. Para Formaldehyde 0.088 kg 115

Case No.:34/48/82‐ALC4/2009

Party Name:TITAN LABORATORIES PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01097/AM10/ RLA File :03/95/040/00617/AM10/ Lic.No/Date:0310551871 21.12.2009 Defer Date:23.03.2010 Decision :Committee considered case as per agenda and decided to call for a copy of Drug Manufacturing Licence from the firm. Accordingly, the case was deferred for 23.03.2010. 116

Case No.:56/48/82‐ALC4/2009

Party Name:PAB ORGANICS PVT.LTD, 23.02.2010 Status:Case Approved HQ File :01/82/050/01119/AM10/ RLA File :34/24/040/00153/AM10/ Lic.No/Date:3410025954 22.12.2009 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 37/82 meeting held on 09.12.2008 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

Export product Export Qty. Sl.No. Import item Qty. allowed 5‐Bromo Phthalide 1 Kg. 1. Hydrobromic Acid 48% 5.00 kg 2. 5‐Amino Phthalide 0.87 kg 117

Case No.:55/48/82‐ALC4/2009

23.02.2010 Status:Case Approved HQ File :01/82/050/01118/AM10/ RLA File :03/94/040/00828/AM10/ Lic.No/Date:0310552727 29.12.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/127/2009‐PI‐(Norms) dated 11.02.2010 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Fipronil 9.7% w/v 3x0.67 ml 1 ml 1. Fipronil 97.97 mg Fipronil 9.7% w/v 3x1.34 ml 1 ml 1. Fipronil 97.97 mg Fipronil Spray 0.25% w/v 100 ml 100 ml 1. Fipronil 0.2525 gm Fipronil Spray 0.25% w/v, 250 ml 250 ml 1. Fipronil 0.63125 gm RLA may calculate the quantity of different packs of Fipronil 8.7% w/v on pro‐rata basis. 118

Case No.:59/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01122/AM10/ RLA File :03/94/040/00837/AM10/ Lic.No/Date:0310553012 30.12.2009 Defer Date:23.03.2010 119

Case No.:37/48/82‐ALC4/2009

Party Name:GLENMARK GENERICS LIMITED 23.02.2010 Status:Case Approved HQ File :01/82/050/01100/AM10/ RLA File :03/94/040/00811/AM10/ Lic.No/Date:0310553930 06.01.2010 Decision : Committee considered case as per agenda and in light of comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

Export product Exp. Qty. Sl.No. Import items Qty. allowed Ezetimibe 1 Kg. 1. Dimethyl Amino Pyridine 0.09 kg 2. N,N‐Dimethyl Formamide 1.52 kg 3. S(+) 4‐Phenyl‐2‐Oxazolidinone 0.93 kg 4. Borane Dimethyl Sulfide 0.424 kg 5. (R)‐2‐Methyl‐CBS‐Oxazaborolidine (1 M Solution in Toluene) 0.057 kg 6. N,O‐Bis (Trimethylsilyl) Acetamide 1.07 kg 7. Tetrahydrofuran 0.074 kg 120

Case No.:53/48/82‐ALC4/2009

Party Name:SUNSHIELD CHEMICALS LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01116/AM10/ RLA File :03/95/040/00592/AM10/ Lic.No/Date:0310554251 07.01.2010 Defer Date:23.03.2010 121

Case No.:68/48/82‐ALC4/2009

23.02.2010 Status:Case Approved HQ File :01/82/050/01131/AM10/ RLA File :03/94/040/00861/AM10/ Lic.No/Date:0310554274 07.01.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/153/2009‐PI‐(Norms) dated 19.01.2010 and in consultation with technical authority present in meeting, decided to revise norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty allowed Telmisartan and Amlodipine Tablet 40/10 mg Each uncoated tablet contains: Telmisartan Granules 67.36 mg equivalent to Telmisartan 40 mg, Amlodipine USP 10 mg 10,00,000 Nos 1. Telmisartan Granules 1477.2005 kg 2. Amlodipine Besilate 93.371 kg Telmisartan and Amlodipine Tablet 80/10 mg Each uncoated tablet contains: Telmisartan Granules 134.72 mg equivalent to Telmisartan 80 mg, Amlodipine USP 10 mg 30,00,000 Nos. Telmisartan and Amlodipine Tablet 40/5 40,00,000

mg Each uncoated tablet contains: Telmisartan Granules 67.36 mg equivalent to Telmisartan 40 mg, Amlodipine USP 5 mg Nos. Telmisartan and Amlodipine Tablet 80/5 mg Each uncoated tablet contains: Telmisartan Granules 134.72 mg equivalent to Telmisartan 80 mg, Amlodipine USP 5 mg 52,50,000 Nos. RA concerned may take further necessary action as per above decision of NC 122

Case No.:4/44/82‐ALC4/2009

Party Name:SARNA CHEMICALS PVT.LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00889/AM10/ RLA File :03/95/040/00601/AM10/ Lic.No/Date:0310555001 13.01.2010 Defer Date:23.03.2010 123

Case No.:6/44/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/00891/AM10/ RLA File :03/95/040/00683/AM10/ Lic.No/Date:0310555180 13.01.2010 Defer Date:23.03.2010 124

Case No.:7/44/82‐ALC4/2009

Party Name:ANUPAM RASAYAN (INDIA) LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/00892/AM10/ RLA File :52/24/040/00027/AM10/ Lic.No/Date:5210029364 13.01.2010 Defer Date:23.03.2010 125

Case No.:9/44/82‐ALC4/2009

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 23.02.2010 HQ File :01/82/050/00894/AM10/ RLA File :31/24/040/00130/AM10/ Lic.No/Date:3110041489 13.01.2010 126

Case No.:10/44/82‐ALC4/2009

Party Name:SANDOZ PRIVATE LIMITED Status:Case

23.02.2010 Deferred HQ File :01/82/050/00895/AM10/ RLA File :03/95/040/00667/AM10/ Lic.No/Date:0310555381 14.01.2010 Defer Date:23.03.2010 127

Case No.:8/44/82‐ALC4/2009

Party Name:EMAMI LIMITED, 23.02.2010 Status:Case Deferred HQ File :01/82/050/00893/AM10/ RLA File :02/24/040/00173/AM10/ Lic.No/Date:0210136503 14.01.2010 Defer Date:23.03.2010 Decision : Committee decided to defer case for 23.03.2010 for comments of DC(MSME). 128

Case No.:16/48/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/01079/AM10/ RLA File :03/94/040/00926/AM10/ Lic.No/Date:0310556732 22.01.2010 Defer Date:23.03.2010 129

Case No.:1/48/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01064/AM10/ RLA File :03/95/040/00722/AM10/ Lic.No/Date:0310558310 03.02.2010 Defer Date:23.03.2010 130

Case No.:2/48/82‐ALC4/2009

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/01065/AM10/ RLA File :31/24/040/00408/AM08/ Lic.No/Date:3110041801 03.02.2010 Defer Date:23.03.2010 131

Case No.:6/48/82‐ALC4/2009

23.02.2010 Status:Case Deferred HQ File :01/82/050/01069/AM10/ RLA File :05/24/040/00445/AM10/ Lic.No/Date:0510257659 03.02.2010 Defer Date:23.03.2010

132

Case No.:7/48/82‐ALC4/2009

23.02.2010 HQ File :01/82/050/01070/AM10/ RLA File :05/24/040/00407/AM10/ Lic.No/Date:0510257661 03.02.2010 133

Case No.:10/48/82‐ALC4/2009

Party Name:ANUH PHARMA LTD. 23.02.2010 Status:Case Approved HQ File :01/82/050/01073/AM10/ RLA File :03/94/040/00877/AM10/ Lic.No/Date:0310558690 04.02.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/171/2009‐PI‐(Norms) dated 04.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Erythromycin Stearate Granulated Direct Compressible for Tablet (86% w/w) 1 Kg. 1. Erythromycin Thiocyanate 0.5385 KGA 134

Case No.:13/48/82‐ALC4/2009

Party Name:KDAC CHEM PVT LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/01076/AM10/ RLA File :34/24/040/00195/AM10/ Lic.No/Date:3410026274 04.02.2010 Defer Date:23.03.2010 135

Case No.:4/48/82‐ALC4/2009

Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01067/AM10/ RLA File :31/24/040/00218/AM10/ Lic.No/Date:3110041820 04.02.2010 Defer Date:23.03.2010 136

Case No.:5/48/82‐ALC4/2009

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 23.02.2010 Status:Case Deferred HQ File :01/82/050/01068/AM10/ RLA File :03/94/040/00927/AM10/ Lic.No/Date:0310558485 04.02.2010 Defer Date:23.03.2010

137

Case No.:8/48/82‐ALC4/2009

Party Name:GUJARAT ORGANICS LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/01071/AM10/ RLA File :03/94/040/00963/AM10/ Lic.No/Date:0310558552 04.02.2010 Defer Date:23.03.2010 138

Case No.:9/48/82‐ALC4/2009

Party Name:OTSUKA CHEMICAL ( INDIA ) LTD. 23.02.2010 Status:Case Approved HQ File :01/82/050/01072/AM10/ RLA File :05/24/040/00468/AM10/ Lic.No/Date:0510257765 04.02.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/151/2009‐PI‐(Norms) dated 05.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed 7‐Phenylacetamideo‐3‐ Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 1 Kg. 1. Penicillin G Potassium Ist Crystal 1.90 kg 2. 2‐Mercaptobenzothiazole 0.511 kg 3. Iso Propyl Alcohol 1.25 kg 4. Methanol 2.00 kg 5. Dimethyl Formamide 3.86 kg 6. Methylene Chloride 2.09 kg 139

Case No.:11/48/82‐ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 23.02.2010 Status:Case Deferred HQ File :01/82/050/01074/AM10/ RLA File :03/94/040/00889/AM10/ Lic.No/Date:0310558811 05.02.2010 Defer Date:23.03.2010 140

Case No.:12/48/82‐ALC4/2009

Party Name:SHREE GANESH REMEDIES PVT.LTD. 23.02.2010 Status:Case Approved HQ File :01/82/050/01075/AM10/ RLA File :34/24/040/00193/AM10/ Lic.No/Date:3410026297 05.02.2010 Decision : Committee considered case as per agenda and observed that Export Cell vide their U.O. 01/91/110/40/AM10/Export Cell dated 03.07.2009 has confirmed that the export product “Di Methyl Amino Propyl Chloride Hydrochloride” does not fall under the Scomet list. They had also furnished the copy of letter dated

23.06.2009 received from Cabinet Secretariate wherein it has been mentioned that the above said export product does not fall under the Scomet. In view of above and and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/135/2009‐PI‐III dated 21.10.2009 and in consultation with technical authority present in meeting, it was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Di Methyl Amino Propyl Chloride Hcl 65% Sodium in water 1 Kg. 1. 1‐Bromo‐3‐Chloro Propane 0.684 kg 141

Case No.:14/48/82‐ALC4/2009

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 23.02.2010 Status:Case Deferred HQ File :01/82/050/01077/AM10/ RLA File :05/23/040/00153/AM10/ Lic.No/Date:0510257903 05.02.2010 Defer Date:23.03.2010 142

Case No.:15/48/82‐ALC4/2009

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 23.02.2010 Status:Case Deferred HQ File :01/82/050/01078/AM10/ RLA File :05/23/040/00165/AM10/ Lic.No/Date:0510257905 05.02.2010 Defer Date:23.03.2010 143

Case No.:3/48/82‐ALC4/2009

Party Name:SRINI PHARMACEUTICALS LTD., 23.02.2010 Status:Case Approved HQ File :01/82/050/01066/AM10/ RLA File :09/24/040/00457/AM10/ Lic.No/Date:0910040840 05.02.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 26/82 meeting held on 23.09.2008 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Levetiracetam 1 Kg 1. (S)+2‐Amino Butyramide Hcl 1.327 kg 144

Case No.:17/48/82‐ALC4/2009

Party Name:AMOLI ORGANICS PVT. LTD., 23.02.2010 Status:Case Deferred

HQ File :01/82/050/01080/AM10/ RLA File :03/94/040/00025/AM10/ Lic.No/Date:0310558999 08.02.2010 Defer Date:23.03.2010 145

Case No.:18/48/82‐ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/01081/AM10/ RLA File :09/24/040/00435/AM10/ Lic.No/Date:0910040860 08.02.2010 Defer Date:23.03.2010 146

Case No.:19/48/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/01082/AM10/ RLA File :09/24/040/00454/AM10/ Lic.No/Date:0910040861 08.02.2010 Defer Date:23.03.2010 147

Case No.:20/48/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/01083/AM10/ RLA File :09/24/040/00455/AM10/ Lic.No/Date:0910040862 08.02.2010 Defer Date:23.03.2010 148

Case No.:21/48/82‐ALC4/2009

Party Name:SAINOR LABORATORIES PVT LTD 23.02.2010 Status:Case Approved HQ File :01/82/050/01084/AM10/ RLA File :09/24/040/00426/AM10/ Lic.No/Date:0910040863 08.02.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 17/82 meeting held on 22.07.2008 and 38/10 meeting held on 15.12.2009, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed N‐Butyl Lithium (15% w/w in n‐ Hexane (100% Active Basis [Total Export Quantity on 100 % Basis = 20950 kgs.] 1 Kg. 1. Lithium Metal 0.300 kg 2. n‐Butyl Chloride 1.60 kg 3. n‐Hexane 6.66 kg

149

Case No.:22/48/82‐ALC4/2009

Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01085/AM10/ RLA File :03/95/040/00724/AM10/ Lic.No/Date:0310559152 09.02.2010 Defer Date:23.03.2010 150

Case No.:23/48/82‐ALC4/2009

Party Name:LAKE CHEMICALS PRIVATE LIMITED 23.02.2010 HQ File :01/82/050/01086/AM10/ RLA File :07/24/040/00418/AM10/ Lic.No/Date:0710069899 09.02.2010 151

Case No.:24/48/82‐ALC4/2009

Party Name:TECKBOND LABORATORIES PRIVATE LIMITED 23.02.2010 Status:Case Deferred HQ File :01/82/050/01087/AM10/ RLA File :09/24/040/00450/AM10/ Lic.No/Date:0910040868 09.02.2010 Defer Date:23.03.2010 152

Case No.:25/48/82‐ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 23.02.2010 Status:Case Deferred HQ File :01/82/050/01088/AM10/ RLA File :03/95/040/00733/AM10/ Lic.No/Date:0310559189 09.02.2010 Defer Date:23.03.2010 153

Case No.:26/48/82‐ALC4/2009

Party Name:SHALINA LABORATORIES PVT. LTD. 23.02.2010 Status:Case Approved HQ File :01/82/050/01089/AM10/ RLA File :03/95/040/00732/AM10/ Lic.No/Date:0310559394 10.02.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 32/82 meeting held on 03.11.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed

Diproson Lotion 30 ml 30 ml pack 1. Betamethasone BP 17.24 mg/30 ml pack 154

Case No.:27/48/82‐ALC4/2009

Party Name:SHALINA LABORATORIES PVT. LTD. 23.02.2010 Status:Case Approved HQ File :01/82/050/01090/AM10/ RLA File :03/95/040/00728/AM10/ Lic.No/Date:0310559399 10.02.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 32/82 meeting held on 03.11.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import item Qty. allowed Betasol Lotion 30 ml (Clobetasol Propionate Topical Solution 0.05% (w/v) 1 No. 1. Betamethasone Base BP 16.816 mg/30 ml bottle 155

Case No.:28/48/82‐ALC4/2009

Party Name:SARNA CHEMICALS PVT.LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01091/AM10/ RLA File :03/95/040/00739/AM10/ Lic.No/Date:0310559500 10.02.2010 Defer Date:23.03.2010 156

Case No.:29/48/82‐ALC4/2009

Party Name:SRINI PHARMACEUTICALS LTD., 23.02.2010 Status:Case Approved HQ File :01/82/050/01092/AM10/ RLA File :09/24/040/00469/AM10/ Lic.No/Date:0910040882 10.02.2010 Decision : Committee considered case as per agenda in light of its earlier decision taken in its 3/82 meeting held on 15.04.2008 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Labetalol Hydro Chloride 1kg. 1. 3‐Amino‐1‐Phenyl Butane/1‐Methyl‐3‐ Phenyl Propylamine 2.70 kg 2. 5‐(bromocetyl) salicylamide 2.48 kg 3. Sodium borohydride 0.20 kg 4. Methanol 6.00 kg

RA concerned may take further necessary action as per above decision of Norms committee. 157

Case No.:30/48/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.02.2010 Status:Case Deferred HQ File :01/82/050/01093/AM10/ RLA File :05/24/040/00476/AM10/ Lic.No/Date:0510258284 11.02.2010 Defer Date:23.03.2010 158

Case No.:31/48/82‐ALC4/2009

Party Name:SARAF CHEMICALS LTD. 23.02.2010 Status:Case Deferred HQ File :01/82/050/01094/AM10/ RLA File :03/95/040/00747/AM10/ Lic.No/Date:0310559872 11.02.2010 Defer Date:23.03.2010

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