IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2010-03-09

DGFT Committee Minutes

Document text

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

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 50/82‐ALC4/2009 MEETING DATE : 09.03.2010 The Meeting No.50/82 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 09.03.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri D.N. Mathur, Dy. IA, Department of Pharmaceuticals 2. Shri M. Mitra, Dy. Drugs Controller (I), DCGI 3. Shri Rajinder Pal Singh, Dy. DGFT 4. Shri Shyam Lal, FTDO

Case No.B‐491

M/S Arch Pharmabals Ltd. Norms Committee Meeting No.49/82 F.No.01/82/050/01348/AM09 F.No.01/82/050/01347/AM09 Meeting Date:02.03.2010 RA F.No.05/24/040/00566/AM03 RA F.No.05/24/040/00562/AM09 Adv.Lic.No.0510231995 dated 02.12.2008 Adv.Lic.No.0510231994dated 02.12.2008 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/50/2009‐PI‐III dated 30.10.2009 and in consultation with technical authority present in meeting, decided to revise 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 Zidovudine USP from Azido Compound 1 Kg. 1. 1‐(4‐Azido‐5‐Trityloxymethyl‐ Tetrahydrofuran‐2‐yl)‐5‐methyl‐1H‐ Pyrimidine‐2,4‐dione (Azido Compound) 2.00 kg RA concerned may take further necessary action as per above decision of NC. The earlier decision taken in 32/82 meeting held on 03.11.2009 may be treated as withdrawn.

Case No. B‐492

M/s Best Value Chem Pvt. Ltd. Norms Committee Meeting No.50/10 F.No.01/82/050/01721/AM09/DES‐III Meeting Date 09.03.2010 RAF No.34/24/040/00225/AM09 Adv. Lic. No. 3410023689 dated 13.03.2009 Committee decided to defer case for 06.04.2010 for comments of Department of C&PC.

Case No. B‐493

M/s Gulbrandsen Chemicals Pvt. Ltd. F.No.01/82/50/01600/AM09/DES‐III RAF No.34/24/040/00197/AM09 Adv. Lic. No. 3410023334 dated 29.01.2009 Committee decided to defer case for 06.04.2010 for comments of Department of C&PC.

Case No. B‐494

M/s Kores (India) Ltd. F.No.01/82/50/00115/AM09/DES‐III RAF No.03/94/040/01072/AM08 Adv. Lic. No. 0310460250 dated 06.02.2008 Committee decided to defer case for 06.04.2010 for comments of Department of Pharmaceuticals.

Case No. B‐495

M/s Cipla Ltd. F.No.01/82/50/00446/AM08/DES‐III RAF No.03/94/040/00857/AM08 Adv. Lic. No. 0310450548 dated 16.11.2007 Committee decided to defer case for 06.04.2010 for comments of Department of Pharmaceuticals.

Case No. B‐447

M/s Cipla Ltd. F.No.01/82/50/00447/AM08/DES‐III RAF No.03/94/040/00860/AM08 Adv. Lic. No. 0310450692 dated 19.11.2007 Committee decided to defer case for 06.04.2010 for comments of Department of Pharmaceuticals.

Case No. B‐497

M/s Cipla Ltd. Norms Committee Meeting No. 50/AM10 F.No.01/82/50/00406/AM08/DES‐III F.No.01/82/50/00408/AM08/DES‐III F.No.01/82/50/00110/AM09/DES‐III RAF No.03/94/040/00250/AM08 RAF No.03/94/040/00383/AM08 RAF No.03/94/040/01099/AM08 Adv. Lic. No. 0310432136 dated 08.06.2007 Adv. Lic. No. 0310436156 dated 13.07.2008

Adv. Lic. No. 0310459961 dated 04.02.2008 Committee decided to defer case for 06.04.2010 for comments of Department of Pharmaceuticals.

Case No. B‐498

M/s Jubilant Organosys Ltd. F.No.01/82/50/00843/AM07/DES‐III RAF No.05/24/040/00455/AM07 Adv. Lic. No0510189933 dated 31.08.2006 Committee decided to defer case for 06.04.2010 for comments of Department of Pharmaceuticals.

Case No. B‐499

M/s Uma Organics Pvt. Ltd. F.No.01/83/050/01094/AM08/DES‐III RAF No.09/24/040/00206/AM08 Adv. Lic. No. 0910031379 dated 03.09.2007 Committee decided to defer case for 06.04.2010 for comments of Department of C&PC.

Case No. B‐500

M/s Benzo Chem Industries P. Ltd. F.No.01/82/050/00449/AM10/DES‐III RAF No.03/95/040/00166/AM10 Adv. Lic. No. 0310533439 dated 12.08.2009 Committee decided to defer case for 04.06.2010 for comments of Department of C&PC.

Case No. B‐501

M/s Cadila Healthcare Ltd. F.No.01/82/050/00495/AM10/DES‐III RAF No.08/24/040/00127/AM10 Adv. Lic. No. 0810082504 dated 24.08.2009 Committee considered case as per agenda and in light of earlier decision taken in 6/82 meeting held on 06.05.2008 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 on repeat basis as per NC decision taken on 06.05.2008:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Meᥰ�ormin tablets 1000 mg 1 Million 1. Meᥰ�ormin Hcl 1020.00 kg 2. Povidone K 90 69.00 kg 3. Microcrystalline Cellulose 54.00 kg 4. Magnesium Stearate 3.90 kg

Hypermellose 79.90 kg 6. Bottles and Caps As per packing policy RA concerned may take further necessary action as per above decision of NC. The earlier decision taken in 32/82 meeting held on 03.11.2009 may be treated as withdrawn.

Case No. B‐502

M/s Reliance Industries Ltd. F.No.01/82/050/01453/AM09/DES‐III RAF No.03/95/040/00598/AM09 Adv. Lic. No. 0310491148 dated 20.10.2008 Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their O.M. No.46011/91/2008‐PC‐II dated 15.12.2009, decided to amend the unit of measurement of import items No. 2 viz. Ammonia from kg to mt without any other change in the decision of NC taken in 34/82 meeting held on 17.11.2009. RA concerned may take further necessary action as per above decision of NC.

Case No. B‐503

M/s Aroma Aromatics & Flavours F.No.01/83/050/01312/AM09/DES‐III RAF No.05/24/040/00524/AM09 Adv. Lic. No. 0510198077 dated 18.01.2007 Adv. Lic. No. 0510231355 dated 24.11.2008 Adv. Lic. No. 0510208035 dated 23.08.2007 Adv. Lic. No. 0510214392 dated 03.01.2008 Adv. Lic. No. 0510220530 dated 14.05.2008 Committee decided to remind Department of C&PC for their comments. Accordingly, case was deferred for 06.04.2010.

Case No. B‐504

M/s Scitech Healthcare Pvt. Ltd. F.No.01/82/050/00436/AM08/DES‐III RAF No.03/95/040/00466/AM08 Adv. Lic. No. 0310445758 dated 09.10.2007 Committee considered case as per agenda and observed that the Drug Manufacturing Licence furnished by firm does not contain the export product i.e. CoQ10 So䬀gel Capsules 30 mg and 120 mg. It was, therefore, decided to reject the case.

Case No. A‐224

M/s Intas Pharma Ltd.

F.No.01/82/162/00205/AM10/DES‐III RAF No.08/24/040/00007/AM10 Adv. Lic. No. 0810079232 dated 09.04.2009 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/175/2009‐PI‐(Norms) dated 15.02.2010, decided to call for the copy of Master Batch Formula certified by Quality Control Incharge for the export product “Terazosin Hydrochloride Tablets” from firm. Accordingly, case was deferred for 20.04.2010.

Case No. A‐225

M/s Shree Ganesh Remedies Pvt. Ltd. F.No.01/82/050/00243/AM08/DES‐III RAF No.34/24/040/00166/AM07 Adv. Lic. No. 3410018711 dated 03.05.2007 Committee decided to defer case for 20.04.2010 for comments of Department of Pharmaceuticals.

Case No. C‐36

M/s. ENCEE Aromatics Pvt. Ltd. Norms Committee Meeting No. 50/10 File No. 01/82/0162/00020/AM10/DES‐III Fixation of SION for Enamber / Kephalis / Tetrambrone. Committee decided to defer case for 06.04.2010 for comments of Department of Pharmaceuticals.

Case No. C‐37

M/s Lupin Ltd. F.No.01/82/162/00853/AM09/DES‐III Committee considered case as per agenda for modification of SION A‐390 and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/168/2009‐PI (Norms) dated 22.02.2010 and in consultation with technical authority present in meeting, decided to modify SION A‐390 as per details below:‐ Export Product Quantity Sl.No. Import items Quantity allowed Rifampicin 1 Kg. 1. Sodium Rifa‐S 0.98 KGA 2. Chloroform 0.661 kg 3. Acetic Acid 0.16 kg 4. Piperzine Anhydrous 0.12 kg 5. Methylene Chloride 0.933 kg 6. Isopropyl Alcohol 0.51 kg 7. Dimethyl Formamide 0.75 kg 8. Tert. Butylamine 0.19 kg 9. Acetone 0.832 kg

1‐Amino‐4‐Methyl Piperazine 0.16 Necessary Public Notice may be issued for publication of modified SION.

Case No. C‐38

M/s Lupin Ltd. F.No.01/82/162/00532/AM08/DES‐III Committee considered case as per agenda for modification of SION A‐225 and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/168/2009‐PI (Norms) dated 22.02.2010 and in consultation with technical authority present in meeting, decided to modify SION A‐225 as per details below:‐ Export Product Quantity Sl.No. Import items Quantity allowed Ethambutol 1 Kg. 1. DL‐2 Amino Butanol 1.6014 kg 2. Tartaric Acid 0.153 kg 3. Methanol 0.562 kg 4. Isopropyl Alcohol 0.278 kg 5. Ethylene Dichloride 0.490 kg 6. Caustic Soda Flakes 0.424 kg 7. Cyclohexane 0.0056 kg 8. Calcium Hydroxide 1.4239 kg Necessary Public Notice may be issued for publication of modified SION.

Case No. C‐39

M/s Gulbrandsen Chemicals Pvt. Ltd. F.No.01/82/162/00210/AM09/DES‐III Committee decided to defer case for 20.04.2010 for comments of Department of C&PC.

Case No. C‐40

M/s Aurobindo Pharma Ltd F.No.01/82/162/00361/AM10/DES‐III Committee considered case as agenda for modification of SION A‐2462 and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/22/2007‐PI‐III dated 24.04.2007 and in consultation with technical authority present in meeting decided to modify SION A‐2462 as per details below:‐ Export Product Quantity Sl.No. Import items Quantity allowed

Cefixime USP 1 Kg. 1. 7‐Phenylacetamideo‐3‐Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) OR 7‐Phenyl Acetamido‐3‐Chloromethyl Cepham‐4‐Carboxylic Acid Diphenyl Methyl Ester (GCLH) 1.555 kg 1.555 kg 2. 4‐Chloro‐2‐(Z) Methyxy Carboxyl Methoxy Amino‐3‐Oxobutyric Acid (CMOBA) OR Alpha‐2‐Amino‐Thiozol‐4‐YL‐Alpha‐Tert. Butoxy Carbonyl 0.82 kg 1.29 kg 3. Triphenyl Phosphine 1.22 kg 4. Triphenyl Phosphite 1.19 kg 5. Phosphorous Oxychloride 0.48 kg 6. Activated Carbon 0.100 kg 7. Cyclo Hexane 0.22 kg 8. Dimethyl Formamide/Acetonitrile 3.07 kg 9. Methylene Chloride/Ethyl Acetate 17.83 kg Necessary Public Notice may be issued for publication of modified SION. 1

Case No.:1/21/82‐ALC4/2007

Party Name:BIOSTADT INDIA LIMITED Meet No/Date:50/82‐ALC4/2009 09.03.2010 Status:Case Approved HQ File :01/82/050/00003/AM08/ RLA File :03/94/040/00819/AM07/ Lic.No/Date:0310416576 18.01.2007 Decision : Committee considered case as per agenda and in light of earlier decision taken in 36/07 meetin held on 14.12.2006 and in consultation with technical authorities 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 on repeat basis:‐

Export product Exp. Qty. Sl.No. Import items Qty. allowed Wokozim Granules (containing 5% Soluble Seaweed Extract Powder) 1 Kg. 1. Soluble Seaweed Extract 0.05 kg 2

Case No.:2/4/85‐ALC3/2007

Party Name:HEINZ INDIA PRIVATE LIMITED 09.03.2010 Status:Case Approved HQ File :01/85/050/00259/AM07/ RLA File :03/94/040/01338/AM07/ Lic.No/Date:0310424928 29.03.2007 Decision :Withdrawn as the case has already been approved in 45/82 meeting held on 02.02.2010. 3

Case No.:52/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 09.03.2010 Status:Case Approved HQ File :01/82/050/00388/AM08/ RLA File :07/24/040/00005/AM08/ Lic.No/Date:0710051374 23.04.2007 Decision : Withdrawn as the case has already been approved in 26/82 meeting held on 22.09.2009. 4

Case No.:19/23/83‐ALC1/2007

Party Name:SEQUENT SCIENTIFIC LIMITED 09.03.2010 Status:Case Approved HQ File :01/83/050/00655/AM08/ RLA File :07/24/040/00234/AM08/ Lic.No/Date:0710052301 04.07.2007 Decision : Withdrawn as the case has already been approved in 45/82 meeting held on 02.02.2010. 5

Case No.:7/25/83‐ALC1/2007

Party Name:ASTRIX LABORATORIES LTD., 09.03.2010 Status:Case Deferred HQ File :01/83/050/01032/AM08/ RLA File :09/24/040/00231/AM08/ Lic.No/Date:0910031314 29.08.2007 Defer Date:30.03.2010 Decision :Committee decided to defer case for 30.03.2010 for comments of Department of Pharmaceuticals. 6

Case No.:35/27/83‐ALC1/2007

Party Name:SHREE GANESH CHEMICALS 09.03.2010 Status:Case Deferred HQ File :01/83/050/01109/AM08/ RLA File :34/24/040/00089/AM08/ Lic.No/Date:3410019570 05.09.2007 Defer Date:30.03.2010 Decision :Committee decided to call the firm for personal hearing alongwith Scomet/Export licence on 30.03.2010. Accordingly, case was deferred for 30.03.2010.

Case No.:62/9/83‐ALC1/2008

Party Name:EXON LABORATORIES PVT LTD 09.03.2010 HQ File :01/83/050/00234/AM09/ RLA File :03/94/040/01245/AM08/ Lic.No/Date:0310466401 27.03.2008 Defer Date:16.03.2010 Decision :Committee decided to defer the case for 16.03.2010 for comments of Department of Pharmaceuticals. 8

Case No.:39/9/82‐ALC4/2008

Party Name:CIPLA LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00272/AM09/ RLA File :03/94/040/01345/AM08/ Lic.No/Date:0310466954 01.04.2008 Defer Date:23.03.2010 Decision:Committee decided to call the firm alongwith a declaration that Zephex 134a/(1,1,1,2,Tetrafluoroethane) (HFA 134A Propellant) is not ODS, for personal hearing in its 52/82 meeting scheduled to be held on 23.03.2010. Accordingly, case was deferred for 23.02.2010. 9

Case No.:79/9/83‐ALC1/2008

Party Name:EXON LABORATORIES PVT LTD 09.03.2010 Status:Case Deferred HQ File :01/83/050/00251/AM09/ RLA File :03/94/040/01323/AM08/ Lic.No/Date:0310466988 01.04.2008 Defer Date:16.03.2010 Decision : Committee decided to defer the case for 16.03.2010 for comments of Department of Pharmaceuticals. 10

Case No.:43/14/83‐ALC1/2008

Party Name:EXON LABORATORIES PVT LTD 09.03.2010 Status:Case Deferred HQ File :01/83/050/00413/AM09/ RLA File :03/94/040/00065/AM09/ Lic.No/Date:0310471590 19.05.2008 Defer Date:16.03.2010 Decision : Committee decided to defer the case for 16.03.2010 for comments of Department of Pharmaceuticals. 11

Case No.:47/14/83‐ALC1/2008

Party Name:EXON LABORATORIES PVT LTD 09.03.2010 Status:Case Deferred HQ File :01/83/050/00417/AM09/ RLA File :03/94/040/00064/AM09/ Lic.No/Date:0310471586 19.05.2008 Defer Date:16.03.2010 Decision : Committee decided to defer the case for 16.03.2010 for comments of Department of Pharmaceuticals. 12

Case No.:2/11/85‐ALC3/2008

Party Name:ASTRIX LABORATORIES LTD., 09.03.2010 Status:Case Approved HQ File :01/85/050/00086/AM09/ RLA File :09/24/040/00079/AM09/ Lic.No/Date:0910034354 19.06.2008

Decision :Withdrawn as the case has already been approved by NC in 45/82 meeting held on 02.02.2010. 13

Case No.:17/15/82‐ALC4/2008

Party Name:EMAMI LIMITED, 09.03.2010 Status:Case Deferred HQ File :01/82/050/00657/AM09/ RLA File :02/24/040/00062/AM09/ Lic.No/Date:0210114088 25.06.2008 Defer Date:06.04.2010 Decision : Committee decided to defer the case for 06.04.2010 for comments of DC(MSME). 14

Case No.:12/17/82‐ALC4/2008

Party Name:ANUS LABORATORIES LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00736/AM09/ RLA File :09/24/040/00552/AM08/ Lic.No/Date:0910034576 11.07.2008 Defer Date:16.03.2010 Decision : Committee decided to defer the case for 16.03.2010 for comments of Department of Pharmaceuticals. 15

Case No.:26/20/82‐ALC4/2008

Party Name:BIOCHEMICAL & SYNTHETIC PRODUCTS LTD 09.03.2010 Status:Case Approved HQ File :01/82/050/00819/AM09/ RLA File :09/24/040/00167/AM09/ Lic.No/Date:0910034850 30.07.2008 Decision :Withdrawn as the case has already been approved by NC in 45/82 meeting held on 02.02.2010. 16

Case No.:20/22/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 09.03.2010 Status:Case approved HQ File :01/82/050/00883/AM09/ RLA File :08/24/040/00070/AM09/ Lic.No/Date:0810073981 14.08.2008 Decision : Withdrawn as the case has already been approved by NC in 45/82 meeting held on 02.02.2010. 17

Case No.:39/22/82‐ALC4/2008

09.03.2010 Status:Case Approved HQ File :01/82/050/00902/AM09/ RLA File :03/94/040/00451/AM09/ Lic.No/Date:0310482900 18.08.2008 18

Case No.:7/41/82‐ALC4/2008

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 09.03.2010 HQ File :01/82/050/01447/AM09/ RLA File :04/24/040/00138/AM09/ Lic.No/Date:0410098239 28.08.2008 Defer Date:30.03.2010

Decision :Committee decided to defer case for 30.03.2010 for reply from firm. 19

Case No.:19/26/82‐ALC4/2008

Party Name:R L FINE CHEM 09.03.2010 HQ File :01/82/050/01017/AM09/ RLA File :07/24/040/00297/AM09/ Lic.No/Date:0710059800 15.09.2008 Defer Date:30.03.2010 Decision :Committee decided to forward a copy of complete application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.03.2010. 20

Case No.:29/28/82‐ALC4/2008

Party Name:ASTRIX LABORATORIES LTD., 09.03.2010 Status:Case Approved HQ File :01/82/050/01078/AM09/ RLA File :09/24/040/00237/AM09/ Lic.No/Date:0910035465 29.09.2008 21

Case No.:33/41/82‐ALC4/2008

Party Name:INTERMED LABS PVT. LTD., 09.03.2010 Status:Case Approved HQ File :01/82/050/01473/AM09/ RLA File :07/24/040/00371/AM09/ Lic.No/Date:0710060370 10.10.2008 22

Case No.:60/29/82‐ALC4/2008

09.03.2010 HQ File :01/82/050/01142/AM09/ RLA File :03/94/040/00672/AM09/ Lic.No/Date:0310489879 10.10.2008 Defer Date:23.03.2010 Decision :Committee decided to call the firm for personal hearing on 23.03.2010. Accordingly, case was deferred for 23.03.2010. 23

Case No.:3/32/82‐ALC4/2008

Party Name:D.TOTLA PLASTIC 09.03.2010 Status:Case Deferred HQ File :01/82/050/01178/AM09/ RLA File :03/94/040/00710/AM09/ Lic.No/Date:0310491145 20.10.2008 Defer Date:30.03.2010 Decision : Committee decided to defer case for 30.03.2010 for comments of Department of C&PC. 24

Case No.:26/33/82‐ALC4/2008

Party Name:SMILAX LABORATORIES LIMITED 09.03.2010 Status:Case Approved

HQ File :01/82/050/01242/AM09/ RLA File :09/24/040/00303/AM09/ Lic.No/Date:0910035860 06.11.2008 25

Case No.:29/41/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/01469/AM09/ RLA File :03/94/040/00752/AM09/ Lic.No/Date:0310493255 06.11.2008 Defer Date:30.03.2010 Decision :Committee considered case as per agenda and observed that the written comments of DC(MSME) are not forthcoming for a long period. It was, therefore, decided to remind DC(MSME) for their comments through DO letter at the level of Chairman, NC‐III. Accordingly, case was deferred for 30.03.2010. 26

Case No.:16/38/82‐ALC4/2008

Party Name:M.J. BIOPHARM PVT. LTD. 09.03.2010 Status:Case Approved HQ File :01/82/050/01365/AM09/ RLA File :03/95/040/00621/AM09/ Lic.No/Date:0310496924 08.12.2008 27

Case No.:20/38/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 09.03.2010 Status:Case Approved HQ File :01/82/050/01369/AM09/ RLA File :05/24/040/00574/AM09/ Lic.No/Date:0510232237 08.12.2008 Decision : Withdrawn as the case has already been approved by NC in 49/82 meeting held on 02.03.2010. 28

Case No.:1/40/82‐ALC4/2008

Party Name:INTAS PHARMACEUTICALS LTD., 09.03.2010 HQ File :01/82/050/01420/AM09/ RLA File :08/24/040/00187/AM09/ Lic.No/Date:0810076754 16.12.2008 Defer Date:13.04.2010 Decision :Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/175/2009‐PI‐(Norms) dated 17.02.2010, decided to call for copy of Master Batch Formula duly certified by Quality Control Incharge. Accordingly, case was deferred for 13.04.2009. 29

Case No.:46/39/82‐ALC4/2008

Party Name:DR REDDYS LABORATORIES LTD 09.03.2010 Status:Case Approved HQ File :01/82/050/01416/AM09/ RLA File :09/24/040/00352/AM09/ Lic.No/Date:0910036323 16.12.2008 Decision :Withdrawn as the case has already been approved by NC in 45/82 meeting held on 02.02.2010.

Case No.:47/39/82‐ALC4/2008

Party Name:DR REDDYS LABORATORIES LTD 09.03.2010 Status:Case Approved HQ File :01/82/050/01417/AM09/ RLA File :09/24/040/00355/AM09/ Lic.No/Date:0910036324 16.12.2008 31

Case No.:2/41/82‐ALC4/2008

Party Name:BALAJI AMINES LIMITED 09.03.2010 Status:Case Rejected HQ File :01/82/050/01442/AM09/ RLA File :31/24/040/00244/AM09/ Lic.No/Date:3110036556 19.12.2008 Decision : Withdrawn as the case has already been rejected by NC in 32/82 meeting held on 03.11.2009. 32

Case No.:35/41/82‐ALC4/2008

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 09.03.2010 Status:Case Approved HQ File :01/82/050/01475/AM09/ RLA File :22/24/040/00055/AM09/ Lic.No/Date:2210008528 24.12.2008 33

Case No.:3/42/82‐ALC4/2008

Party Name:INTAS PHARMACEUTICALS LTD., 09.03.2010 Status:Case Approved HQ File :01/82/050/01481/AM09/ RLA File :08/24/040/00193/AM09/ Lic.No/Date:0810077034 30.12.2008 Decision : Withdrawn as the case has already been approved by NC in 49/82 meeting held on 02.03.2010. 34

Case No.:17/1/83‐ALC1/2009

Party Name:PRACHI PHARMACEUTICALS PVT LTD 09.03.2010 Status:Case Deferred HQ File :01/83/050/01355/AM09/ RLA File :03/95/040/00906/AM09/ Lic.No/Date:0310510030 03.03.2009 Defer Date:06.04.2010 Decision :Committee decided to defer case for 06.04.2010 for comments of Department of Pharmaceuticals. 35

Case No.:7/1/82‐ALC4/2009

Party Name:KAMUD DRUGS PVT.LIMITED., 09.03.2010 Status:Case Approved HQ File :01/82/050/01727/AM09/ RLA File :31/24/040/00327/AM09/ Lic.No/Date:3110037707 17.03.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M.

No.35011/259/2009‐PI‐(Norms) dated 08.03.2010 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 Sertraline 1 Kg. 1. 4‐(3 4‐Dichlorophenyl) 1‐ Tetralone 3.27 kg 36

Case No.:4/54/82‐ALC4/2008

Party Name:PADMINI AROMATICS PVT. LTD 09.03.2010 Status:Case Rejected HQ File :01/82/050/01706/AM09/ RLA File :07/24/040/00660/AM09/ Lic.No/Date:0710063727 19.03.2009 Decision : Withdrawn as the case has already been rejected by NC in 49/82 meeting held on 02.03.2010. 37

Case No.:13/1/82‐ALC4/2009

Party Name:SOLARIS CHEMTECH INDUSTRIES LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/01733/AM09/ RLA File :34/24/040/00232/AM09/ Lic.No/Date:3410023787 20.03.2009 Defer Date:06.04.2010 Decision : Committee decided to defer case for 06.04.2010 for comments of Department of C&PC. 38

Case No.:9/2/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00009/AM10/ RLA File :03/94/040/01131/AM09/ Lic.No/Date:0310514341 02.04.2009 Defer Date:06.04.2010 Decision :Committee decided to forward a copy of application to Department of Animal Husbandry for their comments. Accordingly, case was deferred for 06.04.2010. 39

Case No.:22/14/82‐ALC4/2009

Party Name:INTAS PHARMACEUTICALS LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00192/AM10/ RLA File :08/24/040/00007/AM10/ Lic.No/Date:0810079232 09.04.2009 Defer Date:20.04.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/175/2009‐PI‐(Norms) dated 15.02.2010, decided to call for the copy of Master Batch Formula certified by Quality Control Incharge for the export product “Terazosin Hydrochloride Tablets” from firm. Accordingly, case was deferred for 20.04.2010. 40

Case No.:2/4/82‐ALC4/2009

Party Name:ANUPAM RASAYAN (INDIA) LTD 09.03.2010 Lic.No/Date:5210026130

HQ File :01/82/050/00023/AM10/ RLA File :52/24/040/00032/AM09/ 15.04.2009 Defer Date:06.04.2010 41

Case No.:8/4/82‐ALC4/2009

Party Name:METROPOLITAN EXIMCHEM LTD. 09.03.2010 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:30.03.2010 Decision : Committee decided to defer case for 30.03.2010 for comments of Department of C&PC. 42

Case No.:1/5/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00034/AM10/ RLA File :09/24/040/00005/AM10/ Lic.No/Date:0910037716 22.04.2009 Defer Date:06.04.2010 43

Case No.:14/5/82‐ALC4/2009

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00047/AM10/ RLA File :04/24/040/00002/AM10/ Lic.No/Date:0410104217 24.04.2009 Defer Date:06.04.2010 Decision : Committee decided to defer case for 06.04.2010 for comments of Department of Pharmaceuticals. 44

Case No.:2/3/85‐ALC3/2009

Party Name:S.M. HERBALS PVT.LTD. 09.03.2010 Status:Case Approved HQ File :01/85/050/00017/AM10/ RLA File :05/24/040/00017/AM10/ Lic.No/Date:0510240516 29.04.2009 Decision :Committee considered case as per agenda. The representative of the firm appeared for personal hearing before the committee and explained the case. He informed that he will be making the imports from China and a䬀er purification, the resultant product will be exported to other countries. A䬀er detailed deliberations, Committee 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 Camptothecin (HPLC Purity NLT 98.5%) 1 kg. 1. Crude Camptothecin (HPLC Purity NLT 95%) 1.02 kg 45

Case No.:11/14/82‐ALC4/2009

Party Name:UNIMARK REMEDIES LIMITED., Status:Case

09.03.2010 Approved HQ File :01/82/050/00181/AM10/ RLA File :03/95/040/00212/AM08/ Lic.No/Date:0310518138 04.05.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/262/2009‐PI‐(Norms) dated 08.03.2010 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‐AVCA 1 Kg. 1. 7‐Phenylacetamideo‐3‐Chloromethyl Cephalosporanic Acid Para methoxybenzyl Ester (GCLE) 2.672 kg 2. Methylene Chloride 5.488 kg 3. Triphenyl Phosphite 1.260 kg 4. Sodium Iodide 0.828 kg 5. Dimethyl Formamide 1.743 kg 6. Methanol 13.156 kg 7. Phenol 0.933 kg 8. N‐Butyl Acetate 2.612 kg 9. Ethylene Diamine Tetra Acetic Acid 0.56 kg 10. Activated Carbon 0.100 kg 11. Acetone 2.726 kg 46

Case No.:35/14/82‐ALC4/2009

Party Name:R L FINE CHEM 09.03.2010 Status:Case Deferred HQ File :01/82/050/00205/AM10/ RLA File :07/24/040/00031/AM10/ Lic.No/Date:0710064493 04.05.2009 Defer Date:06.04.2010 Decision :Committee decided to defer case for 06.04.2010 for comments of Department of Pharmaceuticals. 47

Case No.:2/7/82‐ALC4/2009

Party Name:INTAS PHARMACEUTICALS LTD., 09.03.2010 Status:Case Approved HQ File :01/82/050/00073/AM10/ RLA File :08/24/040/00018/AM10/ Lic.No/Date:0810079753 05.05.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/175/2009/‐PI‐(Norms) dated 15.02.2010 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

Alendronic Acid 10 mg Tablets 61,30,000 Nos. 1. Alendronate Sodium PH EUR 160.014 kg Alendronic Acid 70 mg Tablets 8,75,700 No. 48

Case No.:14/7/82‐ALC4/2009

Party Name:SEQUEL PHARMACHEM PRIVATE LIMITED 09.03.2010 Status:Case Approved HQ File :01/82/050/00085/AM10/ RLA File :03/95/040/00058/AM10/ Lic.No/Date:0310519005 08.05.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/266/2009/‐PI‐(Norms) dated 08.03.2010 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 Telmisartan 1 Kg. 1. Methyl‐4‐Bromomethyl‐Biphenyl‐2‐Carboxylate 1.00 kg 2. 2‐N‐Propyl‐4‐Methyl‐6‐(1‐Methyl Benzimidazol‐2‐ YL‐Benzimdazole Monohydrate 0.8345 kg 49

Case No.:15/7/82‐ALC4/2009

Party Name:MOREPEN LABORATORIES LTD., 09.03.2010 Status:Case Approved HQ File :01/82/050/00086/AM10/ RLA File :05/24/040/00032/AM10/ Lic.No/Date:0510241018 08.05.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/216/2009/‐PI‐(Norms) dated 25.02.2010 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 4‐OxiranylMethoxy‐9(H) Cabazole (CD3) Min. Assay 99% 1 Kg. 1. 4‐Hydroxy Carbazole (CD2) 1.13 kg 2. Epichlorohydrin Min. Assay 98% 0.90 kg 3. Isopropanol Min, Assay 99% 0.95 kg 50

Case No.:21/7/82‐ALC4/2009

Party Name:LUPIN LIMITED 09.03.2010 Status:Case Approved HQ File :01/82/050/00092/AM10/ RLA File :03/95/040/00044/AM10/ Lic.No/Date:0310519136

08.05.2009 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 in consultation with the representative of technical authority present in the meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis of NC decision dated 23.02.2009:‐ 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 12. 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 51

Case No.:7/8/82‐ALC4/2009

Party Name:SHILPA MEDICARE LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00102/AM10/ RLA File :07/24/040/00053/AM10/ Lic.No/Date:0710064718 13.05.2009 Defer Date:06.04.2010

Case No.:3/14/82‐ALC4/2009

Party Name:HETERO DRUGS LIMITED, 09.03.2010 Status:Case Deferred HQ File :01/82/050/00173/AM10/ RLA File :09/24/040/00052/AM10/ Lic.No/Date:0910037939 19.05.2009 Defer Date:06.04.2010 53

Case No.:4/14/82‐ALC4/2009

Party Name:MSN PHARMACHEM PRIVATE LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00174/AM10/ RLA File :09/24/040/00054/AM10/ Lic.No/Date:0910037983 21.05.2009 Defer Date:06.04.2010 54

Case No.:28/19/82‐ALC4/2009

Party Name:ONEIRO CHEMICALS LTD 09.03.2010 Status:Case Approved HQ File :01/82/050/00406/AM10/ RLA File :34/24/040/00027/AM10/ Lic.No/Date:3410024237 25.05.2009 Decision : Committee considered case as per agenda for ratification of norms and in light of earlier decision taken in 34/82 meeting held on 17.11.2009 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 on repeat basis (NC decision dated 17.11.2009):‐ Export product Export Qty. Sl.No. Import items Qty. allowed 2‐Chloromethyl‐3,5‐Dimethyl‐4‐ Methoxy Pyridine Hydrochloride 1 Kg. 1. 3,5 Lutidine 1.77 kg 2. Toluene 5.20 kg 3. Methanol 4.14 kg 4. Acetone Not used in process. Hence not allowed. 5. Activated Carbon 0.100 kg 6. Ammonium Persulphates 2.43 kg 55

Case No.:9/21/82‐ALC4/2009

Party Name:DISTO PHARMACEUTICALS PRIVATE LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00436/AM10/ RLA File :09/24/040/00025/AM10/ Lic.No/Date:0910038077 02.06.2009 Defer Date:20.04.2010 Decision :Committee considered case as per agenda and observed that the copy of DML furnished by the firm does not contain the export product Ketoprofen Lysine Eneric Coated Pellets 71%. It was, therefore, decided to call for the copy of relevant DML. Accordingly, case was deferred for 20.04.2010.

py g y 56

Case No.:7/13/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00147/AM10/ RLA File :08/24/040/00034/AM10/ Lic.No/Date:0810080489 05.06.2009 Defer Date:06.04.2010 57

Case No.:7/21/82‐ALC4/2009

Party Name:DIVIS LABORATORIES LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00434/AM10/ RLA File :09/24/040/00078/AM10/ Lic.No/Date:0910038159 05.06.2009 Defer Date:06.04.2010 58

Case No.:39/14/82‐ALC4/2009

Party Name:BAYER CROPSCIENCE LIMITED 09.03.2010 Status:Case Approved HQ File :01/82/050/00209/AM10/ RLA File :03/94/040/00190/AM10/ Lic.No/Date:0310523818 12.06.2009 Decision :Withdrawn as the case has already been approved by NC in 49/82 meeting held on 02.03.2010. 59

Case No.:42/14/82‐ALC4/2009

Party Name:LUPIN LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00212/AM10/ RLA File :03/95/040/00128/AM10/ Lic.No/Date:0310524133 15.06.2009 Defer Date:06.04.2010 Decision :Committee considered case as per agenda and observed that technical comments have been received from Department of Pharmaceuticals in which the quantity of Penicillin G Potassium (First Crystal) has been shown in BOU, while the firm has requested to allow the quantity of the said input in kg. It was, therefore, decided to call for a copy of amendment sheet from the firm. Accordingly, case was deferred for 06.04.2010. 60

Case No.:47/14/82‐ALC4/2009

Party Name:NEON LABORATORIES LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00217/AM10/ RLA File :03/95/040/00165/AM10/ Lic.No/Date:0310524407 16.06.2009 Defer Date:20.04.2010 Decision :Committee decided to defer case for 20.04.2010 for comments of Export Cell. 61

Case No.:35/13/82‐ALC4/2009

09.03.2010 Lic.No/Date:0310524761

HQ File :01/82/050/00225/AM10/ RLA File :03/94/040/00193/AM10/ 18.06.2009 62

Case No.:1/15/82‐ALC4/2009

Party Name:INDO PHYTOCHEM PHARMACEUTICALS 09.03.2010 Status:Case Approved HQ File :01/82/050/00230/AM10/ RLA File :05/24/040/00122/AM10/ Lic.No/Date:0510244074 19.06.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 45/82 meeting held on 02.02.2010 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 on repeat basis (NC decision dated 02.02.2010):‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Reserpine BP/EP/USP 1 Kg. 1. Ruawolfia Vomitoria Bark (containing Reserpine 0.9% to 1.0%) 153.8 kgs. 63

Case No.:3/15/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00232/AM10/ RLA File :03/94/040/00108/AM10/ Lic.No/Date:0310525011 19.06.2009 Defer Date:06.04.2010 64

Case No.:38/13/82‐ALC4/2009

Party Name:SYMED LABS LTD. 09.03.2010 Status:Case Approved HQ File :01/82/050/00228/AM10/ RLA File :09/24/040/00071/AM10/ Lic.No/Date:0910038300 19.06.2009 Decision : Committee considered case as per agenda and in light of decision of NC taken in the case of M/S Anuh Pharma Ltd 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 Gemfibrozil 1 Kg. 1. 5‐(2,5‐Dimethylphenoxy)‐2,2‐ Dimethylpentanoic Acid Net to Net 2. Methanol 1.00 kg

Case No.:30/19/82‐ALC4/2009

Party Name:SURYA PHARMACEUTICAL LTD

65 y 09.03.2010 HQ File :01/82/050/00408/AM10/ RLA File :22/24/040/00015/AM10/ Lic.No/Date:2210009018 22.06.2009 66

Case No.:11/15/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00240/AM10/ RLA File :05/24/040/00169/AM10/ Lic.No/Date:0510244336 23.06.2009 Defer Date:06.04.2010 67

Case No.:7/15/82‐ALC4/2009

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00236/AM10/ RLA File :04/24/040/00059/AM10/ Lic.No/Date:0410105528 23.06.2009 Defer Date:06.04.2010 68

Case No.:27/19/82‐ALC4/2009

Party Name:DR REDDYS LABORATORIES LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/00405/AM10/ RLA File :09/24/040/00113/AM10/ Lic.No/Date:0910038400 02.07.2009 Defer Date:06.04.2010 69

Case No.:11/17/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00274/AM10/ RLA File :05/24/040/00204/AM10/ Lic.No/Date:0510245517 10.07.2009 Defer Date:06.04.2010 70

Case No.:20/46/82‐ALC4/2009

Party Name:ENCUBE ETHICALS PVT LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/00936/AM10/ RLA File :03/94/040/00180/AM10/ Lic.No/Date:0310529948 21.07.2009 Defer Date:06.04.2010 Decision : Committee decided to defer case for 06.04.2010 for comments of DC(MSME).

Case No.:22/46/82‐ALC4/2009

Party Name:GUJARAT ORGANICS LTD., 09.03.2010 Status:Case Deferreed HQ File :01/82/050/00938/AM10/ RLA File :03/94/040/00363/AM10/ Lic.No/Date:0310531789 31.07.2009 Defer Date:06.04.2010 72

Case No.:11/20/82‐ALC4/2009

Party Name:NEULAND LABORATORIES LTD 09.03.2010 Status:Case Approved HQ File :01/82/050/00422/AM10/ RLA File :09/24/040/00144/AM10/ Lic.No/Date:0910038818 06.08.2009 Decision :Committee decided to close the case as the firm has surrendered the licence. 73

Case No.:16/20/82‐ALC4/2009

Party Name:PANACEA BIOTEC LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00427/AM10/ RLA File :05/24/040/00262/AM10/ Lic.No/Date:0510247323 06.08.2009 Defer Date:06.04.2010 Decision : Committee decided to defer case for 06.04.2010 for comments of Department of Bio‐technology. 74

Case No.:18/46/82‐ALC4/2009

09.03.2010 HQ File :01/82/050/00934/AM10/ RLA File :03/94/040/00406/AM10/ Lic.No/Date:0310532726 07.08.2009 75

Case No.:25/46/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00941/AM10/ RLA File :03/94/040/00434/AM10/ Lic.No/Date:0310534556 20.08.2009 Defer Date:06.04.2010 76

Case No.:9/34/82‐ALC4/2009

Party Name:SURYA PHARMACEUTICAL LTD 09.03.2010 HQ File :01/82/050/00654/AM10/ RLA File :22/24/040/00021/AM10/ Lic.No/Date:2210009180 20.08.2009

Case No.:108/46/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 09.03.2010 HQ File :01/82/050/01024/AM10/ RLA File :09/24/040/00182/AM10/ Lic.No/Date:0910039159 31.08.2009 78

Case No.:110/46/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 09.03.2010 HQ File :01/82/050/01026/AM10/ RLA File :09/24/040/00147/AM10/ Lic.No/Date:0910039160 31.08.2009 79

Case No.:111/46/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/01027/AM10/ RLA File :09/24/040/00183/AM10/ Lic.No/Date:0910039161 31.08.2009 Defer Date:06.04.2010 80

Case No.:91/46/82‐ALC4/2009

Party Name:HETERO LABS LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/01007/AM10/ RLA File :09/24/040/00207/AM10/ Lic.No/Date:0910039145 31.08.2009 Defer Date:06.04.2010 81

Case No.:93/46/82‐ALC4/2009

Party Name:GLAND PHARMA LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/01009/AM10/ RLA File :09/24/040/00193/AM10/ Lic.No/Date:0910039156 31.08.2009 Defer Date:06.04.2010 82

Case No.:109/46/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/01025/AM10/ RLA File :09/24/040/00209/AM10/ Lic.No/Date:0910039257 08.09.2009 Defer Date:06.04.2010

Case No.:2/26/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00534/AM10/ RLA File :09/24/040/00185/AM10/ Lic.No/Date:0910039258 09.09.2009 Defer Date:06.04.2010 84

Case No.:3/26/82‐ALC4/2009

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 09.03.2010 Status:Case Approved HQ File :01/82/050/00535/AM10/ RLA File :05/24/040/00298/AM10/ Lic.No/Date:0510248980 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.35011/216/2009‐PI‐(Norms) dated 25.02.2010 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 Sultamicillin Base 1 Kg. 1. Iodomethylsulbactam 1.11 kg 2. Ampicillin Trihydrate/Anhydrous 1.02 kg 3. Isopropyl Ether 0.885 kg 4. Isopropyl Alcohol 3.04 kg 5. N,N Dimethyl Formamide 1.58 kg 6. Methanol 0.44 kg 7. N,N‐Diisopropyl Ethylamine 0.62 kg Committee also accepted the recommendation of Department of Pharmaceuticals received vide O.M. mentioned above for revision of SION A‐2951 and decided to modify SION A‐2951 as per details below:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Sultamicillin Base 1 Kg. 1. 6‐APA 2.05 kg 2. Ampicillin Trihydrate 1.02 kg 3. 2‐Ethyl Hexanoic Acid 0.92 kg 4. Methyl Aceto Acetate 0.51 kg 5. Dimethyl Formamide 1.78 kg 6. Methylene Chloride 5.68 kg 7. Acetonitrile 1.38 kg Necessary Public Notice may be issued for publication of revision of SION A‐2951

Case No.:5/26/82‐ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00537/AM10/ RLA File :03/94/040/00449/AM10/ Lic.No/Date:0310537058 10.09.2009 Defer Date:06.04.2010 86

Case No.:102/46/82‐ALC4/2009

Party Name:MSN LABORATORIES LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/01018/AM10/ RLA File :09/24/040/00211/AM10/ Lic.No/Date:0910039292 11.09.2009 Defer Date:06.04.2010 87

Case No.:29/46/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00945/AM10/ RLA File :03/94/040/00503/AM10/ Lic.No/Date:0310537810 15.09.2009 Defer Date:06.04.2010 88

Case No.:46/46/82‐ALC4/2009

Party Name:TADIMETY AROMATICS PVT. LTD 09.03.2010 Status: Case Deferred HQ File :01/82/050/00962/AM10/ RLA File :07/24/040/00221/AM10/ Lic.No/Date:0710067059 17.09.2009 Defer Date:06.04.2010 89

Case No.:41/46/82‐ALC4/2009

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 09.03.2010 Status:Case Deferred HQ File :01/82/050/00957/AM10/ RLA File :07/24/040/00227/AM10/ Lic.No/Date:0710067164 23.09.2009 Defer Date:06.04.2010 90

Case No.:14/34/82‐ALC4/2009

Party Name:AUROBINDO PHARMA LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00659/AM10/ RLA File :09/24/040/00235/AM10/ Lic.No/Date:0910039409 25.09.2009 Defer Date:06.04.2010

Case No.:15/34/82‐ALC4/2009

Party Name:AUROBINDO PHARMA LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00660/AM10/ RLA File :09/24/040/00213/AM10/ Lic.No/Date:0910039410 25.09.2009 Defer Date:06.04.2010 92

Case No.:97/46/82‐ALC4/2009

Party Name:ANUS LABORATORIES LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/01013/AM10/ RLA File :09/24/040/00161/AM10/ Lic.No/Date:0910039413 25.09.2009 Defer Date:06.04.2010 93

Case No.:71/46/82‐ALC4/2009

Party Name:METROPOLITAN EXIMCHEM LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00987/AM10/ RLA File :03/95/040/00415/AM10/ Lic.No/Date:0310539636 29.09.2009 Defer Date:06.04.2010 94

Case No.:16/34/82‐ALC4/2009

Party Name:APITHECARY PHARMA PVT LTD. 09.03.2010 Status:Case Approved HQ File :01/82/050/00661/AM10/ RLA File :09/24/040/00237/AM10/ Lic.No/Date:0910039469 05.10.2009 Decision : Committee considered case as per agenda and in light of written comments earlier forwarded by Department of Pharmaceuticals vide their U.O. No.35011/81/2007‐PI‐III dated 11.02.2008 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 Exp. Qty. Sl.No. Import items Qty. allowed 5‐O‐Trityl‐2,3‐ Anhydrothymidine 1 Kg. 1. Beta Thymidine 0.6263 kg 2. Trityl Chloride 0.719 kg 3. 1,4‐Dioxane 0.712 kg 4. TEA 0.576 kg 5. M.S.C. 0.365 kg 6. Methylene Chloride 2.80 kg

Case No.:3/30/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00604/AM10/ RLA File :09/24/040/00260/AM10/ Lic.No/Date:0910039512 08.10.2009 Defer Date:06.04.2010 96

Case No.:54/46/82‐ALC4/2009

Party Name:R L FINE CHEM 09.03.2010 Status:Case Approved HQ File :01/82/050/00970/AM10/ RLA File :07/24/040/00242/AM10/ Lic.No/Date:0710067507 09.10.2009 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 19/82 meeting held on 04.08.2009 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 on repeat basis (NC decision dated 04.08.2009):‐ Export Product Export Qty. Sl.No. Import items Qty. allowed Clomipramine Hcl 1 Kg. 1. 1 Bromo 3 Chloro Propane 0.85 kg 2. 3 Chloro Iminodibenzyl 0.91 kg 97

Case No.:10/30/82‐ALC4/2009

Party Name:INTAS PHARMACEUTICALS LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00611/AM10/ RLA File :08/24/040/00174/AM10/ Lic.No/Date:0810083512 12.10.2009 Defer Date:06.04.2010 98

Case No.:107/46/82‐ALC4/2009

Party Name:MSN LABORATORIES LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/01023/AM10/ RLA File :09/24/040/00274/AM10/ Lic.No/Date:0910039680 21.10.2009 Defer Date:06.04.2010 99

Case No.:95/46/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 09.03.2010 HQ File :01/82/050/01011/AM10/ RLA File :09/24/040/00241/AM10/ Lic.No/Date:0910039755 29.10.2009 Decision : Committee decided to defer case for 06.04.2010 for comments of DC(MSME).

100

Case No.:123/46/82‐ALC4/2009

Party Name:VIVEK PHARMACHEM (INDIA) LTD., 09.03.2010 Status:Case Rejected HQ File :01/82/050/01039/AM10/ RLA File :13/24/040/00018/AM10/ Lic.No/Date:1310030395 04.11.2009 Decision :Committee considered case as per agenda and observed that the items of export and import and same. It was, therefore, decided to reject the case. 101

Case No.:44/46/82‐ALC4/2009

Party Name:TORRENT PHARMACEUTICALS LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00960/AM10/ RLA File :08/24/040/00186/AM10/ Lic.No/Date:0810083867 04.11.2009 Defer Date:06.04.2010 102

Case No.:45/46/82‐ALC4/2009

Party Name:POLYGON CHEMICALS 09.03.2010 Status:Case Deferred HQ File :01/82/050/00961/AM10/ RLA File :08/24/040/00192/AM10/ Lic.No/Date:0810083866 04.11.2009 Defer Date:06.04.2010 103

Case No.:89/46/82‐ALC4/2009

Party Name:HETERO LABS LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/01005/AM10/ RLA File :09/24/040/00305/AM10/ Lic.No/Date:0910039817 05.11.2009 Defer Date:06.04.2010 104

Case No.:62/46/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00978/AM10/ RLA File :08/24/040/00194/AM10/ Lic.No/Date:0810083945 06.11.2009 Defer Date:06.04.2010 105

Case No.:96/46/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/01012/AM10/ RLA File :09/24/040/00268/AM10/ Lic.No/Date:0910039892 Defer

12.11.2009 Date:06.04.2010 106

Case No.:105/46/82‐ALC4/2009

Party Name:AUROBINDO PHARMA LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/01021/AM10/ RLA File :09/24/040/00308/AM10/ Lic.No/Date:0910039941 17.11.2009 Defer Date:06.04.2010 107

Case No.:39/46/82‐ALC4/2009

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 09.03.2010 HQ File :01/82/050/00955/AM10/ RLA File :07/24/040/00273/AM10/ Lic.No/Date:0710068432 20.11.2009 108

Case No.:114/46/82‐ALC4/2009

09.03.2010 Status:Case Approved HQ File :01/82/050/01030/AM10/ RLA File :03/94/040/00650/AM10/ Lic.No/Date:0310547042 23.11.2009 Decision : Committee considered case as per agenda 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 Clenbuterol Hydrochloride Oral Paste/Respemin Oral Paste, 500 ml pack 3000 Nos. 1. Clenbuterol Hydrochloride BP 61.200 gram 109

Case No.:79/46/82‐ALC4/2009

Party Name:EXCEL INDUSTRIES LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00995/AM10/ RLA File :03/94/040/00294/AM10/ Lic.No/Date:0310547023 23.11.2009 Defer Date:06.04.2010 110

Case No.:119/46/82‐ALC4/2009

Party Name:GALAXY SURFACTANTS LTD., 09.03.2010 Status:Case Deferred

HQ File :01/82/050/01035/AM10/ RLA File :03/94/040/00636/AM10/ Lic.No/Date:0310547808 26.11.2009 Defer Date:06.04.2010 111

Case No.:2/38/82‐ALC4/2009

Party Name:LUPIN LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00775/AM10/ RLA File :03/95/040/00482/AM10/ Lic.No/Date:0310548046 27.11.2009 Defer Date:06.04.2010 112

Case No.:52/46/82‐ALC4/2009

09.03.2010 Status:Case Approved HQ File :01/82/050/00968/AM10/ RLA File :08/24/040/00222/AM10/ Lic.No/Date:0810084476 27.11.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 6/82 meeting held on 06.05.2008 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 on repeat basis (NC decision dated 06.05.2008):‐ Export product Export Qty. Sl.No. Import items Qty. allowed for 1 lakh tablets of 7.5 mg Qty. allowed for 1 lakh tablets of 15 mg Meloxicam tablets 7.5 mg and 15mg 1 lakh Nos. 1. Meloxicam BP 0.765 1.53 kg 2. Lactose Monohydrate NF 3.025 6.050 kg 3. Magnesium stearate 0.05 0.10 kg 4. Povidone K 30 USP 0.15 0.30 kg 5. Microcrystalline Cellulose (Avicel PH 101) 3.00 6.00 kg 6. Cross povidone 0.70 1.40 kg 7. Bottle & Caps As per packing policy As per packing policy RA concerned may take further necessary action as per above decision of Norms committee.

113

Case No.:59/46/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00975/AM10/ RLA File :08/24/040/00202/AM10/ Lic.No/Date:0810084475 27.11.2009 Defer Date:06.04.2010 114

Case No.:4/38/82‐ALC4/2009

Party Name:LAFFANS PETROCHEMICALS LTD., 09.03.2010 HQ File :01/82/050/00777/AM10/ RLA File :03/95/040/00521/AM10/ Lic.No/Date:0310548240 30.11.2009 115

Case No.:11/38/82‐ALC4/2009

Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 09.03.2010 HQ File :01/82/050/00784/AM10/ RLA File :03/94/040/00743/AM10/ Lic.No/Date:0310548591 01.12.2009 116

Case No.:115/46/82‐ALC4/2009

09.03.2010 Status:Case Approved HQ File :01/82/050/01031/AM10/ RLA File :03/94/040/00741/AM10/ Lic.No/Date:0310548540 01.12.2009 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

117

Case No.:7/38/82‐ALC4/2009

Party Name:PROMED EXPORTS PVT.LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00780/AM10/ RLA File :05/24/040/00382/AM10/ Lic.No/Date:0510253729 01.12.2009 Defer Date:20.04.2010 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to call for the bifurcated quantity and fob value of export product alongwith the copy of relevant DML. Accordingly, case was deferred for 20.04.2010. 118

Case No.:12/38/82‐ALC4/2009

09.03.2010 HQ File :01/82/050/00785/AM10/ RLA File :03/94/040/00711/AM10/ Lic.No/Date:0310548835 03.12.2009 119

Case No.:125/46/82‐ALC4/2009

Party Name:ALEMBIC LIMITED 09.03.2010 Status:Case Approved HQ File :01/82/050/01041/AM10/ RLA File :34/24/040/00137/AM10/ Lic.No/Date:3410025784 03.12.2009 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals dated 09.03.2010 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 Alendronate Tablets 70 mg 1 No. 1. Alendronate Sodium 91.3626 mg/tablet 120

Case No.:13/38/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00786/AM10/ RLA File :03/94/040/00714/AM10/ Lic.No/Date:0310548841 03.12.2009 Defer Date:06.04.2010 121

Case No.:14/38/82‐ALC4/2009

Party Name:INDIA GLYCOLS LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00787/AM10/ RLA File :05/23/040/00098/AM10/ Lic.No/Date:0510253834 03.12.2009 Defer Date:06.04.2010

122

Case No.:15/38/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00788/AM10/ RLA File :09/24/040/00362/AM10/ Lic.No/Date:0910040144 03.12.2009 Defer Date:06.04.2010 123

Case No.:16/38/82‐ALC4/2009

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/00789/AM10/ RLA File :09/24/040/00352/AM10/ Lic.No/Date:0910040145 03.12.2009 Defer Date:06.04.2010 124

Case No.:17/38/82‐ALC4/2009

Party Name:PRACHI PHARMACEUTICALS PVT LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/00790/AM10/ RLA File :03/95/040/00565/AM10/ Lic.No/Date:0310549028 03.12.2009 Defer Date:06.04.2010 125

Case No.:18/38/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00791/AM10/ RLA File :08/24/040/00203/AM10/ Lic.No/Date:0810084675 03.12.2009 Defer Date:06.04.2010 126

Case No.:20/38/82‐ALC4/2009

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/00793/AM10/ RLA File :09/24/040/00355/AM10/ Lic.No/Date:0910040146 03.12.2009 Defer Date:06.04.2010 127

Case No.:21/38/82‐ALC4/2009

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/00794/AM10/ RLA File :09/24/040/00367/AM10/ Lic.No/Date:0910040147 03.12.2009 Defer Date:06.04.2010

128

Case No.:22/38/82‐ALC4/2009

Party Name:LAKE CHEMICALS PRIVATE LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00795/AM10/ RLA File :07/24/040/00339/AM10/ Lic.No/Date:0710068661 03.12.2009 Defer Date:06.04.2010 129

Case No.:24/38/82‐ALC4/2009

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00797/AM10/ RLA File :31/24/040/00169/AM10/ Lic.No/Date:3110040935 03.12.2009 Defer Date:06.04.2010 130

Case No.:63/46/82‐ALC4/2009

09.03.2010 HQ File :01/82/050/00979/AM10/ RLA File :08/24/040/00215/AM10/ Lic.No/Date:0810084676 03.12.2009 131

Case No.:113/46/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 09.03.2010 HQ File :01/82/050/01029/AM10/ RLA File :09/24/040/00216/AM10/ Lic.No/Date:0910040167 04.12.2009 132

Case No.:19/46/82‐ALC4/2009

Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 09.03.2010 Status:Case Deferred HQ File :01/82/050/00935/AM10/ RLA File :04/24/040/00219/AM10/ Lic.No/Date:0410109955 04.12.2009 Defer Date:06.04.2010 133

Case No.:28/38/82‐ALC4/2009

Party Name:PADMINI AROMATICS PVT. LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/00801/AM10/ RLA File :07/24/040/00335/AM10/ Lic.No/Date:0710068685 04.12.2009 Defer

Date:06.04.2010 134

Case No.:29/38/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00802/AM10/ RLA File :05/24/040/00383/AM10/ Lic.No/Date:0510253942 04.12.2009 Defer Date:06.04.2010 135

Case No.:49/46/82‐ALC4/2009

Party Name:MAHAVIR INTERMEDIATES 09.03.2010 Status:Case Deferred HQ File :01/82/050/00965/AM10/ RLA File :52/24/040/00018/AM10/ Lic.No/Date:5210029042 07.12.2009 Defer Date:06.04.2010 136

Case No.:75/46/82‐ALC4/2009

Party Name:VIPUL DYE CHEM LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00991/AM10/ RLA File :03/95/040/00536/AM10/ Lic.No/Date:0310550173 10.12.2009 Defer Date:06.04.2010 137

Case No.:73/46/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00989/AM10/ RLA File :03/95/040/00575/AM10/ Lic.No/Date:0310550407 11.12.2009 Defer Date:06.04.2010 138

Case No.:74/46/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00990/AM10/ RLA File :03/95/040/00578/AM10/ Lic.No/Date:0310550397 11.12.2009 Defer Date:06.04.2010 139

Case No.:78/46/82‐ALC4/2009

Party Name:AVA CHEMICALS PVT.LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00994/AM10/ RLA File :03/94/040/00601/AM10/ Lic.No/Date:0310551543 Defer

18.12.2009 Date:06.04.2010 140

Case No.:36/46/82‐ALC4/2009

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 09.03.2010 Status:Case Deferred HQ File :01/82/050/00952/AM10/ RLA File :07/24/040/00356/AM10/ Lic.No/Date:0710069013 21.12.2009 Defer Date:06.04.2010 141

Case No.:116/46/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/01032/AM10/ RLA File :03/94/040/00821/AM10/ Lic.No/Date:0310552339 23.12.2009 Defer Date:06.04.2010 142

Case No.:58/46/82‐ALC4/2009

Party Name:TORRENT PHARMACEUTICALS LTD. 09.03.2010 Status:Case Approvel HQ File :01/82/050/00974/AM10/ RLA File :08/24/040/00261/AM10/ Lic.No/Date:0810085326 24.12.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 46/82 meeting held on 09.02.2010 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 on repeat basis (NC decision dated 09.02.2010):‐ Export product Export Qty. Sl.No. Import items Qty. allowed Metoprolol Tartrate Tablets 50 mg Metoprolol 50 Heumann 1 No. 1. Metoprolol Tartrate EP 51 mg/tablet 143

Case No.:1/42/82‐ALC4/2009

Party Name:METROPOLITAN EXIMCHEM LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00850/AM10/ RLA File :03/95/040/00517/AM10/ Lic.No/Date:0310552790 29.12.2009 Defer Date:06.04.2010 144

Case No.:3/42/82‐ALC4/2009

Party Name:KLJ PLASTICIZERS LTD, Status:Case

09.03.2010 Deferred HQ File :01/82/050/00852/AM10/ RLA File :05/23/040/00108/AM10/ Lic.No/Date:0510255340 30.12.2009 Defer Date:06.04.2010 145

Case No.:4/42/82‐ALC4/2009

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00853/AM10/ RLA File :31/24/040/00205/AM10/ Lic.No/Date:3110041272 30.12.2009 Defer Date:06.04.2010 146

Case No.:5/42/82‐ALC4/2009

09.03.2010 HQ File :01/82/050/00854/AM10/ RLA File :03/94/040/00772/AM10/ Lic.No/Date:0310552999 30.12.2009 147

Case No.:53/46/82‐ALC4/2009

Party Name:POLYGON CHEMICALS 09.03.2010 HQ File :01/82/050/00969/AM10/ RLA File :08/24/040/00266/AM10/ Lic.No/Date:0810085444 31.12.2009 148

Case No.:55/46/82‐ALC4/2009

Party Name:R.K.INDUSTRIES, 09.03.2010 HQ File :01/82/050/00971/AM10/ RLA File :08/24/040/00259/AM10/ Lic.No/Date:0810085443 31.12.2009 149

Case No.:57/46/82‐ALC4/2009

Party Name:TORRENT PHARMACEUTICALS LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00973/AM10/ RLA File :08/24/040/00268/AM10/ Lic.No/Date:0810085442 31.12.2009 Defer Date:06.04.2010 Decision :Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 06.04.2010.

150

Case No.:8/42/82‐ALC4/2009

Party Name:GEMINI EXPORTS., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00857/AM10/ RLA File :03/94/040/00785/AM10/ Lic.No/Date:0310553150 31.12.2009 Defer Date:06.04.2010 151

Case No.:9/42/82‐ALC4/2009

Party Name:KOPRAN LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00858/AM10/ RLA File :03/94/040/00843/AM10/ Lic.No/Date:0310553154 31.12.2009 Defer Date:20.04.2010 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting decided to call for the content of Cefepime in the export product alongwith copy of relevant DML from firm. Accordingly, case was deferred for 20.04.2010. 152

Case No.:10/42/82‐ALC4/2009

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 09.03.2010 HQ File :01/82/050/00859/AM10/ RLA File :09/24/040/00400/AM10/ Lic.No/Date:0910040501 04.01.2010 153

Case No.:12/42/82‐ALC4/2009

Party Name:LUPIN LIMITED 09.03.2010 Status:Case Approved HQ File :01/82/050/00861/AM10/ RLA File :03/95/040/00205/AM10/ Lic.No/Date:0310553529 04.01.2010 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 154

Case No.:19/42/82‐ALC4/2009

Party Name:OLEOFINE ORGANICS (INDIA)PVT.LTD., Meet No/Date:50/82‐ALC4/2009 09.03.2010 Status:Case Deferred HQ File :01/82/050/00868/AM10/ RLA File :03/95/040/00646/AM10/ Lic.No/Date:0310553708 05.01.2010 Defer Date:06.04.2010 155

Case No.:21/42/82‐ALC4/2009

Party Name:SHIRDI CHEMICALS PVT. LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00870/AM10/ RLA File :03/95/040/00661/AM10/ Lic.No/Date:0310553782 05.01.2010 Defer Date:06.04.2010

156

Case No.:48/46/82‐ALC4/2009

Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00964/AM10/ RLA File :04/24/040/00214/AM10/ Lic.No/Date:0410110585 05.01.2010 Defer Date:06.04.2010 157

Case No.:22/42/82‐ALC4/2009

Party Name:SUNSHIELD CHEMICALS LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00871/AM10/ RLA File :03/95/040/00619/AM10/ Lic.No/Date:0310553858 06.01.2010 Defer Date:06.04.2010 158

Case No.:23/42/82‐ALC4/2009

Party Name:N S CHEMICALS 09.03.2010 Status:Case Deferred HQ File :01/82/050/00872/AM10/ RLA File :03/95/040/00468/AM10/ Lic.No/Date:0310553911 06.01.2010 Defer Date:06.04.2010 Decision :Committee considered case as per agenda and observed that the item of export and import are same. It was, therefore, decided to call the firm for personal hearing on 06.04.2010 along with justification of import and export items. Accordingly, case was deferred for 06.04.2010. 159

Case No.:24/42/82‐ALC4/2009

Party Name:N S CHEMICALS 09.03.2010 Status:Case Deferred HQ File :01/82/050/00873/AM10/ RLA File :03/95/040/00471/AM10/ Lic.No/Date:0310553920 06.01.2010 Defer Date:06.04.2010 Decision : Committee considered case as per agenda and observed that the item of export and import are same. It was, therefore, decided to call the firm for personal hearing on 06.04.2010 along with justification of import and export items. Accordingly, case was deferred for 06.04.2010. 160

Case No.:67/46/82‐ALC4/2009

Party Name:GLENMARK GENERICS LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00983/AM10/ RLA File :03/94/040/00812/AM10/ Lic.No/Date:0310553944 06.01.2010 Defer Date:06.04.2010 161

Case No.:56/46/82‐ALC4/2009

Party Name:EUROMED HEALTH PRIVATE LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00972/AM10/ RLA File :35/24/040/00030/AM10/ Lic.No/Date:3510028802 Defer

07.01.2010 Date:06.04.2010 Decision : Committee decided to defer case for 06.04.2010 for comments of DIPP. 162

Case No.:117/46/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/01033/AM10/ RLA File :03/94/040/00865/AM10/ Lic.No/Date:0310554460 08.01.2010 Defer Date:06.04.2010 163

Case No.:47/46/82‐ALC4/2009

Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/00963/AM10/ RLA File :04/24/040/00211/AM10/ Lic.No/Date:0410110773 11.01.2010 Defer Date:06.04.2010 164

Case No.:1/46/82‐ALC4/2009

Party Name:TITAN LABORATORIES PVT. LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00917/AM10/ RLA File :03/95/040/00693/AM10/ Lic.No/Date:0310556465 21.01.2010 Defer Date:06.04.2010 165

Case No.:3/46/82‐ALC4/2009

Party Name:ORION CHEM PVT.LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/00919/AM10/ RLA File :03/95/040/00692/AM10/ Lic.No/Date:0310556546 22.01.2010 Defer Date:06.04.2010 166

Case No.:4/46/82‐ALC4/2009

Party Name:SOMU ORGANO CHEM PVT.LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00920/AM10/ RLA File :07/24/040/00398/AM10/ Lic.No/Date:0710069607 25.01.2010 Defer Date:06.04.2010 167

Case No.:5/46/82‐ALC4/2009

Party Name:KALPSUTRA CHEMICALS PVT. LTD. 09.03.2010 Status:Case Deferred

HQ File :01/82/050/00921/AM10/ RLA File :03/94/040/00855/AM10/ Lic.No/Date:0310556797 25.01.2010 Defer Date:06.04.2010 168

Case No.:6/46/82‐ALC4/2009

Party Name:KALPSUTRA CHEMICALS PVT. LTD. 09.03.2010 HQ File :01/82/050/00922/AM10/ RLA File :03/94/040/00857/AM10/ Lic.No/Date:0310556801 25.01.2010 169

Case No.:10/46/82‐ALC4/2009

Party Name:FILTRA CATALYSTS & CHEMICALS LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/00926/AM10/ RLA File :03/94/040/00920/AM10/ Lic.No/Date:0310557236 27.01.2010 Defer Date:06.04.2010 170

Case No.:9/46/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/00925/AM10/ RLA File :03/94/040/00899/AM10/ Lic.No/Date:0310557203 27.01.2010 Defer Date:06.04.2010 171

Case No.:98/46/82‐ALC4/2009

Party Name:HETERO LABS LTD. 09.03.2010 Status:Case Deferred HQ File :01/82/050/01014/AM10/ RLA File :09/24/040/00437/AM10/ Lic.No/Date:0910040653 27.01.2010 Defer Date:06.04.2010 172

Case No.:11/46/82‐ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/00927/AM10/ RLA File :09/24/040/00407/AM10/ Lic.No/Date:0910040660 28.01.2010 Defer Date:06.04.2010 173

Case No.:1/50/82‐ALC4/2009

Party Name:SHIVA PHARMACHEM PVT. LTD, 09.03.2010 Status:Case

Deferred HQ File :01/82/050/01155/AM10/ RLA File :34/24/040/00202/AM10/ Lic.No/Date:3410026420 19.02.2010 Defer Date:06.04.2010 174

Case No.:2/50/82‐ALC4/2009

Party Name:LUPIN LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/01156/AM10/ RLA File :03/95/040/00753/AM10/ Lic.No/Date:0310561192 22.02.2010 Defer Date:06.04.2010 175

Case No.:3/50/82‐ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/01157/AM10/ RLA File :03/95/040/00760/AM10/ Lic.No/Date:0310561196 22.02.2010 Defer Date:06.04.2010 176

Case No.:4/50/82‐ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/01158/AM10/ RLA File :03/95/040/00754/AM10/ Lic.No/Date:0310561197 22.02.2010 Defer Date:06.04.2010 177

Case No.:5/50/82‐ALC4/2009

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 09.03.2010 Status:Case Approved HQ File :01/82/050/01159/AM10/ RLA File :04/24/040/00303/AM10/ Lic.No/Date:0410111803 23.02.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/241/2009‐PI‐(Norms) dated 25.01.2010 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 Piroctone Olamine 1 kg. 1. 3,3‐Dimethyl Acrylic Acid 0.878 kg 2. Methanol 4.50 kg

178

Case No.:6/50/82‐ALC4/2009

Party Name:MEDREICH LIMITED 09.03.2010 Status:Case Approved HQ File :01/82/050/01160/AM10/ RLA File :07/24/040/00447/AM10/ Lic.No/Date:0710070179 23.02.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/94/2009‐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 on repeat basis (NC decision dated 03.11.2009):‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Clindamycin Capsules 150 mg 1 No. 1. Clindamycin Hcl BP 173.53 mg 179

Case No.:7/50/82‐ALC4/2009

09.03.2010 Status:Case Deferred HQ File :01/82/050/01161/AM10/ RLA File :08/24/040/00326/AM10/ Lic.No/Date:0810086746 23.02.2010 Defer Date:06.04.2010 180

Case No.:8/50/82‐ALC4/2009

Party Name:GEMINI EXPORTS., 09.03.2010 Status:Case Deferred HQ File :01/82/050/01162/AM10/ RLA File :03/94/040/01023/AM10/ Lic.No/Date:0310561577 23.02.2010 Defer Date:20.04.2010 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting decided to call for the details of export product i.e. whether it is EP or BP or USP and copy of Drug Manufacturing Licence. Accordingly, case was deferred for 20.04.2010. 181

Case No.:9/50/82‐ALC4/2009

Party Name:MEDREICH LIMITED 09.03.2010 Status:Case Approved HQ File :01/82/050/01163/AM10/ RLA File :07/24/040/00449/AM10/ Lic.No/Date:0710070197 23.02.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/94/2009‐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 on repeat basis (NC decision dated 17.11.2009):‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Vitamin C Chewable tablet 500 mg 1 No. 1. Sodium Ascorbate 357 mg 2. Ascorbic Acid 192.78 mg 3. Sodium Cyclamate 17.20 mg

Trusil organe flavor 171063 4.40 mg 5. Trusil nature identical orange flavor 173126 4.40 mg 6. Jaffa orange oil 510154 M 1.20 mg 182

Case No.:10/50/82‐ALC4/2009

Party Name:KOPRAN LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/01164/AM10/ RLA File :03/94/040/01019/AM10/ Lic.No/Date:0310561665 24.02.2010 Defer Date:20.04.2010 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to call for the content of Cefepime in the export product. Accordingly, case was deferred for 20.04.2010. 183

Case No.:11/50/82‐ALC4/2009

Party Name:LAFFANS PETROCHEMICALS LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/01165/AM10/ RLA File :03/95/040/00772/AM10/ Lic.No/Date:0310561666 24.02.2010 Defer Date:06.04.2010 184

Case No.:12/50/82‐ALC4/2009

Party Name:SHILPA MEDICARE LTD., 09.03.2010 Status:Case Approved HQ File :01/82/050/01166/AM10/ RLA File :07/24/040/00442/AM10/ Lic.No/Date:0710070226 24.02.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 41/82 meeting held on 05.01.2010 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 on repeat basis (NC decision dated 05.01.2010):‐ Export Product Export Qty. Sl.No. Import items Qty. allowed Gemcitabine Hcl 1 Kg. 1. 4‐Amino‐1‐(3,3‐difluoro‐4‐hydroxy‐5‐ (Hydroxymethyl) Tetrahydrofuran‐2‐yl)‐1H‐ Pyrimidine‐2‐one (Technical Grade) 0.97 kg/kg 185

Case No.:13/50/82‐ALC4/2009

Party Name:ONEIRO CHEMICALS LTD 09.03.2010 Status:Case Approved

HQ File :01/82/050/01167/AM10/ RLA File :34/24/040/00207/AM10/ Lic.No/Date:3410026471 24.02.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/229/2009‐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 per details below or as applied by firm whichever is lower on repeat basis (NC decision dated 09.02.2010):‐ 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 186

Case No.:14/50/82‐ALC4/2009

Party Name:AMBUJA INTERMEDIATES LIMITED 09.03.2010 Status:Case Deferred HQ File :01/82/050/01168/AM10/ RLA File :03/94/040/01020/AM10/ Lic.No/Date:0310561828 24.02.2010 Defer Date:06.04.2010 187

Case No.:15/50/82‐ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/01169/AM10/ RLA File :03/95/040/00779/AM10/ Lic.No/Date:0310561977 25.02.2010 Defer Date:06.04.2010 188

Case No.:16/50/82‐ALC4/2009

Party Name:SRINI PHARMACEUTICALS LTD., 09.03.2010 Status:Case Deferred HQ File :01/82/050/01170/AM10/ RLA File :09/24/040/00478/AM10/ Lic.No/Date:0910041061 25.02.2010 Defer Date:06.04.2010 189

Case No.:17/50/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/01171/AM10/ RLA File :05/24/040/00486/AM10/ Lic.No/Date:0510259472 25.02.2010 Defer Date:06.04.2010

190

Case No.:18/50/82‐ALC4/2009

Party Name:STERLING AUXILIARIES PVT LTD 09.03.2010 Status:Case Deferred HQ File :01/82/050/01172/AM10/ RLA File :03/95/040/00781/AM10/ Lic.No/Date:0310562269 26.02.2010 Defer Date:06.04.2010

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis has been generated for this document yet.