IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2010-01-06

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade  New Delhi ­0 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Para 4.7 Decision

MEETING NUMBER : 41/82­ALC4/2009 MEETING DATE : 05.01.2010   The Meeting No.41/82 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  scheduled to be held on 05.01.2010  was actually held on 06.01.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber.   Following members were present:‐ 1.        Shri P.P. Shrivastava, Dy.IA, Department of C&PC 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‐386

M/S Lupin Ltd. Norms Committee Meeting No.41/82 F.No.01/82/162/00763/AM10 Meeting Date:05.01.2010 RA F.No.03/95/040/00054/AM08 Adv.Lic.No.0310427685 dated 24.04.2007   Committee decided to defer case for 02.02.2010 for comments of Department of Pharmaceuticals.    

Case No.B‐387

M/S Gulbrandsen Chemicals Pvt. Ltd. Norms Committee Meeting No.41/82 F.No.01/82/050/01600/AM09 Meeting Date:05.01.2010 RA F.No.34/24/040/00197/AM09 Adv.Lic.No.3410023334 dated 29.01.2009   Committee decided to defer case for 02.02.2010 for comments of Department of C&PC.    

Case No.B‐388

M/S Kores (India) Ltd. Norms Committee Meeting No.41/82 F.No.01/82/162/00115/AM09 Meeting Date:05.01.2010 RA F.No.03/94/040/01072/AM08 Adv.Lic.No.0310460250 dated 06.02.2008   Committee decided to defer case for 02.02.2010 for comments of Department of C&PC.    

Case No.B‐389

M/S Jubilant Organosys Ltd. Norms Committee Meeting No.41/82 F.No.01/82/050/00843/AM07 Meeting Date:05.01.2010 RA F.No.05/24/040/00455/AM07 Adv.Lic.No.0510189933 dated 31.08.2006

   

Case No.B‐390

M/S Glenmark Pharma Ltd. Norms Committee Meeting No.41/82 F.No.01/82/162/00137/AM08 Meeting Date:05.01.2010 RA F.No.03/94/040/00412/AM08 Adv.Lic.No.0310437384 dated 25.07.2007      

Case No.B‐391

M/S Coral Drugs Pvt.Ltd. Norms Committee Meeting No.41/10 F.No.01/82/050/00528/AM09 Meeting Date: 05.01.2010 RA F.No.05.24/040/00981/AM08 Adv.Lic.No.0510218739 dated 31.03.2008      

Case No. B‐392

M/s  HETERO LABS Ltd. Norms Committee Meeting No. 41/10 File No. 01/82/050/01403/AM09/DES‐III Meeting Date  05.01.2010 RAF No. 09/24/040/000342/AM09 Adv. Lic. No. 0910036287 dated 12.12.2008     Committee  considered  case  as  per  agenda  and  in  light  of  written  comments  forwarded  by  Department  of Pharmaceuticals vide their O.M. 35011/289/2009‐PI‐III dated 29.12.2009 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 Export Qty. Sl.No. Import items Qty. allowed   Nevirapine 1 kg. 1.  Malononitrile 1.0722 kg 2. Methylene Chloride 4.00 kg 3. Phosphorous Oxychloride 4.2611 kg 4. Phosphorous Pentachloride 0.5781 kg 5. 2‐Chloro Nicotinic Acid 1.1059 kg 6. Pyridine 0.566 kg 7. Methyl Tert. Butyl Ether 3.010 kg 8. Cyclopropylamine 1.20 kg   RA concerned may take further necessary action as per above decision of NC.  The earlier decision taken in 38/82 meeting held on 23.12.2008 may be treated as withdrawn.     

Case No. B‐393

M/s  HETERO LABS Ltd.

File No. 01/82/050/01358/AM09/DES‐III RAF No. 09/24/040/000321/AM09 Adv. Lic. No. 0910036216 dated 05.12.2008     Committee  considered  case  as  per  agenda  and  in  light  of  written  comments  forwarded  by  Department  of Pharmaceuticals vide their O.M. 35011/289/2009‐PI‐III dated 29.12.2009 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 Export Qty. Sl.No. Import items Qty. allowed   Nevirapine 1 kg. 1.  Malononitrile 1.0722 kg 2. Methylene Chloride 4.00 kg 3. Phosphorous Oxychloride 4.2611 kg 4. Phosphorous Pentachloride 0.5781 kg 5. 2‐Chloro Nicotinic Acid 1.1059 kg 6. Pyridine 0.566 kg 7. Methyl Tert. Butyl Ether 3.010 kg 8. Cyclopropylamine 1.20 kg   RA concerned may take further necessary action as per above decision of NC.  The earlier decision taken in 38/82 meeting held on 23.12.2008 may be treated as withdrawn.   

Case No. B‐394

M/s  CONCORD Biotech Ltd. File No. 01/82/050/01035/AM09/DES‐III RAF No. 08/24/040/000138/AM09 Adv. Lic. No. 0810074890 dated 22.9.2008    

Case No. B‐395

M/s. MOREPEN LABS Ltd. File No. 01/82/050/00229/AM09/DES‐III RAF No. 05/24/040/000650/AM08 Adv. Lic. No. 0510212495 dated 26.11.2007    

Case No. B‐396

M/s  CIPLA Ltd. F. No. 01/82/050/00406/AM08 F.No.01/82/050/00408/AM08   F.No.01/82/050/00110/AM09 RA.F. No. 03/94/040/000250/AM08 RA.F.No.03/94/040/000383/AM08 RA.F.No.03/94/040/001099/AM08

Adv. Lic. No. 0310432136 dated 8.6.2007, Adv.Lic.No.0310436156 dated 13.7.2008 Adv.Lic.No.0310459961 dated 4.2.2008      

Case No. B‐397

M/s  CIPLA Ltd. Norms Committee Meeting No. 37/10 File No. 01/82/050/00446/AM08/DES‐III RAF No. 03/94/040/000857/AM08 Adv. Lic. No. 0310450548 dated 16.11.2007    

Case No. B‐398

M/s  CIPLA Ltd. File No. 01/82/050/00447/AM08/DES‐III RAF No. 03/94/040/000860/AM08 Adv. Lic. No. 0310450692 dated 19.11.2007      

Case No. A‐186

M/s  Shree Ganesh Remedies Pvt. Ltd. File No. 01/82/050/00243/AM08/DES‐III RAF No. 34/24/040/00166/AM07 Adv. Lic. No. 3410018711 dated 03.05.2007      

Case No. A‐187

M/s  HETERO Drugs Ltd., File No. 01/82/0162/00094/AM10/DES‐III RAF No. 09/24/040/00013/AM10 Adv. Lic. No.   0910037741 dated 23.4.2009    The case has already been approved on line in this meeting.   

Case No. A‐188

M/s  INTAS PHARMA Ltd., File No. 01/82/0162/00205/AM10/DES‐III RAF No. 08/24/040/07/AM10 Adv. Lic. No.   0810079232 dated 9.4.2009

 

Case No. A‐189

M/s MATRIX LAB Ltd. File No. 01/82/0162/0093/AM10/DES‐III RAF No. 03/95/040/334/AM09 Adv. Lic. No.  0910037757 dated 23.4.2009     

Case No. A‐190

M/s ENALTEC LABS Ltd., File No. 01/82/0162/00166/AM10/DES‐III RAF No. 03/94/040/01133/AM09 Adv. Lic. No.   0310514629 dated 3.4.2009    

Case No. A‐191

M/s Navin Fluorine International Ltd. Norms Committee Meeting No. 37/10 File No. 01/82/050/00408/AM09/DES‐III Meeting Date  08.12.2009 RAF No. 03/95/040/00039/AM09 Adv. Lic. No.   0310469298 dated 23.04.2008    Committee decided to defer case for 02.02.2010 for comments of Department of C&PC.   

Case No. C‐26

M/s. LUPIN Ltd., File No. 01/82/0162/00532/AM08/DES‐III   Modification of SION No. A‐225     

Case No. C‐27

M/s. LUPIN Ltd., File No. 01/82/0162/00853/AM09/DES‐III   Modification of SION No. A‐390      

Case No.C‐28

M/S Gulbrandsen Chemicals Pvt.  Ltd. NC Meeting No.41/AM10 F.No.01/82/162/00210/AM09 Meeting Date:05.01.2010   Case decided to defer case for 02.02.2010 for comments of Department of C&PC.

1

Case No.:10/28/82­ALC4/2008

Party Name:LUPIN LIMITED Meet No/Date:41/82­ALC4/2009 05.01.2010 Status:Case Approved HQ File :01/82/050/01059/AM09/ RLA File :03/95/040/00374/AM09/ Lic.No/Date:0310487704 24.09.2008   Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP.   2

Case No.:17/43/82­ALC4/2008

Party Name:ARCH PHARMALABS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01526/AM09/ RLA File :03/94/040/00899/AM09/ Lic.No/Date:0310501723 07.01.2009 Defer Date:02.02.2010 Decision : Committee decided to defer case for 02.02.2010 for comments of Deptt. Of Pharmaceuticals.   3

Case No.:10/44/82­ALC4/2008

Party Name:KOPRAN LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/01545/AM09/ RLA File :03/94/040/00538/AM09/ Lic.No/Date:0310502325 13.01.2009 Defer Date:02.02.2010   4

Case No.:25/43/82­ALC4/2008

Party Name:HALDIA PETROCHEMICALS LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/01534/AM09/ RLA File :02/24/040/00248/AM09/ Lic.No/Date:0210122139 13.01.2009 Defer Date:02.02.2010 Decision : Committee decided to defer case for 02.02.2010 for comments of Deptt. Of C&PC.   5

Case No.:7/44/82­ALC4/2008

Party Name:ARCH PHARMALABS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01542/AM09/ RLA File :03/94/040/00931/AM09/ Lic.No/Date:0310502289 13.01.2009 Defer Date:02.02.2010   6

Case No.:9/44/82­ALC4/2008

Party Name:KOPRAN LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/01544/AM09/ RLA File :03/94/040/00537/AM09/ Lic.No/Date:0310502324 13.01.2009 Defer Date:02.02.2010

7

Case No.:4/44/82­ALC4/2008

Party Name:SMILAX LABORATORIES LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/01539/AM09/ RLA File :09/24/040/00385/AM09/ Lic.No/Date:0910036721 15.01.2009 Defer Date:02.02.2010   8

Case No.:5/44/82­ALC4/2008

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01540/AM09/ RLA File :09/24/040/00350/AM09/ Lic.No/Date:0910036722 15.01.2009 Defer Date:02.02.2010   9

Case No.:26/44/82­ALC4/2008

Party Name:PARABOLIC DRUGS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/01561/AM09/ RLA File :22/24/040/00059/AM09/ Lic.No/Date:2210008587 16.01.2009 Defer Date:02.02.2010   10

Case No.:21/44/82­ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01556/AM09/ RLA File :05/24/040/00663/AM09/ Lic.No/Date:0510234650 19.01.2009 Defer Date:02.02.2010   11

Case No.:22/44/82­ALC4/2008

Party Name:AKUMS DRUGS & PHARMACEUTICALS LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/01557/AM09/ RLA File :05/24/040/00665/AM09/ Lic.No/Date:0510234676 19.01.2009 Defer Date:02.02.2010   12

Case No.:25/44/82­ALC4/2008

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 05.01.2010 HQ File :01/82/050/01560/AM09/ RLA File :09/24/040/00288/AM09/ Lic.No/Date:0910036749 20.01.2009   13

Case No.:10/45/82­ALC4/2008

Party Name:AUROBINDO PHARMA Status:Case

LIMITED 05.01.2010 Deferred HQ File :01/82/050/01574/AM09/ RLA File :09/24/040/00363/AM09/ Lic.No/Date:0910036805 22.01.2009 Defer Date:02.02.2010   14

Case No.:5/45/82­ALC4/2008

Party Name:PADMINI AROMATICS PVT. LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01569/AM09/ RLA File :07/24/040/00435/AM09/ Lic.No/Date:0710062501 22.01.2009 Defer Date:02.02.2010   15

Case No.:8/45/82­ALC4/2008

Party Name:HETERO LABS LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/01572/AM09/ RLA File :09/24/040/00389/AM09/ Lic.No/Date:0910036803 22.01.2009 Defer Date:02.02.2010   16

Case No.:12/45/82­ALC4/2008

Party Name:SUVEN LIFE SCIENCES LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/01576/AM09/ RLA File :09/24/040/00372/AM09/ Lic.No/Date:0910036817 23.01.2009 Defer Date:02.02.2010   17

Case No.:13/45/82­ALC4/2008

Party Name:MERCK LIMITED 05.01.2010 Status:Case Approved HQ File :01/82/050/01577/AM09/ RLA File :03/95/040/00866/AM09/ Lic.No/Date:0310503731 23.01.2009   Decision  :  Committee  considered  case  as  per  agenda  and  in  light  of  written  comments  forwarded  by  Department  of  Pharmaceuticals  vide  their  U.O. No.35011/132/2009‐PI‐III dated 22.10.2009 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 DL­Alpha  Tocopheryl Acetate USP 1 Kg.  1. 2,3,5­Trimethyl Hydroquinone 0.385 kg 2. Isophytol 0.738 kg   RA concerned may take further necessary action as per above decision of NC.    18

Case No.:17/45/82­ALC4/2008

Status:Case

LIMITED 05.01.2010 Approved HQ File :01/82/050/01581/AM09/ RLA File :09/24/040/00332/AM09/ Lic.No/Date:0910036834 27.01.2009   Decision :Withdrawn as the case has already been approved by NC in its 34/82 meeting held on 17.11.2009.   19

Case No.:18/45/82­ALC4/2008

LIMITED 05.01.2010 Status:Case Approved HQ File :01/82/050/01582/AM09/ RLA File :09/24/040/00368/AM09/ Lic.No/Date:0910036835 27.01.2009   Decision : Withdrawn as the case has already been approved by NC in its 34/82 meeting held on 17.11.2009.   20

Case No.:1/46/82­ALC4/2008

Party Name:ARCH PHARMALABS LTD 05.01.2010 Status:Case Approved HQ File :01/82/050/01583/AM09/ RLA File :03/94/040/00969/AM09/ Lic.No/Date:0310504110 28.01.2009   Decision  :  Committee  considered  case  as  per  agenda  and  in  light  of  written  comments  forwarded  by  Department  of  Pharmaceuticals  vide  their  U.O. No.35011/258/2008‐PI‐III dated 22.10.2009 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 Methyl  (3S)­3­Amino­ 3(2,4,6­ Triflurophenyl)butanoatel­ tartrate  salt  (SCH­ 900511BC) 1 Kg.  1. 2,4,6­trifluroacetophenone 1.07 kg 2. R­(+)­2 Methyl­2­Propanesulfinamide 0.855 kg 3. Titanium Tetracethylate 3.08 kg   RA concerned may take further necessary action as per above decision of NC.    21

Case No.:3/46/82­ALC4/2008

Party Name:TORRENT PHARMACEUTICALS LTD. 05.01.2010 Status:Case Approved HQ File :01/82/050/01585/AM09/ RLA File :08/24/040/00210/AM09/ Lic.No/Date:0810077671 28.01.2009   Decision : Withdrawn as the case has already been approved by NC in its 34/82 meeting held on 17.11.2009.   22

Case No.:4/46/82­ALC4/2008

Party Name:TORRENT PHARMACEUTICALS LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/01586/AM09/ RLA File :08/24/040/00211/AM09/ Lic.No/Date:0810077672 28.01.2009 Defer Date:02.02.2010

23

Case No.:12/46/82­ALC4/2008

Party Name:DIVIS LABORATORIES LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/01594/AM09/ RLA File :09/24/040/00384/AM09/ Lic.No/Date:0910036902 29.01.2009 Defer Date:02.02.2010   24

Case No.:8/48/82­ALC4/2008

Party Name:PAB ORGANICS PVT.LTD, 05.01.2010 Status:Case Deferred HQ File :01/82/050/01613/AM09/ RLA File :34/24/040/00200/AM09/ Lic.No/Date:3410023355 03.02.2009 Defer Date:02.02.2010   25

Case No.:6/48/82­ALC4/2008

Party Name:MSN LABORATORIES LIMITED Meet No/Date:41/82­ALC4/2009 05.01.2010 Status:Case Deferred HQ File :01/82/050/01611/AM09/ RLA File :09/24/040/00366/AM09/ Lic.No/Date:0910036958 04.02.2009 Defer Date:02.02.2010   26

Case No.:10/48/82­ALC4/2008

Party Name:MSN LABORATORIES LIMITED Meet No/Date:41/82­ALC4/2009 05.01.2010 Status:Case Deferred HQ File :01/82/050/01615/AM09/ RLA File :09/24/040/00367/AM09/ Lic.No/Date:0910036968 05.02.2009 Defer Date:02.02.2010   27

Case No.:11/48/82­ALC4/2008

Party Name:MAITHRI LABORATORIES (P) LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/01616/AM09/ RLA File :09/24/040/00327/AM09/ Lic.No/Date:0910036969 05.02.2009 Defer Date:02.02.2010   28

Case No.:12/48/82­ALC4/2008

LIMITED 05.01.2010 Status:Case Approved HQ File :01/82/050/01617/AM09/ RLA File :09/24/040/00382/AM09/ Lic.No/Date:0910036970 05.02.2009   Decision : Withdrawn as the case has already been approved by NC in its 34/82 meeting held on 17.11.2009.

29

Case No.:25/48/82­ALC4/2008

Party Name:VARUN MEDIMPEX INC. 05.01.2010 Status:Transferred to Different Section HQ File :01/82/050/01630/AM09/ RLA File :05/24/040/00678/AM09/ Lic.No/Date:0510235994 06.02.2009   Decision :Case has already been transferred to NC­VII.   30

Case No.:26/48/82­ALC4/2008

Party Name:T.C. HEALTH CARE PVT.LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/01631/AM09/ RLA File :05/24/040/00645/AM09/ Lic.No/Date:0510235995 06.02.2009 Defer Date:02.02.2010   31

Case No.:21/48/82­ALC4/2008

Party Name:CENTURY PHARMACEUTICALS LTD. 05.01.2010 Status:Case Approved HQ File :01/82/050/01626/AM09/ RLA File :34/24/040/00153/AM09/ Lic.No/Date:3410023427 09.02.2009   Decision : Withdrawn as the case has already been approved by NC in its 34/82 meeting held on 17.11.2009.   32

Case No.:23/48/82­ALC4/2008

Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/01628/AM09/ RLA File :03/94/040/01007/AM09/ Lic.No/Date:0310506348 09.02.2009 Defer Date:02.02.2010   33

Case No.:34/48/82­ALC4/2008

Party Name:DIVIS LABORATORIES LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/01639/AM09/ RLA File :09/24/040/00402/AM09/ Lic.No/Date:0910037046 11.02.2009 Defer Date:02.02.2010   34

Case No.:21/49/82­ALC4/2008

Party Name:CIPLA LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/01663/AM09/ RLA File :03/94/040/01030/AM09/ Lic.No/Date:0310507849 18.02.2009 Defer Date:02.02.2010   35

Case No.:7/50/82­ALC4/2008

Party Name:SALICYLATES & CHEMICALS

PRIVATE LIMITED 05.01.2010 HQ File :01/82/050/01674/AM09/ RLA File :09/24/040/00404/AM09/ Lic.No/Date:0910037127 19.02.2009   36

Case No.:1/51/82­ALC4/2008

Party Name:PARABOLIC DRUGS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/01687/AM09/ RLA File :22/24/040/00066/AM09/ Lic.No/Date:2210008674 20.02.2009 Defer Date:02.02.2010   37

Case No.:13/50/82­ALC4/2008

Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED 05.01.2010 HQ File :01/82/050/01680/AM09/ RLA File :04/24/040/00105/AM09/ Lic.No/Date:0410102480 20.02.2009   38

Case No.:10/51/82­ALC4/2008

Party Name:NECTAR LIFESCIENCES LIMITED, 05.01.2010 Status:Case Deferred HQ File :01/82/050/01696/AM09/ RLA File :22/24/040/00068/AM09/ Lic.No/Date:2210008686 25.02.2009 Defer Date:02.02.2010   39

Case No.:4/51/82­ALC4/2008

Party Name:MERIT HEALTHCARE PVT. LTD. 05.01.2010 HQ File :01/82/050/01690/AM09/ RLA File :03/95/040/00909/AM09/ Lic.No/Date:0310509173 25.02.2009   40

Case No.:12/51/82­ALC4/2008

Party Name:MEDREICH LIMITED 05.01.2010 Status:Case Approved HQ File :01/82/050/01698/AM09/ RLA File :07/24/040/00632/AM09/ Lic.No/Date:0710063294 26.02.2009   Decision : Withdrawn as the case has already been approved by NC in its 34/82 meeting held on 17.11.2009.   41

Case No.:13/51/82­ALC4/2008

Party Name:INTERMED LABS PVT. LTD., 05.01.2010 Status:Case Deferred

HQ File :01/82/050/01699/AM09/ RLA File :07/24/040/00642/AM09/ Lic.No/Date:0710063296 26.02.2009 Defer Date:02.02.2010   42

Case No.:8/51/82­ALC4/2008

LIMITED 05.01.2010 Status:Case Approved HQ File :01/82/050/01694/AM09/ RLA File :09/24/040/00430/AM09/ Lic.No/Date:0910037213 26.02.2009   Decision : Withdrawn as the case has already been approved by NC in its 34/82 meeting held on 17.11.2009.   43

Case No.:28/1/82­ALC4/2009

Party Name:STERLING AUXILIARIES PVT LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01748/AM09/ RLA File :03/95/040/00963/AM09/ Lic.No/Date:0310510096 03.03.2009 Defer Date:02.02.2010   44

Case No.:24/1/82­ALC4/2009

LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/01744/AM09/ RLA File :09/24/040/00451/AM09/ Lic.No/Date:0910037365 12.03.2009 Defer Date:02.02.2010   45

Case No.:25/1/82­ALC4/2009

Party Name:MSN LABORATORIES LIMITED 05.01.2010 HQ File :01/82/050/01745/AM09/ RLA File :09/24/040/00441/AM09/ Lic.No/Date:0910037366 12.03.2009   46

Case No.:27/1/82­ALC4/2009

Party Name:M.J. BIOPHARM PVT. LTD. 05.01.2010 HQ File :01/82/050/01747/AM09/ RLA File :03/95/040/00982/AM09/ Lic.No/Date:0310511508 16.03.2009   47

Case No.:4/1/82­ALC4/2009

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 05.01.2010 Status:Case Deferred HQ File :01/82/050/01724/AM09/ RLA File :31/24/040/00331/AM09/ Lic.No/Date:3110037695 Defer

16.03.2009 Date:02.02.2010 Decision : Committee decided to defer case for 02.02.2010 for comments of Deptt. Of C&PC   48

Case No.:5/54/82­ALC4/2008

LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01707/AM09/ RLA File :05/24/040/00746/AM09/ Lic.No/Date:0510237937 16.03.2009 Defer Date:02.02.2010   49

Case No.:7/54/82­ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/01709/AM09/ RLA File :08/24/040/00233/AM09/ Lic.No/Date:0810078677 16.03.2009 Defer Date:02.02.2010   50

Case No.:10/54/82­ALC4/2008

LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01712/AM09/ RLA File :05/24/040/00769/AM09/ Lic.No/Date:0510238138 17.03.2009 Defer Date:02.02.2010   51

Case No.:11/54/82­ALC4/2008

Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:41/82­ALC4/2009 05.01.2010 Status:Case Deferred HQ File :01/82/050/01713/AM09/ RLA File :08/24/040/00235/AM09/ Lic.No/Date:0810078764 18.03.2009 Defer Date:02.02.2010   52

Case No.:12/54/82­ALC4/2008

Party Name:OTSUKA CHEMICAL ( INDIA ) LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/01714/AM09/ RLA File :05/24/040/00712/AM09/ Lic.No/Date:0510238226 18.03.2009 Defer Date:02.02.2010   53

Case No.:8/1/82­ALC4/2009

Party Name:ALEMBIC LIMITED 05.01.2010 Status:Case Approved HQ File :01/82/050/01728/AM09/ RLA File :34/24/040/00211/AM09/ Lic.No/Date:3410023742 18.03.2009

Decision : Withdrawn as the case has already been approved by NC in its 19/82 meeting held on 04.08.2009.   54

Case No.:16/54/82­ALC4/2008

Party Name:MOREPEN LABORATORIES LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/01718/AM09/ RLA File :05/24/040/00615/AM09/ Lic.No/Date:0510238452 20.03.2009 Defer Date:02.02.2010   55

Case No.:42/1/82­ALC4/2009

Party Name:ARCH PHARMALABS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01762/AM09/ RLA File :03/94/040/01026/AM09/ Lic.No/Date:0310512522 20.03.2009 Defer Date:02.02.2010   56

Case No.:3/1/82­ALC4/2009

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 05.01.2010 Status:Case Deferred HQ File :01/82/050/01723/AM09/ RLA File :31/21/040/00430/AM09/ Lic.No/Date:3110037842 24.03.2009 Defer Date:02.02.2010   57

Case No.:49/1/82­ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/01769/AM09/ RLA File :03/95/040/01002/AM09/ Lic.No/Date:0310513238 25.03.2009 Defer Date:02.02.2010   58

Case No.:36/1/82­ALC4/2009

Party Name:ONEIRO CHEMICALS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/01756/AM09/ RLA File :34/24/040/00236/AM09/ Lic.No/Date:3410023843 26.03.2009 Defer Date:02.02.2010   59

Case No.:67/18/82­ALC4/2009

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00341/AM10/ RLA File :03/95/040/01043/AM09/ Lic.No/Date:0310514060 01.04.2009 Defer Date:02.02.2010

60

Case No.:44/18/82­ALC4/2009

Party Name:HETERO LABS LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00318/AM10/ RLA File :09/24/040/00477/AM09/ Lic.No/Date:0910037637 09.04.2009 Defer Date:02.02.2010   61

Case No.:66/18/82­ALC4/2009

Party Name:CORVINE CHEMICALS & PHARMACEUTICALS LIMITED, 05.01.2010 Status:Case Deferred HQ File :01/82/050/00340/AM10/ RLA File :07/24/040/00009/AM10/ Lic.No/Date:0710064113 13.04.2009 Defer Date:02.02.2010   62

Case No.:21/18/82­ALC4/2009

Party Name:ELPPE CHEMICALS PRIVATE LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00295/AM10/ RLA File :03/94/040/01082/AM09/ Lic.No/Date:0310515875 16.04.2009 Defer Date:02.02.2010   63

Case No.:69/18/82­ALC4/2009

Party Name:KUDOS CHEMIE LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00343/AM10/ RLA File :22/24/040/00001/AM10/ Lic.No/Date:2210008835 16.04.2009 Defer Date:02.02.2010   64

Case No.:4/5/82­ALC4/2009

Party Name:ALEMBIC LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00037/AM10/ RLA File :34/24/040/00242/AM09/ Lic.No/Date:3410024018 22.04.2009 Defer Date:02.02.2010   65

Case No.:78/18/82­ALC4/2009

Party Name:HETERO DRUGS LIMITED, 05.01.2010 Status:Case Approved HQ File :01/82/050/00352/AM10/ RLA File :09/24/040/00013/AM10/ Lic.No/Date:0910037741 23.04.2009   Decision  :  Committee  considered  case  as  per  agenda  and  in  light  of  written  comments  forwarded  by  Department  of  Pharmaceuticals  vide  their  O.M. No.35011/87/2009‐PI‐III dated 29.12.2009 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 Fosinopril Sodium 1 Kg.  1. Trans­4­Hydroxy­L­Proline 1.592 kg 2. 4­Dimethyl Amino Pyridine 0.114 kg 3. 5% Palladium on Charcoal 0.078 kg 4. 4­Phenyl­1­Butene 3.06 kg 5. Benzyl Bromo Acetate 4.20 kg 6. Cinchonidine 0.2379 kg 7. Trimethyl Silyl Chloride 3.301 kg 8. N,N­Dicyclohexyl Carbodimide 0.55 kg 9. 2­Ethyl Hexanoic Acid Sodium Salt 0.230 kg 10. Propionyl Bromide 1.77 kg 11. Methanol 10.00 kg 12. Pyridine 2.00 kg 13. Acetone 8.00 kg 14. Di­isopropyl Ether 4.11 kg 15. Tetrahydrofuran 5.00 kg   RA concerned may take further necessary action as per above decision of NC.   66

Case No.:10/18/82­ALC4/2009

Party Name:UNIMAX CHEMICALS PVT LTD. 05.01.2010 HQ File :01/82/050/00284/AM10/ RLA File :03/95/040/00042/AM10/ Lic.No/Date:0310518058 01.05.2009   67

Case No.:11/18/82­ALC4/2009

Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:41/82­ALC4/2009 05.01.2010 Status:Case Deferred HQ File :01/82/050/00285/AM10/ RLA File :03/95/040/01027/AM09/ Lic.No/Date:0310517971 01.05.2009 Defer Date:02.02.2010   68

Case No.:8/18/82­ALC4/2009

Party Name:UNIMAX LABORATORIES PVT.LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00282/AM10/ RLA File :03/95/040/00940/AM09/ Lic.No/Date:0310518060 01.05.2009 Defer Date:02.02.2010   69

Case No.:16/14/82­ALC4/2009

Party Name:HETERO LABS LTD. 05.01.2010 Status:Case Approved

HQ File :01/82/050/00186/AM10/ RLA File :09/24/040/00050/AM10/ Lic.No/Date:0910037893 13.05.2009   Decision  :  Committee  considered  case  as  per  agenda  and  in  light  of  written  comments  forwarded  by  Department  of  Pharmaceuticals  vide  their  O.M. No.35011/289/2009‐PI‐III dated 29.12.2009 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 Oseltamivir Premix Each gram contains: Oseltamivir  Phosphate equivalent  to  Oleltamivir 454.5 mg 1 Kg.  1. Shikimic Acid 2.379 kg 2. 2,2­Dimethoxy Propane 0.0254 kg 3. 3­Pentanone 8.415 kg 4. Trifluoromethane Sulfonic Acid 0.120 kg 5. Triethyl Silane 1.77 kg 6. Methanol 1.425 kg 7. Methylene Chloride 7.99 kg 8. Tetrahydrofuran 1.637 kg 9. Dimethyl formamide 0.927 kg   RA concerned may take further necessary action as per above decision of NC.   70

Case No.:16/18/82­ALC4/2009

Party Name:CIPLA LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00290/AM10/ RLA File :03/94/040/00104/AM10/ Lic.No/Date:0310520417 19.05.2009 Defer Date:02.02.2010   71

Case No.:35/18/82­ALC4/2009

Party Name:CIPLA LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00309/AM10/ RLA File :03/94/040/00115/AM10/ Lic.No/Date:0310520711 21.05.2009 Defer Date:02.02.2010   72

Case No.:38/18/82­ALC4/2009

Party Name:ENALTEC LABS PVT.LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00312/AM10/ RLA File :03/94/040/00101/AM10/ Lic.No/Date:0310520653 21.05.2009 Defer Date:02.02.2010   73

Case No.:39/18/82­ALC4/2009

Party Name:ENCUBE ETHICALS PVT LTD 05.01.2010 Status:Case Deferred

HQ File :01/82/050/00313/AM10/ RLA File :03/94/040/00076/AM10/ Lic.No/Date:0310520964 22.05.2009 Defer Date:02.02.2010 Decision : Committee decided to defer case for 02.02.2010 for comments of DC(MSME).   74

Case No.:40/18/82­ALC4/2009

Party Name:ENCUBE ETHICALS PVT LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00314/AM10/ RLA File :03/94/040/00068/AM10/ Lic.No/Date:0310520972 22.05.2009 Defer Date:02.02.2010 Decision : Committee decided to defer case for 02.02.2010 for comments of DC(MSME).   75

Case No.:41/18/82­ALC4/2009

Party Name:ENCUBE ETHICALS PVT LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00315/AM10/ RLA File :03/94/040/00073/AM10/ Lic.No/Date:0310520968 22.05.2009 Defer Date:02.02.2010 Decision : Committee decided to defer case for 02.02.2010 for comments of DC(MSME).   76

Case No.:23/18/82­ALC4/2009

Party Name:AUCTUS PHARMA LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00297/AM10/ RLA File :09/24/040/00457/AM09/ Lic.No/Date:0910038018 26.05.2009 Defer Date:02.02.2010   77

Case No.:36/18/82­ALC4/2009

Party Name:CHEMILL NUTRACEUTICALS PVT.LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00310/AM10/ RLA File :03/94/040/00148/AM10/ Lic.No/Date:0310521537 27.05.2009 Defer Date:02.02.2010   78

Case No.:14/18/82­ALC4/2009

Party Name:WOCKHARDT LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00288/AM10/ RLA File :03/95/040/00084/AM10/ Lic.No/Date:0310521745 28.05.2009 Defer Date:02.02.2010   79

Case No.:17/18/82­ALC4/2009

Party Name:UNIMARK REMEDIES LIMITED., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00291/AM10/ RLA File :03/95/040/00124/AM10/ Lic.No/Date:0310522329 Defer

02.06.2009 Date:02.02.2010   80

Case No.:37/18/82­ALC4/2009

Party Name:MSN PHARMACHEM PRIVATE LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00311/AM10/ RLA File :09/24/040/00053/AM10/ Lic.No/Date:0910038076 02.06.2009 Defer Date:02.02.2010   81

Case No.:42/18/82­ALC4/2009

Party Name:MAITHRI LABORATORIES (P) LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00316/AM10/ RLA File :09/24/040/00068/AM10/ Lic.No/Date:0910038079 02.06.2009 Defer Date:02.02.2010   82

Case No.:32/18/82­ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00306/AM10/ RLA File :09/24/040/00410/AM09/ Lic.No/Date:0910038108 03.06.2009 Defer Date:02.02.2010   83

Case No.:26/18/82­ALC4/2009

Party Name:ENALTEC LABS PVT.LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00300/AM10/ RLA File :03/94/040/00141/AM10/ Lic.No/Date:0310524174 15.06.2009 Defer Date:02.02.2010   84

Case No.:43/18/82­ALC4/2009

Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00317/AM10/ RLA File :03/94/040/00018/AM10/ Lic.No/Date:0310524605 17.06.2009 Defer Date:02.02.2010   85

Case No.:20/18/82­ALC4/2009

Party Name:ARCH PHARMALABS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00294/AM10/ RLA File :03/94/040/00087/AM10/ Lic.No/Date:0310524765 18.06.2009 Defer Date:02.02.2010

  86

Case No.:13/21/82­ALC4/2009

Party Name:SURYA PHARMACEUTICAL LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00440/AM10/ RLA File :22/24/040/00014/AM10/ Lic.No/Date:2210009017 22.06.2009 Defer Date:02.02.2010   87

Case No.:71/18/82­ALC4/2009

Party Name:NECTAR LIFESCIENCES LIMITED, 05.01.2010 Status:Case Deferred HQ File :01/82/050/00345/AM10/ RLA File :22/24/040/00011/AM10/ Lic.No/Date:2210009016 22.06.2009 Defer Date:02.02.2010   88

Case No.:1/17/82­ALC4/2009

Party Name:INTERMED LABS PVT. LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00264/AM10/ RLA File :07/24/040/00135/AM10/ Lic.No/Date:0710065750 03.07.2009 Defer Date:02.02.2010   89

Case No.:2/17/82­ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00265/AM10/ RLA File :09/24/040/00121/AM10/ Lic.No/Date:0910038452 06.07.2009 Defer Date:02.02.2010   90

Case No.:3/17/82­ALC4/2009

Party Name:CIPLA LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00266/AM10/ RLA File :03/94/040/00279/AM10/ Lic.No/Date:0310527467 06.07.2009 Defer Date:02.02.2010   91

Case No.:4/17/82­ALC4/2009

Party Name:SARAF CHEMICALS LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00267/AM10/ RLA File :03/95/040/00207/AM10/ Lic.No/Date:0310527468 06.07.2009 Defer Date:02.02.2010

92

Case No.:5/17/82­ALC4/2009

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00268/AM10/ RLA File :03/95/040/00102/AM10/ Lic.No/Date:0310527449 06.07.2009 Defer Date:02.02.2010   93

Case No.:7/17/82­ALC4/2009

Party Name:LAKE CHEMICALS PRIVATE LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00270/AM10/ RLA File :07/24/040/00051/AM10/ Lic.No/Date:0710065810 07.07.2009 Defer Date:02.02.2010   94

Case No.:8/17/82­ALC4/2009

LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00271/AM10/ RLA File :05/24/040/00208/AM10/ Lic.No/Date:0510245316 08.07.2009 Defer Date:02.02.2010   95

Case No.:9/17/82­ALC4/2009

Party Name:VISHNU CHEMICALS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00272/AM10/ RLA File :09/24/040/00101/AM10/ Lic.No/Date:0910038523 09.07.2009 Defer Date:02.02.2010   96

Case No.:10/17/82­ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00273/AM10/ RLA File :05/24/040/00203/AM10/ Lic.No/Date:0510245516 10.07.2009 Defer Date:02.02.2010   97

Case No.:48/18/82­ALC4/2009

Party Name:PORUS LABORATORIES PVT LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00322/AM10/ RLA File :09/24/040/00118/AM10/ Lic.No/Date:0910038561 13.07.2009 Defer Date:02.02.2010

98

Case No.:61/18/82­ALC4/2009

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00335/AM10/ RLA File :04/24/040/00057/AM10/ Lic.No/Date:0410106102 14.07.2009 Defer Date:02.02.2010   99

Case No.:80/18/82­ALC4/2009

Party Name:ONEIRO CHEMICALS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00354/AM10/ RLA File :34/24/040/00064/AM10/ Lic.No/Date:3410024680 15.07.2009 Defer Date:02.02.2010   100

Case No.:82/18/82­ALC4/2009

Party Name:LUPIN LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00356/AM10/ RLA File :03/95/040/00079/AM10/ Lic.No/Date:0310529028 16.07.2009 Defer Date:02.02.2010   101

Case No.:87/18/82­ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 05.01.2010 HQ File :01/82/050/00361/AM10/ RLA File :05/24/040/00230/AM10/ Lic.No/Date:0510246091 17.07.2009   102

Case No.:17/29/82­ALC4/2009

LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00587/AM10/ RLA File :09/24/040/00436/AM09/ Lic.No/Date:0910038631 20.07.2009 Defer Date:02.02.2010   103

Case No.:89/18/82­ALC4/2009

LTD 05.01.2010 HQ File :01/82/050/00363/AM10/ RLA File :05/24/040/00226/AM10/ Lic.No/Date:0510246173 20.07.2009   104

Case No.:12/29/82­ALC4/2009

Party Name:DIVIS LABORATORIES LTD.,

05.01.2010 HQ File :01/82/050/00582/AM10/ RLA File :09/24/040/00134/AM10/ Lic.No/Date:0910038660 23.07.2009   105

Case No.:14/29/82­ALC4/2009

Party Name:AUCTUS PHARMA LIMITED 05.01.2010 HQ File :01/82/050/00584/AM10/ RLA File :09/24/040/00111/AM10/ Lic.No/Date:0910038661 23.07.2009   106

Case No.:15/29/82­ALC4/2009

LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00585/AM10/ RLA File :09/24/040/00006/AM10/ Lic.No/Date:0910038659 23.07.2009 Defer Date:02.02.2010   107

Case No.:97/18/82­ALC4/2009

Party Name:KAJAY REMEDIES PVT. LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00371/AM10/ RLA File :03/94/040/00310/AM10/ Lic.No/Date:0310530334 23.07.2009 Defer Date:02.02.2010   108

Case No.:98/18/82­ALC4/2009

Party Name:KAJAY REMEDIES PVT. LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00372/AM10/ RLA File :03/94/040/00019/AM10/ Lic.No/Date:0310530340 23.07.2009 Defer Date:02.02.2010   109

Case No.:100/18/82­ALC4/2009

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00374/AM10/ RLA File :09/24/040/00139/AM10/ Lic.No/Date:0910038692 24.07.2009 Defer Date:02.02.2010   110

Case No.:101/18/82­ALC4/2009

Party Name:PADMINI AROMATICS PVT. LTD 05.01.2010 Status:Case Deferred

HQ File :01/82/050/00375/AM10/ RLA File :07/24/040/00136/AM10/ Lic.No/Date:0710066165 24.07.2009 Defer Date:02.02.2010   111

Case No.:102/18/82­ALC4/2009

LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00376/AM10/ RLA File :05/24/040/00243/AM10/ Lic.No/Date:0510246579 24.07.2009 Defer Date:02.02.2010   112

Case No.:104/18/82­ALC4/2009

Party Name:STERICAT GUTSTRINGS PVT. LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00378/AM10/ RLA File :05/24/040/00759/AM09/ Lic.No/Date:0510246636 27.07.2009 Defer Date:02.02.2010   113

Case No.:16/29/82­ALC4/2009

Party Name:ALEMBIC LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00586/AM10/ RLA File :34/24/040/00068/AM10/ Lic.No/Date:3410024818 03.08.2009 Defer Date:02.02.2010   114

Case No.:13/29/82­ALC4/2009

Party Name:ALEMBIC LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00583/AM10/ RLA File :34/24/040/00070/AM10/ Lic.No/Date:3410024898 12.08.2009 Defer Date:02.02.2010   115

Case No.:10/29/82­ALC4/2009

Party Name:SYMBIOTEC PHARMALAB LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00580/AM10/ RLA File :11/24/040/00012/AM10/ Lic.No/Date:1110020967 25.08.2009 Defer Date:02.02.2010   116

Case No.:21/29/82­ALC4/2009

Party Name:DIVIS LABORATORIES LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00591/AM10/ RLA File :09/24/040/00189/AM10/ Lic.No/Date:0910039075 Defer

27.08.2009 Date:02.02.2010   117

Case No.:22/37/82­ALC4/2009

Party Name:RELIANCE INDUSTRIES LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00765/AM10/ RLA File :03/95/040/00324/AM10/ Lic.No/Date:0310536409 07.09.2009 Defer Date:02.02.2010   118

Case No.:2/29/82­ALC4/2009

Party Name:INTAS PHARMACEUTICALS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00572/AM10/ RLA File :08/24/040/00155/AM10/ Lic.No/Date:0810083127 25.09.2009 Defer Date:02.02.2010   119

Case No.:4/29/82­ALC4/2009

Party Name:INDIA GLYCOLS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00574/AM10/ RLA File :05/23/040/00038/AM10/ Lic.No/Date:0510250014 29.09.2009 Defer Date:02.02.2010   120

Case No.:5/29/82­ALC4/2009

Party Name:INDO PHYTOCHEM PHARMACEUTICALS 05.01.2010 Status:Case Deferred HQ File :01/82/050/00575/AM10/ RLA File :05/23/040/00055/AM10/ Lic.No/Date:0510250016 29.09.2009 Defer Date:02.02.2010   121

Case No.:6/29/82­ALC4/2009

Party Name:INTAS PHARMACEUTICALS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00576/AM10/ RLA File :08/24/040/00161/AM10/ Lic.No/Date:0810083230 30.09.2009 Defer Date:02.02.2010   122 Case No.:7/29/82­ALC4/2009 Party Name:LAKE CHEMICALS PRIVATE LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00577/AM10/ RLA File :07/24/040/00229/AM10/ Lic.No/Date:0710067286 30.09.2009 Defer Date:02.02.2010

  123

Case No.:8/29/82­ALC4/2009

Party Name:LAKE CHEMICALS PRIVATE LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00578/AM10/ RLA File :07/24/040/00230/AM10/ Lic.No/Date:0710067287 30.09.2009 Defer Date:02.02.2010   124

Case No.:24/29/82­ALC4/2009

Party Name:SRINI PHARMACEUTICALS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00594/AM10/ RLA File :09/24/040/00247/AM10/ Lic.No/Date:0910039458 05.10.2009 Defer Date:02.02.2010   125

Case No.:25/29/82­ALC4/2009

Party Name:KAMUD DRUGS PVT.LIMITED., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00595/AM10/ RLA File :31/21/040/00198/AM10/ Lic.No/Date:3110040141 05.10.2009  Defer Date:02.02.2010 Decision : Committee decided to defer case for 02.02.2010 for comments of Dep. Of Pharmaceuticals.     126

Case No.:30/29/82­ALC4/2009

Party Name:PROMED EXPORTS PVT.LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00600/AM10/ RLA File :05/24/040/00332/AM10/ Lic.No/Date:0510250305 06.10.2009 Defer Date:02.02.2010   127

Case No.:28/37/82­ALC4/2009

Party Name:RELIANCE INDUSTRIES LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00771/AM10/ RLA File :03/95/040/00432/AM10/ Lic.No/Date:0310540571 07.10.2009 Defer Date:02.02.2010   128

Case No.:2/33/82­ALC4/2009

Party Name:DORF­KETAL CHEMICALS INDIA PVT.LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00630/AM10/ RLA File :03/94/040/00451/AM10/ Lic.No/Date:0310541892 23.10.2009 Defer Date:02.02.2010

129

Case No.:5/33/82­ALC4/2009

Party Name:KORES (INDIA) LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00633/AM10/ RLA File :03/94/040/00516/AM10/ Lic.No/Date:0310542107 23.10.2009 Defer Date:02.02.2010   130

Case No.:7/33/82­ALC4/2009

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 05.01.2010 Status:Case Deferred HQ File :01/82/050/00635/AM10/ RLA File :03/94/040/00569/AM10/ Lic.No/Date:0310542418 26.10.2009 Defer Date:02.02.2010   131

Case No.:8/33/82­ALC4/2009

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 05.01.2010 Status:Case Deferred HQ File :01/82/050/00636/AM10/ RLA File :03/95/040/00282/AM10/ Lic.No/Date:0310542452 26.10.2009 Defer Date:02.02.2010   132

Case No.:9/33/82­ALC4/2009

Party Name:VISHNU CHEMICALS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00637/AM10/ RLA File :09/24/040/00230/AM10/ Lic.No/Date:0910039712 27.10.2009 Defer Date:02.02.2010   133

Case No.:14/33/82­ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00642/AM10/ RLA File :09/24/040/00262/AM10/ Lic.No/Date:0910039756 29.10.2009 Defer Date:02.02.2010   134

Case No.:15/33/82­ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00643/AM10/ RLA File :09/24/040/00240/AM10/ Lic.No/Date:0910039761 29.10.2009 Defer Date:02.02.2010

135

Case No.:16/33/82­ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00644/AM10/ RLA File :09/24/040/00222/AM10/ Lic.No/Date:0910039762 29.10.2009 Defer Date:02.02.2010   136

Case No.:1/35/82­ALC4/2009

Party Name:NEON LABORATORIES LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00691/AM10/ RLA File :03/95/040/00495/AM10/ Lic.No/Date:0310544646 09.11.2009 Defer Date:02.02.2010   137

Case No.:3/35/82­ALC4/2009

Party Name:V.D.H. ORGANICS PVT. LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00693/AM10/ RLA File :05/24/040/00350/AM10/ Lic.No/Date:0510252131 10.11.2009 Defer Date:02.02.2010   138

Case No.:4/35/82­ALC4/2009

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00694/AM10/ RLA File :03/95/040/00365/AM10/ Lic.No/Date:0310544960 11.11.2009 Defer Date:02.02.2010   139

Case No.:6/35/82­ALC4/2009

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 05.01.2010 Status:Case Deferred HQ File :01/82/050/00696/AM10/ RLA File :05/24/040/00339/AM10/ Lic.No/Date:0510252282 11.11.2009 Defer Date:02.02.2010   140 Case No.:9/35/82­ALC4/2009 Party Name:SHILPA MEDICARE LTD., 05.01.2010 Status:Case Approved HQ File :01/82/050/00699/AM10/ RLA File :07/24/040/00298/AM10/ Lic.No/Date:0710068187 11.11.2009   Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 24/82 meeting held on 08.09.2009 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 items Qty. allowed per unit of export product Gemcitabine Hcl 1 Kg. 1. 4­Amino­1­(3,3­difluoro­4­hydroxy­5­ (Hydroxymethyl)  Tetrahydrofuran­2­ yl)­1H­Pyrimidine­2­one  (Technical Grade) 0.97 kg/kg   RA concerned may take further necessary action as per above decision of NC.   141

Case No.:31/35/82­ALC4/2009

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00721/AM10/ RLA File :09/24/040/00306/AM10/ Lic.No/Date:0910039891 12.11.2009 Defer Date:02.02.2010   142

Case No.:32/35/82­ALC4/2009

Party Name:SMILAX LABORATORIES LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00722/AM10/ RLA File :09/24/040/00299/AM10/ Lic.No/Date:0910039896 12.11.2009  DeferDate: 02.02.2010 Decision :Committee decided to defer case for 02.02.2010 for comments of Deptt. Of Pharmaceuticals.   143

Case No.:34/35/82­ALC4/2009

Party Name:WOCKHARDT LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00724/AM10/ RLA File :03/95/040/00448/AM10/ Lic.No/Date:0310545253 12.11.2009 Defer Date:02.02.2010   144

Case No.:35/35/82­ALC4/2009

Party Name:IPCA LABORATORIES LIMITED Meet No/Date:41/82­ALC4/2009 05.01.2010 Status:Case Deferred HQ File :01/82/050/00725/AM10/ RLA File :03/94/040/00587/AM10/ Lic.No/Date:0310545337 12.11.2009 Defer Date:02.02.2010   145 Case No.:26/37/82­ALC4/2009 Party Name:RELIANCE INDUSTRIES LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00769/AM10/ RLA File :03/95/040/00503/AM10/ Lic.No/Date:0310545423 13.11.2009 Defer Date:02.02.2010

146

Case No.:2/37/82­ALC4/2009

Party Name:PADMINI AROMATICS PVT. LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00745/AM10/ RLA File :07/24/040/00294/AM10/ Lic.No/Date:0710068389 19.11.2009 Defer Date:02.02.2010   147

Case No.:3/37/82­ALC4/2009

Party Name:AARTI INDUSTRIES LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00746/AM10/ RLA File :03/94/040/00606/AM10/ Lic.No/Date:0310546496 19.11.2009 Defer Date:02.02.2010   148

Case No.:5/37/82­ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00748/AM10/ RLA File :09/24/040/00325/AM10/ Lic.No/Date:0910039975 19.11.2009 Defer Date:02.02.2010   149

Case No.:6/37/82­ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00749/AM10/ RLA File :09/24/040/00326/AM10/ Lic.No/Date:0910039976 19.11.2009 Defer Date:02.02.2010   150

Case No.:9/37/82­ALC4/2009

Party Name:ARCH PHARMALABS LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00752/AM10/ RLA File :03/94/040/00704/AM10/ Lic.No/Date:0310546649 19.11.2009 Defer Date:02.02.2010   151

Case No.:7/37/82­ALC4/2009

Party Name:AARTI ORGANIC 05.01.2010 Status:Case Deferred HQ File :01/82/050/00750/AM10/ RLA File :08/24/040/00209/AM10/ Lic.No/Date:0810084279 20.11.2009 Defer Date:02.02.2010

152 Case No.:10/37/82­ALC4/2009 Party Name:SHASUN CHEMICALS & DRUGS LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00753/AM10/ RLA File :04/24/040/00191/AM10/ Lic.No/Date:0410109528 23.11.2009 Defer Date:02.02.2010   153

Case No.:11/37/82­ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00754/AM10/ RLA File :03/95/040/00513/AM10/ Lic.No/Date:0310546961 23.11.2009 Defer Date:02.02.2010   154

Case No.:13/37/82­ALC4/2009

Party Name:WOCKHARDT LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00756/AM10/ RLA File :03/95/040/00508/AM10/ Lic.No/Date:0310547176 24.11.2009 Defer Date:02.02.2010   155

Case No.:15/37/82­ALC4/2009

LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00758/AM10/ RLA File :05/24/040/00368/AM10/ Lic.No/Date:0510253220 24.11.2009 Defer Date:02.02.2010   156

Case No.:16/37/82­ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:41/82­ALC4/2009 05.01.2010 Status:Case Deferred HQ File :01/82/050/00759/AM10/ RLA File :09/24/040/00294/AM10/ Lic.No/Date:0910040009 24.11.2009 Defer Date:02.02.2010   157

Case No.:17/37/82­ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:41/82­ALC4/2009 05.01.2010 Status:Case Deferred HQ File :01/82/050/00760/AM10/ RLA File :09/24/040/00244/AM10/ Lic.No/Date:0910040010 24.11.2009 Defer Date:02.02.2010   158 Case No.:18/37/82­ALC4/2009 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:41/82­ALC4/2009 Status:Case

05.01.2010 Approved HQ File :01/82/050/00761/AM10/ RLA File :09/24/040/00328/AM10/ Lic.No/Date:0910040011 24.11.2009   Decision  :  Committee  considered  case  as  per  agenda  and  in  light  of  written  comments  forwarded  by  Department  of  Pharmaceuticals  vide  their  U.O. No.35011/93/2009‐PI‐III dated 15.06.2009 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 Furaniminium Bromide 1 Kg.  1. Acetonitrile 1.58 kg 2. Isopropyl Alcohol 1.17 kg 3. Toluene 1.47 kg 4. Thionyl Chloride 0.68 kg 5. Chloroform 1.47 kg 6. Acetone 1.47 kg 7. Methanol 2.20 kg   RA concerned may take further necessary action as per above decision of NC.   159

Case No.:19/37/82­ALC4/2009

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 05.01.2010 Status:Case Deferred HQ File :01/82/050/00762/AM10/ RLA File :03/94/040/00621/AM10/ Lic.No/Date:0310547351 25.11.2009 Defer Date:02.02.2010   160

Case No.:20/37/82­ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00763/AM10/ RLA File :05/24/040/00367/AM10/ Lic.No/Date:0510253267 25.11.2009 Defer Date:02.02.2010   161

Case No.:25/37/82­ALC4/2009

Party Name:KDAC CHEM PVT LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00768/AM10/ RLA File :34/24/040/00130/AM10/ Lic.No/Date:3410025692 25.11.2009 Defer Date:02.02.2010   162 Case No.:23/37/82­ALC4/2009 Party Name:SRINI PHARMACEUTICALS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00766/AM10/ RLA File :09/24/040/00343/AM10/ Lic.No/Date:0910040046 Defer

27.11.2009 Date:02.02.2010   163

Case No.:24/37/82­ALC4/2009

Party Name:SRINI PHARMACEUTICALS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00767/AM10/ RLA File :09/24/040/00351/AM10/ Lic.No/Date:0910040047 27.11.2009 Defer Date:02.02.2010   164

Case No.:29/37/82­ALC4/2009

Party Name:OTSUKA CHEMICAL ( INDIA ) LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00772/AM10/ RLA File :05/24/040/00328/AM10/ Lic.No/Date:0510253540 27.11.2009 Defer Date:02.02.2010   165

Case No.:30/37/82­ALC4/2009

Party Name:OTSUKA CHEMICAL ( INDIA ) LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00773/AM10/ RLA File :05/24/040/00376/AM10/ Lic.No/Date:0510253557 27.11.2009 Defer Date:02.02.2010   166

Case No.:1/41/82­ALC4/2009

Party Name:OTSUKA CHEMICAL ( INDIA ) LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00836/AM10/ RLA File :05/24/040/00408/AM10/ Lic.No/Date:0510254931 18.12.2009 Defer Date:02.02.2010   167

Case No.:2/41/82­ALC4/2009

LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00837/AM10/ RLA File :05/24/040/00411/AM10/ Lic.No/Date:0510254932 18.12.2009 Defer Date:02.02.2010   168 Case No.:3/41/82­ALC4/2009 Party Name:KUSUMA PHARMA 05.01.2010 Status:Case Deferred HQ File :01/82/050/00838/AM10/ RLA File :03/94/040/00808/AM10/ Lic.No/Date:0310551825 21.12.2009 Defer Date:02.02.2010

  169

Case No.:4/41/82­ALC4/2009

Party Name:BALAJI AMINES LIMITED 05.01.2010 Status:Case Deferred HQ File :01/82/050/00839/AM10/ RLA File :31/24/040/00192/AM10/ Lic.No/Date:3110041170 21.12.2009 Defer Date:02.02.2010   170

Case No.:5/41/82­ALC4/2009

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00840/AM10/ RLA File :31/24/040/00188/AM10/ Lic.No/Date:3110041172 21.12.2009 Defer Date:02.02.2010   171

Case No.:6/41/82­ALC4/2009

Party Name:CADILA HEALTHCARE LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00841/AM10/ RLA File :08/24/040/00213/AM10/ Lic.No/Date:0810085114 21.12.2009 Defer Date:02.02.2010   172

Case No.:7/41/82­ALC4/2009

Party Name:INTAS PHARMACEUTICALS LTD., 05.01.2010 Status:Case Deferred HQ File :01/82/050/00842/AM10/ RLA File :08/24/040/00258/AM10/ Lic.No/Date:0810085116 21.12.2009 Defer Date:02.02.2010   173

Case No.:8/41/82­ALC4/2009

Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00843/AM10/ RLA File :31/24/040/00186/AM10/ Lic.No/Date:3110041177 21.12.2009 Defer Date:02.02.2010   174

Case No.:9/41/82­ALC4/2009

Party Name:DHANUKA LABORATORIES LTD. 05.01.2010 Status:Case Deferred HQ File :01/82/050/00844/AM10/ RLA File :05/23/040/00120/AM10/ Lic.No/Date:0510255017 21.12.2009 Defer Date:02.02.2010

175

Case No.:10/41/82­ALC4/2009

Party Name:ADCOCK INGRAM LTD, 05.01.2010 Status:Case Deferred HQ File :01/82/050/00845/AM10/ RLA File :07/24/040/00360/AM10/ Lic.No/Date:0710069043 22.12.2009 Defer Date:02.02.2010   176

Case No.:11/41/82­ALC4/2009

Party Name:ADCOCK INGRAM LTD, 05.01.2010 Status:Case Deferred HQ File :01/82/050/00846/AM10/ RLA File :07/24/040/00361/AM10/ Lic.No/Date:0710069044 22.12.2009 Defer Date:02.02.2010   177

Case No.:12/41/82­ALC4/2009

LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00847/AM10/ RLA File :05/24/040/00412/AM10/ Lic.No/Date:0510255095 22.12.2009 Defer Date:02.02.2010   178

Case No.:13/41/82­ALC4/2009

LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00848/AM10/ RLA File :05/24/040/00413/AM10/ Lic.No/Date:0510255096 22.12.2009 Defer Date:02.02.2010   179

Case No.:14/41/82­ALC4/2009

LTD 05.01.2010 Status:Case Deferred HQ File :01/82/050/00849/AM10/ RLA File :05/24/040/00414/AM10/ Lic.No/Date:0510255098 22.12.2009 Defer Date:02.02.2010 Decision :Committee decided to defer case for 02.02.2010 for comments of Deptt. Of Pharmaceuticals.   ###############################

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