IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-10-09

DGFT Committee Minutes

Document text

Directorate General of Foreign Trade Ministry of Commerce & Industry, Maulana Azad Road, Udyog Bhawan New Delhi -110011

Para 4.7 Decision

MEETING NUMBER : 23/82-ALC4/2007 MEETING DATE : 09.10.2007 1

Case No.:10/20/87-

ALC1/2005 Party Name:ALKALOIDS CORP Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00429/AM06/ RLA File : 02/24/040/00081/AM06/ Lic.No/Date:02100800 76 15.07.2005 Defer Date: 06.11.2007 Decision :Committee considered the case as per agenda for ratification of norms for export product Aescin (Horse Chestnut Extract) under para 4.7 of HBP. Committee observed that technical comments were called for from Department of Ayush, but the same has not been received. Committee, therefore, decided to remind Department of Ayush for comments. Accordingly, case was deferred for four weeks. 2

Case No.:8/10/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00096/AM07/ RLA File : 02/24/040/00020/AM07/ Lic.No/Date:02100887 34 28.04.2006 Defer Date: 06.11.2007 Decision : Committee considered the case as per agenda for ratification of norms for export product Aescin (Horse Chestnut Extract) under para 4.7 of HBP. Committee observed that technical comments were called for from Department of Ayush, but the same has not been received. Committee, therefore, decided to remind Department of Ayush for comments. Accordingly, case was deferred for four weeks. 3

Case No.:1/23/87-

ALC1/2006 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00336/AM07/ RLA File : 05/24/040/00255/AM07/ Lic.No/Date:05101852 76 21.06.2006 Defer Date: 06.11.2007

norms for export product Silymarin Extract under para 4.7 of HBP. Committee observed that technical comments were called for from Department of Ayush, but the same has not been received. Committee, therefore, decided to remind Department of Ayush for comments. Accordingly, case was deferred for four weeks. 4

Case No.:363/21/82-

ALC4/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00581/AM07/ RLA File : 09/24/040/00148/AM07/ Lic.No/Date:09100269 38 21.07.2006 Defer Date: 06.11.2007 norms for export product Lisinopril under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/219/2005-PI-III dated 09.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Lisinopril------------------------------------1kg. Import items:

  1. N 2-[(1-S)-Ethoxy Carbonyl-3-Phenyl Propyl] -N 6-trifluoro acetyl-L-lysine benzyl ester-----------------2.58kg/kg
  2. Palladium on carbon 5%-------------------------------------0.011kg/kg
  3. L-Proline---------------------------------------------------------0.927kg/kg
  4. Methanol--------------------------------------------------------5.45kg/kg
  5. Methylene chloride-------------------------------------------10.77kg/kg

RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.
5

Case No.:2/34/82-

ALC1/2006 Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00593/AM07/ RLA File : 08/24/040/00247/AM06/ Lic.No/Date:08100583 23 24.07.2006 Defer Date: 06.11.2007 norms for export product 1-Carbethoxy Ethylidene Triphenyl Phosphorane under para 4.7 of HBP.

The representative of PI Division present in the meeting informed the Committee that the reply received from the firm is under examination in his Department and he sought deferment of four weeks. The Committee accordingly decided to defer the case for four weeks. 6

Case No.:16/27/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00419/AM07/ RLA File : 02/24/040/00123/AM07/ Lic.No/Date:02100921 25 02.08.2006 Defer Date: 06.11.2007 norms for export product Kola Extract under para 4.7 of HBP. Committee observed that technical comments were called for from Department of Ayush, but the same has not been received. Committee, therefore, decided to remind Department of Ayush for comments. Accordingly, case was deferred for four weeks. 7

Case No.:17/31/82-

ALC1/2006 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00911/AM07/ RLA File : 03/94/040/00615/AM07/ Lic.No/Date:03103990 69 12.09.2006 Defer Date: 06.11.2007 norms for export product Terbinafine Hydrochloride Tablets 250mg (Terbinafine Hcl equi. Qty. 1873kg-30s Packs) under para 4.7 of HBP. The Committee observed that the firm was requested to furnish certain technical information vide letter dated 28.09.2007, but the same has not been received. The Committee, therefore, decided to await reply of the firm. Accordingly, case was deferred for four weeks. 8

Case No.:2/31/83-

ALC1/2006 Party Name:PRADEEP SHETYE PVT. LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00707/AM07/ RLA File : 03/95/040/00433/AM07/ Lic.No/Date:03104006 43 22.09.2006 Defer Date: 06.11.2007 norms for export product Micronized Rafoxanide under para 4.7 of HBP. Committee that the case is under examination in his Department and he

sought deferment for four weeks. Accordingly, the Committee decided to defer the case for four weeks. 9

Case No.:2/46/87-

ALC1/2006 Party Name:AVON ORGANICS LTD., Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00663/AM07/ RLA File : 09/24/040/00271/AM07/ Lic.No/Date:09100279 81 30.10.2006 Defer Date: 06.11.2007 norms for export product 5-Aceto Acetyl Amino Benzimidazolone (AABZ) or 5-Aceto Acetyl Amino Benzimidazolon-2 (AABI) under para 4.7 of HBP. 10

Case No.:3/44/82-

ALC1/2006 Party Name:GULF OIL CORPORATION LIMITED. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/01214/AM07/ RLA File : 09/24/040/00174/AM07/ Lic.No/Date:09100280 04 31.10.2006 Defer Date: 06.11.2007 norms for export product Fexofenadine Hcl under para 4.7 of HBP. 11

Case No.:4/44/82-

ALC1/2006 Party Name:GULF OIL CORPORATION LIMITED. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Withdraw n HQ File : 01/82/050/01215/AM07/ RLA File : 09/24/040/00194/AM07/ Lic.No/Date:09100280 05 31.10.2006

norms for export product Sodium Cromo Glycate under para 4.7 of HBP. Committee decided to withdraw this case as the same has already been rejected in its 17/08 meeting held on 30.08.2007.

12

Case No.:608/21/82-

ALC4/2007 Party Name:HETERO LABS LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Approved HQ File : 01/82/050/01217/AM07/ RLA File : 09/24/040/00286/AM07/ Lic.No/Date:09100280 08 31.10.2006

norms for export product Stavudine under para 4.7 of HBP. their U.O. No.35011/219/2005-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Stavudine------------------------------------1kg. Import items:

  1. 5-Methyl Uridin--------------------------3.29kg/kg
  2. Acetonitrile--------------------------------3.72kg/kg
  3. Methanol-----------------------------------3.43kg/kg
  4. Dimethyl Amino Pyridine--------------0.230kg/kg
  5. Trimethyl Ortho Acetate----------------2.00kg/kg
  6. Methylene Chloride----------------------5.59kg/kg 13 Case No.:37/36/83- ALC1/2006 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Approved HQ File : 01/83/050/00874/AM07/ RLA File : 09/24/040/00307/AM07/ Lic.No/Date:09100281 37 07.11.2006

norms for export product Lamotrigine under para 4.7 of HBP. their U.O. No.35011/101/2004-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Lamotrigine-----------------------------------1kg.

Import items:

  1. Amino Guanidine Hcl-------------1.23kg/kg
  2. 1-Methyl-2-Pyrrolidinone--------3.30kg/kg 14

Case No.:12/45/87-

ALC1/2006 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00747/AM07/ RLA File : 09/24/040/00128/AM07/ Lic.No/Date:09100282 49 17.11.2006 Defer Date: 06.11.2007 norms for export product Sterile Ampicillin Sodium + Salbactam Sodium (2:1) under para 4.7 of HBP. 15

Case No.:2/46/82-

ALC1/2006 Party Name:MATRIX LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/01441/AM07/ RLA File : 09/24/040/00390/AM07/ Lic.No/Date:09100286 34 13.12.2006 Defer Date: 06.11.2007 norms for export product N-Trifluoro Acetyl-N-Lysine-Praline (Lyspro Isolated) under para 4.7 of HBP. 16 Case No.:800/21/82- ALC4/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Approved HQ File : 01/82/050/01541/AM07/ RLA File : 09/24/040/00396/AM07/ Lic.No/Date:09100289 52 10.01.2007

norms for export product Sertraline Hcl under para 4.7 of HBP.

their U.O. No.35011/219/2005-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Sertaline Hcl-------------------------------1Kg. Import items:

  1. Alpha Naphthol--------------------3.10kg/kg
  2. Sodium Borohydride--------------0.331kg/kg
  3. D(-) Mandelic Acid----------------0.392kg/kg 17

Case No.:804/21/82-

ALC4/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Approved HQ File : 01/82/050/01552/AM07/ RLA File : 09/24/040/00415/AM07/ Lic.No/Date:09100290 06 12.01.2007

norms for export product Sertraline Hcl under para 4.7 of HBP. their U.O. No.35011/219/2005-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Sertaline Hcl-------------------------------1Kg. Import items:

  1. Alpha Naphthol--------------------3.10kg/kg
  2. Sodium Borohydride--------------0.331kg/kg
  3. D(-) Mandelic Acid----------------0.392kg/kg 18 Case No.:805/21/82- ALC4/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Approved

HQ File : 01/82/050/01553/AM07/ RLA File : 09/24/040/00418/AM07/ Lic.No/Date:09100290 07 12.01.2007

norms for export product Lamivudine under para 4.7 of HBP. their U.O. No.35011/219/2005-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Lamivudine---------------------------1Kg. Import items:

  1. Glyoxylic acid 50%------------------------1.80kg/kg
  2. 1,4-dithiane-2,5-dihydroxy-------------0.739kg/kg
  3. Cytosine-------------------------------------0.955kg/kg
  4. Hexamethyl disilazane--------------------1.89kg/kg
  5. Salicylic acid--------------------------------0.79kg/kg
  6. Sodium borohydride----------------------0.48kg/kg
  7. Dimethyl formamide----------------------0.83kg/kg
  8. N-Hexane---------------------------------3.75kg/kg
  9. Methylene dichloride-------------------5.75kg/kg 19 Case No.:806/21/82- ALC4/2007 Party Name:HETERO LABS LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Approved HQ File : 01/82/050/01554/AM07/ RLA File : 09/24/040/00417/AM07/ Lic.No/Date:09100290 08 12.01.2007

norms for export product Stavudine under para 4.7 of HBP. their U.O. No.35011/219/2005-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Stavudine------------------------------------1kg.

Import items:

  1. 5-Methyl Uridin--------------------------3.29kg/kg
  2. Acetonitrile--------------------------------3.72kg/kg
  3. Methanol-----------------------------------3.43kg/kg
  4. Dimethyl Amino Pyridine--------------0.230kg/kg
  5. Trimethyl Ortho Acetate----------------2.00kg/kg
  6. Methylene Chloride----------------------5.59kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 20

Case No.:807/21/82-

ALC4/2007 Party Name:HETERO LABS LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/82/050/01555/AM07/ RLA File : 09/24/040/00419/AM07/ Lic.No/Date:09100290 09 12.01.2007

norms for export product Nevirapine under para 4.7 of HBP. their U.O. No.35011/237/2006-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Nevirapine-----------------------------------1kg. Import items:

  1. Malononitrile----------------------------1.088kg/kg
  2. Methylene chloride--------------------6.71kg/kg
  3. 2-chloro Nicotininic acid--------------1.13kg/kg
  4. Pyridine-----------------------------------0.566kg/kg
  5. Methyl Tert. Butyl ether---------------3.01kg/kg
  6. Cyclopropylamine-----------------------1.20kg/kg 21 Case No.:2/48/83- ALC1/2006 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01135/AM07/ RLA File : 22/24/040/00291/AM07/ Lic.No/Date:22100064 00 17.01.2007 Defer Date: 06.11.2007

norms for export product Sultamicillin Tosylate under para 4.7 of HBP. 22

Case No.:411/24/83-

ALC1/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/01139/AM07/ RLA File : 09/24/040/00378/AM07/ Lic.No/Date:09100290 84 18.01.2007

norms for export product Ipratropium Bromide under para 4.7 of HBP. their U.O. No.35011/86/2007-PI-III dated 25.09.2007 decided to ratify whichever is lower. Export product: Ipratropium Bromide-------------------------1Kg. Import items:

  1. 2,5 Dimethoxy Tetrahydrofuran--------------2.42kg/kg
  2. Isopropylamine-----------------------------------1.36kg/kg
  3. Methanol-------------------------------------------7.22kg/kg
  4. Methyl Phenyl Acetate--------------------------2.78kg/kg
  5. Ethyl formate--------------------------------------3.64kg/kg
  6. Sodium Hydride-----------------------------------1.16kg/kg
  7. Methylene chloride-------------------------------7.33kg/kg
  8. Sodium Borohydride------------------------------0.27kg/kg
  9. Isopropyl alcohol-----------------------------------2.38kg/kg 23 Case No.:425/24/83- ALC1/2007 Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01203/AM07/ RLA File : 09/24/040/00466/AM07/ Lic.No/Date:09100292 29 07.02.2007 Defer Date: 06.11.2007

norms for export product 5-Methoxy-2-((4-Methoxy-3,5-Dimethyl-2Pyridinyl) Methyl) Thio-1H-Benzimidazole under para 4.7 of HBP. 24

Case No.:500/24/83-

ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00062/AM08/ RLA File : 22/24/040/00297/AM07/ Lic.No/Date:22100064 82 13.02.2007 Defer Date: 06.11.2007 norms for export product Ezetimibe under para 4.7 of HBP. 25 Case No.:3/4/82- ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/82/050/01648/AM07/ RLA File : 09/24/040/00482/AM07/ Lic.No/Date:09100293 48 15.02.2007

norms for export product Oseltamivir Phosphate under para 4.7 of HBP. their U.O. No.35011/87/2007-PI-III dated 03.10.2007 decided to ratify whichever is lower. Export product: Oseltamivir Phosphate----------------------------1kg. Import items:

  1. Shikimic Acid----------------------------------4.025kg/kg

  2. 2,2 Dimethoxy Propane---------------------0.043kg/kg

  3. 3-Pentanone-----------------------------------14.239kg/kg

  4. Trifluoromethane Sulfonic acid------------0.204kg/kg

  5. Triethylsilane-----------------------------------3.00kg/kg

  6. Methanol-----------------------------------------2.41kg/kg

  7. Methylene Dichloride--------------------------13.52kg/kg

  8. Tetrahydrofuran--------------------------------2.77kg/kg

  9. Dimethyl Formamide---------------------------1.57kg/kg 26

Case No.:4/3/83-

ALC1/2007 Party Name:OM SHREE PHARMACHEM PVT.LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01267/AM07/ RLA File : 03/95/040/01424/AM07/ Lic.No/Date:03104204 07 21.02.2007 Defer Date: 06.11.2007 norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. The Committee observed that the information received from the firm is incomplete. The firm has not furnished copy of complete DML. The Committee, therefore, decided to call for complete set of DML. Accordingly, case was deferred for four weeks. 27

Case No.:1/11/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01270/AM07/ RLA File : 03/95/040/01095/AM07/ Lic.No/Date:03104205 22 22.02.2007 Defer Date: 06.11.2007 norms for export product Sertraline Hcl under para 4.7 of HBP. 28 Case No.:449/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/01279/AM07/ RLA File : 05/24/040/00975/AM07/ Lic.No/Date:05102001 10 27.02.2007

norms for export product Ramipril under para 4.7 of HBP.

their U.O. No.35011/85/2007-PI-III dated 19.09.2007 decided to ratify whichever is lower. Export product: Ramipril--------------------------------------------------1kg. Import items:

  1. (+/-)(2A,3AB,AB)Octahydro Cyclopenta (B) Pyrole-2 Carboxylic Acid Phenyl Methyl Ester Hcl 99%------------------------------------- 2.70kg/kg
  2. Acetone-----------------------------------------1.50kg/kg
  3. Methylene chloride---------------------------2.00kg/kg
  4. Diisopropyl ether------------------------------3.15kg/kg
  5. Triethylamine-----------------------------------1.38kg/kg
  6. Toluene-------------------------------------------2.50kg/kg
  7. Dibenzoyl-L-Tartaric Acid Monohydrate---1.699kg/kg
  8. ECPP-Alanine-------------------------------------1.23kg/kg
  9. Methanol------------------------------------------0.85kg/kg 29 Case No.:450/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/01280/AM07/ RLA File : 05/24/040/00964/AM07/ Lic.No/Date:05102001 11 27.02.2007

norms for export product Lisinopril tablets 5mg, 10mg, 20mg, 2.5mg under

para 4.7 of HBP.

their U.O. No.35011/85/2007-PI-III dated 19.09.2007 decided to ratify whichever is lower. Export product: Lisinopril tablets 5mg-------------78,44,00,000Nos. (OR) Lisinopril tablets 10mg------------39,22,00,000Nos. (OR) Lisinopril Tablets 20mg------------19,61,00,000Nos. (OR) Lisinopril Tablets 2.5mg-----------1,56,88,00,000Nos.

Import items:

  1. N TFA L-Proline------------------------5560kg.
  2. Ethyl-2-oxo-4-Phenyl Butanoate---3400kg.
  3. Molecular sieves----------------------1500kg.
  4. Methylene chloride-------------------22360kg
  5. Toluene----------------------------------12800kg.
  6. Activated carbon-----------------------400kg.
  7. Isopropyl Alcohol-----------------------8840kg.
  8. Methanol--------------------------------11600kg. 30

Case No.:455/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/01297/AM07/ RLA File : 09/24/040/00477/AM07/ Lic.No/Date:09100294 96 01.03.2007

norms for export product Doxofylline under para 4.7 of HBP. their U.O. No.35011/254/2006-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Doxofylline---------------------------------------1kg. Import items:

  1. Theophylline---------------------------------------1.17kg/kg
  2. Chloro acetaldehyde dimethyl acetal--------0.81kg/kg
  3. Potassium carbonate----------------------------0.89kg/kg
  4. Methanol-------------------------------------------0.63kg/kg
  5. Dimethyl formamide------------------------------0.56kg/kg 31 Case No.:6/9/82- ALC4/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : RLA File : Lic.No/Date:09100295 Defer

01/82/050/01728/AM07/ 09/24/040/00488/AM07/ 04 01.03.2007 Date: 06.11.2007 norms for export product Cefdinir under para 4.7 of HBP. 32

Case No.:3/1/87-

ALC1/2007 Party Name:AVON ORGANICS LTD., Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/87/050/01107/AM07/ RLA File : 09/24/040/00487/AM07/ Lic.No/Date:09100296 68 14.03.2007 Defer Date: 06.11.2007 norms for export product 5-Aceto Acetyl Amino Benzimidazolone (AABZ (OR) 5-Aceto Acetyl Amino Benzimidazolone-2 (AABI) under para 4.7 of HBP. 33 Case No.:469/24/83- ALC1/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/01337/AM07/ RLA File : 09/24/040/00513/AM07/ Lic.No/Date:09100296 60 14.03.2007

norms for export product Moxifloxacin Hcl under para 4.7 of HBP. their U.O. No.35011/86/2007-PI-III dated 25.09.2007 decided to ratify whichever is lower. Moxifloxacin------------------------------------------------------------1kg Import items:

  1. 1-Cyclopropyl-6,7-difluoro-8-methoxy-4-oxo 1,4-dihydro quinoline-3-carboxylic acid----------------1.31kg/kg

  2. (S,S)-2,8-diazabicyclo (4,3,0) nonane--------------------0.55kg/kg

  3. Acetonitrile----------------------------------------------------3.80kg/kg

  4. Dimethyl formamide-----------------------------------------1.90kg/kg

  5. 1,4-dizabieyclo(2,2,2)octane--------------------------------0.100kg/kg 34

Case No.:7/7/83-

ALC1/2007 Party Name:OM SHREE PHARMACHEM PVT.LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01378/AM07/ RLA File : 03/95/040/01605/AM07/ Lic.No/Date:03104246 23 27.03.2007 Defer Date: 06.11.2007 norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. The Committee observed that the information received from the firm is incomplete. The firm has not furnished copy of complete DML. The Committee, therefore, decided to call for complete set of DML. Accordingly, case was deferred for four weeks. 35

Case No.:23/9/82-

ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/01901/AM07/ RLA File : 03/95/040/01622/AM07/ Lic.No/Date:03104249 15 29.03.2007 Defer Date: 06.11.2007 norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. 36 Case No.:6/11/82- ALC4/2007 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/82/050/01897/AM07/ RLA File : 09/24/040/00529/AM07/ Lic.No/Date:09100298 39 29.03.2007

norms for export product Cyclopentadecanolide (Recrystallised) under para 4.7 of HBP.

their U.O. No.35011/218/2006-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Cyclopentadecanolide (Recrystallised) (Purity not less than 99.5%)-----1kg. Import items:

  1. Cyclopentadecanolide (Tech. Grade) (Purity NMT 90.5%)------------ 1.20kg/kg
  2. Methanol-------------------------------------------------------------------------3.95kg/kg 37

Case No.:2/3/82-

ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00005/AM08/ RLA File : 34/24/040/00301/AM07/ Lic.No/Date:34100184 54 30.03.2007 Defer Date: 06.11.2007 norms for export product Azithromycin Crude under para 4.7 of HBP. 38

Case No.:519/24/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00107/AM08/ RLA File : 05/24/040/00017/AM08/ Lic.No/Date:05102025 04 13.04.2007 Defer Date: 06.11.2007 norms for export product Isotretinoin under para 4.7 of HBP.

39

Case No.:17/7/83-

ALC1/2007 Party Name:R L FINE CHEM Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Approved HQ File : 01/83/050/00149/AM08/ RLA File : 07/24/040/00017/AM08/ Lic.No/Date:07100513 34 19.04.2007

norms for export product Clomipramine Hcl under para 4.7 of HBP. Committee in light of its earlier decision taken in its 22/82 meeting held on 04.10.2007 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower Export product: Clomipramine Hcl-------------------------------------1kg Import item:

  1. 1 Bromo 3 Chloro Propane----------------------------0.85kg/kg
  2. 3 Chloro iminodibenzyl-------------------------------0.91kg/kg 40

Case No.:575/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00265/AM08/ RLA File : 09/24/040/00445/AM07/ Lic.No/Date:09100301 95 07.05.2007 Defer Date: 06.11.2007 norms for export product Nelfinavir Mesylate under para 4.7 of HBP. 41 Case No.:577/24/83- ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00273/AM08/ RLA File : 09/24/040/00444/AM07/ Lic.No/Date:09100302 07 08.05.2007 Defer Date: 06.11.2007 norms for export product Menthyl-5S-Cytosine-1YL-1,3-Oxathiolane-2R

Carboxalate (Lamuvudine Intermediate-Stage-III) under para 4.7 of HBP. 42

Case No.:578/24/83-

ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00274/AM08/ RLA File : 09/24/040/00043/AM08/ Lic.No/Date:09100302 08 08.05.2007 Defer Date: 06.11.2007 norms for export product Menthyl-5S-Cytosine-1YL-1,3-Oxathiolane-2R Carboxalate (Lamuvudine Intermediate-Stage-III) under para 4.7 of HBP. 43

Case No.:579/24/83-

ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00275/AM08/ RLA File : 09/24/040/00039/AM08/ Lic.No/Date:09100302 09 08.05.2007 Defer Date: 06.11.2007 norms for export product 5-O-Benzoyl-3-Mesyl-2,2 Anhydro-5-Methyl Uridine under para 4.7 of HBP. 44 Case No.:589/24/83- ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00308/AM08/ RLA File : 09/24/040/00013/AM08/ Lic.No/Date:09100302 50 14.05.2007 Defer Date: 06.11.2007 norms for export product Benzhydryl Thioacetamide under para 4.7 of HBP.

45

Case No.:29/9/82-

ALC4/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00039/AM08/ RLA File : 05/24/040/01075/AM07/ Lic.No/Date:05102037 51 16.05.2007 Defer Date: 06.11.2007 norms for export product Camptothecin under para 4.7 of HBP. Committee observed that technical comments were called for from Department of Ayush, but the same has not been received. Committee, therefore, decided to remind Department of Ayush for comments. Accordingly, case was deferred for four weeks. 46

Case No.:615/24/83-

ALC1/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00370/AM08/ RLA File : 03/95/040/01389/AM07/ Lic.No/Date:03104300 66 21.05.2007 Defer Date: 06.11.2007 norms for export product Concept Quick Unit Dose Solution (9247X) under

para 4.7 of HBP.

The Committee observed that RA has been requested to clarify as to why Advance Authorisation has been issued to the firm firm without submission of NOC from DBT when the export product is DBT item. Committee also observed that the firm has been requested to furnish NOC obtained from DBT. Both the information have not been received. Committee, therefore, decided to await reply of RA/firm. Accordingly, case was deferred for four weeks. 47 Case No.:622/24/83- ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00388/AM08/ RLA File : 09/24/040/00048/AM08/ Lic.No/Date:09100303 34 24.05.2007 Defer Date: 06.11.2007

norms for export product 2-(2-Methoxy Phenoxy) Ethylamine under para 4.7 of HBP. 48

Case No.:623/24/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00389/AM08/ RLA File : 09/24/040/00049/AM08/ Lic.No/Date:09100303 35 24.05.2007 Defer Date: 06.11.2007 norms for export product 4-(2,3-Epoxy Propoxy) carbaxole under para 4.7 of HBP. 49

Case No.:624/24/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00390/AM08/ RLA File : 09/24/040/00040/AM08/ Lic.No/Date:09100303 36 24.05.2007 Defer Date: 06.11.2007 norms for export product 3-Oxo-4-Aza-5a-Androstane-17b-Carboxylic Acid under para 4.7 of HBP. 50 Case No.:628/24/83- ALC1/2007 Party Name:INVENTIS DRUG DELIVERY SYSTEMS PVT LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00397/AM08/ RLA File : 09/24/040/00047/AM08/ Lic.No/Date:09100303 44 25.05.2007 Defer Date: 06.11.2007

norms for export product Fenofibrate Pellets under para 4.7 of HBP. Committee observed that the firm has been requested to furnish copy of relevant DML alongwith content of Active gradient, but the same has not been received. Committee, therefore, decided to await reply of the firm. Accordingly, case was deferred for four weeks. 51

Case No.:35/9/82-

ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00051/AM08/ RLA File : 34/24/040/00035/AM08/ Lic.No/Date:34100188 54 28.05.2007 Defer Date: 06.11.2007 norms for export product Azithromycin Step-3 under para 4.7 of HBP. 52

Case No.:642/24/83-

ALC1/2007 Party Name:DEVATS (INDIA) PVT.LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00422/AM08/ RLA File : 05/24/040/00921/AM07/ Lic.No/Date:05102041 73 29.05.2007 Defer Date: 06.11.2007 norms for export product Nystatin Oral Suspension (USP) under para 4.7 of HBP. 53 Case No.:653/24/83- ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00456/AM08/ RLA File : 03/95/040/00187/AM08/ Lic.No/Date:03104310 79 30.05.2007 Defer Date: 06.11.2007 norms for export product Cefpodoxime Proxetil under para 4.7 of HBP.

54

Case No.:40/9/82-

ALC4/2007 Party Name:WOCKHARDT LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/82/050/00066/AM08/ RLA File : 03/95/040/00161/AM08/ Lic.No/Date:03104314 94 04.06.2007

norms for export product Hot Lemon Cold Relief Powders 5gm Sachet under

para 4.7 of HBP.

their U.O. No.35011/84/2007-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Hot Lemon Cold Relief Powder 5gm. Sachet (each 5mg Sachet contains 650mg. Paracetamol Ph. Eur.) Import items: Paracetamol Ph. EUR-----------------------------656.5mg/Sachet of 5gm. 55

Case No.:657/24/83-

ALC1/2007 Party Name:LEPRO HERBALS PVT. LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00469/AM08/ RLA File : 05/24/040/00155/AM08/ Lic.No/Date:05102045 04 05.06.2007 Defer Date: 06.11.2007 norms for export product Griffonia Dry Extract under para 4.7 of HBP. Committee observed that technical comments were called for from Department of Ayush, but the same has not been received. Committee, therefore, decided to remind Department of Ayush for comments. Accordingly, case was deferred for four weeks.

56

Case No.:661/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00490/AM08/ RLA File : 09/24/040/00094/AM08/ Lic.No/Date:09100304 86 08.06.2007 Defer Date: 06.11.2007 norms for export product Tenofovir Disoproxil Fumarate under para 4.7 of HBP. 57

Case No.:778/24/83-

ALC1/2007 Party Name:OM SHREE PHARMACHEM PVT.LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00725/AM08/ RLA File : 03/95/040/00230/AM08/ Lic.No/Date:03104321 41 08.06.2007 Defer Date: 06.11.2007 norms for export product Iso Sorbide 5-Mononitrate under para 4.7 of HBP. The Committee observed that the information received from the firm is incomplete. The firm has not furnished copy of complete DML. The Committee, therefore, decided to call for complete set of DML. Accordingly, case was deferred for four weeks. 58 Case No.:714/24/83- ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/00589/AM08/ RLA File : 03/94/040/00248/AM08/ Lic.No/Date:03104329 27 18.06.2007

norms for export product Testosterone Propionate under para 4.7 of HBP. their U.O. No.35011/116/2005-PI-III dated 09.10.2007 in the case of M/S Avik Pharmaceuticals Ltd decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Testosterone Propionate BPUSP-------------------------1kg.

Import items:

  1. 4-Anrostene 3,17 Dione (Androstenedione)—1.25kg/kg
  2. Trimethyl Ortho formate---------------------------0.57kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 59

Case No.:715/24/83-

ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00590/AM08/ RLA File : 03/94/040/00243/AM08/ Lic.No/Date:03104329 29 18.06.2007 Defer Date: 06.11.2007 norms for export product Norethisterone under para 4.7 of HBP. 60

Case No.:706/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00563/AM08/ RLA File : 09/24/040/00080/AM08/ Lic.No/Date:09100306 41 22.06.2007 Defer Date: 06.11.2007 norms for export product Efavirenz under para 4.7 of HBP. 61 Case No.:789/24/83- ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00742/AM08/ RLA File : 03/95/040/00276/AM08/ Lic.No/Date:03104335 02 22.06.2007 Defer Date: 06.11.2007 norms for export product Levetiracetam under para 4.7 of HBP.

62

Case No.:726/24/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00613/AM08/ RLA File : 04/24/040/00113/AM08/ Lic.No/Date:04100901 30 28.06.2007 Defer Date: 06.11.2007 norms for export product 2-Fluoro Adenosin Triacetate (2-Fat) under para 4.7 of HBP. 63

Case No.:727/24/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00614/AM08/ RLA File : 04/24/040/00112/AM08/ Lic.No/Date:04100901 31 28.06.2007 Defer Date: 06.11.2007 norms for export product Levetiracetam under para 4.7 of HBP. 64 Case No.:728/24/83- ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00615/AM08/ RLA File : 04/24/040/00111/AM08/ Lic.No/Date:04100901 32 28.06.2007 Defer Date: 06.11.2007 norms for export product Clopidogrel Bisulphate under para 4.7 of HBP.

65

Case No.:739/24/83-

ALC1/2007 Party Name:PONALAB Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00640/AM08/ RLA File : 07/24/040/00223/AM08/ Lic.No/Date:07100522 85 03.07.2007 Defer Date: 06.11.2007 norms for export product 8-Hydroxyquinoline under para 4.7 of HBP. 66 Case No.:742/24/83- ALC1/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/00662/AM08/ RLA File : 09/24/040/00132/AM08/ Lic.No/Date:09100307 43 04.07.2007

norms for export product 1-(3-Hydroxymethyl-Pyridine-2-YL)-4-Methyl-2- Phenyl Piperazine (M Alcohol) under para 4.7 of HBP. their U.O. No.35011/86/2007-PI-III dated 25.09.2007 decided to ratify whichever is lower. Export product: 1-(3-hydroxymethyl-pyridine-2-YL)-4-Methyl-2-Phenyl Piperazine (M Alcohol) (Drug intermediate of Mirtazapine)------------------1Kg. Import items:

  1. 1-Methyl 3 Phenyl Piperazine---------------------------------1.35 Kg/Kg
  2. 2-chloro Nicotinonitrile-----------------------------------------1.06 Kg/Kg
  3. Chloroform---------------------------------------------------------6.37 Kg/Kg
  4. Dimethyl formamide---------------------------------------------5.38 Kg/Kg
  5. Sodium Bis(2-methoxyethoxy aluminiumhydride --------2.44 Kg /Kg

(Vitride) 67

Case No.:743/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00665/AM08/ RLA File : 09/24/040/00511/AM07/ Lic.No/Date:09100307 57 04.07.2007 Defer Date: 06.11.2007 norms for export product 5,11-Dihydro(I)-Benzoxepino(3,4-b)-Pyridin-5-One under para 4.7 of HBP. 68 Case No.:751/24/83- ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Approved HQ File : 01/83/050/00675/AM08/ RLA File : 22/24/040/00023/AM08/ Lic.No/Date:22100068 57 05.07.2007

norms for export product Atorvastatin Calcium under para 4.7 of HBP. their U.O. No.35011/7/2007-PI-III dated 09.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Atorvastatin Calcium-----------------------------------------------1kg. Import items:

  1. Methyl Isobutyl Acetate----------------------------------------1.76 Kg/Kg

  2. Betaalanine--------------------------------------------------------0.100Kg/Kg

  3. 3-Ethyl-5-0(2-hydroxyethyl)-4-Methyl Thiozolium-------0.30 Kg/Kg Bromide

  4. (4R-cis)-1,1-dimethyl ethyl-6-cyanomethyl-2,-------------1.08Kg/Kg 2-dimethyl-1,3-dioxane-4-acetate(ATS-8)

  5. Sodium Metabisulphide-----------------------------------------0.037 Kg/Kg

  6. Parafluoro benzaldehyde---------------------------------------0.85Kg/Kg

  7. IPA-------------------------------------------------------------------8.375Kg/Kg

  8. Tertiary Butyl Methyl Ether-----------------------------------4.37Kg/Kg 69

Case No.:757/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00687/AM08/ RLA File : 09/24/040/00112/AM08/ Lic.No/Date:09100308 02 06.07.2007 Defer Date: 06.11.2007 norms for export product L-Menthyl Glyoxylate Hydrate (MGH) under para 4.7 of HBP. 70 Case No.:762/24/83- ALC1/2007 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/00695/AM08/ RLA File : 09/24/040/00141/AM08/ Lic.No/Date:09100308 46 11.07.2007

norms for export product Cyclopentadecanolide (Recrystallised) under para 4.7 of HBP. their U.O. No.35011/218/2006-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Cyclopentadecanolide (Recrystallised) (Purity not less than 99.5%)-----1kg. Import items: 3. Cyclopentadecanolide (Tech. Grade) (Purity NMT 90.5%)------------

1.20kg/kg 4. Methanol-------------------------------------------------------------------------3.95kg/kg 71

Case No.:764/24/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00698/AM08/ RLA File : 05/24/040/00274/AM08/ Lic.No/Date:05102060 46 11.07.2007 Defer Date: 06.11.2007 norms for export product Fisinopril Sodium under para 4.7 of HBP. 72 Case No.:765/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/00699/AM08/ RLA File : 05/24/040/00278/AM08/ Lic.No/Date:05102060 47 11.07.2007

norms for export product Lisinopril under para 4.7 of HBP. their U.O. No.35011/85/2007-PI-III dated 19.09.2007 decided to ratify whichever is lower. Export product: Lisinopril---------------------------------1Kg. Import items:

  1. Activated carbon-------------------------------------------------------0.100Kg/Kg
  2. Cyclohexane------------------------------------------------------------0.837Kg/Kg
  3. Ethyl-2-oxo-4-Phenyl Butanoate-------------------------------------0.85Kg/Kg
  4. Isopropyl Alcohol------------------------------------------------------2.21Kg/Kg
  5. Methylene chloride-----------------------------------------------------5.59Kg/Kg
  6. N TFA L-Lysl-L-Proline----------------------------------------------1.39Kg/Kg
  7. Raney Nickel------------------------------------------------------------0.26Kg/Kg
  8. Toluene-------------------------------------------------------------------1.823Kg/Kg

73

Case No.:766/24/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/00700/AM08/ RLA File : 05/24/040/00279/AM08/ Lic.No/Date:05102060 48 11.07.2007

norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. their U.O. No.35011/85/2007-PI-III dated 19.09.2007 decided to ratify whichever is lower. Export product: Cefpodoxime Proxetil--------------------------------1Kg. Import items: 1. 7 ACA----------------------------------------------------1.25Kg/Kg 2. 1-chloroethyl chloro formate--------------------------0.558Kg/Kg 3. 1,8 Diazabicyclo[5,4.0]-undec-7-Ene(DBU)--------0.364Kg/Kg 4. Iodine-----------------------------------------------------0.47Kg/Kg 5. Sulfolane-------------------------------------------------3.70Kg/Kg 6. Trimethylborate-----------------------------------------3.37Kg/Kg 7. Hexamethyl Disilazane---------------------------------0.54Kg/Kg 8. Activated carbon-----------------------------------------0.100Kg/Kg 9. Pyridine----------------------------------------------------0.412Kg/Kg 10. Acetone----------------------------------------------------0.86Kg/Kg 11. Cyclohexane-----------------------------------------------0.28Kg/Kg 12. Ethyl Acetate----------------------------------------------1.17Kg/Kg 13. Isopropyl alcohol------------------------------------------0.335Kg/Kg 14. Methanol----------------------------------------------------1.89Kg/Kg 15. Methylene chloride-----------------------------------------2.72Kg/Kg 16. N,Ndimethyl Acetamide----------------------------------0.56Kg/Kg 17. Toluene-------------------------------------------------------0.29Kg/Kg 74 Case No.:771/24/83- ALC1/2007 Party Name:PRACHI PHARMACEUTICALS PVT LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred

HQ File : 01/83/050/00709/AM08/ RLA File : 03/95/040/00308/AM08/ Lic.No/Date:03104357 14 11.07.2007 Defer Date: 06.11.2007 norms for export product Thiamine Hydrochloride BP/USP under para 4.7 of HBP. 75

Case No.:768/24/83-

ALC1/2007 Party Name:LIQUORS INDIA LTD, Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00702/AM08/ RLA File : 09/24/040/00142/AM08/ Lic.No/Date:09100308 64 12.07.2007 Defer Date: 06.11.2007 norms for export product Lovastatin under para 4.7 of HBP. 76

Case No.:774/24/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00718/AM08/ RLA File : 09/24/040/00118/AM08/ Lic.No/Date:09100308 69 12.07.2007 Defer Date: 06.11.2007 norms for export product Lopinavir under para 4.7 of HBP. 77 Case No.:797/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : RLA File : Lic.No/Date:05102063 Defer

01/83/050/00755/AM08/ 05/24/040/00286/AM08/ 21 16.07.2007 Date: 06.11.2007 norms for export product Citalopram Hydrobromide under para 4.7 of HBP. 78

Case No.:5/17/82-

ALC4/2007 Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/82/050/00115/AM08/ RLA File : 09/24/040/00101/AM08/ Lic.No/Date:09100309 10 17.07.2007

norms for export product Glimepride under para 4.7 of HBP. their U.O. No.35011/130/2006-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Glimepride----------------------------------1Kg. Import items: 1. 3-Ethyl 4-Methyl-3-Pyrroline-2-one-----------------------0.81Kg/Kg 2. Cyclohexane---------------------------------------------------0.78Kg/Kg 3. Methanol-------------------------------------------------------6.75Kg/Kg 4. Trans 4-Methyl Cyclohexyl Isocynate---------------------0.40Kg/Kg 5. Potassium Carbonate-----------------------------------------1.02Kg/Kg 6. Acetone---------------------------------------------------------3.51Kg/Kg 79 Case No.:801/24/83- ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00760/AM08/ RLA File : 09/24/040/00115/AM08/ Lic.No/Date:09100309 17 18.07.2007 Defer Date: 06.11.2007

norms for export product (S)-5-Chloro-a-(Cyclopropylethynyl)-2-[((4- Methoxy Phenyl) methyl) amino]-a-(Trifluoromethyl) Benzene Methanol under para 4.7 of HBP. 80

Case No.:6/17/82-

ALC4/2007 Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/82/050/00117/AM08/ RLA File : 09/24/040/00122/AM08/ Lic.No/Date:09100309 46 19.07.2007

norms for export product Ramipril under para 4.7 of HBP. their U.O. No.35011/16/2007-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Ramipril------------------------------------------1Kg. Import items: 1. ECPP-Alanine--------------------------------------------------1.23Kg/Kg 2. Methylene chloride--------------------------------------------2.50Kg/Kg 3. (S.S.S.) 2-azabicylco (3.3.0) octane –3-carboxylic--------1.20Kg/Kg acid benzylester Hcl. 81 Case No.:905/24/83- ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00915/AM08/ RLA File : 03/95/040/01473/AM07/ Lic.No/Date:03104368 39 19.07.2007 Defer Date: 06.11.2007 norms for export product Carvedilol BP under para 4.7 of HBP.

82

Case No.:906/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00916/AM08/ RLA File : 03/95/040/01472/AM07/ Lic.No/Date:03104368 43 19.07.2007 Defer Date: 06.11.2007 norms for export product Setralone (Tetralone)under para 4.7 of HBP. 83

Case No.:817/24/83-

ALC1/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00803/AM08/ RLA File : 09/24/040/00151/AM08/ Lic.No/Date:09100309 52 20.07.2007 Defer Date: 06.11.2007 norms for export product N-Carbethoxy-4-Piperidinol (OR) 4-Hydroxy- N0Carbethoxy Piperidine (OR) N-Carbethoxy-4-Hydroxy Piperidine under

para 4.7 of HBP.

84 Case No.:908/24/83- ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00919/AM08/ RLA File : 03/95/040/01517/AM07/ Lic.No/Date:03104369 87 20.07.2007 Defer Date: 06.11.2007 norms for export product Ibuprofen DC Granules 90% under para 4.7 of HBP.

85

Case No.:909/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00920/AM08/ RLA File : 03/95/040/01516/AM07/ Lic.No/Date:03104369 93 20.07.2007 Defer Date: 06.11.2007 norms for export product Iburofen DC Granules 65% under para 4.7 of HBP. 86

Case No.:829/24/83-

ALC1/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00821/AM08/ RLA File : 09/24/040/00042/AM08/ Lic.No/Date:09100309 72 23.07.2007 Defer Date: 06.11.2007 norms for export product Cis-4-Amino-3-Methoxy-Piperidine-1-Carboxylic Acid Ethyl Ester Monohydrochloride under para 4.7 of HBP. 87 Case No.:830/24/83- ALC1/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00822/AM08/ RLA File : 09/24/040/00068/AM08/ Lic.No/Date:09100309 73 23.07.2007 Defer Date: 06.11.2007 norms for export product 2-Butyl-4-Chloro-5-Formyl Imidaxole (OR) 2(n- Butyl)-4-Chloro-5-Formyl Imidazole under para 4.7 of HBP.

88

Case No.:832/24/83-

ALC1/2007 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00825/AM08/ RLA File : 03/95/040/00362/AM08/ Lic.No/Date:03104371 94 23.07.2007 Defer Date: 06.11.2007 norms for export product Amodiazuine Base under para 4.7 of HBP. Committee observed that All Industry Data was called for from Pharmexcil, but the same has not been received. Committee, therefore, decided to await data. Accordingly, case was deferred for four weeks. 89

Case No.:840/24/83-

ALC1/2007 Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00837/AM08/ RLA File : 09/24/040/00155/AM08/ Lic.No/Date:09100309 99 25.07.2007 Defer Date: 06.11.2007 norms for export product {3-5[Bromo-1-(flurophenyl)(1,3-dihydro isobenzo furanyl)]-Propyl]dimehylamine oxalate under para 4.7 of HBP. 90 Case No.:4/19/82- ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00145/AM08/ RLA File : 03/95/040/00204/AM08/ Lic.No/Date:03104375 30 26.07.2007 Defer Date: 06.11.2007 norms for export product Betasol Lotion 30ml under para 4.7 of HBP. The representative of PI Division present in the meeting handed over U.O. No.35011/86/2006-PI-III dated 20.09.2007 wherein PI Division has mentioned that the firm has applied for import of Betamethasone base whereas DML specifies use of Clobetasol Propionate. The firm has not given any technical justification for import of above item. Committee, therefore,

decided to seek clarification from the firm. Accordingly, case was deferred for four weeks. 91

Case No.:869/24/83-

ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00871/AM08/ RLA File : 09/24/040/00138/AM08/ Lic.No/Date:09100310 28 01.08.2007 Defer Date: 06.11.2007 norms for export product 5-O Benzoyl-2,3-Didehydro-5-Methyl Uridine under para 4.7 of HBP. 92 Case No.:878/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/00882/AM08/ RLA File : 05/24/040/00354/AM08/ Lic.No/Date:05102071 61 03.08.2007

norms for export product 1-benzyl-3,4-dimethyl-2-(4-methoxy benzyl)- 1,2,5,6-tetrahydropyridine Oxalate under para 4.7 of HBP. their U.O. No.35011/143/2006-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: 1-benzyl-3,4-dimethyl-2-(4-methoxy benzyl)-1,2,5,6, tetrahydropyridine Oxalate (Petazocine intermediate)---------------1Kg. Import items: 1. 3,4 Lutidine ------------------------------------------------------0.55Kg/Kg 2. Sodium boro hydride--------------------------------------------0.153Kg/Kg 3. Acetone------------------------------------------------------------9.24Kg/Kg 4. Toluene------------------------------------------------------------2.18Kg/Kg 5. Methanol----------------------------------------------------------0.71Kg/Kg 6. Iodine--------------------------------------------------------------0.100Kg/Kg 7. Tetrahydrofuran--------------------------------------------------0.45Kg/Kg

93

Case No.:902/24/83-

ALC1/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status: Case Approved HQ File : 01/83/050/00912/AM08/ RLA File : 22/24/040/00027/AM08/ Lic.No/Date:22100069 52 07.08.2007

norms for export product Amoxycillin Trihydrate engymatic route under

para 4.7 of HBP.

their U.O. No.35011/165/2006-PI-III dated 09.10.2007 decided to ratify whichever is lower. Export product: Amoxycillin Trihydrate enzymatic route-----------------1kg. Import items: 1. Penicillin G Pot. 1st crystal-----------------------------------1.664 BOU/Kg 2. D(-) Para hydroxy phenyl glycine methyl ester------------0.608Kg 3. Oxilasa enzyme-------------------------------------------------5.0gm. 4. Penicillin G Amidase enzyme---------------------------------0.852gm. 5. Methanol---------------------------------------------------------0.0215Kg 6. Butyl Acetate----------------------------------------------------0.122Kg 7. Boric acid---------------------------------------------------------0.032Kg 94 Case No.:989/24/83- ALC1/2007 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:23/82- ALC4/2007 09.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01007/AM08/ RLA File : 22/24/040/00034/AM08/ Lic.No/Date:22100069 91 21.08.2007 Defer Date: 06.11.2007 norms for export product Cefprozil under para 4.7 of HBP.

Case No.B-324

M/S Cadila Pharma Ltd. NC Meeting No.23/08 F.No.01/82/50/1433/AM05 Meeting date: 09.10.2007 RLA F.No.08/24/40/95/AM05 Adv.Lic. No.0810036678 dated 05.03.2004 Committee considered the case as per agenda for enhancement in the quantity of input Carbinoxamine under para 4.7 of HBP. Committee decided to call for Production and consumption Data Certified by Central Excise Authority from the firm. It was also decided to call for evidence from the firm that the exports were made through non-infingering process. Accordingly, case was deferred for four weeks.

Case No.B-325

M/S Cipla Ltd. NC Meeting No.23/08 F.No.01/82/50/722/AM07 Meeting date: 09.10.2007 RLA F.No.03/94/40/519/AM07 Adv.Lic. No.0310394029 dated 10.08.2006 Committee considered the case as per agenda for amendment in the description of import items No.2, 3, 4 under para 4.7 of HBP. Committee decided to allow amendment in the description of import item No.1,2, and 3 in the following manner after due verification of the application of the firm. 2.63mcl Aerosol Valves----------------As per packing policy 19ml Aluminium Can-------------------As per packing policy Actuators with Dust Covers/ Caps Fitting to 19ml Aluminium Can----As per packing policy

Case No.B-326

M/S Mission Pharma Ltd. NC Meeting No.23/08 F.No.01/82/50/606/AM07 Meeting date: 09.10.2007 RLA F.No.03/95/40/318/AM04 Adv.Lic. No.0310247155 dated 13.01.2004 Committee considered the case as per agenda for enhancement in the quantity of inputs under para 4.7 of HBP. The representative of PI Division present in the meeting informed the Committee that the item of import is Levamisole BP 98 and not Levamisole Hcl and therefore, the quantity of inputs correctly allowed to them. Committee observed that there is no merit for enhancement in the quantity of inputs and the decision already conveyed to the firm holds good. It was, therefore decided to maintain status quo.

Case No.B-327

M/S Wockhardt Ltd. NC Meeting No.23/08 F.No.01/82/162/549/AM07 Meeting date: 09.10.2007

Committee considered the case as per agenda for fixation of value addition for revision of DEPB rate in respect of export product Dextromethorphan Hydrobromide. Committee observed that the firm has not given data in respect of one input namely Cyclohexanyl Ethyl Amino and after excluding the cif value of this item, the value addition work out to 21.79%. It was also observed that if the cif value of the above input will be included, the value addition will be in minus. Committee, therefore, decided to call for revised data from the firm. Accordingly, the case was deferred for four weeks.

Case No.B-328

M/S Dhanuka Laboratories Ltd. NC Meeting No.23/08 F.No.01/82/50/1514/AM07 Meeting date: 09.10.2007 RLA F.No.05/24/40/648/AM07 Adv.Lic. No.0510197222 dated 03.01.2007 Committee considered the case as per agenda for enhancement in the quantity of inputs under para 4.7 of HBP. The Committee observed that the firm has not given any supporting documents like Production and Consumption Data certified by Central Excise Authority. Committee, therefore, decided to maintain status quo.

Case No.B-329

M/S Ariane Orgachem Pvt. Ltd. M/S Centaur Chemicals Private Ltd. M/S Surya Pharmaceutical Ltd. NC Meeting No.23/08 F.No.01/87/50/448/AM07 F.No.01/87/50/662/AM07 F.No.01/87/50/873/AM07 F.No.01/87/50/1025/AM05 F.No.01/82/50/336/AM08 F.No.01/82/50/264/AM06 F.No.01/82/50/875/AM06 F.No.01/82/50/479/AM06 F.No.01/82/50/1169/AM06 F.No.01/82/50/549/AM07 F.No.01/82/50/1657/AM07 F.No.01/87/50/1474/AM05 F.No.01/87/50/1475/AM05 Meeting date: 09.10.2007

M/S Ariane Orgachem Pvt. Ltd., Mumbai Committee considered the case as per agenda and heard Shri Rakesh Doshi, representative of the firm who appeared for personal hearing before the Committee. The representative explained that the actual consumption of inputs viz. Lasamide, Furfurylamine and Iso Propyl Alcohol is on a higher side as compared to the quantity allowed by Norms Committee against their six Advance Authorisations mentioned below;

  1. 0310394009 dated 10.08.2006
  2. 0310429564 dated 16.05.2007
  3. 0310405378 dated 24.10.2006
  4. 0310414730 dated 05.01.2007
  5. 0310300140 dated 02.11.2004
  6. 0310278686 dated 02.07.2004 The Committee after detailed deliberations and in consultation with the representative of technical authority present in the meeting decided to allow higher quantities of the above three inputs with reference to the actual consumption certified by the Central Excise Authority. The Committee after going through the production and consumption data certified by the Central Excise Authority for the period April, 2002 to March, 2007 decided to enhance the quantity of the following inputs (taking into account the minimum quantity) as detailed below against all the six Advance licences mentioned below.
  7. Lasamide----------1.24kg/kg
  8. Furfurylamine----------1.21kg/kg
  9. Iso Propyl Alcohol-----1.79kg/kg The above decision will be applicable to only six advance licences mentioned above and no repeat licence shall be allowed based on the above decision. The Committee also decided to fix SION in respect of export product Frusemide BP after calling Production and Consumption Data for the last three years from three major exporters of this export product viz M/S IPCA, M/S Ariane Orgachem and M/S Shree Krishna through Pharmexcil. M/S Centaur Chemicals Pvt. Ltd., Mumbai Committee considered the case as per agenda and heard Dr. Girish Kavishwar, Vice President and Dr. Anil Naik, Director of the firm who appeared for personal hearing before the Committee.

The representatives of the firm informed the Committee that their process of production of Clonazepam USP-27 is different from the others and as such the requirement of quantity of input viz.2-amino-2-chloro-5-nitro Benzophenone is on a higher side than mentioned in the SION at Sl.No.A-3358. He also submitted consumption certificate duly certified by Central Excise Authority to the effect that 2.5kg of 2-amino-2-chloro-5-nitro Benzophenone is required for production of 1Kg of export product. On going through the literature furnished in the meeting, Committee observed that the purity of export product is consistently high with low impurity profile; yield is between 35% to 43% as against 70% yield on the basis of which SION has been fixed and the same is justified by literature explained to the technical authority. Committee after detailed deliberations and taking into account the fact the SION has been fixed on the basis of certified data of Central Excise and taking into yield of 70%, decided to enhance the quantity of 2-amino-2-chloro-5-nitro Benzophenone to 2.5kg/kg of the export product in respect of the following six Advance Authorisations obtained by the firm.

  1. 0310334738 dated 17.06.2005
  2. 0310354691 dated 02.11.2005
  3. 0310384994 dated 16.06.2006
  4. 0310361631 dated 02.01.2006
  5. 0310389125 dated 13.07.2006
  6. 0310420158 dated 20.02.2007 The Committee also decided to revise SION in respect of export product Clonazepam USP-27 after calling production and consumption data for the last three years from Pharmexcil. It was also decided to constitute a Committee for plant visit for revision of SION. The member of the Committee and programme of visit may be decided on file. M/S Surya Pharmaceutical Ltd. Committee considered the case as per agenda and heard Shri Imran Shaikh, Commercial Adviser of the firm who appeared for personal hearing before the Committee. The representative of the firm informed the Committee that they have completed export obligation against Advance Authorisation No.2210004190 dated 07.02.2005 and 2210004189 dated 07.02.2005. The quantity of inputs consumed by the firm for production of 7-AVNA and MiCA has been on a higher side as compared to the quantities allowed by the Committee. He stated that they have submitted a copy of Certificate issued by Directorate of Health and Family Welfare, Punjab who has recommended higher input against both the export product. The Committee after deliberations advised the representative of the firm to furnish Consumption and Production Data duly certified by Central Excise Authority

for the above two licences separately to enable the Committee to take a final view. It was also decided to undertake an exercise for fixation of SION for export product 7-AVNA after calling Production and Consumption Data of major exporters of this export product from Pharmexcil

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.

Citation copied