IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-12-04

DGFT Committee Minutes

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

Para 4.7 Decision

MEETING NUMBER : 31/82-ALC4/2007 MEETING DATE : 04.12.2007 The Meeting No.31/08 for the licensing year 2007-08 to consider the cases under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2004-09 pertaining to Pharma Products was held on 04.12.2007 under the Chairmanship of Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No.28/08 dated 13.11.2007 were ratified by the Committee.

Case No.B-416

M/S Avon Organics Ltd., Norms Committee Meeting No.31/08 F.No.01/87/50/127/AM06/DES-III Meeting Date: 04.12.2007 RLA F.No.09/24/40/20/AM06 Adv.Lic. No.0910022755 dated 09.05.2005 Committee considered case as per agenda for ratification of norms for export product 5 Aceto Acetyl Amino Benzimidazolone (AABZ) or 5 Aceto Acetyl Amino Benzimidaxolone-2(AABI) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/100/2005-PI-III dated 30.11.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: 5-Aceto Acetyl Amino Benzimidazolone or 5-Aceto Acetyl Amino Benzimidaxolone-2(AAB)-------------------1kg. Import items:

  1. Acetic Acid--------------------------------------------------------1.43kg/kg
  2. Triethyl phosphate (TEP)--------------------------------------0.0050kg/kg
  3. DABCO Crystalline (1,4 diazobicyclo (2,2,2)-Octane----0.0013kg/kg
  4. Methanol----------------------------------------------------------0.70kg/kg
  5. 5-amino Benzimidazolon -------------------------------------0.89kg/kg OR 5a Ortho Phenylene Diamine------------------------------------0.95kg/kg 5b Urea----------------------------------------------------------------0.57kg/kg 5c Chlorobenzene--------------------------------------------------0.57kg/kg 5d Sodium hydroxide flakes/Caustic Soda flakes-----------0.061kg/kg 5e Raney Nickel-----------------------------------------------------0.100kg/kg 5f Activated Carbon-----------------------------------------------0.050kg/kg

Committee also decided to approve all the pending cases for the above export product with same inputs with the approval of Chairman on file within the validity period of such adhoc norms. RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.B-417

M/S Advy Chemical F.No.01/87/50/313/AM07/DES-III RLA F.No.03/94/40/310/AM07 Adv.Lic. No.0310387468 dated 29.06.2006 Committee considered case as per agenda for ratification of norms for export product HBs Ag Subtypes ad Reagent (4000mgs) (Hepatitis B Surface antigen- subtypes ad) under para 4.7 of HBP. Committee observed that written comments forwarded by Department of Biotechnology vide their letter No.BT/IL/05/231/06/2006-PID dated 06.08.2007 does not contain unit of measurement of quantity of inputs. Committee, therefore, decided to again refer the case to DBT for their comments. Accordingly, case was deferred for four weeks.

Case No.B-418

M/S Cadila Pharmaceuticals Ltd. F.No.01/82/50/757/AM05/DES-III RLA F.No.08/24/40/45/AM05 Adv.Lic. No.0810040146 dated 08.07.2004 Committee considered case as per agenda for ratification of norms for export product Carbetapentane Tannate under para 4.7 of HBP. U.O. No.35011/258/2004-PI-III dated 04.12.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis as per details below or as applied by firm whichever is lower. Export product: Carbetapentane Tannate----------------------------1kg. Import items:

  1. Carbetapentane Citrate------------------0.86kg/kg
  2. Tannic Acid----------------------------------0.73kg/kg

Committee also decided to approve all the pending cases for the above export product with same inputs with the approval of Chairman on file within the validity period of such adhoc norms. RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.B-419

M/S Divi’s Laboratories Ltd. F.No.01/82/50/56/AM07/DES-III RLA F.No.09/24/40/182/AM01 Adv.Lic. No.0910019924 dated 30.08.2004 Committee considered case as per agenda for revision of norms for export product Capecitabine under para 4.7 of HBP. Committee decided to hand over file to representative of PI Division present in meeting for his comments. Accordingly, case was deferred for four weeks.

Case No.B-420

M/S Zandu Chemicals Ltd. F.No.01/83/50/242/AM07/DES-III F.No.01/83/50/428/AM06/DES-III RLA F.No.03/95/40/789/AM06 RLA F.No.03/95/40/123/AM07 Adv.Lic. No.0310355085 dated 10.11.2005 Adv.Lic. No.0310382709 dated 01.06.2006 Committee considered case as per agenda for revision of norms for export product Carbamic Acid-[2-Hydroxy-3-(2-methyl propyl) [4-nitrophenyl)sulphonyl]- Amino]-1-(phenyl methyl) propyl-1,1-dimethyl ester (BOC Nitro) purity 99.5% under

para 4.7 of HBP.

Committee observed that norms were ratified in this case on the basis of written comments of Chemical Division. It was, therefore, decided to transfer the case to DES-IV.

Case No.B-421

M/S Sandoz Pvt. Ltd. F.No.01/82/162/1266/AM01/DES-III

Adv.Lic. No.0310002380 dated

27.07.1999 Committee considered case as per agenda for revision of norms for export product Aminolupetitim under para 4.7 of HBP. Committee observed that a report regarding development of case was called for from concerned RA, but same has not been received. Committee also observed that Advance Authorisation is dated 27.07.99 and it is not possible to revise norms against such an old licence. It was, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.C-26

M/S R.L. Fine Chem. F.No.01/82/162/47/AM08/DES-III

Committee considered case as per agenda for modification of SION in respect of export product at Sl.No.A-3357. Committee observed that All Industry Data was called for from Pharmexcil, but same has not been received. Committee, therefore, decided a plant visit may be taken by a team and recommend the norms. Accordingly, case was deferred till receipt of report is received.

Case No.A-882

M/S Arch Pharma Labs Ltd. F.No.01/82/162/591/AM08/DES-III RLA F.No.03/94/40/125/AM07 Adv.Lic. No.0310381222 dated 25.05.2006 Committee considered case as per agenda for ratification of norms for export product Clopidogrel Bisulphate under para 4.7 of HBP. U.O. No.35011/192/2006-PI-III dated 24.04.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis as per details below or as applied by firm whichever is lower. Export product: Clopidogrel bisulphate---------------------------------1kg. Import items:

  1. DL-2 chloro phenyl glycine------------------1.05kg/kg

  2. Thiophene 2-ethanol--------------------------1.00kg/kg

  3. Thionyl chloride---------------------------------1.30kg/kg

  4. Caustic Soda flakes-----------------------------1.00kg/kg

  5. L+tartaric acid------------------------------------0.70kg/kg

  6. Toluene--------------------------------------------0.20kg/kg

  7. Para toluene sulphonyl chloride-------------1.08kg/kg

  8. Acetonitrile-----------------------------------------1.43kg/kg

  9. Ethyl acetate---------------------------------------0.95kg/kg 10.Isopropyl alcohol----------------------------------0.23kg/kg 11.Methanol--------------------------------------------4.25kg/kg 12.Methylene dichloride-----------------------------1.03kg/kg 13.Acetone-----------------------------------------------1.68kg/kg 14.Formic Acid-------------------------------------------0.185kg/kg Committee also decided to approve all the pending cases for the above export product with same inputs with the approval of Chairman on file within the validity period of such adhoc norms. RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A-883

M/S Sandoz Pvt. Ltd. F.No.01/82/50/209/AM08/DES-III RLA F.No.03/95/40/488/AM08 Adv.Lic. No.0310441155 dated 29.08.2007 Committee considered case as per agenda for ratification of norms for export product Blister (Multi-Bacillary) Child/Adult under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in his Department and he sought deferment for four weeks. 1

Case No.:10/20/87-

ALC1/2005 Party Name:ALKALOIDS CORP Meet No/Date:31/82- ALC4/2007 04.12.2007 Status: Case Deferred HQ File : 01/87/050/00429/AM06/ RLA File : 02/24/040/00081/AM06/ Lic.No/Date:021008 0076 15.07.2005 Defer Date: 01.01.200 8 Decision :Committee considered case as per agenda for ratification of norms for export product Aescin (Horse Chestnut Extract) under para 4.7 of HBP. Representative of MSME present in meeting informed Committee that case is

under examination in his Department and he sought deferment for four weeks. Accordingly, Committee decided to defer case for four weeks. 2

Case No.:31/47/82-

ALC1/2005 Party Name:CALYX CHEMICALS & PHARMACEUTICALS PVT.LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/01335/AM06/ RLA File : 03/94/040/01210/AM06/ Lic.No/Date:031036 5692 03.02.2006 Defer Date: 15.01.200 8 Decision : Committee considered case as per agenda for ratification of norms for export product Coenzyme Q10 under para 4.7 of HBP. Committee observed that Department of Bio-technology vide their letter No.BT/IL/05//231/06/2006/PID dated 20.07.2007 informed Committee that during the manufacturing process, phytochemicals are converted to bio-chemicals through chemical reactions and there is no bio-process involved. Committee, therefore, decided to refer the case to PI Division for their comments. Accordingly, case was deferred for six weeks. 3

Case No.:8/10/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/87/050/00096/AM07/ RLA File : 02/24/040/00020/AM07/ Lic.No/Date:021008 8734 28.04.2006 Defer Date: 01.01.200 8 export product Aescin (Horse Chestnut Extract) under para 4.7 of HBP. Representative of MSME present in meeting informed Committee that case is under examination in his Department and he sought deferment for four weeks. Accordingly, Committee decided to defer case for four weeks. 4

Case No.:1/23/87-

ALC1/2006 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/87/050/00336/AM07/ RLA File : 05/24/040/00255/AM07/ Lic.No/Date:051018 5276 21.06.2006 Defer Date: 15.01.200 8 export product Silymarin Extract under para 4.7 of HBP. Committee observed that Department of MSME vide letter No.5(9)/2005-

Chem dated 26.11.2007 have called for following information from the firm.

  1. Purity of the export product.
  2. End use of the export product.
  3. Published technical literature of crude cardui mariae extract.
  4. Percentage of Silymarine Exract in crude cardui mariae exatarct.
  5. Details of extraction process along with percentage of yield at each step of the extraction. Committee, accordingly, decided to remind the firm to furnish the above information. It was accordingly, decided to defer the case for six weeks. 5

Case No.:16/27/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/87/050/00419/AM07/ RLA File : 02/24/040/00123/AM07/ Lic.No/Date:021009 2125 02.08.2006 Defer Date: 01.01.200 8 export product Kola Extract under para 4.7 of HBP. Representative of MSME present in meeting informed Committee that case is under examination in his Department and he sought deferment for four weeks. Accordingly, Committee decided to defer case for four weeks. 6

Case No.:25/27/87-

ALC1/2006 Party Name:ALCON BIOSCIENCES PRIVATE LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Transferr ed HQ File : 01/87/050/00446/AM07/ RLA File : 03/94/040/01463/AM06/ Lic.No/Date:031039 3946 09.08.2006

export product Benzil Pure 99% under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to transfer case to DES-IV. 7

Case No.:13/29/82-

ALC1/2006 Party Name:INNOVASSYNTH TECHNOLOGIES (INDIA) LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Transferr ed HQ File : 01/82/050/00961/AM07/ RLA File : 03/94/040/00603/AM07/ Lic.No/Date:031040 0077 19.09.2006

export product
5-O-Dimethoxytrityl-2-O-tert-butyldimethylsilyl-N2-isobutyryl Guanosine/DMT-rG(ib)-TBMDS under para 4.7 of HBP. Committee decided to transfer the case to DES-IV as export product pertains to R&D chemicals. 8

Case No.:555/21/82-

ALC4/2007 Party Name:GULF OIL CORPORATION LIMITED. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Rejected HQ File : 01/82/050/01110/AM07/ RLA File : 09/24/040/00247/AM07/ Lic.No/Date:091002 7792 09.10.2006

export product Amoxycillin Capsules 500mg under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to close the case as firm is not entitled to manufacture Amoxycillin Capsules. RA concerned may take further necessary action as per above decision of Norms Committee. 9

Case No.:35/31/82-

ALC1/2006 Party Name:CLARIANT CHEMICALS [INDIA] LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/01132/AM07/ RLA File : 03/94/040/00773/AM07/ Lic.No/Date:031040 3496 11.10.2006 Defer Date: 15.01.200 8 export product 5 Fluoro Cyto Sine under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to call for end use of export product, percentage yield on molar basis and technical literature in support of yield. Accordingly, case was deferred for six weeks. 10 Case No.:2/46/87- ALC1/2006 Party Name:AVON ORGANICS LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/87/050/00663/AM07/ RLA File : 09/24/040/00271/AM07/ Lic.No/Date:091002 7981 30.10.2006

export product 5-Aceto Acetyl Amino Benzimidazolaone (AABZ) (OR) 5-Aceto Acetyl Amino Benzimidazolone-2 (AABI) under para 4.7 of HBP. U.O. No.35011/100/2005-PI-III dated 30.11.2007 and in consultation with technical Export product: 5-Aceto Acetyl Amino Benzimidazolone or 5-Aceto Acetyl Amino Benzimidaxolone-2(AAB)-------------------1kg. Import items:

  1. Acetic Acid--------------------------------------------------------1.43kg/kg
  2. Triethyl phosphate (TEP)--------------------------------------0.0050kg/kg
  3. DABCO Crystalline (1,4 diazobicyclo (2,2,2)-Octane----0.0013kg/kg
  4. Methanol----------------------------------------------------------0.70kg/kg
  5. 5-amino Benzimidazolon -------------------------------------0.89kg/kg OR 5a Ortho Phenylene Diamine------------------------------------0.95kg/kg 5b Urea----------------------------------------------------------------0.57kg/kg 5c Chlorobenzene--------------------------------------------------0.57kg/kg 5d Sodium hydroxide flakes/Caustic Soda flakes-----------0.061kg/kg 5e Raney Nickel-----------------------------------------------------0.100kg/kg 5f Activated Carbon-----------------------------------------------0.050kg/kg Committee also decided to approve all the pending cases for the above export product with same inputs with the approval of Chairman on file within the validity period of such adhoc norms. 11 Case No.:12/45/87- ALC1/2006 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/87/050/00747/AM07/ RLA File : 09/24/040/00128/AM07/ Lic.No/Date:091002 8249 17.11.2006

export product Sterile Ampicillin Sodium+Salbactam Sodium (2:1) under para 4.7 of HBP. U.O. No.35011/274/2006-PI-III dated 26.11.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis as per details below or as applied by firm whichever is lower.

Export product: Sterile Ampicillin Sodium + Salbactam Sodium (2;1)----------1kg. Import items:

  1. 6 APA----------------------------------------------1.039kg/kg
  2. Pivaloyl chloride--------------------------------0.283kg/kg
  3. Triethylamine-----------------------------------0.0171kg/kg
  4. Methylene chloride---------------------------0.745kg/kg
  5. D(-)Alpha Phenyl glycine Base--------------0.374kg/kg
  6. Ethyl Aceto acetate----------------------------0.358kg/kg
  7. Sodium Thiocynate----------------------------0.189kg/kg
  8. Acetonitrile--------------------------------------1.342kg/kg
  9. Isopropyl Alcohol-------------------------------1.684kg/kg 10.Acetone-------------------------------------------0.501kg/kg 11.2-Ethyl Hexanoic Acid-------------------------0.016kg/kg 12.Aluminium Canisters--------------------------As per packing policy 13.MIBK-----------------------------------------------0.24kg/kg 12

Case No.:2/46/82-

ALC1/2006 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/01441/AM07/ RLA File : 09/24/040/00390/AM07/ Lic.No/Date:091002 8634 13.12.2006 Defer Date: 01.01.200 8 export product N-Trifluoro Acetyl-N-1 Ysine-Praline (Lysipro (Isolated) under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that weeks. Committee, accordingly, decided to defer case for four weeks. 13 Case No.:27/48/87- ALC1/2006 Party Name:AROCHEM INDUSTRIES Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : RLA File : Lic.No/Date:031041

01/87/050/00958/AM07/ 03/94/040/01134/AM07/ 6228 16.01.2007 export product Choline Bitartrate-FCC-V/USP (with 1% Silicon dioxide)under para 4.7 of HBP. U.O.35011/271/2006-PI-III dated 04.12.2007 and in consultation with technical Export product: Choline Bitartarate USP Coated---------------------------------1kg. Import item: L-tartaric acid-------------------------------------------------------0.775kg/kg 14

Case No.:2/48/83-

ALC1/2006 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01135/AM07/ RLA File : 22/24/040/00291/AM07/ Lic.No/Date:221000 6400 17.01.2007 Defer Date: 01.01.200 8 export product Sultamicillin Tosylate under para 4.7 of HBP. Committee decided to hand over the file to representative of PI Division for examination of case and their comments. Accordingly, case was deferred for four weeks. 15 Case No.:5/9/82- ALC4/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/01646/AM07/ RLA File : 05/24/040/00937/AM07/ Lic.No/Date:051019 9268 09.02.2007 Defer Date: 01.01.200 8

export product 3,4 Dihydroxy-4-Oxo-6Acetoxy-7Methoxyquinazole under para 4.7 of HBP. Committee observed that firm has been requested to furnish technical details as per Appendix 33 vide letter dated 12.11.2007, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 16

Case No.:500/24/83-

ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00062/AM08/ RLA File : 22/24/040/00297/AM07/ Lic.No/Date:221000 6482 13.02.2007 Defer Date: 01.01.200 8 export product Ezitimibe under para 4.7 of HBP. 17

Case No.:4/21/82-

ALC4/2007 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/00006/AM08/ RLA File : 22/24/040/00295/AM07/ Lic.No/Date:221000 6538 27.02.2007 Defer Date: 15.01.200 8 export product Cephalothin for Injection under para 4.7 of HBP. Committee decided to remind RA to furnish a copy of application alongwith a copy of Advance Authorisation. Accordingly, case was deferred for six weeks. 18 Case No.:6/9/82- ALC4/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/01728/AM07/ RLA File : 09/24/040/00488/AM07/ Lic.No/Date:091002 9504 01.03.2007 Defer Date: 18.12.200 7 export product Cefdinir under para 4.7 of HBP.

case is under examination in his Department and he sought deferment for two weeks. Committee, accordingly, decided to defer case for two weeks. 19

Case No.:3/1/87-

ALC1/2007 Party Name:AVON ORGANICS LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/87/050/01107/AM07/ RLA File : 09/24/040/00487/AM07/ Lic.No/Date:091002 9668 14.03.2007

export product 5-Aceto Acetyl Amino Benzimidazolone (AABZ) (OR) 5-Aceto Acetyl Amino Benzimidazolone-2 (AABI) under para 4.7 of HBP. U.O. No.35011/100/2005-PI-III dated 30.11.2007 and in consultation with technical Export product: 5-Aceto Acetyl Amino Benzimidazolone or 5-Aceto Acetyl Amino Benzimidaxolone-2(AAB)-------------------1kg. Import items:

  1. Acetic Acid--------------------------------------------------------1.43kg/kg
  2. Triethyl phosphate (TEP)--------------------------------------0.0050kg/kg
  3. DABCO Crystalline (1,4 diazobicyclo (2,2,2)-Octane----0.0013kg/kg
  4. Methanol----------------------------------------------------------0.70kg/kg
  5. 5-amino Benzimidazolon -------------------------------------0.89kg/kg OR 5a Ortho Phenylene Diamine------------------------------------0.95kg/kg 5b Urea----------------------------------------------------------------0.57kg/kg 5c Chlorobenzene--------------------------------------------------0.57kg/kg 5d Sodium hydroxide flakes/Caustic Soda flakes-----------0.061kg/kg 5e Raney Nickel-----------------------------------------------------0.100kg/kg 5f Activated Carbon-----------------------------------------------0.050kg/kg 20 Case No.:950/21/82- ALC4/2007 Party Name:LAKE CHEMICALS PRIVATE Meet No/Date:31/82- ALC4/2007 Status:C ase

LIMITED 04.12.2007 Approve d HQ File : 01/82/050/01812/AM07/ RLA File : 07/24/040/00829/AM07/ Lic.No/Date:071005 0672 15.03.2007

export product Midazolam Maleate under para 4.7 of HBP. U.O.35011/70/2005-PI-III dated 04.12.2007 and in consultation with technical Export product: Midazolam Maleate-------------------------------------------1kg. Import item:

  1. 2-Aminomethyl-7-chloro-2,3-dihydro-5- (2-flurophenyl)1H-1,4-benzodiazepine dimaleate--------2.52kg/kg
  2. Triethyl ortho acetate--------------------------------------------1.18kg/kg 21 Case No.:954/21/82- ALC4/2007 Party Name:MERCK LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase approve d HQ File : 01/82/050/01815/AM07/ RLA File : 03/95/040/01559/AM07/ Lic.No/Date:031042 3260 15.03.2007

export product DL-Alpha Tocopheryl Acetate USP under para 4.7 of HBP. Committee in light of its earlier decision taken in its 30/82 meeting held on 08.11.2006 vide Case No.954/21/82 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: DL-Alpha Tocopherol Acetate USP (Vitamin E Acetate USP)---------1kg. Import item:

  1. Isophytol--------------------------------------------------------------0.738kg/kg
  2. 2,3,5-Trimethyl Hydroquinone----------------------------------0.385kg/kg 22

Case No.:17/9/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/01837/AM07/ RLA File : 03/94/040/01468/AM07/ Lic.No/Date:031042 3777 21.03.2007 Defer Date: 18.12.200 7 export product Exemestane under para 4.7 of HBP. Committee observed that firm has been called for personal hearing on 18.12.2007. It was therefore decided to re-list this case on 18.12.2007. 23

Case No.:3/22/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01367/AM07/ RLA File : 09/24/040/00505/AM07/ Lic.No/Date:091002 9769 26.03.2007 Defer Date: 15.01.200 8 export product 1-Acetylamino-5-Nitro-2-Propoxy Benzene under para 4.7 of HBP. Committee observed that this case has been transferred from DES-IV on 23.11.2007. Committee decided to defer case for six weeks for comments of PI Division. 24 Case No.:23/9/82- ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/01901/AM07/ RLA File : 03/95/040/01622/AM07/ Lic.No/Date:031042 4915 29.03.2007 Defer Date: 01.01.200 8

export product Cefpodoxime Proxetil under para 4.7 of HBP. 25

Case No.:2/4/85-

ALC3/2007 Party Name:HEINZ INDIA PRIVATE LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Transferr ed HQ File : 01/85/050/00259/AM07/ RLA File : 03/94/040/01338/AM07/ Lic.No/Date:031042 4928 29.03.2007

export product Vitamin-Mineral Food Supplement Sprinkle under para 4.7 of HBP. Committee observed that firm has not submitted copy of DML alongwith their application and company states that item is a food item. It was, therefore, decided to transfer the case to DES-VI. 26 Case No.:2/3/82- ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/82/050/00005/AM08/ RLA File : 34/24/040/00301/AM07/ Lic.No/Date:341001 8454 30.03.2007

export product Azithromycin Crude under para 4.7 of HBP. U.O. No.35011/227/2006-PI-III dated 12.11.2007 and in consultation with technical Export product: Azithromycin Crude Purity NLT 94.5%------------------------------1Kg. Import items: Sl.No. Description of import items Quantity allowed 1. Erythromycin base 1.75kg/kg 2. Acetone 6.45kg/kg 3. Ethyl Alcohol 2.81kg/kg 4. Hydroxylamine Hcl 0.91kg/kg 5. Methane Sulfonyl chloride 0.72kg/kg 6. Methanol 2.72kg/kg

Platinum Catalyst with base of activated Carbon (5% Platinum on Carbon) 1.00gm/kg 8. Hyflo Not a raw material. Hence not allowed. RA Concerned may take further necessary action as per above decision of Norms Committee. 27

Case No.:9/21/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/00009/AM08/ RLA File : 09/24/040/00543/AM07/ Lic.No/Date:091002 9931 10.04.2007 Defer Date: 01.01.200 8 export product
7-Amino-3[(Z/E)-1-Propen-1-YL]-3-Cepham-4-Carboxylic Acid (APRA) under para 4.7 of HBP. Committee observed that a copy of application along a copy of Advance Authorisation was called for form concerned RA vide letter dated 22.11.2007, but same has not been received. Committee, therefore, decided to remind RA and defer case for four weeks. 28 Case No.:519/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00107/AM08/ RLA File : 05/24/040/00017/AM08/ Lic.No/Date:051020 2504 13.04.2007

export product Isotretinoin under para 4.7 of HBP. U.O. No.35011/85/2007-PI-III dated 20.11.2007 decided to ratify norms under para Export product: Isotretinoin----------------------------------1kg. Import items:

  1. Acetone---------------------------------0.48kg/kg
  2. Activated Carbon---------------------0.100kg/kg
  3. Beta lonone----------------------------3.20kg/kg
  4. Dimethy Acrylic Acid-----------------2.37kg/kg
  5. Hexane----------------------------------9.69kg/kg
  6. Lithium Aluminium Hydride---------0.40kg/kg
  7. Methanol---------------------------------8.56kg/kg
  8. Methylene chloride--------------------9.36kg/kg
  9. N-Butyl Lithium 30%-------------------0.89kg/kg 10.Tetrahydrofuran-------------------------6.59kg/kg 11.Toluene------------------------------------7.53kg/kg 12.Triethylphosphone Acetate------------4.10kg/kg 29

Case No.:18/7/83-

ALC1/2007 Party Name:RESONANCE LABORATORIES PVT LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Rejected HQ File : 01/83/050/00171/AM08/ RLA File : 07/24/040/00048/AM08/ Lic.No/Date:071005 1363 23.04.2007

export product
1-[2,6 Dichloro-4(Trifluoromethyl)Phenyl]-5-[Pyridine-2-YL Methylene) Amino] 1H-Pyrazole-3-Carbonitrile (C-6900) under para 4.7 of HBP. Committee observed that firm has not submitted technical details as per Appendix 33 alongwith their application and in absence of technical details, norms can not be fixed. Accordingly, Committee decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee. 30 Case No.:20/17/83- ALC1/2007 Party Name:DALAS BIOTECH LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00222/AM08/ RLA File : 05/24/040/01077/AM07/ Lic.No/Date:051020 3060 27.04.2007

export product Cefixime Methyl Ester under para 4.7 of HBP.

Committee in light of its earlier decision taken in its 11/82 meeting held on 17.07.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Methyl Ester of Cefixime-----------------------1kg. Import items:

  1. GCLE------------------------------------------1.57kg/kg
  2. Mica Acid------------------------------------0.77kg/kg
  3. Tri Phenyl Phosphine----------------------1.30kg/kg
  4. Methylene chloride------------------------4.32kg/kg 31 Case No.:18/21/82- ALC4/2007 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/82/050/00025/AM08/ RLA File : 07/24/040/00064/AM08/ Lic.No/Date:071005 1499 03.05.2007

export product Ceftriaxone for Inj 500mg BP under para 4.7 of HBP. Committee in light of its earlier decision taken in its 41/82 meeting held on 24.01.2007 vide Case No.23/41/82 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Cefriaxone USP 500mg Injection------------------------1 Vial Import item: Cefriaxone Sodium------------------------------------------624.70mg/Vial

32

Case No.:19/21/82-

ALC4/2007 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/82/050/00026/AM08/ RLA File : 07/24/040/00063/AM08/ Lic.No/Date:071005 1501 03.05.2007

export product Ceftriazone for Inj. USP 1gm Vial under para 4.7 of HBP. Committee in light of its earlier decision taken in its 41/82 meeting held on 24.01.2007 vide Case No.22/41/82 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Cefriaxone USP 1000mg Injection-----------------------1 Vial Import items: Cefriazone Sodium-------------------------------------------1249.50mg/Vial 33

Case No.:15/18/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00252/AM08/ RLA File : 09/24/040/00023/AM08/ Lic.No/Date:091003 0174 04.05.2007 Defer Date: 01.01.200 8 export product Iso Metheptene Mucate under para 4.7 of HBP. Committee observed that firm was requested to furnish technical details as per Appendix 33 vide letter dated 29.10.2007, but same has not been received. Committee, therefore, decided to remind the firm and to defer the case for four weeks.

34

Case No.:20/21/82-

ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/00028/AM08/ RLA File : 05/24/040/00097/AM08/ Lic.No/Date:051020 3344 07.05.2007

DeferDate : 01.01.200 8 export product Clarithromycin Carbomer Granules 44% under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that 35

Case No.:575/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00265/AM08/ RLA File : 09/24/040/00445/AM07/ Lic.No/Date:091003 0195 07.05.2007 Defer Date: 01.01.200 8 export product Nelfinavir Mesylate under para 4.7 of HBP. 36

Case No.:589/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00308/AM08/ RLA File : 09/24/040/00013/AM08/ Lic.No/Date:091003 0250 14.05.2007 Defer Date: 01.01.200 8 export product Benzhydryl Thioacetamide under para 4.7 of HBP. 37 Case No.:29/9/82- ALC4/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred

HQ File : 01/82/050/00039/AM08/ RLA File : 05/24/040/01075/AM07/ Lic.No/Date:051020 3751 16.05.2007 Defer Date: 01.01.200 8 export product Camptothecin under para 4.7 of HBP. Committee observed that firm has been requested to furnish following information vide Department of MSME vide their letter No.5(9)/2005-Chem. Dated 26.11.2007. I) Purity of the export product. II) Technical Literature of Mappia Foetida. III) Percentage of Comptothecin in Mappia Foetida. IV) Details of the extraction process along with the percentage yield as each step of the extraction. Committee, therefore, decided to remind the firm to furnish the above information. Accordingly, case was deferred for four weeks. 38

Case No.:37/16/83-

ALC1/2007 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Withdra wn HQ File : 01/83/050/00385/AM08/ RLA File : 03/94/040/00170/AM08/ Lic.No/Date:031043 0424 23.05.2007

export product Niclosamide Piperazine Salt under para 4.7 of HBP. Committee decided to withdraw this case as the same has already been approved in its 27/82 meeting held on 06.11.2007. 39

Case No.:624/24/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00390/AM08/ RLA File : 09/24/040/00040/AM08/ Lic.No/Date:091003 0336 24.05.2007 Defer Date: 01.01.200 8 export product 3-Oxo-4-Aza-5a-Androstane-17b-Carboxylic Acid under para 4.7 of HBP.

40

Case No.:622/24/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00388/AM08/ RLA File : 09/24/040/00048/AM08/ Lic.No/Date:091003 0334 24.05.2007 Defer Date: 01.01.200 8 export product 2-(2-Methoxy Phenoxy) Ethylamine under para 4.7 of HBP. 41

Case No.:623/24/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00389/AM08/ RLA File : 09/24/040/00049/AM08/ Lic.No/Date:091003 0335 24.05.2007 Defer Date: 01.01.200 8 export product 4-(2,3-Epoxy Propoxy)Carbazole under para 4.7 of HBP. 42 Case No.:24/21/82- ALC4/2007 Party Name:CE-CHEM PHARMACEUTICALS, Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/82/050/00046/AM08/ RLA File : 07/24/040/00136/AM08/ Lic.No/Date:071005 1761 25.05.2007

export product Pencillin V Pottasium 250mg Tablets under para 4.7 of HBP. Committee in consultation with representative of PI Division 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: Pencillin V Pottsasium Tablet 250mg Each tablet containing Pencillin V Potassium

Equivalent to 250mg Pencillin V Import item: Pencillin V Pottasium BP------------------------------282.36mg/tablet 43

Case No.:628/24/83-

ALC1/2007 Party Name:INVENTIS DRUG DELIVERY SYSTEMS PVT LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase withdra wn HQ File : 01/83/050/00397/AM08/ RLA File : 09/24/040/00047/AM08/ Lic.No/Date:091003 0344 25.05.2007

export product Fenofibrate Pellets under para 4.7 of HBP. Committee decided to withdraw this case as same has been decided to be closed in its 27/82 meeting held on 06.11.2007. 44 Case No.:35/9/82- ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/82/050/00051/AM08/ RLA File : 34/24/040/00035/AM08/ Lic.No/Date:341001 8854 28.05.2007

export product Azithromycin Step 3 under para 4.7 of HBP. U.O. No.35011/227/2006-PI-III dated 12.11.2007 and in consultation with technical Export product: Azithromycin Step 3 (Aza Azithromycin)------------------1kg. Import item:

  1. Erythromycin base---------------------------------------------1.86kg/kg

  2. Acetone-----------------------------------------------------------1.27kg/kg

  3. Ethyl Alcohol-----------------------------------------------------3.00ltr/kg

  4. Hydroxylamine Hcl----------------------------------------------0.97kg/kg

  5. Methane sulfonyl chloride------------------------------------0.69kg/kg

  6. Methanol----------------------------------------------------------1.09kg/kg

  7. Platinum Catalyst with base of activated Carbon (5% Platinum Carbon)--------------------------------1.00gm/kg 45

Case No.:653/24/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00456/AM08/ RLA File : 03/95/040/00187/AM08/ Lic.No/Date:031043 1079 30.05.2007 Defer Date: 01.01.200 8 export product Cefpodoxime Proxetil under para 4.7 of HBP. 46 Case No.:648/24/83- ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00442/AM08/ RLA File : 09/24/040/00017/AM08/ Lic.No/Date:091003 0402 31.05.2007

export product Doxofylline under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 vide Case No.455/24/83 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. 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 47 Case No.:32/21/82- ALC4/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/82/050/00060/AM08/ RLA File : 09/24/040/00052/AM08/ Lic.No/Date:091003 0410 01.06.2007

export product Ramipril under para 4.7 of HBP. Committee in light of its earlier decision taken in its 22/82 meeting held on 04.10.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Ramipril------------------------------------------------------------1kg. Import items;

  1. Racemic-2-azabicyclo(3,3,0) Octane-3-carboxylic acid benzylester Hcl// or (S,S)-2-azabicyclo(3.3.0) octane-3-carbocylic acid benzylester hydrochloride-----2.70kg/kg
  2. S(+)-Mandelic acid------------------------------------------------0.81kg/kg
  3. Methylene chloride-----------------------------------------------2.50kg/kg
  4. Cyclohexane---------------------------------------------------------2.50kg/kg
  5. Isopropyl Alcohol---------------------------------------------------2.50kg/kg
  6. ECPP Alanine---------------------------------------------------------1.23kg/kg
  7. 1-Hydroxy Benzotriazole------------------------------------------0.72kg/kg
  8. Dicyclohexyl Carbodimide----------------------------------------1.00kg/kg
  9. Di-isopropyl ether---------------------------------------------------2.50kg/kg 10.5% Palladium on carbon-------------------------------------------0.20kg/kg

48

Case No.:27/22/83-

ALC1/2007 Party Name:METROPOLITAN OVERSEAS LIMITED, Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Rejected HQ File : 01/83/050/00596/AM08/ RLA File : 03/95/040/00198/AM08/ Lic.No/Date:031043 1481 04.06.2007

export product N-[1-(S)-Ethoxy Carbonyl-3-Phenyl Propyl]-L-Alanine under para 4.7 of HBP. Committee noted that against earlier Advance Authorisation for same export and import producs, firm was requested to furnish technical justification alongwith calculations for working out the quantative requirement as applied by them, but same was not received. Committee observed that in this case also, they have not furnished same. It was, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee. 49 Case No.:657/24/83- ALC1/2007 Party Name:LEPRO HERBALS PVT. LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00469/AM08/ RLA File : 05/24/040/00155/AM08/ Lic.No/Date:051020 4504 05.06.2007

export product Griffonia Dry Extract under para 4.7 of HBP. Committee in light of its earlier decision taken in its 30/82 meeting held on 27.11.2007 vide Case No.627/24/83 in the case of M/S Siris Impex and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Griffonia Simplicifolia Extract------------------1kg. Import item: Griffonia Simplicifolia Dried seeds Containing 10% 5HTP by HPLC---------------2.40kg/kg

RA concerned may take further necessary action as per above decision of Norms Committee. 50

Case No.:661/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00490/AM08/ RLA File : 09/24/040/00094/AM08/ Lic.No/Date:091003 0486 08.06.2007 Defer Date: 15.01.200 8 export product Tenofovir Disoproxil Fumarate under para 4.7 of HBP. case is under examination in his Department and he sought deferment for six weeks. Committee, accordingly, decided to defer case for six weeks. 51

Case No.:715/24/83-

ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00590/AM08/ RLA File : 03/94/040/00243/AM08/ Lic.No/Date:031043 2929 18.06.2007 Defer Date: 01.01.200 8 export product Norethisterone under para 4.7 of HBP. 52 Case No.:706/24/83- ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00563/AM08/ RLA File : 09/24/040/00080/AM08/ Lic.No/Date:091003 0641 22.06.2007 Defer Date: 15.01.200 8 export product Efavirenz under para 4.7 of HBP.

53

Case No.:789/24/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00742/AM08/ RLA File : 03/95/040/00276/AM08/ Lic.No/Date:031043 3502 22.06.2007 Defer Date: 01.01.200 8 export product Levetiracetam under para 4.7 of HBP. 54

Case No.:37/21/82-

ALC4/2007 Party Name:SARACA LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Rejected HQ File : 01/82/050/00075/AM08/ RLA File : 09/24/040/00029/AM08/ Lic.No/Date:091003 0654 25.06.2007

export product Gabapentin Hcl (Technical) Powder under para 4.7 of HBP. Committee observed that firm has not submitted technical details as per Appendix 33 alongwith their application and without technical details, norms can not be fixed. Committee, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee. 55 Case No.:10/23/83- ALC1/2007 Party Name:KAIVAL CHEMICALS P LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Transferr ed HQ File : 01/83/050/00575/AM08/ RLA File : 34/24/040/00063/AM08/ Lic.No/Date:341001 9062 25.06.2007

export product Dibenzoyl-D-(+)tartaric acid under para 4.7 of HBP. Committee decided to transfer the case to DES-IV as export product pertains

to Chemical Sector. 56

Case No.:726/24/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00613/AM08/ RLA File : 04/24/040/00113/AM08/ Lic.No/Date:041009 0130 28.06.2007 Defer Date: 15.01.200 8 export product 2-Fluoro Adenosin Triacetate (2-FAT) under para 4.7 of HBP. 57

Case No.:728/24/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00615/AM08/ RLA File : 04/24/040/00111/AM08/ Lic.No/Date:041009 0132 28.06.2007 Defer Date: 15.01.200 8 export product Clopidogrel Bisulphate under para 4.7 of HBP. 58

Case No.:727/24/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00614/AM08/ RLA File : 04/24/040/00112/AM08/ Lic.No/Date:041009 0131 28.06.2007 Defer Date: 15.01.200 8 export product Levetiracetam under para 4.7 of HBP.

59

Case No.:731/24/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00624/AM08/ RLA File : 09/24/040/00425/AM07/ Lic.No/Date:091003 0691 29.06.2007 Defer Date: 01.01.200 8 export product Sertraline Mandelate under para 4.7 of HBP. 60

Case No.:730/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00623/AM08/ RLA File : 09/24/040/00120/AM08/ Lic.No/Date:091003 0686 29.06.2007 Defer Date: 01.01.200 8 export product (S)-3-Hydroxy-N-Benzyl Pyrrolidine under para 4.7 of HBP. 61 Case No.:54/21/82- ALC4/2007 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/82/050/00104/AM08/ RLA File : 09/24/040/00116/AM08/ Lic.No/Date:091003 0710 02.07.2007

export product Levofloxacin Hemihydrate Solid under para 4.7 of HBP. U.O. No.35011/147/2006-PI-III dated 04.12.2007 and in consultation with technical Export product: Levofloxacin Hemihydrate------------------------1kg.

Import item: (-)9,10-difluoro-2,3-dihydro-3-methyl-7-oxo-7H pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid (Levofloxacin Q-acid)--------------------------------1.01kg/kg of Norms Committee. 62

Case No.:739/24/83-

ALC1/2007 Party Name:PONALAB Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00640/AM08/ RLA File : 07/24/040/00223/AM08/ Lic.No/Date:071005 2285 03.07.2007 Defer Date: 15.01.200 8 export product 8-Hydroxyquinoline under para 4.7 of HBP. Committee decided to hand over file to representative of PI Division present in meeting for his comments. Accordingly, case was deferred for six weeks. 63

Case No.:743/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00665/AM08/ RLA File : 09/24/040/00511/AM07/ Lic.No/Date:091003 0757 04.07.2007 Defer Date: 15.01.200 8 export product 5,11-Dhiydro(1)-Benzoxepino(3,1-b)-Pyridin-5-One under para 4.7 of HBP. 64 Case No.:757/24/83- ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d

HQ File : 01/83/050/00687/AM08/ RLA File : 09/24/040/00112/AM08/ Lic.No/Date:091003 0802 06.07.2007

export product L-Menthyl Glyoxylate Hydroate (MGH) under para 4.7 of HBP. 65

Case No.:81/21/82-

ALC4/2007 Party Name:KOPRAN LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:Deffe red and Re- indexed HQ File : 01/82/050/00131/AM0 8/ RLA File : 03/94/040/00173/AM0 8/ Lic.No/Date:031043 5412 09.07.2007 Defer Date:04.12.2 007 export product Azithromycin Dihydrate under para 4.7 of HBP. U.O. No.35011/28/2007-PI-III dated 04.12.2007 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: Azithromycin-------------------------------------1kg. Import items:

  1. Azithromycin amine-----------------------1.04kg/kg
  2. Acetone---------------------------------------0.90kg/kg
  3. Formic Acid-----------------------------------0.210kg/kg of Norms Committee. 66 Case No.:761/24/83- ALC1/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00694/AM08/ RLA File : 09/24/040/00100/AM08/ Lic.No/Date:091003 0845

11.07.2007 export product Cefposoxime Proxetil under para 4.7 of HBP. U.O. No.35011/103/2006-PI-III dated 04.12.2007 and in consultation with technical Export product: Cefpodoxime Proxetil----------------------------------1kg. Import items:

  1. 7 Amino Cephalosporanic Acid (7-ACA)------1.25kg/kg
  2. Mercaptobenzothiozol-2-Aminothiozol- 4YL-Methoxoyimino Acetate-------------------1.25kg/kg
  3. Alpha-chloro Ethyl Isoporopyl Carbonate (CEIPC)------------0.558kg/kg
  4. 1,8-Duatabuctui (5.4.0)-7-Undecene (DBU)—0.364kg/kg
  5. Methanol----------------------------------------------1.08kg/kg
  6. Methylene Chloride---------------------------------1.66kg/kg
  7. Acetone-----------------------------------------------1.79kg/kg
  8. Tetrahydrofuran------------------------------------3.36kg/kg
  9. Cyclohexane-----------------------------------------2.50kg/kg 10.Sodium Iodide---------------------------------------0.39kg/kg 11.Activated Carbon-----------------------------------0.100kg/kg of Norms Committee. 67 Case No.:764/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00698/AM08/ RLA File : 05/24/040/00274/AM08/ Lic.No/Date:051020 6046 11.07.2007

export product Fosinopril Sodium under para 4.7 of HBP. U.O. No.35011/85/2007-PI-III dated 20.11.2007 decided to ratify norms under para

Export product: Fosiniopril Sodium----------------------------------1kg. Import items:

  1. Acetone--------------------------------------3.63kg/kg
  2. Activated Carbon---------------------------0.100kg/kg
  3. Cyclohexane---------------------------------0.60kg/kg
  4. Diisopropyl ether---------------------------4.58kg/kg
  5. Isobutyral dehyde--------------------------0.43kg/kg
  6. Methyl Iso Butyl Ketone------------------0.30kg/kg
  7. Toluene---------------------------------------4.95kg/kg.
  8. Trans-4-Hydroxy-L-proline---------------1.592kg/kg
  9. Triethylamine-------------------------------5.869kg/kg 10.4-Phenyl-1 Butene-------------------------3.06kg/kg 11.5% Rhodium---------------------------------1.286gm/kg 12.Cinchonidine---------------------------------0.2379kgs. 13.Diisopropyl Azodicarboxylate-----------2.535kg/kg 14.Hexamethyl Disilazane-------------------4.922kg/kg 15.Methanol------------------------------------2.97kg/kg 16.Methylene chloride-----------------------12.40kg/kg 17.Palladium on carbon 10%----------------0.039kg/kg 18.Pivaloyal chloride--------------------------0.417kg/kg 19.Propionyl chloride-------------------------1.77kg/kg 20.Pyridine--------------------------------------0.139kg/kg 21.Tetrahydrofuran---------------------------3.24kg/kg 22.Trimethyl Chlorosilane-------------------3.301kg/kg 23.Triphenyl Phosphine----------------------3.293kg/kg of Norms Committee. 68 Case No.:771/24/83- ALC1/2007 Party Name:PRACHI PHARMACEUTICALS PVT LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00709/AM08/ RLA File : 03/95/040/00308/AM08/ Lic.No/Date:031043 5714 11.07.2007 Defer Date: 15.01.200 8 export product Thiamine Hydrochloride BP/USP under para 4.7 of HBP.

69

Case No.:773/24/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00717/AM08/ RLA File : 09/24/040/00119/AM08/ Lic.No/Date:091003 0868 12.07.2007

export product Ritonavir under para 4.7 of HBP. U.O. No. 35011/58/2007-PI-III dated 04.12.2007 decided to ratify norms under

para 4.7 of HBP as per details below or as applied by firm whichever is lower.

Export product: Ritonavir--------------------------------------------1kg. Import items:

  1. L-Phenyl Alanine-----------------------1.23kg/kg
  2. L-Valine-----------------------------------0.510kg/kg
  3. 1,2 Dimethoxy Ethane----------------15.453kg/kg
  4. 5-Hydroxy Methyl Thiazole-----------0.440kg/kg
  5. Isobutramide-----------------------------0.660kg/kg
  6. Sodium Borohydride-------------------0.790kg/kg
  7. Diteritary Butyl Dicarbonate---------0.773kg/kg
  8. Acetonitrile-------------------------------0.530kg/kg
  9. Methanol----------------------------------4.98kg/kg 10.Tetrahydrofuran-------------------------4.81kg/kg 11.N-Heptane---------------------------------1.39kg/kg 12.Iso Propyl Alcohol------------------------4.95kg/kg 13.Methyl Tertiary Butyl Ether------------3.70kg/kg 14.Methylene chloride----------------------2.44kg/kg of Norms Committee. 70 Case No.:774/24/83- ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : RLA File : Lic.No/Date:091003

01/83/050/00718/AM08/ 09/24/040/00118/AM08/ 0869 12.07.2007 export product Lopinavir under para 4.7 of HBP. U.O. No.35011/58/2007-PI-III dated 04.12.2007 decided to ratify norms under para Export product: Lopinavir----------------------------------------------1kg. Import items:

  1. L-Phenyl Alanine--------------------------1.36kg/kg
  2. L-Valine--------------------------------------1.58kg/kg
  3. Triphosgene--------------------------------0.715kg/kg
  4. 2,6 Dimethy Phenol----------------------0.73kg/kg
  5. (L)-Pyroglutamic acid---------------------0.57kg/kg
  6. Sodium Borohydride----------------------0.89kg/kg
  7. Phenyl chloro formate--------------------2.21kg/kg
  8. 1,2 Dimethyl Ethane----------------------29.38kg/kg
  9. Methanol------------------------------------10.59kg/kg 10.Tetrahydrofuran---------------------------12.20kg/kg 11.N-Heptane------------------------------------2.91kg/kg 12.Iso Propyl Alcohol---------------------------2.43kg/kg 13.Methyl Tertiary Butyl Ether--------------14.92kg/kg 14.Methylene chloride-------------------------7.75kg/kg 15.Acetomitrile-----------------------------------0.58kg/kg 16.Dimethyl formamide------------------------1.82kg/kg of Norms Committee. 71 Case No.:768/24/83- ALC1/2007 Party Name:LIQUORS INDIA LTD, Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00702/AM08/ RLA File : 09/24/040/00142/AM08/ Lic.No/Date:091003 0864 12.07.2007 Defer Date: 15.01.200 8 export product Lovastatin under para 4.7 of HBP.

72

Case No.:801/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00760/AM08/ RLA File : 09/24/040/00115/AM08/ Lic.No/Date:091003 0917 18.07.2007 Defer Date: 15.01.200 8 export product
(S)-5-Chloro-a-(Cyclopropylethynyl)-2-[((4-Methoxy phenyl) methyl) amino]-a-(Trifluoromethyl) Benzene Methanol under para 4.7 of HBP. 73

Case No.:28/23/83-

ALC1/2007 Party Name:KESHAVA ORGANICS PVT. LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00775/AM08/ RLA File : 03/94/040/01507/AM07/ Lic.No/Date:031043 6591 18.07.2007 Defer Date: 15.01.200 8 export product Chlorpheniramine Base under para 4.7 of HBP. 74

Case No.:905/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00915/AM08/ RLA File : 03/95/040/01473/AM07/ Lic.No/Date:031043 6839 19.07.2007 Defer Date: 15.01.200 8 export product Carvedilol BP under para 4.7 of HBP.

75

Case No.:906/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00916/AM08/ RLA File : 03/95/040/01472/AM07/ Lic.No/Date:031043 6843 19.07.2007 Defer Date: 15.01.200 8 export product Setralone (Tetralone) under para 4.7 of HBP. 76

Case No.:909/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00920/AM08/ RLA File : 03/95/040/01516/AM07/ Lic.No/Date:031043 6993 20.07.2007 Defer Date: 01.01.200 8 export product Ibuprofen DC Granules 65% under para 4.7 of HBP. 77

Case No.:908/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00919/AM08/ RLA File : 03/95/040/01517/AM07/ Lic.No/Date:031043 6987 20.07.2007 Defer Date: 01.01.200 8 export product Ibuprofen DC Granules 90% under para 4.7 of HBP. 78 Case No.:82/21/82- ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve

d HQ File : 01/82/050/00132/AM08/ RLA File : 05/24/040/00311/AM08/ Lic.No/Date:051020 6654 24.07.2007

export product Simvastatin under para 4.7 of HBP. U.O. No.35011/85/2007-PI-III dated 20.11.2007 decided to ratify norms under para Export product: Simvastatin--------------------------------------1kg. Import items:

  1. Lovastatin---------------------------1.648kg/kg
  2. Acetone------------------------------1.042kg/kg
  3. Activated carbon-------------------0.035kg/lg
  4. Cyclohexane-------------------------1.33kg/kg
  5. Cyclopropylamine------------------1.23kg/kg
  6. Methanol----------------------------19.82kg/kg
  7. N. Butyl Lithium---------------------2.382kg/kg
  8. Pyrrolidine----------------------------1.53kg/kg
  9. Tetrahydrofuran---------------------6.58kg/kg 10.Caustic flakes-------------------------1.484kg/kg 11.Iodine-----------------------------------0.5917kg/kg 12.Ethyl acetate--------------------------4.49kg/kg of Norms Committee. 79 Case No.:840/24/83- ALC1/2007 Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00837/AM08/ RLA File : 09/24/040/00155/AM08/ Lic.No/Date:091003 0999 25.07.2007 Defer Date: 15.01.200 8 export product {3-5[Bromo-1-(flurophenyl)(1,3-dihydro isobenzo furanyl)]- propyl]dimehylamine oxalate under para 4.7 of HBP.

80

Case No.:845/24/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00842/AM08/ RLA File : 09/24/040/00423/AM07/ Lic.No/Date:091003 1011 27.07.2007

export product Nevirapine Hemihydrate under para 4.7 of HBP. U.O. No.35011/81/2007-PI-III dated 19.09.2007 decided to ratify norms under para Export product: Nevirapine-------------------------------------------1kg. Import items:

  1. 2-chloro Nicotinic Acid------------------1.13kg/kg
  2. Cyclo Propylamine------------------------1.20kg/kg
  3. Malono Nitrile------------------------------1.088kg/kg
  4. Acetone--------------------------------------2.31kg/kg
  5. Pyridine--------------------------------------0.566kg/kg
  6. Diglyme---------------------------------------2.16kg/kg
  7. Methylene chloride-------------------------1.30kg/kg
  8. Methanol--------------------------------------8.43kg/kg
  9. Activated Carbon----------------------------0.100kg/kg 10.Acetic Acid-------------------------------------1.073kg/kg of Norms Committee. 81 Case No.:876/24/83- ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/00880/AM08/ RLA File : 09/24/040/00161/AM08/ Lic.No/Date:091003 1051 06.08.2007 Defer Date: 15.01.200 8

export product Cyclohexyl Ester under para 4.7 of HBP. 82

Case No.:937/24/83-

ALC1/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00951/AM08/ RLA File : 09/24/040/00180/AM08/ Lic.No/Date:091003 1081 10.08.2007

export product Lamivudine under para 4.7 of HBP. U.O. No.35011/87/2007-PI-III dated 03.10.2007 decided to ratify norms under para 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 of Norms Committee. 83 Case No.:936/24/83- ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : RLA File : Lic.No/Date:091003

01/83/050/00950/AM08/ 09/24/040/00181/AM08/ 1080 10.08.2007 export product Nevirapine under para 4.7 of HBP. Committee in light of its earlier decision taken in its 38/82 meeting held on 03.01.2007 vide case No.62/23/82 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Nevirapine---------------------------------------1kg. Import items:

  1. Malononitrile------------------------1.088kg/kg
  2. Methylene chloride-----------------6.71kg/kg
  3. 2-chloro nicotinic acid--------------1.13kg/kg
  4. Pyridine--------------------------------0.566kg/kg
  5. Methyl Ter. Buyl Eher---------------3.01kg/kg
  6. Cyclopropylamine--------------------1.20kg/kg of Norms Committee. 84

Case No.:962/24/83-

ALC1/2007 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/00978/AM08/ RLA File : 03/94/040/00493/AM08/ Lic.No/Date:031043 9377 14.08.2007

export product Phenyl Thio Proline under para 4.7 of HBP. Committee decided to defer the case for four weeks for want of comments of PI Division. 85 Case No.:45/25/83- ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d

HQ File : 01/83/050/01070/AM08/ RLA File : 03/95/040/00532/AM08/ Lic.No/Date:031044 1438 30.08.2007

export product Quinine Hydrochloride under para 4.7 of HBP. Committee in light of DGFT Report decided to ratify norms decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Quinine Hydrochloride BP/USP/EP-------------1kg. Import items:

  1. Cinchona Bark-----------------------------29kg/kg
  2. Toluene-------------------------------------34.30kg/kg of Norms Committee. 86

Case No.:32/25/83-

ALC1/2007 Party Name:METROPOLITAN OVERSEAS LIMITED, Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Rejected HQ File : 01/83/050/01057/AM08/ RLA File : 03/95/040/00511/AM08/ Lic.No/Date:031044 1319 30.08.2007

export product N-[1-(S)-Ethoxy Carbonyl-3-phenyl Propyl]-L-Alanine (ECPP-Alanina Ale) under para 4.7 of HBP. Committee noted that against earlier Advance Authorisation, firm was requested to furnish technical justification alongwith calculations for working out the quantative requirement as applied by them, but same was not received. Committee observed that in this case also, they have not furnished same. It was, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee. 87 Case No.:12/27/83- ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred

HQ File : 01/83/050/01086/AM08/ RLA File : 03/94/040/00555/AM08/ Lic.No/Date:031044 1561 31.08.2007 Defer Date: 18.12.200 7 export product Saqunavir 200mg Capsules/Saqvir 200mg Capsules under para 4.7 of HBP. Committee decided to call for the firm for personal hearing on 18.12.2007. 88

Case No.:26/27/83-

ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/01100/AM08/ RLA File : 09/24/040/00227/AM08/ Lic.No/Date:091003 1385 03.09.2007

export product Irbesartan under para 4.7 of HBP. U.O. No.35011/87/2007-PI-III dated 03.10.2007 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: Irbesartan----------------------------------------------------------------1kg. Import items:

  1. 1-2-Cyanobiophenyl-4-yl)methyl)-2-n- butyl-4-spirocyclopentane-2-imidazoloin-5-one-----1.36kg/kg
  2. Methylene chloride------------------------------------------6.15kg/kg
  3. Acetone---------------------------------------------------------2.83kg/kg of Norms Committee. 89 Case No.:25/27/83- ALC1/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : RLA File : Lic.No/Date:091003

01/83/050/01099/AM08/ 09/24/040/00229/AM08/ 1384 03.09.2007 export product Lisinopril under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis 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

of Norms Committee. 90

Case No.:22/27/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01096/AM08/ RLA File : 09/24/040/00166/AM08/ Lic.No/Date:091003 1381 03.09.2007 Defer Date: 15.01.200 8 export product Efavirenz under para 4.7 of HBP. 91 Case No.:54/27/83- ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred

HQ File : 01/83/050/01128/AM08/ RLA File : 03/94/040/00525/AM08/ Lic.No/Date:031044 1978 06.09.2007 Defer Date: 01.01.200 8 export product Aprepitant under para 4.7 of HBP. 92

Case No.:55/27/83-

ALC1/2007 Party Name:UNICHEM LABORATORIES LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/01129/AM08/ RLA File : 03/95/040/00559/AM08/ Lic.No/Date:031044 2110 07.09.2007

export product Amilodipine Maleate under para 4.7 of HBP. The Committee in light of its earlier decision taken in its 15/08 meeting held on 14.08.2007 vide Case No.A-466 and in consultation with technical authorities present in meeting decided to ratify the norms on repeat basis under

para 4.7 of HBP as per details below or as applied by the firm whichever is lower.

Export Product: Amlodipine Maleate------------------------1Kg. Import items:

  1. Phthaloyl Amlodipine------------------1.08kg/kg
  2. Methylene chloride---------------------4.50kg/kg
  3. Isopropyl alcohol------------------------2.40kg/kg of Norms Committee. 93 Case No.:72/27/83- ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01146/AM08/ RLA File : 03/95/040/00570/AM08/ Lic.No/Date:031044 2436 Defer Date:

11.09.2007 15.01.200 8 export product Sterile Ceftriaxone Sodium-Non Infringing under para 4.7 of HBP. Committee decided to examine the case on file from the policy view point. 94

Case No.:111/27/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01185/AM08/ RLA File : 03/94/040/00622/AM08/ Lic.No/Date:031044 3342 17.09.2007 Defer Date: 15.01.200 8 export product Losartan Potassium under para 4.7 of HBP. 95

Case No.:129/27/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01203/AM08/ RLA File : 03/94/040/00632/AM08/ Lic.No/Date:031044 3548 18.09.2007 Defer Date: 15.01.200 8 export product Sibutramine Hydrochloride under para 4.7 of HBP. 96 Case No.:160/27/83- ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01234/AM08/ RLA File : 03/94/040/00658/AM08/ Lic.No/Date:031044 4208 25.09.2007 Defer Date: 15.01.200 8 export product Lamivudine under para 4.7 of HBP.

97

Case No.:191/27/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01265/AM08/ RLA File : 04/24/040/00235/AM08/ Lic.No/Date:041009 1280 01.10.2007 Defer Date: 15.01.200 8 export

product

[Alpha-(Alpha,Beta)]-Beta-Methyl-Alpha-Phenyl-1- Pyrrolidineethanol Base (Pyrrolidinyl Nor ephedrine Base) under para 4.7 of HBP. 98

Case No.:6/29/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01271/AM08/ RLA File : 05/24/040/00525/AM08/ Lic.No/Date:051020 9857 03.10.2007 Defer Date: 01.01.200 8 export product Cefprozil under para 4.7 of HBP. 99 Case No.:47/29/83- ALC1/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/01312/AM08/ RLA File : 09/24/040/00168/AM08/ Lic.No/Date:091003 1717 08.10.2007

export product 7 AVNA under para 4.7 of HBP. Committee in light of its earlier decision taken in its 28/82 held on

13.11.2007 Vide Case No.840/21/82 and in consultation with technical authorities present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: 7-Amino 3-Vinyl Cepholosparanic Acid (7 AVNA)------------1kg. Import items:

  1. 7-Phenyl Acetamideo-3-Chloromethyl Cephalosporanic Acid para Methoxy Benzyl Ester (GCLE)---------------------------- 2.672kg/kg
  2. Methylene Chloride----------------------------------------------------7.59kg/kg
  3. Methanol------------------------------------------------------------------7.78kg/kg of Norms Committee. 10 0

Case No.:43/29/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01308/AM08/ RLA File : 09/24/040/00259/AM08/ Lic.No/Date:091003 1715 08.10.2007 Defer Date: 15.01.200 8 Decision : Committee considered case as per agenda for ratification of norms for export product Cytosine Menthyl Ester (CME) under para 4.7 of HBP. 10 1

Case No.:67/29/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01332/AM08/ RLA File : 03/95/040/00677/AM08/ Lic.No/Date:031044 5931 10.10.2007 Defer Date: 01.01.200 8

for export product Cefpodoxime Proxetil under para 4.7 of HBP. 10 2

Case No.:8/25/82-

ALC4/2007 Party Name:SHASUN CHEMICALS & DRUGS LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/00202/AM08/ RLA File : 04/24/040/00253/AM08/ Lic.No/Date:041009 1459 10.10.2007 Defer Date: 18.12.200 7 for export product Spironolactone Tablets 25mg under para 4.7 of HBP. Committee decided to hand over file to representative of PI Division present in meeting for his comments. Accordingly, case was deferred for two weeks. 10 3

Case No.:9/25/82-

ALC4/2007 Party Name:SHASUN CHEMICALS & DRUGS LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/00203/AM08/ RLA File : 04/24/040/00254/AM08/ Lic.No/Date:041009 1460 10.10.2007 Defer Date: 18.12.200 7 for export product Spironolactone Tablets (50mg) under para 4.7 of HBP. case is under examination in his Department and he sought deferment for two weeks. Committee, accordingly, decided to defer case for two weeks. 10 4

Case No.:10/25/82-

ALC4/2007 Party Name:SHASUN CHEMICALS & DRUGS LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/00204/AM08/ RLA File : 04/24/040/00255/AM08/ Lic.No/Date:041009 1462 10.10.2007 Defer Date: 18.12.200 7 for export product Spironolactone Tablets (100mg) under para 4.7 of HBP.

case is under examination in his Department and he sought deferment for two weeks. Committee, accordingly, decided to defer case for two weeks. 10 5

Case No.:102/29/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01367/AM08/ RLA File : 09/24/040/00271/AM08/ Lic.No/Date:091003 1798 16.10.2007 Defer Date: 15.01.200 8 for export product
2-Chloro-N-(2-Chloro-4-Methyl-3-Pyridinyl)-3-Pyridine Carboxamide under para 4.7 of HBP. 10 6

Case No.:95/29/83-

ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01360/AM08/ RLA File : 03/94/040/00673/AM08/ Lic.No/Date:031044 6503 16.10.2007 Defer Date: 01.01.200 8 for export product Hydrochlorothiazide under para 4.7 of HBP. 10 7

Case No.:4/30/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01373/AM08/ RLA File : 09/24/040/00304/AM08/ Lic.No/Date:091003 1810 17.10.2007 Defer Date: 15.01.200 8 for export product 1-Acetylamino-5-Nitro-2-Propoxy Benzene under para 4.7 of

HBP. 10 8

Case No.:13/30/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01382/AM08/ RLA File : 09/24/040/00330/AM08/ Lic.No/Date:091003 1817 19.10.2007 Defer Date: 15.01.200 8 for export product Atazanavir Sulfate under para 4.7 of HBP. 10 9

Case No.:23/30/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01392/AM08/ RLA File : 09/24/040/00299/AM08/ Lic.No/Date:091003 1841 22.10.2007 Defer Date: 15.01.200 8 for export product Efavirenz-600mg Tablets under para 4.7 of HBP. Committee decided to call for a copy of relevant DML from firm. Accordingly, case was deferred for six weeks. 11 0

Case No.:22/30/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01391/AM08/ RLA File : 09/24/040/00325/AM08/ Lic.No/Date:091003 1837 22.10.2007 Defer Date: 01.01.200 8 for export product 3-Oxo-4-Aza-5a-Androstane-17b-Carboxylic Acid under para 4.7 of HBP.

11 1

Case No.:1/27/82-

ALC4/2007 Party Name:MISSION PHARMACEUTICALS LTD., Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/82/050/00222/AM08/ RLA File : 03/95/040/00545/AM08/ Lic.No/Date:031044 7430 23.10.2007 Defer Date: 15.01.200 8 for export product Ciprofloxacin Tabs BP 500mg under para 4.7 of HBP. Committee decided to remind concerned RA to furnish a copy of application alongwith a copy of Advance Authorisation. Accordingly, case was deferred for six weeks. 11 2

Case No.:52/30/83-

ALC1/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01421/AM08/ RLA File : 09/24/040/00280/AM08/ Lic.No/Date:091003 1880 24.10.2007 Defer Date: 18.12.200 7 for export product Cefdinir under para 4.7 of HBP. case is under examination in his Department and he sought deferment for two weeks. Committee, accordingly, decided to defer case for two weeks. 11 3

Case No.:51/30/83-

ALC1/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01420/AM08/ RLA File : 09/24/040/00276/AM08/ Lic.No/Date:091003 1879 24.10.2007 Defer Date: 01.01.200 8 for export product Indinavir Sulphate under para 4.7 of HBP.

11 4

Case No.:28/32/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01450/AM08/ RLA File : 03/94/040/00789/AM08/ Lic.No/Date:031044 8309 29.10.2007 Defer Date: 15.01.200 8 for export product Losartan Potassium under para 4.7 of HBP. weeks. Committee, accordingly, decided to defer case for six weeks. 11 5

Case No.:60/32/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01482/AM08/ RLA File : 03/94/040/00799/AM08/ Lic.No/Date:031044 8706 01.11.2007 Defer Date: 15.01.200 8 for export product Saquinavir 200mg Capsules/Saqvir 200mg Capsules under

para 4.7 of HBP.

11 6

Case No.:69/32/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01491/AM08/ RLA File : 03/94/040/00803/AM08/ Lic.No/Date:031044 8936 02.11.2007 Defer Date: 15.01.200 8 for export product Simvastatin under para 4.7 of HBP.

11 7

Case No.:82/32/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01504/AM08/ RLA File : 09/24/040/00051/AM08/ Lic.No/Date:091003 1991 05.11.2007 Defer Date: 01.01.200 8 for export product Cefepime Hcl for Injection under para 4.7 of HBP. 11 8

Case No.:106/32/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01528/AM08/ RLA File : 03/94/040/00804/AM08/ Lic.No/Date:031044 9208 05.11.2007 Defer Date: 15.01.200 8 for export product Lamivudine under para 4.7 of HBP. 11 9

Case No.:92/32/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Approve d HQ File : 01/83/050/01514/AM08/ RLA File : 03/94/040/00814/AM08/ Lic.No/Date:031044 9495 06.11.2007

for export product Pantoprazole Sodium Sesquihydrate under para 4.7 of HBP. Committee in consultation with technical authorities present in meeting decided to ratify norms as per SION at Sl.No.A-3166 or as applied by firm

whichever is lower. RA concerned may take further necessary action as per above decision of Norms Committee. 12 0

Case No.:93/32/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01515/AM08/ RLA File : 03/94/040/00815/AM08/ Lic.No/Date:031044 9498 06.11.2007 Defer Date: 15.01.200 8 for export product Efavirenz under para 4.7 of HBP. 12 1

Case No.:7/33/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:31/82- ALC4/2007 04.12.2007 Status:C ase Deferred HQ File : 01/83/050/01536/AM08/ RLA File : 03/94/040/00822/AM08/ Lic.No/Date:031044 9680 07.11.2007 Defer Date: 15.01.200 8 for export product Fluticasone Propionate under para 4.7 of HBP. Date:30.11.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer

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