DGFT Committee Minutes

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

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 38/82-ALC4/2007 MEETING DATE : 22.01.2008 The Meeting No.38/08 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 23.01.2008 under the Chairmanship of Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No.37/08 dated 16.01.2008 was ratified by the Committee.

Case No.B-497

M/S Glenmark Pharmaceuticals Ltd. Norms Committee Meeting No.38/08 F.No.01/82/162/285/AM08 Meeting Date:22.01.2008 RLA F.No.03/24/40/1482/AM05 Advance Licence No.0310295800 dated 07.10.04 Committee considered case as per agenda for ratification of norms for export product Cilazapil under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.B-498

M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/50/1484/AM06 RLA F.No.03/94/40/1374/AM06 Advance Licence No.0310372003 dated 17.03.06 product Cilazapil under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.B-499

M/S Calyx Chemicals & Pharma. Pvt. Ltd. F.No.01/82/50/1369/AM04 RLA F.No.03/24/40/2120/AM04

Advance Licence No.0310249192 dated 22.01.04 Committee considered case as per agenda for allowing additional import item namely Pyrazine 2,3 Dicarboxylic Acid for export of Zopiclone BP/USP under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division.

Case No.B-500

M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/50/696/AM06 RLA F.No.03/94/40/670/AM06 Advance Licence No.0310348307 dated 21.09.05 product Ethoxycarbonylalamine under para 4.7 of HBP. The Committee observed that representation of firm was received on 23.11.2007 and in light of the written comments forwarded by PI Division vide their U.O.No.35011/253/2006-PI-III dated 18.4.2007 and in consultation with representative of PI Division present in meeting decided to ratify Norms on repeat basis under para para 4.7 of HBP as per details below or as applied by the firm whichever is lower:- Export product Export Quantity Import items Quantity allowed per unit of export product Ethoxy Carbonylalanine 1kg.

1. L-Norvaline 1.03kg/kg
2. 10% Palladlum on Carbon 0.100kg/kg
3. Acetone 4.56kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-501

M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/162/207/AM08 RLA F.No.03/24/40/789/AM04 Advance Licence No.0310217859 dated 11.08.03

product Cilostazol under para 4.7 of HBP. Committee in light of the written comments forwarded by PI Division vide their U.O.No.35011/243/2006-PI-III dated 05.12.2006 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quanti ty Import items Quantity allowed per unit of export product Cilostazol 1kg. 1)5-(4-chlorobutyl)-1-cycloh exyl-1-1H- Tetrazole 0.88kg/kg 2)6-Hydroxy-3,4-Dihydro-1Hd-Quinolin-2- one 0.59kg/kg Norms Committee.

Case No.B-502

M/S Brawn Laboratories Ltd. F.No.01/82/50/154/AM08 RLA F.No.05/24//40/163/AM08 Advance Licence No.0510204890 dated 13.06.07 product Kanamycin Acid Sulphate Inj. BP 1gm and Lincomycin Capsules 500mg under para 4.7 of HBP. Committee observed that firm has not submitted copy of DML for second export product namely Lincomycin Capsules and therefore, no norms can be ratified in the absence of DML. As regards first item namely Kanamycin Acid Sulphate Inj BP 1gm, Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/162/2006-PI-III dated 23.01.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product Export Quantity Import items Quantity allowed per unit of export product

Kanamycin Acid Sulphate Injection 1gm Vial (ITC(HS) No.30042069) 1 Vial Kanamycin Acid Sulphate 1.39gm/vial Norms Committee.

Case No.B-503

M/S Avignon Exim Pvt. Ltd. F.No.01/87/50/1102/AM07 RLA F.No.03/94/40/1374/AM07 Advance Licence No.0310422847 dated 13.03.07 product Niacinamide BP/USP under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of MSME.

Case No.B-504

M/S KDL Biotech Ltd. F.No.01/82/50/1415/AM05 RLA F.No.03/24//40/1364/AM05 Advance Licence No.0310301988 dated 11.11.04 product Immobilized Pencillin G Amidase Enzyme under para 4.7 of HBP. Committee in light of written comments forwarded by Department of Bio- technology vide their O.M. No.BT/IL/05/176/2004/PID dated 04.01.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Quantity Import items Quantity allowed per unit of export product Immobilized Penicillin- G-Amidase enzyme 1kg. 1)Yeast Extract 2.456kg/kg 2)Malic acid 4.001kg/kg 3)Sodium Hydroxide 0.600kg/kg 4)Dipotassium 4.500kg/kg

dihydroden Phosphate (k2HPO4) 5)Potassium dihydrogen Phosphate ((KH2PO4) 1.001kg/kg 6)Acetic acid 0.015kg/kg 7)P3 Ultracil 0.500kg/kg 8)Iso Propyl Alcohol 0.422kg/kg 9)Glycedyl Methacrylate 0.643kg/kg 10)Acrylonitrile 0.153kg/kg 11)Divinyl Benzene 0.429kg/kg 12)Cyclohexanol 1.521kg/kg 13)Methanol denine Hemi Sulphate Dihydrate 12.857kg/kg Norms Committee.

Case No.B-505

M/S Neuland Laboratories Ltd. F.No.01/82/50/246/AM08 RLA F.No.09/24//40/307/AM08 Advance Licence No.0910032016 dated 07.11.07 Committee considered case as per agenda for amendment in the description of import item No.1 under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to allow amendment in description of import item No.1 to read as “Racemic-2-azabicyclo (3.3.0) octane-3-carboxylic acid benzylester Hydrochloride

[(S,S)-2-azabicyclo

(3.3.0)octane-3-carboxylic

acid benzylester Hydrochloride’]. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-506

M/S Hetero Drugs Ltd. F.No.01/83/50/1505/AM08 RLA F.No.09/24//40/344/AM08 Advance Licence No.0910031992 dated

05.11.07 Committee considered case as per agenda for allowing additional input namely N,N-Carbonyldimidazole under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/87/2007-PI-III dated 23.01.2008 decided to allow additional input as per details below or as applied by firm whichever is lower:- N,N Carbonyl dimidazole------------------------0.42kg/kg Norms Committee.

Case No.B-507

M/S Ranbaxy Laboratories Ltd. F.No.01/82/50/608/AM08 RLA F.No.05/24/40/248/AM08 Advance Licence No.0510205474 dated 27.06.07 Committee considered case as per agenda for revision of norms for export product Pravastatin Sodium under para 4.7 of HBP. U.O. No.35011/85/2007-PI-III dated 21.01.2008 decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Import items Quantity allowed per unit of export product Pravastatin Sodium (ITC(HS)No.294200 90) 1kg. 1.Compactin 4.00kg/kg 2.Anti Form SAG-71 0.050kg/kg 3.Acetonitrile 19.51kg/kg 4.Acetone 10.67kg/kg 5.Activated Carbon 0.100kg/kg 6.Methanol 2.88kg/kg Norms Committee.

Case No.B-508

M/S Ranbaxy Laboratories Ltd.

F.No.01/83/50/167/AM08 RLA F.No.05/24/40/49/AM08 Advance Licence No.0510202775 dated 20.04.07 Committee considered case as per agenda for revision of norms for export product Pravastatin Sodium under para 4.7 of HBP. U.O. No.35011/85/2007-PI-III dated 21.01.2008 decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Import items Quantity allowed per unit of export product Pravastatin Sodium (ITC(HS)No.294200 90) 1kg. 1.Compactin 4.00kg/kg 2.Aanti Form SAG-71 0.050kg/kg 3.Acetonitrile 19.51kg/kg 4.Acetone 10.67kg/kg 5.Activated Carbon 0.100kg/kg 6.Methanol 2.88kg/kg Norms Committee.

Case No.B-509

M/S Ranbaxy Laboratories Ltd. F.No.01/82/50/617/AM08 RLA F.No.05/24/40/400/AM07 Advance Licence No.0510189882 dated 31.08.06 Committee considered case as per agenda for revision of norms for export product Pravastatin Sodium under para 4.7 of HBP. U.O. No.35011/85/2007-PI-III dated 21.01.2008 decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Import items Quantity allowed per unit of

export product Pravastatin Sodium (ITC(HS)No.294200 90) 1kg. 1.Compactin 4.00kg/kg 2.Aanti Form SAG-71 0.050kg/kg 3.Acetonitrile 19.51kg/kg 4.Acetone 10.67kg/kg 5.Activated Carbon 0.100kg/kg 6.Methanol 2.88kg/kg Norms Committee.

Case No.B-510

M/S Shilpa Medicare Ltd. F.No.01/87/50/1517/AM06 RLA F.No.07/24/40/1025/AM06 Advance Licence No.0710043911 dated 23.03.06 product

N+[β-D-Ribofuranosyl]-5-Hydroxyimidiazole-4-Carboxamide

Technical Grade under para 4.7 of HBP. U.O. No.35011/135/2006-PI-III dated 21.01.2008 and 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 Export Quantity Import items Quantity allowed per unit of export product N+-[β-D- Ribofuranosyl]-5- hydroxyimidazole- 2-carboxamide Technical Grade (ITC(HS)No.294200 90) 1kg. 1)N-(2,3,5-Tri-O-Benzoyl)-B-D- Ribofuranosyl)-5-Hydroxy Imidazole-4-carboxamide 7.50kg/kg 2)Amberlite IRC 748 Resin 0.95kg/kg 3)Amberlite IRA 900 CIResin 1.70kg/kg 4)Tetrahydrofuran 18.66kg/kg Norms Committee.

Case No.B-511

M/S SMS Pharmaceuticals Ltd. F.No.01/83/162/424/AM07 RLA F.No.09/24/40/02/AM06 Advance Licence No.0910023407 dated 05.07.05 Committee considered case as per agenda for revision of norms for export product D-erythro,d-threo-2-Deoxy-2,2-difluro penta furanos-1 ulose-3,5-dibenzoate Committee decided to defer case for four weeks for comments of PI Division.

Case No.B-512

M/S SMS Pharmaceuticals Ltd. F.No.01/83/162/425/AM07 RLA F.No.09/24/40/377/AM06 Advance Licence No.0910025027 dated 28.11.05 Committee considered case as per agenda for revision of norms for export product D-erythro,d-threo-2-Deoxy-2,2-difluro penta furanos-1 ulose-3,5-dibenzoate Committee decided to defer case for comments of PI Division.

Case No.B-513

M/S Vasudha Pharma Chem Ltd. F.No.01/83/50/1097/AM08 RLA F.No.09/24/40/209/AM08 Advance Licence No.0910031382 dated 03.09.07 Committee considered case as per agenda for revision of norms for export product Amitriptyline Crude under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.B-514

M/S Vasudha Pharma Chem Ltd. F.No.01/83/50/1098/AM08 RLA F.No.09/24/40/226/AM08 Advance Licence No.0910031383 dated 03.09.07 Committee considered case as per agenda for revision of norms for export

product Dibenzosuberone under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-975

M/S Amoli Organics Pvt. Ltd. F.No.01/87/50/606/AM07 RLA F.No.03/94/40/411/AM07 Advance Licence No.0310380982 dated 24.07.06 product Noscapine Resin Complex under para 4.7 of HBP. Committee observed that firm was requested to furnish technical details vide letter dated 12.12.2007, but same has not been received. Committee, therefore, decided to close the case as norms can not be ratified in the absence of technical details. Norms Committee.

Case No.A-976

M/S Bal Pharma Ltd. F.No.01/82/50/297/AM08 RLA F.No.07/24/40/671/AM08 Advance Licence No.0710055101 dated 26.12.07 product Amiloride Hcl under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

Case No.A-977

M/S Aurobindo Pharma Ltde. F.No.01/82/50/296/AM08 RLA F.No.09/24/40/428/AM08 Advance Licence No.0910032472 dated 26.12.07 product Carvedilol under para 4.7 of HBP.

Committee decided to defer case for two weeks for comments of PI Division.

Case No.A-978

M/S Aurobindo Pharma Ltd. F.No.01/82/50/294/AM08 RLA F.No.09/24/40/413/AM08 Advance Licence No.0910032473 dated 26.12.07 product Florfenicol under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division.

Case No.A-979

M/S Aurobindo Pharma Ltd. F.No.01/82/50/253/AM08 RLA F.No.09/24/40/205/AM08 Advance Licence No.0910031156 dated 16.08.07 product Ceftiofur Sodium Sterile under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division.

Case No.A-980

M/S Coral Drugs Pvt. Ltd F.No.01/82/50/298/AM08 RLA F.No.05/24/40/699/AM08 Advance Licence No.0510213410 dated 12.12.07 product Finasteride under para 4.7 of HBP. Committee observed that firm has not submitted technical details as per Appendix 33 alongwith their application for Advance licence. Committee, therefore, decided to ask RA as to how Advance licence has been issued to firm without technical details. Committee also decided to call for technical details as per Appendix 33 from firm. Accordingly, case was deferred for six weeks.

Case No.A-981

M/S Coral Drugs Pvt. Ltd F.No.01/82/50/299/AM08 RLA F.No.05/24/40/601/AM08 Advance Licence No.0510212483 dated 26.11.07 product Flutamide USP under para 4.7 of HBP. Committee observed that firm has not submitted technical details as per Appendix 33 alongwith their application for Advance licence. Committee, therefore, decided to ask RA as to how Advance licence has been issued to firm without technical details. Committee also decided to call for technical details as per Appendix 33 from firm. Accordingly, case was deferred for six weeks.

Case No.A-982

M/S Gland Pharma Ltd. F.No.01/82/50/254/AM08 RLA F.No.09/24/40/314/AM08 Advance Licence No.0710055101 dated 26.12.07 product Adenosine Injection USP under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-983

M/S Global Calcium Pvt. Ltd. F.No.01/83/162/1033/AM08 RLA F.No.07/24/40/53/AM08 Advance Licence No.0710051439 dated 26.04.07 product (1) Calcium Gluconate Injectable Grade (2) Calcium Lactate Gluconate, (3) Calcium Glubionate and (4) Calcium Borogluconate under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-984

M/S Nicholas Piramal India Ltd.

F.No.01/82/50/302/AM08 RLA F.No.09/24/40/868/AM08 Advance Licence No.0310454138 dated 14.12.07 product Ultrazyme Tablets (7458X) [contact lens cleaning tablets) under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of DBT.

Case No.A-985

M/S Neuland Laboratories Ltd. F.No.01/82/50/304/AM08 RLA F.No.09/24/40/363/AM08 Advance Licence No.0910032148 dated 26.11.07 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 vide Case No.1/22/82 and 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 Export Quantit y Import items Quantity allowed per unit of export product Ramipril (ITC(HS) No.300490 71) 1kg. 1.Racemic-2-azabicyclo (3.3.0) octane-3- carboxylic acid benzylester Hydrochloride [(S,S)-2-azabicyclo

(3.3.0)octane-3- carboxylic 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 Norms Committee.

Case No.A-986

M/S Intas Pharmaceuticals Ltd. F.No.01/82/50/301/AM08 RLA F.No.08/24/40/226/AM08 Advance Licence No.0810069241 dated 28.12.07 product Doxycyclone Hyclate Tablets USP under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-987

M/S Medreich Ltd. F.No.01/82/50/303/AM08 RLA F.No.07/24/40/620/AM08 Advance Licence No.0710054772 dated 03.12.07 product Glucosamine 1500mg systaubed rekease tavkets (ii) Glucosamine 1000mg Sustained release tablets and (iii) Glucosamine 750mg Sustained release tablets U.O. No.35011/270/2006-PI-III dated 23.01.2008 and 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 Export Qty. Import items Qty. allowed per unit

of

export product Glucosamine 1500mg Sustained Release Tablet (ITC(HS)No.30049 1 tablet Glucosamine

sulphate Sodium Sulphate 1836mg/1500mg tablet

Glucosamine 1000mg Sustained Release Tablet (ITC(HS)No.30049 069) 1 tablet Glucosamine

sulphate Sodium Sulphate 1358.64mg/1000m g tablet Glucosamine 750mg Sustained Release Tablet (ITC(HS)No.30049 069) 1 tablet Glucosamine

sulphate Sodium Sulphate 1018.98mg/750mg tablet Norms Committee.

Case No.A-988

M/S Medreich Ltd. F.No.01/82/50/48/AM08 RLA F.No.07/24/40/810/AM07 Advance Licence No.0710050467 dated 06.03.07 product Paracetamol 450mg + Doxylamine Succinate 5mg + Caffeine 45mg +Codeine Phosphate 10mg Tablets under para 4.7 of HBP. U.O. No.35011/207/2006-PI-III dated 23.01.2007 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product Export Qty. Import items Qty allowed per unit of export product Paracetamol 450mg

Caffiene Anhydrous 45mg +

Doxylamine Succinate 5mg + Codeine 1 tablet 1.Paracetamol 459mg/tab. 2.Doxylamine Succinate 5.1mg/tab. 3.Spectracolquin oline

yellow 800744 B-20 Neither the description nor CI No.

matches

with

the description given in the MBF. Hence not allowed.

Phosphate 10mg tablets (ITC(HS)No.30049 039) 4.Spectracolquin oline Yellow LK 80500 2B10 Neither the description nor CI No.

matches

with

the description given in the MBF. Hence not allowed. Norms Committee. 2 919) Gentian (Aqueous (Powdered extract) (ITC(HS)No.13021 919) 1kg. Gentian (Gentianalutea) Roots 2.194kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

3

Case No.:35/31/82-

ALC1/2006 Party Name:CLARIANT CHEMICALS [INDIA] LTD Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Withdraw n HQ File : 01/82/050/01132/AM07/ RLA File : 03/94/040/00773/AM07/ Lic.No/Date:0310403 496 11.10.2006

Decision : Committee considered case as per agenda for ratification of norms for export product 5 Fluoro Cyto Sine under para 4.7 of HBP. Committee decided to withdraw case as same has already been approved in 37/08 meeting held on 15.01.2008. 4

Case No.:1/42/83-

ALC1/2006 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/00936/AM07/ RLA File : 09/24/040/00218/AM07/ Lic.No/Date:0910028 286 21.11.2006 Defer Date: 04.03.20 08 norms for export product 1,2-Benzisoxazole-3-Methane Sulphonic acid sodium salt under para 4.7 of HBP. Committee decided to call for sequence of events in chronological order from RA. Accordingly, case was deferred for six weeks. 5

Case No.:16/49/82-

ALC1/2006 Party Name:LUPIN LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/82/050/01721/AM07/ RLA File : 03/95/040/01297/AM07/ Lic.No/Date:0310416 716 22.01.2007 Defer Date: 19.02.20 08 norms for export product Strile Ceftriaxone Sodium-Non Infringing under

para 4.7 of HBP.

Committee decided to examine case on file as non-infringing process is involved in manufacturing export product. 6

Case No.:4/9/82-

ALC4/2007 Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Approved HQ File : RLA File : Lic.No/Date:0310419

01/82/050/01644/AM07/ 03/94/040/01206/AM07/ 586 14.02.2007 norms for export product Losartan Potassium USP under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No. 35011/204/2006-PI-III dated 21.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Import items Qty. allowed per unit of export product Losartan Potassium 1kg.

1. 2-Cyano-4-Methyl Piphenyl
   0.79kg/kg
2. N-Bromo Succinimide 0.38kg/kg
3. 2-Butyl-4-chloro-5-formyl Imidazole 0.62kg/kg
4. Sodium Borohydride 0.048kg/kg
5. Sodium Azide 0.50kg/kg
6. Triethyl Amine Hcl 2.20kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 7

Case No.:8/2/83-

ALC1/2007 Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/83/050/01256/AM07/ RLA File : 34/24/040/00259/AM07/ Lic.No/Date:3410018 108 19.02.2007

norms for export product 5-Bromo Phthalide under para 4.7 of HBP. their U.O. No.35011/207/2006-PI-III and 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 Export Qty. Import items Qty. allowed per unit of export product

5-Bromo Phthalide (ITC(HS)No.29420 090) 1kg.

1. Hydrobromic

Acid 48% 0.87kg/kg 2. 5-Amino Phthalide 3.35kg/kg Norms Committee. 8

Case No.:3/19/82-

ALC4/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/82/050/01663/AM07/ RLA File : 05/24/040/00951/AM07/ Lic.No/Date:0510199 828 21.02.2007

norms for export product Nalidixic Acid under para 4.7 of HBP. their U.O. No.35011/111/2007-PI-III dated 21.01.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product Export Qty. Import items Qty. allowed per unit of export product Nalidixic Acid (ITC(HS)No.29183 030) 1kg.

1. Sodium Metal 0.4077kg/kg
2. Alumina-Silica Catalyst 0.0540kg/kg
3. Denatured

Ethyl Alcohol 4.59kg/kg 4. Triethyl

ortho formate 1.233kg/kg 5. Para Toluene Sulfonic acid Monohydrate 0.003kg/kg 6. Diethyl Malonate 1.333kg/kg 7. Ethyl Alcohol 0.200kg/kg 8. Diphenyl DT Not

a

raw material. Hence not allowed 9. Ethyl bromide 0.58kg/kg 10. Dimethyl Formamide 0.833kg/kg

Norms Committee. 9

Case No.:879/21/82-

ALC4/2007 Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/82/050/01714/AM07/ RLA File : 07/24/040/00780/AM07/ Lic.No/Date:0710050 314 27.02.2007 Defer Date: 19.02.20 08 norms for export product Dorzolamide Hcl 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. 10

Case No.:7/2/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/82/050/01804/AM07/ RLA File : 03/94/040/01443/AM07/ Lic.No/Date:0310422 972 13.03.2007 Defer Date: 19.02.20 08 norms for export product (1) Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets and (2) Triomune 40/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. Division. 11

Case No.:474/24/83-

ALC1/2007 Party Name:SHILPA MEDICARE LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Rejected HQ File : 01/83/050/01382/AM07/ RLA File : 07/24/040/00879/AM07/ Lic.No/Date:0710050 972 29.03.2007 : norms for export product N-[B-D-Ribofuranosyl]-5-Hydroxyimidazole-4- Carboxamide Technical Grade under para 4.7 of HBP. Committee observed that firm was requested to furnish technical information vide letter dated 27.08.2007, but they have furnished incomplete information. Accordingly, Committee decided to close the case

as norms can not be ratified in absence of complete information. RA concerned may take further necessary action as per above decision of norms committee. 12

Case No.:25/14/83-

ALC1/2007 Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/83/050/00016/AM08/ RLA File : 04/24/040/00501/AM07/ Lic.No/Date:0410088 727 02.04.2007 Defer Date: 04.03.20 08 norms for export product Allylestrenol under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 13

Case No.:9/21/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/82/050/00009/AM08/ RLA File : 09/24/040/00543/AM07/ Lic.No/Date:0910029 931 10.04.2007 Defer Date: 05.02.20 08 norms for export product 7-Amino-3[(Z/E)-1-Propen-1-YL]-3-Cepham-4- Carbocylic Acid (APRA) under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 14

Case No.:26/9/82-

ALC4/2007 Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Withdraw n HQ File : 01/82/050/00010/AM08/ RLA File : 09/24/040/00555/AM07/ Lic.No/Date:0910029 933 10.04.2007

norms for export product 2-Chloro methyl-3-methyl-4-(2,2,2-trifluoro ethoxy)pyridine Hcl (Lansoprazole Chloro intermediate) under para 4.7 of HBP. Committee decide to withdraw case as same has already been rejected

in its 33/08 meeting held on 18.12.2007. 15

Case No.:566/24/83-

ALC1/2007 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Approved HQ File : 01/83/050/00239/AM08/ RLA File : 05/24/040/00080/AM08/ Lic.No/Date:0510203 207 03.05.2007

norms for export product Montelukast Sodium Min Assay 97% under para 4.7 of HBP. their U.O. No.35011/207/2006-PI-III dated 21.01.2008 decided to ratify Export product Export Qty. Import items Qty. allowed per unit of export product Montelukast Sodium (ITC(HS)No.29420 000) 1kg.

1. 7-chloro quinaldine 8.07kg/kg
2. Isophthal Dehyde 10.406kg/kg
3. Tetrahydrofuran 38.47kg/kg
4. Isopropyl Alcohol 3.33kg/kg
5. Methylene Chloride 64.64kg/kg
6. Triethylamine 11.67kg/kg
7. Methyl-2-iodo benzoate 8.67kg/kg
8. Dimethyl formamide 4.63kg/kg
9. (-)Di-Isopinoicamphey L Chloro Borane)-DPC IN Heptane) 13.80kg/kg

Ceric chloride 2.466kg/kg 11. Acetonitrile 10.13kg/kg 12. N-Butyl Lithium (15% in Hexane) 3.53kg/kg 13. 1,1 Cyclopropane Di Methanol 2.88kg/kg 14. Di-isopropyl Ethylamine 1.24kg/kg Norms Committee.

16

Case No.:11/22/83-

ALC1/2007 Party Name:ORGANON (INDIA) LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/00260/AM08/ RLA File : 02/24/040/00024/AM08/ Lic.No/Date:0210100 541 04.05.2007

norms for export product Norandrostenedione (Nordion) under para 4.7 of HBP. their U.O. No.35011/9/2006-PI-III dated 23.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Import items Qty. allowed per unit of export product Norandrostenedi one (not less than 90% purity (ITC(HS)No.42515 005) 1kg.

1. Sitolactone 1.26kg/kg
2. Chloroket 1.17kg/kg
3. Pyridine 0.56kg/kg
4. Methanol 2.88kg/kg
5. Toluene 5.71kg/kg Norms Committee. 17

Case No.:12/17/83-

ALC1/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/00263/AM08/ RLA File : 05/24/040/00106/AM08/ Lic.No/Date:0510203 343 07.05.2007

norms for export product 1,4-Dihydro-1-ethyl-7-methyl-1-4-oxo-1,8- naphthyridine-3-carboxylic acid-Crude under para 4.7 of HBP. their U.O. No.35011/111/2007-PI-III dated 21.01.2008 decided to ratify

Export product Export Qty. Import items Qty. allowed per unit of export product 1,4 Dihydro-1- Ethyl-7-Methyl- 4-Oxo-1,8 Napthridine-3- Carboxylic Acid- Crude (ITC(HS)No.29183 030) 1kg.

1. Sodium Metal 0.36kg/kg
2. Alumina-Silica Satalyst 0.048kg/kg
3. Denatured

Ethyl Alcohol 4.13kg/kg 4. Triethyl

ortho formate 1.10kg/kg 5. Para Toluene Sulfonic acid Monohydrate 0.0027kg/kg 6. Diethyl Malonate 1.20kg/kg 7. Ethyl Alcohol 0.180kg/kg 8. Diphenyl DT Not

a

raw material. Hence not allowed 9. Ethyl bromide 0.520kg/kg 10. Dimethyl Formamide 0.750kg/kg RA concerned may take further necessary action as per above decision of Norms Committee 18

Case No.:614/24/83-

ALC1/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/83/050/00369/AM08/ RLA File : 03/95/040/01471/AM07/ Lic.No/Date:0310430 058 21.05.2007 Defer Date: 19.02.20 08 norms for export product Ultrazyme Tablets (7458X) [Contact Lens Cleaning Agent] under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of DBT. 19

Case No.:33/9/82-

ALC4/2007 Party Name:DR. WILLMAR SCHWABE INDIA PVT LTD Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/82/050/00044/AM08/ RLA File : 05/24/040/00826/AM07/ Lic.No/Date:0510203 948 22.05.2007 Defer Date: 04.03.20 08

norms for export product White Sugar Globuli (Unarzneiliche Globuli)
Committee was informed that technical comments for above export product has been received from Ministry of Food Processing Industry/Directorate of Sugar in DES-VI Section. Committee, therefore, decided to call for concerned file from DES-VI Section. It was also decided to refer case to Ministry of Food Processing Industry/Directorate of Sugar for their comments. Accordingly, case was deferred for six weeks. 20

Case No.:635/24/83-

ALC1/2007 Party Name:JUPITER BIOSCIENCE LIMITED, Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/83/050/00411/AM08/ RLA File : 09/24/040/00045/AM08/ Lic.No/Date:0910030 362 28.05.2007

norms for export product N-T-Boc-L-Phenylalanine 99% pure under para 4.7 of HBP. their U.O. No.35011/207/2006-PI-III dated 21.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify Export product Export Qty. Import items Qty. allowed per unit of export product N-T-BOC-L- Phenyl Alanine (ITC(HS)No.29374 000) 1kg.

1. L-Phenyl Alanine 0.622kg/kg

Di-Tertiary-Butyl Dicarbonate Anhydride 0.821kg/kg 3. Isopropyl Alcohol 0.394kg/kg 4. N-Hexane 0.986kg/kg 5.Ethyl Acetate 1.134kg/kg 6.Sodium Hydroxide 0.150kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 21

Case No.:645/24/83-

ALC1/2007 Party Name:AYURSIDDHA INC. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred

HQ File : 01/83/050/00438/AM08/ RLA File : 05/24/040/00105/AM08/ Lic.No/Date:0510204 254 30.05.2007 Defer Date: 19.02.20 08 norms for export product Blockbuster All Clear Capsules Made of Citrolive (olive Leaf Citrus) under para 4.7 of HBP. Committee decided to forward a copy of application to Deptt. Of MSME for their comments. Accordingly, case was deferred for four weeks. 22

Case No.:680/24/83-

ALC1/2007 Party Name:DCM SHRIRAM INDUSTRIES LTD, Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/00524/AM08/ RLA File : 05/24/040/00166/AM08/ Lic.No/Date:0510204 918 14.06.2007 Defer Date: 19.02.20 08 norms for export product D(-)Para Hydroxy Phenyl Glycine Sane Salt 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. 23

Case No.:83/19/83-

ALC1/2007 Party Name:SUMITOMO CHEMICAL INDIA PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/00643/AM08/ RLA File : 03/95/040/01529/AM07/ Lic.No/Date:0310433 838 25.06.2007 Defer Date: 12.02.20 08 norms for export product 1,2-Methylenedioxybenzyne under para 4.7 of HBP. Committee observed that firm was requested to furnish end use of export product and technical literature in support of above, but information has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for three weeks. 24

Case No.:730/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred

HQ File : 01/83/050/00623/AM08/ RLA File : 09/24/040/00120/AM08/ Lic.No/Date:0910030 686 29.06.2007 Defer Date: 19.02.20 08 norms for export product (S)-3-Hydroxy-N-Benzyl Pyrrolidine under para 4.7 of HBP. Division. 25

Case No.:19/23/83-

ALC1/2007 Party Name:SEQUENT SCIENTIFIC LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/83/050/00655/AM08/ RLA File : 07/24/040/00234/AM08/ Lic.No/Date:0710052 301 04.07.2007 Defer Date: 12.02.20 08 norms for export product L-(+)-Selenomethionine under para 4.7 of HBP. Committee observed that firm was requested to furnish end use of export product and technical literature in support of above, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for three weeks. 26

Case No.:103/19/83-

ALC1/2007 Party Name:AVIK PHARMACEUTICAL LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/00712/AM08/ RLA File : 03/94/040/00198/AM08/ Lic.No/Date:0310435 816 11.07.2007

norms for export product Clobetasol 17-Propinate BP/USP under para 4.7 of HBP. their U.O. No.35011/134/2005-PI-III dated 23.01.2008 in the case of M/S Anuh Pharma Ltd. and 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 Export Qty. Import items Qty. allowed per unit of export

product Clobetasol Propionate (ITC(HS)No.29379 300) 1kg.

1. Betamethasone base BP 1.19kg/kg Norms Committee. 27

Case No.:797/24/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/00755/AM08/ RLA File : 05/24/040/00286/AM08/ Lic.No/Date:0510206 321 16.07.2007 Defer Date: 19.02.20 08 norms for export product Citalopram Hydrobromide under para 4.7 of HBP. Committee decided to examine case on file as the application of firm is based on non infringing process. 28

Case No.:95/21/82-

ALC4/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/82/050/00144/AM08/ RLA File : 03/95/040/00389/AM08/ Lic.No/Date:0310437 508 26.07.2007 Defer Date: 19.02.20 08 norms for export product Hydrocare Tablets (Contact Lens Cleaning Agent) Committee decided to defer case for four weeks for comments of DBT. 29

Case No.:3/18/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/82/050/00142/AM08/ RLA File : 03/94/040/00455/AM08/ Lic.No/Date:0310438 406 06.08.2007 Defer Date: 19.02.20 08 norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP.

Division. 30

Case No.:897/24/83-

ALC1/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/83/050/00905/AM08/ RLA File : 05/24/040/00287/AM08/ Lic.No/Date:0510207 300 07.08.2007

norms for export product Camptothecin under para 4.7 of HBP. Committee in light of written comments forwarded by Deptt. Of MSME vide their U.O. No.5(9)/2005-Chem dated 21.01.2008 and in consultation with representative of D/O MSME present in meeting decided to ratify Export product Export Qty. Import items Qty. allowed per unit of export product

Camptothecin purity Minimum 99% (ITC(HS)No.13021 919) 1kg. 1.
Mappia foetida (containing Camptothecin 0.14%+ 0.02% 952kg/kg Norms Committee. 31

Case No.:962/24/83-

ALC1/2007 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/00978/AM08/ RLA File : 03/94/040/00493/AM08/ Lic.No/Date:0310439 377 14.08.2007 Defer Date: 19.02.20 08 norms for export product Phenyl Thio Proline under para 4.7 of HBP. Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for four weeks.

32

Case No.:5/20/82-

ALC4/2007 Party Name:RICHY GOLD INTERNATIONAL Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/82/050/00162/AM08/ RLA File : 03/95/040/00461/AM08/ Lic.No/Date:0310439 444 14.08.2007

norms for export product Oral Rehydration Salt BP under para 4.7 of HBP. their U.O. No.35011/104/2007-PI-III dated 21.01.2008 decided to ratify Export product Export Qty. Import items Qty. allowed per unit of export product Oral Rehydration Salt BP 30gm. Sachet (ITC(HS)No.30049 086) 1kg. Dextrose Anhydrous 0.666kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 33

Case No.:16/25/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/83/050/01041/AM08/ RLA File : 03/94/040/00516/AM08/ Lic.No/Date:0310439 736 16.08.2007 Defer Date: 19.02.20 08 norms for export product Losartan Potassium under para 4.7 of HBP. Division. 34

Case No.:14/25/83-

ALC1/2007 Party Name:SANJAY SALES CORPORATION Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Transferr ed HQ File : 01/83/050/01039/AM08/ RLA File : 03/95/040/00475/AM08/ Lic.No/Date:0310439 724

16.08.2007 norms for export product Sodium Salicylate under para 4.7 of HBP. Committee decided to transfer case to DES-IV as export product pertains to chemical sector. 35

Case No.:7/25/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/83/050/01032/AM08/ RLA File : 09/24/040/00231/AM08/ Lic.No/Date:0910031 314 29.08.2007 Defer Date: 19.02.20 08 norms for export product Didanosine under para 4.7 of HBP. Division. 36

Case No.:32/25/83-

ALC1/2007 Party Name:METROPOLITAN OVERSEAS LIMITED, Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Rejected HQ File : 01/83/050/01057/AM08/ RLA File : 03/95/040/00511/AM08/ Lic.No/Date:0310441 319 30.08.2007

norms for export product N-[1-(S)-Ethoxy Carbonyl-3-phenyl propyl]-L- Alanine under para 4.7 of HBP. their U.O. No.35011/193/2006-PI-III dated 22.01.2008 observed that norms applied by firm are not as per chemistry furnished by them. Accordingly, Committee decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee. 37

Case No.:42/25/83-

ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/83/050/01067/AM08/ RLA File : 03/94/040/00299/AM08/ Lic.No/Date:0310441 432 30.08.2007 Defer Date: 05.02.20 08

norms for export product Nitazoxanide under para 4.7 of HBP. Division. 38

Case No.:6/27/83-

ALC1/2007 Party Name:VANI CHEMICALS & INTERMEDIATES LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01080/AM08/ RLA File : 09/24/040/00009/AM08/ Lic.No/Date:0910031 330 31.08.2007 Defer Date: 05.02.20 08 norms for export product 4-(3,4-Dichlorophenyl)1-Tetralone under para 4.7 of HBP. Division. 39

Case No.:8/27/83-

ALC1/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Approved HQ File : 01/83/050/01082/AM08/ RLA File : 05/24/040/00439/AM08/ Lic.No/Date:0510208 408 31.08.2007

norms for export product Camptothecin under para 4.7 of HBP. Committee in light of written comments forwarded by Deptt. Of MSME vide their U.O. No.5(9)/2005-Chem dated 21.01.2008 and in consultation with representative of D/O MSME present in meeting decided to ratify Export product Export Qty. Import items Qty. allowed per unit of export product

Camptothecin purity Minimum 99% (ITC(HS)No.13021 919) 1kg. 1.
Mappia foetida (containing Camptothecin 0.14%+ 0.02% 952kg/kg

RA concerned may take further necessary action as per above decision of Norms Committee. 40

Case No.:4/22/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/82/050/00174/AM08/ RLA File : 09/24/040/00207/AM07/ Lic.No/Date:0910031 328 31.08.2007 Defer Date: 05.02.20 08 norms for export product Cefoperazone Sodium Sterile USP/BP under para 4.7 of HBP. Division. 41

Case No.:19/27/83-

ALC1/2007 Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/01093/AM08/ RLA File : 03/95/040/00427/AM08/ Lic.No/Date:0310441 528 31.08.2007

norms for export product Orlistat Pellets 50% under para 4.7 of HBP. The Committee in light of the oral comments of the representative of PI Division in the meeting 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 Export Qty. Import items Qty. allowed per unit of export product Orlistate Pellets 50% (ITC(HS)No.29322 990) 1kg. Orlistat 0.505kg/kg as per SION Norms Committee. 42

Case No.:9/27/83-

ALC1/2007 Party Name:OM SHREE PHARMACHEM PVT.LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred

HQ File : 01/83/050/01083/AM08/ RLA File : 03/95/040/00534/AM08/ Lic.No/Date:0310441 537 31.08.2007 Defer Date: 29.01.20 08 norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee decided to defer the case as firm has already been called for personal hearing in its meeting to be held on 29.01.2008. 43

Case No.:5/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/82/050/00175/AM08/ RLA File : 03/94/040/00571/AM08/ Lic.No/Date:0310441 556 31.08.2007 Defer Date: 19.02.20 08 norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP. Division. 44

Case No.:33/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01107/AM08/ RLA File : 09/24/040/00192/AM07/ Lic.No/Date:0910031 403 05.09.2007 Defer Date: 05.02.20 08 norms for export product GCLE-Stage-1 under para 4.7 of HBP. Division. 45

Case No.:32/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 StatusCa se Deferred: HQ File : 01/83/050/01106/AM08/ RLA File : 09/24/040/00388/AM07/ Lic.No/Date:0910031 402 05.09.2007 Defer Date: 05.02.20 08 norms for export product Cefpodoxime Proxetil under para 4.7 of HBP.

Division. 46

Case No.:31/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/83/050/01105/AM08/ RLA File : 09/24/040/00470/AM07/ Lic.No/Date:0910031 401 05.09.2007 Defer Date: 05.02.20 08 norms for export product Pivmecillinam Hydrochloride under para 4.7 of HBP. Division. 47

Case No.:35/27/83-

ALC1/2007 Party Name:SHREE GANESH CHEMICALS Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Deferred HQ File : 01/83/050/01109/AM08/ RLA File : 34/24/040/00089/AM08/ Lic.No/Date:3410019 570 05.09.2007 Defer Date: 19.02.20 08 norms for export product Di Ethyl Amino Ethyl Chloride Hydrochloride Committee decided to examine the case on file as to whether the export product falls under SCOMET list. Accordingly, case was deferred for four weeks. 48

Case No.:43/27/83-

ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01117/AM08/ RLA File : 34/24/040/00110/AM08/ Lic.No/Date:3410019 573 06.09.2007 Defer Date: 04.03.20 08 norms for export product Venlafaxine Hydrochloride Extended Release Pellets Stage 1 under para 4.7 of HBP. Committee decided to call for complete description of export product

alongwith copy of DML from firm. Accordingly, case was deferred for six weeks. 49

Case No.:68/27/83-

ALC1/2007 Party Name:AVIK PHARMACEUTICAL LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01142/AM08/ RLA File : 03/94/040/00531/AM08/ Lic.No/Date:0310442 331 10.09.2007 Defer Date: 04.03.20 08 norms for export product Ethisterone under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 50

Case No.:64/27/83-

ALC1/2007 Party Name:KARNATAKA CHEMSYN LTD Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Transferr ed HQ File : 01/83/050/01138/AM08/ RLA File : 07/24/040/00408/AM08/ Lic.No/Date:0710053 251 10.09.2007

norms for export product 5-Hydroxy Methyl 4-Methyl Imidazole 99.5% purity under para 4.7 of HBP. Committee observed that firm has given end use of export product stating that this product is an intermediate and is used in the manufacture of some high quality pigments. Accordingly, Committee decided to transfer case to DES-IV. 51

Case No.:72/27/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01146/AM08/ RLA File : 03/95/040/00570/AM08/ Lic.No/Date:0310442 436 11.09.2007 Defer Date: 19.02.20 08 norms for export product Sterile Ceftriaxone Sodium-Non Infringing under

para 4.7 of HBP.

Committee decided to examine the case on file as the application is based on non infringing process.

52

Case No.:10/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/82/050/00180/AM08/ RLA File : 03/94/040/00615/AM08/ Lic.No/Date:0310442 878 12.09.2007 Defer Date: 19.02.20 08 norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. Division. 53

Case No.:84/27/83-

ALC1/2007 Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Deferred HQ File : 01/83/050/01158/AM08/ RLA File : 05/24/040/00426/AM08/ Lic.No/Date:0510208 879 12.09.2007 Defer Date: 19.02.20 08 norms for export product (4R-Cis)-1,1-Dimethylethyl-6-Cyanomethyl-2,2- Dimethyl-1-3-Dioxane-4-Acetate (ATS-8) NLT 99% under para 4.7 of HBP. Division. 54

Case No.:98/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01172/AM08/ RLA File : 09/24/040/00258/AM08/ Lic.No/Date:0910031 511 14.09.2007 Defer Date: 05.02.20 08 norms for export product Tenofovir Disoproxil Fumerate under para 4.7 of HBP. Division. 55

Case No.:101/27/83-

ALC1/2007 Party Name:DOCTORSORGANIC CHEMICALS LTD Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred

HQ File : 01/83/050/01175/AM08/ RLA File : 26/24/040/00002/AM08/ Lic.No/Date:2610006 381 14.09.2007 Defer Date: 04.03.20 08 norms for export product Sertraline Hydrochloride Solid under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 56

Case No.:134/27/83-

ALC1/2007 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01208/AM08/ RLA File : 03/94/040/00607/AM08/ Lic.No/Date:0310443 695 19.09.2007 Defer Date: 04.03.20 08 norms for export product Fluticasone Propionate under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 57

Case No.:163/27/83-

ALC1/2007 Party Name:SRI KRISHNA DRUGS LIMITED., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Deferred HQ File : 01/83/050/01237/AM08/ RLA File : 09/24/040/00145/AM08/ Lic.No/Date:0910031 618 26.09.2007 Defer Date: 04.03.20 08 norms for export product Folic Acid under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 58

Case No.:173/27/83-

ALC1/2007 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/83/050/01247/AM08/ RLA File : 05/24/040/00486/AM08/ Lic.No/Date:0510209 640 27.09.2007

norms for export product Hyoscine-n-Butyl Bromide or Hyoscine Hydro

Bromide under para 4.7 of HBP. Committee in consultation with representative of Department of MSME present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Import items Qty. allowed per unit of export product Hyoscine-N-Butyl Bromide

or Hyoscine Hydro Bromide (ITC(HS)No.29392 900) 1kg. 1.Dubosia Leaves 85.00kg/kg
2.Methylene Chloride 68.55kg/kg 3.Methanol 26.34kg/kg Norms Committee. 59

Case No.:8/29/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/83/050/01273/AM08/ RLA File : 09/24/040/00251/AM08/ Lic.No/Date:0910031 700 03.10.2007 Defer Date: norms for export product Doxyfylline under para 4.7 of HBP. their U.O. No.35011/254/2006-PI-III dated 23.01.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm Export product Export Qty. Import items Qty. allowed per unit of export product Doxofylline (ITC(HS)No.29420 090) 1kg. 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

Norms Committee. 60

Case No.:39/29/83-

ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01304/AM08/ RLA File : 03/94/040/00643/AM08/ Lic.No/Date:0310445 399 08.10.2007 Defer Date: 19.02.20 08 norms for export product Aprepitant under para 4.7 of HBP. Division. 61

Case No.:84/29/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Deferred HQ File : 01/83/050/01349/AM08/ RLA File : 03/94/040/00712/AM08/ Lic.No/Date:0310446 240 12.10.2007 Defer Date: 19.02.20 08 norms for export product Gentadox Powder under para 4.7 of HBP. Division. 62

Case No.:14/30/83-

ALC1/2007 Party Name:KAIVAL CHEMICALS P LTD Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01383/AM08/ RLA File : 34/24/040/00157/AM08/ Lic.No/Date:3410019 869 18.10.2007 Defer Date 04.03.20 08: norms for export product L(-)Di-P-Toluoyl Tartaric Acid under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 63

Case No.:28/30/83-

ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred

HQ File : 01/83/050/01397/AM08/ RLA File : 09/24/040/00291/AM08/ Lic.No/Date:0910031 844 23.10.2007 Defer Date: 05.02.20 08 norms for export product {1’R,2’S,5’R}-Methyl-5S(Cytosine-1’-YL)-1-3- Oxathiolane-2R-Carboxylate/CME Compound under para 4.7 of HBP. Division. 64

Case No.:7/28/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Withdraw n HQ File : 01/82/050/00241/AM08/ RLA File : 03/94/040/00783/AM08/ Lic.No/Date:0310448 115 26.10.2007

norms for export product Toltrazuril Oral Solution2.5%/Cipcox 2.5% Solution under para 4.7 of HBP. Committee decided to withdraw case as same has already been approved in its 35/08 meeting held on 08.01.2008. 65

Case No.:4/28/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status: Case Deferred HQ File : 01/82/050/00238/AM08/ RLA File : 03/94/040/00792/AM08/ Lic.No/Date:0310448 519 31.10.2007 Defer Date 19.02.20 08: norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/ARVED TABLETS under para 4.7 of HBP. Division. 66

Case No.:9/28/82-

ALC4/2007 Party Name:VIVEK PHARMACHEM (INDIA) LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/82/050/00243/AM08/ RLA File : 13/24/040/00022/AM08/ Lic.No/Date:1310025 278 31.10.2007 Defer Date: 04.03.20 08

norms for export product MEROPENEM INJECTION USP 1GM. POTENCY 100% (+/-5%) under para 4.7 of HBP. Committee decided to call for (1) Actual Potency of import item, (2) Copy of Bill of Entry, (3) Test report from foreign supplier and (4) copy of relevant DML from firm. Accordingly, case was deferred for six weeks. 67

Case No.:10/28/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/82/050/00244/AM08/ RLA File : 13/24/040/00020/AM08/ Lic.No/Date:1310025 280 01.11.2007 Defer Date: 05.02.20 08 norms for export product Ascorbyl Palmitate Granules 95% under para 4.7 of HBP. Division. 68

Case No.:71/32/83-

ALC1/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/01493/AM08/ RLA File : 22/24/040/00049/AM08/ Lic.No/Date:2210007 216 02.11.2007

norms for export product Amoxycillin Trihydrate Through Enzymatic Route Pen G Route 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 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 the firm whichever is lower:- Export product Export Qty. Import items Qty. allowed per unit of export product

Amoxycillin Trihydrate enzymatic route 1kg.

1.Penicillin G Pot. 1st crystal 1.664 BOU/Kg 2.D(-) Para hydroxy phenyl glycine methyl ester 0.608kg/kg

(ITC(HS)No.29411 030) 3.Oxilasa enzyme 5.0gm/kg 4.Penicillin G Amidase enzyme 0.852kg/kg 5.Methanol 0.0215kg/kg 6.Butyl Acetate 0.122kg/kg 7.Boric acid 0.032kg/kg Norms Committee. 69

Case No.:74/32/83-

ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/83/050/01496/AM08/ RLA File : 09/24/040/00242/AM08/ Lic.No/Date:0910031 941 02.11.2007

norms for export product Menthyl-5S-Cytosine-1YL-1,3-Oxathiolane-2R Carboxalate (Lamivudine Intermediate Stage III) under para 4.7 of HBP. their U.O. No.35011/108/2007-PI-III dated 23.01.2008 decided to ratify Export product Export Qty. Import items Qty. allowed per unit of export product

Menthyl-5 S- Cytosine-1YL- 1,3- Oxathiolane-2R Carboxalate (Lamivudine intermediate State 3) (ITC(HS)No.29420 090) 1kg. 1)Menthol 0.87kg/kg
2)Glyoxalic acid 50% 0.90kg/kg

3)2,5 Dihydroxy-1,4 dithiane 0.37kg/kg 4)Triethylamine 0.67kg/kg 5.Cytosine 0.475kg/kg 6.Hexamethyl disilazane 0.75kg/kg 7.Dimethyl formamide 0.31kg/kg Norms Committee.

70

Case No.:75/32/83-

ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01497/AM08/ RLA File : 09/24/040/00253/AM08/ Lic.No/Date:0910031 942 02.11.2007 Defer Date: 19.02.20 08 norms for export product (S)-5-Chloro-1-(Cyclopropylethynyl)-2-Amino-1- (Trifluoromethyl) Benzenemethanol (Amino Carbinol) (Efavirenz Inter) Division. 71

Case No.:84/32/83-

ALC1/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/01506/AM08/ RLA File : 09/24/040/00340/AM08/ Lic.No/Date:0910031 993 05.11.2007

norms for export product Cefdinir under para 4.7 of HBP. U.O. No.35011/274/2006-PI-III dated 23.01.2008 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 Export Qty. Import items Qty. allowed per unit of export product Cefdinir (ITC(HS)No.29419 090) 1kg. 1)7-Phenylacetamideo-3- Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 2.44kg/kg
2)Ethyl-(Z)-2- Hydroxyimino-2-(2- Aminothiazole-4-YL) Acetone (EHATA) 1.896kg/kg 3)Methylene chloride 16.88kg/kg 4)Tetrahydrofuran 2.34kg/kg 5)Methanol 4.68kg/kg 6)Activated Carbon 0.100kg/kg

Norms Committee. 72

Case No.:100/32/83-

ALC1/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Deferred HQ File : 01/83/050/01522/AM08/ RLA File : 05/24/040/00476/AM08/ Lic.No/Date:0510211 700 06.11.2007 Defer Date: 05.02.20 08 norms for export product Pyrazolinone (Galaxy-1) under para 4.7 of HBP. Division. 73

Case No.:89/32/83-

ALC1/2007 Party Name:VITAL LABORATORIES PVT. LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01511/AM08/ RLA File : 03/95/040/00691/AM08/ Lic.No/Date:0310449 448 06.11.2007 Defer Date: 05.02.20 08 norms for export product Digoxin BP/EP/USP under para 4.7 of HBP. Division. 74

Case No.:24/33/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/01553/AM08/ RLA File : 09/24/040/00354/AM08/ Lic.No/Date:0910032 057 12.11.2007

norms for export product Mebeverine HCl under para 4.7 of HBP. The Committee in light of its earlier decision taken in its 14/08 meeting held on 07.08.2007 and in consultation with representative of PI Division present in meeting decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:-

Export product Export Qty. Import items Qty. allowed per unit of export product Mebeverine Hcl (ITC(HS)No.29420 090) 1kg.

1. 2-Chloromethyl Propionate 0.66kg/kg
2. Veratricf acid 0.56kg/kg
3. Methyl

Isobutyl ketone 0.51lit/kg 4. 1,4-dibromo Butane 0.84kg/kg Norms Committee. 75

Case No.:29/33/83-

ALC1/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/83/050/01558/AM08/ RLA File : 09/24/040/00341/AM08/ Lic.No/Date:0910032 076 14.11.2007

norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. Committee in light of its earlier decision taken in its 7/82 meeting held on 17.05.2006 vide case No.20/47/82 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Import items Qty. allowed per unit of export product

Cefpodoxim Proxetil (ITC(HS)No.29419 090) 1kg.

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) 0.36kg/kg 5. Methanol 1.51kg/kg 6. Methylene chloride 2.32kg/kg

7. Acetone 2.50kg/kg
8. Tetrahydrofuran 1.56kg/kg
9. Sodium Iodide 0.39kg/kg 10.Activated Carbon 0.100kg/kg Norms Committee. 76

Case No.:25/39/83-

ALC1/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/01604/AM08/ RLA File : 09/24/040/00346/AM08/ Lic.No/Date:0910032 139 23.11.2007

norms for export product 7-Amino 3-Vinyl Cephalosporonic Acid (7 AVNA) Committee in light of its earlier decision taken in its 28/82 meeting held on 13.11.2007 and 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 Export Qty. Import items Qty. allowed per unit of export product 7-Amino 3-Vinyl Cepholosparanic Acid (7 AVNA) (ITC(HS)No.29419 090) 1kg.

1. 7-Phenyl Acetamideo- 3-Chloromethyl Cephalosporanic

Acid para

Methoxy Benzyl Ester (GCLE)
2.672kg/kg 2. Acetone- 10.11kg/kg 3. Methylene Chloride 7.59kg/kg 4. Methanol 7.78kg/kg Norms Committee. 77

Case No.:24/39/83-

ALC1/2007 Party Name:INVENTIS DRUG DELIVERY SYSTEMS PVT LTD. Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : RLA File : Lic.No/Date:0910032

01/83/050/01603/AM08/ 09/24/040/00379/AM08/ 136 23.11.2007 norms for export product Diltiazem HCL Pellets 50% 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 Export Qty. Import items Qty. allowed per unit of export product Diltiazem

Hcl Pellets 50% (ITC(HS)No.29420 090) 1kg.

1. Diltiazem Hcl 0.505kg/kg
   2.Hydroxy Propyl Methyl Cellulose 0.094kg/kg Norms Committee. 78

Case No.:35/39/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Deferred HQ File : 01/83/050/01614/AM08/ RLA File : 09/24/040/00164/AM07/ Lic.No/Date:0910032 258 28.11.2007 Defer Date: 05.02.20 08 norms for export product Cephapirin Benzathine under para 4.7 of HBP. Division. 79

Case No.:57/39/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/83/050/01636/AM08/ RLA File : 09/24/040/00389/AM08/ Lic.No/Date:0910032 305 30.11.2007

norms for export product Stavudine under para 4.7 of HBP. U.O. No.35011/36/2007-PI-III dated 23.01.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export product Export Qty. Import items Qty. allowed per unit of export product Stavudine (ITC(HS)No.29420 000) 1kg.

1. Beta thymidine 2.36kg/kg
2. Pyridine 5.80kg/kg 3.Methane

Sulfonyl chloride 2.40kg/kg 4.Methanol 6.18kg/kg 5.N-Hexane 1.55kg/kg 6.Potassium Tert. Butoxide 1.08kg/kg 7.Tert. Butanol 0.82kg/kg 8.Acetone 5.59kg/kg 9.Iso Propyl Alcohol 4.20kg/kg Norms Committee. 80

Case No.:96/39/83-

ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/01675/AM08/ RLA File : 22/24/040/00055/AM08/ Lic.No/Date:2210007 283 04.12.2007

norms for export product Nitazoxanide under para 4.7 of HBP. their U.O. No.35011/206/2006-PI-III dated 23.01.2008 decided to ratify Export product Expo rt Qty. Import items Qty. allowed per unit of export product Nitazoxanide (ITC(HS)No.29415 000) 1kg.

1. 2-Acetyloxy benzoic acid (Asprin)
   0.916kg/kg
2. 2-amino-5-nitro thiazole 0.59kg/kg
3. Triethylamine 0.1288kg/kg
4. Methylene chloride 3.17kg/kg
5. N,N

Dimethyl formamide 0.069kg/kg

6. Acetone 2.00kg/kg
7. Thionyl chloride 0.92kg/kg Norms Committee. 81

Case No.:115/39/83-

ALC1/2007 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Approved HQ File : 01/83/050/01694/AM08/ RLA File : 09/24/040/00400/AM08/ Lic.No/Date:0910032 363 07.12.2007

norms for export product Cyclocytidine HCL under para 4.7 of HBP. Committee in light of its earlier decision taken in its 25/08 meeting held on 23.10.2007 vide Case No.B-349 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:- Export product Export Qty. Import items Qty. allowed per unit of export product Cyclocytidine Hcl (O,2-cyclocytidine Hcl) (ITC(HS)No.29420 029) 1kg.

1. Cytidine
   2.93kg/kg
2. Methanol 4.36kg/kg Norms Committee. 82

Case No.:138/39/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Deferred HQ File : 01/83/050/01717/AM08/ RLA File : 03/95/040/00892/AM08/ Lic.No/Date:0310453 332 10.12.2007 Defer Date: 19.04.20 07 norms for export product Sterile Ceftriaxone Sodium – Non Infringing under

para 4.7 of HBP.

Committee decided to examine case on file as application is based on non-infringing process. 83

Case No.:173/39/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase
Deferred HQ File : 01/83/050/01752/AM08/ RLA File : 03/94/040/00853/AM08/ Lic.No/Date:0310453 734 12.12.2007 Defer Date: 04.03.20 08 norms for export product Donepezil Hydrochloride under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 84

Case No.:163/39/83-

ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:38/82- ALC4/2007 22.01.2008 Status:C ase Approved HQ File : 01/83/050/01742/AM08/ RLA File : 03/94/040/00936/AM08/ Lic.No/Date:0310454 006 14.12.2007

norms for export product Amiodarone HCL under para 4.7 of HBP. Committee in the light of written comments forwarded by PI Division vide theirU.O.35011/102/ 2006-PI-III dated 18.04.2007 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Import items Qty. allowed per unit of export product Amiodarone Hcl (ITC(HS)No.29420 090) 1kg.

1. 2-Butyl-3-(3,5-Diiodo- 4-Hydroxybenzoyl) Benzofuran
   1.04kg/kg
2. Iso Propyl Alcohol 0.75kg/kg
3. Toluene 1.95kg/kg Norms Committee.