IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-10-04

DGFT Committee Minutes

Document text

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

Para 4.7 Decision

MEETING NUMBER : 22/82-ALC4/2007 MEETING DATE : 04.10.2007 1

Case No.:154/21/82-

ALC4/2007 Party Name:COLOUR-CHEM LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Transferr ed HQ File : 01/82/050/00200/AM05/ RLA File : 03/24/041/00214/AM04/ Lic.No/Date:03102611 63 26.03.2004

Decision : Committee considered this case as per agenda for ratification of Norms for the Export Product Methyl Aceto Acetate/Acetoacetic Methyl Ester under para 4.7 of HBP. Committee decided to transfer case to DES-IV as export product pertains to Chemical Sector. 2

Case No.:124/24/83-

ALC1/2007 Party Name:NESTOR PHARMACEUTICALS LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Closed HQ File : 01/83/050/00496/AM05/ RLA File : 05/24/040/00126/AM05/ Lic.No/Date:05101285 17 10.06.2004

Decision : The Committee considered this case as per agenda for ratification of Norms for the Export Product Ampicillin and Cloxacillin Capsules (From Pen G Route) under para 4.7 of HBP. Committee perused the written comments forwarded by PI Division vide their U.O. No.35011/131/2005-PI-III dated 04.10.2007 and decided to close the case since the description of export product does not match with the firm’s DML. RA concerned may take further necessary action including cancellation of Advance Authorisation under para 4.7 of HBP as per above decision of Norms Committee. 3

Case No.:242/24/83-

ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved

HQ File : 01/83/050/00494/AM06/ RLA File : 03/95/040/01015/AM06/ Lic.No/Date:03103576 73 01.12.2005

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

Export product: Artesunate-----------------------------1Kg. Import items: Artemisinin--------------------0.9259kg/kg

RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 4

Case No.:251/24/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00570/AM06/ RLA File : 05/24/040/00777/AM06/ Lic.No/Date:05101732 19 29.12.2005

Decision :Committee considered case as per agenda for ratification of norms for export product Ciprofloxacin Hydrochloride under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/85/2007-PI-III dated 19.09.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Ciprofloxacin Hydrochloride--------------------------------1Kg. Import items:

7-chloro-5-fluoro-1-cyclopropyl-1,4-dihydro-4- oxoquinoline-3-carboxylic acid (drug intermediate for Ciprofloxacin)-----------------1.106kg/kg
Piperazine Anhydrous----------------------------------------0.940kg/kg
Methanol-----------------------------------------------------1.00kg/kg
Activated carbon-------------------------------------------0.050kg/kg
Acetone------------------------------------------------------0.148kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 5

Case No.:253/24/83-

ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00600/AM06/ RLA File : 03/95/040/01148/AM06/ Lic.No/Date:03103631 42 13.01.2006

Decision : The Committee considered this case as per agenda for ratification of Norms for the Export Product ARTESUNATE under para 4.7 of HBP. The Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/182/2006-PI-III dated 04.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Artesunate-----------------------------1Kg. Import items: Artemisinin--------------------0.9259kg/kg

RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 6

Case No.:254/24/83-

ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00601/AM06/ RLA File : 03/95/040/01149/AM06/ Lic.No/Date:03103631 49 13.01.2006

Decision : The Committee considered this case as per agenda for ratification of Norms for the Export Product ARTESUNATE under para 4.7 of HBP. their U.O. No.35011/182/2006-PI-III dated 04.10.2007 decided to ratify norms lower. Export product: Artesunate-----------------------------1Kg.

Import items: Artemisinin--------------------0.9259kg/kg

RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 7

Case No.:255/24/83-

ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00612/AM06/ RLA File : 03/95/040/01182/AM06/ Lic.No/Date:03103637 03 18.01.2006

Case No.:259/24/83-

ALC1/2007 Party Name:R L FINE CHEM Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00696/AM06/ RLA File : 07/24/040/00947/AM06/ Lic.No/Date:07100434 31 02.03.2006

Decision :Committee considered case as per agenda for ratification of norms for export product Methane Sulfonate of 10:11, Dihydro-N,N Beta Trimethyl-5H-Dibenzo(B,F)Azepine-5 Propanamine under para 4.7 of HBP. Committee in light of its earlier decision taken in its 14/83 meeting held on 21.07.2004 vide case No.41/12/83 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower.

Export product: Methane Sulfonate of 10,11-dihydro-N, N Beta- Trimethyl-5H-dibenz(b,f) azepine-5-Propanamine------------------1Kg. Import items:

1 Bromo 3 Chloro 2 Methyl Propane--------------------------0.72kg/kg
Iminodibenzyl-------------------------------------------------------0.74kg/kg 9

Case No.:265/24/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00756/AM06/ RLA File : 09/24/040/00467/AM06/ Lic.No/Date:09100257 87 29.03.2006

Decision : The Committee considered the case as per agenda for ratification of norms for the export product 2,3-Di Chloro Benzoyl Cyanide under para 4.7 of HBP. their U.O. No.35011/66/2007-PI-III dated06.08.2007 decided to ratify the norms lower. Export product: 2,3 Dichloro benzoyl cyanide-------------------1Kg. Import items:

2,3 dichloro benzoyl chloride-------------1.50kg/kg
Cuprous Cyanide--------------------------0.70kg/kg
Hexane-------------------------------------1.00kg/kg
Ortho dichloro benzene-------------------Not allowed 10 Case No.:267/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00758/AM06/ RLA File : 05/24/040/01084/AM06/ Lic.No/Date:05101798 98 31.03.2006

Decision :Committee considered case as per agenda for ratification of norm for export product Voline Gel 30gm under para 4.7 of HBP.

their U.O. No.35011/136/2005-PI-III dated 04.10.2007 decided to ratify the norms lower. Export product: Volini Gel 30 gm. Import items: Racementhol----------------------1.575gm/30gm tube 11

Case No.:269/24/83-

ALC1/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00006/AM07/ RLA File : 09/24/040/00537/AM06/ Lic.No/Date:09100258 36 03.04.2006

Decision :Committee considered case as per agenda for ratification of norms for export product Olanzapine under para 4.7 of HBP. their U.O. No.35011/146/2005-PI-III dated 04.10.2007 decided to ratify the norms lower. Export product: Olanzapine--------------------------------1kg. Import items:

Dimethyl Formamide---------2.36kg/kg
2-Fluoro Nirobenzene--------2.04kg/kg
Tetrahydrofuran---------------5.68kg/kg
Methylene chloride------------9.41kg/kg
Dimethyl Sulphoxide-----------1.39kg/kg
Sodium Hydride-----------------1.095kg/kg 12 Case No.:1/31/80- ALC2/2006 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Transferr

CHEM ed HQ File : 01/80/050/00551/AM07/ RLA File : 05/24/040/00424/AM07/ Lic.No/Date:05101890 48 23.08.2006

Decision :Committee considered case as per agenda for ratification of norms for export product 2,3,5 Trichloropyridine under para 4.7 of HBP. Committee decided to transfer case to DES-IV as export product pertains to Chemical Sector. 13

Case No.:29/36/83-

ALC1/2006 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00841/AM07/ RLA File : 03/95/040/00897/AM07/ Lic.No/Date:03104061 00 31.10.2006

Decision : Committee considered case as per agenda for ratification of norms for export product Epiderm Lotion 30ml under para 4.7 of HBP. their U.O. No.35011/86/2006-PI-III dated 25.09.2007 decided to ratify whichever is lower. Export product: Epiderm Lotion 30ml Import item: Betamethasone Dipropionate--------------------19.4829mg/30ml pack 14 Case No.:4/47/87- ALC1/2006 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00827/AM07/ RLA File : 09/24/040/00359/AM07/ Lic.No/Date:09100286 61 18.12.2006 Defer Date: 30.10.2007 norms for export product Lopinavir under para 4.7 of HBP. Committee observed that information called for form firm has been received and is under examination in PI Division. Committee, therefore,

decided to defer case for four weeks. 15

Case No.:1/17/83-

ALC1/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/01047/AM07/ RLA File : 09/24/040/00361/AM07/ Lic.No/Date:09100287 37 21.12.2006

norms for export product Levetiracetam under para 4.7 of HBP. their U.O. No.35011/86/2007-PI-III dated 25.09.2007 decided to ratify the norms lower. Export product: Levetiracetan Powder-----------------------------1kg. Import items:

(S)-2-Amino Butyric Acid------------------------2.29kg/kg
4-Chloro Butyryl Chloride-----------------------1.88kg/kg
Acetonitrile----------------------------------------7.96kg/kg
Methylene Chloride-------------------------------5.37kg/kg
Tetrahydrofuran-----------------------------------4.23kg/kg 16 Case No.:34/44/82- ALC1/2006 Party Name:MEGA FINE PHARMA PVT.LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/82/050/01593/AM07/ RLA File : 03/95/040/01238/AM07/ Lic.No/Date:03104151 64 09.01.2007

norms for export product 3-Methyl Thiophene-2-Aldehyde under para 4.7 of HBP. their U.O. No.35011/54/2007-PI-III dated 28.06.2007 decided to ratify the norms lower. Export product: 3-Methyl Thiophene-2-Aldehyde Liquid--------------1kg.

Import items:

3-Methyl Thiophene----------------------------0.917kg/kg
Dimethyl Formadide----------------------------0.67kg/kg
Toluene--------------------------------------------0.18kg/kg 17 Case No.:15/48/82- ALC1/2006 Party Name:LUPIN LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/82/050/01626/AM07/ RLA File : 03/95/040/01257/AM07/ Lic.No/Date:03104156 01 12.01.2007

norms for export product Cefadroxil under para 4.7 of HBP. The Committee in light of Report forwarded by PI Division vide their U.O.35011/165/2006/PI-III dated 30.07.2007 decided to ratify the norms as per details below or as applied for by the firm whichever is lower. Export Product: Cefadroxil Monohydrate from Pen G Route-----------1Kg. Import items: Penicillin G Potassium 1st Crystal--------------2.34BOU/Kg Pyridine Hydrobromide--------------------------0.320kg/kg OR Hydrobromic acid 48%--------------------------0.375kg/kg Hydrogen Peroxide 60%------------------------0.363kg/kg Acetic Acid-----------------------------------------0.933kg/kg Trimethyl chloro silane--------------------------2.7027kg/kg OR 5(a). Bis trimethyl silyl urea--------------------------1.543kg/kg 5(b). Hexamethyl disilazane--------------------------0.3284kg/kg Trimethyl chloro silane-----------------------------------0.2180kg/kg D(-)para hydroxy Phenyl glycine------------------------0.959kg/kg Methyl/etyl potassium dane salt OR 7(a). D(-) para hydroxyl Phenyl glycine base-----0.5402kg/kg 7(b). Methyl Aceto acetate---------------------------0.4113kg/kg 7©. Methanol------------------------------------------0.3370kg/kg

Dimethyl formamide--------------------------------------2.051kg/kg Toluene-------------------------------------------------------0.583kg/kg Acetone-------------------------------------------------------1.1498kg/kg Methylene chloride----------------------------------------0.407kg/kg Potassium carbonate--------------------------------------0.2418kg/kg Activated Carbon-------------------------------------------0.0839kg/kg Ethyl Chloro formate--------------------------------------0.357kg/kg RLA concerned may take further necessary action as per the above decision of Norms Committee. 18 Case No.:562/24/87- ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/87/050/00889/AM07/ RLA File : 09/24/040/00155/AM07/ Lic.No/Date:09100290 10 12.01.2007

norms for export product Atorvastatin Diprotected under para 4.7 of HBP. their U.O. No.35011/81/2007-PI-III dated 19.09.2007 decided to ratify whichever is lower; Export product: Atorvastatin Diprotected-----------------------------------1Kg. Import items:

Acetone-----------------------------------------------1.00kg/kg
2,2Dimethoxy Propane----------------------------0.444kg/kg
Di Iso Propylamine----------------------------------0.79kg/kg
Ethyl ®-4-Cyano-3-Hydroxy Buttanoate--------1.079kg/kg
Iso Propyl Alcohol-----------------------------------3.28kg/kg
Methanol----------------------------------------------4.00kg/kg
Methoxy Diethyl Borane (50%)(Cylinder)-------0.737kg/kg
Methyl 4-methyl 3-oxopentanoate (Methyl Isobutrylacetate)---------------------------1.105kg/kg
Methylene chloride----------------------------------Not shown in process details

N-Butyl Lithium in Hexanes (as 100%)------------1.759kg/kg 11. Potassium carbonate--------------------------------Not shown in process details 12. Sodium Borohydride---------------------------------0.118kg/kg 13. Tetra Hydrofuran-------------------------------------6.09kg/kg

Case No.:2/7/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/01134/AM07/ RLA File : 05/24/040/00819/AM07/ Lic.No/Date:05101979 30 16.01.2007

norms for export product Ciprofloxacin tablets under para 4.7 of HBP. their U.O. No.35011/85/2007-PI-III dated 19.09.2007 decided to ratify whichever is lower. Export product: Ciprofloxacin tablets 250mg-----------9,80,40,000 Nos. Ciprofloxacin tablets 500mg-----------4,90,20,000 Nos. Ciprofloxacin tablets 750mg-----------3,26,80,000 Nos. Import items:

7-chloro-5-fluoro-1-cyclopropyl-1, 4-dihydro-4-oxaquinoline-3-carboxylic acid (drug intermediate for Ciprofloxacin)------------------27,650kgs
Piperazine Anhydrous--------------------------------------23,500kgs
Methanol------------------------------------------------------25,000kgs
Activated Carbon---------------------------------------------1,250kgs
Acetone----------------------------------------------------3,700kgs 20 Case No.:426/24/83- ALC1/2007 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01206/AM07/ RLA File : 03/95/040/00502/AM07/ Lic.No/Date:03104169 18 23.01.2007 Defer Date: 30.10.2007 norms for export product Cifprozil under para 4.7 of HBP. Committee decided to forward a copy application to PI Division for their

comments. Accordingly, Committee decided to defer case for four weeks. 21

Case No.:427/24/83-

ALC1/2007 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01207/AM07/ RLA File : 03/95/040/00934/AM07/ Lic.No/Date:03104169 45 23.01.2007 Defer Date: 30.10.2007 norms for export product Ethyl-1,4 Dihydro-7-Methyl-4-one-1,8- Napthyridine-3-Carboxylate under para 4.7 of HBP. Committee decided to forward a copy application to PI Division for their comments. Accordingly, Committee decided to defer case for four weeks. 22 Case No.:6/50/87- ALC1/2006 Party Name:ALKEM LABORATORIES LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/87/050/00967/AM07/ RLA File : 03/94/040/01200/AM07/ Lic.No/Date:03104187 37 07.02.2007

norms for export product Amoxycillin and Clavulanate Potassium Tablets 375mg, 625mg and 1000mg under para 4.7 of HBP. their U.O. No.35011/274/2006-PI-III dated 25.09.2007 decided to ratify the norms lower. Export product: Amoxycillin and Clavulanate Potassium Tablets 375mg------13,00,000 Nos. Import items:

Amoxicillin Trihydrate--------------------------------------377.91kg
Clavulanate Potassium with Avicel (1:1)----------------198.25kg Export product: Amoxycillin and Clavulanate Potassium Tablets 625mg------20,00,000 Nos. Import items:
Amoxicillin Trihydrate--------------------------------------1162.80kg
Clavulanate Potassium with Avicel (1:1)----------------305.00kg Export product:

Amoxycillin and Clavulanate Potassium Tablets 1000mg----66,00,000Nos. Import items:

Amoxicillin Trihydrate--------------------------------------671.52kg
Clavulanate Potassium with Avicel (1:1)---------------100.65kg

Case No.:724/24/83-

ALC1/2007 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00610/AM08/ RLA File : 03/94/040/01062/AM07/ Lic.No/Date:03104189 88 09.02.2007

norms for export product Niclosamide Piperazine Salt under para 4.7 of HBP. their U.O. No.35011/122/2006-PI-III dated 04.10.2007 decided to ratify whichever is lower. Export product: Niclosamide Piperazine Salt---------------------------------1kg. Import items:

Salicylic acid------------------------------------------0.65kg/kg
Triethylamine----------------------------------------0.26kg/kg
Piperazine Anhydrous------------------------------0.13kg/kg
Thionyl chloride-------------------------------------0.20kg/kg 24 Case No.:435/24/83- ALC1/2007 Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01234/AM07/ RLA File : 09/24/040/00430/AM07/ Lic.No/Date:09100293 03 12.02.2007 Defer Date: 30.10.2007 norms for export product 1,1-Cyclohexane Diacetic Acid Anhydride 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. 25

Case No.:436/24/83-

ALC1/2007 Party Name:RANTUS PHARMA PVT LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/01235/AM07/ RLA File : 09/24/040/00401/AM07/ Lic.No/Date:09100293 04 12.02.2007

norms for export product Tramadol Crude under para 4.7 of HBP. their U.O. No.35011/96/2007-PI-III dated 26.09.2007 decided to ratify whichever is lower. Export product: Tramadol Crude Purity NLT 98%-------------------------1Kg. Import items:

Cyclohexanon-------------------------------------1.42kg/kg
Paraformaldehyde-------------------------------0.33kg/kg
Dimethylamine hcl-------------------------------1.136kg/kg
Metabromo Anisole------------------------------1.66kg/kg
Isopropyl alcohol----------------------------------1.425kg/kg
Tetrahydrofuran-----------------------------------1.818kg/kg 26 Case No.:651/24/87- ALC1/2007 PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/87/050/00986/AM07/ RLA File : 09/24/040/00302/AM07/ Lic.No/Date:09100292 99 12.02.2007

norms for export product Stavudine under para 4.7 of HBP. whichever is lower.

Export product: Stavudine-----------------------------------------1Kg. Import items:

Acetic Acid-------------------------------1.11kg/kg
Acetone-----------------------------------3.63kg/kg
Beta Thymidine--------------------------2.36kg/kg
Carbon enoanticromos-----------------0.100kg/kg
Isopropyl alcohol------------------------11.64kg/kg
Methane sulfonyl chloride------------2.40kg/kg
Methanol----------------------------------2.22kg/kg
N-Methyl pyrrolidine----------------------1.45kg/kg
Pyridine---------------------------------------5.80kg/kg 27

Case No.:654/24/87-

ALC1/2007 PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/87/050/00987/AM07/ RLA File : 09/24/040/00451/AM07/ Lic.No/Date:09100293 00 12.02.2007 Defer Date: 30.10.2007 norms for export product Ampicillin Sodium Sterile under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in their Department and he sought deferment for four weeks. Committee, accordingly, decided to defer case for four weeks. 28 Case No.:673/24/87- ALC1/2007 PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/87/050/01000/AM07/ RLA File : 09/24/040/00355/AM07/ Lic.No/Date:09100293 22 13.02.2007

norms for export product Quetiapine Fumerate under para 4.7 of HBP. whichever is lower.

Export product: Quetiapine Fumerate---------------------------------------1Kg. Import items:

2-(2-chloromethoxy)ethanol---------------------0.42kg/kg
Carbon Enoanticromos (Activated Carbon)---0.100kg/kg
Dibenzo(b,f)(1,4)Thiazepine-11-(10H)-one----0.93kg/kg
N-Methyl 1-2 Pyrrolidone--------------------------1.171kg/kg
Piperazine Anhydrous-------------------------------0.74kg/kg
Triethylamine-----------------------------------------0.250kg/kg 29

Case No.:8/2/83-

ALC1/2007 Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/01256/AM07/ RLA File : 34/24/040/00259/AM07/ Lic.No/Date:34100181 08 19.02.2007 Defer Date: 30.10.2007 norms for export product 5-Bromo Phthalide under para 4.7 of HBP. for four weeks. 30 Case No.:743/24/87- ALC1/2007 PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/87/050/01082/AM07/ RLA File : 09/24/040/00510/AM07/ Lic.No/Date:09100295 51 06.03.2007

norms for export product Nevirapine (from DMF Route) under para 4.7 of HBP. whichever is lower.

Export product: Nevirapine-----------------------------------------------------1Kg. Import items:

2-chloro Nicotinic Acid----------------------------1.13kg/kg
Cyclo Propylamine----------------------------------1.20kg/kg
Malono Nitrile----------------------------------------1.088kg/kg
Acetone-------------------------------------------------2.31kg/kg
Pyridine-------------------------------------------------0.566kg/kg
Diglyme-------------------------------------------------2.16kg/kg
Methylene chloride----------------------------------1.30kg/kg
Methanol-----------------------------------------------8.43kg/kg
Activated Carbon-------------------------------------0.100kg/kg 31

Case No.:7/2/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/01804/AM07/ RLA File : 03/94/040/01443/AM07/ Lic.No/Date:03104229 72 13.03.2007 Defer Date: 30.10.2007 norms for export product Triomune 30/ Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. for four weeks. 32 Case No.:4/12/82- ALC4/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/01861/AM07/ RLA File : 09/24/040/00500/AM07/ Lic.No/Date:09100297 49 23.03.2007 Defer Date: 30.10.2007 norms for export product Fluoro Lactone under para 4.7 of HBP. their U.O. No.35011/87/2007-PI-III dated 03.10.2007 decided to call for following information from firm.

End use of the export product.
Complete chemical description of export and import items.
The structure of the export product in step V appears to be incorrect. Complete and correct chemistry may be furnished. Accordingly case was deferred for four weeks. 33 Case No.:785/24/87- ALC1/2007 PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/87/050/01135/AM07/ RLA File : 09/24/040/00522/AM07/ Lic.No/Date:09100297 46 23.03.2007

norms for export product Citalopram Hydrobromide (From DMF Route) under para 4.7 of HBP. whichever is lower. Export product: Citalopram Hydrobromide---------------------------------1Kg. Import items:

5-Bromo Phthalide---------------------------------2.37kg/kg
1-Bromo-4-Fluoro Benzene-----------------------2.92kg/kg
Acetic Acid--------------------------------------------10.88kg/kg
Acetone------------------------------------------------10.00kg/kg
Activated Carbon------------------------------------0.057kg/kg
Hydrobromic Acid-----------------------------------0.527kg/kg
Iodine---------------------------------------------------0.0119kg/kg
Methylene chloride----------------------------------10.00kg/kg
Dimethyl formamide--------------------------------2.74kg/kg

Tetrahydrofuran--------------------------------------11.67kg/kg 11. Ethylene diamine--------------------------------------9.80kg/kg 12. Cyclohexane---------------------------------------------1.20kg/kg 13. Potassium Permaganate------------------------------8.36kg/kg 14. N,N-Dimethyl-3-chloro Propylamine Hcl----------2.35kg/kg Committee also in light of above written comments of PI Division

decided to revise the quantities of inputs in the existing SION at Sl.No.A- 3119 as per details below. Import item Existing SION A-3119
Revised quantity 5-Bromo Phthalide------------------------------4.19kg/kg------------------- 2.37kg/kg 1-Bromo-4-Fluoro Benzene-------------------4.31kg/kg------------------- 2.92kg/kg 3-Dimethyl amino Propyl chloride Hcl------2.35kg/kg------------------- 2.35kg/kg Tetrahydrofuran---------------------------------25.63kg/kg------------------ 25.63kg/kg Sulfolane-------------------------------------------1.98kg/kg-------------------- 1.98kg/kg 34

Case No.:786/24/87-

ALC1/2007 PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/87/050/01136/AM07/ RLA File : 09/24/040/00533/AM07/ Lic.No/Date:09100297 47 23.03.2007

norms for export product Mica Ester (Mica Thioester) under para 4.7 of HBP. whichever is lower. Export product: Mica Ester (Mica Thioester)--------------------------------1Kg. Import items:

Mica Acid---------------------------------------------0.83kg/kg
Methanol---------------------------------------------1.94kg/kg
Triethylamine----------------------------------------0.322kg/kg
Triphenyl Phosphine--------------------------------0.911kg/kg
Methylene chloride---------------------------------2.00kg/kg 35 Case No.:474/24/83- Party Name:SHILPA Meet No/Date:22/82- Status:Ca

ALC1/2007 MEDICARE LTD., ALC4/2007 04.10.2007 se Deferred HQ File : 01/83/050/01382/AM07/ RLA File : 07/24/040/00879/AM07/ Lic.No/Date:07100509 72 29.03.2007 Defer Date: 30.10.2007 norms for export product N-[B-D-Ribofuranosyl]-5-Hydroxyimidazole-4- Carboxamide Technical Grade under para 4.7 of HBP. that case is under examination in their Department and he sought for four weeks. 36 Case No.:493/24/83- ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00048/AM08/ RLA File : 34/24/040/00001/AM08/ Lic.No/Date:34100184 93 05.04.2007

norms for export product Leflunomide under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/82/207-PI-III dated 25.9.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Leflunomide-----------------------------------1Kg. Import items:

Ethyl aceo Acetae--------------------1.84kg/kg
4-Trifluoro Methyl aniline----------1.05kg/kg
Acetone---------------------------------0.975kg/kg
Activated charcoal--------------------0.0368kg/kg
Chloroform-----------------------------1.03kg/kg
Hydroxylamine hcl--------------------0.82kg/kg
Isopropanol------------------------------1.2kg/kg
Methylene chloride--------------------1.2kg/kg
Triethylamine---------------------------1.31kg/kg

Toluene-----------------------------------1.kg/kg 11. Triethyl Ortho formate----------------2.09kg/kg 12. Methanol---------------------------------2.50kg/kg

RA concerned may take further necessary action as per above decision of Norms Committee. 37

Case No.:508/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00084/AM08/ RLA File : 09/24/040/00541/AM07/ Lic.No/Date:09100299 35 10.04.2007 Defer Date: 30.10.2007 norms for export product 5-Cyano Phthalide under para 4.7 of HBP. for four weeks. 38 Case No.:522/24/83- ALC1/2007 PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00117/AM08/ RLA File : 09/24/040/00535/AM07/ Lic.No/Date:09100300 05 17.04.2007

norms for export product Paroxetine Hydrochloride Hemihydrate under para 4.7 of HBP. whichever is lower. Export product: Paroxetine Hcl. Hemihydrate-------------------------------1Kg. Import items:

Paroxetine Carbinol {(-) Carboninol)}------------1.33kg/kg
4-Dimethyl Amino Pyridine------------------------0.02kg/kg
Acetone-------------------------------------------------0.398kg/kg
Anhydrous Potassium Carbonate-----------------1.91kg/kg
Carbon Enoanticromos (Activated Carbon)-----0.100kg/kg
Methane sulphonyl chloride-----------------------0.754kg/kg
Methanol-----------------------------------------------0.0475kg/kg
Methyl Isobutyl Ketone------------------------------1.06kg/kg
Methylene chloride-----------------------------------3.28kg/kg

N,N-Di Isopropylethylamine-------------------------0.0907kg/kg 11. Sesamol (3,4-Methylenedioxyphenol)-------------0.55kg/kg 12. Toluene---------------------------------------------------7.84kg/kg 13. Triethylamine--------------------------------------------0.786kg/kg 39

Case No.:523/24/83-

ALC1/2007 Party Name:R L FINE CHEM Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00124/AM08/ RLA File : 07/24/040/00016/AM08/ Lic.No/Date:07100512 74 17.04.2007

norms for export product Nortriptyline Hcl/BP/USP under para 4.7 of HBP. their U.O. No.35011/49/2006-PI-III dated 4.10.2007 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: Nortriptyline hcl BP/USP---------------------------1Kg. Import items:

1-Bromo-3-Chloro Propane--------------0.96kg/kg
Tetrahydrofuran----------------------------0.71kg/kg
Ethyl chloro formate-----------------------0.46kg/kg 40 Case No.:528/24/83- ALC1/2007 PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00141/AM08/ RLA File : 09/24/040/00001/AM08/ Lic.No/Date:09100300 47 18.04.2007

norms for export product Abacavir Sulfate (From DMF Route) under para 4.7 of HBP.

whichever is lower. Export product: Abacavir Sulfate---------------------------------------1Kg. Import items:

2,5 Diamino-4,6-Dihydroxy Pyrmidine Hcl (DADHP)---2.10kg/kg
Vincelactam [+,-)-2 Azabicyclo (2,2,1)- Hepta-5-EN-3-One) (on 100% basis)----------------------2.50kg/kg
Activated Carbon----------------------------------------------0.20kg/kg
Chloroform------------------------------------------------------1.14kg/kg
Cyclopropylamine----------------------------------------------0.19kg/kg
D-(-)Tartaric Acid-----------------------------------------------1.45kg/kg
Dimethyl Formamide------------------------------------------2.69kg/kg
Isopropyl Alcohol-----------------------------------------------0.98kg/kg
Methanol---------------------------------------------------------6.83kg/kg

Methylene dichloride------------------------------------------4.15kg/kg 11. N-Butanol----------------------------------------------------------1.90kg/kg 12. Sodium Borohydride--------------------------------------------0.946kg/kg 41

Case No.:530/24/83-

ALC1/2007 Party Name:ENVEE DRUGS PVT LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00143/AM08/ RLA File : 34/24/040/00296/AM07/ Lic.No/Date:34100186 01 18.04.2007 Defer Date: 30.10.2007 norms for export product Betamethasone Valerate BP/USP under para 4.7 of HBP. for four weeks. 42 Case No.:543/24/83- ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00169/AM08/ RLA File : 03/94/040/00046/AM08/ Lic.No/Date:03104274 26 20.04.2007 Defer Date: 30.10.2007

norms for export product Diclofenac Sodium under para 4.7 of HBP. Committee observed that SION for export product had been delected and Central Excise Data has been called for from firm and Pharmexcil, but the same has not been received. Committee, therefore, decided to await data and to defer case for four weeks. 43

Case No.:544/24/83-

ALC1/2007 Party Name:R L FINE CHEM Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00176/AM08/ RLA File : 07/24/040/00018/AM08/ Lic.No/Date:07100513 69 23.04.2007 : norms for export product Oxo-6,11-Dihydro Dibenzo (B-E) Thiepine under

para 4.7 of HBP.

Committee in light of its earlier decision taken in its 30/83 meeting held on 24.11.2004 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: Oxo-6,11-Dihydro Dibenzo (B-E) Thiepine-------------1Kg. Import item: Thiophenol---------------------------------------------------0.97kg/kg 44 Case No.:8/12/83- ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00205/AM08/ RLA File : 22/24/040/00005/AM08/ Lic.No/Date:22100066 83 26.04.2007 Defer Date: 30.10.2007 norms for export product Clopidogrel Hydrogen Sulphate under para 4.7 of HBP.

for four weeks. 45

Case No.:27/19/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00232/AM08/ RLA File : 09/24/040/00024/AM08/ Lic.No/Date:09100301 58 03.05.2007

norms for export product Phenzopyridine Hcl under para 4.7 of HBP. their U.O. No.35011/57/2006-PI-III dated 04.10.2007 decided to ratify whichever is lower. Export product: Phenazopyridine Hcl--------------------------------------1Kg. Import items:

2,6-Diamino Pyridine----------------------------0.76kg/kg
Aniline----------------------------------------------0.62kg/kg
Sodium Nitrate-----------------------------------0.74kg/kg
Sodium Acetate-----------------------------------1.81kg/kg
Toluene---------------------------------------------1.00kg/kg
Methanol-------------------------------------------2.kg/kg
Activated Carbon----------------------------------0.05kg/kg 46 Case No.:568/24/83- ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00244/AM08/ RLA File : 34/24/040/00022/AM08/ Lic.No/Date:34100187 12 03.05.2007

norms for export product Venlafaxine Hcl under para 4.7 of HBP. their U.O. No.35011/82/2007-PI-III dated 25.09.2007 decided to ratify whichever is lower.

Export product: Venlafaxine Hcl--------------------------------1Kg. Import items:

4-Methoxy Benzyl Cynide----------1.228kg/kg
Methanol------------------------------4.65kg/kg
Toluene---------------------------------0.50kg/kg
Platinum Metal-----------------------1.00gm/kg
Ethyl Acetate--------------------------6.86kg/kg
IPA---------------------------------------4.48kg/kg
Activated charcoal--------------------0.018kg/kg 47

Case No.:643/24/83-

ALC1/2007 Party Name:ALLIANCE LABORATORIES PVT.LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00424/AM08/ RLA File : 03/94/040/00160/AM08/ Lic.No/Date:03104303 99 23.05.2007 Defer Date: 30.10.2007 norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee observed that the firm has been requested to furnish certain technical information, but the same have not been received. Committee, therefore, decided to await reply of the firm and to defer case for four weeks. 48

Case No.:627/24/83-

ALC1/2007 Party Name:SIRIS IMPEX, Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00396/AM08/ RLA File : 09/24/040/00562/AM07/ Lic.No/Date:09100303 42 25.05.2007 Defer Date: 30.10.2007 norms for export product Griffonia Simplicifolia Dry Extract 95% under para 4.7 of HBP. Committee decided to await comments from Department of Ayush. Case was accordingly deferred for four weeks. 49 Case No.:629/24/83- ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved

HQ File : 01/83/050/00398/AM08/ RLA File : 09/24/040/00041/AM08/ Lic.No/Date:09100303 47 25.05.2007

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

R-2-Hydroxy-4-Phenyl Butyric Acid ethylester------0.9091kg/kg
4-Nitrobenzene Sulfonyl Chloride---------------------1.00kg/kg
N,N-Carbonyldimidazole---------------------------------0.45kg/kg
S-3-Amino2,3,4,5 Tetrahydro-2-oxo-1H- benzapepine-1-acetic acid ter. Butyl ester--------------0.8873kg/kg
Sodium Borohydride----------------------------------------0.32kg/kg
Methylene chloride----------------------------------------17.54kg/kg 50

Case No.:645/24/83-

ALC1/2007 Party Name:AYURSIDDHA INC. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00438/AM08/ RLA File : 05/24/040/00105/AM08/ Lic.No/Date:05102042 54 30.05.2007 Defer Date: 30.10.2007 norms for export product Blockbuster All Clear Capsules under para 4.7 of HBP. Committtee decided to forward a copy of application to Department of Ayush for their comments. Accordingly, case was deferred for four weeks. 51 Case No.:39/9/82- ALC4/2007 Party Name:WOCKHARDT LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/82/050/00065/AM08/ RLA File : 03/95/040/00157/AM08/ Lic.No/Date:03104314 90 04.06.2007

norms for export product Flu Strength Hot Lemon Powders 5gm Sachet under para 4.7 of HBP. their U.O. No.35011/84/2007-PI-III dated 19.09.2007 decided to ratify whichever is lower. Export product: Flu Strength Hot Lemon Powder in 5gm. Sachet (each 5gm. Sachet contain Paracetamol Ph. EUR) Import item: Paracetamol PH. EUR----------------------------------1.01gm/5gm Sachet 52 Case No.:660/24/83- ALC1/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00489/AM08/ RLA File : 09/24/040/00077/AM08/ Lic.No/Date:09100304 83 08.06.2007

norms for export product Valacyclovir Hydrochloride/Monohydrate under

para 4.7 of HBP.

whichever is lower. Export product: Valacyclovir Hcl/Monohydrate-----------------------------------1kg Impor items:

L-Valine----------------------------------------------------1.06kg/kg
Di-tert butyl dicarbonate-------------------------------2.26kg/kg
Methylene dichloride----------------------------------4.00kg/kg
2-Amino-1,9-dihydro-9-{(2-Hydroxy ethoxy) Methyl}6H-purin-6-one--------------------------------0.78kg/kg
N,N-Dicyclohexyl carbodiimide-----------------------1.47kg/kg
4-Dimethylamino pyridine-----------------------------0.028kg/kg
Dimethylformamide-------------------------------------3.21kg/kg 53

Case No.:666/24/83-

ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00498/AM08/ RLA File : 09/24/040/00085/AM08/ Lic.No/Date:09100305 05 11.06.2007

norms for export product Didanosine under para 4.7 of HBP. whichever is lower. Export product: Didanosine---------------------------------------------1kg Impor items:

2,3-Dideoxy Inosine-------------------------1.10kg/kg
Acetonitrile-------------------------------2.50kg/kg 54 Case No.:667/24/83- ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00499/AM08/ RLA File : 09/24/040/00084/AM08/ Lic.No/Date:09100305 06 11.06.2007

norms for export product Cilostazol under para 4.7 of HBP. whichever is lower. Export product:

Cilostazol-------------------------------------------------------------1kg Impor items:

4-Amino Phenol-------------------------------------------0.59kg/kg
Dimethyl Sulfoxide---------------------------------------1.90kg/kg
5-(4-chlorobutyl)-1-Cyclohexyl-1 H-tetrazole--------0.88kg/kg
Dimethyl Formamide-------------------------------------2.16kg/kg

Case No.:668/24/83-

ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00500/AM08/ RLA File : 09/24/040/00083/AM08/ Lic.No/Date:09100305 08 11.06.2007

norms for export product Nelfinavir Mesylate under para 4.7 of HBP. whichever is lower. Export product: Nelfinavir Mesylate---------------------------------------------1kg Impor items:

2S,3R-N-Benzyloxy Carbonyl-3-Amino-1-Chloro Phenyl Sulfonyl Butan-2ol-------------------------------1.64kg/kg
(3S,4aS,8aS)-N-Terbutyl Decahydro Isoquinoline Carboxamide------------------------------------------------1.07kg/kg
3-Acetoxy-2-Methyl Benzoic Acid-----------------------0.448kg/kg
Tetrahydrofuran---------------------------------------------2.45kg/kg
Methylene Chloride-----------------------------------------3.00kg/kg 56 Case No.:669/24/83- ALC1/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00501/AM08/ RLA File : 09/24/040/00081/AM08/ Lic.No/Date:09100305 09

11.06.2007 norms for export product Lamivudine under para 4.7 of HBP. whichever is lower. Export product: Lamivudine---------------------------------------------1kg Import items:

Glyoxylic acid 50%---------------------------1.80kg/kg
1,4-dithiane-2,5-dihydroxy-----------------0.739kg/kg
Cytosine----------------------------------------0.955kg/kg
Hexamethyl disilazane-----------------------1.89kg/kg
Salicylic acid-------------------------------------0.79kg/kg
Sodium borohydride---------------------------0.48kg/kg
Dimethyl formamide--------------------------0.83kg/kg
N-Hexane-----------------------------------------3.75kg/kg
Methylene dichloride--------------------------5.75kg/kg 57

Case No.:680/24/83-

ALC1/2007 Party Name:DCM SHRIRAM INDUSTRIES LTD, Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00524/AM08/ RLA File : 05/24/040/00166/AM08/ Lic.No/Date:05102049 18 14.06.2007 Defer Date: 30.10.2007 norms for export product D(-)Para Hydroxy Phenyl Glycine Dane Salt under

para 4.7 of HBP.

for four weeks. 58 Case No.:655/24/83- ALC1/2007 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : RLA File : Lic.No/Date:08100654 Defer

01/83/050/00530/AM08/ 08/24/040/00066/AM08/ 23 15.06.2007 Date: 30.10.2007 norms for export product Methscopolamine Tannate under para 4.7 of HBP. for four weeks. 59

Case No.:2/18/82-

ALC4/2007 Party Name:HARMAN FINOCHEM LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00114/AM08/ RLA File : 03/94/040/00273/AM08/ Lic.No/Date:03104333 97 21.06.2007 Defer Date: 30.10.2007 norms for export product Phenob Arbittal (Phenobarbitone) under para 4.7 of HBP. for four weeks. 60

Case No.:82/19/83-

ALC1/2007 Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Transferr ed HQ File : 01/83/050/00641/AM08/ RLA File : 03/95/040/00229/AM08/ Lic.No/Date:03104338 35 25.06.2007

norms for export product 3,5-Di Methoxy-4-Hydroxy Benzamide (Syringamide) under para 4.7 of HBP. Committee decided to transfer the case to DES-IV as the export product pertains to Chemical Sector. 61 Case No.:732/24/83- ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00625/AM08/ RLA File : 09/24/040/00126/AM08/ Lic.No/Date:09100306 94 29.06.2007

norms for export product Irbesarttan under para 4.7 of HBP. whichever is lower. Export product: Irbesartan------------------------------------------------------------1kg Impor items:

1-[(2-Cyanobiophenyl-4-yl)methyl)-2-n-butyl-4- spirocyclopentane-2-imidazoloin-5-one--------------1.36kg/kg
Methylene chloride----------------------------------------6.15kg/kg
Acetone-------------------------------------------------------2.83kg/kg

Case No.:733/24/83-

ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00626/AM08/ RLA File : 09/24/040/00228/AM07/ Lic.No/Date:09100306 95 29.06.2007

norms for export product Ticonazole under para 4.7 of HBP. whichever is lower. Export product: Ticonazole--------------------------------------------------1kg Impor items:

3-Methyl Thiophene--------------------------------------1.09kg/kg
Sodium Borohydride--------------------------------------0.30kg/kg
N,N-Dimethyl Formamide-------------------------------1.36kg/kg
Acetonitrile--------------------------------------------------0.93kg/kg

Case No.:754/24/83-

ALC1/2007 Party Name:R L FINE CHEM Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00681/AM08/ RLA File : 07/24/040/00246/AM08/ Lic.No/Date:07100523 66 06.07.2007 : norms for export product Clomipramine Hcl under para 4.7 of HBP. Committee in light of its earlier decision taken in its 36/83 meeting held on 12.01.2005 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower Export product: Clomipramine Hcl-------------------------------------1kg Import item:

1 Bromo 3 Chloro Propane----------------------------0.85kg/kg
3 Chloro Iminodibenzyl--------------------------------0.91kg/kg 64 Case No.:756/24/83- ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00686/AM08/ RLA File : 09/24/040/00035/AM08/ Lic.No/Date:09100308 01 06.07.2007

norms for export product Stavudine under para 4.7 of HBP. their U.O. No.35011/36/2007-PI-III dated 04.10.2007 decided to ratify whichever is lower. Export product: Stavudine--------------------------------------------1kg Impor items:

Beta thymidine----------------------------2.36kg/kg
Pyridine-------------------------------------5.80kg/kg
Methane sulfonyl chloride--------------2.40kg/kg
Methanol------------------------------------6.18kg/kg
N-Hexane------------------------------------1.55kg/kg
Potassium Tert. Butoxide-----------------1.08kg/kg
Tert. Butanol---------------------------------0.82kg/kg
Acetone---------------------------------------5.59kg/kg
Iso Propyl Alcohol---------------------------4.20kg/kg 65

Case No.:772/24/83-

ALC1/2007 Party Name:WOCKHARDT LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00711/AM08/ RLA File : 03/95/040/00336/AM08/ Lic.No/Date:03104358 09 11.07.2007

norms for export product Oxybutynin Chloride under para 4.7 of HBP. their U.O. No.35011/84/2007-PI-III dated 19.09.2007 decided to ratify whichever is lower. Export product: Oxybutynine Chloride-------------------------------------1Kg. Import items:

Propargyl Alcohol---------------------------------0.40kg/kg
Cyclo Hexyl Mandelic Acid Methyl Ester-----1.22kg/kg
Isopropyl Ether------------------------------------0.375kg/kg 66 Case No.:767/24/83- ALC1/2007 Party Name:ANJAN DRUGS PRIVATE LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00701/AM08/ RLA File : 04/24/040/00109/AM08/ Lic.No/Date:04100902 36 12.07.2007

norms for export product Magnesium Valproate (Or) Valproate Magnesium

under para 4.7 of HBP. their U.O. No.35011/207/2004-PI-III dated 04.10.2007 decided to ratify whichever is lower. Export product: Magnesium Valproate------------------------------1kg Impor items:

Sodium Metal-------------------------------0.51kg/kg
N-Propyl Bromide---------------------------2.67kg/kg
T-Butanol-------------------------------------0.64kg/kg
Di-Ethyl Malonate---------------------------1.42kg/kg
Potassium Hydroxide------------------------1.50kg/kg 67

Case No.:798/24/83-

ALC1/2007 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00756/AM08/ RLA File : 05/24/040/00241/AM08/ Lic.No/Date:05102063 28 16.07.2007 Defer Date: 30.10.2007 norms for export product Mica Ester under para 4.7 of HBP. for four weeks. 68 Case No.:799/24/83- ALC1/2007 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00757/AM08/ RLA File : 05/24/040/00240/AM08/ Lic.No/Date:05102063 31 16.07.2007 Defer Date 30.10.2007 norms for export product 7AVNA under para 4.7 of HBP.

for four weeks. 69

Case No.:806/24/83-

ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00772/AM08/ RLA File : 03/94/040/00345/AM08/ Lic.No/Date:03104365 67 18.07.2007

norms for export product Ethoxy Carbonylalanine (Perindopril Erbumine Stage D) under para 4.7 of HBP. their U.O. No.35011/253/2006-PI-III dated 04.10.2007 decided to ratify whichever is lower. Export product: Ethoxy Carbonylalanine---------------------------1kg Impor items:

L-Norvaline---------------------------------1.03kg/kg
10% Palladium on Carbon---------------0.100kg/kg
Acetone--------------------------------------4.56kg/kg 70

Case No.:838/24/83-

ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00834/AM08/ RLA File : 34/24/040/00061/AM08/ Lic.No/Date:34100192 69 24.07.2007 Defer Date: 30.10.2007 norms for export product Fenofibrate 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. 71 Case No.:851/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:22/82- ALC4/2007 Status:Ca se

04.10.2007 Deferred HQ File : 01/83/050/00851/AM08/ RLA File : 05/24/040/00313/AM08/ Lic.No/Date:05102066 70 24.07.2007 Defer Date: 30.10.2007 norms for export product Midazolam under para 4.7 of HBP. for four weeks. 72 Case No.:852/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00852/AM08/ RLA File : 05/24/040/00314/AM08/ Lic.No/Date:05102066 71 24.07.2007

norms for export product Oseltamivir Phosphate under para 4.7 of HBP. their U.O. No.35011/228/2006-PI-III dated 04.10.2007 decided to ratify whichever is lower. Export product: Oseltamivir Phosphate---------------------------1Kg. Impor items:

Shikimic Acid-----------------------------4.025kg/kg
2,2 Dimethoxy propane-----------------0.043kg/kg
Toluene-------------------------------------5.73kg/kg
Triethylamine------------------------------3.32kg/kg
Methylene chloride-----------------------13.52kg/kg
Acetone---------------------------------------6.58kg/kg
Methanol-------------------------------------2.41kg/kg
Dimethyl formamide-----------------------1.57kg/kg
3-Pentanone----------------------------------14.239kg/kg

Triflic acid--------------------------------------0.204kg/kg 11. Cyclohexane----------------------------------6.86kg/kg 12. Triethyl silane--------------------------------3.00kg/kg 13. Triphenyl phosphine------------------------7.703kg/kg 14. Activated Carbon----------------------------0.100kg/kg 15. Tetrahydrofuran-----------------------------2.77kg/kg

Case No.:853/24/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00853/AM08/ RLA File : 05/24/040/00324/AM08/ Lic.No/Date:05102066 95 24.07.2007 Defer Date: 30.10.2007 norms for export product Candesartan Cilexetil under para 4.7 of HBP. for four weeks. 74

Case No.:866/24/83-

ALC1/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00868/AM08/ RLA File : 22/21/040/00057/AM08/ Lic.No/Date:22100069 26 31.07.2007

norms for export product Cloxacillin Sodium Pen G Route under para 4.7 of HBP. Committee decided to ratify norms under para 4.7 of HBP as per revised SION at Sl.No.A-152 published vide Public notice No.45 dated 06.09.2007. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 75 Case No.:873/24/83- ALC1/2007 Party Name:AVENTIS PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00877/AM08/ RLA File : 03/94/040/00407/AM08/ Lic.No/Date:03104379 34 31.07.2007

norms for export product Glibenclamide/Glyburide under para 4.7 of HBP. their U.O. No.35011/214/2006-PI-III dated 04.10.2007 decided to ratify

whichever is lower. Export product: Glibenclamide/Glyburide-------------------------------------1kg Impor items:

Cyclohexyl Isocyanate----------------------0.4251kg/kg
Methanol--------------------------------------6.197kg/kg
N,N-Dimethyl Formamide----------------------0.642kg/kg
Activated Charcoal-------------------------------0.0787kg/kg
Diacel------------------------------------------------Filter aid not covered under raw material
LPPE/Polythene bags-----------------------------As per packing policy 76

Case No.:894/24/83-

ALC1/2007 Party Name:DOCTORSORGANIC CHEMICALS LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00902/AM08/ RLA File : 26/24/040/00001/AM08/ Lic.No/Date:26100063 18 07.08.2007 Defer Date: 30.10.2007 norms for export product Clopidogrel Hydrogen Sulfate Solid under para 4.7 of HBP. for four weeks. 77 Case No.:900/24/83- ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00910/AM08/ RLA File : 22/24/040/00031/AM08/ Lic.No/Date:22100069 47 07.08.2007 Defer Date: 30.10.2007 norms for export product 1,3-Dioxolane,4-acetic acid,6-[2-[2-(4- flourophenyl)methyl]-5-(1-methylethyl)-3-phenyl-4- [(phenylamino)carbonyl]-1H-p under para 4.7 of HBP.

for four weeks. 78

Case No.:901/24/83-

ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/83/050/00911/AM08/ RLA File : 22/24/040/00032/AM08/ Lic.No/Date:22100069 48 07.08.2007 Defer Date: 30.10.2007 norms for export product Fexofenadine Hydrochloride under para 4.7 of HBP. for four weeks. 79

Case No.:932/24/83-

ALC1/2007 Party Name:PARABOLIC DRUGS LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/00946/AM08/ RLA File : 22/24/040/00029/AM08/ Lic.No/Date:22100069 55 08.08.2007

norms for export product Cloxacillin Sodium Pen G Route under para 4.7 of HBP. Committee decided to ratify norms under para 4.7 of HBP as per revised SION at Sl.No.A-152 published vide Public notice No.45 dated 06.09.2007. 80 Case No.:990/24/83- ALC1/2007 Party Name:AICO LABORATORIES INDIA LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/83/050/01008/AM08/ RLA File : 08/24/040/00135/AM08/ Lic.No/Date:08100667 63 22.08.2007

norms for export product under para 4.7 of HBP.

their U.O. No.35011/90/2005-PI-III dated 04.10.2007 decided to ratify whichever is lower. Export product: Glycine USP---------------------------------------------1kg Impor items:

Amino Acetic Acid Purity NMT98.5% (chloride content NLT 0.5%)----------------1.05kg/kg
Methanol----------------------------------------0.20kg/kg 81

Case No.:2/22/82-

ALC4/2007 Party Name:ALKEM LABORATORIES LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/82/050/00168/AM08/ RLA File : 03/94/040/00545/AM08/ Lic.No/Date:03104410 51 28.08.2007

norms for export product Ceftazidime for Injection 1gm under para 4.7 of HBP. their U.O. No.35011/6/2007-PI-III dated 04.10.2007 decided to ratify the norms lower. Export product Ceftazidime 1 gm. injection Import item Sterile Ceftazidime USP as Pentahydrate With minimum 8.33% Sodium carbonate------------------1.32gm RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 82 Case No.:3/22/82- ALC4/2007 Party Name:INDO GERMAN ALKALOIDS Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/82/050/00173/AM08/ RLA File : 03/94/040/00505/AM08/ Lic.No/Date:03104410 53

28.08.2007 norms for export product Podophyllum Resin BP/USP under para 4.7 of HBP. Committee in light of the earlier decision taken by NC in its meeting No.2/08 held on 16.05.2007 vide case NO.20/32/82-ALC1/2006 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 Podophyllum Resin-------------------------------------------1kg Import item Poduphyllum root (Podophyllum Resin 5 +_ 10%)-----19.71kg 83 Case No.:1/22/82- ALC4/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/82/050/00167/AM08/ RLA File : 09/24/040/00214/AM08/ Lic.No/Date:09100313 12 29.08.2007

norms for export product Ramipril under para 4.7 of HBP. Committee in light of its earlier decision taken in its 43/83 meeting held on 07.02.2007 vide Case No.3/43/83 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Ramipril-----------------------------------1kg. Import items:

Racemic-2-azabicyclo(3,3,0) Octane- 3-carboxylic acid benzylester Hcl----------------2.70kg/kg
S(+)-Mandelic acid----------------------------------0.81kg/kg
Methylene chloride---------------------------------2.50kg/kg
Cyclohexane------------------------------------------2.50kg/kg
Isopropyl Alcohol------------------------------------2.50kg/kg
ECPP Alanine------------------------------------------1.23kg/kg
1-Hydroxy Benzotriazole---------------------------0.72kg/kg
Dicyclohexyl Carbodimide-------------------------1.00kg/kg
Di-isopropyl ether------------------------------------2.50kg/kg

5% Palladium on carbon----------------------------0.20kg/kg 84

Case No.:4/22/82-

ALC4/2007 PHARMA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00174/AM08/ RLA File : 09/24/040/00207/AM07/ Lic.No/Date:09100313 28 31.08.2007 Defer Date: 30.10.2007 norms for export product Cefoperazone Sodium Sterile USP/BP under para 4.7 of HBP. Committee decided to call for a copy of application alongwith copy of Advance Authorisation from RA. Accordingly, case was deferred for four weeks. 85

Case No.:5/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00175/AM08/ RLA File : 03/94/040/00571/AM08/ Lic.No/Date:03104415 56 31.08.2007 Defer Date: 30.10.2007 norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP. for four weeks. 86 Case No.:6/22/82- ALC4/2007 Party Name:SKM PHARMA(P)LTD., Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00176/AM08/ RLA File : 07/24/040/00339/AM08/ Lic.No/Date:07100531 23 31.08.2007 Defer Date: 30.10.2007 norms for export product Fortified Procaine Pencillin (Procaine Penicillin/Benzyl Penicillin Sodium 3:1 BP under para 4.7 of HBP.

for four weeks. 87

Case No.:7/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00177/AM08/ RLA File : 03/94/040/00586/AM08/ Lic.No/Date:03104418 20 05.09.2007 Defer Date: 30.10.2007 norms for export product Lamotrigine under para 4.7 of HBP. for four weeks. 88

Case No.:8/22/82-

ALC4/2007 Party Name:MEDREICH LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Approved HQ File : 01/82/050/00178/AM08/ RLA File : 07/24/040/00404/AM08/ Lic.No/Date:07100532 40 10.09.2007

norms for export product Paracetamol 250mg + Ibuprofen 200mg Capsules under para 4.7 of HBP. their U.O. No.35011/207/2005-PI-III dated 04.10.2007 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: Paracetamol 250mg + Ibuprofen 200mg Capsules Import items:

Paracetamol ---------------------- -----------255mg/capsule
Ibuprofen -------------------------------------204mg/capsule
Sodium Stearyl Fumarate------------------Not shown in DML(Not allowed) RA concerned may take further necessary action under para 4.7 of HBP as per above decision of the Norms Committee. 89 Case No.:9/22/82- ALC4/2007 Party Name:INDO GERMAN ALKALOIDS Meet No/Date:22/82- ALC4/2007 Status:Ca se

04.10.2007 Approved HQ File : 01/82/050/00179/AM08/ RLA File : 03/94/040/00566/AM08/ Lic.No/Date:03104423 25 10.09.2007

norms for export product Ipecacuanha Extract BP/USP under para 4.7 of HBP. Committee in light of technical report of a DGFT Committee decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Ipecacuanha Liquid Extract----------------------1Kg. Import item: Ipecacuanha Roots---------------------------------4.10kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of the Norms Committee. 90

Case No.:10/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00180/AM08/ RLA File : 03/94/040/00615/AM08/ Lic.No/Date:03104428 78 12.09.2007 Defer Date: 30.10.2007 norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. for four weeks. 91 Case No.:11/22/82- ALC4/2007 Party Name:HARMAN FINOCHEM LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00181/AM08/ RLA File : 03/94/040/00591/AM08/ Lic.No/Date:03104434 68 18.09.2007 Defer Date: 30.10.2007 norms for export product Phenobarbital (Phenobarbitone) under para 4.7 of

HBP. weeks. 92

Case No.:12/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00182/AM08/ RLA File : 03/94/040/00638/AM08/ Lic.No/Date:03104436 98 19.09.2007 Defer Date: 30.10.2007 norms for export product Carvedilol under para 4.7 of HBP. weeks. 93

Case No.:15/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00185/AM08/ RLA File : 03/94/040/00633/AM08/ Lic.No/Date:03104438 47 20.09.2007 Defer Date: 30.10.2007 norms for export product GCS Max Powder under para 4.7 of HBP. weeks. 94 Case No.:13/22/82- ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00183/AM08/ RLA File : 13/24/040/00018/AM08/ Lic.No/Date:13100250 51 21.09.2007 Defer Date: 30.10.2007 norms for export product Biotin Granules under para 4.7 of HBP.

weeks. 95

Case No.:14/22/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00184/AM08/ RLA File : 13/24/040/00017/AM08/ Lic.No/Date:13100250 52 21.09.2007 Defer Date: 30.10.2007 norms for export product Vitamin B12 Granules under para 4.7 of HBP. weeks. 96

Case No.:16/22/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00186/AM08/ RLA File : 03/95/040/00574/AM08/ Lic.No/Date:03104440 49 24.09.2007 Defer Date: 30.10.2007 norms for export product Diproson Lotion (30ml) under para 4.7 of HBP. weeks. 97

Case No.:17/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:22/82- ALC4/2007 04.10.2007 Status:Ca se Deferred HQ File : 01/82/050/00187/AM08/ RLA File : 03/94/040/00650/AM08/ Lic.No/Date:03104442 04 25.09.2007 Defer Date: 30.10.2007 norms for export product Tenofovir Disoprosil Fumarate under para 4.7 of HBP. weeks.

Date:29.09.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer

Minutes of the Norms Committee Meeting No. 22/08 held on 04.10.2007 under the Chairmanship of Sh. S.K. Prasad, Addl. DGFT. The Committee considered each case as per agenda.

Case No.A-750

M/s Alembic Ltd M.No.22/08 F.No.01/82/50/37/AM 08 Meeting Date 04.10.2007 RLA F. No. 34/24/40/290/AM07 Adv. Lic. No. 3410018404 dated 23.03.07 The Committee considered the case as per agenda for ratification of norms for the export product Azhhromycin Crude under para 4.7 of HBP. that case is under examination in their Department and he sought deferment for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-751

M/s Dr. Reddys Lab Ltd M.No.22/08 F.No.01/82/162/2222/AM 08 RLA F. No. 09/24/40/54/AM08 Adv. Lic. No. 0910030527 dated 13.06.07

export product Ch0lorpromazine HCL Tablets 25mg, 50mg and 100mg under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/209/2005-PI-III dated 04.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Cholopromazine Tablets 25mg, 50mg and 100mg. Import items: For export of 1 lakh of tablets Quantity in kg. Sl.N o. Description of import items Qty allowed for

25mg Tablets Qty. allowed for

50mg tablets Qty. allowe for 100mg Tablets 1. Chlorpromazine hcl 2.50 5.00 10.0 2. Lactoser monohydrate 7.48 22.19 26.79 3. Maize Starch 0.87 2.58 3.11 4. Povidone (Povidone K25) 0.35 1.03 1.25 5. Sodium Starch glycolate 0.60 1.65 2.20 6. Silica Colloidal anhydrous 0.04 0.12 0.15 7. Magnesium stearate 0.160 0.40 0.50 8. Hypromellose 5 cps 0.30 0.60 0.75 9. Ethyl cellulose (Ethocel std. 10 premium) 0.080 0.16 0.20 10. Diethyl Phthalate 0.050 0.10 0.125 11. Titanium dioxide 0.080 0.16 0.20 RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A-752

M/s Ranbaxy Lab Ltd M.No.22/08 F.No.01/82/50/97/AM 08 RLA F. No. 05/24/40/36/AM08 Adv. Lic. No. 0510202774 dated 20.04.07

The Committee considered the case as per agenda for ratification of norms for the export product Ciprofloxacin Tablets under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/85/2007-PI-III dated 19.09.2007 decided to ratify norms under

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

Export product: Ciprofloxacin tablets 250mg-----------9,80,40,000 Nos. Ciprofloxacin tablets 500mg-----------4,90,20,000 Nos. Ciprofloxacin tablets 750mg-----------3,26,80,000 Nos. Import items:

7-chloro-5-fluoro-1-cyclopropyl-1, 4-dihydro-4-oxaquinoline-3-carboxylic acid (drug intermediate for Ciprofloxacin)------------------27,650kgs
Piperazine Anhydrous--------------------------------------23,500kgs
Methanol------------------------------------------------------25,000kgs
Activated Carbon---------------------------------------------1,250kgs
Acetone----------------------------------------------------3,700kgs

Case No.A-753

M/s Sun Pharma Industries Ltd. M.No.22/08 F.No.01/82/61/04/AM 08 RLA F. No. 03/24/40/187/AM01 export product Clomipramine HCL under para 4.4.2 of HBP. Committee observed that a report in the matter was called for from Jt. DGFT, Mumbai, but the same has not been received. Committee, therefore, decided to remind RA and to defer the case for six weeks.

Case No.A-754

M/s Sun Pharma Industries Ltd. M.No.22/08 F.No.01/82/162/05/AM 08 RLA F. No. 03/24/40/43/AM01 export product Clomipramine HCL under para 4.7 of HBP. Committee observed that a report in the matter was called for from Jt. DGFT, Mumbai, but the same has not been received. Committee, therefore, decided to remind RA and to defer the case for six weeks.

Case No.A-755

M/s Cadila Healthcare Ltd M.No.22/08 F.No.01/82/50/123/AM 08

RLA F. No. 08/24/40/90/AM08 Adv. Lic. No. 0810065759 dated 04.07.07 export product Atenolol 25 MG Tab under para 4.7 of HBP. their U.O. No.35011/73/2007-PI-III dated 03.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Atenolol 25mg tablets-------------------29,29,06,000Nos. Atenolol 50mg tablets-------------------26,60,30,000Nos. Atenolol 100mg tablets------------------8,84,64,000Nos. Import items: Sl.No. Import items Total quantity allowed in Kgs. 1. Atenolol 30059.90 2. HD Silicified Microcrystalline Celklulose (Prosol V HD 90) 80985.071 3. Povidone K 30 677.823 4. Citric Acid Anhydrous 294.706 5. Croscarmellose Sodium NF 4273.23 6. Magnesium Stearate 854.646 7. Bottles & caps (import item No.a to i) Relevant as per packing policy

Case No.A-756

M/s Cadila Healthcare Ltd M.No.22/08 F.No.01/82/50/122/AM 08 RLA F. No. 08/24/40/91/AM08 Adv. Lic. No. 0810065758 dated 04.07.07

export product Carvedil 3.125 MG Tab under para 4.7 of HBP. their U.O. No.35011/73/2007-PI-III dated 03.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Carvedilol tablets 3.125mg-----------2,71,17,200 Nos. Carvedilol Tablets 6.25mg------------4,47,70,400 Nos. Carvedilol Tablets 12.5mg------------4,05,58,100 Nos. Carvedilol Tablets 25mg---------------5,34,54,400 Nos. Import items: Sl.No. Import items Total quantity allowed in Kgs. 1. Carvedilol 2252.05 2. Cross Povidone 1942.95 3. Povidone K 30 706.53 4. Magnesium Stearate 317.94 7. Bottles & caps (import item No.a to j) Relevant as per packing policy RA concerned may take further necessary action under para 4.7 of

Case No.A-757

M/s Cadila Pharmaceutical Ltd M.No.22/08 F.No.01/82/50/101/AM 08 RLA F. No. 08/24/40/174/AM02 Adv. Lic. No. 0810014354 dated 07.11.01

export product Phenylepherine Tannate Crude under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/204/2005-PI-III dated 04.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Phenyl ephedrine Tannate-------------------1Kg. Import items:

Phenyl ephedrine Hcl----------------0.57kg/kg
Tannic Acid-----------------------------0.87kg/kg RA concerned may take further necessary action under para 4.7 of

Case No.A-758

M/s Glenmark Pharmaceutical Ltd M.No.22/08 F.No.01/82/50/137/AM 08 RLA F. No. 03/94/40/412/AM08 Adv. Lic. No. 0310437384 dated 25.07.07 export product Ethoxy Carbonylalaine under para 4.7 of HBP. their U.O. No.35011/253/2006-PI-III dated 04.10.2007 decided to ratify whichever is lower. Export product: Ethoxy Carbonylalanine---------------------------1kg Impor items:

L-Norvaline---------------------------------1.03kg/kg
10% Palladium on Carbon---------------0.100kg/kg
Acetone--------------------------------------4.56kg/kg RA concerned may take further necessary action under para 4.7 of

Case No.A-759

M/s Cipla Ltd M.No.22/08 F.No.01/82/50/136/AM 08 RLA F. No. 03/94/40/383/AM08 Adv. Lic. No. 0310436156 dated 13.07.07

export product Stavir 15 MG Capsules/Stavudine Capsules 15 MG under para 4.7 of HBP. deferment for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-760

M/s Glenmark Pharmaceutical Ltd M.No.22/08 F.No.01/82/162/294/AM 08 RLA F. No. 03/94/40/1268/AM06 Adv. Lic. No. 0310368263 dated 22.02.06 The Committee considered the case as per agenda for ratification of norms for the export product Adapalene under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/127/2006-PI-III dated 04.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Adapalene-------------------------------------1Kg. Import items: Sl.No. Description of import item Quantity allowed 1. 1-Adamantamol 1.00kg/kg 2. Methyl-6-Bromo-2-Naphthoate 0.67kg/kg 3. Methylene chloride 19.29kg/kg 4. N,N-Dimethyl

Formamide/Dimethyl Formamide 2.07kg/kg 5. Tetrahydrofuran 16.50kg/kg RA concerned may take further necessary action under para 4.7 of

Case No.A-761

M/s Cipla Ltd M.No.22/08 F.No.01/82/50/102 /AM 08 RLA F. No. 03/24/40/2622/AM04 Adv. Lic. No. 0310257978 dated 12.03.04 export product Finpecia 1mg Tablets under para 4.7 of HBP. for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-762

M/s Shalina Lab Ltd M.No.22/08 F.No.01/82/50/165/AM 08 RLA F. No. 03/95/40/205/AM08 Adv. Lic. No. 0310433127 dated 19.06.07 export product Betasol Cream 15 GM Tube under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/86/2006-PI-III dated 25.09.2007 observed that the export product Betasol Cream is based on Clobetasol Propionate whereas the firm has applied for import of Betamethasone base. Committee after detailed deliberations decided to close the case under intimation to firm as well as RA.

Case No.A-763

M/s SKM Pharma Ltd M.No.22/08 F.No.01/82/50/166/AM 08 RLA F. No. 07/24/40/339/AM08 Adv. Lic. No. 0710053123 dated 31.08.07 export product Fortified Procaine 4 Mgs Injection under para 4.7 of HBP. for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-764

M/s Cipla Ltd M.No.22/08 F.No.01/82/50/158/AM 08 RLA F. No. 03/94/40/535/AM08 Adv. Lic. No. 0310440429 dated 22.08.07 export product Budecort 200 Inhaler (200 MD)Aerobud Inhaler (200MD)Budesonide Generis 200 Inhaler (200 MD) under para 4.7 of HBP. for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-765

M/s Cipla Ltd M.No.22/08 F.No.01/82/162/169/AM 08 RLA F. No. 03/94/40/250/AM08 Adv. Lic. No. 310432136 dated 08.06.07

export product Stavir 15 MG Capsules under para 4.7 of HBP. deferment for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-766

M/s Cipla Ltd M.No.22/08 F.No.01/82/50/160/AM 08 RLA F. No. 03/94/40/524/AM08 Adv. Lic. No. 0310440273 dated 21.08.07 export product Irinotecan Hydrochloride Injection 40 MG/2 MG(each Vial 2 ML) Irinotecan Hydrochloride Injection 100 MG/5 ML (each Vial 5 ML) under para 4.7 of HBP. deferment for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-767

M/s Gracure Pharmaceuticals Ltd M.No.22/08 F.No.01/82/162/726/AM 07 RLA F. No. 05/24/40/112/AM07 Adv. Lic. No. 0510185320 dated 22.06.06 export product Daxy 200 Tab under para 4.7 of HBP. deferment for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-768

M/s Cadila Pharmaceuticals Ltd M.No.22/08 F.No.01/82/50/163/AM 08 RLA F. No. 08/24/40/110/AM08 Adv. Lic. No. 0810066435 dated 07.08.07

export product 62/0 Cilostazol under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/73/2007-PI-III dated 14.08.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Cilostazol--------------------------------------------------------------1Kg. Import items:

6-hydroxy-3,4-dihydro 2(1H)-quinolinone---------0.59kg/kg
5-(4-chlorobutyl)-1-cyclo Hexyl 1H-Tetrazol-------0.88 RA concerned may take further necessary action under para 4.7 of HBP as

Case No.A-769

M/s Gulf Oil Corporation M.No.22/08 F.No.01/82/50/47/AM 08 RLA F. No. 09/24/40/538/AM07 Adv. Lic. No. 0910028240 dated 17.11.06 export product Fexafenadine Hydrochloride under para 4.7 of HBP. deferment for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-770

M/s Cipla Ltd M.No.22/08 F.No.01/82/50/159/AM 08 RLA F. No. 03/94/40/516/AM08 Adv. Lic. No. 0310439736 dated 16.08.07 export product Losartan Potassium under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in their Department and he sought deferment for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-771

M/s Cadila Healthcare Ltd M.No.22/08 F.No.01/82/50/161/AM 08 RLA F. No. 08/24/40/136/AM07 Adv. Lic. No. 0810066915 dated 30.08.07

export product 2(2-Methoxyphenoxy)-Ethylamine Base Pharma Grade under para 4.7 of HBP. deferment for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.A-772

M/s Ce- Chem Pharmaceuticals M.No.22/08 F.No.01/82/50/46/AM 08 RLA F. No. 07/24/40/136/AM08 Adv. Lic. No. 0710051761 dated 25.05.07 export product Pencillin V Porrasium 250 MG Tablets under para 4.7 of HBP. Committee noted that the firm was requested to furnish copy of DML alongwith the approved list of import items vide letter dated 14.08.2007, but the same has not been received. Committee, therefore, decided to remind the firm. Accordingly, case was deferred for four weeks.

Case No.B-303

M/S Miles International, Mumbai NC Meeting No.22/08 F.No.01/82/50/1002/AM07/DES-III Meeting date: 04.10.2007 RLA F.No.03/95/40/314/AM07 Adv.Lic.No.0310386250 dated 22.06.2007 Committee considered case as per agenda for ratification of norms for export product Dithranol BP/EP under para 4.7 of HBP. Committee decided to forward a copy of application alongwith copy of reply received from the firm to PI Division for their comments. Accordingly, case was deferred for four weeks.

Case No.B-304

M/S M.J. Biopharma Pvt. Ltd. NC Meeting No.22/08 F.No.01/82/50/17/AM08/DES-III RLA F.No.03/95/40/21/AM08 Adv.Lic.No.0310427662 dated 23.04.2007 Committee considered case as per agenda for ratification of norms for export product Prednilolone sodium phosphate Inj. 30mg/ml under para 4.7 of HBP. Committee decided to forward a copy of application alongwith copy of reply received from the firm to PI Division for their comments. Accordingly, case was deferred for four weeks.

Case No.B-305

M/S KDL Biotech Ltd. NC Meeting No.22/08 F.No.01/82/50/1415/AM05/DES-III RLA F.No.03/24/40/1364/AM05 Adv.Lic.No.0310301988 dated 11.11.2004 Committee considered case as per agenda for ratification of norms for export product Immobilized Pencillin G Amidase Enzyme under para 4.7 of HBP. Committee decided to examine the case on file in respect of comments of DBT, NOC issued by DBT and other related aspects. Accordingly, case was deferred for four weeks.

Case No.B-306

M/S Lupin Ltd. NC Meeting No.22/08 F.No.01/83/50/730/AM08/DES-III RLA F.No.03/95/40/206/AM08 Adv.Lic.No.0310432614 dated 14.06.2007 Committee considered case as per agenda for correction in the description of import item from Diethylamine to Dimethyl Aniline under para 4.7 of HBP. Committee in consultation with the technical authorities present in the meeting decided to allow amendment in the description of import item from Diethylamine to Dimethyl Aniline. RLA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-307

M/S Lupin Ltd. NC Meeting No.22/08 F.No.01/82/50/1028/AM06/DES-III RLA F.No.03/95/40/1052/AM06 Adv.Lic.No.0310358437 dated 06.12.2005 Committee considered case as per agenda for correction in the description of import item from D(-)para hydroxyl phenyl glycine methyl/etyl potassium dane salt to D(-)para hydroxyl phenyl glycine methyl/ethyl potassium dane salt under para 4.7 of HBP.

Committee in consultation with the technical authorities present in the meeting decided to allow amendment in the description of import item from D(-)para hydroxyl phenyl glycine methyl/etyl potassium dane salt to D(-)para hydroxyl phenyl glycine methyl/ethyl potassium dane salt RLA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-308

M/S Ind-Swift Laboratories Ltd. NC Meeting No.22/08 F.No.01/82/50/686/AM07/DES-III RLA F.No.22/24/40/163/AM07 Adv.Lic.No.2210005858 dated 07.08.2006 Committee considered case as per agenda for correction in the description of import item from HPMC Pthalate to HPMC Phthalate under para 4.7 of HBP. Committee in consultation with the technical authorities present in the meeting decided to allow amendment in the description of import item from HPMC Pthalate to HPMC Phthalate . RLA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-309

M/S Ind-Swift Laboratories Ltd. NC Meeting No.22/08 F.No.01/82/50/905/AM07/DES-III RLA F.No.22/24/40/215/AM07 Adv.Lic.No.2210005981 dated 11.09.2006 Committee considered case as per agenda for correction in the description of import item from HPMC Pthalate to HPMC Phthalate under para 4.7 of HBP. Committee in consultation with the technical authorities present in the meeting decided to allow amendment in the description of import item from HPMC Pthalate to HPMC Phthalate. .

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

Case No.B-310

M/S Process Chemicals Co. NC Meeting No.22/08 F.No.01/83/50/485/AM07/DES-III

Adv.Lic.No.0210092098 dated 01.08.2006 Adv.Lic.No.0210083908 dated 01.12.2005 Adv.Lic.No.0210083906 dated 01.12.2005 Committee considered case as per agenda for modification of norms for export product Calcium D-Saccharate and Monopotassium Glucarate 99% Purity under para 4.7 of HBP. for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.B-311

M/S Sandoz Pvt. Ltd. NC Meeting No.22/08 F.No.01/82/162/1266/AM01/DES-III

Adv.Lic.No.0310002380 dated 27.07.1999 Committee considered case as per agenda for modification of norms for export product under para 4.7 of HBP. Committee decided to call for a report in the matter from Jt. DGFT, Mumbai regarding development of the case. Accordingly, case was deferred for four weeks.

Case No.B-312

M/S Aurobindo Pharma Ltd. NC Meeting No.22/08 F.No.01/87/50/319/AM07/DES-III

RLA F.No.09/24/40/116/AM07 Adv.Lic.No.0910026717 dated 30.06.2005 Committee considered case as per agenda for ratification of norms for export product Cloxacillin Sodium from 6-APA route under para 4.7 of HBP. Committee decided to ratify norms under para 4.7 of HBP as per revised SION at Sl.No.A-151 published vide Public Notice No.45 dated 06.09.2007.

Case No.B-313

M/S Glenmark Pharmaceuticals Ltd. NC Meeting No.22/08 F.No.01/82/50/1484/AM06/DES-III RLA F.No.03/94/40/1347/AM06 Adv.Lic.No.0310372003 dated 17.03.2006 export product Cilazapril under para 4.7 of HBP. Committee decided to forward a copy of the representation submitted by the firm to PI Division for their comments . Accordingly, case was deferred for four weeks.

Case No.B-314

M/S Aarti Drugs Ltd. NC Meeting No.22/08 F.No.01/87/50/314/AM07/DES-III RLA F.No.03/94/40/306/AM07 Adv.Lic.No.0310387491 dated 29.06.2006 Committee considered case as per agenda for correction in the description of import item from Diclofenec Sodium to Dichlofenac Sodium under para 4.7 of HBP. Committee in consultation with the technical authorities present in the

meeting decided to allow amendment in the description of first import item from Diclofenec Sodium to Dichlofenac Sodium and second import item from Mono Chloro Aniline (NCA) to Mono Chloro aniline (MCA). RLA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-315

M/S Glenmark Pharmaceuticals Ltd. NC Meeting No.22/08 F.No.01/82/162/285/AM08/DES-III RLA F.No.03/24/40/1482/AM05 Adv.Lic.No.0310295800 dated 07.10.2004 export product Cilazapril under para 4.7 of HBP. for four weeks. Committee, accordingly, decided to defer case for four weeks.

Case No.B-316

M/S Intas Pharma Ltd. NC Meeting No.22/08 F.No.01/82/50/1523/AM07/DES-III RLA F.No.08/24/40/220/AM07 Adv.Lic.No.0810060872 dated 09.11.2006 export product Azithromycin tablets 250mg and 500mg. under para 4.7 of HBP. The Committee in light of its earlier decision (Minutes enclosed with the agenda) taken in its 16/08 meeting held on 21.08.2007 vide case No.B-233 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: Azithromycin tablets 250mg. Import items: Azithromycin monohydrate (average

water content NLT 5%)—---------------268.42mg/tablet Export product: Azithromycin tablets 500mg. Import items: water content NLT 5%)—---------------536.84mg/tablet

Case No.B-317

M/S Intas Pharma Ltd. NC Meeting No.22/08 F.No.01/82/50/105/AM08/DES-III RLA F.No.08/24/40/338/AM07 Adv.Lic.No.0810063278 dated 28.02.2007 export product Azithromycin tablets 250mg and 500mg. under para 4.7 of HBP. The Committee in light of its earlier decision (Minutes enclosed with the agenda) taken in its 16/08 meeting held on 21.08.2007 vide case No.B-233 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: Azithromycin tablets 250mg. Import items: water content NLT 5%)—---------------268.42mg/tablet Export product: Azithromycin tablets 500mg. Import items: water content NLT 5%)—---------------536.84mg/tablet

Case No.B-318

M/S Intas Pharma Ltd. NC Meeting No.22/08 F.No.01/82/50/1025/AM07/DES-III RLA F.No.08/24/40/85/AM07 Adv.Lic.No.0810057893 dated 10.07.2006 export product Azithromycin tablets 250mg and 500mg. under para 4.7 of HBP. The Committee in light of its earlier decision (Minutes enclosed with the agenda) taken in its 16/08 meeting held on 21.08.2007 vide case No.B-233 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: Azithromycin tablets 250mg. Import items: water content NLT 5%)—---------------268.42mg/tablet Export product: Azithromycin tablets 500mg. Import items: water content NLT 5%)—---------------536.84mg/tablet

Case No.B-319

M/S Intas Pharma Ltd. NC Meeting No.22/08 F.No.01/82/50/1565/AM07/DES-III RLA F.No.08/24/40/248/AM07 Adv.Lic.No.0810061717 dated

15.12.2006 export product Azithromycin tablets 250mg and 500mg. under para 4.7 of HBP. The Committee in light of its earlier decision (Minutes enclosed with the agenda) taken in its 16/08 meeting held on 21.08.2007 vide case No.B-233 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: Azithromycin tablets 250mg. Import items: water content NLT 5%)—---------------268.42mg/tablet Export product: Azithromycin tablets 500mg. Import items: water content NLT 5%)—---------------536.84mg/tablet

Case No.B-320

M/S Alkem Laboratories Ltd. NC Meeting No.22/08 F.No.01/82/50/1321/AM04/DES-III RLA F.No.03/24/40/2052/AM04 Adv.Lic.No.0310247427 dated 14.01.2004 export product Cefuroxime Sodium Injection 1.5gm, 750mg and 250mg under para 4.7 of HBP. their U.O. No.35011/241/2006-PI-III dated 04.10.2007 in the case of M/S Karnatake Antibiotics & Pharmaceuticals decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower.

Export Product: Cefuroxime Sodium Injection 1.5g (each vial contains 1.5g of Sterile Cefuroxime Sodium) BP/USP----------------------------13,83,20,000 Vials Import item: Sterile Cefuroxime Sodium BP/USP---------------------226.84kg Export product: Cefuroxime Sodium Injection 750mg (each vial contains 750mg of Sterile Cefuroxime Sodium) BP/USP----------------------------16,10,00,000 Vials Import item: Sterile Cefuroxime Sodium BP/USP---------------------132.02kg Export product: Cefuroxime Sodium Injection 250mg (each vial contains 250mg of Sterile Cefuroxime Sodium) BP/USP----------------------------42,50,000 Vials Import item: Sterile Cefuroxime Sodium BP/USP---------------------1.162kg.

Case No.B-321

M/S Shilpa Medicare Ltd, Raichur NC Meeting No.22/08 F.No.01/83/162/570/AM07/DES-III

Adv.Lic.No.0710014440 dated 20.06.2002 export product 3-Methyl Mercapto Phenothiazine under para 4.7 of HBP. their U.O. No.35011/274/2006-PI-III dated 04.10.2007 in the case of M/S Alchymars ICM SM Pvt. Ltd, decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: 3-Methyl Mercapto Phenothiazine------------------1Kg. Import items:

3-Metthyl Mercapto Acetanalide-------------------2.36kg/kg

Case No.B-322

M/S Shilpa Medicare Ltd, Raichur NC Meeting No.22/08 F.No.01/82/162/355/AM08/DES-III

Adv.Lic.No.0710015550 dated 13.08.2002 export product 3a 7a Dioxy Cholanic Acid under para 4.7 of HBP. The Committee in light of its earlier decision taken in its 10/87 meeting held on 23.06.2004 Vide Case No.14/07/87 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: 3a 7a Dihydroxy 5B Chlolanic Acid-------------------1Kg. Import items:

Cholic Acid---------------------------------------2.55kg/kg
Dimethyl Amino Pyridine---------------------0.048kg/kg
2-Methoxy Ethanol-----------------------------8.50kg/kg
Hydrazine Hydrate (80%)----------------------2.55kg/kg
Methanol------------------------------------------8.80kg/kg
Toluene--------------------------------------------5.32kg/kg
Acetone--------------------------------------------1.47kg/kg
Triethlamine--------------------------------------1.13kg/kg

Case No.B-323

M/S Neuland Laboratories Ltd.

NC Meeting No.22/08 F.No.01/83/162/737/AM07/DES-III

Committee considered case as per agenda for fixation of value addition for DEPB rate in respect of export product Mirtazapine (From 1-Methyl 3- Phenyl Piperazine route) SION at A-3622. Committee decided to refer the case to DEPB Committee with the value addition of 589%.

Case No.C-12

M/S New Medichem Ltd NC Meeting No.22/08 F.No.01/82/162/309/AM08/DES-III

Committee considered case as per agenda for fixation of SION for export product 4-(3,4-Dichloro Phenyl) 3,4-Dihydro-1-(2H) Napthalinone. for six weeks. Committee, accordingly, decided to defer case for six weeks.

Case No.C-13

M/S IPCA Labs Ltd. NC Meeting No.22/08 F.No.01/82/162/328/AM08/DES-III

Committee considered case as per agenda for fixation of SION for export product Morantel Citrate. for six weeks. Committee, accordingly, decided to defer case for six weeks.

Case No.C-14

M/S IPCA Labs Ltd. NC Meeting No.22/08 F.No.01/82/162/329/AM08/DES-III

Committee considered case as per agenda for fixation of SION for export product Hydroxy Chloroquine Sulphate.

for six weeks. Committee, accordingly, decided to defer case for six weeks.

Case No.C-15

M/S IPCA Labs Ltd. NC Meeting No.22/08 F.No.01/82/162/330/AM08/DES-III

Committee considered case as per agenda for fixation of SION for export product 3,4,5-Trimethoxy Toluene. for six weeks. Committee, accordingly, decided to defer case for six weeks.

Case No.C-16

M/S IPCA Labs Ltd. NC Meeting No.22/08 F.No.01/82/162/331/AM08/DES-III

Committee considered case as per agenda for fixation of SION for export product 6-Methoxy-2-Napthaldehyde. for six weeks. Committee, accordingly, decided to defer case for six weeks.

Case No.C-17

M/S S.M. Herbals Pvt. Ltd. NC Meeting No.22/08 F.No.01/82/162/443/AM08/DES-III

Committee considered case as per agenda for fixation of SION for export product Camptothecin. for six weeks. Committee, accordingly, decided to defer case for six weeks.

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