DGFT Committee Minutes

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

Para 4.7 Decision

MEETING NUMBER : 41/82-ALC4/2007 MEETING DATE : 12.02.2008 The Meeting No.41/08 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 due for 12.02.2008 was actually held on 03.03.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No11/08 dated 17.07.2007, 12/08 dated 24.07.2007, 13/08 dated 31.07.2007, 14/08 dated 07.08.2007 and 15/08 dated 15.08.2007 were ratified by the Committee.

Case No.B-536

M/s Alliance Laboratories Ltd M.No.41/08 F.No.01/82/50/424/AM 08 F.No.01/83/50/1037/AM 08 Meeting Date 12.02.2007 Adv. Lic. No. 0310430399 dt. 23.05.2007 Adv. Lic. No. 0310441279 dt. 30.08.2007 The Committee considered the case as per agenda for ratification of norms for the export product Iso Sorbide –5-Mononitrate under para 4.7 of HBP. Committee decided to defer the case for 04.03.2008 as the firm has requested for postponement of personal hearing to 04.03.2008.

Case No.B-537

M/s Aurobindo Pharma Ltd M.No.41/08 F.No.01/87/50/641/AM 07 F.No.01/87/50/400/AM 08 RLA F. No. 09/24/40/134/AM07 RLA F. No. 09/24/40/50/AM08 Adv. Lic. No.0910027866 dt. 18.10.2006 Adv. Lic. No.0910030397 dt. 31.05.2007

for the export product Metformin HCL under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/81/2007-PI-III dated 11.02.2008 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 Sl.N o. Import items Qty. allowed per unit of export product Metformin Hcl 1kg. 1. Di

Cyano Diamide 0.567kg/kg 2. Activated Carbon 0.0546kg/kg 3. Isoamyl alcohol 0.258kg/kg 4. Methanol 1.90kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-538

M/s Pab Organics Pvt.Ltd M.No.41/08 F.No.01/83/50/1052/AM 07 RLA F. No. 33/24/40/219/AM07 Adv. Lic. No.3410017696 dt. 22.12.2006 for the export product 5-Bromo Phthalide under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide 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% 3.35kg/kg 2. 5-Amino Phthalide 0.87kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-539

M/s Unilab Chemical and Pharma Ltd M.No.41/08 F.No.01/82/50/723/AM 08

Adv. Lic. No. 0310126341 dt. 25.2.2002 for the export product under para 4.7 of HBP. Committee observed that the Advance Authorisation was issued on 25.02.2002 while the representation of the firm has been received in this Directorate on 11.10.2007. Representation has been received almost after 5 years. Committee, therefore, decided to maintain status quo.

Case No.B-540

M/s Resonance Laboratories Ltd M.No.41/08 F.No.01/83/50/171/AM 08 RLA F. No. 07/24/40/48/AM08 Adv. Lic. No.0710051363 dt. 23.04.2007 The Committee considered the case as per agenda for ratification of norms for the export product 1-[2,6 DICHLORO-4(TRIFLUOROMETHYL)PHENYL]-5-[PYRIDINE-2- YLMETHYLENE) AMINO]1H-PYRAZOLE-3- CARBONITRILE(C-6900) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/105/2007-PI-III dated 25.01.2008 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 Sl.N o. Import items Qty. allowed per unit of export product 1,[2,6-dichloro-4(trifluoro methyl) Phenyl]-5-[Pyridine-2- yl-methylene)

Amino]1-H- Pyrazole-3-carbonitrile 1kg. 1. 2-Mithoxy

Ethyl Cyanoacetate 0.77kg/k g 2. 2,6-dichloro-4- trifluoro

methyl aniline 1.09kg/k g 3. Pyridine-2-aldehyde 0.56kg/k g RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-1060

M/s Bal Pharma Ltd M.No.41/08 F.No.01/82/50/277/AM 08 RLA F. No. 07/24/40/617/AM08 Adv. Lic. No. 071054687 dt28.11.2007 for the export 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-1061

M/s Cipla Ltd M.No.41/08 F.No.01/82/50/274/AM 08 RLA F. No. 03/94/40/895/AM08 Adv. Lic. No.0310451841 dt. 28.11.2007 for the export product Efavir Capsules under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1062

M/s Cipla Ltd M.No.41/08 F.No.01/82/50/320/AM 08 RLA F. No. 03/24/40/2359/AM04 Adv. Lic. No.0310252990 dt. 13.02.2004 for the export product Amoxycillin P.F. Suspension Syrup 250 Mg/5ML (Pack Size 100ML) Powder for oral Suspension Syrup) under para 4.7 of HBP. Committee decided to call for a complete history of the case from RA through D.O. letter from Export Commissioner (Chairman of Committee). Accordingly, case was deferred for six weeks.

Case No.A-1063

M/s Glenmark Pharmaceutical Ltd M.No.41/08 F.No.01/82/50/287/AM 08 RLA F. No. 03/24/40/514/AM04 Adv. Lic. No.0310210799 dt. 27.06.2003 for the export product Linezolid under para 4.7 of HBP. Committee decided to call for a complete history of the case from RA through D.O. letter from Export Commissioner (Chairman of Committee). Accordingly, case was deferred for six weeks.

Case No.B-1064

M/s Glenmark Pharmaceutical Ltd M.No.41/08 F.No.01/82/50/322/AM 08 RLA F. No. 03/24/40/583/AM04 Adv. Lic. No.0310212698 dt. 08.07.2003 for the export product Tenoxicam under para 4.7 of HBP. Committee decided to call for a complete history of the case from RA through D.O. letter from Export Commissioner (Chairman of Committee). Accordingly, case was deferred for six weeks.

Case No.A-1065

M/s Bal Pharma Ltd M.No.41/08 F.No.01/82/50/333/AM 08 RLA F. No. 07/24/40/721/AM08 Adv. Lic. No. 0710055464 dt. 16.01.2008 for the export 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-1066

M/s Codexis Laboratories (I) Ltd M.No.41/08 F.No.01/82/50/332/AM 08 RLA F. No. 05/24/40/725/AM08 Adv. Lic. No. 0510214137 dt. 28.12 . 2007 for the export product (4R-CIS)-1-Dimethylethyl-6-Cyanomethyl-2,2-Dimethyl-1-3- Dioxane –4-Acetate(Pharma Grade)NLT99% under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

Case No.A-1067

M/s Matrix Ltd M.No.41/08 F.No.01/83/50//AM 08 RLA F. No. 09/24/40/243/AM08 Adv. Lic. No.0910031765 dt. 15.10.2007 for the export product Efavirenz Stage under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

Case No.A-1068

M/s Matrix Ltd M.No.41/08 F.No.01/82/50/261/AM 08 RLA F. No. 09/24/40/255/AM08 Adv. Lic. No. 0910031766 dt. 15.10.2007

for the export product Levetiracetam under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

Case No.A-1069

M/s Lupin Ltd M.No.41/08 F.No.01/82/50/119/AM 08 RLA F. No. 03/95/40/293/AM08 Adv. Lic. No 0310433980. dt. 26.6.2007 for the export product Sterile Ceftriazone Sodium 1gm Injection,Sterile Ceftriaxone Sodium 2 mg Injection and Sterile Ceftriaxone Sodium 250 mg Injection under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1070

M/s Promed Export Pvt. Ltd M.No.41/08 F.No.01/82/50/300/AM 08 RLA F. No. 05/24/40/677/AM08 Adv. Lic. No.0510213441 dt. 12.12.2007 for the export product Inokain Eye Drops 0.4% Solution under para 4.7 of HBP. Committee in light of its earlier decision taken in its 9/82 meeting held on 03.07.2007 vide Case No.30/9/82 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 Quantity Sl.N o. Import item Qty. allowed per unit of export product Inokain Eye Drops 0.4%

solution (Vial 5ml No.1) 1No. 1. Benoxinate Hcl 0.021gm/5ml Vial RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-1071

M/s Unimark Remidies Ltd. M.No.41/08 F.No.01/82/50/331/AM 08 RLA F. No. 03/95/40/1422/AM06 Adv. Lic. No. 0310369915 dt. 03.03.2006

for the export product Amoxicillin Trihydrate under para 4.7 of HBP. Committee decided to ratify norms as per revised SION at Sl.No.A-57 published vide Public Notice No.58 dated 26.09.2006. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-1072

M/s Sandoz Pvt.Ltd M.No.41/08 F.No.01/82/50/330/AM 08 RLA F. No. 03/95/40/1493/AM06 Adv. Lic. No.0310374312 dt. 31.03.2006 for the export product Rifampicin under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O.No.35011/180/2006-PI-III dated 03.03.2008 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 Sl.N o. Import items Quantity allowed per unit of export product Rifampicin 1 Kg. 1. Rifa-S 1.02kg/kg 2. Dimethyl formamide 0.80kg/kg 3. Tertiary Butylamine 0.314kg/kg 4. Piperazine Anhydrous 0.120kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.C-31

M/s Vital Healthcare Ltd M.No.41/08 F.No.01/82/162/705/AM 08 The Committee considered the case as per agenda for fixation of Standard I/O norms SION for the export product Quinine Hydrochloride. Committee decided to defer case for six weeks.

Case No.C-32

M/s Vital Healthcare Ltd M.No.41/08 F.No.01/82/162/691/AM 08

The Committee considered the case as per agenda for fixation of Standard I/O norms SIONA-3542 for the export product Quinine Bisulphate. Committee decided to defer case for six weeks.

Case No.C-33

M/s Vital Healthcare Ltd M.No.41/08 F.No.01/82/162/692/AM 08 The Committee considered the case as per agenda for fixation of Standard I/O norms SIONA-2463 for the export product Quinine Sulphate. Committee decided to defer case for six weeks.

Case No.C-34

M/s Vital Healthcare Ltd M.No.41/08 F.No.01/82/162/690/AM 08 The Committee considered the case as per agenda for fixation of Standard I/O norms SION A-3314 for the export product Quinine Dihydrochloride. Committee decided to defer case for six weeks.

1

Case No.:31/30/87-

ALC1/2005 Party Name:ALKALOIDS CORP Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/87/050/00870/AM06/ RLA File : 02/24/040/00154/AM06/ Lic.No/Date:02100827 77 17.10.2005

Decision :Committee considered case as per agenda for ratification of norms for export product Cascara Dry Extract under para 4.7 of HBP. Committee decided to withdraw case as same has already been approved in its 38/08 meeting held on 22.01.2008. 2

Case No.:31/47/82-

ALC1/2005 Party Name:CALYX CHEMICALS & PHARMACEUTICALS PVT.LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case withdrawn HQ File : 01/82/050/01335/AM06/ RLA File : 03/94/040/01210/AM06/ Lic.No/Date:03103656 92 03.02.2006

Decision : Committee considered case as per agenda for ratification of norms for export product under para 4.7 of HBP. Committee decided to withdraw case as same has already been considered in its 40/08 meeting held on 12.02.2008. 3

Case No.:11/34/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Approved HQ File : 01/87/050/00566/AM07/ RLA File : 02/24/040/00189/AM07/ Lic.No/Date:02100940 06 25.09.2006

norms for export product Senega Soft Extract under para 4.7 of HBP. Committee in light of report forwarded by Department of MSME vide their U.O. No.23(17)/2005-Chem dated 22.01.2008 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 Senega

Soft 1kg. Senega

(Polygala 3.99kg/kg

Extract Senega) Root RA concerned may take further necessary action as per above decision of Norms Committee. 4

Case No.:803/21/82-

ALC4/2007 Party Name:GLOCHEM INDUSTRIES LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/82/050/01546/AM07/ RLA File : 09/24/040/00403/AM07/ Lic.No/Date:09100289 64 10.01.2007 Defer Date: 15.04.2008 norms for export product Amlodipine under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 5

Case No.:16/49/82-

ALC1/2006 Party Name:LUPIN LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/82/050/01721/AM07/ RLA File : 03/95/040/01297/AM07/ Lic.No/Date:03104167 16 22.01.2007 Defer Date: 01.04.2008 norms for export product Sterile Ceftriaxone Sodium Non Infringing under

para 4.7 of HBP.

Committee decided that case may be examined on file. 6

Case No.:445/24/83-

ALC1/2007 Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01268/AM07/ RLA File : 09/24/040/00478/AM07/ Lic.No/Date:09100294 28 22.02.2007 : norms for export product {3-5[Bromo1-(flurophenyl)(1,3-dihydro isobenzo furanyl)]propyl} dimehylamine oxalate under para 4.7 of HBP. Committee decided to withdraw case as case has been considered in its 40/08 meeting. 7

Case No.:3/22/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn

HQ File : 01/83/050/01367/AM07/ RLA File : 09/24/040/00505/AM07/ Lic.No/Date:09100297 69 26.03.2007

norms for export product 1-Acetylamino-5-Nitro-2-Propoxy Benzene under

para 4.7 of HBP.

Committee decided to withdraw case as case has been considered in its 40/08 meeting. 8

Case No.:25/14/83-

ALC1/2007 Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Deferred HQ File : 01/83/050/00016/AM08/ RLA File : 04/24/040/00501/AM07/ Lic.No/Date:04100887 27 02.04.2007 Defer Date: 01.04.2008 norms for export product Allylestrenol under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division. 9

Case No.:9/21/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/82/050/00009/AM08/ RLA File : 09/24/040/00543/AM07/ Lic.No/Date:09100299 31 10.04.2007

norms for export product 7-Amino-3[(Z/E)-1-Propen-1-YL]-3-Cepham-1- Carboxylic Acid (APRA) under para 4.7 of HBP. Committee decided to withdraw case as case has been considered in its 40/08 meeting. 10 Case No.:550/24/83- ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00188/AM08/ RLA File : 09/24/040/00526/AM07/ Lic.No/Date:09100301 04 25.04.2007 Defer Date: 15.04.2008 norms for export product Propafenone Hydrochloride under para 4.7 of

HBP. Committee decided to defer case for six weeks for comments of PI Division. 11

Case No.:566/24/83-

ALC1/2007 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00239/AM08/ RLA File : 05/24/040/00080/AM08/ Lic.No/Date:05102032 07 03.05.2007

norms for export product Montelukast Sodium Min Assay 97% under para 4.7 of HBP. Committee decided to withdraw case as case has been approved in its 38/08 meeting held on 22.01.2008. 12

Case No.:614/24/83-

ALC1/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Approved HQ File : 01/83/050/00369/AM08/ RLA File : 03/95/040/01471/AM07/ Lic.No/Date:03104300 58 21.05.2007

norms for export product Ultrazyme Tablets (7458X) [Contact Lens Cleaning Tablets] 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/05/228/2006-PID dated 20.02.2008 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 Sl.N o. Import items Qty. allowed per unit of export product Ultrazyme tablets (7458X) (Contact lense cleaning tablets) 1 unit (1000 tablets) 1. Subtilisin sorbitol 0.01155kg/unit of 1000 tablets 2. Aluiminium foil plain

not exceeding

60 micron 0.5250kg/unit of 1000 tablets

RA concerned may take further necessary action as per above decision of Norms Committee. 13

Case No.:636/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00412/AM08/ RLA File : 09/24/040/00531/AM07/ Lic.No/Date:09100303 65 28.05.2007 Defer Date: 15.04.2008 norms for export product Cyclohexyl Ester under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 14

Case No.:642/24/83-

ALC1/2007 Party Name:DEVATS (INDIA) PVT.LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00422/AM08/ RLA File : 05/24/040/00921/AM07/ Lic.No/Date:05102041 73 29.05.2007

norms for export product Nystatin Oral Suspension (USP) under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 36/08 meeting held on 08.01.2008. 15

Case No.:655/24/83-

ALC1/2007 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Deferred HQ File : 01/83/050/00530/AM08/ RLA File : 08/24/040/00066/AM08/ Lic.No/Date:08100654 23 15.06.2007 Defer Date: 15.04.2008 norms for export product Methscopolamine Tannete under para 4.7 of HBP. Committee observed that firm was requested to furnish technical details vide letter dated 04.02.2008 but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for six weeks. 16 Case No.:712/24/83- ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn

HQ File : 01/83/050/00584/AM08/ RLA File : 03/94/040/00192/AM08/ Lic.No/Date:03104329 14 18.06.2007

norms for export product Testosterone under para 4.7 of HBP. approved in its 39/08 meeting held on 29.01.2008. 17

Case No.:83/19/83-

ALC1/2007 Party Name:SUMITOMO CHEMICAL INDIA PRIVATE LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00643/AM08/ RLA File : 03/95/040/01529/AM07/ Lic.No/Date:03104338 38 25.06.2007 Defer Date: 15.04.2008 norms for export product 1,2-Methylenedioxy benzene under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical Division of C&PC for their comments. Accordingly case was deferred for six weeks. 18

Case No.:726/24/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00613/AM08/ RLA File : 04/24/040/00113/AM08/ Lic.No/Date:04100901 30 28.06.2007

norms for export product 2-Fluoro Adenosin Triacetate (2-FAT) under para 4.7 of HBP. Considered in its 40/08 meeting.
19 Case No.:728/24/83- ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00615/AM08/ RLA File : 04/24/040/00111/AM08/ Lic.No/Date:04100901 32 28.06.2007

norms for export product Clopidogrel Bisulphate under para 4.7 of HBP. Committee decided to withdraw case as case has already been 20

Case No.:727/24/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00614/AM08/ RLA File : 04/24/040/00112/AM08/ Lic.No/Date:04100901 31 28.06.2007

norms for export product Levetiracetam under para 4.7 of HBP. 21

Case No.:731/24/83-

ALC1/2007 PHARMA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00624/AM08/ RLA File : 09/24/040/00425/AM07/ Lic.No/Date:09100306 91 29.06.2007

norms for export product Sertraline Mandelate under para 4.7 of HBP. 22

Case No.:19/23/83-

ALC1/2007 Party Name:SEQUENT SCIENTIFIC LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00655/AM08/ RLA File : 07/24/040/00234/AM08/ Lic.No/Date:07100523 01 04.07.2007

norms for export product L-(+)-Selenomethionine under para 4.7 of HBP. 23 Case No.:771/24/83- ALC1/2007 Party Name:PRACHI PHARMACEUTICALS PVT LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn

HQ File : 01/83/050/00709/AM08/ RLA File : 03/95/040/00308/AM08/ Lic.No/Date:03104357 14 11.07.2007

norms for export product Thiamine Hydrochloride BP/USP under para 4.7 of HBP. 24

Case No.:768/24/83-

ALC1/2007 Party Name:LIQUORS INDIA LTD, Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00702/AM08/ RLA File : 09/24/040/00142/AM08/ Lic.No/Date:09100308 64 12.07.2007

norms for export product Lovastatin under para 4.7 of HBP. 25

Case No.:797/24/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00755/AM08/ RLA File : 05/24/040/00286/AM08/ Lic.No/Date:05102063 21 16.07.2007 Defer Date: 01.04.2008 norms for export product Citalopram Hydrobromide under para 4.7 of HBP. Committee observed that firm has been requested to furnish information but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 26 Case No.:905/24/83- ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00915/AM08/ RLA File : 03/95/040/01473/AM07/ Lic.No/Date:03104368 39 19.07.2007

norms for export product Carvedilol BP under para 4.7 of HBP.

Committee decided to withdraw case as case has already been 27

Case No.:906/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00916/AM08/ RLA File : 03/95/040/01472/AM07/ Lic.No/Date:03104368 43 19.07.2007

norms for export product Setralone (Tetralone) under para 4.7 of HBP. Committee decided to withdraw case as case has already been 28

Case No.:829/24/83-

ALC1/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00821/AM08/ RLA File : 09/24/040/00042/AM08/ Lic.No/Date:09100309 72 23.07.2007 Defer Date: 01.04.2008 norms for export product Cis-4-Amino-3-Methoxy-Piperidine-1-Carboxylic Acid Ethyl Ester Monohydrochloride under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division. 29

Case No.:840/24/83-

ALC1/2007 Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status Case Withdrawn: HQ File : 01/83/050/00837/AM08/ RLA File : 09/24/040/00155/AM08/ Lic.No/Date:09100309 99 25.07.2007

norms for export product {3-5[Bromo-1-(flurophenyl)(1,3-dihydro isobenzo furanyl)]-propyl]dimehylamine oxalate under para 4.7 of HBP. 30 Case No.:95/21/82- ALC4/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Approved

HQ File : 01/82/050/00144/AM08/ RLA File : 03/95/040/00389/AM08/ Lic.No/Date:03104375 08 26.07.2007

norms for export product Hydrocare Tablets (Contact Lens Cleaning Tablets) under para 4.7 of HBP. Committee in light of written comments forwarded by Deptt. of Biotechnology vide their O.M. No.BT/IL/05/228/2006-PID dated 20.02.2008 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 Sl.N o. Import items Quantity allowed per unit

of export product Hydrocare Tablets (Contact Lense Cleaning Tablets 1 Unit (1000 tablets) 1. Prolase (Papain) 0.0142kg/uni t of 1000 tablets 2. L-Cysteine

Hcl Monohydrate 0.01501kg/u nit of 1000 tablets 3. Aluminium Foil not exceeding 60 Micron 0.18541kg/u nit of 1000 tablets 4. Seal

temper evident 26mm Diameter 63.75Nos/un it of 1000 tablets 5. Vials right 63.75Nos/un it of 1000 tablets 6. Vials left 63.75Nos/un it of 1000 tablets of Norms Committee. 31 Case No.:3/18/82- ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/82/050/00142/AM08/ RLA File : 03/94/040/00455/AM08/ Lic.No/Date:03104384 06 06.08.2007

norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP. Considered in its 39/08 meeting held on 29.01.2008. 32

Case No.:876/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/00880/AM08/ RLA File : 09/24/040/00161/AM08/ Lic.No/Date:09100310 51 06.08.2007

norms for export product Cyclohexyl Ester under para 4.7 of HBP. 33

Case No.:113/21/82-

ALC4/2007 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Rejected HQ File : 01/82/050/00157/AM08/ RLA File : 22/24/040/00030/AM08/ Lic.No/Date:22100069 84 20.08.2007

norms for export product Cefposoxime Proxetil under para 4.7 of HBP. Committee observed that firm was requested to furnish technical details as per Appendix 33 vide letter dated 21.01.2008 but same has not been received. Committee, therefore, decided to close the case, of Norms Committee. 34 Case No.:6/25/83- ALC1/2007 Party Name:BIOCHEMICAL & SYNTHETIC PRODUCTS LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01031/AM08/ RLA File : 09/24/040/00055/AM08/ Lic.No/Date:09100313 13 29.08.2007 Defer Date: 15.04.2008 norms for export product 4-Acetamido-5-Bromo-2-Methoxy Benzoic Acid Methyl Ester (Bromomethopabate) under para 4.7 of HBP.

Committee decided to defer case for six weeks for comments of PI Division. 35

Case No.:42/25/83-

ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01067/AM08/ RLA File : 03/94/040/00299/AM08/ Lic.No/Date:03104414 32 30.08.2007

norms for export product Nitazoxanide under para 4.7 of HBP. 36

Case No.:12/27/83-

ALC1/2007 ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01086/AM08/ RLA File : 03/94/040/00555/AM08/ Lic.No/Date:03104415 61 31.08.2007

norms for export product Saquinavir 200mg Capsules Sazvir 200mg Capsules under para 4.7 of HBP. 37

Case No.:6/27/83-

ALC1/2007 Party Name:VANI CHEMICALS & INTERMEDIATES LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01080/AM08/ RLA File : 09/24/040/00009/AM08/ Lic.No/Date:09100313 30 31.08.2007 Defer Date: 01.04.2008 norms for export product 4-(3,4-Dichlorophenyl)1-Tetralone under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division. 38 Case No.:4/22/82- ALC4/2007 PHARMA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Approved

HQ File : 01/82/050/00174/AM08/ RLA File : 09/24/040/00207/AM07/ Lic.No/Date:09100313 28 31.08.2007

norms for export product Cefoperazone Sodium Sterile USP/BP under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/81/2007-PI-III dated 11.02.2008 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 Sl.N o. Import items Qty allowed per unit of export product Cefoperazone Sodium Sterile 1kg. 1. 7- Aminocephalospor anic Acid (7-ACA) 0.6803kg/k g 2. 1-Methyl-5- Mercapto-1,2,3,4 Tetrazole (MMTZ) 0.2993kg/k g 3. D(-)2-[(4-Ethyl-2,3 Diaxo-1- Piperazinyl)- Carbobyl Amino]HOEPCP 0.8766kg/k g 4. Dimethyl Acetamide 2.32kg/kg 5. Methylene chloride 1.98kg/kg 6. Acetonitrile 2.50kg/kg 7. Acetone 0.83kg/kg 8. Activated carbon 0.100kg/kg 9. Aluminium Canisters 14 Ltrs (5kg capacity) with inner and outer lids and Gaskets As

per packing policy of Norms Committee. 39 Case No.:5/27/83- Meet No/Date:41/82- Status:

ALC1/2007 PHARMA LIMITED ALC4/2007 12.02.2008 Case Withdrawn HQ File : 01/83/050/01079/AM08/ RLA File : 09/24/040/00234/AM08/ Lic.No/Date:09100313 29 31.08.2007

norms for export product Florfenicol under para 4.7 of HBP. 40

Case No.:9/27/83-

ALC1/2007 Party Name:OM SHREE PHARMACHEM PVT.LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e withdrawn HQ File : 01/83/050/01083/AM08/ RLA File : 03/95/040/00534/AM08/ Lic.No/Date:03104415 37 31.08.2007

norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee decided to withdraw case to be re-listed on 4.3.2008 as firm has been called for personal hearing on 4.03.2008. 41

Case No.:29/27/83-

ALC1/2007 Party Name:AVENTIS PHARMA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01103/AM08/ RLA File : 03/94/040/00521/AM08/ Lic.No/Date:03104417 08 03.09.2007

norms for export product Ramipril Precurson II (Step 3) under para 4.7 of HBP. 42 Case No.:33/27/83- ALC1/2007 PHARMA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Approved HQ File : 01/83/050/01107/AM08/ RLA File : 09/24/040/00192/AM07/ Lic.No/Date:09100314 03 05.09.2007

norms for export product GCLE-Stage-I under para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/81/2007-PI-III dated 11.02.2008 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 Sl.N o. Import items Qty allowed per unit of export product GCLE

Stage- 1[Pen

G Sulfoxide PMB Ester) 1kg. 1. Pencillin

G Potassium

1st Crystal 0.89BOU/kg 2. Hydrogen Peroxide 0.247kg/kg 3. Acetic Acid 0.509kg/kg 4. Dimethyl Acetamide 0.948kg/kgk g/kg 5. Methylene chloride 1.55kg/kg of Norms Committee. 43 Case No.:32/27/83- ALC1/2007 PHARMA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Approved HQ File : 01/83/050/01106/AM08/ RLA File : 09/24/040/00388/AM07/ Lic.No/Date:0910031 402 05.09.2007

norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/81/2007-PI-III dated 11.02.2008 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 Sl.N o. Import items Qty allowed per unit of export product Cefpodoxime Proxetil 1kg. 1. 7 ACA 0.998kg/kg 2. 1,8-diazabicyclo [5.4.0]-undec-7-ene 0.341kg/kg

18-crown-6-ether 0.023kg/kg 4. 1-iodo

ethyl isopropy carbonate 0.7412kg/k g 5. 4-Dimethyl amino Pyridine 0.006kg/kg 6. Acetone 1.10kg/kg 7. Carbon Enoanticromos (Activated Carbon) 0.100kg/kg 8. Isopropyl alcohol 0.150kg/kg 9. Mercaptobenzothia zole-4-yl-2-(2- Amino)thiazoly)- Methoxyimino Acetate (MAEM) 0.998kg/kg 10. Methanol 3.85kg/kg 11. Methylene chloride 2.65kg/kg 12. N,N-Dimethyl Acetamide 1.95kg/kg 13. Iodine 0.469kg/kg 14. Sulfolane 1.29kg/kg 15. Tetrahydrofuran 0.52kg/kg 16. Triethylamine 0.562kg/kg 17. Tri phosgene 0.6421kg/k g of Norms Committee. 44 Case No.:31/27/83- ALC1/2007 PHARMA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Approved HQ File : 01/83/050/01105/AM08/ RLA File : 09/24/040/00470/AM07/ Lic.No/Date:09100314 01 05.09.2007

norms for export product Pivmecillinam Hydrochloride under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/81/2007-PI-III dated 11.02.2008 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 Sl.N o. Import items Qty allowed per unit of export product Pivmecillinam Hcl 1kg. 1. 6-Amino Penicillanic

Acid (6-APA) 1.09kg/kg 2. Activated Carbon 0.020kg/kg 3. Di isopropyl ether 2.85kg/kg 4. Dimethyl formamide 0.86kg/kg 5. Hexmethyleneimin e 0.42kg/kg 6. IPA 1.75kg/kg 7. Methanol 2.34kg/kg 8. Methylene chloride 4.38kg/kg 9. Oxalyl chloride 0.58kg/kg 10. Pivaloyl chloride 0.69kg/kg 11. Potassium Carbonate 0.116kg/kg 12. Triethylamine 1.32kg/kg of Norms Committee. 45

Case No.:61/27/83-

ALC1/2007 Party Name:APITHECARY PHARMA PVT LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01135/AM08/ RLA File : 09/24/040/00147/AM08/ Lic.No/Date:09100314 43 07.09.2007

norms for export product Omeprazole Sulphide or 5-Methoxy-2-[([4- Methoxy-3,5-Dimethyl-2-Pyridine-2-Methyl]Thio]-1H-Benzimidazole under

para 4.7 of HBP.

46 Case No.:72/27/83- ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : RLA File : Lic.No/Date:03104424 Defer

01/83/050/01146/AM08/ 03/95/040/00570/AM08/ 36 11.09.2007 Date: 01.04.2008 norms for export product Sterile Ceftriaxone Sodium Non Infringing under

para 4.7 of HBP.

Committee decided to examine the case on file. 47

Case No.:10/22/82-

ALC4/2007 ALC4/2007 12.02.2008 Status:Cas e 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: 01.04.2008 norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division. 48

Case No.:111/27/83-

ALC1/2007 ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01185/AM08/ RLA File : 03/94/040/00622/AM08/ Lic.No/Date:03104433 42 17.09.2007

norms for export product Losartan Potassium under para 4.7 of HBP. Considered in its 39/08 meeting held on 29.01.2008. 49

Case No.:129/27/83-

ALC1/2007 ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01203/AM08/ RLA File : 03/94/040/00632/AM08/ Lic.No/Date:03104435 48 18.09.2007

norms for export product Sibutramine Hydrochloride under para 4.7 of HBP.

50

Case No.:13/22/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/82/050/00183/AM08/ RLA File : 13/24/040/00018/AM08/ Lic.No/Date:13100250 51 21.09.2007

norms for export product Biotin Granules under para 4.7 of HBP. 51

Case No.:14/22/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/82/050/00184/AM08/ RLA File : 13/24/040/00017/AM08/ Lic.No/Date:13100250 52 21.09.2007

norms for export product Vitamin B12 Granules under para 4.7 of HBP. 52

Case No.:160/27/83-

ALC1/2007 ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01234/AM08/ RLA File : 03/94/040/00658/AM08/ Lic.No/Date:03104442 08 25.09.2007

norms for export product Lamivudine under para 4.7 of HBP. 53 Case No.:191/27/83- ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01265/AM08/ RLA File : 04/24/040/00235/AM08/ Lic.No/Date:04100912 80 01.10.2007

norms for export product [Alpha-(Alpha,Bita)]-Beta-Methyl-Alpha-Phenyl-1- Pyrrolidineethanol Base (Pyrrolidinyl Nor ephedrine Base) under para 4.7 of HBP. 54

Case No.:1/25/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Approved HQ File : 01/82/050/00195/AM08/ RLA File : 13/24/040/00019/AM08/ Lic.No/Date:13100250 71 01.10.2007

norms for export product Alpha Lipoic Acid granules 95% under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division 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 Sl.N o. Import items Qty. allowed per unit of export product Alpha

lipoic Acid Granules 95% 1kg. 1. Alpha Lipoic Acid USP 28 0.9595kg/k g 2. Gum Acacia 0.05kg/kg of Norms Committee. 55

Case No.:2/25/82-

ALC4/2007 ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00196/AM08/ RLA File : 03/94/040/00664/AM08/ Lic.No/Date:03104450 42 03.10.2007 Defer Date: 01.04.2008 norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

56

Case No.:25/29/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Case Approved HQ File : 01/83/050/01290/AM08/ RLA File : 03/94/040/00684/AM08/ Lic.No/Date:0310445 036 03.10.2007

norms for export product Lamivudine under para 4.7 of HBP:- Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007-PI-III dated 28.01.2008 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 Expor t Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Lamivudine

1kg. 1.
(2R.5S)-5-[4-Aceta,odp- 2- Pxp-1(2H)- Pyrimidinyl]-1,3- Oxathiolan-2-YL, Methyl Methyl Carbonate 2.63kg/kg of Norms Committee. 57

Case No.:9/29/83-

ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01274/AM08/ RLA File : 09/24/040/00278/AM08/ Lic.No/Date:09100317 04 04.10.2007

norms for export product Tenofovir Disoproxil Fumarate under para 4.7 of HBP. 58 Case No.:33/29/83- ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn

HQ File : 01/83/050/01298/AM08/ RLA File : 09/24/040/00244/AM08/ Lic.No/Date:09100317 13 05.10.2007

norms for export product {1R,2S,5R}-Methyl-5S0(Cytosine-1-YL)-1,3- Oxathiolane-2R-Carboxylate/CME Compound under para 4.7 of HBP. 59

Case No.:43/29/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01308/AM08/ RLA File : 09/24/040/00259/AM08/ Lic.No/Date:09100317 15 08.10.2007

norms for export product Cytosine Menthyl Ester (CME) under para 4.7 of HBP. 60

Case No.:7/25/82-

ALC4/2007 Party Name:MADAUS PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/82/050/00201/AM08/ RLA File : 17/24/040/00068/AM08/ Lic.No/Date:17100017 75 09.10.2007

norms for export product Agiolax (Bulk Granular Laxative Formulation) under para 4.7 of HBP. Considered in its 37/08 meeting held on 15.01.2008. 61 Case No.:102/29/83- ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01367/AM08/ RLA File : 09/24/040/00271/AM08/ Lic.No/Date:09100317 98 16.10.2007

norms for export product 2-Chloro-N-(2-Chloro-4-Methyl-3-Pyridinyl)-3- Pyridine Carboxamide under para 4.7 of HBP.

62

Case No.:4/30/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01373/AM08/ RLA File : 09/24/040/00304/AM08/ Lic.No/Date:09100318 10 17.10.2007 : norms for export product 1-Acetylamino-5-Nitro-2-Propoxy Benzene under

para 4.7 of HBP.

63

Case No.:13/30/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01382/AM08/ RLA File : 09/24/040/00330/AM08/ Lic.No/Date:09100318 17 19.10.2007

norms for export product Atazanavir Sulfate under para 4.7 of HBP. 64

Case No.:28/30/83-

ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01397/AM08/ RLA File : 09/24/040/00291/AM08/ Lic.No/Date:09100318 44 23.10.2007 Defer Date: 01.04.2008 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. Committee decided to defer case for four weeks for comments of PI Division. 65 Case No.:50/30/83- ALC1/2007 Party Name:JUPITER BIOSCIENCE LIMITED, Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn

HQ File : 01/83/050/01419/AM08/ RLA File : 09/24/040/00336/AM08/ Lic.No/Date:09100318 78 24.10.2007

norms for export product N-T-Boc-L-Phyenylalanine 99% purity under para 4.7 of HBP. 66

Case No.:28/32/83-

ALC1/2007 ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01450/AM08/ RLA File : 03/94/040/00789/AM08/ Lic.No/Date:03104483 09 29.10.2007

norms for export product Losartan Potassium under para 4.7 of HBP. 67

Case No.:10/28/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:41/82- ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/82/050/00244/AM08/ RLA File : 13/24/040/00020/AM08/ Lic.No/Date:13100252 80 01.11.2007

norms for export product Ascorbyl Palmitate Granules 95% under para 4.7 of HBP. 68 Case No.:69/32/83- ALC1/2007 ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01491/AM08/ RLA File : 03/94/040/00803/AM08/ Lic.No/Date:03104489 36 02.11.2007

norms for export product Simvastatin under para 4.7 of HBP.

Considered in its 39/08 meeting held on 29.01.2008. 69

Case No.:106/32/83-

ALC1/2007 ALC4/2007 12.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01528/AM08/ RLA File : 03/94/040/00804/AM08/ Lic.No/Date:03104492 08 05.11.2007

norms for export product Lamivudine under para 4.7 of HBP. Considered in its 39/08 meeting held on 29.01.2008.
70

Case No.:100/32/83-

ALC1/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01522/AM08/ RLA File : 05/24/040/00476/AM08/ Lic.No/Date:05102117 00 06.11.2007 Defer Date: 15.04.2008 norms for export product Pyrazolinone (Galaxy-1) under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical Division of C&PC. Accordingly, case was deferred for six weeks. 71

Case No.:4/33/83-

ALC1/2007 Party Name:ALKALOIDS CORPORATION Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01533/AM08/ RLA File : 02/24/040/00216/AM08/ Lic.No/Date:02101058 67 07.11.2007

Decision : Withdrawn 72 Case No.:35/39/83- ALC1/2007 PHARMA LIMITED Meet No/Date:41/82- ALC4/2007 12.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01614/AM08/ RLA File : 09/24/040/00164/AM07/ Lic.No/Date:09100322 58 28.11.2007

norms for export product Cephapirin Benzathine under para 4.7 of HBP. Committee decided to withdraw case as case has been approved in its 40/08 meeting. Date:06.02.2008 Place:New Delhi Shyam Lal Foreign Trade Development Officer