IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-11-13

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 : 28/82-ALC4/2007 MEETING DATE : 13.11.2007

Case No.B-383

M/s Aarti Drugs Ltd M.No.28/08 F.No.01/87/50/238/AM 07 Meeting Date 13.11.2007 RLA F. No. 03/94/40/361/AM07 Adv. Lic. No. 0310383220 dt. 6.6.2006 Committee considered the case as per agenda for amendment in the description of import item No1 under para 4.7 of HBP. Committee in light of written comments of PI Division enclosed with agenda decided to allow amendment in description of import item No.1 to read as ‘N-(2- Chlorobenzyl)-2-(Thipphen-2-YL)Ethanamine Hydrochloride. Other terms and quantities shall remain same. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-384

M/s Aurobindo Pharma Ltd. M.No.28/08 F.No.01/87/50/1062/AM 06 RLA F. No. 09/24/40/300/AM06 Adv. Lic. No. 0910024806 dt. 2.12.2005 The Committee considered the case as per agenda for allowing additional three inputs under para 4.7 of HBP. Committee in light of report received from PI Division vide their U.O. No.35011/165/2006-PI-III dated 14.02.2007 decided to allow additional inputs as per details below. Sl.No. Description of import items Quantity allowed 1. Potassium Carbonate 0.239kg/kg 2. Activated Carbon 0.101kg/kg 3. Dimethyl formadide 0.543kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.B-385

M/s Aurobindo Pharma Ltd. M.No.28/08 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. 31.5.2007 The Committee considered the case as per agenda for ratification of norms for the export product Metformin HCL under para 4.7 of HBP. Committee decided to call for production and consumption data certified by Central Excise Authority from firm and after receipt of data, case may be referred to PI Division for their comments.

Case No.B-386

M/s Auctus Pharma Ltd M.No.28/08 F.No.01/87/50/1106/AM 07 RLA F. No. 09/24/40/480/AM07 Adv. Lic. No. 0910029666 dt. 14.3.2007 The Committee considered the case as per agenda for correction in description of export product. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/274/2006 PI-III dated 13.11.2007 decided to allow amendment in description of export product to read as ‘5-(difluoromethoxy)-2-[3,4-dimethoxy-2- pyridinyl)methyl} thio]-1 H-benzimidazole (Pentaprazole sulphide). RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.B-387

M/s Artemis Biotech M.No.28/08 F.No.01/87/50/1324/AM 05 RLA F. No. 03/24/41/175/AM05 Adv. Lic. No. 03102310813 dt. 5.01.2005 for the export product Losarton 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. Accordingly, case was deferred for four weeks.

Case No.B-388

M/s Hemmo Pharma Ltd. M.No.28/08 F.No.01/82/50/1439/AM 05

RLA F. No. 03/24/41/156/AM05 Adv. Lic. No. 0310302356 dt. 17.11.2004 The Committee considered the case as per agenda for modification of norms for the export product Oxytocin Powder under para 4.7 of HBP. Committee decided to call for representative of firm again for personal hearing before Norms Committee in its meeting to be held on 18.12.2007. The representative may be asked to bring along copy of Advance Authorisation and copy of application. Accordingly, case was deferred for three weeks.

Case No.B-389

M/s Hemmo Pharma Ltd. M.No.28/08 F.No.01/82/50/464/AM 02 RLA F. No. 03/24/40/1025/AM02 Adv. Lic. No. 0310110660 dt. 19.11.2001 for the export product Oxytocin Powder under para 4.7 of HBP. Committee decided to call for representative of firm again for personal hearing before Norms Committee in its meeting to be held on 18.12.2007. The representative may be asked to bring along copy of Advance Authorisation and copy of application. Accordingly, case was deferred for three weeks.

Case No.B-390

M/s Hemmo Pharma Ltd. M.No.28/08 F.No.01/82/50/478/AM 05 RLA F. No. 03/24/40/582/AM05 Adv. Lic. No.031019241 dt. 18.8.2003 for the export product Oxytocin Powder under para 4.7 of HBP. Committee decided to call for representative of firm again for personal hearing before Norms Committee in its meeting to be held on 18.12.2007. The representative may be asked to bring along copy of Advance Authorisation and copy of application. Accordingly, case was deferred for three weeks.

Case No.B-391

M/s Hemmo Pharma Ltd. M.No.28/08 F.No.01/82/50/1763/AM 05 RLA F. No. 03/24/40/2256/AM05 Adv. Lic. No. 0310313830 dt. 27.1.2005

for the export product Oxytocin Solution under para 4.7 of HBP. Committee decided to call for representative of firm again for personal hearing before Norms Committee in its meeting to be held on 18.12.2007. The representative may be asked to bring along copy of Advance Authorisation and copy of application. Accordingly, case was deferred for three weeks.

Case No.B-392

M/s Hemmo Pharma Ltd. M.No.28/08 F.No.01/82/50/477/AM 04 RLA F. No. 03/24/42/281/AM04 Adv. Lic. No.0310219238 dt. 18.8.2003 for the export product Oxytocin Solution under para 4.7 of HBP. Committee decided to call for representative of firm again for personal hearing before Norms Committee in its meeting to be held on 18.12.2007. The representative may be asked to bring along copy of Advance Authorisation and copy of application. Accordingly, case was deferred for three weeks.

Case No.B-393

M/s Hemmo Pharma Ltd. M.No.28/08 F.No.01/82/50/338/AM 05 RLA F. No. 03/24/40/65/AM05 Adv. Lic. No. 0310265856 dt. 28.4.2004 for the export product Oxytocin Solution under para 4.7 of HBP. Committee decided to call for representative of firm again for personal hearing before Norms Committee in its meeting to be held on 18.12.2007. The representative may be asked to bring along copy of Advance Authorisation and copy of application. Accordingly, case was deferred for three weeks.

Case No.B-394

M/s Wockhardt Ltd M.No.28/08 F.No.01/82/162/549/AM 07 The Committee considered the case as per agenda for fixation of DEPB rate for the export product Captopril USP(Powder) Sl.No. A-103 . Committee decided to refer case to DEPB Committee recommending 75% value addition.

Case No.B-395

M/s Wockhardt Ltd M.No.28/08 F.No.01/82/162/548/AM 07

The Committee considered the case as per agenda for fixation of DEPB rate for the export product D-Oxyphene Base (Powder)Sl No. A-166 . Committee decided to re-check the data furnished by firm and defer the case for three weeks.

Case No.B-396

M/s SMS Pharmaceutical Ltd. M.No.28/08 F.No.01/83/162/424/AM 07 RLA F. No. 09/24/40/02/AM06 Adv. Lic. No.0910023407 dt. 5.7.2005 for the export product D-erythro,d-threo-2-Deoxy-2,2-difluro penta furanos-1 ulose-3,5-dibenzoate under para 4.7 of HBP. Committee decided to call for copy of technical literature in support of yield from firm. Accordingly case was deferred for six weeks.

Case No.B-397

M/s SMS Pharmaceutical Ltd. M.No.28/08 F.No.01/83/162/425/AM 07 RLA F. No. 09/24/40/377/AM06 Adv. Lic. No. 0910025027 dt. 28.11.2005 for the export product D-erythro,d-threo-2-Deoxy-2,2-difluro penta furanos-1 ulose-3,5-dibenzoate under para 4.7 of HBP. Committee decided to call for copy of technical literature in support of yield from firm. Accordingly case was deferred for six weeks.

Case No.B-398

M/s Sun Pharmaceutical Industries Ltd M.No.28/08 F.No.01/87/50/1662/AM 05 RLA F. No. 03/24/40/2810/AM05 Adv. Lic. No.0310322837 dt. 23.3.2005 The Committee considered the case as per agenda for ratification of norms for the export product 3 Chloro 5 Acety Iminodibenzyl (pure) under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in his Department and he sought deferment for four weeks. Accordingly, case was deferred for four weeks. It was also decided to link the earlier file of firm. It was also decided to link with earlier file of firm.

Case No.B-399

M/s Shilpa Medicare Ltd. M.No.28/08 F.No.01/87/50/1517/AM 06 RLA F. No. 07/24/40/1025/AM08 Adv. Lic. No. 0710043911 dt. 23.03.2006

for the export product N-[B-Dribofuranosyl]-5-Hydroxyimdiazole-4-Carboxamide Technical Grade under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in his Department and he sought deferment for four weeks for comments on the information received from firm. Accordingly, case was deferred for four weeks.

Case No.B-400

M/s Shasun Chemicals & Drugs Ltd. M.No.28/08 F.No.01/87/50/1540/AM 05 RLA F. No. 04/24/40/290/AM05 Adv. Lic. No0410067420 dt. 18.02.2005 for the export 4-(4-propyl-piperazin-1-YL) Benzoic Acid under para 4.7 of HBP. Committee in consultation with technical authorities present in meeting decided to enhance quantity of input ‘4-Fluorobenzoic Acid Methyl Ester’ from 1.11kg/kg to 1.63kg/kg only against this Advance Authorisation for regularization purpose. RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.B-401

M/s Shalina Laboratories Ltd M.No.28/08 F.No.01/83/50/1084/AM 07 RLA F. No. 03/95/40/1163/AM07 Adv. Lic. No.0310414239 dt. 2.1.2007 The Committee considered the case as per agenda for ratification of norms for the export product Betasol Lotion 30ML under para 4.7 of HBP. Committee observed that letter dated 26.10,2007 was issued to firm for seeking certain clarification, but inadvertently export product was mentioned wrongly. Committee, therefore, decided to issue revised letter to firm for seeking clarification. Accordingly, case was deferred for six weeks.

Case No.B-402

M/s Shalina Laboratories Ltd M.No.28/08 F.No.01/83/50/1083/AM 07 RLA F. No. 03/95/40/1164/AM07 Adv. Lic. No.0310414237 dt. 2.1.2007

for the export product Epiderm Lotion 30ML under para 4.7 of HBP. Committee observed that letter dated 26.10,2007 was issued to firm for seeking certain clarification, but same has not been received. Committee, therefore, decided to await reply of firm. Accoridngly, case was deferred for six weeks.

Case No.A-821

M/s Cipla Ltd. M.No.28/08 F.No.01/82/50/224/AM 08 RLA F. No. 03/94/40/708/AM08 Adv. Lic. No. 0310445737 dt. 09.10.2007 for the export product (1) Nevimune 200 MG Tablets/Nevirapine 200MG Tablet (2) Nevirapine oral suspension 50MG/5ML/Nevimune under para 4.7 of HBP. Committee decided to defer case as firm has been called for personal hearing on 20.11.2007.

Case No.A-822

M/s Cipla Ltd. M.No.28/08 F.No.01/82/50/223/AM 08 RLA F. No. 03/94/40/706/AM08 Adv. Lic. No.0310445735 dt. 09.10.2007 The Committee considered the case as per agenda for ratification of norms for the export product Lamivir under para 4.7 of HBP. It was decided to re-list the case after one week.

Case No.A-823

M/s Cipla Ltd. M.No.28/08 F.No.01/82/50/153/AM 08 RLA F. No. 03/94/40/485/AM08 Adv. Lic. No. 0310439033 dt. 09.08.2007 for the export product Gemcitabine Okasa Pharma under para 4.7 of HBP. Committee decided to defer case as firm has been called for personal hearing on 20.11.2007.

Case No.A-824

M/s Cipla Ltd. M.No.28/08 F.No.01/82/50/151/AM 08 RLA F. No. 03/94/40/431/AM08 Adv. Lic. No. 0310437633 dt. 27.07.2007

for the export product Telmisartain and Rampril Tablets 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 23.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export Product Quantity Import item Quantity allowed Telmisartan

Ramipril Tablets 40mg/2.5mg. 1 Tablet Telmisartan Granules 68.70mg/tablet Telmisartan

Ramipril Tablets 80mg/2.5mg. 1 Tablet Telmisartan Granules 137.41mg/tablet Telmisartan

Ramipril Tablets 40mg/10mg. 1 Tablet Telmisartan Granules 68.70mg/tablet Telmisartan

Ramipril Tablets 80mg/10mg. 1 Tablet Telmisartan Granules 137.41mg/tablet Telmisartan

Ramipril Tablets 40mg/5mgmg. 1 Tablet Telmisartan Granules 68.70mg/tablet Telmisartan

Ramipril Tablets 80mg/5mg. 1 Tablet Telmisartan Granules 137.41mg/tablet RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A-825

M/s Cipla Ltd. M.No.28/08 F.No.01/82/50/155/AM 08 RLA F. No. 03/94/40/473/AM08 Adv. Lic. No.0310438672 dt. 07.08.2007 for the export product Nevimune 200MG Tablets/Nevirapine 200MG Tablets under

para 4.7 of HBP.

Committee decided to defer case as firm has been called for personal hearing on 20.11.2007.

Case No.A-826

M/s Cipla Ltd. M.No.28/08 F.No.01/82/50/152/AM 08 RLA F. No. 03/94/40/437/AM08 Adv. Lic. No. 0310437618 dt. 27.07.2007

for the export product Triomune 30/Lamivudine stavudine and Nevirapine Tablets under para 4.7 of HBP. Committee decided to defer case as firm has been called for personal hearing on 20.11.2007.

Case No.A-827

M/s Cipla Ltd. M.No.28/08 F.No.01/82/50/188/AM 08 RLA F. No. 03/94/40/554/AM08 Adv. Lic. No. 0310441419 dt. 30.08.2007 for the export product 62/0 Lopinavir and Ritonavir Tablets under para 4.7 of HBP. Committee decided to defer case as firm has been called for personal hearing on 20.11.2007.

Case No.A-828

M/s Cipla Ltd. M.No.28/08 F.No.01/82/50/168/AM 08 RLA F. No. 03/94/40/17/AM08 Adv. Lic. No.0310426065 dt.10.04.2007 for the export product Triomune 30 under para 4.7 of HBP. Committee decided to defer case as firm has been called for personal hearing on 20.11.2007.

Case No.A-829

M/s Aurobindo Pharma Ltd. M.No.28/08 F.No.01/82/50/225/AM 08 RLA F. No. 09/24/40/194/AM08 Adv. Lic. No. 0910031159 dt. 16.08.2007 for the export product Sterile Ampicillin Sodium under para 4.7 of HBP. Representative of PI Division informed Committee that case is under examination in his Department and he sought deferment for four weeks. Accordingly, case was deferred for four weeks.

Case No.A-830

M/s Cadila Health Care Ltd. M.No.28/08 F.No.01/82/50/189/AM 08 RLA F. No. 08/24/40/159/AM08 Adv. Lic. No.0810067316 dt. 24.09.2007

for the export product 62/0 Paroxetine HCL under para 4.7 of HBP. examination in his Department and he sought deferment for four weeks. Accordingly, case was deferred for four weeks.

Case No.A-831

M/s Astrix Laboratories Ltd. M.No.28/08 F.No.01/82/50/266/AM 08 RLA F. No. 09/24/40/502/AM07 Adv. Lic. No. 0910030196 dt. 7.05.2007 for the export product Stavudine under para 4.7 of HBP. examination in his Department and he sought deferment for four weeks. Accordingly, case was deferred for four weeks.

Case No.A-832

M/s Matrix Lab Ltd M.No.28/08 F.No.01/82/50/234/AM 08 RLA F. No. 09/24/40/188/AM08 Adv. Lic. No. 0910031126 dt. 13.08.2007 for the export product Valsartan Tablets under para 4.7 of HBP. examination in his Department and he sought deferment for six weeks. Accordingly, case was deferred for six weeks.

Case No.A-833

M/s Matrix Lab Ltd M.No.28/08 F.No.01/82/50/233/AM 08 RLA F. No. 09/24/40/196/AM08 Adv. Lic. No. 0910031321 dt. 30.08.2007 for the export product Emtricitabine under para 4.7 of HBP.

Case No.A-834

M/s Matrix Lab Ltd M.No.28/08 F.No.01/82/50/226/AM 08 RLA F. No. 09/24/40/192/AM08 Adv. Lic. No. 0910031252 dt. 27.08.2007

for the export product Tenofovir under para 4.7 of HBP.

Case No.A-835

M/s Matrix Lab Ltd M.No.28/08 F.No.01/82/50/228/AM 08 RLA F. No. 09/24/40/236/AM08 Adv. Lic. No. 0910031322 dt. 30.08.2007 for the export product Candesartan Cilexetil under para 4.7 of HBP.

Case No.A-836

M/s Matrix Lab Ltd M.No.28/08 F.No.01/82/50/227/AM 08 RLA F. No. 09/24/40/204/AM08 Adv. Lic. No. 0910031354 dt. 31.08.2007 for the export product Tenofovir Disoproxil under para 4.7 of HBP.

Case No.A-837

M/s Matrix Lab Ltd M.No.28/08 F.No.01/82/50/232/AM 08 RLA F. No. 09/24/40/216/AM08 Adv. Lic. No. 0910031186 dt. 21.08.2007 for the export product 1,2-Epoxy under para 4.7 of HBP.

Case No.A-838

M/s Matrix Lab Ltd M.No.28/08 F.No.01/82/50/231/AM 08 RLA F. No. 09/24/40/191/AM08 Adv. Lic. No. 0910031127 dt. 13.08.2007

for the export product Quetiapine Fumarate under para 4.7 of HBP.

Case No.A-839

M/s Matrix Lab Ltd M.No.28/08 F.No.01/82/50/229/AM 08 RLA F. No. 09/24/40/202/AM08 Adv. Lic. No. 0910031202 dt. 24.08.2007 for the export product

Didanosine Delayed Release caps 125MG,200MG,250MG,400MG under para 4.7 of HBP.

Case No.A-840

M/s Matrix Lab Ltd M.No.28/08 F.No.01/82/50/230/AM 08 RLA F. No. 09/24/40/187/AM08 Adv. Lic. No. 0910031251 dt. 27.08.2007 for the export product Abacavie sulfate under para 4.7 of HBP.

Case No.A-841

M/s Honest Bio Pvt. Ltd M.No.28/08 F.No.01/82/50/1761/AM 07 RLA F. No. 08/24/40/304/AM07 Adv. Lic. No. 0810062375 dt. 12.01.2007

for the export product Chloroperoxybenzoic Acid under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/274/2006-PI-III dated 25.10.2007 enclosed with agenda decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Chloroperoxybenzoic Acid-------------------------------1kg. Import items: Sl.No. Description of import item Quantity allowed 1. 3-Chloro Benzoyl Chloride (Meta chloro Benzyl chloride) 1.00kg/kg 2. Tertiary Butanol 1.125kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A-842

M/s Sun Pharma Industries Ltd M.No.28/08 F.No.01/82/61/04/AM 08 RLA F. No. 03/24/40/187/AM01 for the export product Clomipramine HCL under para 4.7 of HBP. Committee observed that firm has submitted application for Advance Authorisation under para 4.4.2 of HBP in the year AM01 and against their application, Advance Authorisation can not be issued now. Accordingly, it was decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-843

M/s Sun Pharma Industries Ltd M.No.28/08 F.No.01/82/162/05/AM 08 RLA F. No. 03/24/40/43/AM01 for the export product Clomipramine HCL under para 4.7 of HBP. Committee observed that firm has submitted application for Advance Authorisation under para 4.4.2 of HBP in the year AM01 and against their application, Advance Authorisation can not be issued now. Accordingly, it was decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-844

M/s Vamshi Chemical Ltd M.No.28/08 F.No.01/83/162/150/AM 08 RLA F. No. 06/24/40/07/AM08 Adv. Lic. No. 0610012062 dt. 20.06.2007 for the export product Iso-Longifolene ,Longifolene Acetate Main under para 4.7 of HBP. Committee decided to call for end use of export product alongwith published technical literature from firm. Accordingly, case was deferred for six weeks.

Case No.C-24

M/s S.M.Herbals Pvt. Ltd M.No.28/08 F.No.01/82/162/443/AM 08 The Committee considered the case as per agenda for Standard Input Output norms for the export product Camptothecin. examination in his Department and he sought deferment for four weeks. Accordingly, case was deferred for four weeks.

Case No.C-25

M/s DCM Industries Ltd M.No.28/08 F.No.01/83/162/286/AM 08 The Committee considered the case as per agenda for Standard Input Output norms for the export product D(-)Para Hyderoxy Phenyl Glycine Methyl Potassium Dane Salt. 1

Case No.:1/6/82-

ALC4/2007 Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/82/050/00389/AM04/ RLA File : 09/24/040/00068/AM04/ Lic.No/Date:09100152 88 05.08.2003

Decision :Committee considered case as per agenda for ratification of norms for export product N,N,Dimethyl Amino Ethoxy Benzylamine under

para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/130/2006-PI-III dated 12.11.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: N,N,Dimethyl Amino Ethoxy Benzylamine----------------------1Kg. Import items:

4-hydroxy Benzaldehyde---------------------------------1.00kg/kg
Hydroxylamine Hcl-----------------------------------------0.50kg/kg
Toluene-------------------------------------------------------0.76kg/kg
Dimethyl formamide---------------------------------------0.375kg/kg
Methanol------------------------------------------------------1.00kg/kg
Isopropyl alcohol--------------------------------------------2.23kg/kg
Methylene chloride-----------------------------------------1.75kg/kg
Caustic Soda Flakes-----------------------------------------0.28kg/kg Committee also decided to approve all the pending cases for the above export product with same inputs on file, as per the above norms with the approval of Chairman within the validity period of such adhoc norms. RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 2

Case No.:2/35/82-

ALC1/2004 Party Name:MADHUR PHARMA & RESEARCH LABORATORIES PVT.LTD., Meet No/Date:28/82- ALC4/2007 13.11.2007 Status: Case Deferred HQ File : 01/82/050/01467/AM05/ RLA File : 07/24/040/00492/AM05/ Lic.No/Date:07100342 46 23.11.2004 Defer Date:26.12.20 07 Decision :Committee considered case as per agenda for ratification of norms for export product Herpasil Capsules and Stimmune Capsules under

para 4.7 of HBP.

Committee observed that firm has been requested to furnish certain technical information vide DC(SSI) letter No.5(9)/2005-Chem dated 05.11.2007. Committee, therefore, decided to await reply of firm. 3

Case No.:2/34/82-

ALC1/2006 Party Name:DISHMAN PHARMACEUTICALS & Meet No/Date:28/82- ALC4/2007 Status:Ca se

CHEMICALS LTD 13.11.2007 Transferr ed HQ File : 01/82/050/00593/AM07/ RLA File : 08/24/040/00247/AM06/ Lic.No/Date:08100583 23 24.07.2006

Decision : Committee considered case as per agenda for ratification of norms for export product 1-Carbethoxy Ethylidene Triphenyl Phosphorane under para 4.7 of HBP. Committee decided to transfer case to DES-IV as export product pertains to Chemical Sector. 4

Case No.:11/34/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/87/050/00566/AM07/ RLA File : 02/24/040/00189/AM07/ Lic.No/Date:02100940 06 25.09.2006 Defer Date: 11.12.2007 norms for export product Senega Soft Extract under para 4.7 of HBP. Committee decided to forward a copy of application again to DC(MSME) for their comments. Accordingly, case was deferred for four weeks. 5

Case No.:11/44/82-

ALC1/2006 Party Name:HETERO DRUGS LIMITED, Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/82/050/01409/AM07/ RLA File : 09/24/040/00374/AM07/ Lic.No/Date:09100285 36 07.12.2006

norms for export product Lisinopril under para 4.7 of HBP. their U.O. No.35011/87/2007-PI-III dated 12.11.2007 alongwith file decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Lisinopril-----------------------------------------------1kg/kg Import items:

3-Benzoyal Acrylic acid Ethyl Ester-----1.77kg/kg
Palladium on Carbon 5%-------------------0.011kg/kg
Trifluoro acetic acid-------------------------1.26kg/kg
L-Proline----------------------------------------0.927kg/kg
N,N carbonyl dimidazole--------------------0.42kg/kg
Methanol---------------------------------------5.45kg/kg
Isopropyl alcohol-----------------------------16.90kg/kg above export product and same inputs on file, as per the above norms with the approval of Chairman within the validity period of such adhoc norms. 6

Case No.:1/48/83-

ALC1/2006 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/83/050/01068/AM07/ RLA File : 09/24/040/00376/AM07/ Lic.No/Date:09100287 91 28.12.2006

norms for export product 5-O-trityl-2,3-anhydro thymidine under para 4.7 of HBP. their U.O. No.35011/108/2007-PI-III dated 30.10.2007 decided to ratify whichever is lower. Export product: 5-O-trityl-2,3-anhydro thymidine------------------------------1kg. Import items:

B-Thymidine-----------------------------------------------0.757kg/kg norms. RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 7

Case No.:631/24/87-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred

HQ File : 01/87/050/00972/AM07/ RLA File : 09/24/040/00440/AM07/ Lic.No/Date:09100292 51 08.02.2007 Defer Date: 11.12.2007 norms for export product Lamivudine (Cyclohexyl Ester Route) under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in his Department and he sought deferment for four weeks. Accordingly, case was deferred for four weeks. 8

Case No.:3/10/83-

ALC1/2007 Party Name:WANKSONS CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/83/050/01262/AM07/ RLA File : 03/95/040/01284/AM07/ Lic.No/Date:03104202 13 20.02.2007

norms for export product Meta Chloro Phenyl Ethyl Ketone under para 4.7 of HBP. their U.O. No.35011/207/2004-PI-III dated 13.11.2007 in the case of M/S Shamrock International Ltd decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Meta Chloro Phenyl Ethyl Ketone-------------------------------1kg. Import items:

Propiophenone--------------------------------------------1.39kg/kg
Ethylene Dichloride---------------------------------------0.67kg/kg
Acetone------------------------------------------------------0.17kg/kg norms. 9

Case No.:840/21/82-

ALC4/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved

HQ File : 01/82/050/01658/AM07/ RLA File : 09/24/040/00472/AM07/ Lic.No/Date:09100293 72 21.02.2007

norms for export product 7-Amino 3-Vinyl Cepholosparanic Acid (7 AVNA) under para 4.7 of HBP. their U.O. No.35011/274/2006-PI-III dated 30.10.2007 decided to ratify whichever is lower. Export product: 7-Amino 3-Vinyl Cepholosparanic Acid (7 AVNA)------------1kg. Import items:

7-Phenyl Acetamideo-3-Chloromethyl Cephalosporanic Acid para Methoxy Benzyl Ester (GCLE)---------------------------- 2.672kg/kg
Acetone--------------------------------------------------------------------10.11kg/kg
Methylene Chloride----------------------------------------------------7.59kg/kg
Methanol------------------------------------------------------------------7.78kg/kg norms. 10

Case No.:445/24/83-

ALC1/2007 Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01268/AM07/ RLA File : 09/24/040/00478/AM07/ Lic.No/Date:09100294 28 22.02.2007 Defer Date: 11.12.2007 Decision :Committee considered case as per agenda for ratification of norms for export product {3-5[Bromo-1-(flurophenyl)(1,3-dihydro isobenzo furanyl)]propyl] dimehylamine oxalate under para 4.7 of HBP. Committee observed that firm has been requested to furnish certain technical information vide letter dated 26.10.2007, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks.

Case No.:850/21/82-

ALC4/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status: Case Approved HQ File : 01/82/050/01677/AM07/ RLA File : 09/24/040/00069/AM07/ Lic.No/Date:09100294 23 22.02.2007

7-Phenyl Acetamideo-3-Chloromethyl Cephalosporanic Acid para Methoxy Benzyl Ester (GCLE)---------------------------- 2.672kg/kg
Acetone--------------------------------------------------------------------10.11kg/kg
Methylene Chloride----------------------------------------------------7.59kg/kg
Methanol------------------------------------------------------------------7.78kg/kg norms. 12 Case No.:860/21/82- ALC4/2007 Party Name:G AMPHRAY LABORATORIES, Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Withdraw n HQ File : 01/82/050/01691/AM07/ RLA File : 03/94/040/01193/AM07/ Lic.No/Date:03104204 96 22.02.2007

norms for export product Piperazine Adipate BP/USP under para 4.7 of HBP. Committee decided to withdraw case as same has already been

approved by NC. 13

Case No.:3/9/83-

ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:28/82- ALC4/2007 13.11.2007 Status: Case Deferred HQ File : 01/83/050/01284/AM07/ RLA File : 03/95/040/01405/AM07/ Lic.No/Date:03104210 71 27.02.2007 Defer Date:26.12.20 07 norms for export product Dihydroartemisinin under para 4.7 of HBP. for six weeks. Accordingly, case was deferred for six weeks. 14

Case No.:6/9/82-

ALC4/2007 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/01728/AM07/ RLA File : 09/24/040/00488/AM07/ Lic.No/Date:09100295 04 01.03.2007 Defer Date: 26.12.2007 norms for export product Cefdinir 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 six weeks. 15

Case No.:12/7/83-

ALC1/2007 Party Name:RANTUS PHARMA PVT LTD Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/00083/AM08/ RLA File : 09/24/040/00433/AM07/ Lic.No/Date:09100299 34 10.04.2007 Defer Date: 11.12.2007 norms for export product Tramadol Base under para 4.7 of HBP. 16 Case No.:577/24/83- ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/83/050/00273/AM08/ RLA File : 09/24/040/00444/AM07/ Lic.No/Date:09100302 07

08.05.2007 norms for export product Menthyl-5 S-Cytosine-1YL-1,3-Oxathiolane-2R Carboxalate (Lamivudine intermediate Stage 3) under para 4.7 of HBP. their U.O. No.35011/108/2007-PI-III dated 30.10.2007 decided to ratify whichever is lower. Export product: Menthyl-5 S-Cytosine-1YL-1,3- Oxathiolane-2R Carboxalate (Lamivudine intermediate Stage 3)----------------1Kg. Import items:

Menthol----------------------------------------0.87kg/kg
Glyoxalic acid 50%---------------------------0.90kg/kg
2,5 Dihydroxy-1,4 dithiane-----------------0.37kg/kg
Triethylamine---------------------------------0.67kg/kg
Cytosine----------------------------------------0.475kg/kg
Hexamethyl disilazane----------------------0.75kg/kg
Dimethyl formamide------------------------0.31kg/kg norms. 17

Case No.:6/4/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00031/AM08/ RLA File : 03/95/040/00095/AM08/ Lic.No/Date:03104289 99 10.05.2007 Defer Date: 11.12.2007 norms for export product Diproson Lotion 30ml under para 4.7 of HBP. Committee observed that firm was requested to furnish certain clarification vide letter dated 26.10.2007, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks.

Case No.:3/16/82-

ALC4/2007 Party Name:NIRAYU PRIVATE LIMITED, Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Rejected HQ File : 01/82/050/00050/AM08/ RLA File : 34/24/040/00034/AM08/ Lic.No/Date:34100188 53 28.05.2007

norms for export product Azithromycin Dihydrate (Micronised) under para 4.7 of HBP. Committee observed that firm was requested to furnish complete specification of import and export items and manufacturing activity involved vide letter dated 05.09.2007, but same has not been received. Committee, therefore, decided to close case. RA concerned may take further necessary action as per above decision of Norms Committee. 19

Case No.:34/18/83-

ALC1/2007 Party Name:HARMAN FINOCHEM LTD. Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/00471/AM08/ RLA File : 03/94/040/01379/AM07/ Lic.No/Date:03104311 13 30.05.2007 Defer Date: 11.12.2007 norms for export product Xipamide under para 4.7 of HBP. 20 Case No.:12/12/82- ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Rejected HQ File : 01/82/050/00069/AM08/ RLA File : 34/24/040/00047/AM08/ Lic.No/Date:34100189 88 15.06.2007

Committee, therefore, decided to close case. RA concerned may take further necessary action as per above decision of Norms Committee. 21

Case No.:2/20/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/82/050/00081/AM08/ RLA File : 03/95/040/00033/AM08/ Lic.No/Date:03104331 29 19.06.2007

norms for export product Betasol Lotion 30 ML (Clobetasol Propionate Topical Solution .05% (w/v) under para 4.7 of HBP. their U.O. No.35011/86/2006-PI-III dated 13.11.2007 decided to ratify whichever is lower. Export product: Betasol Lotion 30ML (Clobetasol Propionate Topical solution 0.05% (w/v) Import items:

Clobetasol Propionate----------------15.15mg/30ml bottle norms. 22 Case No.:850/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/00850/AM08/ RLA File : 05/24/040/00312/AM08/ Lic.No/Date:05102066 55 24.07.2007 Defer Date: 26.12.2007 norms for export product Isotretinon under para 4.7 of HBP.

for six weeks. Accordingly, case was deferred for six weeks. 23

Case No.:838/24/83-

ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/83/050/00834/AM08/ RLA File : 34/24/040/00061/AM08/ Lic.No/Date:34100192 69 24.07.2007

norms for export product Fenofibrate under para 4.7 of HBP. their U.O. No.35011/237/2006-PI-III dated 12.11.2007 decided to ratify whichever is lower. Export product: Fenofibrate---------------------------------------------------------------1Kg. Import items:

4-chloro,4 Hydroxybenzophenone------------------------1.310kg/kg
Acetone-----------------------------------------------------------2.710kg/kg
Ethyl Acetate-----------------------------------------------------4.372kg/kg
Isopropyl Alcohol------------------------------------------------5.43kg/kg
Methylene chloride---------------------------------------------3.127kg/kg
Activated Charcoal----------------------------------------------0.091kg/kg norms. 24 Case No.:3/20/82- ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00146/AM08/ RLA File : 03/95/040/00277/AM08/ Lic.No/Date:03104375 31 26.07.2007 Defer Date: 11.12.2007 norms for export product Epiderm Lotion 30ml under para 4.7 of HBP.

Committee observed that firm was requested to furnish certain clarification vide letter dated 26.10.2007, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 25

Case No.:3/18/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00142/AM08/ RLA File : 03/94/040/00455/AM08/ Lic.No/Date:03104384 06 06.08.2007 Defer Date: 20.11.2007 norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP. Committee observed that firm has been called for personal hearing in other cases on 20.11.2007. Committee, therefore, decided to re-list this case on 20.11.2007. Accordingly, case was deferred for one week. 26 Case No.:101/21/82- ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/82/050/00149/AM08/ RLA File : 34/24/040/00084/AM08/ Lic.No/Date:34100194 03 13.08.2007

norms for export product Azithromycin Step 3 (AZA Azithromycin) under

para 4.7 of HBP.

their U.O. No.35011/227/2006-PI-III dated 12.11.2007 decided to ratify whichever is lower. Export product: Azithromycin Step 3 (AZA Azithromycin)---------------------------1kg. Import items:

Erythromycin base---------------------------------------------1.86kg/kg
Acetone------------------------------------------------------------1.27kg/kg
Ethyl Alcohol------------------------------------------------------3.00Ltr/kg
Hydroxylamine Hcl-----------------------------------------------0.97kg/kg
Methane sulfonyl chloride-------------------------------------0.69kg/kg
Methanol-----------------------------------------------------------1.09kg/kg
Platinum Catalyst with base of activated carbon

(5% Platinum on carbon)---------------------------------------1.00gm/kg norms. 27 Case No.:103/21/82- ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/82/050/00150/AM08/ RLA File : 34/24/040/00085/AM08/ Lic.No/Date:34100194 04 13.08.2007

norms for export product Azithromycin Step 4 (Azithromycin Crude purity NLT 94.5%)) under para 4.7 of HBP. their U.O. No.35011/227/2006-PI-III dated 12.11.2007 decided to ratify whichever is lower. Export product: Azithromycin Step IV (Azithromycin Crude Purity NLT 94.5%)-------1kg. Import items:

Erythromycin base---------------------------------------------1.75kg/kg
Acetone------------------------------------------------------------6.45kg/kg
Ethyl Alcohol------------------------------------------------------2.81kg/kg
Hydroxylamine Hcl-----------------------------------------------0.91kg/kg
Methane sulfonyl chloride-------------------------------------0.72kg/kg
Methanol-----------------------------------------------------------2.72kg/kg
Platinum Catalyst with base of activated carbon (5% Platinum on carbon)---------------------------------------1.00gm/kg
Hyflo-----------------------------------------------------------------Not

raw material, hence not Allo wed

norms. 28

Case No.:1005/24/83-

ALC1/2007 Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01023/AM08/ RLA File : 03/94/040/00234/AM08/ Lic.No/Date:03104406 40 23.08.2007 Defer Date: 11.12.2007 norms for export product Dihydroartemisinin under para 4.7 of HBP. 29 Case No.:998/24/83- ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/83/050/01016/AM08/ RLA File : 09/24/040/00176/AM08/ Lic.No/Date:09100311 99 24.08.2007

norms for export product Menthyl-5 S-Cytosine-1YL-1,3-Oxathiolane-2R Carboxalate (Lamivudine intermediate Stage 3) under para 4.7 of HBP. their U.O. No.35011/108/2007-PI-III dated 30.10.2007 decided to ratify whichever is lower. Export product: Menthyl-5 S-Cytosine-1YL-1,3- Oxathiolane-2R Carboxalate (Lamivudine intermediate Stage 3)----------------1Kg. Import items:

Menthol----------------------------------------0.87kg/kg
Glyoxalic acid 50%---------------------------0.90kg/kg
2,5 Dihydroxy-1,4 dithiane-----------------0.37kg/kg
Triethylamine---------------------------------0.67kg/kg
Cytosine----------------------------------------0.475kg/kg
Hexamethyl disilazane----------------------0.75kg/kg
Dimethyl formamide------------------------0.31kg/kg norms. 30

Case No.:40/25/83-

ALC1/2007 Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/83/050/01065/AM08/ RLA File : 03/94/040/00539/AM08/ Lic.No/Date:03104409 27 27.08.2007

norms for export product Artemether under para 4.7 of HBP. their U.O. No.35011/39/2007-PI-III dated 08.05.2007 decided to ratify whichever is lower. Export product: Artesunate------------------------------------1kg. Import items:

Artemisinin------------------------0.9259kg/kg
Sodium borohydride---------------0.150kg/kg norms. 31 Case No.:30/25/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01055/AM08/ RLA File : 05/24/040/00425/AM08/ Lic.No/Date:05102083 17 Defer Date:

30.08.2007 26.12.2007 norms for export product Sertraline Hcl under para 4.7 of HBP. for six weeks. Accordingly, case was deferred for six weeks. 32

Case No.:42/25/83-

ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01067/AM08/ RLA File : 03/94/040/00299/AM08/ Lic.No/Date:03104414 32 30.08.2007 Defer Date: 11.12.2007 norms for export product Nitazoxanide under para 4.7 of HBP. 33

Case No.:5/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01079/AM08/ RLA File : 09/24/040/00234/AM08/ Lic.No/Date:09100313 29 31.08.2007 Defer Date: 11.12.2007 norms for export product Florfenicol under para 4.7 of HBP. 34 Case No.:24/27/83- ALC1/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01098/AM08/ RLA File : 09/24/040/00226/AM08/ Lic.No/Date:09100313 83 03.09.2007 Defer Date: 11.12.2007 norms for export product Dibenzosuberone under para 4.7 of HBP.

Case No.:30/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01104/AM08/ RLA File : 09/24/040/00239/AM08/ Lic.No/Date:09100314 00 05.09.2007 Defer Date: 11.12.2007 norms for export product Stavudine under para 4.7 of HBP. 36

Case No.:33/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01107/AM08/ RLA File : 09/24/040/00192/AM07/ Lic.No/Date:09100314 03 05.09.2007 Defer Date: 26.12.2007 norms for export product GCLE-Stage-1 under para 4.7 of HBP. Committee decided to call for complete chemical description of export product from firm. Accordingly, case was deferred for six weeks. 37

Case No.:132/27/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/83/050/01206/AM08/ RLA File : 05/24/040/00489/AM08/ Lic.No/Date:05102091 50 18.09.2007 Defer Date: 11.12.2007 norms for export product Lorazepam under para 4.7 of HBP. 38 Case No.:29/30/83- ALC1/2007 Party Name:SYMBIOTEC PHARMALAB LTD., Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/83/050/01398/AM08/ RLA File : 11/24/040/00038/AM08/ Lic.No/Date:11100162 40

22.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Hydrocortisone Sodium Succinate Buffered 5% Sterile under para 4.7 of HBP. The Committee in light of its earlier decision taken in its 25/08 meeting held on 23.10.2007 vide Case No.A-786 decided to ratify the norms of the export product under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: HYDROCORTISONE SODIUM SUCCINATE (BP/USP) --------1Kg. Import items: Hydrocortisone------------------------------------------------------1.10kg/kg

norms. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 39 Case No.:47/30/83- ALC1/2007 Party Name:SHILPA MEDICARE LTD., Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/83/050/01416/AM08/ RLA File : 07/24/040/00419/AM08/ Lic.No/Date:07100539 98 24.10.2007

norms for export product 3a, 7b, Dihydroxy-5b-cholan-24-OIC Acid under

para 4.7 of HBP.

Committee in light of written comments forwarded by DC(SSI) vide their U.O. No.5(4)/02-chem dated 27.04.2004 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: 3a, 7b, Dihydroxy-5b-Cholan-24-OIC Acid----------1kg. Import items:

3a-Hydroxy-Keto-5b-Cholan-24-Oic Acid-----1.328kg/kg
Sodium Metal-----------------------------------------1.86kg/kg
Secondary Butanol-----------------------------------7.17kg/kg

norms. 40

Case No.:48/30/83-

ALC1/2007 Party Name:SHILPA MEDICARE LTD., Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/83/050/01417/AM08/ RLA File : 07/24/040/00421/AM08/ Lic.No/Date:07100539 99 24.10.2007

norms for export product 3a, 7b Dioxy Cholanic Acid under para 4.7 of HBP. Committee in light of written comments forwarded by DC(SSI) vide their U.O. No.5(4)/2000-Chem dated 09.09.2003 decided to ratify norms under

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

lower. Export product: 3a, 7b Dioxy Cholanic 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
Sodium Bromate--------------------0.96kg/kg
Sodium Metal------------------------1.24kg/kg norms. 41 Case No.:1/28/82- ALC4/2007 Party Name:BIOSTADT INDIA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Transferr ed HQ File : RLA File : Lic.No/Date:03104479

01/82/050/00235/AM08/ 03/94/040/00336/AM07/ 00 25.10.2007 norms for export product Wokozim Granules under para 4.7 of HBP. Committee decided to transfer case to DES-IV as export product apparently a Biofertiliser pertains to Chemical Sector. 42

Case No.:2/28/82-

ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00236/AM08/ RLA File : 05/24/040/00592/AM08/ Lic.No/Date:05102111 95 26.10.2007 Defer Date: 26.12.2007 norms for export product Cefuroxime Axetil Amorphous under para 4.7 of HBP. Committee decided to call for a copy of application alongwith a copy of Advance Authorisation from concerned RA. Accordingly case was deferred for six weeks. 43 Case No.:5/28/82- ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/82/050/00239/AM08/ RLA File : 03/94/040/00769/AM08/ Lic.No/Date:03104480 04 26.10.2007

norms for export product Beclate Nasal Spray/Ciplametazon Nasal Spray/ (50MCG/200MD) under para 4.7 of HBP. their U.O. No.35011/49/2005-PI-III dated 13.11.2007 decided to ratify whichever is lower. Export product: Baclate Nasal Spray/Ciplametazon Nasal Spray (50MCG/200MD) Import items:

Beclomethasone Dipropionate------------3700gms
63mcl Aerosol Valves-------------------------As per packing policy
19ml Aluminium Can--------------------------As per packing policy
Actuators with Dust Covedrs/ Caps Fitting to 19ml Aluminium Can-------As per packing policy norms. 44

Case No.:6/28/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/82/050/00240/AM08/ RLA File : 03/94/040/00764/AM08/ Lic.No/Date:03104481 10 26.10.2007

norms for export product Lavacip 10% Powder/Levamisole Hcl Veterinary Oral Powder (per pack 1kg) under para 4.7 of HBP. Committee in consultation with technical authorities 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: Levacip 10% Powder/Levamisole Hcl Veterinary Oral Powder (per pack 1KG) Import items:

Levamisole Hydrochloride BP----------------0.101kg/kg of export norms. 45 Case No.:7/28/82- ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00241/AM08/ RLA File : 03/94/040/00783/AM08/ Lic.No/Date:03104481 15 26.10.2007 Defer Date: 26.12.2007

norms for export product Toltrazuril Oral Solution 2.5%/Cipcox 2.5% Solution under para 4.7 of HBP. Committee decided to call for a copy of application alongwith a copy of Advance Authorisation from concerned RA. Accordingly case was deferred for six weeks. 46

Case No.:3/28/82-

ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/82/050/00237/AM08/ RLA File : 34/24/040/00158/AM08/ Lic.No/Date:34100199 33 29.10.2007

norms for export product Azithromycin Step IV under para 4.7 of HBP. Committee observed that in this case copy of application alongwith a copy of Advance Authorisation has not been received from concerned RA, but in another case of firm against Advance Authorisation No.3410019404 dated 13.08.2007, norms for above export product has been ratified. Committee, therefore, decided to advise concerned RA to dispose off this case under para 4.7.1 of HBP in line with approved norms. 47

Case No.:4/28/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00238/AM08/ RLA File : 03/94/040/00792/AM08/ Lic.No/Date:03104485 19 31.10.2007 Defer Date: 26.12.2007 norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP. Committee decided to call for a copy of application alongwith a copy of Advance Authorisation from concerned RA. Accordingly, case was deferred for six weeks. 48 Case No.:9/28/82- ALC4/2007 Party Name:VIVEK PHARMACHEM (INDIA) LTD., Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00243/AM08/ RLA File : 13/24/040/00022/AM08/ Lic.No/Date:13100252 78 31.10.2007 Defer Date: 26.12.2007

norms for export product Meropenem Injection USP 1GM Potency 100% under para 4.7 of HBP. Committee decided to call for a copy of application alongwith a copy of Advance Authorisation from concerned RA. Accordingly, case was deferred for six weeks. 49

Case No.:8/28/82-

ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00242/AM08/ RLA File : 05/24/040/00598/AM08/ Lic.No/Date:05102114 09 01.11.2007 Defer Date: 26.12.2007 norms for export product Simvastatin under para 4.7 of HBP. their U.O. No.35011/85/2007-PI-III dated 20.11.2007 decided to ratify whichever is lower. Export product: Simvastatin-----------------------------------1kg. Import items:

Lovastatin----------------------------1.648kg/kg
Acetone-------------------------------1.042kg/kg
Activated Carbon-------------------0.035kg/kg
Cyclohexane-------------------------1.33kg/kg
Cyclopropylamine------------------1.23kg/kg
Methanol----------------------------19.82kg/kg
N Butyl Lithium----------------------2.382kg/kg
Pyrrolidine----------------------------1.53kg/kg
Tetrahydrofuran--------------------6.58kg/kg

Caustic flakes------------------------1.484kg/kg 11. Iodine---------------------------------0.5917kg/kg 12. Ethyl acetate------------------------4.49kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 50 Case No.:10/28/82- ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : RLA File : Lic.No/Date:13100252 Defer

01/82/050/00244/AM08/ 13/24/040/00020/AM08/ 80 01.11.2007 Date: 26.12.2007 norms for export product Ascorbyl Palmitate Granules 95% under para 4.7 of HBP. Committee decided to call for a copy of application alongwith a copy of Advance Authorisation from concerned RA. Accordingly, case was deferred for six weeks. 51 Case No.:11/28/82- ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00245/AM08/ RLA File : 34/24/040/00169/AM08/ Lic.No/Date:34100200 03 05.11.2007 Defer Date: 26.12.2007 norms for export product Cefepine (For Injection USP) under para 4.7 of HBP. their U.O. No.35011/182/2005-PI-III dated 23.10.2007 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: Cefepime for Injection USP (Cefepime + Arginine Sterile)----------1Kg. Import items:

7 Amino Cephalospoonic Acid------------------------------------0.84kg/kg
Trimethylsily iodide--------------------------------------------------1.59kg/kg
Hexamethyl Disilazane----------------------------------------------0.88kg/kg
N-Methyl Pyrrolidine------------------------------------------------0.588kg/kg
Methylene Chloride-------------------------------------------------3.60kg/kg
Cyclohexane-----------------------------------------------------------3.98kg/kg
Acetone-----------------------------------------------------------------13.80kg/kg
Isopropyl Alcohol-----------------------------------------------------3.50kg/kg
2-Mercapto Benzothiazolyl (Z)-2-(2-Amino Thiazoyl-4-YL)-2-Methoxy Imino acetate------------------------0.76kg/kg

Triethyl

amine---------------------------------------------------------- 0.147kg/kg 11. Dimethyl

Formamide------------------------------------------------- 1.82kg/kg 12. Activated

Carbon------------------------------------------------------ 0.100kg/kg

Methanol---------------------------------------------------------------- 3.09kg/kg 14. L-Arginine---------------------------------------------------------------- 0.40kg/kg norms. as per above decision of Norms committee. 52

Case No.:13/28/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Deferred HQ File : 01/82/050/00247/AM08/ RLA File : 03/94/040/00784/AM08/ Lic.No/Date:03104492 11 05.11.2007 Defer Date: 26.12.2007 norms for export product Advocip Powder/Danofloxacin Soluble Powder under para 4.7 of HBP. their U.O. No.35011/113/2006-PI-III dated 13.11.2007 and in consultation with technical authorities 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. Danofloxacin soluble powder, 75gm. Sachet Each Sachet contains Danofloxacin Mesylate equivalent to Danofloxacin 12.5gm. Import item: Danofloxacin Mesylate----------------------15.86gm/Sachet of 75gm. norms.

Case No.:12/28/82-

ALC4/2007 Party Name:NEULAND LABORATORIES LTD Meet No/Date:28/82- ALC4/2007 13.11.2007 Status:Ca se Approved HQ File : 01/82/050/00246/AM08/ RLA File : 09/24/040/00307/AM08/ Lic.No/Date:09100320 16 07.11.2007

norms for export product Ramipril under para 4.7 of HBP. their U.O. No.35011/5/2005-PI-III dated 13.11.2007 and in consultation with technical authorities 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: Ramipril------------------------------------------------------------1kg. Import items:

Racemic-2-azabicylco (3.3.0) octane-3- carboxylic acid benzylester Hcl or (S,S)-2- azabicyclo(3.3.0)octane-3-carboxylic acid benzylester Hydrochloride-------------------------------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 norms.

Date:10.11.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis has been generated for this document yet.