IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2008-03-11

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 : 45/82-ALC4/2007 MEETING DATE : 11.03.2008 The Meeting No.44/08 for the licensing year 2007-08 to consider the cases under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2004-09 pertaining to Pharma Products was held on 11.03.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No. 27/08 dated 06.11.2007, 43/08 dated 04.03.2008 and 44/08 dated 04.03.2007 were ratified by the Committee.

Case No.B-575

Policy clarification NC Meeting No.45/08 F.No.01/82/50/369/AM08 Meeting Date:11.03.2008 Committee considered case as per agenda and perused the clarification given by Department of Bio-technology vide their D.O. No.BT/0150/2002-PID(Vol.III) dated 05.02.2008 regarding clarification in respect of Biotechnology items where NOC from their Department is required before grant of Advance Authorisation. Department of Biotechnology opined that when the end product and imported items are free from Genetic Modified Organism/Living Modified Organism, despite emanating from LMO/GMO, there is no need of obtaining the NOC from DBT. Further the micro organism, GMOs etc. have already covered under Annexure III of Scheduled 2 of the Exim Policy under SCOMET items where compulsory licence is necessary for export of such product. In order to facilitate the import and export , RAs may issue Advance Authorisations for import/export of bio-technology product on submission of an undertaking to the effect that the particular product under import and end Product is free of LMO/GMO per se, without obtaining NOC from DBT. Committee accepted the above and decided to refer the minutes of NC to Policy Division alongwith comments of DBT for incorporating in Chapter IV of Exim Policy after approval of DGFT.

Case No.B-576

M/S Arch Pharma Labs Ltd. NC Meeting No.45/08 F.No.01/82/162/591/AM08 RLA F.No.03/94/40/125/AM07 Adv.Lic.No.0310381222 dated 25.05.2006

Committee considered case as per agenda for revision of norms for export product Clopidogrel Bisulphate under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.B-577

M/S Alembic Ltd. NC Meeting No.45/08 F.No.01/82/50/51/AM08 RLA F.No.34/24/40/35/AM08 Adv.Lic.No.3410018854 dated 28.05.2007 Committee considered case as per agenda for amendment in the description of export product under para 4.7 of HBP. Committee observed that firm had obtained Advance Authorisation for export of Azithromycin Step-3 (KGA) while in the decision of NC, same was mentioned “Azithromycin Step 3 (Aza Azithromycin)”. Committee, therefore, in consultation with representative of PI Division present in meeting decided to allow amendment in the description of export product to read as “Azithromycin Step-3 (KGA)”. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-578

M/S Alchem International Ltd. NC Meeting No.45/08 F.No.01/87/50/393/AM06 F.No.01/87/50/1374/AM05 F.No.01/87/50/375/AM06 RLA F.No.05/24/40/201/AM05 RLA F.No.05/24/40/542/AM05 RLA F.No.05/24/40/242/AM05 Adv.Lic.No.0510161341 dated 04.07.2005 Adv.Lic.No.0510148830 dated 17.01.2005 Adv.Lic.No.0510160972 dated 29.06.2005 Committee considered case as per agenda for revision of norms for export product Hyoscine-n-Bromide under para 4.7 of HBP. Committee observed that advance authorizations were issued in 2005 and also norms were ratified by NC in 2005 while representation of firm for revision of norms has been received on 22.01.2008 i.e. after a gap of more than three years. Committee, therefore, decided to maintain status quo.

Case No.B-579

M/S Srini Pharma NC Meeting No.45/08 F.No.01/87/50/1456/AM06 RLA F.No.09/24/40/477/AM06 Adv.Lic.No.0910025616 dated 09.03.2006 Committee considered case as per agenda for revision of norms for export product (S)-Clopidogrel-(S)-10-Camphor Sulfonate (CPG-35) under para 4.7 of HBP. Committee observed that norms were ratified in its meeting held on 20.09.2006 while representation of firm for revision of norms has been received only on 09.01.2008 i.e. after a gap of more than one and a half year. Committee, therefore, decided to maintain status quo.

Case No.A-1098

M/S Intas Pharmaceuticals Ltd. NC Meeting No.45/08 F.No.01/82/50/301/AM08 RLA F.No.08/24/40/226/AM08 Adv.Lic.No.0810069241 dated 28.12.2007 Committee considered case as per agenda for ratification of norms for export product Doxycycline Hyclate Tablets USP under para 4.7 of HBP.

Case No.A-1099

M/S Intervet India Pvt. Ltd. NC Meeting No.45/08 F.No.01/82/162/392/AM08 RLA F.No.09/24/40/328/AM03 Adv.Lic.No.0910013828 dated 03.04.2003 product ND Clone 30-Vaccine 2ml under para 4.7 of HBP. Committee decided to remind DBT for their comments. Accordingly, case was deferred for four weeks.

Case No.A-1100

M/S Matrix Labs. Ltd. NC Meeting No.45/08 F.No.01/82/50/230/AM08 RLA F.No.09/24/40/187/AM08 Adv.Lic.No.0910031251 dated 27.08.2007 product Abacavie Sulfate 300mg tablets under para 4.7 of HBP.

Case No.A-1101

NC Meeting No.45/08 F.No.01/82/50/233/AM08 RLA F.No.09/24/40/196/AM08 Adv.Lic.No.0910031321 dated 30.08.2007 product Emitricitabine 200mg and Tenofovir Disoproxil Fumarate 300mg tablets under para 4.7 of HBP.

Case No.A-1102

NC Meeting No.45/08 F.No.01/82/50/227/AM08 RLA F.No.09/24/40/204/AM08 Adv.Lic.No.0910031354 dated 31.08.2007 product Tenofovir Disoproxil Fumarate 300mg and Lamivudine 300mg tablets under

para 4.7 of HBP.

Case No.A-1103

NC Meeting No.45/08 F.No.01/82/50/234/AM08 RLA F.No.09/24/40/188/AM08 Adv.Lic.No.0910031126 dated 13.08.2007

product Valsartan Tablets 40mg, Valsartan Capsules 40mg, Valsartan Tablets 80mg, Valsartan Capsules 80mg, Valsartan Tablets 160mg and Valsartan 160mg tablets

Case No.A-1104

NC Meeting No.45/08 F.No.01/82/50/226/AM08 RLA F.No.09/24/40/192/AM08 Adv.Lic.No.0910031252 dated 27.08.2007 product Tenofovir Disoproxil Fumarate 300mg tablets under para 4.7 of HBP.

Case No.A-1105

NC Meeting No.45/08 F.No.01/82/50/229/AM08 RLA F.No.09/24/40/202/AM08 Adv.Lic.No.0910031202 dated 24.08.2007 product Didanosine Delayed Release Capsules 125mg, 200mg, 250mg and 400mg

Case No.A-1106

NC Meeting No.45/08 F.No.01/82/50/232/AM08 RLA F.No.09/24/40/216/AM08 Adv.Lic.No.0910031186 dated 21.08.2007 product Citalopram Tablets 10mg, 20mg, 30mg, 40mg and 60mg under para 4.7 of HBP.

Case No.A-1107

NC Meeting No.45/08 F.No.01/82/50/231/AM08 RLA F.No.09/24/40/191/AM08 Adv.Lic.No.0910031127 dated 13.08.2007 product Quetiapine Fumarate Tablets 25mg under para 4.7 of HBP.

Case No.A-1108

M/S Nicholas Piramal India Ltd. NC Meeting No.45/08 F.No.01/82/50/302/AM08 RLA F.No.03/24/40/868/AM08 Adv.Lic.No.0310454138 dated 14.12.2007 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. N-Acetyl Cystein 0.03150kg/unit of 1000 tablets 3. 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.

Case No.A-1109

M/S Krishna Antioxidents Pvt. Ltd. NC Meeting No.45/08 F.No.01/83/50/1047/AM08 RLA F.No.03/95/40/690/AM08 Adv.Lic.No.0310445406 dated 08.08. product 2007Formaldehyde Free Dye Fixing Agent (Aqueous Solution of 2-Hydroxy 3- Dimethyl Amine Chloride Propane Polymer (Active content 55% minimum)under

para 4.7 of HBP.

Committee decided to defer case for three weeks for comments of Chemical Division.

Case No.A-1110

M/S Morepen Labs. Ltd. NC Meeting No.45/08 F.No.01/83/50/1046/AM08 RLA F.No.05/24/40/650/AM08 Adv.Lic.No.0510212495 dated 26.11.2007 product Montelukast Sodium (Intermediate (MT-8) under para 4.7 of HBP. Committee decided to call for details of export product alongwith technical details as per Appendix 33 from firm. Accordingly, case was deferred for six weeks.

Case No.A-1111

M/S Ranbaxy Labs. Ltd. NC Meeting No.45/08 F.No.01/82/50/206/AM08 RLA F.No.05/24/40/401/AM08 Adv.Lic.No.0510207640 dated 17.08.2007 product Citalopram Hydrobromide Tablets 10mg under para 4.7 of HBP. Committee observed that the application has been filed based on Non- Infringing process and the firm has been requested to furnish required information

vide letter dated 13.02.2008, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks.

Case No.A-1112

M/S Coral Drugs Pvt. Ltd. NC Meeting No.45/08 F.No.01/82/50/298/AM08 RLA F.No.05/24/40/699/AM08 Adv.Lic.No.0510213410 dated 12.12.2007 product Finastride under para 4.7 of HBP. Committee decided to call for complete technical details as per Appendix 33 from firm. Accordingly, case was deferred for six weeks.

Case No.A-1113

M/S Coral Drugs Pvt. Ltd. NC Meeting No.45/08 F.No.01/82/50/299/AM08 RLA F.No.05/24/40/601/AM08 Adv.Lic.No.0510212483 dated 26.11.2007 product Flutamide USP under para 4.7 of HBP. Committee decided to call for complete technical details as per Appendix 33 from firm. Accordingly, case was deferred for six weeks.

Case No.A-1114

M/S Bal Pharma Ltd. NC Meeting No.45/08 F.No.01/82/50/297/AM08 RLA F.No.07/24/40/671/AM08 Adv.Lic.No.0710055101 dated 26.12.2007 product Amiloride Hcl under para 4.7 of HBP.

Case No.A-1115

M/S Lupin Ltd. NC Meeting No.45/08 F.No.01/82/50/1106/AM05 RLA F.No.03/24/40/1358/AM05 Adv.Lic.No.0310291255 dated 14.09.2004 product L Mandelic Acid under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of Chemical Division.

Case No.A-1116

M/S Kopran Ltd. NC Meeting No.45/08 F.No.01/82/50/1346/AM05 RLA F.No.03/24/40/1738/AM05 Adv.Lic.No.0310299804 dated 29.10.2004 product Sterile Ceftriaxone Sodium under para 4.7 of HBP on the rquest of RA that no norms has been fixed earlier in this case and no decision of Committee is available with them. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/65/2007-PI-III dated 11.03.2008 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 Qty allowed per unit of export product Ceftriaxone Sodium Sterile 1kg. 1. Ceftriaxone Sodium Sterile 1.00kg/kg 2. Acetone 2.08kg/kg RA concerned may take further necessary action as per above decision of Norms committee. In case any different decision has been taken contrary to above decision, the onus lies on the RA & firm.

Case No.A-1117

M/S Kopran Ltd. NC Meeting No.45/08 F.No.01/82/50/1371/AM07

RLA F.No.03/94/40/950/AM07 Adv.Lic.No.0310410417 dated 01.12.2006 product Azithromycin Dihydrate under para 4.7 of HBP.
Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/28/2007-PI-III dated 11.03.2008 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 Qty allowed per unit of export product Azithromycin Dihydrate 1kg. 1.

Azithromycin amine 1.04kg/kg 2. Acetone 0.90kg/kg 3. Formic Acid 0.210kg/kg RA concerned may take further necessary action as per above decision of Norms committee.
1

Case No.:31/21/82-

ALC4/2007 Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00057/AM06/ RLA File : 07/24/040/00013/AM06/ Lic.No/Date:07100374 27 21.04.2005 Defer Date: 08.04.2008 Decision :Committee considered case as per agenda for ratification of norms for export product Minoxidil under para 4.7 of HBP. Committee observed that application was called for from RA vide letter dated 01.03.2008, but same has not been received. Committee, therefore, decided to remind RA to furnish application. Accordingly, case was deferred for four weeks. 2

Case No.:61/24/87-

ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Withdrawn HQ File : 01/87/050/00084/AM06/ RLA File : 34/24/040/00007/AM06/ Lic.No/Date:34100132 61 27.04.2005

Decision : Committee considered case as per agenda for ratification of norms for export product Modafinil under para 4.7 of HBP.

Committee decided to withdraw case as case has been considered in its 43/08 meeting held on 04.03.2008. 3

Case No.:205/21/82-

ALC4/2007 Party Name:IGOR PHARMACHEM LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00268/AM06/ RLA File : 09/24/040/00086/AM06/ Lic.No/Date:09100232 19 21.06.2005

norms for export product 2-Aminomethyl-7-Chloro-2,3-Dihydro-5-(2- Fluorophenyl)-1H-1,4-Benzodiazepine Dimaleate under para 4.7 of HBP. Committee decided to withdraw case as case has been considered in its 44/08 meeting held on 04.03.2008. 4

Case No.:579/21/82-

ALC4/2007 Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/01174/AM07/ RLA File : 07/24/040/00449/AM07/ Lic.No/Date:07100479 85 19.10.2006 Defer Date: 08.04.2008 norms for export product Zinc Pyrithione under para 4.7 of HBP. Committee observed that application was called for from RA vide letter dated 01.03.2008, but same has not been received. Committee, therefore, decided to remind RA to furnish application. Accordingly, case was deferred for four weeks. 5

Case No.:3/44/83-

ALC1/2006 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e withdrawn HQ File : 01/83/050/00905/AM07/ RLA File : 09/24/040/00292/AM07/ Lic.No/Date:09100281 94 14.11.2006

norms for export product Lebetalol Hydrochloride under para 4.7 of HBP. Committee decided to withdraw case as case has been considered and deferred for four weeks in its 44/08 meeting held on 04.03.2008. 6

Case No.:6/44/83-

ALC1/2006 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Withdrawn

HQ File : 01/83/050/00948/AM07/ RLA File : 09/24/040/00337/AM07/ Lic.No/Date:09100283 60 23.11.2006

norms for export product 2-(1-H-Tetrazol-5-YL)Phenyl Boronic Acid Dihydrate under para 4.7 of HBP. deferred for four weeks in its 44/08 meeting held on 04.03.2008. 7

Case No.:16/49/82-

ALC1/2006 Party Name:LUPIN LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Withdrawn HQ File : 01/82/050/01721/AM07/ RLA File : 03/95/040/01297/AM07/ Lic.No/Date:03104167 16 22.01.2007

norms for export product Sterile Ceftriaxone Sodium Non Infringing under

para 4.7 of HBP.

deferred for four weeks in its 43/08 meeting held on 04.03.2008. 8

Case No.:858/21/82-

ALC4/2007 Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/01685/AM07/ RLA File : 07/24/040/00761/AM07/ Lic.No/Date:07100502 36 22.02.2007 Defer Date: 22.04.2008 norms for export product Zinc Pyrithione under para 4.7 of HBP. Committee decided to call for application from RA. Accordingly, case was deferred for six weeks. 9

Case No.:852/21/82-

ALC4/2007 Party Name:METROCHEM API PVT. LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Withdrawn HQ File : 01/82/050/01678/AM07/ RLA File : 09/24/040/00436/AM07/ Lic.No/Date:09100294 25 22.02.2007

norms for export product Lansoprazole Pellets 11.2% under para 4.7 of HBP.

Committee decided to withdraw case as case has already been approved in its 16/08 meeting held on 21.08.2007. 10

Case No.:879/21/82-

ALC4/2007 Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Withdrawn HQ File : 01/82/050/01714/AM07/ RLA File : 07/24/040/00780/AM07/ Lic.No/Date:07100503 14 27.02.2007

norms for export product Dorzolamide Hcl under para 4.7 of HBP. Committee decided to withdraw case as case has been approved in its 43/08 meeting held on 04.03.2008. 11

Case No.:7/2/82-ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:45/82-

ALC4/2007 11.03.2008 Status:Cas e Withdrawn HQ File : 01/82/050/01804/AM07/ RLA File : 03/94/040/01443/AM07/ Lic.No/Date:03104229 72 13.03.2007

norms for export product Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets, (2) Triomune40/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. deferred for four weeks in its 43/08 meeting held on 04.03.2008. 12

Case No.:17/9/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/82/050/01837/AM07/ RLA File : 03/94/040/01468/AM07/ Lic.No/Date:03104237 77 21.03.2007

norms for export product Exemestate under para 4.7 of HBP. Committee decided to withdraw case as case has been rejected in its 43/08 meeting held on 04.03.2008. 13 Case No.:25/14/83- ALC1/2007 Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : RLA File : Lic.No/Date:04100887

01/83/050/00016/AM08/ 04/24/040/00501/AM07/ 27 02.04.2007 norms for export product Allylestrenol under para 4.7 of HBP. deferred for six weeks in its 44/08 meeting held on 04.03.2008. 14

Case No.:19/19/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/00029/AM08/ RLA File : 09/24/040/00534/AM07/ Lic.No/Date:09100298 86 04.04.2007

norms for export product Naproxen Granules DC Grade 80% (Compresso NAP 80) under para 4.7 of HBP. deferred for six weeks in its 43/08 meeting held on 04.03.2008. 15

Case No.:27/19/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/83/050/00232/AM08/ RLA File : 09/24/040/00024/AM08/ Lic.No/Date:09100301 58 03.05.2007 Defer Date: 08.04.2008 norms for export product Phenazopyridine Hydrochloride under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division. 16 Case No.:20/21/82- ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/82/050/00028/AM08/ RLA File : 05/24/040/00097/AM08/ Lic.No/Date:05102033 44 07.05.2007

norms for export product Clarithromycin Carbomer Granules 44% under

para 4.7 of HBP.

deferred for four weeks in its 40/08 meeting held on 03.03.2008. 17

Case No.:614/24/83-

ALC1/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn 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. 41/08 meeting held on 03.03.2008. 18

Case No.:622/24/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/00388/AM08/ RLA File : 09/24/040/00048/AM08/ Lic.No/Date:09100303 34 24.05.2007

norms for export product 2-(2-Methoxy Phenoxy) Ethylamine under para 4.7 of HBP. deferred for six weeks in its 40/08 meeting held on 03.03.2008. 19

Case No.:730/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/00623/AM08/ RLA File : 09/24/040/00120/AM08/ Lic.No/Date:09100306 86 29.06.2007

norms for export product (S)-3-Hydroxy-N-Benzyl Pyrrolidine under para 4.7 of HBP. deferred for four weeks in its 43/08 meeting held on 04.03.2008. 20 Case No.:731/24/83- ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 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. 41/08 meeting held on 03.03.2008. 21

Case No.:95/21/82-

ALC4/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn 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) 41/08 meeting held on 03.03.2008. 22

Case No.:113/21/82-

ALC4/2007 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn 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 Cefpodoxime Proxetil under para 4.7 of HBP. Committee decided to withdraw case as case has been rejected in its 43/08 meeting held on 04.03.2008. 23 Case No.:7/25/83- ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/01032/AM08/ RLA File : 09/24/040/00231/AM08/ Lic.No/Date:09100313 14 29.08.2007

norms for export product Didanosine under para 4.7 of HBP.

24

Case No.:42/25/83-

ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 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. 40/08 meeting held on 03.03.2008. 25

Case No.:12/27/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 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/Saqvir 200mg Capsules under para 4.7 of HBP. deferred for four weeks in its 43/08 meeting held on 04.03.2008. 26

Case No.:5/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: 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. 40/08 meeting held on 03.03.2008. 27 Case No.:9/27/83- ALC1/2007 Party Name:OM SHREE PHARMACHEM PVT.LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case 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. 28

Case No.:33/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn 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. 41/08 meeting held on 03.03.2008. 29

Case No.:54/27/83-

ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/01128/AM08/ RLA File : 03/94/040/00525/AM08/ Lic.No/Date:03104419 78 06.09.2007

norms for export product Aprepitant under para 4.7 of HBP. 30

Case No.:69/27/83-

ALC1/2007 Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/01143/AM08/ RLA File : 05/24/040/00396/AM08/ Lic.No/Date:05102087 76 10.09.2007

norms for export product (4R-Cis)-1,1-Dimethylethyl-6-Cyanomethyl-2,2- Dimethyl-1-3-Dioxane-4-Acetate (ATS-8) under para 4.7 of HBP. deferred for four weeks in its 43/08 meeting held on 04.03.2008. 31 Case No.:72/27/83- ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:45/82- ALC4/2007 Status: Case

11.03.2008 Withdrawn HQ File : 01/83/050/01146/AM08/ RLA File : 03/95/040/00570/AM08/ Lic.No/Date:03104424 36 11.09.2007

norms for export product Sterile Ceftriazone Sodium Non Infringing under

para 4.7 of HBP.

deferred for four weeks in its 44/08 meeting held on 04.03.2008. 32

Case No.:10/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/82/050/00180/AM08/ RLA File : 03/94/040/00615/AM08/ Lic.No/Date:03104428 78 12.09.2007

norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. 33

Case No.:189/27/83-

ALC1/2007 Party Name:KESHAVA ORGANICS PVT. LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/83/050/01263/AM08/ RLA File : 03/94/040/00595/AM08/ Lic.No/Date:03104447 05 01.10.2007 Defer Date: 22.04.2008 norms for export product Chlorpheniramine Base 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. 34 Case No.:1/25/82- ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn 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.

41/08 meeting held on 03.03.2008. 35

Case No.:2/25/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/82/050/00196/AM08/ RLA File : 03/94/040/00664/AM08/ Lic.No/Date:03104450 42 03.10.2007

norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. 36

Case No.:7/29/83-

ALC1/2007 Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/01272/AM08/ RLA File : 05/24/040/00518/AM08/ Lic.No/Date:05102098 61 03.10.2007

norms for export product (4R-Cis)-1,1-Dimethylethyl-6-Cyanomethyl-2,2- Dimethyl-1-3-Dioxane-4-Acetate (ATS-8) under para 4.7 of HBP. 37

Case No.:53/30/83-

ALC1/2007 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/01422/AM08/ RLA File : 09/24/040/00560/AM07/ Lic.No/Date:09100318 81 24.10.2007

norms for export product Cyclopropyl Diol Cyclic Sulfite under para 4.7 of HBP. 38 Case No.:51/30/83- ALC1/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:45/82- ALC4/2007 Status: Case

11.03.2008 Withdrawn HQ File : 01/83/050/01420/AM08/ RLA File : 09/24/040/00276/AM08/ Lic.No/Date:09100318 79 24.10.2007

norms for export product Indinavir Sulphate under para 4.7 of HBP. 39

Case No.:81/32/83-

ALC1/2007 Party Name:METROCHEM API PVT. LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/83/050/01503/AM08/ RLA File : 09/24/040/00240/AM08/ Lic.No/Date:09100319 88 05.11.2007 Defer Date: 22.04.2008 norms for export product 2-Chloro Methyl-3-Methyl-4-(2,2,2-Trifloro Ethoxy)- Pyridine hydrochloride 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. 40

Case No.:82/32/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/01504/AM08/ RLA File : 09/24/040/00051/AM08/ Lic.No/Date:09100319 91 05.11.2007

norms for export product Cefepime Hcl for Injection under para 4.7 of HBP. 43/08 meeting held on 04.03.2008. 41 Case No.:32/33/83- ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/01561/AM08/ RLA File : 09/24/040/00256/AM08/ Lic.No/Date:09100320 90 14.11.2007

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

42

Case No.:32/39/83-

ALC1/2007 Party Name:VANI CHEMICALS & INTERMEDIATES LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/83/050/01611/AM08/ RLA File : 09/24/040/00219/AM08/ Lic.No/Date:09100322 33 27.11.2007

norms for export product Metformin Hcl BP/EP under para 4.7 of HBP. Committee in line with revised SION No. A-290 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. Sl.No. Import items Qty. allowed per unit of export product Metformin Hcl BP/EP 1kg. 1. Dicyandiamide 0.567kg/kg 2. Ortho-xylene 0.75kg/kg of NC. 43

Case No.:34/39/83-

ALC1/2007 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/01613/AM08/ RLA File : 09/24/040/00385/AM08/ Lic.No/Date:09100322 45 28.11.2007

norms for export product (s) Alpha-Ethyl-2-Oxo-1-Pyrrolidineacetic Acid (LVA-40) under para 4.7 of HBP. 44 Case No.:74/45/82- ALC4/2007 Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00537/AM08/ RLA File : 05/24/040/00727/AM08/ Lic.No/Date:05102137 20 18.12.2007 Defer Date: 01.04.2008

norms for export product Thymol above 98.5% Pure under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of Chemical Division. 45

Case No.:77/45/82-

ALC4/2007 Party Name:ANJAN DRUGS PRIVATE LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00540/AM08/ RLA File : 04/24/040/00058/AM08/ Lic.No/Date:04100928 18 19.12.2007

norms for export product Divalproex Sodium under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/207/2004-PI-III dated 11.03.2008 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as Export product Export Qty. Sl.No . Import items Qty. allowed per unit of export product Divalproex Sodium 1kg. 1. Sodium Metal 0.52kg/kg 2. N-Propyl Bromide 2.69kg/kg 3. T-Butanol 0.69kg/kg 4. Sodium Hydroxide 0.13kg/kg 5. Di-ethyl malonate 1.43kg/kg of NC. 46

Case No.:63/45/82-

ALC4/2007 Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00526/AM08/ RLA File : 03/95/040/00918/AM08/ Lic.No/Date:03104549 61 20.12.2007 Defer Date: 01.04.2008 norms for export product 2[(Chloro Methyl) Mercapto] Benzo Thiazole (CMBT) under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of Chemical Division.

47

Case No.:33/45/82-

ALC4/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00496/AM08/ RLA File : 03/94/040/00644/AM08/ Lic.No/Date:03104551 27 26.12.2007 Defer Date: 08.04.2008 norms for export product Clopidogrel Bisulphate under para 4.7 of HBP. Division. 48

Case No.:85/45/82-

ALC4/2007 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00548/AM08/ RLA File : 03/95/040/00947/AM08/ Lic.No/Date:03104551 79 26.12.2007 Defer Date: 08.04.2008 norms for export product Copper Dibutyl Dithiocarbamate under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Chemical Division. 49

Case No.:64/45/82-

ALC4/2007 Party Name:NANDOLIA ORGANIC CHEMICALS PVT.LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00527/AM08/ RLA File : 03/95/040/00872/AM08/ Lic.No/Date:03104553 96 27.12.2007 Defer Date: 08.04.2008 norms for export product Para Anisyl Alcohol under para 4.7 of HBP. Chemical Division. 50 Case No.:9/40/83- ALC1/2007 Party Name:KUDOES CHEMIE LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status: Case Withdrawn HQ File : 01/83/050/01774/AM08/ RLA File : 22/24/040/00059/AM08/ Lic.No/Date:22100073 29 27.12.2007

norms for export product Caffeine under para 4.7 of HBP. deferred for six weeks in its 43/08 meeting held on 04.03.2008. 51

Case No.:2/45/82-

ALC4/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00465/AM08/ RLA File : 09/24/040/00420/AM08/ Lic.No/Date:09100324 92 28.12.2007 Defer Date: 08.04.2008 norms for export product Stavudine under para 4.7 of HBP. Division.

52

Case No.:66/45/82-

ALC4/2007 Party Name:HILDOSE Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00529/AM08/ RLA File : 03/94/040/00984/AM08/ Lic.No/Date:03104556 68 28.12.2007 Defer Date: 08.04.2008 norms for export product Methyl 2,2 Dimethyl Cyanoacetate under para 4.7 of HBP. Chemical Division. 53

Case No.:1/45/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00464/AM08/ RLA File : 09/24/040/00246/AM08/ Lic.No/Date:09100324 96 31.12.2007 Defer Date: 08.04.2008 norms for export product Piperacillin Sodium Sterile and Tazobactam Sodium Sterile (8:1) under para 4.7 of HBP. Division. 54

Case No.:5/45/82-

ALC4/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00468/AM08/ RLA File : 09/24/040/00361/AM08/ Lic.No/Date:09100324 97 31.12.2007 Defer Date: 08.04.2008 norms for export product 4-Amino-2-oxo-Pyrimidinyl-Oxathiolane-2- Carboxylic acid-Isopropyl-Methyl-Cyclohexyl Ester (Cyclohexyl Ester) under

para 4.7 of HBP.

Division. 55 Case No.:75/45/82- ALC4/2007 Party Name:VIDA LABORATORIES (P) LTD Meet No/Date:45/82- ALC4/2007 Status:Cas e Deferred

11.03.2008 HQ File : 01/82/050/00538/AM08/ RLA File : 07/24/040/00686/AM08/ Lic.No/Date:07100551 40 31.12.2007 Defer Date: 22.04.2008 norms for export product Cefuroxime Sodium for Injection, Piperacillin Sodium + Tazobactam Sodium Sterile for injection and Amocicillin Sodium

  • Clavulanate Potassium for Injection under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 56

Case No.:65/45/82-

ALC4/2007 Party Name:KAJAY REMEDIES PVT. LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00528/AM08/ RLA File : 03/94/040/00993/AM08/ Lic.No/Date:03104558 79 01.01.2008 Defer Date: 08.04.2008 norms for export product Para nitro phenol under para 4.7 of HBP. Chemical Division. 57

Case No.:25/45/82-

ALC4/2007 Party Name:AROMA AROMATICS & FLAVOURS Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00488/AM08/ RLA File : 05/24/040/00766/AM08/ Lic.No/Date:05102143 92 03.01.2008 Defer Date: 08.04.2008 norms for export product Propenyl Guaethol above 99% pure (Crystals) Chemical Division. 58 Case No.:14/45/82- ALC4/2007 Party Name:ALKALOIDS CORPORATION Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00477/AM08/ RLA File : 02/24/040/00270/AM08/ Lic.No/Date:02101078 30 04.01.2008 Defer Date: 08.04.2008 norms for export product Digoxin (Dititalis Extract) under para 4.7 of HBP.

Committee decided to forward a copy of application to Department of MSME for their comments. Accordingly, case was deferred for four weeks. 59

Case No.:19/45/82-

ALC4/2007 Party Name:ALKALOIDS CORPORATION Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00482/AM08/ RLA File : 02/24/040/00269/AM08/ Lic.No/Date:02101078 28 04.01.2008

norms for export product Yohimbine Hcl USP under para 4.7 of HBP. Committee in light of its earlier decision taken in its 24/82 meeting held on 16.10.2007 in the case of Indo Phytochem Pharmaceuticals and in consultation with representative of MSME present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Import item Qty. allowed per unit of export product Yohimbine Hydrochloride USP 1kg. Yohimbine Bark (containing Yohimbine Content maximum

1- 1.2%) 133.44kg/kg of NC. 60

Case No.:20/45/82-

ALC4/2007 Party Name:ALKALOIDS CORPORATION Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00483/AM08/ RLA File : 02/24/040/00272/AM08/ Lic.No/Date:02101078 33 04.01.2008 Defer Date: 22.04.2008 norms for export product Artesunate Int PH3 under para 4.7 of HBP. Committee decided to call for complete description of export and import items, copy of DML and technical details as per Appendix 33 from firm. Accordingly, case was deferred for six weeks.

61

Case No.:24/45/82-

ALC4/2007 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00487/AM08/ RLA File : 05/24/040/00740/AM08/ Lic.No/Date:05102145 22 04.01.2008 Defer Date: 08.04.2008 norms for export product Digoxin under para 4.7 of HBP. Division. 62

Case No.:57/45/82-

ALC4/2007 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00520/AM08/ RLA File : 03/95/040/00956/AM08/ Lic.No/Date:03104566 85 07.01.2008 Defer Date: 08.04.2008 norms for export product Para Fluoro Bromo Benzene (4 Fluoro Bromo Benzene) under para 4.7 of HBP. Chemical Division. 63

Case No.:15/45/82-

ALC4/2007 Party Name:ANUH PHARMA LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00478/AM08/ RLA File : 03/94/040/00916/AM08/ Lic.No/Date:03104569 83 08.01.2008 Defer Date: 22.04.2008 norms for export product Mometasone Furoate under para 4.7 of HBP. Committee decided to call for complete details of import item alongwith chemistry from firm. Accordingly, case was deferred for six weeks. 64 Case No.:16/45/82- ALC4/2007 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00479/AM08/ RLA File : 03/94/040/00980/AM08/ Lic.No/Date:03104569 99 08.01.2008 Defer Date: 08.04.2008 norms for export product N,Ethyl Ortho Toluidine (NEOT) under para 4.7 of

HBP. Chemical Division. 65

Case No.:18/45/82-

ALC4/2007 Party Name:ANUH PHARMA LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00481/AM08/ RLA File : 03/94/040/00917/AM08/ Lic.No/Date:03104569 85 08.01.2008 Defer Date: 22.04.2008 norms for export product Clobetasone Butyrate under para 4.7 of HBP. Division. 66

Case No.:84/45/82-

ALC4/2007 Party Name:SALVI CHEMICAL INDUSTRIES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00547/AM08/ RLA File : 03/95/040/00997/AM08/ Lic.No/Date:03104569 69 08.01.2008 Defer Date: 22.04.2008 norms for export product 3,5 Di-Iodo Salicylic Acid under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of Chemical Division. 67

Case No.:44/45/82-

ALC4/2007 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00507/AM08/ RLA File : 03/94/040/00971/AM08/ Lic.No/Date:03104571 90 09.01.2008 Defer Date: 08.04.2008 norms for export product 2 Chloro 14 Dimethoxybenzene under para 4.7 of HBP. Chemical Division. 68 Case No.:28/45/82- ALC4/2007 Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred

HQ File : 01/82/050/00491/AM08/ RLA File : 04/24/040/00335/AM08/ Lic.No/Date:04100931 38 10.01.2008 Defer Date: 08.04.2008 norms for export product 1,1-Di-Methyl 3 Hydroxy Butyl Peroxy neodecanoate 50% Non Frozen Emulsion (Luperox 610 EN 50) under para 4.7 of HBP. Chemical Division. 69

Case No.:70/45/82-

ALC4/2007 Party Name:SOUTHERN PETROCHEMICAL IND. CORPN. LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00533/AM08/ RLA File : 04/24/040/00337/AM08/ Lic.No/Date:04100931 39 10.01.2008 Defer Date: 08.04.2008 norms for export product N-(2-Hydroxyethyl) Pyrrolidine Pyrrolidine - Liquid Chemical Division. 70 Case No.:90/45/82- ALC4/2007 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Case Apporved HQ File : 01/82/050/00553/AM08/ RLA File : 09/24/040/00433/AM08/ Lic.No/Date:0910032 640 10.01.2008 : norms for export product Cyclopentadecanolide (Recrystallised) under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 vide Case No.6/11/82 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 Qty. Sl.N o. Import items Qty. allowed per unit of export product

Cyclopentadecan olide (Recrystallised) (Purity not less than 99.5%) 1kg. 1. Cyclopentadecanol ide (Tech. Grade) (Purity

NMT 90.5%) 1.20kg/kg 2. Methanol 3.95kg/kg RA concerned may take further necessary action as per above decision of NC. 71

Case No.:91/45/82-

ALC4/2007 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00554/AM08/ RLA File : 09/24/040/00432/AM08/ Lic.No/Date:09100326 41 10.01.2008

norms for export product Levetiracetam under para 4.7 of HBP. their U.O. No.35011/218/2006-PI-III dated 11.03.2008 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Levetiraceta m 1kg. 1. 2-Pyrrolidone 2.57kg/kg 2. D(+)Alpha Phenylethylamine 0.87kg/kg 3. Ethyl-2-Bromo Butyrate 5.89kg/kg 4. Methanol 3.22kg/kg 5. Iso Propyl Alcohol 4.90kg/kg of NC. 72 Case No.:4/45/82- ALC4/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00467/AM08/ RLA File : 09/24/040/00411/AM08/ 46 11.01.2008 Defer Date: 08.04.2008

norms for export product {1 R,2 S,5R}-Methyl-5S-(Cytosine-1-YL)-1-3- Oxathiolane-2R-Carboxylate under para 4.7 of HBP. Division. 73

Case No.:12/45/82-

ALC4/2007 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00475/AM08/ RLA File : 03/94/040/00999/AM08/ Lic.No/Date:03104574 07 11.01.2008 Defer Date: 08.04.2008 norms for export product 2,5-Dimethyl Phenyl Acetyl Chloride under para 4.7 of HBP. Chemical Division. 74

Case No.:13/45/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00476/AM08/ RLA File : 03/94/040/01028/AM08/ Lic.No/Date:03104575 08 11.01.2008 Defer Date: 08.04.2008 norms for export product Lamivir 150mg Tablets etc. under para 4.7 of HBP. Division. 75

Case No.:21/45/82-

ALC4/2007 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00484/AM08/ RLA File : 03/94/040/00979/AM08/ Lic.No/Date:03104575 14 11.01.2008

norms for export product Fluticasone Propionate under para 4.7 of HBP. their U.O. No.35011/150/2005-PI-III dated 11.03.2008 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as

Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Fluticasone Propionate 1kg. 1. Flumethasone 2.50kg/kg 2. Bromo Fluro Methane 0.68kg/kg 3. N,N-carboxyl Di-imidazole 1.62kg/kg of NC. 76

Case No.:47/45/82-

ALC4/2007 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00510/AM08/ RLA File : 09/24/040/00371/AM08/ 45 11.01.2008 Defer Date: 08.04.2008 norms for export product 1,2-Epoxy-2(2,4-Difluorophenyl)-3-(1-(H)-1,2,4- Triazole,1 Propane Methane Sulphonate under para 4.7 of HBP. Division. 77

Case No.:49/45/82-

ALC4/2007 Party Name:INVENTIS DRUG DELIVERY SYSTEMS PVT LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00512/AM08/ RLA File : 09/24/040/00222/AM08/ 44 11.01.2008 Defer Date: 22.04.2008 norms for export product Lansoprazole Pellets 8.5% under para 4.7 of HBP. Division. 78 Case No.:61/45/82- ALC4/2007 Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00524/AM08/ RLA File : 03/94/040/01014/AM08/ Lic.No/Date:03104575 13 11.01.2008 Defer Date: 08.04.2008

norms for export product Hamber under para 4.7 of HBP. Chemical Division. 79

Case No.:48/45/82-

ALC4/2007 Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00511/AM08/ RLA File : 03/95/040/00974/AM08/ Lic.No/Date:03104576 22 14.01.2008 Defer Date: 08.04.2008 norms for export product 5 Amino 6 Methyl Benzimidazolone under para 4.7 of HBP. Chemical Division. 80

Case No.:80/45/82-

ALC4/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00543/AM08/ RLA File : 09/24/040/00450/AM08/ 59 15.01.2008 Defer Date: 08.04.2008 norms for export product (2-Chloro-5-Iodo Phenyl)-(4-Fluoro Phenyl) Methanone under para 4.7 of HBP. Division. 81

Case No.:87/45/82-

ALC4/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00550/AM08/ RLA File : 09/24/040/00452/AM08/ 58 15.01.2008 Defer Date: 08.04.2008 norms for export product (2-Chloro-5-Iodophenyl)-[4-(Terahydrofuran-3- Yloxy) Phenyl]-Methanone under para 4.7 of HBP. Division.

82

Case No.:8/45/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00471/AM08/ RLA File : 03/94/040/01041/AM08/ Lic.No/Date:03104578 81 16.01.2008 Defer Date: 08.04.2008 norms for export product Nevimine 200mg Tablets and Nevirapine Oral Sulpension under para 4.7 of HBP. Division. 83

Case No.:9/45/82-

ALC4/2007 Party Name:GALAXY LABORATORIES PVT LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00472/AM08/ RLA File : 03/94/040/01004/AM08/ Lic.No/Date:03104577 55 16.01.2008 Defer Date: 08.04.2008 norms for export product Furfurylamine under para 4.7 of HBP. Chemical Division. 84

Case No.:10/45/82-

ALC4/2007 Party Name:GEMINI EXPORTS., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00473/AM08/ RLA File : 03/94/040/01035/AM08/ Lic.No/Date:03104578 91 16.01.2008 Defer Date: 08.04.2008 norms for export product Ferrous Fumarate under para 4.7 of HBP. Chemical Division. 85 Case No.:23/45/82- ALC4/2007 Party Name:FINE ORGANIC INDUSTRIES(MUMBAI) PVT. LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00486/AM08/ RLA File : 03/94/040/01026/AM08/ Lic.No/Date:03104578 84 16.01.2008 Defer Date: 08.04.2008 norms for export product Sodium Stearyl Lactylate under para 4.7 of HBP.

Chemical Division. 86

Case No.:45/45/82-

ALC4/2007 Party Name:LAFFANS PETROCHEMICALS LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00508/AM08/ RLA File : 03/95/040/01003/AM08/ Lic.No/Date:03104578 33 16.01.2008 Defer Date: 08.04.2008 norms for export product Laffsolve MEB (Ethylene Glycol mono butyl Ether) Chemical Division. 87

Case No.:46/45/82-

ALC4/2007 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00509/AM08/ RLA File : 03/95/040/01017/AM08/ Lic.No/Date:03104577 18 16.01.2008 Defer Date: 08.04.2008 norms for export product N Acetoxy Ethyl N Cyano Ethyl Meta Amino Acetanilide (1-Acetylamino-3-N(2 Acetoxy Ethyl-3-N(2 Cyano Ethyl) under

para 4.7 of HBP.

Division. 88

Case No.:50/45/82-

ALC4/2007 Party Name:KALPSUTRA CHEMICALS PVT. LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00513/AM08/ RLA File : 03/94/040/01020/AM08/ Lic.No/Date:03104577 97 16.01.2008 Defer Date: 08.04.2008 norms for export product Timberfleur (1-(2,2,6-Trimethyl Cyclohexyl)- Hexan-3-01) under para 4.7 of HBP. Chemical Division.

89

Case No.:51/45/82-

ALC4/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00514/AM08/ RLA File : 03/94/040/00996/AM08/ Lic.No/Date:03104578 11 16.01.2008 Defer Date: 22.04.2008 norms for export product Nabumetone under para 4.7 of HBP. Division. 90

Case No.:52/45/82-

ALC4/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00515/AM08/ RLA File : 03/94/040/00974/AM08/ Lic.No/Date:03104578 05 16.01.2008

norms for export product Testosterone under para 4.7 of HBP. their U.O. No.35011/88/2007-PI-III dated 11.03.2008 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Testosteron 1kg. 1. Androst-4-ene-3,17 dione 1.33kg/kg 2. Triethyl Ortho Formate 0.36kg/kg of NC. 91 Case No.:27/45/82- ALC4/2007 Party Name:GEMINI EXPORTS., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00490/AM08/ RLA File : 03/94/040/00812/AM08/ Lic.No/Date:03104580 56 17.01.2008 Defer Date: 22.04.2008 norms for export product Metoprolol Succinate under para 4.7 of HBP.

Committee decided to defer case for six weeks for comments of PI/Chem. Division. 92

Case No.:79/45/82-

ALC4/2007 Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00542/AM08/ RLA File : 09/24/040/00434/AM08/ 65 17.01.2008 Defer Date: 22.04.2008 norms for export product Spironolactone Tablets 25mg and 100mg under

para 4.7 of HBP.

Division. 93

Case No.:53/45/82-

ALC4/2007 Party Name:METROPOLITAN OVERSEAS LIMITED, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00516/AM08/ RLA File : 03/95/040/01030/AM08/ Lic.No/Date:03104581 66 18.01.2008 Defer Date: 22.04.2008 norms for export product N-[1-(S)-Ethoxy Carbonyl-3-Phenyl Propyl]-L- Alanine under para 4.7 of HBP. Committee observed that norms applied by firm are not as per chemistry furnished by them. Committee, therefore, decided to call from firm the technical justification alongwith calculations for working out the quantative requirement as applied by them. Accordingly, case was deferred for six weeks. 94

Case No.:58/45/82-

ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00521/AM08/ RLA File : 03/95/040/01026/AM08/ Lic.No/Date:03104583 00 18.01.2008 Defer Date: 22.04.2008 norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. Division.

95

Case No.:8/44/83-

ALC1/2007 Party Name:SHIVA PHARMACHEM PVT. LTD, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/83/050/01802/AM08/ RLA File : 34/24/040/00208/AM08/ Lic.No/Date:34100206 55 21.01.2008 Defer Date: 08.04.2008 norms for export product n-Butyryl Chloride/Butyryl Chloride under para 4.7 of HBP. Chemical Division. 96

Case No.:62/45/82-

ALC4/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00525/AM08/ RLA File : 03/95/040/01007/AM08/ Lic.No/Date:03104583 73 21.01.2008 Defer Date: 08.04.2008 norms for export product Oxysept Tablets (9081X) Contact Lens Cleaning Tablets under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of DBT. 97

Case No.:86/45/82-

ALC4/2007 Party Name:VIJAYASRI ORGANICS LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00549/AM08/ RLA File : 09/24/040/00469/AM08/ 88 21.01.2008 Defer Date: 22.04.2008 norms for export product 2-Butyl-5-Chloro=3H-Imidazole-4-Carbaldehyde (IMAL) (Or) (2-N-Butyl-4-Chloro-5-Formylimidazole (BCFI) under para 4.7 of HBP. Division. 98 Case No.:89/45/82- ALC4/2007 Party Name:VIJAYASRI CHEMICALS Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00552/AM08/ RLA File : 09/24/040/00470/AM08/ 89 21.01.2008 Defer Date: 22.04.2008

norms for export product 2-Butyl-5-Chloro=3H-Imidazole-4-Carbaldehyde (IMAL) (Or) (2-N-Butyl-4-Chloro-5-Formylimidazole (BCFI) under para 4.7 of HBP. Division. 99

Case No.:56/45/82-

ALC4/2007 Party Name:OLEOFINE ORGANICS (INDIA)PVT.LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00519/AM08/ RLA File : 03/95/040/01050/AM08/ Lic.No/Date:03104585 76 22.01.2008 Defer Date: 08.04.2008 norms for export product Behenamide under para 4.7 of HBP. Chemical Division. 10 0

Case No.:59/45/82-

ALC4/2007 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00522/AM08/ RLA File : 03/95/040/01022/AM08/ Lic.No/Date:03104586 69 22.01.2008 Defer Date: 22.04.200 8 norms for export product Amodiaquine hydrochloride under para 4.7 of HBP. Committee decided to call for All Industry Data from Pharmexcil for revision of SION. Accordingly, case was deferred for six weeks. 10 1

Case No.:3/45/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00466/AM08/ RLA File : 09/24/040/00405/AM08/ Lic.No/Date:09100327 11 23.01.2008 Defer Date: 22.04.200 8 norms for export product Lopinavir under para 4.7 of HBP.

Division. 10 2

Case No.:68/45/82-

ALC4/2007 Party Name:SHASUN CHEMICALS & DRUGS LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00531/AM08/ RLA File : 04/24/040/00309/AM08/ Lic.No/Date:04100934 23 23.01.2008

norms for export product Sulfasalazine Tablets (500mg) under para 4.7 of HBP. I was decided to ratify the subject Advance Authorisation with 2% wastage or as applied for whichever is less subject to verification of DML and other relevant documents by RA. of NC. 10 3

Case No.:69/45/82-

ALC4/2007 Party Name:SHASUN CHEMICALS & DRUGS LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00532/AM08/ RLA File : 04/24/040/00318/AM08/ Lic.No/Date:04100934 28 23.01.2008 Defer Date: 22.04.200 8 norms for export product 1,4-Dithia 7-Azaspiro(4,4) nonane-8(S)- Carbolylicacid Hydrobromide under para 4.7 of HBP. Division. 10 4

Case No.:60/45/82-

ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00523/AM08/ RLA File : 03/95/040/01054/AM08/ Lic.No/Date:03104589 92 24.01.2008 Defer Date: 22.04.200 8 norms for export product Sterile Ceftriaxone Sodium Non Infringing under

para 4.7 of HBP.

Committee decided to examine case on file.

10 5

Case No.:76/45/82-

ALC4/2007 Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00539/AM08/ RLA File : 05/24/040/00787/AM08/ Lic.No/Date:05102153 90 24.01.2008 Defer Date: 08.04.200 8 norms for export product (4R-Cis)-1,1-Dimethylethyl-6-Cyanomethyl-2,2- Dimethyl-1-3-Dioxane-4-Acetate (ATS-8) under para 4.7 of HBP. Division. 10 6

Case No.:82/45/82-

ALC4/2007 Party Name:SUDERSHAN LABORATORIES LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00545/AM08/ RLA File : 09/24/040/00476/AM08/ Lic.No/Date:09100327 26 24.01.2008 Defer Date: 08.04.200 8 norms for export product N Butyl Lithium (1.6 M Solution As 100% under

para 4.7 of HBP.

Chemical Division. 10 7

Case No.:11/45/82-

ALC4/2007 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00474/AM08/ RLA File : 03/94/040/01078/AM08/ Lic.No/Date:03104591 41 25.01.2008 Defer Date: 08.04.200 8 norms for export product 2,4 Dichloro Aniline under para 4.7 of HBP. Chemical Division. 10 8

Case No.:40/45/82-

ALC4/2007 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : RLA File : Lic.No/Date:02101085 Defer

01/82/050/00503/AM08/ 02/24/040/00285/AM08/ 51 25.01.2008 Date: 08.04.200 8 norms for export product Benzene under para 4.7 of HBP. Chemical Division. 10 9

Case No.:54/45/82-

ALC4/2007 Party Name:LAFFANS PETROCHEMICALS LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00517/AM08/ RLA File : 03/95/040/01046/AM08/ Lic.No/Date:03104591 72 25.01.2008 Defer Date: 08.04.200 8 norms for export product Lafftol DEB (Di Ethylene Glycol Mono Butyl Ether) (Butyl Di Glycol) under para 4.7 of HBP. Chemical Division. 11 0

Case No.:6/45/82-

ALC4/2007 Party Name:JOCIL LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00469/AM08/ RLA File : 09/24/040/00417/AM08/ Lic.No/Date:09100327 43 28.01.2008 Defer Date: 08.04.200 8 norms for export product Pink/Yellow/Green Soap Noodles Sodium Salt of Palmitic Acid under para 4.7 of HBP. Chemical Division. 11 1

Case No.:7/45/82-

ALC4/2007 Party Name:METROCHEM API PVT. LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00470/AM08/ RLA File : 09/24/040/00456/AM08/ Lic.No/Date:09100327 40 28.01.2008 Defer Date: 22.04.200 8

norms for export product Rabeprazole Sodium under para 4.7 of HBP. Division. 11 2

Case No.:17/45/82-

ALC4/2007 Party Name:ANJAN DRUGS PRIVATE LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00480/AM08/ RLA File : 04/24/040/00213/AM08/ Lic.No/Date:04100934 97 29.01.2008

norms for export product Divalproex Sodium under para 4.7 of HBP. their U.O. No.35011/207/2004-PI-III dated 11.03.2008 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as Export product Export Qty. Sl.No . Import items Qty. allowed per unit of export product Divalproex Sodium 1kg. 1. Sodium Metal 0.52kg/kg 2. N-Propyl Bromide 2.69kg/kg 3. T-Butanol 0.69kg/kg 4. Sodium Hydroxide 0.13kg/kg 5. Di-ethyl malonate 1.43kg/kg of NC. 11 3

Case No.:22/45/82-

ALC4/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00485/AM08/ RLA File : 07/24/040/00725/AM08/ Lic.No/Date:07100556 35 29.01.2008 Defer Date: 01.04.200 8 norms for export product Calcium Gluconate Powder under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of PI/Chemical Division.

11 4

Case No.:83/45/82-

ALC4/2007 Party Name:DUJODWALA PAPER CHEMICALS LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00546/AM08/ RLA File : 03/94/040/00956/AM08/ Lic.No/Date:03104594 19 29.01.2008 Defer Date: 22.04.200 8 norms for export product Polyamide Resin under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of Chemical Division. 11 5

Case No.:88/45/82-

ALC4/2007 Party Name:VIVIMED LABS LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00551/AM08/ RLA File : 09/24/040/00422/AM08/ Lic.No/Date:09100328 08 29.01.2008 Defer Date: 22.04.200 8 norms for export product Benzophenone-3/2-Hydroxy-4-Methoxy Benzophenone/Oxybenzone under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of Chemical Division. 11 6

Case No.:30/45/82-

ALC4/2007 Party Name:ANUH PHARMA LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00493/AM08/ RLA File : 03/94/040/01047/AM08/ Lic.No/Date:03104595 39 30.01.2008 Defer Date: 22.04.200 8 norms for export product Clobetasol Propionate BP under para 4.7 of HBP. Division. 11 7

Case No.:26/45/82-

ALC4/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00489/AM08/ RLA File : 07/24/040/00593/AM08/ Lic.No/Date:07100556 73 Defer Date:

31.01.2008 01.04.200 8 norms for export product Calcium Lactobionate, Calcium Glubionate and Calcium Bromolactobionate under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of PI/Chemical Division. 11 8

Case No.:32/45/82-

ALC4/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00495/AM08/ RLA File : 03/94/040/01031/AM08/ Lic.No/Date:03104597 14 31.01.2008 Defer Date: 08.04.200 8 norms for export product 1-(4 Methyl Phenyl)-4,4,4 Trifluorobutane-3-Dione (Diketone) under para 4.7 of HBP. Division. 11 9

Case No.:73/45/82-

ALC4/2007 Party Name:WIN-MEDICARE PVT. LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00536/AM08/ RLA File : 05/24/040/00267/AM08/ Lic.No/Date:05102157 25 31.01.2008 Defer Date: 22.04.200 8 norms for export product Betadine Standardised Microbicidal Solution 10% USP/IP 100ml, 500ml and 50ml, Betadine Surgical Scrub 7.5% USP/IP 50ml and 500ml, Betadine Gargle 1% USP/IP 50ml and 100ml under para 4.7 of HBP. Division. 12 0

Case No.:38/45/82-

ALC4/2007 Party Name:NANAVATI SPECIALITY CHEMICALS PVT LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00501/AM08/ RLA File : 03/95/040/01002/AM08/ Lic.No/Date:03104597 96 01.02.2008 Defer Date: 08.04.200 8

norms for export product 2 Nitro Dimethyl Terephthalate Chemical under

para 4.7 of HBP.

Chemical Division. 12 1

Case No.:41/45/82-

ALC4/2007 Party Name:MAKAM PHARMACHEM Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00504/AM08/ RLA File : 07/24/040/00741/AM08/ Lic.No/Date:07100556 77 01.02.2008 Defer Date: 08.04.200 8 norms for export product Fluemetrin 1% W/V Pour under para 4.7 of HBP. Chemical Division. 12 2

Case No.:71/45/82-

ALC4/2007 Party Name:SKY LIFE SCIENCE. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00534/AM08/ RLA File : 34/24/040/00214/AM08/ Lic.No/Date:34100207 57 01.02.2008 Defer Date: 22.04.200 8 norms for export product Clobetasol Propionate under para 4.7 of HBP. Division. 12 3

Case No.:72/45/82-

ALC4/2007 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00535/AM08/ RLA File : 34/24/040/00216/AM08/ Lic.No/Date:34100207 58 01.02.2008 Defer Date: 08.04.200 8 norms for export product Methyl Tributyl Ammonium Chloride Cas No.56375-79-2 under para 4.7 of HBP.

Chemical Division. 12 4

Case No.:31/45/82-

ALC4/2007 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00494/AM08/ RLA File : 03/94/040/01086/AM08/ Lic.No/Date:03104599 38 04.02.2008 Defer Date: 08.04.200 8 norms for export product Protectol DA or 2,4-Dichloro Benzyl Alcohol Chemical Division. 12 5

Case No.:55/45/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00518/AM08/ RLA File : 03/94/040/01098/AM08/ Lic.No/Date:03104599 56 04.02.2008

norms for export product Tenofovir Disoproxil Fumarate Tablets 300mg 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 Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Tenofovir Disoproxil Fumerate Tablets 300mg/Tenvir Tablets 2349180N os. 1. 9-[2-(Phosphonyl Methoxy)Propyl] Adenine 0.8026kg/k g

of Tenofovir Disoproxil Fumerate

Total weight of Tenofovir Disoproxil Fumerate— 704.754kgs. 2. Chloromethyl Isopropyl carbonate 2.08670kg/ kg

of Tenofovir Disoproxil Fumerate RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms committee. 12 6

Case No.:34/45/82-

ALC4/2007 Party Name:HILDOSE Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00497/AM08/ RLA File : 03/94/040/01100/AM08/ Lic.No/Date:03104602 75 06.02.2008 Defer Date: 08.04.200 8 norms for export product Dichloro Meta Xylenol under para 4.7 of HBP. Chemical Division. 12 7

Case No.:36/45/82-

ALC4/2007 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00499/AM08/ RLA File : 03/95/040/01065/AM08/ Lic.No/Date:03104602 71 06.02.2008 Defer Date: 22.04.200 8 norms for export product Chloroquine Phosphate under para 4.7 of HBP. Division. 12 8

Case No.:39/45/82-

ALC4/2007 Party Name:KORES (INDIA) LTD. Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00502/AM08/ RLA File : 03/94/040/01071/AM08/ Lic.No/Date:03104602 46 06.02.2008 Defer Date: 22.04.200 8 norms for export product 2(7 Theophylline Methyl)1,3 Dioxolane under

para 4.7 of HBP.

Division. 12 9

Case No.:121/42/82-

ALC4/2007 Party Name:BODAL CHEMICALS LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00457/AM08/ RLA File : 08/24/040/00251/AM08/ Lic.No/Date:08100699 63 06.02.2008 Defer Date: 08.04.200 8 norms for export product under para 4.7 of HBP. Chemical Division. 13 0

Case No.:35/45/82-

ALC4/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00498/AM08/ RLA File : 03/94/040/01104/AM08/ Lic.No/Date:03104605 32 11.02.2008

norms for export product Morantel Citrate under para 4.7 of HBP. their U.O. No.35011/259/2006-PI-III dated 11.03.2008 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Morantel Citrate 1kg. 1. 3-Methyl Thiophene 0.330kg/kg 2. Acetonitrile 0.180kg/kg 3. Dimethyl Formamide 0.270kg/kg 4. Citric Acid 0.640kg/kg 5. Ethylene dichloride 0.165kg/kg 6. Iso Propyl Alcohol 0.225kg/kg of NC.

13 1

Case No.:37/45/82-

ALC4/2007 Party Name:PRIVI ORGANICS LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00500/AM08/ RLA File : 03/95/040/01082/AM08/ Lic.No/Date:03104605 11 11.02.2008 Defer Date: 08.04.200 8 norms for export product Amber Fleur under para 4.7 of HBP. Chemical Division. 13 2

Case No.:42/45/82-

ALC4/2007 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00505/AM08/ RLA File : 07/24/040/00745/AM08/ Lic.No/Date:07100557 84 11.02.2008

norms for export product Cefuroxime 750mg Inj. USP under para 4.7 of HBP. their U.O. No.35011/266/2006-PI-III dated 11.03.2008 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as Export product Expo rt Qty. Sl.N o. Import items Qty. allowed per unit of export product Cefuroxime 750mg Injection USP, each vial containing Cefuroxime Sodium USP equivalent to Cefuroxime 750mg, 10ml vial 1 Vial 1. Cefuroxime Sodium Sterile 817.50mg/v ial of NC. 13 3

Case No.:43/45/82-

ALC4/2007 Party Name:KARNATAKA ANTIBIOTICS & Meet No/Date:45/82- ALC4/2007 Status:Cas e

PHARMACEUTICALS LTD., 11.03.2008 Approved HQ File : 01/82/050/00506/AM08/ RLA File : 07/24/040/00746/AM08/ Lic.No/Date:07100557 83 11.02.2008

norms for export product Kanamycin Acid Sulphate for Inj BP 1gm under

para 4.7 of HBP.

Committee in light of its earlier decision taken in its 2/82 meeting held on 16.05.2005 vide Case No.42/28/82 in the case of M/S Brawn Laboratories Ltd decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Kanamycin acid sulphate Injection 1gm vial 1. Kanamycin acid sulphate 1.39gm/vial of NC. 13 4

Case No.:67/45/82-

ALC4/2007 Party Name:SHREYA LIFE SCIENCES PRIVATE LIMITED Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00530/AM08/ RLA File : 03/95/040/01035/AM08/ Lic.No/Date:03104605 08 11.02.2008

norms for export product Prednisolone Sodium Phosphate Injection 30mg/ml, 1ml under para 4.7 of HBP. Committee in light of its earlier decision taken in its 46/83 meeting held on 28.02.2007 vide case No.45/23/83 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product

Prednisolone Sodium Phosphate Injection 30mg/ml, 1ml. 1vial 1. Prednisolone Sodium Phosphate 42.628mg/vi al

of NC. 13 5

Case No.:29/45/82-

ALC4/2007 Party Name:CENTAUR CHEMICALS PVT. LTD., Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00492/AM08/ RLA File : 03/94/040/01129/AM08/ Lic.No/Date:03104606 71 12.02.2008 Defer Date: 22.04.200 8 norms for export product Rivastigmine Hydrogen Tartrate under para 4.7 of HBP. Division. 13 6

Case No.:78/45/82-

ALC4/2007 Party Name:BAL PHARMA LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Deferred HQ File : 01/82/050/00541/AM08/ RLA File : 07/24/040/00742/AM08/ Lic.No/Date:07100557 99 12.02.2008 Defer Date: 22.04.200 8 norms for export product Amiloride Hcl under para 4.7 of HBP. Division. 13 7

Case No.:81/45/82-

ALC4/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:45/82- ALC4/2007 11.03.2008 Status:Cas e Approved HQ File : 01/82/050/00544/AM08/ RLA File : 09/24/040/00497/AM08/ Lic.No/Date:09100329 35 12.02.2008

norms for export product Tert-N-Boc-4-Piperidone (OR) N-BOC-4-Piperidone Committee in light of its earlier decision taken in its 7/83 meeting held on 17.05.2006 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. Sl.N o. Import items Qty. allowed per unit of export product Tertiary-N-BOC-4- Piperidone (OR) N- Boc-4-Piperidone 1kg. 1. Methanol 5.95kg/kg 2. Methyl Acrylate 2.74kg/kg 3. Sodium Methoxide 1.04kg/kg 4. Ethyl Chloro Formate 1.73kg/kg 5. Trimethyl

Ortho Formate 0.64kg/kg 6. Phosphoric Acid 0.98kg/kg 7. Iso Propyl Alcohol 0.39kg/kg 8. Di Tert Butyl di carbonate 1.08kg/kg of NC.

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