DGFT Committee Minutes

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

Para 4.7 Decision

MEETING NUMBER : 40/82-ALC4/2007 MEETING DATE : 03.03.2008 The Meeting No.40/08 for the licensing year 2007-08 to consider the cases under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2004-09 pertaining to Pharma Products due for 05.02.2008 was actually held on 03.03.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No.6/08 dated 15.06.2007, 7/08 dated 21.06.2007, 8/08 dated 28.06.2007, 9/08 dated 03.07.2007, 10/08 dated 10.07.2007 and 39/08 dated 31.01.2008 were ratified by the Committee.

Case No.B-529

M/S Honest Bio-vet Pvt. Ltd. NC Meeting No.40/08 F.No.01/82/50/1761/AM07 Meeting date: 12.02.2008 RLA F.No.08/24/40/304/AM07 Adv.Lic.No.0810062375 dated 12.01.2007 Committee considered case as per agenda for revision of norms for export product 3-Chloroperoxybenzoic acid under para 4.7 of HBP. Committee decided to call for complete chemical reactions showing utilization of Tertiary Butanol in the process from the firm. Accordingly, case was deferred for four weeks.

Case No.B-530

M/S Lupin Ltd. NC Meeting No.40/08 F.No.01/83/50/1508/AM08 RLA F.No.03/95/40/776/AM08 Adv.Lic.No.0310449360 dated 06.11.2007 Committee considered case as per agenda for correction in the description of import item under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to allow amendment in the description of import items at Sl.No.2 and 9 to read as “EDTA disodium’ and “Dimethyl Aniline” respectively.

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

Case No.B-531

M/S Nicholas Piramal India Ltd. NC Meeting No.40/08 F.No.01/83/50/370/AM08 RLA F.No.03/95/40/1389/AM07 Adv.Lic.No.0310430066 dated 21.05.2007 Committee considered case as per agenda for ratification of norms for export product Concept Quick Unit Dose Solution under para 4.7 of HBP. Committee in light of written comments forwarded by Deptt. of Bio- technology vide their O.M. No.BT/IL/05/228/2006/PID dated 15.11.2006 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. Description

of import item Qty. allowed Concept

2U/D Solution (15ml per vial) ITC 33079020 1000 Vials 1. Catalase Solution 0.0336 liter/1000 Vials 2. Exxonmobil

LD 100 MED LDPE LD 100 MED 8.925kgs/10 00 Vials Norms Committee.

Case No.B-532

M/S Cipla Ltd. NC Meeting No.40/08 F.No.01/82/50/558/AM04 RLA F.No.03/94/40/1099/AM04 Adv.Lic.No.0310224465 dated 12.09.2003 product Clavet Drops (Palatable Drops) (Amoxicillin & Clavulanate Potassium for oral suspension) under para 4.7 of HBP. Committee observed that Advance Authorisation was issued in 2003 while the representation of firm has been received only on 14.12.2007. Committee noticed that representation of firm is time barred. Accordingly, Committee decided to close the case.

Norms Committee.

Case No.B-533

M/S Aurobindo Pharma Ltd. NC Meeting No.40/08 F.No.01/87/50/230/AM07 RLA F.No.09/24/40/11/AM07 Adv.Lic.No.0910026489 dated 02.06.2006 Committee considered case as per agenda for revision of norms for export product Indinavir Sulfate under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O.No.35011/81/2007-PI-III dated 11.02.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Indinavir sulfate 1 Kg. 1. Ally bromide 0.366kg/kg 2. 3-phenyl proponyl chloride 0.5322kg/kg 3. 2-Cyano Pyrazine 0.839kg/kg 4. 2-Methoxy propene 0.7138kg/kg 5. 3-Picolyl chloride 0.3965kg/kg 6. Acetonitrile 2.19kg/kg 7. Activated Carbon 0.0174kg/kg 8. Di Tert. Butyl Di Carbonate 0.489kg/kg 9. Di-Methyl Formamide 2.20kg/kg 10. L(+) Tartaric Acid 1.3432kg/kg 11. Indene 1.4565kg/kg 12. Iso Propyl Acetate 1.35kg/kg 13. Iso Propyl alcohol 0.93kg/kg 14. Methanol 8.67kg/kg 15. Methylene chloride 3.24kg/kg 16. N-Hexane 1.19kg/kg 17. N-Propanol 1.42kg/kg 18. Sodium Iodide 0.6938kg/kg 19. Tetra hydro Fruan 11.27kg/kg 20. Tri Ethyl amine 1.54kg/kg 21. Tri methyl chloro Silane 3.41kg/kg

Norms Committee.

Case No.B-534

M/S Bharat Serum and Vaccines Ltd. NC Meeting No.40/08 F.No.01/82/54/3/AM07

Committee considered case as per agenda for inclusion of a separate category of ‘Biotechnologicals’ in the DEPB Schedule. Committee observed that DEPB rate could be fixed for the export product for which SION has been fixed and the Input Output norms for entire bio-technologicals can not be fixed under one SION. Committee, therefore, decided to close the case.

Case No.B-535

M/S Biological E Ltd. NC Meeting No.40/08 F.No.01/82/50/1860/AM07 RLA F.No.09/24/040/481/AM07 Adv.Lic.No.0910029748 dated 23.03.2007 Committee considered case as per agenda for revision of norms for export product Noscapine Hcl under para 4.7 of HBP. Committee decided to call for a testing report of item already imported by the firm indicating purity duly certified by Quality Control Incharge from the firm. Accordingly, case was deferred for six weeks.

Case No.A-1032

M/S Anuh Pharma Ltd. NC Meeting No.40/08 F.No.01/82/50/316/AM08 RLA F.No.03/94/40/997/AM08 Adv.Lic.No.0310456126 dated 02.01.2008 product Fluticasone Propionate under para 4.7 of HBP. Committee in light of comparison with its earlier decision taken in its 01/08 meeting held on 09/05/2007 vide case no. A-16 in the case of M/s Coral Drugs Limited and in consultation with representative of PI Division present in the meeting noticed that firm has applied for quantities lower than approved earlier in case mentioned above. Committee, accordingly, decided to ratify norms as applied by

firm under para 4.7 of HBP.

Norms Committee.

Case No.A-1033

M/S Cipla Ltd. NC Meeting No.40/08 F.No.01/82/50/317/AM08 RLA F.No.03/94/40/975/AM08 Adv.Lic.No.0310455195 dated 26.12.2007 product Irinotecan Hcl Injection 40mg/2ml and 100ml under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1034

M/S Cipla Ltd. NC Meeting No.40/08 F.No.01/82/50/318/AM08 RLA F.No.03/94/40/945/AM08 Adv.Lic.No.0310454389 dated 17.12.2007 product Ipravent HFA 20mcg Inhaler (200MD)/Ipratropium Bromide HFA 20mcg Inhaler (200MD)/Ciplatropium HFA 20mcg Inhaler (200MD) under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1035

M/S Cipla Ltd. NC Meeting No.40/08 F.No.01/82/50/319/AM08 RLA F.No.03/94/40/976/AM08 Adv.Lic.No.0310455192 dated 26.12.2007 product Carvedilol under para 4.7 of HBP. U.O. No.35011/83/2007-PI-III dated 28.01.2008 decided to ratify norms under para Export product Export quantity Sl.N o. Description of import items Quantity allowed

Carvedilol ITC30041090 1kg. 1. 4-hydroxy Carbazol 1.06kg/kg 2. N-[2-(2-methoxy phenoxy)ethyl]benzyl amine hcl 1.089kg/kg Norms committee.

Case No.A-1036

M/S Glenmark Pharmaceuticals Ltd. NC Meeting No.40/08 F.No.01/82/50/321/AM08 RLA F.No.03/94/40/989/AM08 Adv.Lic.No.0310455413 dated 27.12.2007 product Atovaquone under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1037

M/S Aurobindo Pharma Ltd. NC Meeting No.40/08 F.No.01/82/50/323/AM08 RLA F.No.09/24/40/407/AM08 Adv.Lic.No.0910032639 dated 10.01.2008 product Ritonavir under para 4.7 of HBP. Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Ritonavir ITC 29419090 1 Kg. 1. 4-Di

Methyl Aminopyridine 0.0781kg/kg 2. Ethylene Glycol Dimethyl Ether 15.453kg/kg 3. N-Heptane 1.00kg/kg

Methane Sulphonic Acid 2.25kg/kg 5. Trifluorocacetic acid 2.21kg/kg 6. MTBE

(Methyl Tert. Buytyl Ether) 5.20kg/kg 7. Isoamyl Alcohol 1.76kg/kg 8. Lithium aluminium hydride 0.200kg/kg 9. L-phenylalanine 1.23kg/kg 10. L-Valine 0.510kg/kg 11. Potassium Carbonate 3.72kg/kg 12. Sodium borohydride 0.790kg/kg 13. DIBOC (Di Tert. Butyl Dicarbonate) 0.773kg/kg 14. Carbon Enoanticromos (Activated carbon) 0.0368kg/kg 15. Acetonitrile 0.900kg/kg 16. Dimethyl formamide 1.00kg/kg 17. Isopropyl alcohol 0.900kg/kg 18. Methanol 5.90kg/kg 19. Methylene chloride 4.50kg/kg 20. n-Hexane 4.00kg/kg 21. Tetrahydrofuran 6.20kg/kg Norms Committee.

Case No.A-1038

M/S Aurobindo Pharma Ltd. NC Meeting No.40/08 F.No.01/82/50/324/AM08 RLA F.No.09/24/40/339/AM08 Adv.Lic.No.0910032495 dated 31.12.2007 product Anhydrothymidine under para 4.7 of HBP.

Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product 5-0-Trityl-2,3- Anhydrothymidine 1 Kg. 1. Beta Thymidine 0.6263kg/kg 2. Methane sulfonyl chloride 0.365kg/kg 3. Triethylamine 2.34kg/kg 4. Activated carbon 0.012kg/kg 5. Methanol 1.50kg/kg 6. Methylene chloride 3.05kg/kg Norms Committee.

Case No.A-1039

M/S Aurobindo Pharma Ltd. NC Meeting No.40/08 F.No.01/82/50/325/AM08 RLA F.No.09/24/40/419/AM08 Adv.Lic.No.0910032637 dated 10.01.2008 product Cephapirin Benzathine under para 4.7 of HBP. Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Cephapirin Benzathine 1 Kg. 1. 4-chloropyridine hcl. 1.226kg/kg 2. 2-Mercapto Acetic Acid 0.966kg/kg 3. Activated carbon 0.100kg/kg 4. Iso Propyl Alcohol 0.957kg/kg 5. Methylene chloride 23.22kg/kg 6. 7-ACA 0.901kg/kg 7. Triethylamine 1.45kg/kg 8. Acetone 10.50kg/kg 9. N,N- Dibenzylethylenedia mine Diacetate 0.409kg/kg Norms Committee.

Case No.A-1040

M/S Belco Pharma NC Meeting No.40/08 F.No.01/82/50/305/AM08 RLA F.No.05/24/40/743/AM08 Adv.Lic.No.0510214132 dated 28.12.2007 product Hydrocortisone Cream BP 1% W/W 15gm, Hydrocortisone Ointment BP 1% w/w 5gm and Hydrocortisone Cream BP 1% w/w 5gm under para 4.7 of HBP. Committee in consultation with representative of PI Division present in the meeting decided to ratify norms as per SION at SL. No. A-1931. Norms Committee.

Case No.A-1041

M/S Aurobindo Pharma Ltd. NC Meeting No.40/08 F.No.01/82/50/253/AM08 RLA F.No.09/24/40/205/AM08 Adv.Lic.No.0910031156 dated 16.08.2007 product Ceftiofur Sodium Sterile under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Ceftiofur Sodium Strile 1 Kg. 1. 7-ACA 1.16kg/kg 2. MAEM 0.809kg/kg 3. Acetone 5.63kg/kg 4. THF 2.55kg/kg 5. Activated Carbon 0.100kg/kg Norms Committee.

Case No.A-1042

M/S Aurobindo Pharma Ltd. NC Meeting No.40/08 F.No.01/82/50/296/AM08 RLA F.No.09/24/40/428/AM08 Adv.Lic.No.0910032472 dated 26.12.2007 product Carvedilol under para 4.7 of HBP. Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Carvedilol ITC 29419090 1 Kg. 1. 4-hydroxy-9H- Carbazole 1.06kg/kg 2. Activated carbon 0.100kg/kg Norms Committee.

Case No.A-1043

M/S Aurobindo Pharma Ltd. NC Meeting No.40/08 F.No.01/82/50/294/AM08 RLA F.No.09/24/40/413/AM08 Adv.Lic.No.0910032473 dated 26.12.2007 product Florfenicol under para 4.7 of HBP. Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Florfenicol ITC 29419090 1 Kg. 1. (1R,2S)-1-[4- (methylsulfonyl)ph enyl]-2-amino-3- fluoro-1-propanol [Fluoroamine] 1.095kg/kg 2. Methyl

Dichloro Acetate 1.588kg/kg 3. Toluene 1.61kg/kg 4. Methanol 1.21kg/kg

Ethanol 2.41kg/kg 6. Carbon enoanticromos (Activated Carbon) 0.047kg/kg Norms Committee.

Case No.A-1044

M/S Bal Pharma Ltd. NC Meeting No.40/08 F.No.01/82/50/289/AM08 RLA F.No.07/24/40/652/AM08 Adv.Lic.No.0710055002 dated 14.12.2007 product Amiloride Hcl under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

Case No.A-1045

M/S Codexis Laboratories India Pvt. Ltd. NC Meeting No.40/08 F.No.01/82/50/290/AM08 RLA F.No.05/24/40/660/AM08 Adv.Lic.No.0510212818 dated 30.11.2007 product

(4R-Cis)-1,1-Dimethylethyl-6-Cyanomethyl-2,2-Dimethyl-1-3-Dioxane-4- Acetate (ATS-8) NLT 99% under para 4.7 of HBP.

Case No.A-1046

M/S Gland Pharma Ltd. NC Meeting No.40/08 F.No.01/82/50/257/AM08 RLA F.No.09/24/40/356/AM08 Adv.Lic.No.0910032089 dated 14.11.2007 product Adenosine Injections under para 4.7 of HBP.

Case No.A-1047

M/S Nicholas Piramal India Ltd. NC Meeting No.40/08 F.No.01/82/50/326/AM08 RLA F.No.03/95/40/937/AM08 Adv.Lic.No.0310454966 dated 20.12.2007 product Concept Quick Unit dose solution under para 4.7 of HBP. Committee in light of written comments forwarded by Deptt. of Bio- technology vide their O.M. No.BT/IL/05/228/2006/PID dated 15.11.2006 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Quantity Sl.N o. Description

of import item Qty. allowed Concept

2U/D Solution (15ml per vial) ITC 33079020 1000 Vials 1. Catalase Solution 0.0336 liter/1000 Vials 2. Exxonmobil

LD 100 MED LDPE LD 100 MED 8.925kgs/10 00 Vials Norms Committee.

Case No.A-1048

M/S Mangalam Drugs & Organics Ltd. NC Meeting No.40/08 F.No.01/82/50/327/AM08 RLA F.No.03/95/40/961/AM08 Adv.Lic.No.0310456184 dated 02.01.2008 product Amodiaquine Base under para 4.7 of HBP. Committee decided to defer the case for four weeks.

Case No.A-1049

M/S Kamud Drugs Pvt. Ltd. NC Meeting No.40/08 F.No.01/83/50/314/AM08 RLA F.No.31/24/40/298/AM08 Adv.Lic.No.3110031879 dated 11.12.2007

product Ketamine Hcl under para 4.7 of HBP.

Case No.A-1050

M/S Kamud Drugs Pvt. Ltd. NC Meeting No.40/08 F.No.01/83/50/315/AM08 RLA F.No.31/24/40/320/AM08 Adv.Lic.No.3110032124 dated 31.12.2007 product Ketamine Hcl under para 4.7 of HBP.

Case No.A-1051

M/S Medreich Ltd. NC Meeting No.40/08 F.No.01/82/50/313/AM08 RLA F.No.07/24/40/651/AM08 Adv.Lic.No.0710055104 dated 26.12.2007 product Glucosamine under para 4.7 of HBP. Committee in consultation with representative of PI Division present in the meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export Product Export Quantity Sl. No . Import Item Quantity allowed per unit of export product Glucosamine 750mg+Chondroiti n Sulphate 600mg Sustained Release Tablets ITC-30049069 1 Tablet 1. Glucosamine HCL BP/USP/EP 765mg per tablet 2. Chondroitin Sulphate BP/USP/EP 612mg per tablet RA concerned may take further necessary action as per above decision of NC.

Case No.A-1052

M/S Smilax Laboratories Ltd. NC Meeting No.40/08 F.No.01/82/50/310/AM08

RLA F.No.09/24/40/298/AM08 Adv.Lic.No.0910032150 dated 26.11.2007 product 2-Hydroxy methyl-3,5-dimethyl-4-Methoxy pyridine Hcl under para 4.7 of HBP.

Case No.A-1053

M/S Smilax Laboratories Ltd. NC Meeting No.40/08 F.No.01/82/50/311/AM08 RLA F.No.09/24/40/362/AM08 Adv.Lic.No.0910032152 dated 26.11.2007 product Pentoprazole Sodium Pellets 15% under para 4.7 of HBP.

Case No.A-1054

M/S Win Medicare Ltd. NC Meeting No.40/08 F.No.01/82/50/312/AM08 RLA F.No.05/24/40/664/AM08 Adv.Lic.No.0510213367 dated 11.12.2007 product 2Betadine Standardised Microbicidal solution 10% USP/IP 500ml under para 4.7 of HBP. Committee in light of its earlier decision taken in its 15/04 meeting held on 16/07/2003 vide case no. A-654 and in consultation with representative of PI Division present in the meeting decided to ratify norms on repeat basis under para Export Item Export Quantity Sl. No . Import Item Quantity allowed per unit of export product Betadine Standarized Microbicidal Solution 10%USP/IP 500ml (each

500ml contains Providone Pack of 500ml 1. Povidone Iodine 50.75 gm/pack

Iodine

USP 10%w/v(available iodine 1%w/v)

Case No.A-1055

M/S Softgel Healthcare Pvt. Ltd. NC Meeting No.40/08 F.No.01/82/50/306/AM08 RLA F.No.04/24/40/271/AM08 Adv.Lic.No.0410093473 dated 04.12.2007 product Vitamin A&D Capsules BP, Vitamin A Capsules USP and Vitamin A Capsules USP under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1056

M/S Dalas Biotech Ltd. NC Meeting No.40/08 F.No.01/82/50/307/AM08 RLA F.No.05/24/40/659/AM08 Adv.Lic.No.0510212617 dated 27.11.2007 product 7-AVCA under para 4.7 of HBP. Committee in light of its earlier decision taken in its 34/82 meeting held on 26.12.2007 vide Case No.1/29/83 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export product Export Quantity Sl.N o. Description

of import item Qty. allowed 7 Amino Acid-3- Vinyl-3 Cephem-4 Carboxylic

Acid Diphenyl Ester Hcl (7 AVCA) ITC-29411090 1kg. 1. 7- Phenylacetamido- 3-chloromethyl cephalosporanic Acid para Methoxybenzyl Ester (GCLE) 2.672kg/kg 2. Triphenyl Phosphine 1.26kg/kg 3. Methylene 10.31kg/kg

Chloride Norms Committee.

Case No.A-1057

M/S Scitech Healthcare Pvt. Ltd. NC Meeting No.40/08 F.No.01/82/50/308/AM08 RLA F.No.03/94/40/466/AM08 Adv.Lic.No.0910032150 dated 26.11.2007 product CoQ10 Softgel Capsules (30mg) and CoQ10 Softgel Capsules (120mg) under

para 4.7 of HBP.

Case No.A-1058

M/S Vijayasri Organics Ltd. NC Meeting No.40/08 F.No.01/82/50/309/AM08 RLA F.No.09/24/40/294/AM08 Adv.Lic.No.0910032155 dated 26.11.2007 product 2-Butyl-5-Chloro-3H-Imidazole-4-Carbaldehyde (IMAL) under para 4.7 of HBP.

Case No.A-1059

M/S Sandoz Pvt. Ltd. NC Meeting No.40/08 F.No.01/82/50/328/AM08 RLA F.No.03/95/40/1458/AM06 Adv.Lic.No.0310374310 dated 31.03.2006 product Rifampicin under para 4.7 of HBP. U.O.No.35011/180/2006-PI-III dated 03.03.2008 decided to ratify norms under para Export product Export Sl.N Import items Quantity allowed

Quantity o. per unit of export product Rafampicin ITC-29419011 1 Kg. 1. Rifa-S 1.02kg/kg 2. Dimethyl formamide 0.80kg/kg 3. Tertiary Butylamine 0.314kg/kg 4. Piperazine Anhydrous 0.120kg/kg Norms Committee. 1

Case No.:10/20/87-

ALC1/2005 Party Name:ALKALOIDS CORP Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/87/050/00429/AM06/ RLA File : 02/24/040/00081/AM06/ Lic.No/Date:02100800 76 15.07.2005

Decision :Committee considered case as per agenda for ratification of norms for export product Aescin (Horse Chestnut Extract) under para 4.7 of HBP. Committee decided to withdraw case as case has been approved by NC in its 39/82 meeting held on 29.01.2008. 2

Case No.:12/38/83-

ALC1/2005 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/83/050/00495/AM06/ RLA File : 03/95/040/01004/AM06/ Lic.No/Date:03103576 75 01.12.2005 : Decision : Committee considered case as per agenda for ratification of norms for export product Cephalexin Monohydrate under para 4.7 of HBP. Committee decided to ratify norms as per revised SION at Sl.No.A-116 published vide Public Notice No.2 dated 19.04.2007 or as applied by firm whichever is lower. RA concerned may take further necessary action as per above decision of Norms Committee. 3

Case No.:31/47/82-

Party Name:CALYX Meet No/Date:40/82- Status:Cas

ALC1/2005 CHEMICALS & PHARMACEUTICALS PVT.LTD. ALC4/2007 05.02.2008 e Deferred HQ File : 01/82/050/01335/AM06/ RLA File : 03/94/040/01210/AM06/ Lic.No/Date:03103656 92 03.02.2006 Defer Date: 01.04.2008 norms for export product under para 4.7 of HBP. Committee decided to handover file to representative of PI Division present in the meeting for his comments. Accordingly case was deferred for four weeks. 4

Case No.:280/24/83-

ALC1/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/83/050/00097/AM07/ RLA File : 03/95/040/00073/AM07/ Lic.No/Date:03103777 92 26.04.2006

norms for export product Diproson Lotion 30ml under para 4.7 of HBP. Committee in light of its earlier decision taken in its 35/82 meeting held on 08.01.2008 vide Case No.9/35/82 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Sl.N o. Description

of import item Qty. allowed Diproson Lotion 30ml 30ml bottle 1. Betamethsone Base BP 15.15mg/30 ml bottle Norms Committee. 5

Case No.:8/10/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/87/050/00096/AM07/ RLA File : 02/24/040/00020/AM07/ Lic.No/Date:02100887 34 28.04.2006

norms for export product Aescin (Horse Chestnut Extract) Extract under

para 4.7 of HBP.

6

Case No.:1/23/87-

ALC1/2006 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/87/050/00336/AM07/ RLA File : 05/24/040/00255/AM07/ Lic.No/Date:05101852 76 21.06.2006

norms for export product Silymarin Extract under para 4.7 of HBP. Committee decided to withdraw case as case has been rejected by NC 7

Case No.:16/27/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/87/050/00419/AM07/ RLA File : 02/24/040/00123/AM07/ Lic.No/Date:02100921 25 02.08.2006

norms for export product Kola Extract under para 4.7 of HBP. 8

Case No.:25/27/87-

ALC1/2006 Party Name:ALCON BIOSCIENCES PRIVATE LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/87/050/00446/AM07/ RLA File : 03/94/040/01463/AM06/ Lic.No/Date:03103939 46 09.08.2006 Defer Date: 15.04.2008 norms for export product Benzil Pure 99% under para 4.7 of HBP. Committee decided to refer the case to Chemical Division of Deptt. Of C&PC for their comments. Accordingly the case was deferred for six weeks. 9

Case No.:35/31/82-

ALC1/2006 Party Name:CLARIANT CHEMICALS [INDIA] LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/01132/AM07/ RLA File : 03/94/040/00773/AM07/ Lic.No/Date:03104034 96

11.10.2006 norms for export product 5 Fluoro Cyto Sine under para 4.7 of HBP. in its 37/82 meeting held on 15.01.2008. 10

Case No.:14/37/83-

ALC1/2006 Party Name:UNICHEM LABORATORIES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/83/050/00965/AM07/ RLA File : 03/95/040/01024/AM07/ Lic.No/Date:03104104 52 01.12.2006

norms for export product Amlodipine Maleate under para 4.7 of HBP. Committee in light of its earlier decision taken in its 31/82 meeting held on 04.12.2007 vide Case No.55/27/83 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 Quantity Sl.N o. Description

of import item Qty. allowed Amlodipine Maleate 1kg. 1. Phthaloyl Amlodipine 1.08kg/kg 2. Methylene chloride 4.50kg/kg 3. Isopropyl alcohol 2.40kg/kg Norms Committee. 11

Case No.:2/46/82-

ALC1/2006 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/82/050/01441/AM07/ RLA File : 09/24/040/00390/AM07/ Lic.No/Date:09100286 34 13.12.2006 Defer Date: 01.04.2008 norms for export product under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

12

Case No.:2/48/83-

ALC1/2006 Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01135/AM07/ RLA File : 22/24/040/00291/AM07/ Lic.No/Date:22100064 00 17.01.2007

norms for export product Sultamicillin Tosylate under para 4.7 of HBP. in its 32/82 meeting held on 11.12.2007. 13

Case No.:5/9/82-ALC4/2007 Party Name:JUBILANT

ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/01646/AM07/ RLA File : 05/24/040/00937/AM07/ Lic.No/Date:05101992 68 09.02.2007

norms

for

export

product

3,4

Dihydroxy-4-Oxo-6Acetoxy- 7Methoxyquinazole under para 4.7 of HBP. in its 35/82 meeting held on 08.01.2008. 14

Case No.:500/24/83-

ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00062/AM08/ RLA File : 22/24/040/00297/AM07/ Lic.No/Date:22100064 82 13.02.2007

norms for export product Ezetimibe under para 4.7 of HBP. 15 Case No.:445/24/83- ALC1/2007 Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case 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: 01.04.2008

norms for export product under para 4.7 of HBP. Division. 16

Case No.:873/21/82-

ALC4/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/82/050/01709/AM07/ RLA File : 05/24/040/00952/AM07/ Lic.No/Date:05102001 15 27.02.2007 Defer Date: 15.04.2008 norms for export product under para 4.7 of HBP. Committee decided to refer the case to Chemical Division of Deptt. Of C&PC for their comments. Accordingly the case was deferred for six weeks. 17

Case No.:4/21/82-

ALC4/2007 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00006/AM08/ RLA File : 22/24/040/00295/AM07/ Lic.No/Date:22100065 38 27.02.2007

norms for export product Cephalothin for Injection under para 4.7 of HBP. 18

Case No.:6/9/82-ALC4/2007 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/01728/AM07/ RLA File : 09/24/040/00488/AM07/ Lic.No/Date:09100295 04 01.03.2007

norms for export product Cefdinir under para 4.7 of HBP. in its 33/82 meeting held on 18.12.2007. 19 Case No.:467/24/83- Party Name:RA CHEM Meet No/Date:40/82- Status:Cas

ALC1/2007 PHARMA LIMITED. ALC4/2007 05.02.2008 e Deferred HQ File : 01/83/050/01334/AM07/ RLA File : 09/24/040/00519/AM07/ Lic.No/Date:09100296 57 14.03.2007 Defer Date: 15.04.2008 norms for export product 2-Aminomethyl 7-Chloro-2,3 Dihydro-5(2- Fluorophenyl)1H-4-Benzodiazepine Dimalleate under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 20

Case No.:17/9/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Rejected 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 Exemestane under para 4.7 of HBP. Committee observed that firm was requested to furnish technical details vide letter dated 22/01/2007 but no reply has been received. Committee, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of NC. 21

Case No.:3/22/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01367/AM07/ RLA File : 09/24/040/00505/AM07/ Lic.No/Date:09100297 69 26.03.2007 Defer Date: 15.04.2008 norms for export product 1-Acetylamino-5-Nitro-2-Propoxy Benzene under

para 4.7 of HBP.

Committee decided to refer the case to Chemical Division of Deptt. Of C&PC for their comments. Accordingly, the case was deferred for six weeks. 22 Case No.:23/9/82- ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn

HQ File : 01/82/050/01901/AM07/ RLA File : 03/95/040/01622/AM07/ Lic.No/Date:03104249 15 29.03.2007

norms for export product Cefposoxime Proxetil under para 4.7 of HBP. 23

Case No.:474/24/83-

ALC1/2007 Party Name:SHILPA MEDICARE LTD., Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01382/AM07/ RLA File : 07/24/040/00879/AM07/ Lic.No/Date:07100509 72 29.03.2007

norms for export product N-[B-D-Ribofuranoxyl]-5-Hydroxyimidazole-4- Carboxamide Technical Grade under para 4.7 of HBP. Committee decided to withdraw case as case has been Rejected by NC in its 38/82 meeting held on 22.01.2008. 24

Case No.:9/21/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/82/050/00009/AM08/ RLA File : 09/24/040/00543/AM07/ Lic.No/Date:09100299 31 10.04.2007

norms for export product 7-Amino-3[(Z/E)-1-YL]-3-Cepham-4-Carboxylic Acid (APRA) under para 4.7 of HBP. Committee noted the report sent by RLA and observed that the license was issued under para 4.7.1 of HBP against norms fixed category. Committee, therefore, decided to close the case. 25 Case No.:12/7/83- ALC1/2007 Party Name:RANTUS PHARMA PVT LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00083/AM08/ RLA File : 09/24/040/00433/AM07/ Lic.No/Date:09100299 34 10.04.2007

norms for export product Tramadol Base under para 4.7 of HBP.

in its 36/82 meeting held on 08.01.2008. 26

Case No.:15/18/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e withdrawn HQ File : 01/83/050/00252/AM08/ RLA File : 09/24/040/00023/AM08/ Lic.No/Date:09100301 74 04.05.2007

norms for export product Iso Metheptene Mucate under para 4.7 of HBP. in its 34/82 meeting held on 26.12.2007. 27

Case No.:20/21/82-

ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/82/050/00028/AM08/ RLA File : 05/24/040/00097/AM08/ Lic.No/Date:05102033 44 07.05.2007 Defer Date: 15.04.2008 norms for export product Clarithromycin Carbomer Granules 44% under

para 4.7 of HBP.

Committee decided to remind concerned RA to furnish a copy of application along with copy of advance authorization. Accordingly, the case was deferred for six weeks. 28

Case No.:575/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00265/AM08/ RLA File : 09/24/040/00445/AM07/ Lic.No/Date:09100301 95 07.05.2007

norms for export product Nelfinavir Mesylate under para 4.7 of HBP. 29 Case No.:6/4/82-ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : RLA File : Lic.No/Date:03104289

01/82/050/00031/AM08/ 03/95/040/00095/AM08/ 99 10.05.2007 norms for export product Diproson Lotion 30ml under para 4.7 of HBP. in its 36/82 meeting held on 08.01.2008. 30

Case No.:589/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e withdrawn HQ File : 01/83/050/00308/AM08/ RLA File : 09/24/040/00013/AM08/ Lic.No/Date:09100302 50 14.05.2007

norms for export product Benzhydryl Thioacetamide under para 4.7 of HBP. 31

Case No.:29/9/82-

ALC4/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00039/AM08/ RLA File : 05/24/040/01075/AM07/ Lic.No/Date:05102037 51 16.05.2007

norms for export product Camptothecin under para 4.7 of HBP. 32

Case No.:622/24/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/00388/AM08/ RLA File : 09/24/040/00048/AM08/ Lic.No/Date:09100303 34 24.05.2007 Defer Date: 15.04.2008 norms for export product 2-(2-Methoxy Phenoxy) Ethylamine under para 4.7 of HBP. Committee decided to remind RA to furnish relevant application of the firm. Accordingly, the case was deferred for six weeks.

33

Case No.:623/24/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case withdrawn HQ File : 01/83/050/00389/AM08/ RLA File : 09/24/040/00049/AM08/ Lic.No/Date:09100303 35 24.05.2007

norms for export product 4-(2,3-Epoxy Propoxy) Carbazole under para 4.7 of HBP. 34

Case No.:653/24/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00456/AM08/ RLA File : 03/95/040/00187/AM08/ Lic.No/Date:03104310 79 30.05.2007

norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. 35

Case No.:661/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00490/AM08/ RLA File : 09/24/040/00094/AM08/ Lic.No/Date:09100304 86 08.06.2007

norms for export product Tenofovir Disoproxil Fumarate under para 4.7 of HBP. 36 Case No.:715/24/83- ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00590/AM08/ RLA File : 03/94/040/00243/AM08/ Lic.No/Date:03104329 29 18.06.2007

norms for export product Norethisterone under para 4.7 of HBP. 37

Case No.:706/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00563/AM08/ RLA File : 09/24/040/00080/AM08/ Lic.No/Date:09100306 41 22.06.2007

norms for export product Efavirenz under para 4.7 of HBP. 38

Case No.:789/24/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00742/AM08/ RLA File : 03/95/040/00276/AM08/ Lic.No/Date:03104335 02 22.06.2007

norms for export product Levetiracetam under para 4.7 of HBP. 39

Case No.:726/24/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/00613/AM08/ RLA File : 04/24/040/00113/AM08/ Lic.No/Date:04100901 30 28.06.2007 Defer Date: 15.04.2008 norms for export product 2-Fluoro Adenosin Triacetate (2-FAT) under para 4.7 of HBP. Division. 40 Case No.:728/24/83- ALC1/2007 Party Name:MALLADI DRUGS & Meet No/Date:40/82- ALC4/2007 Status: Case

PHARMACEUTICALS LIMITED 05.02.2008 Deferred HQ File : 01/83/050/00615/AM08/ RLA File : 04/24/040/00111/AM08/ Lic.No/Date:04100901 32 28.06.2007 Defer Date: 15.04.2008 norms for export product Clopidogrel Bisulphate under para 4.7 of HBP. Division. 41

Case No.:727/24/83-

ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/00614/AM08/ RLA File : 04/24/040/00112/AM08/ Lic.No/Date:04100901 31 28.06.2007 Defer Date: 15.04.2008 norms for export product Levetiracetam under para 4.7 of HBP. Division. 42

Case No.:730/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/00623/AM08/ RLA File : 09/24/040/00120/AM08/ Lic.No/Date:09100306 86 29.06.2007 Defer Date: 01.04.2008 norms for export product (S)-3-Hydroxy-N-Benzyl Pyrrolidine under para 4.7 of HBP. Division. 43

Case No.:731/24/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Approved 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.

Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Sertraline Mandelate 1 Kg. 1. (R )-(-)Mandelic Acid 0.27kg/kg 2. Ethanol 0.43kg/kg 3. Ethyl Acetate 1.46kg/kg 4. Methanol 5.77kg/kg 5. Sodium Borohydride 0.225kg/kg 6. Tetralone 2.22kg/kg Norms Committee. 44

Case No.:739/24/83-

ALC1/2007 Party Name:PONALAB Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00640/AM08/ RLA File : 07/24/040/00223/AM08/ Lic.No/Date:07100522 85 03.07.2007

norms for export product 8-Hydroxyquinoline under para 4.7 of HBP. 45

Case No.:19/23/83-

ALC1/2007 Party Name:SEQUENT SCIENTIFIC LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/00655/AM08/ RLA File : 07/24/040/00234/AM08/ Lic.No/Date:07100523 01 04.07.2007 Defer Date: 01.04.2008 norms for export product L-(+)-Selenomethionine under para 4.7 of HBP. Committee observed that firm was requested to furnish technical details vide letter dated 04.01.2008, but letter was received back undelivered. Therefore, letter was again sent on 08.02.2008, but reply has not been received. Committee, therefore, decided to await reply. Accordingly, case was deferred for four weeks

46

Case No.:743/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00665/AM08/ RLA File : 09/24/040/00511/AM07/ Lic.No/Date:09100307 57 04.07.2007

norms for export product 5,11-Dihydro(1)-Benzoxepino(3,4-b)-Pyridin-5-One under para 4.7 of HBP. 47

Case No.:757/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00687/AM08/ RLA File : 09/24/040/00112/AM08/ Lic.No/Date:09100308 02 06.07.2007

norms for export product L-Menthyl Glyoxylate Hydrate (MGH) under para 4.7 of HBP. 48

Case No.:771/24/83-

ALC1/2007 Party Name:PRACHI PHARMACEUTICALS PVT LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00709/AM08/ RLA File : 03/95/040/00308/AM08/ Lic.No/Date:03104357 14 11.07.2007 Defer Date: 15.04.2008 norms for export product Thiamine Hydrochloride BP/USP under para 4.7 of HBP. Committee observed that both import and export items are bulk drugs BP/USP and this is not a conventional process adopted for manufacturing. Committee, therefore, decided to seek clarification from firm. Accordingly, case was deferred for six weeks. 49 Case No.:768/24/83- ALC1/2007 Party Name:LIQUORS INDIA LTD, Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved

HQ File : 01/83/050/00702/AM08/ RLA File : 09/24/040/00142/AM08/ Lic.No/Date:09100308 64 12.07.2007

norms for export product Lovastatin under para 4.7 of HBP. U.O.No.35011/30/2007-PI-III dated 03.03.2008 decided to ratify norms under para Export product Export Quantity Sl.N o. Import items Quantity allowed

per unit of export product Lovastatin 1 Kg. 1. Dextrose Monohydrate 6.63kg/kg 2. Sugar No justification. Hence

not allowed. 3. Soya Milk No justification. Hence

not allowed. 4. Milk Powder Not

to

be allowed 5. Soya Oil No justification. Hence

not allowed 6. Isopropyl alcohol 0.749kg/kg 7. Toluene 5.00kg/kg Norms Committee. 50

Case No.:801/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00760/AM08/ RLA File : 09/24/040/00115/AM08/ Lic.No/Date:09100309 17 18.07.2007

norms for export product (S)-5-Chloro-a-(Cyclopropylethynyl)-2-[((4-Methoxy phenyl) methyl) amino]-a-(Trifluoromethyl) Benzene Methanol under para 4.7 of HBP.

51

Case No.:28/23/83-

ALC1/2007 Party Name:KESHAVA ORGANICS PVT. LTD., Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00775/AM08/ RLA File : 03/94/040/01507/AM07/ Lic.No/Date:03104365 91 18.07.2007

norms for export product Chlorpheniramine Base under para 4.7 of HBP. 52

Case No.:905/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/00915/AM08/ RLA File : 03/95/040/01473/AM07/ Lic.No/Date:03104368 39 19.07.2007 Defer Date: 01.04.2008 norms for export product Carvedilol BP under para 4.7 of HBP. Division. 53

Case No.:906/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00916/AM08/ RLA File : 03/95/040/01472/AM07/ Lic.No/Date:03104368 43 19.07.2007 Defer Date: 15.04.2008 norms for export product Setralone (Tetralone) under para 4.7 of HBP. Division. 54 Case No.:909/24/83- ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00920/AM08/ RLA File : 03/95/040/01516/AM07/ Lic.No/Date:03104369 93 20.07.2007

norms for export product Ibuprofen DC Granules 65% under para 4.7 of HBP.

55

Case No.:908/24/83-

ALC1/2007 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00919/AM08/ RLA File : 03/95/040/01517/AM07/ Lic.No/Date:03104369 87 20.07.2007

norms for export product Ibuprofen DC Granules 90% under para 4.7 of HBP. 56

Case No.:840/24/83-

ALC1/2007 Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00837/AM08/ RLA File : 09/24/040/00155/AM08/ Lic.No/Date:09100309 99 25.07.2007 Defer Date: 15.04.2008 norms for export product {3-5[Bromo-1-flurophenyl)(1,3-dihydro isobenzo furanyl)]-propyl]demehylamine oxalate under para 4.7 of HBP. Division. 57

Case No.:876/24/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/00880/AM08/ RLA File : 09/24/040/00161/AM08/ Lic.No/Date:09100310 51 06.08.2007 Defer Date: 01.04.2008 norms for export product Cyclohexyl Ester under para 4.7 of HBP. Division. 58 Case No.:962/24/83- ALC1/2007 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved

HQ File : 01/83/050/00978/AM08/ RLA File : 03/94/040/00493/AM08/ Lic.No/Date:03104393 77 14.08.2007

norms for export product Phenyl Thio Proline under para 4.7 of HBP. Committee in light of its earlier decision taken in its 42/07 meeting held on 31.01.2007 vide Case No.B-1209 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Phenyl

Thio Proline 1 Kg. 1. Trans-4-Hydroxy- L-Proline 1.466kg/kg 2. Isobutyl Acetate 1.65kg/kg 3. Methane Sulfonyl Chloride 1.78kg/kg 4. Thio Phenol 0.99kg/kg Norms Committee. 59

Case No.:977/24/83-

ALC1/2007 Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00994/AM08/ RLA File : 03/94/040/00492/AM08/ Lic.No/Date:03104399 50 17.08.2007 Defer Date: 01.04.2008 norms for export product Artemether under para 4.7 of HBP. Division. 60 Case No.:972/24/83- ALC1/2007 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00988/AM08/ RLA File : 09/24/040/00554/AM07/ Lic.No/Date:09100311 78 21.08.2007 Defer Date: 15.04.2008 norms for export product 1,2-Epoxy-2-(2,4-Difluorophenyl)-3(1(H)-Triazole- 1-YL) Propane Methane Sulphonate under para 4.7 of HBP.

Division. 61

Case No.:973/24/83-

ALC1/2007 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00990/AM08/ RLA File : 09/24/040/00139/AM08/ Lic.No/Date:09100311 79 21.08.2007 Defer Date: 15.04.2008 norms for export product 1,2-Epoxy-2-(2,4-Difluorophenyl)-3(1(H)-Triazole- 1-YL) Propane Methane Sulphonate under para 4.7 of HBP. Division. 62

Case No.:999/24/83-

ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/01017/AM08/ RLA File : 09/24/040/00154/AM08/ Lic.No/Date:09100312 00 24.08.2007 Defer Date: 15.04.2008 norms for export product [1S,4R]-4-[(2-Amino-6-Chloro-5-Formamido-4- Pyrimidinyl)Amino]-2-yclopentene-1-Methanol under para 4.7 of HBP. Division. 63

Case No.:1000/24/83-

ALC1/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/01018/AM08/ RLA File : 09/24/040/00185/AM08/ Lic.No/Date:09100312 01 24.08.2007 Defer Date: 15.04.2008 norms

for

export

product

8-Chloro-5,6-Dihydro-11h- benzo(5,6)Cyclohepta(1,2-b)Pyridene-11-one under para 4.7 of HBP. Division. 64 Case No.:42/25/83- ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved

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. U.O.No.35011/178/2006-PI-III dated 11.02.2008 decided to ratify norms under

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

Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Nitazoxanide 1 Kg. 1. 2-Acetyloxy benzoic

acid (Asprin) 0.916kg/kg 2. 2-amino-5-nitro thiazole 0.590kg/kg 3. Triethylamine 0.716kg/kg 4. Methylene Chloride 1.35kg/kg 5. Dimethyl formamide 0.70kg/kg 6. Methanol 3.20kg/kg 7. Charcoal 0.100kg/kg Norms Committee. 65

Case No.:12/27/83-

ALC1/2007 ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01086/AM08/ RLA File : 03/94/040/00555/AM08/ Lic.No/Date:03104415 61 31.08.2007 Defer Date: 01.04.2008 norms for export product Saquinavir 200mg Capsules/Saqvir 200mg Capsules under para 4.7 of HBP. Division. 66 Case No.:5/27/83- ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved 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. Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of

export product Florfenicol 1 Kg. 1. (1R,2S)-1-[4- (methylsulfonyl)ph enyl]-2-amino-3- fluoro-1-propanol [Fluoroamine] 1.095kg/kg 2. Methyl

Dichloro Acetate 1.588kg/kg 3. Toluene 1.61kg/kg 4. Methanol 1.21kg/kg 5. Ethanol 2.41kg/kg 6. Carbon enoanticromos (Activated Carbon) 0.047kg/kg Norms Committee. 67

Case No.:22/27/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01096/AM08/ RLA File : 09/24/040/00166/AM08/ Lic.No/Date:09100313 81 03.09.2007

norms for export product Efavirenz under para 4.7 of HBP. Committee decided to withdraw case as case has been approved in its 31/08 meeting held on 15/01/2008. 68 Case No.:29/27/83- ALC1/2007 Party Name:AVENTIS PHARMA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/83/050/01103/AM08/ RLA File : 03/94/040/00521/AM08/ Lic.No/Date:03104417 08 03.09.2007 :

norms for export product Ramipril Precursor II (Step 3) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Ramipril Precursor II (Step 3) 1 Kg. 1. L-Serinemethyl Ester Hcl 1.38kg/kg 2. Phosphorous Pentachloride 2.08kg/kg 3. Methylene Chloride 1.76kg/kg 4. Acetyl Chloride 0.59kg/kg Norms Committee. 69

Case No.:54/27/83-

ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01128/AM08/ RLA File : 03/94/040/00525/AM08/ Lic.No/Date:03104419 78 06.09.2007 Defer Date: 15.04.2008 norms for export product Aprepitant under para 4.7 of HBP. Division. 70 Case No.:61/27/83- ALC1/2007 Party Name:APITHECARY PHARMA PVT LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/01135/AM08/ RLA File : 09/24/040/00147/AM08/ Lic.No/Date:09100314 43 07.09.2007 Defer Date: 01.04.2008 norms for export product Omeprazole Sulphide or 5-Methoxy-2-[([4- Mehoxy-3,5-Dimehyl-2-Pyridine-2-Methyl]hio]-1H-Benzimidazole under

para 4.7 of HBP.

Division. 71

Case No.:94/27/83-

ALC1/2007 Party Name:ENVEE DRUGS PVT LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Approved HQ File : 01/83/050/01168/AM08/ RLA File : 34/24/040/00082/AM08/ Lic.No/Date:34100196 47 14.09.2007

norms for export product Betamethasone Valerate BP/USP under para 4.7 of HBP. Committee in consultation with representative of PI Division present in the meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Sl.N o. Import items Quantity allowed per

unit

of export product Betamethasone Valerate BP/USP 1 Kg. 1. Betamethasone BP/USP 0.915kg/kg Norms Committee. 72 Case No.:98/27/83- ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Approved HQ File : 01/83/050/01172/AM08/ RLA File : 09/24/040/00258/AM08/ Lic.No/Date:09100315 11 14.09.2007

norms for export product Tenofovir Disoproxil Fumerate under para 4.7 of HBP. Export product Export Quantity Sl.N o. Import items Quantity allowed per

unit

of export product Tenofovir Disoproxil Fumerate 1 Kg. 1. Adenine 1.28kg/kg 2. Diethyl-p- tolunesulfonylmet hyl Phosphonate 3.52kg/kg 3. Dimethyl 6.66kg/kg

formamide 4. (R)-(+)-Propylene carbonate 1.19kg/kg 5. Methylene dichloride 19.18kg/kg 6. Acetonitrile 3.20kg/kg 7. Acetone 0.93kg/kg 8. N-methyl-2- pyrrolidone 3.92kg/kg 9. Triethylamine 1.080kg/kg 10. Chloromethyl isopropyl carbonate 2.708kg/kg 11. Isopropyl alcohol 6.18kg/kg Norms Committee. 73

Case No.:111/27/83-

ALC1/2007 ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01185/AM08/ RLA File : 03/94/040/00622/AM08/ Lic.No/Date:03104433 42 17.09.2007

norms for export product Losartan Potassium under para 4.7 of HBP. Committee decided to withdraw case as case has been approved in its 39/82 meeting held on 29.01.2008. 74 Case No.:129/27/83- ALC1/2007 ALC4/2007 05.02.2008 Status: Case Approved HQ File : 01/83/050/01203/AM08/ RLA File : 03/94/040/00632/AM08/ Lic.No/Date:03104435 48 18.09.2007

norms for export product Sibutramine Hydrochloride under para 4.7 of HBP. U.O.No.35011/83/2007-PI-III dated 28.01.2008 decided to ratify norms under para Export product Export Sl.N Import items Quantity

Quantity o. allowed per unit of

export product Sibutramine Hcl 1 Kg. 1. 1-1(4- chlorophenyl)Cyclo butyl

3- Methylbutylamine (Fumarate Salt)SM- III Compound 1.53kg/kg Norms Committee. 75

Case No.:12/22/82-

ALC4/2007 ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/82/050/00182/AM08/ RLA File : 03/94/040/00638/AM08/ Lic.No/Date:03104436 98 19.09.2007

norms for export product Carvedilol under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007-PI-III dated 28.01.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Quantity Sl.N o. Description of import item Qty. allowed Carvedilol 1kg. 1. 4-hydroxy carbazol 1.06kg/kg 2. N-[2-(2-methoxy phenoxy)ethyl]benzyl amine hcl 1.089kg/kg Norms Committee. 76 Case No.:14/22/82- ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/82/050/00184/AM08/ RLA File : 13/24/040/00017/AM08/ Lic.No/Date:13100250 52 21.09.2007

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

Committee in light of written comments forwarded by PI Division decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of

export product Vitamin

B12 Granules 1 Kg. 1. Vitamin B12 USP 0.0101kg/kg 2. Micro

Cellulose Crysteline 0.99kg/kg Norms Committee. 77

Case No.:13/22/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/82/050/00183/AM08/ RLA File : 13/24/040/00018/AM08/ Lic.No/Date:13100250 51 21.09.2007

norms for export product Biotin Granules under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of

export product Biotin Granules 1 Kg. 1. Biotin USP 0.0101kg/kg 2. Micro

Crystalline Cellulose 0.99kg/kg Norms Committee. 78 Case No.:16/22/82- ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00186/AM08/ RLA File : 03/95/040/00574/AM08/ Lic.No/Date:03104440 49 24.09.2007

norms for export product Diproson Lotion (30ml) under para 4.7 of HBP. in its 36/82 meeting held on 08.01.2008. 79

Case No.:160/27/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Case Approved HQ File : 01/83/050/01234/AM08/ RLA File : 03/94/040/00658/AM08/ Lic.No/Date:0310444 208 25.09.2007

norms for export product Lamivudine under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007-PI-III dated 28.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Expor t Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Lamivudine ITC(HS)No.29349 000 1kg. 1.
(2R.5S)-5-[4-Aceta,odp- 2- Pxp-1(2H)- Pyrimidinyl]-1,3- Oxathiolan-2-YL, Methyl Methyl Carbonate 2.63kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 80 Case No.:191/27/83- ALC1/2007 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/01265/AM08/ RLA File : 04/24/040/00235/AM08/ Lic.No/Date:04100912 80 01.10.2007 Defer Date: 15.04.2008 norms for export product [Alpha-(Alpha,Beta)]-Beta-Methyl-Alpha-Phenyl-1- Pyrrolidineethanol Base (Pyrrolidinyl Nor ephedrine Base) under para 4.7 of HBP.

Division. 81

Case No.:6/29/83-

ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01271/AM08/ RLA File : 05/24/040/00525/AM08/ Lic.No/Date:05102098 57 03.10.2007

norms for export product Cefprozil under para 4.7 of HBP. 82

Case No.:12/29/83-

ALC1/2007 Party Name:SYMBIOTEC PHARMALAB LTD., Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Approved
HQ File : 01/83/050/01277/AM08/ RLA File : 11/24/040/00034/AM08/ Lic.No/Date:11100161 41 04.10.2007

norms for export product Hydrocortisone Acetate BP (Micronised) 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 M/s Aarti Drugs Limited and in consultation with representative of PI Division present in meeting decided to ratify norms under

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

Export product Export Quantity Sl.N o. Import items Quantity allowed per

unit

of export product Hydrocortisone Acetate 1 Kg. 1. Hydrocortisone 1.00kg/kg Norms Committee. 83 Case No.:9/29/83- ALC1/2007 Party Name:HETERO LABS LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Deferred HQ File : 01/83/050/01274/AM08/ RLA File : 09/24/040/00278/AM08/ Lic.No/Date:09100317 04 04.10.2007 Defer Date: 15.04.2008

norms for export product Tenofovir Disoproxil Fumarate under para 4.7 of HBP. Division. 84

Case No.:29/29/83-

ALC1/2007 Party Name:RAY CHEMICALS PRIVATE LIMITED, Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/83/050/01294/AM08/ RLA File : 07/24/040/00471/AM08/ Lic.No/Date:07100536 84 05.10.2007

norms for export product Doxepin Hcl under para 4.7 of HBP. Committee in light its earlier decision taken in its 10/83 meeting held on 07/06/2006 and in consultation with representative of PI Division present in the meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of export product Doxepin Hcl 1 Kg. 1. 1 Bromo 3 Chloro Propane 1.12kg/kg 2. Tetra Hydro Furan 0.68kg/kg 3. Magnisium Ingot 0.19kg/kg Norms Committee. 85

Case No.:33/29/83-

ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01298/AM08/ RLA File : 09/24/040/00244/AM08/ Lic.No/Date:09100317 13 05.10.2007 Defer Date: 01.04.2008 norms for export product {1R,2S,5R}-Methyl-5S-(Cytosine-1-Yl)-1,3- Oxathiolane-2R-Carboxylate/CME Compound under para 4.7 of HBP. Division. 86 Case No.:43/29/83- Party Name:MATRIX Meet No/Date:40/82- Status:Cas

ALC1/2007 LABORATORIES LTD ALC4/2007 05.02.2008 e Deferred HQ File : 01/83/050/01308/AM08/ RLA File : 09/24/040/00259/AM08/ Lic.No/Date:09100317 15 08.10.2007 Defer Date: 01.04.2008 norms for export product Cytosine Menthyl Ester (CME) under para 4.7 of HBP. Division. 87

Case No.:67/29/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01332/AM08/ RLA File : 03/95/040/00677/AM08/ Lic.No/Date:03104459 31 10.10.2007

norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. 88

Case No.:8/25/82-

ALC4/2007 Party Name:SHASUN CHEMICALS & DRUGS LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00202/AM08/ RLA File : 04/24/040/00253/AM08/ Lic.No/Date:04100914 59 10.10.2007

norms for export product Spironolactone Tablets 25mg under para 4.7 of HBP. in its 32/82 meeting held on 11.12.2007. 89 Case No.:9/25/82- ALC4/2007 Party Name:SHASUN CHEMICALS & DRUGS LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00203/AM08/ RLA File : 04/24/040/00254/AM08/ Lic.No/Date:04100914 60 10.10.2007

norms for export product Spironolactone Tablets 50mg under para 4.7 of

HBP. in its 36/82 meeting held on 08.01.2008. 90

Case No.:10/25/82-

ALC4/2007 Party Name:SHASUN CHEMICALS & DRUGS LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00204/AM08/ RLA File : 04/24/040/00255/AM08/ Lic.No/Date:04100914 62 10.10.2007

norms for export product Spironolactone Tablets 100mg under para 4.7 of HBP. in its 36/82 meeting held on 08.01.2008. 91

Case No.:71/29/83-

ALC1/2007 Party Name:HONEST BIO- VET PVT. LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01336/AM08/ RLA File : 08/24/040/00174/AM08/ Lic.No/Date:08100677 47 11.10.2007

norms for export product Menadione Sodium Bisulphite Complex (MSB65%) under para 4.7 of HBP. in its 36/82 meeting held on 08.01.2008. 92

Case No.:102/29/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01367/AM08/ RLA File : 09/24/040/00271/AM08/ Lic.No/Date:09100317 98 16.10.2007 Defer Date: 15.04.2008 norms for export product 2-Chloro-N-(2-Chloro-4-Methyl-3-Pyridinyl)-3- Pyridine Carboxamide under para 4.7 of HBP. Committee decided to defer case for six weeks for appropriate application to be received from RA.

93

Case No.:95/29/83-

ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01360/AM08/ RLA File : 03/94/040/00673/AM08/ Lic.No/Date:03104465 03 16.10.2007

norms for export product Hydrochlorothiazide under para 4.7 of HBP. 94

Case No.:4/30/83-

ALC1/2007 Party Name:RA CHEM PHARMA LIMITED. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01373/AM08/ RLA File : 09/24/040/00304/AM08/ Lic.No/Date:09100318 10 17.10.2007 Defer Date: 15.04.2008 norms for export product 1-Acetylamino-5-Nitro-2-Propoxy Benzene under

para 4.7 of HBP.

Committee decided to forward a copy of application to Chemical Division of C&PC. Accordingly, the case was deferred for six weeks. 95

Case No.:13/30/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01382/AM08/ RLA File : 09/24/040/00330/AM08/ 17 19.10.2007 Defer Date: 15.04.2008 norms for export product Atazanavir Sulfate under para 4.7 of HBP. Division. 96 Case No.:2/26/82- ALC4/2007 Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00220/AM08/ RLA File : 03/94/040/00755/AM08/ Lic.No/Date:03104473 19 22.10.2007

norms for export product Drug formulations Drops under para 4.7 of HBP. 97

Case No.:23/30/83-

ALC1/2007 Party Name:MATRIX LABORATORIES LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Withdrawn HQ File : 01/83/050/01392/AM08/ RLA File : 09/24/040/00299/AM08/ 41 22.10.2007

norms for export product Efavirenz-600mg Tablets under para 4.7 of HBP. Committee decided to withdraw case as case has been rejected by NC 98

Case No.:22/30/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01391/AM08/ RLA File : 09/24/040/00325/AM08/ 37 22.10.2007

norms for export product 3-Oxo-4-Aza-5a-Androstane-17b-Carboxylic Acid under para 4.7 of HBP. 99

Case No.:1/27/82-

ALC4/2007 Party Name:MISSION PHARMACEUTICALS LTD., Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00222/AM08/ RLA File : 03/95/040/00545/AM08/ Lic.No/Date:03104474 30 23.10.2007

norms for export product Ciprofloxacin Tablets BP 500mg under para 4.7 of HBP. 10 0

Case No.:52/30/83-

ALC1/2007 Party Name:COVALENT LABORATORIES PRIVATE Meet No/Date:40/82- ALC4/2007 Status:Cas e

LIMITED 05.02.2008 Withdrawn HQ File : 01/83/050/01421/AM08/ RLA File : 09/24/040/00280/AM08/ 80 24.10.2007

norms for export product Cefdinir under para 4.7 of HBP. in its 32/82 meeting held on 11.12.2007. 10 1

Case No.:51/30/83-

ALC1/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01420/AM08/ RLA File : 09/24/040/00276/AM08/ 79 24.10.2007 Defer Date: 15.04.200 8 norms for export product Indinavir Sulphate under para 4.7 of HBP. Division. 10 2

Case No.:50/30/83-

ALC1/2007 Party Name:JUPITER BIOSCIENCE LIMITED, Meet No/Date:40/82- ALC4/2007 05.02.2008 Status: Case Approved HQ File : 01/83/050/01419/AM08/ RLA File : 09/24/040/00336/AM08/ 78 24.10.2007

norms for export product N-T-Boc-L-Phyenylalanine 99% Purity under para 4.7 of HBP. Committee in light of its earlier decision taken in its 38/82 meeting held on 22.01.2008 vide Case No.635/24/83 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 N-T-BOC-L- Phenyl Alanine 1kg. 1. L-Phenyl Alanine 0.622kg/kg 2. Di-Tertiary-Butyl 0.821kg/kg

(ITC(HS)No.29374 000) Dicarbonate Anhydride 3. Isopropyl Alcohol 0.394kg/kg 4. N-Hexane 0.986kg/kg 5. Ethyl Acetate 1.134kg/kg 6. Sodium Hydroxide 0.150kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 10 3

Case No.:15/32/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/83/050/01437/AM08/ RLA File : 09/24/040/00321/AM08/ 97 26.10.2007

norms for export product 5-Cyano Phthalide under para 4.7 of HBP. Committee in light of its earlier decision taken in its 34/82 meeting held on 26.12.2007 vide Case No.508 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 Expo rt Qty. Sl.N o. Import items Qty. allowed per unit of export product 5-Cyano Phthalide 1kg. 1. Sulfolane 6.184kg/kg 2. Sulfamide 1.020kg/kg 3. Para Formaldehyde 0.53kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 104 Case No.:28/32/83- ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Case Approved HQ File : 01/83/050/01450/AM08/ RLA File : 03/94/040/00789/AM08/ Lic.No/Date:0310448 309 29.10.2007

norms for export product Losartan Potassium under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007-PI-III dated 28.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Losartan Potassium

1kg 1. 2-Butyl-4-chloro- 1-[{2’- (3-triphenyl methyl-1H- tetrazole-2yl) (1,1’- biphenyl)-4yl)-1H- Imidazole-5- methanol] 2.00kg/kg 2. Tetrahydrofuran 1.80kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 10 5

Case No.:64/32/83-

ALC1/2007 Party Name:VITAL LABORATORIES PVT. LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01486/AM08/ RLA File : 03/95/040/00758/AM08/ Lic.No/Date:03104487 92 01.11.2007 Defer Date: 01.04.200 8 norms for export product Yohimbine Hydrochloride under para 4.7 of HBP. Division. 10 6

Case No.:65/32/83-

ALC1/2007 Party Name:VITAL LABORATORIES PVT. LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e
Approved HQ File : RLA File : Lic.No/Date:03104487

01/83/050/01487/AM08/ 03/95/040/00680/AM08/ 95 01.11.2007 norms for export product 10-DAB under para 4.7 of HBP. Committee in light of DGFT Report dated 31.03.2005 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Sl.N o. Import items Quantity allowed per

unit

of export product 10-DAB 1 Kg. 1. Taxus

Baccata Leaves 1148kg/kg Norms Committee. 10 7

Case No.:60/32/83-

ALC1/2007 ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01482/AM08/ RLA File : 03/94/040/00799/AM08/ Lic.No/Date:03104487 06 01.11.2007 Defer Date: 01.04.200 8 norms for export product Saquinavir 200mg Capsules/Saqvir 200mg Capsules under para 4.7 of HBP. Division. 10 8

Case No.:10/28/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/82/050/00244/AM08/ RLA File : 13/24/040/00020/AM08/ Lic.No/Date:13100252 80 01.11.2007

norms for export product Ascorbyl Palmitate Granules 95% under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm

Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of

export product Ascorbyl Palmitate Granules 95% 1 Kg. 1. Ascorbyl Palmitate USP 0.9595kg/kg 2. Polyvinyl Pyrrolidone 0.0196kg/kg Norms Committee. 10 9

Case No.:69/32/83-

ALC1/2007 ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01491/AM08/ RLA File : 03/94/040/00803/AM08/ Lic.No/Date:03104489 36 02.11.2007

norms for export product under para 4.7 of HBP. Committee decided to withdraw case as case has been approved in its 39/08 meeting held on 29/01/2008. 11 0

Case No.:78/32/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Approved HQ File : 01/83/050/01500/AM08/ RLA File : 09/24/040/00305/AM08/ Lic.No/Date:09100319 87 05.11.2007

norms for export product under para 4.7 of HBP. Export product Export Quantity Sl.N o. Import items Quantity allowed per unit of

export product Florfenicol 1 Kg. 1. (1R,2S)-1-[4- (methylsulfonyl)ph enyl]-2-amino-3- fluoro-1-propanol [Fluoroamine] 1.095kg/kg

Methyl

Dichloro Acetate 1.588kg/kg 3. Toluene 1.61kg/kg 4. Methanol 1.21kg/kg 5. Ethanol 2.41kg/kg 6. Carbon enoanticromos (Activated Carbon) 0.047kg/kg Norms Committee. 11 1

Case No.:82/32/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01504/AM08/ RLA File : 09/24/040/00051/AM08/ Lic.No/Date:09100319 91 05.11.2007 Defer Date: 15.04.200 8 norms for export product Cefepime Hcl for Injection (Cefepime Hcl under

para 4.7 of HBP.

Committee decided to defer case for six weeks. 11 2

Case No.:106/32/83-

ALC1/2007 ALC4/2007 05.02.2008 Status:Cas e withdrawn HQ File : 01/83/050/01528/AM08/ RLA File : 03/94/040/00804/AM08/ Lic.No/Date:03104492 08 05.11.2007

norms for export product Lamivudine under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 39/08 meeting held on 29.01.2008. 11 3

Case No.:90/32/83-

ALC1/2007 Party Name:VITAL LABORATORIES PVT. LTD. Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01512/AM08/ RLA File : 03/95/040/00683/AM08/ Lic.No/Date:03104494 50 06.11.2007 Defer Date: 01.04.200 8 norms for export product Reserpine BP/EP/USP under para 4.7 of HBP.

Division. 11 4

Case No.:7/33/83-

ALC1/2007 ALC4/2007 05.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01536/AM08/ RLA File : 03/94/040/00822/AM08/ Lic.No/Date:03104496 80 07.11.2007

norms for export product Fluticasone Propionate under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 39/08 meeting held on 29.01.2008. 11 5

Case No.:1/35/82-

ALC4/2007 Party Name:FDC LTD Meet No/Date:40/82- ALC4/2007 05.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00280/AM08/ RLA File : 03/94/040/00771/AM08/ Lic.No/Date:03104506 16 19.11.2007 Defer Date: 15.04.200 8 norms for export product under para 4.7 of HBP. Committee decided to remind RA to furnish a copy of application alongwith copy of Advance Authorisation. Accordingly, case was deferred for six weeks.