IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2010-02-16

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 47/82‐ALC4/2009 MEETING DATE : 16.02.2010 The Meeting No.47/82 in the year 2009‐10 to consider the cases under Duty Exemption Scheme (Chapter‐4) of Foreign Trade Policy, 2004‐09 pertaining to products falling in Chapter 29 and 30 scheduled to be held on 16.02.2010 was actually held on 23.02.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Shaish Kumar, IA, DIPP 2. Shri D.N. Mathur, Dy. IA, Department of Pharmaceuticals 3. Shri Rajinder Pal Singh, Dy. DGFT 4. Shri Shyam Lal, FTDO It was noted that neither the representative of DC(MSME) nor the representative of Department of Ayush are attending the Norms Committee meeting resulting pending of large number for cases for fixation of norms. It was, therefore, decided to remind both the Departments to depute the representative for attending meeting through D.O. letter at the level of DG. At the outset, minutes of Norms Committee Meeting No. 44/82 dated 27.01.2010 were ratified by the Committee.

Case No. B‐460

M/s Watson Pharma Pvt. Ltd. Norms Committee Meeting No. 47/10 File No. 01/83/050/00752/AM04/DES‐III Meeting Date 16.02.2010 RAF No. 03/24/040/01025/AM04 Adv. Lic. No. 0310221706 dated 29.8.2003 Withdrawn as the case has already been approved by NC in 46/82 meeting held on 09.02.2010.

Case No. B‐461

M/s GVS Labs Ltd. F.No.01/82/50/1561/AM06/DES‐III F.No.01/82/50/1215/AM06/DES‐III RAF No.03/94/040/1305/AM06 RAF No.03/94/040/1137/AM06 Adv. Lic. No. 0310368505 dated 24.02.2006 Adv. Lic. No. 0310363042 dated 13.01.2006 Committee considered case as per agenda and decided to seek comments from Zonal Jt. DGFT, Mumbai regarding circumstances in which the name of M/S Milan Laboratories (India) Pvt. Ltd has not been endorsed as supporting manufacturer in Advance licence No. 0310368505 dated 24.02.2006 and 0310363042 dated 13.01.2006 issued to

M/S GVS Ltd. Since the licences are very old, it was also decided to close the case and reopen the same a䬀er receipt of reply from RA.

Case No. B‐462

M/s Kopran Ltd. File No. 01/82/050/01021/AM08 File No. 01/82/050/01704/AM07 File No. 01/82/050/01330/AM07 File No. 01/82/050/01372/AM07 RAF No. 03/94/040/00511/AM08 RAF No. 03/94/040/01184/AM07 RAF No. 03/94/040/653/AM07 RAF No. 03/94/040/00951/AM07 Adv. Lic. No. 0310440478 dated 22.08.2007 Adv. Lic. No. 0310420811 dated 23.02.2007 Adv. Lic. No. 0310409126 dated 22.11.2006 Adv. Lic. No. 0310410420 dated 01.12.2006 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultation with technical authority present in meeting, decided to revise norms under para 4.7 of HBP against Advance licence mentioned above as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Ce䬀riaxone Sodium Sterile 1 Kg. 1. Ce䬀riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg As regards Advance licence Nos. 0310408804 dated 20.11.2006 and 0310438246 dated 06.08.2007 for the export product Cefepime for Injection, it was decided to call for the content of Cefepime Hcl (Non‐Sterile) and L‐Arginine (Non‐sterile) in the export product. RA concerned may take further necessary action as per above decision of NC.

Case No. B‐463

M/s Emcure Pharmaceuticals Ltd. File No. 01/82/050/00263/AM10 RAF No. 31/24/040/00058/AM10 Adv. Lic. No. 3110039081 dated 03.07.2009 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/268/2009‐PI‐III dated 24.12.2009 and in consultation with technical authorities present in meeting, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

Export product Export Qty. Sl.No. Import items Qty. allowed Efavirenz Micronized 1 kg. 1. (S)‐5‐Chloro‐(Cyclopropylethynyl)‐2‐ Amino‐(Trifluoromethyl)‐Benzene Methanol 1.0173 kg

Case No. B‐464

M/s Emcure Pharmaceuticals Ltd. File No. 01/82/050/00596/AM10 RAF No. 31/24/040/00111/AM10 Adv. Lic. No. 3110040145 dated 05.10.2009 of Pharmaceuticals vide their O.M. No.35011/268/2009‐PI‐III dated 24.12.2009 and in consultation with technical authorities present in meeting, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Efavirenz Micronized 1 kg. 1. (S)‐5‐Chloro‐(Cyclopropylethynyl)‐2‐ Amino‐(Trifluoromethyl)‐Benzene Methanol 1.0173 kg

Case No. B‐465

M/s Metropolitan Eximchem Ltd. File No. 01/82/050/01144/AM09 RAF No. 03/95/040/00594/AM10 Adv. Lic. No. 0310489940 dated 13.10.2008 Committee decided to defer case for 16.03.2010 for comments of Department of C&PC.

Case No. B‐466

M/s Fermenta Biotech Ltd. File No. 01/82/162/00831/AM09 Case under para 4.4.2 of HBP. Committee considered case as per agenda and decided to call for the specific import item No.1 i.e.either Cholesterol NF or Cholesteryl Acetate from firm. Accordingly, case was deferred for 16.06.2010.

Case No. B‐467

M/s Chemill Nutraceuticals Pvt.Ltd. File No. 01/82/050/00011/AM10 RAF No. 03/94/040/01119/AM09 Adv. Lic. No. 0310516126 dated 17.04.2009 Committee decided to forward a copy of application to DC(MSME) and Department of Ayush for their comments. Accordingly, case was deferred for 16.03.2010.

Case No. B‐468

M/s Sterling Biotech Ltd. File No. 01/82/050/00655/AM09 RAF No. 34/24/040/00055/AM09 Adv. Lic. No. 3410021673 dated 23.06.2008 Committee considered case as per agenda and taking 95% yield and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed 2 Chloro 4 Methyl Sulfonyl Benzoic Acid 1 Kg. 1. Calcium Acetate As applied 2. Cobalt‐II‐Acetate‐4‐Hydrate As applied 3. Manganese‐II‐Acetate As applied 4. 2‐Chl‐4‐methylsulfonyltoluene 0.92 kg 5. Hydrobromic Acid 62‐63% As applied

Case No. B‐469

M/s Alkaloids Corporation File No. 01/82/050/00483/AM08 RAF No. 02/24/040/00272/AM08 Adv. Lic. No. 0210107833 dated 04.01.2008 Committee considered case as per agenda and observed that the technical information received from the firm has been forwarded to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 16.03.2010.

Case No. A‐212

M/s Fleming Lab Ltd. File No. 01/82/162/01125/AM09 RAF No. 09/24/040/00030/AM09 Adv. Lic. No. 0910033923 dated 15.05.2008 of Pharmaceuticals vide their O.M. No.35011/187/2009‐PI‐(Norms) dated 07.01.2010 and in consultation with

technical authorities present in meeting, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Ketofifen hydrogen Gumarate EP/Ketotifen Furarate 1 kg. 1. 10‐Methoxy‐4H‐Benzo (4,5) Cyclohepta (1,2‐b) Thiopen‐4‐one 1.179 kg

Case No. A‐213

M/s Cipla Ltd. File No. 01/82/162/00107/AM10 RAF No. 03/94/040/00994/AM09 Adv. Lic. No. 0310505514 dated 04.02.2009 of Pharmaceuticals vide their O.M. No.35011/153/2009‐PI‐(Norms) dated 19.01.2010 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed Telmisartan and Amlodipine Tablets 80/5 mg 11,13,420 Nos. 1. Telmisartan Granules 153 kg 2. Amlodipine Besilate 6.027 kg

Case No. A‐214

M/s Unimark Remedies Ltd. File No. 01/82/162/00858/AM09 RAF No. 03/95/040/00095/AM08 Adv. Lic. No. 0310494004 dated 12.11.2008 of Pharmaceuticals vide their O.M. No.35011/186/2009‐PI‐(Norms) dated 19.01.2010 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed Naphtyridine Derivative 1 Kg. 1. 2‐Amino‐6‐Methyl‐Pyridine 0.81 kg 2. Ethoxy Methylene Malonic Ester 1.677 kg

Diphenyl Oxide 0.31 kg 4. Dimethyl Formamide 0.90 kg

Case No. A‐215

M/s Srini Pharmaceuticals Ltd. File No. 01/82/162/01222/AM09 RAF No. 09/24/040/00442/AM09 Adv. Lic. No. 0910037267 dated 03.03.2009 of Pharmaceuticals vide their O.M. No.35011/209/2009‐PI‐(Norms) dated 15.02.2010 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed Carvedilal 1 Kg. 1. 9‐H‐Carbazol‐4‐ol 1.06 kg 2. 2‐(‐2‐Methoxy‐Phenoxy)‐Ethylamine 1.089 kg

Case No. A‐216

M/s Sandoz Pvt. Ltd. File No. 01/82/162/00859/AM09 RAF No. 03/95/040/00518/AM09 Adv. Lic. No. 0310485890 dated 10.09.2008 of Pharmaceuticals vide their O.M. No.35011/174/2009‐PI‐(Norms) dated 22.02.2010 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed MDT‐MB Adult 1 No. 1. Rifampicin 612 mg 2. Dapsone Tablets 100 mg 28 Nos. 3. Hard Gelatin Empty Capsules As per packing policy 4. Lamprene 100 mg Capsules 3 Nos. 5. Lamprene 50 mg Capsules 27 Nos. MDT‐PB Adult 1 No. 1. Rifampicin 612 mg 2. Dapsone Tablets 100 mg 28 Nos. 3. Hard Gelatin Empty Capsules (For 2 As per packing policy

Nos. Rifampicin

Case No. A‐217

M/s Cipla Ltd. File No. 01/82/162/00110/AM10 RAF No. 03/94/040/01006/AM09 Adv. Lic. No. 0310505855 dated 05.02.2009 of Pharmaceuticals vide their O.M. No.35011/223/2009‐PI‐(Norms) dated 22.02.2010 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed Stavudine Capsules 15 mg [Stavudine =15.3 mg/capsule] 1 No.. 1. 2,2’‐anhydro,3’‐O‐Mesyl,5’‐O‐ benzoyl,5‐Methyl Uridine 2.73 kg/kg of Stavudine Stavudine Capsules 20 mg [Stavudine =20.4 mg/capsule] 1 No. Stavudine Capsules 30 mg [Stavudine =30.6 mg/capsule] 1 No. Stavudine Capsules 40 mg [Stavudine =40.8 mg/capsule] 1 No. Lamivudine 150 mg Stavudine 30 mg tablet [Stavudine =30.6 mg/tablet] 1 No. Lamivudine 150 mg Stavudine 40 mg tablet [Stavudine =40.8 mg/tablet] 1 No. 1

Case No.:18/22/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., Meet No/Date:47/82‐ALC4/2009 16.02.2010 Status:Case Approved HQ File :01/82/050/00881/AM09/ RLA File :08/24/040/00076/AM09/ Lic.No/Date:0810073944 13.08.2008 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export product Export Qty. Sl. No. Import items Qty. allowed

Paroxetine 10 mg Tablets 3,01,00,000 Nos 1. Paroxetine Hcl Hemihydrate 4606.37 kg 2. Lactose Anhydrous NF 29978.74 kg Paroxetine 20 mg Tablets 15,06,80,000 Nos. 3. Dibasic Calcium Phosphate Anhydrous 10561.389 kg Paroxetine 30 mg Tablets 1,51,55,000 Nos. Paroxetine 40 mg Tablets 1,96,75,000 Nos. 4. Magnesium Stearate 500.276 kg 5. BOTTLES & CAPS (PACKING MATERIALS IN FINISHED FORM 60 CC WHITE HDPE ROUND BOTTLE As per packing policy 6. 75 CC WHITE HDPE ROUND BOTTLE As per packing policy 7. 100 CC WHITE HDPE ROUND BOTTLE As per packing policy 8. 150 CC WHITE HDPE ROUND BOTTLE As per packing policy 9. 400 CC WHITE HDPE ROUND BOTTLE As per packing policy 10. 500 CC WHITE HDPE ROUND BOTTLE As per packing policy 11. 200 CC Straight Sided WHITE HDPE BOTTLE As per packing policy 12. Cap 33 MM White PP CRC with Pulp Liner As per packing policy 13. Cap 53 MM WHITE PP NCRC with Pulp Liner As per packing policy 14. Cap 38 MM WHITE PP NCRC with Pulp Liner As per packing policy RA concerned may take further necessary action as per above decision of Norms Committee. 2

Case No.:24/23/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 16.02.2010 Status:Case Deferred HQ File :01/82/050/00928/AM09/ RLA File :03/94/040/00512/AM09/ Lic.No/Date:0310483819 26.08.2008 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of Pharmaceuticals.

Case No.:28/28/82‐ALC4/2008

Party Name:METROCHEM API PVT. LTD. 16.02.2010 Status:Case Deferred HQ File :01/82/050/01077/AM09/ RLA File :09/24/040/00204/AM09/ Lic.No/Date:0910035464 29.09.2008 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of Pharmaceuticals. 4

Case No.:51/29/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 16.02.2010 Status:Case Approved HQ File :01/82/050/01133/AM09/ RLA File :03/94/040/00529/AM09/ Lic.No/Date:0310489370 07.10.2008 Decision : Withdrawn as the case has already been closed by NC in 36/82 meeting held on 01.12.2010. 5

Case No.:4/31/82‐ALC4/2008

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED Meet No/Date:47/82‐ALC4/2009 16.02.2010 Status:Case Deferred HQ File :01/82/050/01161/AM09/ RLA File :03/94/040/00851/AM08/ Lic.No/Date:0310490762 17.10.2008 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of Pharmaceuticals. 6

Case No.:9/31/82‐ALC4/2008

Party Name:SYMED LABS LTD. 16.02.2010 Status:Case Approved HQ File :01/82/050/01166/AM09/ RLA File :09/24/040/00286/AM09/ Lic.No/Date:0910035677 17.10.2008 Decision : Committee considered case as per agenda and in light of decision of NC taken in the case of M/S Anuh Pharma Ltd and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed Gemfibrozil 1 Kg. 1. 5‐(2,5‐Dimethylphenoxy)‐2,2‐ Dimethylpentanoic Acid Net to Net 2. Methanol 1.00 kg 7

Case No.:6/32/82‐ALC4/2008

Party Name:KRISHNA CHEMICAL INDUSTRIES 16.02.2010 Case Approved HQ File :01/82/050/01181/AM09/ RLA File :34/24/040/00136/AM09/ Lic.No/Date:3410022579 21.10.2008 Decision :Withdrawn as the case has already been approved by NC in 45/82 meeting held on 02.02.2010.

Case No.:21/24/82‐ALC4/2009

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 16.02.2010 Status:Case Deferred HQ File :01/82/050/00518/AM10/ RLA File :03/95/040/00331/AM10/ Lic.No/Date:0310535917 31.08.2009 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of C&PC. 9

Case No.:9/47/82‐ALC4/2009

Party Name:STAR ORECHEM INTERNATIONAL PVT. LTD. 16.02.2010 Status:Case Deferred HQ File :01/82/050/01052/AM10/ RLA File :50/24/040/00006/AM10/ Lic.No/Date:5010000150 25.09.2009 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of C&PC. 10

Case No.:11/47/82‐ALC4/2009

Party Name:KUDOS CHEMIE LTD., 16.02.2010 Status:Case Approved HQ File :01/82/050/01054/AM10/ RLA File :22/24/040/00031/AM10/ Lic.No/Date:2210009319 01.10.2009 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 52/09 meeting held on 31.12.2008 and in consultation with technical authority 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 Caffeine (Synthetic Caffeine Anhydrous) 1kg. 1. Crude Theophylline 80% w/w (wet) Loss on Drying NLT 15% 1.15 kg 2. Caustic Soda (flakes of Lye) 0.24 kg 3. Dimethyl sulphate 0.68 kg 4. Activated Carbon 0.100 kg 11

Case No.:10/47/82‐ALC4/2009

Party Name:SURYA PHARMACEUTICAL LTD 16.02.2010 Status:Case Approved HQ File :01/82/050/01053/AM10/ RLA File :22/24/040/00032/AM10/ Lic.No/Date:2210009349 14.10.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/206/2009‐PI‐(Norms) dated 19.01.2010 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed

Fexofinadine Hcl 1 Kg. 1. 4‐Chloro Butyryl Chloride 1.216 kg 2. Isonepecotic Acid 0.725 kg 3. Chlorobenzene 1.60 kg 4. Magmegioum 0.879 kg 5. Tetrahydrofuran 1.00 kg 6. Toluene 1.09 kg 7. Potassium Iodide 0.009 kg 8. Potassium Bicarbonate 0.300 kg 9. Dimethyl Sulfoxide 1.12 kg 10. Toluene Already covered 11. Monoethylene Glycol 1.24 kg 12. Methanol 4.00 kg 13. 1,2 Dimethoxy Ethane 1.12 kg 14. Sodium Borohydride 0.332 kg 15. Hexane 1.00 kg 16. Methylene Dichloride 3.00 kg 17. Acetone 2.20 kg 18. Methyl Iso Butylketone 3.00 kg 19. Isopropyl Alcohol 1.90 kg 20. Ethyl Acetate 2.50 kg 12

Case No.:1/37/82‐ALC4/2009

Party Name:LAFFANS PETROCHEMICALS LTD., 16.02.2010 Status:Case Deferred HQ File :01/82/050/00744/AM10/ RLA File :03/95/040/00472/AM10/ Lic.No/Date:0310546350 18.11.2009 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of C&PC. 13

Case No.:1/47/82‐ALC4/2009

Party Name:ALEMBIC LIMITED 16.02.2010 Status:Case Approved HQ File :01/82/050/01044/AM10/ RLA File :34/24/040/00150/AM10/ Lic.No/Date:3410025800 04.12.2009 Decision : Committee considered case as per agenda and in light of written comments earlier forwarded by Department of Pharmaceuticals vide their U.O.. No.35011/11/2005‐PI‐III dated 02.02.2010 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed

Fenofibrate 1 Kg. 1. 4‐Chloro,4 Hydroxybenzophenone 1.316 kg 2. Acetone 2.71 kg 3. Ethyl Acetate 4.47 kg 4. Iso Propyl Alcohol 5.43 kg 5. Methylene Chloride 4.92 kg 6. Activated Charcoal 0.100 kg 14

Case No.:2/47/82‐ALC4/2009

Party Name:ALEMBIC LIMITED 16.02.2010 Status:Case Approved HQ File :01/82/050/01045/AM10/ RLA File :34/24/040/00146/AM10/ Lic.No/Date:3410025799 04.12.2009 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 32/82 meeting held on 03.11.2009 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed Azithromycin Step 3 (AZA Azithromycin 1 KGA. 1. Erythromycin Base 1.86 kg 2. Acetone 1.27 kg 3. Ethyl Alcohol 3.00 ltr. 4. Hydroxylamine Hcl 0.97 kg 5. Methane Sulfonyl Chloride 0.69 kg 6. Methanol 1.09 kg 7. Platinum Catalyst with base of activated carbon (5% Platinum on carbon) 1.00 gm 15

Case No.:5/47/82‐ALC4/2009

Party Name:ALEMBIC LIMITED 16.02.2010 Status:Case Approved HQ File :01/82/050/01048/AM10/ RLA File :34/24/040/00149/AM10/ Lic.No/Date:3410025806 07.12.2009 Decision : Committee considered case as per agenda and in light of written comments earlier forwarded by Department of Pharmaceuticals vide their U.O. No.35011/55/2005‐PI‐III dated 08.11.2005 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed Nitazoxanide 1 Kg. 1. 2‐Amino‐5‐Nitrothiazole 0.59 kg 2. Methylene Chloride 2.48 kg

Acetone 2.75 kg 4. Activated Carbon 0.100 kg 16

Case No.:6/47/82‐ALC4/2009

Party Name:ALEMBIC LIMITED 16.02.2010 Status:Case Approved HQ File :01/82/050/01049/AM10/ RLA File :34/24/040/00160/AM10/ Lic.No/Date:3410025856 11.12.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 17/82 meeting held on 21.07.2009 and in consultation with technical authority 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 Azithromycin Crude purity Not less than 94.5% 1 KGA. 1. Erythromycin Thiocyanate 1.99 KGA 2. Acetone 4.45 kg 3. Hydroxylamine Hcl 0.91 kg 4. Methanol 2.72 kg 5. Plathinum Catalyst with base of activated carbon (5% platinum on carbon) 1.00 gm 6. Methylene Chloride 2.18 kg 7. Activated Carbon 0.01 kg 17

Case No.:4/47/82‐ALC4/2009

Party Name:ONEIRO CHEMICALS LTD 16.02.2010 Status:Case Approved HQ File :01/82/050/01047/AM10/ RLA File :34/24/040/00155/AM10/ Lic.No/Date:3410025872 15.12.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/229/2009‐PI‐(Norms) dated 05.01.2010 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed 4,5,6,7‐Tetrahydro (3,2,C) Thiono Pyridine Hcl 1 Kg. 1. Thephen‐2‐Ethylamine 1.13 kg 2. Methanol 1.956 kg 3. Methylene Chloride 1.03 kg

Case No.:6/43/82‐ALC4/2009

Party Name:PI INDUSTRIES LTD., 16.02.2010 Status:Case Deferred HQ File :01/82/050/00880/AM10/ RLA File :13/24/040/00026/AM10/ Lic.No/Date:1310031040 06.01.2010 Defer Date:16.03.2009 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of C&PC 19

Case No.:3/43/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 16.02.2010 Status:Case Deferred HQ File :01/82/050/00877/AM10/ RLA File :03/94/040/00784/AM10/ Lic.No/Date:0310554371 08.01.2010 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of Pharmaceuticals. 20

Case No.:4/43/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 16.02.2010 Status:Case Deferred HQ File :01/82/050/00878/AM10/ RLA File :03/94/040/00773/AM10/ Lic.No/Date:0310554372 08.01.2010 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of Pharmaceuticals. 21

Case No.:10/43/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 16.02.2010 Status:Case Approved HQ File :01/82/050/00884/AM10/ RLA File :09/24/040/00411/AM10/ Lic.No/Date:0910040593 12.01.2010 Decision : Committee considered case as per agenda and in light of written comments earlier forwarded by Department of Pharmaceuticals vide their U.O.. No.35011/98/2007‐PI‐III dated 31.03.2008 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed Mebeverine Hcl 1 Kg. 1. Methyl‐2‐Chloromethyl Propionate 0.66 kg 2. Veratic Acid 0.56 kg 3. Methanol 0.45 kg 4. Toluene 0.57 kg 5. 1,4‐Dibromobutane 0.84 kg

Case No.:11/43/82‐ALC4/2009

Party Name:CADILA HEALTHCARE LTD., 16.02.2010 Status:Case Defered HQ File :01/82/050/00885/AM10/ RLA File :08/24/040/00277/AM10/ Lic.No/Date:0810085697 12.01.2010 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of Pharmaceuticals. 23

Case No.:9/43/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 16.02.2010 Status:Case Deferred HQ File :01/82/050/00883/AM10/ RLA File :09/24/040/00354/AM10/ Lic.No/Date:0910040592 12.01.2010 Defer Date:16.03.2010 Decision : Committee decided to call for a copy of Drug Manufacturing Licence from firm. Accordingly, case was deferred for 16.03.2010. 24

Case No.:12/47/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 16.02.2010 Status:Case Approved HQ File :01/82/050/01055/AM10/ RLA File :05/24/040/00452/AM10/ Lic.No/Date:0510257143 29.01.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/150/2009‐PI (Norms) dated 01.02.2010 and in consultation with technical authority 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 Amoxycillin Trihydrate 500 mg & Clavulanate Potassium + Microcrystalline Cellulose (1:1) (250 + 125 mg Tablet 1No.. 1. Amoxycillin Trihydrate (OR) 255 mg/tablet Its raw materials as per revised SION A‐57 2. Potassium Lavulanate + Microcrystalline Cellulose (1:1) 303.45 mg/tablet Amoxycillin Trihydrate 500 mg + Potassium Calavulanate 125 mg + Microcrystalline Cellulose (1:1) Tablet 1 No. 1. Amoxycillin Trihydrate (OR) 510 mg/tablet Its raw materials as per revised SION A‐57 2. Potassium Lavulanate + Microcrystalline Cellulose (1:1) 303.45 mg/tablet Amoxycillin Trihydrate 750 mg + Potassium Calavulanate 125 mg + Microcrystalline Cellulose (1:1) Tablet 1 No. 1. Amoxycillin Trihydrate (OR) 765 mg/tablet

Its raw materials as per revised SION A‐57 2. Potassium Lavulanate + Microcrystalline Cellulose (1:1) 303.45 mg/tablet 25

Case No.:13/47/82‐ALC4/2009

Party Name:DHANUKA LABORATORIES LTD. 16.02.2010 Status:Case Approved HQ File :01/82/050/01056/AM10/ RLA File :05/23/040/00160/AM10/ Lic.No/Date:0510257148 29.01.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 44/82 meeting held on 27.01.2010 and in consultation with technical authority 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 item Qty. allowed Mica Ester 1 Kg. 1. CMOBA 0.793 kg 2. Thiourea 0.360 kg 3. Triphyenyl Phosphene 0.911 kg 4. Mercaptobenso Thiazol Disulphide 1.157 kg 5. Acetone 1.94 kg 6. Triethylamine 0.322 kg 26

Case No.:3/47/82‐ALC4/2009

Party Name:SUVEN LIFE SCIENCES LIMITED 16.02.2010 Status:Case Approved HQ File :01/82/050/01046/AM10/ RLA File :09/24/040/00432/AM10/ Lic.No/Date:0910040753 29.01.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/332/2009‐PI‐(Norms) dated 09.01.2010 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed Methyl 2‐2‐ Chloromethylphenyl‐3‐ Methoxy‐2‐Acrylate 1 Kg. 1. 3‐Isochromanone 0.957 kg 2. O‐Xylene 1.04 kg 3. Sodium Methoxide Powder 0.416 kg 4. N‐Methylformaniolde 0.083 kg 5. Methanol 2.31 kg

Methyl Formate 0.543 kg 27

Case No.:7/47/82‐ALC4/2009

Party Name:ATUL LIMITED, 16.02.2010 Status:Case Approved HQ File :01/82/050/01050/AM10/ RLA File :08/24/040/00294/AM10/ Lic.No/Date:0810086114 29.01.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/192/2009‐PI‐III dated 26.10.2009 and in consultation with technical authority 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 Exp. Qty. Sl.No. Import items Qty. allowed N‐Carbenzyloxy Carbonyl (CBZ‐L‐Valine) 1 Kg. 1. L‐Valine 0.667 kg 28

Case No.:8/47/82‐ALC4/2009

Party Name:H.J.AROCHEM PVT. LTD., 16.02.2010 Status:Case Approved HQ File :01/82/050/01051/AM10/ RLA File :08/24/040/00295/AM10/ Lic.No/Date:0810086115 29.01.2010 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 29

Case No.:14/47/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 16.02.2010 Status:Case Deferred HQ File :01/82/050/01057/AM10/ RLA File :03/95/040/00711/AM10/ Lic.No/Date:0310557940 01.02.2010 Defer Date:16.03.2010 Decision :Committee decided to defer case for 16.03.2010 for comments of Department of C&PC. 30

Case No.:15/47/82‐ALC4/2009

Party Name:HALDIA PETROCHEMICALS LTD. 16.02.2010 Status:Case Approved HQ File :01/82/050/01058/AM10/ RLA File :02/24/040/00213/AM10/ Lic.No/Date:0210137253 02.02.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Petrochemicals Division vide their O.M. No.46011/54/2008‐PC.II dated 23.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed

Benzene (from Olefin Complex) 1 MT 1. Naphtha 1.194 MT 31

Case No.:16/47/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 16.02.2010 Status:Case Deferred HQ File :01/82/050/01059/AM10/ RLA File :03/95/040/00709/AM10/ Lic.No/Date:0310558091 02.02.2010 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of C&PC. 32

Case No.:17/47/82‐ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 16.02.2010 Status:Case Approved HQ File :01/82/050/01060/AM10/ RLA File :03/94/040/00949/AM10/ Lic.No/Date:0310558204 02.02.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O.. No.35011/169/2008‐PI‐III dated 09.04.2009 and in consultation with technical authority 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 Triamcinolone Acetonide 1 kg. 1. 9 Beta‐11 Beta‐Epoxy‐16 Alpha, 17 Alpha, 21‐Trihydroxy‐Pregna‐1,4‐ Diene‐3,20‐Dione (5TR) 1.05 kg 33

Case No.:18/47/82‐ALC4/2009

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 16.02.2010 Status:Case Deferred HQ File :01/82/050/01061/AM10/ RLA File :31/24/040/00226/AM10/ Lic.No/Date:3110041784 02.02.2010 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of C&PC. 34

Case No.:19/47/82‐ALC4/2009

Party Name:SHIVA PHARMACHEM PVT. LTD, 16.02.2010 Status:Case Deferred HQ File :01/82/050/01062/AM10/ RLA File :34/24/040/00184/AM10/ Lic.No/Date:3410026242 02.02.2010 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of C&PC.

Case No.:20/47/82‐ALC4/2009

Party Name:STERLING BIOTECH LTD. 16.02.2010 Status:Case Deferred HQ File :01/82/050/01063/AM10/ RLA File :34/24/040/00188/AM10/ Lic.No/Date:3410026245 02.02.2010 Defer Date:16.03.2010 Decision : Committee decided to defer case for 16.03.2010 for comments of Department of C&PC.

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