DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 31/82ALC4/2010 MEETING DATE : 02.11.2010 The Meeĕng No.31/82 in the year 2010‐11 to consider the cases under Duty Exempĕon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 02.11.2010 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 Jasbir Singh, IA, Department of C&PC 3. Shri D.N. Mathur, Dy. IA, Department of Pharmaceuĕcals 4. Shri M. Mitra, Dy. DCGI, DCGI 5. Shri Krishan Kumar, Dy. DGFT 6. Shri Shyam Lal, FTDO At the outset, minutes of Norms Commiĥee Meeĕng No. 28/82 dated 12.10.2010 were raĕfied by the Commiĥee.
Case No. B258
M/s Hildose Ltd. Norms Committee Meeting No. 31/11 F.No.01/82/050/00497/AM08/DESIII Meeting Date 02.11.2010 RLA F. No. 03/94/040/01100/AM08 Adv. Lic. No.0310460275 dated 06.02.2008 Committee considered case as per agenda and observed that in this case the supplier and buyer is same i.e. M/S Transo Pharm, Germany and the supplier has supplied the raw material free of cost. Further the supplier has agreed and accepted 20% wastage in the raw material. After detailed deliberations and in consultation with technical authorities present in meeting, Committee decided to revise norms under para 4.7 of HBP as applied by the firm. The earlier decision taken in 17/11 meeting held on 27.07.2010 stands withdrawn. This decision is, however, for regularization purpose only and no repeat licence would be issued based on this decision. RA concerned may take further necessary action as per above decision of NC.
Case No. B259
M/s Punjab Chemicals & Crop Protection Ltd. Norms Committee Meeting No. 31/11 F.No.01/82/050/01157/AM10/DESIII F.No.01/82/050/00809/AM10/DESIII Meeting Date 02.11.2010 RLA F. No. 03/95/040/00760/AM10 RLA F. No. 03/95/040/00557/AM10 Adv. Lic. No.0310561196 dated 22.02.2010 Adv. Lic. No.0310550660 dated 14.12.2009 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of
Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/76/2005/Ch.II dated 02.06.2022.07.201009 and in consultaĕon with technical authority present in meeĕng, decided to revise 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 3,4,5Trimethoxy Toluene 1 kg 1. 3,4,5Trimethoxy Benzaldehyde 1.25 kg 2. Hydrazine Hydrate 0.420 kg 3. PEG600 1.00 kg RA concerned may take further necessary action as per above decision of NC. The earlier decision taken in 11/82 meeting held on 15.06.2010 and 12/82 meeting held on 22.06.2010 stands withdrawn.
Case No. B260
M/s FMC India Pvt. Ltd. Norms Committee Meeting No. 31/11 F.No.01/82/050/00212/AM08/DESIII F.No.01/82/050/00612/AM08/DESIII F.No.01/82/050/01173/AM08/DESIII F.No.01/82/050/01575/AM08/DESIII F.No.01/82/050/00777/AM09/DESIII Meeting Date 02.11.2010 RLA F. No. 07/24/040/00820/AM08 RLA F. No. 07/24/040/00789/AM07 RLA F. No. 07/24/040/00433/AM08 RLA F. No. 07/24/040/00577/AM08 RLA F. No. 07/24/040/00193/AM09 Adv. Lic. No.0710056292 dated 07.03.2008 Adv. Lic. No.0710056002 dated 22.02.2008 Adv. Lic. No.0710053369 dated 14.09.2007 Adv. Lic. No.0710054550 dated 16.11.2007 Adv. Lic. No.0710058652 dated 22.07.2008 Committee considered case as per agenda and in light of production and consumption data certified by Central Excise Authority and in consultation with technical authority present in meeting, decided to enhance the quantity of Lithium Metal to read as 0.2982 kg/kg of export product without any other change in the decision taken in 19/82 meeting held on 05.08.2008, 1/82 meeting held on 01.04.2008, 39/83 meeting held on 14.09.2007 and 38/83 meeting held on 26.12.2007.
Case No. B261
M/s Kopran Ltd. Norms Committee Meeting No. 31/11 F.No.01/82/050/00147/AM08/DESIII Meeting Date 02.11.2010 RLA F. No. 03/94/040/00443/AM08 Adv. Lic. No.0310438246 dated 06.08.2007 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/6/2010‐PI‐(Norms) dated 08.06.2010 and in consultaĕon with technical
authority present in meeĕng, decided to revise 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 Cefepime for Injection 1 Kg. 1. Cefepime Hcl (NonSterile) 0.655 kg 2. Methanol 0.742 kg 3. Eno Carbon 0.034 kg 4. Acetone 1.816 kg 5. LArginine (NonSterile) 0.370 kg 6. IPA (Iso Propyl Alcohol) 0.392 kg RA concerned may take further necessary action as per above decision of NC. The earlier decision taken in 21/82 meeting held on 25.09.2007 stands withdrawn.
Case No. B262
M/s Kopran Ltd. Norms Committee Meeting No. 31/11 F.No.01/82/050/01818/AM07/DESIII Meeting Date 02.11.2010 RLA F. No. 03/94/040/01416/AM07 Adv. Lic. No.0310423486 dated 16.03.2007 Committee decided to defer case for 30.12.2010 for comments of Department of Pharmaceuticals.
Case No. B263
M/s Hetero Labs Ltd. Norms Committee Meeting No. 31/11 F.No.01/82/050/01005/AM10/DESIII Meeting Date 02.11.2010 RLA F. No. 09/24/040/00305/AM10 Adv. Lic. No.0910039817 dated 05.11.2009 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/68/2010‐PI‐(Norms) dated 05.10.2010 and decision taken in 18/82 meeĕng held on 03.08.2010 in the case of M/S Aurobindo Pharma and in consultaĕon with technical authority present in meeĕng, decided to revise 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 Lamivudine (Purity NLT 99.8%) 1 Kg. 1. (2RCis)4Amino1(2Hydroxy Methyl)1,3Oxathiolan5YL2 (1H)Pyrimidinone 1.10 kg 2. Salicylic Acid 0.395 kg 3. Dimethyl Formamide 0.29 kg 4. Methanol 2.51 kg 5. Sodium Borohydride 0.480 kg
Case No. B264
M/s Fleming Labs. Ltd. Norms Committee Meeting No. 31/11 F.No.01/82/050/00777/AM06/DESIII Meeting Date 02.11.2010 RLA F. No. 09/24/040/00280/AM06 Adv. Lic. No.0910024270 dated 13.10.2005 Commiĥee considered case as per agenda and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as applied by the firm. 1
Case No.:29/41/82ALC4/2008
Party Name:ARCH PHARMALABS LTD Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/01469/AM09/ RLA File :03/94/040/00752/AM09/ Lic.No/Date:0310493255 06.11.2008 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by DC(MSME) vide their U.O.23(2)/DGFT/2010 dated 05.10.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 3aHydroxy7Keto5bCholan24 Acid 1 Kg. 1. Ox Bile Solids 75% 4.456 kg 2. Methanol 2.29 kg 3. Heptane 4.52 kg 4. Ethyl Acetate 4.76 kg 2
Case No.:27/42/82ALC4/2008
Party Name:ARCH PHARMALABS LTD 02.11.2010 Status:Case Approved HQ File :01/82/050/01505/AM09/ RLA File :03/94/040/00904/AM09/ Lic.No/Date:0310501134 05.01.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by DC(MSME) vide their U.O.23(2)/DGFT/2010 dated 05.10.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 3aHydroxy7 Keto5bCholan 24Acid 1 Kg. 1. 3,7Diacetoxy12oxocholanic Acid Methyl Ester 1.43 kg 2. Ethyl Acetate 4.85 kg 3. Hydrazine Hydrate 80% 1.05 kg 4. nPropanol 1.57 kg
3
Case No.:28/42/82ALC4/2008
Party Name:ARCH PHARMALABS LTD 02.11.2010 Status:Case Approved HQ File :01/82/050/01506/AM09/ RLA File :03/94/040/00920/AM09/ Lic.No/Date:0310501141 05.01.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by DC(MSME) vide their U.O.23(2)/DGFT/2010 dated 05.10.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 3aHydroxy7 Keto5bCholan 24Acid 1 Kg. 1. 3,7Diacetoxy12oxocholanic Acid Methyl Ester 1.43 kg 2. Ethyl Acetate 4.85 kg 3. Hydrazine Hydrate 80% 1.05 kg 4. nPropanol 1.57 kg 4
Case No.:55/18/82ALC4/2009
Party Name:ARCH PHARMALABS LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00329/AM10/ RLA File :03/94/040/00949/AM09/ Lic.No/Date:0310503316 21.01.2009 Defer Date:16.11.2010 Decision :Committee decided to defer case for 16.11.2010 for comments of Department of Pharmaceuticals. 5
Case No.:9/2/82ALC4/2009
Party Name:ARCH PHARMALABS LTD 02.11.2010 Status:Case Approved HQ File :01/82/050/00009/AM10/ RLA File :03/94/040/01131/AM09/ Lic.No/Date:0310514341 02.04.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by DC(MSME) vide their U.O.23(2)/DGFT/2010 dated 05.10.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 3aHydroxy7 Keto5bCholan 24Acid 1 Kg. 1. Ox Bile Solids 75% 4.456 kg 2. Methanol 2.29 kg 3. Heptane 4.52 kg 4. Ethyl Acetate 4.76 kg RA concerned may take further necessary acĕon as per above decision of NC. 6
Case No.:66/18/82ALC4/2009
Party Name:CORVINE CHEMICALS & PHARMACEUTICALS LIMITED, 02.11.2010 Status:Case Deferred HQ File :01/82/050/00340/AM10/ RLA File :07/24/040/00009/AM10/ Lic.No/Date:0710064113 13 04 2009 Defer D t 16 11 2010
13.04.2009 Date:16.11.2010 Decision :Committee decided to defer case for 16.11.2010 for comments of Department of C&PC. 7
Case No.:21/18/82ALC4/2009
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00295/AM10/ RLA File :03/94/040/01082/AM09/ Lic.No/Date:0310515875 16.04.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 21/11 meeting held on 24.08.2010 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 5 Hydroxy Isophthalic Acid 1 kg 1. Isophthalic Acid 2.248824 kg 2. Caustic Soda Flakes 2.00 kg 3. Caustic Potash Flakes 1.8 kg 8
Case No.:7/9/82ALC4/2009
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00120/AM10/ RLA File :04/24/040/00040/AM10/ Lic.No/Date:0410104760 21.05.2009 Decision : Committee considered case as per agenda and taking cue from SION A412 and in consultation with technical authority present in meeting, decided to ratify norms with 2% wastage 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 Natural Vitamin E 400 IU Softgel Capsules (Soft Gelatin Capsules) 4800000 Nos. 1. Natural Vitamin E 1000 IU (D Alpha Tocopherol Oil 1000IU/G 1958.4 kg 9
Case No.:9/13/82ALC4/2009
Party Name:ENCUBE ETHICALS PVT LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00149/AM10/ RLA File :03/94/040/00063/AM10/ Lic.No/Date:0310522513 03.06.2009 Defer Date: 30.11.2010 Decision :Committee noted that the firm has sent copy of DML and decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 10
Case No.:30/13/82ALC4/2009
Party Name:SHILPA MEDICARE LTD., 02.11.2010 Status:Case Deferred HQ File :01/82/050/00170/AM10/ RLA File :07/24/040/00103/AM10/ Lic.No/Date:0710065349 11.06.2009 Defer Date:30.11.2010
Decision :Committee decided to defer the case for 30.11.2010 for reply from firm. 11
Case No.:20/18/82ALC4/2009
Party Name:ARCH PHARMALABS LTD 02.11.2010 Status:Case Approved HQ File :01/82/050/00294/AM10/ RLA File :03/94/040/00087/AM10/ Lic.No/Date:0310524765 18.06.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by DC(MSME) vide their U.O.23(2)/DGFT/2010 dated 05.10.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 3aHydroxy7 Keto5bCholan 24Acid 1 Kg. 1. Ox Bile Solids 75% 4.456 kg 2. Methanol 2.29 kg 3. Heptane 4.52 kg 4. Ethyl Acetate 4.76 kg 12
Case No.:30/19/82ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00408/AM10/ RLA File :22/24/040/00015/AM10/ Lic.No/Date:2210009018 22.06.2009 Defer Date:30.11.2010 Decision :Committee considered case as per agenda and observed that the technical information called from the firm has been received and the same has been forwarded to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 13
Case No.:13/21/82ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00440/AM10/ RLA File :22/24/040/00014/AM10/ Lic.No/Date:2210009017 22.06.2009 Defer Date:30.11.2010 Decision : Committee considered case as per agenda and observed that the technical information called from the firm has been received and the same has been forwarded to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 14
Case No.:23/15/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00252/AM10/ RLA File :09/24/040/00109/AM10/ Lic.No/Date:0910038369 29.06.2009 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 15
Case No.:10/17/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 02.11.2010 Status:Case Rejected HQ Fil 01/82/050/00273/AM10/ RLA Fil 05/24/040/00203/AM10/ Li N /D t 0510245516
15 HQ File :01/82/050/00273/AM10/ RLA File :05/24/040/00203/AM10/ Lic.No/Date:0510245516 10.07.2009 Decision :Withdrawn as the case has already been rejected by NC in 22/82 meeting held on 31.08.2010. 16
Case No.:5/19/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00590/AM11/ RLA File :09/24/040/00119/AM10/ Lic.No/Date:0910038697 24.07.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/137/2008‐ PI‐III dated 27.02.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 (2S,3S,5S)2 Amino3Hydroxy 5(Tert Butyloxy Carbonyl)Amino 1,6Diphenyl Hemi Succinic Acid Salt (BDH) 1 Kg. 1. LPhenylalanine 1.039 kg 2. 1,2 Dimethoxy Ethane 13.06 kg 3. Acetonitrile 0.445 kg 4. Citric Acid Monohydrate 5.74 kg 5. Ditertiary Butyl Dicarbonate 0.653 kg 6. Iso Propyl Alcohol 2.86 kg 7. Methanol 3.475 kg 8. Methylene Dichloride 1.91 kg 9. NHeptane 0.28 kg 10. Potassium Carbonate 3.52 kg 11. Sodium Boro Hydride 0.667 kg 12. Tetrahydrofuran 1.028 kg 17
Case No.:26/21/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 02.11.2010 Status:Case Rejected HQ File :01/82/050/00453/AM10/ RLA File :09/24/040/00112/AM10/ Lic.No/Date:0910038897 12.08.2009 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish technical information vide letter dated 17.08.2010, but no reply has been received and norms can not be fixed in absence of the required technical information. Accordingly, it was decided to reject the case. 18
Case No.:9/34/82ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00654/AM10/ RLA File :22/24/040/00021/AM10/ Lic.No/Date:2210009180 20.08.2009 Defer Date:30.11.2010 Decision :Committee considered case as per agenda and observed that the technical information called from the firm have been received from the firm and the same
Decision :Committee considered case as per agenda and observed that the technical information called from the firm have been received from the firm and the same have been forwarded to Department of Pharmaceuticals vide U.O. dated 09.11.2010 for their comments. Accordingly, case was deferred for 30.11.2010. 19
Case No.:5/28/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 02.11.2010 Status:Case Rejected HQ File :01/82/050/00565/AM10/ RLA File :05/24/040/00308/AM10/ Lic.No/Date:0510249608 18.09.2009 Decision :Committee considered case as per agenda and observed that the firm was requested vide letter dated 23.07.2010 to clarify that the process details and export product do not match, but no reply has been received and norms can not be fixed in absence of required clarification. Accordingly, it was decided to reject the case. 20
Case No.:6/28/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 02.11.2010 Status:Case Deferred HQ File :01/82/050/00566/AM10/ RLA File :05/24/040/00275/AM10/ Lic.No/Date:0510249610 18.09.2009 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 21
Case No.:38/15/82ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00475/AM11/ RLA File :09/70/040/00114/AM10/ Lic.No/Date:0910039454 01.10.2009 Defer Date:30.11.2010 22
Case No.:3/29/87ALC1/2009
Party Name:PARABOLIC DRUGS LTD., 02.11.2010 Status:Case Deferred HQ File :01/87/050/00216/AM10/ RLA File :05/24/040/00302/AM10/ Lic.No/Date:0510250358 06.10.2009 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for reply from firm. 23
Case No.:74/5/82ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 02.11.2010 Status:Case Deferred HQ File :01/82/050/00108/AM11/ RLA File :09/24/040/00203/AM10/ Lic.No/Date:0910039636 16.10.2009 Defer Date:28.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/34/2010PI (Norms) dated 01.07.2010, decided to call for the following information from the firm. 1. Details of manufacturing process. 2. Molecular weight. 3. Percentage yield on molar basis. 4. Other technical details as per Appendix 33.
4. Other technical details as per Appendix 33. Accordingly, case was deferred for 28.12.2010. 24
Case No.:70/5/82ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00104/AM11/ RLA File :09/24/040/00228/AM10/ Lic.No/Date:0910039743 28.10.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 19/82 meeting held on 10.08.2010 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 Moxifloxacin Hcl 1 Kg. 1. 1‐Cyclopropyl‐6,7‐difluoro‐8‐ Methoxy‐4‐oxo 1,4‐Dihydro Quinoline‐3‐Carboxylic Acid 1.31 kg 2. (S,S)‐2,8‐Diazabicyclo (4,3,0) Nonane 0.55 kg 25
Case No.:44/15/82ALC4/2010
Party Name:KAMUD DRUGS PVT.LIMITED., 02.11.2010 Status:Case Approved HQ File :01/82/050/00481/AM11/ RLA File :31/24/040/00135/AM10/ Lic.No/Date:3110040400 29.10.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/110/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Ketamine Hcl 1 Kg. 1. Cyclo Pentyl Chloride 1.876 kg 2. O Chloro Benzonitril 1.684 kg 3. Magnesium Turning 0.467 kg 4. Bromoine 1.83 kg 5. Methanol 6.81 kg 6. Toluene 10.32 kg 7. Acetone 0.031 kg 8. Iso Propyl Alcohol 2.71 kg
Case No.:96/46/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 02.11.2010 Status:Case Rejected
26 0 . . 0 0 ejected HQ File :01/82/050/01012/AM10/ RLA File :09/24/040/00268/AM10/ Lic.No/Date:0910039892 12.11.2009 Decision : Committee considered case as per agenda and observed that the firm was requested to furnish technical information vide letter dated 17.08.2010, but no reply has been received and norms can not be fixed in absence of the required technical information. Accordingly, it was decided to reject the case. 27
Case No.:39/46/82ALC4/2009
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 02.11.2010 Status:Case Deferred HQ File :01/82/050/00955/AM10/ RLA File :07/24/040/00273/AM10/ Lic.No/Date:0710068432 20.11.2009 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 28
Case No.:15/38/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00788/AM10/ RLA File :09/24/040/00362/AM10/ Lic.No/Date:0910040144 03.12.2009 Defer Date:30.11.2010 Decision : Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 29
Case No.:29/38/82ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 02.11.2010 Status:Case Rejected HQ File :01/82/050/00802/AM10/ RLA File :05/24/040/00383/AM10/ Lic.No/Date:0510253942 04.12.2009 Defer Date: Decision : Committee considered case as per agenda and observed that the firm was requested to furnish technical information vide letter dated 21.06.2010, but no reply has been received and norms can not be fixed in absence of the required technical information. Accordingly, it was decided to reject the case. 30
Case No.:113/46/82ALC4/2009
Party Name:MATRIX LABORATORIES LTD 02.11.2010 Status:Case Rejected HQ File :01/82/050/01029/AM10/ RLA File :09/24/040/00216/AM10/ Lic.No/Date:0910040167 04.12.2009 Decision :Committee considered case as per agenda and observed that the firm has sought for import of Drug Intermediate as well as its raw materials. Accordingly, the firm was requested to furnish revised application opting either import of Drug Intermediate or its raw materials, but the firm has furnished the copy of the same application and norms can not be fixed in absence of revised application. It was, therefore, decided to reject the case.
Case No.:73/46/82ALC4/2009
Party Name:YASHO INDUSTRIES PVT.LTD. 02 11 2010 Status:Case Approved
31 02.11.2010 Approved HQ File :01/82/050/00989/AM10/ RLA File :03/95/040/00575/AM10/ Lic.No/Date:0310550407 11.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/60/2010‐Ch.II dated 01.11.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Yapox CL 30/10 Hydroquinone Bis (2 Hydroxy Ethyl Ether) 1 Kg. 1. Hydroquinone 0.611 kg 2. 2Chloro Ethanol 0.903 kg 32
Case No.:9/40/82ALC4/2009
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00824/AM10/ RLA File :05/24/040/00404/AM10/ Lic.No/Date:0510254651 16.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/99/2010‐ PI‐(Norms) dated 11.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Orlistat 1 Kg. 1. (S)()2,2bis(diphenylphosphino)1,1binaphthyl 0.0166 kg 2. 2 Methoxy Propane 13.10 kg 3. Acetone 0.95 kg 4. Activated Carbon 0.100 kg 5. Dicyclohexyl Carbodiimide 1.189 kg 6. Diisobutyl Aluminium hydride 10.76 kg 7. Dimethyl Formamide 0.194 kg 8. Ethyl Acetate 0.40 kg 9. Formic Acid 0.643 kg 10. Lithium Hexamethyldisilazide 2.865 kg 11. LLeucine 0.921 kg 12. Meldrum Acid 2.985 kg 13. Methanol 19.70 kg 14. Methylene Chloride 11.08 kg 15. Palladium Sponge 0.00618 kg 16. Pivaloyl Chloride 0.848 kg 17. Tetrachlorobis)PCymene)Diruthenium(II) 0.0083 kg 18. Tetrahydrofuran 3.97 kg 19. Toluene 21.305 kg 20. Triethylamine 0.780 kg
33
Case No.:14/40/82ALC4/2009
Party Name:ARCH PHARMALABS LTD 02.11.2010 Status:Case Approved HQ File :01/82/050/00829/AM10/ RLA File :03/94/040/00513/AM10/ Lic.No/Date:0310551191 16.12.2009 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by DC(MSME) vide their U.O.23(2)/DGFT/2010 dated 05.10.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 3aHydroxy7 Keto5bCholan 24Acid 1 Kg. 1. Ox Bile Solids 75% 4.456 kg 2. Methanol 2.29 kg 3. Heptane 4.52 kg 4. Ethyl Acetate 4.76 kg 34
Case No.:36/46/82ALC4/2009
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 02.11.2010 Status:Case Deferred HQ File :01/82/050/00952/AM10/ RLA File :07/24/040/00356/AM10/ Lic.No/Date:0710069013 21.12.2009 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 35
Case No.:14/41/82ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00849/AM10/ RLA File :05/24/040/00414/AM10/ Lic.No/Date:0510255098 22.12.2009 Defer Date:30.11.2010 Decision :Committee decided to forward a copy of application to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 30.11.2010. 36
Case No.:83/46/82ALC4/2009
Party Name:EUROLIFE HEALTHCARE PVT. LTD. 02.11.2010 Status:Case Deferred HQ File :01/82/050/00999/AM10/ RLA File :03/94/040/00805/AM10/ Lic.No/Date:0310552288 23.12.2009 Defer Date:28.12.2010 Decision :Committee decided to call for a copy of Drug Manufacturing licence from the firm. Accordingly, case was deferred for 28.12.2010. 37
Case No.:51/31/82ALC4/2010
Party Name:GUJARAT NARMADA VALLEY FERTILIZERS CO LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00976/AM11/ RLA File :34/24/040/00114/AM10/ Lic.No/Date:3410025974 23.12.2009 Defer Date:30.11.2010
Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 38
Case No.:60/9/82ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00275/AM11/ RLA File :09/24/040/00394/AM10/ Lic.No/Date:0910040426 24.12.2009 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/70/2010‐ PI‐(Norms) dated 25.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Oseltamivir Phosphate 1 Kg. 1. Shikimic Acid 4.025 kg 2. 2,2Dimethoxy Propane 0.043 kg 3. 3Pentanone 14.239 kg 4. Triethylsilane 3.0 kg 5. Triethylamine 3.32 kg 6. Trifluoromethane Sulfonicacid 0.12 kg 39
Case No.:79/5/82ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 02.11.2010 Status:Case Rejected HQ File :01/82/050/00113/AM11/ RLA File :09/24/040/00413/AM10/ Lic.No/Date:0910040795 02.02.2010 Defer Date: Decision :Committee considered case as per agenda and observed that the firm was requested to furnish technical details vide letter dated 04.08.2010, but the same have not been received and norms can not be fixed in absence of required technical information. It was, therefore, decided to reject the case. 40
Case No.:32/31/82ALC4/2010
Party Name:HERBOCHEM 02.11.2010 Status:Case Deferred HQ File :01/82/050/00957/AM11/ RLA File :09/24/040/00015/AM10/ Lic.No/Date:0910040823 05.02.2010 Defer Date:30.11.2010 Decision :Committee decided to call from the firm a copy of Drug Manufacturing Licence, Certificate of Analysis from foreign supplier. Accordingly, the case was deferred for 30.11.2010.
Case No.:65/9/82ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00280/AM11/ RLA File :09/24/040/00434/AM10/ Lic.No/Date:0910041039 22.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O M
41 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/288/2009‐PI (Norms) dated 30.04.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 Clopidogrel Camphorsulfonate (CPCSA Salt) 1 Kg. 1. Toluene 1.35 kg 2. ()Camphor Sulfonic Acid 0.455 kg 3. Methylene Chloride 1.51 kg 4. Acetone 3.56 kg 5. Dimethyl formamide 0.87 kg 6. Methanol 2.525 kg 7. 2Thiophene Ethylamine 0.87 kg 8. Alpha Bromo2Chlorophenyl Methyl Ester 1.52 kg 42
Case No.:52/9/82ALC4/2010
Party Name:GRANULES INDIA LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00267/AM11/ RLA File :09/24/040/00495/AM10/ Lic.No/Date:0910041156 03.03.2010 Defer Date:30.11.2010 43
Case No.:22/9/82ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 02.11.2010 Status:Case Deferred HQ File :01/82/050/00237/AM11/ RLA File :03/94/040/01136/AM10/ Lic.No/Date:0310567221 30.03.2010 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 44
Case No.:43/15/82ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 02.11.2010 Status:Case Approved HQ File :01/82/050/00480/AM11/ RLA File :52/24/040/00041/AM10/ Lic.No/Date:5210030155 31.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/45/2010‐Ch.II dated 27.09.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Sulpho Gamma Acid (7Amino1 Naphthol3,6Disulfonic Acid 1 Kg. 1. K Acid 2.500 kg
45
Case No.:106/9/82ALC4/2010
Party Name:CIPLA LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00321/AM11/ RLA File :03/94/040/01141/AM10/ Lic.No/Date:0310568171 06.04.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/87/2010‐ PI (Norms) dated 05.10.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 Tenofovir Disoproxil Fumerate Tablets 300mg /Tenvir Tablets 1 Kg. 1. 9[2Phosphonyl Methodoxy) Propyl] Adenine (PMPA) 0.8026 kg 2. Chloromethyl Isopropyl Carbonate 2.0867 kg 3. N Methyl 2 Pyrrolidone 3.297 kg 4. Fumeric Acid 0.304 kg 5. Methylene Dichloride 6.70 kg 6. Isopropyl Acetate 2.35 kg RA concerned may take further necessary acĕon as per above decision of NC. 46
Case No.:50/15/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00487/AM11/ RLA File :05/24/040/00040/AM11/ Lic.No/Date:0510263624 04.05.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/19/2009PIIII dated 01.06.2009 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 Simvastatin Bulk Drug/Pharmaceutical Grade) 1 Kg. 1. Acetone 1.042 kg 2. Activated Carbon 0.035 kg 3. Caustic Soda Flakes 0.484 kg 4. Clohexane 1.33 kg 5. Cyclopropylamine 1.23 kg 6. Ethyl Acetate 4.49 kg 7. Iodine 0.5917 kg 8. Lovastatin 1.648 kg 9. Methanol 19.82 kg 10. NButyl Lithium (30% in Hexane) 2.382 kg 11. Pyrrolidine 1.53 kg 12. Tetrahydrofuran 6.58 kg
47
Case No.:57/15/82ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 02.11.2010 Status:Case Approved HQ File :01/82/050/00494/AM11/ RLA File :03/94/040/00097/AM11/ Lic.No/Date:0310573529 10.05.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/105/2010PI (Norms) dated 18.10.2010 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 Febuxostat 1 Kg. 1. 2(3Cyano4(2Methylpropoxy)Phenyl)4 Methyl5Thiazolecarboxylic Acid ethyl Ester 1.512 kg 48
Case No.:45/15/82ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00482/AM11/ RLA File :11/24/040/00005/AM11/ Lic.No/Date:1110022402 14.05.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/117/2010PI (Norms) dated 18.10.2010 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 Hydrocortisone Sodium Succinate for injection USP 1 Kg. 1. Hydrocortisone Hemisuccinate IP/BP (Organic Chemical) 1.00 kg 49
Case No.:58/15/82ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 02.11.2010 Status:Case Approved HQ File :01/82/050/00495/AM11/ RLA File :03/94/040/00158/AM11/ Lic.No/Date:0310574362 14.05.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/105/2010PI (Norms) dated 18.10.2010 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 Glimepiride USP 1 Kg. 1. N(4(2(3Ethyl4Methyl2Oxo3Pyrroline1 Carboxamido)Ethyl)Benzene Sulfonamide 0.80 kg
50
Case No.:4/10/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00357/AM11/ RLA File :08/24/040/00036/AM11/ Lic.No/Date:0810089052 18.05.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/126/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Phthalimido Amlodipine 1 Kg. 1. Ethyl4Chloro Aceto Acetate 0.795 kg 2. Toluene 0.62 kg 3. Methanol 0.92 kg 4. Iso Propyl Alcohol 3.53 kg 5. Methylene di Chloride 0.80 kg 51
Case No.:7/10/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00360/AM11/ RLA File :09/24/040/00063/AM11/ Lic.No/Date:0910042101 20.05.2010 Defer Date:30.11.2010 Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 52
Case No.:54/15/82ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 02.11.2010 Status:Case Approved HQ File :01/82/050/00491/AM11/ RLA File :03/94/040/00159/AM11/ Lic.No/Date:0310575440 21.05.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/127/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Prasugrel Hcl 1 Kg. 1. Cyclopropyl2Fluorobenzyl Ketone 2.26 kg
Case No.:55/15/82ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 02.11.2010 Status:Case Approved HQ File :01/82/050/00492/AM11/ RLA File :03/94/040/00168/AM11/ Lic.No/Date:0310575941
53 Q e :0 /8 /050/00 9 / / e :03/9 /0 0/00 68/ / c.No/ ate:03 05759 25.05.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/105/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Olmesartan Medoxomil 1 Kg. 1. Trityl Olmesartan Medoxomil 1.79 kg 54
Case No.:65/15/82ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00502/AM11/ RLA File :11/24/040/00006/AM11/ Lic.No/Date:1110022474 26.05.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/117/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Tiramcinolone Acetonide IP/BP/USP 1 Kg. 1. Prednisolone 1.334 kg RA concerned may take further necessary acĕon as per above decision of NC. 55
Case No.:28/15/82ALC4/2010
Party Name:PI INDUSTRIES LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00465/AM11/ RLA File :13/24/040/00011/AM11/ Lic.No/Date:1310032259 31.05.2010 Decision :Withdrawn as the case has already been approved by NC in its 23/82 meeting held on 29.09.2010. 56
Case No.:62/15/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 02.11.2010 HQ File :01/82/050/00499/AM11/ RLA File :05/23/040/00041/AM11/ Lic.No/Date:0510265059 31.05.2010 Defer Date:30.11.2010
Case No.:68/15/82ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 02.11.2010 Status:Case Approved
57 HQ File :01/82/050/00505/AM11/ RLA File :09/24/040/00022/AM11/ Lic.No/Date:0910042203 01.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/109/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed N[2(Cyano Biphenyl)4 YL]MethylLValine Methyl Ester Hcl 1 Kg. 1. LValine 0.51 kg 2. 4Methyl2Cyanobiphenyl 0.84 kg 3. NBromo Succinimide 0.28 kg 4. Methylene Chloride 1.55 kg 5. Acetone 0.47 kg 6. Ethyl Acetate 1.81 kg 58
Case No.:6/19/82ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 02.11.2010 Status:Case Deferred HQ File :01/82/050/00591/AM11/ RLA File :09/24/040/00064/AM11/ Lic.No/Date:0910042200 01.06.2010 Defer Date:30.11.2010 59
Case No.:14/31/82ALC4/2010
Party Name:HETERO LABS LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00939/AM11/ RLA File :09/24/040/00086/AM11/ Lic.No/Date:0910042201 01.06.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of Pharmaceuticals. 60
Case No.:32/15/82ALC4/2010
Party Name:INTAS PHARMACEUTICALS LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00469/AM11/ RLA File :08/24/040/00072/AM11/ Lic.No/Date:0810089369 02.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/103/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms as per details below or as applied for by the firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Terazosin Hydrochloride Tablets/Capsules 1mg 1 No. 1. Terazosin Hydrochloride (As Dihydrate) 1.2109 mg
Tablets/Capsules 2mg 1 No. 1. Dihydrate) 2.4217 mg Tablets/Capsules 5mg 1 No. 1. Dihydrate) 6.0544 mg Tablets/Capsules 10mg 1 No. 1. Dihydrate) 12.1087mg Other import items are not allowed as the firm has not given any justification for requirement of these items. RA concerned may take further necessary action as per above decision of NC. 61
Case No.:33/15/82ALC4/2010
Party Name:INTAS PHARMACEUTICALS LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00470/AM11/ RLA File :08/24/040/00073/AM11/ Lic.No/Date:0810089370 02.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/103/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms as per details below or as applied for by the firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Docetaxel Inj. 20 mg/0.5 ml‐ 0.5 ml Vial 1 No. 1. Docetaxel Anhydrous USP 22.0 mg Docetaxel Inj. 80 mg/2.0 ml‐ 2.0 ml Vial 1 No. 1. Docetaxel Anhydrous USP 88.0 mg Note: Each ml contains Docetaxel Anhydrous USP 40 mg (in which acĕve ingredient Docetaxel Anhydrous USP used is 2.280 kg. 62
Case No.:64/15/82ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00501/AM11/ RLA File :11/24/040/00007/AM11/ Lic.No/Date:1110022521 02.06.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/117/2010PI (Norms) dated 18.10.2010 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 DTMD Mesylate (Diflorasone 17 Propionate 21Mesylate) Organic Chemical 1 Kg. 1. 17 Alpha, 21Dihydroxy16 Beta Methyl, 9Beta11BetaEpoxy Pregna 1,4Diene3,20 Dione (DB 1.07 kg
g g , , ( XII) (BB11) (Organic Chemical) 63
Case No.:70/15/82ALC4/2010
Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 02.11.2010 Status:Case Approved HQ File :01/82/050/00507/AM11/ RLA File :03/95/040/00157/AM11/ Lic.No/Date:0310577797 08.06.2010 Decision :Committee considered case as per agenda and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP on net to net basis with accountability in export. 64
Case No.:19/15/82ALC4/2010
Party Name:S.M. CHEMICALS 02.11.2010 Status:Case Deferred HQ File :01/82/050/00456/AM11/ RLA File :03/95/040/00179/AM11/ Lic.No/Date:0310578621 14.06.2010 Defer Date:28.12.2010 Decision :Committee decided to defer case for 28.12.2010 for comments of Department of C&PC. 65
Case No.:71/15/82ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 02.11.2010 HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date:28.12.2010 Decision :Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/107/2010PI (Norms) dated 25.10.2010, decided to call for the following information from the firm. 1. Stepwise complete and balance chemical reacĕons to show requirements of all the 19 imported inputs. 2. % yield on molar basis for each step of manufacturing process. 3. Past producĕon vis‐à‐vis actual consumpĕon of all the imported inputs duly cerĕfied by Central Excise Authority. Accordingly, case was deferred for 28.12.2010. 66
Case No.:20/15/82ALC4/2010
Party Name:MEDREICH LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00457/AM11/ RLA File :07/24/040/00072/AM11/ Lic.No/Date:0710072323 18.06.2010 Defer Date:28.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/104/2010PI (Norms) dated 21.10.2010, decided to call for the following information from the firm. 1. Specificaĕon for Ferrous Sulphate Pellets 18/25 from supplier in terms of control of API. 2. Specificaĕon for Folic Acid Pellets 18/25 from supplier in terms of control of API.
. Specificaĕon for Folic Acid Pellets 8/ 5 from supplier in terms of control of API. 3. Specificaĕon for Non‐Pareil Seeds 20/25 from supplier. Accordingly, case was deferred for 28.12.2010. 67
Case No.:44/31/82ALC4/2010
Party Name:J.S. CHEMICALS 02.11.2010 Status:Case Deferred HQ File :01/82/050/00969/AM11/ RLA File :52/24/040/00007/AM11/ Lic.No/Date:5210031079 18.06.2010 Defer Date:30.12.2010 Decision :Committee decided to defer case for 30.12.2010 for comments of Department of C&PC. 68
Case No.:1/15/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00438/AM11/ RLA File :08/24/040/00088/AM11/ Lic.No/Date:0810089940 23.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/108/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Promethazine 12.5 mg tablets (73.63 kgs) 1 No. 1. Promethazine Hcl USP 12.75 mg 2. Hydroxypropyl Cellulose NF 4.0 mg 3. Lactose Monohydrate NF 81.0 mg 4. Packing Material 4(a) to 4(e) As per packing policy Promethazine 25.0 mg tablets 1240.50 kgs) 1 No. 1. Promethazine Hcl USP 25.50 mg 2. Hydroxypropyl Cellulose NF 8.0 mg 3. Lactose Monohydrate NF 162.0 mg 4. Packing Material 4(a) to 4(e) As per packing policy Promethazine 50.0 mg tablets (77.00 kgs) 1No. 1. Promethazine Hcl USP 51.0 mg 2. Hydroxypropyl Cellulose NF 16.0 mg 3. Lactose Monohydrate NF 324.0 mg 4. Packing Material 4(a) to 4(e) As per packing policy Note: Weight indicated above are for total quanĕty of tablets applied for by the firm
Case No.:2/15/82ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 02 11 2010
69 02.11.2010 HQ File :01/82/050/00439/AM11/ RLA File :08/24/040/00087/AM11/ Lic.No/Date:0810089958 24.06.2010 Defer Date:30.11.2010 70
Case No.:5/15/82ALC4/2010
Party Name:SHODHANA LABORATORIES LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00442/AM11/ RLA File :09/24/040/00113/AM11/ Lic.No/Date:0910042470 25.06.2010 Defer Date:28.12.2010 Decision :Committee decided to defer case for 28.12.2010 for comments of Department of Pharmaceuticals. 71
Case No.:26/31/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00951/AM11/ RLA File :09/24/040/00081/AM11/ Lic.No/Date:0910042501 25.06.2010 Defer Date:30.11.2010 72
Case No.:28/31/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 02.11.2010 HQ File :01/82/050/00953/AM11/ RLA File :09/24/040/00083/AM11/ Lic.No/Date:0910042514 25.06.2010 Defer Date:30.11.2010 Decision : Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 73
Case No.:9/15/82ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00446/AM11/ RLA File :03/94/040/00267/AM11/ Lic.No/Date:0310580981 28.06.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/106/2010PI (Norms) dated 18.10.2010 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 Paroxetine Hcl Hemihydrate 1 Kg. 1. () Trans4R(4Fluorophenyl)3S HydroxymethylNMethyl Piperidine 0.9511 2. Sesamol 0.55 kg 3. Dimethyl Sulfoxide 2.9293 kg
Case No :29/31/82 ALC4/2010
Party Name:MATRIX LABORATORIES LTD Meet No/Date:31/82 ALC4/2010 Status:Case
74
Case No.:29/31/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00954/AM11/ RLA File :09/24/040/00082/AM11/ Lic.No/Date:0910042522 28.06.2010 Defer Date:28.12.2010 75
Case No.:12/15/82ALC4/2010
Party Name:MEDREICH LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00449/AM11/ RLA File :07/24/040/00099/AM11/ Lic.No/Date:0710072561 29.06.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of Pharmaceuticals. 76
Case No.:24/15/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00461/AM11/ RLA File :09/24/040/00115/AM11/ Lic.No/Date:0910042551 30.06.2010 Defer Date:30.11.2010 Decision : Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 77
Case No.:73/15/82ALC4/2010
Party Name:POLYGON CHEMICALS 02.11.2010 Status:Case Approved HQ File :01/82/050/00510/AM11/ RLA File :08/24/040/00091/AM11/ Lic.No/Date:0810090184 30.06.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/9/2010/Ch.II dated 01.11.2010 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 3Methyl 5Pyrazolone 1 Kg. 1. Acetic Acid Methyl Ester 1.287 kg 2. Hydrazine Hydrate (Purity 80%) 0.692 kg 78
Case No.:77/15/82ALC4/2010
Party Name:ALEMBIC LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00514/AM11/ RLA File :34/24/040/00074/AM11/ Lic.No/Date:3410027387 30.06.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 50/82 meeĕng held on 09.03.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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
Alendronate Tablets 70 mg 1 No. 1. Alendronate Sodium 91.3626 mg/tablet 79
Case No.:78/15/82ALC4/2010
Party Name:ALEMBIC LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00515/AM11/ RLA File :34/24/040/00070/AM11/ Lic.No/Date:3410027389 30.06.2010 Defer Date:28.12.2010 Decision :Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/115/2010PI (Norms) dated 11.10.2010, decided to call for the following information from the firm: 1. Copy of valid Drug Manufacturing Licence for each export product. 2. Copy of Master Batch Formula for each export product duly cerĕfied by their Quality Control Incharge showing net content and wastage claimed for each excipients. Accordingly, case was deferred for 28.12.2010. 80
Case No.:31/15/82ALC4/2010
Party Name:INTAS PHARMACEUTICALS LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00468/AM11/ RLA File :08/24/040/00107/AM11/ Lic.No/Date:0810090244 02.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/103/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms as per details below or as applied for by the firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Tablets/Capsules 1mg 1 No. 1. Dihydrate) 1.2109 mg Tablets/Capsules 2mg 1 No. 1. Dihydrate) 2.4217 mg Tablets/Capsules 5mg 1 No. 1. Dihydrate) 6.0544 mg Tablets/Capsules 10mg 1 No. 1. Dihydrate) 12.1087mg
Case No.:6/23/82ALC4/2010
Party Name:BELCO PHARMA 02.11.2010 Status:Case Approved HQ File :01/82/050/00774/AM11/ RLA File :05/23/040/00076/AM11/ Lic No/Date:0510267537
81 HQ File :01/82/050/00774/AM11/ RLA File :05/23/040/00076/AM11/ Lic.No/Date:0510267537 05.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/250/2009‐PI(Norms) dated 16.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Hydrocortisone Cream/Ointment 5 gm Tube 1 No. 1. Hydrocortisone Base 0.0510 gm/5 gm Tube Hydrocortisone Cream/Ointment 15 gm Tube 1 No. 1. Hydrocortisone Base 0.153 gm/15 gm Tube 82
Case No.:13/23/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 02.11.2010 Status:Case Approved HQ File :01/82/050/00781/AM11/ RLA File :05/23/040/00220/AM10/ Lic.No/Date:0510267997 13.07.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/82/2010/Ch.II dated 01.11.2010 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 Pyridine 2 Aldehyde 1 Kg. 1. Alpha Picoline 1.80 kg 2. Acetic Acid 1.75 kg 3. Hydrogen Peroxide (50%) 2.50 kg 4. Caustic Soda Lye (46%)2.10 kg 5. Selenium Dioxide 0.05 kg 6. Ethylene dichloride (EDC) 1.60 kg 83
Case No.:101/22/82ALC4/2010
Party Name:TONIRA PHARMA LTD, 02.11.2010 Status:Case Approved HQ File :01/82/050/00754/AM11/ RLA File :34/24/040/00072/AM11/ Lic.No/Date:3410027519 16.07.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/260/2008PIIII dated 23.04.2009 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 Exp. Qty. Sl.No. Import items Qty. allowed Aceclofenac 1 Kg. 1. Dichlofenac Sodium 1.11 kg
84
Case No.:1/18/82ALC4/2010
Party Name:SUPER URECOAT INDUSTRIES 02.11.2010 Status:Case Deferred HQ File :01/82/050/00544/AM11/ RLA File :08/24/040/00112/AM11/ Lic.No/Date:0810090597 19.07.2010 Defer Date:30.12.2010 Decision :Committee decided to defer case for 30.12.2010 for comments of Department of C&PC. 85
Case No.:33/31/82ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00958/AM11/ RLA File :09/24/040/00144/AM11/ Lic.No/Date:0910042771 20.07.2010 Defer Date:30.11.2010 86
Case No.:15/23/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 02.11.2010 Status:Case Approved HQ File :01/82/050/00783/AM11/ RLA File :05/23/040/00213/AM10/ Lic.No/Date:0510268834 22.07.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/82/2010/Ch.II dated 01.11.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Qty. Sl.No. Import items Qty. allowed Cetyl Pyridinium Chloride 1 Kg. 1. Cetyl Chloride 0.930 kg 2. Ethyl Alcohol (Denatured) 0.930 kg 3. Methanol 0.450 kg 4. Alumino Silicate Catalyst 0.0076 kg 5. Hydrogen Peroxide 0.07 kg 6. Acĕvated Carbon 0.20 kg 87
Case No.:8/19/82ALC4/2010
Party Name:SHASUN CHEMICALS & DRUGS LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00593/AM11/ RLA File :04/24/040/00085/AM11/ Lic.No/Date:0410115832 27.07.2010 Defer Date:28.12.2010
Case No.:30/31/82ALC4/2010
02 11 2010 Status:Case A
88 02.11.2010 Approved HQ File :01/82/050/00955/AM11/ RLA File :03/94/040/00382/AM11/ Lic.No/Date:0310585513 30.07.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 9/08 meeĕng held on 03.07.2007 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Baclate Aquanase Nasal Spray (50 mcg/150 MD) 1 No. 1. Beclomethasone Dipropionate Net to Net 2. Vials 10 ml Amber Coloured Glass (Component) Net to Net with accountability clause 3. Pump Vol.,0.05 ml, 20 mm Crimp (Component) Net to Net with accountability clause 4. Applicator Nasal Spray EGS (Component) Net to Net with accountability clause 89
Case No.:45/31/82ALC4/2010
Party Name:DSM ANTIINFECTIVES INDIA LTD 02.11.2010 Status:Case Deferred HQ File :01/82/050/00970/AM11/ RLA File :22/24/040/00022/AM11/ Lic.No/Date:2210010238 04.08.2010 Defer Date:30.11.2010 90
Case No.:15/31/82ALC4/2010
Party Name:R L FINE CHEM 02.11.2010 Status:Case Deferred HQ File :01/82/050/00940/AM11/ RLA File :07/24/040/00156/AM11/ Lic.No/Date:0710073569 12.08.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of Pharmaceuticals. 91
Case No.:23/31/82ALC4/2010
02.11.2010 Status:Case Approved HQ File :01/82/050/00948/AM11/ RLA File :03/94/040/00459/AM11/ Lic.No/Date:0310588154 17.08.2010 Decision : Commiĥee considered case as per agenda in light of earlier decision taken in 27/82 meeĕng held on 05.10.2010 and in consultaĕon with representaĕve of Department of Pharmaceuĕcals present in meeĕng, decided to raĕfy 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 TyloDox Plus Powder/Tylosin and Doxycycline Powder (Pack size 1 kg) 1 No. 1. Tylosin Tartrate BP (Vet) 0.101 kg/pack 2. Doxycycline Hydrochloride 0.202 kg/pack
92
Case No.:25/31/82ALC4/2010
02.11.2010 Status:Case Approved HQ File :01/82/050/00950/AM11/ RLA File :03/94/040/00458/AM11/ Lic.No/Date:0310588160 17.08.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 15/82 meeĕng held on 14.08.2007 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Tylocip Powder 50%/Tylosin Soluble Powder 50% w/w (100 gm Pack) 1 Kg. 1. Tylosin Tartarate BP (Vet.) 0.505 kg 93
Case No.:1/23/82ALC4/2010
Party Name:KOPRAN LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00769/AM11/ RLA File :03/94/040/00369/AM11/ Lic.No/Date:0310588661 19.08.2010 Defer Date:28.12.2010 Decision Committee decided to defer case for 28.12.2010 for comments of Department of Pharmaceuticals. 94
Case No.:24/31/82ALC4/2010
02.11.2010 Status:Case Deferred HQ File :01/82/050/00949/AM11/ RLA File :03/94/040/00463/AM11/ Lic.No/Date:0310588650 19.08.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of Pharmaceuticals.
Case No.:27/31/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 02.11.2010 Status:Case Approved HQ File :01/82/050/00952/AM11/ RLA File :05/23/040/00211/AM10/ Lic.No/Date:0510271109 20.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010//2/2010/Ch.II dated 01.11.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed 2 3 1 1 A 2 39
95 2,3,5 Trichloropyridine 1 Kg. 1. Denatured Ethyl Alcohol 2.39 kg 2. Methanol 1.44 kg 3. Alumino Silicate Catalyst 0.0197 kg 4. Dimethyl Formamide 0.350 kg 5. Toluene 0.126 kg 6. Thionyl Chloride 0.960 kg 7. Sodium Nitrite 0.566 kg 8. Styrene 0.001 kg 9. Caustic Soda Lye (46%) 2.00 kg 96
Case No.:31/31/82ALC4/2010
02.11.2010 Status:Case Deferred HQ File :01/82/050/00956/AM11/ RLA File :03/94/040/00475/AM11/ Lic.No/Date:0310589085 23.08.2010 Defer Date:28.12.2010 97
Case No.:18/23/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Deferred HQ File :01/82/050/00786/AM11/ RLA File :09/24/040/00196/AM11/ Lic.No/Date:0910043220 24.08.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of Pharmaceuticals. 98
Case No.:19/23/82ALC4/2010
Party Name:LUPIN LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00787/AM11/ RLA File :03/95/040/00395/AM11/ Lic.No/Date:0310589114 24.08.2010 Decision :Withdrawn as the case has already been approved by NC in its 23/82 meeting held on 07.09.2010. 99
Case No.:23/23/82ALC4/2010
Party Name:DELTA FINOCHEM PVT.LTD. 02.11.2010 Status:Case Deferred HQ File :01/82/050/00791/AM11/ RLA File :03/94/040/00249/AM11/ Lic.No/Date:0310589441 25.08.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of C&PC.
Case No.:24/23/82ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00792/AM11/ RLA File :03/94/040/00421/AM11/ Lic.No/Date:0310589680 26.08.2010
100 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/83/2006‐Ch.II dated 11.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Menthanol (4‐Isopropyl Cyclohexyl Methanol) 1 Kg. 1. Cuminique Aldehyde 1.250 kg 2. 5% Ruthenium on Carbon Catalyst 0.0035 kg 101
Case No.:27/23/82ALC4/2010
Party Name:PORUS LABORATORIES PVT LTD. 02.11.2010 Status:Case Approved HQ File :01/82/050/00795/AM11/ RLA File :09/24/040/00216/AM11/ Lic.No/Date:0910043307 26.08.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/3/2010‐Ch.II dated 17.05.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 2Phenyl3,3Bis(4 hydroxy phenyl)phthalimidine (PPPBP) 1 Kg. 1. Phthalic Anhydride 0.550 kg 2. Phenol 0.850 kg 3. Zinc Chloride 0.350 kg 4. Aniline 0.420 kg 5. Methanol 1.35 kg 102
Case No.:30/23/82ALC4/2010
Party Name:MEDREICH LIMITED 02.11.2010 HQ File :01/82/050/00798/AM11/ RLA File :07/24/040/00200/AM11/ Lic.No/Date:0710073911 30.08.2010 Defer Date:28.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/104/2010PI (Norms) dated 21.10.2010, decided to call for the following information from the firm. 1. Specificaĕon for Ferrous Sulphate Pellets 18/25 from supplier in terms of control of API. 2. Specificaĕon for Folic Acid Pellets 18/25 from supplier in terms of control of API. 3. Specificaĕon for Non‐Pareil Seeds 20/25 from supplier. Accordingly, case was deferred for 28.12.2010.
Case No.:31/23/82ALC4/2010
Party Name:MAHIMA LIFE SCIENCES PVT.LTD. 02.11.2010 Status:Case Approved
103 HQ File :01/82/050/00799/AM11/ RLA File :05/24/040/00193/AM11/ Lic.No/Date:0510271761 30.08.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/28/2008PIIII dated 08.07.2008 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 per unit of export product Clobetasol Propionate 1 Kg. 1. Betamethasone BP 1.04 kg/kg 2. TriEthyl Ortho Propionate (C.P.) 0.95 kg/kg 104
Case No.:32/23/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 02.11.2010 HQ File :01/82/050/00800/AM11/ RLA File :09/24/040/00211/AM11/ Lic.No/Date:0910043338 31.08.2010 Defer Date:28.12.2010 105
Case No.:40/31/82ALC4/2010
02.11.2010 Status:Case Approved HQ File :01/82/050/00965/AM11/ RLA File :03/94/040/00496/AM11/ Lic.No/Date:0310590423 31.08.2010 Decision : Commiĥee considered case as per agenda in light of earlier decision taken in 27/82 meeĕng held on 05.10.2010 and in consultaĕon with representaĕve of Department of Pharmaceuĕcals present in meeĕng, decided to raĕfy 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 TyloDox Plus Powder/Tylosin and Doxycycline Powder (Pack size 1 kg) 1 No. 1. Tylosin Tartrate BP (Vet) 0.101 kg/pack 2. Doxycycline Hydrochloride 0.202 kg/pack 106
Case No.:17/31/82ALC4/2010
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 02.11.2010 HQ File :01/82/050/00942/AM11/ RLA File :07/24/040/00202/AM11/ Lic.No/Date:0710073938 01.09.2010 Defer Date:28.12.2010 Decision :Committee decided to defer case for 28.12.2010 for comments of Department of C&PC.
Case No.:18/31/82ALC4/2010
Party Name:GLOBAL CALCIUM PRIVATE
107 y LIMITED, 02.11.2010 HQ File :01/82/050/00943/AM11/ RLA File :07/24/040/00204/AM11/ Lic.No/Date:0710073940 01.09.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of C&PC. 108
Case No.:34/31/82ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 02.11.2010 Status:Case Approved HQ File :01/82/050/00959/AM11/ RLA File :03/94/040/00419/AM11/ Lic.No/Date:0310590544 01.09.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 19/82 meeting held on 10.08.2010 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 Moxifloxacin Hcl 1 Kg. 1. 1‐Cyclopropyl‐6,7‐difluoro‐8‐ Methoxy‐4‐oxo 1,4‐Dihydro Quinoline‐3‐Carboxylic Acid 1.31 kg 2. (S,S)‐2,8‐Diazabicyclo (4,3,0) Nonane 0.55 kg 109
Case No.:38/31/82ALC4/2010
02.11.2010 Status:Case Approved HQ File :01/82/050/00963/AM11/ RLA File :03/94/040/00491/AM11/ Lic.No/Date:0310590888 03.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/87/2010‐PI (Norms) dated 05.10.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to raĕfy 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 Tenofovir Disoproxil Fumerate Tablets 300mg /Tenvir Tablets 1 Kg. 1. 9[2Phosphonyl Methodoxy) Propyl] Adenine (PMPA) 0.8026 kg 2. Chloromethyl Isopropyl Carbonate 2.0867 kg 3. N Methyl 2 Pyrrolidone 3.297 kg 4. Fumeric Acid 0.304 kg 5. Methylene Dichloride 6.70 kg 6. Isopropyl Acetate 2.35 kg
Case No.:19/31/82ALC4/2010
Party Name:BAL PHARMA LTD 02.11.2010
110 HQ File :01/82/050/00944/AM11/ RLA File :07/24/040/00213/AM11/ Lic.No/Date:0710074045 06.09.2010 Defer Date:28.12.2010 111
Case No.:37/31/82ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 02.11.2010 Status:Case Approved HQ File :01/82/050/00962/AM11/ RLA File :03/94/040/00509/AM11/ Lic.No/Date:0310591338 07.09.2010 Defer Date: Decision : The case was deferred for 30.11.2010 for comments of Department of C&PC. 112 Case No.:35/31/82ALC4/2010 Party Name:HEMA DYE CHEM PVT. LTD. 02.11.2010 Status:Case Approved HQ File :01/82/050/00960/AM11/ RLA File :03/94/040/00505/AM11/ Lic.No/Date:0310591651 08.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O.No.14010/50/2007‐Ch.II dated 03.02.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm Export Product Export Qty. Sl.No. Import items Qty. allowed 2‐Chloro‐1‐4‐Dimethoxy Benzene 1 kg 1. 1,4‐Dihydroxy Benzene 0.692 kg 113
Case No.:39/31/82ALC4/2010
02.11.2010 Status:Case Approved HQ File :01/82/050/00964/AM11/ RLA File :03/94/040/00530/AM11/ Lic.No/Date:0310591446 08.09.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 45/82 meeting held on 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 Export Qty. Sl.No. Import items Qty. allowed Cipcox 2.5% liquid (solution)/Toltrazuril Oral Soln. 2.5% 200 liter pack 200 liter pack 1. Toltrazuril 5.100 kg/pack of 200 ltr. 114 Case No.:41/31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00966/AM11/ RLA File :03/94/040/00527/AM11/ Lic.No/Date:0310591713 09 09 2010
09.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/15/2010‐ PI (Norms) dated 08.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Amoxicillin & Clavulanate Potassium for Suspension USP 75 ml pack 1. Amoxycillin Trihydrate 4.200 2. Clavulanate Potassium Syloid 2.3444 3. Silicon Dioxide (Syloid AL1FP)NF 1.500 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) As per packing policy 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M1 Amoxicillin & Clavulanate Potassium for Suspension USP 100 ml pack 1. Amoxycillin Trihydrate 5.649 2. Clavulanate Potassium Syloid 3.126 3. Silicon Dioxide (Syloid AL1FP)NF 2.00 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M1 Amoxicillin & Clavulanate Potassium for Suspension USP 150 ml pack 1. Amoxycillin Trihydrate 8.274 2. Clavulanate Potassium Syloid 4.6888 3. Silicon Dioxide (Syloid AL1FP)NF 3.00 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M1 RA concerned may take further necessary acĕon as per above decision of NC.
Case No.:36/31/82ALC4/2010
Party Name:CORAL DRUGS PVT. LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00961/AM11/ RLA File :05/23/040/00166/AM11/ Lic.No/Date:0510272828 16.09.2010 i i C i i i i f i f f i i i O
115 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/214/2009PI(Norms) dated 09.01.2010 and in consultation with technical authority present in meeting decided to ratify the norms as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Flutamide USP 1 kg. 1. 4‐Nitro‐3‐Trifluoro Methylaniline 1.04 kg 116
Case No.:20/31/82ALC4/2010
Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00945/AM11/ RLA File :04/24/040/00159/AM11/ Lic.No/Date:0410117338 22.09.2010 Defer Date:28.12.2010 Decision :Committee decided to defer case for 28.12.2010 for comments of Department of C&PC. 117
Case No.:21/31/82ALC4/2010
Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00946/AM11/ RLA File :04/24/040/00160/AM11/ Lic.No/Date:0410117337 22.09.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of C&PC. 118 Case No.:22/31/82ALC4/2010 Party Name:INTAS PHARMACEUTICALS LTD., 02.11.2010 Status:Case Approved HQ File :01/82/050/00947/AM11/ RLA File :08/24/040/00182/AM11/ Lic.No/Date:0810092394 22.09.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/103/2010‐PI (Norms) dated 18.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms as per details below or as applied for by the firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Docetaxel Inj. 20 mg/0.5 ml‐ 0.5 ml Vial 1 No. 1. Docetaxel Anhydrous USP 22.0 mg Docetaxel Inj. 80 mg/2.0 ml‐ 2.0 ml Vial 1 No. 1. Docetaxel Anhydrous USP 88.0 mg
Case No.:43/31/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 02.11.2010 Status:Case Deferred
119 HQ File :01/82/050/00968/AM11/ RLA File :03/95/040/00341/AM11/ Lic.No/Date:0310593360 22.09.2010 Defer Date:28.12.2010 Decision :Committee decided to call for technical details as per Appendix 33 from the firm. Accordingly, case was deferred for 28.12.2010. 120
Case No.:42/31/82ALC4/2010
02.11.2010 Status:Case Deferred HQ File :01/82/050/00967/AM11/ RLA File :03/94/040/00570/AM11/ Lic.No/Date:0310594232 28.09.2010 Defer Date:28.12.2010 Decision :Committee decided to remind Ministry of Environment and Forests for their NOC/comments. Accordingly, case was deferred for 28.12.2010. 121
Case No.:16/31/82ALC4/2010
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00941/AM11/ RLA File :09/24/040/00444/AM10/ Lic.No/Date:0910043815 06.10.2010 Defer Date:30.11.2010 122
Case No.:2/31/82ALC4/2010
Party Name:PANACEA BIOTEC LTD., 02.11.2010 Status:Case Deferred HQ File :01/82/050/00927/AM11/ RLA File :05/24/040/00235/AM11/ Lic.No/Date:0510274701 11.10.2010 Defer Date:28.12.2010 Decision :Committee decided to defer case for 28.11.2010 for comments of Department of Biotechnology. 123
Case No.:1/31/82ALC4/2010
Party Name:R.K.INDUSTRIES, 02.11.2010 Status:Case Approved HQ File :01/82/050/00926/AM11/ RLA File :08/24/040/00199/AM11/ Lic.No/Date:0810093011 12.10.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/11/2010/Ch.II dated 09.02.2010 and in consultation with technical authority present in meeting decided to ratify the norms as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Ortho Toluidine 5‐Sulfonic Acid 1 kg. 1. Ortho Toluidine 0.786 kg 2. Causĕc Soda 0.310 kg 124
Case No.:3/31/82ALC4/2010
Party Name:EMAMI LIMITED, 02.11.2010 Status:Case Deferred HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Defer Date:28.12.2010
12.10.2010 Date:28.12.2010 Decision :Committee decided to defer for 28.12.2010 for comments of DC(MSME). 125
Case No.:4/31/82ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 02.11.2010 Status:Case Deferred HQ File :01/82/050/00929/AM11/ RLA File :52/24/040/00020/AM11/ Lic.No/Date:5210032206 13.10.2010 Defer Date:30.11.2010. Decision :Committee decided to defer case for 30.11.2010 for comments of Department of C&PC. 126
Case No.:5/31/82ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00930/AM11/ RLA File :03/95/040/00485/AM11/ Lic.No/Date:0310596586 13.10.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of C&PC. 127 Case No.:6/31/82ALC4/2010 Party Name:OMKAR SPECIALITY CHEMICALS LIMITED 02.11.2010 Status:Case Approved HQ File :01/82/050/00931/AM11/ RLA File :03/95/040/00513/AM11/ Lic.No/Date:0310596790 13.10.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/13/2008/Ch.III dated 15.05.2008 and in consultation with technical authority present in meeting decided to ratify the norms as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Benzene Seleninic Anhydride 1 kg. 1. Selenium Metal 0.527 kg 128
Case No.:10/31/82ALC4/2010
Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 02.11.2010 Status:Case Approved HQ File :01/82/050/00935/AM11/ RLA File :05/24/040/00246/AM11/ Lic.No/Date:0510274867 13.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/88/2004‐Ch.III dated 27.10.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed Thymol (Purity 98.5% Min.) 1 Kg. 1. Meta Cresol 0.785 kg
129 Case No.:11/31/82ALC4/2010 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00936/AM11/ RLA File :05/24/040/00231/AM11/ Lic.No/Date:0510274868 13.10.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/19/2009PIIII dated 01.06.2009 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 Simvastatin (Bulk Drug/Pharmaceutical Grade) 1 Kg. 1. Acetone 1.042 kg 2. Activated Carbon 0.035 kg 3. Caustic Soda Flakes 0.484 kg 4. Clohexane 1.33 kg 5. Cyclopropylamine 1.23 kg 6. Ethyl Acetate 4.49 kg 7. Iodine 0.5917 kg 8. Lovastatin 1.648 kg 9. Methanol 19.82 kg 10. NButyl Lithium (30% in Hexane) 2.382 kg 11. Pyrrolidine 1.53 kg 12. Tetrahydrofuran 6.58 kg 130
Case No.:12/31/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00937/AM11/ RLA File :05/24/040/00232/AM11/ Lic.No/Date:0510274870 13.10.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of earlier decision taken in 48/82 meeting held on 17.02.2009 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Volini Gel 30 gm tube (Each tube contains 1.5 gm Racementhol) 1 No. 1. Raccmenthol 1.575 gm/30 gm tube
Case No.:7/31/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Deferred
131 HQ File :01/82/050/00932/AM11/ RLA File :09/24/040/00288/AM11/ Lic.No/Date:0910043910 14.10.2010 Defer Date:28.12.2010 132
Case No.:8/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00933/AM11/ RLA File :09/24/040/00290/AM11/ Lic.No/Date:0910043914 14.10.2010 Defer Date:30.11.2010 133 Case No.:9/31/82ALC4/2010 Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 02.11.2010 Status:Case Approved HQ File :01/82/050/00934/AM11/ RLA File :09/24/040/00302/AM11/ Lic.No/Date:0910043929 15.10.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 1/82 meeĕng held on 06.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 1,1Cyclohexane Diacetic Anhydride 1 Kg. 1. 1,1 Cyclohexane Diacetic Acid 1.20 kg 134
Case No.:13/31/82ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 02.11.2010 Status:Case Deferred HQ File :01/82/050/00938/AM11/ RLA File :09/24/040/00303/AM11/ Lic.No/Date:0910043939 15.10.2010 Defer Date:30.11.2010 135
Case No.:46/31/82ALC4/2010
Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Deferred HQ File :01/82/050/00971/AM11/ RLA File :03/95/040/00569/AM11/ Lic.No/Date:0310597665 19.10.2010 Defer Date:28.12.2010 Decision : Committee decided to defer case for 28.12.2010 for comments of Department of C&PC. 136
Case No.:47/31/82ALC4/2010
Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Deferred HQ File :01/82/050/00972/AM11/ RLA File :03/95/040/00554/AM11/ Lic.No/Date:0310597803 20.10.2010 Defer Date:28.12.2010
Decision : Committee decided to defer case for 28.12.2010 for comments of Department of C&PC. 137
Case No.:48/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00973/AM11/ RLA File :09/24/040/00297/AM11/ Lic.No/Date:0910043978 20.10.2010 Defer Date:30.11.2010 Decision : Committee decided to defer case for 30.11.2010 for comments of Department of Pharmaceuticals. 138 Case No.:49/31/82ALC4/2010 Party Name:HETERO DRUGS LIMITED, 02.11.2010 Status:Case Approved HQ File :01/82/050/00974/AM11/ RLA File :09/24/040/00305/AM11/ Lic.No/Date:0910043986 20.10.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/87/2009‐ PI‐III dated 29.12.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Fosinopril Sodium 1 Kg. 1. Trans4HydroxyLProline 1.592 kg 2. 4Dimethyl Amino Pyridine 0.114 kg 3. 5% Palladium on Charcoal 0.078 kg 4. 4Phenyl1Butene 3.06 kg 5. Benzyl Bromo Acetate 4.20 kg 6. Cinchonidine 0.2379 kg 7. Trimethyl Silyl Chloride 3.301 kg 8. N,NDicyclohexyl Carbodimide 0.55 kg 9. 2Ethyl Hexanoic Acid Sodium Salt 0.230 kg 10. Propionyl Bromide 1.77 kg 11. Methanol 10.00 kg 12. Pyridine 2.00 kg 13. Acetone 8.00 kg 14. Diisopropyl Ether 4.11 kg 15. Tetrahydrofuran 5.00 kg RA concerned may take further necessary acĕon as per above decision of NC.
Case No.:50/31/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00975/AM11/ RLA File :05/24/040/00248/AM11/ Lic.No/Date:0510275385 21.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/151/2009‐PI‐(Norms) dated 05.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per
139 details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefuroxime Axeĕl Amorphous 1 Kg. 1. Cefuroxime Axeĕl Crystalline 1.05 kg 2. Acetone 2.43 kg 140 Case No.:52/31/82ALC4/2010 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00977/AM11/ RLA File :09/24/040/00287/AM11/ Lic.No/Date:0910044007 22.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/12/2010‐ PI (Norms) dated 08.06.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Lamivudine 1 kg 1. nhexane 4.534 kg 2. Acetone 0.309 kg 3. Carbon Enoanticromos (Activated Carbon) 0.100 kg 4. Methylene Chloride 10.439 kg 5. 2,5dihydroxy,1,4dithiane 0.739 kg 6. Cytosine 0.955 kg 7. Methyl Alcohol (Methanol) 1.235 kg 8. Sodium Borohydride 0.480 kg 9. Triethylamine (TEA) 2.00 kg 10. Trimethtyl Chlorosilane (TMCS) 2.74 kg 11. Dimethyl Formamide 0.410 kg 12. Glyoxalic Acid 50% 1.80 kg 13. Cyclohexane 0.100 kg 14. Steam/Thermal Coal As per Fuel Policy RA concerned may take further necessary acĕon as per above decision of NC.
Case No.:53/31/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:31/82ALC4/2010 02.11.2010 Status:Case Approved HQ File :01/82/050/00978/AM11/ RLA File :09/24/040/00263/AM11/ Lic.No/Date:0910044008 22.10.2010
141 Decision: Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M.No.35011/121/2010‐PI (Norms) dated 11.10.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Mirtazapine 1 kg 1. 1‐Methyl‐3‐Phenyl Piperazine 1.446 kg 2. 2‐Chloro Nicoĕno Nitrile 1.290 kg 3. Carbon (Acĕvated Carbon) 0.070 kg 4. Cyclohexane 2.434 kg 5. DI ISOpropyl Ether 1.600 kg 6. Dimethyl Formamide 2.156 kg 7. Uthhium Aluminium Hydride 0.203 kg 8. Methylene Chloride 4.071 kg 9. Methanol 1.370 kg 10. Tetrahydrofuran 2.711 kg 142
Case No.:54/31/82ALC4/2010
Party Name:PROMED EXPORTS PVT.LTD. 02.11.2010 Status:Case Approved HQ File :01/82/050/00979/AM11/ RLA File :05/24/040/00262/AM11/ Lic.No/Date:0510275524 22.10.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/30/2009‐ PI‐III dated 26.10.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Inokain Eye Drops 0.4% Solution, 5 ml Vial 1 No. 1. Benoxinate Hcl 0.021 gm/Vial of 5 ml 143
Case No.:55/31/82ALC4/2010
Party Name:PROMED EXPORTS PVT.LTD. 02.11.2010 Status:Case Approved HQ File :01/82/050/00980/AM11/ RLA File :05/24/040/00264/AM11/ Lic.No/Date:0510275526 22.10.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/336/2009‐PI‐(Norms) dated 13.05.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms on repeat basis under para 4 7 of HBP as per details below or as applied by firm whichever is lower:
143 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 Ciprofloxacin 0.3% and Dexamethasone 0.1% Eye ear drops 5 ml pack 1 pack 1. Dexamethasone 5.1 mg/5 ml pack RA concerned may take further necessary acĕon as per above decision of NC. 144
Case No.:56/31/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00981/AM11/ RLA File :09/24/040/00308/AM11/ Lic.No/Date:0910044015 22.10.2010 Defer Date:28.12.2010 145 Case No.:57/31/82ALC4/2010 Party Name:VIVIMED LABS LIMITED 02.11.2010 Status:Case Deferred HQ File :01/82/050/00982/AM11/ RLA File :09/24/040/00296/AM11/ Lic.No/Date:0910044017 22.10.2010 Defer Date:30.11.2010
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