DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 110011
Para 4.7 Decision
MEETING NUMBER : 7/82ALC4/2011 MEETING DATE : 17.05.2011 The Meeting No.7/82 in the year 201112 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 scheduled to be held on 17.05.2011 was actually held on 19.05.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri B.K. Tyagi, Dy.I.A, Department of Pharmaceuticals 2. Shri Jasbir Singh, Consultant, Department of C&PC 3. Dr. Nitin K. Jain, Department of Biotechnology 4. Shri Pramod Bharti, Asstt. Director, DC(MSME) 5. Shri Krishan Kumar, Dy. DGFT 6. Shri Shyam Lal, FTDO
Case No.B57
M/S SI Group India Ltd. Norms Committee Meeting No.7/12 F.No.01/83/050/AM07/DESIII Meeting Date:17.05.2011 RA F.No.03/95/040/01232/AM06 Adv.Lic.No.0310374271 dated 30.03.2006 Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/59/2006Ch.II dated 14.12.2009 and in consultation with technical authority 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 TRIMETHYL Cyclohexanone 1 KG. 1. Acetone 1.547 kg 2. 3% Palladium Paste Type 38H 0.000017 kg RA concerned may take further necessary action as per above decision of NC.
Case No.B58
M/S Dujodwala Products Ltd. F.No.01/82/050/00167/AM10/DESIII RA F.No.03/94/040/00162/AM10 Adv.Lic.No.0310523652 dated 11.06.2009 Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/231/2007Ch.II dated 12.05.2011 and in consultation with technical authority 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 Dipentine (Mixture of Monocyclic Terpenes) 1 KG. 1. Gum Turpentine Oil 1.08 kg
Case No.B59
M/S Lake Chemicals Pvt. Ltd. F.No.01/82/050/01217/AM11/DESIII RA F.No.07/24/040/00283/AM11 Adv.Lic.No.0710074995 dated 22.10.2010 Committee decided to defer case for 12.07.2011 for comments of Department of Pharmaceuticals.
Case No.B60
M/S Honest Biovet Pvt. Ltd. F.No.01/82/050/00203/AM11/DESIII RA F.No.08/24/040/00048/AM11 Adv.Lic.No.0810088931 dated 12.05.2010 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/67/2010PI(Norms) dated 01.10.2010 and in consultation with technical authority present in meeting, decided to enhance the quantity of import item No.1 i.e.Menadione Sodium Bisulphite 94% to the extent of 0.917 kg/kg of export product without any other change in the decision taken in 32/82 meeting held on 09.11.2010.
Case No.B61
M/S Benzo Chem Industries Pvt. Ltd. F.No.01/82/050/00291/AM10/DESIII RA F.No.03/94/040/00273/AM10 Adv.Lic.No.0310528642 dated 13.07.2009 Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/11/2008Ch.II dated 15.02.2010 and in consultation with technical authority 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 4Chloro Benzyl Cyanide 75% in NButyl Acetate or Para Chloro Benzyl Cyanide 75% in NButyl Acetate 1 KG. 1. Para Chloro Benzyl Cuanide 0.787 kg 2. NButyl Acetate 0.262 kg
Case No.B62
M/S Biological E. Ltd. F.No.01/82/050/00099/AM11/DESIII RA F.No.09/24/040/00442/AM10
Adv.Lic.No.09100040651 dated 27.01.2010 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/184/2010PI(Norms) dated 15.04.2011 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 Heparin Sodium 1 Kg. 1. Crude Heparin Sodium Potency: 145 IU/MG 1.055 kg
Case No.B63
M/S Biological E. Ltd. F.No.01/82/050/00098/AM11/DESIII RA F.No.09/24/040/00433/AM10 Adv.Lic.No.09100040650 dated 27.01.2010 Committee decided to defer case for 12.07.2011 for comments of Department of Pharmaceuticals.
Case No.B64
M/S Kopran Ltd. F.No.01/82/050/01319/AM07/DESIII RA F.No.03/94/040/00891/AM07 Adv.Lic.No.0310408804 dated 20.11.2006 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/6/2010PI(Norms) dated 08.06.2010 and in consultation with technical authority 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 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 1/82 meeting held on 09.05.2007 stands withdrawn.
Case No.B65
M/S Aurobindo Pharma Ltd. F.No.01/82/050/00819/AM11/DESIII RA F.No.09/24/040/00227/AM11 Adv.Lic.No.0910043502 dated 14.09.2010
Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to allow import of Thionyl Chloride to the extent of 1.947 kg/kg of export product without any other change in the decision taken in 34/82 meeting held on 23.11.2010. 1
Case No.:6/46/82ALC4/2007
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:7/82ALC4/2011 17.05.2011 Status:Case Approved HQ File :01/82/050/00560/AM08/ RLA File :03/95/040/01119/AM08/ Lic.No/Date:0310461636 19.02.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/27/2008 Ch.II dated 10.11.2008 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 Ortho Amino Benzo Trifluoride (Amino Benzo Trifluoride 1 KG. 1. Benzotrichloride 1.760 kg 2. Fluorspar (Acid Grade) 1.460 kg 3. Sulphur 0.700 kg 2
Case No.:3/29/87ALC1/2009
Party Name:PARABOLIC DRUGS LTD., 17.05.2011 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:14.06.2011 Decision :Committee decided to defer case for 14.06.2011 for comments of Department of Pharmaceuticals. 3
Case No.:28/26/82ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/00846/AM11/ RLA File :09/24/040/00397/AM10/ Lic.No/Date:0910042652 08.07.2010 Defer Date:12.07.2011 Decision :Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/174/2010PI(Norms) dated 13.04.2011, observed that the norms applied by the firm do not match with the chemistry given by them. Accordingly, it was decided to call for a clarification from the firm and defer the case for 12.07.2011. 4
Case No.:48/41/82ALC4/2010
Party Name:MEDITAB SPECIALITIES PVT. LTD. 17.05.2011 Status:Case Deferred HQ File :01/82/050/01396/AM11/ RLA File :03/95/040/00356/AM11/ Lic.No/Date:0310589522 25.08.2010 Defer Date:12.07.2011
Decision :Committee decided to defer case for 12.07.2011 for comments of Department of Pharmaceuticals. 5
Case No.:3/27/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/00870/AM11/ RLA File :09/24/040/00139/AM11/ Lic.No/Date:0910043602 23.09.2010 Defer Date:14.06.2011 Decision :Committee decided to call for a copy of application and copy of advance authorization from RA/firm. Accordingly, case was deferred for 14.06.2011. 6
Case No.:16/39/82ALC4/2010
Party Name:CTX LIFESCIENCES PVT LTD, 17.05.2011 Status:Case Deferred HQ File :01/82/050/01097/AM11/ RLA File :03/94/040/00500/AM11/ Lic.No/Date:0310595131 04.10.2010 Defer Date:12.07.2011 Decision : Committee decided to defer case for 12.07.2011 for comments of Department of Pharmaceuticals. 7
Case No.:9/29/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 17.05.2011 Status:Case Approved HQ File :01/82/050/00919/AM11/ RLA File :09/24/040/00255/AM11/ Lic.No/Date:0910043812 06.10.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/190/2010PI(Norms) dated 11.04.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export Product Export Qty. Sl.No. Import items Qty. allowed Trityl Zidovudine (Intermediate of Zidovudine) [3’Azido3’Deoxy5’O Tritylthymidine] 1 KG. 1. Dimethyl Sulfoxide (DMSO) 1.60 kg 2. Methane Sulphonyl Chloride 0.310 kg 3. Tri Ethyl Amine 0.790 kg 4. Beta Thymidine 0.600 kg 5. Methanol 1.62 kg 6. Methylene Chloride 2.04 kg 7. Toluene 0.610 kg 8. Coal As per fuel policy 8
Case No.:28/47/82ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/01618/AM11/ RLA File :09/24/040/00162/AM11/ Lic.No/Date:0910043817 06.10.2010 Defer Date:12.07.2011
9
Case No.:40/39/82ALC4/2010
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/01121/AM11/ RLA File :04/24/040/00167/AM11/ Lic.No/Date:0410117838 07.10.2010 Defer Date:12.07.2011 10
Case No.:8/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 17.05.2011 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:12.07.2011 11
Case No.:48/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 17.05.2011 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:12.07.2011 12
Case No.:56/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/01255/AM11/ RLA File :09/24/040/00236/AM11/ Lic.No/Date:0910044022 26.10.2010 Defer Date:12.07.2011 13
Case No.:80/39/82ALC4/2010
Party Name:STAR ORECHEM INTERNATIONAL PVT. LTD. 17.05.2011 Status:Case Approved HQ File :01/82/050/01161/AM11/ RLA File :50/24/040/00017/AM11/ Lic.No/Date:5010000436 28.10.2010 Decision : Commi猄ee considered case as per agenda and in light of earlier decision taken in 41/11 mee韜�ng held on 11.01.2011 and in consulta韜�on with technical authority present in mee韜�ng, 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 Metal ExtractantT 40 1kg. 1. Nonyl Phenol 0.651 kg 2. Paraformaldehyde 96% 0.269 kg 3. Hydroxylamine Sulphate Monohydrate 0.205 kg 4. Hydrocarbon Solvent 0.078 kg 5. Texamol Isobutyrate (TXIB) 0.400 kg 6. Toluene 0.315 kg
14
Case No.:3/35/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/01019/AM11/ RLA File :04/24/040/00215/AM11/ Lic.No/Date:0410118914 16.11.2010 Defer Date:12.07.2011 15
Case No.:7/35/82ALC4/2010
Party Name:RA CHEM PHARMA LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01023/AM11/ RLA File :09/24/040/00359/AM11/ Lic.No/Date:0910044295 18.11.2010 Defer Date:12.07.2011 16
Case No.:3/40/82ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/01202/AM11/ RLA File :07/24/040/00316/AM11/ Lic.No/Date:0710075478 18.11.2010 Decision : Committee considered case as per agenda and in light of NC’s decision in meeting No.49/82 dated 24.02.2009 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 4(2,2,3rimethyl Cyclopent3 enlyl)2EthylBut2en1 ol,50% (Mysore Base SA) 1 Kg. 1. Alpha Pinene 0.654 kg 2. nButyraldehyde 0.279 kg 3. Sodium Borohydride 0.038 kg 17
Case No.:12/35/82ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/01028/AM11/ RLA File :05/24/040/00286/AM11/ Lic.No/Date:0510277419 22.11.2010 Defer Date:12.07.2011 18
Case No.:17/35/82ALC4/2010
Party Name:ALEMBIC LIMITED 17.05.2011 HQ File :01/82/050/01033/AM11/ RLA File :34/24/040/00216/AM11/ Lic.No/Date:3410028617 22.11.2010 Defer Date:12.07.2011 19
Case No.:6/43/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 17.05.2011
HQ File :01/82/050/01469/AM11/ RLA File :09/24/040/00292/AM11/ Lic.No/Date:0910044462 25.11.2010 Defer Date:12.07.2011 20
Case No.:19/47/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/01609/AM11/ RLA File :09/24/040/00291/AM11/ Lic.No/Date:0910044461 25.11.2010 Defer Date:12.07.2011 21
Case No.:35/48/82ALC4/2010
Party Name:METROCHEM API PVT. LTD. 17.05.2011 Status:Case Approved HQ File :01/82/050/01678/AM11/ RLA File :09/24/040/00325/AM11/ Lic.No/Date:0910044430 25.11.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 51/82 meeting held on 22.03.2011 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 2Hydroxy Methyl3Methyl4 (2,2,2 Trifluoro Ethoxy) Pyridine Hydrochloride 1kg. 1. 2,3DimethylPyridine 0.79 kg 2. 2,2,2Trifluoro Ethanol 0.936 kg 22
Case No.:102/39/82ALC4/2010
Party Name:LUPIN LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01183/AM11/ RLA File :03/95/040/00687/AM11/ Lic.No/Date:0310603435 29.11.2010 Defer Date:12.07.2011 Decision :Committee considered case as per agenda and decided to remind the firm to intimate whether the export product is being manufactured through non infringing process. Accordingly, case was deferred for 12.07.2011. 23
Case No.:25/47/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01615/AM11/ RLA File :09/24/040/00346/AM11/ Lic.No/Date:0910044599 07.12.2010 Defer Date:12.07.2011 24
Case No.:13/7/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/00179/AM12/ RLA File :09/24/040/00385/AM11/ Lic.No/Date:0910044627 10.12.2010 Defer Date:12.07.2011
25
Case No.:149/40/82ALC4/2010
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01348/AM11/ RLA File :04/24/040/00252/AM11/ Lic.No/Date:0410120021 22.12.2010 Defer Date:12.07.2011 26
Case No.:33/41/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 17.05.2011 HQ File :01/82/050/01381/AM11/ RLA File :09/24/040/00447/AM11/ Lic.No/Date:0910044965 31.12.2010 Defer Date:12.07.2011 27
Case No.:14/51/82ALC4/2010
Party Name:TITAN LABORATORIES PVT. LTD. 17.05.2011 Status:Case Deferred HQ File :01/82/050/01731/AM11/ RLA File :03/95/040/00694/AM11/ Lic.No/Date:0310609837 06.01.2011 Defer Date:12.07.2011 Decision :Committee considered case as per agenda and decided to call for a copy of Drug Manufacturing Licence from the firm. Accordingly, case was deferred for 12.07.2011. 28
Case No.:32/7/82ALC4/2011
Party Name:BALAJI AMINES LIMITED 17.05.2011 Status:Case Approved HQ File :01/82/050/00198/AM12/ RLA File :31/24/040/00117/AM11/ Lic.No/Date:3110046322 06.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/113/2008/Ch.II dated 15.06.2010 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 Diethyl Amino Ethanol 1kg. 1. Ethanol 0.834 kg 2. Ammonia Anhydrous 0.154 kg 3. Ethylene Oxide 0.395 kg 29
Case No.:33/7/82ALC4/2011
Party Name:BALAJI AMINES LIMITED 17.05.2011 Status:Case Approved HQ File :01/82/050/00199/AM12/ RLA File :31/24/040/00116/AM11/ Lic.No/Date:3110046325 06.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O.
No.14010/113/2008/Ch.II dated 26.10.2010 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 NMethyl2Pyrrolidone 1kg. 1. Methanol 0.377 kg 2. Ammonia 0.164 kg 3. 1,4 Butanediol 1.01 kg 4. Methylamine Catalyst 0.00080 kg 5. GBL Catalyst 0.00075 kg 30
Case No.:14/43/82ALC4/2010
Party Name:VITAL LABORATORIES PVT. LTD. 17.05.2011 Status:Case Deferred HQ File :01/82/050/01477/AM11/ RLA File :03/95/040/00790/AM11/ Lic.No/Date:0310610687 12.01.2011 Defer Date:12.07.2011 31
Case No.:11/47/82ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/01601/AM11/ RLA File :13/24/040/00029/AM11/ Lic.No/Date:1310034441 24.01.2011 Defer Date:12.07.2011 32
Case No.:22/51/82ALC4/2010
Party Name:BALAJI AMINES LIMITED 17.05.2011 Status:Case Approved HQ File :01/82/050/01739/AM11/ RLA File :31/24/040/00062/AM11/ Lic.No/Date:3110046571 24.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/68/2006 Ch.II dated 10.05.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Morpholine 1 Kg. 1. Diethylene Glycol 1.354 kg 2. Ammonia Anhydrous 0.217 kg The firm has not given the details of Catalyst and hence not allowed. Further, Hydrogen is not a importable commodity and therefore not allowed. 33
Case No.:24/51/82ALC4/2010
Party Name:BALAJI AMINES LIMITED 17.05.2011 Status:Case Approved
HQ File :01/82/050/01741/AM11/ RLA File :31/24/040/00128/AM11/ Lic.No/Date:3110046569 24.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/68/2006 Ch.II dated 10.05.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Morpholine 1 Kg. 1. Diethylene Glycol 1.354 kg 2. Ammonia Anhydrous 0.217 kg The firm has not given the details of Catalyst and hence not allowed. Further, Hydrogen is not a importable commodity and therefore not allowed. 34
Case No.:25/51/82ALC4/2010
Party Name:BALAJI AMINES LIMITED 17.05.2011 Status:Case Approved HQ File :01/82/050/01742/AM11/ RLA File :31/24/040/00147/AM11/ Lic.No/Date:3110046572 24.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/68/2006 Ch.II dated 10.05.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Morpholine 1 Kg. 1. Diethylene Glycol 1.354 kg 2. Ammonia Anhydrous 0.217 kg The firm has not given the details of Catalyst and hence not allowed. Further, Hydrogen is not a importable commodity and therefore not allowed. 35
Case No.:47/3/82ALC4/2011
Party Name:MSN LABORATORIES LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/00047/AM12/ RLA File :09/24/040/00463/AM11/ Lic.No/Date:0910045251 27.01.2011 Defer Date:12.07.2011 36
Case No.:16/7/82ALC4/2011
Party Name:KUDOS CHEMIE LTD., 17.05.2011 Status:Case Approved HQ File :01/82/050/00182/AM12/ RLA File :22/21/040/00098/AM11/ Lic.No/Date:2210010926 31.01.2011 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 51/82 meeting held on 22.03.2011 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 37
Case No.:17/7/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/00183/AM12/ RLA File :22/24/040/00089/AM11/ Lic.No/Date:2210010929 31.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/182/2009PI(Norms) dated 04.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate 1 Kg. 1. 6Amino Penicillanic Acid 0.568 kg 2. Oxilasa (Enzyme) 5.00 gm. 3. D() PHydroxy Phenyl Glycine Methylester 0.608 kg 38
Case No.:18/7/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/00184/AM12/ RLA File :22/24/040/00088/AM11/ Lic.No/Date:2210010928 31.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/182/2009PI(Norms) dated 04.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate 1 Kg. 1. 6Amino Penicillanic Acid 0.568 kg 2. Oxilasa (Enzyme) 5.00 gm. 3. D() PHydroxy Phenyl Glycine Methylester 0.608 kg 39
Case No.:25/7/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/00191/AM12/ RLA File :22/24/040/00087/AM11/ Lic.No/Date:2210010927
31.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/182/2009PI(Norms) dated 04.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate 1 Kg. 1. 6Amino Penicillanic Acid 0.568 kg 2. Oxilasa (Enzyme) 5.00 gm. 3. D() PHydroxy Phenyl Glycine Methylester 0.608 kg 40
Case No.:6/51/82ALC4/2010
Party Name:LAKELAND CHEMICALS (INDIA) LTD. 17.05.2011 Status:Case Approved HQ File :01/82/050/01723/AM11/ RLA File :03/95/040/00807/AM11/ Lic.No/Date:0310613564 01.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/32/2005/Ch.III dated 27.11.2007 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 Lakpol EI 250 (Sorbitan Mono Oleate) 1kg. 1. Oleic Acid 0.658 kg 2. Sorbitol (70%) 0.425 kg 41
Case No.:15/3/82ALC4/2011
Party Name:KLJ PLASTICIZERS LTD, 17.05.2011 Status:Case Deferred HQ File :01/82/050/00015/AM12/ RLA File :05/23/040/00312/AM11/ Lic.No/Date:0510283071 03.02.2011 Defer Date:14.06.2011 Decision :Committee decided to defer case for 14.06.2011 for comments of Department of C&PC. 42
Case No.:8/46/82ALC4/2010
Party Name:VARUN MEDIMPEX INC. 17.05.2011 Status:Case Deferred HQ File :01/82/050/01563/AM11/ RLA File :05/24/040/00363/AM11/ Lic.No/Date:0510283385 08.02.2011 Defer Date:14.06.2011 Decision : Committee decided to defer case for 14.06.2011 for comments of Department of C&PC, Petrochemicals Division. 43
Case No.:7/51/82ALC4/2010
Party Name:LUPIN LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01724/AM11/ RLA File :03/95/040/00869/AM11/ Lic.No/Date:0310614766 08.02.2011 Defer Date:12.07.2011
44
Case No.:31/47/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01621/AM11/ RLA File :09/24/040/00510/AM11/ Lic.No/Date:0910045498 09.02.2011 Defer Date:14.06.2011 Decision : Committee decided to defer case for 14.06.2011 for comments of Department of C&PC. 45
Case No.:20/7/82ALC4/2011
Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:7/82ALC4/2011 17.05.2011 Status:Case Approved HQ File :01/82/050/00186/AM12/ RLA File :22/24/040/00093/AM11/ Lic.No/Date:2210010981 10.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/175/2008PIIII dated 12.12.2008 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 7ANCA 1 Kg. 1. Penicillin G Potassium First Crystal 9.63 kg 2. Para Nitro Benzyl Bromide 5.71 kg 3. Acetic Acid 8.63 kg 4. Trimethyl Phosphite 9.58 kg 5. Para Toluene sulphonyl chloride 2.54 kg 6. Morpholine 2.158 kg 7. Triethylamine 1.50 kg 8. Eno Carbon 0.100 kg 9. Dimethyl Formamide 5.72 kg 10. Methanol 17.59 kg 11. Toluene 4.00 kg 12. Ethyl Acetate 10.00 kg 13. Pyridine 0.44 kg 14. Methylene Chloride 21.00 kg 15. Tetrahydrofuran 2.95 kg 16. Acetone 0.40 kg 46
Case No.:36/47/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01626/AM11/ RLA File :09/24/040/00509/AM11/ Lic.No/Date:0910045516 11.02.2011 Defer Date:12.07.2011
47
Case No.:40/47/82ALC4/2010
Party Name:PERKIN LABORATORIES 17.05.2011 Status:Case Deferred HQ File :01/82/050/01630/AM11/ RLA File :09/24/040/00460/AM10/ Lic.No/Date:0910045524 11.02.2011 Defer Date:12.07.2011 48
Case No.:4/3/82ALC4/2011
Party Name:JINDAL DRUGS LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/00004/AM12/ RLA File :03/94/040/01005/AM11/ Lic.No/Date:0310616177 15.02.2011 Defer Date:14.06.2011 Decision : Committee decided to defer case for 14.06.2011 for comments of Department of C&PC. 49
Case No.:8/3/82ALC4/2011
Party Name:LAFFANS PETROCHEMICALS LTD., 17.05.2011 Status:Case Approved HQ File :01/82/050/00008/AM12/ RLA File :03/95/040/00437/AM11/ Lic.No/Date:0310617226 22.02.2011 Decision : Committee considered case as per agenda and in light of earlier decision teken 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 Exp. Qty. Sl.No. Import items Qty. allowed Diethylene Glycol Monoethyl Ether 1 Kg. 1. Denatured Ethyl Alcohol 0.350 kg 2. Ethylene Oxide 0.670 kg 50
Case No.:35/3/82ALC4/2011
Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED 17.05.2011 HQ File :01/82/050/00035/AM12/ RLA File :04/24/040/00285/AM11/ Lic.No/Date:0410121952 24.02.2011 Defer Date:14.06.2011 Decision : Committee decided to defer case for 14.06.2011 for comments of Department of C&PC. 51
Case No.:11/51/82ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01728/AM11/ RLA File :03/94/040/01049/AM11/ Lic.No/Date:0310619151 03.03.2011 Defer Date:12.07.2011 52
Case No.:31/51/82ALC4/2010
Party Name:MASS DYECHEM PVT LTD., 17.05.2011 Status:Case Deferred
HQ File :01/82/050/01748/AM11/ RLA File :31/24/040/00263/AM11/ Lic.No/Date:3110047188 03.03.2011 Defer Date:14.06.2011 Decision : Committee decided to defer case for 14.06.2011 for comments of Department of C&PC. 53
Case No.:32/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 17.05.2011 Status:Case Deferred HQ File :01/82/050/01749/AM11/ RLA File :09/24/040/00251/AM11/ Lic.No/Date:0910045763 03.03.2011 Defer Date:12.07.2011 54
Case No.:33/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 17.05.2011 Status:Case Deferred HQ File :01/82/050/01750/AM11/ RLA File :09/24/040/00541/AM11/ Lic.No/Date:0910045764 03.03.2011 Defer Date:12.07.2011 55
Case No.:34/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 17.05.2011 Status:Case Deferred HQ File :01/82/050/01751/AM11/ RLA File :09/24/040/00503/AM11/ Lic.No/Date:0910045771 03.03.2011 Defer Date:12.07.2011 56
Case No.:35/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 17.05.2011 Status:Case Deferred HQ File :01/82/050/01752/AM11/ RLA File :09/24/040/00062/AM11/ Lic.No/Date:0910045773 03.03.2011 Defer Date:12.07.2011 57
Case No.:36/51/82ALC4/2010
Party Name:PERKIN LABORATORIES 17.05.2011 HQ File :01/82/050/01753/AM11/ RLA File :09/24/040/00449/AM11/ Lic.No/Date:0910045776 03.03.2011 Defer Date:12.07.2011 58
Case No.:43/51/82ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/01760/AM11/ RLA File :09/24/040/00539/AM11/ Lic.No/Date:0910045802 04.03.2011 Defer Date:12.07.2011
59
Case No.:26/7/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 17.05.2011 Status:Case Deferred HQ File :01/82/050/00192/AM12/ RLA File :22/24/040/00098/AM11/ Lic.No/Date:2210011064 04.03.2011 Defer Date:12.07.2011 60
Case No.:34/7/82ALC4/2011
Party Name:SARNA CHEMICALS PVT.LTD. 17.05.2011 Status:Case Approved HQ File :01/82/050/00200/AM12/ RLA File :52/24/040/00047/AM11/ Lic.No/Date:5210034392 04.03.2011 : Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/48/2008 Ch.II dated 09.05.2011 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 4(2Chloro Ethylsulfonyl Butyric Acid (XAZ Base) 1 KG. 1. Gamma Butyrolactone (YButyrolacton) 0.665 kg 2. Isopropyl Alcohol 0.705 kg 3. 2Mercapto Ethanol 0.691 kg 61
Case No.:46/51/82ALC4/2010
Party Name:HETERO LABS LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01763/AM11/ RLA File :09/24/040/00544/AM11/ Lic.No/Date:0910045817 07.03.2011 Defer Date:12.07.2011 62
Case No.:47/51/82ALC4/2010
Party Name:SHASUN PHARMACEUTICALS LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01764/AM11/ RLA File :04/24/040/00321/AM11/ Lic.No/Date:0410122330 08.03.2011 Defer Date:12.07.2011 63
Case No.:52/51/82ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 17.05.2011 Status:Case Deferred HQ File :01/82/050/01769/AM11/ RLA File :03/94/040/01002/AM11/ Lic.No/Date:0310620013 08.03.2011 Defer Date:12.07.2011 64
Case No.:48/51/82ALC4/2010
Party Name:ADVANCE PETROCHEMICALS Status:Case
LIMITED 17.05.2011 Approved HQ File :01/82/050/01765/AM11/ RLA File :08/24/040/00374/AM11/ Lic.No/Date:0810097060 09.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/40/2008 Ch.II dated 18.05.2011 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 Diethylene Glycol Mono Methyl Ether 1 KG. 1. Methanol 0.280 kg 2. Ethylene Oxide 0.748 kg 65
Case No.:49/51/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/01766/AM11/ RLA File :04/24/040/00333/AM11/ Lic.No/Date:0410122404 09.03.2011 Defer Date:12.07.2011 66
Case No.:50/51/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 17.05.2011 Status:Case Approved HQ File :01/82/050/01767/AM11/ RLA File :04/24/040/00335/AM11/ Lic.No/Date:0410122405 09.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/226/2009PI(Norms) dated 27.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Vitamin A Capsules 100000 Nos. 1 No.. Vitamin A Palmitate 1.7 MIU 12.00 kg 67
Case No.:51/51/82ALC4/2010
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 17.05.2011 Status:Case Approved HQ File :01/82/050/01768/AM11/ RLA File :04/24/040/00334/AM11/ Lic.No/Date:0410122406 09.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/226/2009PI(Norms) dated 27.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Vitamin A Capsules 100000 1 No.. Vitamin A Palmitate 1.7 MIU 12.00 kg
Nos. 68
Case No.:12/7/82ALC4/2011
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/00178/AM12/ RLA File :04/24/040/00331/AM11/ Lic.No/Date:0410122523 15.03.2011 Decision : Committee considered case as per agenda and in light of SION A412 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 Valacyclovir Tablet 500 mg 1 No. 1 No.. Valacyclovir 510 mg Valacyclovir Tablet 1000 mg 1 No. 1 No.. Valacyclovir 1020 kg 69
Case No.:8/2/82ALC4/2011
Party Name:VASUDHA PHARMA CHEM LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/01798/AM11/ RLA File :09/24/040/00254/AM11/ Lic.No/Date:0910045963 18.03.2011 Defer Date:12.07.2011 70
Case No.:4/2/82ALC4/2011
Party Name:THERMAX LTD., 17.05.2011 Status:Case Approved HQ File :01/82/050/01794/AM11/ RLA File :31/24/040/00268/AM11/ Lic.No/Date:3110047460 21.03.2011 Decision :Withdrawn as the case has already been approved in 6/82 meeting held on 10.05.2011. 71
Case No.:6/2/82ALC4/2011
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 17.05.2011 Status:Case Approved HQ File :01/82/050/01796/AM11/ RLA File :05/23/040/00364/AM11/ Lic.No/Date:0510286767 24.03.2011 Defer Date: Decision : Withdrawn as the case has already been approved in 6/82 meeting held on 10.05.2011. 72
Case No.:7/2/82ALC4/2011
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 17.05.2011 Status:Case Approved HQ File :01/82/050/01797/AM11/ RLA File :05/23/040/00290/AM11/ Lic.No/Date:0510286771 24.03.2011 Defer Date:
Decision : Withdrawn as the case has already been approved in 6/82 meeting held on 10.05.2011. 73
Case No.:8/7/82ALC4/2011
Party Name:THEMIS PHARMACEUTICALS(PROP.CHEMOSYN LTD.) 17.05.2011 Status:Case Deferred HQ File :01/82/050/00174/AM12/ RLA File :08/24/040/00383/AM11/ Lic.No/Date:0810097586 24.03.2011 Defer Date:12.07.2011 74
Case No.:22/7/82ALC4/2011
Party Name:TRIGON ANTIOXIDANTS PVT. LTD, 17.05.2011 Status:Case Deferred HQ File :01/82/050/00188/AM12/ RLA File :03/95/040/01027/AM11/ Lic.No/Date:0310623197 24.03.2011 Defer Date:14.06.2011 Decision : Committee decided to defer case for 14.06.2011 for comments of Department of C&PC. 75
Case No.:23/7/82ALC4/2011
Party Name:NARSIPUR CHEMICALS PVT LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/00189/AM12/ RLA File :03/95/040/01032/AM11/ Lic.No/Date:0310623117 24.03.2011 Defer Date:12.07.2011 Decision :Committee decided to call for a copy of application and copy of advance authorization from RA/firm. Accordingly, case was deferred for 12.07.2011. 76
Case No.:27/7/82ALC4/2011
Party Name:SURYA PHARMACEUTICAL LTD Meet No/Date:7/82ALC4/2011 17.05.2011 Status:Case Approved HQ File :01/82/050/00193/AM12/ RLA File :22/24/040/00100/AM11/ Lic.No/Date:2210011135 24.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/206/2009PI(Norms) dated 19.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Fexofinadine Hcl 1 Kg. 1. 4Chloro 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
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 77
Case No.:11/2/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/01801/AM11/ RLA File :09/24/040/00588/AM11/ Lic.No/Date:0910046079 25.03.2011 Defer Date:12.07.2011 78
Case No.:12/2/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 17.05.2011 HQ File :01/82/050/01802/AM11/ RLA File :09/24/040/00589/AM11/ Lic.No/Date:0910046080 25.03.2011 Defer Date:12.07.2011 79
Case No.:13/2/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/01803/AM11/ RLA File :09/24/040/00590/AM11/ Lic.No/Date:0910046081 25.03.2011 Defer Date:12.07.2011 80
Case No.:14/2/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/01804/AM11/ RLA File :09/24/040/00591/AM11/ Lic.No/Date:0910046082 25.03.2011 Defer Date:12.07.2011 81
Case No.:4/7/82ALC4/2011
Party Name:ANUH PHARMA LTD. 17.05.2011 Status:Case Deferred HQ File :01/82/050/00170/AM12/ RLA File :03/94/040/01146/AM11/ Lic.No/Date:0310623422 25.03.2011 Defer Date:12.07.2011
82
Case No.:6/7/82ALC4/2011
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/00172/AM12/ RLA File :04/24/040/00355/AM11/ Lic.No/Date:0410122929 25.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of SION A412 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 Valacyclovir Tablet 500 mg 1 No. 1 No.. Valacyclovir 510 mg Valacyclovir Tablet 1000 mg 1 No. 1 No.. Valacyclovir 1020 kg 83
Case No.:16/2/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 17.05.2011 Status:Case Approved HQ File :01/82/050/01806/AM11/ RLA File :09/24/040/00581/AM11/ Lic.No/Date:0910046114 29.03.2011 Decision :Withdrawn as the case has already been approved in 4/82 meeting held on 26.04.2011. 84
Case No.:3/3/82ALC4/2011
Party Name:ALKYL AMINES CHEMICALS LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/00003/AM12/ RLA File :03/94/040/00515/AM11/ Lic.No/Date:0310624109 29.03.2011 Defer Date:14.06.2011 Decision : Committee decided to defer case for 14.06.2011 for comments of Department of C&PC. 85
Case No.:3/7/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/00169/AM12/ RLA File :03/94/040/01125/AM11/ Lic.No/Date:0310624076 29.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/49/2010PI(Norms) dated 29.06.2010 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 2’Deoxy2’,2’DifluoroN1 Acetyl Cytidine3’,5 Dibenzoate 1 Kg. 1. 2Deoxy2,2DifluoroDErythro Pentofuranose3,5Dibenzoate1 Methanesulfonate 1.10 kg 2. NAcetyl Cytosine 1.10 kg 3. Trimethyl Silyl Trifluoromethane Sulfonate (Triflate) 1.95 kg
86
Case No.:31/7/82ALC4/2011
Party Name:PADMINI AROMATICS PVT. LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/00197/AM12/ RLA File :07/24/040/00535/AM11/ Lic.No/Date:0710078404 29.03.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 3/82 meeting held on 19.04.2011 and in consultation with technical authoritiy 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 Sandol 1 Kg. 1. Alpha Pinene 1.81 kg 2. Sodium Borohydride 0.08 kg 3. N Butyraldehyde 0.78 kg 87
Case No.:17/2/82ALC4/2011
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 17.05.2011 Status:Case Approved HQ File :01/82/050/01807/AM11/ RLA File :05/23/040/00374/AM11/ Lic.No/Date:0510287218 30.03.2011 Decision :Withdrawn as the case has already been approved in 6/82 meeting held on 10.05.2011. 88
Case No.:7/7/82ALC4/2011
Party Name:TORRENT PHARMACEUTICALS LTD. 17.05.2011 Status:Case Approved HQ File :01/82/050/00173/AM12/ RLA File :08/24/040/00387/AM11/ Lic.No/Date:0810097823 30.03.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 40/82 meeting held on 04.01.2011 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. S.No. Qty. allowed Paracetamol Tablets 500 mg Heumann Tabletten (Pack Size 10,20 and 30 tablets) 1674000 Nos. 1. Paracetamol Granules DC 90% 939.3 kg 89
Case No.:15/7/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 17.05.2011 Status:Case Approved HQ File :01/82/050/00181/AM12/ RLA File :22/24/040/00101/AM11/ Lic.No/Date:2210011172 30.03.2011
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/4/2010PI(Norms) dated 09.06.2010 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 Cefepime for Injection (Cefepime Hcl+L Arginine in 68:32 ratio) 1 Kg. 1. Cefepime Hcl Non Sterile 0.707 kg 2. LArginine 0.320 kg 3. Acetone 2.14 kg 4. Methanol 0.81 kg 5. Eno Carbon 0.034 kg 90
Case No.:19/7/82ALC4/2011
Party Name:INDSWIFT LABORATORIES LTD., 17.05.2011 Status:Case Approved HQ File :01/82/050/00185/AM12/ RLA File :22/24/040/00103/AM11/ Lic.No/Date:2210011178 30.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/73/2010PI (Norms) dated 05.10.2010 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 Atorvastatin Calcium 1 Kg. 1. Methyl Isobutyryl Acetate 1.646 kg 2. Beta Ananine 0.100 kg 3. Sodium Meta Bisulphite 0.037 kg 4. Para Fluoro Benzaldehyde 0.70 kg 5. 3Ethyl5(2Hydroxy Ethyl)4Methyl Thiazolium Bromide 0.262 kg 6. Isopropyl Alcohol 8.375 kg 7. (4RCis)1,1Dimethylethyl6Cyanomethyl2,2 Dimethyl12Dioxane4Acetate (ATS8) 1.003 kg 8. Tert. Butyl Methyl Ether 4.151 kg 91
Case No.:21/7/82ALC4/2011
Party Name:INDSWIFT LABORATORIES LTD., 17.05.2011 Status:Case Approved HQ File :01/82/050/00187/AM12/ RLA File :22/24/040/00104/AM11/ Lic.No/Date:2210011177 30.03.2011 Decision : Committee considered the case as per agenda and in light of earlier decision taken in 49/82 meeting held on 08.03.2011 and in consultation with Technical Authority present in the meeting decided 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
1,3Dioxolane,4Acetic Acid,6[2[2(4 Flourophenyl)Methyl]5(1 Methylethyl)3Phenyl4 [(Phenylamino) Carbonyl]1HPyrrole1 YL]Ethyl] 2,2Dimethyl(1,1 Dimethylethyl)Ester (Atorvastatin Intermediate AT1) 1 Kg. 1. Methyl Isobutyryl Acetate 0.97 kg 2. Benzaldehyde 0.458 kg 3. BAlanine 0.0735 kg 4. 4Fluoro Benzaldehyde 0.556 kg 5. 3Ethyl5 (2Hydroxyethyl)4 Methyl Thiozolium Bromide 0.12 kg 6. (4RCis)1,1Dimethylethyl6 Cyanomethyl2,2Dimethyl1,3 Dioxane4Acetate (ATS8) 0.635 kg 7. Heptane 4.37 kg 92
Case No.:11/7/82ALC4/2011
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 17.05.2011 HQ File :01/82/050/00177/AM12/ RLA File :04/24/040/00356/AM11/ Lic.No/Date:0410123134 31.03.2011 Defer Date:12.07.2011 93
Case No.:30/3/82ALC4/2011
Party Name:ALKYL AMINES CHEMICALS LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/00030/AM12/ RLA File :03/94/040/00645/AM11/ Lic.No/Date:0310624746 01.04.2011 Decision : Committee considered the case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/3/2005/Ch.III dated 04.05.2009 and in consultation with Technical Authority present in the meeting decided 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 1,2Dimethylpropylamine 1 Kg. 1. Methyl Isopropyl Ketone 1.041 kg 2. Raney Nickel Catalyst 0.012 kg 94
Case No.:49/3/82ALC4/2011
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/00049/AM12/ RLA File :31/24/040/00292/AM11/ Lic.No/Date:3110047691 01.04.2011 Defer Date:14.06.2011 Decision :Committee decided to call for a copy of application and copy of advance authorization from RA/firm. Accordingly, case was deferred for 14.06.2011. 95
Case No.:2/7/82ALC4/2011
Party Name:AARTI DRUGS LIMITED Status:Case
17.05.2011 Approved HQ File :01/82/050/00168/AM12/ RLA File :03/94/040/01114/AM11/ Lic.No/Date:0310624803 01.04.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 17/82 meeting held on 27.07.2010 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 Nitazoxanide 1 Kg. 1. 2‐Acetyloxy benzoic acid (Asprin) 0.916 kg 2. 2‐amino‐5‐nitro thiazole 0.590 kg 3. Triethylamine 0.716 kg 4. Methylene Chloride 1.35 kg 5. Dimethyl formamide 0.70 kg 6. Methanol 3.20 kg 7. Charcoal 0.100 kg RA concerned may take further necessary action as per above decision of Norms Committee. 96
Case No.:10/7/82ALC4/2011
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 17.05.2011 Status:Case Approved HQ File :01/82/050/00176/AM12/ RLA File :04/24/040/00359/AM11/ Lic.No/Date:0410123157 01.04.2011 Defer Date: Decision : Committee considered case as per agenda and in light of SION A412 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 Valacyclovir Tablet 500 mg 1 No. 1 No.. Valacyclovir 510 mg Valacyclovir Tablet 1000 mg 1 No. 1 No.. Valacyclovir 1020 kg 97
Case No.:14/7/82ALC4/2011
Party Name:INDSWIFT LABORATORIES LTD., 17.05.2011 Status:Case Approved HQ File :01/82/050/00180/AM12/ RLA File :22/24/040/00001/AM12/ Lic.No/Date:2210011194 06.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/39/2010PI(Norms) dated 01.07.2010 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 Clopidogrel Camphor Sulfonate 1 Kg. 1. 4,5,6,7 Tetrahydro Thieno(3,2C) Pyridine Hcl 1.012 kg 2. AlphaBromo2Chloro Phenyl Acetic 1.52 kg
Acid/Methyl Ester 3. N,NDimethyl Formamide 1.26 kg 4. Triethylamine 1.265 kg 5. Methylene Chloride 2.20 kg 6. Acetone 6.34 kg 7. L() Camphor Sulphonic Acid 0.455 kg 98
Case No.:1/7/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 17.05.2011 Status:Case Approved HQ File :01/82/050/00167/AM12/ RLA File :05/24/040/00005/AM12/ Lic.No/Date:0510288068 13.04.2011 Defer Date: 99
Case No.:24/7/82ALC4/2011
Party Name:SAVLA CHEMICALS LIMITED 17.05.2011 Status:Case Approved HQ File :01/82/050/00190/AM12/ RLA File :03/95/040/00020/AM12/ Lic.No/Date:0310628771 29.04.2011 Decision : Committee considered case as per agenda and in light of written comments of Department of C&PC dated 30.07.2010 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 High Purity Methyl Tertiary Butyl Ether Purity Min. 99.8% 1 kg 1. MTBE (Methyl Tertiary Butyl Ether) (Purity max.98%) 1.01 kg 100
Case No.:5/7/82ALC4/2011
Party Name:PAYAL POLYPLAST PVT.LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/00171/AM12/ RLA File :05/24/040/00026/AM12/ Lic.No/Date:0510289321 02.05.2011 Defer Date:14.06.2011 Decision : Committee decided to defer case for 14.06.2011 for comments of Department of C&PC. 101
Case No.:9/7/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 17.05.2011 Status:Case Deferred HQ File :01/82/050/00175/AM12/ RLA File :05/24/040/00034/AM12/ Lic.No/Date:0510289332 02.05.2011 Defer Date:12.07.2011 102 Case No.:28/7/82ALC4/2011 Party Name:EMBIO LTD 17.05.2011 Status:Case
Deferred HQ File :01/82/050/00194/AM12/ RLA File :03/94/040/01026/AM11/ Lic.No/Date:0310629152 03.05.2011 Defer Date:12.07.2011 103
Case No.:29/7/82ALC4/2011
Party Name:EMBIO LTD 17.05.2011 Status:Case Deferred HQ File :01/82/050/00195/AM12/ RLA File :03/94/040/01027/AM11/ Lic.No/Date:0310629153 03.05.2011 Defer Date:12.07.2011 104
Case No.:30/7/82ALC4/2011
Party Name:GLENMARK GENERICS LIMITED 17.05.2011 Status:Case Approved HQ File :01/82/050/00196/AM12/ RLA File :03/94/040/00038/AM12/ Lic.No/Date:0310629275 03.05.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 48/82 meeting held on 23.02.2010 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 Bupropion Hydrochloride BP 1 kg 1. MChloropropiophenone 0.85 kg 2. Methylene Chloride/MDC/Methylene Dichloride 2.00 kg 3. Methanol 1.00 kg
Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.
No analysis has been generated for this document yet.