DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 48/82ALC4/2010 MEETING DATE : 01.03.2011 The Meeting No.48/82 in the year 201011 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 01.03.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri Jasbir Singh, IA, Department of C&PC 2. Shri Shaish Kumar, IA, DIPP 3. Shri D.N. Mathur, Dy.I.A, Department of Pharmaceuticals 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO
Case No.B403
M/S VHB Medi Sciences Ltd. Norms Committee Meeting No.48/11 F.No.01/82/050/00021/AM11/DESIII Meeting Date:01.03.2011 RA F.No.03/95/040/00015/AM11 Adv.Lic.No.0310569153 dated 12.04.2010 Committee considered case as per agenda and observed that the norms has already been fixed correctly on the basis of SION for Injections and there is no justification for enhancement in the quantity of inputs. Accordingly, it was decided to reject the case.
Case No.B404
M/S FMC India Pvt. Ltd. F.No.01/82/050/00776/AM09/DESIII RA F.No.07/24/040/00192/AM09 Adv.Lic.No.0710058651 dated 22.07.2008 Committee considered case as per agenda and observed that the firm has got the description of import and export items and their quantities vide Amendment Sheet No.2 dated 25.08.2008. Committee, in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below: Export product Exp. Qty. Sl.No. Import items Qty. allowed N. Hexyl Lithium 33% dissolved in Hexane (Containing 40000 kgs. N Hexyl Lithium dissolved in 81212 kg Hexane) 121212 kgs. 1. Manufacturing Intermediate n Hexyl Lithium in Hexane (35% n Hexyl Lithium 65% Hexane)40000 kgs of n Hexyl Lithium dissolved in 74286 kgs of Hexane 114286 kgs. RA concerned may take further necessary action as per above decision of NC.
Case No.B405
M/S MSN Pharma Pvt. Ltd. F.No.01/82/050/00191/AM11/DESIII RA F.No.09/24/040/00039/AM11 Adv.Lic.No.0910041949 dated 06.05.2010 Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No.35011/131/2010PI (Norms) dated 25.11.2010 and O.M. No.35011/398/2009PI (Norms) dated 07.06.2010 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. S.No. Qty. allowed Montelukast Sodium 1 kg 1. [(S)(E)[2[3[2(7Chloro2 Quinolinyl)Ethenyl]Phenyl]3 Hydroxypropyl]Phenyl]2Propanol OR a[3[2(7Chloro2 Quinolinyl)Ethenyl]Phenyl]2(1 Hydroxy1Methylethyl),[S(E)] Benzenepropanol 1.424 kg 2. 1(Hydroxymethyl) Cyclopropane Acetonitrile 1.00 kg Decision taken in NC meeting No.8/82 dated 25.05.2010 vide2/8/82 stands withdrawn.
Case No.B406
M/S Gopinath ChemTech Ltd. F.No.01/82/050/01215/AM10/DESIII RA F.No.08/24/040/00313/AM10 Adv.Lic.No.0810087248 dated 11.03.2010 Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/67/2008/Ch.II dated 17.01.2011 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 Exp. Qty. S.No. Import items Qty. allowed 4Sulpho Hydrazone (BECA) 1 kg 1. Toluene 2.140 kg 2. Sodium Nitrite 0.558 kg 3. Caustic Soda Flakes or Caustic Soda Lye (100% Real basis) 2.790 kg 4. Soda Ash 2.880 kg
Case No.B407
M/S Enaltec Labs Ltd. F.No.01/82/050/00998/AM10/DESIII RA F.No.03/94/040/00732/AM10 Adv.Lic.No.0310548785 dated 02.12.2009 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of import item No.1 to read as “1Cyclopropyl6,7Difluoro 1,4Dihydro8Methoxy4Oxo3Quinoline Carboxylic Acid Ethyl Ester – 98% Min.” and import item No.2 to read as “_(S,S)_2,8Diazabicyclo (4,3,0) Nonane” without any other change in the decision taken in 46/82 meeting held on 09.02.2010.
Case No.B408
M/S Privi Organics Ltd. F.No.01/83/050/00265/AM07/DESIII RA F.No.03/95/040/00272/AM07 Adv.Lic.No.0310383683 dated 08.06.2006 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “Gamma Methyl Ionone” for regularization purpose without any other change in the decision taken in 33/11 meeting held on 16.11.2010.
Case No.B409
M/S Arch Pharma Labs. F.No.01/82/050/01429/AM10/DESIII RA F.No.03/94/040/00871/AM09 Adv.Lic.No.0310498562 dated 17.12.2008 Committee considered case as per agenda 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. Import items Qty. allowed (1S,3aR,6aS)tertButyl Octahydrocyclopenta[C] Pyrrole1Carboxylic Acid Oxalate 1 kg 1. 3Azabicyclo[3.3.O] Octane Hydrochloride 1.888 kg 2. CDX 656 Mono Amine Oxygenase (CDX 656 Lyophilised Enzyme (Powder) 0.21 kg 3. Catalase 25L (Enzyme) 0.100 kg 4. TertButyl Acetate 4.18 kg 5. Isopropanol 3.792 kg
Case No.A81
M/S Divis Laboratories Ltd. F.No.01/82/162/01023/AM11/DESIII Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals.
Case No.A82
F.No.01/82/162/01024/AM11/DESIII
Case No.A83
F.No.01/82/162/01025/AM11/DESIII
Case No.A84
F.No.01/82/162/01027/AM11/DESIII
Case No.A85
F.No.01/82/162/01072/AM11/DESIII
Case No.A86
F.No.01/82/162/01076/AM11/DESIII
Case No.A87
F.No.01/82/162/01080/AM11/DESIII
Case No.A88
F.No.01/82/162/01081/AM11/DESIII
Case No.A89
F.No.01/82/162/01082/AM11/DESIII
Case No.A90
F.No.01/82/162/01083/AM11/DESIII
Case No.A91
F.No.01/82/162/01084/AM11/DESIII
Case No.A92
F.No.01/82/162/01085/AM11/DESIII
Case No.A93
F.No.01/82/162/01086/AM11/DESIII
Case No.A94
F.No.01/82/162/01087/AM11/DESIII
Case No.A95
F.No.01/82/162/01088/AM11/DESIII
Case No.A96
F.No.01/82/162/01089/AM11/DESIII
Case No.A97
F.No.01/82/162/01090/AM11/DESIII
Case No.A98
F.No.01/82/162/01091/AM11/DESIII
Case No.A99
F.No.01/82/162/01092/AM11/DESIII
Case No.A100
F.No.01/82/162/01093/AM11/DESIII
Case No.A101
F.No.01/82/162/01094/AM11/DESIII
Case No.A102
F.No.01/82/162/01095/AM11/DESIII
Case No.A103
F.No.01/82/162/01096/AM11/DESIII
Case No.A104
F.No.01/82/162/01097/AM11/DESIII
Case No.A105
F.No.01/82/162/01098/AM11/DESIII
Case No.A106
F.No.01/82/162/01099/AM11/DESIII
Case No.A107
F.No.01/82/162/01100/AM11/DESIII
Case No.A108
F.No.01/82/162/01101/AM11/DESIII
Case No.A109
F.No.01/82/162/01102/AM11/DESIII
Case No.A110
F.No.01/82/162/01105/AM11/DESIII
Case No.A111
F.No.01/82/162/01106/AM11/DESIII
Case No.A112
F.No.01/82/162/01107/AM11/DESIII
Case No.A113
F.No.01/82/162/01108/AM11/DESIII
Case No.A114
F.No.01/82/162/01109/AM11/DESIII
Case No.A115
F.No.01/82/162/01110/AM11/DESIII
Case No.A116
F.No.01/82/162/01111/AM11/DESIII
Case No.A117
F.No.01/82/162/01104/AM11/DESIII
Case No.A118
F.No.01/82/162/01103/AM11/DESIII
Case No.A119
F.No.01/82/162/01026/AM11/DESIII
Case No.A120
F.No.01/82/162/01028/AM11/DESIII
Case No.A121
F.No.01/82/162/01021/AM11/DESIII
Case No.A122
F.No.01/82/162/01022/AM11/DESIII
Case No.A123
F.No.01/82/162/01079/AM11/DESIII
Case No.A124
F.No.01/82/162/01077/AM11/DESIII
Case No.A125
F.No.01/82/162/01078/AM11/DESIII
Case No.A126
F.No.01/82/162/01073/AM11/DESIII
Case No.A127
F.No.01/82/162/01074/AM11/DESIII
Case No.A128
F.No.01/82/162/01075/AM11/DESIII 1
Case No.:7/8/82ALC4/2009
Party Name:SHILPA MEDICARE LTD., Meet No/Date:48/82ALC4/2010 01.03.2011 Status:Case Approved HQ File :01/82/050/00102/AM10/ RLA File :07/24/040/00053/AM10/ Lic.No/Date:0710064718 13.05.2009 Decision : Committee considered case as per agenda 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. Import items Qty. allowed Gemcitabine Hcl 1 kg 1. 2Deoxy2,2DifluoroDErythro Pentafuranous1Ulose3,5Dibenzoate 5.14 kg 2. Tetra Hydro Furan 4.609 kg 3. Methylene Dichloride 6.285 kg 4. NAcetyl Cytosine 7.46 kg 5. Trimethyl Silyl Trifluoromethane Sulfonate 8.358 kg 6. Methanol 6.285 kg 2
Case No.:30/19/82ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD 01.03.2011 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:15.03.2011 Decision :Committee considered case as per agenda. The representative of the firm appeared before the Committee for personal hearing and explained the case. He explained that they had furnished the complete information, but one page of the information was missed. He again supplied
p p y p , p g g pp the complete information including yield achieved by them. After detailed deliberations, it was decided to forward a copy of reply received from the representative of the firm to Department of Pharmaceuticals for their comments. Accordingly, case was deferred for 15.03.2011. 3
Case No.:146/40/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/01345/AM11/ RLA File :09/24/040/00461/AM09/ Lic.No/Date:0910039053 20.08.2009 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Export product Exp. Qty. S.No. Import items Qty. allowed Sterile Ampicillin Sodium + Sulbactam Sodium (2:1) 1 kg 1. 6Amino Penicillanic Acid (6 APA) 0.476 kg 2. Acetone 0.338 kg 3. Acetonitrile 0.9494 kg 4. D() Alpha Phenyl Glycine Base 0.350 kg 5. Ethyl Aceto Acetate 0.314 kg 6. Iso Propyl Alcohol 1.602 kg 7. Methylene Chloride 0.63 kg 8. Pivolyl Chloride 0.283 kg 9. Sodium Thiocyanate 0.200 kg 10. Triethylamine 0.015 kg 11. Sulbactam Acid 0.328 kg 12. Potassium Carbonate 0.1495 kg 14. Activated Carbon 0.023 kg 15. Aluminium Canisters 20 Ltrs. (10 kg capacity) As per packing Policy 16. High Speed Diesel As per Fuel Policy 4
Case No.:14/33/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/00642/AM10/ RLA File :09/24/040/00262/AM10/ Lic.No/Date:0910039756 29.10.2009 Defer Date:29.03.2011 Decision :Committee decided to defer the case for 29.03.2011 for comments of Department of Pharmaceuticals. 5
Case No.:3/43/82ALC4/2009
Party Name:ARCH PHARMALABS LTD 01.03.2011 Status:Case Approved HQ File :01/82/050/00877/AM10/ RLA File :03/94/040/00784/AM10/ Lic.No/Date:0310554371 08.01.2010 Defer Date:
Decision : Committee considered case as per agenda and in light of earlier decision taken in 45/82 meeting held on 08.02.2011 and in consultation with representative of Department of Pharmaceuticals 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 (1R,2S,5S)6,6Dimethyl3 Azabicyclo[3.1.0]Hexane 2Carboxylic Acid methyl Ester hydrochloride (BPVR503034T) 1 kg 1. Caronic Anhydrate 3.029 kg 2. Vitride [Sodium Bis(2 Methoxyethoxy) Aluminium 20.00 kg 3. Lypholized Enzyme Powder (CDX 616) 0.076 kg 6
Case No.:41/9/82ALC4/2010
Party Name:CIPLA LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/00256/AM11/ RLA File :03/94/040/00980/AM10/ Lic.No/Date:0310559358 09.02.2010 Defer Date:15.03.2011 Decision :Committee decided to remind Ministry of Environment and Forests for NOC. Accordingly, case was deferred for 15.03.2011. 7
Case No.:26/50/82ALC4/2009
Party Name:CENTURY PHARMACEUTICALS LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/01180/AM10/ RLA File :34/24/040/00208/AM10/ Lic.No/Date:3410026508 02.03.2010 Decision : Committee considered case as per agenda 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 9Deoxo9AAza9A Hemoerythromycin A (Azithromycin Amine) 1 kg 1. Erythromycin Thiocyanate 1.64 KGA 8
Case No.:15/2/82ALC4/2010
Party Name:COMBITIC GLOBAL CAPLET PVT. LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/01249/AM10/ RLA File :33/24/040/00016/AM10/ Lic.No/Date:3310015180 26.03.2010 Decision : Committee considered case as per agenda. The representative of the firm appeared before the Committee for personal hearing and explained the case. He gave the copy of DMLto the Committee, but in the DML, the specific name of the export product was not mentioned. Committee also observed that the export product is not a drug item. The firm furnished Certificate of Analysis. After detailed deliberations and in consultation with technical authorities present in meeting, Committee decided to ratify norms for only regularization purpose 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 Vitamin C 95% (Feed Grade) 21000 kg 1. Ascorbic Acid Vit. C 21150 kg 2. Di Calcium Phosphate Feed Grade 1020 kg The above decision of NC is for this licence only and no repeat licence is to be issued. 9
Case No.:11/5/82ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 01.03.2011 Status:Case Deferred HQ File :01/82/050/00045/AM11/ RLA File :05/24/040/00017/AM11/ Lic.No/Date:0510262860 22.04.2010 Defer Date: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.35011/72/2010PI (Norms) dated 01.10.2010, decided to call for technical details as per Appendix 33 from the firm. Accordingly, case was deferred for 29.03.2011. 10
Case No.:6/26/82ALC4/2010
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/00824/AM11/ RLA File :09/24/040/00567/AM10/ Lic.No/Date:0910042108 25.05.2010 Decision :Withdrawn as the case has already been approved by NC in its 30/82 meeting held on 26.10.2010. 11
Case No.:7/26/82ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/00825/AM11/ RLA File :09/24/040/00061/AM11/ Lic.No/Date:0910042109 25.05.2010 Defer Date:26.04.2011 Decision :Committee decided to defer the case for 26.04.2011 for comments of Department of Pharmaceuticals.. 12
Case No.:8/26/82ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/00826/AM11/ RLA File :09/24/040/00060/AM11/ Lic.No/Date:0910042112 25.05.2010 Defer Date:26.04.2011 Decision : Committee decided to defer the case for 26.04.2011 for comments of Department of Pharmaceuticals. 13
Case No.:21/26/82ALC4/2010
Party Name:VIRCHOW PETROCHEMICAL PVT LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/00839/AM11/ RLA File :09/24/040/00550/AM10/ Lic.No/Date:0910042135 25.05.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under
Export product Exp. Qty. S.No. Import items Qty. allowed 7Phenylacetamideo3 Chloromethyl Cephalosporonic Acid Para Methoxybenzyl Ester (GCLE) 1 kg 1. Penicillin GPotassium First Crystal 2.81 kg 2. Acetone 1.971 kg 3. Isopropyl Alcohol 0.66 kg 4. Dimethyl Formamide 1.314 kg 5. Methylene Chloride 3.29 kg 6. 2 Mercapto Benzo Thiazole 0.511 kg 7. Methanol 1.971 kg 14
Case No.:14/31/82ALC4/2010
Party Name:HETERO LABS LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/00939/AM11/ RLA File :09/24/040/00086/AM11/ Lic.No/Date:0910042201 01.06.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Export product Exp. Qty. S.No. Import items Qty. allowed Gemcitabine Hcl 1 kg 1. 2Deoxy2,2DifluoroDErythro Pentafuranous1Ulose3,5 Dibenzoate 5.14 kg 2. Methane Sulfonyl Chloride 2.89 kg 3. Iso Propyl Alcohol 10.53 kg 4. Hexamethyl Disilazane 1.28 kg 5. Methanol 1.60 kg 6. Acetone 5.05 kg 15
Case No.:77/40/82ALC4/2010
Party Name:SHREE VINAYAKA LIFE SCIENCES PVT LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/01276/AM11/ RLA File :09/24/040/00512/AM10/ Lic.No/Date:0910042212 02.06.2010 Defer Date:15.03.2011 Decision :Committee decided to defer case for 15.03.2011 for comments of Department of C&PC. 16
Case No.:83/40/82ALC4/2010
Party Name:SHREE VINAYAKA LIFE SCIENCES PVT LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/01282/AM11/ RLA File :09/24/040/00444/AM09/ Lic.No/Date:0910042211 02.06.2010 Defer Date:15.03.2011 Decision :Committee decided to defer case for 15.03.2011for comments of Department of C&PC.
17
Case No.:147/40/82ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01346/AM11/ RLA File :09/24/040/00072/AM11/ Lic.No/Date:0910042270 07.06.2010 Defer Date:26.04.2011 Decision :Committee decided to defer case for 26.04.2011 for comments of Department of Pharmaceuticals. 18
Case No.:12/26/82ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/00830/AM11/ RLA File :09/24/040/00093/AM11/ Lic.No/Date:0910042310 14.06.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Export product Exp. Qty. S.No. Import items Qty. allowed Telmisartan 1 kg 1. NMethylOPhenylendiamine dihydrochloride 0.74 kg 2. 7Methyl 2Propyl 3HBenzimidazole 5 Carboxylic Acid 0.75 kg 3. 4Bromo MethylBiphenyl 2Carboxylic Acid Methyl Ester 0.87 kg 19
Case No.:24/18/82ALC4/2010
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/00567/AM11/ RLA File :03/95/040/00196/AM11/ Lic.No/Date:0310579194 17.06.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Export product Exp. Qty. S.No. Import items Qty. allowed Choline Bitartrate USP 1 kg 1. L + Tartaric Acid 0.775 kg 20
Case No.:28/31/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/00953/AM11/ RLA File :09/24/040/00083/AM11/ Lic.No/Date:0910042514 25.06.2010 Defer Date:26.04.2011 Decision : Committee considered case as per agenda and observed that the firm has obtained the licence for export of Lamivudine (through Non Infringing Process) and in terms of Public Notice No.29 dated 14.02.211, the new cases are to be considered by RA. As regards the instant case,
g g ) , y g , Committee decided to call for Production and Consumption data certified by Central Excise Authority from the firm. Accordingly, the case was deferred for 26.04.2011. 21
Case No.:29/31/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 01.03.2011 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:29.03.2011 22
Case No.:11/16/82ALC4/2010
Party Name:ALEMBIC LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/00527/AM11/ RLA File :34/24/040/00077/AM11/ Lic.No/Date:3410027449 07.07.2010 Defer Date:15.03.2011 Decision :Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals. 23
Case No.:14/16/82ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/00530/AM11/ RLA File :09/24/040/00109/AM11/ Lic.No/Date:0910042643 08.07.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Export product Exp. Qty. S.No. Import items Qty. allowed Telmisartan 1 kg 1. 1,4Dimethyl2Propyl1H,3H[2.5] Dibenzimidazole 0.82 kg 2. 4Bromo MethylBiphenyl 2Carboxylic Acid Methyl Ester 0.87 kg 24
Case No.:28/26/82ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:48/82ALC4/2010 01.03.2011 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:15.03.2011 Decision :Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals. 25
Case No.:1/18/82ALC4/2010
Party Name:SUPER URECOAT INDUSTRIES Meet No/Date:48/82ALC4/2010 01.03.2011 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:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of C&PC, Petrochemicals Division.
26
Case No.:110/40/82ALC4/2010
Party Name:DSM ANTIINFECTIVES INDIA LTD 01.03.2011 Status:Case Approved HQ File :01/82/050/01309/AM11/ RLA File :22/24/040/00016/AM11/ Lic.No/Date:2210010202 21.07.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/182/2009PI(Norms) dated 04.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 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 27
Case No.:123/40/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 01.03.2011 Status:Case Deferred HQ File :01/82/050/01322/AM11/ RLA File :22/24/040/00015/AM11/ Lic.No/Date:2210010200 21.07.2010 Defer Date:15.03.2011 Decision :Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals. 28
Case No.:39/18/82ALC4/2010
Party Name:RELIANCE INDUSTRIES LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/00582/AM11/ RLA File :03/95/040/00277/AM11/ Lic.No/Date:0310584525 22.07.2010 Decision :Committee decided to close the case as the firm has surrendered the Advance Authorisation to RA for cancellation. 29
Case No.:40/18/82ALC4/2010
Party Name:RELIANCE INDUSTRIES LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/00583/AM11/ RLA File :03/95/040/00278/AM11/ Lic.No/Date:0310584527 22.07.2010 Decision : Committee decided to close the case as the firm has surrendered the Advance Authorisation to RA for cancellation. 30
Case No.:122/40/82ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01321/AM11/ RLA File :22/24/040/00025/AM11/ Lic.No/Date:2210010236 03.08.2010 Defer Date:26.04.2011 31
Case No.:106/40/82ALC4/2010
Party Name:DSM ANTIINFECTIVES INDIA Status:Case
LTD 01.03.2011 Approved HQ File :01/82/050/01305/AM11/ RLA File :22/24/040/00021/AM11/ Lic.No/Date:2210010237 04.08.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/182/2009PI(Norms) dated 04.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 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 32
Case No.:6/20/82ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:48/82ALC4/2010 01.03.2011 Status:Case Deferred HQ File :01/82/050/00632/AM11/ RLA File :09/24/040/00167/AM11/ Lic.No/Date:0910043026 10.08.2010 Defer Date:15.03.2011 Decision :Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals. 33
Case No.:15/31/82ALC4/2010
Party Name:R L FINE CHEM 01.03.2011 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:22.03.2011 Decision :Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 34
Case No.:10/48/82ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/01653/AM11/ RLA File :03/94/040/00442/AM11/ Lic.No/Date:0310588092 17.08.2010 Decision : : Committee considered case as per agenda and in light of earlier decision taken in 25/82 meeting held on 21.09.2010 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 Rosuvastatin Calcium 1 KG. 1. (4RCIS) 6[(ACETYLOXY) METHYL]2.2DIMETHYL1,3 DIOXANE4ACETIC ACID 1,1DIMETHYLETHYL ESTER 1.871 kg
35
Case No.:121/40/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 01.03.2011 Status:Case Deferred HQ File :01/82/050/01320/AM11/ RLA File :22/24/040/00030/AM11/ Lic.No/Date:2210010307 18.08.2010 Defer Date:29.03.2011 Decision :Committee decided to defer case for 29.03.2011 for comments of Department of Pharmaceuticals. 36
Case No.:23/23/82ALC4/2010
Party Name:DELTA FINOCHEM PVT.LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/00791/AM11/ RLA File :03/94/040/00249/AM11/ Lic.No/Date:0310589441 25.08.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.14010/111/2010Ch.II dated 28.02.2011 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 N Decyl Bromide 1 KG. 1. Decyl Alcohol 0.777 kg 2. Liquid Bromine 0.393 kg 37
Case No.:30/23/82ALC4/2010
Party Name:MEDREICH LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/00798/AM11/ RLA File :07/24/040/00200/AM11/ Lic.No/Date:0710073911 30.08.2010 Defer Date:29.03.2011 Decision :Committee decided to defer case for 29.03.2011 for comments of Department of Pharmaceuticals. 38
Case No.:32/23/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/00800/AM11/ RLA File :09/24/040/00211/AM11/ Lic.No/Date:0910043338 31.08.2010 Defer Date:22.03.2011 Decision :Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 39
Case No.:6/24/82ALC4/2010
Party Name:AARTI INDUSTRIES LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/00806/AM11/ RLA File :03/94/040/00373/AM11/ Lic.No/Date:0310590944 06.09.2010 Decision : : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms Export Product Export Qty. Sl.No. Import items Qty. allowed Ifosfamide 1 KG. 1. SKInt/3(2Chloroacetyl)2[(2Chloroethyl) Amino] Tetrahydro2H1,2,3 1.734 kg
] y , , Oxazephosphorine2Oxide 40
Case No.:9/24/82ALC4/2010
Party Name:RAMPEX LABS PVT. LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/00809/AM11/ RLA File :09/24/040/00194/AM11/ Lic.No/Date:0910043391 07.09.2010 Defer Date:29.03.2011 Decision :Committee decided to defer the case for 29.03.2011 for comments of Department of Pharmaceuticals. 41
Case No.:11/24/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 01.03.2011 Status:Case Approved HQ File :01/82/050/00811/AM11/ RLA File :03/94/040/00502/AM11/ Lic.No/Date:0310591355 07.09.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Export product Exp. Qty. S.No. Import items Qty. allowed (1S,3aR,6aS)tertButyl Octahydrocyclopenta[C] Pyrrole1Carboxylic Acid Oxalate 1 kg 1. 3Azabicyclo[3.3.O] Octane Hydrochloride 1.888 kg 2. CDX 656 Mono Amine Oxygenase (CDX 656 Lyophilised Enzyme (Powder) 0.21 kg 3. Catalase 25L (Enzyme) 0.100 kg 4. TertButyl Acetate 4.18 kg 5. Isopropanol 3.792 kg 42
Case No.:12/24/82ALC4/2010
Party Name:VHB MEDISCIENCES LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/00812/AM11/ RLA File :03/95/040/00447/AM11/ Lic.No/Date:0310591500 08.09.2010 Defer Date:26.04.2011 43
Case No.:43/31/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/00968/AM11/ RLA File :03/95/040/00341/AM11/ Lic.No/Date:0310593360 22.09.2010 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of Pharmaceuticals.
44
Case No.:70/40/82ALC4/2010
Party Name:INDSWIFT LABORATORIES LTD., 01.03.2011 Status:Case Deferred HQ File :01/82/050/01269/AM11/ RLA File :22/24/040/00042/AM11/ Lic.No/Date:2210010445 24.09.2010 Defer Date:29.03.2011 Decision : Committee decided to defer case for 29.03.2011 for comments of Department of Pharmaceuticals. 45
Case No.:100/40/82ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/01299/AM11/ RLA File :09/24/040/00249/AM11/ Lic.No/Date:0910043644 24.09.2010 Decision : Committee considered the case as per agenda and in light of earlier decision taken in 14/82 meeting held on 06.07.2010 and in consultation with Technical Authority present in the meeting decided to ratify the norms as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Cyclopentadecanolide (Recrystallised) 1 Kg. 1. Cyclopentadecanolide (technical grade) (purity NMT 98.5%) 1.075 kg 2. Methanol 2.00 kg RA Concerned may take further necessary action as per above decision of NC. 46
Case No.:5/28/82ALC4/2010
Party Name:ANUS LABORATORIES LTD., 01.03.2011 Status:Case Deferred HQ File :01/82/050/00887/AM11/ RLA File :09/24/040/00137/AM11/ Lic.No/Date:0910043673 28.09.2010 Defer Date:29.03.2011 Decision :Committee decided to defer case for 29.03.2011 for comments of Department of Pharmaceuticals. 47
Case No.:141/40/82ALC4/2010
Party Name:PERKIN LABORATORIES 01.03.2011 Status:Case Deferred HQ File :01/82/050/01340/AM11/ RLA File :09/24/040/00406/AM10/ Lic.No/Date:0910043680 28.09.2010 Defer Date:26.04.2011 48
Case No.:10/28/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/00892/AM11/ RLA File :09/24/040/00273/AM11/ Lic.No/Date:0910043757 30.09.2010 Defer Date:29.03.2011 Decision :Committee decided to defer case for 29.03.2011 for comments of Department of C&PC. 49
Case No.:20/28/82ALC4/2010
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 01.03.2011 Status:Case Approved
HQ File :01/82/050/00902/AM11/ RLA File :03/94/040/00567/AM11/ Lic.No/Date:0310594816 01.10.2010 Decision : Committee considered the case as per agenda and in consultation with Technical Authority present in the meeting decided to ratify the norms as per details below or as applied by the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Imipenem & Cilastatin for Injection USP 500 mg 1 Vial 1. Imipenem & Cilastatin USP (with Buffered Sodium Bicarbonate) 1023.488 mg/vial RA Concerned may take further necessary action as per above decision of NC. 50
Case No.:7/31/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/00932/AM11/ RLA File :09/24/040/00288/AM11/ Lic.No/Date:0910043910 14.10.2010 Decision : Committee considered the case as per agenda 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 Bisoprolol Fumarate 1 Kg. 1. 2Iso Propoxy Ethanol 3.0936 kg 2. Acetone 0.627 kg 3. Activated Carbon (Carbon Enoanticromos) 0.021 kg 4. Iso Propyl Alcohol 0.47 kg 5. Methanol (Methyl Alcohol) 1.00 kg 6. Methylene Chloride 4.036 kg 7. ParaHydroxy Benzyl Alcohol 1.203 RA Concerned may take further necessary action as per above decision of NC. 51
Case No.:8/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 01.03.2011 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:22.03.2011 Decision : Committee decided to defer the case for 22.03.2011 for comments of Department of Pharmaceuꬅcals. 52
Case No.:17/40/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01216/AM11/ RLA File :09/24/040/00304/AM11/ Lic.No/Date:0910043904 14.10.2010 Defer Date:26.04.2011
53
Case No.:60/40/82ALC4/2010
Party Name:INDIAN IMMUNOLOGICALS LTD., 01.03.2011 Status:Case Deferred HQ File :01/82/050/01259/AM11/ RLA File :09/24/040/00301/AM11/ Lic.No/Date:0910043933 15.10.2010 Defer Date:26.04.2011 Decision :Committee decided to defer case for 26.04.2011 for comments of Department of Biotechnology. 54
Case No.:124/40/82ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01323/AM11/ RLA File :22/24/040/00049/AM11/ Lic.No/Date:2210010535 18.10.2010 Deferred Date:22.03.2011 Decision :Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 55
Case No.:116/40/82ALC4/2010
Party Name:DSM ANTIINFECTIVES INDIA LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01315/AM11/ RLA File :22/24/040/00017/AM10/ Lic.No/Date:2210010540 19.10.2010 Defer Date:29.03.2011 Decision :Committee decided to defer case for 29.03.2011 for comments of Department of Pharmaceuticals. 56
Case No.:48/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 01.03.2011 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:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 57
Case No.:57/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01256/AM11/ RLA File :09/24/040/00237/AM11/ Lic.No/Date:0910043987 20.10.2010 Defer Date:26.04.2011 58
Case No.:130/40/82ALC4/2010
Party Name:UCB INDIA PVT. LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/01329/AM11/ RLA File :03/95/040/00585/AM11/ Lic.No/Date:0310598207 21.10.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.14010/31/2004Ch.II dated 14.01.2011 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
Chloroethoxy Acetamide/2 (2Chloro Ethoxy) Acetamide 1 KG. 1. 2(2Chloro Ethoxy) Acetic Acid 1.10 kg 59
Case No.:56/31/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/00981/AM11/ RLA File :09/24/040/00308/AM11/ Lic.No/Date:0910044015 22.10.2010 Decision : Committee considered case as per agenda and in consultation with representative of Department of Pharmaceuticals 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 NBenzyl 3(S)Hydroxy Pyrrolidine (BHP) 1 kg 1. LMalic Acid 2.69 kg 2. Benzyl Amine 2.28 kg 3. Tetrahydro Furan 3.77 kg 4. Sodium Boro Hydride 2.26 kg 5. RMandelic Acid 1.60 kg 60
Case No.:57/31/82ALC4/2010
Party Name:VIVIMED LABS LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/00982/AM11/ RLA File :09/24/040/00296/AM11/ Lic.No/Date:0910044017 22.10.2010 Decision : Committee considered the case as per agenda and in light of earlier decision taken in 15/11 meeting held on 13.07.2010 and in light of SION A2514 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 Trichlosan Oral Grade 60% Solution )VIVL60) confirming the following specifications: 2,3,7,8 Tetra Chloro Dibenzofuran<1 PPT, 2,4,4 Trichloro2Amino Diphenyl Ether<0.01%, 2,4,4 Trichloro2Amino Diphenyl Ether<0.01% 1 Kg. 1. 2,4 Dichloro Phenol 1.80 kg 2. Perchloro Ethylene 6.00 kg 3. Sodium Nitrite 0.38 kg RA Concerned may take further necessary action as per above decision of NC. 61
Case No.:18/40/82ALC4/2010
Party Name:LAKE CHEMICALS PRIVATE LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/01217/AM11/ RLA File :07/24/040/00283/AM11/ Lic.No/Date:0710074995 22.10.2010
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/64/2010PI (Norms) dated 01.10.2010 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 8Chloro3A, 4Dihydro6 (2 Fluorophenyl)1Methyl 3HImidazo(1,5A)(1,4) Benzodiazepine 1 Kg. 1. 2Amino Methyl7Chloro23 Dihydro5(2Flurophenyl) 1H1,4 Benzodiazepine Dimaleate 2.52 kg 2. Triethyl Ortho Acetate 0.90 kg 62
Case No.:3/32/82ALC4/2010
Party Name:ANUH PHARMA LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/00985/AM11/ RLA File :03/94/040/00649/AM11/ Lic.No/Date:0310598571 25.10.2010 Defer Date:26.04.2011 63
Case No.:125/40/82ALC4/2010
Party Name:DSM ANTIINFECTIVES INDIA LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01324/AM11/ RLA File :22/24/040/00055/AM11/ Lic.No/Date:2210010568 25.10.2010 Defer Date:26.04.2011 64
Case No.:41/40/82ALC4/2010
Party Name:LUPIN LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01240/AM11/ RLA File :03/95/040/00522/AM11/ Lic.No/Date:0310598693 26.10.2010 Defer Date:26.04.2011 65
Case No.:53/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01252/AM11/ RLA File :09/24/040/00281/AM11/ Lic.No/Date:0910044023 26.10.2010 Defer Date:26.04.2011 66
Case No.:2/32/82ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 01.03.2011 Status:Case Deferred HQ File :01/82/050/00984/AM11/ RLA File :07/24/040/00286/AM11/ Lic.No/Date:0710075068 27.10.2010 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals.
67
Case No.:6/32/82ALC4/2010
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 01.03.2011 Status:Case Deferred HQ File :01/82/050/00988/AM11/ RLA File :05/24/040/00266/AM11/ Lic.No/Date:0510275802 27.10.2010 Defer Date:26.04.2011 68
Case No.:50/40/82ALC4/2010
Party Name:CIPLA LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/01249/AM11/ RLA File :03/94/040/00679/AM11/ Lic.No/Date:0310598966 27.10.2010 Defer Date:22.03.2011 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms Export product Exp. Qty. Sl.No. Import items Qty. allowed Potassium Chloride Extended Release Capsules 750 mg/Potassium Chlor ER Caps USP 750 mg (Pack Size 100 Capsules Each) Each Extended Release Capsule contains: Potassium Chloride USP 750 mg 1 No. 1. Potassium Chloride USP 765 mg/Cap. 2. Citric Acid (Monohydrate USP) 10.00 mg/cap. 3. Dibutyl Sebacate NF 12.00 mg/cap 4. Ethanol USP 99.9% 2.62 ml/cap 5 to 8 Bottles, CRC and Screw Caps etc. Relevant as per packing policy Potassium Chloride Extended Release Capsules 750 mg/Potassium Chlor ER Caps USP 750 mg (Pack Size 500 Capsules Each) Each Extended Release Capsule contains: Potassium Chloride USP 750 mg 1 No. 69
Case No.:7/32/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 01.03.2011 Status:Case Approved HQ File :01/82/050/00989/AM11/ RLA File :03/94/040/00657/AM11/ Lic.No/Date:0310599277 28.10.2010 Defer Date: Decision : : Committee considered case as per agenda and in consultation with representative of Department of Pharmaceuticals 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 (1R,2S,5S)6,6Dimethyl3 Azabicyclo[3.1.0]Hexane 2Carboxylic Acid methyl Ester hydrochloride (BPVR503034T) 1 kg 1. Caronic Anhydrate 3.029 kg 2. Vitride [Sodium Bis(2 Methoxyethoxy) Aluminium 20.00 kg 3. Lypholized Enzyme Powder (CDX 616) 0.076 kg 70
Case No.:8/32/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 01.03.2011 Status:Case Deferred HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:26.04.2011 71
Case No.:140/40/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01339/AM11/ RLA File :05/23/040/00179/AM11/ Lic.No/Date:0510275915 28.10.2010 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 72
Case No.:12/32/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/00994/AM11/ RLA File :09/24/040/00300/AM11/ Lic.No/Date:0910044098 02.11.2010 Defer Date:26.04.2011 73
Case No.:1/33/82ALC4/2010
Party Name:SMILAX LABORATORIES LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/00995/AM11/ RLA File :09/24/040/00121/AM11/ Lic.No/Date:0910044100 02.11.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 2/09 meeting held on 08.04.2008 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 2Chloro Methyl3Methyl4 (2,2,2Trifluoro Ethoxy) Pyridine Hcl (Lansoprozole Chloro) 1 kg 1. 2,3Lutidine 0.79 kg 2. 2,2,2Trifluoro Ethanol 0.915 kg 3. Methylene DiChloride 1.68 kg
74
Case No.:36/40/82ALC4/2010
Party Name:CIPLA LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/01235/AM11/ RLA File :03/94/040/00694/AM11/ Lic.No/Date:0310600270 04.11.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/82 meeting held on 22.02.2011 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 Darunavir Hydrate 1 Kg. 1. Potassium Borohydride 0.29 kg 2. (3aR, 4S, 6aS)—4MethoxyTetrahydroFuro [3,4b]Furan2One [DNFuranone) 0.606 kg 3. N,NDisuccinimidyl Carbonate 0.90 kg 4. (2R,3S)N(3Amino2Hydroxy4 Phenylbutyl) –NIsobutyl4Amino Benzenesulfonamide (DNSulfonamide) 1.09 kg 75
Case No.:1/34/82ALC4/2010
01.03.2011 Status:Case Deferred HQ File :01/82/050/01007/AM11/ RLA File :09/24/040/00335/AM11/ Lic.No/Date:0910044198 10.11.2010 Defer Date:15.03.2011 Decision :Committee decided to defer the case for 15.03.2011 for comments of Department of Pharmaceuticals. 76
Case No.:44/40/82ALC4/2010
Party Name:LUPIN LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01243/AM11/ RLA File :03/95/040/00638/AM11/ Lic.No/Date:0310600874 11.11.2010 Defer Date:26.04.2011 77
Case No.:13/40/82ALC4/2010
Party Name:INDOCO REMEDIES LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01212/AM11/ RLA File :03/94/040/00680/AM11/ Lic.No/Date:0310601101 12.11.2010 Defer Date:26.04.2011 Decision :Committee decided to call for a copy of DML from the firm. Accordingly, case was deferred for 26.04.2011. 78
Case No.:91/40/82ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/01290/AM11/ RLA File :11/24/040/00025/AM11/ Lic.No/Date:1110023538 15.11.2010
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/275/2009PI(Norms) dated 09.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Prednisolone Sodium Phosphate 1 Kg. 1. Prednisolone (Prednisolone Base) 0.90 kg 79
Case No.:35/40/82ALC4/2010
Party Name:CIPLA LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/01234/AM11/ RLA File :03/94/040/00741/AM11/ Lic.No/Date:0310601510 16.11.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/82 meeting held on 22.02.2011 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 Atazanavir Sulphate 1 Kg. 1. 1[4(Pyridine2yl)Phenyl]5(S)2,5Bis [TertButyloxycarbonyl)Amino]4(S) Hydroxy6Phenyl2Azahexane (DIBOC Compound) 1.00 kg 2. NMethoxy CarbonylLTertLeucine (MOC Tertleucine) 0.933 kg 3. 1Ethyl3(3Dimethylaminopropyl) Carbodiimide Hydrochloride (EDC. Hcl) 0.79 kg 80
Case No.:3/40/82ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD Meet No/Date:48/82ALC4/2010 01.03.2011 Status:Case Deferred HQ File :01/82/050/01202/AM11/ RLA File :07/24/040/00316/AM11/ Lic.No/Date:0710075478 18.11.2010 Defer Date:15.03.2011 Decision :Committee decided to defer case for 15.03.2011 for comments of Department of C&PC. 81
Case No.:5/40/82ALC4/2010
Party Name:ALEMBIC LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01204/AM11/ RLA File :34/24/040/00214/AM11/ Lic.No/Date:3410028630 22.11.2010 Defer Date:26.04.2011
82
Case No.:5/36/82ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 01.03.2011 Status:Case Approved HQ File :01/82/050/01043/AM11/ RLA File :05/23/040/00219/AM11/ Lic.No/Date:0510277735 24.11.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.14010/82/2010Ch.II dated 04.02.2011 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 3Amino Methyl Pyridine 1 KG. 1. 3Cyanopyridine 1.13 kg 83
Case No.:8/36/82ALC4/2010
Party Name:ALKALOIDS CORPORATION 01.03.2011 Status:Case Approved HQ File :01/82/050/01046/AM11/ RLA File :02/24/040/00149/AM11/ Lic.No/Date:0210151007 24.11.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms Export product Exp. Qty. Sl.No. Import items Qty. allowed PapaverineHcl BP 1 Kg. 1. Papaverine Crude 1.00 kg 84
Case No.:28/40/82ALC4/2010
Party Name:HETERO DRUGS LIMITED, 01.03.2011 Status:Case Deferred HQ File :01/82/050/01227/AM11/ RLA File :09/24/040/00355/AM11/ Lic.No/Date:0910044427 24.11.2010 Defer Date:15.03.2011 Decision :Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals. 85
Case No.:59/40/82ALC4/2010
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01258/AM11/ RLA File :09/24/040/00324/AM11/ Lic.No/Date:0910044428 24.11.2010 Defer Date:15.03.2011 Decision :Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals. 86
Case No.:9/36/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01047/AM11/ RLA File :09/24/040/00311/AM11/ Lic.No/Date:0910044459 25.11.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals.
p 87
Case No.:22/40/82ALC4/2010
01.03.2011 Status:Case Approved HQ File :01/82/050/01221/AM11/ RLA File :09/24/040/00358/AM11/ Lic.No/Date:0910044449 25.11.2010 Decision : Committee considered the case as per agenda 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 Darunavir 1 Kg. 1. (2S,3S)1,2Epoxy3(BOCAmino)4Phenyl Butane 1.41 kg 2. (3aS,6aR)Tetrahydro4Methoxy Furo(3,4b) Furan2(3H)One 0.86 kg 3. Isobutyl Amine 2.06 kg 4. N,NDisuccinimidyl Carbonate 0.90 kg 5. Toluene 12.4 kg 6. Acetonitrile 3.90 kg RA Concerned may take further necessary action as per above decision of NC. 88
Case No.:25/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01224/AM11/ RLA File :09/24/040/00238/AM11/ Lic.No/Date:0910044429 25.11.2010 Defer Date:29.03.2011 Decision :Committee decided to defer case for 29.03.2011 for comments of Department of Pharmaceuticals. 89
Case No.:26/40/82ALC4/2010
01.03.2011 Status:Case Deferred HQ File :01/82/050/01225/AM11/ RLA File :09/24/040/00357/AM11/ Lic.No/Date:0910044448 25.11.2010 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 90
Case No.:29/40/82ALC4/2010
01.03.2011 Status:Case Approved HQ File :01/82/050/01228/AM11/ RLA File :09/24/040/00373/AM11/ Lic.No/Date:0910044455 25.11.2010 Decision : Committee considered the case as per agenda 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 Tenofovir Disoproxil Fumarate 1 Kg. 1. Adenine 0.914 kg 2. RPropylene Carbonate 0.7938 kg
Dimethyl Formamide 4.117 kg 4. Toluene 1.058 kg 5. Diethyl pToluene Sulphonyloxy Methyl Phosphonate 2.025 kg 6. Hydrobromic Acid 48% 6.54 kg 7. Methylene Chloride 7.84 kg 8. Chloromethyl Isopropyl Carbonate 2.0867 kg 9. NMethyl2Pyrrolidone 3.92 kg RA Concerned may take further necessary action as per above decision of NC. 91
Case No.:27/40/82ALC4/2010
01.03.2011 Status:Case Approved HQ File :01/82/050/01226/AM11/ RLA File :09/24/040/00367/AM11/ Lic.No/Date:0910044483 26.11.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/82 meeting held on 22.02.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 as per details below or as applied by the firm whichever is lower; Export product Exp. Qty. Sl.No. Import items Qty. allowed Tenofovir Disoproxil Fumarate 1 kg 1. R9(2Phosphonyl Methoxy Propyl)Propyl) Adenine 0.8026 kg 2. Chloromethyl Isopropyl Carbonate 2.0867 kg 3. NMethyl2Pyrrolidone 3.297 kg RA concerned may take further necessary action as per above decision of NC 92
Case No.:136/40/82ALC4/2010
Party Name:ALKALOIDS CORPORATION 01.03.2011 Status:Case Deferred HQ File :01/82/050/01335/AM11/ RLA File :02/24/040/00151/AM11/ Lic.No/Date:0210151146 26.11.2010 Defer Date:26.04.2011 93
Case No.:31/40/82ALC4/2010
Party Name:M.J. BIOPHARM PVT. LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/01230/AM11/ RLA File :03/95/040/00675/AM11/ Lic.No/Date:0310603466 29.11.2010 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of Pharmaceuticals. 94
Case No.:16/48/82ALC4/2010
Party Name:STERLING AUXILIARIES PVT LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01659/AM11/ RLA File :03/95/040/00651/AM11/ Lic.No/Date:0310603721 Defer
30.11.2010 Date:29.03.2011 Decision : Committee decided to defer case for 29.03.2011 for comments of Department of C&PC, Petrochemicals Division. 95
Case No.:14/48/82ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/01657/AM11/ RLA File :09/24/040/00356/AM11/ Lic.No/Date:0910044518 01.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms Export product Exp. Qty. Sl.No. Import items Qty. allowed Simvastatin 1 Kg. 1. Lovastatin 1.39 kg 2. 2,4Ditertiary Butyl Phenol 0.030 kg 3. Imidazole 0.58 kg 4. Tertiary Butyl Dimethyl Chlorosila 0.81 kg 5. 2,2Dimethyl Butyl Chloride 0.97 kg 6. 4Dimethyl Butyl Chloride 0.030 kg 96
Case No.:15/48/82ALC4/2010
Party Name:VIJAYASRI ORGANICS LTD 01.03.2011 Status:Case Approved HQ File :01/82/050/01658/AM11/ RLA File :09/24/040/00360/AM11/ Lic.No/Date:0910044517 01.12.2010 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed (1S,4R)4Amino 2Cyclopentene 1Methanol Tartrate (Cap2) 1 Kg. 1. Methylene Dichloride (MDC) 5.30 kg 2. Vincelactum 1.495 kg 3. Pyridine 1.923 kg 4. Sodium Boro Hydride (SBH) 0.22 kg 5. Methanol 4.88 kg 6. DTartaric Acid 1.089 kg 97
Case No.:2/40/82ALC4/2010
Party Name:MEDREICH LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/01201/AM11/ RLA File :07/24/040/00346/AM11/ Lic.No/Date:0710075813 02.12.2010
Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms under Export Product Export Qty. Sl.No. Import items Qty. allowed Paserix Forte Oral Solution 200 ml (32000 Nos) [Each 5 ml contains: Cyproheptadine Hcl 1.5 mg + Carnitine Hcl 150 mg + Lysine Hcl 150 mg + Thiamine Hcl 10 mg + Pyridoxine Hcl 10 mg + Cyanocobalamin 100 mcg] 321.60 mg/5 ml 411.648 kg 1. Carnitine Hcl BP/USP/EP/IH 195.84 kg 98
Case No.:20/40/82ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/01219/AM11/ RLA File :03/94/040/00755/AM11/ Lic.No/Date:0310604218 02.12.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 44/82 meeting held on 27.01.2010 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Atorvastatin Calcium 1 Kg. 1. (4RCIS)1,1Dimethyl Ethyl6(2[2(4 Fluorophenyl)5(1,Methylethyl)3 Phenyl4[(Phenylamino)]Carbonyl]1H Pyrrol1yl)Ethyl2,2Dimethyl1,3 Dioxan4Acetate 1.00 kg 2. 4Fluoro9(2Methyl1Oxopropyl)9 OxoN,Beta Diaphenyl Benzenebutanamide 1.15 kg 99
Case No.:13/48/82ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 01.03.2011 Status:Case Deferred HQ File :01/82/050/01656/AM11/ RLA File :09/24/040/00329/AM11/ Lic.No/Date:0910044574 06.12.2010 Defer Date:26.04.2011 100 Case No.:10/43/82ALC4/2010 Party Name:HETERO DRUGS LIMITED, 01.03.2011 Status:Case Approved
HQ File :01/82/050/01473/AM11/ RLA File :09/24/040/00403/AM11/ Lic.No/Date:0910044668 13.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Export product Exp. Qty. Sl.No. Import items Qty. allowed Lisinopril 1 Kg. 1. N2[(1S)Ethoxy Carbonyl3PhenylPropyl]N6 TrifluoroacetylLLysine 1.92 kg 2. LProline 0.927 kg 3. N,NCarbonyldiimidazole 0.400 kg 4. Methanol 2.82 kg 5. Methylene Chloride 9.59 kg 6. Isopropyl Alcohol 3.80 kg 101
Case No.:11/43/82ALC4/2010
01.03.2011 Status:Case Approved HQ File :01/82/050/01474/AM11/ RLA File :09/24/040/00411/AM11/ Lic.No/Date:0910044666 13.12.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 45/82 meeting held on 08.02.2011 and in consultation with representative of Department of Pharmaceuticals 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 Quetiapine Hemifumarate 1 kg 1. 1[2(2Hydroxyethoxy)Ethyl]Piperazine 0.714 kg 2. Toluene 1.40 kg 3. Methanol 1.06 kg 102
Case No.:10/44/82ALC4/2010
Party Name:TRIGON CHEMICALS PVT. LTD. Meet No/Date:48/82ALC4/2010 01.03.2011 Status:Case Deferred HQ File :01/82/050/01509/AM11/ RLA File :31/24/040/00178/AM11/ Lic.No/Date:3110045863 13.12.2010 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of C&PC. 103 Case No.:12/44/82ALC4/2010 Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/01511/AM11/ RLA File :31/24/040/00133/AM11/ Lic.No/Date:3110045861 13.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/6/2009Ch.II dated 28.02.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of
y p g, y p Export Product Export Qty. Sl.No. Import items Qty. allowed Acetyl Anisole 1 KG. 1. Phenol 0.885 kg 2. Caustic Soda Lye 0.440 kg 3. Dimethyl Sulfate 0.680 kg 104
Case No.:37/44/82ALC4/2010
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/01536/AM11/ RLA File :31/24/040/00187/AM11/ Lic.No/Date:3110045874 13.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/6/2009Ch.II dated 28.02.2011 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 Acetyl Anisole 1 KG. 1. Phenol 0.885 kg 2. Caustic Soda Lye 0.440 kg 3. Dimethyl Sulfate 0.680 kg 105
Case No.:73/40/82ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.03.2011 Status:Case Deferred HQ File :01/82/050/01272/AM11/ RLA File :17/24/040/00086/AM09/ Lic.No/Date:1710003611 14.12.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of C&PC. 106 Case No.:7/40/82ALC4/2010 Party Name:SUVEN LIFE SCIENCES LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/01206/AM11/ RLA File :09/24/040/00414/AM11/ Lic.No/Date:0910044683 15.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms Export product Exp. Qty. Sl.No. Import items Qty. allowed N(2Amino4,6Dichloro Pyrimidin5YL)Fromamide 1 Kg. 1. 2,5Diamino4, 6Hydroxy Pyrimidine Hcl 1.72 kg 2. N,NDimethyl Formamide 0.58 kg 3. Chloroform 3.89 kg
107
Case No.:11/40/82ALC4/2010
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 01.03.2011 Status:Case Deferred HQ File :01/82/050/01210/AM11/ RLA File :05/23/040/00250/AM11/ Lic.No/Date:0510279466 15.12.2010 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of Pharmaceuticals. 108
Case No.:74/40/82ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.03.2011 Status:Case Deferred HQ File :01/82/050/01273/AM11/ RLA File :17/24/040/00165/AM08/ Lic.No/Date:1710003615 15.12.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of C&PC. 109
Case No.:62/40/82ALC4/2010
Party Name:M.J. BIOPHARM PVT. LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/01261/AM11/ RLA File :03/95/040/00719/AM11/ Lic.No/Date:0310606819 16.12.2010 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of Pharmaceuticals. 110
Case No.:64/40/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01263/AM11/ RLA File :09/24/040/00416/AM11/ Lic.No/Date:0910044737 16.12.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals. 111
Case No.:65/40/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 01.03.2011 Status:Case Deffered HQ File :01/82/050/01264/AM11/ RLA File :09/24/040/00417/AM11/ Lic.No/Date:0910044738 16.12.2010 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 112
Case No.:75/40/82ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.03.2011 Status:Case Deferred HQ File :01/82/050/01274/AM11/ RLA File :17/24/040/00045/AM09/ Lic.No/Date:1710003616 16.12.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of C&PC. 113 Case No.:9/48/82ALC4/2010 Party Name:LUPIN LIMITED Status:Case
01.03.2011 Deferred HQ File :01/82/050/01652/AM11/ RLA File :03/95/040/00715/AM11/ Lic.No/Date:0310606750 16.12.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals. 114
Case No.:71/40/82ALC4/2010
Party Name:ANDHRA ORGANICS LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01270/AM11/ RLA File :09/24/040/00354/AM11/ Lic.No/Date:0910044743 20.12.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of Pharmaceuticals. 115
Case No.:76/40/82ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.03.2011 Status:Case Deferred HQ File :01/82/050/01275/AM11/ RLA File :17/24/040/00033/AM10/ Lic.No/Date:1710003624 20.12.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of C&PC. 116
Case No.:142/40/82ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.03.2011 Status:Case Deferred HQ File :01/82/050/01341/AM11/ RLA File :17/24/040/00167/AM08/ Lic.No/Date:1710003626 21.12.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of C&PC. 117
Case No.:143/40/82ALC4/2010
Party Name:ESTEEM INDUSTRIES PVT. LTD, 01.03.2011 Status:Case Deferred HQ File :01/82/050/01342/AM11/ RLA File :17/24/040/00153/AM08/ Lic.No/Date:1710003627 21.12.2010 Defer Date:15.03.2011 Decision : Committee decided to defer case for 15.03.2011 for comments of Department of C&PC. 118 Case No.:32/44/82ALC4/2010 Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/01531/AM11/ RLA File :31/24/040/00188/AM11/ Lic.No/Date:3110046108 23.12.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/6/2009Ch.II dated 28.02.2011 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 Monomethyl Ether of Hydroquinone MEHQ 1 KG. 1. Phenol 1.19 kg 2. Dimethyl Sulphate 0.640 kg
Caustic Soda Flakes 0.415 kg 4. Hydrogen Peroxide (50%) 0.610 kg 5. Acetone 0.300 kg 119
Case No.:8/48/82ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/01651/AM11/ RLA File :09/24/040/00424/AM11/ Lic.No/Date:0910044887 24.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms Export Product Export Qty. Sl.No. Import items Qty. allowed Bicalutamide 1 KG. 1. N[(4Cyano3Trifluoromethyl)methyl]2 Methyl Oxirane Carboxamide 1.11 kg 2. 4Fluorobenzothiol 0.50 kg 120
Case No.:20/41/82ALC4/2010
01.03.2011 Status:Case Approved HQ File :01/82/050/01368/AM11/ RLA File :09/24/040/00430/AM11/ Lic.No/Date:0910044915 27.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms Export Product Export Qty. Sl.No. Import items Qty. allowed 2Amino5Chloro2,2,2Trifluoro Acetophenone 1 KG. 1. 4Chloro2Trifluoro Acetylaniline Hydrochloride Hydrate 1.24 kg 2. Methanol 0.70 kg 3. Methylene Chloride 0.77 kg 121 Case No.:21/41/82ALC4/2010 01.03.2011 Status:Case Approved HQ File :01/82/050/01369/AM11/ RLA File :09/24/040/00429/AM11/ Lic.No/Date:0910044916 27.12.2010 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms
Export Product Export Qty. Sl.No. Import items Qty. allowed 2ChloroN(2Chloro4Methyl3 Pyridinyl)3Pyridine Carboxamide 1 KG. 1. 2Chloro Nicotinic Acid 0.777 kg 2. Thionyl Chloride 1.00 kg 3. Dimethyl Formamide 3.88 kg 4. Malononitrile 0.724 kg 5. Toluene 2.42 kg 6. Phosphorous Oxychloride 2.49 kg 7. Methylene Chloride 2.61 kg 8. Dimethyl Sulfoxide 1.40 kg 9. Sodium Hydroxide 1.20 kg 10. Pyridine 0.405 kg 122
Case No.:16/44/82ALC4/2010
Party Name:GLENMARK GENERICS LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01515/AM11/ RLA File :03/94/040/00851/AM11/ Lic.No/Date:0310608261 28.12.2010 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 123
Case No.:27/44/82ALC4/2010
Party Name:SARAF CHEMICALS LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/01526/AM11/ RLA File :03/95/040/00788/AM11/ Lic.No/Date:0310608152 28.12.2010 Defer Date:26.04.2011 Decision :Committee decided to call for purity of import and export items and process details from the firm. Accordingly, case was deferred for 26.04.2011. 124
Case No.:25/44/82ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 01.03.2011 Status:Case Approved HQ File :01/82/050/01524/AM11/ RLA File :52/24/040/00028/AM11/ Lic.No/Date:5210033299 05.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/45/2010Ch.II dated 27.09.2010 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of Export product Exp. Qty. Sl.No. Import items Qty. allowed Sulpho Gamma Acid (7 Amino1Naphthol3,6 Disulfonic Acid 1 Kg. 1. K Acid 2.500 kg
125
Case No.:15/44/82ALC4/2010
Party Name:BLISS GVS PHARMA LTD. 01.03.2011 Status:Case Deferred HQ File :01/82/050/01514/AM11/ RLA File :03/94/040/00887/AM11/ Lic.No/Date:0310609857 06.01.2011 Defer Date:22.03.2011 Decision : Committee decided to defer case for 22.03.2011 for comments of Department of Pharmaceuticals. 126
Case No.:14/44/82ALC4/2010
Party Name:CIPLA LIMITED 01.03.2011 Status:Case Approved HQ File :01/82/050/01513/AM11/ RLA File :03/94/040/00892/AM11/ Lic.No/Date:0310610020 07.01.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/82 meeting held on 22.02.2011 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 Atazanavir Sulphate 1 Kg. 1. 1[4(Pyridine2yl)Phenyl]5(S)2,5Bis [TertButyloxycarbonyl)Amino]4(S) Hydroxy6Phenyl2Azahexane (DIBOC Compound) 1.00 kg 2. NMethoxy CarbonylLTertLeucine (MOC Tertleucine) 0.933 kg 3. 1Ethyl3(3Dimethylaminopropyl) Carbodiimide Hydrochloride (EDC. Hcl) 0.79 kg 127
Case No.:33/44/82ALC4/2010
Party Name:CLARION DRUGS LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/01532/AM11/ RLA File :50/24/040/00023/AM11/ Lic.No/Date:5010000500 13.01.2011 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms Export product Exp. Qty. Sl.No. Import items Qty. allowed 3Hydroxy Acetophenone 99% Assay Value 1 Kg. 1. Acetophenone 99.5 Assay Value 2.37 kg 128 Case No.:1/44/82ALC4/2010 Party Name:VISEN INDUSTRIES LIMITED 01.03.2011 Status:Case Deferred
HQ File :01/82/050/01500/AM11/ RLA File :03/95/040/00749/AM11/ Lic.No/Date:0310611695 19.01.2011 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of C&PC, Petrochemicals Division. 129
Case No.:2/44/82ALC4/2010
Party Name:ARCH PHARMALABS LTD 01.03.2011 Status:Case Approved HQ File :01/82/050/01501/AM11/ RLA File :03/94/040/00901/AM11/ Lic.No/Date:0310611746 19.01.2011 Decision : Committee considered case as per agenda and in consultation with representative of Department of Pharmaceuticals 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 (1R,2S,5S)6,6Dimethyl3 Azabicyclo[3.1.0]Hexane 2Carboxylic Acid methyl Ester hydrochloride (BPVR503034T) 1 kg 1. Caronic Anhydrate 3.029 kg 2. Vitride [Sodium Bis(2 Methoxyethoxy) Aluminium 20.00 kg 3. Lypholized Enzyme Powder (CDX 616) 0.076 kg 130
Case No.:3/44/82ALC4/2010
Party Name:STERLING AUXILIARIES PVT LTD 01.03.2011 Status:Case Approved HQ File :01/82/050/01502/AM11/ RLA File :03/95/040/00797/AM11/ Lic.No/Date:0310611792 19.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/34/2010Ch.II dated 28.02.2011 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 Stero MEA (Mono Ethanol Amine Purity 99%) 1 kg 1. Mono Ethanol Amine (Purity 90%) 1.11 kg Stero Co 300 (BG) (Polyoxyethylene Ricinoleic Acid 40 Mole Ethoxylate 1 kg 1. Ethylene Oxide 0.667 kg 131
Case No.:35/44/82ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:48/82ALC4/2010 01.03.2011 Status:Case Deferred HQ File :01/82/050/01534/AM11/ RLA File :09/24/040/00421/AM11/ Lic.No/Date:0910045225 25.01.2011 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of Pharmaceuticals.
132
Case No.:36/44/82ALC4/2010
Party Name:VASANT CHEMICALS PRIVATE LIMITED 01.03.2011 Status:Case Deferred HQ File :01/82/050/01535/AM11/ RLA File :09/24/040/00480/AM11/ Lic.No/Date:0910045226 25.01.2011 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of C&PC. 133
Case No.:1/48/82ALC4/2010
Party Name:CHIRAG ENTERPRISE 01.03.2011 Status:Case Deferred HQ File :01/82/050/01644/AM11/ RLA File :24/24/040/00014/AM11/ Lic.No/Date:2410030871 14.02.2011 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of C&PC. 134
Case No.:4/48/82ALC4/2010
Party Name:ORION CHEM PVT.LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/01647/AM11/ RLA File :03/95/040/00901/AM11/ Lic.No/Date:0310615898 14.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/34/2010Ch.II dated 09.04.2010 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 2,3 Dimethyl 2,3 Dinitro Butane 1 kg 1. 2Nitro Propane 1.12 kg 135
Case No.:5/48/82ALC4/2010
Party Name:ALKYL AMINES CHEMICALS LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01648/AM11/ RLA File :03/94/040/00428/AM10/ Lic.No/Date:0310615980 14.02.2011 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of C&PC. 136
Case No.:6/48/82ALC4/2010
Party Name:ALKYL AMINES CHEMICALS LTD 01.03.2011 Status:Case Deferred HQ File :01/82/050/01649/AM11/ RLA File :03/94/040/00124/AM10/ Lic.No/Date:0310615982 14.02.2011 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of C&PC. 137 Case No.:7/48/82ALC4/2010 Party Name:ALKYL AMINES CHEMICALS Status:Case
LTD 01.03.2011 Deferred HQ File :01/82/050/01650/AM11/ RLA File :03/94/040/00121/AM10/ Lic.No/Date:0310615984 14.02.2011 Defer Date:26.04.2011 Decision : Committee decided to defer case for 26.04.2011 for comments of Department of C&PC. 138
Case No.:2/48/82ALC4/2010
Party Name:PI INDUSTRIES LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/01645/AM11/ RLA File :13/24/040/00036/AM11/ Lic.No/Date:1310034609 15.02.2011 Decision :Committee decided to close the case as the Advance Authorisation has been issued under para 4.7.1 of HBP. 139
Case No.:3/48/82ALC4/2010
Party Name:PI INDUSTRIES LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/01646/AM11/ RLA File :13/24/040/00035/AM11/ Lic.No/Date:1310034610 15.02.2011 Decision : Committee decided to close the case as the Advance Authorisation has been issued under para 4.7.1 of HBP. 140
Case No.:11/48/82ALC4/2010
Party Name:PI INDUSTRIES LTD., 01.03.2011 Status:Case Approved HQ File :01/82/050/01654/AM11/ RLA File :13/24/040/00034/AM11/ Lic.No/Date:1310034611 15.02.2011 Decision : Committee decided to close the case as the Advance Authorisation has been issued under para 4.7.1 of HBP. 141
Case No.:12/48/82ALC4/2010
Party Name:HALDIA PETROCHEMICALS LTD. 01.03.2011 Status:Case Approved HQ File :01/82/050/01655/AM11/ RLA File :02/24/040/00200/AM11/ Lic.No/Date:0210154872 15.02.2011 Decision : Committee considered case as per agenda for ratification of norms and in light of earlier decision taken in 15/82 meeting held on 13.07.2010 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 Benzene (from Olefin Complex) 1 MT 1. Naphtha 1.194 MT
Case No.Outside Agenda1
M/S Amines & Plasticizers Ltd. F.No.01/83/050/01084/AM08/DESIII F.No.01/83/050/00958/AM08/DESIII F.No.01/82/050/00251/AM09/DESIII
F.No.01/82/050/00364/AM11/DESIII F.No.01/82/050/00611/AM11/DESIII RA F.No.03/94/040/00567/AM08 RA F.No.03/94/040/00478/AM08 RA F.No.03/94/040/01217/AM08 RA F.No.03/94/040/00066/AM11 RA F.No.03/94/040/00391/AM11 Adv.Lic.No.0310441545 dated 31.08.2007 Adv.Lic.No.0310439186 dated 10.08.2007 Adv.Lic.No.0310463452 dated 03.03.2008 Adv.Lic.No.0310573855 dated 12.05.2010 Adv.Lic.No.0310595070 dated 04.10.2010 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “Aminosol CST 115” without any other change in the earlier decisions of NC.
Case No.Outside Agenda2
M/S Shalina Laboratories Pvt. Ltd. F.No.01/82/050/00724/AM11/DESIII RA F.No.03/95/040/00213/AM11 Adv.Lic.No.0310582826 dated 09.07.2010 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to enhance the quantity of Gentamycin Sulphate to the extent of 25.704 mg/15 gram tube and 51.408 mg/30 mg tube without any other change in the decision taken in 26/82 meeting held on 28.09.2010.
Case No.Outside Agenda3
M/S Sarna Chemicals Pvt. Ltd. F.No.01/82/050/01131/AM09/DESIII RA F.No.03/95/040/00570/AM09 Adv.Lic.No.0310489322 dated 07.10.2008 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “2(3Amino Benzamido) Ethylsulfontl Ethyl Hydrogensulfate (Samba Amine or Samba OR XE Base” without any other change in the decision taken in 35/82 meeting held on 25.11.2008.
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