DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 24/82ALC4/2011 MEETING DATE : 13.09.2011 The Meeting No.24/82 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 was held on 13.09.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri M. Mitra, Dy. DCGI, Office of DCGI 2. Shri V.K. Tyagi, Dy.I.A, Department of Pharmaceuticals 3. Shri S.S. Bose, Sr. D.O., DIPP 4. Shri Jasbir Singh, Consultant, Department of C&PC 5. Shri Pramod Bharti, Asstt. Director, DC(MSME) 6. Shri D.N. Mathur, Pharmexcil 7. Shri D. Dwarkanath, Dy. DGFT 8. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No.23/82 dated 06.09.2011 were ratified by the Committee.
Case No.B254
M/S Parabolic Drugs Ltd. Norms Committee Meeting No.24/AM12 F.No.01/82/050/00802/AM10/DESIII Meeting Date:13.09.2011 RA F.No.05/24/040/00383/AM10 Adv.Lic.No.0510253942 dated 04.12.2009 Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing. It was, therefore, decided to give one more opportunity of personal hearing to the firm for 27.09.2011. Accordingly, the case was deferred for 04.10.2011.
Case No.B255
M/S Porus Laboratories Pvt. Ltd. F.No.01/82/050/00888/AM11/DESIII F.No.01/82/050/01478/AM11/DESIII F.No.01/82/050/01717/AM11/DESIII F.No.01/82/050/00611/AM12/DESIII RA F.No.09/24/040/00274/AM11 RA F.No.09/24/040/00457/AM11 RA F.No.09/24/040/00536/AM11 RA F.No.09/24/040/00133/AM12 Adv.lic.No.0910043692 dated 28.09.2010 Adv.lic.No.0910045121 dated 12.01.2011 Adv.lic.No.0910045740 dated 28.02.2011 Adv.lic.No.0910047479 dated 05.07.2011 Committee considered case as per agenda. Shri Namala, Director of the company appeared before the company for personal hearing. He explained that they have sought import of Activated Carbon for purification
against four advance authorizations and he submitted production and consumption data certified by Central Excise Authority certifying the consumption of Activated Carbon to the extent of 0.483 kg/kg of export product. After detailed deliberations and in consultation with technical authority present in meeting, Committee decided to allow import of Activated Carbon to the extent of 0.483 kg/kg of export product without any other change in the earlier decision of NC. RA concerned may take further necessary action as per above decision of NC.
Case No.B256
M/S Navin Fluorine International Ltd. F.No.01/82/050/00909/AM09/DESIII RA F.No.03/95/040/00339/AM09 Adv.Lic.No.0310483194 dated 21.08.2008 Committee considered case as per agenda and in light of earlier decision taken in 40/82 meeting held on 30.12.2008 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 Exp. Qty. Sl.No. Import items Qty. allowed MetaAmino Benzo Trifluoride Purity 100% 1 kg 1. Meta Amino Benzo Trifluoride 1.01 kg
Case No.B257
M/S Navin Fluorine International Ltd. F.No.01/82/050/00701/AM09/DESIII RA F.No.03/95/040/00154/AM09 Adv.Lic.No.0310474030 dated 10.06.2008 Committee considered case as per agenda and in light of earlier decision taken in 18/82 meeting held on 03.08.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ortho Amino Benzo Tri Fluoride NLT 99.9% 1 kg 1. Ortho Amino Benzotrifluoride NMT 99.5% 1.01 kg
Case No.B258
M/S Auctus Pharma Ltd. F.No.01/82/050/00879/AM10/DESIII RA F.No.09/70/040/00176/AM10 Adv.Lic.No.0910040573 dated 08.01.2010 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 “Pentoprazole Sulfide (OR) 5(Difluoro
Methoxy)2{[(3,4Dimethoxy2Pyridinyl(Methyl]thio}1H Benzimidazole” without any other change in the earlier decisions of NC.
Case No.B259
M/S Aurobindo Pharma Ltd. F.No.01/82/050/00471/AM12/DESIII RA F.No.09/24/040/00227/AM11 Adv.Lic.No.09100466589 dated 02.05.2011 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of import item No.5 to read as “Methyl Iodide” and to revise its quantity to 0.61 kg/kg of export product without any other change in the decision taken in 16/82 meeting held on 19.07.2011.
Case No.B260
M/S Vijayasri Organics Ltd. F.No.01/82/050/00643/AM10/DESIII RA F.No.09/24/040/00240/AM10 Adv.Lic.No.0910039761 dated 29.10.2009 Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/71/2008PIIII dated 30.08.2008 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 (1S,4R)4(2Amino6Chloro 5Formamido4Pyrimidinyl) Amino2Cyclopentene1 Methanol (AFC) 1kg. 1. (+)2Azabicyclo (2.2.1) Hept Ene3One (Vancelactam) 100% 2.18 kg kg 2. Methylene Dichloride 5.00 kg 3. Pyridine 3.48 kg 4. Sodium Borohydride (SBH) 0.317 kg 5. Methanol 2.60 kg 6. DTartaric Acid 1.06 kg 7. Dimethyl Formamide (DMF) 0.433 kg 8. 2,5 Diamino 4,6 Dihydroxypyrimidine (DADHP) 1.638 kg 9. Toluene 1.76 kg 10. Propionic Acid 1.35 kg
Case No.B261
M/S Divis Laboratories Ltd. F.No.01/82/162/01029/AM11/DESIII F.No.01/82/162/01030/AM11/DESIII F.No.01/82/162/01031/AM11/DESIII F.No.01/82/162/01032/AM11/DESIII F.No.01/82/162/01036/AM11/DESIII F.No.01/82/162/01037/AM11/DESIII F.No.01/82/162/01038/AM11/DESIII F.No.01/82/162/01039/AM11/DESIII F.No.01/82/162/01040/AM11/DESIII F.No.01/82/162/01041/AM11/DESIII F.No.01/82/162/01042/AM11/DESIII F.No.01/82/162/01043/AM11/DESIII F.No.01/82/162/01044/AM11/DESIII Adv.Lic.No.09100466589 dated 02.05.2011 Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals.
Case No.B262
M/S Divis Laboratories Ltd. Norms Committee Meeting No.24/12 F.No.01/82/162/00152/AM12/DESIII F.No.01/82/162/00153/AM12/DESIII F.No.01/82/162/00154/AM12/DESIII F.No.01/82/162/00155/AM12/DESIII F.No.01/82/162/00156/AM12/DESIII F.No.01/82/162/00157/AM12/DESIII F.No.01/82/162/00158/AM12/DESIII F.No.01/82/162/00159/AM12/DESIII F.No.01/82/162/00160/AM12/DESIII F.No.01/82/162/00161/AM12/DESIII F.No.01/82/162/00162/AM12/DESIII F.No.01/82/162/00163/AM12/DESIII F.No.01/82/162/00164/AM12/DESIII F.No.01/82/162/00165/AM12/DESIII F.No.01/82/162/00166/AM12/DESIII F.No.01/82/162/00167/AM12/DESIII F.No.01/82/162/00168/AM12/DESIII F.No.01/82/162/00169/AM12/DESIII F.No.01/82/162/00170/AM12/DESIII Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals.
Case No.B263
M/S Divis Laboratories Ltd. Norms Committee Meeting No.24/12 F.No.01/82/162/01092/AM12/DESIII F.No.01/82/162/01093/AM12/DESIII
F.No.01/82/162/00171/AM12/DESIII F.No.01/82/162/00172/AM12/DESIII F.No.01/82/162/00173/AM12/DESIII F.No.01/82/162/00174/AM12/DESIII F.No.01/82/162/00175/AM12/DESIII F.No.01/82/162/00176/AM12/DESIII F.No.01/82/162/00177/AM12/DESIII F.No.01/82/162/00178/AM12/DESIII F.No.01/82/162/00179/AM12/DESIII F.No.01/82/162/00180/AM12/DESIII F.No.01/82/162/00182/AM12/DESIII F.No.01/82/162/00183/AM12/DESIII F.No.01/82/162/00184/AM12/DESIII F.No.01/82/162/00185/AM12/DESIII F.No.01/82/162/00186/AM12/DESIII F.No.01/82/162/00187/AM12/DESIII F.No.01/82/162/00188/AM12/DESIII F.No.01/82/162/00189/AM12/DESIII F.No.01/82/162/00190/AM12/DESIII F.No.01/82/162/00191/AM12/DESIII F.No.01/82/162/00192/AM12/DESIII F.No.01/82/162/00193/AM12/DESIII F.No.01/82/162/00194/AM12/DESIII Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals.
Case No.B264
M/S Camphor & Allied Products Ltd F.No.01/82/050/01154/AM11/DESIII RA F.No.03/94/040/00534/AM11 Adv.Lic.No.0310592694 dated 16.09.2010 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 “Camphor Technical” without any other change in the decision taken in 39/82 meeting held on 28.12.2010.
Case No.B265
M/S Merck Ltd. F.No.01/82/050/00950/AM11/DESIII RA F.No.03/95/040/00409/AM10 Adv.Lic.No.0310540425 dated 06.10.2009 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the uom of Acetone from kg to liter without any other change in the decision taken in 46/82 meeting held on 09.02.2010.
Case No.B266
M/S Camphor & Allied Products Ltd F.No.01/82/050/00714/AM11/DESIII F.No.01/82/050/00962/AM11/DESIII F.No.01/82/050/01525/AM11/DESIII RA F.No.03/94/040/00299/AM11 RA F.No.03/94/040/00509/AM11 RA F.No.03/94/040/00840/AM11 Adv.Lic.No.0310581965 dated 02.07.2010 Adv.Lic.No.0310591338 dated 07.09.2010 Adv.Lic.No.0310608725 dated 30.12.2010 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 “Astrolide Pure” without any other change in the earlier decisions.
Case No.B267
M/S Euromed Health Pvt. Ltd. F.No.01/82/050/00712/AM11/DESIII RA F.No.35/24/040/00018/AM11 Adv.Lic.No.3510030697 dated 21.06.2010 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to call for production and consumption data certified by Central Excise Authority certifying the consumption of imported and indigenous inputs. Accordingly, the case was deferred for 11.10.2011.
Case No.B268
M/S GVS Labs. F.No.01/82/162/00397/AM12/DESIII F.No.01/82/162/00396/AM12/DESIII RA F.No.03/94/040/01305/AM06 RA F.No.03/94/040/01137/AM06 Adv.Lic.No.0310368505 dated 24.02.2006 Adv.Lic.No.0310363042 dated 13.01.2006 Committee considered case as per agenda and in light of earlier decision taken in 44/11 meeting held on 01.02.2011 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 the firm whichever is lower: Advance licence No.0310368505 dated 24.02.2006 Export product Exp. Qty. Sl.No. Import items Qty. allowed Clavumoccid 125 Oral Suspension 60 ml Bottles containing 80% Amoxicilline 46000 Nos. 1. 80% Amoxicilline Trihydrate & 20% Clavulanate Potassium) (Mixed Powder Form) 86.1695 kg.
Trihydrate and 20% Clavulanate Potassium) Advance licence No.0310363042 dated 13.01.2006 Export product Exp. Qty. Sl.No. Import items Qty. allowed Clavumoccid 250 Oral Suspension 60 ml Bottles containing 80% Amoxicilline Trihydrate and 20% Clavulanate Potassium) 23000 Nos. 1. 80% Amoxicilline Trihydrate & 20% Clavulanate Potassium) (Mixed Powder Form) 86.1695 kg.
Case No.B269
M/S Medreich Ltd. F.No.01/82/050/01543/AM11/DESIII RA F.No.07/24/040/00433/AM11 Adv.Lic.No.0710076954 dated 27.01.2011 Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals.
Case No.A30
M/S Camlin Fine Chemicals Ltd. F.No.01/82/162/00471/AM12/DESIII Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to call for the following information from the firm: 1. Details of manufacturing process with chemical equations. 2. Molecular Formula. 3. Molecular weight. 4. Yield obtained at each stage of manufacturing process. 5. Production and consumption data certified by C.A. for the last three years. Accordingly, case was deferred for 11.10.2011.
Case No.C52
M/S Alkem Laboratories Ltd. F.No.01/82/162/01131/AM11/DESIII Committee considered case as per agenda and decided to remind the firm to furnish production and consumption data certified by Central Excise Authority and also to remind Pharmexcil to furnish All Industry data. Accordingly, case was deferred for 11.10.2011.
Case No.C53
M/S Shasun Pharmaceuticals Ltd. F.No.01/82/162/01146/AM11/DESIII Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 11.10.2011. 1
Case No.:3/32/82ALC4/2008
Party Name:D.TOTLA PLASTIC Meet No/Date:24/82ALC4/2011 13.09.2011 Status:Case Deferred HQ File :01/82/050/01178/AM09/ RLA File :03/94/040/00710/AM09/ Lic.No/Date:0310491145 20.10.2008 Defer Date:27.09.2011 Decision :Committee decided to call for the firm for personal hearing on 27.09.2011. The representative of Department of C&PC (Petrochemicals Division) may also be requested to attend the meeting. Accordingly, case was deferred for 27.09.2011. 2
Case No.:12/49/82ALC4/2009
Party Name:B. BRAUN MEDICAL (INDIA) PVT. LTD 13.09.2011 Status:Case Rejected HQ File :01/82/050/01147/AM10/ RLA File :04/24/040/00144/AM10/ Lic.No/Date:0410111650 17.02.2010 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish technical details vide letter dated 23.07.2010, but no reply has been received and norms can not be fixed in the absence of required information. Accordingly, it was decided to reject the case. 3
Case No.:30/4/82ALC4/2011
Party Name:ASTRIX LABORATORIES LTD., 13.09.2011 Status:Case Approved HQ File :01/82/050/00081/AM12/ RLA File :09/24/040/00330/AM10/ Lic.No/Date:0910042634 07.07.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/68/2008PIIII dated 17.07.2008 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. Description of import item Qty. allowed 5OTrityl Thymidine 1kg. 1. Beta Thymidine 0.507 kg 2. Trityl Chloride 0.583 kg 3. Triethylamine 0.757 kg 4. 1,4Dioxane 1.94 kg 5. Toluene 2.32 kg
4
Case No.:28/26/82ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 13.09.2011 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:11.10.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 11.10.2011. 5
Case No.:56/41/82ALC4/2010
Party Name:LUPIN LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/01404/AM11/ RLA File :03/95/040/00392/AM11/ Lic.No/Date:0310589566 26.08.2010 Defer Date:27.09.2011 Decision :Committee decided to defer case for 27.09.2011 for comments of Department of Pharmaceuticals. 6
Case No.:80/41/82ALC4/2010
Party Name:CHIRAG ENTERPRISE 13.09.2011 Status:Case Deferred HQ File :01/82/050/01428/AM11/ RLA File :24/24/040/00009/AM11/ Lic.No/Date:2410029974 27.10.2010 Defer Date:27.09.2011 Decision : Committee decided to call for the firm for personal hearing on 27.09.2011. The representative of Department of C&PC (Petrochemicals Division) may also be requested to attend the meeting. Accordingly, case was deferred for 27.09.2011. 7
Case No.:28/4/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 13.09.2011 Status:Case Approved HQ File :01/82/050/00079/AM12/ RLA File :22/24/040/00056/AM11/ Lic.No/Date:2210010630 16.11.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 23/82 meeting held on 06.09.2011 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 Cefpirome Sulphate for Injections (Sterile) 1 Kg. 1. Cefpirome Sulphate Non Sterile 0.86 kg 2. Sodium Carbonate 0.17 kg 3. Acetic Acid 2.27 kg 4. Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate (EDTA) 0.0019 kg 5. Carbon DCEcoantiromos 0.083 kg 6. Acetone 2.295 kg
8
Case No.:31/4/82ALC4/2011
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00082/AM12/ RLA File :04/24/040/00218/AM11/ Lic.No/Date:0410119146 24.11.2010 Defer Date:11.10.2011 Decision :Committee decided to call for a copy of Drug Manufacturing Licence from the firm. Accordingly, case was deferred for 11.10.2011. 9
Case No.:20/47/82ALC4/2010
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/01610/AM11/ RLA File :09/24/040/00230/AM11/ Lic.No/Date:0910044835 21.12.2010 Defer Date:11.10.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 11.10.2011. 10
Case No.:8/44/82ALC4/2010
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 13.09.2011 Status:Case Approved HQ File :01/82/050/01507/AM11/ RLA File :03/94/040/00811/AM11/ Lic.No/Date:0310612024 20.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Biotechnology vide their O.M. No.BT/IL/05/345/2011PID dated 12.09.2011 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 Leuprolide 1 gm. 1. BocArg(Hcl)OH 3.53 gms 2. BocProOH 1.669 gms 3. FmocLeuOH 3.77 gms 4. FmocDLeuOH 3.76 gms 5. FmocTyr(tBu)OH 3.67 gms 6. FmocSer(tBu)OH 3.18 gms 7. FmocTrpOH 3.04 gms 8. FmocHis(Trt)OH 4.41 gms 9. Cessium Carbonate 1.637 gms 10. Merrifield Resin 2.547 gms. 11. Pyroglutamic Acid (PgluOH) 1.10 gms 12. Hydroxybenxotriazole (HOBt) 35.31 gms 13. Diisopropylcarbodiimide (DIPCDI) 12.56 ml 14. Diethyl Ether Dried 932.584 ml 15. Piperidine 55.45 ml 16. Tri fluoroacetic Acid (TFA) 70.38 ml 17. Diisopropylethylamine (DIEA) 8.53 ml 18. Ethyl Alcohol 696.629 ml 19. Kromasil 2.00 gms
11
Case No.:35/44/82ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 13.09.2011 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:11.10.2011 Decision : Committee decided to call from the firm production and consumption data for the export product Methyl2(2Chloro5Propionyl Phenyl) Acetate certified by Central Excise Authority. Accordingly, case was deferred for 11.10.2011. 12
Case No.:3/4/82ALC4/2011
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00054/AM12/ RLA File :04/24/040/00291/AM11/ Lic.No/Date:0410121620 14.02.2011 Defer Date:11.10.2011 Decision :Committee decided to call for a copy of Drug Manufacturing Licence from the firm. Accordingly, case was deferred for 11.10.2011. 13
Case No.:4/3/82ALC4/2011
Party Name:JINDAL DRUGS LIMITED 13.09.2011 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:11.10.2011 Decision :Committee decided to defer case for 11.10.2011 for comments of Department of C&PC. 14
Case No.:11/8/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00211/AM12/ RLA File :09/24/040/00499/AM11/ Lic.No/Date:0910045601 18.02.2011 Defer Date:27.09.2011 Decision :Committee decided to defer case for 27.09.2011 for comments of Department of Pharmaceuticals. 15
Case No.:12/8/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 13.09.2011 Status:Case Approved HQ File :01/82/050/00212/AM12/ RLA File :09/24/040/00485/AM11/ Lic.No/Date:0910045600 18.02.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/393/2009PI(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. Sl.No. Import items Qty. allowed Lopinavir (TPA Route) 1 Kg. 1. (2S)(1Tetrahydro Pyrimid2Only)3Methyl Butanoic Acid (TPA) 1.161 kg 2. Triphosgene 0.715 kg 3. Tetrahydrofuran 5.25 kg
2,6Dimethoxy Phenol 0.618 kg 5. Sodium Borohydride 0.89 kg 6. Dimethyl formamide 2.48 kg 7. Methylene Di Chloride 9.62 kg 8. Methane Sulfonic Acid 2.485 kg 9. Iso Propyl Alcohol 1.07 kg 10. 1,2Dimethoxy Ethane 29.38 kg 11. Methyl Tertiary Butyl Ether 2.86 kg 12. Methanol 7.62 kg 13. (L)Pyroglu Tamic Acid 0.57 kg 16
Case No.:13/8/82ALC4/2011
Party Name:HETERO LABS LIMITED 13.09.2011 Status:Case Approved HQ File :01/82/050/00213/AM12/ RLA File :09/24/040/00532/AM11/ Lic.No/Date:0910045591 18.02.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 22/82 meeting held on 04.10.2007 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 Benazepril Hcl 1 Kg. 1. R2Hydroxy4Phenyl Butyric Acid Ethyl Ester 0.9091 kg 2. NNitrobenzene Sulfonyl Chloride 1.00 kg 3. N,NCarbonyldimidazole 0.45 kg 4. S3Amino2,3,4,5tetrahydro2oxo—1H Benzazepine1acetic acid tert. Butyl ester 0.8873 kg 5. Sodium Borohydride 0.32 kg 6. Methylene Chloride 17.54 kg 17
Case No.:5/4/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 13.09.2011 Status:Case Deferred HQ File :01/82/050/00056/AM12/ RLA File :03/95/040/00949/AM11/ Lic.No/Date:0310620143 08.03.2011 Defer Date:11.10.2011 Decision :Committee decided to defer case for 11.10.2011 for comments of Department of Biotechnology. 18
Case No.:29/8/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00229/AM12/ RLA File :03/94/040/01012/AM11/ Lic.No/Date:0310620022 08.03.2011 Defer Date:11.10.2011 Decision : Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals.
19
Case No.:9/4/82ALC4/2011
Party Name:UCB INDIA PVT. LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00060/AM12/ RLA File :03/95/040/01000/AM11/ Lic.No/Date:0310620783 11.03.2011 Defer Date:11.10.2011 Decision : Committee decided to defer case for 11.10.2011 for comments of Department of C&PC. 20
Case No.:30/8/82ALC4/2011
Party Name:KOPRAN LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00230/AM12/ RLA File :03/94/040/01136/AM11/ Lic.No/Date:0310623342 25.03.2011 Defer Date:11.10.2011 21
Case No.:15/19/82ALC4/2011
Party Name:HETERO LABS LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00529/AM12/ RLA File :09/24/040/00597/AM11/ Lic.No/Date:0910046128 29.03.2011 Defer Date:11.10.2011 22
Case No.:16/19/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00530/AM12/ RLA File :09/24/040/00314/AM11/ Lic.No/Date:0910046126 29.03.2011 Defer Date:11.10.2011 23
Case No.:13/4/82ALC4/2011
Party Name:HETERO LABS LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00064/AM12/ RLA File :09/24/040/00594/AM11/ Lic.No/Date:0910046274 06.04.2011 Defer Date:11.10.2011 24
Case No.:15/4/82ALC4/2011
13.09.2011 Status:Case Deferred HQ File :01/82/050/00066/AM12/ RLA File :09/24/040/00604/AM11/ Lic.No/Date:0910046277 06.04.2011 Defer Date:11.10.2011 25
Case No.:18/4/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES Status:Case
LIMITED (FORMERLY JUBILANT 13.09.2011 Deferred HQ File :01/82/050/00069/AM12/ RLA File :05/23/040/00380/AM11/ Lic.No/Date:0510287716 07.04.2011 Defer Date:11.10.2011 Decision :Committee considered case as per agenda and observed that Department of C&PC vide their letter No.14010/82/2010Ch.II dated 19.07.2011, has called for the following information from the firm which has not been received: 1. Details of manufacturing process with chemical equations, molecular formula and molecular weight. 2. Yields obtained in each step. 3. Printed technical literature in support of yield obtained in each step supported with authentic technical literature and norms claimed. 4. CA certificate regarding past three years production and corresponding consumption of different raw materials. 5. Central Excise data. It was decided to remind the firm to furnish the above information. Accordingly, case was deferred for 11.10.2011. 26
Case No.:19/4/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 13.09.2011 Status:Case Deferred HQ File :01/82/050/00070/AM12/ RLA File :05/23/040/00381/AM11/ Lic.No/Date:0510287719 07.04.2011 Defer Date:11.10.2011 Decision : Committee considered case as per agenda and observed that Department of C&PC vide their letter No.14010/82/2010Ch.II dated 19.07.2011, has called for the following information from the firm which has not been received: 1. Details of manufacturing process with chemical equations, molecular formula and molecular weight. 2. Yields obtained in each step. 3. Printed technical literature in support of yield obtained in each step supported with authentic technical literature and norms claimed. 4. CA certificate regarding past three years production and corresponding consumption of different raw materials. 5. Central Excise data. It was decided to remind the firm to furnish the above information. Accordingly, case was deferred for 11.10.2011. 27
Case No.:33/4/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 13.09.2011 Status:Case Approved HQ File :01/82/050/00084/AM12/ RLA File :09/24/040/00599/AM11/ Lic.No/Date:0910046300 08.04.2011 Decision : Committee considered case as per agenda and in light of production and consumption data certified by Central Excise Authority and in consultation with technical authority present in meeting, decided to 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 2Chloro Thioxanthane (CTX) 1 Kg. 1. 4Chlorothiophenol 1.00 kg 2. 2Chlorobenzonitrile 0.94 kg 3. Dimethyl Sulfoxide 1.54 kg 4. Poly Phosphoric Acid 3.517 kg
28
Case No.:45/4/82ALC4/2011
Party Name:UNI WORLD PHARMA PVT LTD 13.09.2011 Status:Case Approved HQ File :01/82/050/00096/AM12/ RLA File :03/95/040/00014/AM12/ Lic.No/Date:0310625967 11.04.2011 Decision : Committee considered case as per agenda and observed that the NOC for import of “HFA227 Propellant (1,1,1,2,3,3,3Heptafluoropropane gas)” has been received from Ministry of Environment & Forests vide their O.M. No.11/10/2011OC dated 13.09.2011. Committee after detailed deliberations and in light of earlier decision taken in 4/82 meeting held on 26.04.2011 and 13/12 meeting held on 28.06.2011 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 Ipratropium Bromide 20 mcg inhaler (200MD) with 50 mcl Aerosol Valves 1 No. 1. Ipratropium Bromide 4.00 mg 2. 50 mcl Aerosol valve As per packing policy 3. 19 ml Aluminium Can 4. Activators with dust covers/caps fitting to 19ml Aluminium can 5. HFA227 Propellant (1,1,1,2,3,3,3Heptafluoropropane gas) 16.76 gm. Salbutamol 100 mcg and Ipratropium Bromide 20 mcg inhaler (200MD) with 50 mcl Aerosol valves 1 No. 1. Sulbutamol 20.00 mg 2. Ipratropium Bromide 4.00 mg 3. 19 ml Aluminium Can As per packing policy 4. 63 mcl Aerosol valve 5. Activators with dust covers/caps fitting to 19ml Aluminium can 6. HFA227 Propellant (1,1,1,2,3,3,3Heptafluoropropane gas) 16.76 mg Budesonide 100 mcg inhaler (200MD) with 50 mcl Aerosol valves 1 No. 1. Budesonide 20.00 mg 2. 63 mcl Aerosol valve As per packing policy 3. 19 ml Aluminium Can 4. Activators with dust covers/caps fitting to 19ml Aluminium can 5. HFA227 Propellant (1,1,1,2,3,3,3Heptafluoropropane gas) 16.76 mg Budesonide 200 mcg inhaler (200MD) with 50 mcl Aerosol valves 1 No. 1. Budesonide 40.00 mg 2. 63 mcl Aerosol valve As per packing policy 3. 19 ml Aluminium Can 4. Activators with dust covers/caps fitting to 19ml Aluminium can 5. HFA227 Propellant 16.76 mg
(1,1,1,2,3,3,3Heptafluoropropane gas) RA concerned may take further necessary action as per above decision of NC subject to the condition that firm shall maintain proper record for actual consumption of Gas against this licence and pay duty on any unutilized gas since they have shown 20% overfilling of HFA227 Propellant Gas. 29
Case No.:48/4/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00099/AM12/ RLA File :09/24/040/00003/AM12/ Lic.No/Date:0910046368 12.04.2011 Defer Date:11.10.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 11.10.2011. 30
Case No.:49/4/82ALC4/2011
13.09.2011 Status:Case Deferred HQ File :01/82/050/00100/AM12/ RLA File :09/24/040/00564/AM11/ Lic.No/Date:0910046383 13.04.2011 Defer Date:11.10.2011 Decision :Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals. 31
Case No.:33/12/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 13.09.2011 HQ File :01/82/050/00366/AM12/ RLA File :08/24/040/00002/AM12/ Lic.No/Date:0810098227 13.04.2011 Defer Date:11.10.2011 32
Case No.:16/12/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00349/AM12/ RLA File :03/94/040/00042/AM12/ Lic.No/Date:0310627685 21.04.2011 Defer Date:27.09.2011 Decision : Committee decided to defer case for 27.09.2011 for comments of DC(MSME). 33
Case No.:11/19/82ALC4/2011
Party Name:PORUS LABORATORIES PVT LTD. 13.09.2011 Status:Case Approved HQ File :01/82/050/00525/AM12/ RLA File :09/24/040/00019/AM12/ Lic.No/Date:0910046428 21.04.2011 Decision :Committee considered case as per agenda. Shri Namala, Director of the company appeared before the Committee for personal hearing and explained the case. He informed the Committee that the purity of export product is 99% whereas the purity of import item is 2%. After detailed deliberations and in consultation with technical authority present in meeting, Committee decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:
Export product Exp. Qty. Sl.No. Import items Qty. allowed 2(2(3(2(7Chloro2 Quinolinyl)Ethenyl Phenyl)3 Hydroxy Propyl)Phenyl)2 Propanol 1 Kg. 1. 2(2(3(2(7Chloro2 Quinolinyl)Ethenyl Phenyl)3 Hydroxy Propyl)Phenyl)2 Propanol (Crude) 1.02 kg 34
Case No.:23/12/82ALC4/2011
Party Name:CIPLA LIMITED 13.09.2011 Status:Case Approved HQ File :01/82/050/00356/AM12/ RLA File :03/94/040/00084/AM12/ Lic.No/Date:0310628617 28.04.2011 Decision : Committee considered case as per agenda and observed that the NOC for import of “HFA134A Gas (1,1,1,2 Tetrafluroethane) (HFA134 A Propellant) has been received from Ministry of Environment & Forests vide their O.M. No.11/10/2011OC dated 28.06.2011. Committee after detailed deliberations and in light of earlier decision taken in 35/82 meeting held on 25.11.2008 and 13/12 meeting held on 28.06.2011 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 Aerobud 100mcg Inhaler (200MD) with 50mcl Aerosol Valve (Budenoside inhaler 100mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. 0.5 mm OD Acuators with dust covers/caps fitting to 19ml Aluminium Can As per packing policy 5. Zephex 134 A (1,1,1,2 Tetrafluoro ethane)(HFA 134 A Propellant) 16.76 gm. Aerobud 200mcg Inhaler (200MD) with 50mcl Aerosol Valve (Budenoside inhaler 200mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 16.76 gm. Aerobud 100mcg Inhaler (200MD) with 58mcl Aerosol Valve (Budenoside inhaler 100mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing
) policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler (200MD) with 58mcl Aerosol Valve (Budenoside inhaler 200mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler (200MD) with 63mcl Aerosol Valve (Budenoside inhaler 200mcg (200MD)) with 63 mcl Aerosol Valve (Contains Zephex 134 A & Ethanol) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 63 mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 21.12 gm. 6. Ethanol 2.73 gm. Aerobud 100mcg Inhaler (300MD) with 40mcl Aerosol Valve (Budenoside inhaler 100mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 17.0 gm. Aerobud 200mcg Inhaler (300MD) with 40mcl Aerosol Valve (Budenoside inhaler 200mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.06 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 17.0 gm.
Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 14.4 gm. Salbutamol 100mcg Inhaler (200MD) with 58mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Salbutamol 300mcg Inhaler (300MD) with 40mcl Aerosol Valve (Asthavent 100 mcg inhaler (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 17.00 gm. Beclate 50mcg Inhaler Valve (Beclomethasone Dipropionate50 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. Beclomethasone Dipropionate 0.01 gm. 2. Aerosol Valves 63mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 17.74 gm. 6. Ethanol 0.455 gm. Beclate 100mcg Inhaler Valve (Beclomethasone Dipropionate100 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. As per packing
covers/caps fitting to 19ml Aluminium Can policy 5. 17.30 gm. 6. Ethanol 0.91 gm. Beclate 200mcg Inhaler Valve (Beclomethasone Dipropionate200 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 16.4 gm. 6. Ethanol 1.82 gm. Beclate 250mcg Inhaler Valve (Beclomethasone Dipropionate250 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.05 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 15.9 gm. 6. Ethanol 2.27 gm. The Ministry of Environment and Forests (Ozone Cell) have given their No Objection Certificate for import of Zephex 134a (1,1,1,2 Tetrafluoroethane) Propolen Gas by M/S Cipla Ltd vide their O.M. No.11/10/2008OC dated 28.07.2008. The above norms have been ratified by NC subject to the following conditions: 1. The quantity of HFA 134A Propellant Gas in the above norms is inclusive of 20% overages to compensate leakage, priming and non retrieval dose remaining inside the Can and and allowance for shot weight variation. However no wastage is claimed for APIs by the firm. 2. The firm will maintain a separate record for the actual consumption of HFA 134A Propellant Gas and will pay duty on the surplus quantity of gas remained unutilized, if any. 35
Case No.:20/12/82ALC4/2011
Party Name:CIPLA LIMITED 13.09.2011 Status:Case Approved HQ File :01/82/050/00353/AM12/ RLA File :03/94/040/00095/AM12/ Lic.No/Date:0310628898 29.04.2011 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. Sl.No. Import items Qty. allowed Florfenicol Oral Powder 50%/Florfenox 50% Premix (per pack 10 kg) 1 pack of 10 kg 1. Florfenicol 5.05 kg 36
Case No.:4/8/82ALC4/2011
13.09.2011 Status:Case Deferred HQ File :01/82/050/00204/AM12/ RLA File :09/24/040/00606/AM11/ Lic.No/Date:0910046587 02.05.2011 Defer Date:11.10.2011 37
Case No.:6/8/82ALC4/2011
13.09.2011 Status:Case Deferred HQ File :01/82/050/00206/AM12/ RLA File :09/24/040/00032/AM12/ Lic.No/Date:0910046590 02.05.2011 Defer Date:11.10.2011 38
Case No.:8/8/82ALC4/2011
Party Name:MAITHRI LABORATORIES (P) LTD., 13.09.2011 HQ File :01/82/050/00208/AM12/ RLA File :09/24/040/00015/AM12/ Lic.No/Date:0910046598 03.05.2011 39
Case No.:22/12/82ALC4/2011
Party Name:CIPLA LIMITED 13.09.2011 Status:Case Approved HQ File :01/82/050/00355/AM12/ RLA File :03/94/040/00101/AM12/ Lic.No/Date:0310629181 03.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by DOP vide their U.O. No.35011/101/2008PIIII dated 03.12.2008 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 Aerobud 100mcg Inhaler (200MD) with 50mcl Aerosol Valve (Budenoside inhaler 100mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml As per packing policy
Aluminium Can 5. 16.76 gm. Aerobud 200mcg Inhaler (200MD) with 50mcl Aerosol Valve (Budenoside inhaler 200mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 16.76 gm. Aerobud 100mcg Inhaler (200MD) with 58mcl Aerosol Valve (Budenoside inhaler 100mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler (200MD) with 58mcl Aerosol Valve (Budenoside inhaler 200mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 63 mcl Aerosol Valve (Contains Zephex 134 A & Ethanol) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 63 mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 21.12 gm. 6. Ethanol 2.73 gm. Aerobud 100mcg Inhaler (300MD) with 40mcl Aerosol Valve (Budenoside inhaler 1 No. 1. Budenoside 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy
100mcg (300MD)) with 40 mcl Aerosol Valve) 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 17.0 gm. Aerobud 200mcg Inhaler (300MD) with 40mcl Aerosol Valve (Budenoside inhaler 200mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.06 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 17.0 gm. Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 16.76 gm. Salbutamol 100mcg Inhaler (200MD) with 58mcl Aerosol Valve (Asthavent 100 mcg inhaler (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Salbutamol 300mcg Inhaler (300MD) with 40mcl Aerosol Valve (Asthavent 100 mcg inhaler (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 17.00 gm.
Beclate 50mcg Inhaler Valve (Beclomethasone Dipropionate50 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.01 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 17.74 gm. 6. Ethanol 0.455 gm. Beclate 100mcg Inhaler Valve (Beclomethasone Dipropionate100 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 17.30 gm. 6. Ethanol 0.91 gm. Beclate 200mcg Inhaler Valve (Beclomethasone Dipropionate200 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 16.4 gm. 6. Ethanol 1.82 gm. Beclate 250mcg Inhaler Valve (Beclomethasone Dipropionate250 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. 0.05 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fitting to 19ml Aluminium Can As per packing policy 5. 15.9 gm. 6. Ethanol 2.27 gm. The Ministry of Environment and Forests (Ozone Cell) have given their No Objection Certificate for import of Zephex 134a (1,1,1,2 Tetrafluoroethane) Propolen Gas by M/S Cipla Ltd vide their O.M. No.11/10/2008OC dated 28.07.2008.
The above norms have been ratified by NC subject to the following conditions: 3. The quantity of HFA 134A Propellant Gas in the above norms is inclusive of 20% overages to compensate leakage, priming and non retrieval dose remaining inside the Can and and allowance for shot weight variation. However no wastage is claimed for APIs by the firm. 4. The firm will maintain a separate record for the actual consumption of HFA 134A Propellant Gas and will pay duty on the surplus quantity of gas remained unutilized, if any. 40
Case No.:18/16/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00476/AM12/ RLA File :09/24/040/00011/AM12/ Lic.No/Date:0910046614 03.05.2011 Defer Date:11.10.2011 Decision :Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals. 41
Case No.:3/8/82ALC4/2011
Party Name:NAPROD LIFE SCIENCES PVT. LTD. 13.09.2011 Status:Case Deferred HQ File :01/82/050/00203/AM12/ RLA File :03/95/040/00084/AM12/ Lic.No/Date:0310629782 05.05.2011 Defer Date:11.10.2011 42
Case No.:13/12/82ALC4/2011
Party Name:UCB INDIA PVT. LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00346/AM12/ RLA File :03/95/040/00091/AM12/ Lic.No/Date:0310629593 05.05.2011 Defer Date:11.10.2011 Decision : Committee decided to defer case for 11.10.2011 for comments of Department of C&PC. 43
Case No.:20/16/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00478/AM12/ RLA File :09/24/040/00007/AM12/ Lic.No/Date:0910046649 05.05.2011 Defer Date:11.10.2011 Decision : Committee decided to defer case for 11.10.2011 for comments of Department of C&PC. 44
Case No.:2/8/82ALC4/2011
Party Name:EMBIO LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00202/AM12/ RLA File :03/94/040/01025/AM11/ Lic.No/Date:0310629987 06.05.2011 Defer Date:11.10.2011
45
Case No.:19/8/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00219/AM12/ RLA File :09/24/040/00071/AM12/ Lic.No/Date:0910046667 06.05.2011 Defer Date:11.10.2011 46
Case No.:16/16/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00474/AM12/ RLA File :09/24/040/00070/AM12/ Lic.No/Date:0910046668 06.05.2011 Defer Date:11.10.2011 47
Case No.:15/16/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00473/AM12/ RLA File :09/24/040/00035/AM12/ Lic.No/Date:0910046677 09.05.2011 Defer Date:11.10.2011 48
Case No.:42/8/82ALC4/2011
Party Name:FRESENIUS KABI ONCOLOGY LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00242/AM12/ RLA File :05/23/040/00366/AM11/ Lic.No/Date:0510290205 10.05.2011 Defer Date:11.10.2011 49
Case No.:43/8/82ALC4/2011
Party Name:EMBIO LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00243/AM12/ RLA File :03/94/040/01024/AM11/ Lic.No/Date:0310630508 10.05.2011 Defer Date:11.10.2011 50
Case No.:44/8/82ALC4/2011
Party Name:EMBIO LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00244/AM12/ RLA File :03/94/040/01023/AM11/ Lic.No/Date:0310630510 10.05.2011 Defer Date:11.10.2011 51
Case No.:5/12/82ALC4/2011
Party Name:LUPIN LIMITED 13.09.2011 Status:Case Deferred
HQ File :01/82/050/00338/AM12/ RLA File :03/95/040/00067/AM12/ Lic.No/Date:0310630428 10.05.2011 Defer Date:11.10.2011 52
Case No.:14/12/82ALC4/2011
Party Name:LUPIN LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00347/AM12/ RLA File :03/95/040/00098/AM12/ Lic.No/Date:0310630420 10.05.2011 Defer Date:11.10.2011 53
Case No.:29/12/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00362/AM12/ RLA File :22/24/040/00096/AM11/ Lic.No/Date:2210011304 10.05.2011 Defer Date:11.10.2011 Decision :Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011. 54
Case No.:31/12/82ALC4/2011
LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00364/AM12/ RLA File :22/24/040/00097/AM11/ Lic.No/Date:2210011303 10.05.2011 Defer Date:11.10.2011 Decision : Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011. 55
Case No.:50/8/82ALC4/2011
Party Name:VIJAYASRI ORGANICS LTD 13.09.2011 HQ File :01/82/050/00250/AM12/ RLA File :09/24/040/00592/AM11/ Lic.No/Date:0910046744 12.05.2011 Decision :Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals. 56
Case No.:28/12/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD 13.09.2011 HQ File :01/82/050/00361/AM12/ RLA File :22/24/040/00006/AM12/ Lic.No/Date:2210011337 12.05.2011 Decision : Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011.
57
Case No.:30/12/82ALC4/2011
LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00363/AM12/ RLA File :22/24/040/00007/AM12/ Lic.No/Date:2210011338 12.05.2011 Defer Date:11.10.2011 Decision : Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011. 58
Case No.:17/16/82ALC4/2011
Party Name:SMILAX LABORATORIES LIMITED 13.09.2011 HQ File :01/82/050/00475/AM12/ RLA File :09/24/040/00501/AM11/ Lic.No/Date:0910046743 12.05.2011 Decision :Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals. 59
Case No.:37/12/82ALC4/2011
LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00370/AM12/ RLA File :22/24/040/00008/AM12/ Lic.No/Date:2210011350 13.05.2011 Defer Date:11.10.2011 Decision : Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011. 60
Case No.:32/12/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 13.09.2011 Status:Case Approved HQ File :01/82/050/00365/AM12/ RLA File :22/24/040/00009/AM12/ Lic.No/Date:2210011368 20.05.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 23/82 meeting held on 06.09.2011 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 Dexketoprofen Trometamol 1 kg 1. Ketoprofen 1.700 kg 2. NOctylDGlucamine 0.46 kg 61
Case No.:44/14/82ALC4/2011
Party Name:ONEIRO CHEMICALS LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00435/AM12/ RLA File :34/24/040/00037/AM12/ Lic.No/Date:3410030415 30.05.2011 Defer Date:11.10.2011
Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 11.10.2011. 62
Case No.:14/11/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 13.09.2011 Status:Case Deferred HQ File :01/82/050/00328/AM12/ RLA File :09/24/040/00106/AM12/ Lic.No/Date:0910046965 01.06.2011 Defer Date:11.10.2011 Decision :Committee decided to defer case for 11.10.2011 for comments of Department of Pharmaceuticals. 63
Case No.:18/11/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 13.09.2011 HQ File :01/82/050/00332/AM12/ RLA File :09/24/040/00080/AM12/ Lic.No/Date:0910046973 02.06.2011 Decision : Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 11.10.2011. 64
Case No.:38/12/82ALC4/2011
Party Name:SRINI PHARMACEUTICALS LTD., 13.09.2011 Status:Case Deferred HQ File :01/82/050/00371/AM12/ RLA File :09/24/040/00113/AM12/ Lic.No/Date:0910046991 03.06.2011 Defer Date:11.10.2011 Decision : Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 11.10.2011. 65
Case No.:22/16/82ALC4/2011
LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00480/AM12/ RLA File :22/24/040/00013/AM12/ Lic.No/Date:2210011461 03.06.2011 Defer Date:11.10.2011 Decision : Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011. 66
Case No.:23/16/82ALC4/2011
LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00481/AM12/ RLA File :22/24/040/00012/AM12/ Lic.No/Date:2210011462 03.06.2011 Defer Date:11.10.2011 Decision : Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011.
67
Case No.:34/12/82ALC4/2011
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00367/AM12/ RLA File :03/94/040/01112/AM11/ Lic.No/Date:0310634571 06.06.2011 Defer Date:11.10.2011 68
Case No.:10/19/82ALC4/2011
13.09.2011 Status:Case Deferred HQ File :01/82/050/00524/AM12/ RLA File :09/24/040/00128/AM12/ Lic.No/Date:0910047036 07.06.2011 Defer Date:11.10.2011 69
Case No.:19/19/82ALC4/2011
13.09.2011 Status:Case Deferred HQ File :01/82/050/00533/AM12/ RLA File :09/24/040/00107/AM12/ Lic.No/Date:0910047035 07.06.2011 Defer Date:11.10.2011 70
Case No.:21/16/82ALC4/2011
LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00479/AM12/ RLA File :22/24/040/00015/AM12/ Lic.No/Date:2210011478 08.06.2011 Defer Date:11.10.2011 Decision : Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011. 71
Case No.:25/16/82ALC4/2011
LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00483/AM12/ RLA File :22/24/040/00016/AM12/ Lic.No/Date:2210011477 08.06.2011 Defer Date:11.10.2011 Decision : Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011. 72
Case No.:27/16/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00485/AM12/ RLA File :34/24/040/00039/AM12/ Lic.No/Date:3410030563 10.06.2011 Defer Date:11.10.2011
73
Case No.:18/19/82ALC4/2011
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00532/AM12/ RLA File :09/24/040/00527/AM11/ Lic.No/Date:0910047090 10.06.2011 Defer Date:11.10.2011 74
Case No.:31/19/82ALC4/2011
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00545/AM12/ RLA File :09/24/040/00575/AM11/ Lic.No/Date:0910047086 10.06.2011 Defer Date:11.10.2011 75
Case No.:34/19/82ALC4/2011
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00548/AM12/ RLA File :09/24/040/00616/AM11/ Lic.No/Date:0910047091 10.06.2011 Defer Date:11.10.2011 76
Case No.:4/16/82ALC4/2011
Party Name:BOSTIK INDIA PRIVATE LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00462/AM12/ RLA File :07/24/040/00073/AM12/ Lic.No/Date:0710079777 13.06.2011 Defer Date:11.10.2011 Decision : Committee decided to defer case for 11.10.2011 for comments of Department of C&PC (Petrochemicals Division). 77
Case No.:26/16/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 13.09.2011 Status:Case Deferred HQ File :01/82/050/00484/AM12/ RLA File :22/24/040/00018/AM12/ Lic.No/Date:2210011505 14.06.2011 Defer Date:11.10.2011 78
Case No.:21/19/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00535/AM12/ RLA File :09/24/040/00138/AM12/ Lic.No/Date:0910047112 14.06.2011 Defer Date:11.10.2011 Decision : Committee decided to defer case for 11.10.2011 for comments of Department of C&PC. 79
Case No.:24/16/82ALC4/2011
Status:Case
LTD 13.09.2011 Deferred HQ File :01/82/050/00482/AM12/ RLA File :22/24/040/00020/AM12/ Lic.No/Date:2210011512 15.06.2011 Defer Date:11.10.2011 Decision : Committee considered case as per agenda and observed that the firm was called for personal hearing, but they have sought postponement of personal hearing and have sought another date for the same. It was, therefore, decided to give one more opportunity for personal hearing on 11.10.2011. 80
Case No.:14/19/82ALC4/2011
Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 13.09.2011 Status:Case Deferred HQ File :01/82/050/00528/AM12/ RLA File :09/24/040/00134/AM12/ Lic.No/Date:0910047151 15.06.2011 Defer Date:11.10.2011 81
Case No.:20/19/82ALC4/2011
Party Name:AVON ORGANICS LTD., 13.09.2011 HQ File :01/82/050/00534/AM12/ RLA File :09/24/040/00136/AM12/ Lic.No/Date:0910047133 15.06.2011 82
Case No.:22/19/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 13.09.2011 Status:Case Deferred HQ File :01/82/050/00536/AM12/ RLA File :09/24/040/00121/AM12/ Lic.No/Date:0910047114 15.06.2011 Defer Date:11.10.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 11.10.2011. 83
Case No.:23/19/82ALC4/2011
13.09.2011 Status:Case Deferred HQ File :01/82/050/00537/AM12/ RLA File :09/24/040/00105/AM12/ Lic.No/Date:0910047123 15.06.2011 Defer Date:11.10.2011 84
Case No.:24/19/82ALC4/2011
13.09.2011 Status:Case Deferred HQ File :01/82/050/00538/AM12/ RLA File :09/24/040/00125/AM12/ Lic.No/Date:0910047121 15.06.2011 Defer Date:11.10.2011
85
Case No.:13/19/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 13.09.2011 Status:Case Deferred HQ File :01/82/050/00527/AM12/ RLA File :09/24/040/00148/AM12/ Lic.No/Date:0910047160 16.06.2011 Defer Date:11.10.2011 86
Case No.:32/19/82ALC4/2011
Party Name:MAITHRI LABORATORIES (P) LTD., 13.09.2011 Status:Case Deferred HQ File :01/82/050/00546/AM12/ RLA File :09/24/040/00139/AM12/ Lic.No/Date:0910047161 16.06.2011 Defer Date:11.10.2011 87
Case No.:5/19/82ALC4/2011
Party Name:CIPLA LIMITED 13.09.2011 HQ File :01/82/050/00519/AM12/ RLA File :03/94/040/00258/AM12/ Lic.No/Date:0310636879 17.06.2011 88
Case No.:36/19/82ALC4/2011
Party Name:CENTURY PHARMACEUTICALS LTD. 13.09.2011 HQ File :01/82/050/00550/AM12/ RLA File :34/24/040/00020/AM12/ Lic.No/Date:3410030669 22.06.2011 89
Case No.:15/20/82ALC4/2011
Party Name:PI INDUSTRIES LTD., 13.09.2011 Status:Case Approved HQ File :01/82/050/00577/AM12/ RLA File :13/24/040/00013/AM12/ Lic.No/Date:1310035747 22.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.15022/6/2010/Ch.II dated 12.09.2010 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 Exp. Qty. Sl.No. Import items Qty. allowed Brom Dichlor Benzol (BDB) (1Bromo3,4 Dichlorobenzene) 1 Kg. 1. Bromine 1.116 kg 90
Case No.:17/20/82ALC4/2011
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS 13.09.2011
LTD) HQ File :01/82/050/00579/AM12/ RLA File :03/95/040/01042/AM11/ Lic.No/Date:0310637757 22.06.2011 91
Case No.:35/19/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 13.09.2011 HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 92
Case No.:2/16/82ALC4/2011
Party Name:WOCKHARDT LIMITED 13.09.2011 Status:Case Approved HQ File :01/82/050/00460/AM12/ RLA File :03/95/040/00192/AM12/ Lic.No/Date:0310639497 30.06.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 44/82 meeting held on 27.01.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import item Qty. allowed Vitamin B12 (Cyanocobalamin) USP Micronised As per particle size A) Minimum 80% Less than 125 Microns B) Minimum 98% Less than 150 Microns 1 Kg. 1. Vitamin B12 (Cyanocobalamin) USP Micronised As per particle size Not more than 66% less than 125 Microns and Not more than 77% less than 150 Microns 1.01 kg 93
Case No.:16/20/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 13.09.2011 HQ File :01/82/050/00578/AM12/ RLA File :22/24/040/00024/AM12/ Lic.No/Date:2210011568 01.07.2011 94
Case No.:9/16/82ALC4/2011
Party Name:ALCHEM INTERNATIONAL LTD. 13.09.2011 Status:Case Approved HQ File :01/82/050/00467/AM12/ RLA File :05/23/040/00121/AM12/ Lic.No/Date:0510295547 04.07.2011
04.07.2011 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 41/82 meeting held on 11.01.2011 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 Export Quantity Sl.No. Import items Total Quantity Digoxin 1 Kg. 1. Digitalis Lanata Leaves 444.4 kg 95
Case No.:31/16/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 13.09.2011 HQ File :01/82/050/00489/AM12/ RLA File :05/24/040/00115/AM12/ Lic.No/Date:0510295736 05.07.2011 96
Case No.:32/16/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 13.09.2011 Status:Case Deferred HQ File :01/82/050/00490/AM12/ RLA File :05/24/040/00116/AM12/ Lic.No/Date:0510295739 05.07.2011 Defer Date:11.10.2011 Decision :Committee decided to call from the firm Certificate of Analysis in respect of export product and Certificate of Analysis in respect of import item from the foreign supplier. Accordingly, case was deferred for 11.10.2011. 97
Case No.:14/20/82ALC4/2011
Party Name:LUPIN LIMITED 13.09.2011 Status:Case Deferred HQ File :01/82/050/00576/AM12/ RLA File :03/95/040/00228/AM12/ Lic.No/Date:0310640699 06.07.2011 Defer Date:11.10.2011 98
Case No.:34/16/82ALC4/2011
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 13.09.2011 Status:Case Deferred HQ File :01/82/050/00492/AM12/ RLA File :03/95/040/01038/AM11/ Lic.No/Date:0310641073 07.07.2011 Defer Date:11.10.2011 99
Case No.:35/16/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 13.09.2011 Status:Case Approved HQ File :01/82/050/00493/AM12/ RLA File :05/24/040/00121/AM12/ Lic.No/Date:0510295990 07.07.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 3/82 meeting held on 20.04.2010 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 T3811A05 Intermediate for Quinoloine (Garenoxacin) Ethyl 7 Bromo1Cyclopropyl8 Difluoromethoxy)4OXO1,4 Dihydro3Quinolinecarboxylate 1 Kg. 1. 3Hydroxy Benzoic Acid 0.782 kg 2. Liquid Bromine 1.653 kg 3. Tertiary Butylamine 1.532 kg 4. Toluene 4.88 kg 5. Dimethyl Formamide 1.68 kg 6. Cyclohexane 2.893 kg 7. Ethyl 3,3 Dimethyl Acrylate 0.554 kg 8. Trimethylamine 0.518 kg 9. Cyclopropylamine 0.259 kg 10. Iso Propyl Alcohol 1.53 kg 11. Methanol 1.288 kg 12. Dimethyl Sulphoxide 5.749 kg 13. Acetone 2.041 kg RA concerned may take further necessary action as per above decision of Norms committee. 100
Case No.:28/19/82ALC4/2011
Party Name:R L FINE CHEM 13.09.2011 Status:Case Approved HQ File :01/82/050/00542/AM12/ RLA File :07/24/040/00109/AM12/ Lic.No/Date:0710080465 07.07.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 19/82 meeting held on 04.08.2009 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 Doxilamine Succinate BP/USP 1 Kg. 1. 2 Acetyl Pyridine 0.58 kg 2. Tetrahydrofuran 1.03 kg 101
Case No.:37/16/82ALC4/2011
Party Name:SHIRDI CHEMICALS PVT. LTD. 13.09.2011 Status:Case Deferred HQ File :01/82/050/00495/AM12/ RLA File :03/95/040/00244/AM12/ Lic.No/Date:0310641314 08.07.2011 Defer Date:11.10.2011 Decision : Committee decided to defer case for 11.10.2011 for comments of Department of C&PC. 102 Case No.:2/19/82ALC4/2011 Party Name:ARCH PHARMALABS LTD 13.09.2011 Status:Case Deferred Lic.No/Date:0310643597
HQ File :01/82/050/00516/AM12/ RLA File :03/94/040/00014/AM12/ 21.07.2011 Defer Date:11.10.2011 103
Case No.:44/19/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 13.09.2011 Status:Case Approved HQ File :01/82/050/00558/AM12/ RLA File :05/24/040/00145/AM12/ Lic.No/Date:0510297774 27.07.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 32/82 meeting held on 11.12.2007 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 Lorazepam 1 Kg. 1. 2Amino2,5Dichloro Benzophenone 1.60 kg 2. Acetone 2.67 kg 3. Activated Carbon 0.0687 kg 4. Chloro Acetaldehyde Dimethyl Acetal (CADMA) 0.82 kg 5. Cyclohexane 1.71 kg 6. Isopropyl Alcohol 1.91 kg 7. Methylene Chloride 7.74 kg 8. Methanol 6.16 kg 9. Toluene 1.11 kg RA concerned may take further necessary action as per above decision of Norms committee. 104
Case No.:47/19/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 13.09.2011 HQ File :01/82/050/00561/AM12/ RLA File :04/24/040/00104/AM12/ Lic.No/Date:0410126561 28.07.2011 105
Case No.:1/20/82ALC4/2011
Party Name:UCB INDIA PVT. LIMITED 13.09.2011 HQ File :01/82/050/00562/AM12/ RLA File :03/95/040/00340/AM12/ Lic.No/Date:0310645502 01.08.2011 Decision : Committee decided to defer case for 11.10.2011 for comments of Department of C&PC. 106 Case No.:2/20/82ALC4/2011 Party Name:ZENITH DYEINTERMEDIATES LIMITED 13.09.2011 Status:Case Approved HQ File :01/82/050/00563/AM12/ RLA File :03/95/040/00310/AM12/ Lic.No/Date:0310645518
01.08.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/99/2011/Ch.II dated 08.09.2011 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 Sulfo Tobias Acid Purity 97% Min. 1 Kg. 1. Sulfo Tobias Acid 1.100 kg 107
Case No.:3/20/82ALC4/2011
Party Name:MAHARASHTRA ORGANO METALLIC CATALYSTS PVT.LTD. 13.09.2011 Status:Case Approved HQ File :01/82/050/00564/AM12/ RLA File :03/95/040/00334/AM12/ Lic.No/Date:0310645530 01.08.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/53/2008/Ch.II dated 12.09.2011 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 Tri Butyl Tin Chloride 1 Kg. 1. Tetra Butyl Tin (TBT) Crude 0.852 kg 2. Tin Ingots (Min. Purity 99.50%) 0.092 kg 108
Case No.:1/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 13.09.2011 Status:Case Deferred HQ File :01/82/050/00662/AM12/ RLA File :05/24/040/00150/AM12/ Lic.No/Date:0510298306 01.08.2011 Defer Date:11.10.2011 109
Case No.:2/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 13.09.2011 Status:Case Deferred HQ File :01/82/050/00663/AM12/ RLA File :05/24/040/00149/AM12/ Lic.No/Date:0510298304 01.08.2011 Defer Date:11.10.2011 110
Case No.:3/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 13.09.2011 Status:Case Deferred HQ File :01/82/050/00664/AM12/ RLA File :05/24/040/00083/AM12/ Lic.No/Date:0510298301 01.08.2011 Defer Date:11.10.2011
111
Case No.:4/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 13.09.2011 Status:Case Approved HQ File :01/82/050/00665/AM12/ RLA File :05/24/040/00051/AM12/ Lic.No/Date:0510298299 01.08.2011 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. Sl.No. Import items Qty. allowed Ampicillin Sodium Sterile + Sulbactam Sodium Sterile (2:1) 1 Kg. 1. Ampicillin Sodium Sterile 0.666 kg 2. Sulbactam Sodium Sterile 0.333 kg 112
Case No.:18/20/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 13.09.2011 Status:Case Approved HQ File :01/82/050/00580/AM12/ RLA File :03/94/040/00157/AM12/ Lic.No/Date:0310645895 03.08.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/8/2010PI(Norms) dated 10.06.2010 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 Hydroxynitrile 1 Kg. 1. Lyophilised Enzyme Powder (CDX403) 0.012 kg 2. Ethyl 4 Chloro Aceto Acetate 1.039 kg 3. DGlucose (Dextrose) 0.451 kg 4. Lyophilised Enzyme Powder (CDX014) 0.005 kg 5. Lyophilised Enzyme Powder (CDX901) 0.004 kg 6. NADPSP BNicotinamideAdenine Dinucleotide Phosphate Oxidized Form, Monosodiu M Salt (BNADP+,B Tan+,CoenzymeII) 0.001 kg 113
Case No.:19/20/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 13.09.2011 Status:Case Deferred HQ File :01/82/050/00581/AM12/ RLA File :04/24/040/00363/AM11/ Lic.No/Date:0410126761 03.08.2011 Defer Date:11.10.2011 114
Case No.:20/20/82ALC4/2011
Party Name:SONKAMAL ENTERPRISES PVT Meet No/Date:24/82ALC4/2011 Status:Case
LTD. 13.09.2011 Approved HQ File :01/82/050/00582/AM12/ RLA File :03/95/040/00307/AM12/ Lic.No/Date:0310646054 03.08.2011 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. Sl.No. Import items Qty. allowed Phenol 300 MT 1. Phenol 300 MT 2. MS/GI Drums As per packing policy 115
Case No.:5/24/82ALC4/2011
Party Name:SHREE SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. 13.09.2011 Status:Case Deferred HQ File :01/82/050/00666/AM12/ RLA File :03/95/040/00398/AM12/ Lic.No/Date:0310650902 30.08.2011 Defer Date:11.10.2011 Decision : Committee decided to defer case for 11.10.2011 for comments of Department of C&PC. 116
Case No.:6/24/82ALC4/2011
Party Name:WOCKHARDT LIMITED 13.09.2011 Status:Case Approved HQ File :01/82/050/00667/AM12/ RLA File :03/95/040/00421/AM12/ Lic.No/Date:0310650940 30.08.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 39/82 meeting held on 23.12.2008 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 item Qty. allowed Vitamin B12 (Cyanocobalamin) USP Micronised As per particle size A) Minimum 80% Less than 125 Microns B) Minimum 98% Less than 150 Microns 1 Kg. 1. Vitamin B12 (Cyanocobalamin) USP Micronised As per particle size Not more than 66% less than 125 Microns and Not more than 77% less than 150 Microns 1.01 kg 117
Case No.:14/16/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 13.09.2011 Status:Case Deferred HQ File :01/82/050/00472/AM12/ RLA File :05/24/040/00087/AM12/ Lic.No/Date:0510293897 Defer
20.06.2011 Date:11.10.2011
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