DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi
Para 4.7 Decision
MEETING NUMBER : 41/82ALC4/2011 MEETING DATE : 10.01.2012 The Meeting No.41/82 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 held on 10.01.2012 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Pramod Bharti, Asstt. Director, DC(MSME) 2. Shri Jasbir Singh, Consultation, Department of C&PC 3. Shri D.N. Mathur, Consultation, Department of Pharmaceuticals 4. Ms.Lalita Maini, FTDO At the outset, minutes of Norms Committee Meeting No.40/82 dated 03.01.2012 were ratified by the Committee.
Case No.B 434
M/s. Divis Laboratories Limited Norms Committee Meeting No.41/AM12 (i) F.No 01/82/162/1029/AM 11/DES III (ii) F.No 01/82/162/1030/AM 11/DES III (iii) F.No 01/82/162/1031/AM 11/DES III (iv) F.No 01/82/162/1032/AM 11/DES III (v) F.No 01/82/162/1036/AM 11/DES III (vi) F.No 01/82/162/1037/AM 11/DES III (vii) F.No 01/82/162/1038/AM 11/DES III (viii) F.No 01/82/162/1039/AM 11/DES III (ix) F.No 01/82/162/1040/AM 11/DES III (x) F.No 01/82/162/1041/AM 11/DES III (xi) F.No 01/82/162/1042/AM 11/DES III (xii) F.No 01/82/162/1043/AM 11/DES III (xiii) F.No 01/82/162/1044/AM 11/DES III Meeting Date:10.01.2012 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer all above cases for 21.02.2012. However, in respect of F.No (ix) above, on the basis of written comments forwarded by department of Pharmaceuticals vide their OM No. 35011/214/2011PI(Norms) dated 23.12.2011 it has been decided to call from the firm Copy of valid Drug
Manufacturing License showing the approved composition of the export products and also Coy of Master Batch Formula duly authenticated by Quality Control Incharge. In respect of F.No. (x) above, it has been decided to call from the firm production and consumption data duly certified by Central Excise Authorities.
Case No.B 435
M/s. Prachi Pharmaceuticals Pvt. Limited, Mumbai F.No 01/82/50/01323/AM 09/DES III F.No 01/82/162/1008/AM 10/DES III Advance License NO. 0310508539 dated 20.02.2009 Advance License No. 0310390437 dated 28.7.2006 Decision: Shri Pankah Shah, Managing Director of the firm came for the personal hearing and explained the case. After detailed deliberations and in consultation with technical authority present in meeting, Committee norms have been ratified under Para 4.7 of HBP , on the basis of Central Excise Data, as per details below or as applied by the firm whichever is lower: Export product Export Quantity Sl.No. Import items Qty. allowed Providone Iodine 20% 1 Kg 1. 2. Polyvinyl Pyrrolidone Iodine Crystals 0.75 kg 0.27 kg RA concerned may take further necessary action as per above decision of NC.
Case No.B 436
M/s. Neuland Laboratories Limited F.No 01/82/162/01028/AM 07/DES III present in the meeting, it has been decided to reject the request of the firm as there is no scope for enhancement. However, it has been decided that if firm is not satisfied with the decision of the Committee, their representative may come for Personal Hearing with prior appointment in the afternoon of any Tuesday.
Case No.B 437
M/s. Aqua Pharma Limited, Pune F.No 01/87/162/00672/AM 12/DES III
present in the meeting, it has been decided to defer the case for 6.3.2012 for comments of Department of C&PC.
Case No.B 438
M/s. Aqua Pharma Limited, Pune F.No 01/87/162/00674/AM 12/DES III present in the meeting, it has been decided to defer the case for 6.3.2012 for comments of Department of C&PC.
Case No.B 439
M/s. Aqua Pharma Limited, Pune F.No 01/87/162/00671/AM 12/DES III present in the meeting, it has been decided to defer the case for 6.3.2012 for comments of Department of C&PC.
Case No.B 440
M/s. Aqua Pharma Limited, Pune F.No 01/87/162/00868/AM 09/DES III present in the meeting, it has been decided to defer the case for 6.3.2012 for comments of Department of C&PC.
Case No.B 441
M/s. Aqua Pharma Limited, Pune F.No 01/82/162/00670/AM 12/DES III present in the meeting, it has been decided to defer the case for 6.3.2012 for comments of Department of C&PC.
Case No.B 442
M/s. Aqua Pharma Limited, Pune F.No 01/82/162/00673/AM 12/DES III present in the meeting, it has been decided to defer the case for 6.3.2012 for comments of Department of C&PC.
Case No.B 437
M/s. Aktions Pharma Pvt. Limited F.No 01/85/050/00010/AM 11/DESII(pt)162/00672/AM 12/DES III RLA File No. 03/94/040/00300/AM 10 Advance Authorisation NO. 0910041041 dated 22.02.2010 present in the meeting, it has been found that export product is not mentioned in the agenda. The case has been deferred for 24.1.2012.
Case No.B 444
M/s. Jubliant Lifesciences Limited F.No 01/82/50/01598/AM 11/DES III Adv. Lic. No. 0510271327 dated 25.08.2010 present in the meeting, it has been decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, the case has been deferred for 7.02.2012.
Case No.B 445
M/s. Jubliant Lifesciences Limited F.No 01/82/50/01600/AM 11/DES III R.A File No. 05/23/040/00082/AM 11 Adv. Lic. No.0510267990 dated 13.7.2010 present in the meeting, it has been decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, the case has been deferred for 7.02.2012.
Case No.B 446
M/s. Jubliant Lifesciences Limited F.No 01/82/50/01593/AM 11/DES III
Adv. Lic. No. 0510272117 dated 06.09.2010 present in the meeting, it has been decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, the case has been deferred for 7.02.2012.
Case No.B 447
M/s. Emami Limited F.No 01/82/50/0449/AM 12/DES III RA No. 02/24/40/00017/AM 12 Adv. Lic. No. 0210155350 dated 24.02.2011 present in the meeting, decided to defer the case for 6.3.2012 for comments of technical authority.
Case No.B 448
M/s. Emami Limited F.No 01/82/50/01708/AM 11/DES III RA No. 02/24/40/00202/AM 11 Adv. Lic. No. 0210155350 dated 24.02.2011 present in the meeting, decided to defer the case for 6.3.2012 for comments of technical authority.
Case No.B 449
M/s. K.v. Arochem Pvtl. Ltd. F.No 01/82/50/00450/AM 12/DES III RA No. 03/94/40/00161/AM 12 Adv. Lic. No. 03106335171 dated 30.05.11 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to revise the norms in terms of Para 4.7 of HBP v 1 norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export product Export Quantity Sl.No. Import items Qty. allowed 7Acetyl1,1,3,4,4,6 Hexamethyl 1,2,3,4 Tetrahydro Naphthalene (KEVOLID) (Purity Min. 97%) 1 kg 1. 2. 3. HMTCrude (Hexamethyl, Tetralene) (Purity Min. 85%) Aluminium Chloride (Purity Min. 98%) Acetyl Chloride (Purity Min. 98%) 1.180 kg 0.720 kg 0.420 kg
RA may take necessary action as per the decision of Norms Committee. 1
Case No.:57/41/82ALC4/2010
Party Name:LUPIN LIMITED Meet No/Date:41/82ALC4/2011 10.01.2012 Status:Case Approved HQ File :01/82/050/01405/AM11/ RLA File :03/95/040/00382/AM11/ Lic.No/Date:0310589551 26.08.2010 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/08/2011PINorms dated 28.11.2011 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 Sterile Cefotaxime Sodium 500 MG/IGM/2GM Injection (Wt. of drug 367.22 kgs) 1 Kg 1 7 Amino Cehalosporanic Acid 0.741 2. Ethyle Acetate 5.94 3 Tetra Hydrofuran 2.66 4 Methylene Chloride 6.84 5 Isopropyl Alcohol 0.35 6 Sodium 2Ethyl Hexanoate 0.40 7 7 Hexamethyl Dislazane 0.36 8 Methanol 0.83 9 Phsophorous Pentachloride 0.5968 10 Triethyl Amine 0.410 11 Activated Carbon 0.100 12 Trimethyl Chlorosilane 0.1796 13. Sodium Hydrosulphite 0.060 14. 4Bromo2Methoxyimino3Oxo Butyric acid (Bromo Acid) 0.6596 15. Thiourea 0.222 16. Ethylene Diamine Tetra Acide Disodium Salt (E.D.T.A Di Sodium) 0.0145 2
Case No.:32/23/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00800/AM11/ RLA File :09/24/040/00211/AM11/ Lic.No/Date:0910043338 31.08.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, based on the Central Excise data provided by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed
Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Amino 5Chloro Benzamide (ACBAM) 1 kg 1 2 3 Isatoic Anhydride Sulfolane Ammonium Carbonate 1.51 kg 1.30 1.07 RA may take appropriate action as per the decision of Norms Committee. 3
Case No.:43/31/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 6.3.2012 for comments of technical authority. 4
Case No.:20/39/82ALC4/2010
Party Name:MADHUKAR HORMONES & STERODIS [P] LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/01101/AM11/ RLA File :03/95/040/00321/AM11/ Lic.No/Date:0310593366 22.09.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 6.3.2012 for comments of technical authority 5
Case No.:14/28/82ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00896/AM11/ RLA File :09/24/040/00272/AM11/ Lic.No/Date:0910043780 01.10.2010 Defer Date:06.03.2012 Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals and in consultation with technical authority present in meeting, decided to call the following details from the firm: Stepwise complete and balanced chemical reaction showing Mo. Wt. of each input & output product and molar requirement of each reactant. % yield on molar basis for each step. Requirement & Recovery of solvent at each step of manufacturing process. 6
Case No.:55/41/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/01403/AM11/ RLA File :09/24/040/00298/AM11/ Lic.No/Date:0910043877 11.10.2010 Defer
Date:06.03.2012 Decision : The Committee considered the case as per agenda and observed that the firm’s plant is US FDA approved plant and their manufacturing process is also approved by US FDA. This Plant was visited by a team constituted by DGFT about a year back for another product i.e. prefilled syringes and it was cross checked at the time of visit that the components which are in excess in a batch are disposed off as a waste and cannot be reused in the next batch as per US FDA guidelines. The firm has also assured that they export directly to US and no other country. The firm has already given actual production and consumption data duly certified by Central Excise Authority in respect of the higher wastage in the packaging material. As these packaging material are different from that of our Policy, it has been decided in the Committee to seek the approval of DG(FT) for higher norms. 7
Case No.:54/41/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/01402/AM11/ RLA File :09/24/040/00289/AM11/ Lic.No/Date:0910043863 8.10.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and observed that the firm’s plant is US FDA approved plant and their manufacturing process is also approved by US FDA. This Plant was visited by a team constituted by DGFT about a year back for another product i.e. prefilled syringes and it was cross checked at the time of visit that the components which are in excess in a batch are disposed off as a waste and cannot be reused in the next batch as per US FDA guidelines. The firm has also assured that they export directly to US and no other country. The firm has already given actual production and consumption data duly certified by Central Excise Authority in respect of the higher wastage in the packaging material. As these packaging material are different from that of our Policy, it has been decided in the Committee to seek the approval of DG(FT) for higher norms 8
Case No.:3/31/82ALC4/2010
Party Name:EMAMI LIMITED, 10.01.2012 Status:Case Deferred HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 9
Case No.:8/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and observed that the firm’s plant is US FDA approved plant and their manufacturing process is also approved by US FDA. This Plant was visited by a team constituted by DGFT about a year back for another product i.e. prefilled syringes and it was cross checked at the time of visit that the components which are in excess in a batch are disposed off as a waste and cannot be reused in the next batch as per US FDA guidelines. The firm has also assured that they export directly to US and no other country. The firm has already given actual production and consumption data duly certified by Central Excise Authority in respect of
the higher wastage in the packaging material. As these packaging material are different from that of our Policy, it has been decided in the Committee to seek the approval of DG(FT) for higher norms 10
Case No.:124/40/82ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 10.01.2012 Status:Case deferred HQ File :01/82/050/01323/AM11/ RLA File :22/24/040/00049/AM11/ Lic.No/Date:2210010535 18.10.2010 Defer Date: 21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 21.02.2012 for comments of technical authority 11
Case No.:116/40/82ALC4/2010
Party Name:DSM ANTIINFECTIVES INDIA LTD Meet No/Date:41/82ALC4/2011 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to remind the firm the furnish following details : Complete chemical reactions for each step showing Mol. Wt. and molar requirement of each reactant and output product. % yield on Molar Basis for each step of manufacturing process. Material Balance for entire process showing justification for requirement of enzymes used in the process. Requirement & Recovery of solvents of each step of manufacturing process. Production and Consumption data certified by Central Excise Authority. Accordingly, the case has been deferred for 6.3.2012. 12
Case No.:48/31/82ALC4/2010
Party Name:GLAND PHARMA LIMITED 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and observed that the firm’s plant is US FDA approved plant and their manufacturing process is also approved by US FDA. This Plant was visited by a team constituted by DGFT about a year back for another product i.e. prefilled syringes and it was cross checked at the time of visit that the components which are in excess in a batch are disposed off as a waste and cannot be reused in the next batch as per US FDA guidelines. The firm has also assured that they export directly to US and no other country. The firm has already given actual production and consumption data duly certified by Central Excise Authority in respect of the higher wastage in the packaging material. As these packaging material are different from that of our Policy, it has been decided in the Committee to seek the approval of DG(FT) for higher norms
13
Case No.:57/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 14
Case No.:63/40/82ALC4/2010
Party Name:EMAMI LIMITED, 10.01.2012 Status:Case Deferred HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 15
Case No.:125/40/82ALC4/2010
Party Name:DSM ANTIINFECTIVES INDIA LTD Meet No/Date:41/82ALC4/2011 10.01.2012 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:06.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to remind the firm the furnish following details : Complete chemical reactions for each step showing Mol. Wt. and molar requirement of each reactant and output product. % yield on Molar Basis for each step of manufacturing process. Material Balance for entire process showing justification for requirement of enzymes used in the process. Requirement & Recovery of solvents of each step of manufacturing process. Production and Consumption data certified by Central Excise Authority. Accordingly, the case has been deferred for 6.3.2012. 16
Case No.:6/32/82ALC4/2010
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 10.01.2012 Status:Case Approved HQ File :01/82/050/00988/AM11/ RLA File :05/24/040/00266/AM11/ Lic.No/Date:0510275802 27.10.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities and it has been seen that this case has already been approved in the Norms Committee Meeting 22/82 dated 30.08.2011. 17
Case No.:8/32/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, Status:Case
10.01.2012 Deferred HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 18
Case No.:22/3/82ALC4/2011
Party Name:CIPLA LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00022/AM12/ RLA File :03/94/040/00998/AM11/ Lic.No/Date:0310615336 10.02.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 19
Case No.:28/3/82ALC4/2011
Party Name:LUPIN LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00028/AM12/ RLA File :03/95/040/00900/AM11/ Lic.No/Date:0310615412 10.02.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/66/2011PINorms dated 8.12.2011 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 Lovastatin USP 1 Kg 1. Activated Carbon 0.022 2. Caustic Soda Flakes 0.1896 3. Toluene 2.4537 4 Methylene Chloride 0.8201 RA may take further action as per decision of Norms Committee. 20
Case No.:10/3/82ALC4/2011
Party Name:LUPIN LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00010/AM12/ RLA File :03/95/040/00936/AM11/ Lic.No/Date:0310617943 25.02.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/79/2011PI (Norms) dated 8.12.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg
g SIMVASTATIN 1 kg 1. Activated Carbon 0.035 2. Caustic Soda Flakes 0.358 3/ Cyclohexane 3.334 4. Ethyl Acetate 3.414 5. Methhl Ethyl Ketone 0.685 6. Imidazol 0.58 7. Methanol 7.374 8. Toluene 2.388 9. Tri Ethyl Amine 0.972 10. Methane Sulphonic Acid 0/173 11. Tertiary Butyl Dimethyl Silyl Chlo TBDMS 0.779 12. 2 2 Dimethyl Chloride 1.215 13 Lovastatin 1.39 21
Case No.:3/52/82ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD., 10.01.2012 Status:Case Approved HQ File :01/82/050/01772/AM11/ RLA File :09/24/040/00558/AM11/ Lic.No/Date:0910045891 11.03.2011 Defer Date Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/155/2011PI (Norms) dated 4.1.2012 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 Item Qty. allowed/kg Trazodone HCL 1 Kg 1. 1(3Chlorophenyl) Piperazine HCL 1.282 2. 1Bromo3Chloro Propane 2.01 3. 2Chloro Pyridine 0.984 4. Semicarbazide HCL 1.968 5. Ethoxy Ethanol 1.829 6. Acetonitrile 4.19 22
Case No.:10/2/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 10.01.2012 Status:Case Approved
HQ File :01/82/050/01800/AM11/ RLA File :09/24/040/00583/AM11/ Lic.No/Date:0910046056 25.03.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/168/2011PI (Norms) dated 4.1.2012 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 Item Qty. allowed/kg 3,4Dihydroxy5 NitroBenzaldehyde 1 Kg 1. 2 3 Vanillin Dichloro Methane Pyridine 1.97 0.93 0.457 23
Case No.:16/19/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 24
Case No.:11/7/82ALC4/2011
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00177/AM12/ RLA File :04/24/040/00356/AM11/ Lic.No/Date:0410123134 31.03.2011 Defer Date:06.03.2012 Decision : The committee considered the case as per agenda and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/96/2011PI (Norms) dated 6.1.2012 and in consultation with technical authorities, it has been decided to call from the firm the following details: Stepwise complete and balanced chemical reaction showing Mol. Wt. of each reactant & output product. % yield on molar basis for each step. Material balance for entire process. Copy of authentic technical literature in support of yields envisaged in the process. Production actual consumption data duly certified by Central Excise Authorities for the above export product. Accordingly, the case has been deferred for 6.3.2012.
25
Case No.:2/3/82ALC4/2011
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00002/AM12/ RLA File :04/24/040/00358/AM11/ Lic.No/Date:0410123153 01.04.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/106/2011PI (Norms) dated 6.1.2012 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 Item Qty. allowed/kg 4HYdroxy coumarin 1 kg 1. 2Hydroxy Acetophenone 1.24 2. Diethyl Carbonate 2.15 3. Toluene 1.41 4. Methanol 1.11 RA may take further action as per the decision of Norms Committee. 26
Case No.:13/4/82ALC4/2011
Party Name:HETERO LABS LIMITED 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 27
Case No.:15/4/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 28
Case No.:49/4/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 10.01.2012 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:06.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 29
Case No.:33/12/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 10.01.2012 Status:Case Rejected HQ File :01/82/050/00366/AM12/ RLA File :08/24/040/00002/AM12/ Lic.No/Date:0810098227 13.04.2011 Defer Date: Decision : The firm was requested to furnish some information. But the firm could not furnish the information despite reminder. The Committee decided to close the case. 30
Case No.:7/5/82ALC4/2011
Party Name:NEULAND LABORATORIES LTD 10.01.2012 Status:Case Approved HQ File :01/82/050/00109/AM12/ RLA File :09/24/040/00561/AM11/ Lic.No/Date:0910046412 19.04.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/240/2011PI (Norms) dated 3.1.2012 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 Item Qty. allowed/kg Posaconazol 1 Kg 1. 2 3 2[(1S, 2S)1Ethyl2 Bezyloxypropyl]2,4Dihydro4[4[4[4 Hydroxyphenyl)1Piperazinyl] Phenyl]3H1,2,4Triazol3one (5RCIS)5(2,4Difluorophenyl)5 [(1H1,2,4Triazol1YL)Methyl] Tetrahydro3Furanmethanol,4 Toluenesulphonate 10% Palladium on Carbon 1.23 1.27 0.200 RA may take further action as per the decision of Norms Committee. 31
Case No.:32/6/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00150/AM12/ RLA File :09/24/040/00037/AM12/ Lic.No/Date:0910046439 21.04.2011 Defer Date:06.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 32
Case No.:33/6/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00151/AM12/ RLA File :09/24/040/00031/AM12/ Lic.No/Date:0910046440 21.04.2011 Defer Date:06.03.2012 Decision : . The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 6.3.2012 for comments of technical authority 33
Case No.:32/14/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00423/AM12/ RLA File :09/24/040/00605/AM11/ Lic.No/Date:0910046500 26.04.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/273/2011PI (Norms) dated 4.1.2012 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 Item Qty. allowed/kg Cefuroxime Axetil Crystalline 1 Kg 1. 7Aminocephalosporanic Acid (7 ACA) 0.769 2. Chlorosulphonyl Isocynate 0.4754 3. (Z)2Methoxy Imino (Furyl2YL) Acetic Acid Ammonium Salt (SMIA) 0.6152 4. Acetone 1.83 5. Methylene Chloride 6.36 6. Activated Carbon 0.093 7. N, NDimethyl Acetamide 4.02 8. Potassium Carbonate 0.0602 9. Cyclohexane 2.14 10. Methanol 2.78 RA may further necessary action as per the decision of Norms Committee 34
Case No.:28/7/82ALC4/2011
Party Name:EMBIO LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00194/AM12/ RLA File :03/94/040/01026/AM11/ Lic.No/Date:0310629152 03.05.2011 Defer Date:07.02.2012
Decision : : The Committee considered the case as per the agenda and in the light of written comments from Department of Pharmaceuticals vide their OM No. 35011/279/2011PI(Norms) dated 23.12.2011 and in consultation with technical authority it has been decided to call from the firm the following technical details: Stepwise complete and balanced chemical reaction showing mol. Wt. of all inputs and output production and their molar requirements. % yield on molar basis for each step and its justification. Materail balance for entire process. Detailed working with technical justification for utilizing 36.0 kg molasses per kg export product. Requirement & Recovery of solvent at each step. The committee also decided to call the firm for Personal Hearing on 07.02.2012 35
Case No.:29/7/82ALC4/2011
Party Name:EMBIO LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00195/AM12/ RLA File :03/94/040/01027/AM11/ Lic.No/Date:0310629153 03.05.2011 Defer Date:07.02.2012 Decision : : The Committee considered the case as per the agenda and in the light of written comments from Department of Pharmaceuticals vide their OM No. 35011/279/2011PI(Norms) dated 23.12.2011 and in consultation with technical authority it has been decided to call from the firm the following technical details: Stepwise complete and balanced chemical reaction showing mol. Wt. of all inputs and output production and their molar requirements. % yield on molar basis for each step and its justification. Materail balance for entire process. Detailed working with technical justification for utilizing 36.0 kg molasses per kg export product. Requirement & Recovery of solvent at each step. The committee also decided to call the firm for Personal Hearing on 07.02.2012 36
Case No.:19/10/82ALC4/2011
Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00278/AM12/ RLA File :61/24/040/00097/AM11/ Lic.No/Date:6110000608 03.05.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 37
Case No.:50/8/82ALC4/2011
Party Name:VIJAYASRI ORGANICS LTD 10.01.2012 Status:Case Deferred
HQ File :01/82/050/00250/AM12/ RLA File :09/24/040/00592/AM11/ Lic.No/Date:0910046744 12.05.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 38
Case No.:17/16/82ALC4/2011
Party Name:SMILAX LABORATORIES LIMITED Meet No/Date:41/82ALC4/2011 10.01.2012 Status:Case Deferred HQ File :01/82/050/00475/AM12/ RLA File :09/24/040/00501/AM11/ Lic.No/Date:0910046743 12.05.2011 Defer Date:21.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 21.02.2012 for comments of technical authority 39
Case No.:3/9/82ALC4/2011
Party Name:EMBIO LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00254/AM12/ RLA File :03/94/040/00120/AM12/ Lic.No/Date:0310631346 16.05.2011 Defer Date:07.02.2012 Decision : The Committee considered the case as per the agenda and in the light of written comments from Department of Pharmaceuticals vide their OM No. 35011/279/2011PI(Norms) dated 23.12.2011 and in consultation with technical authority it has been decided to call from the firm the following technical details: Stepwise complete and balanced chemical reaction showing mol. Wt. of all inputs and output production and their molar requirements. % yield on molar basis for each step and its justification. Material balance for entire process. Detailed working with technical justification for utilizing 36.0 kg molasses per kg export product. Requirement & Recovery of solvent at each step. The committee also decided to call the firm for Personal Hearing on 07.02.2012 40
Case No.:4/9/82ALC4/2011
Party Name:EMBIO LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00255/AM12/ RLA File :03/94/040/00121/AM12/ Lic.No/Date:0310631350 16.05.2011 Defer Date:07.02.2012 Decision : The Committee considered the case as per the agenda and in the light of written comments from Department of Pharmaceuticals vide their OM No. 35011/279/2011PI(Norms) dated 23.12.2011 and in consultation with technical authority it has been decided to call from the firm the following technical details: Stepwise complete and balanced chemical reaction showing mol. Wt. of all inputs and output production and their molar requirements.
% yield on molar basis for each step and its justification. Materail balance for entire process. Detailed working with technical justification for utilizing 36.0 kg molasses per kg export product. Requirement & Recovery of solvent at each step. The committee also decided to call the firm for Personal Hearing on 07.02.2012 41
Case No.:2/9/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:41/82ALC4/2011 10.01.2012 Status:Case Deferred HQ File :01/82/050/00253/AM12/ RLA File :09/24/040/00012/AM12/ Lic.No/Date:0910046777 18.05.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per the agenda and in the light of written comments from Department of Pharmaceuticals vide their OM No. 35011/279/2011PI(Norms) dated 23.12.2011 and in consultation with technical authority it has been decided to call from the firm the following technical details: Stepwise complete and balanced chemical reaction showing mol. Wt. of all inputs and output production and their molar requirements. % yield on molar basis for each step and its justification. Materail balance for entire process. Detailed working with technical justification for utilizing 36.0 kg molasses per kg export product. Requirement & Recovery of solvent at each step. The committee also decided to call the firm for Personal Hearing on 07.02.2012 42
Case No.:6/9/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:41/82ALC4/2011 10.01.2012 Status:Case Approved HQ File :01/82/050/00257/AM12/ RLA File :09/24/040/00608/AM11/ Lic.No/Date:0910046785 19.05.2011 Defer Date: Decision : The Committee considered the case as per agenda in consultation with the technical authority and it has been observed that this case has already been approved in the Norms Committee Meeting No. 36/82 dated 6.12.2011. 43
Case No.:34/10/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 10.01.2012 Status:Case Approved HQ File :01/82/050/00293/AM12/ RLA File :05/23/040/00046/AM12/ Lic.No/Date:0510291487 24.05.2011 Defer Date: Decision : The Committee considered the case as per agenda in consultation with the technical authority and it has been observed that this case has already been approved in the Norms Committee Meeting No. 35/82 dated 29.11.2011.
44
Case No.:41/10/82ALC4/2011
Party Name:HETERO LABS LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00300/AM12/ RLA File :09/24/040/00111/AM12/ Lic.No/Date:0910046916 26.05.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 45
Case No.:43/10/82ALC4/2011
Party Name:DR REDDYS LABORATORIES LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00302/AM12/ RLA File :09/24/040/00093/AM12/ Lic.No/Date:0910046918 26.05.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 46
Case No.:19/11/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00333/AM12/ RLA File :09/24/040/00079/AM12/ Lic.No/Date:0910046974 02.06.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities it has been observed that the firm has not furnished the requisite information. It has been decided to remind the firm to furnish the requisite information expeditiously and accordingly, case has been deferred for 21.2.2012. 47
Case No.:18/11/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00332/AM12/ RLA File :09/24/040/00080/AM12/ Lic.No/Date:0910046973 02.06.2011 Defer Date:21.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 21.02.2012 for comments of technical authority 48
Case No.:27/19/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00541/AM12/ RLA File :09/24/040/00086/AM12/ Lic.No/Date:0910046997 06.06.2011 Defer Date:21.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 21.02.2012 for comments of technical authority
49
Case No.:1/13/82ALC4/2011
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00373/AM12/ RLA File :03/94/040/01111/AM11/ Lic.No/Date:0310635238 09.06.2011 Defer Date:21.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 21.02.2012 for comments of technical authority 50
Case No.:4/13/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 10.01.2012 Status:Case Approved HQ File :01/82/050/00376/AM12/ RLA File :05/24/040/00424/AM11/ Lic.No/Date:0510292794 09.06.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/249/2011PI (Norms) dated 4.1.2012 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 Item Qty. allowed/kg 2[3(S)[3[2(7Chloro2 Quinolinyl)Ethenyl)Phenyl)3 Hydroxypropyl[Benzoic Acid Methyl Ester Hydrate (HCP) (MT7) 1 Kg 1. 2. Methyl[E]3[3[2(7CHLORO2 QUINOLINYL)ETHENYL] PHENYL]3 OXOPROPYL]PHENYL]PROPANOATE () DIISOPINOCAMPHENYL CHLOROBORANE IN HEPTANE (60 65% SOLUTION)(ACTIVE) (DIP CHLORIDE) (UOMKGA) 1.2.18 1.427 RA may take appropriate action as per the decision of the Norms Committee. 51
Case No.:5/13/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 10.01.2012 Status:Case Approved HQ File :01/82/050/00377/AM12/ RLA File :05/24/040/00442/AM11/ Lic.No/Date:0510292795 09.06.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No.
35011/249/2011PI (Norms) dated 4.1.2012 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 Item Qty. allowed/kg 2[3(S)[3[2(7Chloro2 Quinolinyl)Ethenyl)Phenyl)3 Hydroxypropyl[Benzoic Acid Methyl Ester Hydrate (HCP) (MT7) 1 Kg 1. 2. Methyl[E]3[3[2(7CHLORO2 QUINOLINYL)ETHENYL] PHENYL]3 OXOPROPYL]PHENYL]PROPANOATE () DIISOPINOCAMPHENYL CHLOROBORANE IN HEPTANE (60 65% SOLUTION)(ACTIVE) (DIP CHLORIDE) (UOMKGA) 1.2.18 1.427 RA may take appropriate action as per the decision of the Norms Committee. 52
Case No.:12/19/82ALC4/2011
Party Name:BALAJI AMINES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00526/AM12/ RLA File :31/83/040/00047/AM12/ Lic.No/Date:3110048658 15.06.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011/Ch.II dated 23.12.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg NEthyl2 Pyrrolidone 1 Kg 1. 2. 3. 4. 1,4, Butanediol Ammonia Anhydrous Ethyl Alcohol (95% Minimum) (denatured) Ethylamine Catalyst 0.882 kg 0.176 kg 0.512 kg 0.001 kg
53
Case No.:14/19/82ALC4/2011
Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 6.3.2012 for comments of technical authority 54
Case No.:22/19/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 10.01.2012 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:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 55
Case No.:49/21/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00631/AM12/ RLA File :05/24/040/00093/AM12/ Lic.No/Date:0510293830 17.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 06.03.2012 for comments of technical authority 56
Case No.:36/14/82ALC4/2011
Party Name:SHASUN PHARMACEUTICALS LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00427/AM12/ RLA File :04/24/040/00069/AM12/ Lic.No/Date:0410125143 20.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, it has been decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, the case has been deferred for 06.03.2012,. 57
Case No.:26/21/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00608/AM12/ RLA File :09/24/040/00147/AM12/ Lic.No/Date:0910047215 21.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, based on the Central Excise data provided by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed
6Bromo3 (Tetrahydro Pyran 4YL Amino) Indazole1 Carboxylic Acid Tert. Butyl Ester 1 kg 1 2 3 4 5 6 7 4Bromo2 Fluoro Benzonitrile Hydrazine Hydrate Tetra Hydro Pyran4One Sodium Triacetoxy Borohydride Tetrahydrofuran BOC Anhydride NMethyl Imidazole 1.01 /kg 1.04/ kg 0.85/ kg 1.51/kg 8.95/kg 1.408/kg 0.50/kg RA may take appropriate action as per the decision of Norms Committee 58
Case No.:34/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:41/82ALC4/2011 10.01.2012 Status:Case Deferred HQ File :01/82/050/00616/AM12/ RLA File :09/24/040/00089/AM12/ Lic.No/Date:0910047213 21.06.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 59
Case No.:41/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00623/AM12/ RLA File :09/24/040/00040/AM12/ Lic.No/Date:0910047212 21.06.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 60
Case No.:42/21/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00624/AM12/ RLA File :09/24/040/00142/AM12/ Lic.No/Date:0910047214 21.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, based on the Central Excise data provided by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed
1,2,3,5TetraO AcetylBD Riboduranose 1 kg 1 2 3 DRibose Iso Propyl Alcohol Toluene 1.30 kg 2.43 kg 0.273 kg RA may take appropriate action as per the decision of Norms Committee 61
Case No.:43/21/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00625/AM12/ RLA File :09/24/040/00150/AM12/ Lic.No/Date:0910047217 21.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, based on the Central Excise data provided by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed 5(4 Methyltetrahydropyran) [1,2,4] Triazolo [1,5 a]2Pyridineamine 1 kg 1 2 3 4 5 6Methyl2Amino Pyridine 2Methyl Tetrahydrofuran Tetrahydrofuran Tetrahydro Pyran4One Acetonitrile 1.64 kg 15.22 kg 8.15 kg 2.80 kg 3.545 kg RA may take appropriate action as per the decision of Norms Committee 62
Case No.:44/21/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00626/AM12/ RLA File :09/24/040/00141/AM12/ Lic.No/Date:0910047216 21.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, based on the Central Excise data provided by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed 1Tert Butoxycarbonylamino 1 kg 1 2 Ethyl Cyanoacetate 13Dibromopropane 2.657 kg 5.24 kg
1Cyclo Butylcarboxylic Acid 3 4 5 Acetone Di Tert Butyl Dicarbonate Triethylamine 3.09 kg 2.085 kg 1.30 kg RA may take appropriate action as per the decision of Norms Committee 63
Case No.:18/21/82ALC4/2011
Party Name:SHREE JAYA LABORATORIES PVT LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00600/AM12/ RLA File :09/24/040/00623/AM11/ Lic.No/Date:0910047446 01.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 64
Case No.:9/21/82ALC4/2011
Party Name:MODEPRO (INDIA) PRIVATE LIMITED., 10.01.2012 Status:Case Approved HQ File :01/82/050/00591/AM12/ RLA File :03/95/040/01031/AM11/ Lic.No/Date:0310640432 05.07.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/104/2011/Ch.II dated 30.11.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg 2Benzolpyridine 1 Kg 1 2. Pyridine Potassium Permanganate 0.534 kg 1.077 kg RA may take appropriate action as per the decision of the Norms Committee. 65
Case No.:16/21/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 10.01.2012 Status:Case Deferred HQ File :01/82/050/00598/AM12/ RLA File :09/24/040/00165/AM12/ Lic.No/Date:0910047474 05.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the
66
Case No.:17/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED Meet No/Date:41/82ALC4/2011 10.01.2012 Status:Case Deferred HQ File :01/82/050/00599/AM12/ RLA File :09/24/040/00153/AM12/ Lic.No/Date:0910047476 05.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 67
Case No.:31/16/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00489/AM12/ RLA File :05/24/040/00115/AM12/ Lic.No/Date:0510295736 05.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 68
Case No.:60/21/82ALC4/2011
Party Name:INDSWIFT LABORATORIES LTD., 10.01.2012 Status:Case Deferred HQ File :01/82/050/00642/AM12/ RLA File :22/24/040/00026/AM12/ Lic.No/Date:2210011604 06.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 69
Case No.:5/21/82ALC4/2011
10.01.2012 Status:Case Deferred HQ File :01/82/050/00587/AM12/ RLA File :03/94/040/00319/AM12/ Lic.No/Date:0310641299 08.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 70
Case No.:3/17/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00498/AM12/ RLA File :05/24/040/00124/AM12/ Lic.No/Date:0510296379 12.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 71
Case No.:6/17/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES Status:Case
LIMITED (FORMERLY JUBILANT 10.01.2012 Deferred HQ File :01/82/050/00501/AM12/ RLA File :05/23/040/00137/AM12/ Lic.No/Date:0510296623 14.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 72
Case No.:58/21/82ALC4/2011
Party Name:ESSIX BIOSCIENCES LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00640/AM12/ RLA File :22/24/040/00028/AM12/ Lic.No/Date:2210011653 14.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 73
Case No.:9/17/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00504/AM12/ RLA File :03/94/040/00318/AM12/ Lic.No/Date:0310642597 15.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 74
Case No.:1/35/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 10.01.2012 Status:Case Deferred HQ File :01/82/050/00928/AM12/ RLA File :03/95/040/00278/AM12/ Lic.No/Date:0310642739 18.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 75
Case No.:19/21/82ALC4/2011
Party Name:SAIRAM ORGANICS PVT. LTD., 10.01.2012 Status:Case Deferred HQ File :01/82/050/00601/AM12/ RLA File :09/24/040/00174/AM12/ Lic.No/Date:0910047733 19.07.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 76
Case No.:28/21/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 10.01.2012 Status:Case Deferred
HQ File :01/82/050/00610/AM12/ RLA File :09/24/040/00178/AM12/ Lic.No/Date:0910047796 21.07.2011 Defer Date: 21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 77
Case No.:19/20/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 10.01.2012 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:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 78
Case No.:22/31/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00848/AM12/ RLA File :09/24/040/00206/AM12/ Lic.No/Date:0910048050 03.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities observed that this case has already been approved in the Norms Committee Meeting No. 39/82 held on 27.12.2011, 79
Case No.:52/21/82ALC4/20111
Party Name:LUPIN LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00634/AM12/ RLA File :03/95/040/00311/AM12/ Lic.No/Date:0310644692 27.7.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/79/2011PI (Norms) dated 8.12.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg SIMVASTATIN 1 kg 1. Activated Carbon 0.035 2. Caustic Soda Flakes 0.358 3/ Cyclohexane 3.334 4. Ethyl Acetate 3.414 5. Methhl Ethyl Ketone 0.685 6. Imidazol 0.58 7. Methanol 7.374
Toluene 2.388 9. Tri Ethyl Amine 0.972 10. Methane Sulphonic Acid 0/173 11. Tertiary Butyl Dimethyl Silyl Chlo TBDMS 0.779 12. 2 2 Dimethyl Chloride 1.215 13 Lovastatin 1.39 Ra may take appropriate action as per the decision of Norms Committee. 80
Case No.:14/27/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00764/AM12/ RLA File :03/94/040/00395/AM12/ Lic.No/Date:0310646407 04.08.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 81
Case No.:13/25/82ALC4/2011
Party Name:EMAMI LIMITED, 10.01.2012 Status:Case Deferred HQ File :01/82/050/00680/AM12/ RLA File :02/24/040/00060/AM12/ Lic.No/Date:0210163383 05.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 06.03.2012 for comments of technical authority 82
Case No.:2/25/82ALC4/2011
Party Name:RUPA ORGANICS PVT. LTD. 10.01.2012 Status:Case Approved HQ File :01/82/050/00669/AM12/ RLA File :03/95/040/00341/AM12/ Lic.No/Date:0310647067 08.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/108/2011/Ch.II dated 30.11.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg 3 Amino 4 Methyl Benzamide (Aptam) 1 Kg Para Toluic Acid 1.280 kg
83
Case No.:34/31/82ALC4/2011
Party Name:HETERO LABS LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00860/AM12/ RLA File :09/24/040/00189/AM12/ Lic.No/Date:0910048117 08.08.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 84
Case No.:9/26/82ALC4/2011
10.01.2012 Status:Case Deferred HQ File :01/82/050/00692/AM12/ RLA File :03/94/040/00409/AM12/ Lic.No/Date:0310647117 09.08.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 21.02.2012 for comments of technical authority 85
Case No.:27/31/82ALC4/2011
Party Name:SAIRAM ORGANICS PVT. LTD., 10.01.2012 Status:Case Approved HQ File :01/82/050/00853/AM12/ RLA File :09/24/040/00217/AM12/ Lic.No/Date:0910048206 10.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals OM No. 35011/103/2011PI (Norms) dated 3.1.2012 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 Item Qty. allowed/kg Flavoxate HCL Bp 1 Kg 3Methyl Flavone8Carboxylic Acid 0.883 86
Case No.:41/31/82ALC4/2011
Party Name:AUCTUS PHARMA LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00867/AM12/ RLA File :09/24/040/00196/AM12/ Lic.No/Date:0910048207 10.08.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the
87
Case No.:45/31/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00871/AM12/ RLA File :09/24/040/00220/AM12/ Lic.No/Date:0910048208 10.08.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 88
Case No.:16/25/82ALC4/2011
Party Name:STERICAT GUTSTRINGS PVT. LTD. Meet No/Date:41/82ALC4/2011 10.01.2012 Status:Case Deferred HQ File :01/82/050/00683/AM12/ RLA File :05/24/040/00154/AM12/ Lic.No/Date:0510299727 17.08.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 89
Case No.:8/27/82ALC4/2011
Party Name:GLENMARK GENERICS LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00758/AM12/ RLA File :03/94/040/00397/AM12/ Lic.No/Date:0310648930 17.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to ratify the 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 Item Qty. allowed/kg Ciclopirox Gel 0.77%, 30 gm 1 Kg Ciclopirox USP 3.181 kg Ciclopirox Gel 0.77%, 45 gm 1 Kg Ciclopirox USP 3.212 kg Ciclopirox Gel 0.77%, 100 gm 1 Kg Ciclopirox USP 3.611 kg 90
Case No.:9/23/82ALC4/2011
Party Name:RELIANCE INDUSTRIES LTD. 10.01.2012 Status:Case Approved HQ File :01/82/050/00661/AM12/ RLA File :03/95/040/00193/AM12/ Lic.No/Date:0310650093 24.08.2011 Defer Date:
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed that this case has already been approved in the Norms Committee meeting No . 36/82 dated6.12.2011. 91
Case No.:11/27/82ALC4/2011
Party Name:INDOFIL INDUSTRIES LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00761/AM12/ RLA File :03/94/040/00465/AM12/ Lic.No/Date:0310650141 24.08.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 92
Case No.:9/27/82ALC4/2011
Party Name:INDOFIL INDUSTRIES LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00759/AM12/ RLA File :03/94/040/00464/AM12/ Lic.No/Date:0310650335 25.08.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 93
Case No.:46/31/82ALC4/2011
Party Name:POSY PHARMACHEM PVT. LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00872/AM12/ RLA File :08/24/040/00084/AM12/ Lic.No/Date:0810102781 25.08.2011 Defer Date:21.02.2012 Decision : Committee decided to remind the firm to furnish the required technical information within 15 days otherwise case would be closed. Accordingly case has been deferred for 21.2.2012. 94
Case No.:21/29/82ALC4/2011
Party Name:AARTI INDUSTRIES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00820/AM12/ RLA File :03/94/040/00467/AM12/ Lic.No/Date:0310650671 26.08.2011 Defer Date: Decision Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals UO No.14010/137/2011Ch. II dated 22.12.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg 2,4 Dichloro Aniline 1 Kg Meta Dichloro Benzene 1.13 kg
95
Case No.:10/27/82ALC4/2011
10.01.2012 Status:Case Deferred HQ File :01/82/050/00760/AM12/ RLA File :03/94/040/00480/AM12/ Lic.No/Date:0310650724 26.08.2011 Defer Date:21.02.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 21.02.2012 for comments of technical authority 96
Case No.:19/31/82ALC4/2011
Party Name:MICRO LABS LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00845/AM12/ RLA File :07/24/040/00199/AM12/ Lic.No/Date:0710081875 29.08.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 97
Case No.:37/31/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 10.01.2012 Status:Case Approved HQ File :01/82/050/00863/AM12/ RLA File :22/24/040/00029/AM12/ Lic.No/Date:2210011825 30.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/91/2010PI(Norms) dated 1.10.2010 and in consultation with technical authority present in the 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 Homatropine Methyl Bromide Synonyms N,Ndimethyl8 Azoniabicyclo(3.2.1)octane3yl)2 hydroxy2phenylacetate bromide C.A.S. No.80499 formula C6H4CH2Bro2N Quality 99% Purity 1 kg 1. Tropine 0.718 kg 2. DLMandelic Acid 0.862 kg 3. Methylene Dichloride 5.20 kg 4. Acetone 5.37 kg RA concerned may take further necessary action as per above decision of NC. 98
Case No.:39/31/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 10.01.2012 Status:Case Deferred HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the
99
Case No.:6/27/82ALC4/2011
10.01.2012 Status:Case Deferred HQ File :01/82/050/00756/AM12/ RLA File :03/94/040/00489/AM12/ Lic.No/Date:0310651351 02.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 100
Case No.:16/29/82ALC4/2011
10.01.2012 Status:Case Deferred HQ File :01/82/050/00815/AM12/ RLA File :03/94/040/00501/AM12/ Lic.No/Date:0310651860 06.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 101
Case No.:35/31/82ALC4/2011
Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 10.01.2012 Status:Case Approved HQ File :01/82/050/00861/AM12/ RLA File :04/24/040/00162/AM12/ Lic.No/Date:0410127820 07.09.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals vide their UO No. 14010/7/2010Ch. II dated 30.11.2010 and in consultation with technical authority present in the 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 2TriFluoromethyl Benzene Sulfonamide 1 kg 2Aminobenzotrifluoride 0.842 kg 102
Case No.:11/31/82ALC4/2011
Party Name:ESTEEM INDUSTRIES PVT. LTD, 10.01.2012 Status:Case Deferred HQ File :01/82/050/00837/AM12/ RLA File :17/24/040/00044/AM12/ Lic.No/Date:1710004498 08.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 103
Case No.:50/31/82ALC4/2011
Party Name:SHASUN PHARMACEUTICALS LIMITED 10.01.2012 Status:Case Deferred Lic.No/Date:0410127861
HQ File :01/82/050/00876/AM12/ RLA File :04/24/040/00165/AM12/ 08.09.2011 Defer Date:21.02.2012 Decision :The Committee considered the case as per agenda in consultation with the technical authorities present in the meeting and decided to call from the firm Master Batch Formula along with the Drug Manufacturing License. Accordingly, the case has been deferred for 21.2.2012. 104
Case No.:4/28/82ALC4/2011
Party Name:LUPIN LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00774/AM12/ RLA File :03/95/040/00441/AM12/ Lic.No/Date:0310652782 09.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/79/2011PI (Norms) dated 8.12.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg SIMVASTATIN 1 kg 1. Activated Carbon 0.035 2. Caustic Soda Flakes 0.358 3/ Cyclohexane 3.334 4. Ethyl Acetate 3.414 5. Methhl Ethyl Ketone 0.685 6. Imidazol 0.58 7. Methanol 7.374 8. Toluene 2.388 9. Tri Ethyl Amine 0.972 10. Methane Sulphonic Acid 0/173 11. Tertiary Butyl Dimethyl Silyl Chlo TBDMS 0.779 12. 2 2 Dimethyl Chloride 1.215 13 Lovastatin 1.39 Ra may take appropriate action as per the decision of Norms Committee. 105
Case No.:15/31/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 10.01.2012 Status:Case Deferred HQ File :01/82/050/00841/AM12/ RLA File :05/23/040/00197/AM12/ Lic.No/Date:0510302069 13.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the
106
Case No.:16/31/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 10.01.2012 Status:Case Approved HQ File :01/82/050/00842/AM12/ RLA File :05/23/040/00213/AM12/ Lic.No/Date:0510302070 13.09.2011 Defer Date: 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 Item Qty. allowed/kg Donepezil Tablets 5 mg Donepezil Hydrochloride Donepezil Tablets 10 mg Donepezil Hydrochloride IH (US) 107
Case No.:21/31/82ALC4/2011
Party Name:PI INDUSTRIES LTD., 10.01.2012 Status:Case Approved HQ File :01/82/050/00847/AM12/ RLA File :13/24/040/00022/AM12/ Lic.No/Date:1310036750 14.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals & Petrochemicals vide their U.O No. 14010/6/2010Ch.II dated 30.11.2011 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 3[5 (difuoromethoxy)1 methyl3 (trifluromethyl) pyrazole4 ylemethy (sulfonyl)4,5 dihydro5,5 dimethyl1,2 oxazole 1 Kg 1 2 3 4 5 6 7 8 8. Glyoxalic acid 50% Min. Hydroxylamine Sulfate 98% Min. Bromine 99% Min. Thiourea 99% Min. 1Methyl3(trifluroromethyl)1H pyrazole(MTP) 96% Min. Potassium Carbonate 98% Min. nButyl Acetate 98% Min. Acetonitrile 98.5% Min. Isopropyl alcohol 98% Min. 0.870 kg 0482 kg 1.670 kg 0.295 kg 0.652 kg 0.523 kg 1.757 kg 1.970 kg 0.525 kg
108
Case No.:28/31/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 10.01.2012 Status:Case Deferred HQ File :01/82/050/00854/AM12/ RLA File :22/24/040/00044/AM12/ Lic.No/Date:2210011894 14.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 109
Case No.:7/29/82ALC4/2011
Party Name:MEDICAMEN BIOTECH LTD., 10.01.2012 Status:Case Deferred HQ File :01/82/050/00806/AM12/ RLA File :05/24/040/00208/AM12/ Lic.No/Date:0510302892 19.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 110
Case No.:5/29/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00804/AM12/ RLA File :05/24/040/00210/AM12/ Lic.No/Date:0510303168 20.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 111
Case No.:6/29/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 10.01.2012 Status:Case Approved HQ File :01/82/050/00805/AM12/ RLA File :05/24/040/00198/AM12/ Lic.No/Date:0510303163 20.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 25/82 meeting held on 20.09.2011 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 Isotretinoin 1 Kg. 1. Acetone 0.48 kg 2. Activated Carbon 0.100 kg 3. Beta Ionone 3.20 kg 4. Dimethyl Acrylic Acid 2.37 kg 5. Hexane 9.69 kg 6. Lithium Aluminium Hybride 0.40 kg 7. Methanol 8.56 kg
Methylene Chloride 9.36 kg 9. N Butyl Lithium 30% 0.89 kg 10. Tetrahydrofuran 6.59 kg 11. Toluene 7.53 kg 12. Triethylphosphone Acetate 4.10 kg RA may take appropriate action as per the decision of Norms Committee.. 112
Case No.:19/29/82ALC4/2011
Party Name:ANUH PHARMA LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00818/AM12/ RLA File :03/94/040/00448/AM12/ Lic.No/Date:0310654715 20.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 113
Case No.:18/27/82ALC4/2011
Party Name:DUJODWALA PRODUCTS LTD., 10.01.2012 Status:Case Approved HQ File :01/82/050/00768/AM12/ RLA File :03/94/040/01036/AM11/ Lic.No/Date:0310654841 20.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of the written comments of Department of Chemicals and Petrochemicals forwarded vide U.O No. 14010/231/2007Ch. II dated 12.5.2011 and in consultation with the technical authorities and based on the details of manufacturing process furnished by the firm, decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Dipentine (mixture of Monocyclic Terpenes) 1 Kg Gum Purpentine Oil 1.08 kg 114
Case No.:19/27/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00769/AM12/ RLA File :03/95/040/00407/AM12/ Lic.No/Date:0310654860 20.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the
115
Case No.:20/31/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 10.01.2012 Status:Case Deferred HQ File :01/82/050/00846/AM12/ RLA File :05/23/040/00218/AM12/ Lic.No/Date:0510303152 20.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities decided to call from the firm the Drug Manufacturing License. Accordingly, the case has been deferred for 21.2.2012. 116
Case No.:36/31/82ALC4/2011
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00862/AM12/ RLA File :04/24/040/00177/AM12/ Lic.No/Date:0410128297 20.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of the written comments of Department of Pharmaceuticals forwarded vide OM No. 35011/106/2011PI(Norms) dated 6.1.2012 and in consultation with the technical authorities and based on the details of manufacturing process furnished by the firm, decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by firm Export product Exp. Qty. Sl.No. Import items Qty. allowed 4Hydroxy Coumarin an organic intermediate used in the manufacture of few active pharmaceutical ingredients 1 Kg Ortho Hydroxy Acetophenone Raw material 1.24 kg 117
Case No.:12/29/82ALC4/2011
Party Name:GLENMARK GENERICS LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00811/AM12/ RLA File :03/94/040/00530/AM12/ Lic.No/Date:0310655109 21.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 118
Case No.:4/31/82ALC4/2011
10.01.2012 Status:Case Deferred HQ File :01/82/050/00830/AM12/ RLA File :03/94/040/00540/AM12/ Lic.No/Date:0310655386 22.09.2011 Defer Date:21.02.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 119
Case No.:49/31/82ALC4/2011
Party Name:ASCENT FINECHEM PVT. LTD., 10.01.2012 Status:Case Deferred HQ File :01/82/050/00875/AM12/ RLA File :08/24/040/00147/AM12/ Lic.No/Date:0810103865 22.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 120
Case No.:21/41/82ALC4/2011
Party Name:R L FINE CHEM 10.01.2012 Status:Case Approved HQ File :01/82/050/01022/AM12/ RLA File :07/24/040/00238/AM12/ Lic.No/Date:0710082814 27.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 3/82 meeting held on 19.4.2011 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 Clomipramine Hcl 1 Kg. 1. 1 Bromo 3 Chloro Propane 0.85 kg 2. 3 Chloro Iminodibenzyl 0.91 kg RA concerned may take further necessary action as per above decision of NC. 121
Case No.:17/28/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00787/AM12/ RLA File :03/95/040/00471/AM12/ Lic.No/Date:0310656673 28.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 122
Case No.:1/29/82ALC4/2011
Party Name:SANDOZ PRIVATE LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00800/AM12/ RLA File :03/95/040/00325/AM12/ Lic.No/Date:0310657295 30.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the
123
Case No.:14/41/82ALC4/2011
Party Name:MEDREICH LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/01015/AM12/ RLA File :07/24/040/00254/AM12/ Lic.No/Date:0710083012 04.10.2011 Defer Date:21.02.2012 Decision : the Committee considered the case as per agenda and in consultation with the technical authorities decided to call from the firm the following information : Details of Pellets Master Batch Formula Production and Consumption Data certified by Central Excise Authority. Accordingly, the case has been deferred for 21.2.2012. 124
Case No.:6/31/82ALC4/2011
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/00832/AM12/ RLA File :03/95/040/00513/AM12/ Lic.No/Date:0310659452 13.10.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities and in the light of the letter No. 14010/143/2011Ch.II dated 23.12.2011 written to the firm by Department of Chemicals & Petrochemicals, it has been decided to call following information within 10 days from the firm: Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular weight. Complete material balance. Stagewise% yield on molecular weight basis alongwith justification supported with authentic/printed technical literature. Chartered Accountant’s certificate regarding past two years production of the export item and corresponding consumption of each input. Photocopy of the earlier norms fixed by ALC for same export item in the recent past. Accordingly, the case has been deferred for 21.2.2012. 125
Case No.:7/31/82ALC4/2011
Party Name:EMBIO LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00833/AM12/ RLA File :03/94/040/00612/AM12/ Lic.No/Date:0310659475 13.10.2011 Defer Date:07.02.2012 Decision : The Committee considered the case as per the agenda and in the light of written comments from Department of Pharmaceuticals vide their OM No. 35011/279/2011PI(Norms) dated 23.12.2011 and in consultation with technical authority it has been decided to call from the firm the following technical details:
Stepwise complete and balanced chemical reaction showing mol. Wt. of all inputs and output production and their molar requirements. % yield on molar basis for each step and its justification. Materail balance for entire process. Detailed working with technical justification for utilizing 36.0 kg molasses per kg export product. Requirement & Recovery of solvent at each step. The committee also decided to call the firm for Personal Hearing on 07.02.2012 126
Case No.:8/31/82ALC4/2011
Party Name:EMBIO LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00834/AM12/ RLA File :03/94/040/00611/AM12/ Lic.No/Date:0310659491 13.10.2011 Defer Date:07.02.2012 Decision : The Committee considered the case as per the agenda and in the light of written comments from Department of Pharmaceuticals vide their OM No. 35011/279/2011PI(Norms) dated 23.12.2011 and in consultation with technical authority it has been decided to call from the firm the following technical details: Stepwise complete and balanced chemical reaction showing mol. Wt. of all inputs and output production and their molar requirements. % yield on molar basis for each step and its justification. Materail balance for entire process. Detailed working with technical justification for utilizing 36.0 kg molasses per kg export product. Requirement & Recovery of solvent at each step. The committee also decided to call the firm for Personal Hearing on 07.02.2012 127
Case No.:44/31/82ALC4/2011
Party Name:PRATAP ORGANICS PRIVATE LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00870/AM12/ RLA File :03/95/040/00583/AM12/ Lic.No/Date:0310660025 17.10.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of the written comments of Department of Chemicals and Petrochemicals forwarded vide U.o No. 14010/140/2011/Ch.II dated 23.12.2011 and in consultation with the technical authorities and based on the details of manufacturing process furnished by the firm, decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2 Methylbenzhydrylchloride 1 kg 1 2Methylbenzophenone 1.121 kg
2 Sodium Borohydride 0.323 kg 128
Case No.:11/41/82ALC4/2011
Party Name:INDIA GLYCOLS LTD., 10.01.2012 Status:Case Deferred HQ File :01/82/050/01012/AM12/ RLA File :05/23/040/00237/AM12/ Lic.No/Date:0510305501 17.10.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 129
Case No.:54/31/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/00880/AM12/ RLA File :03/94/040/00647/AM12/ Lic.No/Date:0310660797 19.10.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 130
Case No.:21/36/82ALC4/2011
Party Name:MEDREICH LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/00978/AM12/ RLA File :07/24/040/00285/AM12/ Lic.No/Date:0710083447 21.10.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities , decided to ratify norms under
Para 4.7 of HBP v1 as per details below or as applied by firm whichever is lower:
Export product Exp. Qty. Sl.No. Import items Qty. allowed Nortriptyline 25 mg Tablets 1 Kg Nortriptyline HCL 29.025 mg Nortriptyline 10 mg Tablets 1 Kg Nortriptyline HCL 11.61 mg 131
Case No.:6/41/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/01007/AM12/ RLA File :03/94/040/00618/AM12/ Lic.No/Date:0310661493 21.10.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the
. 132
Case No.:10/41/82ALC4/2011
Party Name:DALAS BIOTECH LTD. 10.01.2012 Status:Case Approved HQ File :01/82/050/01011/AM12/ RLA File :05/23/040/00274/AM12/ Lic.No/Date:0510306547 24.10.2011 Defer Date: Decision : Committee considered the case as per agenda and in light of the written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/262/2009PI(Norms) dated 8.3.2010 and in consultation with the technical authority present in meeting, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 7AVCA 1 Kg 1 2 3 7Phenylacetamideo3Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) Tri Phenyl Phospine Methylene Chloride 2.672 kg 1.260 Kg 5.488 kg RA may take appropriate action as per the decision of Norms Committee 133
Case No.:12/41/82ALC4/2011
Party Name:DALAS BIOTECH LTD. 10.01.2012 Status:Case Approved HQ File :01/82/050/01013/AM12/ RLA File :05/23/040/00273/AM12/ Lic.No/Date:0510306544 24.10.2011 Defer Date: Decision : Committee considered the case as per agenda and in light of the written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/262/2009PI(Norms) dated 8.3.2010 and in consultation with the technical authority present in meeting, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 7AVCA 1 Kg 1 2 3 7Phenylacetamideo3Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) Tri Phenyl Phospine Methylene Chloride 2.672 kg 1.260 Kg 5.488 kg
y g RA may take appropriate action as per the decision of Norms Committee 134
Case No.:7/41/82ALC4/2011
Party Name:AMINES & PLASTICIZERS LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/01008/AM12/ RLA File :03/94/040/00641/AM12/ Lic.No/Date:0310662257 25.10.2011 Defer Date: Decision : Committee considered the case as per agenda and in light of the written comments forwarded by Department of Chemicals and Petrochemicals vide their OM No. 14010/23/2007Ch.II dated 11.7.2011and in consultation with the technical authority present in meeting, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed NMethyl Morpholine Oxide 50% 1 Kg Morpholine Hydrogen Peroxide (50%) Formic Acid 0.391 kg 0.302 kg 0.207 kg 135
Case No.:9/41/82ALC4/2011
Party Name:BEST VALUE CHEM PVT. LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/01010/AM12/ RLA File :34/24/040/00154/AM12/ Lic.No/Date:3410032044 25.10.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 136
Case No.:8/41/82ALC4/2011
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 10.01.2012 Status:Case Approved HQ File :01/82/050/01009/AM12/ RLA File :05/23/040/00280/AM12/ Lic.No/Date:0510306966 02.11.2011 Defer Date: Decision : Committee considered the case as per agenda and in light of the written comments forwarded by Department of Chemicals and Petrochemicals vide their OM No. 14010/4/2009Ch.II dated 3.12.2009 and in consultation with the technical authority present in meeting, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Mikrofine TSH 1 kg 1 Toluene 0.684 kg
pToluene Sulfonyl Hydrazide 2 3 4 Chlorosulfonic Acid Hydrazine Hydrate 80% Dicumyl Peroxide 3.81 kg 0.420 kg 0.100 kg 137
Case No.:13/41/82ALC4/2011
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 10.01.2012 Status:Case Deferred HQ File :01/82/050/01014/AM12/ RLA File :07/24/040/00300/AM12/ Lic.No/Date:0710083654 02.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 138
Case No.:17/41/82ALC4/2011
Party Name:SHIVA PHARMACHEM LTD, 10.01.2012 Status:Case Deferred HQ File :01/82/050/01018/AM12/ RLA File :34/24/040/00158/AM12/ Lic.No/Date:3410032075 02.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 139
Case No.:18/41/82ALC4/2011
Party Name:R L FINE CHEM 10.01.2012 Status:Case Approved HQ File :01/82/050/01019/AM12/ RLA File :07/24/040/00291/AM12/ Lic.No/Date:0710083689 02.11.2011 Defer Date: Decision : Committee considered the case as per agenda and in light of its earlier decision taken in its 19/82 meeting held on 4.8.2009 and meeting no. 22/82 dated 30.8.2011 and in consultation with the technical authority present in meeting, decided to ratify norms under on repeat basis under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Clomipramine HCL 1 kg 1 2 1 Bromo 3 Chloro Propane 3 Chloro Iminodibenzyl 0.85 kg 0.91 kg 140
Case No.:23/41/82ALC4/2011
Party Name:TRIGON CHEMICALS PVT. LTD. 10.01.2012 Status:Case Approved
HQ File :01/82/050/01024/AM12/ RLA File :31/83/040/00149/AM12/ Lic.No/Date:3110051282 02.11.2011 Defer Date: Decision : Committee considered the case as per agenda and in light of the written comments forwarded by Department of Chemicals and Petrochemicals vide their OM No. 14010/113/2010Ch.II dated 24.6.2011 and in consultation with the technical authority present in meeting, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Potassium Benzoate 1 Kg Benzoic Acid (98%) Caustic Potash (97%) 0.819 kg 0.555 kg 141
Case No.:16/41/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/01017/AM12/ RLA File :34/24/040/00159/AM12/ Lic.No/Date:3410032102 04.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 06.03.2012 for comments of technical authority 142
Case No.:20/41/82ALC4/2011
Party Name:BAL PHARMA LTD 10.01.2012 Status:Case Approved HQ File :01/82/050/01021/AM12/ RLA File :07/24/040/00302/AM12/ Lic.No/Date:0710083774 04.11.2011 Defer Date: Decision : Committee considered the case as per agenda and in light of its earlier decision taken in its 36/82 meeting held on 6.12.2011 and in consultation with the technical authority present in meeting, decided to ratify norms under on repeat basis under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amiloride HCL 1 kg 1. Methyl 3,5Diamino6Chloro Pyrazine2 Carboxylate 0.838 kg 143
Case No.:24/41/82ALC4/2011
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 10.01.2012 Status:Case Approved HQ File :01/82/050/01025/AM12/ RLA File :34/24/040/00155/AM12/ Lic.No/Date:3410032100 04.11.2011 Defer Date:
Decision : Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/8/2010Ch.II dated 30.8.2010 and in consultation with the technical authorities present in the meeting and also based on details of manufacturing process furnished by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ethyl Triphenyl Phosphonium Bromide 1 kg Triphenyl Phosphine Ethyl Bromide Acetonitrile 0.850 kg 0.360 kg 0.100 kg 144
Case No.:26/41/82ALC4/2011
Party Name:INTAS PHARMACEUTICALS LTD., 10.01.2012 Status:Case Deferred HQ File :01/82/050/01027/AM12/ RLA File :08/24/040/00185/AM12/ Lic.No/Date:0810105210 04.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 145
Case No.:15/41/82ALC4/2011
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 10.01.2012 Status:Case Deferred HQ File :01/82/050/01016/AM12/ RLA File :07/24/040/00306/AM12/ Lic.No/Date:0710083782 08.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 146
Case No.:19/41/82ALC4/2011
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 10.01.2012 Status:Case Deferred HQ File :01/82/050/01020/AM12/ RLA File :07/24/040/00308/AM12/ Lic.No/Date:0710083783 08.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 147
Case No.:25/41/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 10.01.2012 Status:Case Deferred HQ File :01/82/050/01026/AM12/ RLA File :08/24/040/00179/AM12/ Lic.No/Date:0810105257 Defer
08.11.2011 Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 148
Case No.:28/41/82ALC4/2011
Party Name:LIV MEDICA PRODUCTS PVT. LTD. Meet No/Date:41/82ALC4/2011 10.01.2012 Status:Case Deferred HQ File :01/82/050/01029/AM12/ RLA File :04/24/040/00210/AM12/ Lic.No/Date:0410130168 09.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 06.03.2012 for comments of technical authority 149
Case No.:29/41/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 10.01.2012 Status:Case Deferred HQ File :01/82/050/01030/AM12/ RLA File :08/24/040/00180/AM12/ Lic.No/Date:0810105379 11.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 150
Case No.:30/41/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 10.01.2012 Status:Case approved HQ File :01/82/050/01031/AM12/ RLA File :08/24/040/00138/AM12/ Lic.No/Date:0810105380 11.11.2011 Defer Date Decision : Committee considered case as per agenda and in light of earlier decision taken by the Committee in its Meeting NO. 25/82 dated 20.9.2011 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 Exp. Qty. Sl. No. Import items Qty. allowed Pravastatin 10 mg tablet 1No. 1. Pravastatin Sodium 10.2 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 32.25 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 51.24 mg 4. 60 CC White HDPE Bottle As per packing policy 5. Bottle 75 CC White HDPE Bottle As per packing policy 6. 150 CC White HDPE Bottle As per packing policy 7. CRC White Cap 33 MM As per packing policy
p y 8. CRC White Cap 38 MM As per packing policy Pravastatin 20 mg tablet 1 No. 1. Pravastatin Sodium 20.4 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 64.50 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 102.48 mg 4. 60 CC White HDPE Bottle As per packing policy 5. Bottle 75 CC White HDPE Bottle As per packing policy 6. 150 CC White HDPE Bottle As per packing policy 7. CRC White Cap 33 MM As per packing policy 8. CRC White Cap 38 MM As per packing policy Pravastatin 40 mg tablet 1 No. 1. Pravastatin Sodium 40.8 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 129.00 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 204.97 mg 4. 60 CC White HDPE Bottle As per packing policy 5. Bottle 75 CC White HDPE Bottle As per packing policy 6. 150 CC White HDPE Bottle As per packing policy 7. CRC White Cap 33 MM As per packing policy 8. CRC White Cap 38 MM As per packing policy Pravastatin 80 mg Tablet 1 No. 1. Pravastatin Sodium 81.6 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 258.0 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 409.94 mg 4. 60 CC White HDPE Bottle As per packing policy 5. Bottle 75 CC White HDPE Bottle As per packing policy 6. 150 CC White HDPE Bottle As per packing policy 7. CRC White Cap 33 MM As per packing policy 8. CRC White Cap 38 MM As per packing policy
RA concerned may take further necessary action as per above decision of NC. 151
Case No.:32/41/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/01033/AM12/ RLA File :34/24/040/00166/AM12/ Lic.No/Date:3410032153 14.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 152
Case No.:22/41/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/01023/AM12/ RLA File :05/24/040/00267/AM12/ Lic.No/Date:0510308239 17.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 153
Case No.:27/41/82ALC4/2011
Party Name:MEDREICH LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/01028/AM12/ RLA File :07/24/040/00328/AM12/ Lic.No/Date:0710084048 18.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 154
Case No.:31/41/82ALC4/2011
Party Name:ALEMBIC LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/01032/AM12/ RLA File :34/24/040/00161/AM12/ Lic.No/Date:3410032232 18.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 155
Case No.:33/41/82ALC4/2011
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 10.01.2012 Status:Case Deferred HQ File :01/82/050/01034/AM12/ RLA File :52/24/040/00036/AM12/ Lic.No/Date:5210037111 21.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the
156
Case No.:1/37/82ALC4/2011
Party Name:THERMAX LTD., 10.01.2012 Status:Case Deferred HQ File :01/82/050/00983/AM12/ RLA File :31/83/040/00157/AM12/ Lic.No/Date:3110051627 28.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 157
Case No.:2/37/82ALC4/2011
Party Name:POLYDRUG LABORATORIES PVT.LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00984/AM12/ RLA File :03/95/040/00667/AM12/ Lic.No/Date:0310667832 29.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 158
Case No.:3/37/82ALC4/2011
Party Name:RELIANCE LIFE SCIENCES PVT. LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/00985/AM12/ RLA File :03/95/040/00538/AM12/ Lic.No/Date:0310668193 30.11.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 159
Case No.:1/41/82ALC4/2011
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/01002/AM12/ RLA File :31/83/040/00190/AM12/ Lic.No/Date:3110052067 27.12.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 160
Case No.:2/41/82ALC4/2011
Party Name:BALAJI AMINES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/01003/AM12/ RLA File :31/83/040/00197/AM12/ Lic.No/Date:3110052163 29.12.2011 Defer Date: Decision : Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/113/2010Ch.II dated 29.3.2009 and in consultation with the technical authorities present in the
p meeting and also based on details of manufacturing process furnished by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Gamma Butyrolactone 1 kg 1 2 Butanediol GBL Dehydrogenation Catalyst 1.16 kg 0.001 kg 161
Case No.:3/41/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 10.01.2012 Status:Case Deferred HQ File :01/82/050/01004/AM12/ RLA File :03/95/040/00803/AM12/ Lic.No/Date:0310673724 30.12.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 162
Case No.:4/41/82ALC4/2011
Party Name:BALAJI AMINES LIMITED 10.01.2012 Status:Case Approved HQ File :01/82/050/01005/AM12/ RLA File :31/83/040/00198/AM12/ Lic.No/Date:3110052165 30.12.2011 Defer Date: Decision : : Committee considered the case as per agenda and in the light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch.II dated 23.12.2011 and in consultation with the technical authorities present in the meeting and also based on details of manufacturing process furnished by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed NEthyl2 Pyrrolidone 1 kg 1 2 3 4 1,4 Butanediol Ammonia Anhydrous Ethyl Alcohol (95% Minimum) (denatured) Ethylamine Catalyst 0.882 kg 0.176 kg 0.512 kg 0.001 kg
163
Case No.:5/41/82ALC4/2011
Party Name:SOHAN HEALTHCARE PVT. LTD 10.01.2012 Status:Case Deferred HQ File :01/82/050/01006/AM12/ RLA File :31/83/040/00195/AM12/ Lic.No/Date:3110052178 30.12.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the 164
Case No.:4/31/82ALC4/2011
10.01.2012 Status:Case Deferred HQ File : / 01/82/050/00830/AM12/ dated 16.10.2011 RLA file No. 03/94/040/00540/AM 12 dated 19.9.2011 Lic.No/Date:0310655386 22.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities, it has been decided to defer the case for 21.02.2012 for comments of technical authority Outside Agenda 1 M/s. Navin Fluorine International Limited F.No 01/82/50/713/AM09/DES III Pt. Advance License NO. 0310477465 dated 4.7.2008 Decision: The Committee considered the case as per agenda and in consultation with the members present in the meeting decided to ratify norms under Para 4.7 of HBP v 1, as per details below or as applied by the firm Export product Export Quantity Sl.No. Import items Qty. allowed Para Fluoro Phenol (4 Fluoro Phenol) 1 Kg 1. Fluoro Benzene 2.435/Kg
Bromine 1.390/Kg RA concerned may take further necessary action as per above decision of NC. Outside Agenda 2 M/s R L Fine Chem F.No 01/82/50/971/AM09/DES III Pt. Advance License NO. 0710059547 dated 2.9.2008 0710064293 dated 21.04.2009 0710069721 dated 1.2.2010 Decision: The Committee considered the case as per agenda and in consultation with the members present in the meeting decided to ratify norms under Para 4.7 of HBP v 1, as per details below or as applied by the firm Export product Export Quantity Sl.No. Import items Qty. allowed Carbinoxamine Maleate 1 Kg 1. 2. 3. Pyridine 2Aldehyde Tetra Hydro Furan Acetone 0.833/kg 0.468/kg 1.500/kg RA concerned may take further necessary action as per above decision of NC.
Date:11.01.2012 Place:New Delhi Lalita Maini Foreign Trade Development Officer
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