DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 47/82ALC4/2011 MEETING DATE : 21.02.2012 Cipla The Meeting No.46/82 in the year 201112 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 14.02.2012 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 V.K. Tyagi, Dy. Industrial Adviser, Department of Pharmaceuticals 4. Ms.Lalita Maini, FTDO At the outset, minutes of Norms Committee Meeting No.46/82 dated 14.2.2012 were ratified by the Committee.
Case No.B 488
M/s. Shree Ganesh Remedies Pvt. Ltd. Norms Committee Meeting No.47/AM12 F.No. 01/82/050/01642/AM 09/DES III Meeting Date:21.02.2012 Adv. Lic. No3410023446 dated 11.2.2009 R.A F.NO 34/24/040/00199/AM 09 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2011 for comments of Department of Pharmaceuticals.
Case No.B 489
M/s. Intas Pharma Limited Norms Committee Meeting No.47/AM12 F.No. 01/82/050/01420/AM 09/DES III Meeting Date:21.02.2012 Adv. Lic. No 0810076754 dated 15.7. 2009 R.A F.NO 34/24/040/00199/AM 09 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2011 for comments of Department
of Pharmaceuticals.
Case No.B 490
M/s. Gulbrandson Chemicals Pvt. Ltd. Norms Committee Meeting No.47/AM12 F.No. 01/82/050/01420/AM 09/DES III Meeting Date:21.02.2012 Adv. Lic. No 3410030091 dated 4.5.2011 R.A F.NO 34/24/040/00196/AM 09 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting and on the basis of Central Excise Data 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. S.No Import Items (in Kgs) Qty. Allowed (Kgs) 5% Triethyl Aluminium in Hexane 1 kg 1 Aluminium Grit/Granules 0.0135 kg 2 Hexane 0.970 kg RA may take appropriate action as per the decision of Norms Committee.
Case No.B 491
M/s. Gulbrandson Chemicals Pvt. Ltd. Norms Committee Meeting No.47/AM12 F.No. 01/82/050/00282/AM 12/DES III Meeting Date:21.02.2012 Adv. Lic. No 3410029995 dated 25.04.11 R.A F.NO 34/24/040/00009/AM 12 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting and on the basis of Central Excise Data 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. S.No Import Items (in Kgs) Qty. Allowed (Kgs) Ethyl Aluminium Sesqui Chloride (EASC) 1 kg 1 Aluminium Grit/Granules 0.140 kg Diethyl Aluminium Chloride (DEAC) 1 kg 1 Aluminium Grit/Granules 0.195 kg Triethyl Aluminium 1 kg 1 Aluminium Grit/Granules 0.270 kg
(TEAL)
Case No.B 492
M/s. Kedia Organic Chemicals Pvt. Ltd. Norms Committee Meeting No.47/AM12 F.No. 01/82/050/01349/AM 11/DES III Meeting Date:21.02.2012 Adv. Lic. No 0310607421 dated 22.12.10 R.A F.NO 34/94/040/00792/AM 11 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authority. Accordingly, the case has been deferred for 20.3.2012.
Case No.B 493
M/s. Divis Laboratories Limited Norms Committee Meeting No.47/AM12 F.No. 01/82/162/00177/AM 12/DES III F.No. 01/82/162/00178/AM 12/DES III F.No. 01/82/162/00179/AM 12/DES III F.No. 01/82/162/00180/AM 12/DES III F.No. 01/82/162/00182/AM 12/DES III F.No. 01/82/162/00183/AM 12/DES III F.No. 01/82/162/00184/AM 12/DES III F.No. 01/82/162/00185/AM 12/DES III F.No. 01/82/162/00186/AM 12/DES III F.No. 01/82/162/00187/AM 12/DES III F.No. 01/82/162/00188/AM 12/DES III F.No. 01/82/162/00189/AM 12/DES III F.No. 01/82/162/00190/AM 12/DES III F.No. 01/82/162/00191/AM 12/DES III F.No. 01/82/162/00192/AM 12/DES III F.No. 01/82/162/00193/AM 12/DES III F.No. 01/82/162/00194/AM 12/DES III Meeting Date:21.02.2012 Decision: . In respect of F.No. 01/82/162/00182/AM 12 DES III The Committee considered the case as per agenda in the light of written comments of Department of Pharmaceuticals decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by the firm whichever is lower: Export Product Exp. Qty. S.No Import Item Qty. allowed kg/kg
ZValaciclovir 1 kg Acyclovir 0.64 N,N Dicyclohexylcarbodimide 0.910 N,NDimethyl formamide 6.42 4Dimethyl aminopyridine 0.020 DC may take appropriate action as per the decision of Norms Committee. In respect of other file numbers, the Committee decided to remind the firm to furnish : Copy of valid Drug Manufacturing License showing the approved composition of the export products. Copy of Master Batch Formula duly authenticated by Quality Control Incharge production and consumption data certified by Central Excise Authority for the last three years. Accordingly, the case has been deferred for 20.3.2012. 1
Case No.:24/28/82ALC4/2011
Party Name:SARNA CHEMICALS PVT.LTD. Meet No/Date:47/82ALC4/2011 21.02.2012 Status:Case Deferred HQ File :01/82/050/00794/AM12/ RLA File :03/88/040/00005/AM10/ Lic.No/Date:0310517425 27.04.2009 Defer Date 20.03.2012 Decision : The Committee considered the case as per agenda and decided to remind the firm to furnish the requisite information. Accordingly, the case has been deferred for 20.03.2012. 2
Case No.:44/39/82ALC4/2010
Party Name:ASTRIX LABORATORIES LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/01125/AM11/ RLA File :09/24/040/00301/AM10/ Lic.No/Date:0910040874 09.02.2010 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.03.2012 for comments of Department of Chemicals and Petrochemicals. 3
Case No.:48/14/82ALC4/2010
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 21.02.2012 Status:Case Rejected HQ File :01/82/050/00410/AM11/ RLA File :03/94/040/00933/AM10/ Lic.No/Date:0310570355 20.04.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to close the case as the firm has not provided the information despite repeated reminder.
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Case No.:11/5/82ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 21.02.2012 Status:Case Approved HQ File :01/82/050/00045/AM11/ RLA File :05/24/040/00017/AM11/ Lic.No/Date:0510262860 22.04.2010 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 Norms Committee meeting No. 44/82 dated 31.1.2012. 5
Case No.:62/15/82ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 21.02.2012 Status:Case Approved HQ File :01/82/050/00499/AM11/ RLA File :05/23/040/00041/AM11/ Lic.No/Date:0510265059 31.05.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 6
Case No.:71/15/82ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 21.02.2012 Status:Case Deferred HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish following information : 1. Stepwise complete and balance chemical reactions to show requirements of all the 19 imported inputs. 2. % yield on molar basis for each step of manufacturing process. 3. Past production visàvis actual consumption of all the imported inputs duly certified by Central Excise Authority. Accordingly, the case has been deferred for 20.3.2012. 7
Case No.:56/41/82ALC4/2010
Party Name:LUPIN LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/01404/AM11/ RLA File :03/95/040/00392/AM11/ Lic.No/Date:0310589566 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.35011/08/2010PI(Norms) 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. S.No Import Item Qty. allowed
STERILE CEFTRIAXONE SODIUM (Non Infringing) (STERILE CEFTRIAXONE SODIUM 275 mg/250 mg) 1 kg of API 1. ETHYL ACETATE 2.181kg/kg of Sterile Ceftriaxone Sodium 2. METHYLENE CHLORIDE 2.00kg/kg of Sterile Ceftriaxone Sodium 3. SODIUM HYDROSULPHITE 0.0049 kg/kg of Sterile Ceftriaxone Sodium 4. 7 AMINO CEPHALOSPORANIC ACID 0.668 kg/kg of Sterile Ceftriaxone Sodium 5. 2,5,DIHYDRO6HYDROXY3 MERCAPTO2METHYL5OXO 1,2,4TRIAZENE 0.360 kg/kg of Sterile Ceftriaxone Sodium 6. BORON TRIFLUORIDE GAS 0.611 kg/kg of Sterile Ceftriaxone Sodium 7. METHANOL 2.60 kg/kg of Sterile Ceftriaxone Sodium 8. ACETONE 11.50 kg/kg of Sterile Ceftriaxone Sodium 9. ACTIVATED CARBON 0.100 kg/kg of Sterile Ceftriaxone Sodium
TETRA HYDROFURAN 1.23 kg/kg of Sterile Ceftriaxone Sodium 11. FORMIC ACID 3.158 kg/kg of Sterile Ceftriaxone Sodium 12. HEXAMETHYL DISILAZANE 0.540 kg/kg of Sterile Ceftriaxone Sodium 13. TRIETHYL AMINE 0.514 kg/kg of Sterile Ceftriaxone Sodium 14. PHOSPHOROUS PENTACHLORIDE 0.474 kg/kg of Sterile Ceftriaxone Sodium 15. ISOPROPYL ALCOHOL 0.400 kg/kg of Sterile Ceftriaxone Sodium 16. THIOUREA 0.180 kg/kg of Sterile Ceftriaxone Sodium 17. ETHYLENE DIAMINE TETRA ACETIC ACID DISODIUM SALT (E.D.T.A DI SODIM) 0.040 kg/kg of Sterile Ceftriaxone Sodium 18. SODIUM BICARBONATE 0.511 kg/kg of Sterile Ceftriaxone Sodium 19. TRIMETHYL CHLOROSILANE 0.079 kg/kg of Sterile Ceftriaxone Sodium
SODIUM 2ETHYL HEXANOATE 0.684 kg/kg of Sterile Ceftriaxone Sodium 21. 4BROMO2METHOXYIMINO3 OXO BUTYRIC ACID (BROMO ACID) 0.485 kg/kg of Sterile Ceftriaxone Sodium RA concerned may take further necessary action as per above decision of NC. 8
Case No.:9/24/82ALC4/2010
Party Name:RAMPEX LABS PVT. LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00809/AM11/ RLA File :09/24/040/00194/AM11/ Lic.No/Date:0910043391 07.09.2010 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 9
Case No.:124/40/82ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals 10
Case No.:53/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/01252/AM11/ RLA File :09/24/040/00281/AM11/ Lic.No/Date:0910044023 26.10.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 11
Case No.:56/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/01255/AM11/ RLA File :09/24/040/00236/AM11/ Lic.No/Date:0910044022 26.10.2010 Defer Date:20.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm the technical details as per Appendix 33. Accordingly, the case has been deferred for 20.3.2012. 12
Case No.:12/32/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/00994/AM11/ RLA File :09/24/040/00300/AM11/ Lic.No/Date:0910044098 02.11.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 13
Case No.:44/40/82ALC4/2010
Party Name:LUPIN LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/01243/AM11/ RLA File :03/95/040/00638/AM11/ Lic.No/Date:0310600874 11.11.2010 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 14
Case No.:25/40/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/01224/AM11/ RLA File :09/24/040/00238/AM11/ Lic.No/Date:0910044429 25.11.2010 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 15
Case No.:13/7/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00179/AM12/ RLA File :09/24/040/00385/AM11/ Lic.No/Date:0910044627 10.12.2010 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 16
Case No.:23/4/82ALC4/2011
Party Name:PADMINI AROMATICS PVT. LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00074/AM12/ RLA File :07/24/040/00352/AM11/ Lic.No/Date:0710075977 13.12.2010 Defer Date: 20.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals. 17
Case No.:5/41/82ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/01353/AM11/ RLA File :09/24/040/00415/AM11/ Lic.No/Date:0910044855 22.12.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and observed that the firm has been requested to come for Personal Hearing on 28.2.2012. Accordingly, the case has been deferred for 28.2.2012. 18
Case No.:1/42/82ALC4/2010
Party Name:SHAMROCK PHARMACHEMI PRIVATE LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/01448/AM11/ RLA File :03/95/040/00825/AM11/ Lic.No/Date:0310609520 05.01.2011 Defer Date:20.03.2012 Decision : Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to remind the firm to send complete technical details as per Appendix 33. Accordingly, the case has been deferred for 20.03.2012. 19
Case No.:4/44/82ALC4/2010
Party Name:VIJAYASRI ORGANICS LTD Meet No/Date:47/82ALC4/2011 21.02.2012 Status:Case Approved HQ File :01/82/050/01503/AM11/ RLA File :09/71/040/00083/AM11/ Lic.No/Date:0910045205 19.01.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 20
Case No.:7/44/82ALC4/2010
Party Name:SAIRAM ORGANICS PVT. LTD., 21.02.2012 Status:Case Approved HQ File :01/82/050/01506/AM11/ RLA File :09/24/040/00488/AM11/ Lic.No/Date:0910045214 20.01.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 21
Case No.:7/48/82ALC4/2010
Party Name:ALKYL AMINES CHEMICALS LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/01650/AM11/ RLA File :03/94/040/00121/AM10/ Lic.No/Date:0310615984 14.02.2011 Defer Date:
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 22
Case No.:50/48/82ALC4/2010
Party Name:SVR LABORATORIES PRIVATE LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/01693/AM11/ RLA File :09/24/040/00523/AM11/ Lic.No/Date:0910045599 18.02.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/94/2011PI(Norms) dated 4.1.2012 and in consultation with the technical authorities 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. S.No Import Item Qty. allowed kg/kg {3aS[3s*(R*)]3a alpha,8a alpha]} (3,3a,8,8a)tetrahydro 2,2dimethyl3(2 oxyranylmethyl)1 oxo3phenyl propyl)2Hindino (1,2d)oxazole 1 kg 1 2 3 4 5 6 Indene Acetonitrile L(+) Tartaric Acid 2Methoxy Propene Tetrahydrofuran Isopropyl Acetate 1.932 2.90 1.781 0.947 14.95 1.79 23
Case No.:5/4/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD.(FORMERLY NICHOLAS PIRAMAL) 21.02.2012 Status:Case Deferred HQ File :01/82/050/00056/AM12/ RLA File :03/95/040/00949/AM11/ Lic.No/Date:0310620143 08.03.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Biotechnology.
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Case No.:29/8/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00229/AM12/ RLA File :03/94/040/01012/AM11/ Lic.No/Date:0310620022 08.03.2011 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 Norms Committee meeting No. 44/82 dated 31.1.2012 25
Case No.:29/6/82ALC4/2011
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 21.02.2012 Status:Case Approved HQ File :01/82/050/00147/AM12/ RLA File :03/94/040/01046/AM11/ Lic.No/Date:0310621245 15.03.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 26
Case No.:30/8/82ALC4/2011
Party Name:KOPRAN LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00230/AM12/ RLA File :03/94/040/01136/AM11/ Lic.No/Date:0310623342 25.03.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 27
Case No.:37/6/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 21.02.2012 Status:Case Deferred HQ File :01/82/050/00155/AM12/ RLA File :05/24/040/00437/AM11/ Lic.No/Date:0510286990 28.03.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Pharmaceuticals. 28
Case No.:15/19/82ALC4/2011
Party Name:HETERO LABS LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00529/AM12/ RLA File :09/24/040/00597/AM11/ Lic.No/Date:0910046128 29.03.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed
29
Case No.:41/14/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00432/AM12/ RLA File :09/24/040/00609/AM11/ Lic.No/Date:0910046267 05.04.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Chemicals and Petrochemicals. 30
Case No.:6/5/82ALC4/2011
21.02.2012 Status:Case Deferred HQ File :01/82/050/00108/AM12/ RLA File :09/24/040/00004/AM12/ Lic.No/Date:0910046405 18.04.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Chemicals and Petrochemicals 31
Case No.:16/12/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/00349/AM12/ RLA File :03/94/040/00042/AM12/ Lic.No/Date:0310627685 21.04.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 32
Case No.:47/6/82ALC4/2011
Party Name:JOCIL LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00166/AM12/ RLA File :09/24/040/00051/AM12/ Lic.No/Date:0910046581 29.04.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Industrial Policy and Promotion. 33
Case No.:8/8/82ALC4/2011
Party Name:MAITHRI LABORATORIES (P) LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00208/AM12/ RLA File :09/24/040/00015/AM12/ Lic.No/Date:0910046598 03.05.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Pharmaceuticals.
34
Case No.:18/16/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00476/AM12/ RLA File :09/24/040/00011/AM12/ Lic.No/Date:0910046614 03.05.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Pharmaceuticals. 35
Case No.:2/8/82ALC4/2011
Party Name:EMBIO LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00202/AM12/ RLA File :03/94/040/01025/AM11/ Lic.No/Date:0310629987 06.05.2011 Defer Date:20.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 13.3.2012. 36
Case No.:19/8/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00219/AM12/ RLA File :09/24/040/00071/AM12/ Lic.No/Date:0910046667 06.05.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Pharmaceuticals. 37
Case No.:45/8/82ALC4/2011
21.02.2012 Status:Case Deferred HQ File :01/82/050/00245/AM12/ RLA File :09/24/040/00078/AM12/ Lic.No/Date:0910046700 11.05.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Chemicals and Petrochemicals 38
Case No.:31/14/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/00422/AM12/ RLA File :09/24/040/00023/AM12/ Lic.No/Date:0910046786 19.05.2011 Defer Date:
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 39
Case No.:33/10/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 21.02.2012 Status:Case Approved HQ File :01/82/050/00292/AM12/ RLA File :05/23/040/00045/AM12/ Lic.No/Date:0510291486 24.05.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/38/2011Ch II dated 10.2.2012 2012and 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 2Chloro6 Trichloromethyl Pyridine 1 kg 1 2 3 4 5 Alpha Picoline 1,2,4Trichlorobenzene Heptane Stergene Carbon 0.658 kg 0.220 kg 0.280 kg 0.006 kg 0.005 kg RA may take appropriate action as per the decision of Norms Committee 40
Case No.:35/10/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 21.02.2012 Status:Case Deferred HQ File :01/82/050/00294/AM12/ RLA File :05/23/040/00048/AM12/ Lic.No/Date:0510291488 24.05.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 41
Case No.:55/10/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00314/AM12/ RLA File :09/24/040/00108/AM12/ Lic.No/Date:0910046940 27.05.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
42
Case No.:44/14/82ALC4/2011
Party Name:ONEIRO CHEMICALS LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00435/AM12/ RLA File :34/24/040/00037/AM12/ Lic.No/Date:3410030415 30.05.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 43
Case No.:2/15/82ALC4/2011
Party Name:ACHARYA CHEMICALS 21.02.2012 Status:Case Deferred HQ File :01/82/050/00442/AM12/ RLA File :03/94/040/00130/AM12/ Lic.No/Date:0310633824 31.05.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm the following details: End use of the export product In case it is a drug, a copy of Drug Manufacturing License. Accordingly, the case has been deferred for 20.3.2012. 44
Case No.:5/15/82ALC4/2011
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00445/AM12/ RLA File :03/94/040/00139/AM12/ Lic.No/Date:0310634097 01.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 45
Case No.:25/19/82ALC4/2011
21.02.2012 Status:Case Deferred HQ File :01/82/050/00539/AM12/ RLA File :09/24/040/00085/AM12/ Lic.No/Date:0910046996 06.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Chemicals and Petrochemicals
46
Case No.:19/19/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00533/AM12/ RLA File :09/24/040/00107/AM12/ Lic.No/Date:0910047035 07.06.2011 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call the firm for personal hearing on 28.2.2012. Accordingly, the case has been deferred for 28.2.2012. 47
Case No.:27/16/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00485/AM12/ RLA File :34/24/040/00039/AM12/ Lic.No/Date:3410030563 10.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm technical details as per Appendix 33. Accordingly, the case has been deferred for 20.3.2012. 48
Case No.:34/19/82ALC4/2011
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00548/AM12/ RLA File :09/24/040/00616/AM11/ Lic.No/Date:0910047091 10.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 49
Case No.:26/16/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 21.02.2012 Status:Case Approved HQ File :01/82/050/00484/AM12/ RLA File :22/24/040/00018/AM12/ Lic.No/Date:2210011505 14.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 50
Case No.:33/19/82ALC4/2011
21.02.2012 Status:Case Deferred HQ File :01/82/050/00547/AM12/ RLA File :09/24/040/00130/AM12/ Lic.No/Date:0910047113 15.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for comments of Department of Chemicals and Petrochemicals
51
Case No.:13/19/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00527/AM12/ RLA File :09/24/040/00148/AM12/ Lic.No/Date:0910047160 16.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 52
Case No.:32/19/82ALC4/2011
Party Name:MAITHRI LABORATORIES (P) LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00546/AM12/ RLA File :09/24/040/00139/AM12/ Lic.No/Date:0910047161 16.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 53
Case No.:5/19/82ALC4/2011
Party Name:CIPLA LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00519/AM12/ RLA File :03/94/040/00258/AM12/ Lic.No/Date:0310636879 17.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 54
Case No.:17/19/82ALC4/2011
21.02.2012 Status:Case Deferred HQ File :01/82/050/00531/AM12/ RLA File :09/24/040/00137/AM12/ Lic.No/Date:0910047175 20.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authorities. Accordingly, the case has been deferred for 20.3.2012. 55
Case No.:23/21/82ALC4/2011
21.02.2012 Status:Case Deferred HQ File :01/82/050/00605/AM12/ RLA File :09/24/040/00129/AM12/ Lic.No/Date:0910047176 20.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authorities. Accordingly, the case has been
deferred for 20.3.2012. 56
Case No.:46/14/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 21.02.2012 Status:Case Approved HQ File :01/82/050/00437/AM12/ RLA File :05/23/040/00105/AM12/ Lic.No/Date:0510294191 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, as per SION A412 and also in the light of earlier decision taken in meeting No. 44/82 dated 31.1.2012 , 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 (mg per tablet) Atorvastatin Tablets 5 mg 1 no of tablet 1 2 3 4 5 6 7 Atorvastatin Calcium Microcrystallin Cellulose (PH101) Calmellose Calcium (ECG 505) Hydroxypropylcellulose (SSL) Magnesium Oxide (XP103) Mircrocrystalline Cellulose (KG1000) Magnesium Stearate 5.42 12.48 16.00 0.700 15.00 2.00 0.4 Atorvastatin Tablets 10 mg 1 no of tablet 1 2 3 4 5 6 Atorvastatin Calcium Microcrystallin Cellulose (PH101) Calmellose Calcium (ECG 505) Hydroxypropylcellulose (SSL) Magnesium Oxide (XP103) Magnesium Stearate 10.84 8.66 20.00 1.00 16.00 0.5
57
Case No.:35/19/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 21.02.2012 Status:Case Deferred HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 58
Case No.:31/16/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 59
Case No.:32/16/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00490/AM12/ RLA File :05/24/040/00116/AM12/ Lic.No/Date:0510295739 05.07.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and decided to remind the firm to furnish Certificate of Analysis in respect of import items from the foreign supplier. Accordingly, the case has been deferred for 20.3.2012. 60
Case No.:1/23/82ALC4/2011
Party Name:MEDISPRAY LABORATORIES PVT. LTD. 21.02.2012 Status:Case Approved HQ File :01/82/050/00653/AM12/ RLA File :03/95/040/00264/AM12/ Lic.No/Date:0310642543 15.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 61
Case No.:5/23/82ALC4/2011
Party Name:MEDISPRAY LABORATORIES PVT. LTD. 21.02.2012 Status:Case Approved HQ File :01/82/050/00657/AM12/ RLA File :03/95/040/00297/AM12/ Lic.No/Date:0310643130 19.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed
62
Case No.:10/18/82ALC4/2011
Party Name:ELDER PHARMACEUTICALS LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00514/AM12/ RLA File :03/94/040/00289/AM12/ Lic.No/Date:0310643401 20.07.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 63
Case No.:2/19/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00516/AM12/ RLA File :03/94/040/00014/AM12/ Lic.No/Date:0310643597 21.07.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 64
Case No.:42/19/82ALC4/2011
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/00556/AM12/ RLA File :31/83/040/00080/AM12/ Lic.No/Date:3110049430 26.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 65
Case No.:45/19/82ALC4/2011
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/00559/AM12/ RLA File :31/83/040/00081/AM12/ Lic.No/Date:3110049481 27.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 66
Case No.:1/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00662/AM12/ RLA File :05/24/040/00150/AM12/ Lic.No/Date:0510298306 01.08.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
67
Case No.:2/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00663/AM12/ RLA File :05/24/040/00149/AM12/ Lic.No/Date:0510298304 01.08.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 68
Case No.:3/24/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00664/AM12/ RLA File :05/24/040/00083/AM12/ Lic.No/Date:0510298301 01.08.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 69
Case No.:12/25/82ALC4/2011
Party Name:GOPINATH CHEMTECH LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00679/AM12/ RLA File :08/24/040/00107/AM12/ Lic.No/Date:0810102095 03.08.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals. 70
Case No.:21/28/82ALC4/2011
Party Name:AMOLI ORGANICS PVT. LTD., 21.02.2012 Status:Case Rejected HQ File :01/82/050/00791/AM12/ RLA File :03/94/040/00337/AM12/ Lic.No/Date:0310646104 03.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to close the case as the firm has not furnished the Certificate of Analysis despite reminders. 71
Case No.:20/29/82ALC4/2011
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00819/AM12/ RLA File :03/94/040/00413/AM12/ Lic.No/Date:0310646512 04.08.2011 Defer Date 20.3.2012: Decision : The Committee considered the case as per agenda and decided to defer the case for 20.3.2012 for the information from the firm.
72
Case No.:2/22/82ALC4/2011
Party Name:STERLING AUXILIARIES PVT LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/00645/AM12/ RLA File :03/95/040/00303/AM12/ Lic.No/Date:0310648749 16.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their note dated 15.2.2012 in line with SION A1388 and in consultation with the technical authorities present in the meeting, decided to ratify norms under Para 4.7 of HBP v1, as per details given below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed ( Stero MDEA (Methyl Diethanol Amine) 1 kg 1 2 Mono Methyl Amine Ethylene Oxide 0.286 kg 0.810 kg 73
Case No.:3/22/82ALC4/2011
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 21.02.2012 Status:Deffered and Reindexed HQ File :01/82/050/00646/AM12/ RLA File :31/83/040/00088/AM12/ Lic.No/Date:3110049781 16.08.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 74
Case No.:5/22/82ALC4/2011
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00648/AM12/ RLA File :03/94/040/00391/AM12/ Lic.No/Date:0310649216 18.08.2011 Defer Date:20.03.2012 Decision : The committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for the information from the firm. 75
Case No.:34/32/82ALC4/2011
Party Name:VINEET LABORATORIES PRIVATE LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00915/AM12/ RLA File :09/24/040/00157/AM12/ Lic.No/Date:0910048352 23.08.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
76
Case No.:3/27/82ALC4/2011
Party Name:CIPLA LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00753/AM12/ RLA File :03/94/040/00466/AM12/ Lic.No/Date:0310650270 25.08.2011 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 norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: S.No Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler 1 Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhalation BP 100 mcg (200 MD) with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms As per packing policy As per packing policy As per packing policy 18.20 gms 2 Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 1 no of inhaler 1 2 3 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can 0.020 gms As per packing policy As per packing policy
MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhalation BP 100 mcg (200 MD) with 50 mcl Aerosol Valve and 19 ml Aluminium Can 4 5 0.48 mm OD Actuators with Dus covers/caps 1,1,1,2,Tetrafluoroethane (HFA 134 A Propellant) As per packing policy 14.40 gms 3 Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can. 1 no of inhaler 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dus covers/caps (HFA 134 A Propellant) Ethanol 0.05 gms as per packing policy as per packing policy as per packing policy 17.74 gms 0.456 gms 4 Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can 1 no of inhaler 1 2 3 4 BECLOMETHASONE DIPROPIONATE 63mcl AEROSOL VALVES 19ml ALUMINIUM CAN 0.06 gms As per packing policy As per packing policy
5 6 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS ETHANOL As pr packing policy 17.288 gms 0.912 gms 5 Beclometasona Dipropionate 200mcg Inhaler (200MD) / Beclocip 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) with 63mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BECLOMETHASONE DIPROPIONATE 19ml ALUMINIUM CAN WITH DUST COVERS /CAPS ETHANOL 0.04 gms As per packing policy As per packing policy As per packing policy 16.37 gms 1.824 gms 6 Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclocip 250mcg HFA Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) 1 no of inhaler 1 2 3 BECLOMETHASONE DIPROPIONATE 19ml ALUMINIUM CAN 0.05 gms As per packing policy As per packing policy
Valve and 19ml Aluminium Can 4 5 6 WITH DUST COVERS /CAPS ETHANOL As per packing policy 15.90 gms 2.28 gms 7 Budespray 200mcg HFA Inhaler (200MD) / Budesonide Inhaler 200mcg (200MD) with 58mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 58 mcl AEROSOL VALVES 19ml ALUMINIUM CAN WITH DUST COVERS /CAPS 0.07 gms As per packing policy As per packing policy As per packing policy 18.2 gms 8 Budespray 100mcg HFA Inhaler (200MD) / Budesonide Inhaler 100mcg (200MD) with 58mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 BUDESONIDE 58 mcl AEROSOL VALVES 19ml ALUMINIUM CAN WITH DUST COVERS /CAPS 0.02 gms As per packing policy As per packing policy As per packing policy
5 18.2 gms 9 Salmeterol Inhaler 25mcg (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN WITH DUST COVERS /CAPS ETHANOL 0.03 gms As per packing policy As per packing policy As per packing policy 12.50 gms 0.256 gms 10 Fluticort Plus 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Fluticasone Propionate 125mcg Inhaler (120MD) 1 no of inhaler 1 2 3 SALMETEROL FLUTICASONE PROPIONATE 0.003 gms 0.015 gms As per packing policy
Valve and 14ml Aluminium Can 4 5 6 7 14ml ALUMINIUM CAN WITH DUST COVERS /CAPS ETHANOL As per packing policy As per packing policy 12.5 gms 0.256 gms 11 Fluticort Plus 250mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Fluticasone Propionate 250mcg Inhaler (120MD) / Flunacross S 250mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL FLUTICASONE PROPIONATE 14ml ALUMINIUM CAN WITH DUST COVERS /CAPS ETHANOL 0.003 gms 0.03 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms 12 Fluticort Plus 50mcg HFA Inhaler (120MD) / 1 no of inhaler 1 2 SALMETEROL 0.003 gms
Salmeterol 25mcg and Fluticasone Propionate 50mcg Inhaler (120MD) / Flunacross S 50mcg HFA Inhaler (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 3 4 5 6 7 FLUTICASONE PROPIONATE 14ml ALUMINIUM CAN WITH DUST COVERS /CAPS ETHANOL 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms 13 Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALBUTAMOL BECLOMETHASONE DIPROPIONATE 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN WITH DUST COVERS /CAPS ETHANOL 0.02 gms 0.01 gms As per packing policy As per packing policy As per packing policy 14.04 gms 0.36 gms
g 14 Fluticasone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 FLUTICASONE PROPIONATE 14ml ALUMINIUM CAN WITH DUST COVERS /CAPS ETHANOL 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms 15 Fluticasone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 FLUTICASONE PROPIONATE 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN WITH DUST COVERS /CAPS 0.015 gms As per packing policy As per packing policy As per packing policy As per packing policy 12.5 gms
7 ETHANOL 0.256 gms 16 Fluticasone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 FLUTICASONE PROPIONATE 63 mcl Aerosol vale 14ml ALUMINIUM CAN WITH DUST COVERS /CAPS ETHANOL 0.03 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms 17 Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN WITH DUST COVERS /CAPS 0.0014 gms As per packing policy As per packing policy As per packing policy
5 6 ETHANOL 7.84 gms 0.16 gms 18 Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) with 58mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BUDESONIDE Formoterol Fumarate 58 mcl AEROSOL VALVES 19ml ALUMINIUM CAN WITH DUST COVERS /CAPS 0.012 gms 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms 19 Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) with 58mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 BUDESONIDE Formoterol Fumarate 58 mcl AEROSOL VALVES 19ml ALUMINIUM CAN 0.0007 gms 0.024 gms As per packing policy As per packing
5 6 7 WITH DUST COVERS /CAPS Ethanol policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption 77
Case No.:33/32/82ALC4/2011
Party Name:DR REDDYS LABORATORIES LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00914/AM12/ RLA File :09/24/040/00228/AM12/ Lic.No/Date:0910048380 25.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 78
Case No.:38/32/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00919/AM12/ RLA File :09/24/040/00239/AM12/ Lic.No/Date:0910048379 25.08.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals.
79
Case No.:6/28/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00776/AM12/ RLA File :08/24/040/00092/AM12/ Lic.No/Date:0810102939 29.08.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish Drug Manufacturing License. Accordingly, the case has been deferred for 20.3.2012. 80
Case No.:30/32/82ALC4/2011
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/00911/AM12/ RLA File :09/24/040/00231/AM12/ Lic.No/Date:0910048496 29.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 81
Case No.:38/31/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 21.02.2012 Status:Case Deferred HQ File :01/82/050/00864/AM12/ RLA File :22/24/040/00041/AM12/ Lic.No/Date:2210011844 01.09.2011 Defer Date:21.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals 82
Case No.:22/28/82ALC4/2011
Party Name:CIPLA LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00792/AM12/ RLA File :03/94/040/00497/AM12/ Lic.No/Date:0310651339 02.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 83
Case No.:23/28/82ALC4/2011
Party Name:CIPLA LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00793/AM12/ RLA File :03/94/040/00496/AM12/ Lic.No/Date:0310651347 02.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed
84
Case No.:29/32/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00910/AM12/ RLA File :09/24/040/00259/AM12/ Lic.No/Date:0910048529 02.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals 85
Case No.:9/32/82ALC4/2011
21.02.2012 Status:Case Deferred HQ File :01/82/050/00890/AM12/ RLA File :09/24/040/00242/AM12/ Lic.No/Date:0910048539 05.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals. 86
Case No.:14/32/82ALC4/2011
Party Name:SRINI PHARMACEUTICALS LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00895/AM12/ RLA File :09/24/040/00250/AM12/ Lic.No/Date:0910048565 05.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals 87
Case No.:16/32/82ALC4/2011
Party Name:AUCTUS PHARMA LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00897/AM12/ RLA File :09/24/040/00257/AM12/ Lic.No/Date:0910048616 06.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals 88
Case No.:28/28/82ALC4/2011
Party Name:DHANUKA LABORATORIES LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00798/AM12/ RLA File :05/23/040/00214/AM12/ Lic.No/Date:0510301712 08.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided remind the firm to furnish complete chemical description of export product. Accordingly, the case has been deferred for 20.3.2012.
89
Case No.:6/32/82ALC4/2011
21.02.2012 Status:Case Deferred HQ File :01/82/050/00887/AM12/ RLA File :09/24/040/00277/AM12/ Lic.No/Date:0910048658 08.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals. 90
Case No.:15/32/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00896/AM12/ RLA File :09/24/040/00273/AM12/ Lic.No/Date:0910048689 09.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals 91
Case No.:19/32/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00900/AM12/ RLA File :09/24/040/00268/AM12/ Lic.No/Date:0910048699 09.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals 92
Case No.:28/32/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00909/AM12/ RLA File :09/24/040/00272/AM12/ Lic.No/Date:0910048688 09.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 93
Case No.:5/32/82ALC4/2011
21.02.2012 Status:Case Deferred HQ File :01/82/050/00886/AM12/ RLA File :09/24/040/00275/AM12/ Lic.No/Date:0910048753 13.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals.
94
Case No.:9/29/82ALC4/2011
Party Name:CIPLA LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00808/AM12/ RLA File :03/94/040/00519/AM12/ Lic.No/Date:0310653828 15.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 95
Case No.:10/29/82ALC4/2011
Party Name:CIPLA LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/00809/AM12/ RLA File :03/94/040/00526/AM12/ Lic.No/Date:0310653874 15.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 96
Case No.:8/32/82ALC4/2011
Party Name:PORUS LABORATORIES PVT LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00889/AM12/ RLA File :09/24/040/00264/AM12/ Lic.No/Date:0910048808 15.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for information from the firm. 97
Case No.:8/36/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/00965/AM12/ RLA File :05/24/040/00205/AM12/ Lic.No/Date:0510303164 20.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 26/82 held on 27.9.2011 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 Valacyclovir Hydrochloride 1 Kg. 1. 4Dimethylamino Pyridine 0.028 kg 2. Acetone 3.09 kg 3. Activated Carbon 0.0242 kg 4. Acyclovir 0.78 kg 5. CBZLValine 1.1824 kg 6. Dicyclohexyl Carbodimide 1.3871 kg
Dimethyl Formamide 3.51 kg 8. Formic Acid 0.150 kg 9. Methanol 3.16 kg 10. Palladium Sponge 0.005 kg . 98
Case No.:5/29/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/00804/AM12/ RLA File :05/24/040/00210/AM12/ Lic.No/Date:0510303168 20.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 46/82 dated 9.2.2010 and in consultation with technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by the firm whichever is lower: Export Product Export Quantity S.No Import Items Quantity allowed Candesartan Cilexetil 1 kg 1 2 3 4 5 6 7 8 9 10 1Chloroethyl Chloroformate 4(Bromomethyl)2 cyanobiphenyl Acetone Acetonitrile Activated Carbon Cyclohexane Dimethyl Formamide Ethyl Acetate Formic Acid Iso Propyl Alcohol 0.45 kg 1.66 kg 3.45 kg 2.50 kg 0.100 kg 5.88 kg 1.52 kg 10.00 kg 1.30 kg 0.50 kg
11 12 13 14 15 16 17 Methanol Methylene Chloride Tertiary Butanol Tetra Ethyl Ortho Carbonate Tetrabutyl ammonium bromide (TBAB) Toulene Triethylamine 10.00 kg 5.00 kg 2.00 kg 1.19 kg 0.18 kg 5.00 kg 0.31 kg RA may take appropriate action as per the decision of Norms Committee 99
Case No.:19/29/82ALC4/2011
Party Name:ANUH PHARMA LTD. 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 100
Case No.:22/32/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00903/AM12/ RLA File :04/24/040/00155/AM12/ Lic.No/Date:0410128356 21.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 101 Case No.:23/32/82ALC4/2011 Party Name:SOFTGEL HEALTH CARE PVT. LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00904/AM12/ RLA File :04/24/040/00153/AM12/ Lic.No/Date:0410128355 21.09.2011 Defer Date:20.03.2012 Decision : The committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
call from the firm the Drug Manufacturing License and also production and consumption data duly certified by Central Excise Authority for the last two years. Accordingly, the case been deferred for 20.3.2012. 102
Case No.:24/32/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/00905/AM12/ RLA File :04/24/040/00154/AM12/ Lic.No/Date:0410128434 22.09.2011 Defer Date:20.03.2012 Decision : The committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to send Drug Manufacturing License and also production and consumption data duly certified by Central Excise Authority for the last two years. Accordingly, the case been deferred for 20.3.2012. 103
Case No.:39/32/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 21.02.2012 Status:Case Deferred HQ File :01/82/050/00920/AM12/ RLA File :22/24/040/00046/AM12/ Lic.No/Date:2210011928 22.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 104
Case No.:27/32/82ALC4/2011
Party Name:FORACE POLYMERS (P) LTD. 21.02.2012 Status:Case Approved HQ File :01/82/050/00908/AM12/ RLA File :05/23/040/00235/AM12/ Lic.No/Date:0510303607 23.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their OM No. 46011/18/2011PC II dated 30.1.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms under para 4.7 of HBP v1 as per details below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Items Quantity allowed Hardener containing 85% Polymethane Polyphenyl Isocyanate and 15% C10 solvent Hardener forcold 1070 1 kg 1 2 Polymethane Polyphenyl Isocyanate C10 Solvent 0.8665 kg 0.1535 kg 105 Case No.:18/32/82ALC4/2011 Party Name:ENVEE DRUGS PVT LTD Status:Case
21.02.2012 Approved HQ File :01/82/050/00899/AM12/ RLA File :34/24/040/00123/AM12/ Lic.No/Date:3410031758 28.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 106
Case No.:26/32/82ALC4/2011
Party Name:MEDICAMEN BIOTECH LTD., 21.02.2012 Status:Case Approved HQ File :01/82/050/00907/AM12/ RLA File :05/24/040/00219/AM12/ Lic.No/Date:0510304120 28.09.2011 Defer Date: 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. 35011/24/2012PI(Norms) dated 1.2.2012 and in consultation with the technical authority present in the meeting observed that quantity of API applied for import for 250 mg. tablets is as per published SION vide A54 for Tablets. As regards 500 mg tablets, being derived from the same API, double quantity, as permissible for 250 mg tablets may be allowed. Since the quantities applied by the firm are within the norms, RA may take appropriate action accordingly. 107
Case No.:18/36/82ALC4/2011
Party Name:MEDREICH LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00975/AM12/ RLA File :07/24/040/00178/AM12/ Lic.No/Date:0710082847 28.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 108
Case No.:17/28/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 109 Case No.:25/32/82ALC4/2011 Party Name:RANBAXY LABORATORIES LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00906/AM12/ RLA File :05/24/040/00194/AM12/ Lic.No/Date:0510304240 29.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
110
Case No.:5/36/82ALC4/2011
Party Name:MICRO LABS LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00962/AM12/ RLA File :07/24/040/00219/AM12/ Lic.No/Date:0710082912 29.09.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 111
Case No.:10/32/82ALC4/2011
Party Name:DHANUKA LABORATORIES LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00891/AM12/ RLA File :05/23/040/00244/AM12/ Lic.No/Date:0510304494 03.10.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 112
Case No.:14/41/82ALC4/2011
Party Name:MEDREICH LIMITED 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 113
Case No.:12/32/82ALC4/2011
Party Name:AMI LIFESCIENCES P LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00893/AM12/ RLA File :34/24/040/00137/AM12/ Lic.No/Date:3410031901 12.10.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 114 Case No.:5/31/82ALC4/2011 Party Name:TITAN LABORATORIES PVT. LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00831/AM12/ RLA File :03/95/040/00570/AM12/ Lic.No/Date:0310659395 13.10.2011 Defer Date:20.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to remind the firm to furnish Drug Manufacturing License and also Master Batch Formula duly certified by Quality Control Incharge. Accordingly, the case has been deferred for 20.3.2012. 115
Case No.:11/41/82ALC4/2011
Party Name:INDIA GLYCOLS LTD., 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Petrochemicals. 116
Case No.:12/36/82ALC4/2011
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 21.02.2012 Status:Case Approved HQ File :01/82/050/00969/AM12/ RLA File :07/24/040/00275/AM12/ Lic.No/Date:0710083317 18.10.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting and also in the light of written comments forwarded by Department of Pharmaceuticals vide their OM No. 35011/29/2012PI (Norms) dated 56.2.2012 has observed that quantity applied for import is within the quantity permitted earlier. It has also been observed that earlier 1.32 gm Sterile Ceftazidime USP as Pentahydrate with Sodium Carbonate per vial was allowed and now the firm has applied for only 1.13 gm/vial, which is better than earlier norms. Accordingly, the Committee ratify the request of the firm as applied by them. RA may take appropriate action accordingly. 117 Case No.:19/36/82ALC4/2011 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 21.02.2012 Status:Case Approved HQ File :01/82/050/00976/AM12/ RLA File :07/24/040/00274/AM12/ Lic.No/Date:0710083319 18.10.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting and in the light of earlier decision taken in the case of 1 gm of Ceftazidime Injection vial decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is earlier: Export Product Export Quantity S.No Import Items Quantity allowed Ceftazidime 500 mg Inj. Vial Size 7.5 ml 1 vial 1. Sterile Ceftazidime USP as pentahydrate with sodium 0.565 gm/vial
Carbonate USP 118
Case No.:21/36/82ALC4/2011
Party Name:MEDREICH LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00978/AM12/ RLA File :07/24/040/00285/AM12/ Lic.No/Date:0710083447 21.10.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 119
Case No.:6/41/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Petrochemicals 120
Case No.:2/32/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00883/AM12/ RLA File :03/95/040/00615/AM12/ Lic.No/Date:0310662064 25.10.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Petrochemicals 121 Case No.:9/41/82ALC4/2011 Party Name:BEST VALUE CHEM PVT. LTD. 21.02.2012 Status:Case Approved HQ File :01/82/050/01010/AM12/ RLA File :34/24/040/00154/AM12/ Lic.No/Date:3410032044 25.10.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. C.II 14011/22/2012SO (Ch.II) dated 6.2.2012 and in consultation with the technical authorities present in the meeting decided to ratify norms norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is earlier: Export Product Export S.No Import Items Quantity allowed
Quantity Verdyl Isobutyrate 1 kg 1 2 Dicylopentadiene Isobutyric Acid 0.705 kg 0.493 kg 122
Case No.:13/41/82ALC4/2011
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals 123
Case No.:17/41/82ALC4/2011
Party Name:SHIVA PHARMACHEM LTD, 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals 124
Case No.:26/41/82ALC4/2011
Party Name:INTAS PHARMACEUTICALS LTD., 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 125 Case No.:77/42/82ALC4/2011 Party Name:RA CHEM PHARMA LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/01112/AM12/ RLA File :09/24/040/00364/AM12/ Lic.No/Date:0910049614 04.11.2011 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.
p p Q y p Q y allowed/kg 3,4Dihydroxy5 NitroBenzaldehyde 1 Kg 1. 2 3 Vanillin Dichloro Methane Pyridine 1.97 0.93 0.457 126
Case No.:24/36/82ALC4/2011
Party Name:MEDREICH LIMITED 21.02.2012 Status:Case Deferred HQ File :01/82/050/00981/AM12/ RLA File :07/24/040/00305/AM12/ Lic.No/Date:0710083785 08.11.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 127
Case No.:15/41/82ALC4/2011
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals. 128 Case No.:19/41/82ALC4/2011 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 21.02.2012 Status:Case Approved HQ File :01/82/050/01020/AM12/ RLA File :07/24/040/00308/AM12/ Lic.No/Date:0710083783 08.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in Meeting No. 37/82 dated 14.12.2010 and also 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 Magnesium Orotate 1 Kg. 1. Orotic Acid 1.104 kg Calcium Orotate 1 kg. 1. Orotic Acid 1.059 kg Potassium Orotate 1 kg. 1. Orotic Acid 1.055 kg Zinc Orotate 1 kg. 1. Orotic Acid 0.994 kg
129
Case No.:25/41/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/01026/AM12/ RLA File :08/24/040/00179/AM12/ Lic.No/Date:0810105257 08.11.2011 Defer Date: 20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Pharmaceuticals. 130
Case No.:6/36/82ALC4/2011
Party Name:AUROLAB 21.02.2012 Status:Case Deferred HQ File :01/82/050/00963/AM12/ RLA File :35/24/040/00027/AM12/ Lic.No/Date:3510036087 11.11.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals. 131 Case No.:29/41/82ALC4/2011 Party Name:CADILA HEALTHCARE LTD., 21.02.2012 Status:Case Approved HQ File :01/82/050/01030/AM12/ RLA File :08/24/040/00180/AM12/ Lic.No/Date:0810105379 11.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 44/82 dated 27.1.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Carvvedilol 3.125 mg Tablet 1 Million 1. Carvedilol 3.1875 kg 2. Crospovidone NF 2.75 kg 3. Povidone K30 1.00 kg 4. Magnesium Stearate 0.450 kg 5. Lactose Monohydrate 37.4875 kg 6. Bottles and Caps (packing material in finished form a. 60 CC White HDPE Round Bottle As per packing policy 7. 75 CC White HDPE Round Bottle do 8. 100 CC White HDPE CRC Bottle do
150 CC White HDPE Round Bottle do 10. Bottle 400 CC White HDPE do 11. 33 MM White PP Screw Cap do 12. 38 MM White PP Screw Cap do 13. 53 MM White PP Screw Cap do Carvedilol 6.25 mg Tablet 1 million 1. Carvedilol 6.375 kg 2. Crospovidone NF 5.50 kg 3. Povidone K30 2.00 kg 4. Magnesium Stearate 0.900 kg 5. Lactose Monohydrate 74.975 kg 6. Bottles and Caps (packing material in finished form a. 60 CC White HDPE Round Bottle As per packing policy 7. 75 CC White HDPE Round Bottle do 8. 100 CC White HDPE CRC Bottle do 9. 150 CC White HDPE Round Bottle do 10. Bottle 400 CC White HDPE do 11. 33 MM White PP Screw Cap do 12. 38 MM White PP Screw Cap do 13. 53 MM White PP Screw Cap do Carvedilol 12.5 mg Tablet 1 million 1. Carvedilol 12.75 kg 2. Crospovidone NF 11.00 kg 3. Povidone K30 4.22 kg 4. Magnesium Stearate 1.80 kg 5. Lactose Monohydrate 149.95 kg 6. Bottles and Caps (packing material in finished form a. 60 CC White HDPE Round Bottle As per packing policy 7. 75 CC White HDPE Round Bottle do 8. 100 CC White HDPE CRC Bottle do 9. 150 CC White HDPE Round Bottle do 10. Bottle 400 CC White HDPE do 11. 33 MM White PP Screw Cap do 12. 38 MM White PP Screw Cap do 13. 53 MM White PP Screw Cap do Carvedilol 25.0 mg Tablet 1 million 1. Carvedilol 25.50 kg
Crospovidone NF 22.00 kg 3. Povidone K30 8.00 kg 4. Magnesium Stearate 3.60 kg 5. Lactose Monohydrate 299.90 kg 6. Bottles and Caps (packing material in finished form a. 60 CC White HDPE Round Bottle As per packing policy 7. 75 CC White HDPE Round Bottle do 8. 100 CC White HDPE CRC Bottle do 9. 150 CC White HDPE Round Bottle do 10. Bottle 400 CC White HDPE do 11. 33 MM White PP Screw Cap do 12. 38 MM White PP Screw Cap do 13. 53 MM White PP Screw Cap do 132
Case No.:32/41/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/01033/AM12/ RLA File :34/24/040/00166/AM12/ Lic.No/Date:3410032153 14.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 47/82 dated 16.2.2010 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Fenofibrate 1 Kg. 1. 4Chloro,4 Hydroxybenzophenone 1.316 kg 2. Acetone 2.71 kg 3. Ethyl Acetate 4.47 kg 4. Iso Propyl Alcohol 5.43 kg 5. Methylene Chloride 4.92 kg 6. Activated Charcoal 0.100 kg RA concerned may take further necessary action as per above decision of NC 133 Case No.:22/41/82ALC4/2011 Party Name:RANBAXY LABORATORIES lIMITED 21.02.2012 Status:Case Approved
HQ File :01/82/050/01023/AM 12 dated 3.1.2012 RLA File :05/24/040/00267/AM 12/ dated 3.11.2011 Lic.No/Date:0510308239 17.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 26/82 held on 27.9.2011 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 Valacyclovir Hydrochloride 1 Kg. 1. 4Dimethylamino Pyridine 0.028 kg 2. Acetone 3.09 kg 3. Activated Carbon 0.0242 kg 4. Acyclovir 0.78 kg 5. CBZLValine 1.1824 kg 6. Dicyclohexyl Carbodimide 1.3871 kg 7. Dimethyl Formamide 3.51 kg 8. Formic Acid 0.150 kg 9. Methanol 3.16 kg 10. Palladium Sponge 0.005 kg 134 Case No.:27/41/82ALC4/2011 Party Name:MEDREICH LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/01028/AM12/ RLA File :07/24/040/00328/AM12/ Lic.No/Date:0710084048 18.11.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of earlier decision taken in meeting No. 26/07 held on 4.10.2006 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by the firm, whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Kercavit Capsules Thiamine Mononitrate 60 mg=66 mg, Calcium D Pantothemate 60 mg Para Amino Benzoic Acid 30 mg = 33 mg, Yeast 130 mg=136.5 mg Lcystine 20 1 kg 1 Hydrolysed Keratin 20.4 mg/capsule
mg=22 mg, Hydrolysed Keratin 20 mg = 21 mg] 135
Case No.:31/41/82ALC4/2011
Party Name:ALEMBIC LIMITED 21.02.2012 Status:Case Approved HQ File :01/82/050/01032/AM12/ RLA File :34/24/040/00161/AM12/ Lic.No/Date:3410032232 18.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 33/10 dated 10.11.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Fortified Procaine Penicillin 4 meha Injection 1,00,000 Vials 1. Procaine Benzyl Penilillin 300 BOU 2. Benzyl Penicillin Sodium 100 BOU 136
Case No.:2/36/82ALC4/2011
Party Name:EMCURE PHARMACEUTICALS LTD. 21.02.2012 Status:Case Deferred HQ File :01/82/050/00959/AM12/ RLA File :31/83/040/00170/AM12/ Lic.No/Date:3110051562 21.11.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 137
Case No.:33/41/82ALC4/2011
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals 138 Case No.:1/40/82ALC4/2011 Party Name:CLEAN SCIENCE AND Status:Case
TECHNOLOGY PVT.LTD. 21.02.2012 Deferred HQ File :01/82/050/00997/AM12/ RLA File :31/83/040/00191/AM12/ Lic.No/Date:3110051996 20.12.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals 139
Case No.:2/40/82ALC4/2011
Party Name:FDC LTD 21.02.2012 Status:Case Deferred HQ File :01/82/050/00998/AM12/ RLA File :03/94/040/00819/AM12/ Lic.No/Date:0310671854 20.12.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm complete description of export product as per Drug Manufacturing License and also to furnish a copy of Drug Manufacturing License. Accordingly, the case has been deferred for 20.3.2012. 140
Case No.:4/40/82ALC4/2011
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:47/82ALC4/2011 21.02.2012 Status:Case Deferred HQ File :01/82/050/01000/AM12/ RLA File :31/83/040/00137/AM12/ Lic.No/Date:3110052056 22.12.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals 141
Case No.:5/40/82ALC4/2011
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:47/82ALC4/2011 21.02.2012 Status:Case Approved HQ File :01/82/050/01001/AM12/ RLA File :31/83/040/00174/AM12/ Lic.No/Date:3110052057 22.12.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed 142
Case No.:1/47/82ALC4/2011
Party Name:BROOKS LABORATORIES LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/01301/AM12/ RLA File :22/24/040/00067/AM12/ Lic.No/Date:2210012351 23.12.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
143
Case No.:2/47/82ALC4/2011
Party Name:BROOKS LABORATORIES LTD., 21.02.2012 Status:Case Deferred HQ File :01/82/050/01302/AM12/ RLA File :22/24/040/00066/AM12/ Lic.No/Date:2210012352 23.12.2011 Defer Date:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 144
Case No.:1/41/82ALC4/2011
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 20.3.2012 for comments of Department of Chemicals and Petrochemicals. 145
Case No.:3/41/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 146
Case No.:5/41/82ALC4/2011
Party Name:SOHAN HEALTHCARE PVT. LTD 21.02.2012 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:20.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 147 Case No.:6/47/82ALC4/2011 Party Name:INDSWIFT LABORATORIES LTD., 21.02.2012 Status:Case Approved HQ File :01/82/050/01306/AM12/ RLA File :22/24/040/00081/AM12/ Lic.No/Date:2210012436 16.01.2012 Defer Date: Decision : Committee considered case as per agenda for ratification of norms and in light of earlier decision taken in meeting No. 26/82 dated 27.09.2011 and in consultation with Technical Authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
Export product Export Qty. Sl.No. Import items Qty. allowed Clopidogrel Hydrogen Sulphate) 1 Kg. 1. DL2Chlorophenyl Glycine 1.00 kg 2. L(+) Tartaric Acid 0.667 kg 3. Thiphene2Ethonal 0.60 kg 4. PToluene Sulphonyl Chloride 1.029 kg 5. Methanol 4.87 kg 6. Methylene Chloride 2.03 kg 7. Acetone 0.34 kg 8. Toluene 1.11 kg 9. Isopropyl Alcohol 0.99 kg 148
Case No.:5/47/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/01305/AM12/ RLA File :22/21/040/00114/AM12/ Lic.No/Date:2210012444 17.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 31/82 dated 1.11.2011 in consultation with technical authority present in meeting, decided to ratify norms as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Through Enzymatic Route 1 kg. 1. 6Amino Penicillinic Acid (6 APA) 0.568 kg 2. Formidase (Enzyme 5 gm 3. Methanol 0.020 kg 4. D()PHydroxy Phenyl Glycine Methylester (BBH) 0.608 kg 149 Case No.:7/47/82ALC4/2011 Party Name:DSM ANTIINFECTIVES INDIA LTD 21.02.2012 Status:Case Approved HQ File :01/82/050/01307/AM12/ RLA File :22/21/040/00115/AM12/ Lic.No/Date:2210012445 17.01.2012 Defer Date:
Decision : : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 31/82 dated 1.11.2011 in consultation with technical authority present in meeting, decided to ratify norms as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Through Enzymatic Route 1 kg. 1. 6Amino Penicillinic Acid (6 APA) 0.568 kg 2. Formidase (Enzyme 5 gm 3. Methanol 0.020 kg 4. D()PHydroxy Phenyl Glycine Methylester (BBH) 0.608 kg 150
Case No.:4/47/82ALC4/2011
Party Name:INDSWIFT LABORATORIES LTD., 21.02.2012 Status:Case Approved HQ File :01/82/050/01304/AM12/ RLA File :22/24/040/00082/AM12/ Lic.No/Date:2210012446 18.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 7/82 held on 17.5.2011 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 Atorvastatin Calcium 1 Kg. 1. Methyl Isobutyryl Acetate 1.646 kg 2. Beta Ananine 0.100 kg 3. Sodium Meta Bisulphite 0.037 kg 4. Para Fluoro Benzaldehyde 0.70 kg 5. 3Ethyl5(2Hydroxy Ethyl)4Methyl Thiazolium Bromide 0.262 kg 6. Isopropyl Alcohol 8.375 kg 7. (4RCis)1,1Dimethylethyl6 Cyanomethyl2,2Dimethyl12Dioxane4 Acetate (ATS8) 1.003 kg 8. Tert. Butyl Methyl Ether 4.151 kg 151 Case No.:3/47/82ALC4/2011 Party Name:DSM ANTIINFECTIVES Status:Case
INDIA LTD 21.02.2012 Approved HQ File :01/82/050/01303/AM12/ RLA File :22/21/040/00116/AM12/ Lic.No/Date:2210012449 20.01.2012 Defer Date: Decision : : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 31/82 dated 1.11.2011 in consultation with technical authority present in meeting, decided to ratify norms as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Through Enzymatic Route 1 kg. 1. 6Amino Penicillinic Acid (6 APA) 0.568 kg 2. Formidase (Enzyme 5 gm 3. Methanol 0.020 kg 4. D()PHydroxy Phenyl Glycine Methylester (BBH) 0.608 kg Outside Agenda Case No1 M/s. Symbiotec Pharmalab Ltd. Norms Committee Meeting No.47/AM12 F.No. 01/82/050/010874/AM 09/DES III Meeting Date:21.02.2012 Adv. Lic. No 1110018129 dated 11.8.2008 R.A F.NO 11/24/040/00017/AM 09 Decision: The representative of the firm appeared before the Committee and discussed the case. After detailed deliberation, Committee decided to call from the firm the following details: Certificate of Analysis indicating specifically the purity and impurity profile of export product as many impurities are unknown and also similar details of the importing company. Accordingly, the case has been deferred for 20.3.2012. Date:22.02.2012 Place:New Delhi Lalita Maini Foreign Trade Development Officer
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