IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2012-06-05

DGFT Committee Minutes

Document text

Case No.B 103

M/s. Shamrock Pharmachem Pvt. Ltd. Norms Committee Meeting No.10/AM13 F.No. 01/82/050/01448/AM11/DES III Meeting Date:05.06.2012 Advance licence No. & date 0310609520 dated 05.01.2011 Decision: Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to send the requisite information received from the firm alongwith application to TA for their comments and defer the case for 03.07.2012. Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision

MEETING NUMBER : 10/82ALC4/2012 MEETING DATE : 05.06.2012 The Meeting No.9& 10/82in the year 201213 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 to be held on 05.06.2012 was act held on 13.06.2012 under the Chairmanship of Addl DGFT, Shri N.P.S Monga, in Room No.4, Udyog Bhawan, New Delh.. Following members were present: 1. Shri Jasbir Singh, Consultant, Department of Chemicals and Petrochemicals 2. Shri D.N. Mathur, Consultant, Department of Pharmaceutical 3. Shri R.C. Meena, Dy. Director General of Foreign Trade

Case No.B104

M/S Sandoz Pvt. Ltd. F.No.01/82/162/00801/AM12/DESIII RA F.No.03/95/040/00940/AM08 Advance licence No. & date 0310454721 dated 19.12.2007 Decision : Committee considered case as per agenda and in light of earlier decision taken in 33/82 meeting held on 11.11.2008 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 Dlianos 0.1% Adult 1 ml bottle 1 No. 1. Xylometazoline Hcl 10.5mg 2. Spray bottle 10ml As per packing policy 3. Nozzle with dip tube do 4. Relevant Caps do RA concerned may take further necessary action as per above decision of NC.

Case No.B105

M/S Alembic Ltd. , Ahmedabad F.No.01/82/050/01204/AM12/DESIII RA F.No.34/24/040/00214/AM11 Adv.lic.No. 3410028630 dated 22.11.2010 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the UOM of Erythromycin Thiocyanate from kg to KGA without any other change in the earlier decision of NC.

Case No.B106

M/S Alembic Ltd. , Ahmedabad F.No.01/82/050/01033AM11/DESIII RA F.No.34/24/040/00216/AM11 Adv.lic.No. 3410028617 dated 22.11.2010 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the UOM of Erythromycin Thiocyanate from kg to KGA without any other change in the earlier decision of NC. RA concerned may take further necessary action as per above decision of NC

Case No.B107

M/S Alembic Ltd. , Ahmedabad F.No.01/82/050/00643/AM12/DESIII

RA F.No.34/24/040/00060/AM12 Adv.lic.No. 3410030897 dated 11.07.2010 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the UOM of Erythromycin Thiocyanate from kg to KGA without any other change in the earlier decision of NC.

Case No.B108

M/S Alembic Ltd. , Ahmedabad F.No.01/82/050/00682/AM10/DESIII RA F.No.34/24/040/00098/AM10 Adv.lic.No. 3410025107 dated 17.09.2009 Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the UOM of Azithromycin Crude from kg to KGA without any other change in the earlier decision of NC.

Case No.B109

M/S Actavis Pharma Manufacturing Pvt Ltd., Chennai F.No.01/82/050/00178/AM12/DESIII F.No.01/82/050/00172/AM12/DESIII F.No.01/82/050/00176/AM12/DESIII RA F.No.34/24/040/00098/AM10 Adv.lic.Nos and date 0410122523 dated 15.03.2011 0410122929 dated 25.03.2012 0410123157 dated 01.04.2011 RA File Nos 04/24/040/00331/AM11 04/24/040/00355/AM11 04/24/040/00359/AM11 Decision: Committee decided to defer case for 03.07.2012 for comments of Department of Pharmaceuticals.

Case No.B110

M/S Prachi Pharmaceuticals Pvt. Ltd. F.No.01/82/162/00770/AM12/DESIII RA F.No.03/95/040/00907/AM09 Adv.lic.No. 0310509144 dated 25.02.2009 Committee considered case as per agenda and in light of earlier decision taken in 40/07 meeting held on 17.01.07 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 Potassium Iodide 1 Kgm 1. Pottassium Iodide Solution (Streanght 32.7%w/w 3.05 kg

Case No.B111

M/S Alkyl Amines Chemicals Ltd. F.No.01/82/162/00025/AM13/DESIII RA F.No.03/95/040/00426/AM10 Adv.lic.No. 0310615974 dated 14.02.2011 Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/27/2009Ch. II dated 08.06.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 2 ethyl Hexylamine 1 Kg 1. 2 Ethyl Hexanol 1.06 kg

Case No.B112

M/S Alkyl Amines Chemicals Ltd. F.No.01/82/162/00026/AM13/DESIII RA F.No.03/95/040/00976/AM10 Adv.lic.No. 0310652974 dated 12.09.2011 Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/27/2009Ch. II dated 08.06.2011 and in

consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 2 ethyl Hexylamine 1 Kg 1. 2 Ethyl Hexanol 1.06 kg

Case No.B113

M/S Lupin Ltd. F.No.01/82/050//00703/AM12/DESIII RA F.No.03/95/040/00318/AM12 Adv.lic.No. 0310645266 dated 29.07.2011 Committee decided to defer case for 03.07.2012 for comments of Department of Pharmaceuticals.

Case No.B114

M/S Cipla Ltd. F.No.01/82/050/00587/AM12/DESIII RA F.No.03/95/040/00319/AM12 Adv.lic.No. 0310641299 dated 08.07.2011 Withdrawn as the case has already been approved by NC in 45/82 meeting held on 08.07.2011.

Case No.B115

M/S Metropolitan Eximchem Ltd. F.No.01/82/050/00987/AM10/DESIII RA F.No.03/95/040/00415/AM10 Adv.lic.No. 0310539636 dated 29.09.09 Committee considered case as per agenda and in light of written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/75/2008Ch. II dated 09.05.2012 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 Export Qty. Sl.No. Import items Qty. allowed NEthyl Carbazole 1 Kg 1. Carbazole 1.13 kg

Case No.B116

M/S Jubilant Lifesciences Ltd. F.No.01/82/050//00921/AM11/DESIII RA F.No.05/23/040/00168/AM11 Adv.lic.No. 0510274506 dated 08.10.10 Committee decided to defer case for 03.07.2012 for comments of Department of C & PC.

Case No.B117

M/S Jubilant Lifesciences Ltd. F.Nos.01/82/050//00114/AM12/DESIII 01/82/050//00293/AM12/DESIII RA F.Nos.05/24/040/0026/AM12 05/24/040/0046/AM12 Adv.lic.Nos. 0510288429 dated 20.04.2011 0510288487 dated 24.05.2011 Committee decided to defer case for 03.07.2012 for comments of Department of C & PC.

Case No.B118

M/S Best Value Chem. Pvt. Ltd. F.No.01/82/050//01021/AM09/DESIII RA F.No.34/24/040/00109/AM09 Adv.lic.Nos. 3410022305 dated 16.09.08 Decision: Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “Undecavertol (Kakdinol) instead of “4Methyl3decen5ol ” without any other change in the earlier decision of NC.

Case No.B119

M/S Galpha Labs Ltd. F.No.01/82/050//01044/AM11/DESIII RA F.No.03/94/040/00747/AM11

Adv.lic.Nos. 0310602797 dated 24.11.2010 Committee considered case as per agenda and in light of earlier decision taken in 16/AM12 meeting held on 19.07.2011 and in consultation with technical authority present in meeting, decided to revise the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxicillin and Clavulanate Potassium Tablets USP 625 mg (Clavugen 625mg) each tablet contains:1) Amoxicillin Trihydrate Equuvalent to Amoxicillin 500mg and 2) Clavulanate Potassium Equivalent to Clavulanic Acid 125 mg) 1 No. 1. Potassium Clavulanate with Avicel (1:1) 291.37 mg

Case No.B120

M/S Kedia Organic Chemicals Pvt. Ltd. F.No.01/82/050//01349/AM11/DESIII RA F.No.03/94/040/00792/AM11 Adv.lic.Nos. 0310607421 dated 22.12.2012 Committee decided to defer case for 03.07.2012 for comments of Department of C & PC.

Case No.B121

M/S Best Value Chem. Pvt. Ltd. F.No.01/82/050//00785/AM11/DESIII RA F.No.34/24/040/00115/AM11 Adv.lic.Nos. 3410027765 dated 20.08.2010 Decision: Committee considered case as per agenda and in light of earlier decision taken in 42/82 meeting held on 17.01.2012, Case No. B452 and in consultation with technical authority present in meeting, decided to amend the description of import item to read as “Primary Amyl Alcohol” instead of “Pentanol mixture or Primary Amyl Alcohol without any other change in the earlier decision of NC.

Case No.B122

M/S Fine Organics Industries Ltd. F.Nos.01/82/050//00824/AM12/DESIII 01/82/050//00709/AM12/DESII 01/82/050//01425/AM12/DESII RA F.Nos.03/94/040/00601/AM12 03/94/040/00507/AM12 03/94/040/01114/AM12 Adv.lic.Nos. 0310658433 dated 20.08.2011 0310653747 dated 15.09.2011 0310685519 dated 09.03.2012 Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O.No. 14010/129/2011ChII dated 04.06.2012 and in consultation with technical authority present in meeting, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Stearyl Erucanmide 1 kg 1. Erucic Acid Steraryl Amine 0.592 kg 0.471 kg

Case No.B123

M/S Encee Aromatics Pvt. Ltd. F.Nos.01/82/162//00020/AM10/DESIII Decision : In the light of written comments for Department of C&PC received vide their U.O. No.14010/53/2011Ch.II dated 29.05.2012, it was decided to call from the firm the following information:

1. Comparative statement of norms of consumption of Secretary Butyl Quinoline of other exporters from the office of CHEMEXCIL, Mumbai. 2. To submit Central Excise Data certifying production of Secondary Butyl Quinoline achieved by you in the last 3 years and the corresponding consumption of different raw materials . 3. Technical literature in support of the norms and yield claimed. Accordingly, case was deferred for 03.07.2012.

Case No.B124

M/S Vivimed Labs Ltd. F.No.01/83/050/00351AM09/DESIII RA F.No.09/24/040/00514/AM08 Adv.lic.No. 0910033449 dated 26.03.08 Committee decided to defer case for 03.07.2012 for comments of Department of C & PC.

Case No.B125

M/S PI Industries Ltd. Udaipur F.Nos.01/82/050//00847/AM12/DESIII RA F.Nos.13/24/040/00039/AM12 Adv.lic.Nos. 1310038523 dated 19.01.2011 Decision: Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 15022/6/2010Ch.II dated 1.6.2012 and in consultation with technical authority present in meeting, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Chloro 6Thiomethyl Toluene (2C6SMT) 1 kg 1. 1. 3Chloro2 Methyl Aniline (CMA) 0.970 kg 2. Sodium Methyl Mercaptide 2.464 kg 3. Sodium Nitrite 0.582 kg

Case No: B 126

M/s. Divis Laboratories Ltd. Norms Committee Meeting No. 10/AM13 Sl. No. F.No. Name of export product 1. 01/82/162/01029/AM11/DESIII 2(4BROMOPHENYL)PYRIDAZIN3(2H) – ONE 2. 01/82/162/01030/AM11/DESIII 2,4WING ACTIVE ESTER 3. 01/82/162/01031/AM11/DESIII 3Hydroxy Acetophenone 4. 01/82/162/01032/AM11/DESIII 4CPCCA 5. 01/82/162/01036/AM11/DESIII 4ISO Propyl 3 Methyl Phenol (4IPMP) 6. 01/82/162/01037/AM11/DESIII Apocarotenal 02% 7. 01/82/162/01038/AM11/DESIII Apomix 73 8. 01/82/162/01039/AM11/DESIII Apocarotenal 9. 01/82/162/01040/AM11/DESIII Asta Feed 10% 10. 01/82/162/01041/AM11/DESIII Astaxanthine 11. 01/82/162/01042/AM11/DESIII (S) –Amine – ( R ) – Mandelate 12. 01/82/162/01043AM11/DESIII (2R,3R)3(2,5difluorophenyl)3hydroxy2methyl4 (1H1,24triazol1yl)butanethiomide (BAL 0017697) 13. 01/82/162/01044/AM11/DESIII 2((1,5bis(benzhydryloxy) 4oxo1,4 dihydropyridin2yl)methoxy) isoindoline1,3dione (BAL 0029711) Decision: Committee considered case as per agenda and observed that above export products Sl. No. 1 to 4, 11and 12 already fixed norms and for Sl No 5 to 10 decided to call DML from firm. Accordingly, defer the case for 03.07.2012 for comments of Department of Pharmaceuticals.

Case No.B127

M/S Divis Laboratories Ltd. F.No.01/82/162/00111/AM13/DESIII Decision: Committee decided to defer case for 03.07.2012 for comments of Department of

Pharmaceuticals.

Case No.B128

M/S Divis Laboratories Ltd. F.No.01/82/162/00114/AM13/DESIII Decision: Committee decided to defer case for 03.07.2012 for comments of Department of Pharmaceuticals.

Case No.B129

M/S Divis Laboratories Ltd. F.No.01/82/162/00113/AM13/DESIII Decision: Committee decided to defer case for 03.07.2012 for comments of Department of Pharmaceuticals.

Case No.B130

M/S Divis Laboratories Ltd. F.No.01/82/162/00112/AM13/DESIII Decision: Committee decided to defer case for 03.07.2012 for comments of Department of Pharmaceuticals.

Case No.A1

M/S Kopran Ltd. F.No.01/82/162/00212/AM12/DESIII Decision: Committee decided to defer case for 03.07.2012 for comments of Department of Pharmaceuticals.

Case No.C10

M/S R L Fine Chem, Hyderabad F.No.01/82/162/00005/AM13/DESIII Decision: Committee decided to advise the firm to route this application through Pharmaxil giving all Industry and Production and Consumption data for last 3 years certified by Central Excise Authority. According to defer the case for 03.07.2012.

Case No.C11

M/S. Shasun Pharmaceuticals Ltd. F.No.01/82/162/01146/AM11/DESIII Decision: Decision: Committee decided to advise the firm to route this application through Pharmaxil giving all Industry and Production and Consumption data for last 3 years certified by Central Excise Authority. According to defer the case for 03.07.2012.

Case No.C12

M/S. Shasun Pharmaceuticals Ltd. F.No.01/82/162/00267/AM12/DESIII Decision: Committee decided to defer case for 03.07.2012 for comments of Department of Pharmaceuticals.

Case No.C13

M/S. Shasun Pharmaceuticals Ltd. F.No.01/82/162/00261/AM12/DESIII Decision: Committee decided to advise the firm to route this application through Pharmaxil giving all Industry and Production and Consumption data for last 3 years certified by Central Excise Authority. According to defer the case for 03.07.2012.

Case No.C14

M/S. Reliance Industries Ltd. F.No.01/82/162/01122/AM10/DESIII Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC (Petrochemicals Division) vide their O.M. No.46011/91/2008PC.II dated 31.05.2012 and in consultation with technical authority present in meeting, decided to revise SION for the export product Acrylonitrile as per details below: Export product Exp. Qty. Sl.No. Import items Qty. allowed

Acrylonitrile 1 MT. 1. Propylene 1.034 MT 2. Ammonia 0.442 MT Necessary Public Notice may be issued after approval of DG for publication of SION. 1

Case No.:44/39/82ALC4/2010

Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:10/82ALC4/2012 05.06.2012 Status:Case Approved HQ File :01/82/050/01125/AM11/ RLA File :09/24/040/00301/AM10/ Lic.No/Date:0910040874 09.02.2010 Defer Date: Decision : Withdrawn as the case has already been approved by NC in 2/82 meeting held on 10.04.2012. 2

Case No.:71/15/82ALC4/2010

Party Name:NECTAR LIFESCIENCES LIMITED, 05.06.2012 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:03.07.2012 Decision : Committee decided to defer case for 03.07.2012 for comments of Department of Pharmaceuticals. 3

Case No.:68/39/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 05.06.2012 HQ File :01/82/050/01149/AM11/ RLA File :09/24/040/00054/AM11/ Lic.No/Date:0910042623 06.07.2010 Decision : Committee decided to call from the firm Appendix 33 of application and also call for Personal hearing , if the firm have required PH and defer the case for 03.07.2012. 4

Case No.:72/39/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 05.06.2012 HQ File :01/82/050/01153/AM11/ RLA File :09/24/040/00146/AM11/ Lic.No/Date:0910042671 12.07.2010 Decision : Committee decided to call from the firm Appendix 33 of application and also call for Personal hearing , if the firm have required PH and defer the case for 03.07.2012w 5

Case No.:9/24/82ALC4/2010

Party Name:RAMPEX LABS PVT. LTD. 05.06.2012 HQ File :01/82/050/00809/AM11/ RLA File :09/24/040/00194/AM11/ Lic.No/Date:0910043391 07.09.2010 Defer Date: Decision: Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/414/2011PI (Norms) dated 13.6..2012 and in consultation with technical authority 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 METACLOROFENIL PIPERAZINA OR (1(3 CHLOROPHENYL) PIPERAZINE) 1 kg 1. 1. META CHLORO ANILINE 2. THIONYL CHLORIDE 3.DIETHANOLAMINE 1.10 kg/kg 1.87 kg/kg 0.83 kg/kg 6

Case No.:3/31/82ALC4/2010

Party Name:EMAMI LIMITED, 05.06.2012 HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Decision : Committee decided to defer case for 03.07.2012 for comments of DC (MSME). 7

Case No.:124/40/82ALC4/2010

Party Name:SURYA PHARMACEUTICAL LTD 05.06.2012 HQ File :01/82/050/01323/AM11/ RLA File :22/24/040/00049/AM11/ Lic.No/Date:2210010535 18.10.2010

Decision : Committee decided to call from the firm Appendix 33 of application within 15 days failing which the case ill be decided on merit. Accordingly, defer the case for 03.07.2012. 8

Case No.:57/40/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 05.06.2012 HQ File :01/82/050/01256/AM11/ RLA File :09/24/040/00237/AM11/ Lic.No/Date:0910043987 20.10.2010 Decision : Committee decided to send the application to TA and defer the case for 03.07.2012 9

Case No.:63/40/82ALC4/2010

Party Name:EMAMI LIMITED, 05.06.2012 HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Decision : Committee decided to defer case for 03.07.2012 for comments of DC (MSME). 10

Case No.:56/40/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 05.06.2012 HQ File :01/82/050/01255/AM11/ RLA File :09/24/040/00236/AM11/ Lic.No/Date:0910044022 26.10.2010 Decision : Committee decided to send the application to TA and defer the case for 03.07.2012 11

Case No.:8/32/82ALC4/2010

Party Name:SAURAV CHEMICALS LTD, 05.06.2012 HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Decision : Committee decided to defer case for 03.07.2012 for comments of DC (MSME). 12

Case No.:44/40/82ALC4/2010

Party Name:LUPIN LIMITED 05.06.2012 HQ File :01/82/050/01243/AM11/ RLA File :03/95/040/00638/AM11/ Lic.No/Date:0310600874 11.11.2010 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals. 13

Case No.:25/40/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 05.06.2012 HQ File :01/82/050/01224/AM11/ RLA File :09/24/040/00238/AM11/ Lic.No/Date:0910044429 25.11.2010 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals. 14

Case No.:24/47/82ALC4/2010

Party Name:AUROBINDO PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01614/AM11/ RLA File :09/24/040/00404/AM11/ Lic.No/Date:0910044631 10.12.2010 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals. 15

Case No.:43/3/82ALC4/2011

Party Name:MATRIX LABORATORIES LTD 05.06.2012 HQ File :01/82/050/00043/AM12/ RLA File :09/24/040/00452/AM11/ Lic.No/Date:0910045290 28.01.2011 Decision : Committee decided to call from the firm for production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 03.07.2012. 16

Case No.:44/3/82ALC4/2011

Party Name:MATRIX LABORATORIES LTD

05.06.2012 HQ File :01/82/050/00044/AM12/ RLA File :09/24/040/00422/AM11/ Lic.No/Date:0910045287 28.01.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals. 17

Case No.:32/48/82ALC4/2010

Party Name:DR. SABHARWALS WOUND CARE 05.06.2012 HQ File :01/82/050/01675/AM11/ RLA File :06/24/040/00057/AM11/ Lic.No/Date:0610020786 01.02.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of IPP 18

Case No.:22/3/82ALC4/2011

Party Name:CIPLA LIMITED 05.06.2012 HQ File :01/82/050/00022/AM12/ RLA File :03/94/040/00998/AM11/ Lic.No/Date:0310615336 10.02.2011 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. Sl.No. Import items Qty. allowed Tenofovir Disoproxil Fumarate and Emtricitabine Tablets / Didivir Tablets (Each Tablet contains: Tenofovir Disoproxil fumarate 300mg, Emtricitabine 200mg 1 kg 1. 1. 2R,5R)5(4amino5fluoro2 oxo2HPyrimidin1yl)[1,3] oxathiolane2carboxylic acid, 2Sisopropyl5R Methyl 1Rcyclohexyl ester. (FCME Compound) 2.50 kg/kg 2. Sodium Borohydride 0.510 kg/kg 3. Dipotassium Hydrogen Phosphate 3.425 kg/kg 19

Case No.:5/4/82ALC4/2011

Party Name:PIRAMAL HEALTHCARE LTD.(FORMERLY NICHOLAS PIRAMAL) 05.06.2012 HQ File :01/82/050/00056/AM12/ RLA File :03/95/040/00949/AM11/ Lic.No/Date:0310620143 08.03.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. Biotechnology. 20

Case No.:37/6/82ALC4/2011

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 05.06.2012 HQ File :01/82/050/00155/AM12/ RLA File :05/24/040/00437/AM11/ Lic.No/Date:0510286990 28.03.2011 Defer Date: Decision : 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 lo Export product Exp. Qty. Sl.No. Import items Qty. allowed RISPERIDONE INTERMEDIATE ( RA04) 1 kg 1. 6FLUORO3(4 PIPERIDINYL)1,2 BENZISOXAZOLE 0.953 kg/kg 21

Case No.:13/5/82ALC4/2011

Party Name:EMBIO LTD 05.06.2012

HQ File :01/82/050/00115/AM12/ RLA File :03/94/040/00009/AM12/ Lic.No/Date:0310627428 20.04.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals. 22

Case No.:14/5/82ALC4/2011

05.06.2012 HQ File :01/82/050/00116/AM12/ RLA File :03/94/040/00008/AM12/ Lic.No/Date:0310627429 20.04.2011 Defer Date: 03.07.2012 23

Case No.:32/6/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 05.06.2012 HQ File :01/82/050/00150/AM12/ RLA File :09/24/040/00037/AM12/ Lic.No/Date:0910046439 21.04.2011 24

Case No.:33/6/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 05.06.2012 HQ File :01/82/050/00151/AM12/ RLA File :09/24/040/00031/AM12/ Lic.No/Date:0910046440 21.04.2011 25

Case No.:19/10/82ALC4/2011

Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 05.06.2012 HQ File :01/82/050/00278/AM12/ RLA File :61/24/040/00097/AM11/ Lic.No/Date:6110000608 03.05.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of DC (MSME). 26

Case No.:2/8/82ALC4/2011

05.06.2012 HQ File :01/82/050/00202/AM12/ RLA File :03/94/040/01025/AM11/ Lic.No/Date:0310629987 06.05.2011 27

Case No.:43/8/82ALC4/2011

05.06.2012 HQ File :01/82/050/00243/AM12/ RLA File :03/94/040/01024/AM11/ Lic.No/Date:0310630508 10.05.2011 28

Case No.:44/8/82ALC4/2011

05.06.2012 HQ File :01/82/050/00244/AM12/ RLA File :03/94/040/01023/AM11/ Lic.No/Date:0310630510 10.05.2011 29

Case No.:3/9/82ALC4/2011

05.06.2012 HQ File :01/82/050/00254/AM12/ RLA File :03/94/040/00120/AM12/ Lic.No/Date:0310631346 16.05.2011

Case No.:4/9/82ALC4/2011

05.06.2012 HQ File :01/82/050/00255/AM12/ RLA File :03/94/040/00121/AM12/ Lic.No/Date:0310631350 16.05.2011 31

Case No.:1/10/82ALC4/2011

05.06.2012 HQ File :01/82/050/00260/AM12/ RLA File :03/94/040/00148/AM12/ Lic.No/Date:0310631875 19.05.2011 32

Case No.:2/10/82ALC4/2011

05.06.2012 HQ File :01/82/050/00261/AM12/ RLA File :03/94/040/00151/AM12/ Lic.No/Date:0310631883 19.05.2011 33

Case No.:44/14/82ALC4/2011

Party Name:ONEIRO CHEMICALS LTD 05.06.2012 HQ File :01/82/050/00435/AM12/ RLA File :34/24/040/00037/AM12/ Lic.No/Date:3410030415 30.05.2011 34

Case No.:2/15/82ALC4/2011

Party Name:ACHARYA CHEMICALS 05.06.2012 HQ File :01/82/050/00442/AM12/ RLA File :03/94/040/00130/AM12/ Lic.No/Date:0310633824 31.05.2011 35

Case No.:5/15/82ALC4/2011

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 05.06.2012 Status:Case Rejected HQ File :01/82/050/00445/AM12/ RLA File :03/94/040/00139/AM12/ Lic.No/Date:0310634097 01.06.2011 Defer Date: Decision : It was decided to close the case as the firm has not furnished information despite repeated reminders. RA may take appropriate action as per the decision of Norms Committee. 36

Case No.:25/19/82ALC4/2011

Party Name:VIVIMED LABS LIMITED 05.06.2012 HQ File :01/82/050/00539/AM12/ RLA File :09/24/040/00085/AM12/ Lic.No/Date:0910046996 06.06.2011 Decision : It was decided to give final reminder to the firm to furnish the requisite information within 15 days failing which the case would be closed. 37

Case No.:27/16/82ALC4/2011

Party Name:ALEMBIC PHARMACEUTICALS LTD 05.06.2012 HQ File :01/82/050/00485/AM12/ RLA File :34/24/040/00039/AM12/ Lic.No/Date:3410030563 10.06.2011 38

Case No.:34/19/82ALC4/2011

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 05.06.2012 HQ File :01/82/050/00548/AM12/ RLA File :09/24/040/00616/AM11/ Lic.No/Date:0910047091 10.06.2011 Defer Date:

Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/417/2011PI (Norms) dated 13.6.2012 and in consultation with technical autho 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 Cefprozil 1 kg. 1. 7 AMINO CEPHALOSPORONIC ACID (7 ACA) 1.77 kg/kg 2. METHYLENE CHLORIDE 6.98 kg/kg 3. DIMETHYL FORMAMIDE (DMF) 0.96 kg/kg 4. (IODO)TRIMETHYLSILANE (TMSI) 2.02 kg/kg 5. N,OBIS(TRIMETHYLSILYL)ACETAMIDE (BSA) 0.004 kg/kg 6. ACTIVATED CARBON 0.078 kg/kg 39

Case No.:14/19/82ALC4/2011

Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 05.06.2012 HQ File :01/82/050/00528/AM12/ RLA File :09/24/040/00134/AM12/ Lic.No/Date:0910047151 15.06.2011 Defer Date: Decision : Decision: Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/417/2011PI (Norms) dated 13.6.2012 and in consultation with tech 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 NPHENOXY CARBONYLL VALINE 1 No. 1. LVALINE 0.66 kg/kg 2. LITHIUM CHLORIDE 0.1 kg/kg 3. LITHIUM HYDROXIDE MONO HYDRATE 0.1 kg/kg 4. PHENYL CHLORO FORMATE 0.88 kg/k 5. METHYL TERITIORY BUTYL ETHE 0.28 kg/kg 6. TOULENE 0.89 kg/kg 40

Case No.:22/19/82ALC4/2011

Party Name:RAMPEX LABS PVT. LTD. 05.06.2012 HQ File :01/82/050/00536/AM12/ RLA File :09/24/040/00121/AM12/ Lic.No/Date:0910047114 15.06.2011 Defer Date: Decision : Decision : Decision: Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/414/2011PI (Norms) dated 13.6.2012 and in consultation 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 METACLOROFENIL PIPERAZINA OR (1(3 CHLOROPHENYL) PIPERAZINE) 1 kg 1. 1. META CHLORO ANILINE 2. THIONYL CHLORIDE 3.DIETHANOLAMINE 1.10 kg/kg 1.87 kg/kg 0.83 kg/KG 41

Case No.:13/19/82ALC4/2011

Party Name:NIFTY LABS PVT LTD., 05.06.2012 Status:Case Approve

HQ File :01/82/050/00527/AM12/ RLA File :09/24/040/00148/AM12/ Lic.No/Date:0910047160 16.06.2011 Defer Date: Decision :Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/416/2011PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed DOXAZOSIN MESYLATE 1 kg 1. 4Amino2Chloro6,7di methoxy quinazoline 1.0 kg/kg 2. Potassium Carbonate 0.7 kg/kg 3. Toluene 2.5 kg/kg 4. Acetone 6.25 kg/k 42

Case No.:32/19/82ALC4/2011

Party Name:MAITHRI LABORATORIES (P) LTD., 05.06.2012 Status:C Approve HQ File :01/82/050/00546/AM12/ RLA File :09/24/040/00139/AM12/ Lic.No/Date:0910047161 16.06.2011 Defer Da Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/416/2011PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed GEMIFLOXACIN MESYLATE 1 kg 1. Glycine ethylester HCL 1.32 kg/kg 2. DiBOC 4.54 kg/kg 3. Methoxyl amine HCL Not shown in reaction 4. 2,6dichloro 5fluoronicotinonitrile 0.85 kg/kg 5. Cyclopropyl amine Not shown in reaction 43

Case No.:36/14/82ALC4/2011

Party Name:SHASUN PHARMACEUTICALS LIMITED 05.06.2012 HQ File :01/82/050/00427/AM12/ RLA File :04/24/040/00069/AM12/ Lic.No/Date:0410125143 20.06.2011 Decision : : It was decided to give reminder to the firm to furnish the requisite information within 15 days failing which the case would be closed. Accordingly, the case was deferred for 03.07.2012. 44

Case No.:35/19/82ALC4/2011

Party Name:NECTAR LIFESCIENCES LIMITED, 05.06.2012 HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 45

Case No.:11/26/82ALC4/2011

Party Name:ARCH PHARMALABS LTD 05.06.2012 Status:Case Approv HQ File :01/82/050/00694/AM12/ RLA File :03/94/040/00317/AM12/ Lic.No/Date:0310642955 19.07.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/417/2011PI (Norms) dated 13.6.2012 and in consultation with technical au 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 Dicyclo hexyl amine (S)4fluoro 4methyl2 (((s)2,2,2trifluoro 1(4 (methylsulfonyl) 1 kg 1. Thioanisole 0.37 kg/kg 2. Triisopropyl Borate 0.56 kg/kg 3. Ethyl Trifluoroacetate 0.929 kg/kg 4. Methyl Tertiry Butyl Ether 3.80 kg/kg

(methylsulfonyl) [1,1biphenyl]4 yl)ethyl)amino) pentanoate Biphenyl acid DCHA Salt 5. Tetrahydrofuran 5.94 kg/kg 6. Acetonitrile 1.58 kg/kg 7. Pd116 (Bis(tritertbutylphosphine) palladium (O)) 0.00115 kg/kg 46

Case No.:10/18/82ALC4/2011

Party Name:ELDER PHARMACEUTICALS LTD., 05.06.2012 HQ File :01/82/050/00514/AM12/ RLA File :03/94/040/00289/AM12/ Lic.No/Date:0310643401 20.07.2011 47

Case No.:2/19/82ALC4/2011

05.06.2012 HQ File :01/82/050/00516/AM12/ RLA File :03/94/040/00014/AM12/ Lic.No/Date:0310643597 21.07.2011 Defer Date: Decision :Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/433/2011PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed 5(S){3(S)[4 methoxy3(3 methoxypropoxy) benzyl]4 methylpentyl}3(S) isopeopyl tetrahydrofuran2 one 1 kg 1. ()BocLactone: 5(S){1(S)(tert Butoxycarbonyl)amino3(S) [4methoxy3(3methoxypropoxy) benzyl]4methyl pently}3(S) isopropyl tetrahydrofuran2one 1.304 kg/kg 2. Con Hydrochloric acid Not an importable 3. Sodium Hydroxide 0.130 kg/kg 48

Case No.:1/24/82ALC4/2011

Party Name:PARABOLIC DRUGS LTD., 05.06.2012 HQ File :01/82/050/00662/AM12/ RLA File :05/24/040/00150/AM12/ Lic.No/Date:0510298306 01.08.2011 Decision : Committee decided to call from the firm Appendix 33 of the application proforma. Accordingly, case was deferred for 03.07.2012. 49

Case No.:2/24/82ALC4/2011

Party Name:PARABOLIC DRUGS LTD., 05.06.2012 Status:Case HQ File :01/82/050/00663/AM12/ RLA File :05/24/040/00149/AM12/ Lic.No/Date:0510298304 01.08.2011 Defer Date:03.07.20 Decision : Committee decided to call from the firm Appendix 33 of the application. Accordingly, case was deferred for 03.07.2012. 50

Case No.:3/24/82ALC4/2011

Party Name:PARABOLIC DRUGS LTD., 05.06.2012 HQ File :01/82/050/00664/AM12/ RLA File :05/24/040/00083/AM12/ Lic.No/Date:0510298301

01.08.2011 Decision : Committee decided to call from the firm Appendix 33 of the application proforma. Accordingly, case was deferred for 03.07.2012. 51

Case No.:30/31/82ALC4/2011

Party Name:RA CHEM PHARMA LIMITED 05.06.2012 HQ File :01/82/050/00856/AM12/ RLA File :09/24/040/00199/AM12/ Lic.No/Date:0910048014 01.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/22/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed Mebeverine Hcl 1 KG 1. Methyl2Chloro methyl Propionate 0.66 kg/kg 2. Catechol 0.75 kg/kg 3. Methanol 0.45 kg/kg 4. 1,4Dibromobutane 0.84 kg/k 5. Toluene 0.57 kg/kg 52

Case No.:12/25/82ALC4/2011

Party Name:GOPINATH CHEMTECH LTD., 05.06.2012 HQ File :01/82/050/00679/AM12/ RLA File :08/24/040/00107/AM12/ Lic.No/Date:0810102095 03.08.2011 53

Case No.:9/22/82ALC4/2011

Party Name:EMCURE PHARMACEUTICALS LTD. 05.06.2012 HQ File :01/82/050/00652/AM12/ RLA File :31/83/040/00103/AM12/ Lic.No/Date:3110049873 19.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/16/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed ATAZANAVIR SULPHATE IP 1 KG 1. BOC EPOXIDE 0.49 kg/kg 2. TBOC HYDRAZINE 0.50 kg/kg 3. NMETHOXYCARBONYLLTERT LEUCINE (MOCTLEUCINE) 0.77 kg/kg 4. (13DIMETHYLAMINOPROPYL)3 ETHYLCARBODIIMIDE HYDROCHLORIDE (EDC HCL) 0.79 kg/kg 54

Case No.:34/32/82ALC4/2011

Party Name:VINEET LABORATORIES PRIVATE LIMITED 05.06.2012 HQ File :01/82/050/00915/AM12/ RLA File :09/24/040/00157/AM12/ Lic.No/Date:0910048352 23.08.2011

Case No.:38/32/82ALC4/2011

Party Name:GRANULES INDIA LIMITED 05.06.2012 HQ File :01/82/050/00919/AM12/ RLA File :09/24/040/00239/AM12/ Lic.No/Date:0910048379 25.08.2011 56

Case No.:46/31/82ALC4/2011

Party Name:POSY PHARMACHEM PVT. LTD. 05.06.2012 HQ File :01/82/050/00872/AM12/ RLA File :08/24/040/00084/AM12/ Lic.No/Date:0810102781 25.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/4/2012 CH.II dated 05.06.2012 and in consultation with technical authority present in me 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 CITRIC ACID ANHYDROUS USP/KOSHER 1 kg 1. Citric Acid Anhydrous 1.01kg 57

Case No.:6/28/82ALC4/2011

Party Name:CADILA HEALTHCARE LTD., 05.06.2012 HQ File :01/82/050/00776/AM12/ RLA File :08/24/040/00092/AM12/ Lic.No/Date:0810102939 29.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide their U.O.No. 35011/06/2012PI(Norms) dated 13.06.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed Minocycline Hydrochloride (modified release) 100 mg Capsules. 1 No. 1. Minocycline Hydrochloride Ph EUR 0.1113 gms 2. Hard Gelatin Capsules Opaque Brown/ Opaque Orange As per packing policy 58

Case No.:38/31/82ALC4/2011

Party Name:NECTAR LIFESCIENCES LIMITED, 05.06.2012 HQ File :01/82/050/00864/AM12/ RLA File :22/24/040/00041/AM12/ Lic.No/Date:2210011844 01.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of pharmaceutical vide their O.M..No. 35011/21/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefotaxime Sodium Sterile 1 kg 1. Cefotaxime Acid 0.989 kg/kg 2. Ethyl Acetate 3.16 kg/kg 3. Methanol 0.44 kg/kg 4. TEA 0.178 kg/k 5. Eno Carbon 0.031 kg/kg

Sod2Ethyl Hexanoate 0.44 kg/kg 7. Methyl Iso Butyl Ketone 0.25 kg/kg 59

Case No.:39/31/82ALC4/2011

Party Name:SAURAV CHEMICALS LTD, 05.06.2012 HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 60

Case No.:29/32/82ALC4/2011

Party Name:RA CHEM PHARMA LIMITED 05.06.2012 HQ File :01/82/050/00910/AM12/ RLA File :09/24/040/00259/AM12/ Lic.No/Date:0910048529 02.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of pharmaceutical vide their O.M..No. 35011/60/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed 1Benzyl4[(5,6 Dimethoxy1 Indanon)2Ylidenyl] Methyl Piperidine 1 kg 1. Vitride 70% 2.316 kg/kg 2. Oxalyl Chloride 1.375 kg/kg 3. 5,6Dimethoxy 1Indanone 0.73 kg/kg 4. Benzyl Chloride 0.89 kg/k 5. ISO Nipecotic Acid Ethyl Ester 1.10 kg/kg 6. Methanol 2.07 kg/kg 61

Case No.:14/32/82ALC4/2011

Party Name:SRINI PHARMACEUTICALS LTD., 05.06.2012 HQ File :01/82/050/00895/AM12/ RLA File :09/24/040/00250/AM12/ Lic.No/Date:0910048565 05.09.2011 62

Case No.:16/32/82ALC4/2011

Party Name:AUCTUS PHARMA LIMITED 05.06.2012 HQ File :01/82/050/00897/AM12/ RLA File :09/24/040/00257/AM12/ Lic.No/Date:0910048616 06.09.2011 63

Case No.:28/28/82ALC4/2011

Party Name:DHANUKA LABORATORIES LTD. 05.06.2012 HQ File :01/82/050/00798/AM12/ RLA File :05/23/040/00214/AM12/ Lic.No/Date:0510301712 08.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of pharmaceutical vide their O.M..No. 35011/03/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho

Export product Exp. Qty. Sl.No. Import items Qty. allowed GCTA Powder 1 kg 1. GCLE 1.282 kg/kg 2. TRIPHENYL PHOSPHINE 0.726 kg/kg 3. 4Methyl,5Formyl Thiazol 0.769 kg/kg 4. PROPAN1ol 2.40 kg/kg 5. CHLOROFORM 4.27 kg/kg 6. SODIUM IODIDE 0.41 kg/kg 7. METHANOL 1.918 kg/kg 8. Potassium Meta Bisulphite 2.353 kg/kg 64

Case No.:15/32/82ALC4/2011

Party Name:RAMPEX LABS PVT. LTD. 05.06.2012 HQ File :01/82/050/00896/AM12/ RLA File :09/24/040/00273/AM12/ Lic.No/Date:0910048689 09.09.2011 65

Case No.:19/32/82ALC4/2011

Party Name:MATRIX LABORATORIES LIMITED 05.06.2012 HQ File :01/82/050/00900/AM12/ RLA File :09/24/040/00268/AM12/ Lic.No/Date:0910048699 09.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of pharmaceutical vide their O.M..No. 35011/55/2012PI (Norms) dated 013.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed VALACYCLOVIR HYDROCHLORIDE 1 kg 1. Acyclovir 0.78 kg/kg 2. CBZLValine 1.1824 kg/kg 3. 1,3DICYCLOHEXYL CARBODIMIDE 1.3871 kg/kg 4. DIMETHYL FORMAMIDE 3.36 kg/kg 5. 4DIMETHYLAMINOPYRIDINE 0.028kg/kg 6. METHANOL 6.20 kg/.kg 7. TETRAHYDROFURAN 0.200 kg/kg 66

Case No.:28/32/82ALC4/2011

Party Name:RAMPEX LABS PVT. LTD. 05.06.2012 HQ File :01/82/050/00909/AM12/ RLA File :09/24/040/00272/AM12/ Lic.No/Date:0910048688 09.09.2011

Case No.:22/32/82ALC4/2011

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 05.06.2012 HQ File :01/82/050/00903/AM12/ RLA File :04/24/040/00155/AM12/ Lic.No/Date:0410128356 21.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide O.M No. 35011/33/2012PI (Norms) and in consultation with technical authority present in meeting, de 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 SOFTGELATIN CAPSULES BP/USP 10 MG/20 MG 1 No. 1. 2. ISOTRETINOIN BP (10 MG) ISOTRETINOIN USP (20 MG) 10.2 mg 20.4 mg 68

Case No.:24/32/82ALC4/2011

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 05.06.2012 HQ File :01/82/050/00905/AM12/ RLA File :04/24/040/00154/AM12/ Lic.No/Date:0410128434 22.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide O.M No. 35011/64/2012PI (Norms) and in consultation with technical authority present in meeting, de 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 Softgelatin Capsules Evening Primrose Oil 400 mg 1Lakh Nos 1. Evening Primrose Oil 10% GLA 40.0 kgs Softgelatin Capsules Evening Primrose Oil 800 mg 1Lakh Nos 2. Evening Primrose Oil 10% GLA 80.0 kgs Softgelatin Capsules Evening Primrose Oil 500 mg 1Lakh Nos 3. Evening Primrose Oil 10% GLA 50.0 kgs Softgelatin Capsules Evening Primrose Oil 1000 mg 1Lakh Nos 4. Evening Primrose Oil 10% GLA 100.0 kgs 69

Case No.:39/32/82ALC4/2011

Party Name:NECTAR LIFESCIENCES LIMITED, 05.06.2012 HQ File :01/82/050/00920/AM12/ RLA File :22/24/040/00046/AM12/ Lic.No/Date:2210011928 22.09.2011 70

Case No.:17/28/82ALC4/2011

Party Name:RUSAN PHARMA LTD. 05.06.2012 Status:Deffered and Reindexed HQ File :01/82/050/00787/AM12/ RLA File :03/95/040/00471/AM12/ Lic.No/Date:0310656673 28.09.2011 Defer Date:05.06.2012 71

Case No.:18/36/82ALC4/2011

Party Name:MEDREICH LIMITED 05.06.2012 HQ File :01/82/050/00975/AM12/ RLA File :07/24/040/00178/AM12/ Lic.No/Date:0710082847

28.09.2011 72

Case No.:25/32/82ALC4/2011

Party Name:RANBAXY LABORATORIES LTD 05.06.2012 HQ File :01/82/050/00906/AM12/ RLA File :05/24/040/00194/AM12/ Lic.No/Date:0510304240 29.09.2011 73

Case No.:16/35/82ALC4/2011

Party Name:HIRAN ORGOCHEM LIMITED 05.06.2012 HQ File :01/82/050/00943/AM12/ RLA File :03/94/040/00474/AM12/ Lic.No/Date:0310657248 30.09.2011 Decision : Committee decided to call from the firm Appendix 33 of the application. Accordingly, case was deferred for 03.07.2012. 74

Case No.:17/35/82ALC4/2011

Party Name:ENALTEC LABS PVT.LTD. 05.06.2012 HQ File :01/82/050/00944/AM12/ RLA File :03/94/040/00574/AM12/ Lic.No/Date:0310657228 30.09.2011 Defer Date: Decision : 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 lo Export product Exp. Qty. Sl.No. Import items Qty. allowed DRONEDARONE HCL 1 kg 1. N(3 CHLOROPROPYL) DIBUTYLAMINE 0.80 kg/kg 2. (2 BUTYL 5 BITROBENZOFURAN3YL)(4 HYDROXYPHENYL) METHANONE 1.20 kg/kg 75

Case No.:7/35/82ALC4/2011

Party Name:IPCA LABORATORIES LIMITED 05.06.2012 Status:Case Approv HQ File :01/82/050/00934/AM12/ RLA File :03/94/040/00539/AM12/ Lic.No/Date:0310657331 30.09.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of pharmaceutical vide their O.M..No. 35011/73/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed HYDROXY CHLOROQUINE SULPHATE 1 kg 1. Ethoxy Methylene Malonic Acid Ester [ EMME ] 1.1481 kg/kg 2. Metachloro Aniline 0.6756 kg/kg 3. Hydroxy Novaldiamine 0.9988 kg/kg 4. S. B. Toluene 0.702 kg/kg 5. Methanol 2.7796 kg/kg 6. Iso Propyl Alcohol 1.49 kg/.kg 7. Methylene Chloride 2.29 kg/kg 76

Case No.:10/32/82ALC4/2011

Party Name:DHANUKA LABORATORIES LTD. 05.06.2012

HQ File :01/82/050/00891/AM12/ RLA File :05/23/040/00244/AM12/ Lic.No/Date:0510304494 03.10.2011 77

Case No.:2/35/82ALC4/2011

05.06.2012 HQ File :01/82/050/00929/AM12/ RLA File :03/94/040/00572/AM12/ Lic.No/Date:0310658087 05.10.2011 78

Case No.:24/35/82ALC4/2011

Party Name:LUPIN LIMITED 05.06.2012 HQ File :01/82/050/00951/AM12/ RLA File :03/95/040/00562/AM12/ Lic.No/Date:0310658391 07.10.2011 79

Case No.:10/35/82ALC4/2011

Party Name:RANBAXY LABORATORIES LTD 05.06.2012 HQ File :01/82/050/00937/AM12/ RLA File :05/24/040/00233/AM12/ Lic.No/Date:0510304887 11.10.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of pharmaceutical vide their O.M..No. 35011/70/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed Nevirapine 1 kg 1. 3(2Chloro3PyridineCarbonyl) Amino2Chloro4Methyl Pyridine] 1.428 kg/kg 2. Cyclopropylamine 0.57 kg/kg 3. Dimethyl Formamide 0.754 kg/kg 4. Toluenee 2.73 kg/kg 5. Activated Carbon 0.100 kg/kg 6. Methanol 0.98 kg/.kg 80

Case No.:26/35/82ALC4/2011

Party Name:INDOFIL INDUSTRIES LTD. 05.06.2012 HQ File :01/82/050/00953/AM12/ RLA File :03/94/040/00606/AM12/ Lic.No/Date:0310658741 11.10.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of C& PC 81

Case No.:9/35/82ALC4/2011

Party Name:UNITED BIOTECH PVT.LTD. 05.06.2012 HQ File :01/82/050/00936/AM12/ RLA File :05/24/040/00226/AM12/ Lic.No/Date:0510304974 11.10.2011 82

Case No.:12/32/82ALC4/2011

Party Name:AMI LIFESCIENCES P LTD 05.06.2012 HQ File :01/82/050/00893/AM12/ RLA File :34/24/040/00137/AM12/ Lic.No/Date:3410031901 12.10.2011 Defer Date:

Decicion: Committee considered case as per agenda and in light of written comments forwarded by Deptt of pharmaceutical vide their O.M..No. 35011/59/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed DIACEREIN 1 kg 1. ALOE EMODIN 95% 1.181 kg/kg 83

Case No.:5/31/82ALC4/2011

Party Name:TITAN LABORATORIES PVT. LTD. 05.06.2012 HQ File :01/82/050/00831/AM12/ RLA File :03/95/040/00570/AM12/ Lic.No/Date:0310659395 13.10.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals 84

Case No.:7/31/82ALC4/2011

05.06.2012 HQ File :01/82/050/00833/AM12/ RLA File :03/94/040/00612/AM12/ Lic.No/Date:0310659475 13.10.2011 85

Case No.:8/31/82ALC4/2011

05.06.2012 HQ File :01/82/050/00834/AM12/ RLA File :03/94/040/00611/AM12/ Lic.No/Date:0310659491 13.10.2011 86

Case No.:11/41/82ALC4/2011

Party Name:INDIA GLYCOLS LTD., 05.06.2012 HQ File :01/82/050/01012/AM12/ RLA File :05/23/040/00237/AM12/ Lic.No/Date:0510305501 17.10.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of C&PC. 87

Case No.:21/36/82ALC4/2011

Party Name:MEDREICH LIMITED 05.06.2012 HQ File :01/82/050/00978/AM12/ RLA File :07/24/040/00285/AM12/ Lic.No/Date:0710083447 21.10.2011 88

Case No.:6/41/82ALC4/2011

05.06.2012 HQ File :01/82/050/01007/AM12/ RLA File :03/94/040/00618/AM12/ Lic.No/Date:0310661493 21.10.2011 89

Case No.:2/32/82ALC4/2011

Party Name:RUSAN PHARMA LTD. 05.06.2012 HQ File :01/82/050/00883/AM12/ RLA File :03/95/040/00615/AM12/ Lic.No/Date:0310662064 25.10.2011 Defer Date: Decicion: Committee considered case as per agenda and in light of written comments forwarded by Deptt of pharmaceutical vide their O.M..No. 35011/69/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed NALTREXONE HYDROCHLORIDE 1 kg 1. NOROXYMORPHONE 1.162 kg/kg

PHARMA GRADE 90

Case No.:13/41/82ALC4/2011

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 05.06.2012 HQ File :01/82/050/01014/AM12/ RLA File :07/24/040/00300/AM12/ Lic.No/Date:0710083654 02.11.2011 Defer Date: Decicion: Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/56/2011Ch.II dated 22.05.2012 and in consultation with technical authority present in meet 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 Zinc Gluconate Powder 1 kg 2. Zinc Gluconate Granular 1.025 kg 91

Case No.:16/41/82ALC4/2011

Party Name:ALEMBIC PHARMACEUTICALS LTD 05.06.2012 HQ File :01/82/050/01017/AM12/ RLA File :34/24/040/00159/AM12/ Lic.No/Date:3410032102 04.11.2011 92

Case No.:15/41/82ALC4/2011

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 05.06.2012 Status:Case Appro HQ File :01/82/050/01016/AM12/ RLA File :07/24/040/00306/AM12/ Lic.No/Date:0710083782 08.11.2011 Defer Date: Decicion: Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/56/2011Ch.II dated 22.05.2012 and in consultation with technical authority present in meet 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 Copper Gluconate Powder 1 kg 1. Copper Gluconate Granular 1.025 kg 93

Case No.:24/36/82ALC4/2011

Party Name:MEDREICH LIMITED 05.06.2012 HQ File :01/82/050/00981/AM12/ RLA File :07/24/040/00305/AM12/ Lic.No/Date:0710083785 08.11.2011 94

Case No.:25/41/82ALC4/2011

05.06.2012 HQ File :01/82/050/01026/AM12/ RLA File :08/24/040/00179/AM12/ Lic.No/Date:0810105257 08.11.2011 Defer Date: 95

Case No.:28/41/82ALC4/2011

Party Name:LIV MEDICA PRODUCTS PVT. LTD. 05.06.2012 HQ File :01/82/050/01029/AM12/ RLA File :04/24/040/00210/AM12/ Lic.No/Date:0410130168 09.11.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of DIPP

Case No.:6/36/82ALC4/2011

Party Name:AUROLAB 05.06.2012 HQ File :01/82/050/00963/AM12/ RLA File :35/24/040/00027/AM12/ Lic.No/Date:3510036087 11.11.2011 97

Case No.:3/45/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 05.06.2012 HQ File :01/82/050/01180/AM12/ RLA File :03/94/040/00691/AM12/ Lic.No/Date:0310664617 14.11.2011 98

Case No.:4/45/82ALC4/2011

Party Name:KOPRAN LIMITED 05.06.2012 HQ File :01/82/050/01181/AM12/ RLA File :03/94/040/00521/AM12/ Lic.No/Date:0310664771 14.11.2011 99

Case No.:14/35/82ALC4/2011

Party Name:PREGNA INTERNATIONAL LTD. 05.06.2012 Status:Case Approve HQ File :01/82/050/00941/AM12/ RLA File :03/95/040/00635/AM12/ Lic.No/Date:0310665072 15.11.2011 Defer Date: Decicion: Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 46011/22/2008PCII dated 22.05.2012 and in consultation with technical authority present in me 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 INTRA UTERINE CONTRACEPTIVE DEVICE 1000 No. 1. Copper Wire with Silver Core 1.05 kg./kg content 2. Copper Tube 99.99% purity 1.05 kg./kg content 3. HDPE Granules 1.20 kg./kg content 4. Pouches (plastic) As per packaging policy 5. Compound of LDPE Resin & Barium Sulphate 1.20 kg./kg content 6. PVC Granules 1.20 kg./kg content 7. HDPE Granules (or Nylon resin) Medical grade 1.20 kg./kg content 8. Polypropylene Granules 1.20 kg./kg content 9. Polypropylene “Gama Radiation Stabilized” 1.20 kg./kg content 100

Case No.:22/45/82ALC4/2011

Party Name:AUCTUS PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01199/AM12/ RLA File :09/24/040/00341/AM12/ Lic.No/Date:0910049706 15.11.2011

101

Case No.:4/9/82ALC4/2012

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.06.2012 HQ File :01/82/050/00249/AM13/ RLA File :17/24/040/00067/AM12/ Lic.No/Date:1710004590 15.11.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of C&PC 102

Case No.:31/49/82ALC4/2011

Party Name:SMILAX LABORATORIES LIMITED 05.06.2012 Status:Case Deferred HQ File :01/82/050/01340/AM12/ RLA File :09/24/040/00332/AM12/ Lic.No/Date:0910049719 16.11.2011 Defer Date: 03.07.2012 103

Case No.:35/45/82ALC4/2011

Party Name:RA CHEM PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01212/AM12/ RLA File :09/24/040/00374/AM12/ Lic.No/Date:0910049718 16.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of pharmaceutical vide their O.M..No. 35011/60/2012PI (Norms) dated 13.6.2012 and in consultation with technical autho Export product Exp. Qty. Sl.No. Import items Qty. allowed 1Benzyl4[(5,6 Dimethoxy1 Indanon)2Ylidenyl] Methyl Piperidine 1 kg 1. Vitride 70% 2.316 kg/kg 2. Oxalyl Chloride 1.375 kg/kg 3. 5,6Dimethoxy 1Indanone 0.73 kg/kg 4. Benzyl Chloride 0.89 kg/k 5. ISO Nipecotic Acid Ethyl Ester 1.10 kg/kg 6. Methanol 2.07 kg/kg 104

Case No.:39/45/82ALC4/2011

Party Name:AARTI DRUGS LIMITED 05.06.2012 Status:Case Approv HQ File :01/82/050/01216/AM12/ RLA File :03/94/040/00664/AM12/ Lic.No/Date:0310665403 17.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments of PI Division vide their O.M..No. 35011//264/2006PIII dated 13.06.2012 and in consultation with technical authority present in meeting, de 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 Aceclofenec BP 1 kg 1. Diclofenec Sodium 1.11 kg 2. Mono Chloro Aniline (MCA) 0.42 kg 3. 10% Palldium on carbon 0.03 kg 4. Methylene Chloride 1.00 kg 5. Xylene 0.40 kg

Dimethyl formamide 1.00 kg 7. Methanol 1.37 kg 105

Case No.:27/49/82ALC4/2011

Party Name:ANDHRA ORGANICS LIMITED 05.06.2012 HQ File :01/82/050/01336/AM12/ RLA File :09/24/040/00344/AM12/ Lic.No/Date:0910049777 18.11.2011 106

Case No.:31/45/82ALC4/2011

Party Name:MYLAN LABORATORIES LIMITED 05.06.2012 HQ File :01/82/050/01208/AM12/ RLA File :09/24/040/00348/AM12/ Lic.No/Date:0910049778 18.11.2011 107

Case No.:2/36/82ALC4/2011

Party Name:EMCURE PHARMACEUTICALS LTD. 05.06.2012 HQ File :01/82/050/00959/AM12/ RLA File :31/83/040/00170/AM12/ Lic.No/Date:3110051562 21.11.2011 108

Case No.:33/41/82ALC4/2011

Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 05.06.2012 HQ File :01/82/050/01034/AM12/ RLA File :52/24/040/00036/AM12/ Lic.No/Date:5210037111 21.11.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of C &PC. 109

Case No.:29/49/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01338/AM12/ RLA File :09/24/040/00379/AM12/ Lic.No/Date:0910049906 24.11.2011 110

Case No.:63/46/82ALC4/2011

Party Name:ANDHRA ORGANICS LIMITED 05.06.2012 HQ File :01/82/050/01279/AM12/ RLA File :09/24/040/00387/AM12/ Lic.No/Date:0910049937 29.11.2011 111

Case No.:33/49/82ALC4/2011

Party Name:DR REDDYS LABORATORIES LIMITED 05.06.2012 HQ File :01/82/050/01342/AM12/ RLA File :09/24/040/00396/AM12/ Lic.No/Date:0910049978 30.11.2011 112

Case No.:6/45/82ALC4/2011

Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 05.06.2012 Status:Case HQ File :01/82/050/01183/AM12/ RLA File :04/24/040/00236/AM12/ Lic.No/Date:0410131109 30.11.2011 Defer Date:

Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/7/2010Ch.II dated 05.06.2012 decided to ratify norms under para 4.7 of HBP as per d as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 4(2Aminoethyl)2 methoxyphenol. 1 kg 1. 2. Vanillin Sodium Cyanide 1.124 kg 0.416 kg 113

Case No.:7/45/82ALC4/2011

Party Name:SANO MEDICAL KITS PVT. LTD., 05.06.2012 HQ File :01/82/050/01184/AM12/ RLA File :04/24/040/00244/AM12/ Lic.No/Date:0410131205 01.12.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of DIPP. 114

Case No.:54/46/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01270/AM12/ RLA File :09/24/040/00398/AM12/ Lic.No/Date:0910050048 05.12.2011 115

Case No.:34/49/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01343/AM12/ RLA File :09/24/040/00358/AM12/ Lic.No/Date:0910050099 08.12.2011 116

Case No.:82/46/82ALC4/2011

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 05.06.2012 HQ File :01/82/050/01298/AM12/ RLA File :09/24/040/00127/AM12/ Lic.No/Date:0910050138 09.12.2011 Defer Date: 03.07.2012 117

Case No.:1/39/82ALC4/2011

Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 05.06.2012 HQ File :01/82/050/00993/AM12/ RLA File :03/95/040/00718/AM12/ Lic.No/Date:0310670262 13.12.2011 Defer Date: 03.07.2012 118

Case No.:2/39/82ALC4/2011

Party Name:BILCARE LIMITED 05.06.2012 HQ File :01/82/050/00994/AM12/ RLA File :31/83/040/00167/AM12/ Lic.No/Date:3110051868 13.12.2011 119

Case No.:23/45/82ALC4/2011

Party Name:SUTURES INDIA PRIVATE LIMITED, 05.06.2012 HQ File :01/82/050/01200/AM12/ RLA File :07/24/040/00341/AM12/ Lic.No/Date:0710084630 13.12.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of DIPP

120

Case No.:23/46/82ALC4/2011

Party Name:ROYAL PHARMA 05.06.2012 HQ File :01/82/050/01239/AM12/ RLA File :03/95/040/00738/AM12/ Lic.No/Date:0310670268 13.12.2011 121

Case No.:26/46/82ALC4/2011

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 05.06.2012 Status:Case Approv HQ File :01/82/050/01242/AM12/ RLA File :03/94/040/00751/AM12/ Lic.No/Date:0310670327 13.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/29/2011Ch.II dated 25.05.2012 decided to ratify norms under para 4.7 of HBP below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed PARA CHLORO PHENYL ACETIC ACID 1 kg 1. Para Chloro Bklenzyl Cyanide 1.021 kg 2. Sodium Cyanide 0.230 kg 3. Caustic Soda Flakes 0.360 kg 122

Case No.:8/45/82ALC4/2011

Party Name:SHASUN PHARMACEUTICALS LIMITED 05.06.2012 HQ File :01/82/050/01185/AM12/ RLA File :04/24/040/00253/AM12/ Lic.No/Date:0410131573 13.12.2011 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from firm to furnish production and consumption data duly certified by Central Ex Accordingly, the case has been deferred for 03.07.2012 123

Case No.:24/46/82ALC4/2011

Party Name:ASHISH LIFE SCIENCE PVT.LTD. 05.06.2012 HQ File :01/82/050/01240/AM12/ RLA File :03/94/040/00737/AM12/ Lic.No/Date:0310670672 14.12.2011 124

Case No.:74/46/82ALC4/2011

Party Name:HETERO DRUGS LIMITED, 05.06.2012 HQ File :01/82/050/01290/AM12/ RLA File :09/24/040/00421/AM12/ Lic.No/Date:0910050231 14.12.2011 125

Case No.:81/46/82ALC4/2011

Party Name:HETERO DRUGS LIMITED, 05.06.2012 HQ File :01/82/050/01297/AM12/ RLA File :09/24/040/00422/AM12/ Lic.No/Date:0910050232 14.12.2011 126

Case No.:59/46/82ALC4/2011

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 05.06.2012 HQ File :01/82/050/01275/AM12/ RLA File :09/24/040/00413/AM12/ Lic.No/Date:0910050238 15.12.2011

127

Case No.:2/40/82ALC4/2011

Party Name:FDC LTD 05.06.2012 HQ File :01/82/050/00998/AM12/ RLA File :03/94/040/00819/AM12/ Lic.No/Date:0310671854 20.12.2011 128

Case No.:2/9/82ALC4/2012

Party Name:GRAND ORGANICS PVT.LTD. 05.06.2012 HQ File :01/82/050/00247/AM13/ RLA File :17/24/040/00009/AM11/ Lic.No/Date:1710004681 20.12.2011 129

Case No.:3/9/82ALC4/2012

Party Name:GRAND ORGANICS PVT.LTD. 05.06.2012 HQ File :01/82/050/00248/AM13/ RLA File :17/24/040/00047/AM09/ Lic.No/Date:1710004679 20.12.2011 Decision : 130

Case No.:9/45/82ALC4/2011

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 05.06.2012 Status:Case Ap HQ File :01/82/050/01186/AM12/ RLA File :07/24/040/00373/AM12/ Lic.No/Date:0710084836 20.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/56/2011Ch.II dated 29.05.2012 and in consultation with the technical authorities 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 Calcium D Pantotheonate Powder 1 kg 1. Calcium D Pantotheonate Granular 1.025 kg 131

Case No.:30/46/82ALC4/2011

Party Name:DSM ANTIINFECTIVES INDIA LTD 05.06.2012 HQ File :01/82/050/01246/AM12/ RLA File :22/24/040/00076/AM12/ Lic.No/Date:2210012341 22.12.2011 132

Case No.:30/49/82ALC4/2011

Party Name:VASANT CHEMICALS PRIVATE LIMITED 05.06.2012 Status:C Approve HQ File :01/82/050/01339/AM12/ RLA File :09/24/040/00417/AM12/ Lic.No/Date:0910050342 22.12.2011 Defer Da Decision : Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/17/2011Ch.II dated 07.05.2012 and in consultation with the techn 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 5Methoxy 2Tetralone (Mol.Wt. 176.21) (Appearance White to Yellowish or reddish solid or semisolid) 1 kg 1. 1,6,Di Hydroxy Naphthalene (Ash colored powder purity by HPLC (Area %) : NLT: 98% 2.400 kg

133

Case No.:4/40/82ALC4/2011

Party Name:DEEPAK NITRITE LIMITED 05.06.2012 Status:Case Deferre HQ File :01/82/050/01000/AM12/ RLA File :31/83/040/00137/AM12/ Lic.No/Date:3110052056 22.12.2011 Defer Date:03.07.20 Decision : 134

Case No.:46/49/82ALC4/2011

Party Name:ANDHRA ORGANICS LIMITED 05.06.2012 HQ File :01/82/050/01355/AM12/ RLA File :09/24/040/00418/AM12/ Lic.No/Date:0910050347 22.12.2011 135

Case No.:1/47/82ALC4/2011

Party Name:BROOKS LABORATORIES LTD., 05.06.2012 HQ File :01/82/050/01301/AM12/ RLA File :22/24/040/00067/AM12/ Lic.No/Date:2210012351 23.12.2011 136

Case No.:2/47/82ALC4/2011

Party Name:BROOKS LABORATORIES LTD., 05.06.2012 HQ File :01/82/050/01302/AM12/ RLA File :22/24/040/00066/AM12/ Lic.No/Date:2210012352 23.12.2011 137

Case No.:14/46/82ALC4/2011

Party Name:STAR DRUGS & RESEARCH LABS LTD 05.06.2012 HQ File :01/82/050/01230/AM12/ RLA File :04/24/040/00242/AM12/ Lic.No/Date:0410132171 27.12.2011 138

Case No.:15/46/82ALC4/2011

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 05.06.2012 HQ File :01/82/050/01231/AM12/ RLA File :04/24/040/00259/AM12/ Lic.No/Date:0410132173 27.12.2011 139

Case No.:4/46/82ALC4/2011

Party Name:AMI LIFESCIENCES P LTD 05.06.2012 HQ File :01/82/050/01220/AM12/ RLA File :34/24/040/00189/AM12/ Lic.No/Date:3410032719 27.12.2011 140

Case No.:38/46/82ALC4/2011

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 05.06.2012 Status:Case HQ File :01/82/050/01254/AM12/ RLA File :03/94/040/00817/AM12/ Lic.No/Date:0310673330 28.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/29/2011Ch.II dated 25.05.2012 and in consultation with the technical authorities meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,5Dimethyl Phenyl Acetyl Chloride 1 kg 1. Para Xylene 1.485 kg

Paraformaldehyde 1.032 kg 3. Sodium Cyanide 0.570 kg 4. Caustic Soda Flakes 0.500 kg 5. Thionyl Chloride 0.980 kg 141

Case No.:1/9/82ALC4/2012

Party Name:ESTEEM INDUSTRIES PVT. LTD, 05.06.2012 HQ File :01/82/050/00246/AM13/ RLA File :17/24/040/00090/AM12/ Lic.No/Date:1710004717 29.12.2011 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of C&PC. 142

Case No.:15/49/82ALC4/2011

Party Name:PI INDUSTRIES LTD., 05.06.2012 Status: Case Approv HQ File :01/82/050/01324/AM12/ RLA File :13/24/040/00033/AM12/ Lic.No/Date:1310038283 30.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 15022/6/2010Ch.II dated 1.6.2012 and in consultation with the technical authorities present Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Methyl1Methylthio2 Propanamine 1 kg 1. 2Amino 2Methyl1 Propanol (AMP) 1.006 kg 2. Toluene 0.307 kg 143

Case No.:3/41/82ALC4/2011

Party Name:RUSAN PHARMA LTD. 05.06.2012 HQ File :01/82/050/01004/AM12/ RLA File :03/95/040/00803/AM12/ Lic.No/Date:0310673724 30.12.2011 144

Case No.:39/46/82ALC4/2011

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 05.06.2012 HQ File :01/82/050/01255/AM12/ RLA File :03/94/040/00856/AM12/ Lic.No/Date:0310673730 30.12.2011 Defer Date: Decision : Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/29/2011Ch.II dated 25.05.2012 decided to ratify norms under para 4.7 details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,5Dimethyl Phenyl Acetyl Chloride 1 kg 1. Para Xylene 1.485 kg 2. Paraformaldehyde 1.032 kg 3. Sodium Cyanide 0.570 kg 4. Caustic Soda Flakes 0.500 kg

Thionyl Chloride 0.980 kg 145

Case No.:5/41/82ALC4/2011

Party Name:SOHAN HEALTHCARE PVT. LTD 05.06.2012 HQ File :01/82/050/01006/AM12/ RLA File :31/83/040/00195/AM12/ Lic.No/Date:3110052178 30.12.2011 146

Case No.:5/45/82ALC4/2011

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 05.06.2012 HQ File :01/82/050/01182/AM12/ RLA File :03/94/040/00755/AM12/ Lic.No/Date:0310674056 02.01.2012 147

Case No.:16/29/85ALC3/2011

Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 05.06.2012 HQ File :01/85/050/00173/AM12/ RLA File :03/95/040/00831/AM12/ Lic.No/Date:0310674968 05.01.2012 148

Case No.:20/51/82ALC4/2011

Party Name:POLYDRUG LABORATORIES PVT.LTD. 05.06.2012 HQ File :01/82/050/01413/AM12/ RLA File :03/95/040/00819/AM12/ Lic.No/Date:0310674929 05.01.2012 Defer Date: 03.07.2012 149

Case No.:14/45/82ALC4/2011

Party Name:DIVIS LABORATORIES LTD., 05.06.2012 HQ File :01/82/050/01191/AM12/ RLA File :09/24/040/00468/AM12/ Lic.No/Date:0910050661 06.01.2012 150

Case No.:47/1/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 05.06.2012 HQ File :01/82/050/01489/AM12/ RLA File :09/24/040/00477/AM12/ Lic.No/Date:0910050664 06.01.2012 151

Case No.:34/45/82ALC4/2011

Party Name:PARAGON INDUSTRIES 05.06.2012 HQ File :01/82/050/01211/AM12/ RLA File :08/24/040/00233/AM12/ Lic.No/Date:0810107536 09.01.2012 152

Case No.:36/46/82ALC4/2011

Party Name:ALTA LABORATORIES LTD. 05.06.2012 Stat App HQ File :01/82/050/01252/AM12/ RLA File :03/94/040/00826/AM12/ Lic.No/Date:0310675431 09.01.2012 Defe Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/37/2012Ch.II dated 25.05.2012 and in consultation with the technical authorities 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 Propyl Paraben 1 kg 1. Para Hydroxy Benzoic Acid 0.850 kg 2. NPropanol 0.500 kg 153

Case No.:37/46/82ALC4/2011

Party Name:ALTA LABORATORIES LTD. 05.06.2012 Status Case A HQ File :01/82/050/01253/AM12/ RLA File :03/94/040/00825/AM12/ Lic.No/Date:0310675410 09.01.2012 Defer D Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/37/2012Ch.II dated 25.05.2012 and in consultation with the technical authorities present Export product Exp. Qty. Sl.No. Import items Qty. allowed Methyl Praben 1 kg 1. Para Hydroxy Benzoic Acid 0.969 kg 2. Methanol 0.500 kg 154

Case No.:36/1/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 05.06.2012 HQ File :01/82/050/01478/AM12/ RLA File :09/24/040/00489/AM12/ Lic.No/Date:0910050751 12.01.2012 155

Case No.:52/1/82ALC4/2012

Party Name:HETERO LABS LIMITED 05.06.2012 HQ File :01/82/050/01494/AM12/ RLA File :09/24/040/00461/AM12/ Lic.No/Date:0910050752 12.01.2012 156

Case No.:18/1/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01460/AM12/ RLA File :09/24/040/00493/AM12/ Lic.No/Date:0910050772 13.01.2012 157

Case No.:65/1/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 05.06.2012 HQ File :01/82/050/01507/AM12/ RLA File :09/24/040/00483/AM12/ Lic.No/Date:0910050770 13.01.2012 Defer Date: 03.07.2012 158

Case No.:69/1/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 05.06.2012 HQ File :01/82/050/01511/AM12/ RLA File :09/24/040/00496/AM12/ Lic.No/Date:0910050771 13.01.2012

159

Case No.:17/49/82ALC4/2011

Party Name:AARTI DRUGS LIMITED 05.06.2012 Status:Cas HQ File :01/82/050/01326/AM12/ RLA File :03/94/040/00823/AM12/ Lic.No/Date:0310677093 17.01.2012 Defer Date Decision : Committee considered case as per agenda and in light of earlier decision taken in 39/09 meeting held on 02.12.2008, Case No. B417 and in consultation with technical authority present in meeting, decided to ratify norms o 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 Diclofenac Sodium 1 kg. 1. Acetic Acid 1.250 kg 2. Methanol 1.00 kg 3. 2,6 Dichlorophenol 1.521 kg 4. Toluene 1.995 kg 5. Potassium Carbonate 1.00 kg 6. Aniline 1.198 kg 7. Sodium Methoxide 0.795 kg 8. Sodium Hydroxide Flakes 0.285 kg 9. Isopropyl Alcohol 2.04 kg 10. Dimethyl formamide 0.469 kg 160

Case No.:21/1/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01463/AM12/ RLA File :09/24/040/00447/AM12/ Lic.No/Date:0910050799 17.01.2012 161

Case No.:66/1/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 05.06.2012 HQ File :01/82/050/01508/AM12/ RLA File :09/24/040/00479/AM12/ Lic.No/Date:0910050800 17.01.2012 162

Case No.:84/46/82ALC4/2011

Party Name:TRANSPEK INDUSTRY LIMITED 05.06.2012 HQ File :01/82/050/01300/AM12/ RLA File :34/24/040/00220/AM12/ Lic.No/Date:3410032968 17.01.2012 Decision : In the light of written comments for Department of C&PC received vide their OM No.14010/6/2011Ch.II dated 14.05.2012, it was decided to call from the firm the following information: 4. Complete material balance with the formation of isomers. 5. Stagewise % yield on molecular weight basis alongwith justification suppoted with authentic/printed technical literature 6. Production of export item for the past 3 years and corresponding consumption of each input duly certified by CA. 7. Detail of isomers/byproducts recovered in terms of quantity and value 8. Complete specification of export item. Accordingly, case was deferred for 03.07.2012. 163

Case No.:11/49/82ALC4/2011

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 05.06.2012 HQ File :01/82/050/01320/AM12/ RLA File :04/24/040/00280/AM12/ Lic.No/Date:0410132899 18.01.2012

164

Case No.:39/1/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 05.06.2012 HQ File :01/82/050/01481/AM12/ RLA File :09/24/040/00505/AM12/ Lic.No/Date:0910050872 19.01.2012 165

Case No.:44/49/82ALC4/2011

Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 05.06.2012 HQ File :01/82/050/01353/AM12/ RLA File :03/94/040/00911/AM12/ Lic.No/Date:0310677527 19.01.2012 166

Case No.:45/1/82ALC4/2012

Party Name:SMILAX LABORATORIES LIMITED 05.06.2012 HQ File :01/82/050/01487/AM12/ RLA File :09/24/040/00474/AM12/ Lic.No/Date:0910050867 19.01.2012 167

Case No.:70/1/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 05.06.2012 HQ File :01/82/050/01512/AM12/ RLA File :09/24/040/00504/AM12/ Lic.No/Date:0910050873 19.01.2012 168

Case No.:25/49/82ALC4/2011

05.06.2012 HQ File :01/82/050/01334/AM12/ RLA File :03/94/040/00925/AM12/ Lic.No/Date:0310677829 20.01.2012 169

Case No.:73/49/82ALC4/2011

Party Name:DAIICHI KARKARIA LIMITED 05.06.2012 HQ File :01/82/050/01382/AM12/ RLA File :03/94/040/00905/AM12/ Lic.No/Date:0310677824 20.01.2012 170

Case No.:78/49/82ALC4/2011

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 05.06.2012 Status:Case Approv HQ File :01/82/050/01387/AM12/ RLA File :07/24/040/00416/AM12/ Lic.No/Date:0710085722 20.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/56/2011ChII (Norms) dated 23.05.2012 and in consultation with technical autho Export product Exp. Qty. Import items Qty. allowed Calcium Lactate Gluconate 1 kg . Lactic Acid Calcium Gluconate Oral Grade Calcium Carbonate 0.560 kg 0.686 kg 0.310 kg Ferrous Gluconate 1kg Lactic Acid 1.028 kg Magnesium 1 kg Lactic Acid 1.19 kg

Lactate Zinc Lactate 1 kg Lactic Acid 0.990 kg Magnesium Lactate Gluconate 1 kg Lactic Acid 0.390 kg 171

Case No.:14/49/82ALC4/2011

Party Name:VD.H. ORGANICS PVT. LTD 05.06.2012 Status:Case Ap HQ File :01/82/050/01323/AM12/ RLA File :05/24/040/00374/AM12/ Lic.No/Date:0510315475 24.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/28/2012 CH_II dated 4.6.2012 and in consultation with the technical authorities 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 Thymol (Above 98.5% Pure) 1 kg 1. Meta Cresol (above 98.5% pure) 0.785 kg 172

Case No.:23/49/82ALC4/2011

Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 05.06.2012 HQ File :01/82/050/01332/AM12/ RLA File :03/95/040/00884/AM12/ Lic.No/Date:0310678434 24.01.2012 173

Case No.:2/1/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01444/AM12/ RLA File :09/24/040/00511/AM12/ Lic.No/Date:0910050974 25.01.2012 174

Case No.:52/49/82ALC4/2011

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 05.06.2012 HQ File :01/82/050/01361/AM12/ RLA File :08/24/040/00239/AM12/ Lic.No/Date:0810108117 25.01.2012 175

Case No.:79/49/82ALC4/2011

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 05.06.2012 HQ File :01/82/050/01388/AM12/ RLA File :07/24/040/00425/AM12/ Lic.No/Date:0710085812 25.01.2012 Defer Date: 03.07.2012 Decision : : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals 176

Case No.:2/45/82ALC4/2011

Party Name:FDC LTD 05.06.2012 HQ File :01/82/050/01179/AM12/ RLA File :03/94/040/00938/AM12/ Lic.No/Date:0310678976 27.01.2012 177

Case No.:24/49/82ALC4/2011

Party Name:AARTI DRUGS LIMITED 05.06.2012

HQ File :01/82/050/01333/AM12/ RLA File :03/94/040/00882/AM12/ Lic.No/Date:0310678942 27.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 34/82 meeting held on 06.07.2010 and in consultation with technical authority present in meeting decided to ratify norms on repeat ba 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 Ticlopidine Hcl 1 kg. 1. Thiophene2ethanol 0.72 kg 2. Toluene 1.61 kg 3. Tri ethyl amine 0.25 kg 4. Benzene Sulphonyl chloride 0.99 kg 5. Sodium Hydroxide Flakes 0.747 kg 6. Ortho chloro benzyl amine 0.80 kg 7. Acetone 0.22 kg 8. IPA 0.85 kg 9. Methanol 0.90 kg 10. Paraformaldehyde 0.300 kg 178

Case No.:39/49/82ALC4/2011

Party Name:AMI LIFESCIENCES P LTD 05.06.2012 HQ File :01/82/050/01348/AM12/ RLA File :34/24/040/00226/AM12/ Lic.No/Date:3410033054 27.01.2012 179

Case No.:42/49/82ALC4/2011

05.06.2012 HQ File :01/82/050/01351/AM12/ RLA File :08/24/040/00236/AM12/ Lic.No/Date:0810108169 27.01.2012 180

Case No.:56/49/82ALC4/2011

Party Name:IPCA LABORATORIES LIMITED 05.06.2012 HQ File :01/82/050/01365/AM12/ RLA File :03/94/040/00927/AM12/ Lic.No/Date:0310678993 27.01.2012 181

Case No.:42/1/82ALC4/2012

Party Name:RASULA PHARMACEUTICALS & FINE CHEMICALS 05.06.2012 HQ File :01/82/050/01484/AM12/ RLA File :09/24/040/00426/AM12/ Lic.No/Date:0910051005 30.01.2012 182

Case No.:20/49/82ALC4/2011

Party Name:SANDOZ PRIVATE LIMITED 05.06.2012 Status:Case Approv HQ File :01/82/050/01329/AM12/ RLA File :03/95/04 0/00897/AM12/ Lic.No/Date:0310679524 31.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt Pharmaceuticals vide their O.M..No. 35011/61/2012 PI (Norms) dated 13.06.2012 and in consultation with the tech 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 Quetiapine Fumarate 1 kg 1. Dibenzo(B,F) (1,4) Thiazepine11(10H) one) 0.58 kg

1(2(2Hydroxy Ethoxy) Ethul) Piperazine 0.714 kg 3. Ethyl Alcohol 2.46 kg 183

Case No.:32/46/82ALC4/2011

05.06.2012 HQ File :01/82/050/01248/AM12/ RLA File :03/94/040/00942/AM12/ Lic.No/Date:0310679417 31.01.2012 184

Case No.:47/46/82ALC4/2011

05.06.2012 HQ File :01/82/050/01263/AM12/ RLA File :03/94/040/00943/AM12/ Lic.No/Date:0310679893 02.02.2012 Decision : 185

Case No.:66/49/82ALC4/2011

05.06.2012 HQ File :01/82/050/01375/AM12/ RLA File :08/24/040/00259/AM12/ Lic.No/Date:0810108376 03.02.2012 186

Case No.:8/1/82ALC4/2012

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 05.06.2012 HQ File :01/82/050/01450/AM12/ RLA File :09/24/040/00513/AM12/ Lic.No/Date:0910051113 03.02.2012 187

Case No.:26/1/82ALC4/2012

Party Name:METROCHEM API PVT. LTD. 05.06.2012 HQ File :01/82/050/01468/AM12/ RLA File :09/24/040/00480/AM12/ Lic.No/Date:0910051119 06.02.2012 188

Case No.:34/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01476/AM12/ RLA File :08/24/040/00238/AM12/ Lic.No/Date:0810108441 06.02.2012 189

Case No.:41/49/82ALC4/2011

05.06.2012 HQ File :01/82/050/01350/AM12/ RLA File :08/24/040/00244/AM12/ Lic.No/Date:0810108442 06.02.2012 190

Case No.:49/46/82ALC4/2011

Party Name:SV PLASTOCHEM PVT.LTD. 05.06.2012 HQ File :01/82/050/01265/AM12/ RLA File :31/24/040/00030/AM11/ Lic.No/Date:3110052741

06.02.2012 Decision : In the light of written comments for Department of C&PC received vide their OM No.14010/41/2012Ch.II dated 02.05.2012, it was decided to call from the firm the following information: 1. Details of manufacturing process with chemical equations, molecular formulas and molecular weights 2. Yield obtained in each step supported with authentic technical literature. 3. Quantity of solvents charged, recovered and loss in process for per kg of export item along with justification. Accordingly, case was deferred for 03.07.2012. 191

Case No.:59/49/82ALC4/2011

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 05.06.2012 Status:Case Appr HQ File :01/82/050/01368/AM12/ RLA File :03/94/040/00939/AM12/ Lic.No/Date:0310680393 06.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments received from Department of C&PC vide their OM No.14010/20/2012Ch.II dated 05.06.2012 and in consultation with the technical author 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 ASTROLIDE (DEP/IPM/BB (Astrolide in Diethyl Phthalate/ IsopropylMyristate/Benzyl Benzoate Astrolide content 62.5% min ) 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 3. Alpha Methyl Styrene 0.500 kg 4. Paraformaldehyde 0.088 kg 192

Case No.:71/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01513/AM12/ RLA File :08/24/040/00235/AM12/ Lic.No/Date:0810108440 06.02.2012 193

Case No.:12/49/82ALC4/2011

Party Name:AMI LIFESCIENCES P LTD 05.06.2012 HQ File :01/82/050/01321/AM12/ RLA File :34/24/040/00237/AM12/ Lic.No/Date:3410033146 07.02.2012 194

Case No.:29/1/82ALC4/2012

Party Name:HETERO DRUGS LIMITED, 05.06.2012 HQ File :01/82/050/01471/AM12/ RLA File :09/24/040/00546/AM12/ Lic.No/Date:0910051150 07.02.2012 195

Case No.:18/49/82ALC4/2011

Party Name:ASCENT FINECHEM PVT. LTD., 05.06.2012 Status:Case Appr HQ File :01/82/050/01327/AM12/ RLA File :08/24/040/00265/AM12/ Lic.No/Date:0810108613 08.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/2012ChII dated 30.05.2012 and in consultation with technical authority present in me ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Import items Qty. allowed 4Methoxy Phenyl Acotonitrile/Anisyl Cyanide/4Methoxy Benzyl Cyanide 1 kg . Para Cresol 1.469 kg

Colourless to Pale Yellow liquid Sodium Cyanide 0.410 kg Para Methoxyphenyl Acetic Acid (White Powder) 1kg Para Cresol (Clear colourless liquid) 1.501 kg 196

Case No.:50/49/82ALC4/2011

Party Name:ALEMBIC PHARMACEUTICALS LTD 05.06.2012 HQ File :01/82/050/01359/AM12/ RLA File :34/24/040/00239/AM12/ Lic.No/Date:3410033158 08.02.2012 197

Case No.:51/46/82ALC4/2011

Party Name:RELIANCE INDUSTRIES LTD. 05.06.2012 HQ File :01/82/050/01267/AM12/ RLA File :03/95/040/00867/AM12/ Lic.No/Date:0310680799 08.02.2012 198

Case No.:43/1/82ALC4/2012

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 05.06.2012 HQ File :01/82/050/01485/AM12/ RLA File :09/24/040/00540/AM12/ Lic.No/Date:0910051179 09.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/34//2011ChII dated 30.05.2012 and in consultation with technical authority present in me 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. Import items Qty. allowed Diazolidinyl Urea 1 kg . Diazolidinyl Urea Technical Grade) 1.03 kg 199

Case No.:48/1/82ALC4/2012

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 05.06.2012 HQ File :01/82/050/01490/AM12/ RLA File :09/24/040/00541/AM12/ Lic.No/Date:0910051180 09.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/34//2011ChII dated 30.05.2012 and in consultation with technical authority prese Export product Exp. Qty. Import items Qty. allowed Imidazolidinyl Urea 1 kg . Imidazolidinyl Urea (Technical Grade) 1.03 kg 200

Case No.:5/1/82ALC4/2012

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 05.06.2012 HQ File :01/82/050/01447/AM12/ RLA File :03/94/040/00985/AM12/ Lic.No/Date:0310681094 09.02.2012 Defer Date: Decision : Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their OM No.14010/20/2012Ch.II dated 05.06.2012 and in consultation with the technical au 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

ASTROLIDE (DEP/IPM/BB (Astrolide in Diethyl Phthalate/ IsopropylMyristate/Benzyl Benzoate Astrolide content 62.5% min ) 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 3. Alpha Methyl Styrene 0.500 kg 4. Paraformaldehyde 0.088 kg 201

Case No.:33/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01475/AM12/ RLA File :08/24/040/00269/AM12/ Lic.No/Date:0810108704 10.02.2012 202

Case No.:40/1/82ALC4/2012

Party Name:MEDREICH LIMITED 05.06.2012 HQ File :01/82/050/01482/AM12/ RLA File :07/24/040/00455/AM12/ Lic.No/Date:0710086215 10.02.2012 203

Case No.:15/1/82ALC4/2012

Party Name:CIPLA LIMITED 05.06.2012 HQ File :01/82/050/01457/AM12/ RLA File :03/94/040/01006/AM12/ Lic.No/Date:0310681617 13.02.2012 204

Case No.:63/1/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 05.06.2012 HQ File :01/82/050/01505/AM12/ RLA File :03/94/040/00965/AM12/ Lic.No/Date:0310681706 13.02.2012 205

Case No.:7/1/82ALC4/2012

Party Name:HETERO LABS LIMITED 05.06.2012 HQ File :01/82/050/01449/AM12/ RLA File :09/24/040/00562/AM12/ Lic.No/Date:0910051229 13.02.2012 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals.. 206

Case No.:11/1/82ALC4/2012

Party Name:AARTI INDUSTRIES LIMITED 05.06.2012 HQ File :01/82/050/01453/AM12/ RLA File :03/94/040/00982/AM12/ Lic.No/Date:0310681772 14.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/137//2011ChII dated 12.06.2012 and in consultation with technical authority present in m 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. Import items Qty. allowed 3,5 Dichloro Nitro Benzene 1 kg . Para Nitro Aniline Sodium 0.910 kg 0.393 kg

207

Case No.:12/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01454/AM12/ RLA File :03/94/040/00984/AM12/ Lic.No/Date:0310681831 14.02.2012 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals.. 208

Case No.:16/1/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 05.06.2012 HQ File :01/82/050/01458/AM12/ RLA File :09/24/040/00526/AM12/ Lic.No/Date:0910051248 14.02.2012 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of Pharmaceuticals.. 209

Case No.:27/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01469/AM12/ RLA File :03/94/040/00983/AM12/ Lic.No/Date:0310681784 14.02.2012 210

Case No.:38/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01480/AM12/ RLA File :03/94/040/00992/AM12/ Lic.No/Date:0310681860 14.02.2012 211

Case No.:55/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01497/AM12/ RLA File :03/94/040/00996/AM12/ Lic.No/Date:0310681891 14.02.2012 212

Case No.:56/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01498/AM12/ RLA File :03/94/040/00991/AM12/ Lic.No/Date:0310681844 14.02.2012 213

Case No.:57/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01499/AM12/ RLA File :03/94/040/00995/AM12/ Lic.No/Date:0310681873 14.02.2012 214

Case No.:49/1/82ALC4/2012

Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 05.06.2012 HQ File :01/82/050/01491/AM12/ RLA File :03/94/040/00757/AM12/ Lic.No/Date:0310682083 15.02.2012 215

Case No.:67/1/82ALC4/2012

Party Name:CHEMSPEC CHEMICALS PVT LTD 05.06.2012 HQ File :01/82/050/01509/AM12/ RLA File :03/94/040/01007/AM12/ Lic.No/Date:0310682171 15.02.2012

216

Case No.:35/1/82ALC4/2012

Party Name:SPECTRUM LIFE SCIENCES PRIVATE LIMITED Meet No/Date:10/82ALC4/2012 05.06.2012 HQ File :01/82/050/01477/AM12/ RLA File :04/24/040/00309/AM12/ Lic.No/Date:0410133868 16.02.2012 217

Case No.:6/2/82ALC4/2012

Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED 05.06.2012 Status:Case Approv HQ File :01/82/050/01523/AM12/ RLA File :04/24/040/00281/AM12/ Lic.No/Date:0410133867 16.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/34//2012ChII dated 07.05.2012 and in consultation with technical authority prese Export product Exp. Qty. Import items Qty. allowed Tertiary Butyl Peroxy Benzorate 98% 1 kg . 1. Benzoyl Chloride 0.765 kg 2.Tertiary Butyl Hydro Peroxide 70% 0.720 kg 218

Case No.:26/49/82ALC4/2011

Party Name:MAGBRO HEALTHCARE PVT.LTD. 05.06.2012 Status:Case A HQ File :01/82/050/01335/AM12/ RLA File :30/24/040/00070/AM12/ Lic.No/Date:3010083707 17.02.2012 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 v1 as per SION A412 with 2 % wastage. 219

Case No.:28/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01470/AM12/ RLA File :03/94/040/01016/AM12/ Lic.No/Date:0310682483 17.02.2012 220

Case No.:31/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01473/AM12/ RLA File :03/94/040/01011/AM12/ Lic.No/Date:0310682526 17.02.2012 221

Case No.:32/1/82ALC4/2012

Party Name:AARTI INDUSTRIES LIMITED 05.06.2012 Status:Case Ap HQ File :01/82/050/01474/AM12/ RLA File :03/94/040/00981/AM12/ Lic.No/Date:0310682472 17.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/137//2011ChII dated 12.06.2012 and in consultation with technical authority prese Export product Exp. Qty. Import items Qty. allowed 3,5 Dichloro Aniline 1 kg . Para Nitro Aniline 1.18 kg

Sodium Nitrite 0.520s kg 222

Case No.:64/1/82ALC4/2012

05.06.2012 HQ File :01/82/050/01506/AM12/ RLA File :03/94/040/01012/AM12/ Lic.No/Date:0310682484 17.02.2012 223

Case No.:30/1/82ALC4/2012

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 05.06.2012 Status:Case Approve HQ File :01/82/050/01472/AM12/ RLA File :04/24/040/00278/AM12/ Lic.No/Date:0410133977 21.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of Pharmaceuticals vide O.M No. 35011/33/2012PI (Norms) and in consultation with technical authority present in meeting 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 SOFTGELATIN CAPSULES BP/USP (10 MG and 20 MG) 1 No. 1. 2. ISOTRETINOIN BP (10 MG) ISOTRETINOIN USP (20 MG) 10.2 mg 20.4 mg 224

Case No.:51/1/82ALC4/2012

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 05.06.2012 HQ File :01/82/050/01493/AM12/ RLA File :09/24/040/00579/AM12/ Lic.No/Date:0910051360 21.02.2012 225

Case No.:3/49/82ALC4/2011

Party Name:KOPRAN LIMITED 05.06.2012 HQ File :01/82/050/01312/AM12/ RLA File :03/94/040/01022/AM12/ Lic.No/Date:0310683054 22.02.2012 226

Case No.:58/1/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 05.06.2012 HQ File :01/82/050/01500/AM12/ RLA File :09/24/040/00564/AM12/ Lic.No/Date:0910051391 22.02.2012 227

Case No.:5/2/82ALC4/2012

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 05.06.2012 HQ File :01/82/050/01522/AM12/ RLA File :04/24/040/00314/AM12/ Lic.No/Date:0410134051 23.02.2012 228

Case No.:6/49/82ALC4/2011

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 05.06.2012 HQ File :01/82/050/01315/AM12/ RLA File :03/94/040/01010/AM12/ Lic.No/Date:0310683482 24.02.2012

229

Case No.:7/49/82ALC4/2011

Party Name:EMCURE PHARMACEUTICALS LTD. 05.06.2012 HQ File :01/82/050/01316/AM12/ RLA File :31/83/040/00236/AM12/ Lic.No/Date:3110053141 24.02.2012 230

Case No.:8/49/82ALC4/2011

Party Name:YASHO INDUSTRIES PVT.LTD. 05.06.2012 HQ File :01/82/050/01317/AM12/ RLA File :03/95/040/01006/AM12/ Lic.No/Date:0310683642 27.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/95//2011ChII dated 23.05.2012 and in consultation with technical authority present in me 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. Import items Qty. allowed Dimethyl Diphenyl Thiuram Disulfide (MPTD) 1 kg . N Methyl Aniline 0.651 kg 231

Case No.:9/1/82ALC4/2012

Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 05.06.2012 Status:Case Appro HQ File :01/82/050/01451/AM12/ RLA File :52/24/040/00046/AM12/ Lic.No/Date:5210037937 27.02.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/118//2004ChII dated 16.09.2008 and in consultation with technical authority prese Export product Exp. Qty. Import items Qty. allowed 2(3Amino Phenyl Sulfonamide) Naphthalene 6,8 Disulfonic Acid 1 kg . Beta Naphthol 0.875 kg 232

Case No.:60/49/82ALC4/2011

05.06.2012 HQ File :01/82/050/01369/AM12/ RLA File :03/94/040/00125/AM12/ Lic.No/Date:0310683824 29.02.2012 233

Case No.:62/49/82ALC4/2011

Party Name:YASHO INDUSTRIES PVT.LTD. 05.06.2012 HQ File :01/82/050/01371/AM12/ RLA File :03/95/040/01014/AM12/ Lic.No/Date:0310683984 29.02.2012 234

Case No.:63/49/82ALC4/2011

Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 05.06.2012 HQ File :01/82/050/01372/AM12/ RLA File :03/95/040/00967/AM12/ Lic.No/Date:0310683994 29.02.2012 235

Case No.:10/1/82ALC4/2012

Party Name:ANUPAM RASAYAN (INDIA) LTD 05.06.2012

HQ File :01/82/050/01452/AM12/ RLA File :52/24/040/00052/AM12/ Lic.No/Date:5210037972 01.03.2012 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of C&PC. 236

Case No.:24/1/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 05.06.2012 HQ File :01/82/050/01466/AM12/ RLA File :05/23/040/00468/AM12/ Lic.No/Date:0510319139 01.03.2012 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 v1 as per SION A 412 with 2 % wastage. 237

Case No.:3/1/82ALC4/2012

Party Name:CORAL DRUGS PVT. LTD., 05.06.2012 HQ File :01/82/050/01445/AM12/ RLA File :05/23/040/00457/AM12/ Lic.No/Date:0510319267 02.03.2012 238

Case No.:61/1/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 05.06.2012 HQ File :01/82/050/01503/AM12/ RLA File :05/24/040/00429/AM12/ Lic.No/Date:0510319400 02.03.2012 239

Case No.:76/1/82ALC4/2012

Party Name:STERLING AUXILIARIES PVT LTD 05.06.2012 HQ File :01/82/050/01518/AM12/ RLA File :03/95/040/01086/AM12/ Lic.No/Date:0310687507 22.03.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/74//2011ChII dated 29.05.2012 and in consultation with technical authority prese Export product Exp. Qty. Import items Qty. allowed STERO AEEA (M) (Amino Ethyl Ethanol Amine) 1 kg Amino Ethyl Ethanol Amine 0.980 kg 240

Case No.:77/1/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 05.06.2012 HQ File :01/82/050/01519/AM12/ RLA File :03/95/040/00865/AM11/ Lic.No/Date:0310687522 22.03.2012 241

Case No.:78/1/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 05.06.2012 HQ File :01/82/050/01520/AM12/ RLA File :03/95/040/00719/AM12/ Lic.No/Date:0310687530 22.03.2012 242

Case No.:79/1/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 05.06.2012 Status:Case A

HQ File :01/82/050/01521/AM12/ RLA File :03/95/040/01060/AM12/ Lic.No/Date:0310687701 26.03.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/117//2011ChII dated 29.05.2012 and in consultation with technical authority prese Export product Exp. Qty. Import items Qty. allowed 2Bromo Iso Butyric Iso Propyl Ester (2Bromo Isobutyrated Isopropyl / Iso Propyl 2 Bromo Isobutyrate) 1 kg Iso Butyric Acid 0.701 kg Liquid Bromine 1.276 kg Iso Propanol 1.078 kg 243

Case No.:9/2/82ALC4/2012

Party Name:ENALTEC LABS PVT.LTD. 05.06.2012 HQ File :01/82/050/01526/AM12/ RLA File :03/94/040/01166/AM12/ Lic.No/Date:0310688004 27.03.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 49/82 meeting held on 06.03.2012 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Rosuvastatin Calcium 1 kg. 1. (4RCis) 6(Acetyloxy) –Methyl)2,2 Dimethyl1,3Dioxane4Acetic Acid1,1 Dimethylethyl Ester 1.871 kg 2. 4(4Fluorophenyl)6Isopropyl2[(N MethylN Methylsulphonyl)Amino)] Pyrimidine 5YLMethanol 1.871 kg 245

Case No.:1/2/82ALC4/2012

NICHOLAS PIRAMAL) 05.06.2012 HQ File :01/82/050/00001/AM13/ RLA File :03/95/040/00970/AM12/ Lic.No/Date:0310688849 30.03.2012 246

Case No.:10/2/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 05.06.2012 Status:Case Approve HQ File :01/82/050/01527/AM12/ RLA File :03/95/040/01059/AM12/ Lic.No/Date:0310688787 30.03.2012 Defer Date: Decision : Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/117//2011ChII dated 29.05.2012 and in consultation with technical a Export product Exp. Qty. Import items Qty. allowed 2Bromo Iso Butyric Iso Propyl Ester (2Bromo Isobutyrated Isopropyl / Iso Propyl 2 Bromo Isobutyrate) 1 kg Iso Butyric Acid 0.701 kg Liquid Bromine 1.276 kg Iso Propanol 1.078 kg 247

Case No.:2/2/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 05.06.2012 HQ File :01/82/050/00002/AM13/ RLA File :03/95/040/01032/AM12/ Lic.No/Date:0310688856 30.03.2012

248

Case No.:3/2/82ALC4/2012

NICHOLAS PIRAMAL) 05.06.2012 HQ File :01/82/050/00003/AM13/ RLA File :03/95/040/01037/AM12/ Lic.No/Date:0310688874 30.03.2012 249

Case No.:4/2/82ALC4/2012

Party Name:WOCKHARDT LIMITED 05.06.2012 HQ File :01/82/050/00004/AM13/ RLA File :03/95/040/01085/AM12/ Lic.No/Date:0310689242 02.04.2012 250

Case No.:19/9/82ALC4/2012

NICHOLAS PIRAMAL) 05.06.2012 HQ File :01/82/050/00264/AM13/ RLA File :03/95/040/00963/AM12/ Lic.No/Date:0310690704 13.04.2012 251

Case No.:1/5/82ALC4/2012

Party Name:MITHILA RASAYAN PVT.LTD., 05.06.2012 Status:Cas HQ File :01/82/050/00173/AM13/ RLA File :03/95/040/00020/AM13/ Lic.No/Date:0310691303 19.04.2012 Defer Date Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/44//2011ChII dated 23.05.2012 and in consultation with technical authority present in m ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Import items Qty. allowed Anisole 1 kg Anisole Crude 1.207 kg 252

Case No.:2/5/82ALC4/2012

Party Name:TITAN LABORATORIES PVT. LTD. 05.06.2012 HQ File :01/82/050/00174/AM13/ RLA File :03/95/040/00048/AM13/ Lic.No/Date:0310691572 20.04.2012 253

Case No.:6/5/82ALC4/2012

Party Name:THERMAX LTD., 05.06.2012 HQ File :01/82/050/00178/AM13/ RLA File :31/83/040/00252/AM12/ Lic.No/Date:3110053908 24.04.2012 254

Case No.:1/6/82ALC4/2012

Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 05.06.2012 HQ File :01/82/050/00179/AM13/ RLA File :03/94/040/00055/AM13/ Lic.No/Date:0310692273 26.04.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 23/82 meeting held on 06.09.2011 and in consultation with technical authority present in meeting, decided to ratify norms on repeat bas of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanamycin Acid Sulphate for Injectin BP 1 gm, Vial 1 Vial 1. Kanamycin Acid Sulphate BP 1.39 gm

Size 10 ml 255

Case No.:3/6/82ALC4/2012

Party Name:ROYAL PHARMA 05.06.2012 HQ File :01/82/050/00181/AM13/ RLA File :03/95/040/00056/AM13/ Lic.No/Date:0310692521 27.04.2012 256

Case No.:4/6/82ALC4/2012

Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. 05.06.2012 HQ File :01/82/050/00182/AM13/ RLA File :03/94/040/00019/AM13/ Lic.No/Date:0310692539 27.04.2012 257

Case No.:6/6/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 05.06.2012 HQ File :01/82/050/00184/AM13/ RLA File :31/83/040/00262/AM12/ Lic.No/Date:3110053954 30.04.2012 Decision : : Committee decided to defer case for 03.07.2012 for comments of Deptt. of C&PC. 258

Case No.:5/9/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 05.06.2012 Status:Case HQ File :01/82/050/00250/AM13/ RLA File :31/83/040/00002/AM13/ Lic.No/Date:3110054157 10.05.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 6/82 meeting held on .08.05.2012 and in consultation with technical authority present in meeting, decided to ratify norms on repeat bas of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed NMethyl2Pyrrolidone 1 Kg 1. Methanol 0.377 kg 2. Ammonia 0.164 kg 3. 1,4 Butanediol 1.01 kg 4. Methylamine Catalyst 0.00080 kg 5. GBL Catalyst 0.00075 kg 259

Case No.:6/9/82ALC4/2012

Party Name:DEEPAK NITRITE LIMITED 05.06.2012 HQ File :01/82/050/00251/AM13/ RLA File :31/83/040/00018/AM13/ Lic.No/Date:3110054170 10.05.2012 260

Case No.:7/9/82ALC4/2012

Party Name:RELIANCE INDUSTRIES LTD. 05.06.2012 HQ File :01/82/050/00252/AM13/ RLA File :03/95/040/00013/AM13/ Lic.No/Date:0310694105 10.05.2012

261

Case No.:8/9/82ALC4/2012

Party Name:RELIANCE INDUSTRIES LTD. 05.06.2012 HQ File :01/82/050/00253/AM13/ RLA File :03/95/040/00067/AM13/ Lic.No/Date:0310694114 10.05.2012 262

Case No.:9/9/82ALC4/2012

Party Name:FINE ORGANIC INDUSTRIES, 05.06.2012 HQ File :01/82/050/00254/AM13/ RLA File :03/94/040/00041/AM13/ Lic.No/Date:0310694405 11.05.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 46/82 meeting held on .15.02.2011 and in consultation with technical authority present in meeting decided to ratify norms on repeat b 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 Neutralized Amide Ester (Ethanol Amide Stearate) 1 Kg 1. Stearic Acid 1.064 kg 2. Mono Ethanol Amine 0.114 kg 263

Case No.:10/9/82ALC4/2012

NICHOLAS PIRAMAL) 05.06.2012 HQ File :01/82/050/00255/AM13/ RLA File :03/95/040/00094/AM13/ Lic.No/Date:0310694706 15.05.2012 Decision : In the light of written comments of Department of Pharmaceuticals received vide their OM No.35011/68/2012PI (Norms) dated 13.06.2012, it was decided to call from the firm the following information: 1. Copy of Drug Manufacturing Licence alongwith list of approved items and approved composition of export product. 2. Copy of Master Batch formula duly certified by Quality – Control Incharge. Accordingly, case was deferred for 03.07.2012. 264

Case No.:11/9/82ALC4/2012

NICHOLAS PIRAMAL) 05.06.2012 HQ File :01/82/050/00256/AM13/ RLA File :03/95/040/00093/AM13/ Lic.No/Date:0310694735 15.05.2012 Decision : In the light of written comments of Department of Pharmaceuticals received vide their OM No.35011/68/2012PI (Norms) dated 13.06.2012, it was decided to call from the firm the following information: 1. Copy of Drug Manufacturing Licence alongwith list of approved items and approved composition of export product. 2. Copy of Master Batch formula duly certified by Quality – Control Incharge. Accordingly, case was deferred for 03.07.2012. 265

Case No.:12/9/82ALC4/2012

Party Name:KEDIA ORGANIC CHEMICALS PVT.LTD. 05.06.2012 HQ File :01/82/050/00257/AM13/ RLA File :03/94/040/00085/AM13/ Lic.No/Date:0310694811 16.05.2012 Decision : Committee decided to defer case for 03.07.2012 for comments of Deptt. of C & PC. 266

Case No.:13/9/82ALC4/2012

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 05.06.2012 Status:Case Approv HQ File :01/82/050/00258/AM13/ RLA File :31/83/040/00017/AM13/ Lic.No/Date:3110054300 16.05.2012 Defer Date:

Decision : Committee considered case as per agenda and in light of earlier decision taken in 37/82 meeting held 13.12.2011 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis und of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,6 Xylidine 1 kg. 1. 2,6 Xylenol 1.946 kg 267

Case No.:14/9/82ALC4/2012

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 05.06.2012 HQ File :01/82/050/00259/AM13/ RLA File :03/95/040/01114/AM12/ Lic.No/Date:0310694910 16.05.2012 268

Case No.:15/9/82ALC4/2012

NICHOLAS PIRAMAL) 05.06.2012 HQ File :01/82/050/00260/AM13/ RLA File :03/95/040/00089/AM13/ Lic.No/Date:0310694925 16.05.2012 Decision : In the light of written comments of Department of Pharmaceuticals received vide their OM No.35011/68/2012PI (Norms) dated 13.06.2012, it was decided to call from the firm the following information: 1. Copy of Drug Manufacturing Licence alongwith list of approved items and approved composition of export product. 2. Copy of Master Batch formula duly certified by Quality – Control Incharge. Accordingly, case was deferred for 03.07.2012. 269

Case No.:16/9/82ALC4/2012

NICHOLAS PIRAMAL) 05.06.2012 HQ File :01/82/050/00261/AM13/ RLA File :03/95/040/00090/AM13/ Lic.No/Date:0310694936 16.05.2012 Decision : In the light of written comments of Department of Pharmaceuticals received vide their OM No.35011/68/2012PI (Norms) dated 13.06.2012, it was decided to call from the firm the following information: 1 Copy of Drug Manufacturing Licence alongwith list of approved items and approved composition of export product. 2 Copy of Master Batch formula duly certified by Quality – Control Incharge. Accordingly, case was deferred for 03.07.2012. 270

Case No.:17/9/82ALC4/2012

Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. 05.06.2012 HQ File :01/82/050/00262/AM13/ RLA File :03/94/040/00004/AM13/ Lic.No/Date:0310695086 17.05.2012 271

Case No.:18/9/82ALC4/2012

Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 05.06.2012 HQ File :01/82/050/00263/AM13/ RLA File :03/94/040/00111/AM13/ Lic.No/Date:0310695465 21.05.2012 272

Case No.:20/9/82ALC4/2012

Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 05.06.2012 Status:Case Approv HQ File :01/82/050/00265/AM13/ RLA File :31/83/040/00030/AM13/ Lic.No/Date:3110054374 22.05.2012 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Deptt of C&PC vide their U.O.No. 14010/3/2012ChII dated 05.03.2012 and in consultation with technical authority present in me 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. Import items Qty. allowed Mono Methyl Ether of Hydroquinone – MEHQ 99.0% purity 1 kg Phenoxy methane anisole Purity 93% Minimum 1.31 kg

Hydrogen Peroxide (50%) Purity 50% 0.825 kg Acetone (Solvent) Purity 99% & above 0.270 kg 273

Case No.:21/9/82ALC4/2012

Party Name:EMCURE PHARMACEUTICALS LTD. 05.06.2012 HQ File :01/82/050/00266/AM13/ RLA File :31/83/040/00026/AM13/ Lic.No/Date:3110054379 22.05.2012 274

Case No.:22/9/82ALC4/2012

Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 05.06.2012 HQ File :01/82/050/00267/AM13/ RLA File :03/95/040/00052/AM13/ Lic.No/Date:0310695632 22.05.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 6/82 meeting held 08.05.2012 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Quantity S.No Import Product Quantity Allowed Trimethylsilyl Trifluoromethanesulfonate (CAS#276077778 ) 1 kg 1 Triflic Acid (Trifluoromethane sulfonic acid) 0.892 kg Trifluoro Methane Sulphonic Anhydride (Triflic Anhydride) (CAS#258236) 1 kg 1 Triflic Acid (Trifluoromethane sulfonic acid) 0.442 kg RA may take appropriate action as per the decision of Norms Committee Date: Place:New Delhi Lalita Maini Foreign Trade Development Officer

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