IN FORCE Norms Committee — Engineering (Gr B / NC-I) Advance Authorisation 2008-04-01

DGFT Committee Minutes

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Directorate General of Foreign Trade Ministry of Commerce & Industry, Maulana Azad Road, Udyog Bhawan New Delhi ‐110011 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Para 4.7 Decision

MEETING NUMBER : 1/82‐ALC4/2008 MEETING DATE : 01.04.2008 The Meeting No.47/08 for the licensing year 2007‐08 to consider the cases under Duty Exemption Scheme (Chapter‐4) of Foreign Trade Policy, 2004‐09 pertaining to Pharma Products was held on 01.04.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi. Following members were present in meeting. 1. Shri Jasbir Singh, IA, Chemical Divisision, C&PC. 2. Shri Shaish Kumar, IA, DIPP. 3. Shri D.N. Mathur, Dy. IA, PI Division, C&PC. 4. Dr. Arun Kumar, AD, Dep. of MSME 5. Shri Rajinder Pal Singh, DDG.

Case No.B‐1

M/S Biological E Ltd. Norms Committee Meeting No.1/09 F.No.01/82/50/1860/AM07 Meeting Date:01.04.2008 RLA F.No.09/24/040/481/AM07 Adv.Lic.No.0910029748 dated 23.03.2007 Committee considered case as per agenda for revision of norms for export product Noscapine Hcl under para 4.7 of HBP. Committee decided to call from firm a copy of specification of import item from foreign supplier in respect of this licence, alongwith copy of Bill of Entry. Accordingly, case was deferred for six weeks.

Case No.B‐2

M/S Aar奱� Drugs Ltd F.No.01/83/50/170/AM08 RLA F.No.03/94/040/41/AM08 Adv.Lic.No.0310427432 dated 20.04.2007 Committee considered case as per agenda for correction in the quantity of item No.4 namely Eimethylamine Hcl.

Committee in consultation with representative of PI Division present in meeting decided to allow amendment in the quantity of item No.4 namely Dimethylamine Hcl to read as “0.60 kg/kg”. RA concerned may take further necessary as per above decision of NC.

Case No.B‐3

M/S Divis Labs Ltd. F.No.01/82/50/56/AM07 RLA F.No.09/24/040/182/AM01 Adv.Lic.No.0910019924 dated 30.08.2004 Committee considered case as per agenda for revision of norms for export product Capecitabine Committee observed that in its 32/08 meeting held on 11.12.2007, following norms were fixed:‐ Export product: Capecitabine‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐1kg. Import items: 1. D‐Ribose‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐8.57kg/kg 2. 2,2 Dimethoxy Propane‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐11.88kg/kg 3. Methanol‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐11.61kg/kg 4. 4‐amino‐5‐fluoro‐2‐hydroxy pyrimidine‐‐‐‐Not required in process. Hence not allowed. 5. Sodium Boro hydride‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.75kg/kg 6. P‐toluene sulfonyl chloride‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐6.53kg/kg Representative of PI Division present in meeting informed Committee that earlier firm had not submitted Process Chart for import of 4th item namely 4‐amino‐5‐fluoro‐2‐hydroxy pyrimidine. The firm has submitted the process chart now. Committee, therefore, in consultation with representative of PI Division decided to allow import of 4th item as per details below or as applied by firm whichever is lower:‐ 4‐amino‐5‐fluoro‐2‐hydroxy pyrimidine‐‐‐‐‐‐‐‐‐1.47kg/kg RA concerned may take further necessary action as per above decision of NC.

Case No.B‐4

M/S Shilpa Medicare Ltd. F.No.01/83/50/1418/AM08 RLA F.No.07/24/040/420/AM08 Adv.Lic.No.0710054000 dated 30.08.2004 Committee considered case as per agenda for revision of norms for export product 3A 7B Dioxy Cholanic Acid under para 4.7 of HBP. Committee decided to hand over file to representative of Department of MSME for his comments. Accordingly, case was deferred for four weeks.

Case No.A‐1

M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/50/321/AM08 RLA F.No.03/94/040/989/AM08 Adv.Lic.No.0310455413 dated 27.12.2007 Committee considered case as per agenda for ratification of norms for export product Atovaquone Committee decided to defer case for four weeks for comments of PI Division.

Case No.A‐2

M/S Codexis Laboratories India Pvt. Ltd. F.No.01/82/50/290/AM08 RLA F.No.05/24/040/660/AM08 Adv.Lic.No.0510212818 dated 30.11.2007 Committee considered case as per agenda for ratification of norms for export product (4R‐CIS)‐1,1‐ Dimethylethyl‐6‐Cyanomethyl‐2,2‐Dimethyl‐1‐3‐Dioxane‐4‐Acetate (ATS‐8) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/20/2007‐ PI‐III dated 24.03.2008 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 Sl No Import items Qty allowed per

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (4‐R‐Cis)‐1,1 dimethyl ethyl‐6‐ cyanomethyl‐2,2 dimethyl‐ 1,3‐dioxane‐4‐acetate (ATS 8) 1kg. 1. Ethyl ®‐4‐cyno‐3‐Hydroxy Butanoate 1.00 kg/kg 2. N‐Butyl Lithium (15% in Hexane) 1.90 kg/kg 3. Tertiary Butyl Acetate 2.11 kg/kg 4. Tetra Hydro Furan 5.63 kg/kg 5. 2,2‐Dimethoxy propane 2.79 kg/kg 6. Ketroreducatse YDH/KRED 0.013 kg/kg 7. Glucose Dehydrogenase Enzyme GDH 0.0045 kg/kg 8. B‐Nicotinamide‐adenine dinucleotide phosphate oxidized form, monosodium salt (Enzyme NADP) 0.90 gm/kg

Case No.A‐3

M/S Bal Pharma Ltd. F.No.01/82/50/289/AM08 RLA F.No.07/24/040/652/AM08 Adv.Lic.No.0710055002 dated 14.12.2007 Committee considered case as per agenda for ratification of norms for export product Amiloride Hcl

Case No.A‐4

M/S Cipla Ltd. F.No.01/82/50/317/AM08 RLA F.No.03/94/040/975/AM08 Adv.Lic.No.0310455413 dated 27.12.2007

Committee considered case as per agenda for ratification of norms for export product Irinotecan Hydrochloride Injection 40mg/2ml and 100mg/5ml under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

Case No.A‐5

M/S Cipla Ltd. F.No.01/82/50/318/AM08 RLA F.No.03/94/040/945/AM08 Adv.Lic.No.0310454389 dated 17.12.2007 Committee considered case as per agenda for ratification of norms for export product Ipratropium bromide HFA 20mcg inhaler (200MD)under para 4.7 of HBP. Committee perused written comments forwarded by PI Division vide their U.O. No.35011/83/2007‐PI‐ III dated 12.03.2008 and observed that the following inputs have been recommended subject to the conditions mentioned in their U.O. Export product Export Qty. Sl.No. Import items Qty. allowed Ipratropium bromide HFA 20mcg inhaler (200MD) 1 pack of 200MD 1. Ipratropium bromide 4.00 mg per pack of 200 MD 2. 63 mcl Aerosol Valves As per packing policy 3. 19 ml Aluminium can As per packing policy 4. Actuators with dust covers/caps fi܂ng to 19 ml Aluminium Can As per packing policy 5. Gas (1,1,1,2,3,3,3 Heptafluoropropane) (HFA 227 propellant) 17.60 gm per pack of 200MD Committee decided to seek comments from M/O E&F before sending instructions to RA, as to whether any licence is required for import of item No.5.

Case No.A‐6

M/S Cipla Ltd. F.No.01/82/162/912/AM08 M 奱� D t 01 04 2008 RLA F N 03/94/040/1198/AM08

RLA F.No.03/94/040/1198/AM08 Committee considered case as per agenda for fixation of norms for export product Asthalin Inhaler (200MD) under para 4.4.2 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

Case No.A‐7

M/S MDB Chemicals India Pvt. Ltd. F.No.01/82/50/1980/AM08 RLA F.No.31/21/40/147/AM08 Adv.Lic.No.3110030001 dated 25.07.2007 Committee considered case as per agenda for ratification of norms for export product 1,2‐ Methylenedioxybenzene under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical Division of C&PC for their comments. Accordingly, case was deferred for four weeks.

Case No.A‐8

M/S Neo Medichem Pvt. Ltd. F.No.01/82/50/329/AM08 RLA F.No.09/21/040/288/AM08 Adv.Lic.No.0910031762 dated 12.10.2007 Committee considered case as per agenda for ratification of norms for export product 1‐(2,4‐Difluoro Phenyl)‐2‐(1H‐1,2,4 Triazole‐1‐yl) Ethanone (Ethanone derivate) under para 4.7 of HBP. Committee in light of its earlier decision taken in its 43/06 meeting held on 01.02.2006 enclosed with agenda and in consultation with representative of PI Division 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 on repeat basis:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 1(2,4‐Difluoro phenyl)‐2‐(1H‐ 1,2,4‐triazole‐1‐yl) ethanone (ethanone derivative 1 kg. 1. 1,3‐difluoro benzene 0.914 kg/kg 2. 4‐amino‐1,2,4 triazole 0.667 kg/kg 3. Methylene chloride 1.60 kg/kg

y g/ g 4. Acetonitrile 1.65 kg/kg

Case No.A‐9

M/S Kamud Drugs Pvt. Ltd. F.No.01/83/50/315/AM08 RLA F.No.31/24/040/320/AM08 Adv.Lic.No.3110032124 dated 31.12.2007 Committee considered case as per agenda for ratification of norms for export product Ketamine Hcl Committee decided to defer case for six weeks for comments of PI Division.

Case No.A‐10

M/S Kamud Drugs Pvt. Ltd. F.No.01/83/50/314/AM08 RLA F.No.31/24/040/298/AM08 Adv.Lic.No.3110031879 dated 11.12.2007 Committee considered case as per agenda for ratification of norms for export product Ketamine Hcl Committee decided to defer case for six weeks for comments of PI Division.

Case No.A‐11

M/S Mangalam Drugs & Organics Ltd. F.No.01/82/50/327/AM08 RLA F.No.03/95/040/961/AM08 Adv.Lic.No.0310456184 dated 02.01.2008 Committee considered case as per agenda for ratification of norms for export product Amodiaquine Base under para 4.7 of HBP.

Committee decided to call for production and consumption data certified by Central Excise Authority from firm and All Industry Data from Pharmexcil. Accordingly, case was deferred for six weeks.

Case No.A‐12

M/S Matrix Labs. F.No.01/82/50/261AM08 RLA F.No.09/24/040/255/AM08 Adv.Lic.No.0910031766 dated 15.10.2007 Committee considered case as per agenda for ratification of norms for export product Levetiracetam

Case No.A‐13

M/S Lupin Ltd. F.No.01/82/50/119/AM08 RLA F.No.03/95/040/293/AM08 Adv.Lic.No.0310433980 dated 26.06.2007 Committee considered case as per agenda for ratification of norms for export product Sterile Ce䬀riazone Sodium 1gm and 2 gm and 250mg Injection under para 4.7 of HBP.

Case No.A‐14

M/S Matrix Ltd. F.No.01/82/50/259/AM08 RLA F.No.09/24/040/243/AM08 Adv.Lic.No.0910031765 dated 15.10.2007 Committee considered case as per agenda for ratification of norms for export product Efavirenz Stage‐ V ((S)‐5‐Chloro‐(cyclopropylethynyl)‐2‐amino‐(trifluoromethyl) Benzenemethanol) MMAA‐1 under para 4.7 of HBP.

Case No.A‐15

M/S Smilax Laboratories Ltd. F.No.01/82/50/310/AM08 RLA F.No.09/24/040/298/AM08 Adv.Lic.No.0910032150 dated 26.11.2007 Committee considered case as per agenda for ratification of norms for export product 2‐Hydroxy methyl‐3,5‐dimethyl‐4‐methoxy pyridine Hcl under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division 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 per unit of export product 2‐Hydroxy methyl‐3,5‐ dimethyl‐4‐methoxy Pyridine Hcl 1kg. 1. 3,5‐Lutidine 1.45 kg/kg 2. Hydrogen Peroxide 1.13 kg/kg 3. Methanol 2.15 kg/kg 4. Toluene 2.38 kg/kg 5. Amonium Persulphate 1.86 kg/kg 6. NaOH Flakes 1.26 kg/kg 7. Iso Propyl Alcohol 0.24 kg/kg

Case No.A‐16

M/S Smilax Laboratories Ltd. F.No.01/82/50/311/AM08 RLA F.No.09/24/40/362/AM08 Adv.Lic.No.0910032152 dated 26.11.2007 Committee considered case as per agenda for ratification of norms for export product Pantoprazole Sodium Pettets 15% under para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division 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 per unit of export product Pantoprazole Sodium Pellets – 15% 1kg. 1. 2,5‐(Difluoromethoxy)‐2 Mercapto‐1H‐benzimidazole 0.1212 kg/kg 2. 2‐Chloromethyl‐3,4 Dimethoxy Pyridine Hydrochloride 0.1212 kg/kg 3. Methylene Dichloride 1.06 kg/kg 4. Tetrahydrofuran 0.303 kg/kg 5. PVPK 0.010 kg/kg 6. Iso Propyl Alcohol 0.100 kg/kg 7. Mannitol 0.150 kg/kg 8. Hydroxy Propyl Methyl Cellusose E5 0.080 kg/kg 9. Methacrylic Acid 0.610 kg/kg

Case No.A‐17

M/S Vijayasri Organics Ltd. F.No.01/82/50/309/AM08 RLA F.No.09/24/040/294/AM08 Adv.Lic.No.0910032155 dated 26.11.2007 Committee considered case as per agenda for ratification of norms for export product 2‐Butyl‐5‐ Chloro‐3H‐Imidazole‐4‐Carbaldehyde (IMAL) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division 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 per unit of export product 2‐Butyl‐5‐Chloro‐3H‐ Imidazole‐4‐ 1kg. 1. Valeronitrile 1.19 kg/kg 2. Methanol 1.08 kg/kg

Carbaldehyde (IMAL) g/ g 3. Glycine 0.80 kg/kg 4. Toluene 1.50 kg/kg 5. Dimethyl Formamide 1.16 kg/kg 6. Methyl Cyclohexane 2.00 kg/kg

Case No.C‐01

M/S Lupin Ltd. F.No.01/82/162/797/AM08 Committee considered case as per agenda for modification of SION at Sl.No.A‐225 Rifampicin. Committee decided to defer case for six weeks for comments of PI Division.

Case No.C‐02

M/S India Glycols Ltd. F.No.01/82/162/940/AM08 Committee considered case as per agenda for fixation of SION for export product Ethylene Glycol Mono Ethyl Ether Acetate (IGACE6701E). Committee decided to defer case for two weeks for comments of Chemical Division.

Case No.C‐03

M/S India Glycols Ltd. F.No.01/82/162/941/AM08 Committee considered case as per agenda for fixation of SION for export product Ethylene Glycol Mono Ethyl Ether (IGSOL‐12026E). Committee decided to defer case for two weeks for comments of Chemical Division

Committee decided to defer case for two weeks for comments of Chemical Division.

Case No.C‐04

M/S India Glycols Ltd. F.No.01/82/162/942/AM08 Committee considered case as per agenda for fixation of SION for export product Diethylene Glycol Mono Ethyl Ether Acetate (IGACE‐8801E). Committee decided to defer case for two weeks for comments of Chemical Division.

Case No.C‐05

M/S India Glycols Ltd. F.No.01/82/162/928/AM08 Committee considered case as per agenda for fixation of SION for export product Diethylene Glycol Mono Ethyl Ether (IGTOL‐12016E). Committee decided to defer case for two weeks for comments of Chemical Division. 1

Case No.:31/47/82‐ALC1/2005

Party Name:CALYX CHEMICALS & PHARMACEUTICALS PVT.LTD. Meet No/Date:1/82‐ALC4/2008 01.04.2008 Status:Case Deferred HQ File :01/82/050/01335/AM06/ RLA File :03/94/040/01210/AM06/ Lic.No/Date:0310365692 03.02.2006 Defer Date: 13.05.2008 Decision :Committee considered case as per agenda for ratification of norms for export product under para 4.7 of HBP. Committee decided to call for end use of export product and copy of Drug Manufacturing Licence from firm. Accordingly, case was deferred for six weeks.

Case No.:7/42/82‐ALC4/2007

Party Name:GOPINATH CHEM‐TECH LTD., 01.04.2008 Status:Case Deferred

2 HQ File :01/82/050/00343/AM08/ RLA File :08/24/040/00259/AM06/ Lic.No/Date:0810054157 22.02.2006 Defer Date: 13.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product under para 4.7 of HBP. Committee decided to call for a copy of application alongwith copy of Advance Authorisation from RA. Accordingly, case was deferred for six weeks. 3

Case No.:2/46/82‐ALC1/2006

Party Name:MATRIX LABORATORIES LTD 01.04.2008 Status:Case Approved HQ File :01/82/050/01441/AM07/ RLA File :09/24/040/00390/AM07/ Lic.No/Date:0910028634 13.12.2006 Decision : Committee considered case as per agenda for ratification of norms for export product N Trifluoro Acetyl‐N‐Lysine‐Praline (Lyspro Isolated) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/93/2007‐PI‐III dated 12.03.2008 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 per unit of export product N Trifluoro Acetyl‐N‐ Lysine‐Praline (Lyspro Isolated) 1kg. 1. L‐Proline 0.564 kg/kg 2. Dichloromethane 1.42 kg/kg 3. Diisopropyl ether 9.65 kg/kg 4. Toluene 4.20 kg/kg 5. Trifluoro acetic acid 0.90 kg/kg 6. Iso propyl alcohol 0.23 kg/kg 7. L‐Lysisne Hcl 1.11 kg/kg 8. Benzyl chloroformate 0.930 kg/kg 9. Hexane 2.29 kg/kg 10. Triethylamine 0.363 kg/kg 11. Pivaloyl chloride 0.413 kg/kg 12. 5% Palladium on carbon 0.0079 kg/kg 13. Methanol 2.98 kg/kg 14. N‐Butanol 0.46 kg/kg 15. Eno Anticromos (Activated Carbon) 0.071 kg/kg

y y� p 4

Case No.:10/42/82‐ALC4/2007

Party Name:DELTA FINOCHEM PVT.LTD. 01.04.2008 Status:Case Approved HQ File :01/82/050/00346/AM08/ RLA File :03/94/040/00890/AM07/ Lic.No/Date:0310415522 11.01.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Ethyl riphenyl Phosphonium Bromide under

para 4.7 of HBP.

Committee in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/89/2002‐Ch.II signed on 01.04.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Ethyl Triphenyl Phosphonium Bromide 1 kg. 1. Triphenyl Phosphine 0.780 kg/kg 2. Ethyl Bromide 0.363 kg/kg 5

Case No.:11/42/82‐ALC4/2007

Party Name:MORAYA GLOBAL LTD. 01.04.2008 Status:Case Approved HQ File :01/82/050/00347/AM08/ RLA File :03/95/040/01114/AM07/ Lic.No/Date:0310415496 11.01.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Ethyl Linalool Pure 99% under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/23/2006‐Ch.II Signed on 01.04.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Ethyl Linalool (Pure min.99%) 1 kg. 1. Ethyl Lanialool Technical (Purity 90% max.) 1.15 kg/kg

Case No.:16/49/82‐ALC1/2006

Party Name:LUPIN LIMITED 01.04.2008 Status:Case Deferred HQ File :01/82/050/01721/AM07/ RLA File :03/95/040/01297/AM07/ Lic.No/Date:0310416716 22.01.2007 Defer Date: 13.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Sterile Ce䬀riaxone Sodium Non Infringing Committee decided to defer case for six weeks. 7

Case No.:48/42/82‐ALC4/2007

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 01.04.2008 Status:Case Approved HQ File :01/82/050/00384/AM08/ RLA File :03/94/040/01225/AM07/ Lic.No/Date:0310419338 12.02.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Astrolide in diethyl Phthalate/isopropyl Myristate Total Astrolide Content: 62.5% min. under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/9/2005‐Ch.II signed on 01.04.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Astrolide in Diethyl Phthalate/Isopropyl Myristate Total Astrolide content; 62.5% minium 1 kg. 1. Alpha Methyl Styrene 0.500 kg/kg 2. Isoamylene 0.380 kg/kg 3. Propylene Oxide 0.280 kg/kg 4. Para Formaldehyde 0.088 kg/kg 5. Diethyl Phthalate 0.350 kg/kg 8

Case No.:445/24/83‐ALC1/2007

Party Name:SMILAX LABORATORIES LIMITED 01.04.2008 Status:Case Approved HQ File :01/83/050/01268/AM07/ RLA File :09/24/040/00478/AM07/ Lic.No/Date:0910029428 22.02.2007 Decision : Committee considered case as per agenda for ratification of norms for export product {3‐5[Bromo‐1‐(flurophenyl)(1,3‐dihydro isobenzo furanyl)] Propyl]dimehylamine oxalate under para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division 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 per unit of export product {3‐5[Bromo‐1‐(flurophenyl) (1,3‐dihydro isobenzo furanyl)] propyl] dimehylamine oxalate 1kg. 1. 1‐Bromo‐3‐Chloro Propane 1.85 kg/kg 2. Toluene 6.80 kg/kg 3. 1‐Bromo 4‐Fluro Benzene 1.38 kg/kg 4. Tetra Hydro Furan 5.39 kg/kg 5. 5‐Bromo Phthalide 1.35 kg/kg 6. Iso Propyl Alcohol 0.40 kg/kg 9

Case No.:4/9/83‐ALC1/2007

Party Name:ZANDU CHEMICALS LIMITED 01.04.2008 Status:Case Approved HQ File :01/83/050/01315/AM07/ RLA File :03/95/040/01260/AM07/ Lic.No/Date:0310422065 06.03.2007 Decision : Committee considered case as per agenda for ratification of norms for export product 2 Methyl 4,6 Bis (Trichloromethyl) 1,3,5,Triazine (TAZ) under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/72/2005‐Ch.II signed on 01.04.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2‐methyl‐4,6‐bis‐ (trichloromethyl) 1,3,5‐ Triazine (TAZ) 1 kg. 1. Trichloro Acetonitrile 1.25 kg/kg 2. Methanol 1.00 kg/kg 10

Case No.:25/14/83‐ALC1/2007

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 01.04.2008 Status:Case Deferred HQ File :01/83/050/00016/AM08/ RLA File :04/24/040/00501/AM07/ Lic.No/Date:0410088727 02 04 2007 Defer Date: 29 04 2008

10 02.04.2007 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Allylestrenol under para 4.7 of HBP. 11

Case No.:52/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.04.2008 Status:Case Deferred HQ File :01/82/050/00388/AM08/ RLA File :07/24/040/00005/AM08/ Lic.No/Date:0710051374 23.04.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Calcium L‐Aspartate, Magnesium L‐Aspartate and Zinc L‐Aspartate under para 4.7 of HBP. 12

Case No.:53/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.04.2008 Status:Case Deferred HQ File :01/82/050/00389/AM08/ RLA File :07/24/040/00862/AM07/ Lic.No/Date:0710051389 24.04.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Calcium Lactobionate, Calcium Glubionate and Calcium Bromolactobionate under para 4.7 of HBP. 13

Case No.:54/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.04.2008 Status:Case Deferred HQ File :01/82/050/00390/AM08/ RLA File :07/24/040/00861/AM07/ Lic.No/Date:0710051390 24.04.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Zinc Gluconate, Magnesium Gluconate, Potassium Gluconate, Ferrous Gluconate, Manganese Gluconate, Calcium Magnesium Lactate Gluconate, Magnesium Lactate Gluconate, Cobalt Gluconate and Copper Gluconate under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Chemical Division.

Case No.:56/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.04.2008 Status:Case Deferred HQ File :01/82/050/00392/AM08/ RLA File :07/24/040/00052/AM08/ Lic.No/Date:0710051438 26 04 2007 Defer Date: 29 04 2008

14 26.04.2007 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Calcium Gluconate and Calcium Lactate Gluconate under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Chemical Division. 15

Case No.:57/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.04.2008 Status:Case Deferred HQ File :01/82/050/00393/AM08/ RLA File :07/24/040/00053/AM08/ Lic.No/Date:0710051439 26.04.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Calcium Gluconate – Injectable Grade, Calcium Lactate Gluconate, Calcium Glubionate and Calcium Borogluconate under para 4.7 of HBP. 16

Case No.:60/42/82‐ALC4/2007

Party Name:REDOX PHARMACHEM PVT LTD. 01.04.2008 Status:Case Rejected HQ File :01/82/050/00396/AM08/ RLA File :05/24/040/00092/AM08/ Lic.No/Date:0510203860 18.05.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Thymol and Para‐Cymene 95% under para 4.7 of HBP. Committee observed that Department of C&PC, Chemical Division vide their letter No.14010/141/2003‐Ch.III dated 07.09.2007 had called for CA certificate certifying the production of export item (Thymol) achieved by them for the last three years and corresponding consumption of different raw materials, but no reply has been received from firm. Accordingly, Committee decided to close the case. 17

Case No.:61/42/82‐ALC4/2007

Party Name:GULBRANDSEN CHEMICALS PVT LTD 01.04.2008 Status:Case Deffered HQ File :01/82/050/00397/AM08/ RLA File :34/24/040/00037/AM08/ Lic.No/Date:3410018872 01.06.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Tetra Butyl Tin, Mono Butyl Tin Trichloride and Di Butyl Tin Oxide under para 4.7 of HBP.

Case No.:655/24/83‐ALC1/2007

Party Name:CADILA PHARMACEUTICALS LTD. 01.04.2008 Status:Case Deferred HQ File :01/83/050/00530/AM08/ RLA File :08/24/040/00066/AM08/ Lic.No/Date:0810065423 15.06.2007 Defer Date: 13.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Methscopolamine Tannate under para 4.7 of HBP. Committee observed that reply received from firm is incomplete. They have not furnished Molecular weight of export product, Percentage yield on molar basis and copy of Drug Manufacturing Licence. Committee, therefore, decided to call for above information/documents from firm. Accordingly, case was deferred for six weeks. 19

Case No.:83/19/83‐ALC1/2007

Party Name:SUMITOMO CHEMICAL INDIA PRIVATE LIMITED 01.04.2008 Status:Case Deferred HQ File :01/83/050/00643/AM08/ RLA File :03/95/040/01529/AM07/ Lic.No/Date:0310433838 25.06.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 1,2‐Methylenedioxybenzene under para 4.7 of HBP. Committee decided to forward a copy of application alongwith a copy of reply received from firm to Chemical Division for their comments. Accordingly, case was deferred for four weeks. 20

Case No.:730/24/83‐ALC1/2007

Party Name:SUVEN LIFE SCIENCES LIMITED 01.04.2008 Status:Case Deferred HQ File :01/83/050/00623/AM08/ RLA File :09/24/040/00120/AM08/ Lic.No/Date:0910030686 29.06.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product (S)‐3‐Hydroxy‐N‐Benzyl Pyrrolidine under para 4.7 of HBP. 21

Case No.:19/23/83‐ALC1/2007

Party Name:SEQUENT SCIENTIFIC LIMITED 01.04.2008 Status:Case Deferred HQ File :01/83/050/00655/AM08/ RLA File :07/24/040/00234/AM08/ Lic.No/Date:0710052301 04.07.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product L‐(+)‐Selenomethionine under para 4.7 of HBP.

Committee decided to hand over the reply received from firm to representative of PI Division for his comments. Accordingly, case was deferred for four weeks. 22

Case No.:93/19/83‐ALC1/2007

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM 01.04.2008 Status:Case Approved HQ File :01/83/050/00673/AM08/ RLA File :05/24/040/00171/AM08/ Lic.No/Date:0510205792 05.07.2007 Decision : Committee considered case as per agenda for ratification of norms for export product 1,4‐Dihydro‐1‐ethyl‐7‐methyl‐4‐oxo‐1,8‐ naphthyridine‐3‐carboxylic acid ‐ Crude under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/111/2007‐PI‐III dated 21.01.2008 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 per unit of export product 1,4‐Dihydro‐1‐ethyl‐7‐ methyl‐4‐oxo‐1,8‐ naphthyridine‐3‐ carboxylic acid ‐ Crude 1 kg. 1. 2‐Amino 6‐Methyl Pyridine OR 0.81 kg/kg 1(a). Sodium Metal 0.36 kg/kg 1(b). Alumina‐Silica Catalyst 0.048 kg/kg 1© Denatured Ethyl Alcohol 4.13 kg/kg 2. Triethyl ortho formate 1.10 kg/kg 3. Para Toluene Sulfonic acid Monohydrate 0.0027 kg/kg 4. Diethyl Malonate 1.20 kg/kg 5. Ethyl Alcohol 0.180 kg/kg 6. Diphenyl DT Not a raw material. Hence not allowed. 7. Ethyl bromide 0.520 kg/kg 8. Dimethyl Formamide 0.750 kg/kg

Case No.:771/24/83‐ALC1/2007

Party Name:PRACHI PHARMACEUTICALS PVT LTD 01.04.2008 Status:Case Deferred HQ File :01/83/050/00709/AM08/ RLA File :03/95/040/00308/AM08/ Lic.No/Date:0310435714 11.07.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Thiamine Hydrochloride BP/USPCitalopram Hydrobromide under para 4.7 of HBP. Committee observed that firm has been requested to furnish a clarification as both import and export items are bulk drugs BP/USP and this is not a conventional process adopted for manufacturing vide letter dated 26.03.2008. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 24

Case No.:797/24/83‐ALC1/2007

Party Name:RANBAXY LABORATORIES LTD 01.04.2008 Status:Case Rejected HQ File :01/83/050/00755/AM08/ RLA File :05/24/040/00286/AM08/ Lic.No/Date:0510206321 16.07.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Citalopram Hydrobromide under para 4.7 of HBP. Committee observed that firm was requested to furnish information regarding non‐infringing process vide letter dated 13.02.2008, but same has not been received. Committee, therefore, decided to close the case. 25

Case No.:75/42/82‐ALC4/2007

Party Name:GULBRANDSEN CHEMICALS PVT LTD 01.04.2008 Status:Case Deferred HQ File :01/82/050/00411/AM08/ RLA File :34/24/040/00083/AM08/ Lic.No/Date:3410019350 02.08.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Tetra Butyl Tin, Mono Butyl Tin Trichloride and Di Butyl Tin Oxide under para 4.7 of HBP.

Case No.:876/24/83‐ALC1/2007

Party Name:MATRIX LABORATORIES LTD 01.04.2008 Status:Case Approved

26 HQ File :01/83/050/00880/AM08/ RLA File :09/24/040/00161/AM08/ Lic.No/Date:0910031051 06.08.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Cyclohexyl Ester under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/93/2007‐PI‐III dated 12.03.2008 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 per unit of export product Cyclohexyl Ester 1kg. 1. Glyoxylic acid 50% 0.90 kg/kg 2. Formaldehyde 0.566 kg/kg 3. 2,5‐Dihydroxy‐1‐4 dithiane (or) 1,4 Dithiane 2,5‐DIOL 0.365 kg/kg 4. Cytosine 0.455 kg/kg 5. Thionyl chloride 0.391 kg/kg 6. Dimethyl formamide 0.20 kg/kg 7. Acetic acid 0.010 kg/kg 8. Methane Sulphonic acid 0.0125 kg/kg 9. Dichloromethane 2.37 kg/kg 10. Toluene 1.67 kg/kg 11. Hexamethyl disilazane 0.75 kg/kg 12. Triethylamine 0.664 kg/kg 13. Hexane 1.83 kg/kg 14. Isopropyl acetate 0.67 kg/kg 15. Cyclohexane 2.31 kg/kg 27

Case No.:3/18/82‐ALC4/2007

Party Name:CIPLA LIMITED 01.04.2008 Status:Case Withdrawn HQ File :01/82/050/00142/AM08/ RLA File :03/94/040/00455/AM08/ Lic.No/Date:0310438406 06.08.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Lamivudine and Zidovaudine Tablets/Duovir/Bivir under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 39/08 meeting held on 29.01.2008.

Case No.:77/42/82‐ALC4/2007

Party Name:GULBRANDSEN CHEMICALS PVT LTD 01.04.2008 Status:Case Deferred HQ File :01/82/050/00413/AM08/ RLA File :34/24/040/00087/AM08/ Lic.No/Date:3410019376 07.08.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Tetra Butyl Tin, Mono Butyl Tin Trichloride and Di Butyl Tin Oxide under para 4.7 of HBP. 29

Case No.:14/25/83‐ALC1/2007

Party Name:SANJAY SALES CORPORATION 01.04.2008 Status:Case Approved HQ File :01/83/050/01039/AM08/ RLA File :03/95/040/00475/AM08/ Lic.No/Date:0310439724 16.08.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Sodium Salicylate under para 4.7 of HBP. Committee in consultation with representative of PI Division 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 per unit of export product Sodium Salicylate 1 kg. 1. Salicylic Acid 0.90 kg/kg 30

Case No.:977/24/83‐ALC1/2007

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 01.04.2008 Status:Case Approved HQ File :01/83/050/00994/AM08/ RLA File :03/94/040/00492/AM08/ Lic.No/Date:0310439950 17.08.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Artemether under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division 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 per unit of export product A th th 1 k 1 A t i i i 1 50 k /k

Arthmether 1 kg. 1. Artemisinin 1.50 kg/kg 2. Sodium Borohydride 0.188 kg/kg 31

Case No.:12/27/83‐ALC1/2007

Party Name:CIPLA LIMITED 01.04.2008 Status:Case Approved HQ File :01/83/050/01086/AM08/ RLA File :03/94/040/00555/AM08/ Lic.No/Date:0310441561 31.08.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Saquinavir 200mg Capsules under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007‐PI‐III dated 12.03.2008 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 per unit of export product Saquinavir 200mg Capsules [Saquinavir Mesylate 204mg/capsule] 1 No. 1. L‐Asparagine, N2‐(2‐ Quinolinylcarbonyl) (SQN III) 0.55 kg/kg of Saquinavir Mesylate 2. 2‐Pyridinol 1‐Oxide 0.020 kg/kg of Saquinavir Mesylate 3. (S)‐N‐T‐Butyl Decahydro‐3‐ Isoquinoline carboxamide) 0.536 kg/kg of Saquinavir Mesylate 4. Tetrahydrofuran 0.45 kg/kg of Saquinavir Mesylate 5. CBZ‐Epoxide 0.666 kg/kg of Saquinavir Mesylate

Case No.:6/27/83‐ALC1/2007

Party Name:VANI CHEMICALS & INTERMEDIATES LTD. 01.04.2008 Status:Case Withdrawn

32 HQ File :01/83/050/01080/AM08/ RLA File :09/24/040/00009/AM08/ Lic.No/Date:0910031330 31.08.2007 Decision : Committee considered case as per agenda for ratification of norms for export product 4‐(3,4‐Dichlorophenyl)1‐Tetrakibe under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 45/08 meeting held on 11.03.2008. 33

Case No.:33/27/83‐ALC1/2007

Party Name:AUROBINDO PHARMA LIMITED 01.04.2008 Status:Case Withdrawn HQ File :01/83/050/01107/AM08/ RLA File :09/24/040/00192/AM07/ Lic.No/Date:0910031403 05.09.2007 Decision : Committee considered case as per agenda for ratification of norms for export product GCLE‐Stage‐I under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 41/08 meeting held on 03.03.2008. 34

Case No.:32/27/83‐ALC1/2007

Party Name:AUROBINDO PHARMA LIMITED 01.04.2008 Status:Case Withdrawn HQ File :01/83/050/01106/AM08/ RLA File :09/24/040/00388/AM07/ Lic.No/Date:0910031402 05.09.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 41/08 meeting held on 03.03.2008. 35

Case No.:31/27/83‐ALC1/2007

Party Name:AUROBINDO PHARMA LIMITED 01.04.2008 Status:Case Withdrawn HQ File :01/83/050/01105/AM08/ RLA File :09/24/040/00470/AM07/ Lic.No/Date:0910031401 05.09.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Pivmecillinam Hydrochloride under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 41/08 meeting held on 03.03.2008.

Case No.:61/27/83‐ALC1/2007

Party Name:APITHECARY PHARMA PVT LTD. 01.04.2008 Status: Case Deferred

36 HQ File :01/83/050/01135/AM08/ RLA File :09/24/040/00147/AM08/ Lic.No/Date:0910031443 07.09.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Omeprazole Sulphide or 5‐Methoxy‐2‐[([4‐ Methoxy‐3,5‐Dimethyl‐2‐Pyridine‐2‐Methyl]Thio]‐1H‐Benzimidazole under para 4.7 of HBP. 37

Case No.:64/27/83‐ALC1/2007

Party Name:KARNATAKA CHEMSYN LTD 01.04.2008 Status:Case Deferred HQ File :01/83/050/01138/AM08/ RLA File :07/24/040/00408/AM08/ Lic.No/Date:0710053251 10.09.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 5‐Hydroxy Methyl 4‐Methyl Imidazole 99.0% purity under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical Division for their comments. Accordingly, case was deferred for four weeks. 38

Case No.:10/22/82‐ALC4/2007

Party Name:CIPLA LIMITED 01.04.2008 Status:Case Approved HQ File :01/82/050/00180/AM08/ RLA File :03/94/040/00615/AM08/ Lic.No/Date:0310442878 12.09.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Abacavir Sulphate tablets 300mg under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007‐PI‐III dated 12.03.2008 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 per unit of export product Abacavir Sulphate tablets 300mg [Abacavir sulphate 306mg/tablet] 1 No. 1. Triethyl orthoformate 0.69 kg/kg of Abacavir sulphate 2. Cyclopropylamine 0.19kg/kg of Abacavir sulphate

Case No :129/27/83 ALC1/2007

Party Name:CIPLA LIMITED Meet No/Date:1/82 ALC4/2008 Status:Case

Case No.:129/27/83‐ALC1/2007

Party Name:CIPLA LIMITED 01.04.2008 Status:Case Withdrawn HQ File :01/83/050/01203/AM08/ RLA File :03/94/040/00632/AM08/ Lic.No/Date:0310443548 18.09.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Sibutramine Hydrochloride under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 40/08 meeting held on 03.03.2008. 40

Case No.:33/29/83‐ALC1/2007

Party Name:AUCTUS PHARMA PRIVATE LIMITED 01.04.2008 Status:Case Approved HQ File :01/83/050/01298/AM08/ RLA File :09/24/040/00244/AM08/ Lic.No/Date:0910031713 05.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product {1R,2S,5R}‐Methyl‐5S‐(Cytosine‐1‐YL)‐1,3‐ Oxathiolane‐2R‐Carboxylate under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/123/2007‐PI‐III dated 24.03.2008 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 per unit of export product {1’R.2’S.5R’}‐Methyl‐5S‐ (Cytosine‐1‐YL)‐1,3‐ Oxathiolane‐2R‐ Carboxylate 1 kg. 1. Glyoxalic acid 50% 0.90 kg/kg 2. 2,5‐Dihydroxy‐1,4‐Diethane 0.365 kg/kg 3. Cytosine 0.455 kg/kg 4. Cyclohexane 1.40 kg/kg 5. Toluene 4.20 kg/kg 6. Methylene chloride 2.10 kg/kg 7. Acetone 1.40 kg/kg

Case No.:43/29/83‐ALC1/2007

Party Name:MATRIX LABORATORIES LTD 01.04.2008 Status:Case Approved HQ File :01/83/050/01308/AM08/ RLA File :09/24/040/00259/AM08/ Lic.No/Date:0910031715 08.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Cytosine Menthyl Ester (CME) under para 4.7 of HBP.

41 of H P. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/93/2007‐PI‐III dated 12.03.2008 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 per unit of export product Cyclohexyl Ester 1kg. 1. Glyoxylic acid 50% 0.90 kg/kg 2. Formaldehyde 0.566 kg/kg 3. 2,5‐Dihydroxy‐1‐4 dithiane (or) 1,4 Dithiane 2,5‐DIOL 0.365 kg/kg 4. Cytosine 0.455 kg/kg 5. Thionyl chloride 0.391 kg/kg 6. Dimethyl formamide 0.20 kg/kg 7. Acetic acid 0.010 kg/kg 8. Methane Sulphonic acid 0.0125 kg/kg 9. Dichloromethane 2.37 kg/kg 10. Toluene 1.67 kg/kg 11. Hexamethyl disilazane 0.75 kg/kg 12. Triethylamine 0.664 kg/kg 13. Hexane 1.83 kg/kg 14. Isopropyl acetate 0.67 kg/kg 15. Cyclohexane 2.31 kg/kg 42

Case No.:102/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.04.2008 Status:Case Deferred HQ File :01/82/050/00438/AM08/ RLA File :07/24/040/00455/AM08/ Lic.No/Date:0710053787 12.10.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Magnesium Orotate (Dihydrate), Calcium Orotate (Dihydrate), Potassium Orotate and Zinc Orotate (Dihydrate) under para 4.7 of HBP.

Case No.:28/30/83‐ALC1/2007

Party Name:AUCTUS PHARMA PRIVATE LIMITED 01.04.2008 Status:Case Approved

43 HQ File :01/83/050/01397/AM08/ RLA File :09/24/040/00291/AM08/ Lic.No/Date:0910031844 23.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product {1R,2S,5R}‐Methyl‐5S‐(Cytosine‐1‐YL)‐1,3‐ Oxathiolane‐2R‐Carboxylate under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/123/2007‐PI‐III dated 24.03.2008 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 per unit of export product {1’R.2’S.5R’}‐Methyl‐5S‐ (Cytosine‐1‐YL)‐1,3‐ Oxathiolane‐2R‐ Carboxylate 1 kg. 1. Glyoxalic acid 50% 0.90 kg/kg 2. 2,5‐Dihydroxy‐1,4‐Diethane 0.365 kg/kg 3. Cytosine 0.455 kg/kg 4. Cyclohexane 1.40 kg/kg 5. Toluene 4.20 kg/kg 6. Methylene chloride 2.10 kg/kg 7. Acetone 1.40 kg/kg 44

Case No.:51/30/83‐ALC1/2007

Party Name:HETERO DRUGS LIMITED, 01.04.2008 Status:Case Deferred HQ File :01/83/050/01420/AM08/ RLA File :09/24/040/00276/AM08/ Lic.No/Date:0910031879 24.10.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Indinavir Sulphate under para 4.7 of HBP. 45

Case No.:64/32/83‐ALC1/2007

Party Name:VITAL LABORATORIES PVT. LTD. 01.04.2008 Status:Case Deferred HQ File :01/83/050/01486/AM08/ RLA File :03/95/040/00758/AM08/ Lic.No/Date:0310448792 01.11.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Yohimbine Hydrochloride under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Department of MSME.

Case No.:60/32/83‐ALC1/2007

Party Name:CIPLA LIMITED 01.04.2008 Status:Case Approved HQ File :01/83/050/01482/AM08/ RLA File :03/94/040/00799/AM08/ Lic.No/Date:0310448706 01.11.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Saquinavir 200mg Capsules under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007‐PI‐III dated 12.03.2008 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 per unit of export product Saquinavir 200mg Capsules [Saquinavir Mesylate 204mg/capsule] 1 No. 1. L‐Asparagine, N2‐(2‐ Quinolinylcarbonyl) (SQN III) 0.55 kg/kg of Saquinavir Mesylate 2. 2‐Pyridinol 1‐Oxide 0.020 kg/kg of Saquinavir Mesylate 3. (S)‐N‐T‐Butyl Decahydro‐3‐ Isoquinoline carboxamide) 0.536 kg/kg of Saquinavir Mesylate 4. Tetrahydrofuran 0.45 kg/kg of Saquinavir Mesylate 5. CBZ‐Epoxide 0.666 kg/kg of Saquinavir Mesylate 47

Case No.:10/28/82‐ALC4/2007

Party Name:AMOL PHARMACEUTICALS PVT. LTD. 01.04.2008 Status:Case Withdrawn HQ File :01/82/050/00244/AM08/ RLA File :13/24/040/00020/AM08/ Lic.No/Date:1310025280 01.11.2007 D i i C i id d d f 奱�fi 奱� f f d A b l P l i G l 95% d 4 7 f

Decision : Committee considered case as per agenda for ratification of norms for export product Ascorbyl Palmitate Granules 95% under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 40/08 meeting held on 03.03.2008. 48

Case No.:90/32/83‐ALC1/2007

Party Name:VITAL LABORATORIES PVT. LTD. 01.04.2008 Status:Case Deferred HQ File :01/83/050/01512/AM08/ RLA File :03/95/040/00683/AM08/ Lic.No/Date:0310449450 06.11.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Resfrpine BP/EP/USP under para 4.7 of HBP. Committee decided to hand over file to representative of Department of MSME for his comments. Accordingly, case was deferred for four weeks. 49

Case No.:89/32/83‐ALC1/2007

Party Name:VITAL LABORATORIES PVT. LTD. 01.04.2008 Status:Case Deferred HQ File :01/83/050/01511/AM08/ RLA File :03/95/040/00691/AM08/ Lic.No/Date:0310449448 06.11.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Digoxin BP/EP/USP under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Department of MSME. 50

Case No.:4/33/83‐ALC1/2007

Party Name:ALKALOIDS CORPORATION 01.04.2008 Status:Case Deferred HQ File :01/83/050/01533/AM08/ RLA File :02/24/040/00216/AM08/ Lic.No/Date:0210105867 07.11.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Noscapine BP/Noscapine Hydrochloride BP 51

Case No.:108/42/82‐ALC4/2007

Party Name:GULBRANDSEN CHEMICALS PVT LTD 01.04.2008 Status:Case Deferred HQ File :01/82/050/00444/AM08/ RLA File :34/24/040/00167/AM08/ Lic.No/Date:3410020048 08.11.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Dibutyl Tin Oxide and Monobutyl Tin Trichloride under para 4 7 of HBP

Trichloride under para 4.7 of HBP. 52

Case No.:109/42/82‐ALC4/2007

Party Name:GLAND PHARMA LIMITED 01.04.2008 Status:Case Deferred HQ File :01/82/050/00445/AM08/ RLA File :09/24/040/00356/AM08/ Lic.No/Date:0910032089 14.11.2007 Defer Date: 15.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Adenosine Injection USP Prefilled Syringes 2mg/ml 2ml in a PFS and Adenosine Injection USP Prefilled Syringes 3mg/ml 4ml in a PFS under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 53

Case No.:113/42/82‐ALC4/2007

Party Name:STERLING AUXILIARIES PVT LTD 01.04.2008 Status:Case Deferreed HQ File :01/82/050/00449/AM08/ RLA File :03/95/040/00634/AM08/ Lic.No/Date:0310450751 20.11.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Stero TIPA 85 (Triisopropanolamine) and Stero DEIPA 85 [N,N‐bis‐(2‐hydroxyethyl)‐2‐propanolamine] and Stero Co 360 (Polyoxyethylene Ricinoleic Acid) under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical Division for their comments. Accordingly, case was deferred for four weeks. 54

Case No.:116/42/82‐ALC4/2007

Party Name:ESTELLE CHEMICALS PVT LTD 01.04.2008 Status:Case Rejected HQ File :01/82/050/00452/AM08/ RLA File :31/24/040/00284/AM08/ Lic.No/Date:3110031671 23.11.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Sorbitan Monostearate, Glyceryl Monostearate and Sorbitan Tristearate under para 4.7 of HBP. Representative of Chemical Division informed Committee that he has called for technical information vide his letter No.14010/103/2007‐ Ch.II dated 11.02.2008, but no reply has been received. Committee, therefore, decided to close the case.

Case No.:118/42/82‐ALC4/2007

Party Name:AKRY ORGANICS PVT. LTD. 01 04 2008 Status:Case Deferred

55 01.04.2008 Deferred HQ File :01/82/050/00454/AM08/ RLA File :03/94/040/00902/AM08/ Lic.No/Date:0310452257 30.11.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Diethylene Glycol and Tri Ethylene Glycol under

para 4.7 of HBP.

Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for his comments. Accordingly, case was deferred for four weeks. 56

Case No.:74/45/82‐ALC4/2007

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 01.04.2008 Status:Case Deferred HQ File :01/82/050/00537/AM08/ RLA File :05/24/040/00727/AM08/ Lic.No/Date:0510213720 18.12.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Thymol under para 4.7 of HBP. 57

Case No.:63/45/82‐ALC4/2007

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 01.04.2008 Status:Case Deferred HQ File :01/82/050/00526/AM08/ RLA File :03/95/040/00918/AM08/ Lic.No/Date:0310454961 20.12.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2[(Chloro Methyl)Mercapto]Benzo Thiazole (CMBT) under para 4.7 of HBP. Committee observed that firm has mentioned that export product is used in synthesis of Leather Chemicals and therefore, comments of Chemical Division is required. Committee, therefore, decided to forward a copy of application to Chemical division for their comments. Accordingly, case was deferred for four weeks. 58

Case No.:7/1/82‐ALC4/2008

Party Name:INDIA GLYCOLS LTD 01.04.2008 Status:Case Deferred HQ File :01/82/050/00613/AM08/ RLA File :05/24/040/00749/AM08/ Lic.No/Date:0510214151 31.12.2007 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Ethylene Glycol Mono Ethyl Ether Acetate (IGACE‐670‐E) Ethylene Glycol Mono Ethyl Ether Acetate (IGACE‐670‐E)under para 4.7 of HBP. C N 61/45/82 ALC4/2007 P N HINDUSTAN POLYAMIDES & FIBRES M N /D 1/82 ALC4/2008 S C

Case No.:61/45/82‐ALC4/2007

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 01.04.2008 Status:Case Deferred HQ File :01/82/050/00524/AM08/ RLA File :03/94/040/01014/AM08/ Lic.No/Date:0310457513 11.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Hamber under para 4.7 of HBP. 60

Case No.:9/45/82‐ALC4/2007

Party Name:GALAXY LABORATORIES PVT LTD., 01.04.2008 Status:Case Approved HQ File :01/82/050/00472/AM08/ RLA File :03/94/040/01004/AM08/ Lic.No/Date:0310457755 16.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Furfurylamine under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/199/2001‐Ch.III signed on 01.04.2008 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 per unit of export product Furfurylamine 1kg. 1. Furfural 1.164 kg/kg 61

Case No.:10/45/82‐ALC4/2007

Party Name:GEMINI EXPORTS., 01.04.2008 Status:Case Deferred HQ File :01/82/050/00473/AM08/ RLA File :03/94/040/01035/AM08/ Lic.No/Date:0310457891 16.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Ferrous Fumarate under para 4.7 of HBP.

Case No.:23/45/82‐ALC4/2007

Party Name:FINE ORGANIC INDUSTRIES(MUMBAI) PVT. LTD. 01.04.2008 Status:Case Approved HQ File :01/82/050/00486/AM08/ RLA File :03/94/040/01026/AM08/ Lic.No/Date:0310457884 16.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Sodium Stearyl Lactylate under para 4 7 of

62 Decision : Committee considered case as per agenda for ratification of norms for export product Sodium Stearyl Lactylate under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/108/2003‐Ch.III signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Sodium Stearyl Lactate 1kg. 1. Lactic Acid 0.444 kg/kg 2. Stearic Acid 0.700 kg/kg 63

Case No.:45/45/82‐ALC4/2007

Party Name:LAFFANS PETROCHEMICALS LTD., 01.04.2008 Status:Case Deferred HQ File :01/82/050/00508/AM08/ RLA File :03/95/040/01003/AM08/ Lic.No/Date:0310457833 16.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Laffsolve MEB (Ethylene Glycol Mono Butyl Ether) under para 4.7 of HBP. 64

Case No.:50/45/82‐ALC4/2007

Party Name:KALPSUTRA CHEMICALS PVT. LTD. 01.04.2008 Status:Case Deferred HQ File :01/82/050/00513/AM08/ RLA File :03/94/040/01020/AM08/ Lic.No/Date:0310457797 16.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Timberfleur (1‐(2,2,6‐Trimethyl Cyclohexyl)‐ Hexan‐3‐01) under para 4.7 of HBP. 65

Case No.:8/44/83‐ALC1/2007

Party Name:SHIVA PHARMACHEM PVT. LTD, 01.04.2008 Status:Case Deferred HQ File :01/83/050/01802/AM08/ RLA File :34/24/040/00208/AM08/ Lic.No/Date:3410020655 21.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product n‐Butyryl Chloride/Butyryl Chloride under 4 7 f HBP

para 4.7 of HBP.

Case No.:62/45/82‐ALC4/2007

Party Name:NICHOLAS PIRAMAL INDIA LTD. 01.04.2008 Status:Case Deferred HQ File :01/82/050/00525/AM08/ RLA File :03/95/040/01007/AM08/ Lic.No/Date:0310458373 21.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Oxysept Tablets (9081X) Contact Lens Cleaning tablets under para 4.7 of HBP. Committee decided to remind DBT for their comments. Accordingly, case was deferred for four weeks. 67

Case No.:56/45/82‐ALC4/2007

Party Name:OLEOFINE ORGANICS (INDIA)PVT.LTD., 01.04.2008 Status:Case Deferred HQ File :01/82/050/00519/AM08/ RLA File :03/95/040/01050/AM08/ Lic.No/Date:0310458576 22.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Behenamide under para 4.7 of HBP. 68

Case No.:82/45/82‐ALC4/2007

Party Name:SUDERSHAN LABORATORIES LTD. 01.04.2008 Status:Case Deferred HQ File :01/82/050/00545/AM08/ RLA File :09/24/040/00476/AM08/ Lic.No/Date:0910032726 24.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product N Butyl Lithium (1.6 M Solution‐As 100% W/W)

Case No.:11/45/82‐ALC4/2007

Party Name:AARTI INDUSTRIES LIMITED 01.04.2008 Status:Case Approved HQ File :01/82/050/00474/AM08/ RLA File :03/94/040/01078/AM08/ Lic.No/Date:0310459141 25.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2,4 Dichloro Aniline under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/28/2005/Ch.III signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2,4 Dichloro Aniline 1kg. 1. Meta Dichloro Benzene 1.18 kg/kg 70

Case No.:40/45/82‐ALC4/2007

Party Name:HALDIA PETROCHEMICALS LTD. 01.04.2008 Status:Case Deferred HQ File :01/82/050/00503/AM08/ RLA File :02/24/040/00285/AM08/ Lic.No/Date:0210108551 25.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Benzene under para 4.7 of HBP. Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for his comments. Accordingly, case was deferred for four weeks. 71

Case No.:54/45/82‐ALC4/2007

Party Name:LAFFANS PETROCHEMICALS LTD., 01.04.2008 Status:Case Deferred HQ File :01/82/050/00517/AM08/ RLA File :03/95/040/01046/AM08/ Lic.No/Date:0310459172 25.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Laᡓ�ol DEB (Di Ethylene Glycol Mono Butyl Ether)(Butyl Di Glycol) under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Chemical Division

Case No.:2/1/82‐ALC4/2008

Party Name:ALKALI METALS LTD., 01.04.2008 Status:Case Approved HQ File :01/82/050/00608/AM08/ RLA File :09/24/040/00250/AM08/ Lic.No/Date:0910032782 28.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2,6‐Diamino Pyridine under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/114/2002‐Ch.III signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2,6‐Diamino Pyridine 1kg. 1. Pyridine 0.805 kg/kg 2. Sodium Metal 0.469 kg/kg 73

Case No.:3/1/82‐ALC4/2008

Party Name:ALKALI METALS LTD., 01.04.2008 Status:Case Approved HQ File :01/82/050/00609/AM08/ RLA File :09/24/040/00095/AM08/ Lic.No/Date:0910032780 28.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2,6,Diamino Pyridine under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/114/2002‐Ch.III signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2,6‐Diamino Pyridine 1kg. 1. Pyridine 0.805 kg/kg 2. Sodium Metal 0.469 kg/kg

Case No.:4/1/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 01.04.2008 Status:Case Approved HQ File :01/82/050/00610/AM08/ RLA File :09/24/040/00436/AM08/ Lic.No/Date:0910032779 28.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Cefposoxime Proxetil under para 4.7 of HBP. Committee in light of its earlier decision taken in its 41/82 meeting held on 12.02.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Quantity Sl.No. Import items Qty allowed per unit of export product Cefpodoxime Proxetil 1kg. 1. 7 ACA 0.998kg/kg 2. 1,8‐diazabicyclo [5.4.0]‐ undec‐7‐ene 0.341kg/kg 3. 18‐crown‐6‐ether 0.023kg/kg 4. 1‐iodo ethyl isopropy carbonate 0.7412kg/kg 5. 4‐Dimethyl amino Pyridine 0.006kg/kg 6. Acetone 1.10kg/kg 7. Carbon Enoanticromos (Activated Carbon) 0.100kg/kg 8. Isopropyl alcohol 0.150kg/kg 9. Mercaptobenzothiazole‐4‐ yl‐2‐(2‐Amino)thiazoly)‐ Methoxyimino Acetate (MAEM) 0.998kg/kg 10. Methanol 3.85kg/kg 11. Methylene chloride 2.65kg/kg 12. N,N‐Dimethyl Acetamide 1.95kg/kg 13. Iodine 0.469kg/kg 14. Sulfolane 1.29kg/kg 15. Tetrahydrofuran 0.52kg/kg 16. Tri phosgene 0.6421kg/kg

RA concerned may take further necessary action as per above decision of Norms Committee. 75

Case No.:5/1/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 01.04.2008 Status:Case Deferred HQ File :01/82/050/00611/AM08/ RLA File :09/24/040/00038/AM08/ Lic.No/Date:0910032781 28.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Cefprozil (Cefprozil Monohydrate) under para 4.7 of HBP. 76

Case No.:1/42/82‐ALC4/2007

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 01.04.2008 Status:Case Approved HQ File :01/82/050/00334/AM08/ RLA File :08/24/040/00205/AM07/ Lic.No/Date:0810069835 28.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Tetra‐N‐Octyl Ammonium Bromide under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/34/2003/Ch.III signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Tetra N‐octyl Ammonium Bromide 1kg. 1. Tri‐n‐octyl Amine 0.718 kg/kg 2. n‐Octanol 0.294 kg/kg 3. Liquid Bromide 0.362 kg/kg

Case No.:2/42/82‐ALC4/2007

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 01.04.2008 Status:Case Approved HQ Fil 01/82/050/00335/AM08/ RLA Fil 08/24/040/00229/AM07/ Li N /D t 0810069836

77 HQ File :01/82/050/00335/AM08/ RLA File :08/24/040/00229/AM07/ Lic.No/Date:0810069836 28.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Methyl Tri Phenyl Phosphonium Chloride Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/89/2002/Ch.III signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Methyl Triphenyl Phosphonium Chloride 1kg. 1. Triphenyl Phosphine 1.035 kg/kg 2. Acetonitrile 0.400 kg/kg 3. Isopropyl Alcohol 0.200 kg/kg 78

Case No.:3/42/82‐ALC4/2007

Party Name:R.K.INDUSTRIES, 01.04.2008 Status:Case Approved HQ File :01/82/050/00336/AM08/ RLA File :08/24/040/00247/AM08/ Lic.No/Date:0810069837 28.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Ortho Toluidine 5 Sulfonic Acid under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/147/2005/Ch.II signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Ortho Toluidine 5‐Sulfonic Acid 1kg. 1. Ortho Toluidine 0.786 kg/kg 2. Caustic Soda 0.310 kg/kg

Case No.:6/45/82‐ALC4/2007

Party Name:JOCIL LTD., 01.04.2008 Status:Case Deferred HQ Fil 01/82/050/00469/AM08/ RLA Fil 09/24/040/00417/AM08/ Li N /D t 0910032743 D f D t

79 HQ File :01/82/050/00469/AM08/ RLA File :09/24/040/00417/AM08/ Lic.No/Date:0910032743 28.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Pink/Yellow/Green Soap Noodles Sodium Salt of Palmitic Acid under para 4.7 of HBP. Committee decided to call for following information from firm:‐ 1. Percentage TFM content in export. 2. Calculation Sheet to arrive at the quantity of raw materials asked for on the basis of percentage TFM content in export and 3. Quantity and commercial value of each of the by product obtained during manufacture. Accordingly, case was deferred for four weeks. 80

Case No.:83/45/82‐ALC4/2007

Party Name:DUJODWALA PAPER CHEMICALS LTD 01.04.2008 Status:Case Deferred HQ File :01/82/050/00546/AM08/ RLA File :03/94/040/00956/AM08/ Lic.No/Date:0310459419 29.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Polyamide Resin under para 4.7 of HBP. Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for his comments. Accordingly, case was deferred for four weeks. 81

Case No.:88/45/82‐ALC4/2007

Party Name:VIVIMED LABS LIMITED 01.04.2008 Status:Case Approved HQ File :01/82/050/00551/AM08/ RLA File :09/24/040/00422/AM08/ Lic.No/Date:0910032808 29.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product BEN‐3/Benzophenone‐3/2‐Hydroxy‐4‐Methoxy Benzophenone/Oxybenzone under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/84/2007/Ch.II dated 08.02.2008 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 per unit of export

product Benzophenone‐3 (Purity min. 99%) 1kg. 1. Benzophenone‐3 Crude (Purity 96‐97%) 1.05 kg/kg 2. Methanol 0.500 kg/kg 82

Case No.:4/42/82‐ALC4/2007

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 01.04.2008 Status:Case Approved HQ File :01/82/050/00337/AM08/ RLA File :08/24/040/00180/AM07/ Lic.No/Date:0810069862 30.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Methyl Tri Butyl Ammonium Chloride 75% solution in Water under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/34/2003/Ch.III signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Methyl Tributyl Ammonium Chloride 75% Solution in water 1kg. 1. Tributyl Amine 0.655 kg/kg 2. Acetonitrile Not allowed because not supported by technical literature 83

Case No.:26/45/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.04.2008 Status:Case Deferred HQ File :01/82/050/00489/AM08/ RLA File :07/24/040/00593/AM08/ Lic.No/Date:0710055673 31.01.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Calcium Lactobionate, Calcium Glubionate and Calcium Bromolactobionate under para 4.7 of HBP. C i d id d d f f f k f f Ch i l Di i i

Case No.:38/45/82‐ALC4/2007

Party Name:NANAVATI SPECIALITY CHEMICALS PVT LTD 01.04.2008 Status:Case Approved HQ File :01/82/050/00501/AM08/ RLA File :03/95/040/01002/AM08/ Lic.No/Date:0310459796 01.02.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2 Nitro Dimethyl Terephthalate under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/88/2007‐Ch.II signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2 Nitro Dimethyl Terephthalate 1kg. 1. Dimethyl Terephthalate 0.810 kg/kg 85

Case No.:41/45/82‐ALC4/2007

Party Name:MAKAM PHARMACHEM 01.04.2008 Status:Case Deferred HQ File :01/82/050/00504/AM08/ RLA File :07/24/040/00741/AM08/ Lic.No/Date:0710055677 01.02.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Fluemetrin 1% W/V Pour under para 4.7 of HBP. Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for four weeks.

Case No.:72/45/82‐ALC4/2007

Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 01.04.2008 Status:Case Approved HQ File :01/82/050/00535/AM08/ RLA File :34/24/040/00216/AM08/ Lic.No/Date:3410020758 01.02.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Methyl Tributyl Ammonium Chloride under

para 4.7 of HBP.

Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/84/2002‐Ch.II signed on 01.04.2008 d id d 奱�f d 4 7 f HBP d il b l li d b fi hi h i l

86 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Methyl Tributyl Ammonium Chloride (Assay:75+ 2%) 1kg. 1. Tributylamine 0.625 kg/kg 87

Case No.:31/45/82‐ALC4/2007

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 01.04.2008 Status:Case Approved HQ File :01/82/050/00494/AM08/ RLA File :03/94/040/01086/AM08/ Lic.No/Date:0310459938 04.02.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Protectol DA Or 2,4‐Dichloro Benzyl Alcohol Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/106/2004/Ch.II signed on 01.04.2008 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2,4 Dichloro Benzyl Alcohol (Protectol DA) 1kg. 1. 2,4 Dichloro Benzyl Chloride 1.412 kg/kg 2. Caustic Soda 0.730 kg/kg

Case No.:121/42/82‐ALC4/2007

Party Name:BODAL CHEMICALS LTD 01.04.2008 Status:Case Approved HQ File :01/82/050/00457/AM08/ RLA File :08/24/040/00251/AM08/ Lic.No/Date:0810069963 06.02.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Acid Brown 355 under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/1/2007/Ch.III signed on 01.04.2008

88 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Acid Brown 355 1kg. 1. Beta Napthol 0.542 kg/kg 2. Sodium Nitrite 0.337 kg/kg 3. 1‐Phenyl 3‐Methyl‐5‐ Pyrazolone 0.225 kg/kg 4. Salicylic Acid 0.160 kg/kg 89

Case No.:37/45/82‐ALC4/2007

Party Name:PRIVI ORGANICS LTD 01.04.2008 Status:Case Deferred HQ File :01/82/050/00500/AM08/ RLA File :03/95/040/01082/AM08/ Lic.No/Date:0310460511 11.02.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Amber Fleur under para 4.7 of HBP. 90

Case No.:1/1/82‐ALC4/2008

Party Name:ANUS LABORATORIES LTD., 01.04.2008 Status:Case Deferred HQ File :01/82/050/00607/AM08/ RLA File :09/24/040/00477/AM08/ Lic.No/Date:0910033036 21.02.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Sodium Methoxide Solution 25% under para 4.7 of HBP. 91

Case No.:8/1/82‐ALC4/2008

Party Name:AMBUJA INTERMEDIATES PVT. LTD. 01.04.2008 Status:Case Deferred HQ File :01/82/050/00614/AM08/ RLA File :03/94/040/01106/AM08/ Lic.No/Date:0310462021 21.02.2008 Defer Date: 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐CNS Acid under para 4.7 of HBP.

Case No.:6/1/82‐ALC4/2008

Party Name:FMC INDIA PRIVATE LIMITED 01.04.2008 Status:Case Approved HQ File :01/82/050/00612/AM08/ RLA File :07/24/040/00789/AM08/ Lic.No/Date:0710056002 22.02.2008 Decision : Committee considered case as per agenda for ratification of norms for export product N‐Butyl Lithium (15% Hexane as 100%) under

para 4.7 of HBP.

Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/8/2003‐Ch.III signed on 01.04.2008 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 per unit of export product N‐Butyl Lithium (15% w/w in n‐Hexane) 1kg. 1. Lithium Metal 0.023 kg/kg 2. n‐Butyl Chloride 0.240 kg/kg 3. n‐Hexane 1.000 kg/kg 93

Case No.:9/1/82‐ALC4/2008

Party Name:BODAL CHEMICALS LTD 01.04.2008 Status:Case Deferred HQ File :01/82/050/00615/AM08/ RLA File :08/24/040/00269/AM08/ Lic.No/Date:0810070791 19.03.2008 Defer Date: 13.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product under para 4.7 of HBP. Committee decided to call for a copy of application alongwith a copy of Advance Authorisation from RA/firm. Accordingly, case was deferred for six weeks.

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