IN FORCE Norms Committee — Engineering (Gr B / NC-I) Advance Authorisation 2008-08-12

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Para 4.7 Decision

MEETING NUMBER : 21/82‐ALC4/2008 MEETING DATE : 19.08.2008 The Meeting No.21/09 in the year 2008‐09 to consider the cases under Duty Exemption Scheme (Chapter‐4) of Foreign Trade Policy, 2004‐09 pertaining to products falling in Chapter 29 and 30 due for 19.08.2008 was actually held on 21.08.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. Following members were present:‐ 1. Shri Jasbir Singh, IA, Chemical Division, C & PC 2. Shri D.N. Mathur, Dy. IA, PI Division, C & PC. 3. Shri Rajinder Pal Singh, Dy. DGFT 4. Shri Shyam Lal, FTDO

Case No.B‐151

M/S Camphor & Allied Products Ltd. Norms Committee Meeting No.21/09 F.No.01/83/050/01024/AM08 Meeting Date: 19.08.2008 RA F.No.03/94/040/00453/AM08 Adv.Lic.No.0310439513 dated 14.08.2007 Committee considered case as per agenda for allowing import of Dipropylene Glycol and in consultation with technical authority present in meeting decided to amend the description of import item No.5 to read as “Diethyl Phthalate/Isopropyl myristate/Benzyl Benzoate/Dipropylene Glycol”. RA concerned may take further necessary action as per above decision of NC.

Case No.B‐152

M/S Vivimed Labs. F.No.01/83/050/00820/AM08 RA F.No.09/24/040/00156/AM08 Adv.Lic.No.0910030971 dated 23.07.2007 Committee considered the case as per agenda and observed that earlier NC in its 45/83 meeting held on 13.02.2008 had allowed the quantity of Para Tertiary Butyl as 1.387 kg, while the firm has applied the quantity of said product as 1.148 kg. Committee, therefore, decided to reduce the quantity of Para Tertiary Butyl to read as 1.148 kg. and to enhance the quantity of Methanol to read as 2.056 kg.

Case No.B‐153

M/S Vivimed Labs.

F.No.01/83/050/00387/AM08 RA F.No.09/24/040/00060/AM08 Adv.Lic.No.0910030685 dated 29.06.2007 Committee considered the case as per agenda and observed that earlier NC in its 1/83 meeting held on 02.04.2008 had allowed the quantity of Para Tertiary Butyl as 1.387 kg, while the firm has applied the quantity of said product as 1.148 kg. Committee, therefore, decided to reduce the quantity of Para Tertiary Butyl to read as 1.148 kg. and to enhance the quantity of Methanol to read as 2.056 kg.

Case No.B‐154

M/S Vivimed Labs. F.No.01/83/050/00622/AM08 RA F.No.09/24/040/00106/AM08 Adv.Lic.No.0910030685 dated 29.06.2007 Committee considered the case as per agenda and observed that earlier NC in its 45/83 meeting held on 13.02.2008 had allowed the quantity of Para Tertiary Butyl as 1.387 kg, while the firm has applied the quantity of said product as 1.148 kg. Committee, therefore, decided to reduce the quantity of Para Tertiary Butyl to read as 1.148 kg. and to enhance the quantity of Methanol to read as 2.056 kg.

Case No.B‐155

M/S Vivimed Labs. F.No.01/83/050/01192/AM07 RA F.No.09/24/040/00449/AM07 Adv.Lic.No.0910029183 dated 05.02.2007 Committee considered the case as per agenda and observed that earlier NC in its 46/83 meeting held on 20.02.2008 had allowed the quantity of Para Tertiary Butyl as 1.387 kg, while the firm has applied the quantity of said product as 1.148 kg. Committee, therefore, decided to reduce the quantity of Para Tertiary Butyl to read as 1.148 kg. and to enhance the quantity of Methanol to read as 2.056 kg.

Case No.B‐156

M/S Vivimed Labs. F.No.01/83/050/01405/AM08 RA F.No.09/24/040/00318/AM08 Adv.Lic.No.0910031862 dated 23.10.2007 Committee considered the case as per agenda for enhancement in the quantity of Methanol and in consultation with technical authority present in meeting decided to allow enhancement in the quantity of Methanol from 0.500 kg to 1.00 kg.

Case No.B‐157

M/S Redox Pharmachem Pvt. Ltd. F.No.01/83/050/01547/AM08 RA F.No.05/24/040/00624/AM08 Adv.Lic.No.0510211848 dated 08.11.2007 Committee considered case as per agenda and in consultation with technical authority present in meeting decided to call for copy of invoice and Bill of Entry indicating the purity level of the import item. Accordingly, case was deferred for 07.10.2008.

Case No.B‐158

M/S Aurobindo Pharma Ltd. F.No.01/83/050/01504/AM08 RA F.No.09/24/040/00051/AM08 Adv.Lic.No.0910031991 dated 05.11.2007 Committee considered the case as per agenda and observed that there is a typographical mistake in the description of import items at Sl.No.8 and 10. Committee, therefore, decided to allow correction in the description of above two inputs to read as “Trimethyl Chlorosilane (TMCS) and Iso Propyl Alcohol (IPA).

Case No.B‐159

M/S Alkem Laboratories Ltd. F.No.01/83/050/00409/AM08 RA F.No.03/94/040/00187/AM08 Adv.Lic.No.0310430680 dated 25.05.2007 Committee decided to defer case for 07.10.2008 for comments of PI Division.

Case No.B‐160

M/S Cipla Ltd. F.No.01/82/050/01837/AM07 RA F.No.03/94/040/01468/AM07 Adv.Lic.No.0310423777 dated 21.03.2007 Committee decided to defer case for 23.09.2008 for comments of PI Division.

Case No.B‐161

M/S Global Calcium Pvt. Ltd. F.No.01/82/050/00879/AM07 RA F.No.07/24/040/00365/AM07 Adv.Lic.No.0710047301 dated 08.09.2006

Committee considered case as per agenda for enhancement in the quantity of Copper Carbonate 80% (Cupric Carbonate) and in light of Production and consumption data certified by Central Excise Authority enclosed with the agenda and in consultation with technical authority present in meeting decided to allow enhancement in the quantity of above input from 0.379 kg to 0.391 kg. per kg. of export product.

Case No.B‐162

M/S Aroma Aromatics & Flavours F.No.01/83/050/01014/AM08 RA F.No.05/24/040/00387/AM08 Adv.Lic.No.0510208035 dated 23.08.2007 Committee considered case as per agenda for enhancement in the quantity of inputs and in consultation with technical authority present in meeting decided to maintain status quo as there is no justification for enhancement in the quantity of inputs.

Case No.B‐163

M/S Anuh Pharma Ltd. F.No.01/87/050/00015/AM07 RA F.No.03/94/040/01269/AM06 Adv.Lic.No.0310368569 dated 24.02.2006 Committee decided to defer case for 07.10.2008 for comments of PI Division.

Case No.B‐164

M/S Siddi Vinayaka Spechem Pvt. Ltd. F.No.01/87/050/01441/AM06 RA F.No.07/24/040/00915/AM06 Adv.Lic.No.0710043512 dated 06.03.2006 Committee considered case as per agenda and in consultation with technical authority present in meeting decided to call from firm Production and Consumption data certified by Central Excise Authority. Accordingly, case was deferred for 07.10.2008.

Case No.B‐165

M/S Acacia Sciences Pvt. Ltd. F.No.01/87/050/01086/AM07 RA F.No.09/24/040/00492/AM07 Adv.Lic.No.0910029581 dated 08.03.2007 Committee decided to defer case for 07.10.2008 for comments of PI Division.

Case No.B‐166

M/S Kudoes Chemie Ltd F.No.01/83/050/01362/AM06

RA F.No.22/24/040/00067/AM06 Adv.Lic.No.2210005252 dated 15.02.2006 Committee considered case as per agenda for ratification of norms and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import item Qty. allowed Caffeine anhydrous 1 kg. 1. Theophylline Anhydrous BP2003/USP28 1 kg.

Case No.B‐167

M/S Lupin Ltd. F.No.01/82/050/01655/AM07 RA F.No.03/95/040/01385/AM07 Adv.Lic.No.0310420107 dated 20.02.2007 Committee considered case as per agenda for amendment in the measurement of the quantity of import item Sodium Rifa‐S and in consultation with technical authority present in meeting decided to allow amendment in the measurement in the quantity of above input from KG to KGA. Committee observed that the unit of measurement of Sodium Rifa‐S is KGA (Kg. Activity), but in the online system, this unit is not available and computer does not accept “KGA” on online applications and firm has to write this unit of measurement manually in the applications which are submitted to RLA. NIC may be requested to take necessary action for making necessary amendments in so䬀ware so that the applications where unit of measurement against import item is written as “KGA” are accepted in the same form.

Case No.B‐168

M/S Kores (India) Ltd. F.No.01/83/050/00502/AM08 RA F.No.07/24/040/00915/AM06 Adv.Lic.No.0710043512 dated 06.03.2006 Committee decided to defer case for 07.10.2008 for comments of PI Division.

Case No.B‐169

M/S Agio Pharmaceuticals Ltd. F.No.01/87/050/00925/AM08 Committee considered case as per agenda and decided to call for an undertaking from firm that Prednisolone Sodium Phosphate Injections exported by them against the 20 Advance licences were actually based on 30 mg/ml of

Prednisolone Base on Anhydrous basis. Accordingly, case was deferred for 02.09.2008.

Case No.B‐170

M/S Jaytick Intermediates Pvt. Ltd. F.No.01/82/050/00400/AM09 RA F.No.03/94/040/00008/AM09 Adv.Lic.No.0310469569 dated 25.04.2008 Committee considered case as per agenda and observed that this case was considered by NC in its 17/82 meeting held on 22.07.2008 and following decision was taken:‐ “Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/136/2004/Ch.II dated 05.09.2005 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 1:6 Cleves Acid (1‐ Napthylamine 6‐Sulphonic Acid) 98% purity 1 Kg. 1. 1:6 Cleves Acid Crude (purity 93‐ 97%) 1.057 kg/kg Committee was informed that the firm was allowed 4% wastage in respect of Advance Authorisation No.0310290449 dated 10.09.2004 (purity of import item 97% max.). Committee in consultation with the representative of Technical Authority present in the meeting decided to allow 4% wastage in respect of Advance Authorisation dated 25.04.2008.

Case No.B‐171

M/S Vivek Pharmachem Ltd F.No.01/82/050/00243/AM08 RA F.No.13/24/40/00022/AM08 Adv.Lic.No.1310025278 dated 31.10.2007 Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/140/2007‐PI‐III dated 17.07.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Meropenem Injection USP 1 GM. Potency 100% (+/‐5%)Total weight (1080 kgs) 1 Vial 1. Meropenem for Injection USP Potency Between 69 to 84% on as is basis 1197.90 mg

Case No.B‐172

M/S Jaytick Intermediates Pvt. Ltd. F.No.01/82/050/00471/AM07 F.No.01/83/162/1502/AM01 RA F.No.03/94/040/298/AM07 RA F.No.03/24/040/839/AM00 Adv.Lic.No.0310386025 dated 21.06.2006 Adv.Lic.No.031057245 dated 16.10.2000 Committee considered case as per agenda and decided to defer case for 02.09.2008.

Case No.B‐173

M/S Jubilant Organosys F.No.01/82/162/415/AM09 Committee considered case as per agenda and in consultation with representative of technical authority present in meeting decided to clarify that “1,4 Dihydro‐1‐ethyl‐7‐methyl‐4‐Oxo‐1, 8‐naphlhyridine‐3‐Carboxylic and Crude” and N alidixic Acid are same export product with different purity level having same ITC(HS) Classification No. viz 29183030. It was decided to send clarification to JDG(TM).

Case No.A‐78

M/S Baader Schulz Laboratoires F.No.01/82/162/00368/AM09 RA F.No.03/94/040/00202/AM09 Case under para 4.4.2 of HBP. Committee considered case as per agenda and decided to call for a copy of Drug Manufacturing Licence from firm. Accordingly, case was deferred for 07.10.2008.

Case No.C‐53

M/S Aar奱� Industries Ltd. F.No.01/82/162/01049/AM08 Committee considered the case for fixation of SION for export product Mono Methyl Aniline and decided to forward a copy of letter received from Chemexcil to Chemical Division of C&PC for their comments. Accordingly case was deferred for 07.10.2008.

Case No.C‐54

M/S India Glycol Ltd. F.No.01/82/162/00940/AM08 Committee considered case as per agenda for fixation of SION for export product (1) Ethylene Glycol Mono Ethyl/Ether Acetate (IGACE6701 E), (2) Ethylene Glycol Mono Ethyl Ether (IGSOL 12026E), (3) Diethylene Glycol Mono Ethyl Ether (IGTOL‐12016E) and (4) Diethylene Glycol Mono Ethyl Ether Acetate (IGACE‐8801 E). Committee in light of written comments forwarded by Chemical Division of C&PC vide their U.O. Nos.14010/7/2003/Ch.III all dated 21.04.2008 and in consultation with technical authority present in meeting decided to fix SIONs as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Ethylene Glycol Mono Ethyl Ether Acetate (IGACE‐6701 E) 1 Kg. 1. Denatured Ethyl alcohol 0.920 kg. 2. Acetic Acid 0.470 kg 3. Silver Catalyst 0.000288 kg 4. Alumina Catalyst 0.000264 kg 5. Sodium Hydroxide 0.0033 kg. Diethylene Glycol Mono Ethyl Ether (IGTOL‐12016 E) 1 Kg. 1. Denatured Ethyl alcohol 1.32 kg. 2. Sodium Hydroxide 0.0048 kg 3. Silver Catalyst 0.000288 kg 4. Alumina Catalyst 0.000264 kg Diethylene Glycol Mono Ethyl Ether Acetate (IGACE‐8801 E) 1 Kg. 1. Denatured Ethyl alcohol 1.08 kg. 2. Acetic Acid 0.371 kg 3. Silver Catalyst 0.000288 kg 4. Alumina Catalyst 0.000264 kg 5. Sodium Hydroxide 0.0033 kg. On the basis of written comments referred to above, Committee also decided to amend SION at Sl.No.A‐3303 as under:‐ Ethylene Glycol Mono Ethyl Ether (IGSOL‐12026E) 1 Kg. 1. Denatured Ethyl alcohol 1.30 kg. 2. Silver Catalyst 0.000288 kg 3. Alumina Catalyst 0.000264 kg 4. Sodium Hydroxide 0.0048 kg. It was also decided to delete the entry appearing at Sl.No.A‐3447 being duplicate entry appearing at Sl.No.A‐ 3303 also. 1

Case No.:533/21/82‐ALC4/2007

Party Name:LUPIN LIMITED Meet No/Date:21/82‐ALC4/2008 Status:Case

19.08.2008 Approved HQ File :01/82/050/01054/AM07/ RLA File :03/95/040/00793/AM07/ Lic.No/Date:0310401715 28.09.2006 Decision :Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/238/2006‐PI‐III dated 21.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Rifampicin BP/USP 1 Kg. 1. Sodium Rifa‐S 1.02 KGA 2. Chloroform 0.661 kg 3. Acetic Acid 0.16 kg 4. Piperazine Anhydrous 0.12 kg 5. Methylene Chloride 0.933 kg. 6. Isopropyl alcohol 0.615 kg 7. Dimethyl formamide 0.80 kg 8. Tertiary Butyl Amine 0.314 kg 9. Acetone 0.832 kg 10. 1‐Amino‐4‐methyl piperazine 0.16 kg 2

Case No.:7/2/82‐ALC4/2007

Party Name:CIPLA LIMITED 19.08.2008 Status:Case Deferred HQ File :01/82/050/01804/AM07/ RLA File :03/94/040/01443/AM07/ Lic.No/Date:0310422972 13.03.2007 Defer Date:16.09.2008 Decision :Committee decided to defer case for 16.09.2008 for comments of PI Division. 3

Case No.:2/4/85‐ALC3/2007

Party Name:HEINZ INDIA PRIVATE LIMITED 19.08.2008 Status:Case Deferred HQ File :01/85/050/00259/AM07/ RLA File :03/94/040/01338/AM07/ Lic.No/Date:0310424928 29.03.2007 Defer Date:16.09.2008 Decision : Committee decided to defer case for 16.09.2008 for comments of Ministry of Food Processing Industry. 4

Case No.:52/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 19.08.2008 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:16.09.2008 Decision : Committee decided to defer case for 16.09.2008 for comments of Chemical Division.

Case No.:591/24/83‐ALC1/2007

Party Name:GANGWAL CHEMICALS (P) LTD. 19.08.2008 Status:Case Transferred HQ File :01/83/050/00315/AM08/ RLA File :03/94/040/00122/AM08/ Lic.No/Date:0310429161 11.05.2007 Decision :Committee decided to transfer the case to NC‐VI as the export product pertains to Food Products. 6

Case No.:893/24/83‐ALC1/2007

Party Name:GARUDA CHEMICALS 19.08.2008 Status:Case Deferred HQ File :01/83/050/00900/AM08/ RLA File :03/94/040/00413/AM08/ Lic.No/Date:0310438614 07.08.2007 Defer Date:16.09.2008 Decision :Committee observed that the firm has been requested to furnish technical information vide letter dated 25.07.2008, but no reply has been received. It was, therefore, decided to await reply of firm and defer the case for 16.09.2008. 7

Case No.:86/42/82‐ALC4/2007

19.08.2008 Status:Case Approved HQ File :01/82/050/00422/AM08/ RLA File :03/94/040/00524/AM08/ Lic.No/Date:0310440273 21.08.2007 Decision :Case has already been approved by NC in its 18/09 meeting held on 29.07.2008. 8

Case No.:87/42/82‐ALC4/2007

19.08.2008 Status:Case Deferred HQ File :01/82/050/00423/AM08/ RLA File :03/94/040/00535/AM08/ Lic.No/Date:0310440429 22.08.2007 Defer Date:16.09.2008 Decision : Committee decided to defer case for 16.09.2008 for comments of PI Division. 9

Case No.:35/27/83‐ALC1/2007

Party Name:SHREE GANESH CHEMICALS 19.08.2008 Status:Case Deferred HQ File :01/83/050/01109/AM08/ RLA File :34/24/040/00089/AM08/ Lic.No/Date:3410019570 05.09.2007 Defer Date:16.09.2008 10

Case No.:95/42/82‐ALC4/2007

19.08.2008 Status:Case Deferred HQ File :01/82/050/00431/AM08/ RLA File :03/94/040/00674/AM08/ Lic.No/Date:0310445040 03.10.2007 Defer Date:16.09.2008

Case No.:53/30/83‐ALC1/2007

Party Name:MANTENA LABORATORIES LIMITED 19.08.2008 Status:Case Approved HQ File :01/83/050/01422/AM08/ RLA File :09/24/040/00560/AM07/ Lic.No/Date:0910031881 24.10.2007 Decision : Case has already been approved by NC in its 19/09 meeting held on 05.08.2008. 12

Case No.:106/42/82‐ALC4/2007

Party Name:LUPIN LIMITED 19.08.2008 Status:Case Deferred HQ File :01/82/050/00442/AM08/ RLA File :03/95/040/00604/AM08/ Lic.No/Date:0310447771 25.10.2007 Defer Date:16.09.2008 13

Case No.:75/32/83‐ALC1/2007

Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:21/82‐ALC4/2008 19.08.2008 Status:Case Approved HQ File :01/83/050/01497/AM08/ RLA File :09/24/040/00253/AM08/ Lic.No/Date:0910031942 02.11.2007 Decision : Case has already been approved by NC in its 19/09 meeting held on 05.08.2008. 14

Case No.:110/42/82‐ALC4/2007

19.08.2008 Status:Case Approved HQ File :01/82/050/00446/AM08/ RLA File :03/94/040/00857/AM08/ Lic.No/Date:0310450548 16.11.2007 Decision : Case has already been approved by NC in its 18/09 meeting held on 29.07.2008. 15

Case No.:111/42/82‐ALC4/2007

19.08.2008 Status:Case Approved HQ File :01/82/050/00447/AM08/ RLA File :03/94/040/00860/AM08/ Lic.No/Date:0310450692 19.11.2007 16

Case No.:8/40/81‐ALC2/2007

Party Name:ULTRA‐TECH INDIA LTD. 19.08.2008 Status:Case Approved HQ File :01/81/050/00446/AM08/ RLA File :03/95/040/00813/AM08/ Lic.No/Date:0310450707

19.11.2007 17

Case No.:173/39/83‐ALC1/2007

19.08.2008 Status:Case Approved HQ File :01/83/050/01752/AM08/ RLA File :03/94/040/00853/AM08/ Lic.No/Date:0310453734 12.12.2007 18

Case No.:50/9/82‐ALC4/2008

19.08.2008 Status:Case Approved HQ File :01/82/050/00283/AM09/ RLA File :03/94/040/00975/AM08/ Lic.No/Date:0310455195 26.12.2007 Decision : Case has already been approved by NC in its 19/09 meeting held on 05.08.2008. 19

Case No.:75/45/82‐ALC4/2007

Party Name:VIDA LABORATORIES (P) LTD 19.08.2008 Status:Case Deferred HQ File :01/82/050/00538/AM08/ RLA File :07/24/040/00686/AM08/ Lic.No/Date:0710055140 31.12.2007 Defer Date:16.09.2008 20

Case No.:20/45/82‐ALC4/2007

Party Name:ALKALOIDS CORPORATION 19.08.2008 Status:Case Deferred HQ File :01/82/050/00483/AM08/ RLA File :02/24/040/00272/AM08/ Lic.No/Date:0210107833 04.01.2008 Defer Date:16.09.2008 21

Case No.:18/45/82‐ALC4/2007

Party Name:ANUH PHARMA LTD. 19.08.2008 Status:Case Approved HQ File :01/82/050/00481/AM08/ RLA File :03/94/040/00917/AM08/ Lic.No/Date:0310456985 08.01.2008 Decision : Case has already been approved by NC in its 19/09 meeting held on 05.08.2008. 22

Case No.:81/11/82‐ALC4/2008

Party Name:INDO AMINES LIMITED 19.08.2008 Status:Case Deferred

HQ File :01/82/050/00401/AM09/ RLA File :03/94/040/01098/AM07/ Lic.No/Date:0310458675 23.01.2008 Defer Date:16.09.2008 Decision :Committee observed that the firm has been requested to furnish end use of export product and technical literature in support of yield claimed vide letter dated 11.08.2008, but no reply has been received. It was, therefore, decided to await reply of firm and defer the case for 16.09.2008. 23

Case No.:73/45/82‐ALC4/2007

Party Name:WIN‐MEDICARE PVT. LTD 19.08.2008 Status:Case Approved HQ File :01/82/050/00536/AM08/ RLA File :05/24/040/00267/AM08/ Lic.No/Date:0510215725 31.01.2008 Decision : Case has already been approved by NC in its 19/09 meeting held on 05.08.2008. 24

Case No.:19/46/82‐ALC4/2007

19.08.2008 Status:Case Approved HQ File :01/82/050/00573/AM08/ RLA File :03/94/040/01202/AM08/ Lic.No/Date:0310462533 25.02.2008 25

Case No.:123/11/82‐ALC4/2008

Party Name:HETERO LABS LTD. 19.08.2008 Status:Case Approved HQ File :01/82/050/00443/AM09/ RLA File :09/24/040/00561/AM08/ Lic.No/Date:0910033211 04.03.2008 Decision : Case has already been approved by NC in its 19/09 meeting held on 05.08.2008. 26

Case No.:3/3/82‐ALC4/2008

Party Name:PRATAP ORGANICS 19.08.2008 Status:Case Approved HQ File :01/82/050/00003/AM09/ RLA File :03/95/040/01189/AM08/ Lic.No/Date:0310463615 04.03.2008 27

Case No.:34/9/82‐ALC4/2008

Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 19.08.2008 Status:Case Approved HQ File :01/82/050/00267/AM09/ RLA File :03/94/040/01102/AM08/ Lic.No/Date:0310465020 14.03.2008

Case No.:10/9/82‐ALC4/2008

Party Name:LUPIN LIMITED 19.08.2008 Status:Case Deferred HQ File :01/82/050/00243/AM09/ RLA File :03/95/040/01136/AM08/ Lic.No/Date:0310466199 26.03.2008 Defer Date:16.09.2008 29

Case No.:27/9/82‐ALC4/2008

Party Name:RELIANCE INDUSTRIES LTD. 19.08.2008 Status:Case Approved HQ File :01/82/050/00260/AM09/ RLA File :03/95/040/01172/AM08/ Lic.No/Date:0310467221 03.04.2008 Decision :Case has already been approved by NC in its 13/09 meeting held on 24.06.2008. 30

Case No.:47/9/82‐ALC4/2008

Party Name:EUROLIFE HEALTHCARE PVT. LTD. 19.08.2008 Status:Case Deferred HQ File :01/82/050/00280/AM09/ RLA File :03/94/040/00446/AM08/ Lic.No/Date:0310467448 04.04.2008 Defer Date:30.09.2008 Decision :Committee decided to call for a copy of DML from firm. Accordingly, case was deferred for 30.09.2008. 31

Case No.:11/13/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 19.08.2008 Status:Case Approved HQ File :01/82/050/00518/AM09/ RLA File :09/24/040/00592/AM08/ Lic.No/Date:0910033594 09.04.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/22/2007‐ PI‐III dated 21.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Lamivudine 1 Kg. 1. 2‐5‐Dihydroxy‐1,4 Dithiane 0.739 kg 2. Cystosine 0.955 kg 3. Sodium borohydride 0.480 kg 4. Glyoxalic acid 50% 1.80 kg 5. Acetic Acid 0.213 kg 6. Triethylamine 2.00 kg 7. Toluene 4.08 kg 8. Dimethyl Formamide 0.68 kg 9. Trimethyl Chlorosilane 2.74 kg 10. Methylene Chloride 7.13 kg 11. Methanol 1.035 kg

Carbon Eoanticromos (Activated Carbon) 0.100 kg 13. Acetone 0.510 kg 14. Ethyl Acetate 4.98 kg 32

Case No.:42/11/82‐ALC4/2008

Party Name:SARAF CHEMICALS LTD. 19.08.2008 Status:Case Deferred HQ File :01/82/050/00362/AM09/ RLA File :03/95/040/00036/AM09/ Lic.No/Date:0310468037 10.04.2008 Defer Date:16.09.2008 Decision :Committee observed that the firm was requested to furnish end use of export product, copy of DML, if applicable and technical details as per Appendix 33 vide letter dated 23.07.2008, but no reply has been received. It was, therefore, decided to await reply of firm and defer the case for 16.09.2008. 33

Case No.:8/13/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 19.08.2008 Status:Case Approved HQ File :01/82/050/00515/AM09/ RLA File :09/24/040/00585/AM08/ Lic.No/Date:0910033736 24.04.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/81/2007‐ PI‐III dated 19.09.2007 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Nelfinavir Mesylate 1 Kg. 1. Cis‐2‐Butane‐1,4‐Diol 1.061 kg 2. 2,2 Dimethoxy Propane 2.507 kg 3. 3‐Acetoxy‐2‐Methylbenzoic Acid 0.448 kg 4. Acetone 3.14 kg 5. Acetonitrile 0.43 kg 6. Carbon Enoanticromos (Activated Carbon) 0.090 kg 7. Isopropyl alcohol 3.74 kg 8. Methane Sulfonyl chloride 0.649 kg 9. Methanol 4.26 kg 10. Methylene Chloride 7.93 kg 11. Methyl Isobutyl Ketone 4.58 kg 12. (S)‐N‐T‐Butyl decahydro Iso Quinoline Carboxamide (PHIQ) 0.801 kg 13. Thiophenol (Benzene Thiol) 0.479 kg 14. Toluene 7.57 kg

Case No.:17/13/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 19.08.2008 Status:Case Deferred HQ File :01/82/050/00524/AM09/ RLA File :09/24/040/00576/AM08/ Lic.No/Date:0910033739 24.04.2008 Defer Date:16.09.2008 35

Case No.:9/13/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 19.08.2008 Status:Case Deferred HQ File :01/82/050/00516/AM09/ RLA File :09/24/040/00235/AM08/ Lic.No/Date:0910034003 19.05.2008 Defer Date:16.09.2008 36

Case No.:142/11/82‐ALC4/2008

Party Name:DUJODWALA PAPER CHEMICALS LTD 19.08.2008 Status:Case Deferred HQ File :01/82/050/00462/AM09/ RLA File :03/94/040/01247/AM08/ Lic.No/Date:0310472195 27.05.2008 Defer Date:16.09.2008 Decision : Committee decided to defer case for 16.09.2008 for comments of PC Division. 37

Case No.:44/15/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 19.08.2008 Status:Case Deferred HQ File :01/82/050/00684/AM09/ RLA File :09/24/040/00090/AM09/ Lic.No/Date:0910034164 05.06.2008 Defer Date:16.09.2008 Decision :Committee observed that the firm was requested to furnish copy of DML and copy of Master Batch Formula certified by Quality Control Incharge vide letter dated 23.07.2008, but no reply has been received. It was, therefore, decided to await reply of firm and defer the case for 16.09.2008. 38

Case No.:2/13/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 19.08.2008 Status:Case Deferred HQ File :01/82/050/00509/AM09/ RLA File :09/24/040/00098/AM09/ Lic.No/Date:0910034260 11.06.2008 Defer Date:16.09.2008 39

Case No.:38/13/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 19.08.2008 Status:Case Deferred Lic.No/Date:0910034291

HQ File :01/82/050/00545/AM09/ RLA File :09/24/040/00101/AM09/ 13.06.2008 Defer Date:16.09.2008 40

Case No.:45/13/82‐ALC4/2008

Party Name:AVENTIS PHARMA LIMITED 19.08.2008 Status:Case Approved HQ File :01/82/050/00552/AM09/ RLA File :03/94/040/00238/AM09/ Lic.No/Date:0310474565 13.06.2008 41

Case No.:42/13/82‐ALC4/2008

Party Name:IND‐SWIFT LABORATORIES LTD., 19.08.2008 Status:Case Approved HQ File :01/82/050/00549/AM09/ RLA File :22/24/040/00017/AM09/ Lic.No/Date:2210007881 16.06.2008 Decision :Case has already been approved by NC in its 18/82 meeting held on 29.07.2008. 42

Case No.:3/15/82‐ALC4/2008

Party Name:ORGANO FINE CHEMICALS 19.08.2008 Status:Case Deferred HQ File :01/82/050/00643/AM09/ RLA File :03/95/040/01201/AM08/ Lic.No/Date:0310475865 23.06.2008 Defer Date:16.09.2008 43

Case No.:14/15/82‐ALC4/2008

Party Name:SUPREET CHEMICALS PVT.LTD. 19.08.2008 Status:Case Deferred HQ File :01/82/050/00654/AM09/ RLA File :03/95/040/00265/AM09/ Lic.No/Date:0310476204 24.06.2008 Defer Date:16.09.2008 44

Case No.:20/15/82‐ALC4/2008

Party Name:KESHAVA ORGANICS PVT. LTD., 19.08.2008 Status:Case Deferred HQ File :01/82/050/00660/AM09/ RLA File :03/94/040/00263/AM09/ Lic.No/Date:0310476290 25.06.2008 Defer Date:16.09.2008 45

Case No.:15/17/82‐ALC4/2008

Party Name:IND‐SWIFT LABORATORIES LTD., 19.08.2008 Status:Case Approved

HQ File :01/82/050/00739/AM09/ RLA File :22/24/040/00021/AM09/ Lic.No/Date:2210007930 25.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/77/2007‐ PI‐III dated 21.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Ezetimibe 1 Kg. 1. Glutaric Anhydride 1.45 kg 2. Methylene Chloride 21.12 kg 3. 4‐(S)‐Phenyl‐2‐Oxazolidinone 0.93 kg 4. 4‐Dimethylamino Pyridine 0.09 kg 5. Borane Dimethyl sulfide Complex 0.424 kg 6. (R)‐Methyl Oxazaborolidine 0.057 kg 7. L(+) Tartaric Acid 1.90 kg 8. N,O‐Bis Trimethyl silyl Acetamide 1.07 kg 9. n‐Heptane 2.53 kg 10. Tert. Butyl Methyl Ether 6.00 kg 46

Case No.:25/15/82‐ALC4/2008

Party Name:PRAVEEN LABORATORIES PVT LTD, 19.08.2008 Status:Case Approved HQ File :01/82/050/00665/AM09/ RLA File :52/24/040/00008/AM09/ Lic.No/Date:5210023809 26.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/47/2006‐ PI‐III dated 21.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Hydrazine Carboximidazole 2 Cyano (2,3 Dichlorophenyl) Methane 1 Kg. 1. 2,3 Dichloro Benzoyl chloride 1.67 kg 2. Amino Guanidine Bicarbonate 1.06 kg 47

Case No.:26/15/82‐ALC4/2008

Party Name:ADCOCK INGRAM LTD, 19.08.2008 Status:Case Deferred HQ File :01/82/050/00666/AM09/ RLA File :07/24/040/00142/AM09/ Lic.No/Date:0710058154 26.06.2008 Defer Date:16.09.2008

Decision :Committee observed that the firm was requested to furnish a copy of DML vide letter dated 25.07.2008, but no reply has been received. It was, therefore, decided to await reply of firm and defer the case for 16.09.2008. 48

Case No.:27/15/82‐ALC4/2008

Party Name:ALTA LABORATORIES LTD. 19.08.2008 Status:Case Approved HQ File :01/82/050/00667/AM09/ RLA File :03/94/040/00100/AM09/ Lic.No/Date:0310476493 26.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 10/82 meeting held on 10.07.2007 vide Case No.4/4/82 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 Acetyl Salicylic acid (Aspirin) 1 Kg. 1. Salicylic Acid 0.820 kg 2. Acetic Anhydride 0.697 kg 49

Case No.:28/15/82‐ALC4/2008

Party Name:CLARIANT CHEMICALS [INDIA] LTD 19.08.2008 Status:Case Deferred HQ File :01/82/050/00668/AM09/ RLA File :03/94/040/00336/AM09/ Lic.No/Date:0310476575 26.06.2008 Defer Date:16.09.2008 50

Case No.:30/15/82‐ALC4/2008

Party Name:ALLIED FABRICHEM PVT. LTD. 19.08.2008 Status:Case Deferred HQ File :01/82/050/00670/AM09/ RLA File :09/24/040/00120/AM09/ Lic.No/Date:0910034444 27.06.2008 Defer Date:16.09.2008 51

Case No.:51/15/82‐ALC4/2008

Party Name:NEULAND LABORATORIES LTD 19.08.2008 Status:Case Approved HQ File :01/82/050/00691/AM09/ RLA File :09/24/040/00115/AM09/ Lic.No/Date:0910034484 01.07.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/86/2007‐ PI‐III dated 21.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

Export product Export Qty. Sl.No. Import items Qty. allowed 1‐(3‐hydroxymethyl‐pyridine‐2‐ YL)‐4‐Methyl‐2‐Phenyl Piperazine (M Alcohol) (Drug intermediate of Mirtazapine) 1 Kg. 1. 1‐Methyl 3 Phenyl Piperazine 1.35 kg 2. 2‐chloro Nicotinonitrile 1.06 kg 3. Chloroform 6.37 kg 4. Dimethyl formamide 5.38 kg 5. Sodium Bis (2‐methoxyethoxy aluminiumhydride (Vitride) 2.44 kg 52

Case No.:53/15/82‐ALC4/2008

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 19.08.2008 Status:Case Deferred HQ File :01/82/050/00693/AM09/ RLA File :31/24/040/00406/AM08/ Lic.No/Date:3110034279 01.07.2008 Defer Date:16.09.2008 53

Case No.:4/17/82‐ALC4/2008

Party Name:ALEMBIC LIMITED 19.08.2008 Status:Case Approved HQ File :01/82/050/00728/AM09/ RLA File :34/24/040/00058/AM09/ Lic.No/Date:3410021783 10.07.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/218/2005‐PI‐III dated 21.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details Export product Export Qty. Sl.No. Import items Qty. allowed Azithromycin Isopropanolate Monohydrate 1 Kg. 1. Erythromycin Thiocyanate (on 100% activity basis) 2.258 kg 2. Acetone 7.285 kg 3. Ethyl acetate 1.34 kg 4. Isopropyl alcohol 2.54 kg 5. Hydroxylamine Hcl 1.036 kg 6. Ammonium Thiocyanate 0.088 kg 7. Methanol 3.078 kg 8. Methylene Chloride 3.18 kg 9. Absolute Ethyl alcohol with DE 1.14 kg 10. Plathinum Metal 99.95% 0.101 gm 11. Activated Carbon qualigens SQ 0.027 kg

Case No.:6/17/82‐ALC4/2008

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 19.08.2008 Status:Case Deferred HQ File :01/82/050/00730/AM09/ RLA File :03/95/040/00330/AM09/ Lic.No/Date:0310478312 11.07.2008 Defer Date:16.09.2008 55

Case No.:10/17/82‐ALC4/2008

Party Name:HETERO DRUGS LIMITED, 19.08.2008 Status:Case Deferred HQ File :01/82/050/00734/AM09/ RLA File :09/24/040/00146/AM09/ Lic.No/Date:0910034574 11.07.2008 Defer Date:16.09.2008 56

Case No.:12/17/82‐ALC4/2008

Party Name:ANUS LABORATORIES LTD., 19.08.2008 Status:Case Deferred HQ File :01/82/050/00736/AM09/ RLA File :09/24/040/00552/AM08/ Lic.No/Date:0910034576 11.07.2008 Defer Date:30.09.2008 Decision :Committee decided to call for a copy of application from RA/firm. Accordingly, case was deferred for 30.09.2008. 57

Case No.:13/17/82‐ALC4/2008

Party Name:FINE ORGANIC INDUSTRIES(MUMBAI) PVT. LTD. 19.08.2008 Status:Case Deferred HQ File :01/82/050/00737/AM09/ RLA File :03/94/040/00375/AM09/ Lic.No/Date:0310478323 11.07.2008 Defer Date:16.09.2008 58

Case No.:16/17/82‐ALC4/2008

Party Name:NAGARJUNA AGRICHEM LTD 19.08.2008 Status:Case Approved HQ File :01/82/050/00740/AM09/ RLA File :09/24/040/00138/AM09/ Lic.No/Date:0910034593 14.07.2008 Decision :Committee considered case as per agenda for ratification of norms and in light of written comments of Chemical Division vide their U.O. No.15022/11/2008‐ Ch.III dated 21.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Sl.No. Import items Qty. allowed

Qty. 4‐Chloro Phenol (Para Chloro Phenol) 1 Kg. 1. Phenol 0.750 kg 59

Case No.:18/17/82‐ALC4/2008

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 19.08.2008 Status:Case Deferred HQ File :01/82/050/00742/AM09/ RLA File :03/95/040/00254/AM09/ Lic.No/Date:0310478484 14.07.2008 Defer Date:16.09.2008 60

Case No.:19/17/82‐ALC4/2008

Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 19.08.2008 Status:Case Approved HQ File :01/82/050/00743/AM09/ RLA File :03/94/040/00325/AM09/ Lic.No/Date:0310478565 14.07.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/93/2004‐Ch.III dated 26.09.2007 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details Export product Export Qty. Sl.No. Import items Qty. allowed Antifoulane‐ DA 2339 Containing: 13% of 4,4’(1,10 Dioxo 1,10 Decanedyl) bis (2,2,6,6‐Tetra methyl‐1 piperidineyloxy) 10% of 2,6 ditertiary butyl‐4‐ Benzylideene 2,5‐Dienone, 30% of Penta (2 Methylene 4 nonyl phenol) TEPA adduct 25.8% of Aromatic Solvent (C10‐ C20) 1 Kg. 1. 4 Hydroxy Tempo (4 Hydroxy‐2,2,6,6‐ Tetra methyl‐1 piperidineyloxy) 0.0216 kg 2. 2,6 Ditertiary butyl phenol 0.0769 kg 3. Dimethyl sebacate 0.0130 kg 4. Dibutyl 奱�n oxide 0.0050 kg 5. Morpholine 0.0328 kg 6. Benzaldehyde 0.040 kg 7. N‐butanol 0.176 kg 8. Dimethyl sulfate 0.0476 kg 9. Tetra ethylene penta‐amine 0.0420 kg 10. Nonyl Phenol 0.0889 kg 11. Paraformaldehyde 0.0145 kg 12. Aromatic solvent (C10‐C20) 0.258 kg

Case No.:26/17/82‐ALC4/2008

Party Name:SKM PHARMA(P)LTD., 19.08.2008 Status:Case Deferred HQ File :01/82/050/00750/AM09/ RLA File :07/24/040/00096/AM09/ Lic.No/Date:0710058483 14.07.2008 Defer Date:16.09.2008 62

Case No.:27/17/82‐ALC4/2008

Party Name:METROPOLITAN OVERSEAS LIMITED, 19.08.2008 Status:Case Deferred HQ File :01/82/050/00751/AM09/ RLA File :03/95/040/00308/AM09/ Lic.No/Date:0310478772 15.07.2008 Defer Date:16.09.2008 63

Case No.:28/17/82‐ALC4/2008

Party Name:MODEPRO (INDIA) PRIVATE LIMITED., 19.08.2008 Status:Case Approved HQ File :01/82/050/00752/AM09/ RLA File :03/95/040/00299/AM09/ Lic.No/Date:0310478777 15.07.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/20/2004‐Ch.III dated 15.05.2006 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details Export product Export Qty. Sl.No. Import items Qty. allowed 2 Benzoyl Pyridine 1 Kg. 1. Pyridine 0.534 kg 2. Potassium Permanganate 1.077 kg 64

Case No.:29/17/82‐ALC4/2008

Party Name:EMCURE PHARMACEUTICALS LTD. 19.08.2008 Status:Case Deferred HQ File :01/82/050/00753/AM09/ RLA File :31/24/040/00103/AM09/ Lic.No/Date:3110034394 15.07.2008 Defer Date:30.09.2008 Decision :Committee decided to call for a copy of application from RA/firm. Accordingly, case was deferred for 30.06.2008. 65

Case No.:1/21/82‐ALC4/2008

Party Name:AROMA AROMATICS & FLAVOURS 19.08.2008 Status:Case Deferred HQ File :01/82/050/00856/AM09/ RLA File :05/24/040/00274/AM09/ Lic.No/Date:0510225070 07.08.2008 Defer Date:16.09.2008

Case No.:2/21/82‐ALC4/2008

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 19.08.2008 Status:Case Approved HQ File :01/82/050/00857/AM09/ RLA File :03/94/040/00322/AM09/ Lic.No/Date:0310481750 07.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/56/2007‐ PI‐III dated 21.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Meloxicam 1 Kg. 1. 2‐Amin‐5‐Methyl thiazole 0.45 kg 67

Case No.:3/21/82‐ALC4/2008

Party Name:HETERO LABS LTD. 19.08.2008 Status:Case Approved HQ File :01/82/050/00858/AM09/ RLA File :09/24/040/00153/AM09/ Lic.No/Date:0910034959 07.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/69/2008‐PI‐III dated 01.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Bicalutamide 1 Kg. 1. 4‐Amino‐2‐Trifluoro Methyl 1.47 kg 2. P‐Fluoro Thio Phenol 0.53 kg 3. Tetrahydrofuran 1.10 kg 68

Case No.:4/21/82‐ALC4/2008

Party Name:SAINOR LABORATORIES PVT LTD 19.08.2008 Status:Case Approved HQ File :01/82/050/00859/AM09/ RLA File :09/24/040/00187/AM09/ Lic.No/Date:0910034966 07.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/8/2003‐Ch.II dated 30.06.2008 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 (on 100% basis) N‐Butyl Lithium (15% w/w in n‐Hexane (100% Active Basis [Total Export Quantity on 100 % Basis = 10000 kgs.] 1 Kg. 1. Lithium Metal 0.153 kg 2. n‐Butyl Chloride 1.60 kg 3. n‐Hexane 6.66 kg 69

Case No.:5/21/82‐ALC4/2008

Party Name:EMCURE PHARMACEUTICALS LTD. 19.08.2008 Status:Case Deferred HQ File :01/82/050/00860/AM09/ RLA File :31/24/040/00128/AM09/ Lic.No/Date:3110034769 07.08.2008 Defer Date:16.09.2008 70

Case No.:6/21/82‐ALC4/2008

Party Name:EMCURE PHARMACEUTICALS LTD. 19.08.2008 Status:Case Deferred HQ File :01/82/050/00861/AM09/ RLA File :31/24/040/00126/AM09/ Lic.No/Date:3110034770 07.08.2008 Defer Date: 16.09.2008 71

Case No.:7/21/82‐ALC4/2008

Party Name:PI INDUSTRIES LTD., 19.08.2008 Status:Case Approved HQ File :01/82/050/00862/AM09/ RLA File :13/24/040/00006/AM09/ Lic.No/Date:1310026681 08.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.15022/9/2006‐Ch.II dated 05.05.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details Export product Export Qty. Sl.No. Import items Qty. allowed 2‐Cyanimino 1,3 Thiazolidine (CIT) 1 Kg. 1. Cysteamine Hydrochloride (CIED) 1.315 kg 2. Dimethyl N‐Cyanodithioimino Carbonate (CCITM) 1.668 kg 3. Toluene 0.684 kg

Case No.:8/21/82‐ALC4/2008

Party Name:SHIVA PHARMACHEM PVT. LTD, 19.08.2008 Status:Case Approved HQ File :01/82/050/00863/AM09/ RLA File :34/24/040/00086/AM09/ Lic.No/Date:3410022054 08.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/101/2002‐Ch.II dated 04.10.2007 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details Export product Export Qty. Sl.No. Import items Qty. allowed Isononamoyl Chloride 1 Kg. 1. Isononanonic Acid 0.942 kg 2. Thionyl Chloride 0.578 kg Outside Agenda M/S Nectar Lifescience Ltd. F.No.01/82/50/00157/AM08 Meeting Date:19.08.2008 RA F.No.22/24/40/30/AM08 Adv.Lic. No.221006984 dated 20.08.2004 This case was considered by NC in its 17/09 meeting held on 22.07.2008 vide case No.B‐130 and following decision was taken:‐ “Committee considered case as per agenda and in light of its earlier decision taken in its 13/82 meeting held on 31.07.2007 vide case No.25/9/82 decided to ratify norms under para 4.7 of HBP on repeat basis 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 Cefpodoxime Proxetil 1 Kg. 1. 7 ACA 1.25 kg 2. Sulfolane 3.70 kg 3. Boron Trifluride 1.54 kg 4. Methanol 1.00 kg 5. Methylene Chloride 1.50 kg 6. Triethylamine 5.62 kg 7. Tetrahydrofuran 2.10 kg 8. S‐2 Benzothiazolyl‐2‐amino‐2‐ (methoxyimino)‐4‐奱�azolyl acetate MAEM) 1.25 kg 9. Chloroethyl Isopropyl carbonate 0.558 kg

Sodium Iodide 0.756 kg 11. 18‐Crown‐6‐Ether 0.030 kg 12. Cyclohexane 1.00 kg 13. Acetone 1.00 kg 14. 1,8‐diazabicyclo [5.4.0]‐undec‐7‐ene 0.364 kg 15. Dimethyl acetamide 1.50 kg 16. Eno Carbon 0.100 kg Committee considered the case again in consultation with technical authority present in meeting and decided to revise the norms 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 Cefpodoxime Proxetil 1 Kg. 1. 7 ACA 0.998 kg 2. Sulfolane 0.659 kg 3. Boron Trifluride 1.10 kg 4. Methanol 1.481 kg 5. Methylene Chloride 3.541 kg 6. Triethylamine 0.562 kg 7. Tetrahydrofuran 1.59 kg 8. S‐2 Benzothiazolyl‐2‐amino‐2‐ (methoxyimino)‐4‐奱�azolyl acetate (MEAM) 0.998 kg 9. Chloroethyl Isopropyl carbonate 0.558 kg 10. Sodium Iodide 0.390 kg 11. 18‐Crown‐6‐Ether 0.023 kg 12. Cyclohexane 1.10 kg 13. Acetone 2.475 kg 14. 1,8‐diazabicyclo [5.4.0]‐undec‐7‐ene (DBU) 0.341 kg 15. Dimethyl acetamide 0.655 kg 16. Eno Carbon 0.100 kg Outside Agenda M/S Covalent Laboratories Pvt. Ltd. F.No.01/82/50/00589/AM08 Meeting Date:19.08.2008 RA F.No.09/24/040/00070/AM09

Adv.Lic. No.0910034344 dated This case was considered by NC in its 18/09 meeting held on 29.07.2008 vide case No.37/14/82 and following decision was taken:‐ Committee considered case as per agenda and in consultation with Technical Authority and in light of its earlier decision taken in its 24/82 meeting held on 16.10.2007 decided to ratify norms under para 4.7 of HBP as per details Export product Export Qty. Sl.No. Import item Qty. allowed per unit of export product Cefpodoxim Proxetil 1 Kg. 1. 7 Amino Cephalosporanic Acid (7‐ACA) 1.25kg 2. Mercaptobenzothiozol‐2‐Aminothiozol‐4YL‐ Methoxoyimino Acetate 1.25kg 3. Alpha‐chloro Ethyl Isoporopyl Carbonate (CEIPC) 0.558kg 4. 1, 8‐Duatabuctui (5.4.0)‐7‐Undecene (DBU) 0.364kg 5. Methanol 1.08kg 6. Methylene chloride 1.66kg 7. Acetone 1.79kg 8. Tetrahydrofuran 3.36kg 9. Cyclohexane 2.50kg 10. Sodium Iodide 0.39kg Committee considered the case again in consultation with technical authority present in meeting and decided to revise the norms as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import item Qty. allowed per unit of export product Cefpodoxim Proxetil 1 Kg. 1. 7 Amino Cephalosporanic Acid (7‐ACA) 0.998 kg 2. 2‐Mecraptoben Zothiazoly(z)‐2‐2(2‐Aminothaizole‐4‐ YL)‐2‐Methoxyimino Acetate 0.998 kg 3. Chloro Ethyl Isoporopyl Carbonate (CEIPC) 0.558 kg 4. 1, 8‐Duatabuctui (5.4.0)‐undec‐7‐ene (DBU) 0.341 kg 5. Methanol 1.481 kg 6. Methylene chloride 3.541 kg 7. Acetone 2.475 kg 8. Tetrahydrofuran 2.85 kg

Cyclohexane 1.16 kg 10. Sodium Iodide 0.390 kg **********************

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