IN FORCE Norms Committee — Engineering (Gr B / NC-I) Advance Authorisation 2008-07-29

DGFT Committee Minutes

Reliability

IN FORCE

In force — no superseding record on file.

Issuer: DGFT
Type: Committee Minutes
Committee / bench: Norms Committee — Engineering (Gr B / NC-I)
Date: 2008-07-29
Topic: Advance Authorisation
Official copy: Download source PDF ↗

Referenced in this document

Tariff

Chapter 29 Organic chemicals

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Chapter 30 Pharmaceutical products

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Policy

Para 4.7 ×30
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Amended 6× , last 2010-07-22.

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Para 4.7.1 ×2
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Parties

Fuji Film Fine Chemicals
Also cited by 1 other document:
- #6509 2008-08-05
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Parabolic Drugs Ltd.
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Vital Laboratories Ltd.
Also cited by 1 other document:
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Document text

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

Para 4.7 Decision

MEETING NUMBER : 18/82‐ALC4/2008 MEETING DATE : 29.07.2008 The Meeting No.18/09 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 was held on 29.07.2008 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 At the outset minutes of Norms Committee Meeting No.16/09 dated 15.07.2008 were ratified by the Committee. 1

Case No.:1/6/82‐ALC4/2008

Party Name:MANALI PETROCHEMICAL LTD Meet No/Date:18/82‐ALC4/2008 29.07.2008 Status:Case Rejected HQ File :01/82/050/00084/AM09/ RLA File :04/24/040/00127/AM05/ Lic.No/Date:0410061064 04.08.2004 Decision :Committee considered case as per agenda and observed that RA and firm were requested to furnish a copy of application vide letter dated 21.05.2008, but no reply has been received and norms can not be fixed in absence of application. It was, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of NC. 2

Case No.:10/6/82‐ALC4/2008

Party Name:M D CORPORATION 29.07.2008 HQ File :01/82/050/00093/AM09/ RLA File :03/95/040/01314/AM06/ Lic.No/Date:0310367100 15.02.2006 Decision : Committee considered case as per agenda and observed that RA and firm were requested to furnish a copy of application vide letter dated 21.05.2008, but no reply has been received and norms can not be fixed in absence of application. It was, therefore, decided to close the case. 3

Case No.:76/6/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 29.07.2008 HQ File :01/82/050/00159/AM09/ RLA File :08/24/040/00269/AM06/ Lic.No/Date:0810054536

Q / / / / / / / / / / / 07.03.2006 Decision : Committee considered case as per agenda and observed that RA and firm were requested to furnish a copy of application vide letter dated 22.05.2008, but no reply has been received and norms can not be fixed in absence of application. It was, therefore, decided to close the case. 4

Case No.:7/2/82‐ALC4/2007

Party Name:CIPLA LIMITED 29.07.2008 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:26.08.2008 Decision :Committee decided to defer case for 26.08.2008 for comments of PI Division. 5

Case No.:70/42/82‐ALC4/2007

29.07.2008 Status:Case Approved HQ File :01/82/050/00406/AM08/ RLA File :03/94/040/00250/AM08/ Lic.No/Date:0310432136 08.06.2007 Decision :Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007‐PI‐III dated nil 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 per unit of export product Stavudine Capsules 15 mg [Stavudine = 15.30 mg] 1 Kg. 1. 2’,3’‐dihydro,5’‐O‐Benzoyl,5‐ Methyl Uridine 2.00 kg/kg of Stavudine Stavudine Capsules 20mg [Stavudine = 20.40 mg 1 Kg. Stavudine Capsules 30 mg [Stavudine = 30.60 mg] 1 Kg. Stavudine Capsules 40 mg [Stavudine = 40.80 mg] 1 kg. Lamivir S 30 tablets [Stavudine = 30.6 mg] 1 Kg. Lamivir S 40 tablets [Stavudine 40.8 mg] 1 Kg. RA concerned may take further necessary action as per above decision of NC

Case No.:682/24/83‐ALC1/2007

Party Name:SALICYLATES & CHEMICALS P.LTD. 29.07.2008 HQ File :01/83/050/00526/AM08/ RLA File :09/24/040/00074/AM08/ Lic.No/Date:0910030570 15.06.2007 Decision :Case has already been rejected by NC in its 10/09 meeting held on 03.06.2008. 7

Case No.:82/19/83‐ALC1/2007

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 29.07.2008 Status:Case Deferred HQ File :01/83/050/00641/AM08/ RLA File :03/95/040/00229/AM08/ Lic.No/Date:0310433835 25.06.2007 Defer Date:05.08.2008 Decision :Committee decided to defer case for 05.08.2008 for comments of Chemical Division. 8

Case No.:728/24/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 29.07.2008 HQ File :01/83/050/00615/AM08/ RLA File :04/24/040/00111/AM08/ Lic.No/Date:0410090132 28.06.2007 Defer Date: 09.09.2008 Decision :Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/122/2007‐PI‐III dated 22.07.2008 decided to call for the following information from firm:‐ 1. Complete and balanced chemical reactions for each step of manufacturing process alongwith % yield on molar basis and vol. wt. of each input and output product with Technical literature, if any. 2. Complete description of intermediate product in stage III. 3. It appears that vol wt. of input and output item in stage II are wrongly given. The amended reaction may be furnished. 4. Requirement and Recovery of solvents of each step may be furnished. Accordingly, case was deferred for 09.09.2008.

Case No :727/24/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS Meet No/Date:18/82‐ALC4/2008 Status:Case Approved

Case No.:727/24/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 29.07.2008 Status:Case Approved HQ File :01/83/050/00614/AM08/ RLA File :04/24/040/00112/AM08/ Lic.No/Date:0410090131 28.06.2007 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/122/2007‐PI‐III dated 17.07.2008 decided to ratify Export product Export Qty. Sl.No. Import item of export product Levetiracetam 1 Kg. 1. (‐)‐2(S)‐(2‐oxo‐pyrrolidin‐1‐yl)‐ butyric acid (S‐PIA) 1.75 kg 2. Methanol 3.50 kg 3. Acetone 4.12 kg 10

Case No.:730/24/83‐ALC1/2007

Party Name:SUVEN LIFE SCIENCES LIMITED 29.07.2008 HQ File :01/83/050/00623/AM08/ RLA File :09/24/040/00120/AM08/ Lic.No/Date:0910030686 29.06.2007 Defer Date: 09.09.2008 Decision: Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/226/2006‐PI‐III dated 11.07.2008 decided to call for following information/clarification from firm. 1. It has been observed from the purchase order that the export product will be supplied to M/S Fuji Film Fine Chemicals Co. Ltd, Japan who are apparently not bulk drug manufacturers. However, in the declaration, the firm has declared that the export product is meant for the purpose of Phase I trials of a new drug and it is used for the Human Health. The firm may be asked to clarify the matter in this regard. 2. The firm may also be asked to clarify that once the export product is formed at stage II, what is the need for stage III and IV through Recrimination and extraction process. Accordingly, case was deferred for 09.09.2008. 11

Case No.:19/23/83‐ALC1/2007

Party Name:SEQUENT SCIENTIFIC LIMITED 29.07.2008 HQ File :01/83/050/00655/AM08/ RLA File :07/24/040/00234/AM08/ Lic.No/Date:0710052301 04.07.2007 Defer Date:26.08.2008 Decision : Committee decided to defer case for 26.08.2008 for comments of DGHS. 12

Case No.:104/6/82‐ALC4/2008

Party Name:INTAS PHARMACEUTICALS LTD., 29.07.2008 Status:Case Deferred HQ File :01/82/050/00187/AM09/ RLA File :08/24/040/00123/AM08/ Lic.No/Date:0810066581 14.08.2007 Defer Date: 26.08.2008 Decision :Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for 26.08.2007.

Case No.:86/42/82‐ALC4/2007

29.07.2008 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 : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007‐PI‐III dated Nil decided to ratify Export product Export Qty. Sl.No. Import item Qty. allowed per unit of export product Irinotecan Hcl Injection 40 mg/2ml 1 Vial 1. 10‐Hydroxy Camptothecin 70.04 mg/vial Irinotecan Hcl Injection 100 mg/5ml 1 vial 1. 176.0 mg/vial 14

Case No.:54/27/83‐ALC1/2007

Party Name:GLENMARK PHARMACEUTICALS LTD., 29.07.2008 HQ File :01/83/050/01128/AM08/ RLA File :03/94/040/00525/AM08/ Lic.No/Date:0310441978 06.09.2007 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish technical information vide letter dated 20.06.2008, but no reply has been received and norms can not be fixed in absence of required technical information. It was, therefore decided to close the case. 15

Case No.:62/27/83‐ALC1/2007

Party Name:APITHECARY PHARMA PVT LTD. 29.07.2008 Status:Case Approved HQ File :01/83/050/01136/AM08/ RLA File :09/24/040/00146/AM08/ Lic.No/Date:0910031444 07.09.2007 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.35011/129/2007‐PI‐III dated 23.06.2008 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 of export product Lansoprazole Sulphide Or (2‐[(4‐[2,2,2‐ Trifluoro Ethoxy)‐3‐Methyl‐2‐ Pyridinyl]‐2‐Thio]‐1H‐Benzamidazole 1 Kg. 1. 2,3 Lutidine 0.95 kg 2. Trifloro Ethanol 1.12 kg 3. Methylene Dichloride 2.02 kg 16

Case No.:72/27/83‐ALC1/2007

Party Name:LUPIN LIMITED Status: Case

29.07.2008 Approved HQ File :01/83/050/01146/AM08/ RLA File :03/95/040/00570/AM08/ Lic.No/Date:0310442436 11.09.2007 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.35011/60/2008‐PI‐III dated 07.07.2008 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 of export product Sterile Ce䬀riaxone Sodium – Non Infringing 1 Kg. 1. 7 ACA 0.668 kg/kg 2. Ethyl Acetate 1.1744 kg 3. Methyl Chloride 8.6964 kg 4. Sodium Hydrosulphite 0.0047 kg 5. Sodium Carbonate Anhydrous 0.0162 kg 6. 2,5 Dihydro‐6‐Hydroxy‐3‐Mercapto‐ 2‐Methyl‐5‐Oxo‐1,2,4‐Triazene 0.3740 kg 7. Boron Trifluoride Gas 0.7140 kg 8. Acetonitrile 1.6367 kg 9. Acetone 9.7809 kg 10. Activated Carbon 0.4911 kg 11. Tetra Hydrofuran 0.8013 kg 12. Formic Acid 2.8514 kg 13. Hexamethyl Disilazane 0.5408 kg 14. Triethylamine 0.8301 kg 15. Phasphorous Pentachloride 0.4744 kg 16. Isopropyl Alcohol 0.2393 kg 17. Thiourea 0.1799 kg 18. Trimethyl Chlorosilane 0.0789 kg 19. Sodium 2‐Ethyl Hexanoate 0.3813 kg 20. Bromo Acid 0.4854 kg 21. Aluminium Containers of 20 Ltrs Capacity with caps & Plus As per packing policy 17

Case No.:93/27/83‐ALC1/2007

Party Name:SOLARIS CHEMTECH LIMITED 29.07.2008 Status:Case Approved HQ File :01/83/050/01167/AM08/ RLA File :34/24/040/00119/AM08/ Lic.No/Date:3410019636 14.09.2007 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.35011/41/2008‐PI‐III dated 17.07.2008 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 of export product hl hl k

6‐Chloro‐2‐Hexanone 1 Kg. 1. 1‐Bromo‐3‐Chloro Propane 1.90 kg 18

Case No.:95/42/82‐ALC4/2007

29.07.2008 HQ File :01/82/050/00431/AM08/ RLA File :03/94/040/00674/AM08/ Lic.No/Date:0310445040 03.10.2007 Defer Date:26.08.2008 Decision : Committee decided to defer case for 26.08.2008 for comments of PI Division. 19

Case No.:51/30/83‐ALC1/2007

Party Name:HETERO DRUGS LIMITED, 29.07.2008 Status:Case Approved HQ File :01/83/050/01420/AM08/ RLA File :09/24/040/00276/AM08/ Lic.No/Date:0910031879 24.10.2007 Decision :Case has already been approved by NC in its 17/09 meeting held on 22.07.2008. 20

Case No.:106/42/82‐ALC4/2007

Party Name:LUPIN LIMITED 29.07.2008 HQ File :01/82/050/00442/AM08/ RLA File :03/95/040/00604/AM08/ Lic.No/Date:0310447771 25.10.2007 Defer Date: 26.08.2008 21

Case No.:90/32/83‐ALC1/2007

Party Name:VITAL LABORATORIES PVT. LTD. 29.07.2008 Status:Case Approved HQ File :01/83/050/01512/AM08/ RLA File :03/95/040/00683/AM08/ Lic.No/Date:0310449450 06.11.2007 Decision :Case has already been approved by NC in its 9/09 meeting held on 27.05.2008. 22

Case No.:1/38/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 29.07.2008 Status:Case Approved HQ File :01/83/050/01563/AM08/ RLA File :04/24/040/00281/AM08/ Lic.No/Date:0410092096 15.11.2007 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.35011/122/2007‐PI‐III dated 18.07.2008 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 of export product (6‐methoxy‐1‐oxoisoindolin‐2‐ yl)methyl pivalate 1 Kg. 1. ‐Bromo‐5‐methoxybenzoic acid‐ methyl benzonate 3.00 kg 2 Toluene 6 22 kg

Toluene 6.22 kg 3. Tetrahydrofuran 10.00 kg 4. 1,3‐Dimethyl‐3,4,5,6‐Tetra hydro‐ 2(1H) Pyrimidinone Not shown in Process. Hence not allowed 5. Sodium t‐butoxide 0.424 kg 6. Chloromethylpivalate 0.77 kg 7. Ethyl Acetate 7.65 kg 23

Case No.:110/42/82‐ALC4/2007

29.07.2008 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 : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007‐PI‐III dated Nil decided to ratify Export product Export Qty. Sl.No. Import item of export product Irinotecan Hcl Injection 40 mg/2ml 1 Vial 1. 70.04 mg/vial Irinotecan Hcl Injection 100 mg/5ml 1 vial 1. 176.0 mg/vial 24

Case No.:111/42/82‐ALC4/2007

29.07.2008 Status:Case Approved HQ File :01/82/050/00447/AM08/ RLA File :03/94/040/00860/AM08/ Lic.No/Date:0310450692 19.11.2007 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007‐PI‐III dated Nil decided to ratify Export product Export Qty. Sl.No. Import item of export product Irinotecan Hcl Injection 40 mg/2ml 1 Vial 1. 70.04 mg/vial Irinotecan Hcl Injection 100 mg/5ml 1 vial 1. 176.0 mg/vial

Case No.:8/40/81‐ALC2/2007

Party Name:ULTRA‐TECH INDIA LTD. 29.07.2008 Status:Case Approved HQ File :01/81/050/00446/AM08/ RLA File :03/95/040/00813/AM08/ Lic.No/Date:0310450707 19.11.2007 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/10/2008‐PI‐III dated 24.07.2008 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 item of export product 2‐[((3‐Methyl‐4‐(2,2,2‐Trifluoro Ethoxy)‐2‐Pyridinyl)‐ Methyl)Thio}‐1H‐Benzimidazole 1 kg. 1. 2,3 Lutidine (2,3 Dimethyl Pyridine) 0.95 kg 2. Trifluro Ethanol (2,2,2‐Trifluro Ethanol) 1.12 kg 26

Case No.:26/6/82‐ALC4/2008

Party Name:RELIANCE INDUSTRIES LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00109/AM09/ RLA File :03/95/040/00753/AM08/ Lic.No/Date:0310450853 20.11.2007 Decision : Committee considered case as per agenda and in light of written comments forwarded by PC Division vide their O.M. No.46011/20/2008‐PC.II dated 23.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Propylene 1 MT. 1. Naphtha 1.2359 MT 27

Case No.:68/39/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 29.07.2008 HQ File :01/83/050/01647/AM08/ RLA File :04/24/040/00289/AM08/ Lic.No/Date:0410092451 30.11.2007 Defer Date:09.09.2008 Decision :Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/122/2007‐PI‐III dated 22.07.2008 decided to call for the following information from firm/DBT:‐ 1. The firm have shown the ITC clarification of the export product as 29153990 and have stated that the export item is an intermediate for new API Inhalers in the IEM filed. This item has been filed under 3049 falling under the broad description as “Manufacture of other pharmaceutical products NEC (This class includes manufacture of the following Glands and other organs for oregano‐therapeutic uses, Heparin and its salts, other Human or Animal Substances to). As per the IEM, views of DBT may be taken. 2. The firm has not given % conversion yield on molar basis as per the proforma. 3. No technical literature is furnished by the firm in support of export product and its end use or the conversion yields envisaged by the firm in the application which may be

called for. Accordingly, case was deferred for 09.09.2008. 28

Case No.:138/39/83‐ALC1/2007

Party Name:LUPIN LIMITED 29.07.2008 Status:Case Approved HQ File :01/83/050/01717/AM08/ RLA File :03/95/040/00892/AM08/ Lic.No/Date:0310453332 10.12.2007 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.35011/60/2008‐PI‐III dated 07.07.2008 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 of export product Sterile Ce䬀riaxone Sodium – Non Infringing 1 Kg. 1. 7 ACA 0.668 kg 2. Ethyl Acetate 1.1744 kg 3. Methyl Chloride 8.6964 kg 4. Sodium Hydrosulphite 0.0047 kg 5. Sodium Carbonate Anhydrous 0.0162 kg 6. 2,5 Dihydro‐6‐Hydroxy‐3‐Mercapto‐ 2‐Methyl‐5‐Oxo‐1,2,4‐Triazene 0.3740 kg 7. Boron Trifluoride Gas 0.7140 kg 8. Acetonitrile 1.6367 kg 9. Acetone 9.7809 kg 10. Activated Carbon 0.4911 kg 11. Tetra Hydrofuran 0.8013 kg 12. Formic Acid 2.8514 kg 13. Hexamethyl Disilazane 0.5408 kg 14. Triethylamine 0.8301 kg 15. Phasphorous Pentachloride 0.4744 kg 16. Isopropyl Alcohol 0.2393 kg 17. Thiourea 0.1799 kg 18. Trimethyl Chlorosilane 0.0789 kg 19. Sodium 2‐Ethyl Hexanoate 0.3813 kg 20. Bromo Acid 0.4854 kg 21. Aluminium Containers of 20 Ltrs Capacity with caps & Plus As per packing policy

Case No.:173/39/83‐ALC1/2007

29.07.2008 Status:Case Approved HQ File :01/83/050/01752/AM08/ RLA File :03/94/040/00853/AM08/ Lic.No/Date:0310453734 12.12.2007 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007‐PI‐III dated 17.07.2008 decided

29 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007 PI III dated 17.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Donepezil Hydrochloride 1 Kg. 1. 3‐(3,4‐dimethoxyphenyl) propionic Acid (DP3 Compound) 1.366 kg 2. Pyridine‐4‐Aldehyde 0.827 kg 30

Case No.:74/45/82‐ALC4/2007

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:18/82‐ALC4/2008 29.07.2008 Status:Rejected HQ File :01/82/050/00537/AM08/ RLA File :05/24/040/00727/AM08/ Lic.No/Date:0510213720 18.12.2007 Decision :Case has already been rejected by NC in its 14/09 meeting held on 01.07.2008. 31

Case No.:66/45/82‐ALC4/2007

Party Name:HILDOSE 29.07.2008 HQ File :01/82/050/00529/AM08/ RLA File :03/94/040/00984/AM08/ Lic.No/Date:0310455668 28.12.2007 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish production and consumption data certified by Central Excise Authority and end use of export product alongwith technical literature vide letter dated 27.05.2008, but no reply has been received and norms can not be fixed in absence of required information/documents. It was, therefore, decided to close the case. 32

Case No.:75/45/82‐ALC4/2007

Party Name:VIDA LABORATORIES (P) LTD 29.07.2008 HQ File :01/82/050/00538/AM08/ RLA File :07/24/040/00686/AM08/ Lic.No/Date:0710055140 31.12.2007 Defer Date: 26.08.2008 33

Case No.:37/6/82‐ALC4/2008

Party Name:STERLING AUXILIARIES PVT LTD 29.07.2008 HQ File :01/82/050/00120/AM09/ RLA File :03/95/040/00916/AM08/ Lic.No/Date:0310455865 31.12.2007 Defer Date: 26.08.2008 Decision :Committee decided to defer case for 26.08.2008 for comments of Chemical Division.

Case No.:6/8/82‐ALC4/2008

Party Name:KAMUD DRUGS PVT.LIMITED., 29.07.2008 l / / / / / l / / / / / /

34 HQ File :01/82/050/00228/AM09/ RLA File :31/24/040/00320/AM08/ Lic.No/Date:3110032124 31.12.2007 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish technical details as per Appendix 33 vide letter dated 10.06.2008, but no reply has been received and norms can not be fixed in absence of required technical details. It was, therefore, decided to close the case. 35

Case No.:33/6/82‐ALC4/2008

Party Name:SEQUENT SCIENTIFIC LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00116/AM09/ RLA File :03/95/040/00973/AM08/ Lic.No/Date:0310455972 01.01.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/26/2008‐Ch.III dated 17.07.2008 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 item of export product 2,4‐Bis‐(Biphenyl)‐6‐(1,3‐ Dihydroxy‐4‐Phenyl)‐1,3,5‐ Triazine 1 Kg. 1. Cyanuric Chloride 0.513 kg 2. Ethyl Mercaptan 0.173 kg 3. Biphenyl 0.771 kg 4. Resorcinol 0.248 kg 36

Case No.:1/47/82‐ALC4/2007

Party Name:KUMAR ORGANIC PRODUCTS LIMITED, 29.07.2008 Status:Case Approved HQ File :01/82/050/00594/AM08/ RLA File :07/24/040/00669/AM08/ Lic.No/Date:0710055191 01.01.2008 Decision :Case has already been approved by NC in its 13/09 meeting held on 24.06.2008. 37

Case No.:12/42/83‐ALC1/2007

Party Name:PARABOLIC DRUGS LTD., 29.07.2008 HQ File :01/83/050/01788/AM08/ RLA File :22/24/040/00053/AM08/ Lic.No/Date:2210007356 04.01.2008 Defer Date: 26.08.2008 38

Case No.:8/47/82‐ALC4/2007

Party Name:DHANUKA LABORATORIES LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00601/AM08/ RLA File :05/24/040/00718/AM08/ Lic.No/Date:0510214784 10.01.2008 Decision :Case has already been approved by NC in its 14/82 meeting held on 01.07.2008.

Case No.:51/45/82‐ALC4/2007

Party Name:IPCA LABORATORIES LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00514/AM08/ RLA File :03/94/040/00996/AM08/ Lic.No/Date:0310457811 16.01.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/22/2008‐PI‐III dated 08.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Nabumetone 1 Kg. 1. Beta Naphthol 1.777 kg 2. Acetone 1.26 kg 3. Bromine 0.527 kg 4. Dimethyl Formamide 0.666 kg 5. Ethylene Dichloride 0.509 kg 6. N‐Butanol 1.184 kg 7. Tetrahydrofuran 0.411 kg 8. Methanol Not used in process Hence not allowed 9. Iso Propyl Alcohol 1.91 kg 40

Case No.:27/45/82‐ALC4/2007

Party Name:GEMINI EXPORTS., 29.07.2008 Status:Case Approved HQ File :01/82/050/00490/AM08/ RLA File :03/94/040/00812/AM08/ Lic.No/Date:0310458056 17.01.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/04/2008‐PI‐III dated 26.06.2008 decided Export product Export Qty. Sl.No. Import item of export product Metoprolol Succinate Tech. Spec.Pharmacopial Grade 1 Vial 1. 4‐Methoxy Ethyl Phenol 0.81 kg 2. Epichlorohydrin 0.695 kg 3. Methyl Isopropyl Amine 1.59 kg 41

Case No.:58/45/82‐ALC4/2007

Party Name:LUPIN LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00521/AM08/ RLA File :03/95/040/01026/AM08/ Lic.No/Date:0310458300 18.01.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/25/2008‐PI‐III dated 27.06.2008 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 item of export product Cefpodoxime Proxetil 1 Kg. 1. 7 Amino Cephalosporanic Acid (7ACA) 0.998 kg 2. MEAM 0.998 kg 3. Activated Carbon 0.100 kg 4. Chloro Ethyl Isopropyl carbonate 0.558 kg 5. Sodium Hydrosulphite 0.198 kg 6. Tri Ethyl Amine 0.562 kg 7. Methane Sulphonic Acid 1.434 kg 8. Sodium Iodide 0.390 kg 9. Trimethyl Borate 1.85 kg 10. 1,8‐Diazabicylo‐(5,4,0)Undec‐7ene (DBU) 0.341 kg 11. Sulfolane 0.659 kg 12. Acetone 2.475 kg 13. Cyclohexane 0.348 kg 14. Demethyl Acetamide 0.655 kg 15. Ethyl Acetate 2.184 kg 16. Methanol 1.481 kg 17. Methylene Chloride 3.541 kg 18. Toluene 0.822 kg 19. Celite Not a raw material. Hence not allowed 42

Case No.:59/45/82‐ALC4/2007

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00522/AM08/ RLA File :03/95/040/01022/AM08/ Lic.No/Date:0310458669 22.01.2008 Decision : Case has already been approved by NC in its 16/09 meeting held on 15.07.2008. 43

Case No.:3/45/82‐ALC4/2007

Party Name:AUROBINDO PHARMA LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00466/AM08/ RLA File :09/24/040/00405/AM08/ Lic.No/Date:0910032711 23.01.2008 Decision :Case has already been approved by NC in its 17/09 meeting held on 22.07.2008. 44

Case No.:5/1/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00611/AM08/ RLA File :09/24/040/00038/AM08/ Lic.No/Date:0910032781 28.01.2008

Decision : Case has already been approved by NC in its 17/09 meeting held on 22.07.2008. 45

Case No.:38/6/82‐ALC4/2008

Party Name:DUJODWALA PAPER CHEMICALS LTD 29.07.2008 HQ File :01/82/050/00121/AM09/ RLA File :03/94/040/00957/AM08/ Lic.No/Date:0310459411 29.01.2008 Decision :Committee considered case as per agenda and observed that the firm vide C&PC letter No.46011/116/2008‐PC.II dated 19.06.2008 has been requested to furnish technical information, but the same has not been received and norms can not be fixed in absence of technical information. It was, therefore, decided to close the case. 46

Case No.:36/6/82‐ALC4/2008

Party Name:ULTRA‐TECH INDIA LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00119/AM09/ RLA File :03/95/040/01080/AM08/ Lic.No/Date:0310459552 30.01.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/10/2008‐PI‐III dated 24.07.2008 decided Export product Export Qty. Sl.No. Import item of export product 2‐[((3‐Methyl‐4‐(2,2,2‐Trifluoro Ethoxy)‐2‐Pyridinyl)‐ Methyl)Thio}‐1H‐Benzimidazole 1 Vial 1. 2,3 Lutidine (2,3 Dimethyl Pyridine) 0.95 kg 2. Trifluro Ethanol (2,2,2‐Trifluro Ethanol) 1.12 kg 47

Case No.:5/47/82‐ALC4/2007

Party Name:SAINOR LABORATORIES PVT LTD 29.07.2008 HQ File :01/82/050/00598/AM08/ RLA File :09/24/040/00497/AM07/ Lic.No/Date:0910032864 01.02.2008 Defer Date: 05.08.2008 Decision :Committee decided to defer case for 05.08.2008 for comments of Chemical Division. 48

Case No.:27/6/82‐ALC4/2008

29.07.2008 Status:Case Approved HQ File :01/82/050/00110/AM09/ RLA File :03/94/040/01099/AM08/ Lic.No/Date:0310459961 04.02.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007‐PI‐III dated nil decided to ratify

Export product Export Qty. Sl.No. Import item of export product Stavudine Capsules 15 mg [Stavudine = 15.30 mg] 1 Kg. 1. 2’,3’‐dihydro,5’‐O‐Benzoyl,5‐ Methyl Uridine 2.00 kg/kg of Stavudine Stavudine Capsules 20mg [Stavudine = 20.40 mg 1 Kg. Stavudine Capsules 30 mg [Stavudine = 30.60 mg] 1 Kg. Stavudine Capsules 40 mg [Stavudine = 40.80 mg] 1 kg. Lamivir S 30 tablets [Stavudine = 30.6 mg] 1 Kg. Lamivir S 40 tablets [Stavudine 40.8 mg] 1 Kg. 49

Case No.:36/45/82‐ALC4/2007

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 29.07.2008 HQ File :01/82/050/00499/AM08/ RLA File :03/95/040/01065/AM08/ Lic.No/Date:0310460271 06.02.2008 Defer Date: 26.08.2008 Decision :Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for 26.08.2008. 50

Case No.:29/6/82‐ALC4/2008

Party Name:GLENMARK PHARMACEUTICALS LTD., 29.07.2008 HQ File :01/82/050/00112/AM09/ RLA File :03/94/040/01032/AM08/ Lic.No/Date:0310460255 06.02.2008 Defer Date:26.08.2008 Decision :Committee observed that the firm has been requested to furnish technical information vide letter dated 22.07.2008, but no reply has been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for 26.08.2008. 51

Case No.:38/46/82‐ALC4/2007

Party Name:TTK LIG LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00592/AM08/ RLA File :04/24/040/00351/AM08/ Lic.No/Date:0410093705 07.02.2008 Decision :Case has already been approved by NC in its 17/09 meeting held on 22.07.2008.

Case No.:29/45/82‐ALC4/2007

Party Name:CENTAUR CHEMICALS PVT. LTD., 29.07.2008 Status:Case Approved HQ File :01/82/050/00492/AM08/ RLA File :03/94/040/01129/AM08/ Lic.No/Date:0310460671 12.02.2008 Decision :Case has already been approved by NC in its 15/09 meeting held on 08.07.2008. 53

Case No.:17/46/82‐ALC4/2007

Party Name:ARCH PHARMALABS LTD 29.07.2008 HQ File :01/82/050/00571/AM08/ RLA File :03/94/040/01117/AM08/ Lic.No/Date:0310461019 14.02.2008 Defer Date: 02.09.2008 Decision :Case has already been considered by NC in its 17/09 meeting held on 22.07.2008 and deferred for 02.09.2008. 54

Case No.:27/46/82‐ALC4/2007

Party Name:RELIANCE INDUSTRIES LTD. 29.07.2008 Status:Deffered and Re‐indexed HQ File :01/82/050/00581/AM08/ RLA File :03/95/040/01105/AM08/ Lic.No/Date:0310460988 14.02.2008 Defer Date:29.07.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PC Division vide their O.M. No.46011/20/2008‐PC.II dated 23.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Propylene 1 MT. 1. Naphtha 1.2359 MT 55

Case No.:4/47/82‐ALC4/2007

Party Name:SUDERSHAN LABORATORIES LTD. 29.07.2008 HQ File :01/82/050/00597/AM08/ RLA File :09/24/040/00523/AM08/ Lic.No/Date:0910033012 19.02.2008 Defer Date: 05.08.2008 Decision :Committee decided to defer case for 05.08.2008 for comments of Chemical Division. 56

Case No.:18/46/82‐ALC4/2007

Party Name:GITANJALI CHEMICALS PVT LTD 29.07.2008 HQ File :01/82/050/00572/AM08/ RLA File :03/94/040/01120/AM08/ Lic.No/Date:0310461653 19.02.2008 Defer Date:26.08.2008 Decision :Committee decided to defer case for 26.08.2008 for comments of Chemical Division. 57

Case No.:36/14/82‐ALC4/2008

Party Name:ESTELLE CHEMICALS PVT LTD 29.07.2008 Status:Case Approved

HQ File :01/82/050/00588/AM09/ RLA File :31/24/040/00370/AM08/ Lic.No/Date:3110032800 20.02.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their O.M. No.14010/103/2007‐Ch.III dated 17.07.2008 Export product Export Qty. Sl.No. Import item of export product Sorbitan Tristearate 1 Kg. 1. Sorbitol 0.195 kg 2. Stearic Acid (Stearic Acid content: 50 + 10% Stearic Acid + Palmitic acid content: 90% min.) 0.915 kg 58

Case No.:19/46/82‐ALC4/2007

29.07.2008 Status:Case Approved HQ File :01/82/050/00573/AM08/ RLA File :03/94/040/01202/AM08/ Lic.No/Date:0310462533 25.02.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007‐PI‐III dated nil decided to ratify Export product Export Qty. Sl.No. Import item of export product Stavudine Capsules 15 mg [Stavudine = 15.30 mg] 1 Kg. 1. 2’,3’‐dihydro,5’‐O‐Benzoyl,5‐ Methyl Uridine 2.00 kg/kg of Stavudine Stavudine Capsules 20mg [Stavudine = 20.40 mg 1 Kg. Stavudine Capsules 30 mg [Stavudine = 30.60 mg] 1 Kg. Stavudine Capsules 40 mg [Stavudine = 40.80 mg] 1 kg. Lamivir S 30 tablets [Stavudine = 30.6 mg] 1 Kg. Lamivir S 40 tablets [Stavudine 40.8 mg] 1 Kg.

Case No.:32/46/82‐ALC4/2007

Party Name:DUJODWALA PAPER CHEMICALS LTD 29.07.2008 HQ File :01/82/050/00586/AM08/ RLA File :03/94/040/01210/AM08/ Lic.No/Date:0310462982 27.02.2008 Decision :Committee considered case as per agenda and observed that the firm vide C&PC letter dated 19.06.2008 was requested to furnish technical details, but no reply has been received and norms can not be fixed in absence of required technical details. It was, therefore, decided to close the case. 60

Case No.:54/6/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 29.07.2008 HQ File :01/82/050/00137/AM09/ RLA File :09/24/040/00526/AM08/ Lic.No/Date:0910033127 28.02.2008 Defer Date: 09.09.2008 Decision :Committee decided to call for a copy of Drug Manufacturing Licence from firm. Accordingly, case was deferred for 09.09.2008. 61

Case No.:57/6/82‐ALC4/2008

Party Name:CORAL DRUGS PVT. LTD., 29.07.2008 HQ File :01/82/050/00140/AM09/ RLA File :05/24/040/00884/AM08/ Lic.No/Date:0510217198 28.02.2008 Defer Date: 26.08.2008 Decision :Committee decided to forward a copy of application to Department of MSME for their comments. Accordingly, case was deferred for 26.08.2008. 62

Case No.:61/6/82‐ALC4/2008

Party Name:DHANUKA LABORATORIES LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00144/AM09/ RLA File :05/24/040/00894/AM08/ Lic.No/Date:0510217254 29.02.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/43/2008‐PI‐III dated 17.07.2008 decided Export product Export Qty. Sl.No. Import item Qty. allowed per unit of export product 7 Amino‐3‐Vinyl Cephalosporanic Acid (7‐AVCA) 1 Kg 1. 7‐Phenylacetamideo‐3‐Chloromethyl Cephalosporaonic Acid Para methoxy benzyl Ester (GCLE) 2.672 kg/kg 2. Methanol 8.00 kg 3. Butyl Acetate 5.06 kg 4. Methylene Chloride 12.66 kg 5. Triphenyl Phosphine 1.26 kg 6. Phenol 0.933 kg

Case No.:64/6/82‐ALC4/2008

Party Name:DHANUKA LABORATORIES LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00147/AM09/ RLA File :05/24/040/00831/AM08/ Lic.No/Date:0510217272 29.02.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/43/2008‐PI‐III dated 17.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Cefdinir 1 Kg 1. 7‐Phenylacetamideo‐3‐Chloromethyl Cephalosporaonic Acid Para methoxy benzyl Ester (GCLE) 2.44 kg 2. Triphenyl Phosphene 2.429 kg 3. Phenol 2.42 kg 4. Methanol 7.12 kg 5. Methylene Chloride 23.64 kg 6. Tetra Hydro furan 3.91 kg 7. Acetone 3.21 kg 8. (Z)‐2‐(2‐Aminothiazole‐4YL)‐2‐Hydroxyimino Acetic (ATHIAA) 1.097 kg 9. Sodium Iodide 0.76 kg 64

Case No.:18/9/82‐ALC4/2008

Party Name:AMINES & PLASTICIZERS LIMITED 29.07.2008 HQ File :01/82/050/00251/AM09/ RLA File :03/94/040/01217/AM08/ Lic.No/Date:0310463452 03.03.2008 Defer Date:02.09.2008 Decision :Case has already been considered by NC and deferred for 02.09.2008. 65

Case No.:62/6/82‐ALC4/2008

Party Name:SUDERSHAN LABORATORIES LTD. 29.07.2008 HQ File :01/82/050/00145/AM09/ RLA File :09/24/040/00549/AM08/ Lic.No/Date:0910033166 03.03.2008 Defer Date:05.08.2008 Decision :Committee decided to defer case for 05.08.2008 for comments of Chemical Division. 66

Case No.:66/6/82‐ALC4/2008

Party Name:WIN‐MEDICARE PVT. LTD 29.07.2008 Status:Case Approved HQ File :01/82/050/00149/AM09/ RLA File :05/24/040/00235/AM08/ Lic.No/Date:0510217302

03.03.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/11/2008‐PI‐III dated 28.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Betadine Standardised Microbicidal Solution 10% USP/IP 500 ml (Each 500 ml contains Povidone Iodine USP 10% W/V) USP/IP 1 No. 1. Povidone Iodine USP 50.75 gm/500 ml bottle 67

Case No.:3/3/82‐ALC4/2008

Party Name:PRATAP ORGANICS 29.07.2008 Status:Case Approved HQ File :01/82/050/00003/AM09/ RLA File :03/95/040/01189/AM08/ Lic.No/Date:0310463615 04.03.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/45/2008/Ch.II dated 24.07.2008 Export product Export Qty. Sl.No. Import item of export product Benzophenone Hydrazone 1 Kg. 1. Benzophenone 1.06 kg 2. Hydrazine Hydrate 80% 0.318 kg 68

Case No.:16/9/82‐ALC4/2008

Party Name:GITANJALI CHEMICALS PVT LTD 29.07.2008 Status:Case Approved HQ File :01/82/050/00249/AM09/ RLA File :03/94/040/01207/AM08/ Lic.No/Date:0310463574 04.03.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their 14010/6/2008‐Ch.III dated 17.07.2008 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 item of export product Anisole Pure (Min. 99%) 1 Kg. 1. Anisole Crude (Max. 96%) 1.207 kg 2. Caustic Soda Flakes 0.120 kg

Case No.:55/6/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED Status:Case d

69 29.07.2008 Approved HQ File :01/82/050/00138/AM09/ RLA File :09/24/040/00565/AM08/ Lic.No/Date:0910033296 07.03.2008 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 11.02.2008 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 Quantity allowed per unit of export product Florfenicol 1 Kg. 1. (1R,2S)‐1‐[4‐ (methylsulfonyl)phenyl]‐2‐ amino‐3‐fluoro‐1‐propanol [Fluoroamine] 1.095kg 2. Methyl Dichloro Acetate 1.588kg 3. Toluene 1.61kg 4. Methanol 1.21kg 5. Ethanol 2.41kg 6. Carbon enoanticromos (Activated Carbon) 0.047kg RA concerned may take further necessary action as per above decision of Norms Committee. 70

Case No.:129/6/82‐ALC4/2008

Party Name:FMC INDIA PRIVATE LIMITED 29.07.2008 HQ File :01/82/050/00212/AM09/ RLA File :07/24/040/00820/AM08/ Lic.No/Date:0710056292 07.03.2008 Defer Date:05.08.2008 Decision :Committee decided to defer case for 05.08.2008 for comments of Chemical Div. 71

Case No.:23/9/82‐ALC4/2008

Party Name:SADHANA NITRO CHEM LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00256/AM09/ RLA File :03/95/040/01191/AM08/ Lic.No/Date:0310464442 11.03.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their 14010/85/2006‐Ch.II dated 22.07.2008 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 item of export product Aniline 2, 5 Disulphonic Acid 1 Kg. 1. Benzene 0.510 kg 2. Soda Ash Light 0.358 kg 3. Caustic Soda Flakes/Prills (Sodium Hydroxide) OR 0.0035 kg 3. Caustic Soda Lye (50%) 0.007 kg 4. Sodium Sulphate 0.336 kg 5 Iron Powder 0 814 kg

Iron Powder 0.814 kg 72

Case No.:59/6/82‐ALC4/2008

Party Name:SHASUN CHEMICALS & DRUGS LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00142/AM09/ RLA File :04/24/040/00388/AM08/ Lic.No/Date:0410094353 12.03.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/30/2008‐PI‐III dated 17.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Benzoic Acid‐7‐Hydroxy‐3‐Oxo‐ Tetrahydro Pyrrolo[1,2‐C]Oxazol‐6‐ YL Ester (HOPB) 1 Kg. 1. Methyl Cyclohexane 51.20 kg 73

Case No.:126/6/82‐ALC4/2008

Party Name:LAFFANS PETROCHEMICALS LTD., 29.07.2008 HQ File :01/82/050/00209/AM09/ RLA File :03/95/040/00826/AM08/ Lic.No/Date:0310464745 12.03.2008 Defer Date:26.08.2008 Decision :Committee decided to defer case for 26.08.2008 for comments of Chemical Div. 74

Case No.:118/6/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 29.07.2008 HQ File :01/82/050/00201/AM09/ RLA File :08/24/040/00275/AM08/ Lic.No/Date:0810070672 13.03.2008 Defer Date:09.09.2008 Decision :Committee decided to call for technical details as per Appendix 33 alongwith a copy of Drug Manufacturing Licence, wherever applicable from firm. Accordingly, case was deferred for 09.09.2008. 75

Case No.:34/9/82‐ALC4/2008

Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00267/AM09/ RLA File :03/94/040/01102/AM08/ Lic.No/Date:0310465020 14.03.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/54/2008‐PI‐III dated 02.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Atorvastatin Calcium 1 Kg 1. (4R,Cis) 1,1‐Dimethyl Ethyl‐6‐Cyano Methyl‐2,2‐ Dimethyl 1‐3, Dioxone‐4‐Acetate (ATS‐8) 1.08 kg

amorphous y ( ) 76

Case No.:53/6/82‐ALC4/2008

Party Name:KAMUD DRUGS PVT.LIMITED., 29.07.2008 HQ File :01/82/050/00136/AM09/ RLA File :31/24/040/00394/AM08/ Lic.No/Date:3110033090 14.03.2008 Defer Date:09.09.2008 Decision :Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/5/2008‐PI‐III dated 11.07.2008 decided to call for the following information/documents from firm. 1. Complete and balance chemical reactions indicating molecular weight of each reactant and output material. 2. % yield on molar basis for each step. 3. Material Balance for entire process, and 4. Copy of Technical Literature in support of the yields envisaged by the firm at each step of manufacturing process. Accordingly, the case was deferred for 09.09.2008. 77

Case No.:24/13/82‐ALC4/2008

Party Name:NICHIPLAST INDIA PVT LTD. 29.07.2008 HQ File :01/82/050/00531/AM09/ RLA File :05/24/040/00955/AM08/ Lic.No/Date:0510218631 28.03.2008 Defer Date:02.09.2008 Decision : Case has already been considered by NC in its 17/82 meeting held on 22.07.2008 and deferred for 02.09.2008. 78

Case No.:39/9/82‐ALC4/2008

29.07.2008 HQ File :01/82/050/00272/AM09/ RLA File :03/94/040/01345/AM08/ Lic.No/Date:0310466954 01.04.2008 Defer Date:26.08.2008 Decision : Committee observed that the firm has obtained Advance Authorisation under para 4.7 of HBP for export product Inhalers and sought import of gas against the same in addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 26.08.2008. 79

Case No.:51/6/82‐ALC4/2008

Party Name:HETERO LABS LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00134/AM09/ RLA File :09/24/040/00609/AM08/ Lic.No/Date:0910033526 03.04.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/28/2008‐PI‐III dated 22.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Efavirenz 1 Kg 1 Cyclopropy Acetylene 0 524 kg

Efavirenz 1 Kg. 1. Cyclopropy Acetylene 0.524 kg 2. Diethyl Zinc (20% in toluene) 4.41 kg 3. 2,2,2‐Trifluoro Ethanol 0.642 kg 4. N‐Butyl Chloride Not shown in reaction. Hence not allowed. 5. Triphosgene 0.498 kg 6. Tetrahydrofuran 5.50 kg 7. Methylene Chloride 7.50 kg 8. Cyclohexane 4.20 kg 80

Case No.:50/6/82‐ALC4/2008

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00133/AM09/ RLA File :04/24/040/00419/AM08/ Lic.No/Date:0410095125 07.04.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/122/2007‐PI‐III dated 17.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Levetiracetam 1 Kg. 1. (‐)‐2(S)‐(2‐oxo‐pyrrolidin‐1‐yl)‐butyric acid (S‐PIA) 1.75 kg 2. Methanol 3.50 kg 3. Acetone 4.12 kg 81

Case No.:119/6/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 29.07.2008 HQ File :01/82/050/00202/AM09/ RLA File :08/24/040/00002/AM09/ Lic.No/Date:0810071149 08.04.2008 Defer Date: 09.09.2008 Decision :Committee decided to call for technical details as per Appendix 33 alongwith a copy of DML, wherever applicable from firm. Accordingly, case was deferred for 09.09.2008. 82

Case No.:11/13/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 29.07.2008 HQ File :01/82/050/00518/AM09/ RLA File :09/24/040/00592/AM08/ Lic.No/Date:0910033594 09.04.2008 Defer Date:26.08.2008

Case No.:46/9/82‐ALC4/2008

Party Name:CIPLA LIMITED Meet No/Date:18/82‐ALC4/2008 Status:Case

Case No.:46/9/82 ALC4/2008

Meet No/Date:18/82 ALC4/2008 29.07.2008 Status:Case Approved HQ File :01/82/050/00279/AM09/ RLA File :03/94/040/00018/AM09/ Lic.No/Date:0310467804 09.04.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007‐PI‐III dated Nil decided to ratify Export product Export Qty. Sl.No. Import item of export product Irinotecan Hcl Injection 40 mg/2ml 1 Vial 1. 70.04 mg/vial Irinotecan Hcl Injection 100 mg/5ml 1 vial 1. 176.0 mg/vial 84

Case No.:53/9/82‐ALC4/2008

Party Name:SHALINA LABORATORIES PVT. LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00286/AM09/ RLA File :03/95/040/01274/AM08/ Lic.No/Date:0310468054 10.04.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/56/2008‐PI‐III dated 25.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Germol Antiseptic Liquid (50 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 2.448 gm/50 ml bottle Germol Antiseptic Liquid (100 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 4.896 gm/100 ml bottle Germol Antiseptic Liquid (250 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 12.24 gm/250 ml bottle Germol Antiseptic Liquid (500 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 24.48 gm/500 ml bottle Germol Antiseptic Liquid (1000 ml 1 No. 1. Chloroxylenol 48.96 gm/1000 ml

Germol Antiseptic Liquid (1000 ml pack) [each 100ml contain Chloroxylenol BP 4.896% W/V inclusive of 2% wastage] 1 No. 1. Chloroxylenol 48.96 gm/1000 ml bottle 85

Case No.:25/13/82‐ALC4/2008

Party Name:DHANUKA LABORATORIES LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00532/AM09/ RLA File :05/24/040/00015/AM09/ Lic.No/Date:0510219542 22.04.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/43/2008‐PI‐III dated 17.07.2008 decided Export product Export Qty. Sl.No. Import item Qty. allowed per unit of export product 7 Amino‐3‐Vinyl Cephalosporanic Acid (7‐AVCA) 1 Kg 1. 7‐Phenylacetamideo‐3‐Chloromethyl Cephalosporaonic Acid Para methoxy benzyl Ester (GCLE) 2.672 kg 2. Methanol 8.00 kg 3. Butyl Acetate 5.06 kg 4. Methylene Chloride 12.66 kg 5. Triphenyl Phosphine 1.26 kg 6. Phenol 0.933 kg 86

Case No.:6/12/82‐ALC4/2008

29.07.2008 HQ File :01/82/050/00474/AM09/ RLA File :03/94/040/00104/AM09/ Lic.No/Date:0310469550 25.04.2008 Defer Date:26.08.2008 Decision : Committee observed that the firm has obtained Advance Authorisation under para 4.7 of HBP for export product Inhalers and sought import of gas against the same in addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 26.08.2008. 87

Case No.:10/12/82‐ALC4/2008

29.07.2008 HQ File :01/82/050/00478/AM09/ RLA File :03/94/040/00124/AM09/ Lic.No/Date:0310470252 01.05.2008 Defer Date:26.08.2008 Decision : Committee observed that the firm has obtained Advance Authorisation under para 4.7 of HBP for export product Inhalers and sought import of gas against the same in��

addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 26.08.2008. 88

Case No.:60/14/82‐ALC4/2008

Party Name:SMILAX LABORATORIES LIMITED 29.07.2008 HQ File :01/82/050/00612/AM09/ RLA File :09/24/040/00540/AM08/ Lic.No/Date:0910034044 21.05.2008 Defer Date:26.08.2008 89

Case No.:75/14/82‐ALC4/2008

Party Name:SUVEN LIFE SCIENCES LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00627/AM09/ RLA File :09/24/040/00044/AM09/ Lic.No/Date:0910034059 26.05.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/226/2006‐PI‐III dated 11.07.2008 decided Export product Export Qty. Sl.No. Import item of export product (2‐Chloro‐5‐Iodophenyl)‐[4‐ (Tetrahydrofuran‐3‐Yloxy Phenyl]‐ Methanone 1 Kg. 1. 2‐Chloro‐5‐Iodobenzoicacid 1.09 kg 2. Fluoro Benzene 1.71 kg 3. Methyl Tertiary Butyl ether 0.82 kg 4. Iso Propyl Alcohol 3.34 kg 90

Case No.:64/14/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 29.07.2008 HQ File :01/82/050/00616/AM09/ RLA File :09/24/040/00068/AM09/ Lic.No/Date:0910034075 27.05.2008 Defer Date:26.08.2008 91

Case No.:65/14/82‐ALC4/2008

Party Name:DIVIS LABORATORIES LTD., 29.07.2008 HQ File :01/82/050/00617/AM09/ RLA File :09/24/040/00073/AM09/ Lic.No/Date:0910034076 27.05.2008 Defer Date:26.08.2008

Case No.:66/14/82‐ALC4/2008

Party Name:HETERO LABS LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00618/AM09/ RLA File :09/24/040/00074/AM09/ Lic.No/Date:0910034090 27 05 2008

92 27.05.2008 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 41/82 meeting held on 24.01.2007 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 of export product Zidovudine Powder 1 Kg. 1. 5‐O‐Trityl‐2,3‐Anhydrothymidine 2.64 kg 2. Dimethyl Sulfoxide 2.98 kg 3. Methylene Dichloride 3.00 kg 4. Methanol 3.00 kg 93

Case No.:69/14/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 29.07.2008 Status:Case Approved HQ File :01/82/050/00621/AM09/ RLA File :09/24/040/00063/AM09/ Lic.No/Date:0910034082 27.05.2008 Decision : Committee considered case as per agenda and in consultation with Technical Authority and in light of its earlier decision taken in its 37/87 meeting held on 09.02.2005 and taking cue from SION A‐3208 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 of export product Lamotrigine 1 Kg. 1. Amino Guanidine Hydrochloride 1.23 kg 2. 1‐Methyl‐2‐Pyrrolidinone 3.3 kg 3. 2,3‐Dichloro Benzoyl Chloride 2.05 kg 94

Case No.:70/14/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 29.07.2008 HQ File :01/82/050/00622/AM09/ RLA File :09/24/040/00052/AM09/ Lic.No/Date:0910034083 27.05.2008 Defer Date:26.08.2008 Decision :Committee decided to defer case for 26.08.2008 for comments of Chemical Div. 95

Case No.:71/14/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 29.07.2008 HQ File :01/82/050/00623/AM09/ RLA File :09/24/040/00069/AM09/ Lic.No/Date:0910034081 27.05.2008 Defer Date:26.08.2008

Case No.:13/14/82‐ALC4/2008

Party Name:S. H.KELKAR AND CO.PVT.LTD.,

96 29.07.2008 HQ File :01/82/050/00565/AM09/ RLA File :03/95/040/00145/AM09/ Lic.No/Date:0310472257 28.05.2008 Defer Date:26.08.2008 Decision : Committee decided to defer case for 26.08.2008 for comments of Chemical Div. 97

Case No.:20/14/82‐ALC4/2008

Party Name:S. H.KELKAR AND CO.PVT.LTD., 29.07.2008 HQ File :01/82/050/00572/AM09/ RLA File :03/95/040/00143/AM09/ Lic.No/Date:0310472213 28.05.2008 Defer Date:26.08.2008 Decision : Committee decided to defer case for 26.08.2008 for comments of Chemical Div. 98

Case No.:16/14/82‐ALC4/2008

Party Name:LUPIN LIMITED 29.07.2008 HQ File :01/82/050/00568/AM09/ RLA File :03/95/040/00170/AM09/ Lic.No/Date:0310472351 29.05.2008 Defer Date:26.08.2008 99

Case No.:21/14/82‐ALC4/2008

Party Name:NIKITA CHEMICAL INDUSTRIES 29.07.2008 HQ File :01/82/050/00573/AM09/ RLA File :03/95/040/00163/AM09/ Lic.No/Date:0310472488 29.05.2008 Defer Date:09.09.2008 Decision :Committee decided to call for technical details as per Appendix 33 alongwith a copy of Drug Manufacturing Licence, wherever applicable from firm. Accordingly, case was 100

Case No.:15/14/82‐ALC4/2008

29.07.2008 HQ File :01/82/050/00567/AM09/ RLA File :03/94/040/00144/AM09/ Lic.No/Date:0310472800 02.06.2008 Defer Date:26.08.2008 Decision : Committee observed that the firm has obtained Advance Authorisation under para 4.7 of HBP for export product Inhalers and sought import of gas against the same in addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 26.08.2008. 101

Case No.:73/14/82‐ALC4/2008

Party Name:NEULAND LABORATORIES LTD 29.07.2008 HQ File :01/82/050/00625/AM09/ RLA File :09/24/040/00051/AM09/ Lic.No/Date:0910034133 02.06.2008 Defer Date:26.08.2008

Case No :19/14/82 ALC4/2008

Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:18/82 ALC4/2008 Status:Case

102

Case No.:19/14/82‐ALC4/2008

Party Name:EXCEL INDUSTRIES LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00571/AM09/ RLA File :03/94/040/00357/AM08/ Lic.No/Date:0310473045 04.06.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their 14010/185/2002‐Ch.III dated 28.09.2004 decided Export product Export Qty. Sl.No. Import item of export product Disodium Salt of Diethylene Triamine Pentamethylene Phosphonic Acid (Active content 40% min.) 1 Kg. 1. Diethylene Triamine 0.074 kg 2. Yellow Phosphorous 0.111 kg 3. Formaldehyde (37%) 0.292 kg 4. Caustic Lye 0.230 kg 103

Case No.:23/14/82‐ALC4/2008

29.07.2008 HQ File :01/82/050/00575/AM09/ RLA File :03/94/040/00266/AM09/ Lic.No/Date:0310473365 05.06.2008 Defer Date:26.08.2008 104

Case No.:76/14/82‐ALC4/2008

Party Name:ONEIRO CHEMICALS LTD 29.07.2008 HQ File :01/82/050/00628/AM09/ RLA File :34/24/040/00041/AM09/ Lic.No/Date:3410021533 05.06.2008 Defer Date:26.08.2008 105

Case No.:22/14/82‐ALC4/2008

29.07.2008 HQ File :01/82/050/00574/AM09/ RLA File :03/94/040/00230/AM09/ Lic.No/Date:0310473544 06.06.2008 Defer Date:26.08.2008 106

Case No.:29/14/82‐ALC4/2008

Party Name:ANUH PHARMA LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00581/AM09/ RLA File :03/94/040/00236/AM09/ Lic.No/Date:0310473593 06.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/28/2008‐PI‐III dated 08.07.2008 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 unit

Export product Export Qty. Sl.No. Import items of export product Clobetasol Propionate 1 Kg. 1. Betamethasone BP 1.04 kg 107

Case No.:31/14/82‐ALC4/2008

Party Name:AVIK PHARMACEUTICAL LTD., 29.07.2008 HQ File :01/82/050/00583/AM09/ RLA File :03/94/040/01139/AM08/ Lic.No/Date:0310473589 06.06.2008 Defer Date:26.08.2008 108

Case No.:32/14/82‐ALC4/2008

Party Name:AVIK PHARMACEUTICAL LTD., 29.07.2008 HQ File :01/82/050/00584/AM09/ RLA File :03/94/040/01300/AM08/ Lic.No/Date:0310473591 06.06.2008 Defer Date:26.08.2008 109

Case No.:87/14/82‐ALC4/2008

Party Name:MEDREICH LIMITED 29.07.2008 HQ File :01/82/050/00639/AM09/ RLA File :07/24/040/00107/AM09/ Lic.No/Date:0710057749 06.06.2008 Defer Date:09.09.2008 Decision : Committee decided to call for a copy of Master Batch Formula certified by Quality Control Incharge from firm. Accordingly, case was deferred for 09.09.2008. 110

Case No.:30/14/82‐ALC4/2008

Party Name:ANUH PHARMA LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00582/AM09/ RLA File :03/94/040/00045/AM09/ Lic.No/Date:0310473788 09.06.2008 Decision : Committee considered case as per agenda and in consultation with the representative of T.A. presen in the meeting and in light of its earlier decision taken in its 1/87 meeting held on 05.04.2006 vide Case No.39/30/87 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 of export product Erythromycin 11‐12 Carbonate 1 Kg. 1. Erithromycin Thiocyanate 1.55 kg

Case No.:26/14/82‐ALC4/2008

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 29.07.2008 Status:Case Approved HQ File :01/82/050/00578/AM09/ RLA File :03/94/040/00087/AM09/ Lic.No/Date:0310473999 10 06 2008

111 10.06.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their 14010/106/2004/Ch.II dated 28.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Para Chloro Meta Cresol 1 Kg. 1. Meta Cresol 1.232 kg 2. Sulphuryl Chloride 1.660 kg 112

Case No.:28/14/82‐ALC4/2008

Party Name:AMBUJA INTERMEDIATES PVT. LTD. 29.07.2008 HQ File :01/82/050/00580/AM09/ RLA File :03/94/040/00191/AM09/ Lic.No/Date:0310474041 10.06.2008 Defer Date:09.09.2008 Decision :Committee considered case as per agenda and observed that Department of C&PC, Chemical Division vide their letter No.14010/36/2008‐Ch.III dated 28.07.2008 has called for technical information from firm. Committee, therefore, decided to await reply of firm and defer the case for 09.09.2008. 113

Case No.:37/13/82‐ALC4/2008

Party Name:NOVA INTERNATIONAL 29.07.2008 Status:Case Approved HQ File :01/82/050/00544/AM09/ RLA File :08/24/040/00041/AM09/ Lic.No/Date:0810072569 13.06.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/38/2008/Ch.II dated 14.07.2008 Export product Export Qty. Sl.No. Import item of export product 2,3 Dichloro 1:4 Naphthaquinone (Dichlone) 1 Kg. 1. Sodium Naphthionate 1.495 kg 114

Case No.:38/13/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 29.07.2008 Status:Case Approved HQ File :01/82/050/00545/AM09/ RLA File :09/24/040/00101/AM09/ Lic.No/Date:0910034291 13.06.2008 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 23/87 meeting held on 14.09.2005 and in consultation with the representative of technical authority present in the meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import item of export product ValacyclovirHcl Monohydrate 1 Kg. 1. Carbobenzyloxy‐L‐Valine (CBZ‐L‐ 1.60 kg

Valine) 2. Dicyclohexyl carbodimide (DCC) 1.47 kg 3. 4‐Dimethylamino pyridine 0.028 kg 4. Isopropyl Alcohol 7.0 kg 5. Dimethyl formamide 2.5 kg 115

Case No.:40/13/82‐ALC4/2008

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 29.07.2008 Status:Case Approved HQ File :01/82/050/00547/AM09/ RLA File :07/24/040/00108/AM09/ Lic.No/Date:0710057896 13.06.2008 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import item of export product Zinc Gluconate Powder 1 Kg. 1. Zinc Gluconate Granular 1.01 kg 116

Case No.:45/13/82‐ALC4/2008

Party Name:AVENTIS PHARMA LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00552/AM09/ RLA File :03/94/040/00238/AM09/ Lic.No/Date:0310474565 13.06.2008 Decision : Committee considered case as per agenda and consultation with Technical Authority and in light of written comments forwarded by PI Division vide their U.O. No.35011/214/2006‐PI‐III dated 29.07.2008 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 item of export product Glibenclamide/Glyburide 1 Kg. 1. Cyclohexyl Isocyanate 0.4251 kg 2. Methanol 6.197 kg 3. N,N‐Dimethyl Formamide 0.642 kg 4. Activated Charcoal 0.0787 kg 117

Case No.:7/14/82‐ALC4/2008

29.07.2008 HQ File :01/82/050/00559/AM09/ RLA File :03/94/040/00286/AM09/ Lic.No/Date:0310474589 Defer Date:

13.06.2008 26.08.2008 Decision : Committee decided to defer case for 26.08.2008 for comments of PI Division. 118

Case No.:41/13/82‐ALC4/2008

Party Name:DHANUKA LABORATORIES LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00548/AM09/ RLA File :05/24/040/00077/AM09/ Lic.No/Date:0510222176 16.06.2008 Decision :Case has already been approved by NC in its 13/09 meeting held on 24.06.2008. 119

Case No.:42/13/82‐ALC4/2008

Party Name:IND‐SWIFT LABORATORIES LTD., 29.07.2008 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 : Committee considered case as per agenda and in consultation with Technical Authority and in light of its earlier decision taken in its 46/82 meeting held on 22.02.2006 Export product Export Qty. Sl.No. Import item of export product Pentazocine 1 Kg. 1. 3,4‐Lutidine 2.12 kg 2. Sodium Borohydride 0.584 kg 3. Acetone 5.40 kg 4. Methylene Chloride 6.22 kg 5. 5% Palladium on Carbon 0.100 kg 6. Isoprene 0.66 kg 7. Isopropanol 2.40 kg 8. Hexane 2.75 kg 120

Case No.:43/13/82‐ALC4/2008

Party Name:ANUPAM RASAYAN (INDIA) LTD 29.07.2008 HQ File :01/82/050/00550/AM09/ RLA File :52/24/040/00005/AM09/ Lic.No/Date:5210023726 16.06.2008 Defer Date:09.09.2008 Decision :Committee decided to call for a copy of application alongwith technical details as per Appendix 33 from firm. Accordingly, case was deferred for 09.09.2008.

Case No.:10/14/82‐ALC4/2008

Party Name:AARTI INDUSTRIES LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00562/AM09/ RLA File :03/94/040/01337/AM08/ Lic.No/Date:0310474806 16.06.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their 14010/28/2005/Ch.II dated 17.10.2005 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

121 Export product Export Qty. Sl.No. Import item of export product 2,3 Dichloro 6‐Nitro Aniline 1 Kg. 1. 1,2,3 Trichloro Benzene 1.10 kg 2. Monocchloro Benzene 0.850 kg 122

Case No.:33/14/82‐ALC4/2008

29.07.2008 Status:Case Approved HQ File :01/82/050/00585/AM09/ RLA File :03/94/040/00300/AM09/ Lic.No/Date:0310474925 16.06.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007‐PI‐III dated 28.01.2008 decided Export product Export Qty. Sl.No. Import item of export product Tenofovir Disoproxil Fumarate 1 Kg 1. 9‐[2‐(Phosphonyl Methoxy) Propyl] Adenine 0.8026 kg 2. Chloromethyl Isopropyl Carbonate 2.0867 kg 123

Case No.:34/14/82‐ALC4/2008

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 29.07.2008 Status:Case Approved HQ File :01/82/050/00586/AM09/ RLA File :03/94/040/00288/AM09/ Lic.No/Date:0310474935 16.06.2008 Decision :Case has already been approved by NC in its 14/82 meeting held on 01.07.2008. 124

Case No.:35/14/82‐ALC4/2008

Party Name:FINE ORGANIC INDUSTRIES(MUMBAI) PVT. LTD. 29.07.2008 HQ File :01/82/050/00587/AM09/ RLA File :03/94/040/00278/AM09/ Lic.No/Date:0310474948 16.06.2008 Defer Date:09.09.2008 Decision :Committee decided to call for application alongwith technical details as per Appendix 33 alongwith DML, wherever applicable from RA/firm. Accordingly, case was

Case No.:1/14/82‐ALC4/2008

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED 29 07 2008

125 LIMITED. 29.07.2008 HQ File :01/82/050/00553/AM09/ RLA File :31/24/040/00070/AM09/ Lic.No/Date:3110034059 17.06.2008 Defer Date:09.09.2008 Decision : Committee decided to call for application alongwith technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 09.09.2008. 126

Case No.:2/14/82‐ALC4/2008

Party Name:ANUPAM RASAYAN (INDIA) LTD 29.07.2008 HQ File :01/82/050/00554/AM09/ RLA File :52/24/040/00004/AM09/ Lic.No/Date:5210023736 17.06.2008 Defer Date:09.09.2008 Decision : Committee decided to call for application alongwith technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 09.09.2008. 127

Case No.:37/14/82‐ALC4/2008

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 29.07.2008 Status:Deffered and Re‐indexed HQ File :01/82/050/00589/AM09/ RLA File :09/24/040/00070/AM09/ Lic.No/Date:0910034344 18.06.2008 Defer Date:29.07.2008 Decision : 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 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 128

Case No.:39/14/82‐ALC4/2008

Party Name:AUCTUS PHARMA LIMITED 29.07.2008 HQ File :01/82/050/00591/AM09/ RLA File :09/21/040/00629/AM08/ Lic.No/Date:0910034349 18.06.2008 Defer Date:26.08.2008 C N 49/14/82 ALC4/2008 P N SHALINA LABORATORIES PVT LTD M N /D 18/82 ALC4/2008 S C D f d

129

Case No.:49/14/82‐ALC4/2008

Party Name:SHALINA LABORATORIES PVT. LTD. 29.07.2008 HQ File :01/82/050/00601/AM09/ RLA File :03/95/040/00245/AM09/ Lic.No/Date:0310475408 19.06.2008 Defer Date:26.08.2008 130

Case No.:51/14/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 29.07.2008 HQ File :01/82/050/00603/AM09/ RLA File :09/24/040/00110/AM09/ Lic.No/Date:0910034350 19.06.2008 Defer Date:26.08.2008 131

Case No.:52/14/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 29.07.2008 HQ File :01/82/050/00604/AM09/ RLA File :09/24/040/00357/AM08/ Lic.No/Date:0910034351 19.06.2008 Defer Date:26.08.2008 132

Case No.:53/14/82‐ALC4/2008

Party Name:GRANULES INDIA LIMITED 29.07.2008 HQ File :01/82/050/00605/AM09/ RLA File :09/24/040/00551/AM08/ Lic.No/Date:0910034352 19.06.2008 Defer Date:26.08.2008 133

Case No.:54/14/82‐ALC4/2008

Party Name:GRANULES INDIA LIMITED 29.07.2008 HQ File :01/82/050/00606/AM09/ RLA File :09/24/040/00106/AM09/ Lic.No/Date:0910034353 19.06.2008 Defer Date:26.08.2008 134

Case No.:55/14/82‐ALC4/2008

Party Name:SUVEN LIFE SCIENCES LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00607/AM09/ RLA File :09/24/040/00099/AM09/ Lic.No/Date:0910034356 19.06.2008 Decision :Case has already been approved by NC in its 14/09 meeting held on 01.07.2008. 135

Case No.:79/14/82‐ALC4/2008

29.07.2008 HQ File :01/82/050/00631/AM09/ RLA File :03/94/040/00295/AM09/ Lic.No/Date:0310475486 19 06 2008 Defer Date 09 09 2008

135 19.06.2008 Date:09.09.2008 Decision :Committee considered case as per agenda and observed that the description of export product has been given as “Tenofovir Disoproxil Fumarate + Emtricitabine + Efavirenz Tablets/Viraday Tablets” and the import items have not been asked for all the three products separately. Committee, therefore, decided that the firm may be asked to give the quantity of import items for each export product separately. Accordingly, the case was deferred for 09.09.2008. 136

Case No.:81/14/82‐ALC4/2008

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 29.07.2008 HQ File :01/82/050/00633/AM09/ RLA File :03/95/040/00257/AM09/ Lic.No/Date:0310475550 19.06.2008 Defer Date:26.08.2008 137

Case No.:57/14/82‐ALC4/2008

Party Name:VETINDIA PHARMACEUTICALS LIMITED 29.07.2008 Status:Deffered and Re‐indexed HQ File :01/82/050/00609/AM09/ RLA File :09/24/040/00116/AM09/ Lic.No/Date:0910034365 20.06.2008 Defer Date:29.07.2008 Decision : Committee considered case as per agenda and in consultation with representative of technical authority present in meeting decided to ratify norms with 2% wastage 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 of export product Albendazole Bolus 2.5 Gram 1 No. 1. Albendazole USP 2550 mg/bolus of 2.5 gram 138

Case No.:78/14/82‐ALC4/2008

Party Name:SARNA CHEMICALS PVT.LTD. 29.07.2008 HQ File :01/82/050/00630/AM09/ RLA File :03/95/040/00227/AM09/ Lic.No/Date:0310475758 20.06.2008 Defer Date:26.08.2008 Decision : Committee decided to defer case for 26.08.2008 for comments of Chemical Division. 139

Case No.:82/14/82‐ALC4/2008

29.07.2008 Status:Case Approved HQ File :01/82/050/00634/AM09/ RLA File :03/94/040/00299/AM09/ Lic.No/Date:0310475616 20.06.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007‐PI‐III dated 23.10.2007 decided Export product Export Qty. Sl.No. Import items of export product Tenofovir Disoproxil Fumarate Tablets 1 No. 1. 9‐[2‐(Phosphonyl Methoxy)Propyl] Adenine 0.8026kg/kg of Tenofovir Disoproxil

300mg/Tenvir Tablets [weight of Tenofovir Disoproxil Fumarate—306 mg/300 mg tablet) Fumarate 2. Chloromethyl Isopropyl carbonate 2.08670kg/kg of Tenofovir Disoproxil Fumarate RA concerned may take further necessary action as per above decision of NC. 140

Case No.:83/14/82‐ALC4/2008

29.07.2008 Status:Case Approved HQ File :01/82/050/00635/AM09/ RLA File :03/94/040/00220/AM09/ Lic.No/Date:0310475617 20.06.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007‐PI‐III dated 23.10.2007 decided Export product Export Qty. Sl.No. Import items of export product Tenofovir Disoproxil Fumarate Tablets 300mg/Tenvir Tablets [weight of Tenofovir Disoproxil Fumarate—306 mg/300 mg tablet) 1 No. 1. 9‐[2‐(Phosphonyl Methoxy)Propyl] Adenine 0.8026kg/kg of Tenofovir Disoproxil Fumarate 2. Chloromethyl Isopropyl carbonate 2.08670kg/kg of Tenofovir Disoproxil Fumarate RA concerned may take further necessary action as per above decision of NC. 141

Case No.:85/14/82‐ALC4/2008

29.07.2008 HQ File :01/82/050/00637/AM09/ RLA File :03/94/040/00311/AM09/ Lic.No/Date:0310475620 20.06.2008 Defer Date:26.08.2008 Decision : Committee observed that the firm has obtained Advance Authorisation under para 4.7 of HBP for export product Inhalers and sought import of gas against the same in addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 26.08.2008.

142

Case No.:25/16/82‐ALC4/2008

Party Name:SINGH PLASTICISERS & RESINS (I) PVT.LTD. Meet No/Date:18/82‐ALC4/2008 29.07.2008 HQ File :01/82/050/00718/AM09/ RLA File :05/24/040/00242/AM09/ Lic.No/Date:0510223574 09.07.2008 Defer Date:09.09.2008 Decision :Committee decided to call for application alongwith technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 09.09.2008. 143

Case No.:26/16/82‐ALC4/2008

Party Name:CADILA PHARMACEUTICALS LTD. 29.07.2008 Status:Case Closed HQ File :01/82/050/00719/AM09/ RLA File :08/24/040/00060/AM09/ Lic.No/Date:0810073143 09.07.2008 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 144

Case No.:27/16/82‐ALC4/2008

Party Name:SHALINA LABORATORIES PVT. LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00720/AM09/ RLA File :03/95/040/00323/AM09/ Lic.No/Date:0310477994 09.07.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/56/2008‐PI‐III dated 25.07.2008 decided Export product Export Qty. Sl.No. Import item of export product Germol Antiseptic Liquid (50 ml pack) [Each 50 ml Bottle contains 2.472 gm. Chloroxylenol BP] 1 No. 1. Chloroxylenol 2.472 gm/50 ml bottle Germol Antiseptic Liquid (100 ml pack) [Each 100 ml Bottle contains 4.896 gm. Chloroxylenol BP] 1 No. 1. Chloroxylenol 4.896 gm/100 ml bottle Germol Antiseptic Liquid (250 ml pack) [Each 250 ml Bottle contains 12.24 gm. Chloroxylenol BP] 1 No. 1. Chloroxylenol 12.24 gm/250 ml bottle Germol Antiseptic Liquid (500 ml pack) [Each 500 ml Bottle contains 24.48 gm. Chloroxylenol BP] 1 No. 1. Chloroxylenol 24.48 gm/500 ml bottle Germol Antiseptic Liquid (1000 ml pack) [Each 1000 ml Bottle contains 48.96 gm. Chloroxylenol BP] 1 No. 1. Chloroxylenol 48.96 gm/1000 ml bottle

145

Case No.:28/16/82‐ALC4/2008

Party Name:CAMLIN FINE CHEMICALS LIMITED 29.07.2008 Status:Case Approved HQ File :01/82/050/00721/AM09/ RLA File :03/94/040/00284/AM09/ Lic.No/Date:0310478032 09.07.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/64/2002‐Ch.III dated 18.07.2002 Export product Export Qty. Sl.No. Import item of export product Butylated Hydroxy Anisole 1 Kg. 1. Hydroquinone 1.247 kg 2. Tertiary Butanol 0.839 kg 3. Phosphoric Acid 1.00 kg 4. Hexane 1.00 kg 146

Case No.:29/16/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 29.07.2008 HQ File :01/82/050/00722/AM09/ RLA File :05/24/040/00237/AM09/ Lic.No/Date:0510223637 09.07.2008 Defer Date: 26.08.2008 147

Case No.:30/16/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 29.07.2008 HQ File :01/82/050/00723/AM09/ RLA File :05/24/040/00136/AM09/ Lic.No/Date:0510223638 09.07.2008 Defer Date:09.09.2008 Decision :Committee decided to call for application alongwith details of export product from RA/firm. Accordingly, case was deferred for 09.09.2008. 148

Case No.:31/16/82‐ALC4/2008

Party Name:MAYUKA LABS PRIVATE LIMITED 29.07.2008 HQ File :01/82/050/00724/AM09/ RLA File :05/24/040/00156/AM09/ Lic.No/Date:0510223639 10.07.2008 Defer Date:09.09.2008 Decision :Committee decided to call for the details of import items export product wise from RA/firm. Accordingly, case was deferred for 09.09.2008. 149

Case No.:1/18/82‐ALC4/2008

Party Name:HALDIA PETROCHEMICALS LTD. 29.07.2008 Status:Case Approved HQ File :01/82/050/00754/AM09/ RLA File :02/24/040/00098/AM09/ Lic.No/Date:0210114941 16.07.2008 d d d f� fi� f d l h f f d d b h l d h

Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Petrochemicals Division vide their O.M. No.46011/54/2008‐PC.II dated 23.06.2008 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 of export product Benzene (from Olefin Complex) 1 MT 1. Naphtha 1.194 MT 150

Case No.:2/18/82‐ALC4/2008

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 29.07.2008 Status:Case Added HQ File :01/82/050/00755/AM09/ RLA File :07/24/040/00181/AM09/ Lic.No/Date:0710058568 16.07.2008 Defer Date: Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import item of export product Calcium Pantotheonate Powder 1 Kg. 1. Calcium Pantotheonate Granuler 1.01 kg 151

Case No.:4/18/82‐ALC4/2008

Party Name:RA CHEM PHARMA LIMITED 29.07.2008 HQ File :01/82/050/00757/AM09/ RLA File :09/24/040/00129/AM09/ Lic.No/Date:0910034661 16.07.2008 Defer Date: 26.08.2008 Decision :Committee decided to forward a copy of application to Chemical Division for their comments. Accordingly, case was deferred for 26.08.2008. 152

Case No.:5/18/82‐ALC4/2008

Party Name:RA CHEM PHARMA LIMITED 29.07.2008 HQ File :01/82/050/00758/AM09/ RLA File :09/24/040/00148/AM09/ Lic.No/Date:0910034662 16.07.2008 Defer Date: 09.09.2008 Decision :Committee decided to call for application alongwith technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 09.09.2008. 153

Case No.:6/18/82‐ALC4/2008

Party Name:RA CHEM PHARMA LIMITED 29.07.2008 HQ File :01/82/050/00759/AM09/ RLA File :09/24/040/00111/AM09/ Lic.No/Date:0910034663 16.07.2008 Defer Date: 26.08.2008

Case No.:7/18/82‐ALC4/2008

Party Name:SHODHANA LABORATORIES LTD Status:Case

154 29.07.2008 Approved HQ File :01/82/050/00760/AM09/ RLA File :09/24/040/00147/AM09/ Lic.No/Date:0910034664 16.07.2008 Decision : Committee in light of its earlier decision taken in its 35/08 meeting held on 01.01.2008 and in consultation with representative of PI Division present in meeting decided Export product Export Qty. Sl.No. Import items of export product 4‐(2,3‐Epoxy Propoxy) Carbazole 1kg. 1. 4‐Hydroxy Carbazole 1.14 kg 2. Epichlorophdrin 2.02kg 155

Case No.:3/18/82‐ALC4/2008

Party Name:ALEMBIC LIMITED 29.07.2008 Status:Case Closed HQ File :01/82/050/00756/AM09/ RLA File :34/24/040/00043/AM09/ Lic.No/Date:3410021855 17.07.2008 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 156

Case No.:8/18/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 29.07.2008 Status:Case Approved HQ File :01/82/050/00761/AM09/ RLA File :05/24/040/00257/AM09/ Lic.No/Date:0510224078 18.07.2008 Decision : Committee considered case as per agenda in light of its earlier decision taken in 23/08 meeting held on 09.10.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product Export Qty. Sl.No. Import items of export product Cefpodoxime Proxetil 1kg. 1. 7 ACA 1.25 Kg 2. 1‐chloroethyl chloro formate 0.558 Kg 3. 1,8 Diazabicyclo[5,4.0]‐undec‐7‐ Ene(DBU) 0.364 Kg 4. Iodine 0.47 Kg 5. Sulfolane 3.70 Kg 6. Trimethylborate 3.37 Kg 7. Hexamethyl Disilazane 0.54 Kg 8. Activated carbon 0.100 Kg 9. Pyridine 0.412 Kg 10. Acetone 0.86 Kg 11. Cyclohexane 0.28 Kg 12. Ethyl Acetate 1.17 Kg 13. Isopropyl alcohol 0.335 Kg

Methanol 1.89 Kg 15. Methylene chloride 2.72 Kg 16. N,Ndimethyl Acetamide 0.56 Kg 17. Toluene 0.29 Kg 157

Case No.:9/18/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD 29.07.2008 HQ File :01/82/050/00762/AM09/ RLA File :05/24/040/00258/AM09/ Lic.No/Date:0510224080 18.07.2008 Defer Date: 09.09.2008 Decision :Committee decided to call for application alongwith copy of DML, wherever applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 158

Case No.:10/18/82‐ALC4/2008

Party Name:OMKROWN PHARMA CHEM PVT LTD 29.07.2008 Status:Case Approved HQ File :01/82/050/00763/AM09/ RLA File :07/24/040/00184/AM09/ Lic.No/Date:0710058619 18.07.2008 Decision : Committee considered case as per agenda for ratification of norms and taking que from SION A‐2909 decided to ratify norms under para 4.7 of HBP as per details below or as applied for by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 1,1,1 Tris (Para Hydroxy Phenyl) Ethane 1 Kg. 1. Phenol 1.200 kg 2. Sodium Borohydride 0.003 kg 159

Case No.:11/18/82‐ALC4/2008

Party Name:MEDREICH LIMITED 29.07.2008 HQ File :01/82/050/00764/AM09/ RLA File :07/24/040/00196/AM09/ Lic.No/Date:0710058625 18.07.2008 Defer Date: 26.08.2008 160

Case No.:12/18/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 29.07.2008 HQ File :01/82/050/00765/AM09/ RLA File :09/24/040/00139/AM09/ Lic.No/Date:0910034701 18.07.2008 Defer Date: 09.09.2008 Decision : Committee decided to call for application alongwith copy of DML, wherever applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was

Case No.:13/18/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD Meet No/Date:18/82‐ALC4/2008 Status:Case Deferred

161

Case No.:13/18/82 ALC4/2008

Party Name:RANBAXY LABORATORIES LTD Meet No/Date:18/82 ALC4/2008 29.07.2008 HQ File :01/82/050/00766/AM09/ RLA File :05/24/040/00263/AM09/ Lic.No/Date:0510224123 18.07.2008 Defer Date: 09.09.2008 Decision : Committee decided to call for application alongwith copy of DML, wherever applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 162

Case No.:14/18/82‐ALC4/2008

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 29.07.2008 HQ File :01/82/050/00767/AM09/ RLA File :09/24/040/00161/AM09/ Lic.No/Date:0910034714 21.07.2008 Defer Date: 09.09.2008 Decision : Committee decided to call for application alongwith copy of DML, wherever applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 163

Case No.:15/18/82‐ALC4/2008

Party Name:ALKALOIDS CORPORATION 29.07.2008 Status:Case Approved HQ File :01/82/050/00768/AM09/ RLA File :02/24/040/00105/AM09/ Lic.No/Date:0210115152 21.07.2008 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 5/82 meeting held on 29.04.2008 in the case of M/S Vital Laboratories Ltd Export product Export Qty. Import item Qty. allowed per unit of export product Yohimbine Hydrochloride USP 1kg. Yohimbine Bark (containing Yohimbine Content maximum 1‐1.2%) 133.44kg 164

Case No.:16/18/82‐ALC4/2008

Party Name:STERLING AUXILIARIES PVT LTD 29.07.2008 HQ File :01/82/050/00769/AM09/ RLA File :03/95/040/00355/AM09/ Lic.No/Date:0310479455 21.07.2008 Defer Date: 26.08.2008 Decision :Committee decided to defer case for 26.08.2008 for comments of Chemical Div. 165

Case No.:17/18/82‐ALC4/2008

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 29.07.2008 HQ File :01/82/050/00770/AM09/ RLA File :04/24/040/00091/AM09/ Lic.No/Date:0410097322 21.07.2008 Defer Date: 09.09.2008 Decision : Committee decided to call for application alongwith copy of DML, wherever applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was

Case No.:18/18/82‐ALC4/2008

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED

166 y 29.07.2008 HQ File :01/82/050/00771/AM09/ RLA File :04/24/040/00090/AM09/ Lic.No/Date:0410097323 21.07.2008 Defer Date: 09.09.2008 Decision : Committee decided to call for application alongwith copy of DML, wherever applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 167

Case No.:19/18/82‐ALC4/2008

Party Name:YAG MAG LABS PVT.LTD., 29.07.2008 HQ File :01/82/050/00772/AM09/ RLA File :09/24/040/00159/AM09/ Lic.No/Date:0910034724 22.07.2008 Defer Date: 09.09.2008 Decision : Committee decided to call for application alongwith copy of DML, wherever applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 168

Case No.:20/18/82‐ALC4/2008

Party Name:NEULAND LABORATORIES LTD 29.07.2008 HQ File :01/82/050/00773/AM09/ RLA File :09/24/040/00130/AM09/ Lic.No/Date:0910034725 22.07.2008 Defer Date: 09.09.2008 Decision : Committee decided to call for application alongwith copy of DML, wherever applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 169

Case No.:21/18/82‐ALC4/2008

Party Name:AICO LABORATORIES INDIA LTD. 29.07.2008 HQ File :01/82/050/00774/AM09/ RLA File :08/24/040/00066/AM09/ Lic.No/Date:0810073464 22.07.2008 Defer Date: 09.09.2008 Decision :Committee decided to call for Production and Consumption data certified by Central Excise Authority from firm. Accordingly, case was deferred for 09.09.2008.

Case No.B‐131

M/S Parabolic Drugs Ltd, Chandigarh Norms Committee Meeting No.18/09 F.No.01/82/162/177/AM09 Meeting Date:29.07.2008 Committee considered case as per agenda and decided to seek comments of PI Division and DCGI. Accordingly, case was deferred for 09.09.2008.

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