IN FORCE Norms Committee — Engineering (Gr B / NC-I) Advance Authorisation 2008-10-21

DGFT Committee Minutes

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

Para 4.7 Decision

MEETING NUMBER : 30/82‐ALC4/2008 MEETING DATE : 21.10.2008 The Meeting No.30/09 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 21.10.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. Following members were present:‐ 1. Shri D.N. Mathur, Dy. IA, PI Division, C & PC. 2. Shri Rajinder Pal Singh, DDG 3. Shri Shyam Lal, FTDO

Case No.B‐347

M/S Suven Life Sciences Ltd. Norms Committee Meeting No.30/09 F.No.01/82/050/00543/AM08 Meeting Date: 21.10.2008 RA F.09/24/040/00450/AM08 Adv.Lic.No.0910032659 dated 15.01.2008 Committee decided to defer case for 18.11.2008 for comments of PI Division.

Case No.B‐348

M/S Cipla Ltd. F.No.01/82/050/00651/AM09 RA F.03/94/040/00305/AM09 Adv.Lic.No.0310476019 dated 23.06.2008 Committee decided to defer case for 18.11.2008 for comments of PI Division.

Case No.B‐349

M/S Innovative Healthcare India Pvt. Ltd. F.No.01/85/050/00227/AM06 RA F.04/24/040/00372/AM06 Adv.Lic.No.0410078032 dated 18.01.2006 Committee decided to defer case for 18.11.2008 for comments of Department of MSME.

Case No.B‐350

M/S Alkaloids Corporation F.No.01/87/050/00653/AM07 RA Fo.02/24/040/00202/AM07 Adv.Lic.No.0210094669 dated 21.10.2006

Committee decided to link earlier file in which comments of Department of Revenue had been received and examine case on file.

Case No.B‐352

M/S Omcrown Pharmachem Pvt. Ltd. F.No.01/83/050/00909/AM08 RA Fo.07/24/040/00338/AM08 Adv.Lic.No.0710052771 dated 08.08.2007 Committee decided to defer case for 18.11.2008 for comments of Chemical Division.

Case No.B‐353

M/S J.B. Chemicals & Pharmaceuticals Ltd. F.No.01/82/050/00557/AM08 RA Fo.03/94/040/01161/AM08 Adv.Lic.No.03104622185 dated 22.02.2008 Committee considered case as per agenda and in consultation with technical authority present in meeting decided to allow amendment in the description in import item No. 1 to read as “Cimetidine A type USP” without any other change in the decision of NC taken in its 11/82 meeting held on 10.06.2008. RA concerned may take further necessary action as per above decision of NC.

Case No.B‐354

M/S J.B. Chemicals & Pharmaceuticals Ltd. F.No.01/82/050/00564/AM08 RA Fo.03/94/040/01050/AM08 Adv.Lic.No.0310459136 dated 25.01.2008 Committee decided to call for technical literature from firm in support of their claim. Accordingly, case was deferred for 02.12.2008.

Case No.A‐86

M/S Cipla Ltd. F.No.01/82/162/00912/AM08 RA Fo.03/94/040/01198/AM08 Case under para 4.4.2 of HBP. Committee decided to defer case for 04.11.2008.

Case No.A‐87

M/S Benzo Petro International Ltd. F.No.01/82/050/01013/AM09 RA Fo.03/24/040/01297/AM01 Adv.Lic.No.0310068738 dated 16.01.2001 Committee decided to defer case for 18.11.2008 for comments of Chemical Division.

Case No.C‐55

M/S Aar奱� Industries Ltd.

F.No.01/82/162/01049/AM08 Committee considered case as per agenda and observed that Chemical Division has forwarded the written comments vide their U.O. No.14010/53/2004/Ch.II dated 20.03.2006 which are quite old for fixing SION. It was, therefore, decided to request Chemical Division to furnish their comments based on Central Excise data. Accordingly, case was deferred for 18.11.2008. 1

Case No.:19/23/83‐ALC1/2007

Party Name:SEQUENT SCIENTIFIC LIMITED Meet No/Date:30/82‐ALC4/2008 21.10.2008 Status:Case Deferred HQ File :01/83/050/00655/AM08/ RLA File :07/24/040/00234/AM08/ Lic.No/Date:0710052301 04.07.2007 Defer Date:18.11.2008 Decision :Committee considered case as per agenda and observed that the application of the firm was forwarded to DGHS for their comments, but inspite of D.O. reminder, comments are not forthcoming. It was, therefore, decided to forward a copy of application to Department of MSME for their comments. Accordingly, case was deferred for 18.11.2008. 2

Case No.:104/6/82‐ALC4/2008

Party Name:INTAS PHARMACEUTICALS LTD., 21.10.2008 Status:Case Approved HQ File :01/82/050/00187/AM09/ RLA File :08/24/040/00123/AM08/ Lic.No/Date:0810066581 14.08.2007 Decision :Committee considered case as per agenda for ratification of norms and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Gemcitabine for Injection USP 200mg, Lyophilized 200 mg/vial (10 ml Vial) [Each vial contains Gemcitabine Hcl USP 228 Mg] 1 No. 1. Gemcitabine Hydrochloride USP 250.58 mg/vial Gemcitabine for Injection USP 1000mg, Lyophilized 1000 mg/vial (50 ml Vial) [Each vial contains Gemcitabine Hcl USP 1140 Mg] 1 No. 1. Gemcitabine Hydrochloride USP 1195.95 mg/vial Gemcitabine for Injection USP 2000mg, Lyophilized 2000 mg/vial (100 ml Vial) [Each vial contains Gemcitabine Hcl USP 2280 Mg] 1 No. 1. Gemcitabine Hydrochloride USP 2391.9 mg/vial

Case No.:191/27/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 21.10.2008 Status:Case Deferred HQ File :01/83/050/01265/AM08/ RLA File :04/24/040/00235/AM08/ Lic.No/Date:0410091280 01.10.2007 Defer Date:18.11.2008 Decision :Committee decided to defer case for 18.11.2008 for comments of PI Division. 4

Case No.:61/39/83‐ALC1/2007

Party Name:AARTI INDUSTRIES LIMITED 21.10.2008 Status:Case Approved HQ File :01/83/050/01640/AM08/ RLA File :03/94/040/00816/AM08/ Lic.No/Date:0310451665 27.11.2007 Decision :Committee considered case as per agenda and in light of written comments of Chemical Division vide their U.O. No.14010/28/2005/Ch.III, signed copy handed over in the meeting, 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 N,Ethyl Hydroxy Ethyl Aniline 1 Kg. 1. Aniline 0.626 kg 5

Case No.:12/42/83‐ALC1/2007

Party Name:PARABOLIC DRUGS LTD., 21.10.2008 Status:Case Rejected HQ File :01/83/050/01788/AM08/ RLA File :22/24/040/00053/AM08/ Lic.No/Date:2210007356 04.01.2008 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 vide letter dated 02.09.2008, but no reply has been received and norms can not be fixed in absence of required data. It was, therefore, decided to close the case. 6

Case No.:34/45/82‐ALC4/2007

Party Name:HILDOSE 21.10.2008 Status:Case Rejected HQ File :01/82/050/00497/AM08/ RLA File :03/94/040/01100/AM08/ Lic.No/Date:0310460275 06.02.2008 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish (i) Purity of import item, (ii) Purity of export item and (iii) justification for wastage claimed vide letter dated 29.08.2008, but no reply has been received and norms can not be fixed in absence of required information. It was, therefore, decided to close the case.

Case No.:29/6/82‐ALC4/2008

Party Name:GLENMARK PHARMACEUTICALS LTD., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00112/AM09/ RLA File :03/94/040/01032/AM08/ Lic.No/Date:0310460255 06.02.2008 Defer Date:18.11.2008 Decision :Committee considered case as per agenda and observed that the technical information has been received from the firm and has been forwarded to technical authority for their comments. Accordingly, case was deferred for 18.11.2008. 8

Case No.:104/11/82‐ALC4/2008

Party Name:GRANULES INDIA LIMITED 21.10.2008 Status:Case Approved HQ File :01/82/050/00424/AM09/ RLA File :09/24/040/00384/AM08/ Lic.No/Date:0910032913 08.02.2008 Decision : Committee considered case as per agenda and in light of written comments of PI Division vide their O.M. No.35011/71/2008‐PI‐III dated 30.08.2008 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 Compresso CIP 65 1 Kg. 1. Ciprofloxacin Hydrochloride 0.757 kg 2. Maize Starch 0.159 kg 3. Povidone K‐30 0.005 kg 4. Sodium Starch Glycollate 0.040 kg 5. Magnesium Stearate 0.009 kg 6. Starch Pregelatinised 0.025 kg 7. Silica, Colloidal Anhydrous 0.005 kg 9

Case No.:1/44/82‐ALC4/2007

Party Name:PARABOLIC DRUGS LTD., 21.10.2008 Status:Case Rejected HQ File :01/82/050/00463/AM08/ RLA File :22/24/040/00056/AM08/ Lic.No/Date:2210007484 21.02.2008 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 vide letter dated 28.08.2008, but no reply has been received and norms can not be fixed in absence of required data. It was, therefore, decided to close the case.

Case No.:54/6/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00137/AM09/ RLA File :09/24/040/00526/AM08/ Lic.No/Date:0910033127 28.02.2008 Defer Date:18.11.2008 Decision : Committee decided to defer case for 18.11.2008 for comments of PI Division. 11

Case No.:57/6/82‐ALC4/2008

Party Name:CORAL DRUGS PVT. LTD., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00140/AM09/ RLA File :05/24/040/00884/AM08/ Lic.No/Date:0510217198 28.02.2008 Defer Date:18.11.2008 Decision : Committee decided to defer case for 18.11.2008 for comments of Department of MSME. 12

Case No.:126/11/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 21.10.2008 Status:Case Approved HQ File :01/82/050/00446/AM09/ RLA File :09/24/040/00538/AM08/ Lic.No/Date:0910033204 04.03.2008 Decision : Committee considered case as per agenda and in light of written comments of PI Division vide their O.M. No.35011/71/2008‐PI‐III dated 30.08.2008 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 Efavirenz 1 Kg. 1. D‐(+)Camphoric Acid 2.05 kg 2. Citric Acid 0.81 kg 3. Cyclopropyl acetylene 0.524 kg 4. Dichloro Methane 5.37 kg 5. Dimethyl Formamide 2.22 kg 6. Methanol 0.355 kg 7. N‐Heptane 1.165 kg 8. N‐Hexane 4.445 kg 9. Tetra Hydrofuran 3.848 kg 10. Tetramethyl Ethylelenediamie 0.69 kg 11. Triphosgene 0.498 kg Note:The firm has applied for inputs based on Non Infringing Route, but the inputs have been allowed on conventional process by comparison of data. 13

Case No.:128/11/82‐ALC4/2008

Party Name:METROCHEM API PVT. LTD. 21.10.2008 Status:Case Approved

HQ File :01/82/050/00448/AM09/ RLA File :09/24/040/00536/AM08/ Lic.No/Date:0910033321 11.03.2008 Decision : Committee considered case as per agenda and in light of written comments of PI Division vide their O.M. No.35011/81/2008‐PI‐III dated 30.08.2008 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 2‐Chloro methyl‐3‐methyl‐4‐(3‐ methoxy propoxy)‐pyridine hydrochloride 1 Kg. 1. 2,3 Lutidine 1.00 kg 2. 3 Methoxy Propylamine 1.187 kg 3. Isopropyl Alcohol 1.87 kg 4. Acetone 0.625 kg 5. Sodium Nitrile 1.424 kg 14

Case No.:126/6/82‐ALC4/2008

Party Name:LAFFANS PETROCHEMICALS LTD., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00209/AM09/ RLA File :03/95/040/00826/AM08/ Lic.No/Date:0310464745 12.03.2008 Defer Date:18.11.2008 Decision : Committee decided to defer case for 18.11.2008 for comments of PC Division. 15

Case No.:118/6/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00201/AM09/ RLA File :08/24/040/00275/AM08/ Lic.No/Date:0810070672 13.03.2008 Defer Date:18.11.2008 16

Case No.:125/11/82‐ALC4/2008

21.10.2008 Status:Case Approved HQ File :01/82/050/00445/AM09/ RLA File :09/24/040/00574/AM08/ Lic.No/Date:0910033343 13.03.2008 Decision : Committee considered case as per agenda and in light of written comments of PI Division vide their O.M. No.35011/71/2008‐PI‐III dated 30.08.2008 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 Efavirenz from Camphanic Acid route 1 Kg. 1. (‐)‐(IS,4R)‐Camphoric Acid 1.29 kg 2. Citric Acid 0.81 kg 3. Cyclopropyl acetylene 0.524 kg 4. Dichloro Methane 5.37 kg

Mimethyl Formamide 2.22 kg 6. Methanol 0.355 kg 7. N‐Heptane 1.165 kg 8. N‐Hexane 4.445 kg 9. Tetra Hydro Furan 3.848 kg 10. Tetramethyl Ethyelenediamie 0.69 kg 11. Triphosgene 0.498 kg Note:The firm has applied for inputs based on Non Infringing Route, but the inputs have been allowed on conventional process by comparison of data. 17

Case No.:53/6/82‐ALC4/2008

Party Name:KAMUD DRUGS PVT.LIMITED., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00136/AM09/ RLA File :31/24/040/00394/AM08/ Lic.No/Date:3110033090 14.03.2008 Defer Date:18.11.2008 Decision :Committee decided to forward a copy of application and a copy of reply received from firm to PI Division for their comments. Accordingly, case was deferred for 18.11.2008. 18

Case No.:33/15/82‐ALC4/2008

Party Name:MEDREICH LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00673/AM09/ RLA File :07/21/040/01505/AM08/ Lic.No/Date:0710056528 20.03.2008 Defer Date:18.11.2008 19

Case No.:22/13/82‐ALC4/2008

Party Name:MOREPEN LABORATORIES LTD., 21.10.2008 Status:Case Approved HQ File :01/82/050/00529/AM09/ RLA File :05/24/040/00957/AM08/ Lic.No/Date:0510218439 25.03.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/97/2008‐PI‐III dated 11.09.2008 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 8‐Chloro‐5,6‐Dihidro‐11‐H‐ Benzo (5,6) Ciclohepta (1,2B) Piridine‐11‐one (L7) 1 kg. 1. 3‐Chlorobenzyl Cyanide 1.80 kg 2. Sodium Methoxide 1.20 kg 3. Hydrazine Hydrate 1.26 kg 4. N N Dimethyl Carbomoyl Chloride 2.20 kg 5. Sodium Cyanide 0.20 kg

Potassium Carbonate 0.93 kg 7. NN Dimethyl Formamide 0.05 kg 8. Toluene 7.14 kg 9. Methylene Chloride 4.45 kg 10. Acetonitrile 0.91 kg 11. Isopropyl Alcohol 1.62 kg It was decided to call for Consumption and Production data duly certified by Central Excise Authorities through Pharmexcil for the export product Loratidine (SION A‐ 2409) on account of improvement of yields obtained by some firms, to decide about SION revision. RA concerned may take further necessary action as per above decision of NC. 20

Case No.:23/13/82‐ALC4/2008

Party Name:MOREPEN LABORATORIES LTD., 21.10.2008 Status:Case Approved HQ File :01/82/050/00530/AM09/ RLA File :05/24/040/00956/AM08/ Lic.No/Date:0510218438 25.03.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/97/2008‐PI‐III dated 11.09.2008 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 8‐Chloro‐11 Hidroxy‐N‐Methyl Piperidino Azatadine (L8) 1 kg. 1. 3‐Chlorobenzyl Cyanide 1.82 kg 2. Sodium Hydrate 1.218 kg 3. Hydrazine Hydrate 1.28 kg 4. N,N‐Dimethyl Carbomoyl Chloride 2.233 kg 5. Sodium Cyanide 0.203 kg 6. Potassium Carbonate 0.93 kg 7. N N‐Dimethyl Formamide 0.05 kg 8. Toluene 4.97 kg 9. Methylene Chloride 3.09 kg 10. Acetonitrile 0.63 kg 11. Tetrahydrofuran 3.35 kg 12. Isopropyl Alcohol 2.12 kg RA concerned may take further necessary action as per above decision of NC. 21

Case No.:3/24/82‐ALC4/2008

Party Name:CIPLA LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00936/AM09/ RLA File :03/94/040/00073/AM09/ Lic.No/Date:0310468658 16.04.2008 Defer Date:18.11.2008

Case No.:117/11/82‐ALC4/2008

21.10.2008 Status:Case Approved HQ File :01/82/050/00437/AM09/ RLA File :09/24/040/00590/AM08/ Lic.No/Date:0910033738 24.04.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/71/2008‐PI‐III dated 30.08.2008 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 2‐Nitro‐5‐Phenyl Thiomethoxy Acetanilide (Febantel Intermediate) 1 kg. 1. Methoxy Acetyl Chloride 0.53 kg 2. Methylene Dichloride 1.987 kg 3. Methanol 1.10 kg 4. Toluene 1.45 kg RA concerned may take further necessary action as per above decision of NC. 23

Case No.:6/12/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00474/AM09/ RLA File :03/94/040/00104/AM09/ Lic.No/Date:0310469550 25.04.2008 Defer Date:18.11.2008 24

Case No.:10/12/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00478/AM09/ RLA File :03/94/040/00124/AM09/ Lic.No/Date:0310470252 01.05.2008 Defer Date:18.11.2008 25

Case No.:1/8/82‐ALC4/2008

Party Name:NECTAR LIFESCIENCES LIMITED, 21.10.2008 Status:Case Deferred HQ File :01/82/050/00223/AM09/ RLA File :22/24/040/00075/AM08/ Lic.No/Date:2210007767 05.05.2008 Defer Date:18.11.2008 26

Case No.:14/12/82‐ALC4/2008

Party Name:EMAMI LIMITED, 21.10.2008 Status:Case Deferred HQ File :01/82/050/00482/AM09/ RLA File :02/24/040/00009/AM09/ Lic.No/Date:0210112297 Defer

12.05.2008 Date:18.11.2008 Decision : Committee decided to defer case for 18.11.2008 for comments of Department of MSME. 27

Case No.:15/12/82‐ALC4/2008

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 21.10.2008 Status:Case Deferred HQ File :01/82/050/00483/AM09/ RLA File :07/24/040/00050/AM09/ Lic.No/Date:0710057454 16.05.2008 Defer Date:18.11.2008 Decision : Committee decided to defer case for 18.11.2008 for comments of Chemical Division. 28

Case No.:64/14/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00616/AM09/ RLA File :09/24/040/00068/AM09/ Lic.No/Date:0910034075 27.05.2008 Defer Date:18.11.2008 29

Case No.:70/14/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00622/AM09/ RLA File :09/24/040/00052/AM09/ Lic.No/Date:0910034083 27.05.2008 Defer Date:18.11.2008 30

Case No.:22/14/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00574/AM09/ RLA File :03/94/040/00230/AM09/ Lic.No/Date:0310473544 06.06.2008 Defer Date:18.11.2008 31

Case No.:51/14/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00603/AM09/ RLA File :09/24/040/00110/AM09/ Lic.No/Date:0910034350 19.06.2008 Defer Date:18.11.2008 32

Case No.:52/14/82‐ALC4/2008

21.10.2008 Status:Case Deferred

HQ File :01/82/050/00604/AM09/ RLA File :09/24/040/00357/AM08/ Lic.No/Date:0910034351 19.06.2008 Defer Date:18.11.2008 33

Case No.:81/14/82‐ALC4/2008

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00633/AM09/ RLA File :03/95/040/00257/AM09/ Lic.No/Date:0310475550 19.06.2008 Defer Date:18.11.2008 34

Case No.:85/14/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00637/AM09/ RLA File :03/94/040/00311/AM09/ Lic.No/Date:0310475620 20.06.2008 Defer Date:18.11.2008 35

Case No.:5/15/82‐ALC4/2008

Party Name:LAFFANS PETROCHEMICALS LTD., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00645/AM09/ RLA File :03/95/040/00276/AM09/ Lic.No/Date:0310475880 23.06.2008 Defer Date:18.11.2008 Decision : Committee decided to defer case for 18.11.2008 for comments of PC Division. 36

Case No.:6/15/82‐ALC4/2008

Party Name:FDC LTD 21.10.2008 Status:Case Deferred HQ File :01/82/050/00646/AM09/ RLA File :03/94/040/00249/AM09/ Lic.No/Date:0310475942 23.06.2008 Defer Date:18.11.2008 37

Case No.:15/16/82‐ALC4/2008

Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00708/AM09/ RLA File :11/24/040/00021/AM08/ Lic.No/Date:1110017641 03.07.2008 Defer Date:18.11.2008 38

Case No.:10/17/82‐ALC4/2008

Party Name:HETERO DRUGS LIMITED, 21.10.2008 Status:Case

Approved HQ File :01/82/050/00734/AM09/ RLA File :09/24/040/00146/AM09/ Lic.No/Date:0910034574 11.07.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/160/2008‐PI‐III dated 19.09.2008 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 Cefixime USP 1 kg. 1. G.C.L.E. 1.555 kg 2. Mica Ester 1.112 kg 3. Triethylamine 0.416 kg 4. Thriphenyl Phosphine 1.22 kg 5. Dimethyl Formamide 5.61 kg 6. Methylene Chloride 16.25 kg 7. Acetonitrile 3.84 kg RA concerned may take further necessary action as per above decision of NC. 39

Case No.:13/17/82‐ALC4/2008

Party Name:FINE ORGANIC INDUSTRIES(MUMBAI) PVT. LTD. 21.10.2008 Status:Case Rejected HQ File :01/82/050/00737/AM09/ RLA File :03/94/040/00375/AM09/ Lic.No/Date:0310478323 11.07.2008 Decision :Committee observed that the firm vide C&PC letter No.14010/39/2008‐Ch.III dated 15.07.2008 was requested to furnish technical information, but no reply has been received and norms can not be fixed in absence of required information. It was, therefore, decided to close the case. 40

Case No.:26/17/82‐ALC4/2008

Party Name:SKM PHARMA(P)LTD., 21.10.2008 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:18.11.2008 41

Case No.:27/17/82‐ALC4/2008

Party Name:METROPOLITAN OVERSEAS LIMITED, 21.10.2008 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:18.11.2008

Case No.:6/18/82‐ALC4/2008

Party Name:RA CHEM PHARMA LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00759/AM09/ RLA File :09/24/040/00111/AM09/ Lic.No/Date:0910034663 16.07.2008 Defer Date:18.11.2008 43

Case No.:11/18/82‐ALC4/2008

Party Name:MEDREICH LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00764/AM09/ RLA File :07/24/040/00196/AM09/ Lic.No/Date:0710058625 18.07.2008 Defer Date:18.11.2008 44

Case No.:12/18/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 21.10.2008 Status:Case Approved HQ File :01/82/050/00765/AM09/ RLA File :09/24/040/00139/AM09/ Lic.No/Date:0910034701 18.07.2008 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 applied by firm as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Venlafaxine Hydrochloride 1 kg. 1. 1‐(4‐Methoxyphenyl)‐2‐Aminoethyl Cyclohexanol Hydrochloride 1.07 kg 45

Case No.:14/18/82‐ALC4/2008

Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:30/82‐ALC4/2008 21.10.2008 Status:Case Deferred HQ File :01/82/050/00767/AM09/ RLA File :09/24/040/00161/AM09/ Lic.No/Date:0910034714 21.07.2008 Defer Date:18.11.2008 46

Case No.:16/18/82‐ALC4/2008

Party Name:STERLING AUXILIARIES PVT LTD 21.10.2008 Status:Case Deferred HQ File :01/82/050/00769/AM09/ RLA File :03/95/040/00355/AM09/ Lic.No/Date:0310479455 21.07.2008 Defer Date:18.11.2008 Decision : Committee decided to defer case for 18.11.2008 for comments of Chemical Division.

Case No.:18/18/82‐ALC4/2008

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00771/AM09/ RLA File :04/24/040/00090/AM09/ Lic.No/Date:0410097323 21.07.2008 Defer Date:18.11.2008 48

Case No.:4/19/82‐ALC4/2008

Party Name:MEDREICH LIMITED 21.10.2008 Status:Case Rejected HQ File :01/82/050/00778/AM09/ RLA File :07/24/040/00191/AM09/ Lic.No/Date:0710058662 22.07.2008 Decision : Committee considered case as per agenda and observed that the firm was requested to furnish copy of Master Batch Formula vide letter dated 21.08.2008, but no reply has been received and norms can not be fixed in absence of required information. It was, therefore, decided to close the case. 49

Case No.:5/19/82‐ALC4/2008

Party Name:MEDREICH LIMITED 21.10.2008 Status:Case Rejected HQ File :01/82/050/00779/AM09/ RLA File :07/24/040/00194/AM09/ Lic.No/Date:0710058663 22.07.2008 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish copy of Master Batch Formula vide letter dated 21.08.2008, but no reply has been received and norms can not be fixed in absence of required information. It was, therefore, decided to close the case. 50

Case No.:20/20/82‐ALC4/2008

Party Name:R L FINE CHEM 21.10.2008 Status:Case Approved HQ File :01/82/050/00813/AM09/ RLA File :07/24/040/00167/AM09/ Lic.No/Date:0710058819 30.07.2008 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 19/82 meeting held on 05.08.2008 and in consultation with representative of technical authority present in meeting decided to ratify the 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 Qty. allowed per unit of export product Methane Sulfonate of 10,11‐ Dihydro‐N,N, Betarimethyul‐5H‐ 1 Kg. 1. 1 Bromo 3 chloro 2 methyl propane 0.55 kg

Dibenz(B,F) Azepine‐5‐ Propanamine 2. Iminodibenzyl 0.56 kg 51

Case No.:21/20/82‐ALC4/2008

Party Name:R L FINE CHEM 21.10.2008 Status:Case Approved HQ File :01/82/050/00814/AM09/ RLA File :07/24/040/00168/AM09/ Lic.No/Date:0710058822 30.07.2008 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 22/82 meeting held on 04.10.2007 and in consultation with representative of technical authority present in meeting decided to ratify the norms on repeat basis 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 Qty. allowed per unit of export product Clomipramine Hcl 1 Kg. 1. 1 Bromo 3 chloro Propane 0.85 kg 2. 3 Chloro Iminodibenzyl 0.91 kg 52

Case No.:24/20/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00817/AM09/ RLA File :09/24/040/00140/AM09/ Lic.No/Date:0910034848 30.07.2008 Defer Date:18.11.2008 53

Case No.:26/20/82‐ALC4/2008

Party Name:BIOCHEMICAL & SYNTHETIC PRODUCTS LTD 21.10.2008 Status:Case Deferred HQ File :01/82/050/00819/AM09/ RLA File :09/24/040/00167/AM09/ Lic.No/Date:0910034850 30.07.2008 Defer Date:18.11.2008 54

Case No.:30/20/82‐ALC4/2008

Party Name:SURYA PHARMACEUTICAL LTD 21.10.2008 Status:Case Deferred HQ File :01/82/050/00823/AM09/ RLA File :22/24/040/00032/AM09/ Lic.No/Date:2210008034 30.07.2008 Defer Date:18.11.2008

Case No.:31/20/82‐ALC4/2008

Party Name:STERLING AUXILIARIES PVT LTD 21.10.2008 Status:Case Deferred HQ File :01/82/050/00824/AM09/ RLA File :03/95/040/00312/AM09/ Lic.No/Date:0310480675 01.08.2008 Defer Date:18.11.2008 56

Case No.:34/20/82‐ALC4/2008

Party Name:IPCA LABORATORIES LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00827/AM09/ RLA File :03/94/040/00356/AM09/ Lic.No/Date:0310480702 01.08.2008 Defer Date:18.11.2008 57

Case No.:38/20/82‐ALC4/2008

Party Name:DR REDDYS LABORATORIES LTD 21.10.2008 Status:Case Deferred HQ File :01/82/050/00831/AM09/ RLA File :09/24/040/00166/AM09/ Lic.No/Date:0910034905 01.08.2008 Defer Date:18.11.2008 58

Case No.:41/20/82‐ALC4/2008

Party Name:MEDREICH CEPHTECH PVT LTD. 21.10.2008 Status:Case Deferred HQ File :01/82/050/00834/AM09/ RLA File :09/24/040/00149/AM09/ Lic.No/Date:0910034908 04.08.2008 Defer Date:18.11.2008 59

Case No.:43/20/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00836/AM09/ RLA File :09/24/040/00180/AM09/ Lic.No/Date:0910034928 04.08.2008 Defer Date:18.11.2008 60

Case No.:46/20/82‐ALC4/2008

Party Name:KAMUD DRUGS PVT.LIMITED., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00839/AM09/ RLA File :31/24/040/00119/AM09/ Lic.No/Date:3110034700 04.08.2008 Defer

Date:18.11.2008 61

Case No.:47/20/82‐ALC4/2008

Party Name:AARTI INDUSTRIES LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00840/AM09/ RLA File :03/94/040/00405/AM09/ Lic.No/Date:0310481261 05.08.2008 Defer Date:18.11.2008 62

Case No.:49/20/82‐ALC4/2008

Party Name:AARTI DRUGS LIMITED 21.10.2008 Status:Case Approved HQ File :01/82/050/00842/AM09/ RLA File :03/94/040/00210/AM09/ Lic.No/Date:0310481329 05.08.2008 Decision : Committee considered case as per agenda and in light of written comments of PI Division vide their U.O. No.35011/264/2006‐PI‐III, signed copy handed over in the meeting, 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 Aceclofenec Sodium 1 Kg. 1. Diclofenec Sodium 1.11 kg 2. Mono Chloro Aniline (MCA) 0.42 kg 3. 10% Palldium on carbon 0.03 kg 4. Methylene Chloride 1.00 kg 5. Xylene 0.40 kg 6. Dimethyl formamide 1.00 kg 7. Methanol 1.37 kg 63

Case No.:50/20/82‐ALC4/2008

Party Name:AARTI DRUGS LIMITED 21.10.2008 Status:Case Approved HQ File :01/82/050/00843/AM09/ RLA File :03/94/040/00117/AM09/ Lic.No/Date:0310481343 05.08.2008 Decision : Committee considered case as per agenda and in light of written comments of PI Division vide their U.O. No.35011/178/2006‐PI‐III, signed copy handed over in the meeting, 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 Ticlopidine Hcl 1 Kg. 1. Thiophene‐2‐ethanol 0.72 kg 2. Toluene 1.61 kg

Tri ethyl amine 0.25 kg 4. Benzene Sulphonyl Chloride 0.99 kg 5. Sodium Hydroxide Flakes 0.747 kg 6. Ortho Chloro Benzyl amine 0.80 kg 7. Acetone 0.22 kg 8. IPA 0.85 kg 9. Methanol 0.90 kg 10. Paraformaldehyde 0.300 kg 64

Case No.:51/20/82‐ALC4/2008

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00844/AM09/ RLA File :03/94/040/00339/AM09/ Lic.No/Date:0310481345 05.08.2008 Defer Date:18.11.2008 65

Case No.:52/20/82‐ALC4/2008

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00845/AM09/ RLA File :03/94/040/00335/AM09/ Lic.No/Date:0310481360 05.08.2008 Defer Date:18.11.2008 66

Case No.:53/20/82‐ALC4/2008

Party Name:MAHAVIR DYE CHEM 21.10.2008 Status:Case Approved HQ File :01/82/050/00846/AM09/ RLA File :52/24/040/00011/AM09/ Lic.No/Date:5210024053 05.08.2008 Decision : Committee considered case as per agenda and in light of written comments of Chemical Division vide their U.O. No.14010/64/2008/Ch.III dated 14.10.2008 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 2‐Amino Phenol‐4‐(2‐Carboxy Aniline Sulfomido) 1 Kg. 1. Ortho Nitro Chloro Benzene 0.980 kg 2. Phthalic Anhydride 0.812 kg 3. Caustic Soda Flakes 3.912 kg 67

Case No.:61/20/82‐ALC4/2008

Party Name:HEMMO PHARMACEUTICALS PRIVATE Status:Case

LIMITED 21.10.2008 Deferred HQ File :01/82/050/00854/AM09/ RLA File :03/94/040/00251/AM09/ Lic.No/Date:0310481523 06.08.2008 Defer Date:18.11.2008 Decision : Committee decided to defer case for 18.11.2008 for comments of DBT. 68

Case No.:1/21/82‐ALC4/2008

Party Name:AROMA AROMATICS & FLAVOURS 21.10.2008 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:18.11.2008 69

Case No.:5/22/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00868/AM09/ RLA File :03/94/040/00389/AM09/ Lic.No/Date:0310481960 08.08.2008 Defer Date:18.11.2008 70

Case No.:2/22/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00865/AM09/ RLA File :09/24/040/00174/AM09/ Lic.No/Date:0910035004 11.08.2008 Defer Date:18.11.2008 71

Case No.:3/22/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00866/AM09/ RLA File :09/24/040/00184/AM09/ Lic.No/Date:0910035005 11.08.2008 Defer Date:18.11.2008 72

Case No.:4/22/82‐ALC4/2008

Party Name:HETERO LABS LTD. 21.10.2008 Status:Case Deferred HQ File :01/82/050/00867/AM09/ RLA File :09/24/040/00186/AM09/ Lic.No/Date:0910035006 11.08.2008 Defer Date:18.11.2008

Case No.:11/22/82‐ALC4/2008

Party Name:SYMBIOTEC PHARMALAB LTD., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00874/AM09/ RLA File :11/24/040/00017/AM09/ Lic.No/Date:1110018129 11.08.2008 Defer Date:18.11.2008 74

Case No.:13/22/82‐ALC4/2008

Party Name:IPCA LABORATORIES LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00876/AM09/ RLA File :03/94/040/00463/AM09/ Lic.No/Date:0310482119 11.08.2008 Defer Date:18.11.2008 75

Case No.:10/22/82‐ALC4/2008

Party Name:SUVEN LIFE SCIENCES LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00873/AM09/ RLA File :09/24/040/00189/AM09/ Lic.No/Date:0910035022 12.08.2008 Defer Date:18.11.2008 76

Case No.:19/22/82‐ALC4/2008

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 21.10.2008 Status:Case Approved HQ File :01/82/050/00882/AM09/ RLA File :03/94/040/00204/AM09/ Lic.No/Date:0310482608 14.08.2008 Decision : Committee considered case as per agenda and in light of written comments of Chemical Division vide their U.O. No.14010/11/2008/Ch.II, signed copy handed over in the meeting, and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl. No. Import items Qty. allowed 2‐Coumaranone 30% in Acetic Anhydride 70% 1 Kg. 1. Ortho Chloro Phenyl Acetic Acid 0.653 kg 2. Caustic Soda Flakes 0.900 kg 3. Toluene 0.266 kg 77

Case No.:24/22/82‐ALC4/2008

Party Name:KREATIVE ORGANICS (P) LTD., 21.10.2008 Status:Case Deferred HQ File :01/82/050/00887/AM09/ RLA File :09/24/040/00188/AM09/ Lic.No/Date:0910035081 Defer

14.08.2008 Date:18.11.2008 78

Case No.:29/22/82‐ALC4/2008

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 21.10.2008 Status:Case Approved HQ File :01/82/050/00892/AM09/ RLA File :03/94/040/00262/AM09/ Lic.No/Date:0310482758 14.08.2008 Decision : Committee considered case as per agenda and in light of written comments of Chemical Division vide their U.O. No.14010/11/2008/Ch.II, signed copy handed over in the meeting, and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl. No. Import items Qty. allowed 2‐Coumaranone 30% in Acetic Anhydride 70% 1 Kg. 1. Ortho Chloro Phenyl Acetic Acid 0.653 kg 2. Caustic Soda Flakes 0.900 kg 3. Toluene 0.266 kg 79

Case No.:27/22/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00890/AM09/ RLA File :03/94/040/00490/AM09/ Lic.No/Date:0310482885 18.08.2008 Defer Date:18.11.2008 80

Case No.:33/22/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00896/AM09/ RLA File :03/94/040/00359/AM09/ Lic.No/Date:0310482870 18.08.2008 Defer Date:18.11.2008 81

Case No.:34/22/82‐ALC4/2008

21.10.2008 Status:Case Approved HQ File :01/82/050/00897/AM09/ RLA File :03/94/040/00364/AM09/ Lic.No/Date:0310482880 18.08.2008 Decision :Committee considered case as per agenda and taking que from SION A‐1945 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 Tylodox Water Soluble Powder (Pack Size 1 kg) Each gm. Contains: Tylosin Tartarate BP(Vet) 100mg Doxycyline Hydrochloride 200 mg 500 Packs 1. Tylosin Tartarate BP (Vet) 50.50 kg 2. Doxycycline Hydrochloride 101.0 kg 82

Case No.:38/22/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00901/AM09/ RLA File :03/94/040/00452/AM09/ Lic.No/Date:0310482896 18.08.2008 Defer Date:18.11.2008 83

Case No.:39/22/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00902/AM09/ RLA File :03/94/040/00451/AM09/ Lic.No/Date:0310482900 18.08.2008 Defer Date:18.11.2008 84

Case No.:1/24/82‐ALC4/2008

Party Name:TECKBOND LABORATORIES PVT. LTD. 21.10.2008 Status:Case Deferred HQ File :01/82/050/00934/AM09/ RLA File :09/24/040/00226/AM09/ Lic.No/Date:0910035159 28.08.2008 Defer Date:18.11.2008 85

Case No.:2/24/82‐ALC4/2008

Party Name:TECKBOND LABORATORIES PVT. LTD. 21.10.2008 Status:Case Deferred HQ File :01/82/050/00935/AM09/ RLA File :09/24/040/00227/AM09/ Lic.No/Date:0910035160 28.08.2008 Defer Date:18.11.2008 86

Case No.:13/24/82‐ALC4/2008

21.10.2008 Status:Case Deferred HQ File :01/82/050/00946/AM09/ RLA File :09/24/040/00205/AM09/ Lic.No/Date:0910035176 29.08.2008 Defer Date:02.12.2008

Decision :Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 02.12.2008. 87

Case No.:14/24/82‐ALC4/2008

Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:30/82‐ALC4/2008 21.10.2008 Status:Case Deferred HQ File :01/82/050/00947/AM09/ RLA File :09/24/040/00183/AM09/ Lic.No/Date:0910035179 29.08.2008 Defer Date:02.12.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 02.12.2008. 88

Case No.:15/24/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/00948/AM09/ RLA File :09/24/040/00228/AM09/ Lic.No/Date:0910035181 29.08.2008 Defer Date:18.11.2008 89

Case No.:22/24/82‐ALC4/2008

Party Name:SHALINA LABORATORIES PVT. LTD. 21.10.2008 Status:Case Deferred HQ File :01/82/050/00955/AM09/ RLA File :03/95/040/00435/AM09/ Lic.No/Date:0310484735 01.09.2008 Defer Date:18.11.2008 90

Case No.:23/24/82‐ALC4/2008

Party Name:SCITECH SPECIALITIES PVT. LTD. 21.10.2008 Status:Case Deferred HQ File :01/82/050/00956/AM09/ RLA File :03/95/040/00324/AM09/ Lic.No/Date:0310484762 01.09.2008 Defer Date:02.12.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 02.12.2008. 91

Case No.:25/24/82‐ALC4/2008

Party Name:ALKALOIDS CORPORATION 21.10.2008 Status:Case Deferred HQ File :01/82/050/00958/AM09/ RLA File :02/24/040/00133/AM09/ Lic.No/Date:0210116782 02.09.2008 Defer Date:02.12.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 02.12.2008.

Case No.:9/25/82‐ALC4/2008

Party Name:SUPREET CHEMICALS PVT.LTD. 21.10.2008 Status:Case Deferred HQ File :01/82/050/00989/AM09/ RLA File :03/95/040/00466/AM09/ Lic.No/Date:0310485701 09.09.2008 Defer Date:18.11.2008 93

Case No.:10/25/82‐ALC4/2008

Party Name:SUPREET CHEMICALS PVT.LTD. 21.10.2008 Status:Case Deferred HQ File :01/82/050/00990/AM09/ RLA File :03/95/040/00467/AM09/ Lic.No/Date:0310485712 09.09.2008 Defer Date:18.11.2008 94

Case No.:14/25/82‐ALC4/2008

Party Name:INDIA GLYCOLS LTD 21.10.2008 Status:Case Deferred HQ File :01/82/050/00994/AM09/ RLA File :05/24/040/00228/AM09/ Lic.No/Date:0510227161 09.09.2008 Defer Date:18.11.2008 95

Case No.:7/26/82‐ALC4/2008

Party Name:AARTI INDUSTRIES LIMITED 21.10.2008 Status:Case Approved HQ File :01/82/050/01004/AM09/ RLA File :03/94/040/00357/AM09/ Lic.No/Date:0310485956 10.09.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/53/2008‐PI‐III dated 02.07.2008 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 ‘(S,S)‐2‐Azabbicyclo(3,3,0) Octane‐3‐ Carboxylic Acid Benzylester Hydrochloride 1 Kg. 1. Benzyl Alcohol 7.02 kg 2. Cyclo Pentanone 1.45 kg 3. Di‐Iso Propyl Ether 2.375 kg 4. L‐Serine 1.50 kg 5. Palladium Catalyst 5% Dry 0.05 kg 96

Case No.:8/26/82‐ALC4/2008

21.10.2008 Status:Case Approved

HQ File :01/82/050/01005/AM09/ RLA File :03/94/040/00543/AM09/ Lic.No/Date:0310485962 10.09.2008 Decision : Committee considered case as per agenda for ratification of norms in light of its earlier decision taken in its 2/09 meeting held on 08.04.2008 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Efavirenz Capsules 200mg [Efavirenz 204 mg/Capsule] 1No. 1. (S)‐5‐chloro‐alpha‐(cyclopropyl ethylyl)‐2‐amino‐alpha‐(trifluoro methyl) benzene methanol 1.092 kg/kg of Efavirenz Efavirenz Tablets 600mg [Efavirenz 612 mg/tablet] 1 No. 97

Case No.:9/26/82‐ALC4/2008

21.10.2008 Status:Case Approved HQ File :01/82/050/01006/AM09/ RLA File :03/94/040/00569/AM09/ Lic.No/Date:0310485964 10.09.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2007‐PI‐III dated nil 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 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 2. Butyl Acetate 2.09 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.

Case No.:1/30/82‐ALC4/2008

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/01152/AM09/ RLA File :03/95/040/00522/AM09/ Lic.No/Date:0310490109 14.10.2008 Defer Date:02.12.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 02.12.2008. 99

Case No.:2/30/82‐ALC4/2008

Party Name:BEST VALUE CHEM PVT. LTD. 21.10.2008 Status:Case Deferred HQ File :01/82/050/01153/AM09/ RLA File :34/24/040/00130/AM09/ Lic.No/Date:3410022514 14.10.2008 Defer Date:18.11.2008 100

Case No.:3/30/82‐ALC4/2008

Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 21.10.2008 Status:Case Deferred HQ File :01/82/050/01154/AM09/ RLA File :34/24/040/00128/AM09/ Lic.No/Date:3410022518 14.10.2008 Defer Date:18.11.2008 101

Case No.:4/30/82‐ALC4/2008

Party Name:BALAJI AMINES LIMITED 21.10.2008 Status:Case Deferred HQ File :01/82/050/01155/AM09/ RLA File :31/24/040/00189/AM09/ Lic.No/Date:3110035766 14.10.2008 Defer Date:18.11.2008 102

Case No.:5/30/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 21.10.2008 Status:Case Deferred HQ File :01/82/050/01156/AM09/ RLA File :09/24/040/00282/AM09/ Lic.No/Date:0910035638 15.10.2008 Defer Date:02.12.2008 Decision : Committee decided to call for a copy of application, copy of Drug Manufacturing Licence, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 02.12.2008. 103

Case No.:6/30/82‐ALC4/2008

Party Name:RANBAXY LABORATORIES LTD Status:Case

21.10.2008 Approved HQ File :01/82/050/01157/AM09/ RLA File :05/24/040/00459/AM09/ Lic.No/Date:0510229363 16.10.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 13/82 meeting held on 24.06.2008 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 per unit of export product Volini Gel 30 gm tube (Each tube contains 1.5 gm Racementhol) 1 No. 1. Raccmenthol 1.575 gm/30 gm tube *****************************

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