IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2009-10-06

DGFT Committee Minutes

Document text

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

Para 4.7 Decision

MEETING NUMBER : 28/82‐ALC4/2009 MEETING DATE : 06.10.2009 The Meeting No.28/82 in the year 2009‐10 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 06.10.2009 under the Chairmanship of Jt. DGFT, Shri Anil Aggarwal in his chamber. Following members were present:‐ 1. Shri Jasbir Singh, IA, Department of C&PC 2. Shri Rajinder Pal Singh, Dy. DGFT 3. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No.19/82 dated 04.08.2009 and 20/82 dated 11.08.2009 were ratified by the Committee.

Case No. B‐274

M/s Shirdi Chemicals Pvt. Ltd. Norms Committee Meeting No. 28/10 File No. 01/83/050/00687/AM07 Meeting Date 06.10.2009 RAF No. 03/95/040/00639/AM07 Adv. Lic. No. 0310400054 dated 19.09.2006 Committee considered case as per agenda and in light of written comments of Department of C&PC dated 06.10.2009 and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “4,4‐Cyclohexylidene bis (2‐methylphenol)(DMBPC) (Purity 99.7& min.)” without any other change in the decision taken in 27/83 meeting held on 11.10.2006. RA concerned may take further necessary action as per above decision of NC.

Case No. B‐275

M/s SPC Life Sciences Pvt. Ltd. File No. 01/83/050/00091/AM07 RAF No. 34/24/040/00020/AM07 Adv. Lic. No. 3410015935 dated 25.04.2006 Committee decided to defer case for 03.11.2009 for comments of Department of Pharmaceuticals.

Case No. B‐276

M/s Arch Pharma Ltd. File No. 01/82/50/1341/AM09/DES‐III RAF No. 03/94/040/796/AM09 Adv. Lic. No. 0310496207 dated 02.12.2008

Case No. B‐277

M/s Anupam Rasayan (India) Ltd. File No. 01/82/50/1720/AM09/DES‐III RAF No. 52/24/040/30/AM09 Adv. Lic. No. 5210025830 dated 13.03.2009 Committee considered case as per agenda and in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/97/2008‐Ch.II dated 22.09.2009 and in consultation with technical authority present in meeting, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed DiclofopMethyl (Diclofop Methyl Technical) 1 Kg. 1. Aminofen (4‐Amino‐2,4‐Dichloro Diphenyl Ether) 1.580 kg 2. Dimethyl sulfoxide 0.500 kg 3. 2‐Chloropropionic Acid Methyl Ester 0.524 kg 4. Potassium Carbonate 0.600 kg

Case No. B‐278

M/s Sterling Biotech Ltd. File No. 01/82/50/655/AM09/DES‐III RAF No. 34/24/040/00055/AM09 Adv. Lic. No. 3410021673 dated 23.06.2008

Case No. B‐279

M/s Alembic Ltd. F. No. 01/82/50/1263/AM06/DES‐III Meeting Date 03.11.2009 RAF No. 34/24/040/244/AM06 Adv. Lic. No. 3410015305 dated 24.01.2006

Case No. B‐280

M/s Dishman Pharmaceuticals & Chemicals Ltd. F. No. 01/82/50/593/AM07/DES‐III RAF No. 08/24/040/247/AM08 Adv. Lic. No. 0810058323 dated 24.07.2006

Case No. B‐281

M/s Alkaloids Corporation F.No.01/82/50/483/AM08/DES‐III RAF No.02/24/040/272/AM08 Adv. Lic. No. 0210107833 dated 04.01.2008

Case No. B‐282

M/s Scitech Healthcare Pvt. Ltd. F.No.01/82/50/436/AM08/DES‐III RAF No.03/95/040/466/AM08 Adv. Lic. No. 0310445758 dated 09.10.2007

Case No. B‐283

M/s Sterling Auxiliaries Pvt. Ltd. F. No. 01/82/50/449/AM08/DES‐III RAF No. 03/95/040/634/AM08 Adv. Lic. No. 0310450751 dated 20.11.2007 Committee considered case as per agenda and in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/93/2007‐Ch.II dated 06.10.2009 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Stero TIPA 85 Triisopropanolamine 1 Kg. 1. Propylene Oxide 0.880 kg Stero Deipa 85 (N,N‐Bis(2‐ Hyldroxyethyl)‐2‐propanolamine) 1 Kg. 1. Diethanol Amine 0.580 kg 2. Propylene Oxide 0.363 kg Stero Co 360 (Triglyceride Ricinoleic Acid 45 mole ethoxylate) 1 Kg. 1. Ethylene Oxide 0.694 kg.

Case No. B‐284

M/s Aurbindo Pharma Ltd.. F. No. 01/82/50/137/AM09/DES‐III RAF No. 09/24/040/526/AM08 Adv. Lic. No. 0910033127 dated 28.02.2008

Case No. B‐285

M/s Uma Organics Pvt. Ltd. F. No. 01/82/50/1094/AM08/DES‐III RAF No. 09/24/040/206/AM08 Adv. Lic. No. 0910031379 dated 03.09.2007

Case No. B‐286

M/s Watson Phaema Pvt. Ltd. F.No.01/83/50/752/AM04/DES‐III Meeting Date 03.11.2009 RAF No.03/24/040/1025/AM03 Adv. Lic. No. 0310221706 dated 29.08.2003

Case No.B‐287

M/s Reliance Industries Ltd. F.No.01/82/162/00203/AM10/DES‐III Committee decided to defer case for 03.11.2009.

Case No.C‐13

M/s Lupin Ltd. F.No.01/82/162/00853/AM09/DES‐III

Case No.C‐14

M/s Lupin Ltd. F.No.01/82/162/00532/AM08/DES‐III

Case No.:591/24/83‐ALC1/2007

Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:28/82‐ALC4/2009 06.10.2009 Status:Case Deferred HQ File :01/83/050/00315/AM08/ RLA File :03/94/040/00122/AM08/ Lic.No/Date:0310429161 11.05.2007 Defer Date:03.11.2009 Decision :Committee decided to defer case for 03.11.2009 for comments of Ministry of FPI/DBT. 2

Case No.:19/23/83‐ALC1/2007

Party Name:SEQUENT SCIENTIFIC LIMITED 06.10.2009 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:03.11.2009 Decision :Committee decided to defer case for 03.11.2009 for comments of DC(MSME). 3

Case No.:101/21/82‐ALC4/2007

Party Name:ALEMBIC LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00149/AM08/ RLA File :34/24/040/00084/AM08/ Lic.No/Date:3410019403 13.08.2007 Defer Date:03.11.2009 Decision :Committee decided to defer case for 03.11.2009 for comments of Department of Pharmaceuticals. 4

Case No.:103/21/82‐ALC4/2007

Party Name:ALEMBIC LIMITED 06.10.2009 Status:Case Approved HQ File :01/82/050/00150/AM08/ RLA File :34/24/040/00085/AM08/ Lic.No/Date:3410019404 13.08.2007 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 1/82 meeting held on 08.04.2009, 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 on repeat basis:‐ Export product Export Qty. Sl.No. Import item Qty. allowed Azithromycin Step IV (Azithromycin Crude Purity not less than 94.5%) 1 Kg. 1. Erythromycin Base 1.75 kg 2. Acetone 6.45 kg 3. Ethyl Alcohol 2.81 kg 4. Hydroxylamine Hcl 0.91 kg 5. Methane Sulfonyl Chloride 0.72 kg 6. Methanol 2.72 kg 7. Platinum Catalyst with base of activated carbon (5% platinum on carbon 1.00 Gram

Case No.:7/25/83‐ALC1/2007

Party Name:ASTRIX LABORATORIES LTD., 06.10.2009 Status:Case Deferred HQ File :01/83/050/01032/AM08/ RLA File :09/24/040/00231/AM08/ Lic.No/Date:0910031314 29.08.2007 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of Department of Pharmaceuticals. 6

Case No.:35/27/83‐ALC1/2007

Party Name:SHREE GANESH CHEMICALS 06.10.2009 Status:Case Deferred HQ File :01/83/050/01109/AM08/ RLA File :34/24/040/00089/AM08/ Lic.No/Date:3410019570 05.09.2007 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of Export Cell. 7

Case No.:16/18/82‐ALC4/2008

Party Name:STERLING AUXILIARIES PVT LTD 06.10.2009 Status:Case Approved HQ File :01/82/050/00769/AM09/ RLA File :03/95/040/00355/AM09/ Lic.No/Date:0310479455 21.07.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/93/2007/Ch.II dated 06.10.2009, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Stero MDEA (PIP) Blends of 48% Methyl Di Ethanol Amine and 52% of Piperazine (Purity 68%) 1 Kg. 1. Mono Methyl Ethanol Amine 0.309 kg 2. Ethylene Oxide 0.181 kg 3. Piperazine (60% Purity) 0.520 kg Stero CO 400 (IMP) (Mixture of 90% of PEG 400 and 10% of Triglyceride Ricinoleic Acid) 1 Kg. 1. PEG 400 0.900 Kg 8

Case No.:1/20/82‐ALC4/2008

Party Name:PAUSHAK LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00793/AM09/ RLA File :34/24/040/00049/AM09/ Lic.No/Date:3410021924 25.07.2008 Defer Date:03.11.2009 9

Case No.:18/22/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., Status:Case

06.10.2009 Deferred HQ File :01/82/050/00881/AM09/ RLA File :08/24/040/00076/AM09/ Lic.No/Date:0810073944 13.08.2008 Defer Date:03.11.2009 10

Case No.:20/22/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00883/AM09/ RLA File :08/24/040/00070/AM09/ Lic.No/Date:0810073981 14.08.2008 Defer Date:03.11.2009 11

Case No.:24/23/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/00928/AM09/ RLA File :03/94/040/00512/AM09/ Lic.No/Date:0310483819 26.08.2008 Defer Date:03.11.2009 12

Case No.:32/29/82‐ALC4/2008

Party Name:PAUSHAK LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/01114/AM09/ RLA File :34/24/040/00115/AM09/ Lic.No/Date:3410022467 06.10.2008 Defer Date:03.11.2009 13

Case No.:17/36/82‐ALC4/2008

Party Name:CADILA PHARMACEUTICALS LTD. 06.10.2009 Status:Case Deferred HQ File :01/82/050/01303/AM09/ RLA File :08/24/040/00170/AM09/ Lic.No/Date:0810076097 20.11.2008 Defer Date:03.11.2009 14

Case No.:16/39/82‐ALC4/2008

Party Name:SHREE GANESH CHEMICALS 06.10.2009 Status:Case Deferred HQ File :01/82/050/01386/AM09/ RLA File :34/24/040/00162/AM09/ Lic.No/Date:3410022880 10.12.2008 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of Export Cell.

Case No.:40/39/82‐ALC4/2008

Party Name:CIPLA LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/01410/AM09/ RLA File :03/94/040/01198/AM08/ Lic.No/Date:0310497955 15.12.2008 Defer Date:03.11.2009 16

Case No.:2/41/82‐ALC4/2008

Party Name:BALAJI AMINES LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/01442/AM09/ RLA File :31/24/040/00244/AM09/ Lic.No/Date:3110036556 19.12.2008 Defer Date:03.11.2009 17

Case No.:14/42/82‐ALC4/2008

Party Name:SURYA PHARMACEUTICAL LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/01492/AM09/ RLA File :22/24/040/00056/AM09/ Lic.No/Date:2210008531 24.12.2008 Defer Date:03.11.2009 18

Case No.:24/24/82‐ALC4/2009

Party Name:SONIC BIOCHEM EXTRACTIONS LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00521/AM10/ RLA File :11/24/040/00008/AM10/ Lic.No/Date:1110020502 16.06.2009 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of Ministry of FPI. 19

Case No.:7/28/82‐ALC4/2009

Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00567/AM10/ RLA File :03/94/040/01121/AM09/ Lic.No/Date:0310524602 17.06.2009 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of Department of Bio‐technology. 20

Case No.:2/16/82‐ALC4/2009

Party Name:SRINI PHARMACEUTICALS LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00262/AM10/ RLA File :09/24/040/00091/AM10/ Lic.No/Date:0910038415 03.07.2009 Defer Date:03.11.2009

Case No.:1/23/82‐ALC4/2009

Party Name:OTSUKA CHEMICAL ( INDIA ) LTD. 06.10.2009 Status:Case Deferred HQ File :01/82/050/00493/AM10/ RLA File :05/24/040/00195/AM10/ Lic.No/Date:0510248081 21.08.2009 Defer Date:03.11.2009 22

Case No.:2/23/82‐ALC4/2009

Party Name:V.D.H. ORGANICS PVT. LTD 06.10.2009 Status:Case Approved HQ File :01/82/050/00494/AM10/ RLA File :05/24/040/00283/AM10/ Lic.No/Date:0510248083 21.08.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/88/2004/Ch.III dated 09.09.2005, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Thymol 1 Kg. 1. Meta Cresol 0.800 kg 23

Case No.:3/23/82‐ALC4/2009

Party Name:CADILA HEALTHCARE LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00495/AM10/ RLA File :08/24/040/00127/AM10/ Lic.No/Date:0810082504 24.08.2009 Defer Date:03.11.2009 24

Case No.:4/23/82‐ALC4/2009

Party Name:CADILA HEALTHCARE LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00496/AM10/ RLA File :08/24/040/00128/AM10/ Lic.No/Date:0810082513 24.08.2009 Defer Date:03.11.2009 25

Case No.:5/23/82‐ALC4/2009

Party Name:CADILA HEALTHCARE LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00497/AM10/ RLA File :08/24/040/00129/AM10/ Lic.No/Date:0810082514 24.08.2009 Defer Date:03.11.2009

Case No.:1/24/82‐ALC4/2009

Party Name:SHILPA MEDICARE LTD., 06.10.2009 Status:Case Approved HQ File :01/82/050/00498/AM10/ RLA File :07/24/040/00204/AM10/ Lic.No/Date:0710066662 25.08.2009 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 1/82 meeting held on 08.04.2009, 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 Gemcitabine Hcl 1 Kg. 1. 4‐Amino‐1‐(3,3‐difluoro‐4‐hydroxy‐5‐ (Hydroxymethyl) Tetrahydrofuran‐2‐yl)‐1H‐ Pyrimidine‐2‐one (Technical Grade) 0.97 kg/kg 27

Case No.:2/24/82‐ALC4/2009

Party Name:HETERO LABS LTD. 06.10.2009 Status:Case Approved HQ File :01/82/050/00499/AM10/ RLA File :09/24/040/00188/AM10/ Lic.No/Date:0910039064 25.08.2009 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/69/2008‐PI‐III dated 01.08.2008, 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 Bicalutamide 1 Kg. 1. 4‐Amino‐2‐Trifluoro Methyl Benzonitrile 1.47 kg 2. P‐Fluoro Thio Phenol 0.53 kg 3. Tetrahydrofuran 1.10 kg 28

Case No.:3/24/82‐ALC4/2009

Party Name:HETERO LABS LTD. 06.10.2009 Status:Case Deferred HQ File :01/82/050/00500/AM10/ RLA File :09/24/040/00205/AM10/ Lic.No/Date:0910039065 25.08.2009 Defer Date:03.11.2009 29

Case No.:5/24/82‐ALC4/2009

Party Name:B. BRAUN MEDICAL (INDIA) PVT. LTD Status:Case

06.10.2009 Deferred HQ File :01/82/050/00502/AM10/ RLA File :04/24/040/00126/AM10/ Lic.No/Date:0410107199 25.08.2009 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of DIPP. 30

Case No.:4/24/82‐ALC4/2009

Party Name:CIPLA LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00501/AM10/ RLA File :03/94/040/00454/AM10/ Lic.No/Date:0310535251 26.08.2009 Defer Date:03.11.2009 31

Case No.:6/24/82‐ALC4/2009

Party Name:KLJ PLASTICIZERS LTD, 06.10.2009 Status:Case Deferred HQ File :01/82/050/00503/AM10/ RLA File :05/24/040/00242/AM10/ Lic.No/Date:0510248395 26.08.2009 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of Department of C&PC. 32

Case No.:17/24/82‐ALC4/2009

Party Name:DHANUKA LABORATORIES LTD. 06.10.2009 Status:Case Deferred HQ File :01/82/050/00514/AM10/ RLA File :05/23/040/00011/AM10/ Lic.No/Date:0510248486 27.08.2009 Defer Date:03.11.2009 33

Case No.:7/24/82‐ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00504/AM10/ RLA File :03/94/040/00461/AM10/ Lic.No/Date:0310535512 27.08.2009 Defer Date:03.11.2009 34

Case No.:8/24/82‐ALC4/2009

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/00505/AM10/ RLA File :31/24/040/00409/AM08/ Lic.No/Date:3110039743 27.08.2009 Defer Date:03.11.2009

Case No.:9/24/82‐ALC4/2009

Party Name:LIFE LINE INDUSTRIES LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00506/AM10/ RLA File :03/95/040/00328/AM10/ Lic.No/Date:0310535518 27.08.2009 Defer Date:03.11.2009 36

Case No.:10/24/82‐ALC4/2009

Party Name:AARTI INDUSTRIES LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00507/AM10/ RLA File :03/94/040/00399/AM10/ Lic.No/Date:0310535665 28.08.2009 Defer Date:03.11.2009 37

Case No.:11/24/82‐ALC4/2009

Party Name:SUVEN LIFE SCIENCES LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00508/AM10/ RLA File :09/24/040/00212/AM10/ Lic.No/Date:0910039090 28.08.2009 Defer Date:03.11.2009 38

Case No.:12/24/82‐ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/00509/AM10/ RLA File :09/24/040/00176/AM10/ Lic.No/Date:0910039095 28.08.2009 Defer Date:03.11.2009 39

Case No.:13/24/82‐ALC4/2009

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00510/AM10/ RLA File :09/24/040/00201/AM10/ Lic.No/Date:0910039098 28.08.2009 Defer Date:03.11.2009 40

Case No.:14/24/82‐ALC4/2009

Party Name:ASTRIX LABORATORIES LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00511/AM10/ RLA File :09/24/040/00168/AM10/ Lic.No/Date:0910039133 28.08.2009 Defer Date:03.11.2009

Case No.:15/24/82‐ALC4/2009

Party Name:ASTRIX LABORATORIES LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00512/AM10/ RLA File :09/24/040/00171/AM10/ Lic.No/Date:0910039134 28.08.2009 Defer Date:03.11.2009 42

Case No.:16/24/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00513/AM10/ RLA File :09/24/040/00200/AM10/ Lic.No/Date:0910039135 28.08.2009 Defer Date:03.11.2009 43

Case No.:18/24/82‐ALC4/2009

Party Name:CIPLA LIMITED 06.10.2009 Status:Case Approved HQ File :01/82/050/00515/AM10/ RLA File :03/94/040/00467/AM10/ Lic.No/Date:0310535741 28.08.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by DOP vide their U.O. No.35011/168/2008‐PI‐III dated 24.11.2008 and in consultation with technical authority present in meeting decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import items Qty. allowed per kg of Budnoside Budecort 200 Inhaler (200MD) [Budinoside = 0.04 gms/Inhaler] 1 No. 1. 16alpha‐Hydroxy Prednisolone 1.093 kg. 2. Butyraldehyde 0.350 kg Budecort 100 Inhaler (200MD) [Budinoside = 0.02 gms/Inhaler] 1 No. 1. 16alpha‐Hydroxy Prednisolone 1.093 kg. 2. Butyraldehyde 0.350 kg 44

Case No.:19/24/82‐ALC4/2009

Party Name:PANACEA BIOTEC LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00516/AM10/ RLA File :05/24/040/00299/AM10/ Lic.No/Date:0510248628 28.08.2009 Defer Date:03.11.2009

Case No.:20/24/82‐ALC4/2009

Party Name:LUPIN LIMITED 06.10.2009 Status:Case Approved HQ File :01/82/050/00517/AM10/ RLA File :03/95/040/00320/AM10/ Lic.No/Date:0310535903 31.08.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/128/2009‐ PI‐III dated 12.06.2009, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Levitiracetam 1 Kg. (S)(+)2‐Amino Butyramide Hcl 0.95 kg 2. Methanol 0.71 kg 3. Methylene Chloride 3.74 kg 4. Ethyl Acetate 1.49 kg 5. Activated Carbon 0.0128 kg 46

Case No.:21/24/82‐ALC4/2009

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00518/AM10/ RLA File :03/95/040/00331/AM10/ Lic.No/Date:0310535917 31.08.2009 Defer Date:03.11.2009 47

Case No.:22/24/82‐ALC4/2009

Party Name:LAFFANS PETROCHEMICALS LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00519/AM10/ RLA File :03/95/040/00240/AM10/ Lic.No/Date:0310535934 31.08.2009 Defer Date:03.11.2009 48

Case No.:23/24/82‐ALC4/2009

Party Name:AMBUJA INTERMEDIATES LIMITED 06.10.2009 Status:Case Approved HQ File :01/82/050/00520/AM10/ RLA File :03/94/040/00395/AM10/ Lic.No/Date:0310535942 31.08.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/36/2008/Ch.II dated 26.02.2009, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed

1‐Bromocyclohexylamine Anthraquinone (BC Acid) 1 Kg. 1. 1‐Chloro Anthraquinone 1.153 kg 2. Cyclohexylamine 1.286 kg 3. Bromine 0.775 kg 49

Case No.:25/24/82‐ALC4/2009

Party Name:AARTI INDUSTRIES LIMITED 06.10.2009 Status:Case Approved HQ File :01/82/050/00522/AM10/ RLA File :03/94/040/00409/AM10/ Lic.No/Date:0310535978 01.09.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 38/82 meeting held on 16.12.2008, 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 Fluticasone Propionate 1 Kg. 1. Flumethsone 1.64 kg 2. Bromo Fluro Methane 0.66 kg 50

Case No.:26/24/82‐ALC4/2009

Party Name:ANUPAM RASAYAN (INDIA) LTD 06.10.2009 Status:Case Approved HQ File :01/82/050/00523/AM10/ RLA File :52/24/040/00010/AM10/ Lic.No/Date:5210028021 01.09.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/97/2008/Ch.II dated 16.02.2009, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Diclofop Methyl (Diclofop Methyl Technical) 1 Kg. 1. 2,4‐Dichloro Phenol 1.209 kg. 2. Dimethyl Sulfoxide 0.500 kg. 3. 2‐Chloropropionic Acid Methyl Ester 0.524 kg 4. Potassium Carbonate 0.600 kg. 51

Case No.:27/24/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/00524/AM10/ RLA File :09/24/040/00196/AM10/ Lic.No/Date:0910039221 01.09.2009 Defer Date:03.11.2009

Decision : Committee decided to defer case for 03.11.2009 for comments of DC( MSME). 52

Case No.:28/24/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/00525/AM10/ RLA File :09/24/040/00199/AM10/ Lic.No/Date:0910039222 01.09.2009 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of DC(MSME). 53

Case No.:29/24/82‐ALC4/2009

Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:28/82‐ALC4/2009 06.10.2009 Status:Case Deferred HQ File :01/82/050/00526/AM10/ RLA File :09/24/040/00208/AM10/ Lic.No/Date:0910039223 01.09.2009 Defer Date:03.11.2009 54

Case No.:30/24/82‐ALC4/2009

Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:28/82‐ALC4/2009 06.10.2009 Status:Case Deferred HQ File :01/82/050/00527/AM10/ RLA File :09/24/040/00206/AM10/ Lic.No/Date:0910039224 01.09.2009 Defer Date:03.11.2009 55

Case No.:31/24/82‐ALC4/2009

Party Name:SAINOR LABORATORIES PVT LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/00528/AM10/ RLA File :09/24/040/00137/AM10/ Lic.No/Date:0910039225 01.09.2009 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of Department of C&PC. 56

Case No.:32/24/82‐ALC4/2009

Party Name:UNI SANKYO LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/00529/AM10/ RLA File :09/24/040/00190/AM10/ Lic.No/Date:0910039228 01.09.2009 Defer Date:03.11.2009 57

Case No.:33/24/82‐ALC4/2009

Party Name:INDIA GLYCOLS LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/00530/AM10/ RLA File :05/23/040/00019/AM10/ Lic.No/Date:0510248771 02.09.2009 Defer

Date:03.11.2009 58

Case No.:1/28/82‐ALC4/2009

Party Name:SADHANA NITRO CHEM LIMITED 06.10.2009 Status:Case Approved HQ File :01/82/050/00561/AM10/ RLA File :03/95/040/00385/AM10/ Lic.No/Date:0310538360 17.09.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Chemical Division of C&PC vide their U.O. No.14010/85/2006/Ch.III dated 02.11.2006, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Di(Phenylmethyl) Amine‐6’‐ Diethylamino Spiro (Isobenzo Furan‐1(3H), 9’‐(9H Xanthene)‐3‐one (SNG‐36 1 Kg. 1. Diethyl Meta Amine Phenol (DEMAP) 0.560 kg 2. Phthalic Anhydride 0.600 kg 3. Para Anisidine 0.357 kg 4. Toluene 1.440 kg 5. Caustic Soda Flakes OR Caustic Soda Lye 50% 3.112 kg 6.100 kg 6. Potassium Iodide 0.108 kg 59

Case No.:2/28/82‐ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 06.10.2009 Status:Case Deferred HQ File :01/82/050/00562/AM10/ RLA File :03/94/040/00465/AM10/ Lic.No/Date:0310538431 18.09.2009 Defer Date:03.11.2009 60

Case No.:3/28/82‐ALC4/2009

Party Name:STERLING BIOTECH LTD. 06.10.2009 Status:Case Deferred HQ File :01/82/050/00563/AM10/ RLA File :34/24/040/00082/AM10/ Lic.No/Date:3410025128 18.09.2009 Defer Date:03.11.2009 61

Case No.:4/28/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00564/AM10/ RLA File :05/24/040/00307/AM10/ Lic.No/Date:0510249607 18.09.2009 Defer Date:03.11.2009

Case No.:5/28/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00565/AM10/ RLA File :05/24/040/00308/AM10/ Lic.No/Date:0510249608 18.09.2009 Defer Date:03.11.2009 63

Case No.:6/28/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 06.10.2009 Status:Case Deferred HQ File :01/82/050/00566/AM10/ RLA File :05/24/040/00275/AM10/ Lic.No/Date:0510249610 18.09.2009 Defer Date:03.11.2009 64

Case No.:8/28/82‐ALC4/2009

Party Name:GULBRANDSEN CHEMICALS PVT LTD 06.10.2009 Status:Case Deferred HQ File :01/82/050/00568/AM10/ RLA File :34/24/040/00093/AM10/ Lic.No/Date:3410025155 22.09.2009 Defer Date:03.11.2009 65

Case No.:9/28/82‐ALC4/2009

Party Name:EMCURE PHARMACEUTICALS LTD. 06.10.2009 Status:Case Deferred HQ File :01/82/050/00569/AM10/ RLA File :31/24/040/00110/AM10/ Lic.No/Date:3110040034 23.09.2009 Defer Date:03.11.2009 66

Case No.:10/28/82‐ALC4/2009

Party Name:SINGH PLASTICISERS & RESINS (I) PVT.LTD. 06.10.2009 Status:Case Deferred HQ File :01/82/050/00570/AM10/ RLA File :05/24/040/00323/AM10/ Lic.No/Date:0510249947 24.09.2009 Defer Date:03.11.2009 Decision : Committee decided to defer case for 03.11.2009 for comments of Department of C&PC (Petrochemicals Division).

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