IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2012-09-20

DGFT Committee Minutes

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Case No. B 285

M/s. Vivimed Labs Limited Norms Committee Meeting No.20/AM13 F.No. 01/83/00351/AM09/DES III Meeting Date:20.9.2012 RLA File No. 09/24/040/00514/AM 08 Adv. Lic. No. & Date 0910033449 dated 26.3.2008 Decision:. It was decided to defer the case for 18.10.2012 fo comments of Department of Chemicals and Petrochemicals.

Case No. B 286

M/s. Divis Laboratories Limited F.No. 01/82/162/00111/AM 13/DES III Decision:. It was decided to defer the case for 18.10.2012 fo comments of Department of Pharmaceuticals.

Case No. B 287

M/s. Rohan Exports India Limited & M/s. Mahesh Raj Chemicals Limited F.No. 01/83/162/00654/AM 12/DES III Decision:. It was decided to defer the case for 18.10.2012 fo comments of Department of Chemicals and Petrochemicals.

Case No. B 288

M/s. PCL Oil & Solvents Limited, New Delhi F.No. RLA File No. 05/27/040/00083/AM 13 05/27/040/00454/AM 13 05/27/040/00455/AM 13 Decision:. It was decided to defer the case for 18.10.2012 fo comments of Department of Petrochemical division Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision

MEETING NUMBER : 20/82ALC4/2012 MEETING DATE : 20.09.2012 The Meeting No. 20/82 in the year 201213 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was scheduled to be held on 20.9.2012 under the Chairmanship of Addl DGFT, Shri Mukesh Bhatnagar, in Room No.11, Udyog Bhawan, New Delhi.. Following members were present: 1. Shri Jasbir Singh, Consultant, Department of Chemicals and Petrochemicals 2. Shri D.N. Mathur, Consultant, Department of Pharmaceutical 3. Dr. Nitin Jain, Department of Biotechnology 4. Shri R.C. Meena, Dy. Director General of Foreign Trade

Petrochemical division.

Case No. B 289

M/s. Arch Pharmalabs Pvt. Limited, Mumbai F.No. 01/82/050/01067/AM 12/DES III RLA File No. 03/82/040/00645/AM 12 0310661498 dated 21.10.2011 Decision:. It was decided to amend in the description of import products at S.No. 6 from “Ketroreducatse YDH/RED” to Enzyme Kred (YDH) (CDX041 Lyophilised Enzyme Powder) and description of import product at S.No. 7 from “Glucose Dehydrogenase Enzyme GDH” to “Enzyme GDH (CDX901 Lyophilised Enzyme Powder)”. Rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 290

M/s. Arch Pharmalabs Limited F.No. 01/82/50/00870/AM 09/DES III (Pt.) RLA File No. 03/94/040/00393/AM 09 0310481979 dated 8.8.2008 Decision:. It was decided to defer the case for 18.10.2012 fo comments of Department of Pharmaceuticals..

Case No. B 291

M/s. Arch Pharmalabs Pvt. Limited, Mumbai F.No. 0182/050/01056/AM 12/DES III RLA File No. 03/82/040/00646/Am 12 0310661877 dated 24.10.2011 Decision:. It was decided to amend in the description of import products at S.No. 6 from “Ketroreducatse YDH/RED” to Enzyme Kred (YDH) (CDX041 Lyophilised Enzyme Powder) and description of import product at S.No. 7 from “Glucose Dehydrogenase Enzyme GDH” to “Enzyme GDH (CDX901 Lyophilised Enzyme Powder)”. Rest of the minutes would remain. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 292

M/s. New alliance Dye Chem Pvt. Limited, Mumbai F.No. 0182/050/00440/AM 12/DES III RLA File No. 03/95/040/00227/AM 12 0310638201dated 23.6.2011 Decision:. In the light of written comments received from Department of Chemicals and Petrochemicals vide their note dated 2.8.2012, it was decided to amend the description of export product from “EDTA Diammonium (Liquid) Assay Min. 40%” to “EDTA Diammonium”. The rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 293

M/s. Glenmark Pharma Limited F.No. 0182/050/380/AM 12 F.No 01/82/50/211/AM 11 F.No 01/82/50/1069/AM 12 F.No 01/82/50/238/AM 11 RLA File No. 03/94/040/936/AM 11 RLA File NO. 03/94/040/147/AM 11 RLA file No. 03/94/040/179/AM 12 RA File NO. 03/94/040/826/AM 10 0310616888 dated 21.2.11 0310574313 dated 14.5.10 0310632736 dated 25.5.11 0310555276 dated 14.1.10

0310555276 dated 14.1.10 Decision:. It was decided to amend in the description of import products at S.No. 2 to be read as “5(4Bromomethyl) (1,1Biphenyl)2YL Triphenyl1HTetrazole”.. Rest of the minutes would remain. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 294

M/s. Divis Laboratories Limited F.No 01/82/162/01036/AM 11/DES III F.No 01/82/162/01037/AM 11/DES III F.No 01/82/162/01038/AM 11/DES III F.No 01/82/162/01039/Am 11/DES III F.No 01/82 /162/01040/AM 11/DES III F.No 01/82/162/01041/AM 11/DES III F.No. 01/82/162/01044/AM 11/DES III Decision:. It was decided to give final reminder to the firm to furnish requisite information within 15 days failing which the case would be closed. Accordingly, the case was deferred for 18.10.2012.

Case No. B 295

M/s. Jubilant Lifesciences Limited Norms Committee Meeting No. 20/AM13 F.No. 01/82/50/00114/AM 12/DES III F. No. 01/82/50/00293/AM 12/DES III Meeting Date:20/09/2012 R.A F. No. 05/24/040/00026/AM 12 RA F. No 05/24/040/00046/AM 12 Adv. Lic. No. 0510288429 dated 20.4.2011 Adv. Lic. No. 0510291487 dated 24.5.2011 Decision:. It was decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authority starting manufacturing from 2,3Difluro5Chloro Pyridine. Accordingly, the case was deferred for 18.10.2012..

Case No. B 296

M/s. Coral Drugs Pvt. Ltd. F.No. 01/82/50/00226/AM 09/DES III Meeting Date:20.09.2012 R.A F. No. 05/24/040/00699/AM 08 Adv. Lic. No. 0510213410 dated 12.7.07 Decision:. It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals.

Case No. B 300

M/s. Jubilant Lifesciences Limited F.No. 01/82/50/01598/AM 11/DES III Meeting Date:20.09.2012 R.A F. No. 05/23/040/00129/AM 11 Adv. Lic. No. 0510271327 dated 25.8.2010 Decision:. It was decided to defer the case for 18.1.2012 for comments of Department of Chemicals and Petrochemicals.

Case No.B 301

M/s. Jubilant Lifesciences Ltd. F.No. 01/82/050/01593/AM11/DES III Meeting Date:20.09.2012 RA F.No.05/23/040/00138/AM11 Advance licence No. & date 0510272117dated 06.09.2010 Decision: Committee decided to defer case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals.

Case No.B 302

M/s. Shamrock Pharmachem Pvt. Ltd. F.No. 01/82/050/01448/AM11/DES III Meeting Date:20.09.2012 RA F.No.03/95/040/00825/AM 11 Advance licence No. & date 0310609520 dated 5.1.2011 Decision: It was decided to send again a copy of application to Department of Pharmaceuticals for their comments. Accordingly, the case was deferred for 18.10.2012.

Case No. B 303

M/s. MSN Pharma Pvt. Ltd. F.No. 01/82/50/0012148/AM 12/DES III F. No. 01/82/50/01449/AM 12/DES III R.A F. No. 09/24/040/00383/Am 12 RA F. No 09/24/040/00507/AM 12 Adv. Lic. No. 0910049788 dated 18.11.2011 Adv. Lic. No. 0910050991 dated 27.01.2012 Decision:. It was decided to amend the description of 2nd import item as “Methyl 4(4 fluoropheynyl)6isopropyl2[(Nmethylnmethylsulphonyl)amino pyrimidine5Carboxylate”. Rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 304

M/s. Hindustan Polyamides & Fibres Limited F.No. 01/82/50/001389/AM 11/DES III R.A F. No. 03/94/40/00406/AM 11 Adv. Lic. No. 0310590782 dated 3.9.2010 Decision:. It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals.

Case No. B 305

M/s. Jubilant Lifesciences Limited F.No. 01/82/50/00921/AM 11/DES III R.A F. No. 05/23/040/00168/AM 11 Adv. Lic. No. 0510274506 dated 8.10.10 Decision:. It was decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authority.. Accordingly, the case was deferred for 18.10.2012..

Case No. B 306

M/s. Solvay Specialties India Pvt. Ltd. F.No. 01/82/50/01074/AM 12/DES III R.A F. No. 03/95/040/00596/AM 12 Adv. Lic. No. 0310668225 dated 30.11.2011 Decision In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/106/2008 dated 12.9.2012, it was decided to revise norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Dichloro Diphenyl Sulfone (DCDPS) 1 kg 1. Mono Chloro Benzene 0.940 kg 2. Dimethyl Sulphate 0.150 kg 3 S lf r Trio ide 0 820 kg

Sulfur Trioxide 0.820 kg 4. Caustic Soda Lye 0.018 kg 5. Jumbo Bagas As per packing policy 6. Pallets As per packing policy

Case No. B 307

M/s. Encee Aromatics Pvt. Ltd. F.No. 01/82/162/00020/AM 10/DES III Decision:. It was decided to ask from the Chemexcil to provide All Industry data of other exporters. It was decided to advice the firm to apply under Para 4.4.2 of HBP v1 for the current requirements.

Case No. B 308

M/s. Jubilant Lifesciences Limited F.No. 01/82/50/00248/AM 10/DES III R.A F. No. 05/24/040/00146/AM 10 Adv. Lic. No. 0510244396 dated 24.6.2009 Decision:. It was decided to remind the firm to furnish production and consumption data duly certified by the Central Excise Authority. Accordingly, the case was deferred for 18.10.2012.

Case No. B 309

M/s. Hindustan Polyamides & Fibers Limited F.No. 01/82/162/01180/AM 10/DES III Decision:. It was decided to defer defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals.

Case No. B 310

M/s. Alembic Limited, Vadodara F.No. 01/82/50/00095/AM 12/DES III (pt.) R.A F. No. 34/24/040/00018/AM 10 Adv. Lic. No. 3410024139 dated 8.5.2009 Decision:. It was decided to examine the case on file. Accordingly, the case was deferred for 18.10.2012.

Case No. B 311

M/s. Alembic Pharmaceuticals Limited, Vadodara F.No. 01/82/162/00236/AM 13/DES III R.A F. No. 34/24/040/00196/AM 11 Adv. Lic. No. 3410028466 dated 29.10.2010 Decision:. In the light of earlier decision taken in meeting no. 26 dated 27.9.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Azithromycin Tablet 250 1 No.. 1. Azithromycin Dihydrate 259.50 mg 2. Pregelatinized Starch (Starch 1500) 26.21 mg

mg 2. Pregelatinized Starch (Starch 1500) 26.21 mg 3. Calcium Phosphate Dibasic Anhydrous 134.80 mg 4. Croscarmellose Sodium (AC Di Sol) 8.74 mg 5. Magnesium Stearate 3.628 mg 6. Sodium Lauryl Sulphate 0.900 mg Azithromycin Tablet 500 mg 1 No. 1. Azithromycin Dihydrate 519.02 mg 2. Pregelatinized Starch (Starch 1500) 52.42 mg 3. Calcium Phosphate Dibasic Anhydrous 269.58 mg 4. Croscarmellose Sodium (AC Di Sol) 17.48 mg 5. Magnesium Stearate 7.348 mg 6. Sodium Lauryl Sulphate 1.80 mg Azithromycin Tablet 600 mg 1 No. 1. Azithromycin Dihydrate 622.82 mg 2. Pregelatinized Starch (Starch 1500) 62.91 mg 3. Calcium Phosphate Dibasic Anhydrous 323.50 mg 4. Croscarmellose Sodium (AC Di Sol) 20.97 mg 5. Magnesium Stearate 8.80 mg 6. Sodium Lauryl Sulphate 2.16 mg

Case No. B 312

M/s. Navin Florine International Limited, Mumbai F.No. 01/82/50/00429/AM 12/DES III (pt.) R.A F. No. 03/95/040/00113/AM 12 Adv. Lic. No. 0310637533 dated 21.6.2011 Decision:. It was decided to amend the description of import item from “Trifloride Tetrahydrofuran” to “Boron Trifluoride Tetrahydrofuran”. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 313

M/s. Alembic Limited, Vadodara F.No. 01/82/50/00740/AM 12/DES III (pt.) R.A F. No. 34/24/040/00018/AM 10 Adv. Lic. No. 3410031093 dated 28.7.2011 Decision:. It was decided to amend the UOM of import item at S.No 1 Erythromycin Thiocyanate from KG to KGA. It was also decided to change the export quantity from 50000 kg to 1 kg. Rest of the minutes would remain. RA may take appropriate action as per the decision of Norms Committee.

Case No. C 44

M/s. Shasun Pharmaceuticals Limited F.No. 01/82/162/00261/AM 12/DES III Decision:. It was decided to remind the Pharmaxcil to furnish All Industry Data in respect of Gabapentin. Accordingly, the case was deferred for 18.10.2012.

Case No.C 46

M/s. Bliss G V S Pharma Limited F.No. 01/82/162/1192/AM 10/DES III Meeting Date:20.09.2012 Decision: It was decided to give reminder to DGCI for furnishing their comments in the matter i di t l

immediately. The case was deferred for 18.10.2012.

Case No.C 47

M/s Camlin Fine Chemicals Limited F.No. 01/82/162/00922/AM 12/DES III Meeting Date20.09.2012 Decision: It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals.

Case No.C 48

M/s. Encee Aromatics Pvt. Ltd. F.No. 01/82/162/00008/AM 13/DES III Meeting Date:20.09.2012 Decision It was decided to call from the firm the production and consumption data duly certified by Central Excise Authority. Accordingly, the case was deferred for 18.10.2012.

Case No.C 49

M/s. Encee Aromatics Pvt. Ltd. F.No. 01/82/162/00745/AM 12/DES III Meeting Date:20.09.2012 Decision It was decided to call from the firm the production and consumption data duly certified by Central Excise Authority. Accordingly, the case was deferred for 18.10.2012. 1

Case No.:18/13/83ALC1/2007

Party Name:LACTOSE (INDIA) LTD., Meet No/Date:20/82ALC4/2012 20.09.2012 Status:Case Approved HQ File :01/83/050/00430/AM08/ RLA File :03/95/040/00140/AM08/ Lic.No/Date:0310430885 29.05.2007 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/74/2012Ch. II dated 20.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Lactose Monohydrate BP/Lactose BP/Lactose USP/Lactose EP 1 kg 1 Edible lactose /Refined Edible Grade Lactose/Fine Grind Lactose Edible Grade/ExFine Grind Lactose Edible Grade 1.02 kg 2

Case No.:54/41/82ALC4/2010

Party Name:GLAND PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01402/AM11/ RLA File :09/24/040/00289/AM11/ Lic.No/Date:0910043863 08.10.2010 Defer Date:04.10.2012 Decision : It was decided to defer the case for 4.10.2012 for comments of Department of Pharmaceuticals. Accordingly, the case was deferred for 4.10.2012. C N 55/41/82 ALC4/2010 P t N GLAND PHARMA LIMITED M t N /D t 20/82 ALC4/2012 St t C

Case No.:55/41/82ALC4/2010

Party Name:GLAND PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01403/AM11/ RLA File :09/24/040/00298/AM11/ Lic.No/Date:0910043877 11.10.2010 Defer Date:04.10.2012 Decision : It was decided to defer the case for 4.10.2012 for comments of Department of Pharmaceuticals. Accordingly, the case was deferred for 4.10.2012. 4

Case No.:3/31/82ALC4/2010

Party Name:EMAMI LIMITED, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Defer Date:04.10.2012 Decision : It was decided to defer the case for 4.10.2012 for comments of DC(MSME). 5

Case No.:8/31/82ALC4/2010

Party Name:GLAND PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00933/AM11/ RLA File :09/24/040/00290/AM11/ Lic.No/Date:0910043914 14.10.2010 Defer Date:04.10.2012 Decision : It was decided to defer the case for 4.10.2012 for comments of Department of Pharmaceuticals. Accordingly, the case was deferred for 4.10.2012. 6

Case No.:48/31/82ALC4/2010

Party Name:GLAND PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00973/AM11/ RLA File :09/24/040/00297/AM11/ Lic.No/Date:0910043978 20.10.2010 Defer Date:04.10.2012 Decision : It was decided to defer the case for 4.10.2012 for comments of Department of Pharmaceuticals. Accordingly, the case was deferred for 4.10.2012. 7

Case No.:57/40/82ALC4/2010

Party Name:MATRIX LABORATORIES LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/01256/AM11/ RLA File :09/24/040/00237/AM11/ Lic.No/Date:0910043987 20.10.2010 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 8

Case No.:63/40/82ALC4/2010

Party Name:EMAMI LIMITED, 20.09.2012 Status:Deffered and Reindexed HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Defer Date:18.10.2012 Decision : It was decided to defer the case for 8.10.2012 for comments of DC(MSME).

Case No.:32/6/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00150/AM12/ RLA File :09/24/040/00037/AM12/ Lic.No/Date:0910046439 21.04.2011 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 10

Case No.:33/6/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00151/AM12/ RLA File :09/24/040/00031/AM12/ Lic.No/Date:0910046440 21.04.2011 Defer Date:18.10.2012 11

Case No.:3/17/82ALC4/2011

Party Name:RANBAXY LABORATORIES LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00498/AM12/ RLA File :05/24/040/00124/AM12/ Lic.No/Date:0510296379 12.07.2011 Defer Date:18.10.2012 12

Case No.:1/24/82ALC4/2011

Party Name:PARABOLIC DRUGS LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00662/AM12/ RLA File :05/24/040/00150/AM12/ Lic.No/Date:0510298306 01.08.2011 Defer Date:18.10.2012 Decision : : It was decided to remind the firm to furnish technical details as per Appendix 33. Accordingly, the case was deferred for 18.10.2012. 13

Case No.:2/24/82ALC4/2011

Party Name:PARABOLIC DRUGS LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00663/AM12/ RLA File :05/24/040/00149/AM12/ Lic.No/Date:0510298304 01.08.2011 Defer Date:18.10.2012 Decision : : It was decided to remind the firm to furnish technical details as per Appendix 33. Accordingly, the case was deferred for 18.10.2012. 14

Case No.:3/24/82ALC4/2011

Party Name:PARABOLIC DRUGS LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00664/AM12/ RLA File :05/24/040/00083/AM12/ Lic.No/Date:0510298301 01.08.2011 Defer Date:18.10.2012 Decision : : It was decided to remind the firm to furnish technical details as per Appendix 33. Accordingly, the case was deferred for 18.10.2012. 15

Case No.:25/26/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic No/Date:0310646711 Defer

15 HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic.No/Date:0310646711 05.08.2011 Defer Date:18.10.2012 16

Case No.:19/20/82ALC4/2012

Party Name:MICRO LABS LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00630/AM13/ RLA File :07/24/040/00198/AM12/ Lic.No/Date:0710081872 29.08.2011 Defer Date:20.09.2012 Decision : In line with SION A 54, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Amoxycillin 250 mg tablets 1 number 1. Amoxycillin Trihydrate BP/EP/USP 292.68 mg Amoxycilling 500 mg tablets 1 number 2. Amoxycilling Trihydrate BP/EP/USP 585.36 mg 17

Case No.:39/31/82ALC4/2011

Party Name:SAURAV CHEMICALS LTD, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date:18.10.2012 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals , it was decided to call from the firm the following information:  Complete chemical reaction showing utilization of each inputs, their Mol. Wt. and % yield on molar basis.  Details of recylation of Step 1 product.  Details of Step II reactions showing actual utilization of Iodine and KI in the process as the export product formula does not contain Iodine.  Past production visàvis actual consumption of all inputs duly certified by Central Excise authorities. Accordingly, the case was deferred for 18.10.2012.

Case No.:50/31/82ALC4/2011

Party Name:SHASUN PHARMACEUTICALS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00876/AM12/ RLA File :04/24/040/00165/AM12/ Lic.No/Date:0410127861 08.09.2011 Defer Date: Decision : In the light of written comments received form Department of Pharmaceuticals vide their OM No. 35011/15/2012PI(Norms) dated 13.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed

18 p y , p y Metoprolol Tartrate Tablets 25 mg 1 tablet 1. Metoprolol Tartrate 25.5 mg 2 Magnesium Stearate/SLS 1.53 mg 25 mg 1 tablet 1. Metoprolol Tartrate 25.5. mg 2. 1.53 mg 100 mg 1 tablet 1. Metoprolol Tartrate 102 mg 2. 4.284 mg 100 mg 1 tablet 1. Metoprolol Tartrate 102 mg 2. Magnesium Stearate/SLS4 4.28 mg RA may take appropriate action as per the decision of Norms Commission. 19

Case No.:12/29/82ALC4/2011

Party Name:GLENMARK GENERICS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00811/AM12/ RLA File :03/94/040/00530/AM12/ Lic.No/Date:0310655109 21.09.2011 Defer Date: Decision : In the light of written comments received form Department of Pharmaceuticals vide their OM No. 35011/08/2012PI(Norms) dated 15.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Erdosteine 1 kg 1. NChloroacetyl Homocysteine Thiolactone 0.91 kg 20

Case No.:23/32/82ALC4/2011

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 20.09.2012 Status:Case Approved HQ File :01/82/050/00904/AM12/ RLA File :04/24/040/00153/AM12/ Lic.No/Date:0410128355 21.09.2011 Defer Date: Decision : In the light of written comments received form Department of Pharmaceuticals vide their OM No. 35011/41/2012PI(Norms) dated 13.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Softgelatin Capsules Omega Fish Oil 1000 mg (BP) 1 Capsule 1. Omega 3 Fish Lipid Oil EPA 46 & DHA 38 1020 mg 21

Case No.:9/35/82ALC4/2011

Party Name:UNITED BIOTECH PVT.LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00936/AM12/ RLA File :05/24/040/00226/AM12/ Lic.No/Date:0510304974 11.10.2011 Defer Date:18.10.2012

11.10.2011 Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comment of Department of Pharmaceuticals. 22

Case No.:83/42/82ALC4/2011

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/01118/AM12/ RLA File :09/24/040/00330/AM12/ Lic.No/Date:0910049353 14.10.2011 Defer Date: Decision : In the light of written comments received form Department of Pharmaceuticals vide their OM No. 35011/129/2012PI(Norms) dated 4.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed (1S,4R)4[(2Amino6 Chloro5Formamido4 Pyrimidinyl)Amino]2 Cyclo Pentene1Methanol 1 kg 1. N(2Amino4,6Dichloro5 Pyrimidnyl)Formamide 0.764 kg 2. (+)2Azabicyclo[2.2.1] HEPT5EN3 ONE(Vincelactam) 1.832 kg 3. D() Tartaric Acid 1.06 kg 4. Sodium Borohydride 0.226 kg 5. Pyridine 2.872 kg 6. Isopropyl Alcohol 3.53 kg 7. Methanol 6.058 kg 8. Dichloro Methane 2.817 kg 23

Case No.:30/42/82ALC4/2011

Party Name:GLENMARK GENERICS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01065/AM12/ RLA File :03/94/040/00659/AM12/ Lic.No/Date:0310662250 25.10.2011 Defer Date:18.10.2012 24

Case No.:31/49/82ALC4/2011

Party Name:SMILAX LABORATORIES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01340/AM12/ RLA File :09/24/040/00332/AM12/ Lic.No/Date:0910049719 16.11.2011 Defer Date:18.10.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/251/2012PI(Norms) dated 10.8.2012, it was decided to call from the firm the following information:  Stepwise complete and balanced chemical reaction showing technical justification for utilization of each input their Mol. Wt. and % yield on molar basis.  Requirement and recovery of solvent at each step.  Enduse of the export product indicating name of API produced from it.

End use of the export product indicating name of API produced from it.  Past production visàvis actual consumption of inputs duly certified by Central Excise Authorities. 25

Case No.:7/27/85ALC3/2011

Party Name:BELOOR BAYIR BIOTECH LTD, 20.09.2012 Status:Case Deferred HQ File :01/85/050/00151/AM12/ RLA File :07/24/040/00317/AM12/ Lic.No/Date:0710084045 18.11.2011 Defer Date:18.10.2012 26

Case No.:6/29/85ALC3/2011

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 20.09.2012 Status:Case Approved HQ File :01/85/050/00163/AM12/ RLA File :04/24/040/00239/AM12/ Lic.No/Date:0410131226 02.12.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 41/82 dated 10.1.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Clomipramine Hydrochloride Active Pharmaceutical Ingredient 1 kg 1. 3 Chloroiminodibenzyl 0.91 kg 27

Case No.:33/51/82ALC4/2011

Party Name:RA CHEM PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01426/AM12/ RLA File :09/24/040/00412/AM12/ Lic.No/Date:0910050064 07.12.2011 Defer Date:18.10.2012 28

Case No.:82/46/82ALC4/2011

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/01298/AM12/ RLA File :09/24/040/00127/AM12/ Lic.No/Date:0910050138 09.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/247/2012PI(Norms) dated 1.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed ((2R, 5R)5Hydroxy 1[1,3]Oxathiolane2 Carboxylate, LMenthyl Ester)ECE 1 kg 1 Glyoxylic Acid 50% 0.717 kg

Ester)ECE 2. 2,5 Di Hydroxy 1,4Dithiane 0.30 kg 29

Case No.:23/45/82ALC4/2011

Party Name:SUTURES INDIA PRIVATE LIMITED, 20.09.2012 Status:Case Deferred HQ File :01/82/050/01200/AM12/ RLA File :07/24/040/00341/AM12/ Lic.No/Date:0710084630 13.12.2011 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Industrial Policy and Promotion. 30

Case No.:24/46/82ALC4/2011

Party Name:ASHISH LIFE SCIENCE PVT.LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/01240/AM12/ RLA File :03/94/040/00737/AM12/ Lic.No/Date:0310670672 14.12.2011 Defer Date:18.10.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/113/2012PI(Norms) dated 12.9.2012, it was decided to call from the firm the following technical details:  Quantity of different formulations to be exported.  Composition of each type of formulation (strength wise)  Copy of DML allowing manufacturing of Praziquantel bases Syringes with approved composition.  The unit of measurement of each export product. Accordingly, the case was deferred for 18.10.2012 31

Case No.:4/40/82ALC4/2011

Party Name:DEEPAK NITRITE LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01000/AM12/ RLA File :31/83/040/00137/AM12/ Lic.No/Date:3110052056 22.12.2011 Defer Date:20.09.2012 Decision : It was decided to give final reminder to the firm to furnish the information sought vide minutes of the meeting no. 5/82 dated 1.5.2012 within 15 days failing which the case would be closed. Accordingly, the case was deferred for 20.9.2012. 32

Case No.:1/47/82ALC4/2011

Party Name:BROOKS LABORATORIES LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/01301/AM12/ RLA File :22/24/040/00067/AM12/ Lic.No/Date:2210012351 23.12.2011 Defer Date: 1.11.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No 35011/237/2012PI(Norms) dated 23.7.2012, it was decided to remind the firm to furnish the following technical details: Copy of relevant Drug Manufacturing License. C f M B h F l d l ifi d b Q li C l I h

Copy of Master Batch Formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 1.11.2012. 33

Case No.:2/47/82ALC4/2011

Party Name:BROOKS LABORATORIES LTD., 20.09.2012 Status:Case Approved HQ File :01/82/050/01302/AM12/ RLA File :22/24/040/00066/AM12/ Lic.No/Date:2210012352 23.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No.35011/22/12012PI(Norms) dated 23.7.2012, it was decided to remind the firm to furnish the following technical details: Copy of relevant Drug Manufacturing License. Copy of Master Batch Formula duly certified by Quality Control Incharge. Accordingly, the case was deferred for 1.11.2012. 34

Case No.:4/46/82ALC4/2011

Party Name:AMI LIFESCIENCES P LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/01220/AM12/ RLA File :34/24/040/00189/AM12/ Lic.No/Date:3410032719 27.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/280/2012PI(Norms) dated 10.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Diacerein Crude 1 kg 1 Aloin90% 1.02 kg 35

Case No.:5/41/82ALC4/2011

Party Name:SOHAN HEALTHCARE PVT. LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/01006/AM12/ RLA File :31/83/040/00195/AM12/ Lic.No/Date:3110052178 30.12.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/64/2012PI(Norms) dated 24.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Metformin Hydrochloride BP/EP/USP White Crystalline Powder 1 kg 1. Dicyandiamide (DCDA) 0.567 kg 2. Di Methyl Amine Hydrochloride 0.60 kg 3. Mix Xylene 0.027 kg 4. Methanol 0.237 kg

Methanol 0.237 kg 36

Case No.:69/1/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01511/AM12/ RLA File :09/24/040/00496/AM12/ Lic.No/Date:0910050771 13.01.2012 Defer Date:18.10.2012 Decision : It was decided to remind the firm to furnish production and consumption data duly certified by Central Excise Authority. Accordingly, the case was deferred for 18.10.2012. 37

Case No.:2/1/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01444/AM12/ RLA File :09/24/040/00511/AM12/ Lic.No/Date:0910050974 25.01.2012 Defer Date: 18.10.2012 38

Case No.:52/49/82ALC4/2011

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/01361/AM12/ RLA File :08/24/040/00239/AM12/ Lic.No/Date:0810108117 25.01.2012 Defer Date:18.10.2012 Decision : Department of Chemicals and Petrochemicals vide their letter No. 14010/57/2012Ch. II dated 20.6.2012 has requested the firm to furnish the following information:  Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular weight including complete chemical structure of Methyl Tri Octyl Ammonium Chloride with its molecular weight.  Stagewise % yield on molecular weight basis alongwith justification supported with authentic/printed technical literature.  Production of export item for the past 3 years and corresponding consumption of each input duly certified by CA.  Justification for the requirement of 1.168 kg of Iso Propyl Alcohol for per kg of export item and its role in process, alongwith quantity of charge recovered and loss in process. 39

Case No.:2/45/82ALC4/2011

Party Name:FDC LTD 20.09.2012 Status:Deffered and Reindexed HQ File :01/82/050/01179/AM12/ RLA File :03/94/040/00938/AM12/ Lic.No/Date:0310678976 27.01.2012 Defer Date:18.10.2012

Case No.:39/49/82ALC4/2011

Party Name:AMI LIFESCIENCES P LTD 20.09.2012 Status:Case Approved

40 HQ File :01/82/050/01348/AM12/ RLA File :34/24/040/00226/AM12/ Lic.No/Date:3410033054 27.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/306/2012PI(Norms) dated 10.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Quercetin Dihydrate 1 kg 1. Rutoside Trihydrate (Rutin) 2.00 kg 41

Case No.:42/49/82ALC4/2011

Party Name:CADILA HEALTHCARE LTD., 20.09.2012 Status:Case Approved HQ File :01/82/050/01351/AM12/ RLA File :08/24/040/00236/AM12/ Lic.No/Date:0810108169 27.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/300/2012PI(Norms) dated 10.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Clopidogrel Bisulphate 1 kg 1 4,5,6,7Tetrahydrothieon (3,2 C) Pyridine HCL 1.14 kg 2. LCamphor Sulphonic Acid 0.70 kg 3. Dodecanol 2.72 kg 4. MTBE(Tert Butyl Methyl Ether) 7.12 kg 42

Case No.:45/49/82ALC4/2011

20.09.2012 Status:Case Approved HQ File :01/82/050/01354/AM12/ RLA File :08/24/040/00237/AM12/ Lic.No/Date:0810108168 27.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/331/2012PI(Norms) dated 12.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Kalzana 500 tablets 1 tablet 1. Calcium Carbonate 1275 mg/tablet 43

Case No.:26/1/82ALC4/2012

Party Name:METROCHEM API PVT. LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/01468/AM12/ RLA File :09/24/040/00480/AM12/ Lic.No/Date:0910051119 06.02.2012 Defer Date:18.10.2012

Case No.:34/1/82ALC4/2012

20.09.2012 Status:Case Approved HQ File :01/82/050/01476/AM12/ RLA File :08/24/040/00238/AM12/ Lic.No/Date:0810108441 06.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/389/2012PI(Norms) dated 12.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Sumamed 500 MG Inj. 1 vial 1. Azithromycin dehydrate 0.5765 gm/vial 2. Sodium Hydroxide 1.5926 gm/vial 3. Packing Materials (as per general norms for packing material) a. 20 ML 20 MM Clr Type II LYO Inj. Relevant, as per packing policy 4. 3 b. RS CB LTO RTU (At V9172 FM 140/6) Relevant, as per packing policy 5. 3. c 20 MM TEAR OFF SEAL AL SEAL ATB Relevant, as per packing policy 45

Case No.:71/1/82ALC4/2012

20.09.2012 Status:Case Approved HQ File :01/82/050/01513/AM12/ RLA File :08/24/040/00235/AM12/ Lic.No/Date:0810108440 06.02.2012 Defer Date: Decision : Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/393/2012PI(Norms) dated 6.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Metformin HCL 500 mg tabs. 1 000 tablets 1. Metformin HCL USP. 0.5100 kg 2. Microcrystalline Cellulose, (Avicel PH 101) 0.0225 kg 3. Povidone K 30 0.0200 kg 4. Microcrystalline Cellulose (Avicel PH 102) 0.0200 kg 5. Magnesium Stearate 0.0015 kg 6. Hypermellose 6 CPS 2910 0.0045 kg 7. Bottles & Caps (packing material in finished form) As per packing policy. Metformin HCL 850 mg Tabs 1000 Tablets 1. Meformin HCL USP 0.8670 kg 2. Microcrystalline cellulose, (Avicel PH 101) 0.03825 kg 3. Povidone K 30 0.0340 kg 4. Micrystalline cellulose (Avicel PH 102) 0.0340 kg

Magnesium Stearate 0.00255 kg 6. Hypermellose 6 CPS 2910 0.00765 kg 7. Bottles & Caps (packing material in finished form) As per packing policy Metformin HCL 1000 mg tablets 1000 tablets 1 Meformin HCL USP 1.0200 kg 2 Microcrystalline cellulose, (Avicel PH 101) 0.0450 kg 3 Povidone K 30 0.0400 kg 4 Micrystalline cellulose (Avicel PH 102) 0.0400 kg 5 Magnesium Stearate 0.0030 kg 6 Hypermellose 6 CPS 2910 0.0090 kg 7 Bottles & Caps (packing material in finished form) As per packing policy RA may take appropriate action as per the packing policy. 46

Case No.:12/49/82ALC4/2011

Party Name:AMI LIFESCIENCES P LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/01321/AM12/ RLA File :34/24/040/00237/AM12/ Lic.No/Date:3410033146 07.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/306/2012PI(Norms) dated 10.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Quercetin Dihydrate 1 kg 1. Rutoside Trihydrate (Rutin) 2.00 kg 47

Case No.:25/3/82ALC4/2012

Party Name:HETERO LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00029/AM13/ RLA File :09/24/040/00534/AM12/ Lic.No/Date:0910051148 07.02.2012 Defer Date: 18.10.2012 48

Case No.:29/1/82ALC4/2012

Party Name:HETERO DRUGS LIMITED, 20.09.2012 Status:Case Deferred HQ File :01/82/050/01471/AM12/ RLA File :09/24/040/00546/AM12/ Lic.No/Date:0910051150 07.02.2012 Defer Date:18.10.2012

Case No.:51/46/82ALC4/2011

Party Name:RELIANCE INDUSTRIES LTD. 20 09 2012 Status:Case D f d

49 20.09.2012 Deferred HQ File :01/82/050/01267/AM12/ RLA File :03/95/040/00867/AM12/ Lic.No/Date:0310680799 08.02.2012 Defer Date:18.10.2012 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their letter No. 46011/80/2012PC.II dated 5.9.2012, the firm was requested to submit the Ganguly Committee Method of norms working for Butene1 calculation sheet for the period December 2011 to April 2012/August 2012 monthwise along with price details of Naphtha. 50

Case No.:40/1/82ALC4/2012

Party Name:MEDREICH LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01482/AM12/ RLA File :07/24/040/00455/AM12/ Lic.No/Date:0710086215 10.02.2012 Defer Date:04.10.2012 Decision : It was decided to remind the firm to furnish the following information:  Content of API in Ferrous Sulphate Pellets 18/25.  Content of API in Folic Acid Pellets 18/25  Content of NonPeril Seeds in Export product  Copy of Drug Manufacturing License for making Pellets 1 & 2 above. The firm was requested to come for PH on 4.10.2012 alongwith the above details. The case was deferred for 4.10.2012. 51

Case No.:63/1/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01505/AM12/ R LA File :03/94/040/00965/AM12/ Lic.No/Date:0310681706 13.02.2012 Defer Date:18.10.2012 52

Case No.:7/1/82ALC4/2012

Party Name:HETERO LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01449/AM12/ RLA File :09/24/040/00562/AM12/ Lic.No/Date:0910051229 13.02.2012 Defer Date:18.10.2012 53

Case No.:16/1/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01458/AM12/ RLA File :09/24/040/00526/AM12/ Lic.No/Date:0910051248 14.02.2012 Defer Date:04.10.2012 Decision : It was decided to defer the case for 4.10.2012 for comments of Department of Pharmaceuticals.

Case No.:27/1/82ALC4/2012

Party Name:ARCH PHARMALABS LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/01469/AM12/ RLA File :03/94/040/00983/AM12/ Lic.No/Date:0310681784 14.02.2012 Defer Date:18.10.2012 55

Case No.:38/1/82ALC4/2012

20.09.2012 Status:Case Approved HQ File :01/82/050/01480/AM12/ RLA File :03/94/040/00992/AM12/ Lic.No/Date:0310681860 14.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/337/2012PI(Norms) dated 13.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed 2[(2furylmethyl) sulfinyl] N((2Z)4{[4(piperidin1 ylmethyl) pyridine2yl] oxy} but2en1yl) acetamide (Lafutidine) 1 kg 1. N{4[4 (Piperidinomethyl)pyridyl2 oxy]cis2butene}phthalimide Maleate 1.84 kg 2. pnitrophenyl (furfurylsulfinyl) acetate 0.92 kg 3. Methanol 4.48 kg 4. THF 1.94 kg 5. Ethyl acetate 2.90 56

Case No.:55/1/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/01497/AM12/ RLA File :03/94/040/00996/AM12/ Lic.No/Date:0310681891 14.02.2012 Defer Date:18.10.2012 57

Case No.:56/1/82ALC4/2012

20.09.2012 Status:Case Approved HQ File :01/82/050/01498/AM12/ RLA File :03/94/040/00991/AM12/ Lic.No/Date:0310681844 14.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/285/2012PI(Norms) dated 10th September, 2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or applied by the firm, whichever is less: Item of Export Quantity S No Item of Import Quantity allowed

Item of Export Quantity S,No Item of Import Quantity allowed N(2Butyl3(p(3 (dibutylamino) propoxy) benzoyl)5benzofuranyl) methanesulfonamide (Dronedarone hydrochloride) 1 kg 1. 2nButyl 3(4methoxy benzoyl)5nitrobenzofuran 1.556 kg 2. N(3Chlorophenyl) dibutylamine 0.944 kg 58

Case No.:57/1/82ALC4/2012

20.09.2012 Status:Case Approved HQ File :01/82/050/01499/AM12/ RLA File :03/94/040/00995/AM12/ Lic.No/Date:0310681873 14.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/348/2012PI(Norms) dated 13th September, 2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Tertbutyl 4({[2S,5R)6 benzyloxy7oxo1,6 diazabicyclo [3.2.1] oct2 yl] carbonyl} amino) piperidine1carboxylate (MK 7655 Obenzyl bicyclic urea) 1 kg 1. 1R93, Chloro (1,5 cyclooctadiene Iridium (I) dimer crystal OR Iridium cyclooctadine chloride dimer 0.05 kg 2. 4(Trifluoromethyl) benzene sulfonyl chloride 1.44 kg 3. Obenzyl hydroxylamine HCL 1.17 kg 4. THF 5.80 kg 5. MTBE 7.16 kg 59

Case No.:49/1/82ALC4/2012

Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:20/82ALC4/2012 20.09.2012 Status:Case Deferred HQ File :01/82/050/01491/AM12/ RLA File :03/94/040/00757/AM12/ Lic.No/Date:0310682083 15.02.2012 Defer Date: 1.11.2012 Decision : It was decided to defer the case for 1.11.2012 for comments of Department of Pharmaceuticals..

Case No.:67/1/82ALC4/2012

Party Name:CHEMSPEC CHEMICALS PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/01509/AM12/ RLA File :03/94/040/01007/AM12/ Lic.No/Date:0310682171 15.02.2012 Defer Date:18.10.2012 Decision : in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/347/2012PI(Norms) dated

60 g p ( ) 12.9.2012, it was decided to call from the firm the following technical details:  Complete description of export product.  Complete technical details from the applicant firm as per Appendix33 of the application proforma. 61

Case No.:35/1/82ALC4/2012

Party Name:SPECTRUM LIFE SCIENCES PRIVATE LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/01477/AM12/ RLA File :04/24/040/00309/AM12/ Lic.No/Date:0410133868 16.02.2012 Defer Date:18.10.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/259/2012PI(Norms) dated 1.8.2012, it was decided to call from the firm Drug Manufacturing License for export product. Accordingly, the case was deferred for 18.10.2012. 62

Case No.:5/2/82ALC4/2012

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 20.09.2012 Status:Case Approved HQ File :01/82/050/01522/AM12/ RLA File :04/24/040/00314/AM12/ Lic.No/Date:0410134051 23.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM NO. 35011/255/2012PI(Norms) dated 1.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Softgelatin Capsules DHA 200 mg Capsules 1 capsule 1. DHA Oil 40% from Algae 510 mg Capsules Softgelatin Capsules DHA from Algae+Multivitamin Capsules (Fortalex Prenantal) 1 capsule 1. DHA Oil 40% from Algae 510 mg/capsules 63

Case No.:3/51/82ALC4/2011

Party Name:RANBAXY LABORATORIES LIMITED., 20.09.2012 Status:Case Approved HQ File :01/82/050/01396/AM12/ RLA File :05/24/040/00430/AM 12 Lic.No/Date:0510318656 dated 27.2.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM NO. 25011/245/2012 dated 13.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per the details given below or as applied by the firm, whichever is less: Export Items: 1. Esomeprazole Magnesium Trihydrate10,000 kg 2. Esomeprazole Magnesium Tablets 40 mg 11,87,50,000 nos. (Equivalent to 4750 kg of Esomeprazole Magnesium Trihydrate) 3. Total Export quantity = 14,750 kg Esomerazole Magnesium Trihydrate One tablet contains 40 mg of Esomerprazole Magnesium Trihydrate

One tablet contains 40 mg of Esomerprazole Magnesium Trihydrate Norms for 1million tablets: Esomeprazole Magnesium Trihydrate 40 kg Export product Exp. Qty. Sl.No. Import items Qty. allowed Esomeprazole Magnesium Trihydrate 1 kg 1. (DDet) DDiethyl Tartrate 0.164 kg 2. 5Methoxy2Mercaptobenzimidazole (Metmercazole) 0.702 kg 3. Cumene Hydroperoxide 0.669 kg 4. Diisopropyl Ethylamine 0.098 kg 5. Magnesium Sulfate Dried 0.284 kg 6. Methanol 6.00 kg 7. Potassium Methoxide 0.989 kg 8. Pyramethyl Alcohol 0.633 kg 9. Thionyl Chloride 0.585 kg 10. TitaniumIsopropoxide 0.109 kg 11. Toluene 8.40 kg 12. Empty Open Top Steel Drum Relevant, As per packing policy 13 Aluminium Bag Relevant, as per packing policy 63

Case No.:18/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00098/AM13/ RLA File :03/94/040/01036/AM12/ Lic.No/Date:0310684082 29.02.2012 Defer Date:18.10.2012 64

Case No.:60/49/82ALC4/2011

20.09.2012 Status:Case Deferred HQ File :01/82/050/01369/AM12/ RLA File :03/94/040/00125/AM12/ Lic.No/Date:0310683824 29.02.2012 Defer Date:18.10.2012

Case No.:63/49/82ALC4/2011

Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/01372/AM12/ RLA File :03/95/040/00967/AM12/ Lic.No/Date:0310683994 29.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/266/2012PI(Norms) dated 1 8 2012 i d id d if d P 4 7 f HBP 1 d il i b l li d b h fi hi h i l

65 1.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Elexia (Drospirenone and Ethinylestradiol 3 mg+ 0.03 mg tablets Box of 21 tablets) 1 tablet 1. Drospirenone USP 3.06 mg/tablet 66

Case No.:30/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00110/AM13/ RLA File :03/94/040/01096/AM12/ Lic.No/Date:0310684923 05.03.2012 Defer Date:18.10.2012 67

Case No.:33/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00113/AM13/ RLA File :03/94/040/01099/AM12/ Lic.No/Date:0310684919 05.03.2012 Defer Date:18.10.2012 68

Case No.:33/8/82ALC4/2012

Party Name:SHASUN PHARMACEUTICALS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00225/AM13/ RLA File :04/24/040/00323/AM12/ Lic.No/Date:0410134426 05.03.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 19/82 dated 9.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 on prorata basis, as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Metoprolol Tartrate Tablet 50 mg 64500,000 Nos. 1. Metoprolol Tartrate 3289.500 kg 2. 135.450 kg 3. 400 CC Bottle As per packing Policy 4. 33 MM Closure As per packing Policy RA may take appropriate action as per the decision of Norms Committee 69

Case No.:34/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00114/AM13/ RLA File :03/94/040/01077/AM12/ Lic.No/Date:0310684930 05 03 2012 Defer Date:18 10 2012

05.03.2012 Date:18.10.2012 70

Case No.:71/4/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00151/AM13/ RLA File :07/24/040/00492/AM12/ Lic.No/Date:0710086777 05.03.2012 Defer Date:18.10.2012 Decision : It was decided to call from the firm copy of Drug Manufacturing License. Accordingly, the case was deferred for 18.10.2012. 71

Case No.:1/4/82ALC4/2012

Party Name:BELCO PHARMA 20.09.2012 Status:Case Deferred HQ File :01/82/050/00081/AM13/ RLA File :05/23/040/00485/AM12/ Lic.No/Date:0510319713 06.03.2012 Defer Date:18.10.2012 72

Case No.:28/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00108/AM13/ RLA File :03/94/040/01102/AM12/ Lic.No/Date:0310684966 06.03.2012 Defer Date:18.10.2012 73

Case No.:29/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00109/AM13/ RLA File :03/94/040/01104/AM12/ Lic.No/Date:0310684961 06.03.2012 Defer Date:18.10.2012 74

Case No.:31/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00111/AM13/ RLA File :03/94/040/01101/AM12/ Lic.No/Date:0310684973 06.03.2012 Defer Date:18.10.2012 75

Case No.:32/4/82ALC4/2012

Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/00112/AM13/ RLA File :03/94/040/00919/AM12/ Lic.No/Date:0310684979 06.03.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/84/2010Ch. II dated 23.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

75 , y p g pp y , Export Product Export Qty. Sl.No. Import items Qty. allowed Methylal Dimethoxymethane 1 kg 1. Methanol 0.935 kg 2. Para formaldehyde 0.525 kg 76

Case No.:41/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00121/AM13/ RLA File :03/94/040/01105/AM12/ Lic.No/Date:0310684976 06.03.2012 Defer Date:18.10.2012 77

Case No.:60/3/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00064/AM13/ RLA File :05/24/040/00436/AM12/ Lic.No/Date:0510319553 06.03.2012 Defer Date:18.10.2012 78

Case No.:68/3/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/00072/AM13/ RLA File :05/23/040/00446/AM12/ Lic.No/Date:0510319653 06.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/48/2012PI(Norms) dated 4.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Cefdinir Powder 1 kg 1. 7Phenylacetamideo3 Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 2.44 kg 2. Triphenyl Phosphine 2.037 kg 3. Sodium Iodide 0.11 kg 4. Phenol 2.42 kg 5. Methylene Chloride 22.59 kg 6. Tetra Hydro Furan (THF) 4.36 kg 7. Methanol 7.94 kg 8. Formaldehyde 2,.74 kg 9. CAEM 1.82 kg 10. Triethylamine 0.155 kg 11. nButyl Acetate 2.98 kg

Case No.:86/4/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00166/AM13/ RLA File :09/24/040/00569/AM12/ Lic.No/Date:0910051621 06.03.2012 Defer Date:18.10.2012 80

Case No.:54/3/82ALC4/2012

20.09.2012 Status:Case Approved HQ File :01/82/050/00058/AM13/ RLA File :08/24/040/00286/AM12/ Lic.No/Date:0810109496 07.03.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 30/82 dated 26.10.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed in mg for tablet of 12.5 25.0 50.0 mg mg mg Promethazine HCL 12.5 MG Tablet 25MG Tablet &50 MG tablet 1 Tablet 1. Promethazine Hcl USP 12.75 25.50 51.0 2. Hydroxypropyl Cellulose NF 4.0 8.0 16.0 3. Lacotse Monohydrate NF 81.0 162.0 324.0 4. Other items As per packing policy 81

Case No.:6/3/82ALC4/2012

Party Name:ONEIRO CHEMICALS LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00010/AM13/ RLA File :34/24/040/00267/AM12/ Lic.No/Date:3410033486 07.03.2012 Defer Date:18.10.2012 82

Case No.:61/4/82ALC4/2012

Party Name:ANUGRAHA CHEMICALS 20.09.2012 Status:Case Deferred HQ File :01/82/050/00141/AM13/ RLA File :07/24/040/00489/AM12/ Lic.No/Date:0710086840 07.03.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 83

Case No.:84/4/82ALC4/2012

Party Name:HETERO DRUGS LIMITED, Status:Case

20.09.2012 Approved HQ File :01/82/050/00164/AM13/ RLA File :09/24/040/00598/AM12/ Lic.No/Date:0910051638 07.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/369/2012PI(Norms) dated 6.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Cefixime USP/Cefixime Trihydrate USP 1 kg 1. 7Phenylacetamideo3 Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 1.555 kg 2. 2Benzothiazolyl 2amino alpha(methoxy carbonylmethyloxyimino)4 thiazolethioacetate (MICA ester) 1.112 kg 3. Triethylamine 0.416 kg 4. Triphenyl Phosphine 1.22 kg 5. Dimethyl Formamide 5.61 kg 6. Methylene Chloride 16.25 kg 7. Acetonitrile 3.84 kg 84

Case No.:60/4/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00140/AM13/ RLA File :09/24/040/00606/AM12/ Lic.No/Date:0910051644 08.03.2012 Defer Date:18.10.2012 85

Case No.:62/4/82ALC4/2012

Party Name:MEDREICH LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00142/AM13/ RLA File :07/24/040/00500/AM12/ Lic.No/Date:0710086875 08.03.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 12/82 dated 3.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Terbinafine Tablets 250 mg 1000 tablets 1. Terbinafine HCL 0.2868 kg

Case No.:3/7/82ALC4/2012

Party Name:SIFLON DRUGS 20.09.2012 Status:Case Deferred

86 HQ File :01/82/050/00187/AM13/ RLA File :09/24/040/00591/AM12/ Lic.No/Date:0910051650 09.03.2012 Defer Date:18.10.2012 87

Case No.:44/3/82ALC4/2012

Party Name:INTAS PHARMACEUTICALS LTD., 20.09.2012 Status:Case Approved HQ File :01/82/050/00048/AM13/ RLA File :08/24/040/00288/AM12/ Lic.No/Date:0810109505 09.03.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 2.11.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Terazosin Hydrochloride Tablets/Capsules 1mg 1 No. 1. Terazosin Hydrochloride (As Dihydrate) USP 1.2109 mg Terazosin Hydrochloride Tablets/Capsules 2mg 1 No. 1. Terazosin Hydrochloride (As Dihydrate) USP 2.4217 mg Terazosin Hydrochloride Tablets/Capsules 5mg 1 No. 1. Terazosin Hydrochloride (As Dihydrate) USP 6.0544 mg Terazosin Hydrochloride Tablets/Capsules 10mg 1 No. 1. Terazosin Hydrochloride (As Dihydrate) USP 12.1087mg RA may take appropriate action as per the decision of Norms Committee. 88

Case No.:16/11/82ALC4/2012

Party Name:HETERO LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00283/AM13/ RLA File :09/24/040/00609/AM12/ Lic.No/Date:0910051695 12.03.2012 Defer Date:20.09.2012 89

Case No.:39/8/82ALC4/2012

Party Name:HETERO LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00231/AM13/ RLA File :09/24/040/00610/AM12/ Lic.No/Date:0910051696 12.03.2012 Defer Date: 18.10.2012 90

Case No.:41/51/82ALC4/2011

Party Name:POLYDRUG LABORATORIES PVT.LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/01434/AM12/ RLA File :03/95/040/01030/AM12/ Lic.No/Date:0310685783 12.03.2012 Defer Date:18.10.2012

12.03.2012 Date:18.10.2012 91

Case No.:59/3/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 20.09.2012 Status:Case Deferred HQ File :01/82/050/00063/AM13/ RLA File :05/23/040/00483/AM12/ Lic.No/Date:0510319858 12.03.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 92

Case No.:2/7/82ALC4/2012

Party Name:XL LABORATORIES PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00186/AM13/ RLA File :05/24/040/00412/AM12/ Lic.No/Date:0510319982 13.03.2012 Defer Date:18.10.2012 93

Case No.:28/11/82ALC4/2012

Party Name:PERKIN LABORATORIES 20.09.2012 Status:Case Deferred HQ File :01/82/050/00295/AM13/ RLA File :09/24/040/00517/AM12/ Lic.No/Date:0910051719 13.03.2012 Defer Date:18.10.2012 94

Case No.:47/3/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00051/AM13/ RLA File :08/24/040/00285/AM12/ Lic.No/Date:0810109597 13.03.2012 Defer Date: 18.10.2012 95

Case No.:48/3/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/00052/AM13/ RLA File :34/24/040/00280/AM12/ Lic.No/Date:3410033547 13.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/306/2012PI(Norms) dated 10.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Quercetin Dihydrate 1 kg 1. Rutoside Trihydrate (Rutin) 2.00 kg

Case No.:38/11/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 20.09.2012 Status:Case Deferred

96 20.09.2012 Deferred HQ File :01/82/050/00305/AM13/ RLA File :09/24/040/00501/AM12/ Lic.No/Date:0910051737 14.03.2012 Defer Date:18.10.2012 97

Case No.:50/4/82ALC4/2012

Party Name:MEHTA API PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00130/AM13/ RLA File :03/95/040/01050/AM12/ Lic.No/Date:0310686182 14.03.2012 Defer Date:18.10.2012 98

Case No.:24/11/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00291/AM13/ RLA File :09/24/040/00627/AM12/ Lic.No/Date:0910051747 15.03.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/43/2011Ch. II dated 13.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per the details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Jade Blue or Jarocol Blue 15 1 kg 1. 2,6, Dichloro Benzaldehyde 0.725 kg 2. 2,6Dimethyl Aniline 1.050 kg 3. Para Chloronil 1.011 kg 4. Methanol 0.400 kg 99

Case No.:70/3/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 20.09.2012 Status:Case Deferred HQ File :01/82/050/00074/AM13/ RLA File :05/23/040/00490/AM12/ Lic.No/Date:0510320189 15.03.2012 Defer Date:18.10.2012 100

Case No.:71/3/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00075/AM13/ RLA File :05/23/040/00502/AM12/ Lic.No/Date:0510320188 15.03.2012 Defer Date:18.10.2012 Decision : In the light of written comments received from Department of Industrial Policy and Promotion vide their letter dated 20.9.2012, it was decided to call from the firm the following details:  Manufacturing process indicating stage wise wastage of all the raw materials.  Consumption of all the raw materials (both imported and indigenous) with corresponding production of export items duly certified by

concerned Central Excise/Chartered Accountant for three years. 101

Case No.:12/8/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00204/AM13/ RLA File :09/24/040/00594/AM12/ Lic.No/Date:0910051799 16.03.2012 Defer Date:18.10.2012 102

Case No.:38/8/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00230/AM13/ RLA File :09/24/040/00603/AM12/ Lic.No/Date:0910051798 16.03.2012 Defer Date:18.10.2012 103

Case No.:39/11/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00306/AM13/ RLA File :09/24/040/00600/AM12/ Lic.No/Date:0910051800 16.03.2012 Defer Date:18.10.2012 104

Case No.:43/11/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00310/AM13/ RLA File :09/24/040/00595/AM12/ Lic.No/Date:0910051797 16.03.2012 Defer Date:18.10.2012 105

Case No.:14/8/82ALC4/2012

Party Name:GULBRANDSEN CHEMICALS PVT LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/00206/AM13/ RLA File :34/24/040/00286/AM12/ Lic.No/Date:3410033598 19.03.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/49/2011Ch. II dated 13.7.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Monobutyl tin Trichloride Mixture 3% (SbCI3) 1 kg 1. Tin Ingots 0.482 kg 2. Aluminium Grit/Granules 0.060 kg 3. Butene1 0.437 kg Dibutyl Tin Dichloride 1 kg 1. Tin Ingots 0.457 kg

Dibutyl Tin Dichloride (DBTCL) 1 kg 1. Tin Ingots 0.457 kg 2. Aluminium Grit/Granules 0.077 kg 3. Butene1 0.592 kg Dibutyl Tin Diacetate (DBTDA) 1 kg 1. Tin Ingots 0.418 kg 2. Aluminium Grit/Grnaules 0.071 kg 3. Butene1 0.542 kg RA may take appropriate action as per the decision of Norms Committee. 106

Case No.:21/8/82ALC4/2012

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:20/82ALC4/2012 20.09.2012 Status:Case Deferred HQ File :01/82/050/00213/AM13/ RLA File :34/24/040/00289/AM12/ Lic.No/Date:3410033599 19.03.2012 Defer Date:20.09.2012 107

Case No.:40/8/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00232/AM13/ RLA File :07/24/040/00520/AM12/ Lic.No/Date:0710087119 20.03.2012 Defer Date:18.10.2012 108

Case No.:49/4/82ALC4/2012

Party Name:EMBIO LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/00129/AM13/ RLA File :03/94/040/01158/AM12/ Lic.No/Date:0310687036 20.03.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 15/82 dated 9.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg PyrrolidinylLNorrephedrine Base or (1R,2S)Pyrrolidinyl Norrephedrine 1 kg 1. Benzaldehyde 3.24 2. Hydroxylamine HCL/Hydroxylamine Sulphate 1.71 3. Caustic Soda Lye 9.38 4. Oxalic Acid 2.00 5. EDTA 0.120 6. Methanol 3.15 7. Toluene 4.94 8. Potassium Hydroxide Flakes 2.78 9. Acetone 0.80 10. Activated Carbon 0.036 11 1,4 Dibromobutane 2.36 RA may take appropriate action as per the decision of Norms Committee

109

Case No.:6/8/82ALC4/2012

Party Name:HETERO LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00198/AM13/ RLA File :09/24/040/00625/AM12/ Lic.No/Date:0910051820 20.03.2012 Defer Date:18.10.2012 110

Case No.:17/4/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00097/AM13/ RLA File :03/94/040/01117/AM12/ Lic.No/Date:0310687376 21.03.2012 Defer Date:18.10.2012 111

Case No.:19/8/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 20.09.2012 Status:Case Approved HQ File :01/82/050/00211/AM13/ RLA File :05/23/040/00487/AM12/ Lic.No/Date:0510320546 21.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/290/2012PI(Norms) dated 12.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg Oxcarbazepine Tablet 150 mg 1 number 1. Oxcarbazepine Coprecipitate 73.44 kg Oxcarbazepine Tablet 300 mg 1 number 1. Oxcarbazepine Coprecipitate 146.88 kg Oxcarbazepine Tablet 600 mg 1 number 1. Oxcarbazepine Coprecipitate 293.76 kg 112

Case No.:35/8/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00227/AM13/ RLA File :09/24/040/00632/AM12/ Lic.No/Date:0910051839 21.03.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 113

Case No.:4/8/82ALC4/2012

Party Name:HETERO LABS LIMITED 20.09.2012 Status:Deffered and Reindexed HQ File :01/82/050/00196/AM13/ RLA File :09/24/040/00631/AM12/ Lic.No/Date:0910051837 21.03.2012 Defer Date:16.08.2012 D i i It d id d t d f th f 18 10 2012 f t f D t t f Ph ti l

114

Case No.:44/4/82ALC4/2012

Party Name:GLENMARK GENERICS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00124/AM13/ RLA File :03/94/040/01139/AM12/ Lic.No/Date:0310687345 21.03.2012 Defer Date:18.10.2012 115

Case No.:45/4/82ALC4/2012

Party Name:GLENMARK GENERICS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00125/AM13/ RLA File :03/94/040/00988/AM12/ Lic.No/Date:0310687340 21.03.2012 Defer Date:18.10.2012 116

Case No.:62/3/82ALC4/2012

Party Name:PARABOLIC DRUGS LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00066/AM13/ RLA File :05/24/040/00085/AM12/ Lic.No/Date:0510320612 21.03.2012 Defer Date:18.10.2012 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/424/2011PI(Norms) dated 13.6.2012, it was decided to call from the firm the technical details as per Appendix 33 of HBP v1. Accordingly, the case was deferred for 18.10.2012. 117

Case No.:63/3/82ALC4/2012

Party Name:PARABOLIC DRUGS LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00067/AM13/ RLA File :05/24/040/00447/AM12/ Lic.No/Date:0510320617 21.03.2012 Defer Date:18.10.2012 118

Case No.:70/4/82ALC4/2012

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00150/AM13/ RLA File :07/24/040/00522/AM12/ Lic.No/Date:0710087142 21.03.2012 Defer Date:18.10.2012 Decision : In line with SION A 407, it was decided to ratify norms under Para 4.7 of HBP v1 as applied by the firm: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ceftriaxone for injection USP 1.0 gm) vial size 10 ml (each vial contains: Sterile ceftriaxone sodium USP 1 vial 1. Ceftriaxone Sodium Sterile USP 1.113 gm/vial

equivalent to ceftriaxone 1.0 gm) 119

Case No.:75/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00155/AM13/ RLA File :08/24/040/00292/AM12/ Lic.No/Date:0810110000 22.03.2012 Defer Date:18.10.2012 120

Case No.:25/11/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00292/AM13/ RLA File :09/24/040/00638/AM12/ Lic.No/Date:0910051857 22.03.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/43/2011Ch. II dated 13.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Reversacol Charcoal 1 kg 1. 4,4Difluoro Benzophenone 2.480 kg 2. Pural MG 70 kg 1.00 kg 3. Tetra Hydro Furan (THF) 22.00 kg 4. Trimethyl Silyl Acetylene (TMSA) 1.903 kg 5. Methanol 88.800 kg 6. 4, NNDimethyl Amino Benzaldehyde 4.00 kg 7. Pural MG 30 20.00 kg 8. Toluene 5.000 kg 9. Vitride 10.000 kg 121

Case No.:32/8/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00224/AM13/ RLA File :03/95/040/00950/AM12/ Lic.No/Date:0310687494 22.03.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/117/2011Ch. II dated 12.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed 1Bromo5Chloropentane 1 kg 1. 1,5 Pentanediol 1.562 kg 2. Hydrobromic Acid 48% 2.533 kg

y pp p p 122

Case No.:76/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00156/AM13/ RLA File :08/24/040/00301/AM12/ Lic.No/Date:0810110001 22.03.2012 Defer Date:18.10.2012 123

Case No.:77/1/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 20.09.2012 Status:Case Deferred HQ File :01/82/050/01519/AM12/ RLA File :03/95/040/00865/AM11/ Lic.No/Date:0310687522 22.03.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 124

Case No.:77/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00157/AM13/ RLA File :08/24/040/00304/AM12/ Lic.No/Date:0810109993 22.03.2012 Defer Date:18.10.2012 125

Case No.:78/1/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 20.09.2012 Status:Case Deferred HQ File :01/82/050/01520/AM12/ RLA File :03/95/040/00719/AM12/ Lic.No/Date:0310687530 22.03.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 126

Case No.:78/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00158/AM13/ RLA File :08/24/040/00303/AM12/ Lic.No/Date:0810109994 22.03.2012 Defer Date:18.10.2012 127

Case No.:8/8/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00200/AM13/ RLA File :09/24/040/00641/AM12/ Lic.No/Date:0910051858 22.03.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/43/2011Ch. II dated 13.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Exp. Qty. Sl.No. Import items Qty. allowed Reversacol Amber 1 kg 1. 4Dimethyl Amino Benzaldehyde 1.745 kg 2. Dimethyl Succinate 3.000 kg 3. Methanol 30.00 kg 4. 4,4Dimethoxy Benzophenone 2.000 kg 5. Tetra Hydrofuran (THF) 9.000 kg 6. Trimethyl Silyl Acetylene (TMSA) 1.492 kg 7. Hexane 6.125 kg 8. Siralox 1.000 kg 9. Toluene 4.500 kg 128

Case No.:82/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00162/AM13/ RLA File :08/24/040/00302/AM12/ Lic.No/Date:0810110002 22.03.2012 Defer Date:18.10.2012 129

Case No.:81/4/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00161/AM13/ RLA File :08/24/040/00306/AM12/ Lic.No/Date:0810110029 23.03.2012 Defer Date:18.10.2012 130

Case No.:4/11/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00271/AM13/ RLA File :09/24/040/00634/AM12/ Lic.No/Date:0910051870 26.03.2012 Defer Date:18.10.2012 131

Case No.:90/4/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00170/AM13/ RLA File :05/24/040/00468/AM12/ Lic.No/Date:0510321002 26.03.2012 Defer Date:18.10.2012 132

Case No.:91/4/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00171/AM13/ RLA File :05/24/040/00469/AM12/ Lic.No/Date:0510321003 26 03 2012 Defer 18 10 2012

26.03.2012 Date:18.10.2012 133

Case No.:25/8/82ALC4/2012

Party Name:AARTI INDUSTRIES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00217/AM13/ RLA File :03/94/040/01145/AM12/ Lic.No/Date:0310688061 27.03.2012 Defer Date:18.10.2012 134

Case No.:10/8/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00202/AM13/ RLA File :09/24/040/00647/AM12/ Lic.No/Date:0910051921 28.03.2012 Defer Date:18.10.2012 135

Case No.:11/8/82ALC4/2012

Party Name:MSN PHARMACHEM PRIVATE LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00203/AM13/ RLA File :09/24/040/00636/AM12/ Lic.No/Date:0910051923 28.03.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 49/82 dated 6.3.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Atorvastatin Calcium 1 kg 1. (4RCIS)1,1dimethyl6 cyano methyl2,2dimethyl 1,3dioxane4acetate 1.003 kg 2. Methanol 8.375 kg 3. Methyl Isobutyrl acetate 1.646 kg 136

Case No.:17/11/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00284/AM13/ RLA File :09/24/040/00646/AM12/ Lic.No/Date:0910051917 28.03.2012 Defer Date:18.10.2012 Decision : It was decided to call the firm for PH on 18.10.2012. Accordingly, the case was deferred for 18.10.2012.

Case No.:29/8/82ALC4/2012

Party Name:AGIO PHARMACEUTICALS LTD 20.09.2012 Status:Case Deferred

137 HQ File :01/82/050/00221/AM13/ RLA File :03/94/040/01171/AM12/ Lic.No/Date:0310688368 28.03.2012 Defer Date:18.10.2012 138

Case No.:7/8/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00199/AM13/ RLA File :09/24/040/00642/AM12/ Lic.No/Date:0910051920 28.03.2012 Defer Date:18.10.2012 139

Case No.:9/11/82ALC4/2012

Party Name:CHEMCON SPECIALITY CHEMICALS P LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00276/AM13/ RLA File :34/24/040/00298/AM12/ Lic.No/Date:3410033741 29.03.2012 Defer Date:18.10.2012 140

Case No.:13/8/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00205/AM13/ RLA File :05/24/040/00470/AM12/ Lic.No/Date:0510321504 30.03.2012 Defer Date:18.10.2012 141

Case No.:27/16/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00463/AM13/ RLA File :09/24/040/00671/AM12/ Lic.No/Date:0910052024 30.03.2012 Defer Date:18.10.2012 Decision : It was decided to call from the firm production and consumption data duly certified by Central Excise Authority. Accordingly, the case was deferred for 18.10.2012. 142

Case No.:4/7/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00188/AM13/ RLA File :05/24/040/00471/AM12/ Lic.No/Date:0510321506 30.03.2012 Defer Date:18.10.2012

Case No.:1/3/82ALC4/2012

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 20.09.2012 Status:Case Approved HQ File :01/82/050/00005/AM13/ RLA File :03/94/040/01128/AM12/ Lic.No/Date:0310689553 Defer Date:

143 03.04.2012 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2012Ch. II dated 25.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Astrolide Pure (Astrolide content : 100%) 1 kg 1. Isoamylene 0.584 kg 2. Propylene Oxide 0.430 kg 3. Alpha Methyl Styrene 0.769 kg 4. Paraformaldehyde 0.117 kg 144

Case No.:2/3/82ALC4/2012

Party Name:KOPRAN LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00006/AM13/ RLA File :03/94/040/01167/AM12/ Lic.No/Date:0310689730 04.04.2012 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals OM No. 35011/296/2012PI(Norms) dated 13.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Pregabalin 1 kg 1. (+) 3 (Carbamoylmethyl)5 methylhexanoic acid 2.94 2. Chloroform 4.75 ltr/kg 3. R(+)Methyl Benzyl Amine OR (R)1 Phenylethylamine) 0.114 kg/kg 4. Iso Propryl Alcohol 0.96 Ltr/kg 145

Case No.:34/16/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00470/AM13/ RLA File :09/24/040/00658/AM12/ Lic.No/Date:0910052048 04.04.2012 Defer Date:18.10.2012

Case No.:34/8/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 20.09.2012 Status:Case Deferred

146 HQ File :01/82/050/00226/AM13/ RLA File :22/24/040/00002/AM13/ Lic.No/Date:2210012699 09.04.2012 Defer Date:18.10.2012 147

Case No.:48/11/82ALC4/2012

Party Name:VIHITA CHEM PVT.LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00315/AM13/ RLA File :34/24/040/00282/AM12/ Lic.No/Date:3410033798 10.04.2012 Defer Date:18.10.2012 148

Case No.:1/11/82ALC4/2012

Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00268/AM13/ RLA File :03/94/040/01138/AM12/ Lic.No/Date:0310690368 11.04.2012 Defer Date:18.10.2012 Decision : It was decided to remind the firm to furnish the following information within requisite information within 15 days failing which the case would be closed:  Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular weight.  Stagewise % yield on molecular weight basis along with justification supported with authentic/printed technical literature.  Production of export item for the past three years upto January 2012 and corresponding consumption of each input duly certified by Chartered Accountant.  Details of isomers/by products formed in the process and its recovery in terms of quantity and value supported with documentary evidence. . Accordingly, the case was deferred for 18.10.2012. 149

Case No.:38/16/82ALC4/2012

Party Name:BRILLIANT BIO PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00474/AM13/ RLA File :09/24/040/00664/AM12/ Lic.No/Date:0910052111 11.04.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Biotechnology. 150

Case No.:6/7/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00190/AM13/ RLA File :05/23/040/00526/AM12/ Lic.No/Date:0510322039 11.04.2012 Defer Date: 18.10.2012

Case No.:3/11/82ALC4/2012

Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 20.09.2012 Status:Case Deferred

151 HQ File :01/82/050/00270/AM13/ RLA File :03/94/040/00007/AM13/ Lic.No/Date:0310690582 12.04.2012 Defer Date: 18.10.2012 152

Case No.:3/8/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/00195/AM13/ RLA File :34/24/040/00009/AM13/ Lic.No/Date:3410033820 12.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/306/2012PI(Norms) dated 10.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed Quercetin Dihydrate 1 kg 1. Rutoside Trihydrate (Rutin) 2.00 kg 153

Case No.:32/13/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00367/AM13/ RLA File :22/24/040/00003/AM13/ Lic.No/Date:2210012707 12.04.2012 Defer Date:18.10.2012 154

Case No.:50/3/83ALC1/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 20.09.2012 Status:Case Deferred HQ File :01/83/050/00053/AM13/ RLA File :03/95/040/01118/AM12/ Lic.No/Date:0310690527 12.04.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Biotechnology. 155

Case No.:19/9/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00264/AM13/ RLA File :03/95/040/00963/AM12/ Lic.No/Date:0310690704 13.04.2012 Defer Date:18.10.2012 Decision : It was decided to call from the firm the Master Batch Formula and also the Drug Manufacturing Licence. Accordingly, the case was deferred for 18.10.2012. 156

Case No.:3/4/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00083/AM13/ RLA File :03/95/040/00928/AM12/ Lic.No/Date:0310690677 13.04.2012 Defer Date: Decision : In line with the earlier decision taken in meeting no. 16/82 dated 16.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as d il i b l li d b h fi hi h i l

156 per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Artemether 1 Kg. 1. Artemisinin 1.50 kg 2. Sodium Borohydride 0.188 kg 157

Case No.:4/4/82ALC4/2012

Party Name:UNIMAX CHEMICALS PVT LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/00084/AM13/ RLA File :03/95/040/00016/AM13/ Lic.No/Date:0310690694 13.04.2012 Defer Date: In line with the earlier decision taken in meeting no. 48/82 dated 1.3.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Decision : Export product Exp. Qty. Sl.No. Import items Qty. allowed Prednisolone Sodium Phosphate 1 Kg. 1. Prednisolone (Prednisolone Base) 0.90 kg 158

Case No.:8/7/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00192/AM13/ RLA File :03/95/040/01046/AM12/ Lic.No/Date:0310690715 13.04.2012 Defer Date:18.10.2012 Decision : It was decided to call from the firm the Master Batch Formula and also the Drug Manufacturing Licence. Accordingly, the case was deferred for 18.10.2012. 159

Case No.:10/11/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00277/AM13/ RLA File :34/24/040/00012/AM13/ Lic.No/Date:3410033877 16.04.2012 Defer Date:18.10.2012 160

Case No.:36/11/82ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00303/AM13/ RLA File :07/24/040/00004/AM13/ Lic.No/Date:0710087698 16.04.2012 Defer Date: 1.11.2012 Decision : It was decided to defer the case for 1.11.2012 for comments of Department of Pharmaceuticals.

Case No.:1/8/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. Status:Case

161 20.09.2012 Approved HQ File :01/82/050/00193/AM13/ RLA File :05/24/040/00461/AM12/ Lic.No/Date:0510322389 17.04.2012 Defer Date: Decision : In the light of written comments received from Department of Petrochemicals vide their OM No. 35011/339/2012PI(Norms) dated 13.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed LAsparaginasa Inyectable 10000 UI (LAsparaginase IN 10000 UI Onconase Inj R.M (INJ) 1 vial 1. LAsparaginase (Injectable Grade L \Asparaginase (Injectable Grade) Raw material 81.53 mg/vial 162

Case No.:92/4/82ALC4/2012

Party Name:JESONS INDUSTRIES LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/00172/AM13/ RLA File :03/94/040/00753/AM12/ Lic.No/Date:0310691024 17.04.2012 Defer Date: Decision : In the light of written comments received from Department of Petrochemicals vide their OM No. 46011/93/2011PC.II dated 13.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Chemcoat VV 10 1 kg 1. Vinyl Acetate Monomer 0.0910 kg 2. Polyvinyl Alcohol 0.0023 kg 3. Veova 10 0.9010 kg 163

Case No.:47/8/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00239/AM13/ RLA File :05/24/040/00011/AM13/ Lic.No/Date:0510322536 19.04.2012 Defer Date:18.10.2012 164

Case No.:48/8/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00240/AM13/ RLA File :05/24/040/00014/AM13/ Lic.No/Date:0510322537 19.04.2012 Defer Date:18.10.2012 165

Case No.:2/5/82ALC4/2012

Party Name:TITAN LABORATORIES PVT. LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00174/AM13/ RLA File :03/95/040/00048/AM13/ Lic.No/Date:0310691572 20 04 2012 Defer 18 10 2012

20.04.2012 Date:18.10.2012 166

Case No.:3/5/82ALC4/2012

Party Name:UNIMAX CHEMICALS PVT LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00175/AM13/ RLA File :03/95/040/00040/AM13/ Lic.No/Date:0310691575 20.04.2012 Defer Date: 18.10.2012 167

Case No.:31/11/82ALC4/2012

Party Name:GULBRANDSEN CHEMICALS PVT LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/00298/AM13/ RLA File :34/24/040/00020/AM13/ Lic.No/Date:3410033917 20.04.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/49/2011Ch. II dated 20.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Monobutyl tin Trichloride 1 kg 1. Tin Ingots 0.497 kg 2. Aluminium Grit/Granules 0.062 kg 3. ButeneI 0.451 kg CF 200 1 kg 1. Tin Ingots 0.199 kg 2. Aluminium Grit/Granules 0.025 kg 3. Butene1 0.180 kg 168

Case No.:7/11/82ALC4/2012

Party Name:CIPLA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00274/AM13/ RLA File :03/94/040/00022/AM13/ Lic.No/Date:0310691719 23.04.2012 Defer Date:18.10.2012 169

Case No.:18/11/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 20.09.2012 Status:Deffered and Reindexed HQ File :01/82/050/00285/AM13/ RLA File :22/24/040/00001/AM13/ Lic.No/Date:2210012759 24.04.2012 Defer Date:16.08.2012 Decision : It was decided to defer the case for 20.8.2012 for comments of Department of Pharmaceuticals. 170

Case No.:40/11/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00307/AM13/ RLA File :22/24/040/00005/AM13/ Lic.No/Date:2210012763 2 04 2012 Defer 18 10 2012

25.04.2012 Date:18.10.2012 171

Case No.:5/11/82ALC4/2012

Party Name:JESONS INDUSTRIES LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/00272/AM13/ RLA File :03/94/040/00046/AM13/ Lic.No/Date:0310692023 25.04.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their OM No. 46011/93/2011PC II dated 23.7.2012, it was decided to ratify norms under para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Blend of Methyl Methacrylate Monomer (88 90%) and Butyl Acrylate (8 10%) 1 kg 1. Methyl Methacrylate 0.900 kg 2. Butyl Acrylate Monomer 0.100 kg 172

Case No.:8/11/82ALC4/2012

Party Name:GLENMARK GENERICS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00275/AM13/ RLA File :03/94/040/00002/AM13/ Lic.No/Date:0310692032 25.04.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 46/82 dated 14.2.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Ciclopirox Gel 0.77%, 30 gm 40000 Numbers Ciclopirox USP 9.44 kg Ciclopirox Gel 0.77%, 45 gm 22000 Numbers Ciclopirox USP 7.76 kg Ciclopirox Gel 0.77%, 100 gm 10000 Numbers Ciclopirox USP 7.85 kg 173

Case No.:49/8/82ALC4/2012

Party Name:QUANTUM DRUGS & CHEMICALS 20.09.2012 Status:Case Deferred HQ File :01/82/050/00241/AM13/ RLA File :35/24/040/00001/AM13/ Lic.No/Date:3510038252 26.04.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals.

174

Case No.:34/11/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00301/AM13/ RLA File :07/24/040/00031/AM13/ Lic.No/Date:0710087924 27.04.2012 Defer Date:18.10.2012 175

Case No.:2/14/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00379/AM13/ RLA File :03/94/040/00006/AM13/ Lic.No/Date:0310693056 01.05.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of DC(MSME). 176

Case No.:3/14/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00380/AM13/ RLA File :03/94/040/00053/AM13/ Lic.No/Date:0310692961 01.05.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of DC(MSME). 177 Case No.:13/14/82ALC4/2012 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00390/AM13/ RLA File :03/94/040/00068/AM13/ Lic.No/Date:0310693154 02.05.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 16/82 dated 16.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanamycin Acid Sulphate for Injectin BP 1 gm, Vial Size 10 ml 1 Vial 1. Kanamycin Acid Sulphate Sterile BP 1.39 gm 178

Case No.:23/16/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00459/AM13/ RLA File :09/24/040/00043/AM13/ Lic.No/Date:0910052448 02.05.2012 Defer Date:18.10.2012 D i i It d id d t d f th f 18 10 2012 f t f D t t f Ch i l d P t h i l

179

Case No.:19/11/82ALC4/2012

Party Name:MATANGI INDUSTRIES 20.09.2012 Status:Case Deferred HQ File :01/82/050/00286/AM13/ RLA File :08/24/040/00274/AM12/ Lic.No/Date:0810111329 03.05.2012 Defer Date:18.10.2012 180

Case No.:23/13/82ALC4/2012

Party Name:TADIMETY AROMATICS PVT. LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00358/AM13/ RLA File :07/24/040/00037/AM13/ Lic.No/Date:0710088059 07.05.2012 Defer Date:18.10.2012 181

Case No.:27/13/82ALC4/2012

Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:20/82ALC4/2012 20.09.2012 Status:Case Deferred HQ File :01/82/050/00362/AM13/ RLA File :31/83/040/00015/AM13/ Lic.No/Date:3110054091 07.05.2012 Defer Date:18.10.2012 182

Case No.:5/16/82ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00441/AM13/ RLA File :07/24/040/00041/AM13/ Lic.No/Date:0710088058 07.05.2012 Defer Date:18.10.2012 183

Case No.:14/14/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00391/AM13/ RLA File :03/94/040/00070/AM13/ Lic.No/Date:0310693809 08.05.2012 Defer Date:18.10.2012

Case No.:20/11/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00287/AM13/ RLA File :08/24/040/00039/AM13/ Lic.No/Date:0810111430 08.05.2012 Defer Date:18.10.2012 Decision : It was decided to remind the firm to furnish the following information within 15 days: B l d h i l ti h i ll th t t d t d b d t ith th i l l f l d l l i ht

184  Balanced chemical reaction showing all the reactants, product and by product with their molecular formular and molecular weight.  Stagewise % yield on molecular weight basis along with justification supported with authentic/printed technical literature.  Quantity of solvents charged, recovered and loss in process for per kg of export item along with justification.  Production of export item for the past 3 years and corresponding consumption of each input duly certified by CA.  Photocopy of the earlier norms fixed by ALC for same export item in the recent past. 185

Case No.:21/11/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00288/AM13/ RLA File :08/24/040/00282/AM12/ Lic.No/Date:0810111431 08.05.2012 Defer Date:18.10.2012 Decision : It was decided to remind the firm to furnish the following information within 15 days:  Balanced chemical reaction showing all the reactants, product and by product with their molecular formular and molecular weight.  Stagewise % yield on molecular weight basis along with justification supported with authentic/printed technical literature.  Quantity of solvents charged, recovered and loss in process for per kg of export item along with justification.  Production of export item for the past 3 years and corresponding consumption of each input duly certified by CA.  Photocopy of the earlier norms fixed by ALC for same export item in the recent past. 186

Case No.:22/11/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00289/AM13/ RLA File :08/24/040/00012/AM13/ Lic.No/Date:0810111429 08.05.2012 Defer Date:18.10.2012 Decision : It was decided to remind the firm to furnish the following information within 15 days:  Balanced chemical reaction showing all the reactants, product and by product with their molecular formular and molecular weight.  Stagewise % yield on molecular weight basis along with justification supported with authentic/printed technical literature.  Quantity of solvents charged, recovered and loss in process for per kg of export item along with justification.  Production of export item for the past 3 years and corresponding consumption of each input duly certified by CA.  Photocopy of the earlier norms fixed by ALC for same export item in the recent past. Accordingly, the case was deferred for 18.10.2012 187

Case No.:26/11/82ALC4/2012

Party Name:BEST VALUE CHEM PVT. LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/00293/AM13/ RLA File :34/24/040/00025/AM13/ Lic.No/Date:3410034071 Defer Date:

187 HQ File :01/82/050/00293/AM13/ RLA File :34/24/040/00025/AM13/ Lic.No/Date:3410034071 08.05.2012 Defer Date: Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemcials.. 188

Case No.:27/11/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00294/AM13/ RLA File :34/24/040/00027/AM13/ Lic.No/Date:3410034073 08.05.2012 Defer Date:18.10.2012 189

Case No.:24/13/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00359/AM13/ RLA File :07/24/040/00052/AM13/ Lic.No/Date:0710088126 09.05.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals 190

Case No.:55/11/82ALC4/2012

Party Name:SHASUN PHARMACEUTICALS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00322/AM13/ RLA File :04/24/040/00009/AM13/ Lic.No/Date:0410136201 09.05.2012 Defer Date:18.10.2012 Decision : In the light of earlier decision taken in meeting no. 19/82 dated 9.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 on prorata basis, as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Metoprolol Tartrate Tablet 50 mg 64500,000 Nos. 1. Metoprolol Tartrate 3289.500 kg 2. 135.450 kg 3. 400 CC Bottle As per packing Policy 4. 33 MM Closure As per packing Policy RA may take appropriate action as per the decision of Norms Committee

Case No.:56/11/82ALC4/2012

Party Name:SHASUN PHARMACEUTICALS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00323/AM13/ RLA File :04/24/040/00010/AM13/ Lic.No/Date:0410136203 09.05.2012 Defer Date:20.09.2012 Decision : In the light of written comments received form Department of Pharmaceuticals vide their OM No. 35011/15/2012PI(Norms) dated 13.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed 25 mg 1 tablet 1. Metoprolol Tartrate 25.5 mg

191 25 mg 2 1.53 mg 25 mg 1 tablet 1. Metoprolol Tartrate 25.5. mg 2. 1.53 mg 25 mg 1 tablet 1. Metoprolol Tartrate 25.5 mg 2. 1.53 mg 100 mg 1 tablet 1. Metoprolol Tartrate 102 mg 2. Magnesium Stearate/SLS4 4.284 mg RA may take appropriate action as per the decision of Norms Commission 192

Case No.:57/11/82ALC4/2012

Party Name:INTERMED, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00324/AM13/ RLA File :04/24/040/00004/AM13/ Lic.No/Date:0410136242 09.05.2012 Defer Date:18.10.2012 193

Case No.:6/9/82ALC4/2012

Party Name:DEEPAK NITRITE LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00251/AM13/ RLA File :31/83/040/00018/AM13/ Lic.No/Date:3110054170 10.05.2012 Defer Date:18.10.2012 Decision : It was decided to remind the firm to furnish the following information within 15 days failing which the case would be closed  Manufacturing process in brief.  Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular weight.  Stagewise % yield on molecular weight basis along with justification supported with authentic/printed technical literature.  Complete material balance.  Photocopy of the earlier norms fixed by ALC for same export item in the recent past.  Production of export item in the past 3 years and corresponding consumption of each input duly certified by Chartered Accountant. 194

Case No.:13/11/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00280/AM13/ RLA File :05/24/040/00045/AM13/ Lic.No/Date:0510324687 14.05.2012 Defer Date:18.10.2012

Case No.:21/14/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 20.09.2012 Status:Case Deferred

195 20.09.2012 Deferred HQ File :01/82/050/00398/AM13/ RLA File :05/23/040/00037/AM13/ Lic.No/Date:0510324671 14.05.2012 Defer Date:18.10.2012 Decision : It was decided to call from the firm the following details:  Manufacturing process indicating stage wise wastage of all the raw materials.  Consumption of all the raw materials (both imported and indigenous) with corresponding production of export items duly certified by concerned Central Excise/Chartered Accountant for three years. 196

Case No.:30/13/82ALC4/2012

Party Name:HALDIA PETROCHEMICALS LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00365/AM13/ RLA File :02/24/040/00029/AM13/ Lic.No/Date:0210177518 14.05.2012 Defer Date:18.10.2012 197

Case No.:10/9/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00255/AM13/ RLA File :03/95/040/00094/AM13/ Lic.No/Date:0310694706 15.05.2012 Defer Date:18.10.2012 Decision : It was decided to remind the firm to furnish the requisite information within 15 days failing which the case would be closed. 198

Case No.:11/9/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00256/AM13/ RLA File :03/95/040/00093/AM13/ Lic.No/Date:0310694735 15.05.2012 Defer Date:18.10.2012 Decision : It was decided to give final reminder to the firm to furnish the requisite information within 15 days failing which the case would be closed. Accordingly, the case was deferred for 18.10.2012. 199

Case No.:2/9/83ALC1/2012

20.09.2012 Status:Case Deferred HQ File :01/83/050/00176/AM13/ RLA File :03/95/040/00092/AM13/ Lic.No/Date:0310694716 15.05.2012 Defer Date:18.10.2012 Decision : It was decided to send a copy of application again to Department of Biotechnology for their comments. Accordingly, the case was deferred for 18.10.2012.

Case No.:12/14/82ALC4/2012

Party Name:CIPLA LIMITED 20.09.2012 Status:Case Deferred

200 20.09.2012 Deferred HQ File :01/82/050/00389/AM13/ RLA File :03/94/040/00103/AM13/ Lic.No/Date:0310694809 16.05.2012 Defer Date:18.10.2012 201

Case No.:16/9/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00261/AM13/ RLA File :03/95/040/00090/AM13/ Lic.No/Date:0310694936 16.05.2012 Defer Date:18.10.2012 Decision : It was decided to give final reminder to the firm to furnish the requisite information within 15 days failing which the case would be closed. Accordingly, the case was deferred for 18.10.2012. 202

Case No.:6/16/82ALC4/2012

Party Name:STELLENCE PHARMSCIENCE PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00442/AM13/ RLA File :07/24/040/00062/AM13/ Lic.No/Date:0710088213 16.05.2012 Defer Date:18.10.2012 203

Case No.:35/14/82ALC4/2012

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00412/AM13/ RLA File :03/94/040/00801/AM12/ Lic.No/Date:0310695056 17.05.2012 Defer Date:18.10.2012 204

Case No.:4/13/82ALC4/2012

Party Name:ATUL LIMITED, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00339/AM13/ RLA File :08/24/040/00048/AM13/ Lic.No/Date:0810111728 17.05.2012 Defer Date:18.10.2012 205

Case No.:52/16/82ALC4/2012

Party Name:ARKEMA PEROXIDES INDIA PRIVATE LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00488/AM13/ RLA File :04/24/040/00346/AM12/ Lic.No/Date:0410136505 17.05.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/34/2012/Ch. II dated 3.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed OO TertButyl O(2 Ethylhexyl) Monoperoxy b t 1 kg 1. 2Ethylhexyl chloroformate 0.810 kg

carbonate 2. Tertiary Butyl Hydroperoxide 68% 0.595 kg 206

Case No.:2/13/82ALC4/2012

Party Name:LIV MEDICA PRODUCTS PVT. LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/00337/AM13/ RLA File :04/24/040/00005/AM13/ Lic.No/Date:0410136574 18.05.2012 Defer Date: Decision : In the light of written comments received from Department of Industrial Policy and Promotion vide their note dated 20.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed In numbers 90/0 FIRST AID KIT PROTON 5000.000 1 WOUND WASHER BENZOLKONIUM STANDARD SIZE 145500.000 90/0 FIRST AID KIT 8 POCKETS 5000.000 2 SELF ADHESIVE PLASTER WASH PROOF 19 X 72 MM 691780.000 90/0 FIRST AID KIT 6 POCKETS 2000.000 3 SELF ADHESIVE PLASTER WASH PROOF 25 X 72 MM 206220.000 90/0 FIRST AID KIT PLATE LARGE 500.000 4 SELF ADHESIVE PLASTER WASH PROOF 9 X 39 JUNIOR 10500.000 90/0 FIRST AID KIT PLATE SMALL 500.000 5 SELF ADHESIVE PLASTER WASH PROOF ROUND 25 MM 3600.000 90/0 FIRST AID PLASTER DISPENSER EMPTY 1000.000 6 ELASTIC FABRIC PLASTER 60 MM 3150.000 90/0 FIRST AID WASH PROOF PLASTER POUCH 10 PCS 6080.000 7 BLUNT EDGE SCISSORS 15 MM 7000.000 90/0 FIRST AID WASH PROOF PLASTER POUCH 20 PCS 5600.000 8 VINYL GLOVES LARGE 53000.000 90/0 FIRST AID WASH PROOF PLASTER BOX 5040.000 9 FORCEPS ANATOMISK 8500.000

PLASTER BOX 40 PCS. ANATOMISK 90/0 FIRST AID WASH PROOF PLASTER ASSORTED BOX 24 PCS 600.000 10 CHILDEN PLASTER CASETTE 10 X 4 X 1 CM 5000.000 90/0 FIRST AID FABRIC PLASTER POUCH 10 PCS 6080.000 11 DISINFECTION NAPKINS 10.5 X 6 CM 10000.000 90/0 FIRST AID FABRIC PLASTER POUCH 20 PCS 5600.000 12 BURN GEL NAPKINS 3.5 GR 10000.000 90/0 FIRST AID FABRIC PLASTER ASSORTED BOX 20 PCS 600.000 13 ZINK TAPE 25 MM X 5 METER 6500.000 90/0 FIRST AID FABRIC PLASTER BOX 40 PCS 5040.000 14 SELF ADHESIVE PLASTER FABRIC 19 X 72 MM 543360.000 90/0 FIRST AID FABRIC PLASTER BOX 6 CM X 0.75 CM INCL SCISSORS 600.000 15 SELF ADHESIVE PLASTER FABRIC 25 X 72 MM 112640.000 90/0 FIRST AID REFILL FABRIC PLASTER 5740.000 16 PLASTER DISPENSER 2000.000 90/0 FIRST AID REFILL WASH PROOF PLASTER 5740.000 17 SMALL SCISSOR GREEN HANDLE 600.000 90/0 First Aid Refill Blue Detectable Plaster 19 25 MM 5740.000 18 SELF ADESIVE PLASTER BLUE DETECTABLE 19 X 72 MM 196140.000 90/0 First Aid Refill Blue Detectable Plaster 19mm & Finger tip 5040.000 19 SELF ADESIVE PLASTER BLUE DETECTABLE 80360.000

25 X 72 MM 90/0 FIRST AID KIT LARGE BOX 1500.000 20 SELF ADESIVE PLASTER BLUE DETECTABLE FINGER TIP 75600.000 21 FIRST AID BOX LARGE 1500.000 22 STAINLESS STEEL SCISSORS 14 CM SHARP BLUNT 1500.000 23 ZINK TAPE 12 MM X 5 METER 1500.000 207

Case No.:21/16/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00457/AM13/ RLA File :09/24/040/00071/AM13/ Lic.No/Date:0910052683 18.05.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 208

Case No.:22/16/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00458/AM13/ RLA File :09/24/040/00041/AM13/ Lic.No/Date:0910052681 18.05.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 209

Case No.:29/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00406/AM13/ RLA File :03/94/040/00705/AM12/ Lic.No/Date:0310695318 18.05.2012 Defer Date:18.10.2012 210

Case No.:29/16/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00465/AM13/ RLA File :09/24/040/00067/AM13/ Lic.No/Date:0910052682 18.05.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals.

Case No.:3/13/82ALC4/2012

Party Name:DEEPAK NITRITE LIMITED 20 09 2012 Status:Case Deferred

211 20.09.2012 Deferred HQ File :01/82/050/00338/AM13/ RLA File :34/24/040/00010/AM13/ Lic.No/Date:3410034155 18.05.2012 Defer Date:18.10.2012 212

Case No.:30/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00407/AM13/ RLA File :03/94/040/00706/AM12/ Lic.No/Date:0310695305 18.05.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 213

Case No.:31/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00408/AM13/ RLA File :03/94/040/00807/AM12/ Lic.No/Date:0310695310 18.05.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 214

Case No.:32/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00409/AM13/ RLA File :03/94/040/00802/AM12/ Lic.No/Date:0310695307 18.05.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 215

Case No.:33/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00410/AM13/ RLA File :03/94/040/00815/AM12/ Lic.No/Date:0310695316 18.05.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 216

Case No.:5/13/82ALC4/2012

Party Name:DEEPAK NITRITE LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00340/AM13/ RLA File :34/24/040/00241/AM12/ Lic.No/Date:3410034154 18.05.2012 Defer Date:18.10.2012 217

Case No.:5/9/83ALC1/2012

20.09.2012 Status:Case Deferred HQ File :01/83/050/00179/AM13/ RLA File :03/95/040/00088/AM13/ Lic.No/Date:0310695328 18.05.2012 Defer Date:18.10.2012

18.05.2012 Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Biotechnology. 218

Case No.:15/13/82ALC4/2012

Party Name:NIFTY LABS PVT LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00350/AM13/ RLA File :09/24/040/00077/AM13/ Lic.No/Date:0910052708 21.05.2012 Defer Date: 18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 219

Case No.:18/9/82ALC4/2012

Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00263/AM13/ RLA File :03/94/040/00111/AM13/ Lic.No/Date:0310695465 21.05.2012 Defer Date:18.10.2012 Decision : : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 220

Case No.:27/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00404/AM13/ RLA File :03/94/040/00804/AM12/ Lic.No/Date:0310695480 21.05.2012 Defer Date:18.10.2012 221

Case No.:28/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00405/AM13/ RLA File :03/94/040/00805/AM12/ Lic.No/Date:0310695474 21.05.2012 Defer Date:18.10.2012 222

Case No.:3/16/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00439/AM13/ RLA File :07/24/040/00075/AM13/ Lic.No/Date:0710088327 21.05.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 223

Case No.:32/16/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00468/AM13/ RLA File :09/24/040/00082/AM13/ Lic.No/Date:0910052715 21.05.2012 Defer Date:18.10.2012

224

Case No.:36/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00413/AM13/ RLA File :03/94/040/00811/AM12/ Lic.No/Date:0310695482 21.05.2012 Defer Date:18.10.2012 225

Case No.:39/16/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00475/AM13/ RLA File :07/24/040/00071/AM13/ Lic.No/Date:0710088326 21.05.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Pharmaceuticals. 226

Case No.:9/13/82ALC4/2012

20.09.2012 Status:Case Approved HQ File :01/82/050/00344/AM13/ RLA File :08/24/040/00300/AM12/ Lic.No/Date:0810111841 21.05.2012 Defer Date: Decision : In line Export product Exp. Qty. Sl. No. Import items Qty. allowed Pravastatin 10 mg tablet 1No. 1. Pravastatin Sodium 10.2 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 32.25 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 51.24 mg 4. Bottles & Caps (packing Materials in finished form a 60 CC while HDPE bottle As per packing policy 5. 100 ccWhite HDPE CRC Bottle As per packing policy 6. 4.g. CRC white CAP 33 MM As per packing policy 7. 4.i. CAP 38 MM PP with pulp liner As per packing policy Pravastatin 20 mg tablet 1 No. 1. Pravastatin Sodium 20.4 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 64.50 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 102.48 mg 4. Bottles & Caps As per packing policy 6. 150 CC White HDPE Bottle As per packing policy 7. CRC White Cap 33 MM As per packing li

policy 8. CRC White Cap 38 MM As per packing policy Pravastatin 40 mg tablet 1 No. 1. Pravastatin Sodium 40.8 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 129.00 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 204.97 mg 4. 60 CC White HDPE Bottle As per packing policy 5. Bottle 75 CC White HDPE Bottle As per packing policy 6. 400 CC WH HDPE bottle As per packing policy 7. CRC White Cap 33 MM As per packing policy Pravastatin 80 mg Tablet 1 No. 1. Pravastatin Sodium 81.6 mg 2. Microcrystalline Cellulose NF (Avicel PH 102) 258.0 mg 3. Lactose Anhydrous NF (Pharmatose DCL21) 409.94 mg 4. 4.f.750 CC White HDPE Bottle As per packing policy 5. 150 CC White HDPE Bottle As per packing policy 6. 4.h.CRC White Cap 38 MM As per packing policy 7. 4.j NCRC WH CAP 53 MM pulp liner As per packing policy 227

Case No.:21/9/82ALC4/2012

Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:20/82ALC4/2012 20.09.2012 Status:Case Deferred HQ File :01/82/050/00266/AM13/ RLA File :31/83/040/00026/AM13/ Lic.No/Date:3110054379 22.05.2012 Defer Date:18.10.2012 228

Case No.:31/16/82ALC4/2012

Party Name:HETERO LABS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00467/AM13/ RLA File :09/24/040/00084/AM13/ Lic.No/Date:0910052721 22.05.2012 Defer Date:04.10.2012 Decision : It was decided to defer the case for 4.10.2012 for comments of Department of Pharmaceuticals.

229

Case No.:11/13/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00346/AM13/ RLA File :05/24/040/00048/AM13/ Lic.No/Date:0510325611 23.05.2012 Defer Date:18.10.2012 230

Case No.:6/13/82ALC4/2012

Party Name:BHARAT PARENTERALS LTD, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00341/AM13/ RLA File :34/24/040/00045/AM13/ Lic.No/Date:3410034190 23.05.2012 Defer Date:18.10.2012 231

Case No.:8/14/82ALC4/2012

Party Name:MICRO INKS LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/00385/AM13/ RLA File :03/95/040/00136/AM13/ Lic.No/Date:0310695836 23.05.2012 Defer Date: Decision : In the light of written comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their OM No. 46011/20(A)/2010PCII dated 30.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl. No. Import items Qty. allowed Polyester Acrylate (60% Resin content in tri methylol propane triacrylate) 1 kg 1. Tetra Chlorophthalic Anhydride 0.1250 kg 2. Adipic acid 0.0440 kg 3. Iso phthalic acid 0.1880 kg 4. Petaerythritol 0.0330 kg 5. Neo pentyl glycol 0.1800 kg 6. Propylene glycol 0.0530 kg 7. Phthalic anhydride 0.0460 kg 8. Tri methylol propane triacrylate 0.4020 kg 232

Case No.:4/16/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00440/AM13/ RLA File :07/24/040/00078/AM13/ Lic.No/Date:0710088441 24.05.2012 Defer Date:18.10.2012

233

Case No.:55/14/82ALC4/2012

Party Name:ANUH PHARMA LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00432/AM13/ RLA File :03/94/040/00094/AM13/ Lic.No/Date:0310696080 24.05.2012 Defer Date:18.10.2012 234

Case No.:7/13/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00342/AM13/ RLA File :08/24/040/00062/AM13/ Lic.No/Date:0810111893 24.05.2012 Defer Date: 18.10.2012 235

Case No.:10/14/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00387/AM13/ RLA File :05/24/040/00062/AM13/ Lic.No/Date:0510325995 25.05.2012 Defer Date:18.10.2012 236

Case No.:12/13/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00347/AM13/ RLA File :05/24/040/00061/AM13/ Lic.No/Date:0510325945 25.05.2012 Defer Date:18.10.2012 237

Case No.:38/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00415/AM13/ RLA File :03/94/040/00026/AM13/ Lic.No/Date:0310696238 25.05.2012 Defer Date:18.10.2012 238

Case No.:50/11/82ALC4/2012

Party Name:ALKEM LABORATORIES LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00317/AM13/ RLA File :03/94/040/00054/AM13/ Lic.No/Date:0310696260 25.05.2012 Defer Date:18.10.2012

Case No.:37/14/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 20 09 2012 Status:Case Deferred

239 20.09.2012 Deferred HQ File :01/82/050/00414/AM13/ RLA File :03/94/040/00143/AM13/ Lic.No/Date:0310696330 28.05.2012 Defer Date:18.10.2012 240

Case No.:9/14/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00386/AM13/ RLA File :05/24/040/00063/AM13/ Lic.No/Date:0510326034 28.05.2012 Defer Date:18.10.2012 241

Case No.:53/11/82ALC4/2012

Party Name:STERLING AUXILIARIES PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00320/AM13/ RLA File :03/95/040/00156/AM13/ Lic.No/Date:0310696668 29.05.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 242

Case No.:24/14/82ALC4/2012

Party Name:ANUPAM RASAYAN (INDIA) LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/00401/AM13/ RLA File :52/24/040/00008/AM13/ Lic.No/Date:5210038504 30.05.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/97/2008/Ch. II dated 12.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl. No. Import items Qty. allowed HDC HP 100 (Formulated 2 Hydroxy4,4 Dichloro Diphenyl Ether 30% Solution) 1 kg 1. Parachloro Phenol 0.604 kg 2. Dimethyl Sulfoxide 0.309 kg 3. Perchloro Ethylene 0.309 kg 4. Propylene Glycol 0.707 kg

Case No.:25/16/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00461/AM13/ RLA File :09/24/040/00087/AM13/ Lic.No/Date:0910052841 30.05.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 35/82 dated 30.11.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm whichever is less:

243 per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Methyl 22 Chloromethylphenyl3 Methoxy2Acrylate 1 Kg. 1. 3Isochromanone 0.957 kg 2. OXylene 1.04 kg 3. Sodium Methoxide Powder 0.416 kg 4. NMethylformaniolde 0.083 kg 5. Methanol 2.31 kg 244

Case No.:46/16/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00482/AM13/ RLA File :07/21/040/00128/AM13/ Lic.No/Date:0710088534 30.05.2012 Defer Date:18.10.2012 245

Case No.:51/14/82ALC4/2012

Party Name:AGIO PHARMACEUTICALS LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00428/AM13/ RLA File :03/94/040/01186/AM12/ Lic.No/Date:0310696799 30.05.2012 Defer Date:18.10.2012 246

Case No.:52/14/82ALC4/2012

Party Name:CIPLA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00429/AM13/ RLA File :03/94/040/00157/AM13/ Lic.No/Date:0310696798 30.05.2012 Defer Date:18.10.2012 247

Case No.:20/16/82ALC4/2012

20.09.2012 Status:Case Approved HQ File :01/82/050/00456/AM13/ RLA File :07/24/040/00090/AM13/ Lic.No/Date:0710088562 31.05.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/360/2012PI(Norms) dated 12.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Syndol Tabs – Paracetamol 450 mg + Caffeine 30 mg + Doxylamine Succinate 5 mg +Codeine Phosphate 10 mg Tablets 1000 tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phsophate 10.2 kg

p BP/EP/USP/PH.EUR g 3. Colour Yellow 14037 1H 1.632 kg Adco Dol Tab – Paracetamol 450 mg+ Codeine Phosphate 10 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg 1000 tablets 1. Doxylamine Succinate USP/Ph. Eur Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 2.43 kg 4. Colour Quinoline Yellow WS (spectracol) 4.56 kg Betapyn Tabs – Tablets containing Paracetamol 450 mg +Caffeine 50 mg +Doxylamine Succinate 5 mg+ Codeine Phsophate 10 mg 1000 tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 IH Do not match with MBF Pynstop Tabs – tablets containing Paracetamol 450 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg+Codeine Phosphate 10 mg 1000 tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 248

Case No.:59/11/82ALC4/2012

Party Name:JINDAL DRUGS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00326/AM13/ RLA File :03/94/040/00027/AM13/ Lic.No/Date:0310697012 31.05.2012 Defer Date:18.10.2012 249

Case No.:57/16/82ALC4/2012

Party Name:RIDDHI PHARMA 20.09.2012 Status:Case Approved HQ File :01/82/050/00493/AM13/ RLA File :34/24/040/00052/AM13/ Lic.No/Date:3410034301 01.06.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/76/2010Ch. II dated 12.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp Qty Sl No Import items Qty allowed

Export product Exp. Qty. Sl.No. Import items Qty. allowed 1,3, Dichloro Acetone 1 kg 1 1,3Dichloro2Propanol 1.069 kg 2. Sodium Dichromate 1.700 kg 250

Case No.:60/11/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00327/AM13/ RLA File :31/83/040/00048/AM13/ Lic.No/Date:3110054594 04.06.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011/Ch. II dated 23.12.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed NEthyl2Pyrrolidone 1 kg 1. 1,4 Butanediol 0.882 kg 2. Ammonia Anhydrous 0.176 kg 3. Ethyl Alcohol (95% Minimum) (denatured) 0.512 kg 4. Ethylamine Catalyst 0.001 kg 251

Case No.:46/14/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00423/AM13/ RLA File :03/94/040/00188/AM13/ Lic.No/Date:0310697620 06.06.2012 Defer Date:18.10.2012 252

Case No.:61/11/82ALC4/2012

Party Name:KOPRAN LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00328/AM13/ RLA File :03/94/040/00162/AM13/ Lic.No/Date:0310697570 06.06.2012 Defer Date:18.10.2012 253

Case No.:53/14/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 20.09.2012 Status:Deffered and Reindexed HQ File :01/82/050/00430/AM13/ RLA File :03/94/040/00888/AM12/ Lic.No/Date:0310697981 08.06.2012 Defer Date:20.09.2012 254

Case No.:18/14/82ALC4/2012

Party Name:ASTRIX LABORATORIES LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00395/AM13/ RLA File :09/24/040/00088/AM13/ Lic.No/Date:0910052978 12 06 2012 Defer Date:18 10 2012

12.06.2012 Date:18.10.2012 255

Case No.:53/16/82ALC4/2012

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00489/AM13/ RLA File :04/24/040/00049/AM13/ Lic.No/Date:0410137249 12.06.2012 Defer Date:18.10.2012 256

Case No.:54/16/82ALC4/2012

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00490/AM13/ RLA File :04/24/040/00015/AM13/ Lic.No/Date:0410137244 12.06.2012 Defer Date:18.10.2012 257

Case No.:59/16/82ALC4/2012

Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 20.09.2012 Status:Case Approved HQ File :01/82/050/00495/AM13/ RLA File :34/24/040/00055/AM13/ Lic.No/Date:3410034346 13.06.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/37/20011Ch. II dated 7.9.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Tetra Octyl Ammonium Bromide 1 kg 1. TriNOctylAmine 0.718 kg 2. Octyl Alcohol 0.291 kg 258

Case No.:50/14/82ALC4/2012

Party Name:AARTI INDUSTRIES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00427/AM13/ RLA File :03/94/040/00187/AM13/ Lic.No/Date:0310698861 15.06.2012 Defer Date:18.10.2012 259

Case No.:8/16/82ALC4/2012

Party Name:NECTAR LIFESCIENCES LIMITED, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00444/AM13/ RLA File :22/24/040/00011/AM13/ Lic.No/Date:2210013017 15.06.2012 Defer Date:18.10.2012

260

Case No.:3/12/82ALC4/2012

Party Name:BILCARE LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00333/AM13/ RLA File :31/83/040/00057/AM13/ Lic.No/Date:3110054717 18.06.2012 Defer Date:18.10.2012 Decision : It was decided to examine this case on file. Accordingly, the case was deferred for 18.10.2012 261

Case No.:45/14/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00422/AM13/ RLA File :03/95/040/00081/AM13/ Lic.No/Date:0310699034 18.06.2012 Defer Date:18.10.2012 262

Case No.:11/16/82ALC4/2012

Party Name:NEULAND LABORATORIES LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00447/AM13/ RLA File :09/24/040/00141/AM13/ Lic.No/Date:0910053093 20.06.2012 Defer Date:18.10.2012 263

Case No.:40/14/82ALC4/2012

Party Name:CIPLA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00417/AM13/ RLA File :03/94/040/00224/AM13/ Lic.No/Date:0310699235 20.06.2012 Defer Date:18.10.2012 264

Case No.:1/16/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00437/AM13/ RLA File :03/95/040/00221/AM13/ Lic.No/Date:0310699784 26.06.2012 Defer Date:18.10.2012 265

Case No.:28/13/82ALC4/2012

Party Name:MELZER CHEMICALS PVT. LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00363/AM13/ RLA File :31/83/040/00060/AM13/ Lic.No/Date:3110054836 26.06.2012 Defer Date:18.10.2012 266

Case No.:109/18/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 20.09.2012 Status:Case Deferred

HQ File :01/82/050/00604/AM13/ RLA File :05/23/040/00491/AM12/ Lic.No/Date:0510328334 27.06.2012 Defer Date:18.10.2012 267

Case No.:31/13/82ALC4/2012

Party Name:PALADIN PAINTS AND CHEMICALS PVT. LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00366/AM13/ RLA File :03/95/040/00055/AM13/ Lic.No/Date:0310699970 27.06.2012 Defer Date:18.10.2012 Decision : Department of chemicals and Petrochemicals vide their letter NO. 46011/98/2012PC II dated 31.8.2012 has requested the firm to furnish the following information:  Technical specifications, % composition (by weight) along with specific end use/application and the copy of export order for all the three export products i.e. Phenalkmines Epoxy Hardeners PPA7062/PPA7041X90/PPA7558  Details and quantity of other indigenous inputs to be used in the manufacturing of the export product.  Detailed manufacturing process along with balanced chemical reaction indicating % yield/wastage along with technical justification for wastages at each stage and also on each of the raw material.  Complete material balance indicating input and output material at each stage of manufacturing process for each of the export product.  Standard/authentic technical literature in support of the raw material requirement/formulation for the manufacture of export product.  Details of production of all the three export products under reference and corresponding consumption of raw material in the year 200910, 201011 and 201112 duly certified by CA. If the production has not commenced nthe past, the details from commencement of production duly certified by CA. It was decided to remind the firm to furnish the above information and accordingly, the case was deferred for 18.10.2012. 268

Case No.:2/16/82ALC4/2012

Party Name:CIPLA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00438/AM13/ RLA File :03/94/040/00245/AM13/ Lic.No/Date:0310700244 29.06.2012 Defer Date:18.10.2012 269

Case No.:10/16/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00446/AM13/ RLA File :05/24/040/00116/AM13/ Lic.No/Date:0510328831 04.07.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18 10 2012 for comments of Department of Pharmaceuticals

270

Case No.:16/16/82ALC4/2012

Party Name:FDC LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00452/AM13/ RLA File :03/94/040/00208/AM13/ Lic.No/Date:0310701169 06.07.2012 Defer Date:18.10.2012 271

Case No.:14/16/82ALC4/2012

Party Name:JINDAL DRUGS LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00450/AM13/ RLA File :03/94/040/00194/AM13/ Lic.No/Date:0310701336 09.07.2012 Defer Date:18.10.2012 272

Case No.:69/18/82ALC4/2012

Party Name:SMILAX LABORATORIES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00564/AM13/ RLA File :09/24/040/00156/AM13/ Lic.No/Date:0910053216 09.07.2012 Defer Date:18.10.2012 273

Case No.:23/14/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00400/AM13/ RLA File :31/83/040/00061/AM13/ Lic.No/Date:3110054974 13.07.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 274

Case No.:53/18/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00548/AM13/ RLA File :03/94/040/00304/AM13/ Lic.No/Date:0310702050 17.07.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of DC(MSME) 275

Case No.:57/14/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00434/AM13/ RLA File :31/83/040/00075/AM13/ Lic.No/Date:3110055038 19.07.2012 Defer Date:18.10.2012

276

Case No.:58/14/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00435/AM13/ RLA File :31/83/040/00073/AM13/ Lic.No/Date:3110055046 19.07.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 277

Case No.:10/20/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00621/AM13/ RLA File :03/94/040/00243/AM13/ Lic.No/Date:0310703383 27.07.2012 Defer Date:18.10.2012 278

Case No.:11/20/82ALC4/2012

Party Name:CROWN CHEMICALS PVT.LTD., 20.09.2012 Status:Case Approved HQ File :01/82/050/00622/AM13/ RLA File :03/94/040/00309/AM13/ Lic.No/Date:0310703754 01.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/175/2011Ch. II dated 11.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Piperonal Min. Purity 98% 1 kg 1. Catechol (Min. Purity 99%) 0.862 kg 2. Dichloromethane (Min. Purity 99%) 0.703 kg 3. Dimethylsulfoxide (Min. Purity 99%) 0.875 kg 4. Hexamine (Min. Purity 96%) 1.000 kg 5. Toluene (Min. Purity 97%) 0.430 kg 6. Isopropyl Alcohol (Mion. Purity 99%) 0.220 kg 279

Case No.:15/20/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00626/AM13/ RLA File :03/94/040/00336/AM13/ Lic.No/Date:0310703768 01.08.2012 Defer Date:18.10.2012 280

Case No.:16/20/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00627/AM13/ RLA File :05/24/040/00150/AM13/ Lic.No/Date:0510331127 01.08.2012 Defer Date:18.10.2012

281

Case No.:17/20/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00628/AM13/ RLA File :05/24/040/00148/AM13/ Lic.No/Date:0510331126 01.08.2012 Defer Date:18.10.2012 282

Case No.:18/20/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00629/AM13/ RLA File :09/24/040/00223/AM13/ Lic.No/Date:0910053402 01.08.2012 Defer Date:18.10.2012 283

Case No.:9/20/82ALC4/2012

Party Name:DAIICHI KARKARIA LIMITED 20.09.2012 Status:Case Approved HQ File :01/82/050/00620/AM13/ RLA File :03/94/040/00003/AM13/ Lic.No/Date:0310703690 01.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/162/2011Ch. II dated 12.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Imidazoline Derivative (Dailube As11) Chemical 1 kg 1. Oleic Acid Chemical (Fatty Acid) 0.335 kg 2. Diethylene Triamine Chemical 0.289 kg 284

Case No.:13/20/82ALC4/2012

Party Name:CIPLA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00624/AM13/ RLA File :03/94/040/00342/AM13/ Lic.No/Date:0310703951 03.08.2012 Defer Date:18.10.2012 285

Case No.:41/16/82ALC4/2012

Party Name:V.D.H. ORGANICS PVT. LTD 20.09.2012 Status:Case Deferred HQ File :01/82/050/00477/AM13/ RLA File :05/24/040/00170/AM13/ Lic.No/Date:0510331265 03.08.2012 Defer Date:18.10.2012 286 Case No.:14/20/82ALC4/2012 Party Name:ENALTEC LABS PVT.LTD. 20.09.2012 Status:Case Approved

HQ File :01/82/050/00625/AM13/ RLA File :03/94/040/00332/AM13/ Lic.No/Date:0310704096 06.08.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 16/82 dated 16.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Rosuvastatin Calcium 1 kg. 1. (4RCis) 6[Acetyloxy) –Methyl]2,2 Dimethyl1,3Dioxane4Acetic Acid1,1 Dimethylethyl Ester 1.871 kg 2. 4(4Fluorophenyl)6Isopropyl2[(N MethylN Methylsulphonyl)Amino] Pyrimidine 5YLMethanol 1.871 kg RA concerned may take further necessary action as per above decision of NC. 287

Case No.:44/16/82ALC4/2012

Party Name:SUPREET CHEMICALS PVT.LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00480/AM13/ RLA File :03/95/040/00324/AM13/ Lic.No/Date:0310704113 06.08.2012 Defer Date:18.10.2012 288

Case No.:47/16/82ALC4/2012

Party Name:PARAMOUNT PHARMA 20.09.2012 Status:Case Deferred HQ File :01/82/050/00483/AM13/ RLA File :05/24/040/00178/AM13/ Lic.No/Date:0510331427 07.08.2012 Defer Date:18.10.2012 289

Case No.:48/16/82ALC4/2012

Party Name:PARAMOUNT PHARMA 20.09.2012 Status:Case Deferred HQ File :01/82/050/00484/AM13/ RLA File :05/24/040/00179/AM13/ Lic.No/Date:0510331428 07.08.2012 Defer Date:18.10.2012 290

Case No.:8/20/82ALC4/2012

Party Name:CIPLA LIMITED 20.09.2012 Status:Case Deferred HQ File :01/82/050/00619/AM13/ RLA File :03/94/040/00359/AM13/ Lic.No/Date:0310704519 08.08.2012 Defer Date:18.10.2012

Case No :12/20/82 ALC4/2012

Party Name:CAMPHOR & ALLIED PRODUCTS Meet No/Date:20/82 ALC4/2012 Status:Case

291

Case No.:12/20/82ALC4/2012

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 20.09.2012 Status:Case Deferred HQ File :01/82/050/00623/AM13/ RLA File :03/94/040/00363/AM13/ Lic.No/Date:0310704836 10.08.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 292

Case No.:1/20/82ALC4/2012

Party Name:SUNSHIELD CHEMICALS LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00612/AM13/ RLA File :03/95/040/00261/AM13/ Lic.No/Date:0310705885 22.08.2012 Defer Date:18.10.2012 Decision : It was decided to defer the case for 18.10.2012 for comments of Department of Chemicals and Petrochemicals. 293

Case No.:2/20/82ALC4/2012

Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 20.09.2012 Status:Case Approved HQ File :01/82/050/00613/AM13/ RLA File :31/83/040/00085/AM13/ Lic.No/Date:3110055580 28.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/3/2012Ch. II dated 5.3.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Anisole 99.50% purity 1 kg 1 Phenoxy methane Purity 93% Minimum 1.10 kg 294

Case No.:3/20/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 20.09.2012 Status:Case Deferred HQ File :01/82/050/00614/AM13/ RLA File :05/24/040/00201/AM13/ Lic.No/Date:0510332840 28.08.2012 Defer Date:18.10.2012 295

Case No.:4/20/82ALC4/2012

20.09.2012 Status:Case Deferred HQ File :01/82/050/00615/AM13/ RLA File :05/24/040/00323/AM12/ Lic.No/Date:0510333154 30.08.2012 Defer Date:18.10.2012 296

Case No.:5/20/82ALC4/2012

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 20.09.2012 Status:Case Approved HQ File :01/82/050/00616/AM13/ RLA File :03/94/040/00295/AM13/ Lic.No/Date:0310707018 30.08.2012 Defer Date:

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2012Ch. II dated 5.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Astrolide (DEP/IPM/BB/DPG) (Astrolide in Diethyl Phthalate/Isopropryl Myristate/Benzyl Benzoate Astrolide content 62.5%) 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 3. Alpha Methyl Styrene 0.500 kg 4. Paraformaldehyde 0.088 kg 297

Case No.:6/20/82ALC4/2012

Party Name:PARABOLIC DRUGS LTD., 20.09.2012 Status:Case Deferred HQ File :01/82/050/00617/AM13/ RLA File :05/24/040/00024/AM13/ Lic.No/Date:0510333659 04.09.2012 Defer Date:18.10.2012 298

Case No.:7/20/82ALC4/2012

Party Name:PARABOLIC DRUGS LTD., 20.09.2012 Status:Case Approved HQ File :01/82/050/00618/AM13/ RLA File :05/24/040/00207/AM13/ Lic.No/Date:0510333660 04.09.2012 Defer Date: Decision : Export product Exp. Qty. Sl.No. Import items Qty. allowed Ceftriaxone Sodium Sterile 1 Kg. 1. Ceftriaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3 Eno Carbon 51.66 gm Date:24.09.2012 Lalita Maini

Place:New Delhi Foreign Trade Development Officer

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