IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2013-03-21

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision

MEETING NUMBER : 33/82ALC4/2012 MEETING DATE : 21.03.2013 The Meeting No. 33/82 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 held on 21.03.2013 under the Chairmanship of, Shri Mukesh Bhatnagar, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi.. Following members were present: 1. Shri D.N. Mathur. Advisor, Department of Pharmaceutical 2. Shri Jasbir Singh, Advisor, Department of Chemicals and Petrochemicals 3. Shri R.C. Meena, Deputy Director General of Foreign Trade

Case No. A 10

M/s. Fermenta Biotech Limited Meeting no. 33/AM 13 01/82/162/128/AM 13/DES III Dated 21.3.2013 Decision: It was decided to remind the firm to furnish the production and consumption data duly certified by Central Excise Authority. The case was deferred for 18.4.2013.

Case No. B 498

M/s. Aqua Pharma Chemicals (Pvt.) Limited, Pune Meeting no. 33/AM 13 F. No. 01/82/162/170/AM 12 F, No. 01/82/162/172/AM 12 F. No 01/82/162/173/AM 12 F. No. 01/82/162/183/AM 12 Dated 21.3.2013

Decision: It was decided to defer the case for 18.4.2013 for comments of Department of Chemicals and Petrochemicals.

Case No. B 499

M/s. AMI Lifesciences Pvt. Limited Meeting no. 33/AM 13 dated 21.3.2013 01/82/050/01384/AM 12/DES III 01/82/050/01321/AM 12/DES III 01/82/050/00052/AM 13/DES III 01/82/050/00195/AM 13/DES III Advance Authoristion No. 3410033054 dated 27.1.2012 3410033146 dated 7.2.2012 3410033547 dated 13.3.2012 3410033820 dated 12.4.2012 RLA’s File NO. 34/24/040/00226/AM 12 34/24/040/00237/AM 12 34/24/040/00280/AM 12 34/24/040/00009/AM 13 Decision: It was noticed that certificate of analalysis from the supplier and quantity & value of by product obtained in the process and shown in the reaction are not found. It was decided to request the firm to furnish the same. The case was deferred for 18.4.2013.

Case No. B 500

M/s. Shalina Laboratories Pvt. Limited 01/82/050/00383/AM 13/DES III (Pt.) 0310695641`dated 22.5.2012 RLA’s File No 03/95/040/00077/AM 13 Decision: In line with the earlier decision taken in meeting no. 32/82dated 3.11.2009, it was decided to revise the minutes ratified in NC meeting no. 14/82 dated 31.7.2012 in respect of the above advance authorization 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 Diproson Lotion 30 ml One 30 ml pack 1. Betamethasone Base BP/IP/USP 16.816mg/30 ml pack 2. Propylene Glycol [Mono Propylene Glycol0 18.00 gm/30 ml pack

Purell [packing material] Relevant, as per packing policy RA may take appropriate action as per the decision of Norms Committee.

Case No. B 501

M/s. AMI Lifesciences Pvt. Limited 01/82/050/01220/AM 12/DES III 3410032719 dated 27.12.2011 RLA’s File No 34/24/040/00189/AM 12 Decision: It was decided to reject the request of the firm for enhancement of norms as there is no justification for enhancement. Further the norms are ratified on the basis of comparision of yield.RA may take appropriate action as per the decision of Norms Committee.

Case No. B 502

M/s. Shalina Laboratories Pvt. Limited 01/82/050/00195/AM 12/DES III (Pt.) 0310573268 dated 22.5.2012 RLA’s File No 03/95/040/00077/AM 13 Decision: Iit was decided to revise the minutes ratified in NC meeting no. 19/82 dated 9.8.2011 in respect of the above advance authorization 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 Diproson Lotion 30 ml One 30 ml pack 1. Betamethasone Base BP/IP/USP 16.816 mg/30 ml pack 2. Propylene Glycol [Mono Propylene Glycol0 18.00 gm/30 ml pack 3. Purell [packing material] Relevant, as ki

per packing policy

Case No. B 503

M/s. Sterling Auxillaries Pvt. Limited, Mumbai 01/82/050/01016/AM 11/DES III (Pt.) 0310601007 dated 11/11/2010 RLA’s File No 03/95/040/00600/AM 11 Decision: It was decided to defer the case for 18.4.2013 for comments of Department of Chemicals and Petrochemicals.

Case No. B 504

M/s. Medreich Limited 01/82/050/00764/AM 09/DES III 01/82/050/778/AM 09 DES III 01/82/050/779/AM 09 DES III 01/82/050/1334/AM 09 DES III 0710058625 dated 18.7.2008 0710058622 dated 22.7.2008 0710058663 dated 22.7.2008 0710061410 dated 28.11.2008 RLA’s File No Decision: The following was observed in the meeting:  In terms of Para 4.7(a) (i) of HBP v1, no Advance Authoristion shall be issued under the paragraph for the import of All vegetable/edible oils classified under Chapter 15 and all types of oilseeds classified under chapter 12 of ITC(HS) Book. In view the above, RA is advised not to issue any license for vegetable/edible oils under Para 4.7 of HBP v1.  The firm is also advised not to take license under Para 4.7 of HBP v1 for vegetable oils in future

future.  In view of the comments of Directorate of Vanaspati, Vegetable Oils and Fats, that hydrogenated oil/cottonseed oil is to be used as lubricant to produce Paracetoamol 100 mg, Aspirin 400 mg, and Caffeine 30 tablets and the oil imported was not edible in nature, comments of Department of Pharmacetuicals have been sought. The case was deferred for 18.4.2013 the comments of Department of Pharmaceuticlas. .

Case No. B 505

M/s. Alkyl Amines Chemicals Limited, Mumbai 01/82/162/0025/AM 13/DES III 01310615974 dated 14.2.2011 RLA’s File No 03/94/040/00426/AM 10 Decision: It was decided to defer the case for 18.4.2013 for comments of Department of Pharmaceuticals.

Case No. B 506

M/s. Belchem Industries (India) Pvt. Ltd. 01/82/050/00635/AM 10/DES III 01/82/050/00705/AM 13/DES III 0310567060 dated 29.3.2010 0310711429 dated 3.10.2012 RLA’s File No 03/94/040/00557/AM 13 03/94/040/01031/AM 11 Decision: It was decided to amend the description of export product from DMDM Hydantoiin 52%55% Assay 55% max to “13,Dimethylol5,5Dimethyl Hydantion”. The rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee.

Case No.:8/32/82ALC4/2010

Party Name:SAURAV CHEMICALS LTD, Meet No/Date:33/82ALC4/2012 21.03.2013 Status:Case Deferred HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:18.04.2013 Decision :It was decided to call from the firm as well as RLA a copy of application. The case was deferred for 18.4.2013 2

Case No.:2/34/82ALC4/2010

Party Name:ALEMBIC LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01008/AM11/ RLA File :34/24/040/00207/AM11/ Lic.No/Date:3410028544 09.11.2010 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/604/2012PI(Norms) dated 6.2.2013, 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 Azithromycin Tablet 600 mg (30 pack bottle) 1 tablet 1. Azithromycin Dihydrate or its raw material as per SION A 2440 on pro rata basis 622.82 mg 2. Pregelatinized Starch (Starch 1500) 62.91 mg 3. Anhydrous Diabasic Calcium Phsophate 323.50 mg 4. Croscarmellose Sodium (AC Di Sol) 20.97 mg 5. Magnesium Stearate 8.89 mg 6. Sodium Lauryl Sulphate 2.16 mg 7. HDPE Bottle Relevant , as per packing policy. 8. Closure or Caps 9. Aluminium Foil 10 PVC Foil 11. Peelable Paper/Aluminium Foil

Azithromycin Tablet 250 mg (30 pack bottle) 1 tablet 1. Azithromycin Dihydrate or its raw material as per SION A 2440 on pro rata basis 259.50 mg 2. Pregelatinized Starch (Starch 1500) 26.21 mg 3. Anhydrous Diabasic Calcium Phsophate 138.80 mg 4. Croscarmellose Sodium (AC Di Sol) 8.74 mg 5. Magnesium Stearate 3.628 mg 6. Sodium Lauryl Sulphate 0.900 mg 7. HDPE Bottle Relevant, as per packing policy 8. Closure or Caps 9. Aluminium Foil 10 PVC Foil 11. Peelable Paper/Aluminium Foil Azithromycin Tablet 500 mg ( 30 pack Blister) 1 tablet 1. Azithromycin Dihydrate or its raw material as per SION A 2440 on pro rata basis 519.02 mg 2. Pregelatinized Starch (Starch 1500) 52.42 mg 3. Anhydrous Diabasic Calcium Phsophate 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 7. HDPE Bottle Relevant, as per packing policy 8. Closure or Caps 9. Aluminium Foil

10 PVC Foil 11. Peelable Paper/Aluminium Foil 3

Case No.:30/41/82ALC4/2010

Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 21.03.2013 Status:Case Deferred HQ File :01/82/050/01378/AM11/ RLA File :05/23/040/00270/AM11/ Lic.No/Date:0510280724 30.12.2010 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.4.2013 for comments of Department of Pharmaceuticals. 4

Case No.:23/6/82ALC4/2011

Party Name:MATRIX LABORATORIES LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00141/AM12/ RLA File :09/24/040/00484/AM11/ Lic.No/Date:0910045232 27.01.2011 Defer Date:18.04.2013 Decision :As requested by the technical member from the Department of Pharmaceuticals, a copy of application has been sent to them. The case was deferred for 18.4.2013 for comments of Department of Pharmaceuticals. 5

Case No.:6/8/82ALC4/2011

Party Name:AUROBINDO PHARMA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00206/AM12/ RLA File :09/24/040/00032/AM12/ Lic.No/Date:0910046590 02.05.2011 Defer Date:18.04.2013 Decision :As requested by the technical member from the Department of Pharmaceuticals, a copy of application has been sent to them. The case was deferred for 18.4.2013 for comments of Department of Pharmaceuticals. 6

Case No.:20/14/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/00397/AM13/ RLA File :05/24/040/00082/AM12/ Lic.No/Date:0510292925 10.06.2011 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/626/2012PI(Norms) dated 12.3.2013, 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) Candesartan Cilexetil (Bulk drug/Pharmacopeal Grade) 1 kg 1 1chloroethyl chloroformate 0.45 2 4(bromomethyl)2 cyanobiphenyl 1 66

cyanobiphenyl 1.66 3 Acetone 3.45 4 Acetonitrile 2.50 5 Activated carbon 0.100 6 Cyclohexane 5.88 7 Dimethyl formamide 1.52 8 Ethyl acetate 10.00 9 Formic acid 1.30 10 Iso propyl alcohol 0.50 11 Methanol 10.00 12 Methylene chloride 5.00 13 Tertiary butanol 2.00 14 Tetra ethyl ortho carbonate 1.19 15 Tetrabutyl ammonium bromide (TBAB) 0.18 16 Toluene 5.00 17 Triethylamine 0.31 7

Case No.:47/14/82ALC4/2011

Party Name:FDC LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00438/AM12/ RLA File :03/94/040/00152/AM12/ Lic.No/Date:0310637790 22.06.2011 Defer Date:18.04.2013 Decision : As requested by technical member from Department of Pharmaceuticals, a copy of application has been again sent to them. The case was deferred for 18.4.2013 for comments of Department of Pharmaceuticals.

Case No.:31/21/82ALC4/2011

Party Name:MATRIX LABORATORIES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00613/AM12/ RLA File :09/24/040/00143/AM12/ Lic No/Date:0910047366 Defer Date:

8 HQ File :01/82/050/00613/AM12/ RLA File :09/24/040/00143/AM12/ Lic.No/Date:0910047366 29.06.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/692/2012PI(Norms) dated 12.3.2013, 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) Darunavir (Chloroketone Route) 1 kg 1 (3S)3(tert butoxycarbonyl)amino 1chloro4phenyl2 butanone (Chloroketone) 1.59 2 Isobutylamine 2.06 3 Aluminum isopropoxide 0.38 4 Ceca Carbon 0.100 5 Methylene Dichloride 10.22 6 Methanol 3.06 7 Isopropyl alcohol 3.85 8 NMethyl2pyrrolidone Not shown in Reaction 9 Acetic acid 1.59 RA may take appropriate action as per the decision of Norms Committee. 9

Case No.:28/21/82ALC4/2011

Party Name:HETERO DRUGS LIMITED, 21.03.2013 Status:Case Approved HQ File :01/82/050/00610/AM12/ RLA File :09/24/040/00178/AM12/ Lic.No/Date:0910047796 21.07.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/698/2012PI(Norms) dated 12.3.2013, 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) Cefpodoxime Proxetil 1 kg 1 7Amino Cephalosporanic Acid (7ACA) 0.956 2 Sulfolane Anhydrous 1.29 3 MAEM 0.956

4 Tetrahydrofuran 2.10 5 Methylene Dichloride 3.16 6 1Chloroethyl Isopropyl Carbonate 0.55 7 Sodium lodide 0.39 8 18 Crown6 ether 0.022 9 N,NDimethyl acetamide 2.80 10 1,1,3,3Tetramethyl guanidine 0.223 11 Toluene 2.50 12 Methanol 0.95 10

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

Party Name:ENCUBE ETHICALS PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic.No/Date:0310646711 05.08.2011 Defer Date:18.04.2013 Decision :Reply received from the firm sent to Department of Pharmaceuticals. The case was deferred for the comments of Department of Pharmaceuticals. 11

Case No.:38/32/82ALC4/2011

Party Name:GRANULES INDIA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00919/AM12/ RLA File :09/24/040/00239/AM12/ Lic.No/Date:0910048379 25.08.2011 Defer Date:18.04.2013 Decision : It was decided to call from the firm a copy of Drug Manufacturing License along with list of approved items with their composition. The written comments from Department of Pharmaceuticals in this regard will follow. The case was deferred for 18.4.2013.

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

Party Name:UNITED BIOTECH PVT.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/00936/AM12/ RLA File :05/24/040/00226/AM12/ Lic.No/Date:0510304974 11.10.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012 and written comments received from Department of Pharmaceuticals vide their OM No. 35011/698/2012PI(Norms) dated 12.3.2013, 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:

12 g pp y , Export product Exp. Qty. Sl.No. Import items Qty. allowed LAsparaginasa Inyectable 10000UI (L Asparaginase in 10000UI Onconase 10000 UI Inj. R.M (Inj) 1 vial 1. LAsparaginase (Injectable Grade) Raw Material 81.53 mg/vial Ticarcillin & Clavulanic Acid for Injection USP Ticarnic 1.6 gm 1 vial 1. Ticarcillin Disodium & Potassium Clavulanate (15:1) Raw material (Medicine) 1.68 gm/vial Ticarcillin & Clavulanic Acid for Injection USP Ticarnic 3.2 gm 1 vial 1. Ticarcillin Disodium & Potassium Clavulanate (15:1) Raw material (Medicine) 3.36 gm/vial 13

Case No.:25/41/82ALC4/2011

Party Name:CADILA HEALTHCARE LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01026/AM12/ RLA File :08/24/040/00179/AM12/ Lic.No/Date:0810105257 08.11.2011 Defer Date:18.04.2013 Decision : As requested by technical member from Department of Pharmaceuticals, a copy of application has been sent again to them. The case was deferred for 18.4.2013 for comments of Department of Pharmaceuticals.

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

Party Name:SMILAX LABORATORIES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01340/AM12/ RLA File :09/24/040/00332/AM12/ Lic.No/Date:0910049719 16.11.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/251/2012PI(Norms) dated 12.3.2013, 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) (2S)‐[(2S)‐azido‐2(S)‐4(S)‐ 1 kg 1 (S)Benzyl2

14 (2S) [(2S) azido 2(S) 4(S) isopropyl‐5‐oxo‐ tetrahydrofuran‐2(S)‐yl)‐ ethyl]‐3‐methylbuⷼric acid 2dicyclohexyl amine salt 1 kg 1 (S) Benzyl 2 oxazolidinone (AKN 08) 3.00 2 Isovaleric acid (AKN 04) 2.42 3 Li HMDS solution 24% )1.26 M) 3.00 4 (E)1,4Dibromo but 2ene 1.49 5 Tricapryl methyl ammonium chloride (Aliquate) 0.35 6 nHeptane 5.75 7 Tetrahydrofuran 6.73 8 Methyl tertiary butyl ether 4.19 9 Diisopropyl ether 12.40 15

Case No.:7/45/82ALC4/2011

Party Name:SANO MEDICAL KITS PVT. LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01184/AM12/ RLA File :04/24/040/00244/AM12/ Lic.No/Date:0410131205 01.12.2011 Defer Date:18.04.2013 Decision : The case was deferred for 18.4.2013 for comments of Department of Industrial Policy and Promotion. 16

Case No.:38/3/82ALC4/2012

Party Name:BROOKS LABORATORIES LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/00042/AM13/ RLA File :22/24/040/00068/AM12/ Lic.No/Date:2210012375 29.12.2011 Defer Date:18.04.2013 17

Case No.:41/1/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01483/AM12/ RLA File :09/24/040/00459/AM12/ Lic.No/Date:0910050480 29.12.2011 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.4.2013 for comments of Department of Chemicals and Petrochemicals.

Case No.:43/21/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00673/AM13/ RLA File :09/24/040/00458/AM12/ Lic.No/Date:0910050481 29.12.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011Ch. II dated 27.11.2012, 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) Reversacol Granite 1 kg 1. 4 Fluro 4 Methoxy Benzo Phenone 2.00 2. Tri Methyl Silyl Chloride (TMSC) 1.400 kg 3. Toluene 21.25 kg 4. TMSA (Tri Methyl Silyl Acetylene) 2.30 kg 5. ADHN (1Anisyl3,4 Dihyd Ronaphtalene) 2.80 kg 6. TEPA (Triethylphosphonoacetate) 2.00 kg 7. DMSC15 1.000 kg 8. Methanol 18.00 kg 9. Hexane 28.500 kg 10. Potassium Carbonate 0.901 kg 19

Case No.:3/41/82ALC4/2011

Party Name:RUSAN PHARMA LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01004/AM12/ RLA File :03/95/040/00803/AM12/ Lic.No/Date:0310673724 30.12.2011 Defer Date:18.04.2013 20

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

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00017/AM13/ RLA File :09/24/040/00467/AM12/ Lic.No/Date:0910050600 Defer

03.01.2012 Date:18.04.2013 21

Case No.:16/29/85ALC3/2011

Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/85/050/00173/AM12/ RLA File :03/95/040/00831/AM12/ Lic.No/Date:0310674968 05.01.2012 Defer Date:18.04.2013 Decision :It was decided to call from the firm a copy of Drug Manufacturing License and also a list of approved items. The case was deferred for 18.4.2013. 22

Case No.:11/49/82ALC4/2011

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01320/AM12/ RLA File :04/24/040/00280/AM12/ Lic.No/Date:0410132899 18.01.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 23/82 dated 1.11.2012, 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 Gabapentin 1 kg 1. 1,1Cyclohexane Diacetic Acid Monamide 1.63 kg 2. Methanol 0.445 kg 3. Toluene 0.89 kg 4. Isopropyl alcohol 2.165 kg 5. Caustic Soda Flakes 0.723 kg 23

Case No.:35/3/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00039/AM13/ RLA File :09/24/040/00532/AM12/ Lic.No/Date:0910051038 31.01.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011Ch. II dated 7.3.2013, 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 Royal Purple 1 kg 1. Isobutyl Fischer Base 6.00 kg 2. 1Nitroso2Napthol 7.220 kg 3. Methanol 30.00 kg 4. Toluene 6.250 kg 5. DMF (Di Methyl Formamide) 2.800 kg

Case No.:39/3/82ALC4/2012

21.03.2013 Status:Case Approved

24 HQ File :01/82/050/00043/AM13/ RLA File :09/24/040/00528/AM12/ Lic.No/Date:0910051037 31.01.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011Ch. II dated 7.3.2013, 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 Citrus 1 kg 1. 4Fluoro Benzophenone 0.995 kg 2. Morpholine 1.728 kg 3. NBS(NBromo Succinimide) 0.991 kg 4. 4M2N(4Morpholino2Naphthol) 0.746 kg 5. PuralMG70 0.250 kg 6. TMSA (Trimethyl Silyl Acetylene) 0.500 kg 7. THF (Tetra Hydro Furan) 3.750 kg 8. DMSO(Dimethyl Sulphoxide) 2.625 kg 9. Toluene 15.00 kg 10. Methanol 18.75 kg 11. Hexane 6.250 kg 25

Case No.:56/3/82ALC4/2012

Party Name:VINDHYA PHARMA (INDIA)PVT LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00060/AM13/ RLA File :09/24/040/00494/AM12/ Lic.No/Date:0910051044 31.01.2012 Defer Date:18.04.2013 26

Case No.:28/3/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00032/AM13/ RLA File :09/24/040/00527/AM12/ Lic.No/Date:0910051095 02.02.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011Ch. II dated 7.3.2013, 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 DPESulphate or 2,4 Diaminophenoxy Ethanol Sulphate Dihydrate 1 kg 1. 2,4 Dinitro Choloro Benzene (2,4 DNCB) 2.150 kg 2. Mono Ethylene Glycol (MEG) 4.985 kg 3. Methanol 1.260 kg 27

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

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 21.03.2013 Status:Case Rejected HQ File :01/82/050/00008/AM13/ RLA File :09/24/040/00509/AM12/ Lic.No/Date:0910051114 03.02.2012 Defer Date: Decision :It was decided to close the case as the firm has not submitted the requisite information despite repeated reminders.

Case No.:55/4/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00135/AM13/ RLA File :03/95/040/00886/AM12/ Lic.No/Date:0310681867 14.02.2012 Defer Date:18.04.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33 without any further delay otherwise their case would be closed. The case was deferred for 18.4.2013. 29

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

Party Name:ARCH PHARMALABS LTD 21.03.2013 Status:Case Rejected HQ File :01/82/050/00100/AM13/ RLA File :03/94/040/01027/AM12/ Lic.No/Date:0310683207 23.02.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 30

Case No.:27/4/82ALC4/2012

21.03.2013 Status:Case Rejected HQ File :01/82/050/00107/AM13/ RLA File :03/94/040/01049/AM12/ Lic.No/Date:0310683243 24.02.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 31

Case No.:66/4/82ALC4/2012

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/00146/AM13/ RLA File :07/24/040/00479/AM12/ Lic.No/Date:0710086622 28.02.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 23/82 dated 1.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Quantity S.No Import items Quantity Allowed Amikacin Sulphate Injection USP 250 MG/ML, 2 ml vial 1000 nos. 1. Amikacin Sulphate USP/BP 366.98 gm 32

Case No.:88/4/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00168/AM13/ RLA File :09/24/040/00601/AM12/ Lic.No/Date:0910051490 28.02.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18 4 2013 for comments of Department of Chemicals and Petrochemicals

Case No.:22/4/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00102/AM13/ RLA File :03/94/040/01067/AM12/ Lic.No/Date:0310684092 29.02.2012 Defer Date:18.04.2013 Decision :As requested by technical member from Department of Pharmaceuticals, a copy of application has been again sent to Department of Pharmaceuticals. The case was deferred for 18.4.2013 for comments of Department of Pharmaceuticals. 34

Case No.:32/3/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00036/AM13/ RLA File :03/94/040/01066/AM12/ Lic.No/Date:0310684076 29.02.2012 Defer Date:18.04.2013 35

Case No.:19/3/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00023/AM13/ RLA File :03/94/040/01095/AM12/ Lic.No/Date:0310684494 02.03.2012 Defer Date:21.03.2013 Decision :It was decided to close the case as the firm has not furnished the information despite repeated reminders. 36

Case No.:25/4/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00105/AM13/ RLA File :03/94/040/01078/AM12/ Lic.No/Date:0310684488 02.03.2012 Defer Date:18.04.2013 37

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

Party Name:LAKE CHEMICALS PRIVATE LIMITED 21.03.2013 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:18.04.2013 Decision :In the light of written comments received from Department of Pharmaceuticals, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 18.4.2013. 38

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

Party Name:HETERO LABS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00513/AM13/ RLA File :09/24/040/00034/AM13/ Lic.No/Date:0910052325 25.04.2012 Defer Date:18.04.2013 Decision :As requested by the technical member from Department of Pharmaceuticals, a copy of application has been again sent to them. The case

was deferred for 18.4.2013 for comments of Department of Pharmaceuticals. 39

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

Party Name:BALAJI AMINES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00184/AM13/ RLA File :31/83/040/00262/AM12/ Lic.No/Date:3110053954 30.04.2012 Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch. II dated 10.10.2012, 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 Quantity S.No Import items Quantity Allowed Morpholine 1 kg 1. Diethylene Glycol 1.354 kg 2. Ammonia Anhydrous 0.217 kg 3. Hydrogen Is not an importable commodity 4. Morpholine Catalyst Details not given 40

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

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 21.03.2013 Status:Case Rejected HQ File :01/83/050/00176/AM13/ RLA File :03/95/040/00092/AM13/ Lic.No/Date:0310694716 15.05.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 41

Case No.:19/14/82ALC4/2012

Party Name:NEULAND LABORATORIES LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/00396/AM13/ RLA File :09/24/040/00101/AM13/ Lic.No/Date:0910052939 08.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/631/2012PI(Norms) dated 12.3.2013, 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) Levetiracetam 1 kg 1. (S)+2Amino Butyramide Hcl 0.95 2 4Chlorobutyryl Chloride 1.35 3 Acetonitrile 2.71

4 Potassium Carbonate 0.838 5 Methylene Chloride 1.93 6 DiIsopropyl Ether 1.30 42

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

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00430/AM13/ RLA File :03/94/040/00888/AM12/ Lic.No/Date:0310697981 08.06.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/596/2012PI(Norms) dated 7.2.2013, it was decided to call from the firm the following technical details:  Complete and balanced chemical reaction at each stage showing correct molecular weight of each input and their molar requirement.  Chemical description of intermediates formed in the process and their molecular weight.  % yield on molar basis for each step of manufacturing process.  Copy of technical literature in support of yields envisaged and molar requirement of each input. The case was deferred for 18.4.2013. 43

Case No.:84/18/82ALC4/2012

Party Name:STERICON PHARMA PVT.LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/00579/AM13/ RLA File :07/24/040/00108/AM13/ Lic.No/Date:0710088798 13.06.2012 Defer Date:18.04.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 35011/655/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm the following technical details: DML for the export item no. 2 & 3 as the same is not found in the approved list of DML furnished by them. 44

Case No.:2/23/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/00802/AM13/ RLA File :22/24/040/00012/AM13/ Lic.No/Date:2210013015 14.06.2012 Defer Date:18.04.2013 45

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

Party Name:MYLAN LABORATORIES LIMITED 21.03.2013 Status:Case Approved

HQ File :01/82/050/00509/AM13/ RLA File :09/24/040/00604/AM12/ Lic.No/Date:0910053078 18.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/724/2012PI(Norms) dated 12.3.2013, 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) Gatifloxacin Hemihydrate 1 Ethyl1 cyclopropyl6,7 difluoro1,4 dihydro8 methoxy4oxo3 quinoline carboxylate (GFX Ester) 1.04 2 Acetonitrile 0.70 3 2Methyl piperazine 0.39 4 Methanol 5.00 5 Triethylamine 1.00 46

Case No.:40/18/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00535/AM13/ RLA File :09/24/040/00399/AM12/ Lic.No/Date:0910053076 18.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/723/2012PI(Norms) dated 12.3.2013, 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) Quetiapine Fumarate 1 kg 1. Dibenzo[b,f] [1,4]thiazepine11 (10H)one (DBTP) 0.58 2 Piperzine 0.78 3 2 (2 Chloro ethoxy)

3 2(2Chloro ethoxy) ethanol 0.36 4 NMethyl 2 Pyrrolidone Not required in the process 5 Fumaric Acid 0.39 47

Case No.:44/18/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00539/AM13/ RLA File :09/24/040/00666/AM12/ Lic.No/Date:0910053075 18.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/721/2012PI(Norms) dated 12.3.2013, 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) Capecitabine 1 kg 1 DRibose 2.09 2 Methanol 0.50 3 Acetone 0.95 4 Dichloro methane (MDC) 3.12 5 Sodium borohydride 0.58 6 Dimethyl sulphoxide 0.90 7 Triethyl amine 0.93 8 Isopropyl alcohol 0.22 9 Hexamethyl disilazine (HMDS) 0.60 10 5Fluorocytosine 0.553 11 npentyl chloroformate 1.122 12 nHeptane 0.54

Case No :50/18/82 ALC4/2012

Party Name:AMI LIFESCIENCES P LTD Meet No/Date:33/82 ALC4/2012 Status:Case

Case No.:50/18/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/00545/AM13/ RLA File :34/24/040/00072/AM13/ Lic.No/Date:3410034467 22.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/705/2012PI(Norms) dated 12.3.2013, 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) Quercetin Dihydrate 1 kg 1. Crude Quercetin (Assay NMT 80%) 1.16 49

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

21.03.2013 Status:Case Approved HQ File :01/82/050/00499/AM13/ RLA File :09/24/040/00110/AM13/ Lic.No/Date:0910053114 25.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/722/2012PI(Norms) dated 12.3.2013, 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) Emtricitabine 1 kg 1 (2R,5S)5(4amino5 fluoro2oxo2H pyrimidin1yl) [1,3]oxathiolane2 carboxylicacid2S Isopropyl5RMethyl 1Rcyclohexyl ester(FCE) 2.50 2 Sodium borohydride 0.51 3 Toluene 0.32 4 Methanol 0.64 5 Triethylamine 1.10 6 Methylene dichloride 3.35 RA may take appropriate action as per the decision of Norms Committee

Case No.:108/18/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00603/AM13/ RLA File :05/23/040/00471/AM12/ Lic.No/Date:0510328338 27.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/699/2012PI(Norms) dated 12.3.2013, 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) Paclitaxel Semi Synthetic white to off white powder Assay (on anhydrous solvent free basis) (%w/w): 97.0102.0 1 kg 1. (4S,5R)2(4Methoxy Phenyl)NBenzoyl4 PhenylOxazolidine5 Carboxlic Acid 1.12 2. Silica Gel 60 20.0 3. Taxus Baccatta Leaves 1722.0 51

Case No.:111/18/82ALC4/2012

Party Name:JAGSONPAL PHARMACEUTICALS LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00606/AM13/ RLA File :05/23/040/00075/AM13/ Lic.No/Date:0510328346 27.06.2012 Defer Date:18.04.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/636/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm Drug Manufacturing License for the export product Balancid Capsules. The case was deferred for 18.4.2013. 52

Case No.:31/18/82ALC4/2012

Party Name:SRIAM LABS PRIVATE LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00526/AM13/ RLA File :09/24/040/00143/AM13/ Lic.No/Date:0910053188 04.07.2012 Defer Date:18.04.2013 Decision :Department of Pharmaceuticals vide their OM No. 35011/653/2012PI(Norms) dated 12.3.2013 has informed that the case pertains to Department of Chemicals and Petrochemicals as they have owned this export items in the past also. It was decided to transfer this case to Department of Chemicals and Petrochemicals. The case was deferred for 18.4.2013. 53

Case No.:15/18/82ALC4/2012

Party Name:ASCENT FINECHEM PVT. LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/00510/AM13/ RLA File :08/24/040/00112/AM13/ Lic.No/Date:0810113196 09.07.2012 Defer Date:18.04.2013

Case No.:68/18/82ALC4/2012

Party Name:SMILAX LABORATORIES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00563/AM13/ RLA File :09/24/040/00148/AM13/ Lic.No/Date:0910053214 09.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/642/2012PI(Norms) dated 12.3.2013, 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) 2(NTriphenyl methyl tetrazolyl)4bromo methyl biphenyl (TTBB) 1 kg 1 2Cyano4methyl biphenyl 0.52 2 Toluene 0.20 3 Methylene dichloride 1.74 4 Methanol 0.11 55

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

Party Name:SMILAX LABORATORIES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00564/AM13/ RLA File :09/24/040/00156/AM13/ Lic.No/Date:0910053216 09.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/642/2012PI(Norms) dated 12.3.2013, 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) 2,4OBis(trimethylsilyl) erythromycinA9[O(1 methoxy1 methyl)ethyl)oxime 1 kg 1 Erythromycin thiocyanate 0.86 2 Methylene dichloride 3.80 3 Methanol 0.51 4 Hydroxylamine HCL 0.377 5 2Methoxy propene 0.233 6 Pyridine hydrobromide 0.212 7 Hexamethyl disilazane 0 261

7 Hexamethyl disilazane 0.261 56

Case No.:5/18/82ALC4/2012

Party Name:SWISS PARENTERALS PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00500/AM13/ RLA File :08/24/040/00122/AM13/ Lic.No/Date:0810113430 17.07.2012 Defer Date:18.04.2013 57

Case No.:51/18/82ALC4/2012

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00546/AM13/ RLA File :04/24/040/00074/AM13/ Lic.No/Date:0410138168 17.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/704/2012PI(Norms) dated 12.3.2013, 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) 2Trifluoro Methyl Phenothiazine Drug Intermediate 1 kg 3Trifluoro Methyl Aniline Raw Material 2.36 58

Case No.:70/18/82ALC4/2012

Party Name:INGA LABORATORIES PVT LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00565/AM13/ RLA File :03/94/040/00284/AM13/ Lic.No/Date:0310702227 18.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/652/2012PI(Norms) dated 12.3.2013, 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) Tab. Cholergol (each film coated Tab. Contains 30 mg of nicergoline ) BP/EP 1 tablet 1 Nicergoline 30.6 Mg/Tablet 59

Case No.:23/21/82ALC4/2012

Party Name:ASTRIX LABORATORIES LTD Meet No/Date:33/82ALC4/2012 Status:Case

Case No.:23/21/82 ALC4/2012

Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:33/82 ALC4/2012 21.03.2013 Status:Case Approved HQ File :01/82/050/00653/AM13/ RLA File :09/24/040/00155/AM13/ Lic.No/Date:0910053315 20.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/676/2012PI(Norms) dated 12.3.2013, 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) Stavudine 1 kg 1 3’,5’DiO methanesulfonyl2,2’ anhydro5 methyluridine 3.31 2 HBr in acetic acid (30 35% w/w) 2.78 3 NMethyl pyrrolidinone 1.40 4 Activate Carbon 0.100 5 Methanol 2.95 6 Dimethyl formamide 2.86 7 Iso propyl alcohol 6.93 60

Case No.:31/21/82ALC4/2012

Party Name:MSN LABORATORIES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00661/AM13/ RLA File :09/24/040/00171/AM13/ Lic.No/Date:0910053316 20.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/678/2012PI(Norms) dated 12.3.2013, 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) Finasteride 1 kg 1. NTButyl4aza5 AlphaAndrosta3 one 17Beta carboxamide 1.7647 2

2 Bis(Trimethylsilyl) Trifluoro acetamide 1.47 3 2,3Dichloro5,6 Dicyano1,4 Benzoquinone 0.86 61

Case No.:35/18/82ALC4/2012

Party Name:INTAS PHARMACEUTICALS LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/00530/AM13/ RLA File :08/24/040/00128/AM13/ Lic.No/Date:0810113566 20.07.2012 Defer Date:18.04.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 25011/649/2012PI (Norms) dated 12.3.2013, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 18.4.2013. 62

Case No.:61/21/82ALC4/2012

Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/00691/AM13/ RLA File :09/24/040/00184/AM13/ Lic.No/Date:0910053311 20.07.2012 Defer Date:18.04.2013 63

Case No.:48/18/82ALC4/2012

Party Name:RONAK CHEMICALS 21.03.2013 Status:Case Deferred HQ File :01/82/050/00543/AM13/ RLA File :34/24/040/00109/AM13/ Lic.No/Date:3410034708 23.07.2012 Defer Date:18.04.2013 64

Case No.:1/15/82ALC4/2012

Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:33/82ALC4/2012 21.03.2013 Status:Case Approved HQ File :01/82/050/00436/AM13/ RLA File :31/83/040/00067/AM13/ Lic.No/Date:3110055076 24.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/702/2012PI(Norms) dated 12.3.2013, 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) Dexketoprofen Trometamol (Relevant Bulk Drug) 1 kg 1. 3(1Cynoethyl) Benzophenone 1.82 2. NOctylDGlucamine 0.36

Case No.:58/21/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/00688/AM13/ RLA File :09/24/040/00166/AM13/ Lic.No/Date:0910053338 24.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/671/2012PI(Norms) dated 12.3.2013, 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) Methyl Alpha‐(4,5,6,7‐ Tetrahydra‐5‐ Thieno(3,2‐c)pyridyl)(2‐ Chlorophenyl)Acetate Hyderochloride (CPG‐ 20) 1 kg 1 4,5,6,7 Tetrahydrothieno [3,2c]pyridine hydroxide (CPG 10) 0.74 2 N Bromosuccinamide 0.81 3 Methyl o chlorophenyl acetate 0.77 66

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

Party Name:ANUH PHARMA LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00641/AM13/ RLA File :03/94/040/00293/AM13/ Lic.No/Date:0310703076 25.07.2012 Defer Date:18.04.2013 67

Case No.:27/21/82ALC4/2012

Party Name:STELLENCE PHARMSCIENCE PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00657/AM13/ RLA File :07/24/040/00183/AM13/ Lic.No/Date:0710089972 31.07.2012 Defer Date:18.04.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 35011/667/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm the following details: Complete technical details as per Appendix 33. End use of the export product.

p p It was decided to defer the case for 18.4.2013. 68

Case No.:55/21/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00685/AM13/ RLA File :09/24/040/00203/AM13/ Lic.No/Date:0910053388 31.07.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/662/2012PI(Norms) dated 12.3.2013, 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) Benazepril Hydrochloride 1 kg 1. ®2Hydroxy4Phenyl butanoic acid ethyl ester 0.704 2. 4Nitrobenzensulfonyl Chloride 0.893 3. Carbon Enoanticronos (Activated Carbon) 0.033 4. Hexanes 3.52 5. Potassium Carbonate 0.132 6. TertButyl (S)3Amino Capralactum 0.826 7. Toluene 2.196 8. Triethylamine 0.48 69

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

Party Name:RANBAXY LABORATORIES LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/00628/AM13/ RLA File :05/24/040/00148/AM13/ Lic.No/Date:0510331126 01.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/626/2012PI(Norms) dated 12.3.2013, 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)

Valganciclovir Hydrochloride (Bulk Drug/Pharmacopeal Grade) 1 kg 1 Acetone 1.43 2 Acetivate carbon 0.100 3 CBZLValine 2.465 4 Dicyclohexyl Carbodiimide 3.064 5 Dimethyl Sulphoxide 13.57 6 Ganciclovir 2.14 7 Isopropyl Alchohol 12.85 8 Methanol 31.44 9 Methylene Chloride 11.94 10 Palladium Sponge 1 gm/kg RA may take appropriate action as per the decision of Norms Committee. 70

Case No.:17/21/82ALC4/2012

Party Name:LUPIN LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00647/AM13/ RLA File :03/95/040/00304/AM13/ Lic.No/Date:0310704078 03.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/664/2012PI(Norms) dated 12.3.2013, 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 Meloxicam 7.5 mg tabs (Net Weight 2361.38 kgs, weight of drug 2408.61 kgs) 1 tablet 1. Meloxicam 7.65 mg 2. Microcrystalline Cellulose (Avicel 101) 117.0 mg 3. Lactose Monohydrate (Pharmatose 200 m) 39.7 mg 4. Crospovidone (Kollidon CL) 5.0 mg 5. Povidone (K30/BASF) 5.0 mg 6. Sodium Citrate (Dihydrate/Merck) 2.70 mg 7. Colloidal Silicon Dioxide (Aerosil 200) 0.90 mg

(Aerosil 200) 8. Magnesium Stearate (Veg. Grade) 0.90 mg 9. 33 MM CR Closure with HS 12335 PRT KERR Relevant, as per packing policy Meloxicam 15 mg tabs (Net weight 7745.13 kgs, weight of drug 7900.03 kgs) 1 tablet 1 Meloxicam 15.3 mg 2 Microcrystalline Cellulose (Avicel 101) 110.0 mg 3 Lactose Monohydrate (Pharmatose 200 m) 39.7 mg 4 Crospovidone (Kollidon CL) 5.0 mg 5 Povidone (K30/BASF) 5.0 mg 6 Sodium Citrate (Dihydrate/Merck) 2.70 mg 7 Colloidal Silicon Dioxide (Aerosil 200) 0.90 mg 8 Magnesium Stearate (Veg. Grade) 0.90 mg 9 33 MM CR Closure with HS 12335 PRT KERR Relevant, as per packing policy 71

Case No.:18/21/82ALC4/2012

Party Name:LUPIN LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00648/AM13/ RLA File :03/95/040/00303/AM13/ Lic.No/Date:0310704080 03.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/664/2012PI(Norms) dated 12.3.2013, 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 Levofloxacin 250 mg tabs. (net weight743.75 kgs, weight of drug 758.63 kgs) 1 no. of Levofloxacin Tablet 1. Levofloxacin Hemihydrate 255.0 mg 2. Microcrystalline Cellulose Avicel 101 40.0 mg 3 Crospovidone Kollidon 9 0 mg

Crospovidone Kollidon CL 9.0 mg 4. Hypermellose Methocel E3 LVP 5.0 mg 5. Microcrystalline Cellulose Avicel 102 35.0 mg 6. Magnesium Stearate (Veg. grade) 6.0 mg 7. 33 MM CR closure with HS 12335 PRT KERR Relevant, as per packing policy Levofloxacin 500 mg tabs (Net weight 7163.50 kgs, weight of drug 7306.77 kgs) 1 no. of Levofloxacin Tablet 1. Levofloxacin Hemihydrate 510.0 mg 2. Microcrystalline Cellulose Avicel 101 80.0 mg 3. Crospovidone Kollidon CL 18.0 mg 4. Hypermellose Methocel E3 LVP 10.0 mg 5. Microcrystalline Cellulose Avicel 102 69.0 mg 6. Magnesium Stearate (Veg. grade) 12.0 mg 7. 33 MM CR closure with HS 12335 PRT KERR Relevant, as per packing policy Levofloxacin 750 mg tabs (net weight 2266.76 kgs, weight of drug 2312.10 kgs) 1 no. of levofloxacin tablet 1. Levofloxacin Hemihydrate 765.0 mg 2. Microcrystalline Cellulose Avicel 101 120.0 mg 3. Crospovidone Kollidon CL 27.0 mg 4. Hypermellose Methocel E3 LVP 15.0 mg 5. Microcrystalline Cellulose Avicel 102 104.0 mg

Magnesium Stearate (Veg. grade) 18.0 mg 7. 33 MM CR closure with HS 12335 PRT KERR Relevant, as per packing policy 72

Case No.:20/22/82ALC4/2012

Party Name:HETERO LABS LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00723/AM13/ RLA File :09/24/040/00225/AM13/ Lic.No/Date:0910053420 03.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/664/2012PI(Norms) dated 12.3.2013, 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) Losartan Potassium 1 kg 1 Valeronitrile 0.738 2 Glycine 0.50 3 2Cyano4metnyl biphenyl 0.68 4 1,3dibromo5,5 dimethyl hydantoin 0.205 5 Tetrabutyl ammonium bromide 0.100 6 Sodium borohydride 0.048 7 Sodium azide 0.50 8 Nmethyl pyrrolidone 0.769 It was also decided to call All Industry Production Consumption data from Pharmexcil for revision of SION A 2919 for Losartan Potassium. 73

Case No.:35/21/82ALC4/2012

Party Name:PADMINI AROMATICS PVT. LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00665/AM13/ RLA File :07/24/040/00177/AM13/ Lic.No/Date:0710090045 03.08.2012 Defer Date:18.04.2013 Decision :It was decided to remind the firm to furnish production consumption data duly verified by Central Excise Authority Department of

Decision :It was decided to remind the firm to furnish production consumption data duly verified by Central Excise Authority. Department of Chemicals and Petrochemicals also to give comments whether the export product is perfume or perfumery compound. The case was deferred for 18.4.2013. 74

Case No.:48/21/82ALC4/2012

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:33/82ALC4/2012 21.03.2013 Status:Case Approved HQ File :01/82/050/00678/AM13/ RLA File :34/24/040/00118/AM13/ Lic.No/Date:3410034784 03.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/17/2013PI(Norms) dated 12.3.2013, 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 Theophylline Extended Release Tablets 300 mg (Net content of active ingredients – 2160.66 kgs) 1 no. of tablet 1. Theophylline Anhydrous Powder 200 M (Theophylline Anhydrous USP) 306.0 mg 2 Methocel K 100 Premium LV CR LH (Hydroxypropyl Methylcellulose ) 134.0 mg 3 HPMCMethocel K 100 LVCR Premium 53.0 mg 4 Lactose Monohydrate (Impalpable) 120.40 mg 5 Povidone K30 (Plasdone K29/32) 16.60 mg 6 Ethyl Alcohol Anhydrous USP 318.6 ml 7 Magnesium Stearate 6.00 mg Theophylline Extended Release Tablets 450 mg (Net Content of active ingredients – 67.50 kgs) 1 no. of tablet 1. Theophylline Anhydrous Anhydrous Powder 200 M (Theophylline Anhydrous USP) 459.0 mg 2 Methocel K 100 Premium LV CR LH (Hydroxypropyl Methylcellulose ) 201.0 mg 3 HPMC Methocel K 79 50 mg

3 HPMCMethocel K 100 LVCR Premium 79.50 mg 4 Lactose Monohydrate (Impalpable) 180.60 mg 5 Povidone K30 (Plasdone K29/32) 24.90 mg 6 Ethyl Alcohol Anhydrous USP 574.4 ml 7 Magnesium Stearate 9.00 mg 75

Case No.:63/21/82ALC4/2012

Party Name:ASTRIX LABORATORIES LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/00693/AM13/ RLA File :09/24/040/00227/AM13/ Lic.No/Date:0910053422 03.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/676/2012PI(Norms) dated 12.3.2013, 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 Efavirenz (ESA) 1 kg 1. 4Chloro2 trifluoroacetyl aniline hydrochloride hydrate (E2) 1.45 Cyclo Propyl Acetylene 0.51 Zinc Acetate anhydrous 1.20 Citric Acid Mono hydrate 0.788 Tetra hydrofuran 3.73 Toluene 9.075 Methanol 4.395 Triphosgene 0.448 nButyl Chloride 0.537 1,2Di Bromo Ethane 0.01

(EDB) (1R,2S)NPyrrolidinyl Norephedrine solution (30%40% solution in Toluene) (As 100%) (NPN) 0.08 Tri Fluoro Ethanol (TCE) 0.447 76

Case No.:19/21/82ALC4/2012

Party Name:LUPIN LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00649/AM13/ RLA File :03/95/040/00305/AM13/ Lic.No/Date:0310704227 06.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/664/2012PI(Norms) dated 12.3.2013, 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 (mg) Pravastatin Sodium 10 mg Tablets (Net weight129.84 kgs, weight of drug 132.44 kgs) 1 no. of Pravastatin Tablet 1. Pravastatin Sodium 10.2 mg 2. Lactose Monohydrate (DMV INT DCL 11) 81.6 mg 3, Crospovidone (Kollidon CL) 5.0 mg 4. Sodium Bicarbonate/Cryst Pow/PAU L LOH 0.90 mg 5. Collodial Silicon Dioxide (Aerosil 200) 0.50 mg 6. Magnesium Stearate (Veg. Grade) 2.0 mg 7. 33 MM CR Closure with its 12335 PRT KERR Relevant, as per packing policy Pravastatin Sodium 20 mg Tablets (Net weight 1064.80 kgs, weight of drug 1086.10 kgs) 1 no. of Pravastatin Tablet 1. Pravastatin Sodium 20.4 mg 2. Lactose Monohydrate (DMV INT DCL 11) 163.0 mg 3, Crospovidone (Kollidon CL) 10.0 mg

Sodium Bicarbonate/Cryst Pow/PAU L LOH 1.80 mg 5. Collodial Silicon Dioxide (Aerosil 200) 1.0 mg 6. Magnesium Stearate (Veg. Grade) 4.0 mg 7. 33 MM CR Closure with its 12335 PRT KERR Relevant, as per packing policy Pravastatin Sodium 40 mg Tablets (Net Weight 3682.08 kgs, weight of drug 3755.72 kgs) 1 no. of Pravastatin Tablet 1. Pravastatin Sodium 40.8 mg 2. Lactose Monohydrate (DMV INT DCL 11) 326.0 mg 3, Crospovidone (Kollidon CL) 20.0 mg 4. Sodium Bicarbonate/Cryst Pow/PAU L LOH 3.60 mg 5. Collodial Silicon Dioxide (Aerosil 200) 2.0 mg 6. Magnesium Stearate (Veg. Grade) 8.0 mg 7. 33 MM CR Closure with its 12335 PRT KERR Relevant, as per packing policy Pravastatin sodium 80 mg Tablets (Net weight 2917.14 kgs, weight of drug 2975.48 652.0kgs) 1 no. of Pravastatin Tablet 1. Pravastatin Sodium 81.6 mg 2. Lactose Monohydrate (DMV INT DCL 11) 652.0 mg 3, Crospovidone (Kollidon CL) 40.0 mg 4. Sodium Bicarbonate/Cryst Pow/PAU L LOH 7.0 mg 5. Collodial Silicon Dioxide (Aerosil 200) 4.0 mg 6. Magnesium Stearate (Veg. Grade) 16.0 mg

33 MM CR Closure with its 12335 PRT KERR Relevant, as per packing policy 77

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

Party Name:AUCTUS PHARMA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00725/AM13/ RLA File :09/24/040/00206/AM13/ Lic.No/Date:0910053463 09.08.2012 Defer Date:18.04.2013 Decision : It was decided to defer the case for 18.4.2013 for comments of Department of Pharmaceuticals. 78

Case No.:44/22/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00747/AM13/ RLA File :03/94/040/00347/AM13/ Lic.No/Date:0310704825 10.08.2012 Defer Date:18.04.2013 79

Case No.:3/18/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/00498/AM13/ RLA File :05/24/040/00185/AM13/ Lic.No/Date:0510331907 14.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/635/2012PI(Norms) dated 12.3.2013, 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 (mg) Ticarcillin and Clavulanic Acid for injection USP 1.6 gm (Ticarnic 1.6 gm) 1 no. of vial 1. Ticarcillin Disodium and Potassium Clavulante (15:1) Raw material 1.68 gm Ticarcillin and Clavulanic Acid for injection USP 3.2 gm (Ticarnic 3.2 gm) 1 no. of vial Ticarcillin Disodium and Potassium Clavulanate (15:1) Raw material 3.36 gm 80

Case No.:65/21/82ALC4/2012

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00695/AM13/ RLA File :09/24/040/00239/AM13/ Lic.No/Date:0910053490 14.08.2012 Defer Date:18.04.2013

Case No.:24/22/82ALC4/2012

Party Name:HETERO LABS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00727/AM13/ RLA File :09/24/040/00174/AM13/ Lic.No/Date:0910053519 16.08.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.04.2013 for comments of Department of Pharmaceuticals. 82

Case No.:65/22/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00768/AM13/ RLA File :03/94/040/00380/AM13/ Lic.No/Date:0310705390 16.08.2012 Defer Date:18.04.2013 83

Case No.:25/22/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00728/AM13/ RLA File :09/24/040/00250/AM13/ Lic.No/Date:0910053546 17.08.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/669/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm the technical details as per Appendix 33. The case was deferred for 18.4.2013. 84

Case No.:27/22/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00730/AM13/ RLA File :09/24/040/00249/AM13/ Lic.No/Date:0910053547 17.08.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/669/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm the technical details as per Appendix 33. The case was deferred for 18.4.2013. 85

Case No.:40/21/82ALC4/2012

Party Name:VITAL LABORATORIES PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00670/AM13/ RLA File :03/95/040/00254/AM13/ Lic.No/Date:0310705409 17.08.2012 Defer Date:18.04.2013 86

Case No.:41/21/82ALC4/2012

Party Name:MEDLEY PHARMACEUTICALS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00671/AM13/ RLA File :03/95/040/00273/AM13/ Lic.No/Date:0310705411 17.08.2012 Defer Date:18.04.2013

Decision :It was decided to call from the firm a copy of Drug Manufacturing License. The case was deferred for 18.4.2013. 87

Case No.:62/21/82ALC4/2012

Party Name:VASUDHA PHARMA CHEM LTD 21.03.2013 Status:Deffered HQ File :01/82/050/00692/AM13/ RLA File :09/24/040/00204/AM13/ Lic.No/Date:0910053534 17.08.2012 Defer Date:18.04.2013 Decision : It was decided to defer the case for 18.4.2013 for comments of Department of Pharmaceuticals. 88

Case No.:64/21/82ALC4/2012

Party Name:ECOLOGIC CHEMICALS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00694/AM13/ RLA File :09/24/040/00199/AM13/ Lic.No/Date:0910053533 17.08.2012 Defer Date:18.04.2013 89

Case No.:36/21/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00666/AM13/ RLA File :08/24/040/00147/AM13/ Lic.No/Date:0810114381 21.08.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/663/2012PI(Norms), it was decided to call from the firm the following technical details:  Complete description and quantitative requirement applied for import for the manufacture of 1 kg Omeprazole API.  To furnish applied norms for all the three export products separately. 90

Case No.:69/21/82ALC4/2012

Party Name:ASCENT FINECHEM PVT. LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/00699/AM13/ RLA File :08/24/040/00160/AM13/ Lic.No/Date:0810114398 21.08.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.04.2013 for comments of Department of Chemicals and Petrochemicals. 91

Case No.:24/21/82ALC4/2012

Party Name:R L FINE CHEM 21.03.2013 Status:Case Approved HQ File :01/82/050/00654/AM13/ RLA File :07/24/040/00218/AM13/ Lic.No/Date:0710090322 22.08.2012 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/677/2012PI(Norms) dated 12.3.2013, 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) Nortriptyline HCL BP/USP 1 kg 1 1,Bromo 3 Chloro Propane 0.96 2 Tetra Hydro Furan 0.71 3 Ethyl Chloro Formate 0.46 92

Case No.:52/21/82ALC4/2012

Party Name:BAL PHARMA LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00682/AM13/ RLA File :07/24/040/00221/AM13/ Lic.No/Date:0710090348 23.08.2012 Defer Date:18.04.2013 93

Case No.:5/22/82ALC4/2012

Party Name:SANOFI INDIA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00708/AM13/ RLA File :03/95/040/00318/AM13/ Lic.No/Date:0310706473 27.08.2012 Defer Date:18.04.2013 94

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

Party Name:PROMED EXPORTS PVT.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/00614/AM13/ RLA File :05/24/040/00201/AM13/ Lic.No/Date:0510332840 28.08.2012 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/634/2012PI(Norms) dated 12.3.2013, 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 Cyclomed Eye Drops 1% 5 ml (Net content of bulk drug=92.593 kgs) 1 no. of vial 1. Cyclopentolate HCL 51.0 mg per 5 ml vial. 95

Case No.:6/21/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00636/AM13/ RLA File :05/24/040/00202/AM13/ Lic No/Date:0510332772 Defer

95 HQ File :01/82/050/00636/AM13/ RLA File :05/24/040/00202/AM13/ Lic.No/Date:0510332772 28.08.2012 Defer Date:18.04.2013 96

Case No.:35/24/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00839/AM13/ RLA File :09/24/040/00245/AM13/ Lic.No/Date:0910053622 29.08.2012 Defer Date:18.04.2013 97

Case No.:31/22/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 21.03.2013 Status:Case Approved HQ File :01/82/050/00734/AM13/ RLA File :07/24/040/00230/AM13/ Lic.No/Date:0710090488 30.08.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 15.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg Calcium Carbonate 1250 mg+Glycine 535.7 mg tablets (no. of Tabs 4000000) (Glycine2142.800 kgs+Calcium – 5000.000 kgs) 1000 tablets 1 Glycine USP/BP Not shown in DML 2. Calcium Carbonate Dense BP/USP 1.25 kg 98

Case No.:69/24/82ALC4/2012

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00873/AM13/ RLA File :03/95/040/00323/AM13/ Lic.No/Date:0310707470 03.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/92/2011/Ch. II dated 7.3.2013, 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 3,4,5 Tri Fluoro Bromo Benzene 1 kg 1. 2,3,4 Tri Fluoro Nitro Benzene 1.45 kg 2. Bromine 1.11 kg 3. Sodium Nitrite 0.385 kg

Case No.:45/22/82ALC4/2012

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/00748/AM13/ RLA File :03/94/040/00115/AM13/ Lic.No/Date:0310707571 04.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/686/2012PI(Norms) dated 12.3.2013, 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 Silyl Ester (2,4‐O‐Bis (trimethylsilyl)‐ erythromycin –A‐9[O‐ (methoxy‐1‐methyl ethyl) oxime 1 kg 1 Erythromycin thiocyanate (on 100% Activity Basis) 0.86 2. Hydroxylamine HCL 0.377 3. 2Methoxy propene 0.233 100

Case No.:53/22/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00756/AM13/ RLA File :03/94/040/00137/AM13/ Lic.No/Date:0310707577 04.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, 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 Lumefantrine 1 kg 1. 2,7dichlorofluorene 0.76 kg 2. Chloro acetyl Chloride 0.40 kg 3. Sodium Borohydride 0.06 kg 4. DiNButyl Amine 0.50 kg 5. 4Chloro Benzaldehyde 0.37 kg 6. NButanol 6.28 kg

Case No.:55/22/82ALC4/2012

PHARMACEUTICALS LTD. 21.03.2013 Status:Case Approved

101 21.03.2013 Approved HQ File :01/82/050/00758/AM13/ RLA File :03/94/040/00117/AM13/ Lic.No/Date:0310707585 04.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/686/2012PI(Norms) dated 12.3.2013, 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 Silylester (2,4O Bis(trimethylsillyl) erthromycinA9[O(1 methoxy1methyl ethyl) oxime 1 kg 1. Erythromycin Thiocyanate (on 100% Activity Basis) 0.86 kg 2. Hydroxylamine Hydrochloride 0.377 kg 3. 2Methoxy Propene 0.233 kg 102

Case No.:56/22/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00759/AM13/ RLA File :03/94/040/00034/AM13/ Lic.No/Date:0310707587 04.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, 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 Lumefantrine 1 kg 1. 2,7dichlorofluorene 0.76 kg 2. Chloro acetyl Chloride 0.40 kg 3. Sodium Borohydride 0.06 kg 4. DiNButyl Amine 0.50 kg 5. 4Chloro Benzaldehyde 0.37 kg 6. NButanol 6.28 kg

Case No.:60/22/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00763/AM13/ RLA File :03/94/040/00105/AM13/ Lic.No/Date:0310707569 04.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, 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

103 p p p y p y Lumefantrine 1 kg 1. 2,7dichlorofluorene 0.76 kg 2. Chloro acetyl Chloride 0.40 kg 3. Sodium Borohydride 0.06 kg 4. DiNButyl Amine 0.50 kg 5. 4Chloro Benzaldehyde 0.37 kg 6. NButanol 6.28 kg 104

Case No.:40/22/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00743/AM13/ RLA File :03/94/040/00109/AM13/ Lic.No/Date:0310707803 05.09.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/686/2012PI(Norms) dated 12.3.2013, it was decided call from the firm the following technical details: The firm has applied for the import of 2cyano4methyl biphenyl (OTBN) whereas the chemistry and other details show the starting stage of 2 cyano4bromomethyl biphenyl. The firm is requested to furnish the actual import and the relevant chemistry. 105

Case No.:62/22/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00765/AM13/ RLA File :03/94/040/00429/AM13/ Lic.No/Date:0310707808 05.09.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm complete technical details as per Appendix 33. The case was deferred for 18.4.2013. 106

Case No.:78/22/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00781/AM13/ RLA File :03/94/040/00430/AM13/ Lic.No/Date:0310707806 05.09.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm complete technical details as per Appendix 33. The case was deferred for 18.4.2013

Case No.:79/22/82ALC4/2012

21.03.2013 Status:Case Approved

107 HQ File :01/82/050/00782/AM13/ RLA File :03/94/040/00104/AM13/ Lic.No/Date:0310707802 05.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, 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 Lumefantrine 1 kg 1. 2,7dichlorofluorene 0.76 kg 2. Chloro acetyl Chloride 0.40 kg 3. Sodium Borohydride 0.06 kg 4. DiNButyl Amine 0.50 kg 5. 4Chloro Benzaldehyde 0.37 kg 6. NButanol 6.28 kg 108

Case No.:80/22/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00783/AM13/ RLA File :03/94/040/00118/AM13/ Lic.No/Date:0310707813 05.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/691/2012PI(Norms) dated 12.3.2013, 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 Azithromycin Dihydrate 1 kg 1. Azithromycin Amine 1.00 kg 109

Case No.:39/26/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00947/AM13/ RLA File :09/24/040/00276/AM13/ Lic.No/Date:0910053682 06.09.2012 Defer Date:18.04.2013 110

Case No.:58/22/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00761/AM13/ RLA File :03/94/040/00113/AM13/ Lic.No/Date:0310707983 06.09.2012 Defer Date: 18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/686/2012PI(Norms) dated 12 3 2013 it was decided call from the firm the following technical details:

110 12.3.2013, it was decided call from the firm the following technical details: The firm has applied for the import of 2cyano4methyl biphenyl (OTBN) whereas the chemistry and other details show the starting stage of 2 cyano4bromomethyl biphenyl. The firm is requested to furnish the actual import and the relevant chemistry. 111

Case No.:59/22/82ALC4/2012

21.03.2013 Status:Approved HQ File :01/82/050/00762/AM13/ RLA File :03/94/040/00119/AM13/ Lic.No/Date:0310707975 06.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/691/2012PI(Norms) dated 12.3.2013, 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 Azithromycin Dihydrate 1 kg 1. Azithromycin Amine 1.00 kg 112

Case No.:61/22/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00764/AM13/ RLA File :03/94/040/00106/AM13/ Lic.No/Date:0310707970 06.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, 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 Lumefantrine 1 kg 1. 2,7dichlorofluorene 0.76 kg 2. Chloro acetyl Chloride 0.40 kg 3. Sodium Borohydride 0.06 kg 4. DiNButyl Amine 0.50 kg 5. 4Chloro Benzaldehyde 0.37 kg 6. NButanol 6.28 kg

Case No.:83/22/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00786/AM13/ RLA File :03/94/040/00498/AM11/ Lic.No/Date:0310707992 06.09.2012 Defer Date:

113 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, 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 Lumefantrine 1 kg 1. 2,7dichlorofluorene 0.76 kg 2. Chloro acetyl Chloride 0.40 kg 3. Sodium Borohydride 0.06 kg 4. DiNButyl Amine 0.50 kg 5. 4Chloro Benzaldehyde 0.37 kg 6. NButanol 6.28 kg 114

Case No.:76/22/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00779/AM13/ RLA File :03/94/040/00437/AM13/ Lic.No/Date:0310708094 07.09.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm complete technical details as per Appendix 33. The case was deferred for 18.4.2013 115

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

21.03.2013 Status:Case Approved HQ File :01/82/050/00785/AM13/ RLA File :03/94/040/00017/AM11/ Lic.No/Date:0310708089 07.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, 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 Artesunate 1 kg 1. Artemisinin 0.9259 kg 2. Sodium Borohydride 0.150 kg 3. Succinic Anhydride 0.350 kg

Case No.:85/22/82ALC4/2012

21.03.2013 Status: Approved HQ File :01/82/050/00788/AM13/ RLA File :03/94/040/00136/AM13/ Lic.No/Date:0310708279 10.09.2012 Defer Date:

116 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2012PI(Norms) dated 12.3.2013, 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 Lumefantrine 1 kg 1. 2,7dichlorofluorene 0.76 kg 2. Chloro acetyl Chloride 0.40 kg 3. Sodium Borohydride 0.06 kg 4. DiNButyl Amine 0.50 kg 5. 4Chloro Benzaldehyde 0.37 kg 6. NButanol 6.28 kg RA may take appropriate action as per the decision of Norms Committee 117

Case No.:99/24/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/00903/AM13/ RLA File :34/24/040/00153/AM13/ Lic.No/Date:3410035105 10.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/705/2012PI(Norms) dated 12.3.2013, 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 Quercetin Dihydrate 1 kg 1 Crude Quercetin (Assay NMT 80%) 1.16 kg RA may take appropriate action as per the decision of Norms Committee 118

Case No.:2/21/82ALC4/2012

Party Name:ZEE LABORATORIES 21.03.2013 Status:Case Deferred HQ File :01/82/050/00632/AM13/ RLA File :05/24/040/00220/AM13/ Lic.No/Date:0510334505 12.09.2012 Defer Date:18.04.2013 119

Case No.:3/21/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00633/AM13/ RLA File :08/24/040/00144/AM13/ Lic.No/Date:0810115056 12.09.2012 Defer Date:18.04.2013

120

Case No.:30/26/82ALC4/2012

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/00938/AM13/ RLA File :07/24/040/00253/AM13/ Lic.No/Date:0710090701 12.09.2012 Defer Date: Decision : In line with the earlier decision taken in meeting no. 23/82 dated 1.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Quantity S.No Import items Quantity Allowed Amikacin Sulphate Injection USP 500 MG/ML, 2 ml vial 1000 nos. 1. Amikacin Sulphate USP/BP 733.96 gm 121

Case No.:75/22/82ALC4/2012

Party Name:CIPLA LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/00778/AM13/ RLA File :03/94/040/00499/AM13/ Lic.No/Date:0310708794 12.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/14/2013PI(Norms dated 12.3.2013, 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 Item No. 1 Quantity allowed Ritonavir Tablets 100 mg Ritonavir…………102.0 mg/tablet Export Item No. 2 Quantity allowed Lopinavir and Ritonavir Oral Solution each ml contains Ritonavir 20 mg: 160 ml pack Ritonavir…………3360 mg per pack (B) Norms allowed for Ritonavir S.No Import Item Quantity Allowed kg/kg 1. 1,3Thiazol5ylmylN[(1S,2S,4S)4amino 1benzyl2OH5pylpentyl]carbamic acid tert butyl ester (R8) 1.072 2 (2S)2([[[(2Isopropyl1,3thiazol4 yl)methyl]methylamino]carbonyl]amino)3 methyl butyric acid [R9] 0.74 3. Tetrahydrofuran 4.127 C 62/24/ 2 A C4/2012 A A A S / 33/82 A C4/2012 S C

122

Case No.:62/24/82ALC4/2012

Party Name:AMBUJA INTERMEDIATES LIMITED Meet No/Date:33/82ALC4/2012 21.03.2013 Status:Case Deferred HQ File :01/82/050/00866/AM13/ RLA File :03/94/040/00383/AM13/ Lic.No/Date:0310709139 14.09.2012 Defer Date:18.04.2013 Decision :It was decided to remind the firm to furnish the following information sought by Department of Chemicals and Petrochemicals vide their letter dated 1.3.2013: Details of manufacturing process with chemical equations, molecular formula, molecular weight. Yield obtained in each step. Authentic technical literature in support of yield obtained. CA certificate certifying the production of export item achieved by the firm for the last three years and corresponding consumption of each input. 123

Case No.:66/24/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00870/AM13/ RLA File :03/94/040/00423/AM13/ Lic.No/Date:0310709103 14.09.2012 Defer Date:18.04.2013 124

Case No.:77/24/82ALC4/2012

Party Name:ASHISH LIFE SCIENCE PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00881/AM13/ RLA File :03/94/040/00378/AM13/ Lic.No/Date:0310709108 14.09.2012 Defer Date:18.04.2013 Decision :It was decided to give a final reminder to the firm to furnish the complete details of their export product and also a copy of valid Drug Manufacturing License, within 15 days else their case would be closed. The case was deferred for 18.4.2013.

Case No.:7/33/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 21.03.2013 Status:Case Approved HQ File :01/82/050/01154/AM13/ RLA File :07/24/040/00263/AM13/ Lic.No/Date:0710090784 17.09.2012 Defer Date: Decision :In the light of earlier decision taken in meeting no. 20/82 dated 20.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per 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 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phsophate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 1.632 kg Adco Dol Tab – Paracetamol 450 mg+ Codeine Phosphate 1 million tablets 1. Doxylamine Succinate USP/Ph. Eur Grade 5.10 kg

125 450 mg+ Codeine Phosphate 10 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg tablets Grade 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 1 million 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 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 126

Case No.:63/24/82ALC4/2012

Party Name:GOPALDAS VISRAM & CO.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/00867/AM13/ RLA File :03/94/040/00409/AM13/ Lic.No/Date:0310709515 18.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import items Qty. allowed FunbactA Cream 30 gms/FunbactA Lotion 30 gms 30 gm Tube 1. Clotrimazole USP 0.306 gm/30 gm Tube 2. Neomycin Sulphate USP 0.153 gm/30 gm Tube 127

Case No.:74/24/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00878/AM13/ RLA File :03/94/040/00460/AM13/ Lic.No/Date:0310709540 18.09.2012 Defer Date:18.04.2013 Decision : It was decided to defer the case for 18.04.2013 for comments of Department of Pharmaceuticals.

Case No.:72/21/82ALC4/2012

Party Name:BELCO PHARMA 21.03.2013 Status:Case Approved HQ File :01/82/050/00702/AM13/ RLA File :05/23/040/00176/AM13/ Lic.No/Date:0510335291 20.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 9/82 dated 31.5.2011, 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:

128 details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Hydrocortisone Cream/Ointment 5 gm Tube 1 No. 1. Hydrocortisone Base 0.0510 gm/5 gm Tube Hydrocortisone Cream/Ointment 15 gm Tube 1 No. 1. Hydrocortisone Base 0.153 gm/15 gm Tube 129

Case No.:88/24/82ALC4/2012

Party Name:CHEMSPEC CHEMICALS PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00892/AM13/ RLA File :03/94/040/00230/AM13/ Lic.No/Date:0310709870 21.09.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticlas vide their OM No. 35011/347/2012PI(Norms) dated September, 2012, it was decided to call from the firm the following technical details:  Complete description of export product.  Complete technical detaisl from the applicant firm as per Appendix 33 of the application proforma. 130

Case No.:97/24/82ALC4/2012

Party Name:KUTCH CHEMICAL INDUSTRIES LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/00901/AM13/ RLA File :34/24/040/00164/AM13/ Lic.No/Date:3410035217 21.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/17/2012Ch. II dated 13.3.2013, 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 Acetanilide 1 kg 1. Aniline Oil 0.778 kg 2. Acetic Acid 0.634 kg 131

Case No.:87/24/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00891/AM13/ RLA File :03/95/040/00466/AM13/ Lic.No/Date:0310710207 24.09.2012 Defer Date:18.04.2013

Case No.:85/24/82ALC4/2012

Party Name:MAKSON INDUSTRIES PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00889/AM13/ RLA File :03/95/040/00394/AM13/ Lic.No/Date:0310710561 26 09 2012 Defer D t 18 04 2013

132 26.09.2012 Date:18.04.2013 Decision : It was decided to remind the firm to furnish the following information sought by DC(MSME) vide their letter dated 12.2.2013:  Consumption data of imported and indigenous inputs used for the manufacture of export product quantitywise duly certified by excise department for the last three years.  Detailed justification of wastage claimed at each stage.  Copy of the formulation of export product duly approved by concerned authority under drug and cosmetic act.  Earlier authorization of the above product, if any. The case was deferred for 18.4.2013 133

Case No.:86/24/82ALC4/2012

Party Name:RUPA ORGANICS PVT. LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/00890/AM13/ RLA File :03/95/040/00478/AM13/ Lic.No/Date:0310710764 27.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/104/2012Ch. II dated 7.3.2013, 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 Para Nitro Benzamide (4 Nitro Benzamide) 1 kg 1 Para Nitro Benzoic Acid 1.06 kg 134

Case No.:12/33/82ALC4/2012

Party Name:GODREJ INDUSTRIES LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01159/AM13/ RLA File :03/94/040/00516/AM13/ Lic.No/Date:0310711009 28.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/62/2008Ch. II dated 21.1.2013, 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 Fatty Alcohol (Cetyl Stearyl) 1 kg 1. Palm Fatty Acid Distillate 1.16 kg 2. Copper Chromite Catalyst 0.005 kg 135

Case No.:76/24/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00880/AM13/ RLA File :03/94/040/00500/AM13/ Lic.No/Date:0310711014 28.09.2012 Defer Date:18.04.2013 Decision :A copy of reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 18.4.2013

136

Case No.:96/24/82ALC4/2012

Party Name:TIDE INDUSTRIES 21.03.2013 Status:Case Deferred HQ File :01/82/050/00900/AM13/ RLA File :34/24/040/00158/AM13/ Lic.No/Date:3410035264 01.10.2012 Defer Date:18.04.2013 137

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

21.03.2013 Status:Case Deferred HQ File :01/82/050/00919/AM13/ RLA File :03/94/040/00481/AM13/ Lic.No/Date:0310711379 03.10.2012 Defer Date:18.04.2013 138

Case No.:12/26/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00920/AM13/ RLA File :03/94/040/00522/AM13/ Lic.No/Date:0310711393 03.10.2012 Defer Date:18.04.2013 139

Case No.:13/26/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00921/AM13/ RLA File :03/94/040/00482/AM13/ Lic.No/Date:0310711389 03.10.2012 Defer Date:18.04.2013 140

Case No.:10/26/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00918/AM13/ RLA File :03/94/040/00024/AM13/ Lic.No/Date:0310711638 04.10.2012 Defer Date:18.04.2013 141

Case No.:52/24/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00856/AM13/ RLA File :05/23/040/00253/AM13/ Lic.No/Date:0510336431 04.10.2012 Defer Date:18.04.2013

Case No.:9/26/82ALC4/2012

PHARMACEUTICALS LTD. 21.03.2013 Status:Case Deferred

142 21.03.2013 Deferred HQ File :01/82/050/00917/AM13/ RLA File :03/94/040/00099/AM13/ Lic.No/Date:0310711648 04.10.2012 Defer Date:18.04.2013 143

Case No.:17/31/82ALC4/2012

Party Name:ELPPE CHEMICALS PRIVATE LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01057/AM13/ RLA File :03/94/040/00229/AM13/ Lic.No/Date:0310712416 11.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/115/2011Ch. II dated 17.3.2013, 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 5Nitro Isophthalic Acid Dimethyl Ester or Dimethyl 5 Nitroisophthalate 1 kg 1. Isophthalic Acid 0.857 kg 2. Methanol or Methyl Alcohol 0.890 kg 144

Case No.:91/24/82ALC4/2012

Party Name:SMB MEDICAL DEVICES PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00895/AM13/ RLA File :03/95/040/00446/AM13/ Lic.No/Date:0310712446 11.10.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.04.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals. 145

Case No.:21/31/82ALC4/2012

Party Name:ADESHWAR MEDITEX PVT. LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01061/AM13/ RLA File :03/94/040/00597/AM13/ Lic.No/Date:0310712671 12.10.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.04.2013 for comments of Department of Industrial Policy and Promotions.

Case No.:174/33/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 21.03.2013 Status:Case Approved HQ File :01/82/050/01321/AM13/ RLA File :07/24/040/00284/AM13/ Lic.No/Date:0710091372 15.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their O.M No. 35011/600/2012PI(Norms) dated 6.2.2013, 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 Neuline 125 mg tablets Theophylline 125 mg +Guar gum 4.375 mg 1 no. of Neulin Tablet 1. Theophylline BP/EP/USP/PH.EUR Anhydrous powder 127.5 mg

146 2. Guar Gum IH (BP/EP/USP/PH. EUR) 4.375 mg Neuline 200 mg tablets – Theophylline 200 MG+guar gum 7.00 mg 1 no. of Neulin Tablet 1. Theophylline BP/EP/USP/PH.EUR Anhydrous powder 204.0 mg 2. Guar Gum IH (BP/EP/USP/PH. EUR) 7.00 mg Neulin 250 mg tablets Theophylline 250 mg+Guar gum 8.750 mg 1 no. of Neulin Tablet 1. Theophylline BP/EP/USP/PH.EUR Anhydrous powder 255.0 mg 2. Guar Gum IH (BP/EP/USP/PH. EUR) 8.75 mg Neulin 300 mg tablets+ Theophylline 300 mg +Guar gum 10.5 mg 1 no. of Neulin Tablet 1. Theophylline BP/EP/USP/PH.EUR Anhydrous powder 306.0 mg 2. Guar Gum IH (BP/EP/USP/PH. EUR) 10.5 mg 147

Case No.:92/24/82ALC4/2012

Party Name:UNITED MUDCHEM PVT. LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/00896/AM13/ RLA File :03/95/040/00527/AM13/ Lic.No/Date:0310712861 16.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/77/2012Ch. II dated 15.3.2013, 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 UMCMedium Cloud Point Glycol 101 Slightly yellowish clear liquid, Flash point: 140 C(230F),PH 5% in W/W:68, Density: 1.011.05, Moisture: 6% max. 1 kg 1. Crude Propylene Glycol Slightly Yellowish clear liquid, Flash point 140C(230F), PH5% in W/W 68,Density:1.01 1.05, Moisture:06% 0.965 kg UMC Medium Cloud Point Glycol Slightly Yellowish Clear Liquid, Flash Point 140 C (230F), PH 5% in W/W: 68, Density 1.01 1.05, Moisture: 35% max. 1 kg 1. Crude Propylene Glycol Slightly yellowish clear liquid, flash point: 140C(230F), PH5% in W/W 68, Density: 1.01 1.05, Moisture: 0.6% 0.675 kg 148

Case No.:9/24/82ALC4/2012

Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/00813/AM13/ RLA File :02/24/040/00119/AM13/ Lic.No/Date:0210183299 17.10.2012 Defer Date:18.04.2013

149

Case No.:11/33/82ALC4/2012

Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01158/AM13/ RLA File :03/94/040/00615/AM13/ Lic.No/Date:0310713399 22.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/129/2011Ch. II dated 4.6.2012, 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 Stearyl Erucamide 1 kg 1. Erucic Acid 0.592 kg 2. Stearyl Amine 0.471 kg 150

Case No.:3/23/82ALC4/2012

Party Name:TITAN LABORATORIES PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00803/AM13/ RLA File :03/95/040/00544/AM13/ Lic.No/Date:0310713360 22.10.2012 Defer Date:18.04.2013 151

Case No.:42/31/82ALC4/2012

Party Name:AARTI INDUSTRIES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01082/AM13/ RLA File :03/94/040/00574/AM13/ Lic.No/Date:0310713516 23.10.2012 Defer Date:18.04.2013 152

Case No.:44/31/82ALC4/2012

Party Name:CIPLA LIMITED 21.03.2013 Status:Case Rejected HQ File :01/82/050/01084/AM13/ RLA File :03/94/040/00629/AM13/ Lic.No/Date:0310713535 23.10.2012 Defer Date: Decision :The case was already withdrawn in meeting no. 31 dated 21.2.2013. 153

Case No.:51/28/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01018/AM13/ RLA File :03/95/040/00495/AM13/ Lic.No/Date:0310713489 23.10.2012 Defer Date:18.04.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/576/2012PI(Norms) dated 27.12.2012, it was decided to call from the firm the technical details as per Appendix 33. The case was deferred for 18.4.2013. 154

Case No.:35/31/82ALC4/2012

21.03.2013 Status:Case Rejected HQ File :01/82/050/01075/AM13/ RLA File :03/94/040/00408/AM13/ Lic No/Date:0310713680 Defer Date:

154 HQ File :01/82/050/01075/AM13/ RLA File :03/94/040/00408/AM13/ Lic.No/Date:0310713680 29.10.2012 Defer Date: Decision :The case was already withdrawn in meeting no. 31 dated 21.2.2013. 155

Case No.:36/31/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01076/AM13/ RLA File :03/94/040/00642/AM13/ Lic.No/Date:0310713679 29.10.2012 Defer Date:18.04.2013 156

Case No.:9/28/82ALC4/2012

Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/00976/AM13/ RLA File :09/24/040/00374/AM13/ Lic.No/Date:0910054204 30.10.2012 Defer Date:18.04.2013 157

Case No.:105/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01252/AM13/ RLA File :09/24/040/00361/AM13/ Lic.No/Date:0910054229 01.11.2012 Defer Date:18.04.2013 158

Case No.:37/31/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01077/AM13/ RLA File :03/94/040/00641/AM13/ Lic.No/Date:0310714114 01.11.2012 Defer Date:18.04.2013 159

Case No.:50/31/82ALC4/2012

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01090/AM13/ RLA File :03/94/040/00495/AM13/ Lic.No/Date:0310714105 01.11.2012 Defer Date:18.04.2013 160

Case No.:95/24/82ALC4/2012

Party Name:SOLARIS CHEMTECH INDUSTRIES LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00899/AM13/ RLA File :34/24/040/00188/AM13/ Lic.No/Date:3410035412 01.11.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18 04 2013 for comments of Department of Pharmaceuticals

161

Case No.:7/31/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01047/AM13/ RLA File :05/24/040/00277/AM13/ Lic.No/Date:0510338116 02.11.2012 Defer Date:18.04.2013 162

Case No.:121/33/82ALC4/2012

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01268/AM13/ RLA File :09/24/040/00384/AM13/ Lic.No/Date:0910054251 05.11.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 3.4.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Qty. allowed Homosalate (3,3,5 Trimethyl Cyclohexyl Salicylate) 1 kg 1. 3,3,5Trimethyl cyclohexanol 0.571 kg 2. Methyl Salicylate 0.610 kg 163

Case No.:89/33/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01236/AM13/ RLA File :09/24/040/00376/AM13/ Lic.No/Date:0910054253 05.11.2012 Defer Date:18.04.2013 164

Case No.:19/33/82ALC4/2012

Party Name:KUDOS CHEMIE LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01166/AM13/ RLA File :22/24/040/00043/AM13/ Lic.No/Date:2210013385 08.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/716/2012PI(Norms) dated 27.12.2012, 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 Cyanoacetic Acid 1 kg 1. Cyanoacetic Acid70% Liquid (Contains 30% water) 1.587 kg

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

Party Name:SOMU ORGANO CHEM PVT.LTD., 21 03 2013 Status:Case A

165 21.03.2013 Approved HQ File :01/82/050/01155/AM13/ RLA File :07/24/040/00328/AM13/ Lic.No/Date:0710091832 08.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/151/2011Ch. II dated 21.3.2013, 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 Cyclohexane1,3Dione (1,3 Cyclohexanedione) Dihydro Resorcinol 1 kg 1. Resorcinol Resorcin/m dihydroxybenzene/1,3 dihydrobenzene/3 hydroxyphenol/m hydroquinone 1.24 kg 166

Case No.:95/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01242/AM13/ RLA File :09/24/040/00342/AM13/ Lic.No/Date:0910054286 08.11.2012 Defer Date: 18.04.2013 Decision: It was decided to defer the case for 18.4.2013 for comments of Department of Pharmaceuticals. 167

Case No.:1/25/82ALC4/2012

Party Name:SWISS PARENTERALS PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00905/AM13/ RLA File :08/24/040/00271/AM13/ Lic.No/Date:0810116219 09.11.2012 Defer Date:18.04.2013 168

Case No.:15/33/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01162/AM13/ RLA File :22/24/040/00039/AM13/ Lic.No/Date:2210013390 09.11.2012 Defer Date:18.04.2013 169

Case No.:170/33/82ALC4/2012

Party Name:RANTUS PHARMA PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01317/AM13/ RLA File :09/24/040/00367/AM13/ Lic.No/Date:0910054294 09.11.2012 Defer Date:18.04.2013

Case No.:23/31/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 21.03.2013 Status:Case Deferred

170 HQ File :01/82/050/01063/AM13/ RLA File :03/95/040/00555/AM13/ Lic.No/Date:0310714767 09.11.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/576/2012PI(Norms) dated 27.12.2012, it was decided to call from the firm the technical details as per Appendix 33. The case was deferred for 18.4.2013 171

Case No.:25/31/82ALC4/2012

Party Name:THINQ PHARMACRO LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01065/AM13/ RLA File :03/95/040/00602/AM13/ Lic.No/Date:0310714790 09.11.2012 Defer Date:18.04.2013 172

Case No.:8/31/82ALC4/2012

Party Name:ADVANCE PETROCHEMICALS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01048/AM13/ RLA File :08/24/040/00283/AM13/ Lic.No/Date:0810116295 12.11.2012 Defer Date:18.04.2013 173

Case No.:107/33/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/01254/AM13/ RLA File :09/24/040/00386/AM13/ Lic.No/Date:0910054334 15.11.2012 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/441/2012PI(Norms) , 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 Trihydrate 1 Kg. 1. Acetone 1.355 kg 2. Activated Carbon (Carbon Enoanticromos) 0.100 kg 3. G.C.L.E. 1.50 kg 4. Methanol 7.913 kg 5 Methylene Chloride 4.153 kg 6. Triphenyl Phosphine 0.82 kg 7. 2Mercaptobenzothiazoyl(Z)2 (2Aminothiazoyl4yl)2 (Mica Ester) 0.82 kg 8. Dimethyl Formamide 1.584 kg

174

Case No.:148/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01295/AM13/ RLA File :09/24/040/00359/AM13/ Lic.No/Date:0910054335 15.11.2012 Defer Date:18.04.2013 175

Case No.:39/31/82ALC4/2012

Party Name:CIPLA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01079/AM13/ RLA File :03/94/040/00696/AM13/ Lic.No/Date:0310715048 16.11.2012 Defer Date:18.04.2013 176

Case No.:94/33/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01241/AM13/ RLA File :09/24/040/00388/AM13/ Lic.No/Date:0910054338 16.11.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 8/82 dated 24.5.201, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Export Qty. Sl.No. Import items Qty. allowed Compresso GEM 70 (Gemfibrozil Granules DC 70%) 1 Kg. 1. Gemfibrozil 0.707 kg 2. Maize Starch 0.1485 kg 3. Povidone K30 0.0270 kg 4. Sodium Starch Glycollate 0.030 kg 5. Sodium Lauryl Sulphate 0.00150 kg 6. Starch Pregelatinised 0.083 kg 7. Stearic Acid 0.0100 kg 177

Case No.:90/33/82ALC4/2012

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01237/AM13/ RLA File :09/24/040/00394/AM13/ Lic.No/Date:0910054339 19.11.2012 Defer Date:18.04.2013 178

Case No.:122/33/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/01269/AM13/ RLA File :09/24/040/00402/AM13/ Lic.No/Date:0910054350 20.11.2012 Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O no. 14010/102/2012Ch. II dated 7.3.2013, 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

Export product Export Qty. Sl.No. Import items Qty. allowed Sodium Ascorbyl Phosphate or CVite 1 kg 1. (2R2[(1S)1,2Dihydroxyethyl)4,5 Dihydroxyfuran3One 1.110 kg 2. Methanol 2.664 kg 3. Potassium Carbonate Powder 4.610 kg 179

Case No.:16/33/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01163/AM13/ RLA File :05/24/040/00308/AM13/ Lic.No/Date:0510339206 20.11.2012 Defer Date:18.04.2013 180

Case No.:179/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01326/AM13/ RLA File :09/24/040/00393/AM13/ Lic.No/Date:0910054348 20.11.2012 Defer Date:18.04.2013 181

Case No.:180/33/82ALC4/2012

Party Name:DIVIS PHARMACEUTICALS PRIVATE LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01327/AM13/ RLA File :09/24/040/00395/AM13/ Lic.No/Date:0910054351 20.11.2012 Defer Date: Decision :In the light of earlier decision taken in meeting no. 16/82 dated 19.7.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,3 Dibromo5 Benzoyl Pyrrole 1 Kg. 1. Pyrrole 0.43 kg 2. Dichloro Methane 5.25kg 3. Morpholine 1.29 kg 182

Case No.:181/33/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01328/AM13/ RLA File :09/24/040/00401/AM13/ Lic.No/Date:0910054361 22.11.2012 Defer Date:18.04.2013 183

Case No.:190/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01337/AM13/ RLA File :09/24/040/00406/AM13/ Lic.No/Date:0910054373 23.11.2012 Defer Date:18.04.2013

184

Case No.:22/31/82ALC4/2012

Party Name:YASHO INDUSTRIES PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01062/AM13/ RLA File :03/95/040/00643/AM13/ Lic.No/Date:0310715596 23.11.2012 Defer Date:18.04.2013 185

Case No.:48/31/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01088/AM13/ RLA File :03/94/040/00711/AM13/ Lic.No/Date:0310715606 23.11.2012 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/632/2012PI(Norms) dated 12.3.2013, it was decided to call from the firm the technical details as per Appendix 33 mainly molecular weight of imported inputs and % yield on molar basis alongwith copy of relevant technical literature. 186

Case No.:106/33/82ALC4/2012

Party Name:THERMAX LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01253/AM13/ RLA File :31/83/040/00103/AM13/ Lic.No/Date:3110056320 26.11.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 19/82 dated 6.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Kg/kg Water Corrosion Inhibitor (Brand Name: Corromin 3159) 1 kg 1. Tetraethylene Pentamine (TEPA) 0.050 kg 2. Thioglycolic Acid 0.051 kg 3. Mixed Xylene 0.005 kg 4. Cocoamine acetate 0.050 kg 5. Cocoamine 15 EO 0.030 kg Scale Inhibitor (Brand Name: Scalemin 3640) 1 kg 1. Acrylic Acid 0.190 kg 2. 2 Acrylamido Methyl Propane Sulfonic Acid (AMPS) 0.130 kg 187

Case No.:13/33/82ALC4/2012

Party Name:DEEPAK NITRITE LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01160/AM13/ RLA File :34/24/040/00181/AM13/ Lic.No/Date:3410035545 26.11.2012 Defer Date:18.04.2013

188

Case No.:191/33/82ALC4/2012

Party Name:VANI PHARMA LABS LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01338/AM13/ RLA File :09/24/040/00357/AM13/ Lic.No/Date:0910054379 26.11.2012 Defer Date:18.04.2013 189

Case No.:120/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01267/AM13/ RLA File :09/24/040/00396/AM13/ Lic.No/Date:0910054387 27.11.2012 Defer Date:18.04.2013 190

Case No.:166/33/82ALC4/2012

Party Name:PERKIN LABORATORIES 21.03.2013 Status:Case Deferred HQ File :01/82/050/01313/AM13/ RLA File :09/24/040/00382/AM13/ Lic.No/Date:0910054386 27.11.2012 Defer Date:18.04.2013 191

Case No.:167/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01314/AM13/ RLA File :09/24/040/00391/AM13/ Lic.No/Date:0910054388 27.11.2012 Defer Date:18.04.2013 192

Case No.:73/31/82ALC4/2012

Party Name:ALKYL AMINES CHEMICALS LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01113/AM13/ RLA File :03/94/040/00689/AM13/ Lic.No/Date:0310715835 27.11.2012 Defer Date:18.04.2013 193

Case No.:17/33/82ALC4/2012

Party Name:V.D.H. ORGANICS PVT. LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01164/AM13/ RLA File :05/24/040/00323/AM13/ Lic.No/Date:0510339719 29.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/58/2010Ch. II dated 19.11.2012, 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 Thymol Crystals (3‐Hydroxy‐P‐ Cymene) 1 kg 1. Meta Cresol (M‐Cresol) 0.785 kg 194

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

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01151/AM13/ RLA File :03/94/040/00589/AM13/ Lic.No/Date:0310715883 29.11.2012 Defer Date: Decision :In the light of earlier decision taken in meeting no. 45/82 dated 8.2.2011, 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 Para Terⷼary Butyl Cyclohexyl Acetate 1 Kg. 1. Para Terⷼary Butyl Phenol 0.820 kg 2. 5% Ruthenium on Carbon Catalyst 0.000003 kg 3. Aceⷼc Acid 0.300 kg 4. Methanol 0.330 kg 195

Case No.:62/31/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01102/AM13/ RLA File :03/94/040/00732/AM13/ Lic.No/Date:0310715921 29.11.2012 Defer Date: Decision :In the light of earlier decision taken in meeting no. 22/85 dated 3.08.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Export Qty. Sl.No. Import items Qty. allowed Testosterone Propionate 1 Kg. 1. 4Androstene 3,17 dione 1.19 kg 196

Case No.:72/31/82ALC4/2012

Party Name:ALKYL AMINES CHEMICALS LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01112/AM13/ RLA File :03/94/040/00398/AM13/ Lic.No/Date:0310715907 29.11.2012 Defer Date:18.04.2013 197

Case No.:9/31/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01049/AM13/ RLA File :04/24/040/00182/AM13/ Lic.No/Date:0410141372 29.11.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18 04 2013 for comments of Department of Pharmaceuticals

198

Case No.:108/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01255/AM13/ RLA File :09/24/040/00424/AM13/ Lic.No/Date:0910054414 30.11.2012 Defer Date:18.04.2013 199

Case No.:109/33/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01256/AM13/ RLA File :09/24/040/00409/AM13/ Lic.No/Date:0910054415 30.11.2012 Defer Date:18.04.2013 200

Case No.:51/31/82ALC4/2012

Party Name:STERLING AUXILIARIES PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01091/AM13/ RLA File :03/95/040/00632/AM13/ Lic.No/Date:0310716072 30.11.2012 Defer Date:18.04.2013 201

Case No.:71/31/82ALC4/2012

Party Name:GALAXY SURFACTANTS LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01111/AM13/ RLA File :03/94/040/00324/AM13/ Lic.No/Date:0310715959 30.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/148/2008Ch. II dated 7.3.2013, 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 Galguard NK 1 (Preservative Blend) 1 kg 1. Phenol 0.504 kg 2. Ethylene Oxide 0.237 kg 3. Methyl Paraben 0.160 kg 4. Ethyl Paraben 0.040 kg 5. Propyl Paraben 0.020 kg 6. Butyl Paraben 0.050 kg 7 HDPE Granules Relevant, as per packing policy

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

Party Name:PORUS LABORATORIES PVT LTD. 21.03.2013 Status:Case Deferred

202 HQ File :01/82/050/00956/AM13/ RLA File :09/24/040/00426/AM13/ Lic.No/Date:0910054427 03.12.2012 Defer Date:18.04.2013 203

Case No.:123/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01270/AM13/ RLA File :09/24/040/00405/AM13/ Lic.No/Date:0910054430 03.12.2012 Defer Date:18.04.2013 204

Case No.:128/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01275/AM13/ RLA File :08/24/040/00304/AM13/ Lic.No/Date:0810116598 03.12.2012 Defer Date:18.04.2013 205

Case No.:112/33/82ALC4/2012

Party Name:STERICAT GUTSTRINGS PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01259/AM13/ RLA File :05/24/040/00304/AM13/ Lic.No/Date:0510340033 04.12.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.04.2013 for comments of Department of Industrial Policy and Promotion. 206

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

Party Name:RANBAXY LABORATORIES LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01161/AM13/ RLA File :05/24/040/00324/AM13/ Lic.No/Date:0510340056 04.12.2012 Defer Date:18.04.2013 207

Case No.:18/33/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01165/AM13/ RLA File :05/24/040/00325/AM13/ Lic.No/Date:0510340057 04.12.2012 Defer Date:18.04.2013 208

Case No.:192/33/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01339/AM13/ RLA File :05/24/040/00326/AM13/ Lic.No/Date:0510340034 04.12.2012 Defer Date:

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/698/2012PI(Norms) dated 12.3.2013, 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 Ticarcillin & Clavulanic Acid for Injection USP Ticarnic 1.6 gm 1 vial 1. Ticarcillin Disodium & Potassium Clavulanate (15:1) Raw Pharmaceuticals Ingredient 1.68 gm/vial Ticarcillin & Clavulanic Acid for Injection USP Ticarnic 3.2 gm 1 vial 1. Ticarcillin Disodium & Potassium Clavulanate (15:1) Raw Pharmaceuticals Ingredients 3.36 gm/vial 209

Case No.:2/27/82ALC4/2012

Party Name:GOPINATH CHEMTECH LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/00957/AM13/ RLA File :08/24/040/00295/AM13/ Lic.No/Date:0810116627 04.12.2012 Defer Date:18.04.2013 210

Case No.:24/31/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01064/AM13/ RLA File :03/95/040/00661/AM13/ Lic.No/Date:0310716278 04.12.2012 Defer Date:18.04.2013 211

Case No.:118/33/82ALC4/2012

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 21.03.2013 Status:Case Approved HQ File :01/82/050/01265/AM13/ RLA File :05/24/040/00317/AM13/ Lic.No/Date:0510340120 05.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/28/2012Ch. III dated 10.12.2012, 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 Racemic Menthone 1 kg 1 Meta Cresol Above 98.5% 1.43 kg

Racemic Menthone 1 kg 1 Meta Cresol Above 98.5% pure 1.43 kg 212

Case No.:173/33/82ALC4/2012

Party Name:BELCO PHARMA 21.03.2013 Status:Case Approved HQ File :01/82/050/01320/AM13/ RLA File :05/23/040/00344/AM13/ Lic.No/Date:0510340079 05.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 9/82 dated 31.5.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Hydrocortisone Cream/Ointment 5 gm Tube 1 No. 1. Hydrocortisone Base 0.0510 gm/5 gm Tube Hydrocortisone Cream/Ointment 15 gm Tube 1 No. 1. Hydrocortisone Base 0.153 gm/15 gm Tube 213

Case No.:185/33/82ALC4/2012

Party Name:S.M. HERBALS PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01332/AM13/ RLA File :05/24/040/00331/AM13/ Lic.No/Date:0510340123 05.12.2012 Defer Date:18.04.2013 214

Case No.:187/33/82ALC4/2012

Party Name:MICRO LABS LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01334/AM13/ RLA File :07/24/040/00344/AM13/ Lic.No/Date:0710092287 05.12.2012 Defer Date:18.04.2013 215

Case No.:30/31/82ALC4/2012

Party Name:S.KANT HEALTHCARE LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01070/AM13/ RLA File :03/95/040/00670/AM13/ Lic.No/Date:0310716370 05.12.2012 Defer Date:18.04.2013 216

Case No.:42/33/82ALC4/2012

Party Name:AMIJAL CHEMICALS 21.03.2013 Status:Case Approved HQ File :01/82/050/01189/AM13/ RLA File :03/94/040/00752/AM13/ Lic.No/Date:0310716314 05.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 11/82 dated 14.6.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as

Export Product Export Qty. Sl.No. Import items Qty. allowed Disodium Hydrogen Citrate B.P. 1 KG. 1. Citric Acid Mono Hydrate 0.840 kg 217

Case No.:93/33/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01240/AM13/ RLA File :09/24/040/00237/AM13/ Lic.No/Date:0910054437 05.12.2012 Defer Date:18.04.2013 218

Case No.:57/31/82ALC4/2012

Party Name:ACTGEN PHARMA PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01097/AM13/ RLA File :03/94/040/00728/AM13/ Lic.No/Date:0310716371 05.12.2012 Defer Date:18.04.2013 219

Case No.:73/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01220/AM13/ RLA File :09/24/040/00429/AM13/ Lic.No/Date:0910054448 05.12.2012 Defer Date:18.04.2013 220

Case No.:39/33/82ALC4/2012

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01186/AM13/ RLA File :03/94/040/00719/AM13/ Lic.No/Date:0310716546 06.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Through Enzymatic Route 1 kg. 1. 6Amino Penicillinic Acid (6 APA) 0.568 kg 2. Formidase (Enzyme 5 gm 4. D()PHydroxy Phenyl Glycine Methylester (BBH) 0.608 kg

Methylester (BBH) 221

Case No.:127/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01274/AM13/ RLA File :08/24/040/00155/AM13/ Lic.No/Date:0810116730 07.12.2012 Defer Date:18.04.2013 222

Case No.:168/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01315/AM13/ RLA File :08/24/040/00253/AM13/ Lic.No/Date:0810116731 07.12.2012 Defer Date:18.04.2013 223

Case No.:172/33/82ALC4/2012

Party Name:CADILA PHARMACEUTICALS LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01319/AM13/ RLA File :08/24/040/00303/AM13/ Lic.No/Date:0810116727 07.12.2012 Defer Date:18.04.2013 224

Case No.:176/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01323/AM13/ RLA File :08/24/040/00301/AM13/ Lic.No/Date:0810116729 07.12.2012 Defer Date:18.04.2013 225

Case No.:188/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01335/AM13/ RLA File :05/23/040/00345/AM13/ Lic.No/Date:0510340432 07.12.2012 Defer Date:18.04.2013 226

Case No.:37/33/82ALC4/2012

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 21.03.2013 Status:Case Approved HQ File :01/82/050/01184/AM13/ RLA File :03/94/040/00760/AM13/ Lic.No/Date:0310716663 07.12.2012 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 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:

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 Astrolide (DEP/IPM/BB/DPG) (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 227

Case No.:4/27/82ALC4/2012

Party Name:PORUS LABORATORIES PVT LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/00959/AM13/ RLA File :09/24/040/00408/AM13/ Lic.No/Date:0910054464 07.12.2012 Defer Date:18.04.2013 228

Case No.:41/33/82ALC4/2012

Party Name:GITANJALI CHEMICALS PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01188/AM13/ RLA File :03/94/040/00747/AM13/ Lic.No/Date:0310716657 07.12.2012 Defer Date:18.04.2013 229

Case No.:43/33/82ALC4/2012

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01190/AM13/ RLA File :03/94/040/00727/AM13/ Lic.No/Date:0310716674 07.12.2012 Defer Date:18.04.2013 230

Case No.:101/33/82ALC4/2012

Party Name:SOHAN HEALTHCARE PVT. LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01248/AM13/ RLA File :31/83/040/00129/AM13/ Lic.No/Date:3110056439 10.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 20.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as 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 231

Case No.:175/33/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01322/AM13/ RLA File :05/23/040/00356/AM13/ Lic.No/Date:0510340518 10.12.2012 Defer Date:18.04.2013 232

Case No.:7/27/82ALC4/2012

Party Name:TORRENT PHARMACEUTICALS LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/00962/AM13/ RLA File :08/24/040/00293/AM13/ Lic.No/Date:0810116756 10.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 18/82 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 Bisoprolol Fumarate and Hydrochlorothiazide Tablet Comp. Heumann 5/12.5 mg 1 No. 1. Bisoprolol Fumarate 5.1 mg Bisoprolol Fumarate and Hydrochlorothiazide Tablet Comp. Heumann 10/25 mg 1 No. 1. Bisoprolol Fumarate 10.2 mg 233

Case No.:70/31/82ALC4/2012

Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01110/AM13/ RLA File :03/94/040/00624/AM13/ Lic.No/Date:0310716861 10.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/176/2011Ch. II dated 25.2.2013, 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 Cold Flow process improver/Pour point Depressant (Trade name SR 1637) 1 kg 1. Alpha Olefin C2024 0.102 kg 2. Mix Xylene 0.680 kg 234

Case No.:76/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01223/AM13/ RLA File :09/24/040/00411/AM13/ Lic.No/Date:0910054467 10.12.2012 Defer Date:18.04.2013

235

Case No.:177/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01324/AM13/ RLA File :08/24/040/00251/AM13/ Lic.No/Date:0810116810 11.12.2012 Defer Date:18.04.2013 236

Case No.:10/27/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/00965/AM13/ RLA File :09/24/040/00416/AM13/ Lic.No/Date:0910054496 12.12.2012 Defer Date:18.04.2013 237

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

Party Name:SHIVA PHARMACHEM LTD, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01053/AM13/ RLA File :34/24/040/00218/AM13/ Lic.No/Date:3410035633 12.12.2012 Defer Date:18.04.2013 238

Case No.:66/33/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01213/AM13/ RLA File :09/24/040/00443/AM13/ Lic.No/Date:0910054499 12.12.2012 Defer Date:18.04.2013 239

Case No.:9/27/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/00964/AM13/ RLA File :09/24/040/00418/AM13/ Lic.No/Date:0910054495 12.12.2012 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed Kg/kg Cefuroxime Axetil Crystalline 1 kg 1. 7Aminocephalosporanic Acid (7ACA) 0.769 2 Chlorosulphonyl Isocynate 0.4754 3 (Z)2Methoxy Imino (Furyl2 YL) Acetic Acid Ammonium Salt (SMIA) 0.6152 4 Acetone 1.83

5 Methylene Chloride 6.36 6 Carbon Enoanticromos (Activated Carbon) 0.093 7 N,N,dimethyl Acetamide 4.02 8 Potassium Carbonate 0.0602 9 Cyclohexane 2.14 10 Methanol 2.78 240

Case No.:126/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01273/AM13/ RLA File :08/24/040/00315/AM13/ Lic.No/Date:0810116862 13.12.2012 Defer Date:18.04.2013 Decision :It was decided to call from the firm the full description of export items. The case was deferred for 18.4.2013. 241

Case No.:141/33/82ALC4/2012

Party Name:SUVEN LIFE SCIENCES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01288/AM13/ RLA File :09/24/040/00440/AM13/ Lic.No/Date:0910054506 13.12.2012 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 5Bromo2Iodopyrimidine 1 kg 1. 1,1,3,3Tetra Methoxy Propane 1.43 2. Bromine Liquid 1.25 3. Phosphorous Oxy Chloride 1.27 4. Hydroiodic Acid 55% 1.34 242

Case No.:65/31/82ALC4/2012

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 21.03.2013 Status:Case Approved HQ File :01/82/050/01105/AM13/ RLA File :03/94/040/00745/AM13/ Lic.No/Date:0310717141 13.12.2012 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 13.3.2013, 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 Camphor Technical 1 kg 1. Alpha Pinene 1.146 kg

Case No.:77/33/82ALC4/2012

Party Name:GRANULES INDIA LIMITED Status:Case

243 y 21.03.2013 Deferred HQ File :01/82/050/01224/AM13/ RLA File :09/24/040/00404/AM13/ Lic.No/Date:0910054501 13.12.2012 Defer Date:18.04.2013 244

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

21.03.2013 Status:Case Deferred HQ File :01/82/050/01122/AM13/ RLA File :03/95/040/00691/AM13/ Lic.No/Date:0310717131 13.12.2012 Defer Date:18.04.2013 245

Case No.:10/33/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01157/AM13/ RLA File :03/95/040/00569/AM13/ Lic.No/Date:0310717225 14.12.2012 Defer Date:18.04.2013 246

Case No.:115/33/82ALC4/2012

Party Name:SOMU ORGANO CHEM PVT.LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01262/AM13/ RLA File :07/24/040/00374/AM13/ Lic.No/Date:0710092501 14.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/151/2011Ch. II dated 21.3.2013, 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 Cyclohexanedione1,3 DIONE (1,3 cyclohexanedione) Dihydro Resorcinol 1 kg 1 RESORCINOL 1.24 kg 247

Case No.:140/33/82ALC4/2012

Party Name:HETERO DRUGS LIMITED, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01287/AM13/ RLA File :09/24/040/00448/AM13/ Lic.No/Date:0910054511 14.12.2012 Defer Date:18.04.2013

Case No.:34/33/82ALC4/2012

Party Name:EM BIO LTD 21.03.2013 Status:Case Approved

248 HQ File :01/82/050/01181/AM13/ RLA File :03/94/040/00778/AM13/ Lic.No/Date:0310717243 14.12.2012 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 Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg LNorephedrine HCL 1 kg 1. Benzaldehyde 4.165 2. Hydroxylamine Hcl/Hydroxylamine Sulphate 2.208 3. Caustic Soda Lye 12.104 4. Oxalic Acid 2.528 5. EDTA 0.155 6. Methanol 4.50 7. Potassium Hydroxide Flakes 1.60 8. Toluene 5.94 9. Activated Carbon 0.030 10. Acetone 0.80 249

Case No.:48/33/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01195/AM13/ RLA File :03/94/040/00777/AM13/ Lic.No/Date:0310717291 14.12.2012 Defer Date: Decision : In line with SION A 412 and in the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, 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 Item No. 1 Quantity allowed Allopurinol tablet 200 mg Allupurinol….204 mg/tablet Export Product Export Quantity S.No Import Product Quantity Allowed Allopurinol 200 mg Tablets [Each Tablet contains: 1)3 Amino Pyrazole Carboxamide Hemisulphate307.64 mg 2) Formamide 300.32 mg] 1 kg net content of Allopurinol 1. 3Amino Pyrazole Carboxamide Hemisulphate 1.5384 kg 2. Formamide 1.50 kg 250

Case No.:64/31/82ALC4/2012

Party Name:CONCEPT PHARMACEUTICALS LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01104/AM13/ RLA File :03/94/040/00700/AM13/ Lic.No/Date:0310717229 14 12 2012 Defer 18 04 2013

14.12.2012 Date:18.04.2013 251

Case No.:72/33/82ALC4/2012

Party Name:HETERO DRUGS LIMITED, 21.03.2013 Status:Case Approved HQ File :01/82/050/01219/AM13/ RLA File :09/24/040/00417/AM13/ Lic.No/Date:0910054512 14.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 5/82 dated 4.5.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Nebivolol Hcl 1 Kg. 1. Para Fluorophenol 9.01 kg 2. Methanol 23.6 kg 3. nHexane 24.02 kg 4. Acetone 13.031 kg 5. Dimethyl Sulphoxide 11.74 kg 6. Toluene 15.98 kg 7. DIBALH (Diisobutylaluminium Hydrine) 25% in Toluene 27.03 kg 8. Diisopropyl Ether 12.17 kg 9. Methylene Chloride 4.83 kg 252

Case No.:84/31/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01124/AM13/ RLA File :03/95/040/00696/AM13/ Lic.No/Date:0310717237 14.12.2012 Defer Date:18.04.2013 253

Case No.:85/31/82ALC4/2012

Party Name:SANOFI INDIA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01125/AM13/ RLA File :03/95/040/00465/AM13/ Lic.No/Date:0310717240 14.12.2012 Defer Date:18.04.2013 254

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

Party Name:INDSWIFT LABORATORIES LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/00966/AM13/ RLA File :22/24/040/00051/AM13/ Lic.No/Date:2210013450 17.12.2012 Defer Date:18.04.2013

Case No.:35/33/82ALC4/2012

Party Name:GUJARAT ORGANICS LTD., Meet No/Date:33/82ALC4/2012 Status:Case

255

Case No.:35/33/82 ALC4/2012

Party Name:GUJARAT ORGANICS LTD., Meet No/Date:33/82 ALC4/2012 21.03.2013 Status:Case Approved HQ File :01/82/050/01182/AM13/ RLA File :03/94/040/00786/AM13/ Lic.No/Date:0310717412 17.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Quantity S.No Import Product Quantity Allowed Para Anisic Acid/Para Methoxy Benzoic Acid 1 kg 1. Phenol (Purity Maximum 92%) 0.986 kg 2. Potassium Hydroxide 0.900 kg 256

Case No.:83/31/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01123/AM13/ RLA File :03/95/040/00709/AM13/ Lic.No/Date:0310717365 17.12.2012 Defer Date:18.04.2013 257

Case No.:9/33/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01156/AM13/ RLA File :03/95/040/00683/AM13/ Lic.No/Date:0310717358 17.12.2012 Defer Date:18.04.2013 258

Case No.:103/33/82ALC4/2012

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01250/AM13/ RLA File :31/83/040/00144/AM13/ Lic.No/Date:3110056519 18.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 10/82 dated 5.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,6 Xylidine 1 kg. 1. 2,6 Xylenol 1.946 kg 259

Case No.:104/33/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01251/AM13/ RLA File :05/23/040/00239/AM13/ Lic.No/Date:0510341177 18.12.2012 Defer Date:18.04.2013

260

Case No.:110/33/82ALC4/2012

Party Name:INTAS PHARMACEUTICALS LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01257/AM13/ RLA File :08/24/040/00324/AM13/ Lic.No/Date:0810116928 18.12.2012 Defer Date:18.04.2013 261

Case No.:116/33/82ALC4/2012

Party Name:BAL PHARMA LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01263/AM13/ RLA File :07/24/040/00376/AM13/ Lic.No/Date:0710092545 18.12.2012 Defer Date:18.04.2013 262

Case No.:12/27/82ALC4/2012

Party Name:POLYGON CHEMICALS 21.03.2013 Status:Case Approved HQ File :01/82/050/00967/AM13/ RLA File :08/24/040/00327/AM13/ Lic.No/Date:0810116927 18.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/9/2010/Ch. II dated 7.3.2013, 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 Quantity S.No Import Product Quantity Allowed 3 Methyl 5Pyrazolone 1 kg 1. Acetic Acid Methyl Ester 1.287 kg 2. Hydrazine Hydrate (Purity 80%) 0.692 kg 263

Case No.:125/33/82ALC4/2012

Party Name:SYMBIOTEC PHARMALAB LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01272/AM13/ RLA File :56/24/040/00032/AM13/ Lic.No/Date:5610001382 18.12.2012 Defer Date:18.04.2013 264

Case No.:131/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01278/AM13/ RLA File :07/24/040/00377/AM13/ Lic.No/Date:0710092564 18.12.2012 Defer Date:18.04.2013

265

Case No.:133/33/82ALC4/2012

Party Name:SOMU ORGANO CHEM PVT.LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01280/AM13/ RLA File :07/24/040/00373/AM13/ Lic.No/Date:0710092543 18.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/151/2011Ch. II dated 21.3.2013, 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 Cyclohexane1,3Dione (1,3 Cyclohexanedione) Dihydro Resorcinol 1 kg 1. Resorcinol 1.24 kg 266

Case No.:142/33/82ALC4/2012

Party Name:SOMU ORGANO CHEM PVT.LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01289/AM13/ RLA File :07/24/040/00372/AM13/ Lic.No/Date:0710092537 18.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/151/2011Ch. II dated 21.3.2013, 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 Cyclohexane1,3Dione (1,3 Cyclohexanedione) Dihydro Resorcinol 1 kg 1. Resorcinol 1.24 kg 267

Case No.:169/33/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01316/AM13/ RLA File :05/23/040/00238/AM13/ Lic.No/Date:0510341172 18.12.2012 Defer Date:18.04.2013 268

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

21.03.2013 Status:Case Deferred HQ File :01/82/050/01229/AM13/ RLA File :09/24/040/00421/AM13/ Lic.No/Date:0910054540 18.12.2012 Defer Date:18.04.2013

Case No.:92/33/82ALC4/2012

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01239/AM13/ RLA File :09/24/040/00430/AM13/ Lic.No/Date:0910054539 18.12.2012 Defer Date:

269 Decision : In the light of earlier decision taken in meeting no. 1/82 dated 3.4.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Qty. allowed Homosalate (3,3,5 Trimethyl Cyclohexyl Salicylate) 1 kg 1. 3,3,5Trimethyl cyclohexanol 0.571 kg 2. Methyl Salicylate 0.610 kg 270

Case No.:184/33/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01331/AM13/ RLA File :05/24/040/00347/AM13/ Lic.No/Date:0510341261 19.12.2012 Defer Date:18.04.2013 271

Case No.:44/33/82ALC4/2012

Party Name:CIPLA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01191/AM13/ RLA File :03/94/040/00796/AM13/ Lic.No/Date:0310717688 19.12.2012 Defer Date:18.04.2013 272

Case No.:53/31/82ALC4/2012

Party Name:S.KANT HEALTHCARE LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01093/AM13/ RLA File :03/95/040/00702/AM13/ Lic.No/Date:0310717633 19.12.2012 Defer Date:18.04.2013 273

Case No.:55/31/82ALC4/2012

Party Name:S.KANT HEALTHCARE LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01095/AM13/ RLA File :03/95/040/00701/AM13/ Lic.No/Date:0310717631 19.12.2012 Defer Date:18.04.2013

Case No.:119/33/82ALC4/2012

Party Name:AMI ORGANICS PVT LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01266/AM13/ RLA File :52/24/040/00039/AM13/ Lic.No/Date:5210039292 20.12.2012 Defer Date: Decision : In line with earlier decision taken in meeting no. 1/13 dated 3.4.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as

274 applied by the firm, as per details given below: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg 3,4Dihydroxy5 NitroBenzaldehyde 1 Kg 1. Vanillin 1.6 RA may take appropriate action as per the decision of Norms Committee. 275

Case No.:137/33/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 21.03.2013 Status:Case Added HQ File :01/82/050/01284/AM13/ RLA File :09/24/040/00446/AM13/ Lic.No/Date:0910054592 20.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 18/82 dated 30.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import items Qty. allowed Paracetamol Granules DC Grade 77% (Compresso PAP 77 P) 1 kg 1. Paracetamol 0.769 kg 2. Maize Starch 0.064 kg 3. Cellulose Micro Crystalline 0.092 kg 4. Silica Colloidal Anhydrous 0.007 kg 5. Povidone 0.032 kg 6. Croscamellose Sodium 0.018 kg 7. Magnesium Stearate 0.004 kg 8. Purified Talc 0.012 kg 276

Case No.:182/33/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01329/AM13/ RLA File :22/24/040/00055/AM13/ Lic.No/Date:2210013463 20.12.2012 Defer Date:18.04.2013 277

Case No.:186/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01333/AM13/ RLA File :07/24/040/00387/AM13/ Lic.No/Date:0710092620 20.12.2012 Defer Date:18.04.2013

Case No.:32/33/82ALC4/2012

Party Name:EMBIO LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01179/AM13/ RLA File :03/94/040/00807/AM13/ Lic.No/Date:0310717792 20.12.2012 Defer Date:

278 Decision : In the light of earlier decision taken in meeting no. 14/82 dated 31.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as 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 2.36 279

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

Party Name:EMBIO LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01180/AM13/ RLA File :03/94/040/00798/AM13/ Lic.No/Date:0310717782 20.12.2012 Defer Date: Decision :In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as Export product Export Qty. Sl.No. Import items Qty. allowed Kg/kg dNorpseudoephedrine HCL 1 kg 1. Benzaldehyde 5.22 2. Hyudroxylamine HCL/Hydroxylamine Sulphate 2.76 3. Caustic Soda Lye 15.13 4. Oxalic Acid 3.16 5. EDTA 0.193 6. Methanol 5.08 7. Potassium Hydroxide Flakes 2.00 8. Toluene 7.97 9. Activated Carbon 0.021 10. Acetone 0.333 11 Di Isopropyl Ether 1.237 12. Acetic Anhydride 1.70

Case No.:36/33/82ALC4/2012

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01183/AM13/ RLA File :03/94/040/00795/AM13/ Lic.No/Date:0310717770 20.12.2012 Defer Date:

280 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2011Ch. II dated 24.8.2012, 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 Methyl3Oxo2Pentyl1 Cyclopentane acetate 1 kg 1 Pentyl Endo (2 Pentyl2Cyclopentene1one) (85%) 0.960 2. Dimethyl Malonate 0.775 281

Case No.:45/33/82ALC4/2012

Party Name:CONCEPT PHARMACEUTICALS LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01192/AM13/ RLA File :03/94/040/00421/AM13/ Lic.No/Date:0310717803 20.12.2012 Defer Date:18.04.2013 282

Case No.:46/33/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01193/AM13/ RLA File :03/94/040/00769/AM13/ Lic.No/Date:0310717816 20.12.2012 Defer Date:18.04.2013 283

Case No.:47/33/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 21.03.2013 Status:Case Added HQ File :01/82/050/01194/AM13/ RLA File :03/94/040/00785/AM13/ Lic.No/Date:0310717818 20.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as Export Product Export Quantity S.No Import Product Quantity Allowed Allopurinol 1 kg 1. 3Amino Pyrazole Carboxamide Hemisulphate 1.5384 kg 2. Formamide 1.50 kg RA may take further appropriate action as per the decision of Norms Committee. 284

Case No.:164/33/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01311/AM13/ RLA File :05/24/040/00360/AM13/ Lic.No/Date:0510341511 21.12.2012 Defer Date:18.04.2013

285

Case No.:189/33/82ALC4/2012

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01336/AM13/ RLA File :22/24/040/00054/AM13/ Lic.No/Date:2210013468 21.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Through Enzymatic Route 1 kg. 1. 6Amino Penicillinic Acid (6 APA) 0.568 kg 2. Elcolase (Enzyme) 5 gm 3. D()PHydroxy Phenyl Glycine Methylester 0.608 kg 286

Case No.:40/33/82ALC4/2012

Party Name:FDC LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01187/AM13/ RLA File :03/94/040/00730/AM13/ Lic.No/Date:0310717901 21.12.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/643/2012PI(Norms) dated 12.3.2013, 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 Brimonidine Eye Drops 5 ml 1 vial 1 Brimonidine Tartrate 0.0102 gm/vial 287

Case No.:135/33/82ALC4/2012

Party Name:VIRAT EXPORTS P.LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01282/AM13/ RLA File :05/24/040/00365/AM13/ Lic.No/Date:0510341550 24.12.2012 Defer Date:18.04.2013

288

Case No.:80/31/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01120/AM13/ RLA File :03/95/040/00753/AM13/ Lic.No/Date:0310718342 27.12.2012 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.04.2013 for comments of Department of Chemials and Petrochemicals. 289

Case No.:113/33/82ALC4/2012

Party Name:RIDDHI PHARMA 21.03.2013 Status:Case Deferred HQ File :01/82/050/01260/AM13/ RLA File :34/24/040/00225/AM13/ Lic.No/Date:3410035749 28.12.2012 Defer Date:18.04.2013 290

Case No.:114/33/82ALC4/2012

Party Name:TRANSPEK INDUSTRY LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01261/AM13/ RLA File :34/24/040/00221/AM13/ Lic.No/Date:3410035747 28.12.2012 Defer Date:18.04.2013 291

Case No.:31/33/82ALC4/2012

Party Name:HALCYON LABS PVT. LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01178/AM13/ RLA File :03/94/040/00809/AM13/ Lic.No/Date:0310718510 28.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Quantity S.No Import Product Quantity allowed per unit of export product Clobetasol Propionate 1 kg 1. Betamethasone BP 1.04 kg It was discussed in the meeting and it was observed that there is a need to revise SION No. A 84. It was decided to call all industry data from pharmexcil. 292

Case No.:53/33/82ALC4/2012

Party Name:AVIGNON EXIM PVT.LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01200/AM13/ RLA File :03/94/040/00820/AM13/ Lic.No/Date:0310718503 28.12.2012 Defer Date:18.04.2013

293

Case No.:86/33/82ALC4/2012

Party Name:SAINOR LABORATORIES PVT LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01233/AM13/ RLA File :09/24/040/00434/AM13/ Lic.No/Date:0910054618 28.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 10/82 dated 7.6.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Qty. allowed nButyl Magnesium Chloride 24% 1 KG. 1. nButyl Chloride 0.200 kg 2. Tetrahydrofuran 1.00 kg 294

Case No.:136/33/82ALC4/2012

Party Name:HETERO LABS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01283/AM13/ RLA File :09/24/040/00457/AM13/ Lic.No/Date:0910054624 31.12.2012 Defer Date:18.04.2013 295

Case No.:49/33/82ALC4/2012

Party Name:ANUH PHARMA LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01196/AM13/ RLA File :03/94/040/00791/AM13/ Lic.No/Date:0310718708 31.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 23.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Qty. Sl.No. Import items Qty. allowed Mometasone Furoate 1 Kg. 1. 16Alpha Methyl Epoxide/8 DM 1.04 kg 296

Case No.:111/33/82ALC4/2012

Party Name:ENVEE DRUGS PVT LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01258/AM13/ RLA File :34/24/040/00229/AM13/ Lic.No/Date:3410035774 01.01.2013 Defer Date: Decision: The case was considered in the meeting and in consultation with the technical members present in the meeting, the Committee 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 Clobetasole Propionate BP/USP 1 kg 1 Betamethasone BP/USP/IP 1.04 kg

Case No.:138/33/82ALC4/2012

Party Name:SARACA LABORATORIES LTD Status:Case

297 21.03.2013 Approved HQ File :01/82/050/01285/AM13/ RLA File :09/24/040/00455/AM13/ Lic.No/Date:0910054643 01.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 11/82 dated 19.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Gabapentin HCL Powder 1 kg 1. 1,1 Cyclohexane Di Acetic Acid Monoamide (CAM) 0.988 kg/kg 2. Bromine 0.923 kg/kg 298

Case No.:183/33/82ALC4/2012

Party Name:S.M. HERBALS PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01330/AM13/ RLA File :05/24/040/00366/AM13/ Lic.No/Date:0510342102 01.01.2013 Defer Date:18.04.2013 299

Case No.:70/33/82ALC4/2012

Party Name:RAY CHEMICALS PRIVATE LIMITED, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01217/AM13/ RLA File :07/24/040/00398/AM13/ Lic.No/Date:0710092831 01.01.2013 Defer Date:18.04.2013 300

Case No.:100/31/82ALC4/2012

Party Name:SUN PHARMA MEDICATION PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01140/AM13/ RLA File :03/95/040/00721/AM13/ Lic.No/Date:0310719057 02.01.2013 Defer Date:18.04.2013 Decision :It was decided to examine the application on file and also call the firm for Personal Hearing on 26.4.2013. The case was deferred for 26.4.2013. 301

Case No.:129/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01276/AM13/ RLA File :08/24/040/00336/AM13/ Lic.No/Date:0810117326 02.01.2013 Defer Date:18.04.2013

Case No.:130/33/82ALC4/2012

21 03 2013 Status:Case Deferred

302 21.03.2013 Deferred HQ File :01/82/050/01277/AM13/ RLA File :08/24/040/00161/AM13/ Lic.No/Date:0810117325 02.01.2013 Defer Date:18.04.2013 303

Case No.:165/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01312/AM13/ RLA File :08/24/040/00257/AM13/ Lic.No/Date:0810117317 02.01.2013 Defer Date:18.04.2013 304

Case No.:171/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01318/AM13/ RLA File :08/24/040/00256/AM13/ Lic.No/Date:0810117315 02.01.2013 Defer Date:18.04.2013 305

Case No.:52/33/82ALC4/2012

Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01199/AM13/ RLA File :03/94/040/00846/AM13/ Lic.No/Date:0310719099 02.01.2013 Defer Date:18.04.2013 Decision :It was decided to ask from the firm the chemical name and composition of the export product. the case was deferred for 18.4.2013. 306

Case No.:74/33/82ALC4/2012

Party Name:MELZER CHEMICALS PVT. LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01221/AM13/ RLA File :31/83/040/00168/AM13/ Lic.No/Date:3110056651 02.01.2013 Defer Date:18.04.2013

Case No.:71/33/82ALC4/2012

Party Name:THERMAX LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01218/AM13/ RLA File :31/83/040/00244/AM12/ Lic.No/Date:3110056652 03.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 19/82 dated 6.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Kg/kg Water Corrosion Inhibitor (Brand Name: Corrosion 1 kg 1. Tetraethylene Pentamine (TEPA) 0.050 kg 2. Thioglycolic Acid 0.051 kg

307 3159) 2. Thioglycolic Acid 0.051 kg 3. Mix Xylene 0.005 kg 4. Cocoamine acetate 0.050 kg 5. Cocoamine 15 EO 0.030 kg Scale Inhibitor (Brand Name: Scalemin 3640) 1 kg 1. Acrylic Acid 0.190 kg 2. 2 Acrylamido Methyl Propane Sulfonic Acid (AMPS) 0.130 kg Biocide 1 (Brand Name Biomin 2750) 1 kg 1. Tertrakis Hydroxymethyl Phosphonium SulphateTHPS 75% 0.484 kg Biocide 2 (Brand Name Biomin 4020) 1 kg 1. Myristyl Dimethyl Amine/Tertiary Amine 0.065 kg 2. Gluteraldehyde 0.415 kg 308

Case No.:75/33/82ALC4/2012

Party Name:BALAJI AMINES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01222/AM13/ RLA File :31/83/040/00151/AM13/ Lic.No/Date:3110056653 03.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Qty. Sl.No. Import items Qty. allowed NMethyl2Pyrrolidone 1 kg 1. Methanol 0.377 kg 2. Ammonia Anhydrous 0.164 kg 3. 1,4 Butanediol 1.01 kg 4. Methylamine Catalyst 0.00080 kg 5. GBL Catalyst 0.00075 kg 309

Case No.:124/33/82ALC4/2012

Party Name:GOPINATH CHEMTECH LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01271/AM13/ RLA File :08/24/040/00341/AM13/ Lic.No/Date:0810117376 04.01.2013 Defer Date: 18.4.2013 310

Case No.:78/31/82ALC4/2012

Party Name:STERLING AUXILIARIES PVT LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01118/AM13/ RLA File :03/95/040/00769/AM13/ Lic.No/Date:0310719360 04.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/74/2011Ch. II dated 18.3.2013, 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 Quantity S.No Import items Quantity Allowed kg/kg

Stero MDEA (N Methyl Di Ethanol Amine) 1 kg 1. Monomethyl Ethanol Amine 0.643 2. Ethylene Oxide 0.377 Stero MDEA (PIP) (Blends of Piperazine & Methyl Di Ethanol Amine) 1 kg 1 Monomethyl Ethanol Amine 0.309 kg 2. Ethylene Oxide 0.181 3. Piperazine 68% 0.354 STERO Tea 99(Triethanol Amine) 1 kg 1. Triethanol Amine 99% 0.980 kg STERO MEDA (PIP)EX (Blends of Piperazine & Methyl DiEthanol Amine) 1 kg 1 Monomethyl Ethanol Amine 0.405 2. Ethylene Oxide 0.238 3. Piperazine Chips 0.370 STEROCARE PEG 7 GLC (Polyoxyethlene Glycerol Mono Laurate) 1 kg 1. Lauric Acid 0.423 2. Ethylene Oxide 0.452 STEROCARE TN 20 (Polyoxyethylene Sorbitan Mono Laurate) 1 kg 1 Lauric Acid 0.171 2. Sorbitol 70% 0.216 3. Ethylene Oxide 0.732 STANOX DSTDP (Distearyl Thiodipropionate) 1 kg 1 Di Methyl Thio Di Propionate 0.355 2. Stearyl Alcohol 0.830 STEROL 1306 (Tri Decyl Alcohol six mole Ethoxylate/Tri Decyl Alcohol 6 moles Ethoxylated) 1 kg 1 Tri Decyl Alcohol 0.431 kg 2. Ethylene Oxide 0.568 kg STERO MPEA (B) (Poly Ethoxylated 1 kg 1. Monomethyl Ethanol Amine 0.469

( y y Methyl Amine) 2. Ethylene Oxide 0.550 311

Case No.:178/33/82ALC4/2012

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:33/82ALC4/2012 21.03.2013 Status:Case Approved HQ File :01/82/050/01325/AM13/ RLA File :34/24/040/00234/AM13/ Lic.No/Date:3410035809 07.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 23/AM 13 dated 1.11.2012, 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 Quantity S.No Import items Quantity Allowed kg/kg Azithromycin Step 4 1 kg 1. Erythromycin Base USP 1.75 2. Hydroxylamine Hydrochloride 0.91 3. Methanol 2.72 4 Methane Sulfonyl Chloride 0.72 5. Acetone 6.45 6. Ethyl Alcohol 2.81 7. Platinum Catalyst with base of Activated Carbon 1.00 312

Case No.:40/31/82ALC4/2012

Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01080/AM13/ RLA File :03/95/040/00777/AM13/ Lic.No/Date:0310719514 07.01.2013 Defer Date:18.04.2013 313

Case No.:50/33/82ALC4/2012

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01197/AM13/ RLA File :03/94/040/00844/AM13/ Lic.No/Date:0310719615 07.01.2013 Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2011Ch. II dated 21.3.2013, 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 Strawberry Pure (Ethyl 3 methyl3phenyl glycidate) 1 kg 1. Acetophenone 0.759 kg 2. Ethyl Mono Chloro Acetate (EMCA) 0.688 kg 3. NaEthylate Crystals or Sodium Ethylate Crystals 0.440 kg

314

Case No.:51/33/82ALC4/2012

Party Name:ALTA LABORATORIES LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01198/AM13/ RLA File :03/94/040/00780/AM13/ Lic.No/Date:0310719594 07.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Qty. Sl.No. Import item Qty. allowed Sodium Salicylate 1 Kg. 1. Salicylic Acid 0.80 kg 315

Case No.:132/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01279/AM13/ RLA File :05/23/040/00410/AM13/ Lic.No/Date:0510342696 08.01.2013 Defer Date:18.04.2013 316

Case No.:134/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01281/AM13/ RLA File :05/23/040/00408/AM13/ Lic.No/Date:0510342701 08.01.2013 Defer Date:18.04.2013 317

Case No.:52/31/82ALC4/2012

Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01092/AM13/ RLA File :03/95/040/00708/AM13/ Lic.No/Date:0310719783 08.01.2013 Defer Date:18.04.2013 318

Case No.:74/31/82ALC4/2012

Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01114/AM13/ RLA File :03/95/040/00724/AM13/ Lic.No/Date:0310719791 08.01.2013 Defer Date:18.04.2013 319

Case No.:96/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01243/AM13/ RLA File :07/24/040/00419/AM13/ Lic.No/Date:0710092979 08.01.2013 Defer Date:18.04.2013

08.01.2013 Date:18.04.2013 320

Case No.:23/33/82ALC4/2012

Party Name:RELIANCE INDUSTRIES LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01170/AM13/ RLA File :03/95/040/00656/AM13/ Lic.No/Date:0310719988 09.01.2013 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.4.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 321

Case No.:101/31/82ALC4/2012

Party Name:PI INDUSTRIES LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01141/AM13/ RLA File :13/24/040/00045/AM13/ Lic.No/Date:1310041867 10.01.2013 Defer Date:18.04.2013 322

Case No.:117/33/82ALC4/2012

Party Name:MAHESHRAJ CHEMICALS PVT.LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01264/AM13/ RLA File :08/24/040/00339/AM13/ Lic.No/Date:0810117495 10.01.2013 Defer Date:18.04.2013 323

Case No.:29/33/82ALC4/2012

Party Name:O C SPECIALITIES PVT.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01176/AM13/ RLA File :03/95/040/00490/AM13/ Lic.No/Date:0310720309 10.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemcials vide their U.O No. 14010/108/2012Ch. II dated 19.3.2013, 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 item Qty. allowed N N DIISOPROPYL ETHYL AMINE 1 KG 1 Di Isopropyl Amine 1.18 kg 2. Di Ethyl Sulphate 1.40 kg 3. Causⷼc Soda Lye 48% 0.200 kg 324

Case No.:147/33/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01294/AM13/ RLA File :07/24/040/00429/AM13/ Lic.No/Date:0710093054 11.01.2013 Defer Date:18.04.2013

325

Case No.:203/33/82ALC4/2012

Party Name:SUBHASH CHEMICAL INDUSTRIES PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01350/AM13/ RLA File :31/83/040/00137/AM13/ Lic.No/Date:3110056802 11.01.2013 Defer Date:18.04.2013 326

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

Party Name:GLAND PHARMA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01036/AM13/ RLA File :09/24/040/00497/AM13/ Lic.No/Date:0910054771 11.01.2013 Defer Date:18.04.2013 327 Case No.:54/33/82ALC4/2012 Party Name:CIPLA LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01201/AM13/ RLA File :03/94/040/00872/AM13/ Lic.No/Date:0310720418 11.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed 62/0 Potassium Chloride Extended Release Capsules 600mg / Potassium Chlor ER Caps USP 600mg (Pack Size 100 Capsules Each) Each extended Release Capsule contains: Potassium Chloride USP 600mg 1 no. of Capsules 1 POTASSIUM CHLORIDE USP 612.0 mg 2 CITRIC ACID (MONOHYDRATE USP) 8.0 mg 3 DIBUTYL SEBACATE NF 9.6 mg 4 ETHANOL USP 99.9% 2.62 ml 5 100CC WHITE HDPE BOTTLE WITH 38MM NECK DB02 TRIVENI PLASTIC Relevant, as per packing policy 62/0 Potassium Chloride Extended Release Capsules 750mg / Potassium Chlor ER Caps USP 750mg (Pack Size 90 Capsules Each) Each extended Release Capsule contains: Potassium Chloride USP 750mg 1 no. of Capsules 1 POTASSIUM CHLORIDE USP 765.0 mg 2 CITRIC ACID (MONOHYDRATE USP) 10.0 mg 3 DIBUTYL SEBACATE NF 12.0 mg 4 ETHANOL USP 99.9% 2.62 ml 5 38/400 FG, CRC HAVING UNIPAC SG75M LINER PTD. WITH SFYP IN BLACK (REXAM CLOSURES) Relevant, as per packing policy 62/0 Potassium Chloride Extended Release Capsules 750mg / Potassium Chlor ER Caps USP 750mg (Pack Size 100 Capsules Each) 1 no. of Capsules 1 POTASSIUM CHLORIDE USP 765.0 mg 2 CITRIC ACID (MONOHYDRATE USP) 10.0 mg 3 DIBUTYL SEBACATE NF 12.0 mg 4 ETHANOL USP 99 9% 2 62 ml

( p ) Each extended Release Capsule contains: Potassium Chloride USP 750mg 4 ETHANOL USP 99.9% 2.62 ml 5 53/400 LSC, SCREW CAP HAVING UNIPAC SG75M LINER PTD. WITH SFYP IN BLACK (REXAM CLOSURES) Relevant, as per packing policy 200CC WHITE HDPE BOTTLE WITH 38MM NECK DB02 TRIVENI PLASTIC 6 38/400 FG, CRC HAVING UNIPAC SG75M LINER PTD. WITH SFYP IN BLACK (REXAM CLOSURES) Relevant, as per packing policy Potassium Chloride Extended Release Capsules 750mg / Potassium Chlor ER Caps USP 750mg (Pack Size 500 Capsules Each) Each extended Release Capsule contains: Potassium Chloride USP 750mg 1 no. of capsules 1 POTASSIUM CHLORIDE USP 765.0 mg 2 CITRIC ACID (MONOHYDRATE USP) 10.0 mg 3 DIBUTYL SEBACATE NF 12.0 mg 4 ETHANOL USP 99.9% 2.62 ml 5 950CC WHITE HDPE BOTTLE WITH 53MM NECK DB22 TRIVENI PLASTIC Relevant, as per packing policy 6 53/400 LSC, SCREW CAP HAVING UNIPAC SG75M LINER PTD. WITH SFYP IN BLACK (REXAM CLOSURES) Relevant, as per packing policy 328

Case No.:55/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01202/AM13/ RLA File :03/95/040/00800/AM13/ Lic.No/Date:0310720410 11.01.2013 Defer Date:18.04.2013 329

Case No.:56/33/82ALC4/2012

Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01203/AM13/ RLA File :03/95/040/00801/AM13/ Lic.No/Date:0310720417 11.01.2013 Defer Date:18.04.2013 330

Case No.:194/33/82ALC4/2012

Party Name:AVA CHEMICALS PVT.LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01341/AM13/ RLA File :03/94/040/00831/AM13/ Lic.No/Date:0310720550 14.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 26/82 dated 13.12.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as d l i ll d

Export product Exp. Qty. Sl.No. Import items Qty. allowed EDTA Tetrasodium 1 kg 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.750 kg 331

Case No.:195/33/82ALC4/2012

Party Name:AVA CHEMICALS PVT.LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01342/AM13/ RLA File :03/94/040/00830/AM13/ Lic.No/Date:0310720548 14.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Quantity S.No Import Product Quantity Allowed EDTA Ferric Sodium (Fe content 13%+0.5%) 1 kg 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.730 kg 332

Case No.:58/33/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01205/AM13/ RLA File :03/95/040/00788/AM13/ Lic.No/Date:0310720530 14.01.2013 Defer Date:18.04.2013 333

Case No.:59/33/82ALC4/2012

Party Name:RELIANCE INDUSTRIES LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01206/AM13/ RLA File :03/95/040/00740/AM13/ Lic.No/Date:0310720600 14.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their OM No. 46011/06/2013PC II dated 8.2.2013, 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 item Qty. allowed Benzene 1 MT 1. Reformate 0.866 MT 334

Case No.:199/33/82ALC4/2012

Party Name:INDO AMINES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01346/AM13/ RLA File :03/94/040/00630/AM13/ Lic.No/Date:0310720784 15.01.2013 Defer Date:18.04.2013

335

Case No.:24/33/82ALC4/2012

Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01171/AM13/ RLA File :03/95/040/00806/AM13/ Lic.No/Date:0310720729 15.01.2013 Defer Date:18.04.2013 336

Case No.:57/33/82ALC4/2012

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01204/AM13/ RLA File :03/95/040/00731/AM13/ Lic.No/Date:0310720724 15.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/92/2011/Ch. II dated 23.12.201, 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 Quantity S.No Import Product Quantity Allowed Meta Chloro Benzo Tri Fluoride (MCBTF) 1 kg 1. Benzo Tri Fluoride (BTF) 0.899 kg 337

Case No.:30/33/82ALC4/2012

Party Name:LUPIN LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01177/AM13/ RLA File :03/95/040/00809/AM13/ Lic.No/Date:0310721010 16.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 30/82 dated 25.10.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Rifapentine 150 mg tablets (Rifapex 150 mg) (weight of Bylk drug 74.41 kgs) 1 No. 1. Rifapentine 153 mg 338

Case No.:160/33/82ALC4/2012

Party Name:HALCYON LABS PVT. LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01307/AM13/ RLA File :03/94/040/00859/AM13/ Lic.No/Date:0310721247 17.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Quantity S.No Import Product Quantity allowed per unit of export product Clobetasol Propionate 1 kg 1. Betamethasone BP 1.04 kg

Clobetasol Propionate 1 kg 1. Betamethasone BP 1.04 kg 339

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

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01051/AM13/ RLA File :04/24/040/00217/AM13/ Lic.No/Date:0410142687 18.01.2013 Defer Date:18.04.2013 340

Case No.:202/33/82ALC4/2012

Party Name:AVA CHEMICALS PVT.LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01349/AM13/ RLA File :03/94/040/00877/AM13/ Lic.No/Date:0310721402 18.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Quantity S.No Import Product Quantity Allowed EDTA Ferric Sodium (Fe content 13%+0.5%) 1 kg 1. Ethylene Diamine Tetra Acetic Acid (EDTA) 0.730 kg 341

Case No.:21/33/82ALC4/2012

Party Name:MICRO INKS LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01168/AM13/ RLA File :03/95/040/00812/AM13/ Lic.No/Date:0310721354 18.01.2013 Defer Date: Decision :In the light of earlier decision taken inmeeting no. 46/82 dated 14.2.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Adhesion Promoter containing 62 + 1% Tetra Isopropyl Titanate and 27 + 1% Butanol 1 MT. 1. Butanol 0.2786 MT 2. Tetra Isopropyl Titanate 0.6302 MT 3. Isopropanol 0.1100 MT 342

Case No.:22/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01169/AM13/ RLA File :03/95/040/00815/AM13/ Lic.No/Date:0310721364 18.01.2013 Defer Date:18.04.2013

343

Case No.:25/33/82ALC4/2012

Party Name:PIRAMAL ENTERPRISES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01172/AM13/ RLA File :03/95/040/00383/AM13/ Lic.No/Date:0310721422 18.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 28/82 dated 10.1.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Item: Diltiazem HCL Tablets 30 mg, 60 mg, 90 mg and 120 mg S.No Import item For Export of 1 no. of Tablets 30 mg 60 mg 90 mg 120 mg 1. Dilitazem HCL USP 30.6 mg 61.2 mg 91.8 mg 122.4 mg 2. Lactose Monohydrate NF/BP (200 Mesh) 139.0 mg 278.0 mg 417.0 mg 556.0 mg 3. Bottle HDPE 60 CC white 33/400 Neck (DPG) Relevant, as per packing policy. 4. Plastic CR Closur PP 33400/FS M1(Green) 5. Bottle HDPE 250 CC White 53/400 Neck (DPG) 6. Plastic RS Closur PP 53400/FS ML Liner 7. Bottle HDPE 100 CC White 38/400 NECK(DPG) 8 Plastic CR Closur PP 38400/FS MI(Green) 9 Bottle HDPE 500 CC White 53/400 Neck (DPG) 10. Plastic RS Closur PP 53400/FS MI Liner 11. Bottle HDPE 150 CC white 38/400 Neck (DPG) 12. Plastic CR Closur PP 38400/FS MI(Green) 344

Case No.:26/33/82ALC4/2012

Party Name:PIRAMAL ENTERPRISES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01173/AM13/ RLA File :03/95/040/00374/AM13/ Lic No/Date:0310721416 Defer Date:

HQ File :01/82/050/01173/AM13/ RLA File :03/95/040/00374/AM13/ Lic.No/Date:0310721416 18.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under para 4.7 of HBP v1 as S. No Import Item For export of 1 no. tablet 3.125 mg 6.25 mg 12.5 mg 25.0 mg 1. Carvedilol USP 3.125 mg 6.25 mg 12.5 mg 25.0 mg 2. Lactose Monohydrate NF/BP (200 Mesh) Teva 10.0 mg 20.0 mg 40.0 mg 80.0 mg 3. Povidone USP (PVP K 30) 1.50 3.0 6.0 12.0 4. Crospovidone NF 1.50 3.0 6.0 12.0 5. Lactose Monohydrate (pray dried) 32.75 65.5 131.0 262.0 6. Bottle HDPL 60 CC White 33/400 NECK Relevant, as per packing policy 7. Plastic CR Closur PP 33400/FS MI (Green) 100s 8 BOTTLE HDPE 100CC WHITE 38/400 NECK 9 PLASTIC CR CLOSUR PP 38400/FS M1 (GREEN) 500s 10 BOTTLE HDPE 150CC WHITE 38/400 NECK 11 PLASTIC CR CLOSUR PP 38400/FS M1 (GREEN) 12 BOTTLE HDPE 200CC WHITE 38/400 NECK 13 PLASTIC CR CLOSUR PP 38400/FS M1 (GREEN) 14 BOTTLE HDPE 300CC WHITE 53/400 NECK 15 PLASTIC RS CLOSUR PP 53400/FS M1 LINER 345

Case No.:27/33/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 21.03.2013 Status:Case Approved HQ File :01/82/050/01174/AM13/ RLA File :03/95/040/00384/AM13/ Lic.No/Date:0310721426 Defer Date:

Q 18.01.2013 Decision : In the light of earlier decision taken in meeting no. 28/82 dated 10.1.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Sl.No. Import items Qty. allowed for export of 1 no. of Tablets Cilostazol Tablets 50 mg 100 mg 1. Cilostazol 51.0 102.0 2. Microcrystalline cellulose NF Avicel PH 102 20.0 40.0 3. Povidone USP (PVP K 30) 3.0 6.0 4. Corn Starch NF 16.75 33.50 5. Crospovidone NF 5.0 10.0 6. Magnesium Stearate NF/BP 0.75 1.50 7. Bottle HDPE 60 CC White 33/400 Neck (DPG) Relevant, as per packing policy 8. Plastic CR Closur PP 33/400/FS MI(Green) Relevant, as per packing policy 346

Case No.:28/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01175/AM13/ RLA File :03/95/040/00814/AM13/ Lic.No/Date:0310721359 18.01.2013 Defer Date:18.04.2013 347

Case No.:97/33/82ALC4/2012

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01244/AM13/ RLA File :07/24/040/00437/AM13/ Lic.No/Date:0710093153 18.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 28/82 dated 10.1.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Qty. allowed Cefuroxime 750 mg Inj. USP Vial size 10 ml each vial contains cefuroxime sodium USP equivalent to Cefuroxime 750 mg 1 vial 1. Cefuroxime Sodium Sterile USP 822.50 mg/vial 348

Case No.:98/33/82ALC4/2012

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01245/AM13/ RLA File :07/24/040/00414/AM13/ Lic.No/Date:0710093152 18 01 2013 Defer Date: 18 04 2013

18.01.2013 18.04.2013 349

Case No.:99/33/82ALC4/2012

Party Name:PARAMOUNT AROMACHEM PVT.LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01246/AM13/ RLA File :05/24/040/00381/AM13/ Lic.No/Date:0510343720 18.01.2013 Defer Date:18.04.2013 350

Case No.:100/33/82ALC4/2012

Party Name:INDO PHYTOCHEM PHARMACEUTICALS 21.03.2013 Status:Case Approved HQ File :01/82/050/01247/AM13/ RLA File :05/23/040/00429/AM13/ Lic.No/Date:0510343801 21.01.2013 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 Export product Export Qty. Sl.No. Import items Qty. allowed Yohimbine Hydrochloride USP used as a Aphrodisiac USP 1 Kg. 1. Yohimbine Bark Bark having brown colour(containing Yohimbine content maximum 11.2%) 133.44 kg 351

Case No.:149/33/82ALC4/2012

Party Name:R L FINE CHEM 21.03.2013 Status:Case Approved HQ File :01/82/050/01296/AM13/ RLA File :07/24/040/00426/AM13/ Lic.No/Date:0710093198 21.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 13.9.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import items Qty. allowed Lorazepam BP 1 kg 1. 2 Amino 2,5Dichloro Benzo Phenone 1.60 kg 352

Case No.:150/33/82ALC4/2012

Party Name:R L FINE CHEM 21.03.2013 Status:Case Approved HQ File :01/82/050/01297/AM13/ RLA File :07/24/040/00427/AM13/ Lic.No/Date:0710093200 21.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 41/AM 12 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: Export product Export Qty. Sl.No. Import items Qty. allowed Carbinoxamine Maleate 1 kg 1. Pyridine 2 Aldehyde 0.833 kg 2 Tetra Hydro Furan 0 468 kg

Tetra Hydro Furan 0.468 kg 3. Acetone 1.500 kg 353

Case No.:156/33/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01303/AM13/ RLA File :03/95/040/00698/AM13/ Lic.No/Date:0310721594 21.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 23/82 dated 6.89.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed 5Amino 6 methyl Benzimidazolone 1 kg. 1. 3,4Diamino Toluene (Melene) 1.200 kg 2. Hydrazine Hydrate (as 80% basis) 1.022 kg 354

Case No.:87/33/82ALC4/2012

Party Name:R L FINE CHEM 21.03.2013 Status:Case Deferred HQ File :01/82/050/01234/AM13/ RLA File :07/24/040/00428/AM13/ Lic.No/Date:0710093201 21.01.2013 Defer Date:18.04.2013 355

Case No.:88/33/82ALC4/2012

Party Name:R L FINE CHEM 21.03.2013 Status:Case Deferred HQ File :01/82/050/01235/AM13/ RLA File :07/24/040/00425/AM13/ Lic.No/Date:0710093199 21.01.2013 Defer Date:18.04.2013 356

Case No.:91/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01238/AM13/ RLA File :05/23/040/00415/AM13/ Lic.No/Date:0510343812 21.01.2013 Defer Date: 18.04.2013 Decision : It was decided to defer the case for 18.4.2013 for comments of Department of Chemicals and Petrochemials. 357

Case No.:102/33/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01249/AM13/ RLA File :34/24/040/00239/AM13/ Lic.No/Date:3410035900 22.01.2013 Defer Date:18.04.2013 / 33/82 A C4/2012 S C

358

Case No.:159/33/82ALC4/2012

Party Name:ANUH PHARMA LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01306/AM13/ RLA File :03/94/040/00890/AM13/ Lic.No/Date:0310721686 22.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Prednisolone Sodium Phosphate Ip/BP/USP/EP 1 Kg. 1. Prednisolone (Prednisolone Base) IP/BP/USP/EP 0.90 kg 359

Case No.:80/33/82ALC4/2012

Party Name:SARNA CHEMICALS PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01227/AM13/ RLA File :52/24/040/00041/AM13/ Lic.No/Date:5210039377 22.01.2013 Defer Date:18.04.2013 360

Case No.:145/33/82ALC4/2012

Party Name:SHILPA MEDICARE LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01292/AM13/ RLA File :07/24/040/00454/AM13/ Lic.No/Date:0710093290 23.01.2013 Defer Date:18.04.2013 361

Case No.:146/33/82ALC4/2012

Party Name:SHILPA MEDICARE LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01293/AM13/ RLA File :07/24/040/00453/AM13/ Lic.No/Date:0710093292 23.01.2013 Defer Date:18.04.2013 362

Case No.:193/33/82ALC4/2012

Party Name:GLENMARK GENERICS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01340/AM13/ RLA File :03/94/040/00800/AM13/ Lic.No/Date:0310721794 23.01.2013 Defer Date:18.04.2013 363

Case No.:208/33/82ALC4/2012

Party Name:ARIHANTANAM LIFECARE PVT. LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01355/AM13/ RLA File :03/94/040/00817/AM13/ Lic.No/Date:0310721780 23.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no 16/82 dated 16 8 2013 it was decided to ratify norms under Para 4 7 of HBP v1 as per

Decision :In the light of earlier decision taken in meeting no. 16/82 dated 16.8.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Dihydro Artemisinin 1 kg 1. Artemisinin 1.12 kg 364

Case No.:155/33/82ALC4/2012

Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01302/AM13/ RLA File :03/95/040/00810/AM13/ Lic.No/Date:0310722018 24.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 18/82 dated 10.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Ferrous Fumarate USP 1 kg 1. Fumaric Acid (Technical Grade) 0.856 2. Ferrous Sulphate 1.98 3. Soda Ash 0.944 365

Case No.:158/33/82ALC4/2012

Party Name:FERMENTA BIOTECH LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01305/AM13/ RLA File :03/94/040/00683/AM13/ Lic.No/Date:0310721893 24.01.2013 Defer Date:18.04.2013 366

Case No.:85/33/82ALC4/2012

Party Name:ESTEEM INDUSTRIES PVT. LTD, 21.03.2013 Status:Case Approved HQ File :01/82/050/01232/AM13/ RLA File :17/24/040/00065/AM13/ Lic.No/Date:1710005204 24.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 42/82 dated 17.1.2012, it was decidedto ratify norms under Para 4.7 of HBP v1 as per Export product Export Qty. Sl.No. Import items Qty. allowed PRODUCT LAP‐2 (Phosphated Ester of Lauryl Alcohol 2 mole ethoxylate) 1 kg 1 2 3 Lauryl Alcohol Ethylene Oxide Phosphorous Pentoxide 0.585 kg 0.268 kg 0.148 kg

Case No :143/33/82 ALC4/2012

Party Name:ADCOCK INGRAM LTD Meet No/Date:33/82 ALC4/2012 Status:Case

367

Case No.:143/33/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 21.03.2013 Status:Case Approved HQ File :01/82/050/01290/AM13/ RLA File :07/24/040/00438/AM13/ Lic.No/Date:0710093327 28.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 20.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as 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 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phsophate BP/EP/USP/PH.EUR 10.2 kg 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 1 million 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 1 million 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 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 368

Case No.:157/33/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/01304/AM13/ RLA File :03/95/040/00845/AM13/ Lic.No/Date:0310722147 Defer Date:

HQ File :01/82/050/01304/AM13/ RLA File :03/95/040/00845/AM13/ Lic.No/Date:0310722147 28.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 3/82 dated 17.4.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Quantity S.No Import Product Quantity allowed Dipentamethylene Thiuram Tetra Sulfide (Qureacc DPTT) 1 kg 1 Piperidine 0.490 kg 369

Case No.:211/33/82ALC4/2012

Party Name:O C SPECIALITIES PVT.LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01358/AM13/ RLA File :03/95/040/00841/AM13/ Lic.No/Date:0310722151 28.01.2013 Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/108/2012Ch. II dated 19.3.2013, 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 Quantity S.No Import Product Quantity allowed 2,3Dichloro Pyridine 1 kg 1. 3 Amino Pyridine 1.44 kg 370

Case No.:38/33/82ALC4/2012

Party Name:R L FINE CHEM 21.03.2013 Status:Case Deferred HQ File :01/82/050/01185/AM13/ RLA File :07/24/040/00449/AM13/ Lic.No/Date:0710093355 28.01.2013 Defer Date:18.04.2013 371

Case No.:64/33/82ALC4/2012

Party Name:GOPINATH CHEMTECH LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01211/AM13/ RLA File :08/24/040/00361/AM13/ Lic.No/Date:0810117886 28.01.2013 Defer Date:18.04.2013 372

Case No.:65/33/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01212/AM13/ RLA File :08/24/040/00228/AM13/ Lic.No/Date:0810117887 28.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 ddated 15.11.20126.3.2012, it was decided to ratify norms under Para 4.7 of HBP v1 a0s0 per details given below or as applied by the firm, whichever is less:

HBP v1 a0s0 per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Methyl Triphenyl Phosphonium Bromide 1 kg 1. 2 Triphenyl Phosphine Methyl Ethyl Ketone 0.850 kg 0.270 kg 373

Case No.:69/33/82ALC4/2012

Party Name:TORRENT PHARMACEUTICALS LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01216/AM13/ RLA File :08/24/040/00370/AM13/ Lic.No/Date:0810117848 28.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 27/82 dated 29.12.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Acemetacin Capsules Acemetacin 30 Heumann (Pack Size 20, 50 & 100 Capsules) Each capsule contains Acemetacin 30mg, excipient q.s. Net content of acⷼve ingredient Acemetacin should not be less than 70 kgs in export product 1 Number 1. Acemetacin Condn.:‐This licence issued under

para 4.7 of H.B. 2009‐14 for

fixaⷼon of norms by ALC.,New Delhi. (2) This license is issued in terms of policy circular No.9 dtd.30.06.2003 and public noⷼce No.31 dtd.14.02.2011 30.6 mg Acemetacin Capsules Acemetacin 60 Heumann (Pack Size 20, 50 & 100 Capsules) Each capsule contains Acemetacin 60mg, excipient q.s. Net content of acⷼve ingredient Acemetacin should not be less than 70 kgs in export product 2. Acemetacin Condn.:‐This licence issued under

para 4.7 of H.B. 2009‐14 for

fixaⷼon of norms by ALC.,New Delhi. (2) This license is issued in terms of policy circular No.9 dtd.30.06.2003 and public noⷼce No.31 dtd.14.02.2011 61.2 mg

Case No.:83/33/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 21.03.2013 Status:Case Approved

374 HQ File :01/82/050/01230/AM13/ RLA File :07/24/040/00446/AM13/ Lic.No/Date:0710093332 28.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 20.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as 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 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phsophate BP/EP/USP/PH.EUR 10.2 kg 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 1 million 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 1 million 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 1million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 375

Case No.:153/33/82ALC4/2012

Party Name:ZYTEX BIOTECH PVT. LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01300/AM13/ RLA File :03/95/040/00816/AM13/ Lic.No/Date:0310722230 29.01.2013 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.4.2013 for comments of Department of Pharmaceuticals.

376

Case No.:197/33/82ALC4/2012

Party Name:FERMENTA BIOTECH LTD., 21.03.2013 Status:Case Deferred HQ File :01/82/050/01344/AM13/ RLA File :03/94/040/00917/AM13/ Lic.No/Date:0310722266 29.01.2013 Defer Date:18.04.2013 377

Case No.:201/33/82ALC4/2012

Party Name:ENALTEC LABS PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01348/AM13/ RLA File :03/94/040/00933/AM13/ Lic.No/Date:0310722303 29.01.2013 Defer Date:18.04.2013 378

Case No.:78/33/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/01225/AM13/ RLA File :08/24/040/00366/AM13/ Lic.No/Date:0810117929 29.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 1/82 dated 6.4.2010, it was decided to ratify norms under Para 4.7 of HBP v 1 as per Export product Export Qty. Sl. No. Import items Qty. allowed for 10 mg Tablets Qty. allowed for 20 mg Tablets Qty. allowed for 30 mg Tablets Qty. allowed for 40 mg Tablets Paroxetine 10 mg Tablets 1 Million Nos. 1. Paroxetine Hcl Hemihydrate 11.10 kg 22.20 kg 33.30 kg 44.40 kg 2. Lactose Anhydrous NF 65.93 kg 131.86 kg 197.79 kg 263.72 kg Paroxetine 20 mg Tablets 1 Million Nos. 3. Dibasic Calcium Phosphate Anhydrous 23.18 kg 46.36 kg 69.54 kg 92.22 kg 4. Povidone K 30 4.39 kg 8.78 kg 13.17 kg 17.56 kg Paroxetine 40 mg Tablets 1 Million Nos. 5. Magnesium Stearate 1.10 kg 2.20 kg 3.30 kg 4.40 kg 6. BOTTLES & CAPS ( PACKING MATERIALS As per packing policy As per packing policy As per packing policy As per packing policy Paroxetine 30 mg Tablets

Tablets MATERIALS IN FINISHED FORM) a) 500 CC WHITE HDPE BOTTLE (NET NOS. 7000) 7 6. b) 400 CC WHITE HDPE BOTTLE (NET NOS. 161000) 8. 6. c) 300 CC WHITE HDPE BOTTLE (NET NOS. 16800) As per packing policy As per packing policy As per packing policy As per packing policy 9. 6. d) 225 CC WHITE HDPE CRC BOTTLE (NET NOS. 16000) As per packing policy As per packing policy As per packing policy As per packing policy 10. 6. e) 150 CC WHITE HDPE BOTTLE (NT NOS. 21000) As per packing policy As per packing policy As per packing policy As per packing policy 11. 6. f) 100 CC WHITE HDPE CRC BOTTLE (NET NOS. 22400) As per packing policy As per packing policy As per packing policy As per packing policy 12. 6. g) BOTTLE 75 CC WHITE HDPE ROUND BOTTLE (NET NOS. 29445) As per packing policy As per packing policy As per packing policy As per packing policy 13. 6. h) 60 CC WHITE HDPE BOTTLE (NET NOS. 1703334) As per packing policy As per packing policy As per packing policy As per packing policy 14. 6. i) 40 CC WHITE HDPE BOTTLE (NET NOS. 105000) As per packing policy As per packing policy As per packing policy As per packing policy 15. 6. j) CRC WHT CAP 33 MM As per packing As per packing As per packing As per packing

CAP 33 MM PULP LINER (NET NOS. 1732779) packing policy packing policy packing policy packing policy 16. 6. k) 33 MM WHITE PP NCRC PULP LINER (NET NOS. 105000) As per packing policy As per packing policy As per packing policy As per packing policy 17. 6. l) NCRC WHITE CAP 45 MM PULP LINER (NET NOS. 32800) As per packing policy As per packing policy As per packing policy As per packing policy 18. 6. m) NCRC WHITE CAP 53 MM PULP LINER (NET NOS. 168000) As per packing policy As per packing policy As per packing policy As per packing policy 19 6. n) WHITE CONTINUOUS THREAD 38 MM CAP (NET NOS. 43400) ( This licence is issued as per

para 4.7

H.B.P.200914, subject to fixation of norms by ALC.) As per packing policy As per packing policy As per packing policy As per packing policy 379

Case No.:79/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01226/AM13/ RLA File :05/23/040/00430/AM13/ Lic.No/Date:0510344338 29.01.2013 Defer Date:18.04.2013

Case No.:154/33/82ALC4/2012

Party Name:SATYAM PHARMA CHEM PVT LTD 21.03.2013 Status:Case Deferred

380 HQ File :01/82/050/01301/AM13/ RLA File :03/95/040/00787/AM13/ Lic.No/Date:0310722449 30.01.2013 Defer Date:18.04.2013 381

Case No.:196/33/82ALC4/2012

Party Name:INDO AMINES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01343/AM13/ RLA File :03/94/040/00907/AM13/ Lic.No/Date:0310722359 30.01.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 13/82 dated 17.7.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed INDOEMUL TO 15 1 kg 1. Tallow Amine 0.283 kg/kg 2. Ethylene Oxide 0.716 kg/kg 382

Case No.:207/33/82ALC4/2012

Party Name:ALKYL AMINES CHEMICALS LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01354/AM13/ RLA File :03/94/040/01173/AM12/ Lic.No/Date:0310722427 30.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Quantity S.No Import Product Quantity Allowed 2 Ethyl Hexylamine 1 kg 1. 2 Ethyl Hexanol 1.06 kg 383

Case No.:60/33/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01207/AM13/ RLA File :07/24/040/00430/AM13/ Lic.No/Date:0710093432 30.01.2013 Defer Date:18.04.2013 384 Case No.:1/31/82ALC4/2012 21.03.2013 Status:Case Approved HQ File :01/82/050/01041/AM13/ RLA File :08/24/040/00357/AM13/ Lic No/Date:0810117992 Defer Date:

HQ File :01/82/050/01041/AM13/ RLA File :08/24/040/00357/AM13/ Lic.No/Date:0810117992 31.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 28/82 dated 11.10.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied bythe firm, whichever is less: Export product Export Qty. Sl. No. Import items Qty. allowed for 0.25 mg Tablets Qty. allowed for 0.50 mg Tablets Qty. allowed for 1.0mg Tablets Qty. allowed for 2.0 mg Tablets Qty. allowed for 3.0 mg Tablets Qty. allowed for 4.0 mg Tablets Resperidone Tablets 1 Million Nos. each 1. Risperidone USP 0.255 kg 0.510 kg 1.020 kg 2.040 kg 3.060 kg 4.080 kg 2. Lactose Monohydrate NF 45.0 kg 44.75 kg 89.50 kg 179.0 kg 268.50 kg 358.0 kg 3. Microcryltalline Cellulose NF (Avicel PH) 2.50 kg 2.50 kg 5.0 kg 10.0 kg 15.0 kg 20.0 kg 4. Sodium Lauryl Sulfate NF 0.250 kg 0.250 kg 0.50 kg 1.0 kg 1.50 kg 2.0 kg 5. Magnesium Stearate 0.500 kg 0.500 kg 1.00 kg 2.00 kg 3.00 kg 4.00 kg 6. 400 CC White HDPE Round Bottle As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy 7. 225 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy 8. 100 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy 9. 75 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy 10. 60 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy 11. 33 MM WHITE PP CRC with Pulp Liner As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy 12. 33 MM WHITE As per As per As per As per As per As per

PP SCREW CAP packing policy packing policy packing policy packing policy packing policy packing policy 13. 45 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy 14. 38 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy 15. 53 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy As per packing policy 385

Case No.:152/33/82ALC4/2012

21.03.2013 Status:Case Deferred HQ File :01/82/050/01299/AM13/ RLA File :08/24/040/00363/AM13/ Lic.No/Date:0810117991 31.01.2013 Defer Date:18.04.2013 386

Case No.:198/33/82ALC4/2012

Party Name:CROWN CHEMICALS PVT.LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01345/AM13/ RLA File :03/94/040/00930/AM13/ Lic.No/Date:0310722611 01.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as 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 (Min. Purity 99%) 0.220 kg 387

Case No.:2/31/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01042/AM13/ RLA File :09/24/040/00511/AM13/ Lic.No/Date:0910054886 01.02.2013 Defer Date:18.04.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/669/2012PI(Norms) dated 12.3.2013, it was decided call from the firm a copy of Master Batch formula duly authenticated by Quality Control Incharge. The case was deferred for 18.4.2013.

388

Case No.:200/33/82ALC4/2012

Party Name:CROWN CHEMICALS PVT.LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01347/AM13/ RLA File :03/94/040/00924/AM13/ Lic.No/Date:0310722609 01.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as 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 (Min. Purity 99%) 0.220 kg 389

Case No.:206/33/82ALC4/2012

Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 21.03.2013 Status:Case Approved HQ File :01/82/050/01353/AM13/ RLA File :03/94/040/00944/AM13/ Lic.No/Date:0310722727 01.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/38/2010Ch. II dated 27.4.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given belwo or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Amino5 Chlorobenzophenone CAS#719595 1 kg 1 Anthranil/5 Chloro3Phenylanthranil 1.16 kg 390

Case No.:209/33/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01356/AM13/ RLA File :03/95/040/00804/AM13/ Lic.No/Date:0310722788 04.02.2013 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/576/2012PI(Norms) dated 27.12.2012, it was decided to call from the firm the technical details as per Appendix 33. The case was deferred for 18.4.2013

Case No.:144/33/82ALC4/2012

Party Name:TORRENT PHARMACEUTICALS LTD. 21.03.2013 Status:Case Approved HQ File :01/82/050/01291/AM13/ RLA File :08/24/040/00378/AM13/ Lic.No/Date:0810118081 05.02.2013 Defer Date: Decision :In line with SION 412 A , it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below (@2% wastage) or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Torasemide Tablet 5 mg 1 tablet 1 Torasemide 5 1mg/tablet

391 Torasemide Tablet 5 mg Torasemide Heumann 5 mg Tabletten (pack size 30,50,100 Tablets) Each uncoated tablet contains Torasemide Anhydrous Ph Eur 5 mg. Excipient q.s Net Weight of Torasemide should not be less than 75 kgs in export products 1 tablet 1. Torasemide 5.1mg/tablet Torasemide Tablet 10 mg Torasemide Heumann 10 mg Tabletten (pack size 30,50,100 Tablets) Each uncoated tablet contains Torasemide, Anhydrous Ph Eur 10 mg. Excipient q.s Net Weight of Torasemide should not be less than 75 kgs in export product. 1 tablet 1. Torasemide 10.2 mg/tablet 392

Case No.:61/33/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01208/AM13/ RLA File :08/24/040/00184/AM13/ Lic.No/Date:0810118080 05.02.2013 Defer Date:18.04.2013 393

Case No.:67/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 21.03.2013 Status:Case Deferred HQ File :01/82/050/01214/AM13/ RLA File :07/24/040/00461/AM13/ Lic.No/Date:0710093544 05.02.2013 Defer Date:18.04.2013 394

Case No.:20/33/82ALC4/2012

Party Name:SARNA CHEMICALS PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01167/AM13/ RLA File :52/24/040/00042/AM13/ Lic.No/Date:5210039408 06.02.2013 Defer Date:18.04.2013

Case No.:62/33/82ALC4/2012

Party Name:MINAL INTERMEDIATES 21.03.2013 Status:Case Deferred

395 HQ File :01/82/050/01209/AM13/ RLA File :08/24/040/00385/AM13/ Lic.No/Date:0810118226 06.02.2013 Defer Date:18.04.2013 396

Case No.:63/33/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/01210/AM13/ RLA File :08/24/040/00383/AM13/ Lic.No/Date:0810118232 06.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 47/82 dated 22.2.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Calcitriol 0.25 MCG Caps. 1,12,87,860 Nos. 1. Calcitriol 2.8784 gm 2. Med Chain Triglyceride NF 1749.119 kg 3. Gelatin NF 1608.887 kg 4. Glycerin USP 689.745 kg 5. Noncrystallizing Sorbitol Solution NF 229.708 kg 6. Bottles & caps (Packing Materials in finished form) a 40 CC white HDPE Bottle (net quantity 70000 Nos.) As per packing policy 7. 6) b. CRC WHITE CAP 33 MM (NET QTY. 70000 NOS.) 8 6) c. 60 CC WHITE HDPE BOTTLE (NET QTY. 30000 NOS.) 9 33 MM WHITE PP NCRC CAP (NET QTY. 30000 NOS.) Calcitriol 0.50 MCG Caps 45,74,300 Nos. 1. Calcitriol 2.333 gm 2. Med Chain Triglyceride NF 708.971 kg 3. Gelatin NF 654.125 kg 4. Glycerin USP 279.513 kg 5. Noncrystallizing Sorbitol Solution NF 93.087 kg 6. Bottles & caps (Packing Materials in finished form) a 40 CC white HDPE Bottle (net quantity 70000 Nos.) As per packing policy 7 6) b. CRC WHITE CAP 33 MM (NET QTY. 70000 NOS.) 8 6) c. 60 CC WHITE HDPE BOTTLE (NET QTY. 30000 NOS.) 9 33 MM WHITE PP NCRC CAP (NET QTY. 30000 NOS.)

Case No.:81/33/82ALC4/2012

21.03.2013 Status:Case Approved HQ File :01/82/050/01228/AM13/ RLA File :08/24/040/00382/AM13/ Lic.No/Date:0810118231 Defer Date:

397 06.02.2013 Decision : In the light of earlier decision taken in meeting no. 24/82 dated 15.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Norms allowed for export of Lamotrignie ( 1 no. of Tablet) Qty. in mg S.No Import item 25 mg tabs 100 mg tabs 150 mg tabs 200 mg tabs 1. Lamotrigine 25.5 mg 102 mg 153 mg 204 mg 2. Microcrystalline Cellulose (Avicel PH 101) 30 mg 120 mg 180 mg 240 mg 3 Lactose Monohydrate 15 mg 60 mg 90 mg 120 mg 4. Bottles & Caps Relevant, as per packing policy Norms for 1 kg Lamotrigine S.No Import Item Qty allowed (kg/kg) 1. 2,3 Dichloro Benzoyl Nitrile 1.222 2 Amino Guanidine Bicarbonate 1.222 3 Di Methyl Sulphoxide 0.70 4. Methanol 2.80 398

Case No.:139/33/82ALC4/2012

Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 21.03.2013 Status:Case Deferred HQ File :01/82/050/01286/AM13/ RLA File :05/23/040/00446/AM13/ Lic.No/Date:0510345185 07.02.2013 Defer Date:18.04.2013 399

Case No.:151/33/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01298/AM13/ RLA File :05/23/040/00459/AM13/ Lic.No/Date:0510345208 07.02.2013 Defer Date:18.04.2013 Decision :It was decided to defer the case for 18.4.2013 for comments of Department of Chemicals and Petrochemicals and Department of Industrial Policy and Promotion. 400

Case No.:204/33/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01351/AM13/ RLA File :03/95/040/00483/AM12/ Lic.No/Date:0310723312 07.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 8/82 dated 22.5.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 1 B 6 Chl h 1 k 1 1 6 H di l 0 878 k

1Bromo6Chlorohexane 1 kg 1. 1,6 Hexandiol 0.878 kg 2. Hydrobromic Acid 48% 3.014 kg 401

Case No.:205/33/82ALC4/2012

Party Name:MOHINI ORGANICS PVT. LTD., 21.03.2013 Status:Case Approved HQ File :01/82/050/01352/AM13/ RLA File :03/95/040/00849/AM13/ Lic.No/Date:0310723282 07.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/141/2011Ch. II dated 18.2.2013, 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 Sorbitan Mono Oleate 1 kg 1. Sorbitol 70% 0.501 kg 2. Oleic Acid (Max 80%) 0.768 kg 402

Case No.:210/33/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01357/AM13/ RLA File :03/95/040/00836/AM13/ Lic.No/Date:0310723378 07.02.2013 Defer Date:18.04.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/576/2012PI(Norms) dated 27.12.2012, it was decided to call from the firm the technical details as per Appendix 33. The case was deferred for 18.4.2013 403

Case No.:93/31/82ALC4/2012

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01133/AM13/ RLA File :03/94/040/00926/AM13/ Lic.No/Date:0310723236 07.02.2013 Defer Date:18.04.2013 404

Case No.:84/33/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01231/AM13/ RLA File :05/23/040/00449/AM13/ Lic.No/Date:0510345251 08.02.2013 Defer Date:18.04.2013 405

Case No.:161/33/82ALC4/2012

Party Name:RONAK CHEMICALS 21.03.2013 Status:Case Deferred HQ File :01/82/050/01308/AM13/ RLA File :34/24/040/00257/AM13/ Lic.No/Date:3410036096 12.02.2013 Defer Date:18.04.2013

406

Case No.:163/33/82ALC4/2012

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01310/AM13/ RLA File :03/94/040/00972/AM13/ Lic.No/Date:0310724040 13.02.2013 Defer Date:18.04.2013 407

Case No.:68/33/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 21.03.2013 Status:Case Deferred HQ File :01/82/050/01215/AM13/ RLA File :05/23/040/00456/AM13/ Lic.No/Date:0510345898 13.02.2013 Defer Date:18.04.2013 408

Case No.:162/33/82ALC4/2012

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01309/AM13/ RLA File :03/94/040/00979/AM13/ Lic.No/Date:0310724427 18.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2011Ch. II dated 21.3.2013, 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 Strawberry Pure (Ethyl 3 methyl3phenyl glycidate) 1 kg 1. Acetophenone 0.759 kg 2. Ethyl Mono Chloro Acetate (EMCA) 0.688 kg 3. NaEthylate Crystals or Sodium Ethylate Crystals 0.440 kg 409

Case No.:1/33/82ALC4/2012

Party Name:POLYGON CHEMICALS 21.03.2013 Status:Case Approved HQ File :01/82/050/01148/AM13/ RLA File :08/24/040/00421/AM13/ Lic.No/Date:0810118807 25.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/9/2010/Ch. II dated 7.3.2013, 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 Quantity S.No Import Product Quantity Allowed 3 Methyl 5Pyrazolone 1 kg 1. Acetic Acid Methyl Ester 1.287 kg 2. Hydrazine Hydrate (Purity 80%) 0.692 kg

410

Case No.:2/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 21.03.2013 Status:Case Deferred HQ File :01/82/050/01149/AM13/ RLA File :05/23/040/00474/AM13/ Lic.No/Date:0510347744 28.02.2013 Defer Date:18.04.2013 411

Case No.:3/33/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 21.03.2013 Status:Case Deferred HQ File :01/82/050/01150/AM13/ RLA File :05/24/040/00448/AM13/ Lic.No/Date:0510347967 01.03.2013 Defer Date:18.04.2013 412

Case No.:5/33/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 21.03.2013 Status:Case Approved HQ File :01/82/050/01152/AM13/ RLA File :05/24/040/00444/AM13/ Lic.No/Date:0510348168 05.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 3/82 dated 17.4.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Acebutolol Tablet/Capsule 200 mg 1 No. 1. Acebutolol Hcl 221.698 mg Acebutolol Tablet/Capsule 400 mg 1 No. 1 Acebutolol HCL 443.396 mg 413

Case No.:6/33/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 21.03.2013 Status:Case Approved HQ File :01/82/050/01153/AM13/ RLA File :03/95/040/00939/AM11/ Lic.No/Date:0310727035 06.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 23/82 dated 1.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Qty. Sl.No. Import items Qty. allowed 2Bromo Isobutyrated Isopropyl/Iso propyl 2Bromo Isobutyrate 1 kg 1. Iso Butyric Acid 0.701 kg 2. Liquid Bromine 1.276 kg 3. Iso Propanol 1.078 kg

Outside Agenda No. 1 M/s. IPCA Laboratories Limited 01/82/50/1769/AM 11/DES III 0310620013 dated 8.3.2011 RLA’s File No 03/94/40/1002/AM 11 Decision: It was decided to amend the export quantity from 50 kg to 1 kg. (Refer minutes of NC meeting no. 38/82 dated 20.12.2011). Rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee. Outside Agenda No. 2 M/s. Alkyl Amines Chemicals Limited, Mumbai 01/82/050/00003/AM 12/DES III 0310624109 dated 12.7.2011 RLA’s File No 03/94/040/00515/AM 11 Decision: It was decided to amend the description of the export product as 3(2Ethyl Hexoxy)Propylamine. Rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee. Date:26.03.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer

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Para 4.7 Decision

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