IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2014-04-10

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision (DRAFT)

MEETING NUMBER : 1/82ALC4/2014 MEETING DATE : 10.04.2014 but actually held on 21.04.2014 The Meeting No. 1/82 of 201415 to consider the cases/issues under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products and falling under Chapter 29 and 30 was scheduled for 10.04.2014 but actually held on 21.04.2014 under the Chairmanship of, Shri Jaikant Singh, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were present: Shri D.N. Mathur. Consultant, Department of Pharmaceutical Shri Jasbir Singh, Consultant, Department of C&PC Shri Nirmal Kumar, Deputy Director General of Foreign Trade Dr. Nitin Jain D/o Biotechnology Since no communication /comments were received from any of the Administrative Departments. The minutes of the meeting held on 21.04.2014 was treated as approved. The following cases/issues were discussed and the committee took the decision as mentioned against the case:

Case No. B‐1

M/s Shiva Pharma Ltd Meeﴅng No. 1/AM15 Dated – 21.04.2014 F.No. 01/82/162/00016/AM13/DES‐III Adv. Lic. No. 3410025487 dated 30.10.2009 Adv. Lic. No. 3410025693 dated 25.11.2009 Adv. Lic. No. 3410026511 dated 03.03.2010 Adv. Lic. No. 3410027522 dated 16.07.2010 Decision: It was decided to defer the case for 08.05.2014 for comments of Department of C&PC. Case No. B‐ 2 M/s Dor埘� Ketal Chemicals I Pvt Ltd. F. No. 01/82/162/00280/AM14/DES‐III S.No. Head Qtr. F.No. RLA F.No. Adv. Lic. Nos.

1 01/82/050/00743/AM09 03/94/040/00325/AM09 0310478565 dt. 14.07.2008 2 01/82/050/00596/AM11 03/94/040/00379/AM11 0310585032 dt. 26.07.2010 3 01/82/050/00913/AM11 03/94/040/00575/AM11 0310594926 dt. 04.10.2010 M. No. 1/AM15 4 01/82/050/01630/AM07 03/94/040/01004/AM07 0310418037 dt. 01.02.2007 5 01/82/050/01206/AM09 03/94/040/00662//AM09 0310491961 dt. 24.10.2008 6 01/82/050/00113/AM10 03/94/040/01057/AM09 0310526499 dt. 30.06.2009 7 01/82/050/00630/AM10 03/94/040/00451/AM10 0310541892 dt. 23.10.2009 8 01/82/050/00784/AM10 03/94/040/00743/AM10 310548591 dt. 01.12.2009 Date – 21.04.2014 9 01/82/050/01251/AM10 03/94/040/01001/AM10 0310560279 dt. 15.02.2010 10 01/82/050/01416/AM07 03/94/040/00984/AM07 0310411160 dt. 07.12.2006 11 01/82/050/01307/AM09 03/94/040/00759/AM09 0310495213 dt. 21.11.2008 12 01/82/050/01512/AM09 03/94/040/00838/AM09 0310501369 dt. 16.01.2009 13 01/82/050/00369/AM10 03/94/040/00280/AM10 0310529903 dt. 21.07.2009 Decision: It was decided to defer the case for 08.05.2014 for comments of Department of C&PC. 1

Case No.:1/21/82ALC4/2010

Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Approved HQ File :01/82/050/00639/AM11/ RLA File :09/24/040/00182/AM11/ Lic.No/Date:0910043061 12.08.2010 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/97/2012‐Ch II dated 21.04.2014, it was decided to raﴅfy 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 3,4Ethylene Dioxy Thiophene (EDOT) 1 kg 1. Diethyl Thioglycolate 4.33 kg 2. Methanol 2.49 kg 3. N, NDimethyl Formamide 2.08 kg 4. 1,2Dichloro Ethane 7.00 kg RA may take appropriate acﴅon as per the decision of Norms Commi饫�ee. 2

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

Party Name:MYLAN LABORATORIES LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00995/AM13/ RLA File :09/24/040/00270/AM13/ Lic.No/Date:0910053660 04.09.2012 Defer Date:08.05.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/205/2013PI(Norms) dated 01.04.2014, it was decided to call from the firm the details of Past Production visa vis Actual consumption of inputs duly certified by Central Excise Authorities. The case was deferred for 08.05.2014. 3

Case No.:88/1/82ALC4/2013

LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01446/AM13/ RLA File :09/24/040/00287/AM13/ Lic.No/Date:0910054034 11.10.2012 Defer Date:08.08.2014 Decision: It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals. 4

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

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01049/AM13/ RLA File :04/24/040/00182/AM13/ Lic.No/Date:0410141372 29.11.2012 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/258/2013‐PI(Norms) dated 01.04.2014, it was decided to raﴅfy 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 Cathine Hcl 1kg 1. DiPhenyl Propanolamine Hcl 4.74 2. Iso Propyl Alcohol 5.288 3. Methyl Isobutyl Ketone 1.866 4. Toluene 4.977 5. Acetone 2.488

Causticsoda Flakes 1.437 7. Acetic Anhydride 1.70 5

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

Party Name:JUBILANT LIFE SCIENCES LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01335/AM13/ RLA File :05/23/040/00345/AM13/ Lic.No/Date:0510340432 07.12.2012 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/291/2013‐PI(Norms) dated 01.04.2014, it was decided to raﴅfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product: Atorvastatin Tablets 5mg and 10 mg S.NO. Import Items For export of 1 No. tablet (Qty in mg) 5 mg 10mg 1. Atorvastatin Calcium 5.42 10.84 2. Microcrystalline Cellulose (PH101) 12.48 8.66 3. Calmellose Calcium (ECG 505) 16.00 20.0 4. Hydroxypropylcellulose (SSL) 0.70 1.0 5. Magnesium Oxide (XP103) 15.0 16.0 6. Magnesium Oxide JP 8.0 30.0 7. Microcrystalline Cellulose (KG 1000) 2.0 ‐‐‐‐ 8. Magnesium stearate 0.40 0.50 9. Methylene Chloride 45.0 61.0 10. Anhydrous Ethanol 5.0 16.0 6

Case No.:2/30/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 10.04.2014 Status:Deffered and Reindexed HQ File :01/82/050/01038/AM13/ RLA File :05/24/040/00389/AM13/ Lic.No/Date:0510343975 23.01.2013 Defer Date:08.05.2014 Decision : It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals.

Case No.:151/33/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 10.04.2014 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:08.05.2014 Decision :It was decided to send a copy of application again to Department of Petrochemical Division of D/o C&PC for their comments. The case was deferred for 08.05.2014 8

Case No.:125/10/82ALC4/2013

Party Name:LAXMI ORGANIC INDUSTRIES LTD., 10.04.2014 Status:Case Rejected HQ File :01/82/050/00308/AM14/ RLA File :03/95/040/00911/AM13/ Lic.No/Date:0310728818 20.03.2013 Defer Date: Decision :Already rejected in 24/82 meeting dated 27.03.2014. 9

Case No.:58/10/82ALC4/2013

LIMITED 10.04.2014 Status:Case Rejected HQ File :01/82/050/00241/AM14/ RLA File :09/24/040/00583/AM13/ Lic.No/Date:0910055475 21.03.2013 Defer Date: Decision :Already rejected in 24/82 meeting dated 27.03.2014. 10

Case No.:25/10/82ALC4/2013

Party Name:ANUS LABORATORIES LTD., 10.04.2014 Status:Case Rejected HQ File :01/82/050/00208/AM14/ RLA File :09/24/040/00186/AM12/ Lic.No/Date:0910055523 22.03.2013 Defer Date: Decision :Already rejected in 24/82 meeting dated 27.03.2014. 11

Case No.:33/2/82ALC4/2013

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 10.04.2014 Status:Case Deferred HQ File :01/82/050/01480/AM13/ RLA File :05/24/040/00481/AM13/ Lic.No/Date:0510350279 26.03.2013 Defer Date:08.05.2014 Decision : It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals. 12

Case No.:160/10/82ALC4/2013

Party Name:RIOCARE INDIA PRIVATE LIMITED. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00343/AM14/ RLA File :03/95/040/00024/AM14/ Lic.No/Date:0310731584 17.04.2013 Defer Date:08.05.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/635/2013PI(Norms) dated 04.03.2014, it was decided to call from the firm the following technical details:

i) Export Items 1 and 3 are API`s (100%) and should not fall under chapter 30. The firm should be advised to give correct and relevant HS code ii) whether any chemical reaction is involved in the manufacture of Dimethicone. If so, complete details of reaction, Mol. weight and % yield on molar basis may be furnished. iii) Past production visavis actual consumption of inputs duly certified by Central Excise Authorities be furnished for last 3 years. 13

Case No.:3/3/82ALC4/2013

Party Name:LAKE CHEMICALS PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00036/AM14/ RLA File :07/24/040/00003/AM14/ Lic.No/Date:0710094921 18.04.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals. 14

Case No.:87/14/82ALC4/2013

Party Name:ASTRIX LABORATORIES LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00672/AM14/ RLA File :09/24/040/00009/AM14/ Lic.No/Date:0910055844 23.04.2013 Defer Date:08.05.2014 15

Case No.:142/10/82ALC4/2013

Party Name:WOCKHARDT LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00325/AM14/ RLA File :03/95/040/00101/AM14/ Lic.No/Date:0310734494 15.05.2013 Defer Date:08.05.2014 Decision :It was decided to remind DCGI to furnish their comments. The case was deferred for 08.05.2014. 16

Case No.:42/20/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01028/AM14/ RLA File :09/24/040/00058/AM14/ Lic.No/Date:0910056110 23.05.2013 Defer Date:08.05.2014 Decision :It was decided to remind the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 08.05.2014 17

Case No.:68/10/82ALC4/2013

Party Name:ZEE LABORATORIES 10.04.2014 Status:Case Approved HQ File :01/82/050/00251/AM14/ RLA File :05/24/040/00047/AM14/ Lic.No/Date:0510356364 06.06.2013 Defer Date:

Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/693/2013‐PI(Norms) dated 01.04.2014, it was decided to raﴅfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product: CEFIXIME 100 mg and 200 mg TABLETS S.NO. Import Items 100 mg tablets 200mg tablets 1. CEFIXIME TRIHYDRATE 114.147 mg 228.294 mg 18

Case No.:156/14/82ALC4/2013

Party Name:EYTAN LABS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00741/AM14/ RLA File :09/24/040/00087/AM14/ Lic.No/Date:0910056288 07.06.2013 Defer Date:08.05.2014 Decision : It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals. 19

Case No.:77/14/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00662/AM14/ RLA File :09/24/040/00106/AM14/ Lic.No/Date:0910056304 10.06.2013 Defer Date:08.05.2014 Decision :It was decided to remind the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 08.05.2014. 20

Case No.:199/10/82ALC4/2013

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00382/AM14/ RLA File :04/24/040/00048/AM14/ Lic.No/Date:0410147196 17.06.2013 Defer Date:08.05.2014 21

Case No.:40/12/82ALC4/2013

Party Name:SMILAX LABORATORIES LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00464/AM14/ RLA File :09/24/040/00113/AM14/ Lic.No/Date:0910056355 17.06.2013 Defer Date:08.05.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/678/2013PI(Norms) dated 01.04.2014, it was decided to call the following technical details from the firm: (a) End use of Export product . In case of Drug intermediate, name of the bulk drug manufactured from it may be given. (b) Stepwise complete and balanced chemical reaction showing utilization of ethyl Cyano Acetate and Diethyl malonate, their Mot. Wt. and % yield on

molar basis. 22

Case No.:28/12/82ALC4/2013

Party Name:BLISS GVS PHARMA LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00452/AM14/ RLA File :03/94/040/00245/AM14/ Lic.No/Date:0310738193 19.06.2013 Defer Date:08.05.2014 Decision :it was decided to remind the firm to furnish the following technical details: 1. COA for foreign supplier indicating Potency of Nystatin imported under present A.A 2. Detailed calculation of arriving at the quantity of API applied. 23

Case No.:183/10/82ALC4/2013

Party Name:VIVEK PHARMACHEM (INDIA) LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00366/AM14/ RLA File :13/24/040/00032/AM12/ Lic.No/Date:1310043416 19.06.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 24

Case No.:22/12/82ALC4/2013

Party Name:INDOFIL INDUSTRIES LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00446/AM14/ RLA File :03/94/040/00197/AM14/ Lic.No/Date:0310738404 20.06.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of Chemicals and Petrochemicals 25

Case No.:111/10/82ALC4/2013

Party Name:STERICAT GUTSTRINGS PVT. LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00294/AM14/ RLA File :05/24/040/00091/AM14/ Lic.No/Date:0510358000 25.06.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of IPP. 26

Case No.:90/14/82ALC4/2013

LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00675/AM14/ RLA File :09/24/040/00128/AM14/ Lic.No/Date:0910056460 26.06.2013 Defer Date:08.05.2014 Decision: It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals.

Case No.:39/12/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Approved HQ File :01/82/050/00463/AM14/ RLA File :09/24/040/00138/AM14/ Lic.No/Date:0910056466 26.06.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/687/2013‐PI(Norms) dated 01.04.2014, it was decided to raﴅfy 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 DANTRON 1kg 1. 1,8Dinitro Anthraquinoline 1.72 2. Actone 1.13 3. Toluene 1.40 28

Case No.:172/14/82ALC4/2013

Party Name:RECKON DIAGNOSTICS PVT. LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00757/AM14/ RLA File :34/24/040/00044/AM14/ Lic.No/Date:3410037268 27.06.2013 Defer Date:08.05.2014 Decision :Department of Biotechnology vide their letter NO. BT/IL/05/398/2013PID dated 26.12.2013 has requested the firm to furnish the copy of Manufacturing process flow chart, copy DML (Drug Manufacturing Licence),Batch Manufacturing Record and clarification on the quantities of import inputs (whether it is in Grams or in Milligrams) mentioned in the application. 29

Case No.:201/10/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00384/AM14/ RLA File :04/24/040/00063/AM14/ Lic.No/Date:0410147551 27.06.2013 Defer Date:08.05.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2013PI(Norms) dated 22.01.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 08.05.2014 30

Case No.:173/14/82ALC4/2013

Party Name:ALEMBIC PHARMACEUTICALS LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00758/AM14/ RLA File :34/24/040/00065/AM14/ Lic.No/Date:3410037281 01.07.2013 Defer Date:08.05.2014

Case No.:1/8/85ALC3/2013

Party Name:SRIAM LABS PRIVATE LIMITED 10.04.2014 Status:Case Rejected HQ File :01/85/050/00054/AM14/ RLA File :09/24/040/00115/AM14/ Lic.No/Date:0910056522 01.07.2013 Defer Date: Decision :Already rejected in 24/82 meeting dated 27.03.2014. 32

Case No.:24/12/82ALC4/2013

Party Name:WOCKHARDT LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00448/AM14/ RLA File :03/95/040/00256/AM14/ Lic.No/Date:0310739850 02.07.2013 Defer Date:08.05.2014 Decision :It was decided to remind DCGI to furnish their comments. The case was deferred for 08.05.2014. 33

Case No.:44/12/82ALC4/2013

Party Name:ENCUBE ETHICALS PVT LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00468/AM14/ RLA File :03/94/040/00306/AM14/ Lic.No/Date:0310740922 10.07.2013 Defer Date:08.05.2014 Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/674/2013‐PI(Norms) dated 01.04.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality control Incharge for each of 9 Export Product. 34

Case No.:175/14/82ALC4/2013

Party Name:ONEIRO CHEMICALS LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/00760/AM14/ RLA File :34/24/040/00071/AM14/ Lic.No/Date:3410037375 10.07.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/267/2011‐PI(Norms) dated 01.04.2014, it was decided to raﴅfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: [A] Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg 2Chloromethyl3,5 Dimethyl4 Methoxy Pyridine Hydrochloride 1 Kg. 1. 3.5 Lutidine 1.04 2. Toluene 5.20 3. Methanol 4.14 4. Acetone 2.07 5. Activated Carbon 0.100 6. Ammonium Persulphates 1.80

[B] Revised norms for 2Chloromethyl3,5 Dimethyl4 Methoxy Pyridine Hydrochloride (SION A2684) Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg 2Chloromethyl3,5 Dimethyl4 Methoxy Pyridine Hydrochloride 1 Kg. 1. 1. 3.5 Lutidine OR 2,3,.5Trimethyl Pyridine 1.04 OR 1.175 2. Methylene Chloride 7.83 3. Methanol / Dimethyl Formamide 4.14 4. Acetone / IPA 2.07 5. Activated Carbon 0.100 [C] As per above written comments of D/o Pharmaceuticals and based on improved yield it has been decided to revise SION A321, A322, A323 and A2407 by calling production actual consumption data of other manufacturers exporters duly certified by Central Excise Authorities through Pharmexcil. RA concerned may take further necessary action as per above decision of NC. 35

Case No.:160/14/82ALC4/2013

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00745/AM14/ RLA File :04/24/040/00050/AM14/ Lic.No/Date:0410147942 11.07.2013 Defer Date:08.05.2014 36

Case No.:26/12/82ALC4/2013

Party Name:SANOFI INDIA LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/00450/AM14/ RLA File :03/95/040/00227/AM14/ Lic.No/Date:0310741158 11.07.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/677/2013‐PI(Norms) dated 01.04.2014, it was decided to raﴅfy 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 Rampril Precursor II (Step 3) 1kg 1. LSerine Methyl Ester Hcl 1.38 37

Case No.:5/21/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 10.04.2014 Status:Case Deferred

HQ File :01/82/050/01035/AM14/ RLA File :08/24/040/00157/AM14/ Lic.No/Date:0810122789 15.07.2013 Defer Date:08.05.2014 38

Case No.:60/14/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00645/AM14/ RLA File :09/24/040/00085/AM14/ Lic.No/Date:0910056772 16.07.2013 Defer Date:08.05.2014 Decision :It was decided to request the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 08.05.2014. 39

Case No.:21/12/82ALC4/2013

Party Name:WOCKHARDT LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00445/AM14/ RLA File :03/95/040/00306/AM14/ Lic.No/Date:0310741992 18.07.2013 Defer Date:08.05.2014 Decision :It was decided to remind DCGI to furnish their comments. The case was deferred for 08.05.2014. 40

Case No.:68/17/82ALC4/2013

Party Name:BHARAT PARENTERALS LTD, Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Deferred HQ File :01/82/050/00930/AM14/ RLA File :34/21/040/00163/AM14/ Lic.No/Date:3410037475 23.07.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of Biotechnology 41

Case No.:52/12/82ALC4/2013

Party Name:UNIJULES LIFE SCIENCES LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00476/AM14/ RLA File :03/95/040/00305/AM14/ Lic.No/Date:0310742481 23.07.2013 Defer Date:08.05.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/702/2013PI(Norms) dated 01.04.2014, it was decided to call from the firm the following technical details: 1. Technical details as per Appendix 33 for conversion of Gadolinium to Gadopenteate Dimeglumine. 2. Volume of the Injection /Vial to be exported. 42

Case No.:1/19/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00946/AM14/ RLA File :09/24/040/00176/AM14/ Lic.No/Date:0910056894

Q 24.07.2013 Defer Date:08.05.2014 43

Case No.:46/14/82ALC4/2013

LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00631/AM14/ RLA File :09/24/040/00185/AM14/ Lic.No/Date:0910056909 25.07.2013 Defer Date:08.05.2014 44

Case No.:24/17/82ALC4/2013

Party Name:SMILAX LABORATORIES LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00886/AM14/ RLA File :09/24/040/00180/AM14/ Lic.No/Date:0910056902 25.07.2013 Defer Date:08.05.2014 45

Case No.:43/12/82ALC4/2013

Party Name:AMI ORGANICS PVT LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00467/AM14/ RLA File :52/24/040/00015/AM14/ Lic.No/Date:5210040038 30.07.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of C&PC for their comments. The case was deferred for 08.05.2014 46

Case No.:1/10/82ALC4/2013

Party Name:MICRO LABS LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00184/AM14/ RLA File :07/24/040/00111/AM14/ Lic.No/Date:0710097180 30.07.2013 Defer Date:08.05.2014 Decision :It was decided to call from the firm detailed justification for the import of 1039.076 kg of API against the present advance authorization. The case was deferred for 08.05.2014. 47

Case No.:22/14/82ALC4/2013

Party Name:MSN LABORATORIES PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00607/AM14/ RLA File :09/24/040/00192/AM14/ Lic.No/Date:0910056971 31.07.2013 Defer Date:08.05.2014 48

Case No.:48/14/82ALC4/2013

Party Name:LOUIS PHARMACEUTICALS 10.04.2014 Status:Case

PVT LTD Deferred HQ File :01/82/050/00633/AM14/ RLA File :09/24/040/00200/AM14/ Lic.No/Date:0910057008 02.08.2013 Defer Date:08.05.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/724/2013PI(Norms) dated 21.04.2014, it was decided to call from the firm following information: (a) Complete technical details as per Appendix 33. (b) COA of imported R.M. from the Foreign Supplier. (c) COA of the export item. (d) Past production visàvis actual consumption of inputs duly certified by Central Excise Authority. 49

Case No.:18/14/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 10.04.2014 Status:Deffered and Reindexed HQ File :01/82/050/00603/AM14/ RLA File :09/24/040/00207/AM14/ Lic.No/Date:0910057031 05.08.2013 Defer Date:08.05.2014 Decision : No Data Available for the above case in online agenda available on DGFT server. The case was deferred for 08.05.2014 50

Case No.:45/14/82ALC4/2013

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 10.04.2014 Status:Case Deferred HQ File :01/82/050/00630/AM14/ RLA File :07/24/040/00137/AM14/ Lic.No/Date:0710097392 06.08.2013 Defer Date:08.05.2014 Decision :It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 08.05.2014 51

Case No.:40/14/82ALC4/2013

Party Name:CTX LIFESCIENCES PVT LTD, Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Deferred HQ File :01/82/050/00625/AM14/ RLA File :03/94/040/00307/AM14/ Lic.No/Date:0310744552 07.08.2013 Defer Date:08.05.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/738/2013PI(Norms) dated 21.04.2014, it was decided to call from the firm following information: (a) Complete technical details as per Appendix 33. (b) Past production visàvis actual consumption of inputs duly certified by Central Excise Authority. 52

Case No.:165/14/82ALC4/2013

Party Name: MEDREICH LIMITED 10.04.2014 Status: Case Deferred HQ File :01/82/050/00750/AM14/ RLA File :07/24/040/00135/AM14/ Lic.No/Date:0710097410 Defer

07.08.2013 Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals 53

Case No.:34/13/82ALC4/2013

Party Name: WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 10.04.2014 Status: Case Deferred HQ File :01/82/050/00510/AM14/ RLA File :03/95/040/00132/AM14/ Lic.No/Date:0310744838 12.08.2013 Defer Date:08.05.2014 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/710/2013PI (Norms) dated 01.04.2014, it was decided to call from the firm complete technical details as per Appendix 33. 54

Case No.:36/14/82ALC4/2013

Party Name:GLOBE TROTTERS PVT LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/00621/AM14/ RLA File :03/94/040/00359/AM14/ Lic.No/Date:0310745177 13.08.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/739/2013‐PI(Norms) dated 21.04.2014, it was decided to raﴅfy 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 AMPICILLIN SODIUM STERILE+SULBACTAM SODIUM STERILE ( 2:1 ) ( STERILE,CRYSTALLINE AND APYROGENIC ) 1kg 1. AMPICILLIN TRIYHAYDRATE IP 0.68 2. SULBACTAM SODIUM USP/BULK (STERILE) 0.34 55

Case No.:147/14/82ALC4/2013

LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00732/AM14/ RLA File :09/24/040/00201/AM14/ Lic.No/Date:0910057191 14.08.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 56

Case No.:122/14/82ALC4/2013

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 10.04.2014 Status:Case Deferred HQ File :01/82/050/00707/AM14/ RLA File :03/95/040/00203/AM14/ Lic.No/Date:0310745264 Defer

14.08.2013 Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 57

Case No.:66/14/82ALC4/2013

Party Name:SRINI PHARMACEUTICALS LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00651/AM14/ RLA File :09/24/040/00216/AM14/ Lic.No/Date:0910057203 16.08.2013 Defer Date:08.05.2014 58

Case No.:121/14/82ALC4/2013

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 10.04.2014 Status:Case Deferred HQ File :01/82/050/00706/AM14/ RLA File :03/95/040/00505/AM13/ Lic.No/Date:0310745576 16.08.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 59

Case No.:34/14/82ALC4/2013

Party Name:SMILAX LABORATORIES LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00619/AM14/ RLA File :09/24/040/00231/AM14/ Lic.No/Date:0910057244 19.08.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 60

Case No.:117/14/82ALC4/2013

Party Name:MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00702/AM14/ RLA File :03/95/040/00407/AM14/ Lic.No/Date:0310745962 20.08.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 61

Case No.:26/14/82ALC4/2013

LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00611/AM14/ RLA File :09/24/040/00190/AM14/ Lic.No/Date:0910057247 20.08.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 62

Case No.:57/14/82ALC4/2013

10.04.2014 Status:Case

LIMITED Approved HQ File :01/82/050/00642/AM14/ RLA File :09/24/040/00229/AM14/ Lic.No/Date:0910057251 20.08.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/728/2013PI(Norms) dated 21.04.2014, it was decided to ratify the 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 Item Qty. Allowed kg/kg MONTELUKAST SODIUM 1 kg 1. 2(2(3(S)(3(2(7Chloro2quinolinyl) ethenyl)phenyl)3 hydroxypropyl)phenyl)2propanol 1.24 2. 2[1(Mercapto Methyl) Cyclopropane Acetic Acid 0.40 3. L(+) Tartaric acid 0.643 4. N, NDi isopropyl ethylamine 0.30 5. Acetonitrile 5.401 6. Hexane 10.247 7. Isopropyl ether 0.135 8. Nmethyl 2pyrrolidone Not shown in RXN 9. Dichloromethane 7.281 10. Acetone 1.620 11. Methanol 2.967 RA may take appropriate action as per the decision of Norms Committee. 63

Case No.:3/12/82ALC4/2013

Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00427/AM14/ RLA File :04/24/040/00095/AM14/ Lic.No/Date:0410148864 22.08.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to DCGI for their comments (solution of import items contains 8% water). The case was deferred for 08.05.2014. 64

Case No.:32/14/82ALC4/2013

Party Name:ALEMBIC PHARMACEUTICALS LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00617/AM14/ RLA File :34/24/040/00110/AM14/ Lic.No/Date:3410037709 22.08.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 65

Case No.:10/17/85ALC3/2013

Party Name:BELOOR BAYIR BIOTECH LTD, 10.04.2014 Status:Case Deferred HQ File :01/85/050/00113/AM14/ RLA File :07/24/040/00150/AM14/ Lic.No/Date:0710097664 Defer

22.08.2013 Date:08.05.2014 66

Case No.:47/14/82ALC4/2013

Party Name:VIVIMED LABS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00632/AM14/ RLA File :09/24/040/00251/AM14/ Lic.No/Date:0910057280 22.08.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 67

Case No.:88/13/82ALC4/2013

Party Name:MAKCUR LABORATORIES LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00564/AM14/ RLA File :08/24/040/00232/AM14/ Lic.No/Date:0810124120 26.08.2013 Defer Date:08.05.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/699/2013PI(Norms) dated 01.04.2014, it was decided to call from the firm copy of Drug Manufacturing Licence alongwith list of Approved items showing composition of export product. 68

Case No.:152/14/82ALC4/2013

LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00737/AM14/ RLA File :09/24/040/00211/AM14/ Lic.No/Date:0910057368 27.08.2013 Defer Date:08.05.2014 69

Case No.:116/14/82ALC4/2013

Party Name:UNIJULES LIFE SCIENCES LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00701/AM14/ RLA File :03/95/040/00215/AM14/ Lic.No/Date:0310747079 27.08.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 70

Case No.:51/14/82ALC4/2013

Party Name:RATNAMANI BIO CHEMICALS & PHARMACEUTICALS PVT. LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00636/AM14/ RLA File :34/24/040/00125/AM14/ Lic.No/Date:3410037783 02.09.2013 Defer Date:08.05.2014

Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 71

Case No.:54/14/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/00639/AM14/ RLA File :05/23/040/00233/AM14/ Lic.No/Date:0510364656 05.09.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/726/2013‐PI(Norms) dated 21.04.2014, it was decided to raﴅfy 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 Testosterone Enanthate Bulk Drug 1kg 1. 4Androstene3,17Dione 1.023 72

Case No.:29/14/82ALC4/2013

Party Name:MAITHRI LABORATORIES (P) LTD., 10.04.2014 Status:Case Approved HQ File :01/82/050/00614/AM14/ RLA File :09/24/040/00242/AM14/ Lic.No/Date:0910057495 05.09.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/725/2013‐PI(Norms) dated 21.04.2014, it was decided to raﴅfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Atorvastatin Calcium 1kg 1. (4RCIS)1,1dimethylethyl6Cyano methyl2,2,dimethyl 1,3dioxane4 Acetate 0.733 2. Methyl isobutyryl acetate 1.646 73

Case No.:53/14/82ALC4/2013

Party Name:STERILE INDIA PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00638/AM14/ RLA File :05/24/040/00203/AM14/ Lic.No/Date:0510364653 05.09.2013 Defer Date:08.05.2014 Decision : It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals. 74

Case No.:176/14/82ALC4/2013

Party Name:AMI LIFESCIENCES P LTD Status:Case

10.04.2014 Deferred HQ File :01/82/050/00761/AM14/ RLA File :34/24/040/00132/AM14/ Lic.No/Date:3410037845 06.09.2013 Defer Date:08.05.2014 75

Case No.:30/14/82ALC4/2013

Party Name:HONEST BIOVET PVT. LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/00615/AM14/ RLA File :08/24/040/00250/AM14/ Lic.No/Date:0810124568 06.09.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/730/2013‐PI(Norms) dated 21.04.2014, it was decided to raﴅfy 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 MENADIONE DIMETHYL PYRIMIDINOL BISULPHITE (FEED SUPPLEMENT) 1kg 1. MENADIONE SODIUM BISULPHATE 0.918 2. ACETYL ACETONE 0.40 3. N BUTANOL 0.40 76

Case No.:103/14/82ALC4/2013

Party Name:INTAS PHARMACEUTICALS LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00688/AM14/ RLA File :08/24/040/00242/AM14/ Lic.No/Date:0810124544 06.09.2013 Defer Date:08.05.2014 77

Case No.:56/14/82ALC4/2013

Party Name:VIVEK PHARMACHEM (INDIA) LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00641/AM14/ RLA File :13/24/040/00021/AM14/ Lic.No/Date:1310044273 09.09.2013 Defer Date:08.05.2014 78

Case No.:54/17/82ALC4/2013

Party Name:CIREX PHARMACEUTICALS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00916/AM14/ RLA File :09/24/040/00258/AM14/ Lic.No/Date:0910057517 10.09.2013 Defer Date:08.05.2014

Case No.:149/14/82ALC4/2013

Party Name:MACLEODS 10.04.2014 Status:Case Deferred HQ File :01/82/050/00734/AM14/ RLA File :03/95/040/00465/AM14/ Lic.No/Date:0310748925 10.09.2013 Defer Date:08.05.2014 80

Case No.:69/14/82ALC4/2013

Party Name:ONEIRO CHEMICALS LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/00654/AM14/ RLA File :34/24/040/00138/AM14/ Lic.No/Date:3410037862 11.09.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/267/2011‐PI(Norms) dated 01.04.2014, it was decided to raﴅfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: [A] Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg 2Chloromethyl3,5 Dimethyl4 Methoxy Pyridine Hydrochloride 1 Kg. 1. 3.5 Lutidine 1.04 2. Toluene 5.20 3. Methanol 4.14 4. Acetone 2.07 5. Activated Carbon 0.100 6. Ammonium Persulphates 1.80 [B] Revised norms for 2Chloromethyl3,5 Dimethyl4 Methoxy Pyridine Hydrochloride (SION A2684) Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg 2Chloromethyl3,5 Dimethyl4 Methoxy Pyridine Hydrochloride 1 Kg. 1. 1. 3.5 Lutidine OR 2,3,.5Trimethyl Pyridine 1.04 OR 1.175 2. Methylene Chloride 7.83 3. Methanol / Dimethyl Formamide 4.14 4. Acetone / IPA 2.07 5. Activated Carbon 0.100 [C] As per above written comments of D/o Pharmaceuticals and based on improved yield it has been decided to revise SION A321, A322, A323 and A2407 by calling production actual consumption data of other manufacturers exporters duly certified by Central Excise Authorities

through Pharmexcil. RA concerned may take further necessary action as per above decision of NC. 81

Case No.:63/17/82ALC4/2013

Party Name:DR REDDYS LABORATORIES LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00925/AM14/ RLA File :09/24/040/00261/AM14/ Lic.No/Date:0910057546 13.09.2013 Defer Date:08.05.2014 82

Case No.:10/16/82ALC4/2013

Party Name:STERICON PHARMA PVT.LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00823/AM14/ RLA File :07/24/040/00201/AM14/ Lic.No/Date:0710098284 16.09.2013 Defer Date:08.05.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/681/2013PI(Norms) dated 21.04.2014, it was decided to call copy of Drug Manufacturing licence, from the firm, for each export item. 83

Case No.:151/14/82ALC4/2013

Party Name:THINQ PHARMACRO LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00736/AM14/ RLA File :03/95/040/00432/AM14/ Lic.No/Date:0310749651 16.09.2013 Defer Date:08.05.2014 84

Case No.:35/17/82ALC4/2013

Party Name:S M S PHARMACEUTICALS LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00897/AM14/ RLA File :09/24/040/00083/AM14/ Lic.No/Date:0910057602 18.09.2013 Defer Date:08.05.2014 85

Case No.:46/16/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00859/AM14/ RLA File :04/24/040/00127/AM14/ Lic.No/Date:0410149960 18.09.2013 Defer Date:08.05.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2013PI(Norms) dated

22.01.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. 86

Case No.:49/16/82ALC4/2013

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00862/AM14/ RLA File :04/24/040/00100/AM14/ Lic.No/Date:0410149961 18.09.2013 Defer Date:08.05.2014 87

Case No.:50/17/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 10.04.2014 Status:Case Rejected HQ File :01/82/050/00912/AM14/ RLA File :09/24/040/00294/AM14/ Lic.No/Date:0910057628 19.09.2013 Defer Date: Decision : Already rejected in 24/82 meeting dated 27.03.2014. 88

Case No.:68/14/82ALC4/2013

Party Name:NIFTY LABS PVT LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00653/AM14/ RLA File :09/24/040/00283/AM14/ Lic.No/Date:0910057606 19.09.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 08.05.2014 89

Case No.:64/17/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Deferred HQ File :01/82/050/00926/AM14/ RLA File :09/24/040/00120/AM14/ Lic.No/Date:0910057630 19.09.2013 Defer Date:08.05.2014 90

Case No.:81/23/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01128/AM14/ RLA File :05/24/040/00207/AM14/ Lic.No/Date:0510366184 19.09.2013 Defer Date:08.05.2014 91

Case No.:55/14/82ALC4/2013

Party Name:SAIBABA SURFACTANTS (P) LTD., 10.04.2014 Status:Case Approved

HQ File :01/82/050/00640/AM14/ RLA File :08/24/040/00268/AM14/ Lic.No/Date:0810124942 19.09.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/56/2013‐Ch II dated 11.04.2014, it was decided to raﴅfy 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 Poly Ethylene Glycol 400 1 kg 1 Ethylene Oxide 0.735 kg 92

Case No.:53/17/82ALC4/2013

Party Name:HETERO DRUGS LIMITED, 10.04.2014 Status:Case Deferred HQ File :01/82/050/00915/AM14/ RLA File :09/24/040/00293/AM14/ Lic.No/Date:0910057642 20.09.2013 Defer Date:08.05.2014 93

Case No.:73/23/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 10.04.2014 Status:Case Approved HQ File :01/82/050/01120/AM14/ RLA File :17/24/040/00068/AM14/ Lic.No/Date:1710005519 24.09.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/78/2012‐Ch II dated 11.04.2014, it was decided to raﴅfy 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 PRODUCTPCS20 (PHOSPHATED ESTER OF CETOSTEARYL ALCOHOL 2 MOLE ETHOXYLATE) 1 kg 1. ETHYLENE OXIDE (Colourless Clear Liquid) 0.225 kg 2. CETO STEARYL ALCOHOL (Off White Flakes) 0.675 kg 3. PHOSPHOROUS PENTOXIDE (Soft White Powder) 0.100 kg A may take appropriate acﴅon as per the decision of Norms Commi饫�ee. 94

Case No.:62/17/82ALC4/2013

Party Name:SMILAX LABORATORIES LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00924/AM14/ RLA File :09/24/040/00292/AM14/ Lic.No/Date:0910057671 24.09.2013 Defer Date:08.05.2014

Case No.:121/23/82ALC4/2013

Party Name:STERLING HEALTHCARE LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01168/AM14/ RLA File :31/83/040/00096/AM14/ Lic.No/Date:3110060426 24.09.2013 Defer Date: Decision : In line with SION A 412, 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 300mg Capsules ( Weight 900.6 kgs, net content of Gabapentin 570 kgs) 1 tablet 1. Gabapentin 306 mg/300 mg tablet Gabapentin 400mg Capsules (Weight 438.72 Kgs, net content of Gabapentin 279 kgs) 1 tablet 1. Gabapentin 408 mg/ 400 mg tablets RA may take appropriate action as per the decision of Norms Committee. 96

Case No.:30/17/82ALC4/2013

Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., 10.04.2014 Status:Case Approved HQ File :01/82/050/00892/AM14/ RLA File :09/24/040/00296/AM14/ Lic.No/Date:0910057708 25.09.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/72/2014‐PI(Norms) dated 21.04.2014, it was decided to raﴅfy 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 4HYDROXY CARBAZOLE 1kg 1. 1,3CYCLOHEXANE DIONE OFF WHITE POWDER 1.766 2. PHENYL HYDRAZINE HYDRO CHLORIDE WHITE OR SLIGHTLY CRYSTAL 2.50 3. Hydrochloric Acid Not an importable item 4. Methanol solvent 1.00 5. Caustic Potash 1.76

Flakes 6. Raney Nickel Metal 0.100 7. Tolune Solvent 0.435 litre/kg 97

Case No.:21/19/82ALC4/2013

Party Name:GOPALDAS VISRAM & CO.LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00966/AM14/ RLA File :03/94/040/00502/AM14/ Lic.No/Date:0310751325 26.09.2013 Defer Date:08.05.2014 98

Case No.:14/16/82ALC4/2013

Party Name:SHAMSHREE LIFESCIENCES LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00827/AM14/ RLA File :22/24/040/00046/AM14/ Lic.No/Date:2210014253 30.09.2013 Defer Date:08.05.2014 99

Case No.:41/17/82ALC4/2013

Party Name:HETERO LABS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00903/AM14/ RLA File :09/24/040/00317/AM14/ Lic.No/Date:0910057783 01.10.2013 Defer Date:08.05.2014 100

Case No.:46/17/82ALC4/2013

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00908/AM14/ RLA File :09/24/040/00288/AM14/ Lic.No/Date:0910057784 01.10.2013 Defer Date:08.05.2014 101

Case No.:48/17/82ALC4/2013

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00910/AM14/ RLA File :09/24/040/00287/AM14/ Lic.No/Date:0910057785 01.10.2013 Defer Date:08.05.2014

102

Case No.:32/16/82ALC4/2013

Party Name:FINE CURE 10.04.2014 Status:Case Deferred HQ File :01/82/050/00845/AM14/ RLA File :08/24/040/00292/AM14/ Lic.No/Date:0810125295 03.10.2013 Defer Date:08.05.2014 103

Case No.:39/16/82ALC4/2013

Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 10.04.2014 Status:Case Deferred HQ File :01/82/050/00852/AM14/ RLA File :04/24/040/00146/AM14/ Lic.No/Date:0410150519 03.10.2013 Defer Date:08.05.2014 Decision :In the light of written comments received Department of Chemicals and Petrochemicals vide their OM No. 14010/7/2010ChIII dated 03.03.2014, it was decided to call from the firm the following technical details: 1. Complete set of Application 2. Details of manufacturing process of 4 chlorobutylveratrate 60% solution in Methyl –EthylKetone with chemical equations, molecular formula, molecular weights. 3. Yield obtained in each step. 4. Authentic technical literature in support of yield obtained. 5. Material balance. 6. CA certificate certifying the production of export item achieved by firm for the past three years and corresponding consumption of each input. 7. Detailed calculations, arriving at the norms applied for. 104

Case No.:7/17/82ALC4/2013

Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00869/AM14/ RLA File :34/24/040/00159/AM14/ Lic.No/Date:3410038104 03.10.2013 Defer Date:08.05.2014 Decision :It was decided to send a copy of application again to Department of C&PC for their comments. The case was deferred for 08.05.2014 105

Case No.:107/23/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 10.04.2014 Status:Case Deferred HQ File :01/82/050/01154/AM14/ RLA File :17/24/040/00070/AM14/ Lic.No/Date:1710005529 04.10.2013 Defer Date:12.06.2014 Decision : Written comments forwarded by Department of C&PC is not clear as quantity of export seems to be quite high as compare quantity allowed. The case was deferred for 12.06.2014. 106 Case No.:34/19/82ALC4/2013 Party Name:ELPPE CHEMICALS PRIVATE Status:Case

LIMITED 10.04.2014 Deferred HQ File :01/82/050/00979/AM14/ RLA File :03/94/040/00552/AM14/ Lic.No/Date:0310752484 07.10.2013 Defer Date:08.05.2014 107

Case No.:12/16/82ALC4/2013

Party Name:INTAS PHARMACEUTICALS LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00825/AM14/ RLA File :08/24/040/00303/AM14/ Lic.No/Date:0810125470 08.10.2013 Defer Date:08.05.2014 108

Case No.:26/16/82ALC4/2013

Party Name:INTAS PHARMACEUTICALS LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00839/AM14/ RLA File :08/24/040/00302/AM14/ Lic.No/Date:0810125462 08.10.2013 Defer Date:08.05.2014 109

Case No.:134/23/82ALC4/2013

Party Name:MAKSON INDUSTRIES PVT. LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/01181/AM14/ RLA File :03/95/040/00014/AM14/ Lic.No/Date:0310752666 08.10.2013 Defer Date: Decision : In the light of wri饫�en comments received from O/o DC (MSME) Chemical Division vide their U.O No. 23(2)/2014‐Chem dated 21.04.2014, it was decided to raﴅfy 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 per Kg of export Item VICKS VAPORUB (IN PACKS) 50 GMS. Jars 80 Gms Tubes100 GMS. Jars 1kg 1. DLCamphor (Synthetic Camphor) 0.05365 kg 2. Eucalyptus Oil 0.01356 kg 3. Nutmeg Oil 0.00703 kg 4. Turpentine Oil 0.04773 kg 5. Cedar Leaf Oil 0.00448 kg 6. White Petrolatum (White soft Paraffin) 0.82300 kg 7. Thymol 0.000916 kg

110 Case No.:24/16/82ALC4/2013 Party Name: S.M. HERBALS PVT.LTD. 10.04.2014 Status: Case Deferred HQ File :01/82/050/00837/AM14/ RLA File :05/24/040/00232/AM14/ Lic.No/Date:0510367885 08.10.2013 Defer Date:08.05.2014 111

Case No.:13/16/82ALC4/2013

Party Name:TORRENT 10.04.2014 Status:Case Deferred HQ File :01/82/050/00826/AM14/ RLA File :08/24/040/00296/AM14/ Lic.No/Date:0810125464 08.10.2013 Defer Date:08.05.2014 112

Case No.:27/17/82ALC4/2013

Party Name:EYTAN LABS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00889/AM14/ RLA File :09/24/040/00340/AM14/ Lic.No/Date:0910057882 09.10.2013 Defer Date:08.05.2014 113

Case No.:122/23/82ALC4/2013

Party Name:MELZER CHEMICALS PVT. LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01169/AM14/ RLA File :31/83/040/00116/AM14/ Lic.No/Date:3110060644 09.10.2013 Defer Date:08.05.2014 Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/72/2012‐Ch II dated 25.03.2014, it was decided to raﴅfy 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 Hexahydro1,3,5Tris (2 Hydroxyethyl) S – triazine 1 kg 1. Monoethanol amine 0.671 kg 2. Paraformaldehyde 9193% 0.326 kg 114 Case No.:73/14/82ALC4/2013 Party Name:MSN LABORATORIES PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00658/AM14/ RLA File :09/24/040/00325/AM14/ Lic.No/Date:0910057878 09.10.2013 Defer Date:08.05.2014

p 115

Case No.:36/17/82ALC4/2013

LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00898/AM14/ RLA File :09/24/040/00300/AM14/ Lic.No/Date:0910057877 09.10.2013 Defer Date:08.05.2014 116

Case No.:28/16/82ALC4/2013

Party Name:NECTAR LIFESCIENCES LIMITED, 10.04.2014 Status:Case Deferred HQ File :01/82/050/00841/AM14/ RLA File :22/24/040/00048/AM14/ Lic.No/Date:2210014277 09.10.2013 Defer Date:08.05.2014 117

Case No.:6/17/82ALC4/2013

Party Name:AMI ORGANICS PVT LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00868/AM14/ RLA File :52/24/040/00024/AM14/ Lic.No/Date:5210040263 10.10.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of C&PC. 118

Case No.:135/23/82ALC4/2013

Party Name:N S CHEMICALS 10.04.2014 Status:Case Approved HQ File :01/82/050/01182/AM14/ RLA File :03/95/040/00535/AM14/ Lic.No/Date:0310753107 10.10.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/4/2010‐Ch II dated 25.03.2014, it was decided to raﴅfy 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 Sodium Saccharin (USP) 1 kg 1. Sodium Saccharin 1.02 kg 119 Case No.:55/17/82ALC4/2013 Party Name:SHODHANA LABORATORIES LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00917/AM14/ RLA File :09/24/040/00315/AM14/ Lic.No/Date:0910057889 10.10.2013 Defer Date:08.05.2014

120

Case No.:137/23/82ALC4/2013

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01184/AM14/ RLA File :03/95/040/00454/AM14/ Lic.No/Date:0310753231 11.10.2013 Defer Date:08.05.2014 121

Case No.:37/17/82ALC4/2013

LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00899/AM14/ RLA File :09/24/040/00316/AM14/ Lic.No/Date:0910057908 11.10.2013 Defer Date:08.05.2014 122

Case No.:38/16/82ALC4/2013

Party Name:INTAS PHARMACEUTICALS LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00851/AM14/ RLA File :08/24/040/00321/AM14/ Lic.No/Date:0810125616 14.10.2013 Defer Date:08.05.2014 123

Case No.:38/17/82ALC4/2013

LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00900/AM14/ RLA File :09/24/040/00322/AM14/ Lic.No/Date:0910057914 14.10.2013 Defer Date:08.05.2014 124

Case No.:18/16/82ALC4/2013

Party Name:NEULAND LABORATORIES LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00831/AM14/ RLA File :09/24/040/00323/AM14/ Lic.No/Date:0910057916 14.10.2013 Defer Date:08.05.2014 125 Case No.:133/23/82ALC4/2013 Party Name:STERLING AUXILIARIES PVT LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/01180/AM14/ RLA File :03/95/040/00501/AM14/ Lic.No/Date:0310753527 14.10.2013 Defer Date:

Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/64/2013‐Ch II dated 21.04.2014, it was decided to raﴅfy 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 Stero TEA 85 EX (Containing 50% Tri Ethanol Amine 99% and 50% Mono Ethanolamine) 1 kg 1. TRI ETHANOL AMINE 99% 0.500 kg 2. MONO ETHANOL AMINE 0.500 kg 126

Case No.:39/17/82ALC4/2013

Party Name:ASTRIX LABORATORIES LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00901/AM14/ RLA File :09/24/040/00312/AM14/ Lic.No/Date:0910057944 17.10.2013 Defer Date:08.05.2014 127

Case No.:22/17/82ALC4/2013

Party Name:ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00884/AM14/ RLA File :03/94/040/00458/AM14/ Lic.No/Date:0310753955 17.10.2013 Defer Date:08.05.2014 128

Case No.:67/17/82ALC4/2013

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00929/AM14/ RLA File :09/24/040/00286/AM14/ Lic.No/Date:0910057945 17.10.2013 Defer Date:08.05.2014 129

Case No.:5/17/82ALC4/2013

Party Name:TIDE INDUSTRIES 10.04.2014 Status:Case Deferred HQ File :01/82/050/00867/AM14/ RLA File :34/24/040/00177/AM14/ Lic.No/Date:3410038223 18.10.2013 Defer Date:08.05.2014 130 Case No.:59/17/82ALC4/2013 Party Name:INDSWIFT LABORATORIES LTD., 10.04.2014 Status:Case Deferred

HQ File :01/82/050/00921/AM14/ RLA File :22/24/040/00050/AM14/ Lic.No/Date:2210014300 21.10.2013 Defer Date:08.05.2014 131

Case No.:108/23/82ALC4/2013

Party Name:SYMBIOTEC PHARMALAB LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01155/AM14/ RLA File :56/24/040/00020/AM14/ Lic.No/Date:5610003035 21.10.2013 Defer Date:08.05.2014 132

Case No.:106/23/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 10.04.2014 Status:Case Approved HQ File :01/82/050/01153/AM14/ RLA File :17/24/040/00074/AM14/ Lic.No/Date:1710005551 22.10.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/78/2012‐Ch II dated 11.04.2014, it was decided to raﴅfy 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 ESTEEMMFA (POLYETHYLENE GLYCOL CETOSTEARYL ETHER) (Appearance: White to off white flakes) 1 kg 1. ETHYLENE OXIDE (Colourless clear liquid) 0.793 kg 2. CETO STEARYL ALCOHOL (Off White Flakes) 0.206 kg 133

Case No.:60/17/82ALC4/2013

Party Name:SHAMSHREE LIFESCIENCES LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/00922/AM14/ RLA File :22/24/040/00051/AM14/ Lic.No/Date:2210014319 24.10.2013 Defer Date:08.05.2014 134

Case No.:138/23/82ALC4/2013

Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01185/AM14/ RLA File :03/95/040/00599/AM14/ Lic.No/Date:0310755504 25.10.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of C&PC

135

Case No.:100/23/82ALC4/2013

Party Name:SYMBIOTEC PHARMALAB LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01147/AM14/ RLA File :56/24/040/00025/AM14/ Lic.No/Date:5610003085 25.10.2013 Defer Date:08.05.2014 136

Case No.:36/19/82ALC4/2013

Party Name:SOHAM ORGANICS PVT LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00981/AM14/ RLA File :31/83/040/00124/AM14/ Lic.No/Date:3110060943 29.10.2013 Defer Date:08.05.2014 137

Case No.:14/19/82ALC4/2013

Party Name:BLISS GVS PHARMA LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/00959/AM14/ RLA File :03/94/040/00687/AM14/ Lic.No/Date:0310756546 01.11.2013 Defer Date:08.05.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/660/2013PI(Norms) dated 22..01.2014, it was decided to call from the firm the following technical details: 1. COA for foreign supplier indicating Potency of Nystatin imported under present A.A 2. Detailed calculation of arriving at the quantity of API applied. 138

Case No.:9/21/82ALC4/2013

Party Name:YASHO INDUSTRIES PVT.LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01039/AM14/ RLA File :03/95/040/00617/AM14/ Lic.No/Date:0310756660 01.11.2013 Defer Date:08.05.2014 139

Case No.:3/16/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00816/AM14/ RLA File :09/24/040/00366/AM14/ Lic.No/Date:0910058142 05.11.2013 Defer Date:08.05.2014

140

Case No.:2/19/82ALC4/2013

Party Name:GLENMARK GENERICS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/00947/AM14/ RLA File :03/94/040/00668/AM14/ Lic.No/Date:0310756884 06.11.2013 Defer Date:12.06..2014 Decision : It was decided to defer the case for 12.06.2014 for comments of Department of Pharmaceuticals. 141

Case No.:33/17/82ALC4/2013

Party Name:EMCURE 10.04.2014 Status:Case Deferred HQ File :01/82/050/00895/AM14/ RLA File :31/83/040/00149/AM14/ Lic.No/Date:3110061033 11.11.2013 Defer Date:08.05.2014 142

Case No.:79/23/82ALC4/2013

Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01126/AM14/ RLA File :52/24/040/00028/AM14/ Lic.No/Date:5210040395 13.11.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/45/2010‐Ch II dated 27.03.2014, it was decided to raﴅfy 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 2Naphthylamine6Sulfonamide NMethyl 1 kg 1. Beta Naphthol 1.243 kg 2. Mono Methyl Amine 1.902 kg 3. Caustic Soda Flakes 1.502 kg 143 Case No.:80/23/82ALC4/2013 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01127/AM14/ RLA File :52/24/040/00032/AM14/ Lic.No/Date:5210040396 13.11.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/45/2010‐Ch II dated 27.03.2014, it was decided to raﴅfy 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 4(2CHLOROETHYL SULFONYL) BUTYRIC ACID 1 kg 1. GAMMA BUTYROLACTONE 0.620 kg 2. 2MERCAPTO ETHANOL 0.640 kg

144

Case No.:7/23/82ALC4/2013

Party Name:JESONS INDUSTRIES LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01054/AM14/ RLA File :03/94/040/00713/AM14/ Lic.No/Date:0310757929 14.11.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 145

Case No.:66/23/82ALC4/2013

Party Name:STERICON PHARMA PVT.LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01113/AM14/ RLA File :07/24/040/00259/AM14/ Lic.No/Date:0710099690 18.11.2013 Defer Date:08.05.2014 146

Case No.:45/17/82ALC4/2013

Party Name:TORRENT 10.04.2014 Status:Case Deferred HQ File :01/82/050/00907/AM14/ RLA File :08/24/040/00352/AM14/ Lic.No/Date:0810126495 18.11.2013 Defer Date:08.05.2014 147

Case No.:40/19/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/00985/AM14/ RLA File :05/23/040/00334/AM14/ Lic.No/Date:0510371304 20.11.2013 Defer Date:08.05.2014 148

Case No.:10/17/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Deferred HQ File :01/82/050/00872/AM14/ RLA File :09/24/040/00407/AM14/ Lic.No/Date:0910058254 20.11.2013 Defer Date:08.05.2014 149 Case No.:111/23/82ALC4/2013 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 10.04.2014 Status:Case Deferred

HQ File :01/82/050/01158/AM14/ RLA File :34/24/040/00202/AM14/ Lic.No/Date:3410038488 20.11.2013 Defer Date:08.05.2014 150

Case No.:99/23/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 10.04.2014 Status:Case Approved HQ File :01/82/050/01146/AM14/ RLA File :17/24/040/00080/AM14/ Lic.No/Date:1710005576 21.11.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/78/2012‐Ch II dated 11.04.2014, it was decided to raﴅfy 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 GRANDPE80 (OXIRANE, METHYL, POLYMER WITH OXIRANE) (White to off White Flakes) 1 kg 1. ETHYLENE OXIDE (Colourless clear liquid) 0.583 kg 2. PROPYLENE OXIDE (Colourless liquid) 0.411 kg 151

Case No.:119/23/82ALC4/2013

Party Name:RATNAMANI BIO CHEMICALS & PHARMACEUTICALS PVT. LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01166/AM14/ RLA File :34/24/040/00207/AM14/ Lic.No/Date:3410038507 21.11.2013 Defer Date: 12.06.2014 Decision :It was decided to defer the case for 12.06.2014 for comments of Department of C&PC. 152

Case No.:140/23/82ALC4/2013

Party Name:UNITED PHOSPHORUS LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01187/AM14/ RLA File :03/95/040/00495/AM14/ Lic.No/Date:0310758627 21.11.2013 Defer Date:08.05.2014 153

Case No.:149/23/82ALC4/2013

Party Name:YASHO INDUSTRIES PVT.LTD. 10.04.2014 Status:Deffered and Reindexed HQ File :01/82/050/01196/AM14/ RLA File :03/95/040/00658/AM14/ Lic.No/Date:0310758646 21.11.2013 Defer Date:12.06.2014 Decision : It was decided to send the application Department of C&PC. The case was deferred for 12.06.2014.

154

Case No.:2/23/82ALC4/2013

Party Name:CROWN CHEMICALS PVT.LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01049/AM14/ RLA File :03/94/040/00735/AM14/ Lic.No/Date:0310758837 22.11.2013 Defer Date:08.05.2014 155

Case No.:101/23/82ALC4/2013

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 10.04.2014 Status:Case Deferred HQ File :01/82/050/01148/AM14/ RLA File :07/24/040/00269/AM14/ Lic.No/Date:0710099923 25.11.2013 Defer Date:08.05.2014 156

Case No.:105/23/82ALC4/2013

Party Name:R L FINE CHEM 10.04.2014 Status:Case Approved HQ File :01/82/050/01152/AM14/ RLA File :07/24/040/00264/AM14/ Lic.No/Date:0710099933 25.11.2013 Defer Date: Decision : In the light of earlier decision taken in meeﴅng no. 1/82 dated 04.04.2013, it was decided to raﴅfy 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 Cyclobenzaprine Hcl 1 kg 1. 1 Bromo 3 Chloro Propane 0.95 kg 2. Tetra Hydro Furan 1.00 kg 3. Acetone Not allowed as not shown in process 157

Case No.:1/23/82ALC4/2013

Party Name:CROWN CHEMICALS PVT.LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01048/AM14/ RLA File :03/94/040/00733/AM14/ Lic.No/Date:0310759268 26.11.2013 Defer Date:08.05.2014 158

Case No.:3/23/82ALC4/2013

Party Name:CROWN CHEMICALS PVT.LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01050/AM14/ RLA File :03/94/040/00734/AM14/ Lic.No/Date:0310759273 26.11.2013 Defer Date:08.05.2014

159

Case No.:129/23/82ALC4/2013

Party Name:HETERO LABS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01176/AM14/ RLA File :09/24/040/00421/AM14/ Lic.No/Date:0910058346 26.11.2013 Defer Date:08.05.2014 160

Case No.:77/23/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01124/AM14/ RLA File :04/24/040/00183/AM14/ Lic.No/Date:0410152258 27.11.2013 Defer Date:08.05.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2013PI(Norms) dated 22.01.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. 161

Case No.:4/23/82ALC4/2013

Party Name:DELTA FINOCHEM PVT.LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/01051/AM14/ RLA File :03/94/040/00514/AM14/ Lic.No/Date:0310759628 28.11.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/44/2012‐Ch II dated 20.05.2013, it was decided to raﴅfy 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 Ethyl Triphenyl Phosphonium Bromide 1 kg 1. Tri Phenyl Phosphonium Bromide 0.780 kg 2. Ethyl Bromide 0.361 kg 162

Case No.:94/23/82ALC4/2013

Party Name:DHANUKA LABORATORIES LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01141/AM14/ RLA File :05/23/040/00342/AM14/ Lic.No/Date:0510372219 28.11.2013 Defer Date:08.05.2014 163 Case No.:75/23/82ALC4/2013 Party Name:PCL OIL & SOLVENTS LTD., Status:Case

10.04.2014 Deferred HQ File :01/82/050/01122/AM14/ RLA File :05/24/040/00221/AM14/ Lic.No/Date:0510372153 28.11.2013 Defer Date:08.05.2014 164

Case No.:148/23/82ALC4/2013

Party Name:CTX LIFESCIENCES PVT LTD, Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Deferred HQ File :01/82/050/01195/AM14/ RLA File :03/94/040/00598/AM14/ Lic.No/Date:0310760166 02.12.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of C&PC 165

Case No.:13/23/82ALC4/2013

Party Name:YASHO INDUSTRIES PVT.LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01060/AM14/ RLA File :03/95/040/00696/AM14/ Lic.No/Date:0310759990 02.12.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of C&PC 166

Case No.:147/23/82ALC4/2013

Party Name:AGIO PHARMACEUTICALS LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01194/AM14/ RLA File :03/94/040/00705/AM14/ Lic.No/Date:0310760371 03.12.2013 Defer Date:08.05.2014 167

Case No.:12/23/82ALC4/2013

Party Name:MOHINI ORGANICS PVT. LTD., 10.04.2014 Status:Case Approved HQ File :01/82/050/01059/AM14/ RLA File :03/95/040/00631/AM14/ Lic.No/Date:0310760264 03.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/141/2011‐Ch II dated 25.03.2014, it was decided to raﴅfy 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 STEARATE 1 kg 1. SORBITOL 70% 0.580 kg 2. STEARIC ACID 0.634 kg

168

Case No.:142/23/82ALC4/2013

Party Name:NOCIL LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01189/AM14/ RLA File :03/95/040/00554/AM14/ Lic.No/Date:0310760329 03.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/32/2012‐Ch II dated 11.04.2014, it was decided to raﴅfy 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 N(Cyclohexylthio) phthalimide Brand Name:PILGARD PVI 1 kg 1. Phthalic Anyhdride (PAN) 0.614 kg 2. DICYCLOHEXYL DISULPHIDE (DCDS) 0.488 kg 3. CAUSTIC POTASH FLAKES (Potassium Hydroxide) (KOH) 0.233 kg 169

Case No.:112/23/82ALC4/2013

Party Name:CADILA HEALTHCARE LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01159/AM14/ RLA File :08/24/040/00387/AM14/ Lic.No/Date:0810126887 04.12.2013 Defer Date:08.05.2014 170

Case No.:15/23/82ALC4/2013

Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/01062/AM14/ RLA File :03/95/040/00700/AM14/ Lic.No/Date:0310760526 04.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/22/2012‐Ch II dated 8.04.2014, it was decided to raﴅfy 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 4, 4 BIPHENOL 1 kg 1. ISOBUTYLENE 0.700 kg 2. PHENOL 1.50 kg 3. METHANOL 1.00 kg 171 Case No.:116/23/82ALC4/2013 Party Name:ALCHEM INTERNATIONAL Status:Case

LTD. 10.04.2014 Deferred HQ File :01/82/050/01163/AM14/ RLA File :05/23/040/00341/AM14/ Lic.No/Date:0510372635 05.12.2013 Defer Date:08.05.2014 172

Case No.:62/23/82ALC4/2013

Party Name:LAKE CHEMICALS PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01109/AM14/ RLA File :07/24/040/00238/AM14/ Lic.No/Date:0710100274 05.12.2013 Defer Date:08.05.2014 173

Case No.:18/23/82ALC4/2013

Party Name:NAPROD LIFE SCIENCES PVT. LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01065/AM14/ RLA File :03/95/040/00712/AM14/ Lic.No/Date:0310760768 05.12.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals . 174

Case No.:17/23/82ALC4/2013

Party Name:YASHO INDUSTRIES PVT.LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01064/AM14/ RLA File :03/95/040/00705/AM14/ Lic.No/Date:0310760774 05.12.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08.05.2014 for comments of Department of C&PC 175

Case No.:146/23/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 10.04.2014 Status:Deffered and Reindexed HQ File :01/82/050/01193/AM14/ RLA File :24/24/040/00022/AM14/ Lic.No/Date:2410040396 06.12.2013 Defer Date:12.06.2014 Decision : No Data Available for the above case in online agenda available on DGFT server. The case was deferred for 12.06.2014 176 Case No.:145/23/82ALC4/2013 Party Name:AVA CHEMICALS PVT.LTD., 10.04.2014 Status:Case Approved HQ File :01/82/050/01192/AM14/ RLA File :03/94/040/00741/AM14/ Lic.No/Date:0310761092 09.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011‐Ch II dated 04.04.2013, it was decided to raﴅfy 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 DISODIUM MANGANESE EDTA (Manganese Content 12.5% +/ 0.5) 1 kg 1 Ethylene Diamine Tetra Acetic Acid (EDTA) 0.690 kg 177

Case No.:96/23/82ALC4/2013

Party Name:MOREPEN LABORATORIES LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01143/AM14/ RLA File :05/24/040/00313/AM14/ Lic.No/Date:0510372885 09.12.2013 Defer Date:08.05.2014 178

Case No.:118/23/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01165/AM14/ RLA File :05/24/040/00312/AM14/ Lic.No/Date:0510372882 09.12.2013 Defer Date:08.05.2014 179

Case No.:11/23/82ALC4/2013

Party Name:SCITECH SPECIALITIES PVT. LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01058/AM14/ RLA File :03/95/040/00603/AM14/ Lic.No/Date:0310761103 09.12.2013 Defer Date:08.05.2014 180

Case No.:63/23/82ALC4/2013

Party Name:AMI ORGANICS PVT LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01110/AM14/ RLA File :52/24/040/00037/AM14/ Lic.No/Date:5210040485 10.12.2013 Defer Date:08.05.2014 181 Case No.:2/1/82ALC4/2014 Party Name:GEM AROMATICS PVT.LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/00002/AM15/ RLA File :03/94/040/00771/AM14/ Lic.No/Date:0310761495 11.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/65/2010‐Ch II dated 21.04.2014, it was decided to raﴅfy 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 EUGENOL 1 kg 1 CLOVE LEAF OIL (EUGENOL CONTENT 77%+/4%) 1.31 kg 182

Case No.:95/23/82ALC4/2013

Party Name:JAGSONPAL 10.04.2014 Status:Case Deferred HQ File :01/82/050/01142/AM14/ RLA File :05/23/040/00368/AM14/ Lic.No/Date:0510373220 11.12.2013 Defer Date:08.05.2014 183

Case No.:8/23/82ALC4/2013

Party Name:SIRMAXO CHEMICALS PVT LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01055/AM14/ RLA File :03/95/040/00725/AM14/ Lic.No/Date:0310761482 11.12.2013 Defer Date:08.05.2014 184

Case No.:115/23/82ALC4/2013

Party Name:ALCHEM INTERNATIONAL LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01162/AM14/ RLA File :05/23/040/00365/AM14/ Lic.No/Date:0510373480 13.12.2013 Defer Date:08.05.2014 185

Case No.:83/23/82ALC4/2013

Party Name:SHIVA PHARMACHEM LTD, 10.04.2014 Status:Case Deferred HQ File :01/82/050/01130/AM14/ RLA File :34/24/040/00231/AM14/ Lic.No/Date:3410038734 16.12.2013 Defer Date:08.05.2014 186 Case No.:14/23/82ALC4/2013 Party Name:TITAN LABORATORIES PVT. LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/01061/AM14/ RLA File :03/95/040/00753/AM14/ Lic.No/Date:0310761930 16.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Pharmaceuﴅcals vide their OM No. 35011/547/2012‐PI(Norms) dated

g� p / / ( ) 11.09.2013, it was decided to raﴅfy 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 Flurbiprofen SR Pellets 88.9% 1 kg 1 FLURBIPROFEN 0.898 2. POLYVINYL PYROLIDONE K30 (PVPK30) 0.025 3. EUDRAGIT RS 100 (AMMONIO METHACRYLATE COPOLYMER) 0.019 187

Case No.:126/23/82ALC4/2013

Party Name:TRIGON CHEMICALS PVT. LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/01173/AM14/ RLA File :31/83/040/00134/AM14/ Lic.No/Date:3110061568 16.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/52/2011‐Ch II dated 02.04.2014, it was decided to raﴅfy 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 Sodium Benzoate Micronised SF Grade 1 kg 1 Sodium Benzoate 1.01 kg 188

Case No.:127/23/82ALC4/2013

Party Name:TRIGON CHEMICALS PVT. LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/01174/AM14/ RLA File :31/83/040/00133/AM14/ Lic.No/Date:3110061567 16.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/52/2011‐Ch II dated 02.04.2014, it was decided to raﴅfy 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 Sodium Benzoate Micronised 1 kg 1 Sodium Benzoate 1.01 kg 189 Case No.:128/23/82ALC4/2013 Party Name:TRIGON CHEMICALS PVT. LTD. 10.04.2014 Status:Case Approved

HQ File :01/82/050/01175/AM14/ RLA File :31/83/040/00132/AM14/ Lic.No/Date:3110061569 16.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/52/2011‐Ch II dated 02.04.2014, it was decided to raﴅfy 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 Sodium Benzoate Micronised 1 kg 1 Sodium Benzoate 1.01 kg 190

Case No.:88/23/82ALC4/2013

Party Name:DHANUKA LABORATORIES LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01135/AM14/ RLA File :05/23/040/00375/AM14/ Lic.No/Date:0510373696 17.12.2013 Defer Date:08.05.2014 191

Case No.:39/23/82ALC4/2013

Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Deferred HQ File :01/82/050/01086/AM14/ RLA File :03/94/040/00760/AM14/ Lic.No/Date:0310762301 18.12.2013 Defer Date:08.05.2014 192

Case No.:50/23/82ALC4/2013

Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Deferred HQ File :01/82/050/01097/AM14/ RLA File :03/94/040/00761/AM14/ Lic.No/Date:0310762302 18.12.2013 Defer Date:08.05.2014 193 Case No.:51/23/82ALC4/2013 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 10.04.2014 Status:Case Approved HQ File :01/82/050/01098/AM14/ RLA File :03/94/040/00715/AM14/ Lic.No/Date:0310762311 18.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2012‐Ch II dated 14.01.2014, it was decided to raﴅfy 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

ASTROMUSK (S) (Astromusk Content: 100%) 1 kg 1. ISOAMYLENE 0.580 kg 2. PROPYLENE OXIDE 0.380 kg 3. ALPHA METHYL STYRENE 0.769 kg 4. PARAFORMALDEHYDE 0.117 kg 194

Case No.:86/23/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/01133/AM14/ RLA File :05/23/040/00384/AM14/ Lic.No/Date:0510373927 18.12.2013 Defer Date: Decision : In the light of earlier decision taken by NC in its 2/82 meeﴅng dated 18.04.2013, it was decided to raﴅfy 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 Lynestrenol Bulk Drug 1 kg 1. Sitolactone Intermediate 1.95 kg 2. 5Chloro2Pentanone Reagent 1.81 kg 3. Tetrahydrofuran Solvent 5.80 kg 4. Pyridine Reagent 0.87 kg 195

Case No.:87/23/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 10.04.2014 Status:Deffered and Reindexed HQ File :01/82/050/01134/AM14/ RLA File :05/23/040/00385/AM14/ Lic.No/Date:0510373925 18.12.2013 Defer Date:12.06.2014 Decision : It was decided to defer the case for 12.06.2014 for comments of Department of Pharmaceuticals 196 Case No.:37/23/82ALC4/2013 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01084/AM14/ RLA File :03/95/040/01042/AM13/ Lic.No/Date:0310762360 18.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/92/2011‐Ch II dated 09.04.2014, it was decided to raﴅfy 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 META AMINO BENZO TRI FLUORIDE (MABTF) 1 kg 1 BENZO TRI FLUORIDE (BTF) 1.13 kg 197

Case No.:36/23/82ALC4/2013

Party Name:ORION CHEM PVT.LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/01083/AM14/ RLA File :03/95/040/00729/AM14/ Lic.No/Date:0310762471 18.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/10/2013‐Ch II dated 25.03.2014, it was decided to raﴅfy 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 2,3 DIMETHYL 2,3 DINITRO BUTANE ( DMNB ) 1 kg 1 2 NITRO PROPANE 1.120 kg 198

Case No.:125/23/82ALC4/2013

Party Name:EMCURE 10.04.2014 Status:Deffered and Reindexed HQ File :01/82/050/01172/AM14/ RLA File :31/83/040/00170/AM14/ Lic.No/Date:3110061658 19.12.2013 Defer Date:12.06.2014 Decision : It was decided to defer the case for 08.05.2014 for comments of Department of Pharmaceuticals 199 Case No.:38/23/82ALC4/2013 Party Name:METROPOLITAN EXIMCHEM LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/01085/AM14/ RLA File :03/95/040/00736/AM14/ Lic.No/Date:0310762602 19.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2010‐Ch II dated 11.04.2014, it was decided to raﴅfy 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 MR3 (TRI(DHMP) T (1,4,6Tri (2,4 DIHYDROXY3 METHYL)PHENYL 1,3,5TRIAZINE 1 kg 1. 2 METHYL RESORCINOL 1.140 kg 2. CYANURIC CHLORIDE 0.479 kg 3. SULFOLENE 1.80 kg

200

Case No.:89/23/82ALC4/2013

Party Name:RENOWN PHARMACEUTICALS PVT LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01136/AM14/ RLA File :34/24/040/00225/AM14/ Lic.No/Date:3410038760 19.12.2013 Defer Date:08.05.2014 201

Case No.:84/23/82ALC4/2013

Party Name:TRANSPEK INDUSTRY LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01131/AM14/ RLA File :34/24/040/00236/AM14/ Lic.No/Date:3410038767 19.12.2013 Defer Date:08.05.2014 202

Case No.:40/23/82ALC4/2013

Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Approved HQ File :01/82/050/01087/AM14/ RLA File :03/94/040/00745/AM14/ Lic.No/Date:0310762897 20.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/37/2010‐Ch II dated 21.04.2014, it was decided to raﴅfy 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 6AMINO 1,3DIMETHYL URACIL 1 kg 1 CYANO ACETIC ACID 70% 1.04 kg 203

Case No.:91/23/82ALC4/2013

Party Name:INTAS PHARMACEUTICALS LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01138/AM14/ RLA File :08/24/040/00408/AM14/ Lic.No/Date:0810127281 20.12.2013 Defer Date:08.05.2014 204 Case No.:85/23/82ALC4/2013 Party Name:PARENTERAL DRUGS (INDIA) LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01132/AM14/ RLA File :56/24/040/00033/AM14/ Lic.No/Date:5610003400 Defer

20.12.2013 Date:08.05.2014 205

Case No.:123/23/82ALC4/2013

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/01170/AM14/ RLA File :31/83/040/00164/AM14/ Lic.No/Date:3110061675 23.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/39/2011‐Ch II dated 21.04.2014, it was decided to raﴅfy 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 ACETONITRILE 1 kg 1 ACETIC ACID 1.80 kg 206

Case No.:92/23/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 10.04.2014 Status:Case Approved HQ File :01/82/050/01139/AM14/ RLA File :17/24/040/00099/AM14/ Lic.No/Date:1710005619 23.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/78/2012‐Ch II dated 11.04.2014, it was decided to raﴅfy 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 PRODUCTAFO1002 (OLEYL CETYL ALCOHOL POLY GLYCOL ETHER) (OLEYL CETYL ALCOHOL 25 MOLE ETHOXYLATE) (Appearance at 25 Deg C: White to off white solid) 1 kg 1. OLEYL CETYL ALCOHOL (Colourless / pale clear insoluble liquid) 0.197 kg 2. ETHYLENE OXIDE (Colourless clear liquid) 0.802 kg 207 Case No.:90/23/82ALC4/2013 Party Name:CADILA 10.04.2014 Status:Case Deferred HQ File :01/82/050/01137/AM14/ RLA File :08/24/040/00403/AM14/ Lic.No/Date:0810127360 24.12.2013 Defer Date:08.05.2014

208

Case No.:41/23/82ALC4/2013

Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01088/AM14/ RLA File :03/94/040/00749/AM14/ Lic.No/Date:0310763218 24.12.2013 Defer Date:08.05.2014 209

Case No.:27/23/82ALC4/2013

Party Name:SANDOZ PRIVATE LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01074/AM14/ RLA File :03/95/040/00758/AM14/ Lic.No/Date:0310763292 24.12.2013 Defer Date:08.05.2014 210

Case No.:52/23/82ALC4/2013

Party Name:ALKYL AMINES CHEMICALS LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/01099/AM14/ RLA File :03/94/040/00740/AM14/ Lic.No/Date:0310763366 26.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012‐Ch II dated 13.06.2013, it was decided to raﴅfy 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 2 ETHYL HEXYLAMINE 1 kg 1 2 ETHYL HEXANOL 1.06 kg 211 Case No.:46/23/82ALC4/2013 Party Name:GUJARAT ORGANICS LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01093/AM14/ RLA File :03/94/040/00820/AM14/ Lic.No/Date:0310763352 26.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/73/2013‐Ch II dated 01.04.2013, it was decided to raﴅfy 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 METHYL PARABEN SODIUM (4HYDROXY 1 kg 1. PHENOL 0.950 kg

BENZOIC ACID METHYL ESTER SODIUM SALT) 2. POTASSIUM HYDROXIDE 1.00 kg 3. METHANOL 0.261 kg 212

Case No.:49/23/82ALC4/2013

Party Name:INDO AMINES LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01096/AM14/ RLA File :03/94/040/00804/AM14/ Lic.No/Date:0310763384 26.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/81/2010‐Ch II dated 25.03.2014, it was decided to raﴅfy 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 DIISOBUTYL CARBINOL 1 kg 1 DIISOBUTYL KETONE 1.048 kg 213

Case No.:65/23/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01112/AM14/ RLA File :05/24/040/00258/AM14/ Lic.No/Date:0510374575 27.12.2013 Defer Date:08.05.2014 214

Case No.:71/23/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01118/AM14/ RLA File :05/24/040/00317/AM14/ Lic.No/Date:0510374576 27.12.2013 Defer Date:08.05.2014 215 Case No.:64/23/82ALC4/2013 Party Name:S.M. HERBALS PVT.LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01111/AM14/ RLA File :05/24/040/00321/AM14/ Lic.No/Date:0510374573 27.12.2013 Defer Date:08.05.2014 Decision :It was decided to remind the firm to furnish the following technical details: • COA from foreign supplier for relevant import consignment for the imported input. • COA from Independent and approved Testing Laboratory for export product. • Stepwise process with wastage envisaged in the process.

216

Case No.:43/23/82ALC4/2013

Party Name:ANUH PHARMA LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01090/AM14/ RLA File :03/94/040/00770/AM14/ Lic.No/Date:0310763631 30.12.2013 Defer Date:08.05.2014 Decision :It was decided to defer the case for 08s.05.2014 for comments of Department of Pharmaceuticals 217

Case No.:48/23/82ALC4/2013

Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Deferred HQ File :01/82/050/01095/AM14/ RLA File :03/94/040/00719/AM14/ Lic.No/Date:0310763628 30.12.2013 Defer Date:08.05.2014 218

Case No.:93/23/82ALC4/2013

Party Name:PARAGON INDUSTRIES 10.04.2014 Status:Case Approved HQ File :01/82/050/01140/AM14/ RLA File :08/24/040/00430/AM14/ Lic.No/Date:0810127594 31.12.2013 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/124/2011‐Ch II dated 02.04.2014, it was decided to raﴅfy 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 2,3 Dichloro 1:4 Naphthaquinone 1 kg 1 Sodium Naphthionate 1.00 kg 219

Case No.:55/23/82ALC4/2013

Party Name:SATYAJIT CHEMICALS PVT.LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01102/AM14/ RLA File :03/95/040/00791/AM14/ Lic.No/Date:0310763764 31.12.2013 Defer Date:08.05.2014 Decision : It was decided to defer the case for 08.05.2014 for comments of Department of C&PC. 220 Case No.:53/23/82ALC4/2013 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:1/82ALC4/2014 10.04.2014 Status:Case Deferred HQ File :01/82/050/01100/AM14/ RLA File :03/94/040/00744/AM14/ Lic.No/Date:0310764365 Defer

02.01.2014 Date:08.05.2014 221

Case No.:68/23/82ALC4/2013

Party Name:H.J.AROCHEM PVT. LTD., 10.04.2014 Status:Case Approved HQ File :01/82/050/01115/AM14/ RLA File :08/24/040/00418/AM14/ Lic.No/Date:0810127690 03.01.2014 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/63/2013‐Ch II dated 05.12.2013, it was decided to raﴅfy 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 DIPHENYL OXIDE 1 kg 1. PHENOL 0.449 kg 2. MONO CHLORO BENZENE 0.774 kg 3. CAUSTIC SODA FLAKES 0.425 kg 4. CUPEROS OXIDE 0.049 kg 222

Case No.:56/23/82ALC4/2013

Party Name:AVA CHEMICALS PVT.LTD., 10.04.2014 Status:Case Approved HQ File :01/82/050/01103/AM14/ RLA File :03/94/040/00822/AM14/ Lic.No/Date:0310765132 08.01.2014 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/157/2011‐Ch II dated 22.04.2013, it was decided to raﴅfy 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 EDTA Tetra Sodium 1 kg 1 Ethylene Diamine Tetra Acetic Acid 0.750 kg 223 Case No.:35/23/82ALC4/2013 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 10.04.2014 Status:Case Approved HQ File :01/82/050/01082/AM14/ RLA File :03/94/040/00871/AM14/ Lic.No/Date:0310765141 08.01.2014 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/29/2011‐Ch II dated 21.04.2014, it was decided to raﴅfy 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 2CHLORO4,6DI METHOXY1,3,5 TRIAZINE (CHLORDIMETHOXYTRIAZINE) 1 kg 1. CYANURIC CHLORIDE 1.750 kg 2. SODIUM BI CARBONATE 1.595 kg 224

Case No.:42/23/82ALC4/2013

Party Name:ARIHANTANAM LIFECARE PVT. LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01089/AM14/ RLA File :03/94/040/00881/AM14/ Lic.No/Date:0310765339 09.01.2014 Defer Date:08.05.2014 225

Case No.:21/23/82ALC4/2013

Party Name:UNITED PHOSPHORUS LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01068/AM14/ RLA File :03/95/040/00590/AM14/ Lic.No/Date:0310765258 09.01.2014 Defer Date:08.05.2014 226

Case No.:19/23/82ALC4/2013

Party Name:DANOPHARM CHEMICALS PRIVATE LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01066/AM14/ RLA File :03/94/040/00772/AM14/ Lic.No/Date:0310766076 13.01.2014 Defer Date:08.05.2014 227 Case No.:32/23/82ALC4/2013 Party Name:STERLING AUXILIARIES PVT LTD 10.04.2014 Status:Case Approved HQ File :01/82/050/01079/AM14/ RLA File :03/95/040/00769/AM14/ Lic.No/Date:0310766054 13.01.2014 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/64/2013‐Ch II dated 11.04.2014, it was decided to raﴅfy 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 STERO MDEA (NMethyl Di Ethanol Amine) 1 kg 1. MONO METHYL ETHANOL AMINE 0.643 kg 2. ETHYLENE OXIDE 0.377 kg

228

Case No.:25/23/82ALC4/2013

Party Name:GLENMARK GENERICS LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01072/AM14/ RLA File :03/94/040/00885/AM14/ Lic.No/Date:0310766291 15.01.2014 Defer Date:08.05.2014 229

Case No.:22/23/82ALC4/2013

Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01069/AM14/ RLA File :03/95/040/00802/AM14/ Lic.No/Date:0310766188 15.01.2014 Defer Date:08.05.2014 230

Case No.:33/23/82ALC4/2013

Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01080/AM14/ RLA File :03/95/040/00804/AM14/ Lic.No/Date:0310766192 15.01.2014 Defer Date:08.05.2014 Decision :It was decided to defer the case 08.05.2014 for comments of Department of Chemicals and Petrochemicals. 231

Case No.:26/23/82ALC4/2013

Party Name:RIOCARE INDIA PRIVATE LIMITED. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01073/AM14/ RLA File :03/95/040/00822/AM14/ Lic.No/Date:0310766258 15.01.2014 Defer Date:08.05.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/635/2013PI(Norms) dated 04.03.2014, it was decided to call from the firm the following technical details: i) Export Items 1 and 3 are API`s (100%) and should not fall under chapter 30. The firm should be advised to give correct and relevant HS code ii) whether any chemical reaction is involved in the manufacture of Dimethicone. If so, complete details of reaction, Mol. weight and % yield on molar basis may be furnished. iii) Past production visavis actual consumption of inputs duly certified by Central Excise Authorities be furnished for last 3 years. 232 Case No.:16/23/82ALC4/2013 Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 10.04.2014 Status:Case Deferred

HQ File :01/82/050/01063/AM14/ RLA File :03/95/040/00801/AM14/ Lic.No/Date:0310766418 16.01.2014 Defer Date:08.05.2014 Decision :It was decided to defer the case 08.05.2014 for comments of Department of Chemicals and Petrochemicals. 233

Case No.:31/23/82ALC4/2013

Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01078/AM14/ RLA File :03/95/040/00803/AM14/ Lic.No/Date:0310766423 16.01.2014 Defer Date:08.05.2014 Decision :It was decided to defer the case 08.05.2014 for comments of Department of Chemicals and Petrochemicals. 234

Case No.:24/23/82ALC4/2013

Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 10.04.2014 Status:Case Approved HQ File :01/82/050/01071/AM14/ RLA File :03/94/040/00829/AM14/ Lic.No/Date:0310766713 17.01.2014 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/21/2013‐Ch II dated 27.03.2014, it was decided to raﴅfy 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 Sodium Saccharin 1 kg 1 Saccharin Insoluble 0.910 kg 235

Case No.:2/21/82ALC4/2013

Party Name:HONEST BIOVET PVT. LTD 10.04.2014 Status:Case Deferred HQ File :01/82/050/01032/AM14/ RLA File :08/24/040/00456/AM14/ Lic.No/Date:0810128144 20.01.2014 Defer Date:08.05.2014 Decision :It was decided to defer the case 08.05.2014 for comments of Department of Pharmaceuticals .. 236

Case No.:12/21/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 10.04.2014 Status:Case Deferred HQ File :01/82/050/01042/AM14/ RLA File :22/21/040/00096/AM14/ Lic.No/Date:2210014544 23.01.2014 Defer Date:08.05.2014 Decision :It was decided to defer the case 08.05.2014 for comments of Department of Pharmaceuticals.. 237 Case No.:1/1/82ALC4/2014 Party Name:GEM AROMATICS PVT.LTD. Status:Case

10.04.2014 Approved HQ File :01/82/050/00001/AM15/ RLA File :03/94/040/00904/AM14/ Lic.No/Date:0310769363 05.02.2014 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/65/2010‐Ch II dated 21.04.2014, it was decided to raﴅfy 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 EUGENOL 1 kg 1 CLOVE LEAF OIL (EUGENOL CONTENT 77%+/4%) 1.31 kg A may take appropriate acﴅon as per the decision of Norms Commi饫�ee. 238

Case No.:47/23/82ALC4/2013

Party Name:PORUS LABORATORIES PVT LTD. 10.04.2014 Status:Case Deferred HQ File :01/82/050/01094/AM14/ RLA File :09/24/040/00585/AM14/ Lic.No/Date:0910059356 19.02.2014 Defer Date:08.05.2014 Decision :It was decided to defer the case 08.05.2014 for comments of Department of Pharmaceuticals 239

Case No.:5/1/82ALC4/2014

Party Name:S D INTERMEDIATES 10.04.2014 Status:Case Deferred HQ File :01/82/050/01247/AM14/ RLA File :34/24/040/00297/AM14/ Lic.No/Date:3410039464 10.03.2014 Defer Date:08.05.2014 Decision :It was decided to defer the case 08.05.2014 for comments of Department of Pharmaceuticals.. 240

Case No.:4/1/82ALC4/2014

Party Name:AUROBINDO PHARMA LIMITED 10.04.2014 Status:Case Deferred HQ File :01/82/050/01246/AM14/ RLA File :09/24/040/00649/AM14/ Lic.No/Date:0910059673 28.03.2014 Defer Date:08.05.2014 Decision :It was decided to defer the case 08.05.2014 for comments of Department of Pharmaceuticals.. 241 Case No.:3/1/82ALC4/2014 Party Name:VIVIMED LABS LIMITED 10.04.2014 Status:Case Approved HQ File :01/82/050/01245/AM14/ RLA File :09/24/040/00662/AM14/ Lic.No/Date:0910059659 28.03.2014 Defer Date: Decision : In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011‐Ch. II dated 09.12.2013, it was decided to raﴅfy 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 AVIS (AVOBENZONE) 1 kg 1 PARA TERTIATORY BUTYL BENZOIC ACID (PTBBA) 1.148 kg 2. ACETYL ANISOLE 0.929 kg 3. ACTIVATED CARBON 0.025 kg 4. SODAMIDE 0.206 kg 5. METHANOL 4.00 kg 6. TOLUENE 1.00kg Manual cases considered on file Part –II B

Case No. B‐1 (Part‐II)

M/s Gitanjali Chemicals Pvt. Ltd. Meeﴅng No. 1/AM15 dated – 21.04.2014 F.No. 01/82/050/01188AM13DESIII Adv. Lic. No. 0310708275 dated10.09.2012 Adv.Lic. No. 0310721719 dated 22.01.2013 Decision: In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/41/2011‐Ch. II dated 13.03.2014, it was decided to raﴅfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quanﴅty S,No Item of Import Quanﴅty allowed ANISOLE PURE (MIN.99%) 1 kg 1 ANISOLE CRUDE (MAX.96%) 1.05 kg 2. CAUSTIC SODA FLAKES 0.120 kg

Case No. B‐2 (Part‐II)

M/s M/s Laffans Petrochemicals Ltd. 01/83/050/01875/AM08/ DES‐III RLA File No: 03/95/040/01379/AM07 Adv. Lic. No. 0310419553 dated 13.02.2007 Decision: Decision: In the light of wri饫�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/45/2013‐Ch. II dated 21.01.2014 as the item of export indicated in Advance Authorizaﴅon; Norms fixed by NC and shipping bills are different. There is no jusﴅficaﴅon for amendment to descripﴅon of export product , maintain status qua. RA concerned may take further necessary action as per above decision of NC.

Case No. B‐3 (Part‐II)

M/s VIMAL DRUGS PRIVATE LIMITED 01/83/050/00351/AM13/DES‐III RA File No. 09/24/040/00049/AM13 Adv. Lic. No. 0910052504 dated 08.05.2012 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/622/2012PI(Norms) dated 21.04.2014, it was decided to revise the 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 Item Qty. Allowed kg/kg Cholic Acid 1 kg 1 OxBile Paste (Solid content 75%+10%) Cholic acid content 31% + 1% by HPLC 4.18 RA concerned may take further necessary action as per above decision of NC.

Case No. B‐4 (Part‐II)

M/s RA Chem Pharma Ltd. 01/82/050/00009/AM13/DESIII 01/82/050/01460/AM12/DESIII 01/82/050/01554/AM08/DESIII Adv. Lic. No. 0910051057 dated 01.02.2012 Adv. Lic. No. 0910050772 dated 13.01.2013 Adv. Lic. No. 0910032058 dated 12.11.2007 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/376/2012PI(Norms) dated 01.04.2014, and it was decided to raﴅfy 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 kg/kg Entacapone 1 kg 1. Vaillin 2.306 2. Pyridine 1.02 3. Diethyl amine 1.437 4. Toluene 1.35 5. Methanol 0.62 6. Ethyl Acetate 2.56

RA may take appropriate action as per the decision of Norms Committee.

Case No. B‐5 (Part‐II)

M/s Ni埘�y Labs Pvt. Ltd. 01/82/050/00351/AM13/DES‐III RLA File No. 09/24/040/00076/AM13 Adv. Lic. No. 0910052711 dated 21.05.2012 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/589/2012PI(Norms) dated 01.04.2014, and it was decided to raﴅfy 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 kg/kg 2‐[[[4‐(3‐Methoxy Propoxy)‐3‐Methyl‐2‐ Pyridinyl]Methyl] Sulfinyl]‐1H‐Benzimidazole 1 kg 1. 2,3Lutidine 0.65 2. 3Methoxy1Propanol 0.65 3. Methylene Dichloride 0.40 RA may take appropriate action as per the decision of Norms Committee.

Case No. B‐6 (Part‐II)

M/s JUBILANT LIFE SCIENCES LIMITED F. No.01/82/050/00522/AM14/DES‐III RA F. No. 05/23/040/00164/AM14 Adv. Lic. No. 0510360738 dated 24.07.2013 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/672/2013PI(Norms) dated 01.04.2014, and it was decided to raﴅfy norms under

Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

[1] Export Product : Enrofloxacin Flavored Tablets 22.7 mg S.NO. Import Item Quanﴅty recommended for 1 No. of tablet 1 Enrofloxacin 23.154 mg tablet 2. Arﴅficial Powder Beef Flavor 79.282 mg 3 & 4 Packing materials Relevant as per packing policy

[2] Export Product : Enrofloxacin Flavored Tablets 68 mg S.NO. Import Item Quanﴅty recommended for 1 No. of tablet 1 Enrofloxacin 69.36mg 2. Arﴅficial Powder Beef Flavor 237.5 mg 3 & 4 Packing materials Relevant as per packing policy [3] Export Product : Enrofloxacin Flavored Tablets 136 mg S.NO. Import Item Quanﴅty recommended for 1 No. of tablet 1 Enrofloxacin 138.72 mg tablet 2. Arﴅficial Powder Beef Flavor 475 mg tablet 3 & 4 Packing materials Relevant as per packing policy RA may take appropriate action as per the decision of Norms Committee.

Case No. B‐7 (Part‐II)

M/s Global Calcium Pvt Ltd 01/82/050/00160/AM13/DESIII 01/82/050/01207/AM13/DESIII 01/82/050/01403/AM13/DESIII 01/82/050/00587/AM14/DESIII RLA File No: 07/24/040/00514/AM12 RLA File No: 07/24/040/00430/AM13 RLA File No: 07/24/040/00466/AM13 RLA File No: 07/24/040/00043/AM14 Ad. Lic. No. 0710087005 dated 15.03.2012 Ad. Lic. No. 0710093432 dated 30.01.2013 Ad. Lic. No. 0710093775 dated 19.02.2013 Ad. Lic. No. 0710097663 dated 22.08.2013 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting, it was decided to maintain Status quo.

Case No. B‐8 (Part‐II)

M/s MYLAN LABORATORIES LIMITED 01/82/050/01242/AM13/DES‐III RLA File :09/24/040/00342/AM13 Adv. Lic. No. 0910054286 dated 08.11.2012 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No.

35011/374/2013PI(Norms) dated 21.04.2014, it was decided to revise the norms as earlier decision taken by NC in its 8/82 meeting dated 11.07.2013 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 Item Qty. Allowed kg/kg EMTRICITABINE 1 kg 1 FCE 2.50 2 Sodium borohydride 0.51 3 Isopropyl alcohol 2.11 4 Toluene 0.16 5 Methanol 0.33 6 Triethylamine 1.10 7 Methylene dichloride 1.71 RA may take appropriate action as per the decision of Norms Committee.

Case No. B‐9 (Part‐II)

M/s RANBAXY LABORATORIES LTD 01/82/050/00347/AM13/DESIII RLA File No. 05/24/040/00061/AM13 Ad. Lic. No. 0510325945 dated 25.05.2012 Decision: Department of Pharmaceuticals, vide their OM No. 35011/592/2012PI(Norms) dated 01.04.2014, informed that they have examined the case of export product “ACETYLTHIOSULFAMIDE (ATS) (4‐Nitrobenzyl (2S, 4S)‐4‐acetylthio‐2‐(N‐sulfamoyl‐tert‐butoxycarboxamidomethyl) pyrrolidine‐1‐ carboxylate)” and it was noted that Step II intermediate (MW 354) does not match in the next Step IV where it is supposed to be treated with step III intermediate. It may be seen that firm has not revised the chemistry and the same has been furnished again and again. It was decided to advise the firm to furnish revised chemistry with other details. Date:05.05.2014 Place:New Delhi Nirmal Kumar Dy. Director General of Foreign Trade

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Para 4.7 Decision (DRAFT)

Case No. B‐1

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