IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2014-03-27

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 24/82ALC4/2013 MEETING DATE : 27.03.2014 but actually held on 03.04.2014 The Meeting No. 24/82 of 201314 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 27.03.2014 but actually held on 03.04.2014 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 R.C. Meena, 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 06.03.2014 was treated as approved. The following cases/issues were discussed and the committee took the decision as mentioned against the case:

Case No. A‐58

M/s Wockhardt Ltd.. Mee��ng No.24/AM14 dated – 03.04.2014 F.No. 01/82/162/009/AM14/DES‐III In the light of wri�en comments received from Department of Pharmaceu��cals vide their OM No. 35011/507/2013‐PI(Norms) dated 21.11.2013, it was decided to call from the firm a copy of Master‐Batch formula for each export product duly authen��cated by Quality – Control Incharge. The case was deferred for 24.04.2014.

Case No. A‐59

M/s Hikal Ltd.. Mee��ng No. 24/AM14 dated – 03.04.2014 F.No. 01/82/162/117/AM14/DES‐III Decision: In the light of wri�en comments received from Department of Pharmaceu��cals vide their OM No. 35011/607/2013‐PI(Norms) dated 24.12.2013, it was decided to call the following informa��on from the firm : Certification from MSME, Bangalore on waste generated /solvent waste viz: Certification from Central Excise Authority on past production consumption data of the firm for various export items. Complete technical details as per Appendix 33 for each export items.

The case is deferred for 24.04.2014

Case No. B‐1

M/s Chirag Enterprise, Jamnagar, Gujarat F.No. 01/82/050/00256/AM11/DES‐III F.No. 01/82/050/01090/AM11/DES‐III Adv. Lic. No. 2410029974 dated 27.10.2010 2410030871 dated 27.10.2010 RLA F. No. 24/24/040/00009/AM11 24/24/040/00014/AM11 Decision: It was decided to remind the Department of Petrochemicals to furnish their comments. The case is deferred 24.04.2014.

Case No. B‐2

M/s Navin Florine Interna��onal Ltd., Mumbai F.No. 01/82/050/00398/AM12/DES‐III Adv. Lic. No. 0310630757 dated 11.05.2011 RLA F. No. 03/95/040/0099/AM11 Decision: In the light of wri�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/92/2011‐Ch II dated 03.04.2014, it was decided to ra��fy 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 Chloro 4 Fluoro Benzotrifluoride 1 kg 1. 4 Fluoro Benzotrichloride 0.924 kg RA may take appropriate ac��on as per the decision of Norms Commi�ee.

Case No. B‐3

M/s Otsuka Chemical (India) Pvt Ltd F.No. 01/82/050/00434/AM14/DES‐III

Adv. Lic. No. 0510360662 dated 24.07.2013 RLA F. No. 05/24/040/00137/AM14 Decision: commi�ee considered the case as per agenda and decided to call for technical literature from the firm in support descrip��on of export items.

Case No. B‐4

M/s Titan Laboratories Pvt Ltd., Mumbai F.No. 01/82/050/00831/AM12/DES‐III Adv. Lic. No. 0310659395 dated 13.10.2011 RLA F. No. 03/95/040/00570/AM12 In the light of wri�en comments received from Department of Pharmaceu��cals vide their OM No. 35011/547/2012‐PI(Norms) dated 11.09.2013, it was decided to ra��fy 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. Polyvinylpyrolidone USP, NF,EP, JP (PVPK30) 0.025 3. Eudragit RS 100 (Ammonio Methacrylate Copolymer) 0.019

Case No. B‐5

M/s Navin Florine Interna��onal Ltd., Mumbai F.No. 01/82/050/00648/AM11/DES‐III Adv. Lic. No. 0310587462 dated 13.08.2010 RLA F. No. 03/95/040/00331/AM11 Decision: In the light of wri�en comments received from Department of Chemicals and

Petrochemicals vide their U.O No. 14010/92/2011‐Ch II dated 01.04.2014, it was decided to ra��fy 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 Chloro 4 Fluoro Benzotrifluoride 98% Min. 1 kg 1. 4 Fluoro Benzotrichloride 0.924 kg

Case No. B‐6

M/s Navin Florine Interna��onal Ltd., Mumbai F.No. 01/82/050/01437/AM12/DES‐III Adv. Lic. No. 0310686264 dated 14.03.2012 RLA F. No. 03/95/040/00859/AM12 Decision: In the light of wri�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/92/2011‐Ch II dated 01.04.2014, it was decided to ra��fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Para Fluoro Bromo Benzene 1 kg 1. Fluoro Benzene 0.660 kg 2. Bromine 1.00 kg

Case No. B‐7

M/s The Andhra Sugar Ltd. F.No. 01/82/162/00917/AM12/DES‐III

Adv. Lic. No. 02610010636 dated 04.01.2011 RLA F. No. 26/02/040/00001/AM11 Decision: It was decided to forward a copy of applica��on to Department of Pharmaceu��cals for their comments and deferred the case for 24.04.2014.

Case No. B‐8

M/s Shiva Pharma Ltd. F.No. 01/82/050/01062/AM10/DES‐III Adv. Lic. No. 3410026242 dated 02.02.2010 RLA F. No. 34/24/040/184/AM10 Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/164/2011Ch.II dated 02.04.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed nDecanoyl Chloride/Decanoyl Chloride/Caprionyl Chloride (Appearance : clear to slightly grayish liquid Assay: Min. 98% 1 KG. 1. Decanoic Acid/Capric Acid (App. Clear Liquid assayMin. 99% 0.970 kg RA concerned may take further necessary action as per above decision of NC.

Case No. B‐9

M/s Sriam Labs Pvt Ltd F.No. 01/82/050/00601/AM12/DES‐III F.No. 01/82/050/00526/AM13/DES‐III Adv. Lic. No. 0910047733 dated 19.07.2011 0910053188 dated 04.07.2012

Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo.

Case No. B‐10

M/s Crown Chemicals Pvt Ltd F.No. 01/82/050/00601/AM12/DES‐III Decision: It was decided to send a copy of applica��on to Department of C&PC and defer the case for 24.04.2014

Case No. B‐11

M/s DSM Sinochem Pharmaceu��cals P. F.No. 01/82/050/368/AM07/DES‐III Decision: It was decided to defer the case for 24.4.2014 for wants of comments from D/o Pharmaceu��cals.

Case No. B‐12

M/s Padmini Aroma��cs Pvt Ltd. F.No. 01/82/050/00375/AM10/DES‐III F.No. 01/82/050/00375/AM10/DES‐III Adv. Lic. No. 0710066165 dated 24.07.2009 0710068389 dated 19.11.2009 Decision: It was decided to send a copy of applica��on to Department of C&PC and defer the case for 24.04.2014

Case No. B‐13

M/s Vivimed Labs Ltd., F.No. 01/82/050/00013/AM11/DES‐III F.No. 01/82/050/00183/AM11/DES‐III Adv. Lic. No. 0910041571 dated 07.04.2010 0910041861 dated 03.05.2010

RLA F. No. 09/24/040/00549/AM10 09/24/040/00033/AM11 Decision: Committee considered the case as per agenda and decided to reject the request of the firm as there was no justification for enhancement maintain Status quo

Case No. B‐14

M/s Vivimed Labs Ltd F.No. 01/82/050/00284/AM12/DES‐III Adv. Lic. No. 0910051917 dated 28.03.2012 RLA F. No. 09/24/040/646/AM12 Decision: Committee considered the case as per agenda and decided to reject the request of the firm as there was no justification for enhancement maintain Status quo.

Case No. C‐1

M/s Gulbrandsen Pvt Ltd. F.No. 01/82/162/330/AM14/DES‐III Decision: Committee considered case as per agenda and decided to call for all industry production consumption data from Chemexcil.

Case No. C‐2

M/s Gulbrandsen Pvt Ltd. F.No. 01/82/162/328/AM14/DES‐III Decision: Committee considered case as per agenda and decided to call for all industry production consumption data from Chemexcil.

Case No. C‐3

M/s Gulbrandsen Pvt Ltd.

F.No. 01/82/162/329/AM14/DES‐III Decision: Committee considered case as per agenda and decided to call for all industry production consumption data from Chemexcil.

Case No. C‐4

M/s Gulbrandsen Pvt Ltd. F.No. 01/82/162/331/AM14/DES‐III Decision: Committee considered case as per agenda and decided to call for all industry production consumption data from Chemexcil.

Case No. C‐5

M/s Jubilant Life Sciences Ltd., Noida F.No. 01/82/162/00371/AM14/DES‐III Decision: Committee considered case as per agenda and decided to call for all industry production consumption data from Chemexcil. 1

Case No.:11/20/82ALC4/2009

Party Name:NEULAND LABORATORIES LTD Meet No/Date:24/82ALC4/2013 27.03.2014 Status:Case Deferred HQ File :01/82/050/00422/AM10/ RLA File :09/24/040/00144/AM10/ Lic.No/Date:0910038818 06.08.2009 Defer Date:24.04.2014 Decision :It was decided to remind the firm to furnish production and consumption data for the last three years, certified by Central Excise Authority. The case was deferred for 24.04.2014. 2

Case No.:22/6/82ALC4/2010

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 27.03.2014 Status:Case Deferred HQ File :01/82/050/00169/AM11/ RLA File :03/95/040/00396/AM10/ Lic.No/Date:0310571937 Defer

29.04.2010 Date:24.04.2014 Decision : It was decided to send the copy of application to Department of Pharmaceuticals for their comments. The case defer for 24.04.2014 3

Case No.:38/24/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01237/AM14/ RLA File :09/24/040/00585/AM11/ Lic.No/Date:0910046104 28.03.2011 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals and defer the case for 24.04.2014 4

Case No.:4/16/82ALC4/2011

Party Name:BOSTIK INDIA PRIVATE LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00462/AM12/ RLA File :07/24/040/00073/AM12/ Lic.No/Date:0710079777 13.06.2011 Defer Date:24.04.2014 Decision :It was decided to remind the Department of Petrochemicals to furnish their comments as the case is pending since 13.09.2011.The case is defer 24.04.2014 5

Case No.:11/1/82ALC4/2013

Party Name:BIOCON LIMITED, 27.03.2014 Status:Case Rejected HQ File :01/82/050/01369/AM13/ RLA File :07/24/040/00329/AM12/ Lic.No/Date:0710084173 23.11.2011 Defer Date: Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders. 6

Case No.:196/10/82ALC4/2013

Party Name:BOSTIK INDIA PRIVATE LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00379/AM14/ RLA File :07/24/040/00380/AM12/ Lic.No/Date:0710085024 28.12.2011 Defer Date:24.04.2014 Decision :It was decided to defer the case for 24.04.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 7

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

Party Name:CADILA HEALTHCARE LTD., 27.03.2014 HQ File :01/82/050/00156/AM13/ RLA File :08/24/040/00301/AM12/ Lic.No/Date:0810110001 22.03.2012 Date:27.03.2014 Decision : It was decided to reject the case as the firm has not furnished information despite repeated reminders. 8

Case No.:21/20/82ALC4/2013

Party Name:HETERO DRUGS LIMITED, Status:Case

27.03.2014 Deferred HQ File :01/82/050/01007/AM14/ RLA File :09/24/040/00668/AM12/ Lic.No/Date:0910052113 11.04.2012 Defer Date:24.04.2014 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals. 9

Case No.:44/20/82ALC4/2013

Party Name:HIRAN ORGOCHEM LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01030/AM14/ RLA File :03/94/040/00814/AM12/ Lic.No/Date:0310692029 25.04.2012 Defer Date:24.04.2014 Decision :It was decided to send the copy of application to Department of Pharmaceuticals for their comments. The case defer for 24.04.2014 10

Case No.:25/20/82ALC4/2013

Party Name:DR REDDYS LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01011/AM14/ RLA File :09/24/040/00012/AM13/ Lic.No/Date:0910052380 26.04.2012 Defer Date:24.04.2014 11

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

Party Name:HALDIA PETROCHEMICALS LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00365/AM13/ RLA File :02/24/040/00029/AM13/ Lic.No/Date:0210177518 14.05.2012 Defer Date:24.04.2014 Decision :It was decided to remind the Deparment of Petrochemicals Division fo D/o C&PC to furnish their comments as the case is pending since 13.06.2013. The case was deferred for 24.04.2014 12

Case No.:28/20/82ALC4/2013

Party Name:HETERO LABS LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01014/AM14/ RLA File :09/24/040/00070/AM13/ Lic.No/Date:0910052608 14.05.2012 Defer Date:24.04.2014 Decision :It was decided to defer the case for 24.04.2014 for want of comments of Department of Pharmaceuticals. 13

Case No.:38/20/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/01024/AM14/ RLA File :09/24/040/00069/AM13/ Lic.No/Date:0910052665 17.05.2012 Defer Date:24.04.2014

Case No.:29/20/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/01015/AM14/ RLA File :09/24/040/00090/AM13/ Lic.No/Date:0910052722 22.05.2012 Defer Date:24.04.2014 15

Case No.:39/20/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/01025/AM14/ RLA File :09/24/040/00094/AM13/ Lic.No/Date:0910052780 25.05.2012 Defer Date:24.04.2014 16

Case No.:31/20/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/01017/AM14/ RLA File :09/24/040/00108/AM13/ Lic.No/Date:0910052814 29.05.2012 Defer Date:24.04.2014 17

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

27.03.2014 Status:Case Deferred HQ File :01/82/050/01006/AM14/ RLA File :09/24/040/00127/AM13/ Lic.No/Date:0910052908 07.06.2012 Defer Date:24.04.2014 18

Case No.:17/20/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/01003/AM14/ RLA File :08/24/040/00088/AM13/ Lic.No/Date:0810112512 14.06.2012 Defer Date:24.04.2014 19

Case No.:18/20/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/01004/AM14/ RLA File :08/24/040/00090/AM13/ Lic.No/Date:0810112511 14.06.2012 Defer Date:24.04.2014

Case No.:19/20/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/01005/AM14/ RLA File :08/24/040/00095/AM13/ Lic.No/Date:0810112510 14.06.2012 Defer Date:24.04.2014 21

Case No.:34/20/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/01020/AM14/ RLA File :08/24/040/00100/AM13/ Lic.No/Date:0810112516 14.06.2012 Defer Date:24.04.2014 22

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

Party Name:INDSWIFT LABORATORIES LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00802/AM13/ RLA File :22/24/040/00012/AM13/ Lic.No/Date:2210013015 14.06.2012 Defer Date:24.04.2014 Decision :It was decide to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 24.04.2014 23

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

Party Name:SANOFI INDIA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00708/AM13/ RLA File :03/95/040/00318/AM13/ Lic.No/Date:0310706473 27.08.2012 Defer Date:24.04.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014 24

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

Party Name:RANBAXY LABORATORIES LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00615/AM13/ RLA File :05/24/040/00323/AM12/ Lic.No/Date:0510333154 30.08.2012 Defer Date:24.04.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014. 25

Case No.:40/15/82ALC4/2013

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 27.03.2014 Status:Case Deferred

HQ File :01/82/050/00802/AM14/ RLA File :03/94/040/00199/AM10/ Lic.No/Date:0310707994 06.09.2012 Defer Date:24.04.2014 26

Case No.:2/20/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/00988/AM14/ RLA File :08/24/040/00225/AM13/ Lic.No/Date:0810115340 24.09.2012 Defer Date:24.04.2014 Decision : It was decided to defer the case for 24.04.2014 for want of comments of Department of Pharmaceuticals. 27

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

Party Name:TITAN LABORATORIES PVT. LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00803/AM13/ RLA File :03/95/040/00544/AM13/ Lic.No/Date:0310713360 22.10.2012 Defer Date:24.04.2014 Decision :Reply received from the firm and sent to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014. 28

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

Party Name:CDYMAX (INDIA) PHARMA PVT. LTD. Meet No/Date:24/82ALC4/2013 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01377/AM13/ RLA File :07/24/040/00317/AM13/ Lic.No/Date:0710091789 06.11.2012 Defer Date:27.03.2014 Decision : It was decide to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 24.04.2014 29

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

Party Name:STERICAT GUTSTRINGS PVT. LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/01259/AM13/ RLA File :05/24/040/00304/AM13/ Lic.No/Date:0510340033 04.12.2012 Defer Date:24.04.2014 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of IPP. 30

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

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 27.03.2014 Status:Case Deferred HQ File :01/82/050/01190/AM13/ RLA File :03/94/040/00727/AM13/ Lic.No/Date:0310716674 07.12.2012 Defer Date:24.04.2014 Decision : It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014..

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

Party Name:PORUS LABORATORIES PVT LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00959/AM13/ RLA File :09/24/040/00408/AM13/ Lic.No/Date:0910054464 07.12.2012 Defer Date:24.04.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014. 32

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

27.03.2014 Status:Case Deferred HQ File :01/82/050/01318/AM13/ RLA File :08/24/040/00256/AM13/ Lic.No/Date:0810117315 02.01.2013 Defer Date:24.04.2014 Decision :It was decided to remind the firm to furnish a copy of Master batch Formula duly certified by Quality Control Incharge. 33

Case No.:49/4/82ALC4/2013

Party Name:ALEKHYA DRUGS PVT LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00090/AM14/ RLA File :09/24/040/00157/AM13/ Lic.No/Date:0910054675 03.01.2013 Defer Date:24.04.2014 Decision :In the light of wri�en comments received from Department of Pharmaceu��cals vide thier OM No. 35011/509/2013‐PI(Norms) dated 21.11.2013, It was decided to remind the firm to furnish a copy of Master batch Formula duly certified by Quality Control Incharge. 34

Case No.:38/4/82ALC4/2013

Party Name:AUCTUS PHARMA LIMITED 27.03.2014 HQ File :01/82/050/00079/AM14/ RLA File :09/24/040/00473/AM13/ Lic.No/Date:0910054734 09.01.2013 Defer Date: Decision :: It was decided to reject the case as the firm has not furnished information despite repeated reminders. 35

Case No.:13/12/82ALC4/2013

Party Name:HETERO DRUGS LIMITED, 27.03.2014 Status:Case Deferred HQ File :01/82/050/00437/AM14/ RLA File :09/24/040/00495/AM13/ Lic.No/Date:0910054735 09.01.2013 Defer Date:24.04.2014 Decision : In the light of wri�en comments received from Department of Pharmaceu��cals vide their OM No. 35011/740/2013‐PI(Norms) dated 04.03.2014, it was decided to call the following informa��on from the firm : i) Stepwise chemical reactions showing correct Molecular weight of each reactant & output product, and % yield on molar basis. ii) Justification for requirement of imported inputs in view of CA certificate furnished by the firm.

The case was deferred for 24.04.2014 36

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

Party Name:MAHESHRAJ CHEMICALS PVT.LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/01264/AM13/ RLA File :08/24/040/00339/AM13/ Lic.No/Date:0810117495 10.01.2013 Defer Date:24.04.2014 Decision : Deficiency letter has again been issued by Department of C&PC. It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 24.04.2014. 37

Case No.:16/20/82ALC4/2013

Party Name:ASTRIX LABORATORIES LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/01002/AM14/ RLA File :09/24/040/00451/AM13/ Lic.No/Date:0910054794 17.01.2013 Defer Date:24.04.2014 Decision :It was decided to defer the case for 24.04.2014 for want of comments of Department of Pharmaceuticals. 38

Case No.:3/30/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 27.03.2014 Status:Case Deferred HQ File :01/82/050/01039/AM13/ RLA File :05/24/040/00393/AM13/ Lic.No/Date:0510343986 23.01.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for24.042014 39

Case No.:9/4/82ALC4/2013

Party Name:GOPALDAS VISRAM & CO.LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00050/AM14/ RLA File :03/94/040/00945/AM13/ Lic.No/Date:0310722715 01.02.2013 Defer Date:24.04.2014 Decision :it was decided to remind the firm to furnish the following technical details: (a) Net weight of the cream in each tube. (b) Detailed working on arriving at the norms applied by the firm 40

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

Party Name:CATAPHARMA CHEMICALS PVT. LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00183/AM14/ RLA File :31/83/040/00177/AM13/ Lic.No/Date:3110057032 05.02.2013 Defer Date:24.04.2014

Decision :It was decided to call from the firm COA of import item from the foreign supplier for the relevant consignment . The case was deferred for 24.04.2014. 41

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

Party Name:FORACE POLYMERS (P) LTD. 27.03.2014 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:27.03.2014 Decision :It was decided to remind the Department of Petrochemicals Division of D/o C&PC to furnish their comments. The case was deferred for 24.04.2014 42

Case No.:7/3/82ALC4/2013

Party Name:WOCKHARDT LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00040/AM14/ RLA File :03/95/040/00886/AM13/ Lic.No/Date:0310723636 11.02.2013 Defer Date:24.04.2014 Decision :It was decided to remind the O/o DCGI to furnish their comments. The case was deferred for 24.04.2014. 43

Case No.:26/4/82ALC4/2013

Party Name:S M S PHARMACEUTICALS LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00067/AM14/ RLA File :09/24/040/00501/AM13/ Lic.No/Date:0910055023 12.02.2013 Defer Date:24.04.2014 Decision : In the light of wri�en comments received from Department of Pharmaceu��cals vide thier OM No. 35011/510/2012‐PI(Norms) dated 21.11.2013, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 2.5.2013. 44

Case No.:31/8/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00162/AM14/ RLA File :09/24/040/00537/AM13/ Lic.No/Date:0910055106 19.02.2013 Defer Date:24.04.2014 Decision :It was decided to reminde the firm to furnish the following technical details: • Complete technical details as per Appendix 33 including % Yield on molar basis for each step and solvent Recovery etc. • Past Production visàvis Actual consumption of raw materials duly certified by Central Excise Authorities. 45

Case No.:8/10/82ALC4/2013

Party Name:VIVIMED LABS LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00191/AM14/ RLA File :09/24/040/00554/AM13/ Lic.No/Date:0910055119 21.02.2013 Defer Date:24.04.2014

Decision :It was decided to send the copy of application to Department of Pharmaceuticals for their comments. The case defer for 24.04.2014 46

Case No.:39/24/82ALC4/2013

Party Name:VIRCHOW PETROCHEMICAL PVT LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/01238/AM14/ RLA File :09/24/040/00562/AM13/ Lic.No/Date:0910055266 04.03.2013 Defer Date:24.04.2014 47

Case No.:141/10/82ALC4/2013

Party Name:EUROLIFE HEALTHCARE PVT. LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00324/AM14/ RLA File :03/94/040/00982/AM13/ Lic.No/Date:0310728214 14.03.2013 Defer Date:24.04.2014 Decision :it was decided to call from the firm the following technical details: • Copy of Drug Manufacturing License for the export product. • Detailed justification for various packing materials applied for import. The case was deferred for 24.04.2014. 48

Case No.:32/8/82ALC4/2013

Party Name:BIOLOGICAL E LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00163/AM14/ RLA File :09/24/040/00607/AM13/ Lic.No/Date:0910055421 19.03.2013 Defer Date:24.04.2014 Decision :Reply received from the firm and already sent to Department of Biotechnology for their comments . The case was deferred for 24.04.2014 49

Case No.:57/10/82ALC4/2013

Party Name:BIOLOGICAL E LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00240/AM14/ RLA File :09/24/040/00606/AM13/ Lic.No/Date:0910055420 19.03.2013 Defer Date:24.04.2014 Decision :Reply received from the firm and already sent to Department of Biotechnology for their comments . The case was deferred for 24.04.2014 50

Case No.:140/10/82ALC4/2013

Party Name:EUROLIFE HEALTHCARE PVT. LTD. 27.03.2014 HQ File :01/82/050/00323/AM14/ RLA File :03/94/040/00981/AM13/ Lic.No/Date:0310728713 19.03.2013 Date:27.03.2014 Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders.

Case No.:24/10/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00207/AM14/ RLA File :22/24/040/00083/AM13/ Lic.No/Date:2210013724 20.03.2013 Defer Date:24.04.2014 Decision :it was decided to remind the firm to furnish the following details: Export product is Para Methoxy phenyl acetic acid where as the technical details given is for the production of Admine. Past product visavis actual consumption of all inputs duly certified by Central Excise Authorities. 52

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

Party Name:LAXMI ORGANIC INDUSTRIES LTD., 27.03.2014 HQ File :01/82/050/00308/AM14/ RLA File :03/95/040/00911/AM13/ Lic.No/Date:0310728818 20.03.2013 Defer Date:27.03.2014 Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders. 53

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

Party Name:MYLAN LABORATORIES LIMITED 27.03.2014 HQ File :01/82/050/00241/AM14/ RLA File :09/24/040/00583/AM13/ Lic.No/Date:0910055475 21.03.2013 Defer Date:27.03.2014 Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders. 54

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

Party Name:ANUS LABORATORIES LTD., 27.03.2014 HQ File :01/82/050/00208/AM14/ RLA File :09/24/040/00186/AM12/ Lic.No/Date:0910055523 22.03.2013 Defer Date:27.03.2014 Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders. 55

Case No.:6/10/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00189/AM14/ RLA File :05/24/040/00480/AM13/ Lic.No/Date:0510350030 22.03.2013 Defer Date:24.04.2014 Decision : In the light of wri�en comments received from Department of Pharmaceu��cals vide thier OM No. 35011/691/2013‐PI(Norms) dated 01.04.2014, It was decided to remind the firm to furnish a copy of Master batch Formula duly certified by Quality Control Incharge.

Case No.:113/14/82ALC4/2013

Party Name:PARAMOUNT AROMACHEM PVT.LTD., 27.03.2014 HQ File :01/82/050/00698/AM14/ RLA File :05/24/040/00488/AM13/ Lic.No/Date:0510350269 26.03.2013 Defer Date: Decision: It was decided to withdraw the case . The firm through their letter dated nil informed the Department of C&PC that they have taken advance authorization on repeat basis under para 4.7.1 HBP v1. 57

Case No.:117/10/82ALC4/2013

Party Name:PRASOL CHEMICALS LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00300/AM14/ RLA File :03/95/040/00881/AM13/ Lic.No/Date:0310729886 28.03.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of C&PC and defer the case for 24.04.2014 58

Case No.:148/10/82ALC4/2013

Party Name:ANTHEA AROMATICS PVT.LTD., 27.03.2014 Status:Case Approved HQ File :01/82/050/00331/AM14/ RLA File :03/94/040/00996/AM13/ Lic.No/Date:0310730232 03.04.2013 Defer Date: Decision :In the light of wri�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/35/2012‐Ch II dated 14.03.2014, it was decided to ra��fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import item Qty. allowed BOISAMBER MIN. PURITY 99% 1 Kg. 1. CYCLODODECANOL MIN. PURITY 95% 0.950 kg 2. DIETHOXYMETHANE MIN. PURITY 99% 1.0 kg RA concerned may take further necessary action as per above decision of NC. 59

Case No.:11/8/82ALC4/2013

Party Name:PREMIER INDUSTRIES 27.03.2014 Status:Case Approved HQ File :01/82/050/00142/AM14/ RLA File :50/24/040/00020/AM13/ Lic.No/Date:5010001635 03.04.2013 Defer Date: Decision :In the light of wri�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/55/2012‐Ch II dated 27.03.2014, it was decided to ra��fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export product Export Qty. Sl.No. Import item Qty. allowed PARACHLORO ORTHO NITRO ANILINE (P.C.O.N.A) 1 Kg. 1. PARADICHLORO BENZENE(PDCB) 0.916 kg 2,5 DICHLORONITRO BENZENE(2,5 D.C.N.B.) 1 Kg. 2. PARADICHLORO BENZENE(PDCB) 0.797 kg FAST RED R BASEFLAKES 1 Kg. 3 PARADICHLORO BENZENE(PDCB) 1.15 kg RA concerned may take further necessary action as per above decision of NC. 60

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

Party Name:RANBAXY LABORATORIES LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00200/AM14/ RLA File :05/24/040/00478/AM13/ Lic.No/Date:0510350968 08.04.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals and defer the case for 24.04.2014 61

Case No.:120/10/82ALC4/2013

Party Name:MEHTA API PVT LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00303/AM14/ RLA File :03/95/040/00020/AM14/ Lic.No/Date:0310730905 09.04.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals and defer the case for 24.04.2014 62

Case No.:92/10/82ALC4/2013

Party Name:CATAPHARMA CHEMICALS PVT. LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00275/AM14/ RLA File :31/83/040/00214/AM13/ Lic.No/Date:3110057970 17.04.2013 Defer Date:24.04.2014 Decision :It was decided to call from the firm COA of import item from the foreign supplier for the relevant consignment . The case was deferred for 24.04.2014 63

Case No.:68/4/82ALC4/2013

Party Name:HALDIA PETROCHEMICALS LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00109/AM14/ RLA File :02/24/040/00002/AM14/ Lic.No/Date:0210188734 Defer

17.04.2013 Date:24.04.2014 Decision :It was decided to remind the Department of Petrochemicals to furnish their comments. The case is defer 24.04.2014 64

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

Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:24/82ALC4/2013 27.03.2014 HQ File :01/82/050/00036/AM14/ RLA File :07/24/040/00003/AM14/ Lic.No/Date:0710094921 18.04.2013 Defer Date:27.03.2014 Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders. 65

Case No.:43/10/82ALC4/2013

Party Name:SRINI PHARMACEUTICALS LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00226/AM14/ RLA File :09/24/040/00017/AM14/ Lic.No/Date:0910055800 19.04.2013 Defer Date:24.04.2014 Decision :It was decided to call from the firm COA of import item from the foreign supplier for the relevant consignment . The case was deferred for 24.04.2014. 66

Case No.:76/14/82ALC4/2013

Party Name:ASTRIX LABORATORIES LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00661/AM14/ RLA File :09/24/040/00611/AM13/ Lic.No/Date:0910055845 23.04.2013 Defer Date:24.04.2014 67

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

Party Name:ASTRIX LABORATORIES LTD., 27.03.2014 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:27.03.2014 Decision :It was decided to defer the case for 27.03.2014 for comments of Department of Pharmaceuticals. 68

Case No.:219/10/82ALC4/2013

Party Name:RENOWN PHARMACEUTICALS PVT LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00402/AM14/ RLA File :34/24/040/00005/AM14/ Lic.No/Date:3410036732 29.04.2013 Defer Date:24.04.2014 69

Case No.:157/10/82ALC4/2013

Party Name:LUPIN LIMITED Status:Case

27.03.2014 Deferred HQ File :01/82/050/00340/AM14/ RLA File :03/95/040/00098/AM14/ Lic.No/Date:0310733961 10.05.2013 Defer Date:24.04.2014 Decision :It was decided to ask from the firm whether the export item is noninfringing or otherwise. The case is defer 24.04.2014 70

Case No.:2/5/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00120/AM14/ RLA File :09/24/040/00023/AM14/ Lic.No/Date:0910055979 10.05.2013 Defer Date:24.04.2014 71

Case No.:14/20/82ALC4/2013

Party Name:DIVIS PHARMACEUTICALS PRIVATE LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01000/AM14/ RLA File :09/24/040/00016/AM14/ Lic.No/Date:0910056018 17.05.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals and defer the case for 24.04.2014 72

Case No.:52/13/82ALC4/2013

Party Name:STERICON PHARMA PVT.LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00528/AM14/ RLA File :07/24/040/00039/AM14/ Lic.No/Date:0710095454 17.05.2013 Defer Date:24.04.2014 Decision :It was decided to call from the firm a copy of DML for the export product. The case is defer 24.04.2014 73

Case No.:91/14/82ALC4/2013

Party Name:ALKALOIDS CORPORATION 27.03.2014 Status:Case Deferred HQ File :01/82/050/00676/AM14/ RLA File :02/21/040/00025/AM14/ Lic.No/Date:0210189840 21.05.2013 Defer Date:24.04.2014 Decision : It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals. 74

Case No.:136/14/82ALC4/2013

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00721/AM14/ RLA File :03/94/040/00507/AM13/ Lic.No/Date:0310735110 21.05.2013 Defer Date:24.04.2014

Case No.:10/20/82ALC4/2013

Party Name:DIVIS LABORATORIES LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00996/AM14/ RLA File :09/24/040/00057/AM14/ Lic.No/Date:0910056098 22.05.2013 Defer Date:24.04.2014 76

Case No.:13/20/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/00999/AM14/ RLA File :09/24/040/00068/AM14/ Lic.No/Date:0910056096 22.05.2013 Defer Date:24.04.2014 77

Case No.:12/20/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00998/AM14/ RLA File :09/24/040/00061/AM14/ Lic.No/Date:0910056108 23.05.2013 Defer Date:24.04.2014 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 24.04.2014. 78

Case No.:1/6/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00124/AM14/ RLA File :09/24/040/00077/AM14/ Lic.No/Date:0910056114 23.05.2013 Defer Date:24.04.2014 Decision :It was decided to send the copy of application to Department of Pharmaceuticals for their comments. The case defer for 24.04.2014 79

Case No.:79/14/82ALC4/2013

Party Name:AGOG PHARMA LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00664/AM14/ RLA File :03/94/040/00093/AM14/ Lic.No/Date:0310735570 24.05.2013 Defer Date:24.04.2014 80

Case No.:92/14/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00677/AM14/ RLA File :05/23/040/00043/AM14/ Lic.No/Date:0510355138 24.05.2013 Defer Date:24.04.2014

Case No.:42/15/82ALC4/2013

Party Name:IPCA LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00804/AM14/ RLA File :03/94/040/00071/AM14/ Lic.No/Date:0310735502 24.05.2013 Defer Date:24.04.2014 82

Case No.:207/10/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 27.03.2014 Status:Case Deferred HQ File :01/82/050/00390/AM14/ RLA File :24/24/040/00008/AM14/ Lic.No/Date:2410038996 27.05.2013 Defer Date:24.04.2014 Decision :It was decided to remind the Department of Petrochemicals Division of D/o C&PC to furnish their comments. The case was deferred for 24.04.2014 83

Case No.:71/10/82ALC4/2013

Party Name:SCOTTEDIL PHARMACIA LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00254/AM14/ RLA File :22/24/040/00016/AM14/ Lic.No/Date:2210013890 28.05.2013 Defer Date:24.04.2014 Decision :It was decided to send the copy of application to Department of Pharmaceuticals for their comments. The case defer for 24.04.2014 84

Case No.:225/10/82ALC4/2013

Party Name:APEX HEALTHCARE LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00408/AM14/ RLA File :34/24/040/00035/AM14/ Lic.No/Date:3410037038 31.05.2013 Defer Date:24.04.2014 Decision : It was decided to send the copy of application to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014 85

Case No.:96/10/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00279/AM14/ RLA File :08/24/040/00085/AM14/ Lic.No/Date:0810121573 31.05.2013 Defer Date:24.04.2014 Decision :Reply received from the firm and sent to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014 86

Case No.:139/14/82ALC4/2013

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 27.03.2014 Status:Case Deferred

HQ File :01/82/050/00724/AM14/ RLA File :03/94/040/00160/AM14/ Lic.No/Date:0310736610 04.06.2013 Defer Date:24.04.2014 Decision : It was decided to send the copy of application to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014 87

Case No.:46/15/82ALC4/2013

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00808/AM14/ RLA File :03/94/040/00194/AM14/ Lic.No/Date:0310736613 04.06.2013 Defer Date:24.04.2014 Decision : It was decided to send the copy of application to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014 88

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

27.03.2014 Status:Case Deferred HQ File :01/82/050/00129/AM14/ RLA File :09/24/040/00097/AM14/ Lic.No/Date:0910056251 05.06.2013 Defer Date:24.04.2014 Decision :It was decided to send the copy of application to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014 89

Case No.:227/10/82ALC4/2013

Party Name:SPAN DIAGNOSTICS LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00410/AM14/ RLA File :52/24/040/00002/AM14/ Lic.No/Date:5210039825 05.06.2013 Defer Date:24.04.2014 Decision :Reply received in Department of Biotechnology (as informed by TA , DBT). The case was deferred for 24.04.2014 for comments of D/o Biotechnology. 90

Case No.:109/10/82ALC4/2013

Party Name:INDSWIFT LABORATORIES LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00292/AM14/ RLA File :22/24/040/00022/AM14/ Lic.No/Date:2210013931 11.06.2013 Defer Date:24.04.2014 Decision :Reply received from the firm . The case was deferred for 24.04.2014 comment of Department of Pharmaceuticals. 91

Case No.:18/13/82ALC4/2013

Party Name:STERICON PHARMA PVT.LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00494/AM14/ RLA File :07/24/040/00075/AM14/ Lic.No/Date:0710095973 17.06.2013 Defer Date:24.04.2014

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

Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00447/AM14/ RLA File :03/94/040/00094/AM14/ Lic.No/Date:0310738255 19.06.2013 Defer Date:24.04.2014 Decision :it was decided to remind the firm to furnish the following technical details: 1. Copy of DML for the export product. 2. Detailed working for arriving the import quantity applied by the firm. 93

Case No.:19/13/82ALC4/2013

Party Name:BOSTIK INDIA PRIVATE LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00495/AM14/ RLA File :07/24/040/00502/AM13/ Lic.No/Date:0710096186 25.06.2013 Defer Date:24.04.2014 Decision : It was decided to remind the Department of Petrochemicals to furnish their comments. The case is defer 24.04.2014 94

Case No.:94/13/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 27.03.2014 Status:Case Approved HQ File :01/82/050/00570/AM14/ RLA File :09/24/040/00136/AM14/ Lic.No/Date:0910056467 26.06.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/692/2013PI(Norms) dated 01.04.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl. No. Import items Qty. allowed Kg/kg EPINASTINE HCL Kg 1. 6Aminomethyl6, 11 Dihydro5HDibenz {b,e}Azepine(E) 2Butendioate 2.00 2. Methylene Dichloride 3.37 3. Toluene 2.50 4. Iso Propyl Alcohol 2.435 95

Case No.:204/10/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 27.03.2014 Status:Case Deferred

HQ File :01/82/050/00387/AM14/ RLA File :04/24/040/00065/AM14/ Lic.No/Date:0410147559 27.06.2013 Defer Date:24.04.2014 Decision :it was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control In charge. 96

Case No.:41/8/82ALC4/2013

Party Name:UNITED PHOSPHORUS LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00172/AM14/ RLA File :03/95/040/01020/AM13/ Lic.No/Date:0310739495 28.06.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals and defer the case for 24.04.2014 97

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

Party Name:SRIAM LABS PRIVATE LIMITED 27.03.2014 HQ File :01/85/050/00054/AM14/ RLA File :09/24/040/00115/AM14/ Lic.No/Date:0910056522 01.07.2013 Defer Date:27.03.2014 Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders. (Already rejected in earlier meeting) 98

Case No.:159/14/82ALC4/2013

Party Name:RUCHI INFRASTRUCTURE LTD. 27.03.2014 HQ File :01/82/050/00744/AM14/ RLA File :56/24/040/00010/AM14/ Lic.No/Date:5610002426 04.07.2013 Defer Date: Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders. 99

Case No.:93/13/82ALC4/2013

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 27.03.2014 Status:Case Approved HQ File :01/82/050/00569/AM14/ RLA File :31/83/040/00053/AM14/ Lic.No/Date:3110059198 05.07.2013 Defer Date: Decision ::In the light of wri�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/39/2011‐Ch II dated 02.04.2014, it was decided to ra��fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import item Qty. allowed TETRA METHYL BISPHENOL F 1 Kg. 1. Methanol 0.333 kg 2. Phenol 0.978 kg RA concerned may take further necessary action as per above decision of NC.

100

Case No.:64/13/82ALC4/2013

Party Name:EAGLE CHEMICAL WORKS 27.03.2014 Status:Case Deferred HQ File :01/82/050/00540/AM14/ RLA File :03/94/040/00019/AM14/ Lic.No/Date:0310740489 05.07.2013 Defer Date:24.04.2014 Decision :It was decided to request the firm to identify the export product to be as BP or USP or E.P5 or E.P6. The case was deferred for24.04.2014 101

Case No.:69/13/82ALC4/2013

Party Name:AGIO PHARMACEUTICALS LTD 27.03.2014 Status:Case Approved HQ File :01/82/050/00545/AM14/ RLA File :03/94/040/00231/AM14/ Lic.No/Date:0310740685 08.07.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/700/2013PI(Norms) dated 01.04.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Exp. Qty. Import items Qty. Recommended for 1 No. 1. Albenox 2.5% Suspension 1000 ml Albendazole Oral Suspension 2.5% w/v Albendazole USP 25 mg 1 No. ALBENDAZOLE 0.0255 kg 2. Albenox 10% Suspension 1000 ml Albenox 10% Albendazole Oral Suspension 10% w/v Albendazole USP 100 mg 1 No. ALBENDAZOLE 0.102 kg 3. Albenox 600 Albendazole Bolus 600 mg Each Bolus contains Albendazole USP 600 mg 1 No. ALBENDAZOLE 612 mg 4. Albenox 2500 Albendazole Bolus 2500 mg Each Bolus contains Albendazole USP 2500 mg 1 No. ALBENDAZOLE 2550 mg 5. Bendaz 10% Suspension (1000 ml) Albendazole Oral Suspension 10% w/v Each ml contains Albendazole USP 100 mg 1 No. ALBENDAZOLE 0.102 kg 6. Bendaz 2500 mg Albendazole Bolus 2500 mg 1 No. ALBENDAZOLE 2550 mg

Bendaz 1500 mg Albendazole Bolus 1500 mg 1 No. ALBENDAZOLE 1530 mg 8. Bendaz 600 mg Albendazole Bolus 600 mg 1 No. ALBENDAZOLE 612 mg 9. Bendaz Plus 900 (Albendazole and Oxyclozamide Tablets 600/300 mg) Each uncoated tablet contains Albendazole USP 600 mg Oxyclozamide BP (Vet) 300 mg 1 No. ALBENDAZOLE 612 mg 10 Bendaz 300 Albendazole Bolus 300 mg Each Bolus contains Albendazole USP 300 mg 1 No. ALBENDAZOLE 306 mg 102

Case No.:41/13/82ALC4/2013

Party Name:JAGSONPAL PHARMACEUTICALS LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00517/AM14/ RLA File :05/23/040/00056/AM14/ Lic.No/Date:0510359156 09.07.2013 Defer Date:24.04.2014 103

Case No.:27/13/82ALC4/2013

Party Name:ADVYCHEMICAL PVT.LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00503/AM14/ RLA File :03/94/040/00269/AM14/ Lic.No/Date:0310740927 10.07.2013 Defer Date:24.04.2014 Decision :Committee considered the case and It was decide to request the firm to furnish complete technical details as per Appendix 33 and Central Excise Data. The case was deferred for 24.04.2014 104

Case No.:157/14/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/00742/AM14/ RLA File :09/24/040/00170/AM14/ Lic.No/Date:0910056762 15.07.2013 Defer Date:24.04.2014 Decision :It was decided to send the copy of application to Department of Pharmaceuticals. The case is deferred for 24.04.2014 . 105

Case No.:28/13/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD Status:Case

27.03.2014 Deferred HQ File :01/82/050/00504/AM14/ RLA File :05/24/040/00114/AM14/ Lic.No/Date:0510360180 18.07.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals and defer the case for 24.04.2014 106

Case No.:25/24/82ALC4/2013

Party Name:VIVIMED LABS LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01224/AM14/ RLA File :09/24/040/00169/AM14/ Lic.No/Date:0910056820 18.07.2013 Defer Date:24.04.2014 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of C&PC. 107

Case No.:81/13/82ALC4/2013

Party Name:INDSWIFT LABORATORIES LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00557/AM14/ RLA File :22/24/040/00032/AM14/ Lic.No/Date:2210014016 19.07.2013 Defer Date:24.04.2014 Decision :It was decide to remind the frim to furnish complete technical details as per Appendix 33. This may be treated as last reminder. The case was deferred for 24.04.2014 108

Case No.:103/13/82ALC4/2013

27.03.2014 Status:Case Approved HQ File :01/82/050/00579/AM14/ RLA File :08/24/040/00172/AM14/ Lic.No/Date:0810123115 23.07.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/671/2013PI(Norms) dated 01.04.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl. No. Import items Qty. allowed Kg/kg CANDESARTAN /CANDESARTAN CILEXETIL Kg 1. 1HBenzimidezole7 Carboxylic acid,2ethoxy1 {[2’[1 (Triphenylmethyl)1H Tetrazole5yl] [1,1Biphenyl]4yl]methyl] 1.70 2. DIMETHYL SULFOXIDE 2.328 3. 1CHLOROETHYL CYCLOHEXYL 0.49

CARBONATE 4. METHANOL 3.363 5. ACETONE 3.838 109

Case No.:32/13/82ALC4/2013

Party Name:MERCURY LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00508/AM14/ RLA File :34/24/040/00077/AM14/ Lic.No/Date:3410037467 23.07.2013 Defer Date:24.04.2014 110

Case No.:23/14/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00608/AM14/ RLA File :09/24/040/00191/AM14/ Lic.No/Date:0910056934 29.07.2013 Defer Date:24.04.2014 111

Case No.:28/19/82ALC4/2013

Party Name:SMILAX LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00973/AM14/ RLA File :09/24/040/00181/AM14/ Lic.No/Date:0910056940 29.07.2013 Defer Date:24.04.2014 112

Case No.:17/13/82ALC4/2013

Party Name:PAB ORGANICS PVT.LTD, 27.03.2014 Status:Case Deferred HQ File :01/82/050/00493/AM14/ RLA File :34/24/040/00085/AM14/ Lic.No/Date:3410037541 31.07.2013 Defer Date:24.04.2014 113

Case No.:61/14/82ALC4/2013

Party Name:HETERO DRUGS LIMITED, 27.03.2014 Status:Case Deferred HQ File :01/82/050/00646/AM14/ RLA File :09/24/040/00206/AM14/ Lic.No/Date:0910057007 02.08.2013 Defer Date:24.04.2014 Decision : It was decided to call the following information from the firm :

i) Stepwise chemical reactions showing correct Molecular weight of each reactant & output product, and % yield on molar basis. ii) Justification for requirement of imported inputs in view of CA certificate furnished by the firm. 114

Case No.:148/14/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00733/AM14/ RLA File :09/24/040/00189/AM14/ Lic.No/Date:0910057006 02.08.2013 Defer Date:24.04.2014 115

Case No.:42/14/82ALC4/2013

Party Name:AVA CHEMICALS PVT.LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00627/AM14/ RLA File :03/94/040/00220/AM14/ Lic.No/Date:0310744155 05.08.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals and defer the case for 24.04.2014 116

Case No.:101/13/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 27.03.2014 Status: Approved HQ File :01/82/050/00577/AM14/ RLA File :09/24/040/00204/AM14/ Lic.No/Date:0910057030 05.08.2013 Defer Date:27.03.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/687/2013PI(Norms) dated 01.04.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl. No. Import items Qty. allowed Kg/kg DANTRON Kg 1. 1,8Dinitro Anthraquinoline 1.72 2. Acetone 1.13 3. Toluene 1.40 117

Case No.:22/13/82ALC4/2013

Party Name:PROMED EXPORTS PVT.LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00498/AM14/ RLA File :05/24/040/00171/AM14/ Lic.No/Date:0510362268 07.08.2013 Defer Date:24.04.2014

118

Case No.:11/13/82ALC4/2013

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 27.03.2014 Status:Case Deferred HQ File :01/82/050/00487/AM14/ RLA File :03/95/040/00134/AM14/ Lic.No/Date:0310744468 07.08.2013 Defer Date:24.04.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/704/2013PI(Norms) dated 01.04.2014, it was decided to call the following information from the firm : i) Complete technical details as per Appendix 33 for the export product (ii) Past production visàvis actual consumption of input duly certified by Central Excise Authorities. 119

Case No.:73/13/82ALC4/2013

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 27.03.2014 Status:Case Deferred HQ File :01/82/050/00549/AM14/ RLA File :03/95/040/00133/AM14/ Lic.No/Date:0310744832 12.08.2013 Defer Date:24.04.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/705/2013PI(Norms) dated 01.04.2014, it was decided to call the following information from the firm : i) Complete technical details as per Appendix 33 for the export product (ii) Past production visàvis actual consumption of input duly certified by Central Excise Authorities. 120

Case No.:76/13/82ALC4/2013

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 27.03.2014 Status:Case Deferred HQ File :01/82/050/00552/AM14/ RLA File :03/95/040/00125/AM14/ Lic.No/Date:0310744834 12.08.2013 Defer Date:24.04.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/706/2013PI(Norms) dated 01.04.2014, it was decided to call the following information from the firm : i) Complete technical details as per Appendix 33 for the export product (ii) Past production visàvis actual consumption of input duly certified by Central Excise Authorities. 121

Case No.:75/13/82ALC4/2013

Party Name:WOCKHARDT LIMITED 27.03.2014 Status:Case Deferred

HQ File :01/82/050/00551/AM14/ RLA File :03/95/040/00320/AM14/ Lic.No/Date:0310744861 12.08.2013 Defer Date:24.04.2014 Decision :it was decided to put up the case on file and also sent a copy of application to DCGI for their comments. The case was deferred for 24.04.2014. 122

Case No.:35/13/82ALC4/2013

Party Name:VIDA MEDICAREZ LIMITED 27.03.2014 Status:Case Approved HQ File :01/82/050/00511/AM14/ RLA File :03/95/040/00363/AM14/ Lic.No/Date:0310745048 13.08.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/714/2013PI(Norms) dated 01.04.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Exp. Qty. Import items Qty. Recommended 1. Albenox 2.5% Suspension 1000 ml Albendazole Oral Suspension 2.5% w/v Albendazole USP 25 mg 1 No. Albendazole 0.0255 kg per bo�le 2. Albenox 10% Suspension 1000 ml Albenox 10% Albendazole Oral Suspension 10% w/v Albendazole USP 100 mg 1 No. Albendazole 0.102 kg per bo�le 3. Albenox 600 Albendazole Bolus 600 mg Each bolus contains Albendazole USP 600 mg 1 No. Albendazole 612 mg /bolus 4. Albenox 2500 Albendazole Bolus 2500 mg Each Bolus contains Albendazole USP 2500 mg 1 No. Albendazole 2550 mg /bolus 123

Case No.:107/13/82ALC4/2013

Party Name:DR REDDYS LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00583/AM14/ RLA File :09/24/040/00222/AM14/ Lic.No/Date:0910057189 14.08.2013 Defer Date:24.04.2014 Decision :it was decided to remind the firm to furnish the following information : i) Complete details as per Appendix 33.

ii) Copy relevant technical literature in support of yields envisaged iii) Past production visàvis actual consumption of input duly certified by Central Excise Authorities. 124

Case No.:58/14/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00643/AM14/ RLA File :09/24/040/00212/AM14/ Lic.No/Date:0910057190 14.08.2013 Defer Date:24.04.2014 125

Case No.:84/13/82ALC4/2013

27.03.2014 Status:Case Approved HQ File :01/82/050/00560/AM14/ RLA File :08/24/040/00226/AM14/ Lic.No/Date:0810123950 21.08.2013 Defer Date: Decision :In the light of wri�en comments received from Department of Pharmaceu��cals vide their OM No. 35011/716/2013‐PI(Norms) dated 01.04.2014, it was decided to ra��fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Norms recommended for OMEPRAZOLE DELAYED RELEASE10 mg 20 mg and 40 mg capsule S.NO. Import Items Norms for 1 million capsule (Qty in Kg) 10 mg capsule 20 mg capsule 40 mg capsule 1 SUGAR SPHERES NF (PHARMASPHERES, MESH 2025) 47.50 95.0 190.0 2 HYPROMELLOSE 3 CPS 2910 USP(PHAMACOAT 603) 4.68 9.36 18.6 2 HYPROMELLOSE PHTHALATE NF [HPMCP HP 55) 8.555 17.110 31.0 4 TRIETHYL CITRATE NF (MORFLEX) 1.285 2.570 4.65 5 2 Chloromethyl 3, 5dimethyl4methoxy pyridine hcl 10.76 21.52 43.04 6 2 Mercapto 5 Methoxy Benzamidazole 9.118 18.236 36.472 7 to 15 Import items at Sl. No. 7 to 15 Packing Material Relevant, As per Packing Policy

126

Case No.:20/13/82ALC4/2013

Party Name:VARUN MEDIMPEX INC. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00496/AM14/ RLA File :05/24/040/00134/AM14/ Lic.No/Date:0510363085 21.08.2013 Defer Date:24.04.2014 Decision :reply received from the firm and sent to DIPP for their comments. The case was deferred for 24.04.2014. 127

Case No.:90/13/82ALC4/2013

Party Name:CATAPHARMA CHEMICALS PVT. LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00566/AM14/ RLA File :31/83/040/00054/AM14/ Lic.No/Date:3110060069 23.08.2013 Defer Date:24.04.2014 Decision :It was decided to remind the firm to furnish the copy of COA of import item from the foreign supplier for the relevant consignment. The case was deferred for 24.04.2014. 128

Case No.:86/13/82ALC4/2013

Party Name:GOPINATH CHEMTECH LTD., 27.03.2014 Status:Case Approved HQ File :01/82/050/00562/AM14/ RLA File :08/24/040/00231/AM14/ Lic.No/Date:0810124122 26.08.2013 Defer Date: Decision : In the light of wri�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2012‐Ch. II dated 09.11.2013, it was decided to ra��fy 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 COPPER FORMAZONE BASE 1 kg 1 ORTHO AMINO PHENOL 0.614 kg 2. TOLUENE 1.394 kg 3. CAUSTIC SODA LYE (ON 100% REAL BASIS) 4.160 kg 4. SODA ASH 1.350 kg 5. SODIUM NITRITE 0.225kg 129

Case No.:1/15/82ALC4/2013

Party Name:CORAL LABORATORIES LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00763/AM14/ RLA File :03/94/040/00389/AM14/ Lic.No/Date:0310747134 27.08.2013 Defer Date:24.04.2014

130

Case No.:14/13/82ALC4/2013

Party Name:MONEY & MONEY 27.03.2014 HQ File :01/82/050/00490/AM14/ RLA File :05/24/040/00182/AM14/ Lic.No/Date:0510363833 27.08.2013 Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/1/2014/Ch II dated 02.04.2014, informed that the party has informed that they do not have CIB and RC registration for the manufacture of Tricyclozole WP. They have requested that their case may be closed as goods imported, had been shipped back to china, it was decided to reject the request of the firm RA may take appropriate action as per the decision of Norms Committee. 131

Case No.:25/15/82ALC4/2013

Party Name:IPCA LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00787/AM14/ RLA File :03/94/040/00992/AM13/ Lic.No/Date:0310747414 28.08.2013 Defer Date:24.04.2014 132

Case No.:25/13/82ALC4/2013

Party Name:CORPORATE CHANNELS INDIA PVT. LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00501/AM14/ RLA File :13/24/040/00019/AM14/ Lic.No/Date:1310044179 29.08.2013 Defer Date:24.04.2014 Decision :It was decided to remind the firm to furnish the following information: 2. You have indicated the three different types of Copper Bearing Contraceptive Device (Copper T380A, CU 375 & CU375 SL) in one application. The separate quantity of each of the Copper Bearing Contraceptive Device to be exported along with the separate quantity of raw materials applied for import. 3. Net content of each of the raw material/component in the each of the export item, quality applied for import (Net content+wastage if any ) along with technical justification. 4. Details and quantity of other indigenous inputs to be used in the manufacture of the export product may be indicated. 5. Detailed manufacturing process along with justification for wastages at each stage and also on each of th raw material may be furnished. 6. Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process. 7. Weather the scrape generated in the manufacturing process (injecting/mounding/ extrusion process) is being resued in the manufacturing process. If not, the reasons for the same may be furnished the technical reasons. 8. Details of production of Copper Bearing Contreceptive Device, Copper T 380A CU 375 & CU 375 SL separately and corresponding consumption of raw materials/consumption in the year 201112, 201213 &201314 (AprilDecember) duly certified by CA may be furnished. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA 9. Any other relevant information 10. Small sample of the export product.

133

Case No.:85/13/82ALC4/2013

27.03.2014 Status:Case Approved HQ File :01/82/050/00561/AM14/ RLA File :08/24/040/00240/AM14/ Lic.No/Date:0810124326 30.08.2013 Defer Date: Decision :In the light of wri�en comments received from Department of Pharmaceu��cals vide their OM No. 35011/717/2013‐PI(Norms) dated 01.04.2014, it was decided to ra��fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Norms recommended for DIVALPROEX ER 250 MG. 500 MG TABS S.No Import Item Norms Recommended for 1 No. Tablet (Qty. In mg) 250 mg Tablet 500 mg Tablet 1. DIVALPROEX SODIUM 274.08 548.16 2. HYDROXYPROPYL CELLULOSE NF (KLUCEL EXF) 33.006 66.012 3. HYDROXYPROPYL CELLULOSE NF (KLUCEL HXF) 80.996 161.99 4. HYPERMELLOSE 15000 CPS (METHOCEL K15 PREMIUM) 228.00 456.00 5. HYPERMELLOSE 5 CPS 2910 (METHOCEL E5) 41.99 83.98 6. Items at serial No. 6 to 13 (Packing Material) As per packing policy 134

Case No.:35/14/82ALC4/2013

Party Name:VIRCHOW PETROCHEMICAL PVT LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00620/AM14/ RLA File :09/24/040/00232/AM14/ Lic.No/Date:0910057435 30.08.2013 Defer Date:24.04.2014 135

Case No.:2/12/82ALC4/2013

Party Name:VIVEK PHARMACHEM (INDIA) LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00426/AM14/ RLA File :13/24/040/00022/AM14/ Lic.No/Date:1310044274 09.09.2013 Defer Date:24.04.2014

136

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

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00829/AM14/ RLA File :07/24/040/00189/AM14/ Lic.No/Date:0710098183 10.09.2013 Defer Date:24.04.2014 137

Case No.:105/13/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00581/AM14/ RLA File :09/24/040/00265/AM14/ Lic.No/Date:0910057516 10.09.2013 Defer Date:24.04.2014 138

Case No.:11/15/82ALC4/2013

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 27.03.2014 Status:Case Deferred HQ File :01/82/050/00773/AM14/ RLA File :03/94/040/00352/AM14/ Lic.No/Date:0310749169 11.09.2013 Defer Date:24.04.2014 Decision : It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 24.04.2014.. 139

Case No.:33/15/82ALC4/2013

Party Name:KOPRAN LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00795/AM14/ RLA File :03/94/040/00491/AM14/ Lic.No/Date:0310749151 11.09.2013 Defer Date:24.04.2014 140

Case No.:47/16/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00860/AM14/ RLA File :04/24/040/00130/AM14/ Lic.No/Date:0410149741 11.09.2013 Defer Date:24.04.2014 Decision :it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. 141

Case No.:33/16/82ALC4/2013

Party Name:HETERO DRUGS LIMITED, 27.03.2014 Status:Case Deferred

HQ File :01/82/050/00846/AM14/ RLA File :09/24/040/00278/AM14/ Lic.No/Date:0910057537 12.09.2013 Defer Date:24.04.2014 Decision :it was decided to remind the firm to furnish the following information : i) Stepwise chemical reactions showing correct Molecular weight of each reactant & output product, and % yield on molar basis. ii) Justification for requirement of imported inputs in view of CA certificate furnished by the firm. 142

Case No.:32/15/82ALC4/2013

Party Name:KOPRAN LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00794/AM14/ RLA File :03/94/040/00487/AM14/ Lic.No/Date:0310749296 12.09.2013 Defer Date:24.04.2014 143

Case No.:9/16/82ALC4/2013

Party Name:RASULA PHARMACEUTICALS & FINE CHEMICALS 27.03.2014 Status:Case Approved HQ File :01/82/050/00822/AM14/ RLA File :09/24/040/00262/AM14/ Lic.No/Date:0910057540 12.09.2013 Defer Date: Decision :In the light of wri�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/56/2012‐Ch II dated 25.03.2014, it was decided to ra��fy 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 Propyl Paraben Sodium/Sodium Propyl Hydroxy Benzoate/Sodium Propyl Para Hydroxy Benzoate USP/BP/EP White Powder 1 kg 1. Para Hydroxy Benzoic Acid (PHBA) White Fine Powder Odorless 0.714 kg 2. N. Propanol Colourless Liquid 0.310 kg 144

Case No.:35/15/82ALC4/2013

Party Name:KOPRAN LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00797/AM14/ RLA File :03/94/040/00472/AM14/ Lic.No/Date:0310749439 Defer

13.09.2013 Date:24.04.2014 145

Case No.:36/15/82ALC4/2013

Party Name:CORAL LABORATORIES LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00798/AM14/ RLA File :03/94/040/00524/AM14/ Lic.No/Date:0310749951 17.09.2013 Defer Date:24.04.2014 146

Case No.:17/16/82ALC4/2013

Party Name:TADIMETYAROMATICS PVT. LTD 27.03.2014 Status:Case Approved HQ File :01/82/050/00830/AM14/ RLA File :07/24/040/00195/AM14/ Lic.No/Date:0710098354 18.09.2013 Defer Date: Decision :In the light of wri�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/57/2010‐Ch II dated 10.02.2014, it was decided to ra��fy 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 PHENOXY ETHYL ISO BUTYRATE 1 kg 1. ISO BUTYRIC ACID 0.498 kg 147

Case No.:48/15/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00810/AM14/ RLA File :04/24/040/00128/AM14/ Lic.No/Date:0410150198 23.09.2013 Defer Date:24.04.2014 Decision :it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. 148

Case No.:47/15/82ALC4/2013

Party Name:PI INDUSTRIES LTD., 27.03.2014 Status:Case Deferred

HQ File :01/82/050/00809/AM14/ RLA File :13/24/040/00026/AM14/ Lic.No/Date:1310044452 24.09.2013 Defer Date:24.04.2014 149

Case No.:36/16/82ALC4/2013

27.03.2014 Status:Case Deferred HQ File :01/82/050/00849/AM14/ RLA File :08/24/040/00259/AM14/ Lic.No/Date:0810125075 25.09.2013 Defer Date:24.04.2014 150

Case No.:38/15/82ALC4/2013

Party Name:FDC LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00800/AM14/ RLA File :03/94/040/00256/AM14/ Lic.No/Date:0310751024 25.09.2013 Defer Date:24.04.2014 151

Case No.:49/15/82ALC4/2013

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/00811/AM14/ RLA File :04/24/040/00101/AM14/ Lic.No/Date:0410150375 26.09.2013 Defer Date:24.04.2014 152

Case No.:26/17/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00888/AM14/ RLA File :09/24/040/00302/AM14/ Lic.No/Date:0910057816 04.10.2013 Defer Date:24.04.2014 153

Case No.:15/17/82ALC4/2013

Party Name:AGIO PHARMACEUTICALS LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00877/AM14/ RLA File :03/94/040/00542/AM14/ Lic.No/Date:0310752494 07.10.2013 Defer Date:24.04.2014 154

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

Party Name:MAKSON INDUSTRIES PVT. LTD. Status:Case

27.03.2014 Deferred HQ File :01/82/050/01181/AM14/ RLA File :03/95/040/00014/AM14/ Lic.No/Date:0310752666 08.10.2013 Defer Date:27.03.2014 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of MSME. 155

Case No.:2/24/82ALC4/2013

Party Name:SAINOR LABORATORIES PVT LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/01201/AM14/ RLA File :09/24/040/00147/AM14/ Lic.No/Date:0910057861 08.10.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of C&PC and defer the case for 24.04.2014 156

Case No.:174/14/82ALC4/2013

Party Name:JAINEX SPECIALITY CHEMICAL 27.03.2014 Status:Case Deferred HQ File :01/82/050/00759/AM14/ RLA File :34/24/040/00170/AM14/ Lic.No/Date:3410038226 18.10.2013 Defer Date:24.04.2014 Decision : It was decided to send a copy of application to Department of C&PC and defer the case for 24.04.2014. 157

Case No.:73/17/82ALC4/2013

Party Name:RELIANCE INDUSTRIES LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00935/AM14/ RLA File :03/95/040/00515/AM14/ Lic.No/Date:0310754530 21.10.2013 Defer Date:24.04.2014 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of C&PC (PC Div.). 158

Case No.:6/20/82ALC4/2013

Party Name:ZIM LABORATORIES LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00992/AM14/ RLA File :03/95/040/00591/AM14/ Lic.No/Date:0310754588 21.10.2013 Defer Date:24.04.2014 159

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

Party Name:EYTAN LABS LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01216/AM14/ RLA File :09/24/040/00355/AM14/ Lic.No/Date:0910057998 24.10.2013 Defer Date:24.04.2014

160

Case No.:3/24/82ALC4/2013

Party Name:SANZYME LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/01202/AM14/ RLA File :09/24/040/00295/AM14/ Lic.No/Date:0910058014 25.10.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of Biotechnology and Department of C&PC . The case was deferred for 24.04.2014. 161

Case No.:35/24/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01234/AM14/ RLA File :09/24/040/00346/AM14/ Lic.No/Date:0910058043 28.10.2013 Defer Date:24.04.2014 162

Case No.:7/20/82ALC4/2013

Party Name:HONEST BIOVET PVT. LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00993/AM14/ RLA File :08/24/040/00339/AM14/ Lic.No/Date:0810126094 29.10.2013 Defer Date:24.04.2014 163

Case No.:51/15/82ALC4/2013

Party Name:SAURAV CHEMICALS LTD, 27.03.2014 Status:Case Deferred HQ File :01/82/050/00813/AM14/ RLA File :22/24/040/00049/AM14/ Lic.No/Date:2210014341 29.10.2013 Defer Date:24.04.2014 164

Case No.:21/24/82ALC4/2013

Party Name:SIFLON DRUGS 27.03.2014 Status:Case Deferred HQ File :01/82/050/01220/AM14/ RLA File :09/24/040/00338/AM14/ Lic.No/Date:0910058067 29.10.2013 Defer Date:24.04.2014 165

Case No.:31/24/82ALC4/2013

Party Name:SIFLON DRUGS 27.03.2014 Status:Case Deferred HQ File :01/82/050/01230/AM14/ RLA File :09/24/040/00335/AM14/ Lic.No/Date:0910058070 29.10.2013 Defer Date:24.04.2014

Decision : It was decided to send a copy of application to Department of Biotechnology and Department of C&PC . The case was deferred for 24.04.2014. 166

Case No.:37/24/82ALC4/2013

Party Name:SIFLON DRUGS 27.03.2014 Status:Case Deferred HQ File :01/82/050/01236/AM14/ RLA File :09/24/040/00336/AM14/ Lic.No/Date:0910058069 29.10.2013 Defer Date:24.04.2014 167

Case No.:6/19/82ALC4/2013

Party Name:IPCA LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/00951/AM14/ RLA File :03/94/040/00632/AM14/ Lic.No/Date:0310756255 30.10.2013 Defer Date:24.04.2014 168

Case No.:78/23/82ALC4/2013

Party Name:AMI ORGANICS PVT LTD. 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01125/AM14/ RLA File :52/24/040/00031/AM14/ Lic.No/Date:5210040368 31.10.2013 Defer Date:24.04.2014 Decision :In the light of wri�en comments received from Department of Chemicals & Petrochemicals vide their OM No. 14010/2/2014 CH‐II dated 01.04.2014, it was decided to call from the firm the following technical details: 1. Details of manufacturing process with chemical equa��ons, molecular formula, and molecular weight. 2. Yield obtained in each step supported with authen��c technical literature. 3. Collaborators guaranteed norms. 4. Detailed calcula��on of arriving at the norms. 169

Case No.:33/24/82ALC4/2013

Party Name:PORUS LABORATORIES PVT LTD. 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01232/AM14/ RLA File :09/24/040/00375/AM14/ Lic.No/Date:0910058093 31.10.2013 Defer Date:24.04.2014 Decision :It was decided to send a copy of application to Department of C&PC and defer the case for 24.04.2014 170

Case No.:36/24/82ALC4/2013

Party Name:AKTINOS PHARMA PVT LTD, 27.03.2014 Status:Deffered and Reindexed

HQ File :01/82/050/01235/AM14/ RLA File :09/24/040/00384/AM14/ Lic.No/Date:0910058143 05.11.2013 Defer Date:24.04.2014 171

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

Party Name:ASTRIX LABORATORIES LTD., 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01211/AM14/ RLA File :09/24/040/00359/AM14/ Lic.No/Date:0910058146 05.11.2013 Defer Date:24.04.2014 172

Case No.:4/24/82ALC4/2013

Party Name:DR REDDYS LABORATORIES LIMITED 27.03.2014 Status:Case Approved HQ File :01/82/050/01203/AM14/ RLA File :09/24/040/00369/AM14/ Lic.No/Date:0910058147 05.11.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/663/2013PI(Norms) dated 22.01.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl. No. Import items Qty. allowed kg/kg Capecitabine Kg 1. 2,3DiOacetyl5deoxy5 fluorocytidine 1.33 2. NPentyl Chloro Formate 0.91 3. Methylene Dichloride 4.70 173

Case No.:34/24/82ALC4/2013

27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01233/AM14/ RLA File :09/24/040/00378/AM14/ Lic.No/Date:0910058148 05.11.2013 Defer Date:24.04.2014 174

Case No.:4/22/82ALC4/2013

Party Name:VINDHYA ORGANICS PVT LTD 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01047/AM14/ RLA File :09/24/040/00279/AM14/ Lic.No/Date:0910058161 Defer

06.11.2013 Date:24.04.2014 175

Case No.:22/24/82ALC4/2013

Party Name:DIVIS LABORATORIES LTD., 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01221/AM14/ RLA File :09/24/040/00376/AM14/ Lic.No/Date:0910058165 07.11.2013 Defer Date:24.04.2014 176

Case No.:18/24/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01217/AM14/ RLA File :09/24/040/00388/AM14/ Lic.No/Date:0910058173 08.11.2013 Defer Date:24.04.2014 177

Case No.:19/24/82ALC4/2013

Party Name:SMILAX LABORATORIES LIMITED 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01218/AM14/ RLA File :09/24/040/00382/AM14/ Lic.No/Date:0910058170 08.11.2013 Defer Date:24.04.2014 178

Case No.:7/24/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 27.03.2014 Status:Case Approved HQ File :01/82/050/01206/AM14/ RLA File :09/24/040/00386/AM14/ Lic.No/Date:0910058175 11.11.2013 Defer Date: Decision :In the light of wri�en comments received from Department of Pharmaceu��cals vide their OM No. 35011/721/2013‐PI(Norms) dated 24.12.2013, it was decided to ra��fy 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 Quan��ty S,No Item of Import Quan��ty allowed kg/kg EFAVIRENZ 1 kg 1. AMINOCARBINOL or (S) 5 Chloro(alpha Cyclopropylethynyl) 2 amino alpha (Trifluoromethyl) benzenemethanol 0.987 2. Triphosgene 0.448

Activated Carbon ( Carbon Enoanticromos ) 0.053 4. Hexanes 1.763 5. Isopropyl Alcohol 1.533 6. Methanol 0.357 179

Case No.:27/24/82ALC4/2013

Party Name:DIVIS PHARMACEUTICALS PRIVATE LIMITED 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01226/AM14/ RLA File :09/24/040/00379/AM14/ Lic.No/Date:0910058176 11.11.2013 Defer Date:24.04.2014 180

Case No.:42/24/82ALC4/2013

Party Name:AHLCON PARENTERALS INDIA LTD. 27.03.2014 Status:Deffered and Reindexed HQ File :01/82/050/01241/AM14/ RLA File :05/23/040/00330/AM14/ Lic.No/Date:0510371021 13.11.2013 Defer Date:24.04.2014 181

Case No.:29/24/82ALC4/2013

Party Name:ATGC BIOTECH PVT LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/01228/AM14/ RLA File :09/24/040/00275/AM14/ Lic.No/Date:0910058222 13.11.2013 Defer Date:24.04.2014 Decision : It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals and Department of Biotechnology. 182

Case No.:30/24/82ALC4/2013

Party Name:DIVIS LABORATORIES LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/01229/AM14/ RLA File :09/24/040/00391/AM14/ Lic.No/Date:0910058223 13.11.2013 Defer Date:24.04.2014 183

Case No.:16/24/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01215/AM14/ RLA File :09/24/040/00385/AM14/ Lic.No/Date:0910058218 13.11.2013 Defer Date:24.04.2014

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 24.04.2014. 184

Case No.:26/24/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01225/AM14/ RLA File :09/24/040/00392/AM14/ Lic.No/Date:0910058221 13.11.2013 Defer Date:24.04.2014 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 24.04.2014. 185

Case No.:3/19/82ALC4/2013

Party Name:SIRMAXO CHEMICALS PVT LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/00948/AM14/ RLA File :03/95/040/00625/AM14/ Lic.No/Date:0310757730 13.11.2013 Defer Date:24.04.2014 186

Case No.:28/24/82ALC4/2013

Party Name:PORUS LABORATORIES PVT LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/01227/AM14/ RLA File :09/24/040/00396/AM14/ Lic.No/Date:0910058239 18.11.2013 Defer Date:24.04.2014 187

Case No.:13/24/82ALC4/2013

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 27.03.2014 Status:Case Deferred HQ File :01/82/050/01212/AM14/ RLA File :09/24/040/00408/AM14/ Lic.No/Date:0910058278 21.11.2013 Defer Date:24.04.2014 188

Case No.:74/23/82ALC4/2013

Party Name:SWISS EXPORTS PVT. LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/01121/AM14/ RLA File :08/24/040/00351/AM14/ Lic.No/Date:0810126591 21.11.2013 189

Case No.:15/24/82ALC4/2013

Party Name:VIVIMED LABS LIMITED Status:Case

27.03.2014 Approved HQ File :01/82/050/01214/AM14/ RLA File :09/24/040/00399/AM14/ Lic.No/Date:0910058258 21.11.2013 Defer Date: Decision :In the light of wri�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 ra��fy 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 190

Case No.:20/24/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01219/AM14/ RLA File :09/24/040/00405/AM14/ Lic.No/Date:0910058310 25.11.2013 Defer Date:24.04.2014 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 24.04.2014 191

Case No.:10/24/82ALC4/2013

Party Name:DR REDDYS LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01209/AM14/ RLA File :09/24/040/00380/AM14/ Lic.No/Date:0910058343 26.11.2013 Defer Date:24.04.2014 192

Case No.:14/24/82ALC4/2013

Party Name:DR REDDYS LABORATORIES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01213/AM14/ RLA File :09/24/040/00381/AM14/ Lic.No/Date:0910058344 26.11.2013 Defer Date:24.04.2014

193

Case No.:11/24/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01210/AM14/ RLA File :09/24/040/00420/AM14/ Lic.No/Date:0910058351 26.11.2013 Defer Date:24.04.2014 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 24.04.2014. 194

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

Party Name:GLAND PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01223/AM14/ RLA File :09/24/040/00419/AM14/ Lic.No/Date:0910058352 26.11.2013 Defer Date:24.04.2014 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 24.04.2014. 195

Case No.:32/24/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01231/AM14/ RLA File :09/24/040/00417/AM14/ Lic.No/Date:0910058353 26.11.2013 Defer Date:24.04.2014 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 24.04.2014 196

Case No.:132/23/82ALC4/2013

Party Name:NECTAR LIFESCIENCES LIMITED, 27.03.2014 Status:Case Deferred HQ File :01/82/050/01179/AM14/ RLA File :22/24/040/00063/AM14/ Lic.No/Date:2210014401 26.11.2013 197

Case No.:5/24/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01204/AM14/ RLA File :09/24/040/00343/AM14/ Lic.No/Date:0910058355 26.11.2013 Defer Date:24.04.2014 198

Case No.:9/24/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 27.03.2014 Status:Case Approved

HQ File :01/82/050/01208/AM14/ RLA File :09/24/040/00344/AM14/ Lic.No/Date:0910058356 26.11.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 20/82 dated 16.01.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Gabapentin Kg 1. CYCLOHEXANE1,1DIACETIC ACID MONOAMIDE (CDAM) 0.988 2. Acetone 0.785 199

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

Party Name:SUVEN LIFE SCIENCES LIMITED 27.03.2014 Status:Case Approved HQ File :01/82/050/01222/AM14/ RLA File :09/24/040/00348/AM14/ Lic.No/Date:0910058354 26.11.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 15/82 dated 31.10.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import Items Qty. allowed kg/kg Dibinezoyl –d Tartatic Acid 1 kg 1 D‐(‐) Tartaric Acid 0.52 200

Case No.:76/23/82ALC4/2013

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 27.03.2014 Status:Case Approved HQ File :01/82/050/01123/AM14/ RLA File :04/24/040/00161/AM14/ Lic.No/Date:0410152306 27.11.2013 Defer Date: Decision :In the light of wri�en comments received from Department of Pharmaceu��cals vide their OM No. 35011/258/2013‐PI(Norms) dated 01.04.2014, it was decided to ra��fy 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 Quan��ty S,No Item of Import Quan��ty allowed kg/kg Cathine Hcl (or) dNor 1 kg 1. DiPhenyl Propanolamine 4.74

Pseudoephedrine Hcl Hcl 2. Iso Propyl Alcohol 5.288 3. Methyl Isobutyl Ketone 1.866 4. Toluene 4.977 5. Acetone 2.488 6. Causticsoda Flakes 1.437 7. Acetic Anhydride 1.70 201

Case No.:6/24/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01205/AM14/ RLA File :09/24/040/00365/AM14/ Lic.No/Date:0910058404 29.11.2013 Defer Date:24.04.2014 202

Case No.:8/24/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01207/AM14/ RLA File :09/24/040/00356/AM14/ Lic.No/Date:0910058405 29.11.2013 Defer Date:24.04.2014 203

Case No.:5/23/82ALC4/2013

Party Name:ARIHANTANAM LIFECARE PVT. LTD. 27.03.2014 Status:Case Approved HQ File :01/82/050/01052/AM14/ RLA File :03/94/040/00759/AM14/ Lic.No/Date:0310760168 02.12.2013 Decision :In the light of earlier decision taken in mee��ng no. 8/82 dated 11.7.2013, and in consulta��on with technical authority (D/o Pharmaceu��cals) it was decided to ra��fy 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) Lumefantrine 1 kg 1. 2,7‐Dichloro A‐ (Dibutylamino) Methyl ‐9 H‐fluoren‐4‐ Methanol (DBA) 0.8693 kg

204

Case No.:10/23/82ALC4/2013

Party Name:YASHO INDUSTRIES PVT.LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/01057/AM14/ RLA File :03/95/040/00720/AM14/ Lic.No/Date:0310761106 09.12.2013 Decision : It was decided to send the copy of application to Department of C&PC for their comments. The case defer for 24.04.2014 205

Case No.:44/24/82ALC4/2013

Party Name:SAIBABA SURFACTANTS (P) LTD., 27.03.2014 Status:Case Deferred HQ File :01/82/050/01243/AM14/ RLA File :08/24/040/00389/AM14/ Lic.No/Date:0810127124 16.12.2013 Defer Date:24.04.2014 Decision : It was decided to send the copy of application to Department of C&PC for their comments. The case defer for 24.04.2014 206

Case No.:7/18/82ALC4/2013

Party Name:SWISS EXPORTS PVT. LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00942/AM14/ RLA File :08/24/040/00400/AM14/ Lic.No/Date:0810127123 16.12.2013 Decision : It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals 207

Case No.:8/18/82ALC4/2013

Party Name:TITAN LABORATORIES PVT. LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/00943/AM14/ RLA File :03/95/040/00637/AM14/ Lic.No/Date:0310761921 16.12.2013 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals 208

Case No.:2/22/82ALC4/2013

Party Name:METROCHEM API PVT. LTD. 27.03.2014 Status:Case Deferred HQ File :01/82/050/01045/AM14/ RLA File :09/24/040/00503/AM14/ Lic.No/Date:0910058842 07.01.2014 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of C&PC. 209

Case No.:1/24/82ALC4/2013

Party Name:NECTAR LIFESCIENCES LIMITED, 27.03.2014 Status:Case Deferred HQ File :01/82/050/01200/AM14/ RLA File :22/24/040/00065/AM14/ Lic.No/Date:2210014672 12.03.2014 Defer Date:24.04.2014 Decision : It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals

210

Case No.:40/24/82ALC4/2013

Party Name:ALEMBIC PHARMACEUTICALS LTD 27.03.2014 Status:Case Approved HQ File :01/82/050/01239/AM14/ RLA File :34/24/040/00278/AM14/ Lic.No/Date:3410039568 14.03.2014 Defer Date: Decision :In the light of earlier decision taken in mee��ng no. 11/82 dated 05.09.2013, it was decided to ra��fy norms under Para 4.7 of HBP v1 as per details given below or as applied bythe firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR Its raw material as per SION A2263 on prorata basis. RA may take appropriate action as per the decision of Norms Committee. 211

Case No.:41/24/82ALC4/2013

Party Name:ALEMBIC PHARMACEUTICALS LTD 27.03.2014 Status:Case Approved HQ File :01/82/050/01240/AM14/ RLA File :34/24/040/00279/AM14/ Lic.No/Date:3410039569 14.03.2014 Defer Date: Decision :In the light of earlier decision taken in mee��ng no. 11/82 dated 05.09.2013, it was decided to ra��fy norms under Para 4.7 of HBP v1 as per details given below or as applied bythe firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Clarithromycin Coated Granules (28% to 44%, as per DML) 1 KG 1. Clarithromycin Net Content (as per DML) +1% WASTAGE OR Its raw material as per SION A2263 on prorata basis. RA may take appropriate action as per the decision of Norms Committee. 212

Case No.:43/24/82ALC4/2013

Party Name:THINQ PHARMACRO LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01242/AM14/ RLA File :03/95/040/00987/AM14/ Lic.No/Date:0310774773 18.03.2014 Defer Date:24.04.2014 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals

213

Case No.:45/24/82ALC4/2013

Party Name:VIVIMED LABS ( ALATHUR) PRIVATE LIMITED 27.03.2014 Status:Case Deferred HQ File :01/82/050/01244/AM14/ RLA File :04/24/040/00264/AM14/ Lic.No/Date:0410156358 19.03.2014 Defer Date:24.04.2014 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals Manual Cases considered as Part B‐II

Case No. B‐II‐1

M/s Techno Drugs & Intermediates (P) F.No. 01/83/50/00530/AM07/DES‐III Adv. Lic. No. 0310392619 dated 02.08.2006 RA No. 03/95/040/00486/AM07 Decision: It was decided to send a copy of applica��on to Department of C&PC and defer the case for 24.04.2014.

Case No. B‐II‐2

M/s Aar�� Drugs Ltd. F.No. 01/82/50/00427/AM13/DES‐III Adv. Lic. No. 0310714511 dated 07.11.2012 Adv. Lic. No. 0310737543 dated 13.06.2013 RA No. 03/81/040/00241/AM13 RA No. 03/81/040/00072/AM14 Decision: DL to be taken from shri Mathur

Case No. B‐II‐3

M/s Deepak Nitrite Ltd. F.No. 01/82/50/340/AM13/DES‐III Adv. Lic. No. 3410034154 dated 18.05.2012 Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/36/2012Ch.II dated 18.05.2013

and in consultation with technical authority present in meeting, decided to ratify norms under

para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export Product Export Qty. Sl.No. Import items Qty. allowed Ortho Toluidine 1 KG. 1. Toluene 1.040 kg RA concerned may take further necessary action as per above decision of NC.

Case No. B‐II‐4

M/s Baker Oil Trea��ng (I) Ltd., Pune F.No. 01/82/050/2024/AM05/DES‐III RA No. 03/94/040/00376/AM05 Adv. Lic. No. 0310321502 dated 15.03.2005 Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/70/2013Ch.II dated 01.04.2014 and in consultation with technical authority present in meeting, decided to ratify norms under

para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Sl. No. Export product Exp. Qty. Import items Qty. allowed Kg/kg 1. Aquanox ML 5877 (Demulsifier) 1 kg Mixed Xylene/Orthoxylene Liquid 0.800 kg 2. Cronox ML‐5933 (Oil Corrosion Inhibitor) (OCI) 1 kg Mixed Xylene/Orthoxylene Liquid 0.700 kg Diethylene triamine (DETA) Liquid 0.029 kg Oleic Acid 0.298 kg 3. Magnacide ML‐2514 (Biocide‐I) 1 kg Tetrakis Hydroxy Methyl Phosphonium Sulphate (THPA) 0.250 kg Dimethyl Cocoamine 0.110 kg 4. Magnacide ML‐2515 (Biocide‐II) 1 kg Dimethyl Cocoamine 0.110 kg

Glutaraldehyde 0.110 kg 5. Cronox ML‐5935 (water Corrosiion Inhabitor) (WCI) 1 kg Dimethyl Cocoamine 0.044 kg Dimer Fa�y Acid 0.115 kg 6. Calnox ML‐59319 (water Scale Inhibitor) (WSI) 1 kg Acrylic Acid Liquid 0.415 kg Thioglycolic Acid 0.061 kg 7. D‐Wax ML‐5932 (Pour Point Depressant) (PPD) 1 kg Mixed Xylene/Orthoxylene Liquid 0.490 kg Netrax/Nafol 1822 B/Behenyl Alcohol Solid 0.245 kg Ceto Stearyl Alcohol/Nafol 1618 S&H / Hydranolmy 0.117 kg Acrylic Acid Liquid 0.090 kg

Case No. B‐II‐5

M/s Encube Ethicals Pvt Ltd. F.No. 01/82/50/00232/AM12/DES‐III Adv. Lic. No. 0310625603 dated 07.04.2011 RA No. 03/95/040/01167/AM12 Decision: In the light of wri�en comments received from Department of Pharmaceu��cals vide their OM No. 35011/177/2013‐PI(Norms) dated 04.03.2014, it is informed that the norms for the export of sodium Fusidate Ointment 2% , 15 gm Tube were recommended based on their details given in the applica��on, the Drug Manufacturing License and by comparison with the CA cer��ficate cer��fying their past produc��on vis‐a‐vis Actual consump��on data of inputs forwarded by the company vide their le�er RG: NC: DGFT : 4 dt. 20.10.2012. It was decided to reject the case as norms have been given based on the compara��ve data and there is no need for further amendment.

Case No. B‐II‐6

M/s Encube Ethicals Pvt Ltd. F.No. 01/82/50/00345/AM11/DES‐III Adv. Lic. No. 0310571323 dated 24.06.2010 RA No. 03/95/040/00038/AM11 Decision: It was decided to send a copy of applica��on to O/o DC (MSME) for their comments and deferred the case for 24.04.2014.

Case No. B‐II‐7

M/s Shiva Pharma Ltd Mee��ng No. 24/AM14 Dated – 03.04.2014 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: Committee considered the case as per agenda and decided to reject the request of the firm as there was no justification for enhancement and to maintain Status quo.

Case No. B‐II‐8

M/s Vivimed Labs Ltd F.No. 01/82/50/00875/AM11/DES‐III F.No. 01/82/50/00360/AM11/DES‐III Adv. Lic. No. 0910043635 dated 24.09.2010 Adv. Lic. No. 0910042101 dated 20.05.2010 RA No. 09/24/040/00105/AM11 RA No. 09/24/040/00063/AM11 Decision: Committee considered the case as per agenda and decided to reject the request of the firm as there was no justification for enhancement. It was decided to maintain Status quo.

Case No. B‐II‐9

M/s Malladi Drugs & Pharma Ltd. F.No. 01/82/50/00993/AM13/DES‐III F.No. 01/82/50/01360/AM13/DES‐III Adv. Lic. No. 0410141071 dated 16.11.2012 RA No. 04/24/040/00126/AM13

Adv. Lic. No. 0410141070 dated 04.02.2013 RA No. 04/24/040/00244/AM13 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals.

Case No. B‐II‐10

M/s Ajanta Pharma Ltd F.No. 01/82/50/00041/AM05/DES‐III Adv. Lic. No. 0310262053 dated 31.03.2004. RA No. 03/24/040/02714/AM04 Decision: Committee considered the case as per agenda and decided to reject the request of the firm as there was no justification for enhancement. It was decided to maintain Status quo.

Case No. B‐II‐11

M/s Rohan Exports India Ltd. & M/s Mahesh Raj Chemicals Ltd. F.No. 01/83/162/00654/AM12/DES‐III Appeals Filed Against order of the Jt. DGFT Ahmedabad, in pursuance of order dated 20.01.2010 of the Hon’ble High Court of Gujarat Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and it has been found that despite repeated reminder the Institute of Chemical Technology Mumbai, has not given their opinion whether the export product “4, 4 Diamino Sulfanilide “ is manufactured only of purity 93% on commercial scale. Further the product will always contained 7% or more of impurities. It was also decided to remind the Department of C&PC to take appropriate action and furnish their comments as the case is pending since long. The case is deferred for 24.04.2014

Case No. B‐II‐12

M/s Shilpa Medicare Ltd. F.No. 01/82/50/01380/AM13/DES‐III Adv. Lic. No. 0710091373 dated 15.10.2012. RA No. 07/24/040/00290/AM13 Decision: In the light of earlier decision taken in meeting no. 18/82 dated 2.8.2011, 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 Qty. Sl.No. Import items Qty. allowed Gemcitabine Hcl 1 Kg. 1. 4Amino1(3,3difluoro4 hydroxy5(Hydroxymethyl) Tetrahydrofuran2yl)1H Pyrimidine2one (Technical Grade) 0.97 kg RA may take appropriate action as per the decision of Norms Committee.

Case No. B‐II‐13

M/s Vindhya Pharma (India) Pvt Ltd F.No. 01/82/50/00660/AM14/DES‐III Adv. Lic. No. 0910056447 dated 25.06.2013. RA No. 09/24/040/122/AM12 Decision :It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals.

Case No. B‐II‐14

M/s Vimal Drugs Pvt Ltd F.No. 01/83/50/00351/AM13/DES‐III Adv. Lic. No. 0910052504 dated 08.05.2012. RA No. 09/24/040/00049/AM13

Decision :It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals.

Case No. B‐II‐15

M/s Saurav Chemicals Ltd. F.No. 01/82/50/00865/AM12/DES‐III F.No. 01/82/50/01382/AM13/DES‐III Adv. Lic. No. 2210011843 dated 01.09.2011 Adv. Lic. No. 2210013689 dated 05.03.2013 RA No. 22/24/040/00039/AM12 RA No. 22/24/040/00074/AM13 Decision : It was decided to defer the case for 24.04.2014 for comments of Department of Pharmaceuticals.

Case No. B‐II‐16

M/s Varun Medimpex Inc. F.No. 01/83/50/01147/AM13/DES‐III Adv. Lic. No. 0510347194 dated 22.02.2013. RA No. 05/24/040/00405/AM13 Decision : It was decided to defer the case for 24.04.2014 for comments of Department of IPP. Case No. B‐ II‐17 M/s Dorf 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. 24/82 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 – 03/04/2014 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: Shri Randeep Mathur, President Commercial of M/s Dorf Ketal Chemicals I Pvt. Ltd., appeared Before the Committee and after detailed discussion, the representative from the firm was requested to furnish Batch Log Sheet and Produc��on and Consump��on Data duly cer��fied by Central Excise Authority. The case was deferred for 24.04.2014. Date:07.04.2014 Place:New Delhi Nirmal Kumar Dy. Director General of Foreign Trade

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis has been generated for this document yet.

Para 4.7 Decision(DRAFT)

Case No. A‐58

Case No. A‐59

Case No. B‐1

Case No. B‐2

Case No. B‐3

Case No. B‐4

Case No. B‐5

Case No. B‐6

Case No. B‐7

Case No. B‐8

Case No. B‐9

Case No. B‐10

Case No. B‐11

Case No. B‐12

Case No. B‐13

Case No. B‐14

Case No. C‐1

Case No. C‐2

Case No. C‐3

Case No. C‐4

Case No. C‐5

Case No.:11/20/82­ALC4/2009

Case No.:22/6/82­ALC4/2010

Case No.:38/24/82­ALC4/2013

Case No.:4/16/82­ALC4/2011

Case No.:11/1/82­ALC4/2013

Case No.:196/10/82­ALC4/2013

Case No.:76/4/82­ALC4/2012

Case No.:21/20/82­ALC4/2013

Case No.:44/20/82­ALC4/2013

Case No.:25/20/82­ALC4/2013

Case No.:30/13/82­ALC4/2012

Case No.:28/20/82­ALC4/2013

Case No.:38/20/82­ALC4/2013

Case No.:29/20/82­ALC4/2013

Case No.:39/20/82­ALC4/2013

Case No.:31/20/82­ALC4/2013

Case No.:20/20/82­ALC4/2013

Case No.:17/20/82­ALC4/2013

Case No.:18/20/82­ALC4/2013

Case No.:19/20/82­ALC4/2013

Case No.:34/20/82­ALC4/2013

Case No.:2/23/82­ALC4/2012

Case No.:5/22/82­ALC4/2012

Case No.:4/20/82­ALC4/2012

Case No.:40/15/82­ALC4/2013

Case No.:2/20/82­ALC4/2013

Case No.:3/23/82­ALC4/2012

Case No.:19/1/82­ALC4/2013

Case No.:112/33/82­ALC4/2012

Case No.:43/33/82­ALC4/2012

Case No.:4/27/82­ALC4/2012

Case No.:171/33/82­ALC4/2012

Case No.:49/4/82­ALC4/2013

Case No.:38/4/82­ALC4/2013

Case No.:13/12/82­ALC4/2013

Case No.:117/33/82­ALC4/2012

Case No.:16/20/82­ALC4/2013

Case No.:3/30/82­ALC4/2012

Case No.:9/4/82­ALC4/2013

Case No.:9/9/82­ALC4/2013

Case No.:151/33/82­ALC4/2012

Case No.:7/3/82­ALC4/2013

Case No.:26/4/82­ALC4/2013

Case No.:31/8/82­ALC4/2013

Case No.:8/10/82­ALC4/2013

Case No.:39/24/82­ALC4/2013

Case No.:141/10/82­ALC4/2013

Case No.:32/8/82­ALC4/2013

Case No.:57/10/82­ALC4/2013

Case No.:140/10/82­ALC4/2013

Case No.:24/10/82­ALC4/2013

Case No.:125/10/82­ALC4/2013

Case No.:58/10/82­ALC4/2013

Case No.:25/10/82­ALC4/2013

Case No.:6/10/82­ALC4/2013

Case No.:113/14/82­ALC4/2013

Case No.:117/10/82­ALC4/2013

Case No.:148/10/82­ALC4/2013