IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2014-09-11

DGFT Committee Minutes

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} New Delhi -0 Para 4.7 Decision(DRAFT) MEETING NUMBER : 7/82-ALC4/2014 MEETING DATE:; 11.09.2014

The Meeting No. 7/82 of 2014-15 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Allied products and falling under Chapter 29 and 30 was scheduled for 11.09.2014 but actually held on 23.09.2014 under the Chairmanship of Shri Jaikant Singh, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Dr. Nitin Jain, Scientist-E, D/o Biotechnology

Shri Nirmal Kumar, Deputy Director General of Foreign Trade Shri Mahendra Vikram Singh, Foreign Trade Development Officer Shri D.N. Mathur. Consultant, Department of Pharmaceutical Shri Jasbir Singh, Consultant, Department of C&PC

The committee went through the minutes of earlier NC —IIl meeting No. 6/82 scheduled for 24.07.2014 but actually held on 29.08.2014.2014 and approved the same. ( The following cases/issues were discussed and the committee took the decision as mentioned — against each case.

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----- Start of picture text ----- Case No. A-6 M/s Pharmazell (India) Pvt Ltd. - Meeting No.07/AM15 dated — 11.09.2014 F.No. 01/82/162/00419/AM14/DES-III Decision: Committee considered the case as per agenda and in light of written comments received from (~~. [2] Department of Pharmaceuticals vide their OM No. 35011/234/2014-PI(Norms) dated 05.09.2014 and in a consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:- ----- End of picture text -----

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----- Start of picture text ----- Export product ae Import items Qty.Kg/kg Allowed Dinamo RA concerned may take further necessary action as per above decision of NC. Case No. B-61 M/s Vivimed Labs Ltd.. Meeting No.07/AM15 dated — 11.09.2014 File No. 01/82/162/00050/AM15/DES-III File No. 01/82/162/00053/AM15/DES-III Ady. Lic. No 0910052425 dated 30.04.2012 RA.No.09/24/040/00044/AM13 Ady. Lic. No 0910052164 dated 13.04.2012 RA.No.09/24/040/00016/AM13 \ ! Udyog Bhawan, New Deaihi — a . ea ----- End of picture text -----

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----- Start of picture text ----- ° Hdd | ‘Decision: In the light of earlier decision taken by NC in its 1/82 meeting dated 04.04.2013, 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 [sealQty. betel Import items Qty. allowed Sodium Ascorbyl (2R)-2-[(1S)-1,2- 1.110 kg Phosphate or C-Vite Dimethoxyethyl]-4,5- Dihydroxyfuran-3-One [| Methanol 1 a Potassium Carbonate [4.610kg sd ) ----- End of picture text -----

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

Case No. B-62 M/s Aarti Drugs Ltd. Meeting No.07/AM15 dated — 11.09.2014 F.No. 01/82/050/427/AM13/DES-III RA. No. 03/81/040/241/AM13 Ady, Lic. No. 0310714511 dt. 07.11.2012 RA No. 03/81/040/00072/AM14 Ady. Lic. No. 0310737543 dt. 13.06.2013 Decision: It was decided to remind the firm to furnish relevant portion of British Pharmacopeia to show that 2-Thiophene Ethylamine and Thiophene-2-Ethanol are one and the same. The case was deferred for 09.10.2014.

Case No. B-63 M/s. PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) Meeting No.07/AM15 dated — 11.09.2014 F. No.01/82/50/00557/AM13/DES-III

[hr UTC adv. Lic. No. 0310701405 dated 10.07.2012 Decision: The case was withdrawn as a decision in the matter had alreadybeen taken in 5/82 meeting held on 25.07.2014.

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----- Start of picture text ----- Case No. B-64 M/s. PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) Meeting No.07/AM15 dated — 11.09.2014 F, No.01/82/50/00556/AM 13/DES-III F. No.01/82/50/00001/AM13/DES-III F. No.01/82/50/01173/AM13/DES-III adv. Lic. No. 0310701402 dated 10.07.2012 adv. Lic. No. 0310688849 dated 30.03.2012 adv. Lic. No. 0310721416 dated 18.01.2013 Decision: The case was withdrawn as a decision in the matter had alreadybeen taken in 5/82 meeting held on 25.07.2014, TN ----- End of picture text -----

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Case No. B-65 ' M/s Padmini Aromatics Pvt, Ltd, Meeting No.07/AM15 dated — 11.09.2014 F.No. 01/82/050/00375/AM10/DES-III F.No, 01/82/050/00375/AM 10/DES-III RLA’s File no. 07/24/040/136/AM10 Adv. Lic, No. 0710066165 dt. 24.07.2009 RLA’s File no. 07/24/040/294/AM10 Ady. Lic. No, 0710068389 dt. 19.11.2009

Decision: : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/58/2012-Ch., II dated 10.09.2014, it was decided to ratify norms under Para 4,7 of HBP vl as per details given below or as applied by the firm, whichever is less: (A ) Ady. Lic. No. Adv. Lic. No. 0710066165 dt. 24.07.2009

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----- Start of picture text ----- Export product Exp. Import items Qty. allowed Qty. Alpha Damascone PA 1kg 1 Citral 1.583 kg Beta Damascone PA 1kg 1 Citral. 1.583 kg Mysosan [SA] 1kg 1 AlphaciaPi 1.27 kg Sodium Borohydride 0.077 kg 3 N Propionaldehyde 0.390 kg Sandol SA oe 2 Sodium Borohydride 0.077 kg 452 k Sabanol SA 1kg 1 Alpha Pinene 1.36 kg Sodium Borohydride 0.077 kg Sanflore SA 1kg Alpha Pinene. 1.01 kg Polysandol [PA] ikg 1 Alpha Pinene 1.27 kg }2 | Sodium Borohydride 0.077 kg [3| Methyl todide 0.954 kg Shivanol SA 1kg 1 Alpha Pinene 1.00 kg N Propionaldehyde 0.381 kg Woodamber SA Methyl! Propy! Ketone 0.542 kg Nickle Catalyst 5132 P 0.06 kg \ Dy.wyDirectorABest| “isa Directoratefew enayGunora ? aldooun Trade waftroy aPvOepanme nt of Co agi ; cee bnanoee now Delhi ----- End of picture text -----

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----- Start of picture text ----- 2 ae a Ca "| (B ) Ady. Lic. No. Adv. Lic. No. 0710068389 dt. 19.11.2009 Decision: + In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No, 14010/58/2012-Ch, II dated 10,09,2014, 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 Import items - Qty. allowed " Qty. Mysosan [SA] 1kg AlphasciPi 1.27 kg |3 | NSodium [Propionaldehyde] Borohydride 0.3900.077 kg kg Sandol SA 1kg Alphai Pinene 1.18 kg Sodium Borohydride 0.077 kg i N Butyraldehyde Ones mas Alpha Pinene 1.00kg Shivanol SA N Propionaldehyde 0.381 kg ----- End of picture text -----

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

Case No. B-66 M/s Vindhya Pharma (India) Pvt Ltd. Meeting No.07/AM15 dated — 11.09.2014 F.No, 01/82/050/00660/AM 14/DES-II

RLA’s File no. 09/24/040/122/AM 12 Adv, Lic. No. 0910056447 dt. 25.06.2013

Decision: Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/792/2013-PI(Norms) dated 02.09.2014 and in consultation with technical authorities present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:-

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----- Start of picture text ----- Export product Exp. Import items Qty. Allowed ss ty. ee Kg/kg Dibenzoyllactol 1 kg apt Benny a DeoxyshePiaro-Ly pay Erythropentane-|,4-Lactone . OR Ethyl 2,2-difluoro-3-hydroxy-3-(2,2- dimethyl-1,3 dioxolan-4yl) propionate RA concerned may take further necessary necessary action as per above above decision of NC. Prin & Dy.wa D Fr ‘ udyes Ghawan: how Dain ----- End of picture text -----

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

Decision: Committee considered the case as per agenda and it was decided to call for technical literature in PaRLA’sMeeting No.07/AM15 dated —TTT1 1.09.2014 [FiF.No. 01/82/050/00865/AM12/DES-IIIoma AMTIDEST File no. 22/24/040/00039/AM12 Ady, Lic. No. 2210011843 dt. 01.09.2011 Decision: Copy of fresh representation, alongwith production and consumption data duly certified by Central Excise Authority received from the firm and same has been already sent to Department of

Ltd. .

Decision: order dated 20.01.2010 of the Hon’ble H igh Court of Gujarat. present Committee considered case as per agenda and in consultation with technical authority in the meeting it has been found that despite repeated reminders 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 seale. Further will the product always contained 7% or more of impurities. It was also decided to remind the Department of C&PClong. to take appropriate action and furnish their comments as the case has been pending for The case is deferred for 09.10.2014 aMeeting No.07/AM15 dated — 11.09.2014 F.No. 01/82/050/00256/AM1 1/DES-III RLA’s File no, 24/24/040/00009/AM11 Ady. Lic. No. 2410029974 dt. 27.10.2010 Decision: It was decided to defer the case for 09.10.2014 for comments of Petrochemical division of

eeRRMeetingCase No. B-71 M/s. PIRAMAL HEALTHCARECES LTD. No.07/AM15 dated — 11.09.2014 F. No,01/82/50/256/AM13/DES-III F, No.01/82/50/261/AM13/DES-III F, No.01/82/50/260/AM13/DES-III h F. No.01/82/50/255/AM13/DES-III \ F, No.01 /82/50/928/AM12/DES-III , sUieaey Op[Becton][Goce] Vado MMS 4MV/Depariment Serene Udsed Grewan Now Deihi

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----- Start of picture text ----- tra wid’! A — adv. Lic,’No. 0310694731 dated 15.05.2012 adv. Lic, No.0310694936 dated 16.05.2012 ady. Lic. No. 0310694925 dated 16.05.2012 adv. Lic. No. 0310694706 dated 15.05.2012 Decision: adv. Lic. No. 0310642739 dated 18.07.2011 Pharmaceuticals.It was decided to defer the case for 09.10.2014 for comments of Department of Case No. B-72 M/s The Andhra Sugar Ltd. Meeting No.07/AM15 dated — 11.09.2014 F.No. 01/82/162/00917/AM 12/DES-III RA No. 26/02/040/00001/AM11 Ady, Lic. No. 2610010636 dt. 04.01.2011 25.06.2014.Decision: It was decided to withdraw the case as it had been already approved in 3/82 meeting dated Case No. B-73 M/s Haldia Petrochemicals Ltd. Meeting No.07/AM15 dated — 11.09.2014 F.No. 01/82/050/01534/AM09/DES-III Adv. Lic.No. 0210122139 dated 13.01.2009 RA F.No. 02/24/040/00248/AMO09 Decision: In the light of written comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/24/2003-PC- II dated 22.08.2014, 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. SI.No. | Import items Qty. allowed Qty. Motor Spirit / Pyrolysis 1 kg Naphtha 0.734 kg Gasoline (Py Gas) RA may take appropriate action as per the decision of Norms Committee. Case No. C-8 M/s Reliance Industries Ltd. Meeting No.07/AM15 dated — 11.09.2014 F.No. 01/82/50/00024/AM15/DES-III Decision: Committee considered the case as per agenda and In the light of written comments forwarded by Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 4601 1/55/2014- PC- II dated 16.09.2014, it was decided to amend / correctthe importitem against the published SION Nos. A-1839 A-1841 and A-1842 as details given below: SION No. From To (Import item) (Import item) SION Nos. A-| Heat Transfer Fluid (dowtherm /| Heat Transfer Fluid (dowtherm / A-18421839 A-1841 and | Santotherm 66/Terminal VP 1) Santotherm 66/Therminol VP 1) Case No. A-9 M/s Emami Biotech Ltd. Meeting F Pris ars u oe No.07/AM15 dated — 11.09.2014 F.No. 01/82/50/00108 /AM15/DES-III \N Dy. Draco 10 f& 4 Vi tay Directorate Genoa iface wPrer KAPVDepanment of Commurce Sent wet, ae face Udyog Bhawan, New Delhi ----- End of picture text -----

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----- Start of picture text ----- Decision:It was decided to call from the firm the following technical details/clarifications: * Chemicalreactions, molecular and structural formulate and molecular weights. stage wise percentage Yields  Complete material balance and flow chart of the process. CA,* Detail of by-products/co-products formed in the above production with quantities and values certified by ] + Authentic technical literature in support in support of norms applied for import. The case was deferred for 25.09.2014. [Case No.:11/20/82-ALC4/2009|PartyName:NEULAND Meet No/Date:7/82- Status:Deffered I LABORATORIES LTD ALC4/2014 11.09.2014 1 HQ File RLA File zy Lic.No/Date:0910038818 |Defer |:01/82/050/00422/AM10/ :09/24/040/00144/AM10/ 06.08.2009 Date:09.10.2014 Decision ; Copy of production and consumption data of all inputs has been received from the firm and same has been sent to Department of Pharmaceuticals for their comments. Case is deferred for (09.10.2014. Case No.:38/24/82-ALC4/2013 {Party Name:AUROBINDO Meet No/Date:7/82- Status:Approved PHARMA LIMITED ALC4/2014 11.09.2014 HQ File —_IRLA File - Lic.No/Date:0910046104 Defer Date. :01/82/050/01237/AM14/ :09/24/040/00585/AM11/ 28.03.2011 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/110/2014-PI(Norms) dated 02.09.2014, 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. Import items Qty. Allowed ke/kg Qty. 2 | Nateglinide 1kg Trans-4-Isopropyl cyclohexane carboxylic acid | D-Pheny] alanine 0.954 3 | Activated Carbon 0.040 pe] Pivaloyl Chloride 0.826 Steam/Thermal Coal As per Fuel Policy. RA may take appropriate action as per the decision of Norms Committee. me ee eer ey ee tz [3 [Case No.:4/16/82-ALC4/2011 [Party Name:BOSTIK INDIA Meet No/Date:7/82- preDy. Director \Status:Deffered \ae FTIM we ser ; 4 Directurate General of Foreign Trade altrey frvOeparument of Commerce sen sas, =f facet Udyog Bhawan, New Delhi ----- End of picture text -----

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----- Start of picture text ----- e 4 Wra— 4 } PRIVATE LIMITED ALC4/2014 | * {11.09.2014 | HQ File RLA File Lic,No/Date:0710079777 [Defer | :01/82/050/00462/AM12/ :07/24/040/00073/AM 12/ 13.06.2011 Date:09.10.2014 - Decision :It was decided to defer the case for 09.10.2014 for comments of Petrochemicals cannaDivision of Department ofChemicals and Petrochemicals. ; a Case No.:93/6/82-ALC4/2014 Party Name:SAINOR Meet No/Date:7/82- Status: Approved LABORATORIES PVT LTD ALC4/2014 11.09.2014 4 |HQ File :01/82/050/00495/AM15/ IRLA File Lic.No/Date:0910048657 —|Defer Date: :09/24/040/00234/AM12/ 08.09.2011 29.08.2014.Decision :Withdrawn as the case had already been approved by the NC in its 6/82 meeting dated i | —————_. DT } Case No,:99/6/82-ALC4/2014 Party Name:SAINOR Meet No/Date:7/82- Status: Approved LABORATORIES PVT LTD ALC4/2014 11.09.2014 i 5 |HQ File RLA File Lic.No/Date:0910050210 [Defer Date: :01/82/050/00S01/AM15/ :09/24/040/00400/AM12/ 14.12.2011 29.08.2014.Decision :: Withdrawn as the case had already been approved by the NC in its 6/82 meeting dated a "|Case No.:102/6/82-ALC4/2014 Party Name:SAINOR Meet No/Date:7/82- Status:Approved LABORATORIES PVT LTD ALC4/2014 11.09.2014 6 |HQ File RLA File Lic.No/Date:0910050978 [Defer Date: :01/82/050/00504/AM15/ :09/24/040/00472/AM12/ 25.01.2012 | [datedDecision 29.08.2014,:Withdrawn the case has been already been approved by the NC in its 6/82 meeting eee Case No.:106/6/82-ALC4/2014 Party Name:SAINOR {Meet No/Date:7/82- Status: Approved LABORATORIES PVT LTD ALC4/2014 11.09.2014 7 |HQ File IRLA File Lic.No/Date:0910051321 [Defer Date: :01/82/050/00508/AM15/ :09/24/040/00545/AM12/ 16.02.2012 datedDecision29.08.2014.: Withdrawn the case has been already been approved by the NC in its 6/82 meeting Name:HETERO Case No.:21/20/82-ALC4/2013 PartyLIMITED, DRUGS ALC4/2014[Meet No/Date7/8. Status:Deffered 11.09.2014 g {HQ File RLA File Lic.No/Date:0910052113 [Defer :01/82/050/01007/AM14/ :09/24/040/00668/AM 12/ 11.04.2012 Date:09.10.2014 ‘Decision : It was decided to defer the case for 09.10.2014 for comments of Department of [Pharmaceuticals. artment of ” SSS Peis are/NiRMAL KUMAR BY Term ed Dy, Director Gurw 18 fees eye Directorate Ce 1 mire yp yDspar, ommerce0 Trade Sei was, 1g eet Udyog Bhawan, New Deihi ----- End of picture text -----

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----- Start of picture text ----- ° ee | — Case No.:44/20/82-ALC4/2013 |Party Name:HIRAN Meet No/Date:7/82- Status:Deffered ORGOCHEM LIMITED , ALC4/2014 11.09.2014 9 |HQ File RLA File Lic.No/Date:0310692029 |Defer :01/82/050/01030/AM14/ :03/94/040/008 14/AM12/ 25.04.2012 Date:09.10.2014 Decision :It was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 09.10.2014. Case No.:76/6/82-ALC4/2014 |Party Name:SAINOR Meet No/Date:7/82- Status: Approved p LABORATORIES PVT LTD ALC4/201411.09.2014 10 |HQ File RLA File Lic.No/Date:0910052452 —_|Defer Date: ] :01/82/050/00478/AM15/ 109/24/040/00030/AM13/ |02.05.2012 | 1 Decision : Withdrawn as the case had already been approved by the NC in its 6/82 meeting dated 29.08.2014. Case No.:242/6/82-ALC4/2014 |Party Name:SATYA DEEPTHA Meet No/Date:7/82- Status: Approved PHARMACEUTICALS LTD ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910052505 {Defer Date: :01/82/050/00644/AM15/ :09/24/040/00048/AM13/ 09.05.2012 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/793/2013-PI(Norms) dated 05.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:- | Export product Exp. Qty. Qty. Allowed Kg/kg 'T | (1s, 4R)-4-[(2-AMINO-6-CHLORO- | 4 , N-(2-AMINO-4,6- 0.764 | 5-FORMAMIDO-4- g DICHLORO-5- | PYRIMIDINYL)AMINO--2-CYCLO PYRIMIDINYL) PENTENE-1-METHANOL(AFC) a Pa AZABICYCLO[2.2.1JHEPT-5-EN-3-ONE (VINCELACTAM | [3 | D@)TARTARICACID 1.06 [514| SODIUMBOROHYDRIDE _|0.226 16 __|| PYRIDINE [ISOPROPYL] ALCOHOL [1.00 18 __|METHANOLDICHLORO METHANE [4.23| RA concerned may take further necessary action as per above decision of NC. Case No.:30/13/82-ALC4/2012 {Party Name: HALDIA Meet No/Date:7/82- Status:Deffered PETROCHEMICALS LTD. ALC4/2014 11.09.2014 12 {HQ File 7 RLA File Lic.No/Date:0210177518 [Defer :01/82/050/00365/AM 13/ :02/24/040/00029/AM13/ 14.05.2012 Date:09,10.2014 An Decision :It was decided to defer the case for 09.10.2014 for comments-of Petrochemicals)... Dy. Dist rade faut eazy 1 Directorate General of F oranyn Trade TPMey FHPUDepartment of Commerce wert was, WE fees Udyog Bhawan, New Dethi ----- End of picture text -----

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~~ | Division ofDepartment of Chemicals and Petrochemicals. Case No.:28/20/82-ALC4/2013 |Party Name: HETERO LABS Meet No/Date:7/82Status:Deffered LIMITED ALC4/2014 11.09.2014 13 |HQ File RLA File Lic.No/Date:0910052608 |Defer :01/82/050/01014/AM14/ :09/24/040/00070/AM 13/ 14.05.2012 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:38/20/82-ALC4/2013 |Party Name: HETERO LABS Meet No/Date:7/82Status:Deffered LIMITED ALC4/2014 11.09.2014 14 |HQ File RLA File Lic,No/Date:0910052665 [Defer ‘ :01/82/050/01024/AM14/ :09/24/040/00069/AM13/ 17.05.2012 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. oe ‘Case No.:39/20/82-ALC4/2013 |Party Name: HETERO LABS Meet No/Date:7/82Status:Deffered LIMITED ALC4/2014 11.09.2014 15 |HQ File RLA File Lic.No/Date:0910052780 |Defer :01/82/050/01025/AM14/ :09/24/040/00094/AM13/ 25.05.2012 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals.

~ [Case No.:31/20/82-ALC4/2013 Party Name: HETERO LABS Meet No/Date:7/82Status:Deffered LIMITED ALC4/2014 11.09.2014 16 |HQ File RLA File Lic.No/Date:0910052814 |Defer :01/82/050/01017/AM14/ :09/24/040/00108/AM13/ 29.05.2012 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals.

Case No.:20/20/82-ALC4/2013 |Party Name: HETERO LABS Meet No/Date:7/82Status:Deffered LIMITED ALC4/2014 11.09.2014 17 HQ File RLA File Lic.No/Date:0910052908 — |Defer :01/82/050/01006/AM14/ :09/24/040/00127/AM13/ 07.06.2012 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of EE| ieeePharmaceuticals. | Case No.:17/20/82-ALC4/2013—ES |Party Name:CADILA — Meet No/Date:7/82Status:—EE_ Deffered ] HEALTHCARE LTD., ALC4/2014 18 11.09.2014 | HQ File RLA File Lic.No/Date:0810112512 {Defer :01/82/050/01003/AM14/ :08/24/040/00088/AM13/ 14.06.2012 Date:09.10.2014 \ ** ated TurvDeparment of Commer: Be ican how Deiht

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----- Start of picture text ----- r a . - _ et : } | ~ Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. : Case No.:18/20/82- Party Name:CADILA Meet No/Date:7/82- Status:Deffered ALC4/2013 HEALTHCARE LTD., ALC4/2014 11.09.2014 4 19 HQ File RLA File Lic.No/Date:0810112511 |Defer :01/82/050/01004/AM 14/ :08/24/040/00090/AM13/ 14.06.2012 Date:09.10.2014 Decision :It was decided to call from the firm copy of relevant DML showing composition of the export product, ] ' The case was deferred for 09.10.2014. | a : —E Case No.:19/20/82-ALC4/2013 |Party Name:CADILA Meet No/Date:7/82- Status:Deffered HEALTHCARE LTD., ALC4/2014 11.09.2014 20 |HQ File RLA File Lic.No/Date:0810112510 |Defer :01/82/050/01005/AM14/ 08/24/040/00095/AM13/ 14.06.2012 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:34/20/82-ALC4/2013 [Party Name:CADILA Meet No/Date:7/82- Status:Deffered HEALTHCARE LTD., ALC4/2014 11.09.2014 21 |HQ File RLA File Lic.No/Date:0810112516 —|Defer :01/82/050/01020/AM14/ :08/24/040/00100/AM13/ 14.06.2012 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:4/20/82-ALC4/2012 |Party Name:RANBAXY Meet No/Date:7/82- Status: Deffered LABORATORIES LTD ALC4/2014 11.09.2014 22 |HQ File RLA File Lic.No/Date:0510333154 [Defer | :01/82/050/00615/AM13/ :05/24/040/00323/AM12/ 30.08.2012 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:40/15/82-ALC4/2013 | Party Name:CALYX Meet No/Date:7/82- Status:Deffered CHEMICALS & ALC4/2014 PHARMACEUTICALS LTD. 11.09.2014 23 |HQ File RLA File Lic.No/Date:0310707994 |Defer :01/82/050/00802/AM14/ :03/94/040/00199/AM10/ 06.09.2012 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:112/33/82- Party Name:STERICAT Meet No/Date:7/82- Status: Deffered 24 |ALC4/2012 GUTSTRINGS PVT. LTD, ALC4/2014 MAY: a a11.09.2014 wot 5rapistent & " 7 oy pacha a y 3 1goredeka1Brewersot, 48 ay: [point] ] ----- End of picture text -----

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----- Start of picture text ----- “| |HQFile RLA File Lic.No/Date:0510340033 [Defer || (Decision:01/82/050/01259/AM13/: It was decided to :05/24/040/00304/AM13/defer the case for 09.10.201404.12.2012for comments of DepartmentDate:09.10.2014of IPP. Case No.:43/33/82-ALC4/2012 |Party Name:BENZO CHEM Meet No/Date:7/82- Status: Approved INDUSTRIES PRIVATE ALC4/2014 LIMITED, 11.09.2014 HQ File RLA File Lic.No/Date:0310716674 |Defer Date: :01/82/050/01190/AM13/ 103/94/040/00727/AM 13/ 07.12.2012 ----- End of picture text -----

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Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/287/2011-PI(Norms) dated 05.09.2014 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:-

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----- Start of picture text ----- 25 | Export product Exp. Qty. Qty. Allowed Ka/ka ’ | PROPIOPHENONE 12.10 |2__ 2-(N,N-DIMETHYLAMINO)-2- | [3_| SODIUM CYANIDE 0.768 PHENYL-1-BUTANOL |METHANOL 14 __ | CAUSTIC SODA FLAKES ; 15 _| DIMETHYL SULPHATE 1.019 (8 | FORMALDEHYDE [066 SYNHYDRIDE / VITRIDE 2.412 RA concerned may take further necessary action as per above decision of NC. Case No.:85/31/82-ALC4/2012 {Party Name:SANOFI INDIA _{MeetNo/Date:7/82- Status:Deffered LIMITED ALC4/2014 and Re-indexed 11.09.2014 HQ File RLA File Lic.No/Date:0310717240 {Defer 03/95/040/00465/AM13/ 14.12.2012 Date:11.09.2014 D6 [:01/82/050/01125/AM13/] ----- End of picture text -----

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Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No.

35011/230/2014-Pl(Norms) dated 16.05.2013, stated that there is no manufacturing activity involved as finished formulated injections are to be imported from France and after relabeling /packaging those injections are to be exported to Sri Lanka. Further, since it is more re-export of finishing formulations. The case was deferred for 09.10.2014

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~~ |Case No.:165/33/82Party Name:CADILA Meet No/Date:7/82Status:Deffered ALC4/2012 HEALTHCARE LTD., ALC4/2014 11.09.2014 27 HQ File “IRLA File Lic.No/Date:0810117317 {Defer |:01/82/050/01312/AM13/ :08/24/040/00257/AM13/ 02.01.2013 Date:09.10.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/361/2013-Pl(Norms) dated 11.09.2013, it was decided to call from the firm a copy of Master batch Formula duly certified by Quality -Control In charge. The case was deferred for 09.10.2014. og [Case No.:13/12/82-ALC4/2013 |Party Name:HETERO DRUGS Meet No/Date:7/82" |Status:Deffered LIMITED, ALC42014 | Direc Seorrall/of F cae artery Feitrbeparinont o Commerce uaGrewan heer Eoin

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----- Start of picture text ----- B Se ew v Raat tte > | |~ |TG 0920148—~O—~C~*~‘s«~CSW | HQ File :01/82/050/00437/AM14/ |RLA File ] Lic.No/Date:0910054735 — |Defer :09/24/040/00495/AM13/ 09.01.2013 Date:09.10.2014 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. The case was deferred for 09.10.2014. | Case No.:2/30/82-ALC4/2012 _ {Party Name: MOREPEN Meet No/Date:7/82- Status:Deffered LABORATORIES LTD.& ALC4/2014 ; MOREPEN INTERNATION 11.09.2014 } 29 [HQ File RLA File "|Lic.No/Date:0510343975 [Defer :01/82/050/01038/AM13/ :05/24/040/00389/AM13/ 23.01.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. CaseNo.:3/30/82-ALC4/2012 _ |Party Name: MOREPEN Meet No/Date:7/82- Status:Deffered LABORATORIES LTD.& ALC4/2014 MOREPEN INTERNATION 11.09.2014 30 |HQ File RLA File Lic.No/Date:0510343986 Defer :01/82/050/01039/AM13/ :05/24/040/00393/AM13/ 23.01.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:9/4/82-ALC4/2013 [Party Name:GOPALDAS Meet No/Date:7/82- ——‘[Status:Deffered VISRAM & CO.LTD, ALC4/2014 i 11.09.2014 HQ File RLA File Lic.No/Date:0310722715 [Defer :01/82/050/00050/AM 14/ :03/94/040/00945/AM 13/ 01.02.2013 Date:09.10.2014 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 31 35011/478/2014-PI(Norms) dated 05.09.2014, stated that they have examined the matter and it is noted that the reply received from the firm does not related to the present case under reference , Import item —Betamethasone Dipropinate USP. It was decided to give last reminder to 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 | _ |The case was deferred for 09.10.2014. \Case No.:151/33/82- ‘Party Name:FORACE _ Meet No/Date:7/82- Status:Deffered ALC4/2012 POLYMERS (P) LTD. ALC4/2014 11.09.2014 32 [HQ File RLA File Lic.No/Date:0510345208 Defer 1:0 1/82/050/01298/AM13/ :05/23/040/00459/AM13/ 07.02.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. [33 [{Case] ~ [ No.:7/3/82-ALC4/2013] er lei “Tam cae nh Geo |Party Name:WOCKHARDT Se{Meeteee No/Date:7/82-, een eee _|Status:Defferedoa \ G k 0 . 2 Ty Fairy; ON Teach Sei 2 a tht Of Come 3s = aveg oi A i ----- End of picture text -----

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----- Start of picture text ----- LIMITED [ALC4/2014 — — Ss ———EEe |11.09.2014 HQ File RLA File Lic.No/Date:03 10723636 |Defer lo 1/82/050/00040/AM 14/ :03/95/040/00886/AM13/ 11.02.2013 Date:09.10,.2014 Decision :It was decided to send a copy of application again to DCGI for their comments. The case was deferred for 09.10.2014. Case No.:4/4/82-ALC4/2013 |Party Name:SABERO Meet No/Date:7/82- Status:Deffered ORGANICS GUJARAT ALC4/2014 LIMITED 11.09.2014 34 |HQ File RLA File '{Lic.No/Date:0310724136 |Defer :01/82/050/00045/AM14/ :03/95/040/00880/AM 13/ 14.02.2013 Date:09.10.2014 ] DecisionChemicals and: It was Petrochemicals. decided to defer the case for 09.10.2014 for comments of Department of | —————————————— ———— = Case No.:79/1/82-ALC4/2013 |Party Name:STERICAT Meet No/Date:7/82- Status:Deffered GUTSTRINGS PVT. LTD. ALC4/2014 11.09.2014 35 [HQ File RLA File Lic.No/Date:0510346353 [Defer | :01/82/050/01437/AM13/ :05/24/040/00420/AM13/ 18.02.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of IPP. Case No.:31/8/82-ALC4/2013 |Party Name: MYLAN Meet No/Date:7/82- Status:Deffered LABORATORIES LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910055106 Defer :01/82/050/00162/AM14/ :09/24/040/00537/AM13/ 19.02.2013 Date:09.10.2014 | 36 (Decision :It was decided to remind 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 vis-a-vis Actual consumption of raw materials duly certified by Central Excise Authorities. The case was deferred for 09.10.2014. ~~ {Case No.:8/10/82-ALC4/2013 |Party Name:VIVIMED LABS —_[Meet No/Date:7/82- Status: Approved LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910055119 {Defer Date: :01/82/050/00191/AM14/ :09/24/040/00554/AM13/ 21.02.2013 Decision : Committee considered the case as per agenda and in light of written comments, received from 37 Department of Pharmaceuticals vide their OM No. 35011/744/2013-PI(Norms) dated 09.09.2014 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:- ) Exp. Import items Qty. | Export product aty. Allowed Kg/kg [ DOSSRIOPHENOL po oh 798d rd Belisle of Foreigh jvade anfirsa fHTrVOepariment of Commerce BR Re, Bt Dein! ----- End of picture text -----

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----- Start of picture text ----- E |bie] | va a | | DPQOXODIBENZO[B,F][1,4] (OR) 10,1 1-DIHYDRO-I 1- ie NITROBENZENE1-CHLORO-2- 1.137 THIAZEPINE PHENYL 0.853 CHLOROFORMATE 14|5 || n-HEXANE POLYPHOSPHORIC ACID [2.950.573 | | aaa TOLUENE 1.267 g RA concerned may take further necessary action as per above decision of NC. Case No.:108/6/82-ALC4/2014 |Party Name:SAINOR {Meet No/Date:7/82- Status: Approved LABORATORIES PVT LTD ALC4/2014 f 11.09.2014 3g |HQ File |RLA File Lic.No/Date:0910055386 {Defer Date: :01/82/050/00510/AM15/ :09/24/040/00576/AM13/ 13.03.2013 | Decision : Withdrawn as the case has been already been approved by the NC in its 6/82 meeting \dated 29.08.2014. ----- End of picture text -----

Case No.:32/8/82-ALC4/2013 |Party Name:BIOLOGICALE __|Meet No/Date:7/82Status:Deffered LTD ALC4/2014 11.09.2014 HQ File RLA File ; Lic.No/Date:0910055421 |Defer :01/82/050/00163/AM14/ :09/24/040/00607/AM13/ 19.03.2013 Date:09.10.2014

39 |Decision :Department of Biotechnology vide their letter No. BT/IL/05/382/2013-PID dated 17.04.2014 has informed that the reply received from the firm is incomplete. It was decided to give last reminder to the firm to furnish copy of Batch production record of complete Manufacturing process (up stream, down stream, formulation, filling etc.) showing quantities and use of import inputs”.

The case was deferred for 07.08.2014.

Case No.:57/10/82-ALC4/2013 {Party Name:BIOLOGICALE {Meet No/Date:7/82-—|Status:Deffered LTD ALC4/2014 11.09.2014 HQFile RLA File Lic.No/Date:0910055420 (Defer = :01/82/050/00240/AM14/ :09/24/040/00606/AM13/ 19.03.2013 Date:09.10.2014 40 |Decision :Department of Biotechnology vide their letter No. BT/IL/05/382/2013-PID dated 17.04.2014 has informed that the reply received from the firm is incomplete. It was decided to give last reminder to the firm to furnish copy of Batch production record of complete Manufacturing process (up stream, down stream, formulation, filling etc.) showing quantities and use of import inputs”. The case was deferred for 09.10.2014.

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----- Start of picture text ----- Case No.:6/10/82-ALC4/2013 {Party Name:RANBAXY |Meet No/Date:7/82- —|Status:Deffered LABORATORIES LTD ALC4/2014 11.09.2014 41 [HQ File RLA File Lic.No/Date:0510350030 [Defer :01/82/050/00189/AM14/ :05/24/040/00480/AM13/ 22.03.2013 Date:09.10.2014 Decision :It was decided to remind the firm to furnish a copy of Master batch Formula duly certifie: Quality -Control Incharge. The case was deferred for 09.10.2014. Sy 3 . ; eeEE SSS f te aiftraa fAarVDepariment of Commerce Sam ve, we fee Udyog Bhawan, New Delhi ----- End of picture text -----

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----- Start of picture text ----- oo Case No.:33/2/82-ALC4/2013 Party Name: MOREPEN Meet No/Date:7/82- Status;Deffered LABORATORIES LTD.& ALC4/2014 | MOREPEN INTERNATION 11.09.2014 142 |HQ File RLA File Lic.No/Date:0510350279 [Defer 0 1/82/050/01480/AM13/ :05/24/040/00481/AM13/ 26.03.2013 Date:09.10.2014 Decision : :Reply received from the firm and sent to Department of Pharmaceuticals for their comments. The case was deferred for 09.10.2014. Case No.:117/10/82- PartyName:PRASOL Meet No/Date:7/82- —_—‘[Status:Deffered ALC4/2013 CHEMICALS LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0310729886 [Defer :01/82/050/00300/AM14/ :03/95/040/0088 1/AM13/ 28.03.2013 Date:09.10.2014 Decision : It was decided to remind the firm to furnish the following technical details: | 1. Complete set of application | as [2.] [Details][ of][ Manufacturing] [process][ of][ 3,3,5] [Trimethyl] [Cyclohexanone] [with] [Chemical] [equations,] | molecular formula, molecular weights. 3, Yield obtained in each step. 4. Authentic technical literature in support of yield obtained. 5. Material balance. 6. CA certificate certifying the production of export item achieved by you for the past three years and corresponding consumption of each input 7. Detailed calculations, arriving at the norms applied for. The case was deferred for 09.10.2014. ----- End of picture text -----

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----- Start of picture text ----- Case No.:15/4/82-ALC4/2014 {Party Name:GITANJALI Meet No/Date:7/82- Status:Approved. CHEMICALS PVT LTD ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0310729944 —|Defer Date: :01/82/050/00263/AM15/ 103/94/040/01017/AM13/ 01.04.2013 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals 44 vide their U.O No. 14010/41/2011-Ch. II dated 13.03.2014, it was decided to ratify norms under Para 4.7 lof HBP v1 as per details given below or as applied by the firm, whichever is less: Pr [AWSOLE CRUDE WwaKoem [105k RA may take appropriate action as per the decision of Norms Committee. Case No.:17/10/82-ALC4/2013 |Party Name:RANBAXY Meet No/Date:7/82- Status:Deffered LABORATORIES LTD ALC4/2014 11.09.2014 45 {HQ File ~IRLA File Lic.No/Date:0510350968 [Defer :01/82/050/00200/AM14/ :05/24/040/00478/AM 13/ 08.04.2013 Date:09, 10.2014 Decision :Copy of application has been already sent to Department of Pharmaceutical on dated for their comments. The case is deferred for 09.10.2014. _ PricDy. Diresia= Trade= afro ReeIrvDepertment of Commorce Udyog Bhawan en Dethi ----- End of picture text -----

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----- Start of picture text ----- Z. ~ Case No.:71/4/82-ALC4/2013 |Party Name:CHIRAG Meet No/Date:7/82- _Status:Deffered ENTERPRISE ALC4/2014 11.09.2014 46 |HQ File RLA File Lic.No/Date:2410038645 {Defer :01/82/050/00112/AM14/ :24/24/040/00001/AM14/ 09.04.20 13 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Petrochemicals (Division of Department of Chemicals and Petrochemicals [Case No.:120/10/82- Party Name:MEHTA API PVT {Meet No/Date:7/82- Status:Deffered ALC4/2013 LTD ALC4/2014 11.09.2014 ; HQFile RLA:03/95/040/00020/AM14/File 09.04.2013Lic.No/Date:0310730905 [DeferDate:09.10.2014 ] ” [:01/82/050/00303/AM14/] Decision :It was decided to remind the firm to furnish the following information from the firm : |. Stepwise yield on molar basis for each step of manufacturing process, 2. Material balance for each step. 3. :) Copy of Technical Literature in support of yield claimed 4. Requirement of Calrithromycin Oxime per kg of clarithromycin, (ii) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 09.10.2014 J | Case No.:68/4/82-ALC4/2013 Party Name: HALDIA Meet No/Date:7/82- Status: Approved PETROCHEMICALS LTD. ALC4/2014 11.09.2014 HQ File RLA File - Lic.No/Date:0210188734 [DeferDate: :01/82/050/00109/AM14/ :02/24/040/00002/AM14/ 17.04.2013 Decision In the light of written comments received from Petrochemical Division of Department of | Chemicals and Petrochemicals vide their U.O No, 46011/159/2004-PC- II dated 04.07.2013, it was 4g \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 Import items Qty. allowed | Qty. Cyclopentane (IMT|[1. | Naphtha 1.158 MT RA may take appropriate action as per the decision of Norms Committee. Case No.:160/10/82- [Party Name:RIOCARE INDIA _ [Meet No/Date:7/82- Status:A pproved ALC4/2013 PRIVATE LIMITED. ALC4/2014 | 11.09.2014 HQ File RLA File Lic.No/Date:0310731584 [Defer Date: :01/82/050/00343/AM14/ :03/95/040/00024/AM 14/ 17.04.2013 ; 49 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/635/2013-PI(Norms) dated 02.09.2014 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 Simethicone (3 Export Item) Udyog Bhawan heen, ----- End of picture text -----

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----- Start of picture text ----- 7 | | Export product ~ | Import items Qty. Allowed 4 1 kg Export Product 1 orSimethicone EP 100% USP or BP Silicone Fluid/ Oil of 0.96 kg/kg relevant Viscosityrea 30%Simethicone Emulsion USP Silicone Fluid / Oil of 0.288 kg/kg relevant Viscosity‘ ‘ Dimethicone USP or BP or EP | Silicone Fluid/ Oil of | 1.01 kg/kg r Various Viscosi relevant Viscosi concerned may take further necessary action as per above decision of NC. | Case No.:3/3/82-ALC4/2013 [Party Name:LAKE Meet No/Date:7/82- Status:Deffered CHEMICALS PRIVATE ALC4/2014 50 [HQ File LIMITEDRLA File Lic.No/Date:071009492111.09.2014 [Defer z 1:0 1/82/050/00036/AM14/ :07/24/040/00003/AM14/ 18.04.2013 Date:09.10.2014 Decision :reply received from the firm and sent to department of Pharmaceuticals for their comments. The case is deferred for 09.10.2014 " [Case No.:43/10/82-ALC4/2013 [Party Name:SRINI Meet No/Date:7/82- Status:Deffered PHARMACEUTICALS LTD., |ALC4/2014 11.09.2014 51 (HQ File RLAFile Lic.No/Date:0910055800 {Defer :01/82/050/00226/AM14/ :09/24/040/00017/AM14/ 19.04.2013 Date:09.10.2014 : Decision Se eee eee : It was decided to defer the case for 09.10.2014 for comments ofDepartment of Pharmaceuticals. | [Case No.:76/14/82-ALC4/2013 Party Name:ASTRIX Meet No/Date:7/82- Status:Approved LABORATORIES LTD., ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910055845 [Defer Date: :01/82/050/00661/AM14/ :09/24/040/00611/AM13/ 23.04.2013 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No, 3501 1/751/2013-PI(Norms) dated 09.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP 52 as per details below or as applied by firm whichever is lower:- Export product Exp. Import items Qty. Qty. Allowed| | Kg/kg EMTRICITABINE| 1 kg (2R,5S)-5-(4-Amino-5-fluoro-2-oxo-2H- | pyrimidin-1-yl)-[1,3]oxathiolane-2- carboxylicacid-2S-Isopropyl-5R-Methyl- IR- / cyclohexyl ester (FCE 13 _| SodiumDi potassium borohydride hydrogen phosphate Fe 8:64).2.075 ]. it)\1 a Vv. Dives i han ee Bi Dicense es cere MENTE vy sl + New Delhi ----- End of picture text -----

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—_ 14_|= e [Isopropyl] —_ alcohol — |6 |SSSMethanol BB }8_| [Methylene] [dichloride] |RA concerned may take further necessary action as per above decision of NC. ; | {Case No.:4/7/82-ALC4/2014 Party Name:SAINOR Meet No/Date:7/82- Status:Approved LABORATORIES PVT LTD ALC4/2014 {11.09.2014 HQ File RLA File _ |Lic.No/Date:0910055923 [Defer Date: : :01/82/050/00648/AM15/ :09/24/040/00035/AM14/ 02.05.2013 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/112/2010-Ch. || dated 29.08.2014, it was decided to ratify norms under Para 4.7 53 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. allowed | N Qty.1kg [1 | NBUTYLCHLORIDE | 0.200ke MAGNESIUM BUTYL TETRAHYDROFURAN 1.00 kg CHLORIDE 24% RA may take appropriate action as per the decision of Norms Committee, i [Case No.:18/7/82-ALC4/2014 Party Name: VIVIN ~ [Meet No/Date:7/82- Status:Deffered LABORATORIES PRIVATE ALC4/2014 LIMITED 11.09.2014 54 HQ File :01/82/050/00662/AM15/ |RLA File Lic.No/Date:0910055914 [Defer “| Decision :09/24/040/00624/AM13/ 02.05.2013 Date:09.10.2014 : : It was decided to defer the case for 09.10.2014 for comments ofDepartment of Pharmaceuticals. Case No.:6/7/82-ALC4/2014 Party Name:RA CHEM Meet No/Date:7/82- Status:Deffered PHARMA LIMITED ALC4/2014 11.09.2014 55 |HQ File :01/82/050/00650/AM15/ [RLA File ~ {Lic.No/Date:0910055932 [Defer | :09/24/040/00043/AM14/ 03.05.2013 all 10.2014 Decision9.102014): It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:9/7/82-ALC4/2014__ Party Name: VIRCHOW {Meet No/Date:7/82- Status: Approved PETROCHEMICAL PVT LTD. |ALC4/2014 11.09.2014 56 HQ File - |RLA File 7 Lic,No/Date:0910055941 [Defer Date: |:01/82/050/00653/AM15/ |:09/24/040/00600/AM13/ (06.05.2013 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/63/2013-Pl(Norms) dated 22.09.2014 and in/ enconsultation with technicalanna nO.authority AG.present SSin meeting, decided to oTratify norms under; pata_.4.7ofesHBP MAR RS Perey a yer “aun Trae UdyogSey Bhawanara wea!Weeof CommerceED ----- End of picture text -----

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----- Start of picture text ----- as per details below or as applied by firm whichever is lower:- “| | Export product Exp. Qty. Qty. Allowed Kg/kg 7- PHENYLACETAMIDEO- PENICILLIN G-POTASSIUM 3-CHLOROMETHYL FIRST CRYSTAL : | CEPHALOSPORONIC ACID [2 |ACETONE SSCSCSC*di«SL«974 PARA METHOXYBENZYL |3_| ISOPROPYL ALCOHOL }066 i ESTER (GCLE) |4 | DIMETHYL FORMAMIDE 1.314 [5 _ | METHYLENE CHLORIDE |6 | 2 MERCAPTO BENZO THIAZOLE | METHANOL 0.511|1.971 RA concerned may take further necessary action as per above decision of NC. Case No.:170/10/82- Party Name:AGOG PHARMA _|Meet No/Date:7/82- Status:Approved ALC4/2013 LTD. ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0310733767 |Defer Date: :01/82/050/00353/AM14/ :03/94/040/00075/AM14/ 09.05.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/38/2014-PI(Norms) dated 09.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 57 of HBP as per details below or as applied by firm whichever is lower:- ----- End of picture text -----

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----- Start of picture text ----- || Export product Qty.Exp. Import items AllowedQty. AGOPEN-250 TABLETS PHENOXYMETHYLPENICILLIN wtih| eee TABLETS 250mg mag/tablets RA concerned may take further necessary action as per above decision of NC. Case No.:7/7/82-ALC4/2014 {Party Name:RA CHEM Meet No/Date:7/82- Status:Approved PHARMA LIMITED ALC4/2014 11.09.2014 HQ File RLA File "{Lic.No/Date:0910055973 [Defer Date: :01/82/050/00651/AM15/ :09/24/040/00047/AM14/ 09.05.2013 58 Decision :In the light of written comments received from Department of Pharmaceuticals vide |their OM No. 35011/803/2013-PI(Norms) dated 09.09.2014, and it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export S.No | Import Product Quantity Quanti Allowed kg/ke || RACTOPAMINE HCL lkg 4-(4-Hydroxy Phenyl) -2- | 0.910 ~h\ |\ Butanone Pe ensiy ayer Tayi erey Directorate General of F feign Trade aaiProg BervDepartment of Commerce Udyog Bhawan Weer eons ----- End of picture text -----

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----- Start of picture text ----- ww 11.09.2014 | HQ File :01/82/050/00654/AM15/ |RLA File Lic.No/Date:0910056003 [Defer :09/24/040/00059/AM 14/ 16.05.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:14/20/82-ALC4/2013 {Party Name:DIVIS Meet No/Date:7/82- Status:Approved PHARMACEUTICALS ALC4/2014 } PRIVATE LIMITED 11.09.2014 HQ File RLA File Lic.No/Date:0910056018 — [Defer Date: :01/82/050/01000/AM14/ 109/24/040/00016/AM14/ 17.05.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/219/2014-PI(Norms) dated 02.09.2014 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:- 63 | Export product Exp. Import items Qty. Qty. Allowed | Ka/ka FLUOXETINE HCL BENZALDEHYDE 1.687 '2 | ISO PROPYL ALCOHOL 13 | PALLADIUM 0.008 '4___| PARAFORMALDEHYDE 0.016 |5 [|] [ACETOPHENONE] [6 | SODIUM BORO HYDRIDE DIMETHYL SULPHOXIDE (2.29| TRIFLUORIDEPARA CHLORO BENZO ae | RA concerned may take further necessary action as per above decision of NC. Case No.:11/7/82-ALC4/2014 Party Name:SRINI Meet No/Date:7/82- Status: Deffered PHARMACEUTICALS LTD., ALC4/2014 11.09.2014 64 |HQ File :01/82/050/00655/AM15/ |RLA File Lic.No/Date:0910056024 [Defer :09/24/040/00062/AM14/ 17.05.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:52/13/82-ALC4/2013 |Party Name:STERICON Meet No/Date:7/82- Status:Deffered PHARMA PVT.LTD., JALC4/2014 11.09.2014 65 |HQ File RLA File Lic.No/Date:0710095454 |Defer :01/82/050/00528/AM14/ :07/24/040/00039/AM14/ 17.05.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. 66 Case No.:8/7/82-ALC4/2014 PartySCIENCES LIMITED Name:SUVEN LIFE " {11.09.2014\ALC4/2014[Meet No/Date:7/82- fitterGu ales,anon,Status:DefferedUMA\\ Directorate General ot Faces aafersq Ret Department ot Commis uayegBhawan, Noe Eoin ----- End of picture text -----

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----- Start of picture text ----- :————————— | HQ File :01/82/050/00652/AM15/ |RLA File Lic.No/Date:0910056039 Defer 109/24/040/00049/AM14/ 17.05.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:12/7/82-ALC4/2014{Party Name:VIVIMED LABS —_|Meet No/Date:7/82- Status: Deffered LIMITED ALC4/2014 1 11,09,2014 67 HQ File :01/82/050/00656/AM15/ |RLA File Lic.No/Date:0910056017 [Defer :09/24/040/00060/AM14/ 17.05.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department ofC&PC. | q = Case No.:19/7/82-ALC4/2014 Party Name:COVALENT Meet No/Date:7/82- Status:Deffered | LABORATORIES PRIVATE ALC4/2014 | LIMITED 11.09.2014 68 |HQ File :01/82/050/00663/AM15/ |RLA File Lic.No/Date:0910056083 = |Defer :09/24/040/00325/AM13/ 21.05.2013 Date:09. 10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:10/20/82-ALC4/2013 |Party Name:DIVIS Meet No/Date:7/82- Status: Approved ; LABORATORIES LTD., ALC4/2014 ‘ 11.09.2014 HQ File RLA File Lic.No/Date:0910056098 | Defer Date: :01/82/050/00996/AM14/ 09/24/040/00057/AM14/ 22.05.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/109/2014-PI(Norms) dated 02.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP 69 88 Per details below or as applied by firm whichever is lower:- | Export product Exp. ty. Qty. Allowed | TE a[METHANOL [2[3[4 |||ORTHOXYLENEETHYLTRIFLUOROACETATETTACETONITRLE «AZ| 1.83 RA concerned may take further necessary action as per above decision of NC. Case No.:13/20/82-ALC4/2013 |Party Name: HETERO LABS Meet No/Date:7/82- Status: Deffered LIMITED ALC4/2014 11.09.2014 70 {HQ File RLA File Lic.No/Date:0910056096 |Defer :01/82/050/00999/AM 14/ :09/24/040/00068/AM14/ 22.05.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. ae Case No.:132/14/82- Party Name:BLUE DIP Meet No/Date:7/825 S37 =~ “(Statiis:Deffened,ak \. | saievenBeaTDeparoo: Bhawan,. oe FerNEEof ©"CommercBi,Trad e ----- End of picture text -----

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----- Start of picture text ----- Ee: i es :a| | f | ( | — ————— —EE ALC4/2013 ORGANIC INDUSTRIES, ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0310735418 {Defer :01/82/050/00717/AM14/ :03/94/040/00067/AM14/ 23.05.2013 Date:09.10.2014 Dae‘Decision :It was decided to d e fer the case forCe 09.10.2014Ee forAOE comments of Department ofC&PC, Case No.:14/6/82-ALC4/2014 |Party Name:GLAND PHARMA Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11.09.2014 72 |HQ File RLA File Lic.No/Date:0910056109 —|Defer 0 1/82/050/004 16/AM15/ :09/24/040/00065/AM14/ 23.05.2013 Date:09.10.2014 ye) as war 44 rn Anfnn tha nanan fn TO eeSSsSsSSSsSSsSS————S Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:12/20/82-ALC4/2013 |Party Name:GLAND PHARMA [Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 | 11.09.2014 73 |HQ File RLA File Lic.No/Date:0910056108 [Defer :01/82/050/00998/AM14/ :09/24/040/00061/AM14/ 23.05.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:14/7/82-ALC4/2014 {Party Name:SUVEN LIFE. Meet No/Date:7/82- Status: Approved SCIENCES LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910056111 [Defer Date: :01/82/050/00658/AM15/ :09/24/040/00073/AM14/ 23.05.2013 Decision :: Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No, 3501 1/483/2013-PI(Norms) dated 21.10.2013 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP 74 as per details below or as applied by firm whichever is lower:- Export product Exp. Qty. Qty. Allowed K e/k q 1.587 RA concerned may take further necessary action as per above decision of NC. Case No.:134/14/82- Party Name:CALYX Meet No/Date:7/82- Status:Deffered ALC4/2013 CHEMICALS & ALC4/2014 75 PHARMACEUTICALS LTD. 11.09.2014 {HQ File RLA File ~~ {Lic.No/Date:0310735499 [Defer :01/82/050/00719/AM14/ :03/94/040/00508/AM13/ 24.05.2013 Pri Date:09.10,2014 Decision :It was decided to defer the case for 09.10.2014 for commelits’of Jepartment, of Y wee Pepanmens aan he Loyeg BIO ‘.baCommerce meow Dein} ----- End of picture text -----

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----- Start of picture text ----- P 2 . | Pharmaceuticals | ~|Case No.:92/14/82-ALC4/2013 Party Name:INDO PHYTO Meet No/Date:7/82- Status: Approved CHEMICALS PVT LTD ALC4/2014 11.09.2014 HQ File RLA File ‘{Lic.No/Date:0510355138 [Defer Date: :01/82/050/00677/AM 14/ :05/23/040/00043/AM14/ 24.05.2013 f Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/781/2013-PI(Norms) dated 09.09.2014 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:- 16 Export product Exp. Import items Qty. Qty. Allowed Kg/kg Lynestrenol 19-Nor-4-Androstene-3,17-Dione | 1.40 Bulk Drug Intermediate | TetrahydrofuranSolvent = | Reagent1,2 Ethane Dithiol 0.48 aa ReagentSodium Borohydride RA concerned may take further necessary action as per above decision of NC. { Case No.:207/10/82- Party Name:CHIRAG Meet No/Date:7/82- Status:Deffered ALC4/2013 ENTERPRISE ALC4/2014 11.09.2014 77 |HQ File RLA File Lic.No/Date:2410038996 |Defer :01/82/050/00390/AM 14/ :24/24/040/00008/AM14/ 27.05.2013 Date:09.10,.2014 Decision :It was decided to defer the case for 09.10.2014 for comments Petrochemical Division | of Department of C&PC. Case No.:17/7/82-ALC4/2014 |Party Name:SRINI Meet No/Date:7/82- Status: Approved PHARMACEUTICALS LTD., |ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910056133 |Defer Date: :01/82/050/00661/AM15/ :09/24/040/00080/AM14/ 27.05.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/771/2013-PI(Norms) dated 02.09.2014 and in ye consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- | Export product Exp. Import items Qty. Qty. Allowed Kg/kg FREGABALIN a La R-(-)-3-(CARBAMOYLMETHYL)-5-METHYL HEXANOIC ACID 1.47 r a 6aiforomDirectorateeaeFRIPUDSPONNeaGore Sratmentot FereonofFee CommerceTrace | ----- End of picture text -----

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----- Start of picture text ----- | lea concerned may take further necessary action as per above decision of NC. Case No.:13/7/82-ALC4/2014 Party Name: VIRCHOW Meet No/Date:7/82- Status: PETROCHEMICAL PVT LTD. |ALC4/2014 Approved 11.09.2014 HQ File :01/82/050/00657/AM15/ |RLA File Lic.No/Date:09 10056135 Defer Date: I | :09/24/040/00018/AM14/ 27.05.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/63/2013-Pl(Norms) dated 22.09.2014 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:- 719 | Export product Qty.Exp. AllowedQty. | 7- Kg/kg | 3-CHLOROMETHYLPHENYLACETAMIDEO- 1kg pe PENICILLINFIRST CRYSTAL G-POTASSIUM CEPHALOSPORONIC ACID 12. [ACETONE —~—SSC@dS~S4,OT7A | PARA METHOXYBENZYL ISOPROPYL ALCOHOL 10.66 si | ESTER (GCLE) 14 | DIMETHYL FORMAMIDE 11.314 ||15[6|| METHYLENEMETHANOL2MERCAPTO CHLORIDE BENZO THIAZOLE |0.51113.291.971 || RA concerned may take further necessary action as per above decision of NC. Case No.: 16/7/82-ALC4/2014 Party Name: VIRCHOW Meet No/Date:7/82- Status: PETROCHEMICAL PVT LTD, |ALC4/2014 Approved 11.09,2014 HQ File :01/82/050/00660/AM15/ |RLA File Lic.No/Date:0910056134 [Defer Date: :09/24/040/00064/AM14/ 27.05.2013 Decision : Committee considered the case as per agenda and in light of written comments received from | Department of Pharmaceuticals vide their OM No. 3501 1/63/2013-PI(Norms) dated 22.09.2014 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: 80 | Export product Exp. Import items Qty. Qty. Allowed Ka/ka 3-CHLOROMETHYL7- PHENYLACETAMIDEO- ft] PENICILLINFIRST CRYSTAL G-POTASSIUM CEPHALOSPORONIC ACID ACETONE 1.971 ESTERPARA METHOXYBENZYL (3 | ISOPROPYL ALCOHOL 10.66| (GCLE) 14 | DIMETHYL FORMAMIDE 1.314 [615 __ || METHYLENE2MERCAPTO CHLORIDE BENZO THIAZOLE | [0.511_|] 13.29| METHANOL 1.971 | _ Priel qrie snes av rule, Dy. Directey( ; fate Directorate Ge sanjn Trade TIMED FHT VDopanment of Commores uayeg Ghawan:| Ess ----- End of picture text -----

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----- Start of picture text ----- ; — | bee concerned may take further nec e ssary action as per above decisione of NC. Case No.:71/10/82-ALC4/2013 |Party Name:SCOTT-EDIL Meet No/Date:7/82- Status:Deffered PHARMACIA LTD., ALC4/2014 11.09.2014 8} |HQ File RLA File Lic.No/Date:2210013890 |Defer b :01/82/050/00254/AM14/ :22/24/040/00016/AM14/ 28.05.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:44/15/82-ALC4/2013 |Party Name:IPCA Meet No/Date:7/82- Status: Approved LABORATORIES LIMITED ALC4/2014 11.09.2014 HQ File RLA File (Lic. No/Date:0310735991 [DeferDate: :01/82/050/00806/AM14/ :03/94/040/00103/AM 14/ 129.05.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/23/2014-PI(Norms) dated 22.09.2014 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:- 82 Export product Exp. Qty. | Qty. Allowed | Ke/kg | NABUMETONE 6 Methoxy-2-Naphthaldehyde | Iso Propyl Alcohol | RA concerned may take further necessary action as per above decision of NC, Case No.:225/10/82- Party Name:APEX Meet No/Date:7/82- Status:Deffered ALC4/2013 HEALTHCARE LTD ALC4/2014 11.09.2014 83 |HQ File RLA File Lic.No/Date:3410037038 |Defer :01/82/050/00408/AM14/ :34/24/040/00035/AM14/ 31.05.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:96/10/82-ALC4/2013 |Party Name: TORRENT Meet No/Date:7/82- ——‘([Status:Deffered PHARMACEUTICALS LTD. ALC4/2014 11.09.2014 $4 |HQ File RLA File Lic.No/Date:0810121573 |Defer :01/82/050/00279/AM 14/ |:08/24/040/00085/AM 14/ 31.05.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of eee Pharmaceuticals. Prter weare/nienat Ay) Dy. Dirocior ' ie Directorate Gar 1} ion Trade APE PAPVDeparnwe of Commerce Ud ER ay Bee ----- End of picture text -----

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~ Case No.:6/6/82-ALC4/2013 |Party Name: HETERO LABS Meet No/Date:7/82Status:Deffered |LIMITED ALC4/201411.09.2014 g5 HQ File RLA File Lic.No/Date:0910056251 |Defer :01/82/050/00129/AM14/ :09/24/040/00097/AM14/ 05.06.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:109/10/82Party Name:IND-SWIFT Meet No/Date:7/82Status: Approved ALC4/2013 LABORATORIES LTD., ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:2210013931 |Defer Date: :01/82/050/00292/AM 14/ :22/24/040/00022/AM14/ 11.06.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2013-PI(Norms) dated 02.09.2014 and in | consultationas per details withbelowtechnical authority presentor as applied by firm whicheverin meeting,is lower:-decided to ratify norms under para 4.7 of HBP

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----- Start of picture text ----- | Kg/kg Erythromycin Oxime | 1.988 Base ; ‘ |2.__| 2-Ethoxy Propene 0.686 Cranireaiyemn ane 3 Methylene 8.836 Dichloride [4 | Methanol ___| Not required in the [5 | Toluene __| process given by the }6. |Acetone| firm RA concerned may take further necessary action as per above decision of NC. Case No.:199/10/82- Party Name:MALLADI DRUGS Meet No/Date:7/82- Status: Approved ALC4/2013 & PHARMACEUTICALS ALC4/2014 LIMITED 11.09.2014 HQ File RLA File Lie. No/Date:0410147196 [Defer Date: :01/82/050/00382/AM 14/ :04/24/040/00048/AM14/ 17.06.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/187/2013-PI(Norms) dated 09.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP 87 |as per details below or as applied by firm whichever is lower:- ’ aty. Kg/kg | 2-Fluoro-ara-adenine | Triacetate 2| [Tetrahydrofuran] | Trifluoromethane 0.94 hy sulfonic anhydride Refer grare/NIRMAL KYM 0 T+Dy, Directoroj pake pOGeneral > KIT,Seah aA Uh:OL, PT aS oe rocentaa Trade ar] TD] sahil SOTTO Ue yan Now Delhi ----- End of picture text -----

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----- Start of picture text ----- FE : _ ee F ~~ | [s__T Ethyl Acetate [780 im | | | |6. [Tolu|Ac e netone—sf0.16 0 93.SSS~S6 s—“C* ~ s~SCS~ * ™YSS Acetic 8.79 " Anhydride concerned may take further necessary action as per above decision of NC. SSS SSS EEE Per Shove Cociaion ofNC. Case No.:40/12/82-ALC4/2013 {Party Meet No/Date:7/82- |Status:Deffered Name:SMILAX LABORATORIE ALC4/2014 HQ S LIMITED {11.09.2014 88 File RLA File :09/24/040/001 13/AM14/ |Lic.No/Date:091005635 [Defer |:01/82/050/00464/AM14/ 5 Date:09.10.2014 17.06.2013 Decision :It was decided to defer the case for 09. 10.2014 for comments ofDepartment of Pharmaceuticals. ee | [Case No.:18/13/82-ALC4/2013 | PartyName:STERICON Meet No/Date:7/82- Status: Approved | PHARMA PVT.LTD., ALC4/2014 | 11.09.2014 j ] | HQ:01/82/050/00494/AM14/ File ~— IRLA:07/24/040/00075/AMFile 14/ Lic.No/Date:071009597317.06.2013 _ [Defer Date: | Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/747/2013-PI(Norms) dated 09.09.2014 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 Prod BOOTS PHARMACEUTICALS DRY EYES EYE DROP- Export product Import Recommended 89 | SODIUM Packing Materials HYALURONATE NaF 100 | BOOTS Relevant, Net To Net 1 PHARMACEUTICALS DRY 0.01 gm /bottle EYES EYE DROP-10 ml VIZULIZE MOISTURING Relevant, Net To Net AND COMFORT EYE 0.01 gm /bottle DROPS-10ML BOOTS Relevant, Net To Net | PHARMACEUTICALSEYES INTENSIVE EYE DRY 0.03 gm Jbottie DROPS-10ML | VIZULISE INTENSIVE- Relevant, Net To Net j‘ MOISTURIZING AND COMFORT EYE DROPS- 0.03 gin bottle LOML Peis mere sniensaslt WY) Dy, Dirertess a hi ----- End of picture text -----

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----- Start of picture text ----- er a~ | | : } | DROPS 10ML | 1 TESCO REFRESHINGEYE] | Relevant, Net To Net | VIZULIZEBRIGHTENER EYE10ML Relevant, Net To Net T VIZULIZE LUBRICATING Relevant, Net To Net AND REWETTING EYE NIL DROPS-10ML 1 RA concerned may take further necessary action as per above decision of NC. 1 | = —- _—— | |Case No.:23/12/82-ALC4/2013 Party Name:CIRON DRUGS & [Meet No/Date:7/82- Status:Deffered PHARMACEUTICALS P, LTD., |ALC4/2014 ~ 90/HQFile 11.09.2014 :01/82/050/00447/AM14/ RLA File ‘Lic. No/Date:0310738255 [Defer Decision :03/94/040/00094/AM14/ 19.06.2013 Date:09.10.2014 Pharmaceuticals,: It was decided to defer the case for 09.10.2014 for comments of Department of a — i Case No.:22/12/82-ALC4/2013 Party Name:INDOFIL Meet No/Date:7/82- Status:Deffered INDUSTRIES LTD. ALC4/2014 91 THQFile RLA File Lic.No/Date:031073840411,09.2014 _ [Defer :01/82/050/00446/AM14/ :03/94/040/00197/AM14/ 20.06.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments ofDepartment of C&PC. B Case No.:19/13/82-ALC4/2013 |Party Name:BOSTIK INDIA Meet No/Date:7/82- __|Status:Deffered PRIVATE LIMITED ALC4/2014 HQ 11.09.2014 File oe RLA File [Lie No/Date:0710096186 [Defer | :01/82/050/00495/AM14/ :07/24/040/00502/AM13/ 25.06.2013 Date:09.10.2014 Decisionqe:In the light of written commentsSSS received from Petrochemical DivisionES of Department of Chemicals and Petrochemicals vide their OM No. 4601 1/45/2010-PC-II dated 14.08.2014, it was decided to call from the firm the following technical details: 1. Technical specification % composition (by weight) along with specific end use/application and use/application and the copy of export order for the export product i.e. Hardener for water based Polyurethane Adhesive may be furnished. 92 |2.be Detailsindicated and quantity of other ind igenous input to be used in the manufacture of the export product may : 3. Detailed manufacturing process along with balanced chemical reaction indicating % yield/wastage along with balanced chemical reaction indicating % yield/wastage along with technical Justification for wastage alongfurnished. with technical justification for wastage at each stage and also on each of the raw material may be | ; 4, Complete material balance indicating input and output material at each stage of manufacturing process, 5. Details of production of export product under reference and corresponding consumption of raw material in the year 2012-13 and 2013-14 duly certified by CA may be furnished. Ifthe production has not CA.commenced in the past, the details from commencement ofproduction may be furnished duly certified by 8. Any other relevant information, The eter PATE / Nir nsay Ar case was deferred for 09.10.2014 Dy. Dinnte ad TPTeCtorate TEY RapGe,eparmen:‘ of Comnsice+ ViINT a ----- End of picture text -----

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Case No.:111/10/82Party Name:STERICAT Meet No/Date:7/82Status:Deffered ALC4/2013 GUTSTRINGS PVT. LTD. ALC4/2014 11.09.2014 93 THQ File RLA File Lic.No/Date:0510358000——————— [Defer :01/82/050/00294/AM 14/ :05/24/040/0009 1/AM14/ 25.06.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of IPP. Case No.:90/14/82PartyName:MYLANMeet No/Date:7/82Status: ALC4/2013 LABORATORIES LIMITED |ALC4/2014 Approved 11.09.2014 HQ File RLA File Lic.No/Date:0910056460 |Defer Date: :01/82/050/00675/AM14/ :09/24/040/00128/AM14/ 26.06.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/786/2013-PI(Norms) dated 02.09.2014 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:-

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----- Start of picture text ----- g/kg | ((S)-5-Chloro-Alpha- | 0.987 (cyclopropylethyny])- EFAVIRENZ BETA 1kg 2-Amino-Alpha FORM (EFB) (trifluoro methyl) Benzene methanol [2Ee | TriPhosgene 10.448 RA concerned may take further necessary action as per above decision of NC. Case No,:203/10/82- Party Name:SHASUN Meet No/Date:7/82- ——‘([Status:Deffered ALC4/2013 PHARMACEUTICALS ALC4/2014 LIMITED 11.09.2014 95 |HQ File RLA File ||Lic.No/Date:0410147556 {Defer :01/82/050/00386/AM 14/ :04/24/040/00064/AM14/ 27.06.2013 Date:09.10.2014 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 09.10.2014. Case No.:204/10/82- Party Name:SHASUN Meet No/Date:7/82- Status:Deffered ALC4/2013 PHARMACEUTICALS ALC4/2014 , LIMITED 11.09.2014 96 |HQ File RLA File Lic.No/Date:0410147559 {Defer :01/82/050/00387/AM14/ :04/24/040/00065/AM14/ 27.06.2013 Date:09.10.2014 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 09.10.2014. 97 Case No.:41/8/82-ALC4/2013 |Party Name: UNITED [MeetNo/Date:7/82- Status: mi PySoy werrers ip ree HUMTAR Laven Bineran Wea Baty ----- End of picture text -----

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----- Start of picture text ----- E | —_— _ _— ~ FSE ee$$ 7] [PHOSPHORUS LTD. ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0310739495 [Defer Date: :01/82/050/00172/AM14/ :03/95/040/01020/AM13/ 28.06.2013 Decision :In the light of written comments received from Department of Chemicals and Petrochemicals | vide their U.O No. 15022/22/2012-Ch II dated 18.07.2014, 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 eoQty. Qty. allowed Phenyl Chloroformate = /1kg |41. [ Phenol |__| 2. ——=i|CO.666Ethylene Dichloride 0.292 kg RA may take appropriate action as per the decision of Norms Committee. Case No.:173/14/82- Party Name:ALEMBIC Meet No/Date:7/82- Status: Approved | ALC4/2013 PHARMACEUTICALS LTD ALC4/2014 11.09.2014 HQ File IRLA File Lic.No/Date:3410037281 [Defer Date: | :01/82/050/00758/AM 14/ 14/ :34/24/040/00065/AM14/ 01.07.2013 ----- End of picture text -----

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----- Start of picture text ----- | :01/82/050/00758/AM 14/ 14/ :34/24/040/00065/AM14/ 01.07.2013 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/02/2014-PI(Norms) dated 24.09.2014 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 =a hana Import items Qty. Allowed 98 1 Methyl(2S)-2-{[2Cyano- Valsartan 1,1-bipehyl-4-yl)methyl] | amino}-3-methyl butanoate | 1.455 kge/kg ethanedioate (Bi phenyl | 1kg valine oxalate) | 2.486 lit/kg 12.545 lit/kg | Methylene chloride (or dichloromethane | (4 [Acetone =| 0.002 tk RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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----- Start of picture text ----- Case No.:64/13/82-ALC4/2013 |Party Name:EAGLE Meet No/Date:7/82- Status:Deffered CHEMICAL WORKS ALC4/2014 11.09.2014 99 HQ File RLA File Lic.No/Date:0310740489 {Defer :01/82/050/00540/AM14/ :03/94/040/00019/AM 14/ 05.07.2013 Date:09.10.2014 Decision :It was decided to remind the firm to furnish the following technical details: | ——— = iDy. msDiroctorae?Gona NIRMALnn, (U8) “KUMAerase oie, BIN EY "wifreeree” ----- End of picture text -----

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----- Start of picture text ----- : a Copy of technical literature in support of yield envisaged in the process past production vis-a-vis Actual consumption of all inputs duly certified by Central Excise Authorities. The case was deferred for 09.10.2014. a Case No.:41/13/82-ALC4/2013 Party Name:JAGSONPAL [Meet No/Date:7/82- Status: Deffered ; PHARMACEUTICALS LTD, |ALC4/201411.09.2014 HQ File RLA File ~ [Lic.No/Date:0510359156 [Defer :01/82/050/00517/AM14/ :05/23/040/00056/AM 14/ 09.07.2013 Date:09.10.2014 eslatan clhane du se 910.2014 100 Decision :It was decided to remind the firm to furnish the following technical details: |1. Copy of valid Drug Manufacturing Licence alonwith list of approved items showing the composition of export product, |2. The firm has given license for the import of 1000 kg Indomethacin from China. ]ustification for claiming import of indomethacin Mixed Pellet 53% may be furnished, 3. COA from Foreign Supplier for the import of Indomethacin Mixed Pellet 53%. ----- End of picture text -----

The case was deferred for 09.10.2014

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Case No.:27/13/82-ALC4/2013 Party Name:ADVY Meet No/Date:7/82Status: Deffered CHEMICAL PVT.LTD, ALC4/2014 11.09.2014 101 |HQ File RLA File Lic.No/Date:0310740927 [Defer :01/82/050/00503/AM14/ :03/94/040/00269/AM 14/ 10.07.2013 Date:25.09.2014 Decision :It was decided to sent a copy of application again to department of |Biotechnology for their comments.The case was deferred for 25.09.2014 Case No.:44/12/82-ALC4/2013 |Party Name:ENCUBE Meet No/Date:7/82—-|(Status:Deffered ETHICALS PVT LTD ALC4/2014 11,09.2014 HQ File RLA File Lic,No/Date:03 10740922 Defer :01/82/050/00468/AM 14/ :03/94/040/00306/AM14/ 10.07.2013 Date:09.10.2014 Decisiona.oenO.10-2014 | 02.09.2014,:Department of Pharmaceuticals, vide their OM No. 3501 1/647/2013-PI(Norms) dated mentioned have informed that they have examined the reply received from the firm wherein it is Kollwas that the input appearing at S.No, 1,8,15,22 and 29 is CETOSTEARYL ALCOHOL (Brand 102 CSA 50 or any other) because this input is utilized in the manufacture of the export product (Ref: RG:VC:DGFT:6 dt 14.12.2013. It has been also simultaneously mentioned that the input is correctly mentioned in the Master Batch Formula which was furnished by the firm vide their letter dated 14.12.2013. In the above context, it may be stated that in the Master Batch Formula for Myoflex Cream 10% , 15% and 20% strength, the relevant input is mentioned as CETYL ALCOHOL NF (speziol C16 Pharm) whereas in the firm's letter RG:VC:DGFT:6 dt 14.12.2013, it has been emphasized repeatedly that the said input is actually; CETOSTEARYL ALCOHOL (Brand Kollwas CSA 50 or any other) and that the essential amendment be carried-out in the description of the input while fixing the norms . The request is therefore confusing and the firm may be advised to explain such contradictory statements, which cause delay in the fixation of norms. The firm may also be advised to clarify the actual import description of the said input. The case was deferred for 09.10.2014. 103 Case No.:160/14/82[Party Name:ALCHYMARS [Meet No/Date:7/82. Status:Deffered . |ALC4/2013 ICM SM PRIVATE LIMITED |ALC4/201411.09.2014 ster ge ant { Yt Dy. Diractar Gores al ott 4) ight Tea pies!iconoiama aes fPrvDepanment pepe ena Uayen Bhan yes Dethi

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----- Start of picture text ----- | o HQ File RLA File '|Lic.No/Date:0410147942 Defer :01/82/050/00745/AM14/ :04/24/040/00050/AM14/ 11.07.2013 Date:25.09.2014 Decision ; It was decided to defer the case for 25.09.2014 for comments of Department of Pharmaceuticals. Case No.:28/14/82-ALC4/2013 Party Name:STERICON Meet No/Date:7/82- Status: Approved PHARMA PYT.LTD., ALC4/2014 11.09.2014 HQ File ~— {RLA File Lic.No/Date:0710096793 [Defer Date: :01/82/050/006 13/AM14/ :07/24/040/00107/AM14/ 17.07.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/766/2013-PI(Norms) dated 05.09.2014 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:- 104 |VIZULIZEExport Product MOISTURIZING AND COMFORT EYE DROPS Import Item For Export of 1 No. Bottle Export Item | Export Item | Export Item | Export Item [7 [_[Sorrnorrce] No. 1 No. 2 No. 3 No. 4 [2 |wurrecapssizio01oso | [3 | Relevant as per packing policy [4 |[soowwvacunonareoxoprer ooo | [001 gm [003 gm RA concerned may take further necessary action as per above decision of NC. Case No.:28/13/82-ALC4/2013 |Party Name:RANBAXY Meet No/Date:7/82- Status:Deffered LABORATORIES LTD ALC4/2014 11.09.2014 105 {HQ File RLA File Lic.No/Date:05 10360180 [Defer :01/82/050/00504/AM 14/ 05/24/040/00114/AM14/ 18.07.2013 Date:25.09.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:81/13/82-ALC4/2013 |Party Name:IND-SWIFT Meet No/Date:7/82- Status: Approved LABORATORIES LTD., ALC4/2014 11.09.2014 HQ File 7 RLA File i Lic.No/Date:2210014016 {Defer Date: :01/82/050/00557/AM14/ :22/24/040/00032/AM14/ 19.07.2013 196 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/684/2013-PI(Norms) dated 02.09.2014 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 | Exp. |Si.No. [importitems| Qty. Allowed mud A, Fre expary + mH COR Seip repay hac of Commerc Udyeg Bhawan, Nee ‘i ----- End of picture text -----

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----- Start of picture text ----- il | . } | | . a 1kg Tin «98S bisesiaiiaciaiine [2 [Acetone RA concerned may take further necessary action as per above decision of NC. Case No.:1/19/82-ALC4/2013 _ |Party Name:AUROBINDO Meet No/Date:7/82- Status: Approved PHARMA LIMITED ALC4/2014 11.09.2014 HQ File — RLA File Lic.No/Date:0910056894 [Defer Date: :01/82/050/00946/AM14/ 109/24/040/00176/AM14/ 24.07.2013 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/110/2014-PI(Norms) dated 02.09.2014, 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: | Item of Export Quantity Item of Import Quantity | allowed kg/kg | PIPERACILLIN AND ikg 4. 6-Amino Penicillanic Acid | TAZOBACTAM 8:1 6-APA STERILE 4-Ethyl-2, 3 Dioxo 0.3323 Piperazine Carbon Enoanticromos Activated Carbon 107 D(-) Alpha Phenyl Glycine | 0.359 15. __| EthylBase (AcetoacetatePG BASE 0.346 0.105 18 Methylene Chloride 2.835 19 | Pivaloyl Chloride 0.251 [10 __| Potassium Carbonate [0.164 | Tazobactam acid 0.112 Triethylamine 0.466 13 Trimethy! chlorosilane 0.3069 TMCS Triphosgene 0.281 IRA [may][ take][ appropriate] [action] [as] [per the][ decision] [of][ Norms][ Committee.] policy : Case No.:46/14/82-ALC4/2013 {Party Name: MYLAN Meet No/Date:7/82- _|Status:Deffered LABORATORIES LIMITED — |ALC4/2014 11,09,2014 108 [HQ File “IRLA File Lic.No/Date:0910056909 [Defer :01/82/050/0063 1/AM14/ 109/24/040/00185/AM14/ 25.07.2013 Date:09,10,2014 Decision :It was decided to defer the case for 09.10.2014 for comments of-Department, of... jc, Directorate General of Foreign Trade afroy RervDepartment of Commerse weit tert, He fees Udyog Bhawan, New Deihi ----- End of picture text -----

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----- Start of picture text ----- | | | | [—] || ‘Pharmaceuticals. ‘| '|Case No.:24/17/82- Party [Meet No/Date:7/82- _|Status:Deffered  ALC4/2013 Name:SMILAX LABORATORIES. |ALC4/2014 109 HQ File ~ |RLALIMITEDFile :09/24/040/00180/AM14/ |Lic.No/Date:09100569011.09.2014 [Defer | |:01/82/050/00886/AM14/ 2 Date:09.10.2014 | 25.07.2013 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. [Case No.:23/14/82-ALC4/2013 |Party Name:RA CHEM Meet No/Date:7/82- Status: Approved PHARMA LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910056934 [Defer Date: :01/82/050/00608/AM14/ :09/24/040/00191/AM14/ 29.07.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide | their OM No. 35011/59/2014-Pl(Norms) dated 02.09.2014, 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: | Item of Export Quantity | S,No Item of Import Quantity 110 allowed kg/kg | Efavirenz 1kg 1. 4-Chloro-2- trifiuoroacetylaniline hydrochloride hydrate 2 | Cyclo propyl acetylene 0.376 3. N-butyl chloride 0.515 4 | Trifluoro ethanol 0.447 Triphosgene 0.431 RA may take appropriate action as per the decision of Norms Committee. ~ [Case No.:28/19/82- [Party Meet No/Date:7/82- |Status:Deffered ALC4/2013 Name:SMILAX LABORATORIES |ALC4/2014 LIMITED 11.09.2014 111 HQ File IRLA File :09/24/040/00181/AM14/ |Lic.No/Date:09 1005694 [Defer |-91/82/050/00973/AM14/ 0 Date:09.10.2014 29.07.2013 ‘Decision :It was decided to defer the case for 09.10.2014 for comments of Department of |Pharmaceuticals. . Case No.:43/12/82-ALC4/2013 PVT|Party Name:AMI ORGANICS [Meet No/Date:7/82. ‘Status:Deffered | t [HQ LTD. |11.09.ALC4/ 201 44 aFile IRLA File 7 [Lic-No/Date:52 1004003 Dy [fer][ Ninian] A). Uy Director Genera E 27 a Dinoete eR Mere Udyou |Bhawan,a ----- End of picture text -----

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----- Start of picture text ----- a :01/82/050/00467/AM14/ |:52/24/040/00015/AM14/ 30.07.2013 [Date:09.10.2014 C&PC,Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Case No.:22/14/82- Party Name:MSN Meet No/Date:7/82- Status: | ALC4/2013 LABORATORIES ALC4/2014 Approved HQ PRIVATE LIMITED 11.09.2014 File RLA File Lic.No/Date:09 10056971 |Defer Date: |:01/82/050/00607/AM 14/ :09/24/040/00192/AM14/ 31.07.2013 : ‘Decision ? In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/758/2013-PI(Norms) dated 09.09.2014, 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: Item of Export Quantity Item of Import Quantity '13 allowed kg/kg TROSUVASTATIN tke. 1/1. (4R-Cis)-6- 1.871 CALCIUM [(acetyloxy)methy!]-2,2- dimethyl-1,3-dioxane-4- acetic acid,1,1-dimethy] ethyl ester DIISOBUTYL 2.79 ALUMINIUM HYDRIDE 25% IN TOLUENE (DIBAH 25% IN TOLUENE RA |3.| Methyl Isobutyryl acetate 156 may take appropriate action as per the decision of Norms Committee. Case No.:61/14/82-ALC4/2013 [Party Name:HETERO DRUGS Meet No/Date:7/82- —_‘[Status:Deffered LIMITED, ALC4/2014 11.09.2014 114 HQ File —IRLA File ~~ |Lic.No/Date:0910057007 [Defer |:01/82/050/00646/AM14/ :09/24/040/00206/AM14/ \02.08.2013 Date:09.10.2014 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. The case was deferred for 09.10.2014. (Case No.:148/14/82- (Party Name:SUVEN LIFE Meet No/Date:7/82- Status: Approved ALC4/2013 SCIENCES LIMITED ALC4/2014 11.09.2014 HQ File -|RLA File - ~ Lic.No/Date:0910057006 [Defer Date:. | :01/82/050/00733/AM14/ :09/24/040/00189/AM14/ 02.08.2013 115 |Decision :in the light ofwritten comments received from Department of Pharmaceuticals vide their OM No. 35011/795/2014-Pl(Norms) dated 02.09.2014, 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: | Item of Export Quantity Item of Import Quantity [ allowed.kg/ke. ie ‘areaDirector ReTUDepartmeng Te Terresee ’ ----- End of picture text -----

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----- Start of picture text ----- E ——= 8, SD. | ° | YN-ETHYLPYRROLIDINOLJ akg [1, SODIUM BOROHYDRIDE 2628 | RA [3. | rotassiucarsonate 2.40) may take appropriate action as per the decision of Norms Committee. Case No.:165/14/82- Party Name: MEDREICH Meet No/Date:7/82- ~ (Status: Approved ALC4/2013 LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0710097410 Defer Date: :01/82/050/00750/AM14/ :07/24/040/00135/AM14/ 07.08.2013 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 116 |details35011/783/2013-Pl(Norms) given below or as applieddated by 09.09.2014, the firm, whicheverit was decidedis less: to ratify norms under Para 4.7 of HBP v1 as per ; Item of Export Quantity Item of Import Quantity allowed para al 1kg CEFADROXIL MONOHYDRATE | 535.26 RA COMPACTED USP me/capsule may take appropriate action as per the decision of Norms Committee. Case No.:22/13/82-ALC4/2013 |Party Name:PROMED [Meet No/Date:7/82- Status: Deffered EXPORTS PVT.LTD. ALC4/2014 | 11.09.2014 7 HQ File RLA File _ [Lic.No/Date:0510362268 [Defer :01/82/050/00498/AM14/ :05/24/040/00171/AM14/ 07.08.2013 Date:09,10.2014 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No, 35011/185/2014-Pl(Norms) dated 02.09.2014, it was decided to call from the acopy of Drug Manufacturing Licence for the export product. The case was deferred for 09.10.2014. [Case No.:20/14/82-ALC4/2013 [Party Name:SRIAM LABS Meet No/Date:7/82- Status: Approved PRIVATE LIMITED ALC4/2014 11.09.2014 | HQ File RLA File " |Lic.No/Date:0910057053 [DeferDate: :01/82/050/00605/AM14/ |:09/24/040/00177/AM14/ 07.08.2013 Decision: $e their In the light of written comments received from Department of Pharmaceuticals vide Para OM No. 35011/46/201-PI(Norms) dated 24.09.2014, it was decided to ratify norms under 118 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity | S,No | Item of Import Quantity — 12-Hydroxy-5-[1- allowed kg/kg Hydroxy-2-[(1-Methyl- i; 5-Bromo Acetyl 3-Phenyl Propyl) Salicylamide 1.587 amino] ethyl] Zi 1-Methyl-3-Pheny]l benzamide Propylamine ana gh4l4. pitas et oflige Be enfiyse ferVDepartment of Commerce AP le Meas ELi6 Oeathi ----- End of picture text -----

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----- Start of picture text ----- r - 2 | | hydrochloride 3. Sodium Borohydride | 0.130 RA may take appropriate action as per the decision of Norms Committee. Case No.:147/14/82- Party Name:MYLAN Meet No/Date:7/82- Status: Approved ALC4/2013 LABORATORIES LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910057191 {Defer Date: :01/82/050/00732/AM14/ :09/24/040/00201/AM14/ 14.08.2013 ; Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/785/2013-Pl(Norms) dated 09.09.2014, 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: Item of Export Quantity | S,No Item of Import Quantity allowed kg/kg Imidazole Ester (1H- 0.78 | OLMESARTAN Imidazole-4-Carboxylic 119 MEDOXOMIL Acid, 5-(1-Hydroxy-1- Methylethyl)-2-Propy| Ethyl Ester) |2.__| Potassium Carbonate }3.4 ||6306AcetonitrileAcetone 2.115 CECA carbon(Activated Carbon (ENOPC |6 [|] [Isopropyl] [alcohol] (4.025 7 4-Chloro methyl-5- 0.48 Methyl-2-oxo-1,3- ] dioxolene RA [8 | Methanol fA | may take appropriate action as per the decision of Norms Committee. | Case No.:122/14/82- Party Name: WANBURY '|Meet No/Date:7/82- Status: Approved ALC4/2013 LIMITED(FORMERLY PEARL |ALC4/2014 ORGANICS LTD) 11.09.2014 HQ File RLA File Lic.No/Date:03 10745264 |Defer Date: :01/82/050/00707/AM14/ :03/95/040/00203/AM14/ 14.08.2013 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/805/2013-Pl(Norms) dated 09.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per 120 details given below or as applied by the firm, whichever is less: kg/kg 1kg DICYANODIMIDE METFORMIN HCL 86.6% (DC GRANULES) eS DIMETHYL AMINE 0.525 Ny [4 HYDROCHLORIDE a 1 ——— ee eee| XYLENE MIX | 0.0238,noeIi c anora’ Ffe e SaaTeihteerasGonoralaaah ofPray,ey reranff reairerseae nrSTLLMA ----- End of picture text -----

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----- Start of picture text ----- } T ~ | POLYVINYL Joos f PYRROLIDONE K-30 SODIUM STARCH t GLYCOLATE f MAIZE STRACH . COLLOIDALDIOXIDE SILICON 7 RA may take appropriate action as per the decision of Norms Committee. Case No.:66/14/82- Party Name:SRINI Meet No/Date:7/82- _—‘{Status: Approved ALC4/2013 PHARMACEUTICALS LTD., |ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910057203 {Defer Date: :01/82/050/0065 1/AM14/ 109/24/040/00216/AM14/ 16.08.2013 ! Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/771/2013-Pl(Norms) dated 02.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 121 \of HBP as per details below or as applied by firm whichever is lower:- Export product Exp. Import items Qty. | Qty. Allowed | | Kgikg | 1 R-(-)-3-(CARBAMOYLMETHYL)-5- PREGABALIN METHYL HEXANOIC ACID ISOBUTANOL 1.162 RA concerned may take further necessary action as per above decision of NC. "Case No.:121/14/82- Party Name: WANBURY Meet No/Date:7/82- Status:Deffered ALC4/2013 LIMITED(FORMERLY ALC4/2014 PEARL ORGANICS LTD) 11.09.2014 122 HQ File RLA File Lic.No/Date:0310745576 |Defer |.91/82/050/00706/AM14/ :03/95/040/00505/AM 13/ 16.08.2013 Date:09.10.2014 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/35/2014-Pl(Norms) dated 02.09.2014, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 09.10.2014. Case No.:34/14/82-ALC4/2013 |Party Meet No/Date:7/82- _|Status: Approved Name:SMILAX LABORATORIE |ALC4/2014 S$ LIMITED 11.09.2014 HQ File RLA File Lic.No/Date:091005724 |Defer Date: :01/82/050/00619/AM14/ :09/24/040/0023 1/AM14/ 4 19.08.2013 103 ‘Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/765/2013-Pl(Norms) dated 05.09.2014, 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: Item of Export Quantity Item of Import Quantity : allowed kg/kg \ 1kg Thiophene-2-ethyl amine 10.53 . a | Clopidogrelek alee /2.| Alpha bromo-2-chloro OHSS i id ‘seuleAR Dy. Director Ganera ch eet eae qe Udve t = ----- End of picture text -----

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----- Start of picture text ----- ees ——— 4 camphorsulfonate - phenyl acetic acid methy! ester L (- ) Camphor sulfonic acid | }4|S [Acetone«dS |6 [|] {Methanol [Methylene][ dichloride] 09[5.80SSCS Isopropyl acetate |8_| Triethyl amine RA may take appropriate action as per the decision of Norms Committee. eee Case No.:1/5/82-ALC4/2014__ Party Name:SPAK Meet No/Date:7/82- Status: Approved ORGOCHEM (INDIA) PVT. ALC4/2014 LTD. 11.09.2014 HQ File RLA File - |Lic.No/Date:0310745808 [Defer Date: :01/82/050/00318/AM15/ :03/95/040/00167/AM14/ 19.08,2013 Decision :In the light of written comments received from Department of Chemicals and 124 Petrochemicals vide their U.O No. 14010/5/2009-Ch. II dated 28.07.2014, 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 eeQty. [SNe] Import items Qty. allowed | Sorbitan Mono 1kg Sorbitol 70% Solution 0.470 kg ] Sinaiate a Stearic; Acid: 0.634 kg RA may take appropriate action as per the decision of Norms Committee. Case No.:2/5/82-ALC4/2014 Party Name:SPAK Meet No/Date:7/82- Status: Approved | ORGOCHEM (INDIA) PVT. ALC4/2014 | LTD. 11.09.2014 HQ File ~IRLA File Lic,No/Date:0310745809 [Defer Date: Decision:01/82/050/003: 19/AM15/In the light of:03/95/040/0013written comments 1/AM14/ received19.08.2013from Department of Chemicals and | Petrochemicals vide their U.O No. 14010/5/2009-Ch. Il dated 20.08.2014, it was decided to ratify norms ] 12s under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | Export product |Qty. Import items Qty. allowed | Sorbitan Mono Oleate 1kg [1__| OleicSorbitol Acid 70% Solution | 0. 47 70 k ge | ; RA may take appropriate action as per the decision of Norms Committee. Case No.:26/14/82-ALC4/2013 [Party Name:MYLAN Meet No/Date:7/82- Status: Approved LABORATORIES LIMITED —|ALC4/2014 126 11.09.2014 ( HQ File IRLA File Lic.No/Date:0910057247. Defer Date: ———:01/82/050/0061i———————— 1/AM14/ :09/24/040/00190/AM14/ are —§_Dy--Birestor-Gansrat-ot-Tafa zmin Tre fier sara serene Directorate General of Foreign Trade wftica P€TVDepartment of Commerce wen aes, ae forest Uet, ' ~v Delhi ----- End of picture text -----

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----- Start of picture text ----- I Decision : in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/759/2013-Pl(Norms) dated 05.09.2014, 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: Item of Export Quantity Item of Import Quantity TELAPREVIR allowed kg/kg 1kg 2: 2-((S)-2-cyclohexyl-2- (pyrazine-2-carboxamido) -acetamido)-3,3-dimethyl butanoicacid (Pyrazine | ' cyclohexyl leucine acid | | 2. (1S,3aR,6aS)-ethyl- octahydrocyclopenta [c]- pyrrole- | -carboxylate Hydrochloride (or) (Aza bicyclo ester 3. (3S)-3 Amino -N- 0.67 | cyclopropyl-2-hydroxy hexanamide .HCI (or) hexanamide.HCl | carbodiimideN,N-Di isopropyl! 0.567 ) EsEo | §[nHeptane [098 | 1-Hydroxy-7- [8 [Citricazabenzotriazole acid monohydrate(HOAT [0.60 —| |9_| Methylene Dichloride [956 __—| . Diisopropylethylamine 0.77 DIPEA Methy] tert-butyl ether MTBE 13 2,2,6,6-Tetramethyl- 0.02 piperidin-1-yl)oxy! RA TEMPO) may take appropriate action as per the decision of Norms Committee. PHARMACEUTICALS LTD —|ALC4/2014 Case No.:32/14/82-ALC4/2013 |Party Name:ALEMBIC Meet No/Date:7/82- pene Approved fe:01/82/050/00617/AM14/ File on File ~ [|Lic.No/Date:3410037709] 11.09.2014 [Defer] [Date:] :34/24/040/00110/AM14/ |22.08.20 13 | 127 Decision: in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/800/2013-Pl(Norms) dated 09.09.2014, 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: Item of Export Quantity | S,No Item of Import Quantity me LVALSARTAN [akg [a __| Methyl (28)-2-({2Cyano- [1.455]allowed kg/kg at\ Ae Dy. Director General of Foreign Trade feet warore wer reset Directorate General of Foreign Trade asa frryHepartment of Commerce Udy ' thi ----- End of picture text -----

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----- Start of picture text ----- yy | | -_ 1, 1-biphenyl-4- _ | y))methylJamino} methyl butanoate -3- Valineethanedioate (Bi Phenyl i | 2. [[METHANOL] oxalate | 2.486 ig 3, METHYLENE 12.545 lit/kg CHLORIDE( or RA [4 [[ACETONE] DICHLOROMETHANE| 0.002 ik | ————————S may take appropriate actionSEas per the decision of Norms Committee, Norms CommitteSe ‘Case No.:10/17/85-ALC3/2013 Party Name:BELOOR BAYIR [Meet No/Date:7/82-—‘|(Status:Deffered BIOTECH LTD, ALC4/2014 128 [HQ File RLA File _ Lic.No/Date:071009766411.09.2014 [Defer ; :01/85/050/00113/AM14/ : :07/24/040/00150/AM14/teslai 22.08.2013 Date:09.10.2014 ! Pharmaceuticals,Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Case No.:47/14/82-ALC4/2013 |Party Name: VIVIMED LABS Meet No/Date:7/82- Status: Deffered LIMITED ALC4/2014 129 11.09.2014 |HQ File ~—IRLA File Lic.No/Date:0910057280 Defer :01/82/050/00632/AM 14/ :09/24/040/00251/AM14/ 22.08.2013 Date:09.10,.2014 ‘DecisionPharmaceuticals.:It was decided to defer the case for 09.1 0.2014 for comments ofDepartment of ~— [Case No.:115/14/82-——~—SOSOS Party Name:RIOCARE INDIA ALC4/2013 [Meet No/Date:7/82. Status: Approved PRIVATE LIMITED, ALC4/2014 HQ 11.09.2014 File RLA File Lic.No/Date:03 10746634 [Defer Date: :01/82/050/00700/AM 14/ :03/95/040/00402/AM14/ 23.08.2013 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/635/2013-PI(Norms) dated 02.09.2014 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:- a0 Export Product Simethicone (3 Export Item) Export product Import items Qty. Allowed 1 kg Export Product | F ; 0) =~<_rrc, 100% USP or BP Silicone Fluid/ Oil of | 9-96 kg/kg relevant Viscosity | 30%Simethicone Emulsion USP Silicone Fluid | [2] / Oil of | 9-288 kg/kg 3 N relevant Viscositym - Fr are| NIRMALU KUM \ aaa ee ee wr Ft potionsra: ! LEbreeSosconofeignaS| ‘|TtCak ol N RT ae oral of Foreign tem aiered 18 eke ~ fearTyDepartment CaM ----- End of picture text -----

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----- Start of picture text ----- 1 l. Dimethicone USP | | Various Viscosi orBP or EP | Sire eva t l ico n e Viscosit Fluid/ Oil of 1101 kg/kg IRA concerned may take further necessary action as per above decision of NC. [Case No.:4/4/82-ALC4/2014 |Party Name:SHASUN Meet No/Date:7/82- Status:Deffered PHARMACEUTICALS ALC4/2014 LIMITED 11.09.2014 131 (HQ File ‘IRLA File " |Lic.No/Date:0410148932 [Defer :01/82/050/00252/AM15/ :04/24/040/00107/AM14/ |23.08.2013 Date:09.10.2014 Decision : It was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control In charge. The case was deferred for 09.102014. B Case No.:1/15/82-ALC4/2013 [] [|Party] LABORATORIES [ Name:CORAL] LTD., -[MeetALC4/2014 No/Date:7/82- Status: Approved HQ:01/82/050/00763/AM14/File ~— IRLA File Lic.No/Date:031074713411.09.2014 [Defer Date: :03/94/040/00389/AM14/ 27.08.2013 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No, 3501 1/28/2014-PI(Norms) dated 22.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP 132 as per details below or as applied by firm whichever is lower:- Export product Exp. Import items Qty. | Qty. Allowed Ta bletbles BPyvtocei 50mg) HB6)BP/USPP Y RIDOXINEDROCHLORIDE(VITAMIN mgmg/50 tablets |RA concerned may take further necessary action as per above decision of NC. Case No.:152/14/82- [Party Name: MYLAN Meet No/Date:7/82- —‘[Status: Approved ALC4/2013 LABORATORIES LIMITED |ALC4/2014 HQ:01/82/050/00737/AM14/File - |IRLA:09/24/040/00211/AM14/File ~ |Lic.No/Date:091005736827.08.201311.09.2014 [Defer Date: Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/784/2013-P1(Norms) dated 09.09.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per 133 details given below or as applied by the firm, whichever is less: Item of Export Quantity Item of Import Quantity (CYCLOHEXYLLAMIVUDINE 1kg = [1.[CYCLOHEXYLESTER[219allowed kg/kg| ROUTE) ESTER S SODIUM 0.48 | BOROHYDRIDE [DIPOTASSIUM] 1.9849 \™\ War HYDROGEN Peter saree NinengAl i “ i as TeArVDepaniment peop Udsenbrowan,New Deihl ----- End of picture text -----

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----- Start of picture text ----- ey f | ~ a ———— ] _ ] PHOSPHATE }4. [METHANOL [5 [TOLUENE«0.200__| 0.167 S~*d RA ISOPROPYL ALCOHOL [1.427 may take appropriate action as per the decision of Norms Committee. eeCase No.:116/14/82- Party Name:UNIJULES LIFE=_ |Meet No/Date:7/82-— Status: Deffered ALC4/2013 SCIENCES LTD. ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0310747079 [Defer 134 :01/82/050/00701/AM14/ :03/95/040/00215/AM14/ /27.08.2013 Date:09.10.2014 Decision : in the light of written comments received from Department of Pharmaceuticals vide their OM No. | 35011/801/2013-Pl(Norms) dated 02.09.2014, it was decided to call from the firm following information: | i] Complete description of export product showing the content of API in the Injection, and Il) Copy of relevant DML along with the list of approved items, f The case was deferred for 09.10.2014, ‘|Case No.:25/15/82-ALC4/2013 (Party Name:IPCA Meet No/Date:7/82- - {Status: Approved LABORATORIES LIMITED ALC4/2014 11.09,2014 HQ File RLA File Lic.No/Date:0310747414 {Defer Date: :01/82/050/00787/AM14/ :03/94/040/00992/AM13/ 28.08.2013 et Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No, 3501 1/808/2013-PI(Norms) dated 05.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP 135 [8S per details below or as applied by firm whichever is lower:- | Export product Exp. Import items Qty. Allowed Qty. kg/kg | ACETONIDE RA concerned may take further necessary action as per above decision of NC. Case No.:43/16/82-ALC4/2013 Party Name:SYMBIOTEC Meet No/Date:7/82- 7 Status:Deffered PHARMALAB LTD., ALC4/2014 11.09.2014 136 |HQ File RLA File Lic.No/Date:5610002765 (Defer :01/82/050/00856/AM14/ :56/24/040/00017/AM14/ 03.09.2013 Date:25.09.2014 Decision :It was decidedSSto defer the case for 25.09.2014eefor comments ofDepartment of Pharmaceuticals. 137 Case No.:53/14/82-ALC4/2013 |Party Name:STERILE INDIA _ [Meet No/Date:7/82- Status:Deffered \\ PRIVATE LIMITED ALC4/2014 nena. a 11.09.2014 "St seieann face erat — EE Sirota aerate ™% retell ie siProy farryo. pernet Se udes ‘Bhawan.’New Deini ----- End of picture text -----

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----- Start of picture text ----- ee ; | ; < oT TS . - HQ File RLA File Lic.No/Date:05 10364653 Defer :01/82/050/00638/AM14/ :05/24/040/00203/AM14/ 05.09.2013 Date:25.09.2014 Decision : in the light of written comments received from Department of Pharmaceuticals vide their OM No. as35011/770/2013-PI(Norms) per Appendix 33. The casedated was deferred 09.09.2014,for 09.10.2014.it was decided to call from the firm the complete technical details eee— Case No.:176/14/82- Party Name:AMI Meet No/Date:7/82-—————————— Status: Approved ; ALC4/2013 LIFESCIENCES P LTD ALC4/2014 HQ File _ 11.09.2014 :01/82/050/00761/AM14/ RLA File Lic.No/Date:34 10037845 {DeferDate. Decision |:34/24/040/00132/AM14/ 06.09.2013 :Committce considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/753/2013-PI(Norms) dated 02.09.2014 and in ~ asconsultation per details belowwith technical or as applied authority presentby firm whichever in meeting,is lower:-decided to ratify norms under para 4,7 ofHBP Export Obligation q | Export product ae [Sh Import items Qty. Allowed || RUTOSIDE TRIHYDRATE EP ha 1 ASSAY BYCRUDE RUTIN HPLC (FAVA): NMT 70% 2.36 kg SS CRUDE RUTIN (FAVA) RA concerned may take further necessary action as per above decision of NC. SSS— ENG |Case No.:103/14/82- [Party Name:INTAS Meet No/Date:7/82- |Status: Approved ALC4/2013 PHARMACEUTICALS LTD., |ALC4/2014 HQ 11.09.2014 File RTA File Lic.No/Date:0810124544 [Defer Date: :01/82/050/00688/AM 14/ :08/24/040/00242/AM14/ 06.09.2013 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No, 35011/789/2013-P|( Norms) dated 05.09.2014, 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 139 Simvastatin10mg 20 MG, 40 MG and 80 MG Tablets | Import Items Norms recommended for export 1000 No. Tablets | (Qty. In kg) 10mg Tablets | 20 mg Tablets | 40 mg 80 mg ' | SIMVASTATINEUR. USP/PH. | 0.0102 0.0408Tablets 0.0816Tablets ||2| ASCORBIC ACID 0.0025 | 0.005 Foor Fons | 3 MONOHYDRATECITRIC ACID ' 0.0013 0.0025 0.005 [5__| HYPROMELLOSESODIUMCROSCARMELLOSE 0.00190.0020 | 0.00380.004 | 0,00800077 Fonz — : SA ABT Goneral of FOWIe OyorateOe aura Gener TEINat ofCn CommerceTrade udyog Bhs ----- End of picture text -----

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----- Start of picture text ----- E ' Ps ,| — _ CELLULOSEHYDROXY— PROPYL= = 0.0006= — — 0.0012—— — 0.0024= = 0.0048— —— | 7 LACTOSE 0.0742 0.1484 . 0.2968 0.5936 ps MONOHYDRATE MAGNESIUM STEARATE __ | 0.0008 0.0015 10.003 | 0.006 —=«d MICROCRYSTALLINE 0.0063 0.0125 0.025 0.05 [10 [TALCCELLULOSE | SSS~«& «00008 0.0003 1 11 | TRIETHYL CITRATE 0.0003 100006 [0.0012 —S—=*d 0.0024 [13 [STARCHTITANIUM DIOXIDE 0.00300.0006 0.00120.006 10.012 0.0240.0048 |14__| DEHYDRATED ALCOHOL _| 0.0038 [0.0075 001s —« 003 | jis HDPE BOTTLE As per packing policy [16| PPCRCLOSURES RA may take appropriate action as per the decision of Norms Committee, Case No.:2/12/82-ALC4/2013[PartyName:VIVEK Meet No/Date:7/82-__‘(Status:Deffered PHARMACHEM (INDIA) ALC4/2014 HQ LTD., 11.09.2014 140 File RLA File |Lic.No/Date:1310044274 [Defer |:01/82/050/00426/AM14/ :13/24/040/00022/AM14/ 09.09.2013 Date:09.10.2014 Decision : in the light ofwritten comments received from Department of Pharmaceuticals vide their OM No. 35011/746/2014-Pi(Norms) dated 02.09.2014, it was decided to call from the firm Copy of relevant DML for each export product alongwith detailed working on the requirement of API in each case.The case was deferred for 09.10.2014. Case No.:56/14/82-ALC4/2013 Party Name: VIVEK Meet No/Date:7/82- Status:Deffered | PHARMACHEM (INDIA) ALC4/2014 HQ LTD., {I 1.09.2014 141 File IRLA File Lic.No/Date:1310044273 [Defer |:01/82/050/00641/AM14/ :13/24/040/00021/AM14/ 09.09.2013 Date:09.10.2014 DecisionTm REL PTE . a a : in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/746/2014-Pl(Norms) dated 02.09.2014, it was decided to call from the firm Copy of relevant DML for each export product alongwith detailed working on the requirement of API in each case. The case was deferred for 09.10.2014. a Case No.:54/17/82-ALC4/2013 |Party Name:CIREX Meet No/Date:7/82- Status: Approved HQFile [LIMITEDPHARMACEUTICALS ALC4/201411.09.2014 :01/82/050/00916/AM14/ |RLA File Lic.No/Date:0910057517 [Defer Date: :09/24/040/00258/AM14/ 10.09.2013 Decision :In the light of writtenSS comments received from Department of Pharmaceuticals vide ss their OM No. 35011/17/2014-Pl(Norms) dated 24.09.2014, 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: | Item of Export Quantity | S,No Item of Import Quantity allowed kg/kg | Gemifloxacin Mesylate ‘A 3-Cyano-2,6-Dichloro- f 5-Fluoro Pyridine 0.834 Oy, Director General of Foreign Trade PISVT ear HST Vea Directarate General of For eign Trade witrsa fonV/Department of Commerce UdyogSENBhawan,sa=7, ay faveNew Deini 7 iu ----- End of picture text -----

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----- Start of picture text ----- __ Dimethyl Formamide 4.30 4 | Cyclopropyl Amine 0.261 Glycine Ethyl Ester Hydrochloride 0.967 Di-Tert-Butyl Dicarbonate 2.408 Methoxyamine Hel 0.404 RA may take appropriate action as per the decision of Norms Committee. Case No.:16/16/82-ALC4/2013 |Party Name:KARNATAKA __ [Meet No/Date:7/82- Status: Approved ANTIBIOTICS & ALC4/2014 HQ File RLAPHARMACEUTICALSFile LTD., Lic.No/Date:0710098183{11.09.2014 [Defer Date: :01/82/050/00829/AM14/ :07/24/040/00189/AM14/ 10.09.2013 ----- End of picture text -----

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/10/2014-PI(Norms) dated 02.09.2014 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:-

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----- Start of picture text ----- 143 | Export product a | Import items Qty. Allowed VERCLAV 1.2GM INJ AMOXICILLIN SODIUM 630 MG/600 MG (AMOXICILLIN 1G WITH POTASSIUM VIAL &CLAVULANIC 200MG CLAVULANATE 1260 MG/1.02 FORINJECTION) VIAL MIXTURE(S5:1) STERILE BP GM VIAL SIZE:20ML ----- End of picture text -----

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

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----- Start of picture text ----- | Case No.:149/14/82- Party Name: MACLEODS [Meet No/Date:7/82- Status: Approved ALC4/2013 PHARMACEUTICALS LTD. |ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:03 10748925 |Defer Date: :01/82/050/00734/AM 14/ :03/95/040/00465/AM14/ 10.09.2013 Decision ; Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/787/2013-PI(Norms) dated 09.09.2014 and in 144 \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 Import items Qty. Allowed kg/kg — | IRBESARTAN ae le 2-N-BUTYLDIAZASPIRO -1,3-(4.4) NON-1-__[.,93a oes,PA ETTsnesearare 5 | IOCPoretbn\Traderar UayogVen] Bhawanors oeWeaS Commerce En | ----- End of picture text -----

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----- Start of picture text ----- | F } | 2. | a 7 “T EN-4-ONE , HYDROCHLORIDE RA concerned may take further necessary action as per above decision of NC. Case No.:105/13/82- Party Name:RA CHEM Meet No/Date:7/82- Status: Approved 4 ALC4/2013 PHARMA LIMITED ALC4/2014 11.09.2014 HQ File ~—_{RLA File Lic.No/Date:0910057516 [Defer Date: :01/82/050/0058 1/AM14/ :09/24/040/00265/AM14/ 10.09.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/803/2013-PI(Norms) dated 09.09.2014, and 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: 145 Export Product ExportQuanti S.No | Import Product QuantityAllowed kg/kg | - | RACTOPAMINE HCL 4-(4-HydroxyButanone Phenyl) -2- | 0.910 | 2 Not shown in [3|4.__||874-HydroxyactophenoneMethanol the process [5 | TolueneEthyl Acetate [2.44 | [6 [ActetonefT030sCd RA may take appropriate action as per the decision of Norms Committee, Case No.:11/15/82-ALC4/2013 |Party Name:BENZO CHEM Meet No/Date:7/82- ] Status: Deffered | INDUSTRIES PRIVATE ALC4/2014 LIMITED, 11.09.2014 146 |HQ File RLA File Lic.No/Date:0310749169 {Defer :01/82/050/00773/AM14/ :03/94/040/00352/AM14/ 11.09.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:33/15/82-ALC4/2013 |Party Name:-KOPRAN Meet No/Date:7/82- Status: Approved LIMITED ALC4/2014 HQ:01/82/050/00795/AMFile - 14/ RLA:03/94/040/0049File 1/AM14/ Lic.No/Date:031074915111.09.201311.09,2014 |Defer Date:; Decision : Committee considered the case as per agenda and in light of written comments received from 147 |Department of Pharmaceuticals vide their OM No. 35011/1 1/2014-PI(Norms) dated 22.09.2014 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 Exp. Import items Qty. Allowed} . we A ea Sites, The afereavagfuPUDeparimentbetant how!o at Delntaae ----- End of picture text -----

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----- Start of picture text ----- SS a er eee Se | | : ~ Clarithromycin Granules Clarithromycin 0.2778 aa0, [2 1053Acetone RA concerned may take further necessary action as per above decision of NC. Case No.:33/16/82-ALC4/2013 |Party Name:HETERO DRUGS |Meet No/Date:7/82- Status:Deffered LIMITED, ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910057537 |Defer :01/82/050/00846/AM14/ :09/24/040/00278/AM 14/ 12.09.2013 Date:09,10,2014 Decision ::In the light of written comments received from Department of Pharmaceuticals vide their 14g (OM No. 35011/813/2013-PI(Norms) dated 05.09.2014, it was decided to request the firm to furnish the following information : i) Stepwise chemical reactions showing correct Molecular weight of each input 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 09.10.2014 Case No.:32/15/82-ALC4/2013|Party Name:KOPRAN Meet No/Date:7/82- Status: Approved LIMITED ALC4/2014 11.09.2014 HQ File ‘IRLA File Lic.No/Date:0310749296 [Defer Date: :01/82/050/00794/AM14/ :03/94/040/00487/AM14/ 12.09.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No, 35011/12/2014-P|(Norms) dated 24.09.2014, 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: Item of Export Quantity Item of Import Quantity 149 allowed kg/kg Cefepime for Injection Cefepime Hel (Non- 0.655 Sterile) S| L-Arginine (Non-Sterile) 0.370. Isopropyl! Alcohol 0.392 | CN (a [| RA may take appropriate action as per theLi decision of Norms Committee.oe Case No.:55/4/82-ALC4/2014 {Party Name:NECTAR ——_|[Meet No/Date:7/82- Status:Deffered LIFESCIENCES LIMITED, ALC4/2014 150 11.09.2014 SSHQFile RLA File Lie. No/Date:22100142His {Defer simmat K — ———————— SS——>q= EES)Dy. DirectorSad 502dGeneralsodsSAASof ForeignBe Trade fae zayare terranes Directorate General of Foroign Trade aiersy FeHTWDepartment of Cornmerce Usyog GnawanNow Betni ----- End of picture text -----

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----- Start of picture text ----- E | . | ~~" Neee SS —_———— | |:01/82/050/00303/AM15/ |:22/24/040/00044/AM14/ 12.09.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. ~ |Case No.:63/17/82-ALC4/2013 |Party Name:DR REDDYS Meet No/Date:7/82- Status:Deffered LABORATORIES LIMITED ALC4/2014 11.09.2014 1 151 |HQ File RLA File Lic.No/Date:0910057546 |Defer :01/82/050/00925/AM 14/ 09/24/040/00261/AM14/ 13.09.2013 Date:09,10,2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of | Pharmaceuticals. Case No.:35/15/82-ALC4/2013 |Party Name:KOPRAN Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 ‘ 11.09.2014 152 |HQ File RLA File Lic.No/Date:03 10749439 |Defer :01/82/050/00797/AM 14/ :03/94/040/00472/AM14/ 13.09.2013 Date:09,10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:26/4/82-ALC4/2014 |Party Name:RANBAXY Meet No/Date:7/82- Status:Deffered LABORATORIES LTD ALC4/2014 11.09.2014 153 {HQ File RLA File Lic.No/Date:0510365650 {Defer :01/82/050/00274/AM15/ :05/24/040/00212/AM14/ 16.09.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals, Case No.:151/14/82- "|PartyName:THINQ PHARMA- |Meet No/Date:7/82- Status:Deffered ALC4/2013 CRO LIMITED ALC4/2014 11.09.2014 154 HQ File RLA File Lic.No/Date:0310749651 [Defer :01/82/050/00736/AM14/ :03/95/040/00432/AM 14/ 16.09.2013 Date:09.10.2014 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/804/2013-PI(Norms) dated 05.09.2014, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 09.10.2014. Case No.:49/16/82- Party Name:SOFTGEL Meet No/Date:7/82- Status:Deffered ALC4/2013 HEALTH CARE PVT. LTD., |ALC4/2014 11.09.2014 : 155 |HQ File RLA File Lic.No/Date:04 10149961 |Defer :01/82/050/00862/AM 14/ :04/24/040/00100/AM14/ 18.09.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. 156 CaseNo.:68/14/82-ALC4/2013 [Party Name:NIFTY LABS PVT [Meet No/Date:7/82- Status: Approved LTD., ALC4/2014 Prt are NIRAL AOE 11.09.2014 9 ea of Foods Tae aiepiecefeTPVOepartment General of F arenof Comme Mine: j ----- End of picture text -----

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----- Start of picture text ----- HQ File RLA File Lic.No/Date:0910057606 |Defer Date: | :01/82/050/00653/AM14/ :09/24/040/00283/AM14/ 19.09.2013 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/55/2014-PI(Norms) dated 09.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:- ----- End of picture text -----

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| |

| Export product Exp. Import items Qty. Allowed Qty. kg/kg | Diethyl DG) Tartrate | 1° [ef[3] uene Methylene Di Chloride (0.533

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----- Start of picture text ----- RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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Case No.:30/4/82-ALC4/2014 |Party Name:RA CHEM Meet No/Date:7/82Status: Approved PHARMA LIMITED ALC4/2014 11.09.2014 HQ File RLA File : Lic.No/Date:0910057629 |Defer Date: :01/82/050/00278/AM15/ :09/24/040/00119/AM14/ 19,09,2013

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/96/2014-PI(Norms) dated 24.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP 157 Jas per details given below or as applied by firm whichever is lower:-

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----- Start of picture text ----- Export product Exp. Import items Qty. Allowed | Qty. kg/kg Nitrile2,3-Dichloro Benzoyl ial 1 2,3-Dichlor Benzoyl Chloride RA concerned may take further necessary action as per above decision of NC. [ (Case No.:64/17/82-ALC4/2013 (Party Name:RA CHEM PHARMA LIMITED — MeetALC4/2014 No/Date:7/82- Status: Approved |11.09,2014 HQ File RLA File "{Lic.No/Date:0910057630 {Defer Date: :01/82/050/00926/AM14/ 09/24/040/00120/AM14/ 19.09.2013 Decision : Committee considered the case as per agenda and in light of written comments received from 158 [Department of Pharmaceuticals vide their OM No. 35011/96/2014-PI(Norms) dated 24.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:- | Export product xp. Import items Qty. Allowed | _ Qty. kg/kg 7 a PeterDy. Director ZTGonaral /NIBMALof ForeignKUMARLh ----- End of picture text -----

—¥—¥—¥—«—«—«—«<—<<€£<[$=$[{[[AT_vIIOEsEk€=

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----- Start of picture text ----- . Oo - —2,3-Dichloro= Benzoyl = — —_ ' = = = P 1.30. = = [RA concerned may take further necessary action as per above decision of NC, | Case No.:81/23/82-ALC4/2013 |PartyLABORATORIESName:RANBAXYLTD ALC4/2014Meet No/Date:7/82- Status:Deffered | 11.09.2014 159 {HQ File RLAFile ~ [Lic.No/Date:0510366184 [Defer | :01/82/050/01128/AM14/ :05/24/040/00207/AM 14/ 19.09.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:18/4/82-ALC4/2014 |Party Name:SHASUN Meet No/Date:7/82- Status:Deffered PHARMACEUTICALS ALC4/2014 | LIMITED 11.09.2014 160 |HQ File RLA File Lic.No/Date:0410150092 Defer | :01/82/050/00266/AM15/ :04/24/040/00137/AM14/ 19.09.2013 Date:09.10.2014 Decision It was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control In charge. The case was deferred for 09.10.2014. [Case No.:53/17/82-ALC4/2013 Party Name:HETERO DRUGS |Meet No/Date:7/82- Status: Approved LIMITED, ALC4/2014 11,09,2014 HQFile RLAFile Lic.No/Date:0910057642 [Defer Date: :01/82/050/00915/AM14/ :09/24/040/00293/AM14/ 20.09.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/16/2014-PI(Norms) dated 24.09.2014, and it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export S.No | Import Product Quantity Quanti Allowed ke/ke | Fosinopril Sodium Lkg Trans-4-Hydroxy-L- Proline 1.592 rei 2. | 4-Dimethyl Amino Pyridine 3% 5% Palladium on Charcoal catayst 0.078 6. | Chinchonidine 0.2379 : Trimethyl Silyl Chloride 3.301 N,N-Dicyclohexyl Wy Carbodiimide 0.55 Boies bo KUM Wey ware weer Dire ate Genoral of Foreign Trade WaT Pe epartmant of Commerce Widyou Rese Mas, Hii gc ----- End of picture text -----

Pp a

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OO 9 | 2-Ethyl Hexanoic Acid ] sodium sal 0.230 oe RA may take appropriate action as per the decision of Norms Committee. ———————————— = Case No.:48/16/82-ALC4/2013 |Party Name:SOFTGEL Meet No/Date:7/82Status:Deffered HEALTH CARE PVT. LTD., |ALC4/2014 11.09,2014 162 {HQ File RLA File Lic.No/Date:0410150142 [Defer :01/82/050/00861/AM14/ :04/24/040/00099/AM 14/ 20.09.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:48/15/82-ALC4/2013 |Party Name:SHASUN Meet No/Date:7/82Status:Deffered PHARMACEUTICALS ALC4/2014 LIMITED 11.09.2014 163 |HQ File RLA File Lic.No/Date:0410150198 [Defer :01/82/050/008 10/AM14/ :04/24/040/00128/AM14/ 23.09.2013 Date:09.10.2014 Decision : It was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control In charge. The case was deferred for 09.10.2014. Case No.:41/4/82-ALC4/2014 |Party Name:SATYA DEEPTHA |Meet No/Date:7/82Status: Approved PHARMACEUTICALS LTD —|ALC4/2014 11.09.2014 HQ File RLA File ‘|Lic.No/Date:0910057666 Defer Date: :01/82/050/00289/AM15/ :09/24/040/00297/AM 14/ 24.09.2013 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/793/2013-PI(Norms) dated 05.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP 164 (8 per details below or as applied by firm whichever is lower:-

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----- Start of picture text ----- | Export product Exp. Import items Qty. Qty. Allowed Kg/kg | (1S, [5-FORMAMIDO-4-] 4R)-4-[(2-AMINO-6-CHLORO- N-(2-AMINO-4,6-DICHLORO-5- 0.764 PYRIMIDINYL)AMINO--2-CYCLO PYRIMIDINYL) | PENTENE-1-METHANOL(AFC) FORMAMIDE Lam AZABICYCLO2.2. 1JHEPT-3- EpaAA ANT entered FpITUDepartment pla seat Udped bhawanioe Delhi ----- End of picture text -----

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----- Start of picture text ----- ~ a "| |__] EN-3-ONE (VINCELACTAM) | |3__| TCSY [4 D(@)TARTARIC ACID 11.06 si |5 ||SS=*«dC'4.OD.PYRSOD I UMDINE BOROHYDRIDE 0.226 |6| [ISOPROPYL][ ALCOHOL] CS” [7 [METHANOL [423i 18 | DICHLORO METHANE RA concerned may take further necessary action as per above decision of NC. Case No.:62/17/82- Party Name:SMILAX Meet No/Date:7/82- (Status: Approved ALC4/2013 LABORATORIES ALC4/2014 | LIMITED 11.09.2014 HQ File RLA File "|Lic.No/Date:0910057671 _ [Defer Date: :01/82/050/00924/AM14/ :09/24/040/00292/AM 14/ 24.09.2013 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/60/2014-PI(Norms) dated 22.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:- 165 Export product Exp. Qty. Allowed | Qty. kg/kg Pant wens 1 2,5 Difluoro Methoxy- 0.80 i aeea a 2Mercapto-1 H-Benzimidazole | a 1 kg 2-Chloromethyl-3,4-Dimethoxy | 0.80 13_| [Methylene] pyridine HCL [chloride] [4 |Diisopropyleether«2.00 SS RA concerned may take further necessary action as per above decision of NC. {Case No.:36/16/82-ALC4/2013 [Party Name:CADILA Meet No/Date:7/82- —‘|Status: Approved HEALTHCARE LTD., ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0810125075 |Defer Date: :01/82/050/00849/AM14/ :08/24/040/00259/AM14/ 25.09.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/04/2014-PI(Norms) dated 09.09.2014, 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: 166 Export Product Gabapentin, 400 MG and 800MG Tablets Norms recommended for export 1 No. Tablets ! ||| GABAPENTIN |612.0mg600mg Tablets—«*|:800816.0 mg Tablets 7 Dy. Director Ganerat of Foreign yas Dises TIR neiPreerere ‘ree Fri Ceparinent of ConnMe: Udyog Bhawan Wee enn, ----- End of picture text -----

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----- Start of picture text ----- | ll: = nl ae —— ——! | Mii — = = — = — — = — = |3___| COPOVIDONE 37.54 [500 a5 K 30 Ea sdFy LOW SUBSTITUTED 41,25 55.0 | HYDROXYPROPYL CELLULOSE |6|MAGNESIUM STEARATE 12.24 [7 150 WHITE HDPE BOTTLE |8| CRC WHITE CAP 38 MM Relevant, as per packing policy 19 750 CC WHITE HDPE BOTTLE { {10| 11 || 225NCRC CC WHITE HDPE WHITE CAP 53 CRC MM BOTTLE CRC WHITE CAP 45 MM (14 __| DESI950 C C WHITE HDPANT CANIST E BOTTLER 2 G RA may take appropriate action as per the decision of Norms Committee. Case No.:21/19/82-ALC4/2013 |Party Name:GOPALDAS Meet No/Date:7/82- Status:Deffered VISRAM & CO.LTD. ALC4/2014 11.09.2014 167 |HQ File ~ | :01/82/050/00966/AM14/ :03/94/040/00502/AM14/IRA File 26.09.2013Lic.No/Date:0310751325 Date:09.10.2014Defer Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:14/16/82-ALC4/2013 LIFESCIENCES|Party Name:SHAMSHREELTD., —{MeetALC4/2014No/Date:7/82-__ (Status: Approved 11.09.2014 HQ File RLA File Lic,No/Date:2210014253 [Defer Date. :01/82/050/00827/AM 14/ :22/24/040/00046/AM14/ 30.09.2013 Decision tt : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No, 3501 1/57/2014-PI(Norms) dated 22.09.2014 and in 16g |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:- ----- End of picture text -----

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----- Start of picture text ----- | Export product ae Import items Qty. Allowed kg/kg MEROPENEM FOR 1kg MEROPENEM 1196.667 mg/1000 INJECTION 1000MG FOR INJ. USP mg vial RA concerned may take further necessary action as per above decision of NC. Case No.:41/17/82-ALC4/2013 |Party Name: HETERO LABS Meet No/Date:7/82- Status: Approved LIMITED ALC4/2014 11.09.2014 HQ File 169 :01/82/050/00903/AM14/7 :09/24/040/003RLA File 17/AM14/ Lic.}01,10.2013 No/Date:0910057783 Defer Date: Decision : Committee considered the case as per agenda and in lightof written comments received from Department of Pharmaceuticals vide their OM No. 35011/ 14/2014-PI(Norms) dated 24.09.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of H as per details given below or as applied by firm whichever is lower:- \ ersooo Oe cg, FTE SATIS EHTS TAT Directorate General of Fo foie We = were fT VDepariment of POTN SECS udson Bhawan ;tuber Beth ----- End of picture text -----

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----- Start of picture text ----- i a | Export product Exp. Import items Qty. Allowed Qty. kg/kg . 1 Dehydroepiandrosterone-3- | Abiraterone Acetate 1kg acetate 2.392 | Tetramethyl ethylene diamine 0.725 js | 50% diethyl methoxy borane RA concerned may take further necessary action as per above decision of NC. Case No.:46/17/82-ALC4/2013 Party Name:INCHEM Meet No/Date:7/82- Status:Deffered LABORATORIES PRIVATE ALC4/2014 LIMITED 11.09.2014 170 {HQ File RLA File Lic.No/Date:0910057784 (Defer yl :01/82/050/00908/AM14/ :09/24/040/00288/AM14/ 01.10.2013 Date:09.10.2014 PharmaceuticalsDecision : It was decided to defer the case for 09.10.2014 for comments of Department of Cn |Case No.:48/17/82-ALC4/2013 |Party Name:INCHEM Meet No/Date:7/82- —__‘|Status:Deffered LABORATORIES PRIVATE ALC4/2014 LIMITED 11.09.2014 171 HQ File IRLA File ~ |Lic.No/Date:0910057785 [Defer PharmaceuticalsDecision:01/82/050/00910/AM14/SRT : It wases decideder a to defer:09/24/040/00287/AM14/i i the caseSE for 09,10.20147 e.01.10.2013for— commentsSY. ofDepartment ofSRORTTDate:09,10.2014RT Case No.:32/16/82-ALC4/2013 |Party Name:FINE CURE Meet No/Date:7/82- Status: Approved PHARMACEUTICALS LTD. ALC4/2014 HQ 11.09.2014 File RLA File _ {Lic.No/Date:0810125295 [Defer Date: :01/82/050/00845/AM14/ :08/24/040/00292/AM14/ 03.10.2013 Decision Simniltee coh)...EEE : Committee considered the case as per agenda and in light of written comments received from 172 Department of Pharmaceuticals vide their OM No. 3501 1/20/2014-PI(Norms) dated 22.09.2014 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 Exp. Import items Qty. | Qty. Recommended CO-AMOXICLAV TABLETS | 4 kg | 1 AMOXICILLIN Shown Indigenous B.P 625 MG OR TRIHYDRATE AMOXICILLIN WITH IP/USP/BP } \ fev eqrary Werle vireay Directorate General of F oreign Trade sifrog FErvOepartment of Commerce UdyogBhawanhee Eins ----- End of picture text -----

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----- Start of picture text ----- isos = ee a —— » ee Se | “| [CLAVULANATE eS eesSE POTASSIUM TABLETS 625 2: POTASSIUM 300.90 mg/tablets MG IP/USP CLAVULANATE DILUTED WITH MICROCRYSTALLINE CELLULOSE (1:1) i l RA concerned may take further necessary action as per above decision of NC. Case No.:39/16/82-ALC4/2013 |Party Name:SANMAR Meet No/Date:7/82- Status:Deffered SPECIALITY CHEMICALS ALC4/2014 LIMITED, 11.09.2014 HQ File RLA File Lic.No/Date:0410150519 {Defer :01/82/050/00852/AM14/ :04/24/040/00146/AM14/ 03.10.2013 Date:09,10,.2014 } Decision :It was decided to remind the firm to furnish the following technical details: 1. Complete set of Application 2. Details of manufacturing process of4 chlorobutylveratrate 60% solution in Methyl —Ethyl- 173 |Ketone with chemical equations, molecular formula, molecular weights. 3. Yield obtained in each step. 4, Authentic technical literature in support of yield obtained. 5. Material balance. 6. CA certificate certifying the production of export item achieved by firm for the past three years and corresponding consumption of each input. 7. Detailed calculations, arriving at the norms applied for. The case was deferred for 09.10.2014 Case No.:26/17/82-ALC4/2013 |Party Name:MYLAN Meet No/Date:7/82- Status:Deffered LABORATORIES LIMITED = |ALC4/2014 11.09.2014 174 |HQ File RLA File Lic.No/Date:0910057816 [Defer :01/82/050/00888/AM14/ :09/24/040/00302/AM 14/ 04.10.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals [Case No.:12/16/82-ALC4/2013 {Party Name:INTAS Meet No/Date:7/82- Status: Approved PHARMACEUTICALS LTD., |ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0810125470 |Defer Date: :01/82/050/00825/AM14/ :08/24/040/00303/AM14/ 08.10.2013 | Decision :1n the light of written comments received from Department of Pharmaceuticals vide their 175 (OM No. 35011/814/2013-PI(Norms) dated-.08.2014, 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 . Lithium Carbonate FC Tablets 250mg and 400mg O_O[S.NO.| Importtems For export 1000 Tabletsare / NIRMAL . Diod feiruOepertment pee Ud babwan: New Delhi ----- End of picture text -----

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----- Start of picture text ----- fi | Lithium Carbonate PH. EUR./USP 0.255 kg 0.408 kg [2] Hypromellose 0.0107 0.0172 7 Lactose Monohydrate 0.130 0.208 f 9 | SPly Plain Shipper [10 HDPE Bottle Relevant as per packing policy [| PP CR Closure eeRA may take appropriate action as per the decision of Norms Committee. Case No.:26/16/82-ALC4/2013 Party Name:INTAS Meet No/Date:7/82- Status: Approved PHARMACEUTICALS LTD., |ALC4/2014 11.09.2014 HQ File RLA File ~'|Lic,No/Date:0810125462 [Defer Date: :01/82/050/00839/AM14/ :08/24/040/00302/AM14/ 08.10.2013 Decision = —— oh | OM :in the light of written comments received from Department of Pharmaceuticals vide their HBP No. 35011/815/2013-PI(Norms) dated 02.09.2014, it was decided to ratify norms under Para 4.7 of v1 as per details given below or as applied by the firm, whichever is less: Export Product Spironolactone Tablets BP 25 mg, 50 mg and 100 mg For Export of 1000 NOS Tablets (Qty. in kgs) 176 25mg Tablets | 50mg Tablets 100 mg Tablets S.No, Import Item | 4. PPovidone 25 0.0018 0.0035 0.0070 | 5. [Poly Ethylene Glycol 400 0.0006 0.0012 0.0024 | 6 PPregelatinised Starch 0.0350 0.070 | 040 | 7. [Purified Talc 0.0038 0.0075 0.0150 I ————Er eee rar ta Trade Hrectorate General of Foren Trade ben! TarHDepartment ofCommertee uayed Dhawanit ee ¥ ----- End of picture text -----

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----- Start of picture text ----- by a 9. |Colloidial Anhydrous Silica 0.0005 0.0010 0.0020 |10. Hypromellose 0.0030 0.0060 0.0120 | i. Bply Plain Shipper Relevant, As per packing policy. RA may take appropriate action as per the decision of Norms Committee. F Case No.:27/17/82-ALC4/2013 PartyName:EYTAN LABS Meet No/Date:7/82- Status: Approved LIMITED ALC4/2014 11.09.2014 HQ File ~|RLA File Lic.No/Date:0910057882 [Defer Date: :01/82/050/00889/AM14/ :09/24/040/00340/AM14/ 09.10.2013 Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/54/2014-PI(Norms) dated 22.09.2014 and in jconsultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP , as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Qty. Recommended | 177 | kg/kg (2R,5R)-5-Hydroxy-[1,3]- 0.971 | (2S,CIS)-S-Fluoro(4-Amino- Oxathiol Ane-2-Carboxylic 1,2-Dihydro-20xo-1- . Acid, 2S Isopropy-5R Methyl-1- | 2-CarboxylicPyrimidinyl-1,3-Oxathiolane-Acid(2R,5R)- R Cyclohexy yyl Ester (ECE) Menthylester(FCE | Hexamethy! Disilazane 0.70 (HMDS) RA concerned may take further necessary action as per above decision of NC. Case No.:73/14/82-ALC4/2013. |Party Name: MSN Meet No/Date:7/82- Status: Deffered LABORATORIES PRIVATE —|ALC4/2014 LIMITED 11.09.2014 178 {HQ File RLA File '|Lic.No/Date:0910057878 [Defer :01/82/050/00658/AM14/ :09/24/040/00325/AM14/ 09.10.2013 Date:09, 10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments ofDepartment of Pharmaceuticals Case No.:36/17/82-ALC4/2013 |Party Name:MYLAN- Meet No/Date:7/82- Status:Deffered LABORATORIES LIMITED —|ALC4/2014 | 11.09.2014 179 |HQ File RLAFile Lic.No/Date:0910057877 [Defer :01/82/050/00898/AM14/ :09/24/040/00300/AM14/ 09.10.2013 |Date:09, 10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals resin Bre/NIRA ate restora TU treypfe t) awan, New Deni ----- End of picture text -----

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----- Start of picture text ----- Case No.:28/16/82-ALC4/2013 |Party Name:NECTAR Meet No/Date:7/82- Status: Approved LIFESCIENCES LIMITED, ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:2210014277. |Defer Date: :01/82/050/0084 1/AM14/ :22/24/040/00048/AM 14/ 09.10.2013 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. ; 35011/13/2014-Pl(Norms) dated 24.09.2014, 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: Item of Export Quantity Item of Import Quantity allowed kg/kg Cefixime Trihydrate 1kg GCLE 1.507 }2. Sodium bromide 0.3628 }3. | Tri Phenyl Phosphine 0.820 Methylene Chloride 1.546 9 | Butyl Acetate 0.302 = p12 | EDTA 0.0182 MICA Ester 0.820 p15 Triethylamine (TEA) 0.2717 Ethyl Acetate 0.376 RA may take appropriate action as per the decision of Norms Committee. ~ |Case No.:6/17/82-ALC4/2013 Party Name:AMI ORGANICS __|Meet No/Date:7/82- Status: Approved PVT LTD. ALC4/2014 11.09.2014 HQ File RLA File ~ [Lic.No/Date:5210040263 Defer Date: :01/82/050/00868/AM14/ :52/24/040/00024/AM14/ 10.10.2013 Decision :in the light of written comments received from Department of Chemicals and 181 Petrochemicals vide their U.O No. 14010/24/2011-Ch. II dated 27.08.2014, 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 oeQty. | Ste. Import items Qty. allowed 3-4-DI-HYDROXYDENZALDERYDE 5-NITRONO | 2 ke VANILLIN cial “ih 99% MIN. DIMETHYL FORMAMIDE q lw warare wereersy Directorate General of For ign Trade anitivg fTUDepanment ot Commerce Uayeg Bi rowan eset ----- End of picture text -----

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----- Start of picture text ----- ~ | RA may take appropriate action as per the decision of Norms Committee. Case No.:55/17/82-ALC4/2013 |Party Name:SHODHANA Meet No/Date:7/82- Status: Approved LABORATORIES LTD ALC4/2014 11.09.2014 f HQ File RLA File Lic.No/Date:0910057889 |Defer Date: :01/82/050/00917/AM14/ :09/24/040/003 15/AM14/ 10.10.2013 Decision ; In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/50/2014-Pl(Norms) dated 02.09.2014, 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: 182 Item of Export Quantity Item of Import Quantity allowed kg/kg l L-Alanine Methyl Ester 1, . ‘ 0.89 HCL L-Alanine Technical ° Grade RA may take appropriate action as per the decision of Norms Committee. Case No.:137/23/82- Party Name: MANGALAM Meet No/Date:7/82- _—‘[Status:Deffered ALC4/2013 DRUGS & ORGANICS ALC4/2014 LIMITED 11.09.2014 HQ File RLA File Lic.No/Date:0310753231 |Defer :01/82/050/01184/AM14/ :03/95/040/00454/AM14/ 11.10.2013 Date:09.10.2014 183 [Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/193/2014-PI(Norms) dated 02.09.2014, it was decided to call from the firm following information: I) Complete technical details as per Appendix 33. Il) Past production vis-a-vis Actual consumption of Inputs for last three years duly certified by Central Excise Authorities. The case was deferred for 09.10.2014. Case No.:37/17/82-ALC4/2013 |Party Name: MYLAN Meet No/Date:7/82- Status:Deffered LABORATORIES LIMITED ALC4/2014 11,09,2014 HQ File RLA File Lic.No/Date:0910057908 [Defer :01/82/050/00899/AM 14/ :09/24/040/003 16/AM14/ 11.10.2013 Date:09.10.2014 184 Decision35011/104/2014-PI(Norms): In the light of writtendated comments22.09.2014, receivedit was decided from Department to call from of the Pharmaceuticals firm following information: vide their OM No. Ml) Stepwise % yield on molar basis alongwith copy of technical literature in support of yield envisaged and molar ratio of Diethanolamine, and Iv) Past production vis-a-vis Actual consumption of Input duly certified by Central Excise Authorities in respect of another Advance authorization taken by Matrix in 2010-11. The case was deferred for 09.10.2014. Case No.:38/16/82-ALC4/2013 |PartyName:INTAS —*{Meet No/Date:7/82-__|Status: Approved 185 PHARMACEUTICALS LTD., |ALC4/2014 11.09.2014 | NN HQ File RLA File |Lic.No/Date:08 10125636, {DeferDate- “ON OE eT Te a r mse ory ade Dy, Director Gere werent Directoratefae MS,Genera’Te ot9” Foran{CommerceTrade anferog frATV/Oepartment oo ----- End of picture text -----

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----- Start of picture text ----- “| {:01/82/050/00851/AM14/ :08/24/040/00321/AM14/ 14.10.2013 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/01/2014-Pl(Norms) dated 02.09.2014, 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: Item of Export | Quantity |S,No | Item of Import Quantity allowed Omeprazole Caps 20 fy) 237.927 mg/20 mg 1 mg capsule Omeprazole Pellets(81.5 mg/g to 90.1 mg/g) Omeprazole Caps 40 1: Omeprazole Pellets(81.5 | 475.854 mg/40 mg mg/g to 90.1 mg/g) capsule RA may take appropriate action as per the decision of Norms Committee. Case No.:38/17/82-ALC4/2013 |Party Name:MYLAN Meet No/Date:7/82- Status:Deffered LABORATORIES LIMITED — |ALC4/2014 11.09.2014 186 [HQ File |RLA File Lic.No/Date:0910057914 [Defer :01/82/050/00900/AM14/ :09/24/040/00322/AM14/ 14.10.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:18/16/82-ALC4/2013. |Party Name:NEULAND Meet No/Date:7/82- Status: Approved LABORATORIES LTD ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910057916 {Defer Date: :01/82/050/0083 1/AM14/ :09/24/040/00323/AM14/ 14.10.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/816/2013-PI(Norms) dated 02.09.2014, 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: 187 . 7 | Item of Export Quantity Item of Import Quantity | allowed kg/kg Donepezil Hydrochloride | 1 kg 4. |-Benzyl-4-Piperidine 1.583 Carboxaldehyde RA may take appropriate action as per the decision of Norms Committee. Case No.:39/17/82-ALC4/2013 |Party Name:ASTRIX Meet No/Date:7/82- ~ |Status:Deffered LABORATORIES LTD., ALC4/2014 188 11.09.2014 HQ:01/82/050/00901/AM14/File RLA File ~ |Lie.No/Date:0910057944 [Defer ae :09/24/040/003 12/AM14/ 17.10.2013 Date:09.10.2014 Prefer SeT/NIRMAL KUMAR wroctorate Goneral miboa [fearubeneaneds] of eee [ of] Cone Uayog Bhanan tes Deihi ----- End of picture text -----

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----- Start of picture text ----- ! = : | Decision: It was decided to defer the case for 09.10.2014 for comments of Department of lPharmadeuticals. ~ {Case No.:22/17/82-ALC4/2013 |Party Name:ATHENA DRUG. (Meet No/Date:7/82- Status:Deffered DELIVERY SOLUTIONS ALC4/2014 PRIVATE LIMITED 11.09.2014 189 |HQ File RLA File Lic.No/Date:03 10753955 Defer :01/82/050/00884/AM14/ 103/94/040/00458/AM 14/ 17,10,2013 Date:20.10.2014 Decision : It was decided to call from the firm copy of relevant DML. The case was deferred for { 20.10.2014. Case No.:67/17/82-ALC4/2013 Party Name:COVALENT Meet No/Date:7/82- Status: Approved LABORATORIES PRIVATE — |ALC4/2014 LIMITED 11.09.2014 if | HQ File {RLA File - Lic.No/Date:0910057945 {Defer Date: :01/82/050/00929/AM14/ :09/24/040/00286/AM14/ 17.10.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/52/2014-Pi(Norms) dated 24.09.2014, 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: Item of Export Qty. | S,No | Item of Import Quantity allowed kg/kg | Cefditoren Pivoxil 1kg 7-Phenylacetamideo-3- 3.12 Chloromethy! Cephalosporonic Acid Para Methoxybenzy] Ester (GCLE) 190 Tripheny! Phosphine 1,626 4 | Chloroform 3.126 5. | 4-Methy|-5-Formy! Thiazole (FMT) | }6. 1-Propanol 1.924 Chloromethy! pivalate Methylene Chloride 16.555 [ | RA may take appropriate action as per the decision of Norms Committee. - ‘ Pretewa wearersare NIRSTy SSTMAR Dy, Director Genvarat oF Foreign Trade: uiftroy frVDepadmentof fn " ----- End of picture text -----

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----- Start of picture text ----- ‘Case —— ——————— No.:17/4/82-ALC4/2014 |Party Name:NAPROD LIFE Meet No/Date:7/82- Status:Deffered SCIENCES PVT, LTD, ALC4/2014 11.09.2014 191 |HQ File RLA File Lic.No/Date:0310754049 {Defer :01/82/050/00265/AM15/ :03/95/040/00563/AM14/ 17.10.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Case No.:19/4/82-ALC4/2014 |Party Name:SAVLA Meet No/Date:7/82- Status:Deffered CHEMICALS LIMITED ALC4/2014 i 11.09.2014 192 |HQ File ~— IRLA File Lic.No/Date:0310754070 [Defer :01/82/050/00267/AM15/ :03/95/040/00566/AM 14/ 17.10.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of C&PC. Case No.:59/17/82-ALC4/2013 |Party Name:IND-SWIFT Meet No/Date:7/82- Status:Deffered || 193 {HQ File RLALABORATORIESFile LTD.,7 Lic.No/Date:2210014300ALC4/201411.09.2014 [Defer :01/82/050/00921/AM14/ :22/24/040/00050/AM14/ 21.10.2013 Date:09.10.2014 a Decision hte ete rte : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:108/23/82- Party Name:SYMBIOTEC Meet No/Date:7/82- |Status:Deffered ALC4/2013 PHARMALAB LTD., ALC4/2014 11.09.2014 194 |HQ File RLA File Lic.No/Date:5610003035 [Defer :01/82/050/01155/AM14/ :56/24/040/00020/AM14/ /21.10.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:17/24/82-ALC4/2013 |Party Name:EYTAN LABS __|Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11.09.2014 195 [HQ File RLAFile Lic.No/Date:0910057998 |Defer :01/82/050/01216/AM14/ :109/24/040/00355/AM14/ 24.10.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:48/4/82-ALC4/2014 Party Name: MANGALAM Meet No/Date:7/82- Status: Deffered DRUGS & ORGANICS ALC4/2014 LIMITED 11.09.2014 196 {HQ File RLA File Lic.No/Date:0310755274 [Defer 01/82/050/00296/AM15/ :03/95/040/0057 1/AM14/ 24.10.2013 Date:09, 10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of _ Pharmaceuticals Sil ees : ST Hef ere Tea RWMAR feetOrate General of frat ee ae URTeY Fen Depanmen ene SUNT sre yy 4 ----- End of picture text -----

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----- Start of picture text ----- F . cate i 3 x2 t — — “| Case No.:138/23/82- Party Name:MIDAS CARE —_[Meet No/Date:7/82- __|Status:Deffered ALC4/2013 PHARMACEUTICALS PVT |ALC4/2014 LTD 11,09.2014 | 197 {HQ:01/82/050/01185/AM14/ File ~— IRLA:03/95/040/00599/AM File 14/ 25.10.2013Lic.No/Date:0310755504 [DeferDate:09.10.2014 Decisionee ; It was decided. CERto deferae theReena case forfae 09.10.2014NO 10 9014for comments ofDepartmentSS of Pharmaceuticals ee ~ {Case No.:3/24/82-ALC4/2013 |Party Name:SANZYMELTD [Meet No/Daie-7/82. Status:Deffered ALC4/2014 11.09.2014 198 [HQ File RLA File ~ [Lic.No/Date:0910058014 [Defer |:01/82/050/01202/AM14/ :09/24/040/00295/AM14/ 25.10.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of C&PC. Case No.:35/24/82-ALC4/2013 |Party Name:AUROBINDO Meet No/Date:7/82- Status: Approved PHARMA LIMITED ALC4/2014 | 11.09.2014 HQ File RLA File ~ [Lic.No/Date:0910058043 [Defer Date: :01/82/050/01234/AM14/ :09/24/040/00346/AM 14/ 28.10.2013 Decisioneet: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/225/2014-PI(Norms) dated 02.09.2014, 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: Item of Export Quantity Item of Import Quantity Lamivudine. ikg Glyoxalic Acid 50% 1.738 . | allowed kg/kg 2; 2,5-Dihydroxy, 1,4- Dithiane 0.739 199 |: S| Cyclohexane 1.781 Methylene Chloride 10.43 13 As per fuel Steam/Thermal Coal policy. \ x Wrectorate Gore Tate Udyog Brew an yee, ----- End of picture text -----

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----- Start of picture text ----- | = — ae —y = a | Lhe - | 4— | a eee | its RA may take appropriate action as per the decision of Norms Committee. Case No.:7/20/82-ALC4/2013 Party Name: HONEST BIO-VET |Meet No/Date:7/82- Status: Approved PVT. LTD ALC4/2014 11.09.2014 200 |HQ File RLA File Lic.No/Date:0810126094 |Defer Date: b :01/82/050/00993/AM14/ :08/24/040/00339/AM14/ 29.10.2013 Decision : It was decided to withdrawn the case as it has been already approved by NC in 5/82 meeting dated 24.07.2014. Case No.:21/24/82-ALC4/2013 Party Name:SIFLON DRUGS [Meet No/Date:7/82- Status:Deffered ALC4/2014 11.09,2014 01 |HQ:01/82/050/01220/AM14/File RLA File_ Lic.No/Date:0910058067 {Defer [It][ was][ decided] [to][ defer][ the][ case] [for][ 09.10.2014] [for][ comments][ of Department of] ee[Pharmaceuticals [:] :09/24/040/00338/AM14/ 29.10.2013 Date:09, 10.2014 eee Case No.:31/24/82-ALC4/2013 |Party Name:SIFLON DRUGS _ (Meet No/Date:7/82- Status:Deffered ALC4/2014 11.09.2014 202 |HQ File RLA File Lic.No/Date:0910058070 [Defer :01/82/050/01230/AM14/ :09/24/040/00335/AM14/ 29.10.2013 Date:09.10.2014 Decision eee Oe) : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:37/24/82-ALC4/2013 Party Name:SIFLON DRUGS __|Meet No/Date:7/82- Status:Deffered ALC4/2014 11.09.2014 203 |HQ File RLA File Lic.No/Date:0910058069 [Defer :01/82/050/01236/AM14/ :09/24/040/00336/AM14/ 29.10.2013 Date:09.10.2014 ee Decision ee ; It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:78/23/82-ALC4/2013 |Party Name:AMI ORGANICS _ [Meet No/Date:7/82- Status: Deffered PVT LTD. ALC4/2014 11.09.2014 HQ File RLA File | Lic.No/Date:5210040368 |Defer 204 |:01/82/050/01125/AM14/ :52/24/040/0003 1/AM14/ 31.10.2013 Date:20.10.2014 Decision: It was decided to remind the firm to furnish following technical details: 1. Details of manufacturing process with chemical equations, molecular formula, molecular weight. 2. Yield obtained in each step supported with authentic technical literature. 3, Collaborators guaranteed norms, 4. Detailed calculation of arriving at the norms. The case was deferred for 20.10.2014. 205 Case No.:33/24/82-ALC4/2013 |Party Name:PORUS Meet No/Date:7/82- ~ |Status: Approved LABORATORIES PVT LTD, |ALC4/2014 WAN 1 1.09.2014 fester trae NIRMAL KU wh =. By STIR ie Raion Trade after furv/Deparimant some aesSnawen,:Sin ----- End of picture text -----

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----- Start of picture text ----- | HQ01/82/050/01232/AM14/ File — I[RLA1:09/24/040/00375/AM14/File ~ 31.10.2013[Lic.No/Date:0910058093 [Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/33/2011-Ch. II dated 15.09.2014, 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: | 2-Phenyl-3,3-bis(4- PTHALIC ANHYDRIDE | 0.927 kg hydroxy pheny|)phthalimide PHENOL 1.145 kg (PPP-BP) | ZINC CHLORIDE 0.546 kg P| ANILINE 0.730 kg | METHANOL 2.00 kg | ACTIVATED CARBON_ | 0.400 kg % CAUSTIC SODA LYE/ 2.20 kg LIQUID / SOLUTION ----- End of picture text -----

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

Case No.:12/24/82-ALC4/2013 Party Name:ASTRIX Meet No/Date;7/82Status: Approved LABORATORIES LTD., ALC4/2014 11.09.2014 HO File RLA File Lic.No/Date:0910058146 [Defer Date: :01/82/050/01211/AM14/ 109/24/040/00359/AM14/ 05.11.2013

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No, 35011/749/2013-PI(Norms) dated 24.09.2014, 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:

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----- Start of picture text ----- Item of Export Quantity Item of Import Quantity allowed kg/kg Lamivudine(Glyoxylic 1kg Glyoxylic Acid 0.869 206 Acid Route). 2,5-Dihydroxy-1,4-Dithiane | eae | 1,1,1,3,3,3-Hexamethy] | disilazane ! Ss Dimethyl! Formamide | }6. Methane sulphonic Acid 0.020 Dipotassium Hydrogen Phosphate 1.9849 Cycloh 1.58 | mie “ tor General of Foreign Trade wiferes fRarnDepanmentah omens ----- End of picture text -----

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----- Start of picture text ----- \ : Toluene 2.30 a a [ RA may take appropriate action as per theChdecision of Norms Committee. Case No.:34/24/82-ALC4/2013 Party Name:HETERO LABS Meet No/Date:7/82- Status:Deffered ' LIMITED ALC4/2014 11.09.2014 207 |HQ File RLA File Lic.No/Date:0910058148 |Defer . :01/82/050/01233/AM14/ :09/24/040/00378/AM14/ 05.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals | Case No.:4/22/82-ALC4/2013 |Party Name: VINDHYA Meet No/Date:7/82- Status:Deffered ORGANICS PVT LTD ALC4/2014 11.09.2014 208 [HQ File RLA File Lic.No/Date:0910058161 [Defer :01/82/050/01047/AM14/ :09/24/040/00279/AM14/ 06.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:22/24/82-ALC4/2013 |Party Name:DIVIS Meet No/Date:7/82- Status: Approved LABORATORIES LTD., ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910058165 |Defer Date: :01/82/050/01221/AM14/ :09/24/040/00376/AM14/ 07.11.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/216/2014-PI(Norms) dated 02.09.2014, it was decided to ratify norms under Para 4.7 of 209 |HBP v1 as per details given below or as applied by the firm, whichever is less: = Item of Export Quantity Item of Import Quantity allowed kg/kg DL-2,2-Di Methyl 1kg Neo Pentyl Glycol | Cyclopropane-1- : - 3 Rethenium Chloride 0.0002 [ RA may take appropriate action as per the decision of Norms Committee. Case No.:19/24/82- Party — Meet No/Date:7/82- _[Status:Deffered _ 210 ALC4/2013 ame:SMILAX LABORATORIES |ALC4/2014 LIMITED 11.09.2014 _\OW HQ File __|RLA File :09/24/040/00382/AM14/ [Lic.No/Date:091005817 {Defer inniac jac Ae Directorate Coal aifisaUdyogfeamvDepanmentBhawan Reeof orenicalshe ----- End of picture text -----

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ss :01/82/050/01218/AM14/ 0 Date:09.10.2014 08.11.2013 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of | Pharmaceuticals nn nnneee Case No.:27/24/82-ALC4/2013_ |Party Name:DIVIS Meet No/Date:7/82Status: Approved PHARMACEUTICALS ALC4/2014 PRIVATE LIMITED 11.09.2014 HQ File RLA File ~ {Lic.No/Date:0910058176 {Defer Date: :01/82/050/01226/AM14/ :09/24/040/00379/AM14/ 11.11,2013

Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/219/2014-PI(Norms) dated 02.09.2014 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:-

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----- Start of picture text ----- 211 Export product Exp. Import items Qty. aty. Allowed 2 Kg/kg | FLUOXETINE HCL |1___| BENZALDEHYDE 1.687 [2 | ISO PROPYL ALCOHOL 11.566 | | 3.| PALLADIUM 0.008 [5|4__| PARAFORMALDEHYDE 0.016 |6 _|| SODIUMACETOPHENONE BORO HYDRIDE [1.445 DIMETHYL SULPHOXIDE }2.29 _—i| | PARA CHLORO BENZO | TRIFLUORIDE be concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

Case No.:33/17/82-ALC4/2013 |Party Name:EMCURE Meet No/Date:7/82Status: Approved PHARMACEUTICALS LTD. |ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:3110061033 |Defer Date: :01/82/050/00895/AM14/ :31/83/040/00149/AM14/ 11.11.2013

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/61/2014-Pl(Norms) dated 24.09.2014, 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:

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----- Start of picture text ----- 212 || Item of Export Quantity Item of Import Quantity recommended Prochlorperazine 1kg 4: Prochlorperazine | Edisylate10 mg/2 ml Injection USP Edisylate 16.60 mg/vial | V9239 FM259/0 FLCO Relevant, As per | 006 Serum Stopper packing policy. | 13MM Flip-Off-Seal 4020 | Dark Blue [ | RA may take appropriate action as per the decision of Norms Committee.— Prefer war/ninmahhy\ 4 R ] _———s Dy. Siooe Garena pr Fordiyn Tate pita! Marae errr anftroyDirectoratefrarvoeparimentGeneral of Foreignof CommerceTrade Udyog £Bhawan een, ----- End of picture text -----

Case No.:29/24/82-ALC4/2013 Party Name:ATGC BIOTECH Meet No/Date:7/82Status: Deffered PVT LTD ALC4/2014 11.09.2014 213 'HQ File RLA File Lic.No/Date:0910058222 Defer :01/82/050/01228/AM 14/ :09/24/040/00275/AM14/ 13.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.1 0.2014 for comments of Department of Pharmaceuticals

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----- Start of picture text ----- Case No,:30/24/82-ALC4/2013 Party Name:DIVIS Meet No/Date:7/82- Status: Approved LABORATORIES LTD., |ALC4/2014 | 11,09.2014 HQ File IRLA File |Lic.No/Date:09 10058223 |Defer :01/82/050/01229/AM14/ :09/24/040/0039 1/AM14/ 13.1 1.2013 |Date:09.10.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No, 35011/217/2014-PI(Norms) dated 02.09.2014, 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: 214 Item of Export Quantity= | S,No Item of Import Quantity= allowed kg/kg * a S24 fers a 1k qi, methy enZOlc acl : ‘ Benzoic acid mane Toluene 2.20 |RA may take appropriate action as per the decision of Norms Committee. Case No.:16/24/82-ALC4/2013 |Party Name:GLAND PHARMA [Meet No/Date:7/82- __[Status:Deffered [LIMITED |ALC4/2014 11.09.2014 215 HQ File RLA File Lic, No/Date:0910058218 [Defer :01/82/050/01215/AM14/ :09/24/040/00385/AM14/ 13.11.2013 Date:09.10,2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:26/24/82-ALC4/2013 |Party Name:GLAND PHARMA [Meet No/Date-7/82. Status:Deffered LIMITED ALC4/2014 11,09,2014 216 |HQ File ~_[RLA File ‘Lic. No/Date:0910058221 [Defer :01/82/050/01225/AM14/ :09/24/040/00392/AM14/ 13.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals 217 Case No.:7/23/82-ALC4/2013 Party Name:JESONS Meet No/Date:7/82- Status: Approved | INDUSTRIES LTD. ALC4/201411.09.2014 }XY Pete grr NIRMAL-KUMAR wy HerPreere Rae ence Oy. Director General of Foreign Trade Mev eayrare were strera Directorate Ganerat off 30 Trade Sul Hay, ae feces Udyog Bhawan, New Deaihi ----- End of picture text -----

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----- Start of picture text ----- “| [HQ File “IRLA File Lic.No/Date:0310757929 [Defer Date. :01/82/050/01054/AM14/ :03/94/040/00713/AM14/ 14.11.2013 Decision :It was decided to withdrawn the case as it has been already approved by NC in 5/82 meeting dated 24.07.2014. SSS Case No.:25/4/82-ALC4/2014 [Party Name:S V CHEM Meet No/Date:7/82- Status:Deffered } INTERMEDIATES PLTD —|ALC4/2014 11.09.2014 218 {HQ File ~ IRLA File ~ {Lic.No/Date:0410151914 [Defer :01/82/050/00273/AM15/ :04/24/040/00176/AM14/ 14.11.2013 Date:09.10.2014 C&PC.Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Case No.:28/24/82-ALC4/2013 Party Name:PORUS Meet No/Date:7/82- Status:Deffered LABORATORIES PVT LTD, |ALC4/2014 11.09.2014 219 |HQ File RLA File Lic.No/Date:09 10058239 (Defer :01/82/050/01227/AM14/ :09/24/040/00396/AM14/ 18.11.2013 Date:09.10.2014 | C&PC.Decision : It was decided to defer the case for 09.10.2014 for comments ofDepartment of ~ [Case No.:66/23/82-ALC4/2013 |Party Name-STERICON Meet No/Date:7/82- ——‘|Status:Deffered PHARMA PVT.LTD., ALC4/2014 11.09.2014 220 [HQ File IRLA File Lic.No/Date:0710099690 [Defer :01/82/050/01113/AM14/ ‘|:07/24/040/00259/AM14/ 18.11.2013 Date:20.10.2014 Decision : It was decided to defer the case for 20.10.2014 for comments of Department of Pharmaceuticals. " [Case No.:40/19/82-ALC4/2013 [Party Name:INDO PHYTO Meet No/Date:7/82- Status:Deffered CHEMICALS PVT LTD ALC4/2014 11.09.2014 221 |HQ File RLA File Lic.No/Date:0510371304 [Defer :01/82/050/00985/AM14/ :05/23/040/00334/AM14/ 20.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals a Case No.:13/24/82-ALC4/2013 [Party Name:SATYA DEEPTHA(Meet No/Date:7/82- Status:Deffered PHARMACEUTICALS LTD —/ALC4/2014 11.09.2014 222 |HQ:01/82/050/01212/AM14/File ~— IRLAFile— Lic,No/Date:0910058278 [Defer Decision :09/24/040/00408/AM14/ 21.11.2013 Date:09.10.2014 : It was decided to defer the case for 09.1 0.2014 for comments of Department of Pharmaceuticals —‘\Case No.:74/23/82-ALC4/2013 Party Name:SWISS EXPORTS (Meet No/Date:7/82- \Status:Deffered \ PVT. LTD. ALC4/2014 Peter bere, NIRMAL KUMpA Rae 24 a a rh ae ----- End of picture text -----

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----- Start of picture text ----- i , a i 11.09.2014 HQ File RLA File Lic.No/Date:0810126591 [Defer 01/82/050/01121/AM14/ :08/24/040/00351/AM14/ 21.11.2013 Date:09,10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals . Case No.:140/23/82- Party Name: UNITED Meet No/Date:7/82- Status:Deffered ALC4/2013 PHOSPHORUS LTD. ALC4/2014 11.09.2014 224 |HQ File RLA File Lic.No/Date:0310758627 |Defer :01/82/050/01187/AM14/ :03/95/040/00495/AM14/ 21.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of C&PC, Case No.:149/23/82- Party Name:Y ASHO Meet No/Date:7/82- Status: Approved ALC4/2013 INDUSTRIES PVT.LTD. ALC4/2014 11.09.2014 HQ File ‘IRLA File Lic.No/Date:0310758646 |Defer Date: :01/82/050/01196/AM14/ :03/95/040/00658/AM14/ 21.11.2013 Decision :in the light of written comments received from Department of Chemicals and 225 Petrochemicals vide their U.O No. 14010/95/2011-Ch. Il dated 27.07.2014, 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. allowed Qty. |RAOFDIPHENYLAMINE may take appropriate action as per thePrema4 decision of Norms Committee.(||eee 8 Case No.;101/23/82- Party Name:ACEBRIGHT Meet No/Date:7/82- —(Status:Deffered ALC4/2013 (INDIA) PHARMA PVT LTD, |ALC4/2014 11.09.2014 226 |HQ File RLA File Lic.No/Date:0710099923 |Defer :01/82/050/01148/AM14/ :07/24/040/00269/AM14/ 25.11.2013 Date:09, 10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals CaseNo.:20/24/82-ALC4/2013 |Party Name:GLAND PHARMA (Meet No/Date-7/82. Status:Deffered LIMITED ALC4/2014 11.09.2014 227 |HQ File RLA File Lic.No/Date:0910058310 [Defer :01/82/050/01219/AM14/ :09/24/040/00405/AM14/ 25.11.2013 Date:09.10.2014 a Decision a il : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals ang (Case No.:139/23/82- —*(PartyName:YASHO. ~~ [Meet No/Daie7/@2.S Status: Approved, ( ALC4/2013 INDUSTRIES PVT.LTD. ALC4/2014 frien erwre/nimnaasic . Dy. Director General of Foroinn ey freer eqrore srerfree pee Directorate General otForains todo Udyou Brawan, Wess eon: ----- End of picture text -----

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----- Start of picture text ----- a Oe | = 11.09.2014 [iosaoa HQ File RLA File Lic.No/Date:03 10758995 Defer Date: :01/82/050/01186/AM14/ :03/95/040/00673/AM14/ 25.11.2013 Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011-Ch. |! dated 02.04.2013, 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 aeQty. ee ty. allowed | | METHYL EUGENOL t CLOVE LEAF OIL Laks | (Eugenol Content 78%) RA may take appropriate action as per the decision of Norms Committee. Le Case No.:11/24/82-ALC4/2013 |Party Name:GLAND PHARMA |Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11.09.2014 229 |HQ File RLA File Lic.No/Date:0910058351 |Defer 5 :01/82/050/01210/AM14/ :09/24/040/00420/AM14/ 26.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of | Pharmaceuticals | Case No.:32/24/82-ALC4/2013 |Party Name:GLAND PHARMA—— |Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11.09.2014 230 |HQ File RLA File Lic.No/Date:0910058353 [Defer :01/82/050/0123 1/AM14/ :09/24/040/00417/AM14/ 26.11.2013 Date:09.10.2014 | Decision : It was decided to defer the case for 09.10.2014 for comments of Department of |eiPharmaceuticals ee Case No.:129/23/82- Party Name: HETERO LABS Meet No/Date:7/82- Status:Deffered | ALC4/2013 LIMITED ALC4/2014 ] 11.09.2014 231 |HQ File RLA File Lic.No/Date:0910058346 | Defer ] :01/82/050/01 176/AM14/ :09/24/040/00421/AM14/ 26.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:54/4/82-ALC4/2014 |Party Name:NECTAR Meet No/Date:7/82- Status:Deffered LIFESCIENCES LIMITED, ALC4/2014 11.09.2014 232 |HQ File RLA File Lic.No/Date:2210014403 (Defer :01/82/050/00302/AM15/ 122/24/040/00062/AM 14/ 27.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals 933 (Case No.:77/23/82-ALC4/2013 [Party Name:SHASUN Meet No/Date:7/82- '|Status:Deffered NN PHARMACEUTICALS ALC4/2014 a wf OE NIRMAL Ku \ Ne | eeCpeWreCtorateirector ceeGangralGaneralmTeiPreeneeof7 pisForeian.-z i1 arity FemDepadmentof Commrne ude We, WE Rt YOg Bhawan, New Detni | ----- End of picture text -----

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----- Start of picture text ----- } } |LIMITED 11.09.2014 | HQ File RLA File Lic.No/Date:0410152258 |Defer | :01/82/050/01124/AM14/ :04/24/040/00183/AM14/ 27.11.2013 Date:09.10.2014 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 09.10.2014. Case No.:94/23/82-ALC4/2013 |Party Name:DHANUKA Meet No/Date:7/82- Status:Deffered | LABORATORIES LTD. ALC4/2014 11,09,2014 234 [HQ File RLA File Lic.No/Date:0510372219 [Defer :01/82/050/01141/AM14/ :05/23/040/00342/AM14/ 28.11.2013 Date:09.10.2014 | Decision : It was decided to defer the case for 09.10.2014 for comments of Department of | Pharmaceuticals Case No.:104/23/82- Party Name:PCL OIL & Meet No/Date:7/82- Status: Deffered | ALC4/2013 SOLVENTS LTD., ALC4/2014 11.09.2014 235 |HQ File RLA File Lic.No/Date:0510372321 |Defer :01/82/050/01151/AM14/ :05/24/040/00201/AM14/ 29.11.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of | | C&PC | Case No.:8/24/82-ALC4/2013 |Party Name:SUVEN LIFE Meet No/Date:7/82- Status:Deffered | SCIENCES LIMITED ALC4/2014 11.09.2014 236 |HQ File RLA File Lic.No/Date:0910058405 |Defer :01/82/050/01207/AM 14/ :09/24/040/00356/AM14/ 29.11.2013 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:148/23/82- Party Name:CTX Meet No/Date:7/82- Status: Deffered ALC4/2013 LIFESCIENCES PVT LTD, ALC4/2014 11.09.2014 237 |HQ File RLA File Lic.No/Date:0310760166 Defer 01/82/050/01195/AM14/ :03/94/040/00598/AM14/ 02.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:147/23/82- Party Name:AGIO Meet No/Date:7/82- Status:Deffered ALC4/2013 PHARMACEUTICALS LTD —|ALC4/2014 . 11.09.2014 238 |HQ File RLA File Lic.No/Date:0310760371 |Defer :01/82/050/01194/AM14/ :03/94/040/00705/AM 14/ 03.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals [239 Case No.:150/23/82- Party Name:AGIO [Meet No/Date:7/82- Status:Deffered 7 Lika)et Te/NIRMAL KUMAR | ferey apa rrerftreyiresy Directorate Generat of fF ereign Trade af req PPV Department of Commerce Uayog Bhawan hear Eoin: | ----- End of picture text -----

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----- Start of picture text ----- ~~ —_ _ a $$ —$————— ALC4/2013 PHARMACEUTICALS LTD ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0310760378 {Defer :01/82/050/01197/AM14/ :03/94/040/00706/AM14/ 03.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals i, i CaseALC4/2013No.:112/23/82- | PartyHEALTHCARE Name:CADILALTD., ALC4/2014Meet No/Date:7/82- 1 Status:Deffered 11.09.2014 HQ File RLA File Lic.No/Date:0810126887 |Defer | 240 :01/82/050/01159/AM14/ :08/24/040/00387/AM14/ 04.12.2013 Date:20.10.2014 Decision : It was decided to call following technical details from the firm viz:- (a) Complete technical details as per Appendix-33 for the manufacture of Duloxetine Hcl. (b) Past production of API vis-a-vis actual consumption of its raw materials duly certified by Central Excise Authorities, The case is deferred for 20.10.2014. | Case No.:66/3/82-ALC4/2014 {Party Name:GLAND PHARMA (Meet No/Date-7/82. Status:Deffered LIMITED ALC4/2014 11.09.2014 1941 |HQ File RLAFile Lic.No/Date:0910058454 [Defer :01/82/050/00070/AM15/ :09/24/040/00422/AM14/ 04.12.2013 |Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:116/23/82- Party Name:ALCHEM Meet No/Date:7/82- __|Status:Deffered ALC4/2013 INTERNATIONAL LTD. ALC4/2014 11.09.2014 242 |HQ File RLA File Lic.No/Date:0510372635 [Defer :01/82/050/01163/AM14/ :05/23/040/00341/AM14/ 05.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals { ——e Case No.:18/23/82-ALC4/2013 |Party Name:NAPROD LIFE Meet No/Date:7/82- Status:Deffered SCIENCES PVT. LTD, ALC4/2014 11.09.2014 243 HQ File RLA File Lic.No/Date:0310760768 Defer Decision:01/82/050/01065/AM14/: It was decided: to defer:03/95/040/00712/AM14/ the= case for 09.10.201405.12.2013for comments of DepartmentDate:09, of 10.2014 Pharmaceuticals Case No.: 138/3/82-ALC4/2014 |Party Name:AUROBINDO Meet No/Date:7/82- Status:Deffered PHARMA LIMITED ALC4/2014 11.09.2014 244 |HQ File IRLA File Lic.No/Date:0910058481 [Defer :01/82/050/00142/AM15/ :09/24/040/00424/AM14/ 06.12.2013 |Date:09. 10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of | \y Pharmaceuticals eo Seater tare HIRI } das arent8 er aon trade arfica frvo opariment Nala ae Uae bnawan, New Delhi ----- End of picture text -----

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----- Start of picture text ----- — Case No.:10/23/82-ALC4/2013_[Party : [Meet No/Date:7/82- ‘|Status: Approved — Name:YASHOINDUSTRIES |ALC4/2014 PVT.LTD. 11.09.2014 HQ File IRLA File _ |Lic.No/Date:0310761106 (Defer Date: :01/82/050/01057/AM14/ |:03/95/040/00720/AM 14/ 09.12.2013 Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2014-Ch. II dated 27.07.2014, it was decided to ratify i 25] /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. SI.No. | Import items Qty. allowed Qty. ZINC ETHYL PHENYL 1kg 1 N-ETHYL ANILINE 0,587 kg | DITHIOCARBAMATE (ZEPC) ) RA may take appropriate action as per the decision of Norms Committee. | im Case No.:63/23/82-ALC4/2013 [Party Name:AMI ORGANICS [Meet No/Date:7/82- Status: Approved PVT LTD. ALC4/2014 11.09.2014 :01/82/050/01110/AM14/HQ File ; EA|:52/24/040/00037/AMFile 14/; |Lic.No/Date:521004048510.12.2013 [Defer Date: Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/24/2014-Cch. II dated 27.08.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as 252 per details given below or as applied by the firm, whichever is less: Qty. 2S4DEHYDROXYS:—“[Tkg [1 |VANILLIN-995%MIN| 158%g J MIN. 99% 99.5%DIMETHYLMIN. FORMAMIDE - —| 1-26 kg RA may take appropriate action as per the decision of Norms Committee. Case No.:95/23/82-ALC4/2013 |Party NameJAGSONPAL [Meet No/Date:7/82- ——‘|Status:Deffered PHARMACEUTICALS LTD. |ALC4/2014 11.09.2014 253 {HQ File ~|RLA File [Lie No/Date:0310373220 [Defer :01/82/050/01142/AM14/ |:05/23/040/00368/AM 14/ 11.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:137/3/82-ALC4/2014 Party Name:SUVEN LIFE Meet No/Date:7/82- Status:Deffered _ SCIENCES LIMITED ALC4/2014 11.09.2014 254 |HQ File - File - Lic.No/Date:0910058555 [Defer :01/82/050/00141/AM15/ |:09/24/040/00427/AM14/ 11.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of ¢ | Pharmaceuticals feta 2Te/NIRMAL K ald att Ne neice al of Foroign Trade arferet feurtvOepart nen eters ----- End of picture text -----

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----- Start of picture text ----- P Sl ees - a = SSS —_ Case No.:141/3/82-ALC4/2014 |Party Name:COVALENT Meet No/Date:7/82- Status:Deffered LABORATORIES PRIVATE —|ALC4/2014 LIMITED 11.09.2014 255 |HQ File RLA File Lic.No/Date:0910058567 |Defer :01/82/050/00145/AM15/ :09/24/040/00418/AM14/ 12.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of } Pharmaceuticals Case No.:9/23/82-ALC4/2013 Party Name:NAWAL Meet No/Date:7/82- Status: Deffered PRAKASH AVIKEM ALC4/2014 PVT.LTD., 11.09.2014 256 |HQ File RLA File Lic.No/Date:0310761637 |Defer :01/82/050/01056/AM14/ :03/95/040/00434/AM14/ 12.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of p Pharmaceuticals Case No.:115/23/82- Party Name:ALCHEM Meet No/Date:7/82- Status:Deffered | ALC4/2013 INTERNATIONAL LTD. ALC4/2014 y 11.09.2014 257 |HQ File RLA File Lic.No/Date:0510373480 |Defer :01/82/050/01162/AM14/ :05/23/040/00365/AM14/ 13.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:139/3/82- Party Meet No/Date:7/82- Status:Deffered ALC4/2014 Name:SMILAX LABORATORIE |ALC4/2014 S LIMITED 11.09.2014 258 HQ File RLA File :09/24/040/0044 1/AM14/ |Lic.No/Date:091005859 |Defer |:01/82/050/00143/AM15/ 5 Date:09.10.2014 13.12.2013 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:83/23/82-ALC4/2013 |Party Name:SHIVA Meet No/Date:7/82- —/Status:Deffered PHARMACHEM LTD, ALC4/2014 11.09.2014 259 |HQ File RLA File Lic.No/Date:34 10038734 [Defer :01/82/050/01130/AM14/ :34/24/040/0023 1/AM14/ 16.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of C&PC. ‘Case No.:7/18/82-ALC4/2013 |Party Name:SWISS EXPORTS __|Meet No/Date:7/82- Status:Deffered PVT. LTD. ALC4/2014 , 11.09.2014 260 [HQ File RLAFile Lic.No/Date:0810127123 (Defer :01/82/050/00942/AM 14/ :08/24/040/00400/AM14/ 16.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments ofDepartment ofa Directorate General of Foreign 1m areca frVOepartment of CO UdyogsaryShawan,Wet, 1, fieethNew Ue! ----- End of picture text -----

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----- Start of picture text ----- Z : ———— Re aa| 1 Pharmaceuticals ~ |Case No.:33/3/82-ALC4/2014 {Party Name:HETERO DRUGS [Meet No/Date:7/82- Status:Deffered LIMITED, ALC4/2014 11.09.2014 261 |HQ File RLA File Lic.No/Date:0910058622 |Defer :01/82/050/00037/AM15/ 109/24/040/00466/AM14/ 17.12.2013 Date:09. 10.2014 | Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No,:119/3/82-ALC4/2014 |Party Name; HETERO LABS Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11.09.2014 262 [HQ File RLA File Lic.No/Date:0910058620 [Defer :01/82/050/00123/AM15/ :09/24/040/00470/AM14/ 17.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:98/3/82-ALC4/2014 |Party Name:VIVIMED LABS __ [Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11.09.2014 263 |HQ File RLA File Lic.No/Date:0910058626 [Defer :01/82/050/00102/AM15/ :09/24/040/00448/AM14/ 17.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:39/23/82-ALC4/2013 |Party Name:AARTI Meet No/Date:7/82- Status: Deffered INDUSTRIES LIMITED ALC4/2014 11.09.2014 264 {HQ File RLA File Lic.No/Date:03 10762301 [Defer :01/82/050/01086/AM14/ :03/94/040/00760/AM14/ 18.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals ‘Case No.:50/23/82-ALC4/2013 |Party Name:AARTI Meet No/Date:7/82- Status: Approved INDUSTRIES LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:03 10762302 |Defer Date: :01/82/050/01097/AM14/ 103/94/040/00761/AM14/ 18.12.2013 | Decision : In the light of written comments received from Department of Pharmaceuticals vide their 265 OM No. 35011/189/2014-PI(Norms) dated 02.09.2014, 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: Item of Export Quantity Item of Import allowed kg/kg CAFFEINE ANHYDROUS 1kg 1,02 j CYANO ACETIC ACID 70% \ sy Hetheere fyet ease Dy. Director General of Foreign Trade fae@u cara tWeTfeetesst Directorate General of Foran Trade aise ferru/Deparimient of Commerce vay baton hone ----- End of picture text -----

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----- Start of picture text ----- ~ | bsnn may take appropriate action as per the decision of Norms Committee. Case No.:87/23/82-ALC4/2013 Party Name:INDO PHYTO Meet No/Date:7/82- Status: Deffered CHEMICALS PVT LTD ALC4/2014 11.09.2014 266 [HQ File [RLA File Lic.No/Date:0510373925 [Defer || :01/82/050/01134/AM14/ |:05/23/040/00385/AM 14/ 18.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:68/3/82-ALC4/2014 LABORATORIES|Party Name:PORUSPVT LTD._{Meet|ALC4/2014 No/Date:7/82- Status: Approved HQ 11.09.2014 File RLA File Lie.No/Date:0910058633 [Defer Date: ! :01/82/050/00072/AM15/ :09/24/040/00463/AM14/ 18.12.2013 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/33/2011-Ch. || dated 15.09.2014, 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 eoQty. Import items Qty. allowed | 2-Phenyl-3,3-bis(4- | 1 kg PTHALIC ANHYDRIDE | 0.927 kg 267 hydroxy phenyl)phthalimide PHENOL 1.145 kg (PPP-BP) ZINC CHLORIDE 0.546 kg = | ANILINE 0.730 kg ‘a METHANOL 2.00 kg | a ACTIVATED CARBON _ | 0.400 kg 7. |CAUSTIC SODA LYE/ LIQUID / SOLUTION RA may take appropriate action as per the decision of Norms Committee. SS Case No.:146/3/82-ALC4/2014 |Party Name:LOUIS Meet No/Date:7/82- Status: Approved PHARMACEUTICALS PVT ALC4/2014 LTD 11.09.2014 ’ HQ File ~— IRLA File Lic.No/Date:0910058653 [Defer Date: :01/82/050/00150/AM15/ :09/24/040/00476/AM14/ 19.12.2013 268 |Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/724/2013-PI(Norms) dated 09.09.2014, 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: Item of Export Quantity Item of Import Quantity C DirectoratePRET TTSGone f alos nakof Foreignof CommarceTrade waPerea Rerubepart pai fawn ----- End of picture text -----

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----- Start of picture text ----- —_ i _ ae | es 07)” \ a (2B, 3A,5A,16B,17B)-2-(4- | RCB Diol MORPHOLINYL)-16 (PYRROLIDINYL) ANDROSTANE-3, 17-DIOL | CRUDE RA may take appropriate action as per the decision of Norms Committee. | [Case No.:89/23/82-ALC4/2013 [{Party][Name:RENOWN] [—_[Meet][ No/Date:7/82-] Status:Deffered | PHARMACEUTICALSLTD PVT |ALC4/201411.09.2014 269 |HQ:01/82/050/01136/AM14/File :34/24/040/00225/AMRLA File 14/ Lic.No/Date:341003876019.12.2013 |DeferDate:20.10.2014 Decision : It was decided to defer the case for 20.10.2014 for comments of Department of Pharmaceuticals. | Case No.:91/23/82-ALC4/2013 PHARMACEUTICALS|Party Name:INTAS LTD., |ALC4/2014Meet No/Date:7/82- ‘Status: Approved | 11.09.2014 HQ File RLA File Lic.No/Date:0810127281 [DeferDate: :01/82/050/01138/AM14/ :08/24/040/00408/AM 14/ 20,12.2013 | Decision :in the light of——- written commentsDiniothereceivedlintel from Department of Pharmaceuticals vide——— their | OM No. 35011/161/2014-Pl(Norms) dated 02.09.2014, 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 =Qty. Import items ty. Allowed kge/kg Aspirin Enteric Acetyl Salicylic Acid 270 | Coated Tablets 81 mg EP/BP/USP 82.62 mg/tablets “Ecotrin 81 Microcrystalline: : Cellulose PH102 | 4 | Triethy! Citrate PH.Eur | 200 | 5 | 1Gsilica Gel Canister Relevant, As per 50 ml HDPE white bottle packing policy. with CR cap & seal RA may take appropriate action as per the decision of Norms Committee. | Case No.:85/23/82-ALC4/2013 Party Name:PARENTERAL _/[Meet No/Date:7/82- Status: Deffered {DRUGS (INDIA) LTD., ALC4/2014 271 | 11.09.2014 [He1:0 1/82/050/01132/AM14/ File ze EnRLAFile:56/24/040/00033/AMFras zeAeied 14/ ~~alse {Lie.No/Date:561000340020.12.2013‘— [DeferDate:09.10.2014 Xe4 fart fear eqrare treih i Directorate General of Fore Cody area ferruDepanment ve a : Seea Kany | ----- End of picture text -----

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----- Start of picture text ----- | Decision : It wasdecided to defer the case for 09. 10.2014 for comments ofDepartment of | Pharmaceuticals [Case No.:145/3/82-ALC4/2014 |Party Name:AUROBINDO [Meet No/Daie7/@2. Status: Approved PHARMA LIMITED ALC4/2014 11.09.2014 HQ File ~—{RLA File Lic.No/Date:0910058692 {Defer Date: :01/82/050/00149/AM15/ :09/24/040/00465/AM14/ 23.12.2013 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/110/2014-PI(Norms) dated 02.09.2014, 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. Import items Qty. Allowed kg/kg | Qty. Nateglinide i Trans-4-Isopropyl cyclohexane 272 carboxylic acid D-Pheny] alanine 0,954 3 Activated Carbon 0.040 | a i Pivaloyl Chloride 0.826 [8 | Steam/Thermal Coal As per Fuel Policy. RA may take appropriate action as per the decision of Norms Committee. PT Case No.:11/3/82-ALC4/2014 PartyName:MICRO LABS LTD |Meet No/Date:7/82- a Status:Deffered ALC4/2014 11.09.2014 273 {HQ File |RLA File Lic.No/Date:0710100791 _ |Defer |:01/82/050/00015/AM15/ :07/24/040/00318/AM14/ 23.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:41/23/82-ALC4/2013 |Party Name: HEMMO Meet PHARMACEUTICALS ALC4/2014No/Date:7/82- _|Status: Approved 274 PRIVATE LIMITED 11.09.2014 HQ File RLA File / Lic.No/Date:0310763218 {Defer Date: :01/82/050/01088/AM14/ 7 :03/94/040/00749/AM 14/ 24. 12.2013 Ht = 2MAL KUMAR Director ‘ f Se BrereyUdyoga4 Bhawan, New——.Bot ----- End of picture text -----

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----- Start of picture text ----- “| OM[Decision:in the light of writtencomments received from Department of Pharmaceuticals vide their HBP No. 35011/191/2014-Pl(Norms) dated 05.09.2014, it was decided to ratify norms under Para 4.7 of v1 as per details given below or as applied by the firm, whichever is less: Export Product Leuprolide(Leuprolide Acetate) a ee i i a ee [| i.aei cee a| f [SS [Le a ieg| a —— | _ = PISOaDFYLEARDOOMAIDBDREDH [seat ——— ia [eparrteoenesanaA) s a ra —— ia Ssa em Note:-above norms may be compared with Actual past consumption data certified by Central Excise Authorization and lower of the two may be allowed to the firm, F |RA may take appropriate action as per the decision of Norms Committee. OtOTM Comina PRIVATE LIMITED ALC4/2014 11.09.2014 | newsravers, edgea 275 i |eeFile rma Ee NefDate03 1eon | :01/82/050/01074/AM14/ :03/95/040/00758/AM14/ 24.12.2013 Date:09.10.2014 Decision : It was decided to defer thecase for 09.10.2014 for comments of Department of ‘ ----- End of picture text -----

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----- Start of picture text ----- . oe : | | } t ~— —— $$ Inna... — Case No.:142/3/82-ALC4/2014 Party Name:SRIAM LABS Meet No/Date:7/82- Status:Deffered PRIVATE LIMITED ALC4/2014 11.09.2014 276 |HQ File — IRLA File Lic.No/Date:0910058708 {Defer :01/82/050/00146/AM15/ :09/24/040/00439/AM14/ 24.12.2013 |Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:157/3/82-ALC4/2014 Party Name:ATLAS FINE Meet No/Date:7/82- Status: Approved CHEMICALS PVT LTD ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0310763403 [Defer Date: :01/82/050/00161/AM15/ :03/94/040/00647/AM14/ 26.12.2013 Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/74/2013-Ch. II dated 17.01.2014, 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: Item of Export Item of Import Quantity allowed COUMARIN a: 277 | Apperance: Crystaline: Salicylaldehyde 68CPowder Minimum FreezingMolten Point: Molecularolecalar Weight:Weight: 122.122122. Apperance:; Clear Odor:? Specification:HydroxybenzaldehydeAnpenrsiits SulphuricStandard Assay:Minimum andColorSolution: 99% of 500Siow IE cnlar'l.tsesh shinsiiheaheggg. 0.920 kg 125 Hazen Maximum; GLC 95-99% Minimum | BoilingMolecularPoint:Weight:;310C146 WaterMaxiia Content 0.5% |RA may take appropriate action as per the decision of Norms Committee. Case No.:97/3/82-ALC4/2014 |Party Name:SATYA DEEPTHA [Meet No/Date:7/82- Status:Deffered PHARMACEUTICALS LTD —|ALC4/2014 278 |HQ:01/82/050/00101/AM15/File ~ [RLA File Lic.No/Date:091005873011.09.2014 [Defer :09/24/040/00482/AM14/ 26.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:144/3/82-ALC4/2014_ Party Name:SRINI Meet No/Date:7/82- Status: Deffered PHARMACEUTICALS LTD., |ALC4/2014 11.09.2014 279 {HQ File RLA File - Lic.No/Date:0910058728 [Defer :01/82/050/00148/AM15/ :09/24/040/0047 1/AM14/ 26.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals a ENA fartet Te a ET ae <= sett Boner! bal ee erat uUdyes < ----- End of picture text -----

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----- Start of picture text ----- ~ |Case No.:38/4/82-ALC4/2014 |Party Name:ALTA Meet No/Date:7/82- Status:Deffered LABORATORIES LTD. ALC4/2014 11.09.2014 280 |HQ File RLA File [Lic.No/Date:03 10763559 [Defer :01/82/050/00286/AM15/ :03/94/040/00796/AM14/ 27.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals ‘Case No.:71/23/82-ALC4/2013] Party Name:RANBAXY Meet No/Date:7/82-_ Status:Deffered LABORATORIES LTD ALC4/2014 11.09.2014 281 |HQ File RLA File Lic.No/Date:0510374576 [Defer :01/82/050/01118/AM14/ :05/24/040/003 17/AM14/ 27.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:64/23/82-ALC4/2013_ |Party Name:$.M. HERBALS Meet No/Date:7/82- Status: Approved PVT.LTD. ALC4/2014 11.09.2014 :01/82/050/01111/AM14/HQ File IRLA:05/24/040/00321/AM14/ File 27.12.2013Lic.No/Date:0510374573 [Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No, 35011/51/2014-PI(Norms) dated 09.09.2014, 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: 282 || Item of Export Quantity Item of Import Quantity allowed kg/kg | 10 Deacetyl Baccatin III | 1 kg 10 Deacetyl Baccatin IIT | HPLC Purity NLT HPLC Purity NMT 95% 1.03 98.5%. RA may take appropriate action as per the decision of Norms Committee. Case No.:143/3/82-ALC4/2014 |Party Name:VIVIMED LABS [Meet No/Date:7/82- Status: Approved LIMITED ALC4/2014 11.09.2014 HQ File IRLA File Lic.No/Date:0910058745 |Defer Date: :01/82/050/00147/AM15/ :09/24/040/00461/AM14/ 27.12.2013 283 |Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/43/2011-Ch. II dated 01.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: i [itemofexport | Quantity [S.No | Itemofimport_ | Quantity allowed - Pia Fart/NIRMAL KUMAR ’ peesate ae babii iat ft wifi fearDepariment Relea yon Now Daint ----- End of picture text -----

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----- Start of picture text ----- r Te ————— EE E — SS ee RA may take appropriate action as per the decision of Norms Committee. r ‘Case No.:43/23/82-ALC4/2013 Party Name:ANUH PHARMA _|Meet No/Date:7/82- Status:Deffered LTD. ALC4/2014 11.09.2014 284 |HQ File RLA File Lic.No/Date:03 10763631 |Defer :01/82/050/01090/AM14/ :03/94/040/00770/AM14/ 30.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals [Case No.:48/23/82-ALC4/2013 |Party Name:EXCEL Meet No/Date:7/82- Status:Deffered INDUSTRIES LIMITED ALC4/2014 11.09.2014 285 |HQ File RLA File Lic.No/Date:0310763628 |Defer :01/82/050/01095/AM 14/ :03/94/040/00719/AM14/ 30.12.2013 Date:09.10.2014 | Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals / (Case No.:22/3/82-ALC4/2014 [Party Name:GLAND PHARMA (Meet No/Date:7/82-__|[Status:Deffered LIMITED ALC4/2014 11.09.2014 286 {HQ File RLA File Lic.No/Date:0910058787 [Defer | :01/82/050/00026/AM15/ :09/24/040/00485/AM14/ 31.12.2013 Date:09.10.2014 | Decision : It was decided to defer the case for 09.10.2014 for comments of Department of | Pharmaceuticals | Case No.:96/3/82-ALC4/2014 Party Name:GLAND PHARMA |Meet No/Date:7/82- Status:Deffered | LIMITED ALC4/2014 11.09.2014 287 [HQ File RLA File Lic.No/Date:0910058788 [Defer :01/82/050/00100/AM15/ :09/24/040/00481/AM14/ 31.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:23/3/82-ALC4/2014 |Party Name:MSN Meet No/Date:7/82- Status:Deffered LABORATORIES PRIVATE = |ALC4/2014 ‘ LIMITED 11.09.2014 288 |HQ File RLA File Lic.No/Date:0910058791 Defer :01/82/050/00027/AM15/ :09/24/040/00486/AM14/ 31.12.2013 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals 289 ‘Case No,:88/3/82-ALC4/2014 |Party Name: MYLAN Meet No/Date:7/82- Status:Deffered N R LABORATORIES LIMITED — |ALC4/2014 eg NIRMAL eu +4 DITEHe eyOePIe’: “erat air ue! v erat, 8 sow pein usyos Brewer: ----- End of picture text -----

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----- Start of picture text ----- [11.09.2014 HQ File RLA File Lic.No/Date:0910058792 /Defer :01/82/050/00092/AM15/ :09/24/040/00451/AM14/ 31.12.2013 Date:09.10.2014 P0014 Decision | : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals a ; Case No.:2/2/82-ALC4/2014 Party Name:SAFECON Meet No/Date:7/82- Status:Deffered LIFESCIENCES ALC4/2014 11.09.2014 290 |HQ File RLA File Lic.No/Date:6110001120 |Defer :01/82/050/00004/AM15/ :61/24/040/00033/AM14/ 31.12.2013 Date:09.10.2014 Decisioneos : It was decided. to defer the case for~~) 09.10.20141145014 for5. comments.w. — of Department2S of== Pharmaceuticals Case No.:244/3/82-ALC4/2014 [Party Name:SAFECON [Meet No/Date:7/82. Status: Deffered LIFESCIENCES ALC4/2014 11.09.2014 291 |HQ File RLA File Lic.No/Date:6110001119 [Defer :01/82/050/00248/AM15/ :61/24/040/00023/AM14/ 31.12.2013 Date:09.10.2014 IO? Decision 10.2014  : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:55/23/82-ALC4/2013 Party Name:SATY AJIT Meet No/Date:7/82- - |Status:Deffered CHEMICALS PVT.LTD., ALC4/2014 11.09.2014 292 |HQ File RLA File Lic.No/Date:03 10763764 Defer :01/82/050/01102/AM14/ :03/95/040/00791/AM14/ 31.12.2013 Date:09.10.2014 PharmaceuticalsDecision : It was decided to defer the case for 09.10.2014 for comments of Departmentof Case No.:53/23/82-ALC4/2013 _ Party Name:EXCEL Meet No/Date:7/82- Status: Deffered INDUSTRIES LIMITED ALC4/2014 }11.09.2014 293 |HQ File RLA File Lic.No/Date:0310764365 |Defer :01/82/050/01100/AM14/ :03/94/040/00744/AM14/ 02.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals ee Case No.:114/3/82-ALC4/2014 |Party Name:HETEROLABS [Meet No/Date:7/82-___(Status:Deffered LIMITED ALC4/2014 ’ 11.09.2014 294 |HQ File RLA File Lic.No/Date:0910058802 [Defer :01/82/050/001 18/AM15/ :09/24/040/00497/AM14/ 02.01.2014 Date:09.10.2014 Decisionee : It was decided. to defer the case for 09.10.2014MA MAING AUDSEfor comments Gain ao ofa Departmentee of Pharmaceuticals [295 |Case No.:38/3/82-ALC4/2014 [Party Name:PARENTERAL[Meet No/Date:7/82- _|Status:Deffered eta pare NIRMAL Here Directors as at Cammens wen BUA, Th Te wages ‘Bhawan, New int ----- End of picture text -----

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----- Start of picture text ----- \ — a i al as Cee [i] sss — DRUGS (INDIA)—LTD., ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:5610003472 (Defer :01/82/050/00042/AM15/ :56/24/040/00036/AM14/ 02.01.2014 Date:09, 10,2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:118/3/82-ALC4/2014 |Party Name:PARENTERAL Meet No/Date:7/82- Status: Deffered DRUGS (INDIA) LTD., ALC4/2014 11.09.2014 296 |HQ File 7 RLA File Lic.No/Date:5610003471 {Defer :01/82/050/00122/AM15/ :56/24/040/00035/AM14/ 02.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:24/3/82-ALC4/2014 |Party Name:VIVIMED LABS _ |Meet No/Date:7/82- Status: Approved LIMITED ALC4/2014 11,09,2014 HQ File 7 ~IRLA File Lic.No/Date:0910058808 [Defer Date: | :01/82/050/00028/AM15/ :09/24/040/00492/AM14/ 02.01.2014 Decision: In the light of written 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 ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 297 |Exportproduct_——|AVIS (AVOBENZONE) | Exp. Qty.1kg | S.No.1 | ImportitemsPARA TERTIATORY| Qty.1.148 kg allowed BUTYL BENZOIC ACID PTBBA 12.|ACETYL ANISOLE 0.929 kg 13.|ACTIVATED CARBON 0.025 kg a. |SODAMIDE rs. |METHANOL RA may take appropriate action as per the decision|6.of| NormsTOLUENE Committee. Case No.:45/3/82-ALC4/2014 |Party Name:AKZO NOBEL Meet No/Date:7/82- Status:Deffered INDIA LIMITED ALC4/2014 11.09.2014 298 {HQ File _ ~ [RLA File Lic.No/Date:0210198458 [Defer :01/82/050/00049/AM15/ :02/24/040/00168/AM13/ 03.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:89/3/82-ALC4/2014 |Party Name:ASTRIX Meet No/Date:7/82- Status: Deffered LABORATORIES LTD., ALC4/2014 299 11.09.2014 HQ File RLA File Lic.No/Date:0910058826 |Defer ay :01/82/050/00093/AM 15/ :09/24/040/00496/AM14/ 06.01.2014 friar e{Date:09.10.2014, Ph. BT Asawa Wee AI Dy. Director General of Foreign Trade ffeest error aeiPreynrert Directorate Ganeral of Foreign Trade waft ferry Department of Commerce sen was, ay floc | Udyog Bhawan, New Delhi ----- End of picture text -----

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----- Start of picture text ----- Decision : It was decided to defer the case for 09.1 0.2014 for comments of Department of Pharmaceuticals {Case No.:186/3/82-ALC4/2014 [Party Name:MYLAN Meet No/Date:7/82- _—‘[Status:Deffered LABORATORIES LIMITED |ALC4/2014 11.09.2014 300 [HQ File RLA File Lic.No/Date:0910058825 (Defer | ] :01/82/050/00190/AM15/ :09/24/040/00484/AM14/ 06.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.1 0.2014 for comments of Department of | |Pharmaceuticals Case No.:193/3/82-ALC4/2014 |Party Name:NATCO PHARMA [Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11.09.2014 301 [HQ File ~— |RLA File ~ |Lic.No/Date:0910058829 [Defer :01/82/050/00197/AM15/ :09/24/040/00494/AM14/ |06.01.2014 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of | [Pharmaceuticals ' Case No.:2/22/82-ALC4/2013 Party Name:METROCHEM API {Meet No/Date:7/82- Status:Deffered PVT. LTD. ALC4/2014 11.09.2014 302 /HQ File RLA File - [Lic.No/Date:0910058842 [Defer |:01/82/050/01045/AM14/ :09/24/040/00503/AM14/ 07.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals I Case No.:37/3/82-ALC4/2014 Party Name:NECTAR ‘(Meet No/Date:7/82- Status: Deffered LIFESCIENCES LIMITED, —|ALC4/2014 11.09.2014 303 |HQ File RLA File | Lic.No/Date:2210014502 Defer :01/82/050/00041/AM15/ :22/24/040/00077/AM14/ 07.01.2014 [Date:09. 10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals ‘|Case No.:121/3/82-ALC4/2014 |Party Name:NECTAR ~~ [Meet No/Date:7/82- Status:Deffered LIFESCIENCES LIMITED, —/|ALC4/2014 11.09.2014 304 |HQ File RLA File ‘|Lic.No/Date:2210014501 [Defer ] :01/82/050/00125/AM15/ :22/24/040/00078/AM14/ 07.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals [Case No.:116/3/82-ALC4/2014 Party Name:VIJAYASRI Meet No/Date:7/82- Status:Deffered 1305 ORGANICS LTD ALC4/2014 HQ File 7 | 11.09.2014 :01/82/050/00120/AM15/ RLA File Et vemeeeal Defer aa :09/24/040/00402/AM14/ 07.01.2014 “ 09.1950)df. Dy. Die earare. ET rade ET ey aA, AS, eo aint ueyeu "Swans New Del ----- End of picture text -----

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----- Start of picture text ----- | Decision : It was decided to defer the case for 09.10.2014 for comments ofDepartment of | ‘Pharmaceuticals Case No.:180/3/82-ALC4/2014 Party Name: VISION DRUGS Meet No/Date:7/82- Status: Deffered PVT LTD ALC4/2014 11.09.2014 306 |HQ File -IRLA File Lic.No/Date:0910058839 [Defer ‘ :01/82/050/00184/AM15/ :09/24/040/00426/AM14/ 07.01.2014 Date:09.10.2014 Decision : It was decided= to deferBike the case for 09.10.2014 fors commentsz of Departmentee of Pharmaceuticals Case No.:90/3/82-ALC4/2014 Party Name:SUVEN LIFE Meet No/Date:7/82- Status:Deffered SCIENCES LIMITED ALC4/2014 11.09.2014 307 |HQ File RLA File Lic.No/Date:0910058858 |Defer ‘ :01/82/050/00094/AM15/ :09/24/040/00468/AM14/ 08.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of | Pharmaceuticals a Case No.:203/3/82-ALC4/2014 |Party Name:VINS Meet No/Date:7/82- Status:Deffered BIOPRODUCTS LTD., ALC4/2014 11.09.2014 308 [HQ File RLA File Lic.No/Date:0910058863 {Defer :01/82/050/00207/AM15/ :09/24/040/00362/AM14/ 08.01.2014 Date:09.10,2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals a Case No.:200/3/82-ALC4/2014 Party Name: WEXFORD Meet No/Date:7/82- Status:Deffered LABORATORIES P LTD ALC4/2014 {11.09.2014 309 |HQ File RLA File Lic.No/Date:0710101186 |Defer :01/82/050/00204/AM15/ :07/24/040/00333/AM14/ 08.01.2014 [Date-09, 10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:21/23/82-ALC4/2013 Party Name:UNITED Meet No/Date:7/82- Status: Approved PHOSPHORUS LTD. ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:03 10765258 |Defer Date: :01/82/050/01068/AM14/ :03/95/040/00590/AM14/ 09.01.2014 . 310 Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 15022/22/2012-Ch. Il dated 25.07.2014, 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: Item of Export Quantity [$No[itemofimport Quantity allowed _| Tris 1kg sk Iso Tri Decyl Alcohol (Tri 0.975 k i \ : Tri Decyl Phosphite Decy! Alcohol cbfer gran niRMAL KUNA =~ oe = = caemeteccen ttteamet3 LSS) pies canoe of Foreign Trade aftructeefeHTDepanmentbrewer,‘New 4bagsDeihics ----- End of picture text -----

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----- Start of picture text ----- | (TTDP) aa Yellow Phosphorus 0.068 kg RA may take appropriate action as per the decision of Norms Committee. Case No.:194/3/82-ALC4/2014—__—__—— |Party Name:LOUIS Meet No/Date:7/82- Status: Approved—=——$— || i PHARMACEUTICALS PVT —|ALC4/2014 ] | LTD 11.09.2014 HQ File RLA File ~ [Lic.No/Date:0910058903 [Defer Date: [ :01/82/050/00198/AM15/ :09/24/040/00520/AM14/ 10.01.2014 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/724/2013-PI(Norms) dated 09.09.2014, 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: 311 | ‘tem of Export Quantity Item of Import Quantity allowed 1kg ke/kg RCB A (2B, 3A,5A,16B,17B)-2-(4- Diol MORPHOLINYL)-16 (PYRROLIDINYL) ANDROSTANE:3, 17-DIOL | !-95 CRUDE RA may take appropriate action as per the decision of Norms Committee. Case No.:192/3/82-ALC4/2014 Party Name:VIVIMED LABS __ [Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 312 |HQ:01/82/050/00196/AM15/File : RLA File ~ |Lic.No/Date:091005889611.09.2014 {Defer :09/24/040/005 13/AM14/ 10.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of C&PC CaseNo.:204/3/82-ALC4/2014 (Party Name:VIVIMED LABS {Meet No/Date:7/82. Status:Deffered | LIMITED ALC4/2014 11.09.2014 313 |HQ File IRLA File {Lic.No/Date:0910058895 Defer :01/82/050/00208/AM15/ |:09/24/040/005 14/AM14/ 10.01.2014 Date:09.10.2014 ‘Decision :It was decided to defer the case for 09.10.2014 for comments of Department of \C&PC, Case No.:19/23/82-ALC4/2013 |Party Name:DANOPHARM (Meet No/Date:7/82. Status:Deffered CHEMICALS PRIVATE LTD, |ALC4/2014 Bis 11.09.2014 HQ File ~ [RLA File Lie.No/Date:03 10766076 Defer 1:01/82/050/01066/AM14/ :03/94/040/00772/AM14/ {13.01.2014 Date:09.10.2014 = ‘Decision :It was decided to defer the case for 09.10.2014 forcomments BF Pebarinent:of,‘one TPret PrvOeparynent Carmmerce Udyog Br Gaevael, Rawr rans ----- End of picture text -----

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----- Start of picture text ----- i - SSS SS ee aid aa | Pharmaceuticals ~ [Case No,:197/3/82-ALC4/2014 {Party Name: MALLADI DRUGS (Meet No/Date-7/82- Status:Deffered & PHARMACEUTICALS ALC4/2014 LIMITED 11.09.2014 315 |HQ File ‘IRLA File Lic.No/Date:0410154188 |Defer :01/82/050/00201/AM15/ :04/24/040/00218/AM14/ 13.01.2014 Date:09.10.2014 } Decisionop. :It was decided. to defer thelho caseaan forOn 09.10.2014 TSfor comments of DepartmentEE of Pharmaceuticals a Case No,:134/3/82-ALC4/2014 |Party Name:SHASUN Meet No/Date:7/82- Status:Deffered PHARMACEUTICALS ALC4/2014 LIMITED 11.09.2014 316 |HQ File RLA File Lic.No/Date:0410154220 {Defer :01/82/050/00138/AM15/ :04/24/040/00226/AM14/ 13.01.2014 Date:09,10.2014 Decision. :It was decided: to remindBe ——————— the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 09.10.2014. | EE | ‘Case No.:179/3/82-ALC4/2014 |Party Name: VENUS Meet No/Date:7/82- Status:Deffered ' REMEDIES LTD., ALC4/2014 11,09,2014 317 |HQ File RLA File Lic.No/Date:2210014517 |Defer :01/82/050/00183/AM15/ 122/24/040/00079/AM14/ 13.01.2014 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:196/3/82-ALC4/2014 |Party Name:ARUDAA VIS [Meet No/Date:7/82- Status:Deffered LABS PRIVATE LIMITED ALC4/2014 11.09.2014 318 [HQ File ~—IRLA File Lic.No/Date:0410154292 [Defer | :01/82/050/00200/AM15/ :04/24/040/00219/AM14/ 15.01.2014 Date:09.10.2014 Decisionse :It was decided. to defer the case for 09.10.2014eefor comments of Department of Pharmaceuticals Case No.:182/3/82-ALC4/2014 |Party Name: AUROBINDO Meet No/Date:7/82- Status: Approved PHARMA LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910058925 [Defer Date: :01/82/050/00186/AM15/ :09/24/040/005 16/AM14/ 15.01.2014 Decision :in the light of writtenu comments== received from= Department of Pharmaceuticals vide their 319 OM No. 35011/225/2014-Pl(Norms) dated 02.09.2014, 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. Allowed Qty. kg/kg NEVIRAPINE ( NEVIRAPINE 1kg 1 2-Chloro-3-amino-4-methyl4 ANHYDROUS ) pyridine (CAMP) 0.759 hi Te ----- End of picture text -----

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----- Start of picture text ----- a ai =— Nee = ™ -2——| 2-chloro= nicotinic acid . — 0.902al | 4aA| Cyclo hexane 0.898 | aa Diethylene glycol dimethyl ether 2.518 | | a | Methylene Chloride 1.222 ) As per fuel Steam/Thermal Coal policy. RA may take appropriate action as per the decision of Norms Committee. he = sa } Case No.:26/23/82-ALC4/2013 [Party Name:RIOCARE INDIA [Meet No/Date:7/82- Status: Approved PRIVATE LIMITED, ALC4/2014 | 11.09.2014 HQ File RLA File ~~ [Lic.No/Date:0310766258 (Defer Date: :01/82/050/01073/AM14/ :03/95/040/00822/AM14/ 15.01.2014 ----- End of picture text -----

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----- Start of picture text ----- Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/635/2013-PI(Norms) dated 02.09.2014 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 Simethicone_(3 Export Item) ----- End of picture text -----

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----- Start of picture text ----- 320 | Export product Qty. Allowed | 1 kg Export Product =ee 100% USP or BP Silicone Fluid / Oil of 0.96 kg/kg relevant Viscosity ls ce Emulsion USP Silicone Fluid / Oil of 0.288 kg/kg | * relevant Viscosity Dimethicone USP or BP or EP | Silicone Fluid/Oil of | 1.01 kg/kg Le concernedVariousmay take Viscosifurther necessary actionrelevantas per Viscosi above decision of NC. ; Case No.:40/4/82-ALC4/2014 |Party Name:NEW ALLIANCE Meet No/Date:7/82- Status: Deffered DYE-CHEM PVT. LTD., ALC4/2014 321 11.09.2014 [HQ:01/82/050/00288/AM15/ File :03/95/040/00805/AM14/RLA File ~ [Lic.No/Date:0316.01.2014 10766431 [Defer|Date:09.10.2014 Decision ' :It was decided to defer the case for 09.10.2014 for comments ofDepartment ofC&PC M DY, Directoe Gariera for WT aarcaye Prey ReaTDopactim “et Trade ----- End of picture text -----

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----- Start of picture text ----- E . oS — SST } Case No.:202/3/82-ALC4/2014 |Party Name:PARENTERAL Meet No/Date:7/82- Status:Deffered DRUGS (INDIA) LTD., ALC4/2014 11.09.2014 322 [HQ File IRLA File Lic,No/Date:5610003580 {Defer | :01/82/050/00206/AM15/ :56/24/040/00041/AM14/ 16.01.2014 Date:09.10.2014 Pharmaceuticals | Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Case No.:198/3/82-ALC4/2014 Party Name:SATYA DEEPTHA /Meet No/Date:7/82- Status: Deffered | PHARMACEUTICALS LTD ALC4/2014 11,09,2014 323 {HQ File RLA File Lic.No/Date:0910058953 [Defer :01/82/050/00202/AM15/ :09/24/040/00523/AM14/ 16.01.2014 Date:09.10.2014 i Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:32/3/82-ALC4/2014 |Party Name:DISTO Meet No/Date:7/82- Status:Deffered PHARMACEUTICALS ALC4/2014 PRIVATE LIMITED 11.09.2014 324 {HQ File RLA File Lic.No/Date:0910058977 [Defer :01/82/050/00036/AM15/ :09/24/040/005 19/AM 14/ 17.01.2014 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:42/3/82-ALC4/2014 |Party Name:PAYAL Meet No/Date:7/82- Status: Approved POLYPLAST PVT.LTD., ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0510376324 |Defer Date: :01/82/050/00046/AM15/ :05/24/040/00204/AM14/ 17.01.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/33/2011-Ch. Il dated 14.06.2011, it was decided to ratify 325 |norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity |S,No| Item of Import Quantity allowed Di-Buty! [Phthalate] 1kg |. | Phthalic Anhydride 0.560 KG RA may take appropriate action as per the decision of Norms Committee. Case No.:103/3/82-ALC4/2014 |Party Name:BLISS GVS Meet No/Date:7/82- ‘|Status:Deffered PHARMA LTD. ALC4/2014 11.09.2014 326 |HQ:01/82/050/00107/AM15/File RLA:03/94/040/00942/AMFile 14/ 21.01.2014Lic.No/Date:0310767119 iDate:09.|Defer 10,2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals _ Pet graves aaascse a Dy. Diroctor Gonorat feet, TTT FAST eerpare eee eiaN Trade Directorate Genera Teen Tey PIT FU Deparmen nen raste Uayeg [Brewanya] ernent of Commer ----- End of picture text -----

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----- Start of picture text ----- E — . eae _ — ————— ee ~[Case No.:156/3/82-ALC4/2014 |Party Name:PUNJAB Meet No/Date:7/82- Status:Approved CHEMICALS AND CROP ALC4/2014 PROTECTION LTD., 11.09.2014 HQ File RLA File Lic.No/Date:0310767045 |Defer Date: :01/82/050/00160/AM15/ :03/95/040/00796/AM14/ 21.01.2014 Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/13/2011-Ch. I! dated 13.06.2011, it was decided to ratify } norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 327 || Item of Export Quantity |S,No| Item of Import Quantity allowed 3,4,5 TRIMETHOXY iL; 3,4,5BENZALDEHYDE TRI METHOXY 1.25: kg TOLUENE POLYETHYLENE 0.400 kg GLYCOL (PEG 600 : | Pl HYDRAZINEaon HYDRATE sia RA may take appropriate action as per the decision of Norms Committee. Case No.:51/4/82-ALC4/2014 |Party Name:SHILPA Meet No/Date:7/82- Status: Deffered MEDICARE LTD., ALC4/2014 11.09.2014 328 |HQ File RLA File Lic.No/Date:0710101518 |Defer | :01/82/050/00299/AM15/ :07/24/040/00375/AM14/ 22.01.2014 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals " {Case No.:55/3/82-ALC4/2014 {Party Name:AUROBINDO Meet No/Date:7/82- Status:Deffered PHARMA LIMITED ALC4/2014 329 |HQ File - RLA File Lic.No/Date:091005902511.09.2014 |Defer :01/82/050/00059/AM15/ :09/24/040/00529/AM14/ 23.01.2014 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:60/3/82-ALC4/2014 |Party Name:AUROBINDO Meet No/Date:7/82- Status: Approved PHARMA LIMITED ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0910059028 [Defer Date: :01/82/050/00064/AM15/ :09/24/040/00541/AM14/ 23.01.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their 330 (OM No. 35011/225/2014-Pl(Norms) dated 02.09.2014, 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 aQty. ee | Import items Qty.kg/kg Allowed 1 q a Dy, BroderT Pay eae,{NIRMALeerKl ccarary.d AR peer SINT Tehpet MLCT rate General Ol Foran Teas RirDepariant oy Con as ----- End of picture text -----

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----- Start of picture text ----- ; oe | a | Methylene Chloride | S| N-Methyl-2-Pyrrolidone 1.375 aa Thiophenol 0.424 : |RA >| may take appropriate action as per the decision of Norms Committee. Case No.:21/3/82-ALC4/2014 |Party Name:KUDOS CHEMIE {Meet No/Date-7/82- Status:Deffered LTD., ALC4/2014 11,09,2014 331 |HQ File RLA File Lic.No/Date:2210014543 |Defer :01/82/050/00025/AM15/ :22/24/040/00075/AM14/ 23.01.2014 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals | Case No.:12/21/82-ALC4/2013 |Party Name:KUDOS CHEMIE _ [Meet No/Date:7/82- Status:Deffered LTD., ALC4/2014 11.09.2014 332 [HQ File RLA File Lic.No/Date:2210014544 [Defer | :01/82/050/01042/AM14/ :22/21/040/00096/AM14/ 23.01.2014 Date:09.10.2014 Decision :It was decidedSSto defer the caseS|for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:187/3/82-ALC4/2014 |Party Name:ALCHEM Meet No/Date:7/82- —[Status:Deffered INTERNATIONAL LTD. ALC4/2014 ] 11.09.2014 333 |HQ File RLA File Lic.No/Date:0510376990 |Defer :01/82/050/00191/AM15/ :05/23/040/00413/AM14/ 24.01.2014 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments ofDepartment of Pharmaceuticals = | Case No.:108/3/82-ALC4/2014 |Party Name:CROPNOSYS Meet No/Date:7/82- Status:Deffered (INDIA) PRIVATE LIMITED |ALC4/2014 11.09.2014 334 |HQ File RLA File |Lic.No/Date:0310767733 [Defer :01/82/050/00112/AM15/ :03/94/040/00908/AM14/ 24.01.2014 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Department of C&PC. Case No.:158/3/82-ALC4/2014| Party Name:PRACHI | Meet No/Date:7/82- Status:Approved PHARMACEUTICALS PVT —_/|ALC4/2014 335 LTD 11.09.2014 HQ File RLA File "q Lic.No/Date:0310768015 |Defer Date: :01/82/050/00162/AM15/ :03/95/040/00862/AM14/ 27.01.2014 7 7 7NIRM < Diet Rare re OO Trade poclorata Gonerai ape aa ----- End of picture text -----

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----- Start of picture text ----- Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/34/2014-Ch. Il dated 04.08.2014, 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: Item of Export |Quantity| $,No | Item of Import Quantity allowed RA may take appropriate action as per the decision of Norms Committee. ~ {Case No.:159/3/82-ALC4/2014 |Party Name:PRACHI Meet No/Date:7/82- Status: Approved PHARMACEUTICALS PVT = |ALC4/2014 LTD 11.09.2014 HQ File RLA File Lic.No/Date:0310768009 |Defer Date: :01/82/050/00163/AM15/ 103/95/040/00861/AM14/ 27.01.2014 Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/34/2014-Ch. II dated 04.08.2014, 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: 336 Item of Export Item of Import Quantity allowed RA may take appropriate action as per the decision of Norms Committee. Case No.:19/3/82-ALC4/2014 |Party Name: VARUN Meet No/Date:7/82- Status:Deffered MEDIMPEX INC. ALC4/2014 11.09.2014 337 |HQ File RLA File Lic,No/Date:0510377141 [Defer :01/82/050/00023/AM15/ :05/24/040/00374/AM14/ 27.01.2014 Date:09.10.2014 Decision :It was decided to defer the case for 09.10.2014 for comments of Petrochemical Division of Department of C&PC. Case No.:230/3/82-ALC4/2014 |Party Name:SWISS EXPORTS _|Meet No/Date:7/82- Status:Deffered PVT. LTD. ALC4/2014 11.09.2014 ‘ 338 |HQ File RLA File Lic.No/Date:0810128498 |Defer :01/82/050/00234/AM15/ 08/24/040/00474/AM 14/ 29.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:35/4/82-ALC4/2014 {Party Name:CHIRAG Meet No/Date:7/82- Status: Approved 339 ENTERPRISE ALC4/2014 11.09.2014 _ Priel gone ih eaCtorate G WR enh. oot de Uae ayer pa ee anes . ‘a Seb Nate Bling ----- End of picture text -----

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----- Start of picture text ----- HQ File ; = :01/82/050/00283/AM15/ RLA File ~ [Lic.No/Date:2410040726 Defer Date: :24/24/040/00028/AM14/ 30.01.2014 ; Decision :in the light of written comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/1/2007-PC- II dated 06.08.2014, 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. SI.No. Qty. allowed | Qty. | REGENERATED Lkg BLACK REGENERATED 1.30 kg | METHYL METHYL METHACRYLATE METHACRYLATE MONOMER [PURITY not more MONOMER than 90%] | [PURITY equal or greater than99%] RA may take appropriate action as per the decision of Norms Committee. me odo LLL Case No.:209/3/82-ALC4/2014_ Party Name:DR REDDYS Meet No/Date:7/82- Status:Deffered LABORATORIES LIMITED ALC4/2014 11.09.2014 340 |HQ File RLA File Lic.No/Date:09 10059127 Defer :01/82/050/00213/AM15/ :09/24/040/00540/AM14/ 30.01.2014 Date:09.10.2014 PharmaceuticalsDecision : It was decided to defer the case for 09.10.2014 for comments of Department of Case No.:177/3/82-ALC4/2014 {Party Name:INDO AMINES [Meet No/Date-7/8)- Status:Deffered _ LIMITED ‘|ALC4/2014 ee 11.09.2014 341 |HQ File RLA File Lic.No/Date:0310768616ee Defer :01/82/050/00181/AM15/ :03/94/040/00958/AM14/ 30.01.2014 Date:09.10.2014 C&PC.Decision : It was decided to defer the case for 09.10.2014 for comments of Department of [Ce Case No.:223/3/82-ALC4/2014 Party Name:UNIJULES LIFE [Meet No/Date:7/82- Status: Deffered SCIENCES LTD. ALC4/2014 11.09.2014 342 [HQ File RLA File Lic.No/Date:0310768632 [Defer :01/82/050/00227/AM15/ :03/95/040/00867/AM14/ 30.01.2014 Date:09.10.2014 DecisionPharmaceuticals: It was decided to defer the case for 09.10.2014 for comments of Department of Case No.:206/3/82-ALC4/2014{PartyName:AUROBINDOPHARMA MeetNo/Date:7/82-__|Status:Deffered LIMITED ALC4/2014 343 11.09.2014 [HQ File ~ IRLA File - '|Lic.No/Date:0910059129 [Defer :01/82/050/00210/AM15/ :09/24/040/00556/AM14/ 31.01.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Pepartmentofvrar iu ny; Dy. Director Genera! lang Directorate ¢ ptevoss antyaq lly bi ety mt A oe Udyog Bhawan, Now Delhi ----- End of picture text -----

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----- Start of picture text ----- <= — a | Pharmaceuticals Case No.:165/3/82-ALC4/2014 |Party Name: MANGALAM Meet No/Date:7/82- Status:Deffered ORGANICS LIMITED, ALC4/2014 11.09.2014 344 |HQ File RLA File Lic.No/Date:03 10768928 |Defer :01/82/050/00169/AM15/ :03/94/040/00448/AM14/ 03.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:111/3/82-ALC4/2014 |Party Name:SRIAM LABS '|Meet No/Date:7/82- Status: Deffered PRIVATE LIMITED ALC4/2014 11.09.2014 345 |HQ File RLA File Lic.No/Date:0910059150 |Defer :01/82/050/00115/AM15/ :09/24/040/00509/AM14/ 03.02.2014 Date:09.10.2014 i Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals | Case No,:201/3/82-ALC4/2014 |Party Name:Y ASHASHVI Meet No/Date:7/82- Status: Approved RASAYAN PVT.LTD ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:5210040666 |Defer Date: :01/82/050/00205/AM15/ :52/24/040/00045/AM14/ 03.02.2014 Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2010-Ch II dated 23.07.2014, it was decided to ratify norms 346 under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: )| Export product ee [se Import items Qty. allowed | THISA 1kg 1.480 kg | | (4 Carbomethoxy - THIOPHANONE 2Methyl-sulfonamide thiophene RA may take appropriate action as per the decision of Norms Committee. Case No.:26/3/82-ALC4/2014 Party Name:MEDICEF Meet No/Date:7/82- Status:Deffered PHARMA, ALC4/2014 {11.09.2014 347 |HQ File RLA File Lic.No/Date:2210014587 [Defer :01/82/050/00030/AM15/ :22/24/040/00080/AM14/ 04.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:27/3/82-ALC4/2014 |Party Name: MEDICEF Meet No/Date:7/82- Status:Deffered PHARMA, ALC4/2014 348 11.09.2014 HQ File RLA File ‘Lic. No/Date:2210014589 Defer :01/82/050/0003 1/AM15/ :22/24/040/00081/AM14/ 04.02.2014i - Bu HerrerernDate:09, 10.2014fitevt |r Dy. Director Genera n Trade fay =rraie | Tat Directorate Gene t Fuceagn Trade anita fares artirien of Commerce Udon GrowinNow bain ----- End of picture text -----

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----- Start of picture text ----- | Decision : It was decided to defer the casefor 09.10.2014 for comments of Department of : Pharmaceuticals | Case No.:28/3/82-ALC4/2014 |Party Name: MEDICEF Meet No/Date:7/82- Status:Deffered | PHARMA, ALC4/2014 | 11,09,2014 ] 349 |HQ File RLA File Lic.No/Date:2210014588 |Defer :01/82/050/00032/AM15/ :22/24/040/00082/AM14/ 04.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:87/3/82-ALC4/2014 |Party Name:VIVIMED LABS __|Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11.09.2014 350 |HQ File RLA File Lic.No/Date:0910059155 |Defer :01/82/050/0009 1/AM15/ :09/24/040/00544/AM14/ 04.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of C&PC Case No.:117/3/82-ALC4/2014 |Party Name: VIVIMED LABS _ |Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11,09.2014 351 |HQ File RLA File Lic.No/Date:0910059156 |Defer :01/82/050/00121/AM15/ :09/24/040/00543/AM14/ 04.02.2014 Date:09,10,2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of C&PC. | Case No.:232/3/82-ALC4/2014 |Party Name:CADILA Meet No/Date:7/82- Status:Deffered HEALTHCARE LTD., ALC4/2014 11.09.2014 352 |HQ File RLA File Lic.No/Date:0810128700 |Defer :01/82/050/00236/AM15/ :08/24/040/00485/AM14/ 05.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:221/3/82-ALC4/2014 |Party Name:CIPLA LIMITED _ [Meet No/Date:7/82- Status:Deffered ALC4/2014 11.09.2014 353 |HQ File RLA File ‘Lic. No/Date:0310769240 [Defer :01/82/050/00225/AM15/ :03/94/040/00995/AM14/ 05.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals i Case No.:222/3/82-ALC4/2014. |Party Name:CIPLA LIMITED — {Meet No/Date:7/82- Status:Deffered ALC4/2014 354 11.09.2014 HQ File RLA File Lic.No/Date:0310769244 [Defer :01/82/050/00226/AM15/ :03/94/040/00985/AM14/ 05.02.2014 fersfer Date09, 10,2014... SY ASPs tere ey Dy, Director Genoral of Foreign Trade aferea PeIrUDepwese ail Conia Uayor [Gnawan] Wee Bini ----- End of picture text -----

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----- Start of picture text ----- “| a 6 Teapae Aanidad tr dation ne ee eee [Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:224/3/82-ALC4/2014 |Party Name:CIPLA LIMITED {Meet No/Date:7/82- Status: Deffered ALC4/2014 11.09.2014 | 355 |HQ File RLA File Lic.No/Date:03 10769253 |Defer :01/82/050/00228/AM15/ :03/94/040/00979/AM14/ 05.02.2014 Date:09.10.2014 Decision<3 : Itbac was decideddanided 4Ato deferHefosthe the DD case for 09.10.2014 for comments ofeee Department of Pharmaceuticals Case No.:225/3/82-ALC4/2014 |Party Name:CIPLA LIMITED Meet No/Date:7/82- Status: Deffered ALC4/2014 11.09.2014 , 356 |HQ File RLA File Lic.No/Date:03 10769247 |Defer :01/82/050/00229/AM15/ :03/94/040/0099 1/AM14/ 05.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals a | Case No.:149/3/82-ALC4/2014 |Party Name: MOREPEN Meet No/Date:7/82- Status:Deffered i] LABORATORIES LTD., ALC4/2014 11.09.2014 357 |HQ File RLA File Lic.No/Date:0510378413 [Defer :01/82/050/00153/AM15/ :05/24/040/00420/AM14/ 05.02.2014 Date:09.10,2014 Decisionons Trauma Aantal $a defen eesss SS : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Te Case No.:168/3/82-ALC4/2014 Party Name:CIPLA LIMITED — {Meet No/Date:7/82- Status:Deffered ALC4/2014 ] 11,09,2014 358 |HQ File RLA File Lic.No/Date:0310769592 {Defer :01/82/050/00172/AM15/ :03/94/040/01009/AM14/ 06.02.2014 Date:09.10.2014 Decision : It was decided= to defer the case for 09.10.2014i for comments ofDepartment of Pharmaceuticals Case No.:150/3/82-ALC4/2014 {Party Name: MACLEODS Meet No/Date:7/82- Status:Deffered PHARMACEUTICALS LTD. |ALC4/2014 11.09.2014 359 |HQ File RLA File Lic.No/Date:0310769509 |Defer :01/82/050/00154/AM15/ :03/95/040/00879/AM14/ 06.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals aee Case No.:8/3/82-ALC4/2014 |Party Name:ALEKHYA Meet No/Date:7/82- Status: Deffered DRUGS PVT LTD. ALC4/2014 360 HQ:01/82/050/00012/AM15/File ~ :09/24/040/00548/AM14/[RLA File |Lic.No/Date:091005921807.02.201411.09.2014 Prfa [Defer r x $:09.10,2014 I, maieraaDirectorateFITUDEGer,surement+ T Concentere Uayog Bhawan Wes eon ----- End of picture text -----

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----- Start of picture text ----- =——£—————_ oe - - Se “| [Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:10/3/82-ALC4/2014 Party Name:ARENE LIFE Meet No/Date:7/82- Status:Deffered SCIENCES LIMITED. ALC4/2014 11.09.2014 | 361 |HQ File RLA File Lic.No/Date:0910059227 Defer . :01/82/050/00014/AM15/ ; :09/24/040/00534/AM14/ 07.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals ‘Case No.:59/3/82-ALC4/2014 |Party Name: ARENE LIFE Meet No/Date:7/82- Status:Deffered SCIENCES LIMITED. ALC4/2014 11.09.2014 362 [HQ File RLA File Lic.No/Date:0910059222 [Defer : :01/82/050/00063/AM15/ :09/24/040/00551/AM14/ 07.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:49/3/82-ALC4/2014 |Party [Name:AUROBINDO] |Meet No/Date:7/82- Status:Deffered PHARMA LIMITED ALC4/2014 11.09.2014 363 |HQ File RLA File Lic.No/Date:0910059197 [Defer .. }:01/82/050/00053/AM15/ :09/24/040/00562/AM14/ 07.02.2014 Date:20.10.2014 Decision : It was decided to defer the case for 20.10.2014 for comments of Department of Pharmaceuticals | Case No.:151/3/82-ALC4/2014 |Party Name:CIPLA LIMITED — |Meet No/Date:7/82- Status: Deffered ALC4/2014 11.09.2014 364 HQ File RLA File Lic.No/Date:0310769755 |Defer :01/82/050/00155/AM15/ :03/94/040/01022/AM14/ 07.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:84/3/82-ALC4/2014 |Party Name:STERICON Meet No/Date:7/82- Status: Deffered PHARMA PVT.LTD., ALC4/2014 11.09.2014 365 [HQ File RLA File Lic.No/Date:0710102047 [Defer :01/82/050/00088/AM15/ :07/24/040/004 19/AM14/ 07.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:21/4/82-ALC4/2014 | |Party Name:KREATIVE Meet No/Date:7/82- Status:Deffered 366 ORGANICS (P) LTD., ALC4/201411.09.2014 {HQ File i RLA File Lic.No/Date:0910959237_[Defer |:01/82/050/00269/AM15/ 109/24/040/00577/AM14/ 11.02.2014 By ~ OO a a ee er eee Pst OF General of Ferg ore. UPS apy eo n Tete Bey sre, MY : Her! { Commerce Udyog Shawan, Rew Boing ----- End of picture text -----

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----- Start of picture text ----- .. . 4 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of | C&PC. | Case No.:205/3/82-ALC4/2014 Party Name:FORACE Meet No/Date:7/82- Status: Approved POLYMERS (P) LTD. ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0510379284 |Defer Date: :01/82/050/00209/AM15/ :05/23/040/00466/AM14/ 13.02.2014 Decision :in the light of written comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/18/2011-PC- II dated 14.07.2014, 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: 367 Export product Exp. SLNo. | Import items Qty. q Qty. allowed | HARDENER CONTAINING 85% POLYMETHANE 0.8750 kg POLYMETHANE POLYPHENYL POLY PHENYL ISOCYANATE AND 15% C-9 ISOCYANATE / SHELLSOLL | ©1550 ke | || SOLVENTHARDENER/ FORCOLDSHELLSOLL1070100 2. | c.9100SOLVENT RA may take appropriate action as per the decision of Norms Committee. sed ed ed lca sla Toth a SEES Case No.:166/3/82-ALC4/2014 |Party Name: VAY Meet No/Date:7/82- Status: Deffered PERFUMES PVT.LTD. ALC4/2014 11.09.2014 368 |HQ File RLA File Lic.No/Date:0310770668 |Defer :01/82/050/00170/AM15/ :03/95/040/009 16/AM14/ 18.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of I C&PC. Case No.:65/3/82-ALC4/2014 |Party Name: HETERO LABS Meet No/Date:7/82- Status:Deffered LIMITED ALC4/2014 11.09.2014 369 |HQ File RLA File Lic.No/Date:0910059337 |Defer :01/82/050/00069/AM15/ :09/24/040/00595/AM14/ 19.02.2014 Date:09.10.2014 Pa eh aa Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals | Case No.:132/3/82-ALC4/2014 |Party Name: VENUS Meet No/Date:7/82- Status: Deffered REMEDIES LTD., ALC4/2014 11.09.2014 370 HQ File RLA File Lic.No/Date:2210014635 |Defer :01/82/050/00136/AM15/ :22/24/040/00088/AM14/ 26.02.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Swe ST STR AIRIVIAL KUMAR PAly, Director§ werftesresGone: {PeetFi eroTrade | Pree enniy eyrtensrer Directorate Gene: f oaign Trade maferoa fern epartment of Commerce ----- End of picture text -----

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----- Start of picture text ----- , Oo ~| Pharmaceuticals SSSSSS Case No.:34/4/82-ALC4/2014 Party Name: MOREPEN Meet No/Date:7/82- Status:Deffered LABORATORIES LTD., ALC4/2014 11.09.2014 371 {HQ:01/82/050/00282/AM15/ File RLA File Lic.No/Date:0510380668 [Defer_ :05/24/040/00455/AM14/ 03.03.2014 Date:09.10.2014 ' Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:58/3/82-ALC4/2014 |Party Name:KLJ [Meet No/Date:7/82- Status: Approved PLASTICIZERS LTD., ALC4/2014 11,09.2014 HQ File RLA File Lic.No/Date:0510380925 [Defer Date: }:01/82/050/00062/AM15/ :05/23/040/00492/AM14/ 05.03.2014 Sine ne aaa St Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2011-Ch. Il dated 23.07.2014, 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: 372 | Item of Export Quantity |$,No__| Item of Import Quantity allowed HDPE BLOWING GRADE) | HM-HDPEHDPE BLOWING DRUMS GRADEMADE OF HM. | A$policy Per packing RA may take appropriate action as per the decision of Norms Committee. Case No.:45/4/82-ALC4/2014 {Party Name: TRITECH Meet No/Date:7/82- “| Status: Approved CATALYST AND ALC4/2014 INTERMEDIATE (P) LTD, 11.09.2014 HQ File RLA File Lic.No/Date:3110062950 {Defer Date: :01/82/050/00293/AM15/ :31/83/040/00230/AM14/ 06.03.2014 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/35/2014-Ch. I dated 26.08.2014, 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: 373 Item of Export Quantity |$,No__| Item of Import Quantity allowed t: |-Propanaminium, N,N,N - | TPAOH ie Tripropyl, Bromide. 0.800 kg | Ammonium( Tetra PropylHydroxide) Membrane.lon Exchange Anion oa ( Water based Solution ) 3 lon Exchange Cation 0.013 Nos. he Membrane amay take appropriate action as per the decision of Norms Committee. NN Ash: 5-777 errs ] Se we MRMAL KY AR BY. Director c:., Va Pay TITe Directorateeer ey,¢ ie, ry ’ Tradeag oP rey funn, ‘ta j Trade UayogFEN Brae!ayers wifNow5 ommerceBins ----- End of picture text -----

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----- Start of picture text ----- rr —____ ———_____ ——— - —_ — “| {Case No.:56/4/82-ALC4/2014 [Party NameIND-SWIFT Meet No/Date:7/82- Status:Deffered LABORATORIES LTD.,, ALC4/2014 11.09.2014 374 |HQ File RLA File Lic.No/Date:2210014691 {Defer :01/82/050/00304/AM15/ :22/24/040/00102/AM14/ 14.03.2014 Date:09.10.2014 Decisione« : It was decided. 444, to Ant defer the case for 09.10.2014 for commentsee of Departmentete nl of Pharmaceuticals Case No.:57/4/82-ALC4/2014 |PartyName:IND-SWIFT [Meet No/Date:7/82. Status:Deffered LABORATORIES LTD., ALC4/2014 11.09.2014 375 |HQ File RLA File | Lic.No/Date:2210014692 [Defer :01/82/050/00305/AM15/ :22/24/040/00103/AM14/ 14.03.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.1 0.2014 for comments of Department of Pharmaceuticals a i| Case No.:58/4/82-ALC4/2014 Party Name:IND-SWIFT Meet No/Date:7/82- Status: Deffered LABORATORIES LTD., ALC4/2014 11.09.2014 376 |HQ File RLA File : Lic.No/Date:2210014694 [Defer :01/82/050/00306/AM15/ :22/24/040/00100/AM14/ 14.03.2014 Date:09,10.2014 Decision : It was decided to defer the case for 09.1 0.2014 for comments of Department of / [Ee] Pharmaceuticals Case No.:1/4/82-ALC4/2014 {Party Name:DORF-KETAL Meet No/Date:7/82- Status: Approved CHEMICALS INDIA ALC4/2014 PVT.LTD. 11.09.2014 377 |HQ File RLA File Lic.No/Date:03 10774824 Defer Date: :01/82/050/00249/AM15/ :03/94/040/00999/AM14/ 18.03.2014 advanceDecision : It was decided. to withdraw* the case, as the firm has informedAOS thatFT theyeae haveEy taken SS authorization on repeat basis under para 4.7.1 HBP v1, eee Case No.:42/4/82-ALC4/2014 |Party Name:RECKITT Meet No/Date:7/82- ——‘|Status:Deffered BENCKISER HEALTHCARE ALC4/2014 INDIA LIMITED 11.09.2014 378 |HQ File RLA File Lic.No/Date:05 10382032 |Defer :01/82/050/00290/AM15/ :05/24/040/00480/AM14/ 18.03.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals a Case No.:43/24/82-ALC4/2013 Party Name: THINQ PHARMA- [Meet No/Date:7/82- Status:Deffered CRO LIMITED ALC4/2014 11.09.2014 379 HQ File ~—IRLA File Lic.No/Date:0310774773 [Defer ~ :01/82/050/01242/AM14/ :03/95/040/00987/AM14/ 18.03.2014 Date:09.10.2014 Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/770/2013-Pl(Norms) dated 09.09.2014, it was decided to call from the firm the complete technical details |, , SOas per Appendix 33. The case was ——— deferred for 09.10.2014.a — PaisSINT AL KUMA| | Dy. Drone © Meer erary Directorate ; vit Srey AP Pjry i ae oan) Trade Udyogely Bhawankre ‘ Nea1 Commerceein, ----- End of picture text -----

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----- Start of picture text ----- _ ne =| Case No.:45/24/82-ALC4/2013 [Party Name: VIVIMED LABS (Meet No/Date-7/82. Status:Deffered ALATHUR) PRIVATE ALC4/2014 LIMITED 11.09.2014 380 |HQ File RLA File ~— {Lic.No/Date:0410156358 [Defer | :01/82/050/01244/AM14/ :04/24/040/00264/AM14/ 19.03.2014 Date:09.10.2014 | C&PC.Decision : It was decided to defer the case for 09.10.2014 for comments of Department of a Case No,:33/4/82-ALC4/2014 [Party Name:JAGSONPAL [Meet No/Date-7/82. Status:Deffered PHARMACEUTICALS LTD. |ALC4/2014 11.09.2014 , 381 |HQ File RLA File | Lic.No/Date:0510383280 |Defer ) : :01/82/050/00281/AM15/ :05/23/040/00522/AM14/ 01.04.2014 Date:09, 10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals [Case No.:67/6/82-ALC4/2014 _ [Party Name:RIOCARE INDIA Meet No/Date:7/82- |Status:A pproved PRIVATE LIMITED. ALC4/2014 11.09.2014 HQ File RLA File Lic.No/Date:0310783973 Defer Date: :01/82/050/00469/AM15/ :03/95/040/00135/AM15/ 02.06.2014 Decision : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/635/2013-PI(Norms) dated 02.09.2014 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 Simethicone (3 Export Item) 382 - | Export product Qty. Allowed 1 kg Export Product 1 Simethicone 100% USP or BP or EP | Silicone Fluid / Oil of 0.96 kg/kg relevant viscosi | Simethicone Emulsion USP 30% Silicone Fluid/ Oil of | 0.288 kg/kg | relevant Viscosi Dimethicone USP or BP or EP Silicone Fluid/ Oilof | 1.01 kg/kg Various Viscosi relevant Viscosi RA concerned may take further necessary action as per above decision of NC. Case No.:61/4/82-ALC4/2014 |Party Name:V & VPHARMA [Meet NolDare 7/2. Status:Deffered INDUSTRIES ALC4/2014 11.09.2014 383 lH File ~ REA File ~~ [Lic.No/Date:0310785305 (Defer |:01/82/050/00309/AM15/ |:03/95/040/00190/AM15/ 13.06.2014 Date:09.10.2014 IL PharmaceuticalsDecision; It was decided to defer the case for 09.10.2014 for comments of Department of ~e EE ; frieSy sertevrapares NRfav ‘ara) h Dy. Director G overall Ot 1 e190 Trade picnic en an rade Pe tayry ent of Commerce ----- End of picture text -----

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----- Start of picture text ----- Case No.:64/4/82-ALC4/2014 {Party Name:AUROBINDO Meet No/Date:7/82- Status:Deffered PHARMA LIMITED ALC4/2014 11.09.2014 384 |HQ File RLA File Lic.No/Date:0910060520 |Defer :01/82/050/003 12/AM15/ :09/24/040/00154/AM15/ 23.06.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of b Pharmaceuticals Case No.:67/4/82-ALC4/2014 |Party Name:DIVIS Meet No/Date:7/82- Status:Deffered LABORATORIES LTD., ALC4/2014 11.09.2014 385 |HQ File RLA File Lic.No/Date:0910060535 |Defer :01/82/050/003 15/AM15/ :09/24/040/00165/AM15/ 25.06.2014 Date:20.10.2014 Decision : It was decided to defer the case for 20.10.2014 for comments of Department of Pharmaceuticals | Case No.:68/4/82-ALC4/2014 |Party Name:MICRO LABS LTD |Meet No/Date:7/82- Status:Deffered ALC4/2014 11.09.2014 386 (HQ File _ RLA File Lic.No/Date:0710105379 [Defer |:0 1/82/050/003 16/AM15/ :07/24/040/00106/AM15/ 25.06.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:69/4/82-ALC4/2014 (Party Name:RA CHEM Meet No/Date:7/82- Status:Deffered PHARMA LIMITED ALC4/2014 11.09.2014 387 [HQ File RLA File Lic.No/Date:0910060550 {Defer :01/82/050/003 17/AM15/ :09/24/040/00175/AM15/ 27.06.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:4/6/82-ALC4/2014 {Party Name:SAURAV Meet No/Date:7/82- Status:Approved CHEMICALS LTD, ALC4/2014 11.09.2014 HQ File RLA File ~ [Lic.No/Date:2210015035 [Defer Date: :01/82/050/00406/AM15/ :22/24/040/00029/AM15/ 23.07.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/56/2014-PI(Norms) dated 02.09.2014, it was decided to ratify norms under Para 4.7 of 388 |HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Allowed Dexketoprofen Qty. kg/kg Trometamol 1 kg 1 Ketoprofen 1.78 TCT AT NIRMAL te Rréy; ¢ Trade Direct: a (%s J ----- End of picture text -----

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----- Start of picture text ----- E ee ————__ —— TT | iesRA may takeaappropriate action——as per the[3s decision[Tromethamine of Norms Committee.oo [036] Case No.:1/7/82-ALC4/2014 Party Name:COVALENT Meet No/Date:7/82- Status:Deffered LABORATORIES PRIVATE ALC4/2014 LIMITED 11.09.2014 I 389 |HQ File RLA File Lic.No/Date:0910060890 [Defer :01/82/050/00645/AM15/ :09/24/040/00261/AM15/ 26.08.2014 Date:09,10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:2/7/82-ALC4/2014 Party Name:DR REDDYS Meet No/Date:7/82- Status:Deffered LABORATORIES LIMITED ALC4/201411.09.2014 | 390 [HQ File RLA File Lic.No/Date:0910060892 [Defer | :01/82/050/00646/AM15/ :09/24/040/00263/AM15/ 26.08.2014 Date:09,10.2014 Bee Ve eee oe a me nn a TAT oo Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals |Case No.:3/7/82-ALC4/2014 (Party Name:S VCHEM Meet No/Date:7/82- Status:Deffered | INTERMEDIATES P LTD ALC4/211.09.2 01 44 391 [HQ File RLA File Lic.No/Date:0410159328 [Defer a :01/82/050/00647/AM15/ :04/24/040/00139/AM15/ 02.09.2014 Date:09.10.2014 Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals Case No.:5/7/82- 7 ALC4/2014 P artyHARMACEUTICALS(PROP.CHEMOName:THEMIS |ALC4/2014Meet No/Date:7/82- ——([Status:Deffered SYN LTD.) 11.09.2014 392 HQ File RLA File :08/24/040/00177/AM15/ Lic.No/Date:0810133217 |Defer Date: |:01/82/050/00649/AMI 03.09.2014 10.2014 5/ Decision : It was decided to defer the case for 09.10.2014 for comments of Department of Pharmaceuticals. Manual Part -II (B) Case No. B-1 (Part-I!) M/s AUROBINDO PHARMA LIMITED Meeting No. 7/AM14 dated — 11.09.2014 F.No. 01/82/050/00818/AM11/DES-III Licence No. 0910043467 dated 09.09.2010 Decision: Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/I 25/2014-PI(Norms) 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 i details below or as applied by firm whichever is lower:- | Dy. Ditectar yy) aes’? STUY Rew 2) ha trade Directorate ¢ ANT Ty ----- End of picture text -----

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----- Start of picture text ----- Export product Exp. | SINo. Qty, Allowed : Qty. . Kg/kg pt 7-ADCA 0.7486 J (CEPHRADINECEFRADINE- sRSTERILE)STERILE |2___[Ls ACETONEACTIVATEDD(-) DIHYDRO CARBON PHENYL( CARBON GLYCINE DANE ——0800.032 | SALT . DIMETHYL FORMAMIDE 40 [6 | ETHYL CHLOROFORMATE }0.442 |8_| TRIMETHYL CHLOROSILANEMETHYLENE CHLORIDE (TMCS) [0.5627/15000SC=édi| } As per packing polic RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

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Case No. B-2 (Part-II) M/s AUROBINDO PHARMA LIMITED Meeting No. 7/AM14 dated ~ 11.09.2014 F.No. 01/82/050/00916/AM11/DES-III RA F.No. 09/24/040/00270/AMI1 Licence No. 0910043809 dated 06.10.2010 Decision: Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/125/2014-PI(Norms) 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:-

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----- Start of picture text ----- Export product Qty. Allowed 7-PACA Kg/kg . or [(6R,7R)-7-AMINO -3- CEPHEM- CEFPROZIL 4-CARBOXYLIC ACID CEFPROZILMONOHYDRATE ( [2| ETHYL CHLORO FORMATE ( ECF) }0.383—s—iCs~«~*™S ) |3___| METHYL ACETO ACETATE ( MAA) [0.443 —SC«Y 14 __| TRIMETHYL CHLOROSILANE ( TMCS ) [0.742 «| D(-) P-HYDROXY PHENYL GLYCIN BASE| | 0.508 [6 | P OTASSIUMHPG Base CARBONATE [o2a 0.0386 [9 | DIMETHYL FORMAMIDE (DMF) [374 iS |410 [METHANOL =i 83 [11 | METHYLENE CHLORIDE ————=~d 4.02 RA concerned may take further necessary action as per above decision of NC. Case No. B-3 (Part-II) M/s AUROBINDO PHARMA LIMITED Meeting No. 7/AM14 dated — 11.09.2014 F.No. 01/82/050/01047/AM11/DES-III RA F.No. 09/24/040/00311/AM11 Licence No. 0910044459 dated 25.11.2010 Decision: Committee considered the case as per agenda and in light of written comments received from |) Department of Pharmaceuticals vide their OM No. 3501 1/125/2014-PI(Norms) dated 01.04.2014 and in | 2 rere MAL KUMA Y. Director 6 ATSTR Peet =; 1 Trade Directorate t a 77 HIE FeMTYOeparmen oi ae tase . Uayog Bhswin ESE, ----- End of picture text -----

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----- Start of picture text ----- | 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 ee [ee Import items Qty. Allowed [1 Kg/kg ROSUVASTATIN | DIETHYL METHOXY BORANE (0.84 | CALCIUM [ 32 | METHYLENETERT. BUTYLDIMETHYLSILYL CHLORIDE ____—+‘([440————* CHLORIDE |2.0 [4 __| N-N-CARBONYL DIIMIDAZOLE 12.62 [5[6 [|] |R-(+)-ALPHA-METHYLBENZYLAMINE [DiBAL-H(DLISOBUTYL] _| 0.878 PYRIMIDINE CARBOXALDEHYDEALNYDRIDE) [2.793.182 |8 | STEAM/THERMAL COAL As per fuel policy RA concerned may take further necessary action as per above decision of NC. ----- End of picture text -----

Case No. B-4 (Part-II) Meeting No. 7/AM14 dated — 11.09.2014 F.No. 01/82/050/01264/AM11/DES-III RA F.No. 09/24/040/00417/AMII Licence No. 0910044738 dated 16.12.2010 | Decision: Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/125/2014-PI(Norms) 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:-

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----- Start of picture text ----- Export product ee foe | Import items Qty.Kg/kg Allowed 0.867 ain [2 [ety=iAssioasemte 81 TRIHYDRATE STERILE [3 | PivaloylChioride Cd 0.516 4 | D()AlphaPhenyl GlycineBase | 0.665 [5S| __|«HCPotassiumisopropyl CarbonateAlcohol [7[8 [ethan——SSSCSCS~S~S~———=—SCS~—TNCC*SSSCS RA concerned may take further necessary[9 __||action [Steam/Thermal] MethyleneChiorideas per aboveCoaldecision——s—~—“‘CC™CLCONOASOCCdSof NC.=| AS per fuel polic be Date:11.09.2014 Nirmal Kumar Place:New Delhi Dy. Director General of Foreign Trade ----- End of picture text -----

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