IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2015-01-12

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi

Para 4.7 Decision(DRAFT)

MEETING NUMBER I I5/82-ALC4/2014 MEETING DATE : 12.01.2015 But actually held on 22.01.2015 Meeting No. 15182 of 2014-15, to consider the casevissues under Duty Exemption Scheme (Chapter-4) ofForeign Trade Policy,2009-14 pertaining to Chemical and Allied producis and falling under chapter 29 and 30, was scheduled for 12.01.2015 but actually heldon 2i.01.2014 under the Chairmanship of Shri Jaikant Singh, Addl. DGFT in Room No. l l, udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Deputy Director General of Foreign Trade Ms. Swati Kumari, O/o Dc (MSME) Shri D.N. Mathur. Consultant, Department of pharmaceutical Shri Mahendra Vikram Singh, Foreign Trade Development Officer The committee went through the minutes ofearlier NC -III meeting No. l4lg2 scheduled for 22.122014 but actually held on 07.01.2015 and approved the same. . The following caseVissues were discussed and the committee took the decision as mentioned against each case.

Case No. A-13

M/s Universal Bio- Diesel Ltd.. Meeting No 15/AM 15 dated-21 01 2015 FNo 01/82/162ノ00198/AM 157DES-1‖ Dccision:Itwasdccidcdtodcfcrthccascfor 1201 2015 forcottpcntSOfDcpartmentOfc&Pc

Case No. A-14

Mceing No 12/AM 15 dated-15122014 FNo. 0 I /82/l 62100059/AM I yDESJII Dccision:COmmitcc cOnsidcrcd the casc as per agenda and in‖ ght Of wrltten cOmments rcccived from Depainient Of Pharmaceudcals vide their OM No 350‖ 234/2014_PI(Norms)datcd ぅn nlぅnlく^」: __ 1 | 20 01 2015 and in cOnsuhation wih tcchnical authOrl″ presCnt in meedng,decided tO ra■ ～ nOrrns under para 4 7 of HBP as per details given bclow Or as applied by frm whichcvcris lowcr― above decision ofNC.

Case No B_137

M/S ALCHYMARS ICM SM PRIVAiE LTTV{ITED Mcelng No 15/AM 15 dated 21 01 2015 F.No.Ol /82150/001 I l/AM l4lDES-ilI Adv. Lic. No.0+tOt++:60 aatea 2S.03:Ot: RLA F.No.04/2414 OtOOZlgt Xl/r- tS 葛葛11::こここ1:a、for their ― |・

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case No B-138

RA F No03/95/40/00628/AM-11 AdvLicNo0310602565dt 23 11 2010 |lillil:1)1泄 m No 350H/202/2010-PISO111lS)datCd 07 06 20 H,i ― ―^ ―¨――ヽ`▼■ヽアnDハ1賣_rl、RTNA' ii:.'":i'1111#,Y+$i'l!-Xili'X8:;iiliiin"nntno-rH-(r! BENAZEPIN-2-oNE-r- ACETATE (s AMINE) tn.t""a'o"r lIiInino-l-N-Terbuto*y"riuonyt (s Amine) in the minutes of il "N.-#;; ;;.

qfr;z ax" a 22'02'20 | t as detai ls given bel ow' T_BuTYL,3S‐ AMNO-2,3,4,5可琶猟穏lド ~ xycarbonyl(S The reSt Ofthc mlnutCS WOuld remain same 箭漸郡鮒輔撫琴棟霊調F認瓢∬鰐鰐硝ざI‖ 模品:蔦L罵1:「:ξ ttpiぬby irrll WhthwCr kちWer‐ 912」£亘,塾 lmpOrtitCms ´ n ::11 : : il Qty. allowed Exp Q″ Sl No 0 568 kg l Kg 1 0‐AminO rclllし1ll●inし ｀■‐ 5 00 gm つ４ ^-;1"., (FnTvme) 0 608 kg 3 D(―)P― HydrOxy Phenyl Glycine MCthylester ol Nし :::litii,iilii:iliililliliti:::Fi:itililii:ili「]lliil::i:]:i]:::::::IL::隻 idCd hcvCr iS iOWCr:‐ ______―――――~ t:i慧I″ 鷺rlns 讐≒ :I留 … … _^":■ ●mミ ,1212f翌■ ncAcid(6- 輛よλ ttYlltth Enzymatic Route

Outside Agenda-3 M/s DSM Anti― Infcctives lndia Ltd, Mccting No 15/AM 15 datcd-21012015 F No O1/82/050/00645/AM07/DES― III RLA F No 09/24/040/00152/AM07 Adv lic No 2210005831 datcd 31 07 2006 Decision: It was decided to defer the case for comments of Depu.tment oiFhurma""utiiiif g I Case No.:17/19/82‐ Par″ NamciVIVIMED Meet No/Dttc:15/82- status:DefFered l ‐ ALC4/201l LABS LIMITED IALC4/2014 and Re― indexed 112012015
‐ 41‖)3月5υ0053ν AMlν li;危∠;liα00日7AMIν :1:ごfTCO"004ケ 1,51駐孵F~| DedJon:COpy OfpЮ ducdOn and consump■On data ofJl hputs has bgcn rcc&vcd■。m ic■品 ‐1:tF:Ui:,S been scntto Department of Pharmaceuticals fOrthcir comments Casc is dcfcrred fOr Paty Name:VIVIMED LABS LIMITED RLA F‖ e l:0924/040/00318/AM12/

Case No.: I4l24l82-

Parg Name:SAINOR Meer No/Date:r5/g2- Sratus:Deffered , ALC4I201O LABORATORIES pVT ALC4l20t4 and Re_indexed " I iLTD 'l2.ot.2ols Re-indexed il薇3藤041b094357 112032008 18022015 Decision : lt was decided to defer the case for 18.02.2015 for comments of Department Pharmaceuticals. No/Date:15/82- 2015 Meet No/Datc:15/82‐ ALC4/2014 1201 2015 瓦 Itty~瞬需輛T雨面面而1話 e as itis already approved in 12/82 meeting datcd 125/AM12/

consumpion data ofJl hp耐S has been reCdVCd from the frln ision:COpy ofproduction and same has been SenttO Depaltment of PharmaceutiCals for thcir comments Casc iS deferrcd fOr 18022015 甲蜃ご腰搾"甲棚 | | 'r-^ "r- "RIAFtt.

rl[N"/D"t"o--_'--'q1004'33'qIP^"I:P:]:' llY,lJiro,r',rt reutzr ',bTziiitrorcotttrtutzr lta to:ot t lta oz'zots |I)ecC* t C"pd p.dtt"" and consumption data of all^inputt land same has been sent to Depar ;;;;i i,i;";";ticals for'their comments. case is deferred for Jr r.oz.zots. 嚇猛薇面面面面蔦扇:e fo両面面面高品品薦 `f Dcpartme威 Of lli;;'l'.1i,:Xmvsis rrom Foreign supplier for the relevant consignment or imported crude product. rul LOe oi epon product as per-shipping Bill/Purchase Order' casc is dcferrcd for 18 02 2015 No.:28/28/82‐

5 匝繭冊応蕊蕊話~厩蕊蕊:薦i」 | ICaごNU■2/8/82 1 rLα″∝ 3 Name:B10LOGiCAL E File :09/24/040/00607/AM13/ Meet No/Date:15/82- ALC42014 12012015 Status:Deffered and Re-indexed Ю器3掲50/00“3/AM W )55421 1Defer 5ate: 118022015 IDefcr Date:18022015 Lic No/Date:091005 19032013 … 厠呼甲蜃薦~剛 Ⅲ 両 1協雛 : 隔面瓦稿面高高面高l而扇品」品雨品満品ЬF高乃ぷthc面 1蹄爵 ]ガ埓器tFL詰器:f警謝°稟ごWeLLttattele#S■淵:濯 ‐ ‐ ・ ´ |・ 9V``V■ υ ―
― ― ― ―― ― ― ‐‐― ‐‐- 1～

‐ ‐ ‐ ‐ ●´ , cmhdthe■1:=:to mmish thc fO115=hg mfollllation: 野」訛 f卜i… … 面・d"G嗣取 “ C写 Decision : It was decided to give last reminder to it " itm to fumish record of complete Manufacturing process (up stream, down stream, showing quantities and use of import inputs". The case was deferred for Decision t Cornrnln.. "on.ia". th. "^" *d it is observed that the expoJproduct has wrongly been categorized by the firm under chapter 23. Being the Bulk Drug, the export product needs to ]be classified under chapter 29. Accordingly, it was decided to advise the firm to revise the lapplication with proper ITC (HS) codes for the export product. i ;The case is deferred for 18.02.2015. No.:42/20/82- Name:GLAND No′Date:15/82- LIMITED 唾 ::1ざaにヽ

ん F聴蕊雷雨~瞬郡F面下画面面 `鵬3児5∽“ 52/AM脚匿脇蕊扁戸 | 際L面面而面面 Date: 19062013 18022015 Decision : [t was decided to defer the case for 12.01 .201 5 for comments of Department of Pharmaceuticals. 一 Re-indexed 器3鷺5∽0366/AM W 障ち棚OЮ003νAM口 1蹴鼎 Lic No/Datc:1310043416 Date: 18022015 ion : lt was decided to call from the firm Copy of relevant DML for each export product with detailed working on the requirement ofAPI in each case. The case was deferred for 18022015 : It was decided to defer the case for I 8.02.201 5 for comments of Department of IPP

Case No.:172ノ14/82-

ALC4/2013 Re-indexed 18器 3児50Ю0384ハm″
厩危糀 OЮ∞63ムMW 鱚 18022015 LiNo/Dat●0410147551 1DeferDatei : It was decided to remind the firm to furnish a copy of Master Batch Formula duly by Quality Control Incharge. The case was deferred for I 8.02.201 5. Re-indexed Date: 18022015 ~ 1麗濯湘鶴渓習器'躙酬 5/82‐ w 16に,ハ_=1_ 1、■A r=1^ ~~~~~~――一h:^、1^^●^κ lA●●OmA IA^r__n_4 器 3児5∽0294/AM W「吾百万麗語 Ittτ「 II三7~~~1製:鉗gRtte051""∞OR震 "雛 : 1器鶏j鮒i:譜誌鷺酬11』t螺ぷ酬鶏鳳酬乱糧:7:鷺∬ l富ポ撃臨l器‖■:潔嘱魔肌f器鵠2蹴5h Gmms∝ h MⅢgramo m輛o¨dh■e 1)ecision:It was dccided to remind thc■ H‖ to fumish a copy ofMaster Batch Fol:::ula duly Date: 8022015

certified by Qualig Control Incharge. The case was deferred lor 1g.02.2015. O^M fo: 350111647/20t3-Pl(Norms) dated 20.01.2015, it was decided to rati!, the nor Para 4 7 of HBP v I as per detairs given berow or as applied by the firm, whichev-er is less: S No Import Item Qty Allowcd 1 Cetyl Alcohol Nf(Speziol Cf O pharrn; 10.0 gm/tube 2 Steaりl Alcohol 5.0 gm/tube 3 Sodium Lauryl Sulphate 20gm/tubc 4 Trol印minc 99%usP/NF Lavender Oil 5.3448 gmltube ξ Ｄ 0.022 grnlttbe 6 Plastic Tubes 100gm HDpE Relevant, As per packing policy 7 White bees wax(white wax) USpNF 1.00gmtube Qty Allowcd Alcohol (Speziol Cl6 phann) Lauryl Sulphate rolamine 99o/o min USP/NF 0.01 I gn/tube Tubes 50gm HDpE Relcvallt,As per pttking polcy bees waxlwhite wa*) USp,NF Qty Allowcd 7 F辮脱&~~日澱ξ 躙忌 II脳re15/82 No.:44/12/82- Name:ENCUBE No/Datei1 5/82- ｅ　ｓヽキ :l:,it S No Import Item 1 5 0gln/tubc う４ Stca■/1 AIcohOl 2.50 gn■/tubc つう 1 00 gm/tube ４．　一， 4 006 gn1/tubc Lavender Oil 6 7 0 50gm/tube Aυυ =ι ltCI11 lNO,1ヽ )IleX LxtraC■cmc■5,a■Oo,m____ S No Import Item y ●(a。‐ 避

ち Gtyfrc"t"tNf (SPeziol C16 Pharm) Stearyl Alcohol rffi Iffi I llavender Oil ffi 10.0 gm/tube -to gn /t.b" 2.0 gm/tube sJlrtFtube 0.022 gm/tube 1. 2 つＤ 4 5 Relevant,As per paCking poliCy 6 1.O0gm/tube 7 White bees wax(white wax) usr/.t\r QりAl10WCd (gdtube) 5_50gnゴtube 2 75 gnytube 1 00 gnVtube 5.3448 gdtube 0 0H gmltube Import Item nt^ヽ S No 1 Cetyl Alcohol NI (Spezlol u lo rlarury 姦aryl Alcoh01 sO“Ш L岬l Suphate Trolanune 99%min l」SP/NF Lavender()11 1PlasticTubes50gmHDPE う ‘ 3 4 く０ RclcVant,As pcr paCKing p011じy 6 0.55gm/tube 7 White bees wax(white wax) usr/I\r Q,AlloWed (劃tub0 H.00gm/tube 5 50 gm/tube 2.00 gm/tube S No Import Item t .-fCeryl Alcohol (Speztol c l o rnanlu う ‘ StearvI AlcOh01 SodiuFn LauryI Sulphate り，面 96 gtttubC o022 gm/tube Trolamine 99%min USP/NF 4 く υ -Oogm HDPE 10D′ヽIロ Relevant,As per paCking poll●y 6. 7 WhitC beesヽVaxいVhiC Waxりυ Or′ 1ヽ■ 1い , Fvnor lNo r^_N^たヽイ、′nflF・・Y｀12X20ツoヽV′ W′ ― l | 、■′ lNo I^gヽイ、′^nρv M2x ′0ツoヽV′ W.l υV ttl11 ■μυ｀ `070nOl( t ltem No

q ― ― ― ― ― ― ― ― ― 、 ― ― ― ― ― ― ― ― ― ‐ ‐ ― ― ― １１１ ‐ ‐ ‐ ‐ 「F蕩蕊 F面「 ~丁~ Pa●y Name:ヽVOCKHARDT LIMITED RLA File IMeet No/Date:15/82- lALC4/2014 112012015 ●たNo/Date:0310741992 q-ty.411o*"6 磁討tube Yel10W USP wtt Ycl10W(ReincめUSP 万面郵tubC ― tube 面蕨劃tubC o■RedlmMtiOn C niiJiltaiEfract'ing Poli'Y Or 60gm Qty. ellowed 0.612 gm/tube trFrochtoride USP -Non ste-rite tnlicronized USP 0306ヽlUノTubc 0.153 MUノTube lymyxln B Sulphatc(Non‐ Stcr.MiCro)USP Relevant, As per packing policy il-iniu.cotluptibletubel5gmor30gm may take appropriate action as per the decision of Norms Committee'

|つ場 il漂孟戸艦 Deffer€d Re-indexed 携 it需要晏磯誓i柵湧 No.:52/t2/82- 踏評疏・雨蜆藁勘蕊 ::豆 =1戸 NODate 15/82‐ 贈1lY?2中Ю 31o74248i ёchnical 鰐Ⅷ篇:貶耕職釉矛甕灘 ,ase was defcrred for 鮮喘 =1言 13疏5蕊瓦頂 =]コ墜殿∽∞ぉムm″ 厨鰐鼎。知∞ 37541 No.:l/10/82- : It was decided to defer the case for 18.02.2015 for comments of Department ofC&pC.

Case No.:t7l13/82-

ALC4/2013 Lic No/1)ate:0910056959 すユヽ1灘條鶉黒繭 '14/82 ALC4/2013'呵 NallllcCTX NorDate:15/82 凛 ″ ′NalllcPA3 0RCANIcs LD, No,/Date: No.:31/4182- Name:UNIVERSAL No7Date:15/82‐ 12012015 F‖ e :01/82/050/00279/AM157

（Ｆ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ― ― ― ― ― ― ― ― ― 」／・ ― ― ― ‐ ‐ 「 1徴∫ 1鰍F 1珈 1器3掲50Ю餌87/AM14/臨鳳 iFirFil勇:[]『 | "て戯 “ 鯰■莉, Dyぽ野雪ぉ111野ll 器器蹴墨驚`i=岩I 。.話聾臨鴻既 _ ILIFESCIENCES PVT LTD, ~隔倉棚 OЮ ""AMW~1淵辮 Ю引Oη "21 Decision:ln the light of written comments received from Department of Pharmaceutica:s ther OM No 35011/738/2013-pl(Norms)dated 20 01 2015′ I was decided to ratify norms u para 4 7 of HBP vl as per detalis given below oras applied by the firm′ whicheveris less: Export product Exp Qty SI No lmport items Qty alloWed kg/kg Amiodarone lkg 2 Butyl-3-(3-5-Diodo-4-Hydroxy Benzoyl) Benzofuran 09135 may take appropriate action as per the decision of Norms Committee. “ ,■ド′NI )ecision : In the light of wrinen "ornr.i,, received from Department of pharmaceuticals vide their lo. 350111704/2013-PI(Norms) dated 20.01.2015, it was decid€d to ralifo the norms under para 4.7 of I as per details given below or as applied by the firm, whichever is less: Export Product 呻 ¨ S No Import Item Qty. Allowed ke/ke Tramadol Hydrochloride l kg 1 Cyclohexanone 100 2 N.Bromo Anisole つＪｎン 3 Tetrahydrofuran 157 4 Isopropyl Alcohol 118 n‐Hcxane 058 029 166 0.51 | 6 ParafO.11laldelyde 7 Methanol 8 Tolucnc 9 urmethylamine Hcl --:-'--- OI Nonn< al^hhi6-- 0.81 may take apprOprate acdOn as per the decЫ oF CJl,Om heinnぉ1めwhg hた ~~~υ 4じにυ4 )・nalbn.(1)C° mpたtc tcchiたJ 0‖ o、vino in,、^.:^ ´ 、■~~~ ― ― ―

|ン 1蘊悧鷺聴霊ド:驚繭 lal consumption of hputs duly for 18 02 2015 「出 ~~ Pa,Name:WANBURY LIMITED(FORMERLY IPEARL ORGANICS LTD) : It was decided to call from the firm following information:- (a) Complete technical as per Appendix 33. (b) Past production vis-d-vis actual consumption ofinputs duly by Central Excise Authority. The case was deferred for 18.02.2015. LIMITED(FORMERLY PEAR■ORGANICS LTD) 口QRL IRLAFmc IЮ 1/82/050/00552/AM14/ :03/95/040/00125/AM14/ )ecisio■:In the light of written coml lo 35011/706/2013‐ PIcヾ。●ns)dated 2( l as per details given below or as appli( reDts received from Department of Pharmaceuticals vide their OM ).0t.2015, it was decided to ratift the norms under Para 4.7 of HBP :d by the firm, whichever is less: Export Product 呻 ¨ S No Import [tem Qty. Allowed ksrks Diphenhydramine Hcl. l kg 1 Bromine 057 2 Dimethyl Amino Ethanol 0527 Isopropyl Alchohol 100 4 Mono Chloro Benzene 058 Diphenylemethane 0997 may take appropriate actio, ur p"t tt " a"cision of Norms Committee. No/Date:15/82‐ No:76/13/82-ALC4/2013 No/Date:15/82- No■班3だ '‐ IPan… ~師 Noは '"― ~ほ需ぱ廠釜 __ _ 11ヽ■lTでヽ AI r4′ '0 ILIMlTED iALC442qlF itz'o r 'zor s L : -r:=_-=- 器疏 5υ∞ "1/AM`戸鵬λttγ甲節AMI″ 1蹴辮郎Ю7側 |∬lmm5 -― ― ― ― ― ―一― ― ―― ~~~― ―――一一― ―~~― 一丁~==~~ ● , ^1__^__^´ ^rr"■.。.AAnρ O;arr# a"",.*; "on.ia"r"a tn" "u." "na it rt^ u"""-ou."ed that the export of Entacapone rablets200mgandtheinputi';;;;;;"'{.',"-T-?9^0,:.^L'j}'TJ"Tfii;"[i:i:il'.t; 刷窯讐1翻泥11;鵠蔦襴∬猛言 I」轟而I満卜d・W¨ d畠 “ do"mmd lDCG1 0 fuml■■望 rC°mment:The Case Was deferred fOr 12 01 2015 Д i、ま汽男ヽ nt

′ S

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

Export product Exp Qty Si No lmport items Qty alloWed kg/kg 5,7-E)ichloro-2‐ ((Dimethyl Amino) Methyl)Quin01in-8- OL―Hydrochloride [PBT2 Hcl] lkg 1 5,7-Dichloro-8- Hydroxyquinaldine 7.24 may take appropriate action as per the decision of Norms Committee

Case No.:117/14/82-

ALC4/2013 ‐P離~ 35F罵ス■■Fr~~~~― ――――――――――――― Re-indexed 18022015 1器3掲50Ю餌 27AMl″ 臨肝 ~ ~明 ¨ pe,,bnilwaS,∝dd oS爵こacow of不F「話「8nattbDCCJIおrther∞mttnts~~ (SOluJOn ofimportitems cOntains 8%water)Thc Casc was deferrcd for 18 02 2015 F需蕊而藤正三「繭魔耶Pテ ~1覆穏7蔀た2日蹴圏 191L_ ~ IRLA Fle 経 ― 囃 1躙児50加お績Mw膨淵 ∽m7晨立1″ I邸辮鮒 ∞悦%5騰 18¨ 5 m蕊戸面 ¨ 画 5b∞mmmD"讀肛 “ J、 Name:MAC CHEM (INDIA) ATE LIMITED ~厩乳 OЮ“ Omm″ Decision : lt was decided to call from the firm following technical details: , 0 Content of Buffering agent in the export proluct. iD Complete technical details as per Appendix 33 The case was deferred for I 8.02.201 5 No.:9/30/83‐ Name:STERICON No/Datc:i5/82- PVT LTD, :It was decided to deferthe case for 18 02 2015 for comments ofDepartmcnt of ﹇疑

|｀

Case No:47/16/82-

Pa“y Name:SHASUN 國爾面π 丁 ALC4′ 2013 PHARMACEUTICALS .ALC4/2014 12012015 39 HQ File ,oilszlosolooaszlaNatnr J:09/24l040/00083/AMl4/ 器島児 5υ00900AMW IЪら淵 :ンoo32νAMl″ II Re-indexed 18022015 Re-indexed ALC4/2014 Re-indexed 浙曜 ic No′1)ate:091 18022015 LIヽ41TED :It was decided to remind thc fll11ltO fumish a copy of Mastcr Batch Forllnula duly by Quali″ COntrollnchargc The casc was deferrcd for 18 02 2015 鱚 | に cおお n:I was decid司"mhdぬeimЪ hm、h com口∝ etcchnical details as per Appcndix 3 The case was deferrcd for 18 02 2015 No■38/17/82- 1喩蜃扁話圃飛dルツル 1繹魃…DI眈 | ________ RLA F‖ e :面高雇藻藻面蔦百面高而面・nぬe folЮ Whg"chdCJ de●ls: Molecular weight of each input and output product . .. ;;;;Iil";;1; basis along wiih copv ofiechnical literature in support of vield envisaged. ir.i J.14r",i", ,is-a-vis actual consumption of inputs duly certified by Central Excise Authorities. The CaSe was defercd fOr 18 02 2015 ヽ4eet NolDate:15/82‐ け計鶴 |:

Case No.:35/17′ 82-

ALC4/2013 Meet No/Date:15/82‐ PHARMACEUTICALS 12012015 case was deferred for 18 02'2015' ― 臨蔦絣鼈躙蝙釉淵轟豊認器 by Quality ControHncharge The case Was deferred fOr 18 02 2015 A l it↓:sとき :idきd tO callfrom the trm cOpy of relevant Orug Manufactunng ucence PHARMA CHEM

′5 molecular weights Yield obtained in each step Authentic technical literature in support ofyield obtained CA certificate certifiing the production of export item achieved by you for the past three years and corresponding consumption ofeach input. ＤＤｖ＞ he casc is dcfcrred fOr 18 02 2015 ,ase No■6/20/82-ALC4/2013 1 | l12m2m5 隔薦蕊蕊蕊蔦扇 ; ４ ― ― ― ― ― ― ― ― ― １４ ‐ ‐ Decision : in the light of writte their OM No 35011/375/2014‐ P Para 4 7 of HBP vl as per details n comments received from Department of pharmaceuticals l(Norms) dated 20.01.2015, it was decided to ratify norms u given below or as applied by the firm, whichever is less: Export product ” 呻 SI No lmport items Qty. allowed NICARDIPNE 50 MC PELLETS lkg Nicardipine Hcl 0 2196 kνkg RA may take appropriate action as per the decision of Norms Committee ra 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp Qty SI No lmport items Qty. allowed 7/AM15/ TORIES LTD No/Date:15/82‐ No/Date:15/82- No:28/4/82- PharlnaccuJcJs 嚇而面面高高耐 … ]orcommcnts OfI)epartment of I、1 .

|し Decision : committee considered the case and it has been observed that both import and export i,on. "." same. As per the details given by the firm, purity of import item is Not Less Than.99'0% ・ψ'''Ⅲ… ・‐……― ‐― r― ―― ~~ o
´
‐ - 3(w/w)It Was decidcd to takc W/W)and that of export itcm is NLT 97 5%and lIMT102 0ツ 1蔽面而面而耐 lm柵語 TぶLABS | | 椰33児50Ю ∞05/AM15/ 囲 :OЮ0354/AMW ~ Date:18022015 Party Name:GLAND PHARMA LIMITED Meet No/Date:15/82‐ ALC4/2014 12012015 Meet No/Dae:15/82- ALC4/2014 12012015 18022014 Re-indexed V/ NICARDIPINE 50 MC PELLETS lkg 1 Nicardipine Hcl 0 2196 kttg may take appropriate action rs per the decision of Norms Committee. ０一　 К 胡一Ｄ ‐ ‐ｔｈＰａ淵閣‐~四棚闘hm腰鮮"師漑5υ∞ 25/AM耐~開顧:蒜肝 ~磨群器31100m"嘔 ecision:ln the iight Of written comments received from Department of pharmaceuticals vide eir OM No.35011/369ノ2014-PI(Norms)dated 22 01 2015,t wbS decided tO ratify nOrms under ra 4 7 of HBP vl as per detailS given be10W Or as applied by the firm,whiCheveris less: Export Item S No. Import Item For Export of lNo. vial. 2ml宙al 41111 vial Amikacin Sulfate in」cc■on USP 1 Amikacin Sulfatc 734 459mg 1 469 gm うｚ Serum StopPer Relevant, As Per Packing PolicY' つＤ Flip-off Seals may take aPProPriate action as P(:r the decision of Norms Committee'

case No.:66/3/82-

'ALC4/2014 Re-indexed of DCGI Name:ALCHEM

lη 脇佃協ムm″ IRLA F‖ e l:05/23/040/00341/AM14/ 階だ開°国 "η“ 5 Bttl&m2∝ 5 : It was decided to remind the firm to fumish following technical details: Actual content of Digoxin in imported digitalis Lanata Leaves supported by COA from foreign supplier Assay ofExport Product Past production vis-a-vis Actual consumption of leaves for the last 3years duly certified by Central Excise Authorities. The casc was dcfcred fOr 18 02 2015

Case No.:8/18/82-

ALC4/2013 ＞　００鵬3掲mЮ "`ハ m″ 厩

階だ辮創Ю知明 per above decision ofNC. Status: Deffered and Re-indexed Decision : Committee considered the case as per agenda and in lig received from Department of pharmaceuticals vide thelr OM No. 35 dated October 2014 and in consultation with technical authority presen ratify norms under para 4.7 of HBp as per details given below or as apF ht of written comments 011/170/2014-R(Norml lt in meeting′ decided to ‖ied by nrm whicheveris Export product Exp Qty SI No lmport items Qty A‖ owed Kq/k。 ORLISTAT PELLETS 50% l kg 1 ORLISTAT 0505 2 STARLAC(CompOund Of Maizc Starch USP7NF,EP and Lactosc MonOhydratc USP/NF,EP) Does not match with control of Materials fumished by firm 3 POLYVINYL PYROLIDONE K-30(PVPK-30) 005 concemed take further action as | No J81/3/82- Name:AKZO NOBEL No/Date:15/82- Llヽ41TED :It νvas decidcd tO dcferthc casc fOr 18 02 2015 for comments of Dcpartmcnt of Name:TITAN No/Date:15/82-

IЪ :01/82/050/00688/AM I 5/ |:07'4/040/00323/AM14/ 02.01.2014 : lt was decided to defer the case for 18.02.2015 for comments of Department of Status:Deffered and Re-indexed 18022015 ILic No/Date:0910058826 106012014 : It was decided to call from the firm following information/ technical details: Complete technical details as per Appendix -33 showing complete and balance chemical ● /O Yield ctc Requirement and recovery of solvent at each stage. Technical Justification for requirement of each input. ■ial cOnsumption ofmputs duly ceri■ ed by Ccntral Excヽc ・Past Production vis― a_vis Aく case was defcrrcd for 18 02 2015 Re-indexed 18022015 Decision : It was decided to send a copy ofapplication to Department of Pharmaceuticals for their comments. The case is deferred for 18.02 2015' Re-indexed 一　　　　５６ F M :It was decided to send a coPy ofapplication to Departlncnt of Pharmaceuticals for comments. The case is deferred for 18.02.2015'

Case No:89ノ3/82‐

ALC4/2014 :01/82/050/00093/AM15/ Patty Name:ViVIMED LABS LIヽ41TED

case No.:87/3/82-

ALC4/2014 :lt was decided to dcferthe casc for 18 02 2015 for comments Of of C&PC Name:ASTRIX TORIES LTD, No/Date:15/82‐ No.:192/3/82- Name:VIVIMED LABS l3lAMl4/ il o.0 r.2ol4 No.:204/3/82- NamciVIVIMED LABS No/Date:15/82- No.:208/3/82‐ Name:OGENE No/Date:15/82- INDlA PVT LTD Ftle lLic.No/Date:0910059017 :It was decidcd tO defcrthe case for 18 02 2015 for commcnts ofI)cPaltment of

t1 lna.ty Nami:VrvmO f-ASS IM""t No/Dar"l y8I lsrrtrO"ffer"O ILIMITED ALC4t20l4 laod Re-indexed I rt2.ot.2ols I |~F霊萬 7面藤日3児50Ю鋭創AⅢ夕 ~障危淵 ∽ “`/AM剛 ~ 1蹴 18Ю2期5 1賃謎胤督 /3/82‐ Pary Name:ASTRIX LABORATORIES LTD, 1造き 1房腎に 15/82- Status: Deffered and Re-indexed | IDefer / 「田恣ぼ圏面需百1
開而 | | | | | 112012015 61目漱面高蕊面y―隔蒻扁薦扇面T「漉繭戸面麗雨囮 fnlri"" t It ". a""id"d.".;;;h. fi.- t" f;-i.h ;pr"t" tr,.i""r a"t"ir, * p- epp""a*- i33. The case was deferred for 18.02.201S. :NIon : ln the lighr of written comments received from Depanment of pharmaceuticars vioe theii o 3501I1379/2014-Pl(Norms) dated 22.01.2015, it was decided to rati$ the norms under para 4.7 ofHBp 16z l,ovrzrosoroooos \yty-I.@yyyoosgtrnurur l'ri;)30',1""''"""o lBilil,r.or.rr,,I ] ]|.:Hg l-:-t q:."1aerjl3rr n", th" r,.rn A" "o;pl"t" t*h;i""ie;t"1. ", p;pfidt, x I I rand, ([) past. production v.is-avis actual consumption of inputs duly certified uy centrai bxcise I lAutnonry. I he case was defened for 18.02.2015. I __l iDare:18.02.2015 : In the light of written comments received from Department of pharmaceuticals vide OM No.350ll/331/2014-PI(Norms) dated 01.12.2014, it was decided to call from the firm following information/ technical details: Complete technical details as per Appendix -33 showing complete and balance chemical %Yield etc Requirement and recovery of solvent at each stage. Technical Justification for requirement ofeach input. Past Production vis-d-vis Actual consumption of inputs duly certified by central Excise 」 case was dcferrcd for 18 02 2015 ，　 ¨ ¨ ∠ υ I as per details given below or as applied by the firm, whichever is less: : It was decided to defer the case for I 8.02.201 5 for comments of Department of C&PC. No.:48/3/82-ALC4/2014 Name:VIvIMED LABS Nol)ate:15/82-

)ο V 一　　　　　 “ 吻 l :01/82/050/00466/AM15/ ~ omments ofI)cpartmcnt Of :It was decidcd tO defcrthe case for 18 02.2015 for c … 5,い′ :It was decided to deferthe case for 18 02 2015 for commcnts ofI)cpartment of Deffered Re-indexed 靱 11嶽 :Ъ Quantity k″kg Line I (R)-3-(3- Fluoro-4 Morpholinophenyl) 5-(Hydroxymethyl) Oxazolidin-2-One l kg 1 3,4-Difl uoronitrobenzene 100 Sodium Carbonate 080 Ammonium Chloride Solution 1324 4 Sodium Bl― carbonate 090 5 Lithium Tcrt― Butoxidc 10298 6 Dimethyl Formamide 085 7 Tetra Hydro Furan 170 ヽ4ethanol 0785 9 n-Hexane 574 10 R‐Glycidyl butyratc 0964 .ay tuke app.op.iute action as per the

case No.:64/6ノ82‐

ALC4/2014 No:73/3/82‐ Name:FDC LTD

2′ m配戸面高騰Casc for繭再for comments of Department of ■ １１１ ‥ 彗 : In the light of written comments received from Department of pharmaceuticals vide OM No 35011/315/2014-PINOrms)datCd O1 12 2014,l was decidcd to ca‖ frOm the l:::: following technical details: Copy ofcertificate of Analysis of Imported Azithromycin Dihydrate Ip grade on Actual content vis-a-vis specifications under Indian Pharmacopia. F淵“脱‐ ~1趙吻「 1鰍… 岡忠脚鵬 3児 "Ю m“AMЫ 脇乳 OЮ “ 8吸MW 囲辮 “ Юη "7B為 802釧5 ii) A similar COA ofthe Export Product vis-avis the specifications laid down in USp -36 iii) Justification / Reasons for Reprocessing. case was deferred for 18.02.2015. IHQ File ICase No■233/3/82‐ ALC4/2014F爵百Name:CADILA~~~~IMeetNo/Date 15/82 5己li“ ~ l HEALTHCARE LTD"
ぃL計盤r
卜 ppЮVed l l 1120 lCase No.:233lJ/82 -ALC4/2014 lparry Name:CADtLA iM;;i M/D"i;,15/82- lsd;;$ - i , HEALTHCARE LrD . ,i:;i:::,,: irppi","a nO 1,1"

|RLA r.ite Lic.l,ro/Date:0810 r 29 t 8 j Defe;tate: I :01t8210501002371AM15/ :081241040t00526/ AMt 4t 125.02.20t4 | p..irioo r * . i,**-"".;.".,;ffi1ffi"; r.r;;, "r.r",-;.,u .n or'l No. 35011/358/2014'PI(Norms) dated 22.01.2015. it was decided to ratiry rhe norms under para 4.7 of HBp ]v I as per details given below or as applied by the finn, whichever is less: I t" Ero"t P.oau.tr Buspiro." Hvd.ochloride Tabl"ts USp 5mp. l0ms l5-s and 30mq l i ゾ S No Import Item Norms proposed for I No. Tablets 5mg tablet 10mg tablet 15mg tablet 30mg tablet 1 Buspironc Hydroch10rldc 51 102 1530 306 う乙 Lactose MOnohydrate 48833 97667 14650 2930 つＪ Microcrystalline Cellulose 1l\vicel PH 102) 16667 3333 500 10000 4 Sodium Starch Glycolate 30 60 90 1800 5 Colloidal SilicOn Dioxidc 0750 150 225 450 6 Magnesium Stearate 0750 150 225 450 7 to 15 Packing Materials Relevant, As per packing policy. ヽ (N、 ― ｀ :●■｀二許ヽくη…1ヽ二''. 」硼坦I絲憚鰈 F Name:THINQ No/Date:15/82‐ LIMITED 12012015 ICase No.:105/3/82- IALC4/2014 cision : lt was decided to call from the firm the complete technical details as per Appendix The case was deferred for 18.02.2015. ' Re-indexed

タレ may take appropriate action as per the decision of Norms Committee. 〆 Party Name:INDO PHYTO Meet No71Date:15/82‐ CHEMICALS PVT LTD ALC4/2014 12012015 Lic No′ Date:0510380433 P7022014 Lic No/Date:0310772503 File Jiwas decided to defer the case for .1g.02.2015 for comments of Department of 1颯… Re-indexed !8022015 Re-indexed 18022015 Re-indexed

Case No.:106/3/82-

ALC4/2014 ion : committee considered the case as per aSenda and in light of written comments ed from Department of Pharmaceuticals vide their oM No. 35011/333/2014-Pl(Norms) z2.ol.2ot5 and in consultation with technical authority present in meeting, decided to normsunderpala4'TofHBPasperdetailsgivenbeloworasappliedbyfirmwhicheveris Export product 恥韓 SI No lmport items Qty A‖ oWed Kq/kg 19-Norandrostenedione 997o Intermediate l kg 1 Sitolactone 140 2 5-Chloro-2- Pentanone 130 3 Tetrahydromran 3 50 1it/kg 4 Pyridine 0 62 1it/kg concerned may take further necessary action as per above decision of NC'

Case No.:118/6/82-

ALC4/2014 CROPSCIENCE LIMITED 721

Case No.:58/6/82-

ALC4/2014 28022014 , It rru, a""ia"a to defer the case for 18.02.2015 for comments of Department of 運庸漬露籍ミ科 i轟延 :01/82/050/00110/AM15/ 103/95/040/00960/AM14/ 陽鸞誡」F No:5/3/82-ALC4/2014 File ― iRUM LIFE IMeetNo17Date:15/82‐ KOMAR

25 l eferthe赫繭稿蒜扇編」段 ]蹄総医腑山2 証 1認鼎α側釧 "η 6 75 |||'|… Aンυ ualUЫllC IKg lりeoxンg[1,=:。Sillel o( | IRA concemed may take funher necessary actiOn as per above declslon of NC 「「謎淵畑2~「M棚出sL」1
騰蹴圏 | ２２　ｍ　・Ｆ r : Committee considered the case as per agenda and in light - from Department of Pharmaceuticals vide their OM No. 35011/ .01.2015 and in consultation with technical authority present in r 'ms under para 4.7 of HBp as per details given below or as applied f written commer 382/2014-Pl(Norn neeting, decided by firm whichever S No Export Product Qけ. Import Item Qty. allowed kC/kC. 1 Di MethOxy Trityl Thynlidine kg Thymidine 0483 2 Di Methoxy Trityl Benzoyl Deoxy Cyidine kg Deoxycy'tidine 0553 3 Di Methoxy Trityl Benzoyl Deoxy Adenosine kg Deoxyadenosine 0632 4 Di Methoxy Trityl Isobutyryl Deoxy Guanosine kg Deoxyguanosine 0688 concerned may take further comments ‐PI(Norms) decided to hichever is 賢蹴謬 ‐~甲躙鳳Im臓押 … 蓼而 | HQ ALハ … … … ~1理全,| ~い No/D“ Ю91∞59557Ь証~~ '0vtzrcs0to0,,47/^Mts/ 'pru 4! il.ojlori-'--'---'-"' l6ii"irr.oz.zors 1総盤1認∬“出d。“ι“詭∽ scfOr m矧5缶∞蕊 f助諾淋、へ′ 饉黒鶴錯 I「 1/83/040/00235/AMi4/ 1o o3 2014 :It was dccidcd tO dcfcrthc case fOr 18 02 2015 for commcnts Of Departmcnt of ¨ 蒻﹈

″η

Case No:57/3/82‐

ALC4/2014 :It was decided to dcferthc case for 18 02 2015 for comments OfDepartmcnt ofC&PC Re-index€d :It was decided to dCferthe casc for 18 02 2015 for commclltS OfDcpartmcnt of Re-indexed 18022015 :It was dcCidcd tO deferthe cぉ e fOr i8 02_2015 for commentS OfI)epartment of Pa●y Name:JUBILANT LIFE SCIENCES LIMITED ALC4/2014 12012015

Case No.:180/6/82-

1即ド躙躙EttP秘 18022015 :It was dCCided to deferthe case for 18 02 2015 for commcntS OfI〕epartment of ――――――――~~― ――~~― ―――一――一――´―― ~~―――~~――――― ― nufacturing Licencc alongwith Pision:It waS decided to ca‖ from the fl‖ ‖cOpy of Drug Ma ofapproved i“ ms),an,cOttOfMasにr BttCh Fonnda duけauthenictted by QuJity COntrol Thc case was defcrrCd fOr 18 02 2015 No/Date:15/82‐ No7Date:15/82- No.:55/10/82- Narne:SATYA No/Datc:15/82‐ File No.:48/15/82- Name:SATYA No Date:15/82‐ ALC4l20l4 LTD 12.01.2015 Filc : It was decided to defer the case ior t8'02'2015 for comments of Department of Name:JUBILANT LIFE КUMAR ¨幅・鸞

f 2 84 ICaξ」 … IALC4/2014 | ド M‐D Party Name:KOPRAN 18022015 : It was decided to defer the case for 18.02.2015 for comments of Department Meet No/Date:15/82- 「“ eN∝“ /5/82■f続∝ 4田柵 oK 1靱ri島 Re-indexed 臨 for 18.02.201 5 for comments of Department ぽ~甲赫翻顆¨ 鱚 "鵬 3掲50/003“ 晨my ttt棚 0畑 "8/AM W 悧開 ° "Ю"ω ttB宥 1&鬱2“ 5 1蹴盤ui』l」 as decded ω detrぬe caseおr18022015おr commenおof Depanmcm : It was decided to defer the case for 18.02.2015 for comments of

Case No.:48/5/82‐

PなりName:KOPRAN ALC4/2014 LIMITED :It was dccidcd to dcfcrthc case for i8 02 2015 for commcnts of Dcpa■mcnt of ILABORATORIES LTD m夕浙 1′nnκn`′ AMlИ ′ ~囁 !ザR?りα 091∞ "“ 2 鵬 3掲5∽"71/Amy「蒻応高薦薦~ Meet No/Date■5/82-

Case No:110/6/82‐

ALC4/2014 :01/82/050/00512/AMl5l :09124/MO/OO6O6/AMt4/ 127032014 18022015 Re-indexed 160′りヽM14/ Re-indexed 18022015 | 168/AM14/ Name:NEULAND No/Date:15/82‐ Re-irdexed : It was decided to defer the case for I 8.02.201 5 for comments of Department of

Export product Exp Qty SI No lm port items Qty. allowed kslks Kg 1 7-Phenylacetamideo-3 - Chloromethyl Cephalosporonic Acid Para Methoxybenzyl Ester (GCLE) 150 2 Triphenyl Phosphine う乙ＯＯ０ 3 Activated Carbon くジハ υ ０ 4 Dimethyl Formamide 280 5 Methylene Chloride 1000 6 Mica Ester 082 ′ ルら ¨ ― : Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/360/2014-Pl(Norms) 22.Of.2OfS and in consultation with technical authority present in meeting, decided to norms under para 4.7 of HBP as per details given below or as applied by firm whichever is rnay take appropriate action as per the decision of Norms Committee. Meet No/Date:15/82- Re-indexed ヘ ALC4/2014 112012015 No.:112/6ノ82‐

Case No.:44/5/82-

師扇蔽面雨 ~Med No/D“ o15/82- No:40/10/82-ALC4/2014 Name:COVALENT NoADate:15782- 1棚児50/KIC195仏my膨鵬 ∽∞御ハm″ | : It was decided to defer the case for 18.02.2015 for comments of Department of

ユ¬ 一 ALC4/2014 1棚児5∽ “ aAmy隔蹴 0畑 “ 7A田″ 圏辮 “ Юη “ " |:I1111::lilil『idCCidCdt° dcfcrthe case for 18 02 2015 for comments ofDcparment of F港躙晦 |が0魃厭引 5/82‐ 1鱚田3鷺Ю加 "ν A剛夕
目悧辮 ¨ "6“ 1器田 "m5 :It was dccided tO deferthe case for 18 02 2015 for commcnts ofI)cpartment of 1棚掲50/0045猾脇乳剛 “ 3ハM14/ 囲辮憫Юη “ %B嶽 8池洲 5 :It was dccided tO defcrthc case for 18 02 2015 for commcnts of Department ofC&Pc ALαρ 釧 4 11」 :TIllh t ‐ 981fI漁1110/82- υ d蘭都高L層ヽ酪性1. No:47/5/82- Name:KOPRAN No/Date:15/82- F];1ここ 15]品1ラテ「0059694 p2042014 No.:52/6/82- Name:UPL LTD No/Date■5/82‐ No:73/5/82‐ Name:ARIHANTANAM No/Datel1 5/82‐ :It was dccidcd tO dcferthe casc fOr 18 02 2015 for cOmments Of Dcpartmcnt of No.:47/10/82- :It was decidcd tO deferthe case for 18 02 2015 for cOmmcnts OfDepaimcnt of

2% | 1器3児5900918AMЫ ttυ O“70AM W "1器疏50肥29ハmy 18022015 囮 Re-indexed 18022015 Re-index€d Re-indexed 18022015 :09′24/040/00671/AM14/ :It was dccided to deferthe case for 18 02 2015 for comments of Dcpartmcnt of :It was dcCided to dcferthe case for 18 02 2015 for comments OfI)epartment of

Case No.:67/5′ 82-ALC4′ 2014 Party Name:FDC LTD

Meet No/Date:15/82- 一 ― ― ‐ ｏ ‐ 打 ― 一　　　　　２一　　　　　〇に ‐ ‐ ― ― ‐ ‐ ― ‐ ＩＬ．．１１１１１，１１１１１１ ALC4/2014 12012015 :It was dccided to dcferthe case for 18 02 2015 for comments Of Department of c"." xo*izlslsz-eLc$Dol 4 lParty Name:GLoBE Meet No7Date:15782‐ | ~蹴辮憫Ю "η% 1器疏5∽038りAMW 賠筋器υ∝ЮυAM″ TROTTERS PVT LTD ALC4/2014 112012015 Party Name:KUDOS :It was decided to dcfcrthc Casc fOr 18 02 2015 for comments ofI)epaltment of FF面高耐jT饗 112012015 Lic No17Date10910059706

Case No:15/10′ 82-

ALC4/2014 P肛りNallnelBIOLOGICAL E LTD Meet No′ Date:15/82- Lic No/Date:0910059705 03042014 瞬鮒に耐 2‐ 鵬出脚 15 1 鵬 | | Mcct No7Datc:15/82‐ : It was decided to defer the casl for I g.02.2015 for comments of Department of CHEMIE LTD, No/Date:15/82‐ Filc

ジとく「

い2m2m5 ~ 血:1/2/82‐ALC4/20141取柵継稔 , Ю5鵬 3掲511/OKX103/Amy l鵬肥 ∽∞∝ハM15/~Fザ鼎 α “ Ⅲ∞ "4臨 :It was dccided tO defcrthe case for 18 02 2015 for comments of Depaltmcnt of No.:63/5/82-ALC4/2014 : It was decided to defer the casc fOr 18 02 2015 for commcnts Of Deparment Of ●:^^1^ No.:24/6/82-ALC4/2014 Par"Name:KUDOS LTD, Re-indexed Name:FDC LTD No/Date:15/82‐ Re-indexed 125/AM14/ 1l o4 2014 No:34/5′ 82‐ ALC4/2014 Name:ALEMBIc No/Datc■5/82‐ File 1/83/040/00008/AM15/ : It was decided tO dcfcr thc casc fOr 18 02 2015 for comments Of Dcpartmcnt :It was decidcd tO defcrthc casc fOr 18 02 2015 for commcnts OfI)epaltmcnt of

109 2θ Meet No/Date:15/82‐ ALC4/2014 12012015

Case No.:21/10/82-

PなりName:BIOLOGICAL E Meet No/Date:15/82‐ ALC4/2014 LTD ALC42014 12012015 Re-indexed 浙 LA30RATORIES LIMITED 閻 :Reply received from the fll11.and SCnt to Department of Pharrnaceuticals for comments The case is defened for 18.02.2015, Re-indexed 180220!5 : It was iecided to defer the case for I g.02.201 5 for comments of Department of 一 Party Name:FDC LTD :09724/040700674/AM14/ : Committec cOnsidercd the casc as pcr agenda and in light Of written commCnts frOm Departmcnt of Phal::laccuticals vide their OM No 350 H/554/2014-PISol‖ IS) 20.01.2015 and in consultation with technical authority present in meeting, decided to norms under pata 4.7 of HBP as per details below or as applied by firm whichever is Cefepime Hydrochloride (Non Sterile)/(6R,7R)-7((Z)-2'(2- Amino-4-Th iazolYl)-2- Methoxyimino) Acetamido)-3 - ( l -(l -MethYlPYrrolidinYl) Methyl).8-oxo-5+hia- I - azabicyclo (4.2.0) oct-2-en-2' Carboxylic Acid HYdrochloride Monohydrate. Cefepime for Injection/ CefePime Hcl Sterile (Buffered with L- Arginine) No:39/8/82_ALC4/2014 Namc:MYLAN No.:69/5/82-ALC4/2014 l kg

多 | ^ 2 L-arginine 037 3 Acetone 1816 4 Methanol l 134 5 Activated carbon 0034 6 Isopropyl Alcohol 1 00 7 Aluminium canisters Relevant, As per packing policy RA concerned may take further necessary action as per above decision of NC. lrecision : It was decided to defer the case for 1g.02.2015 for comments of Department of Pharmaceuticals. :It was decided to defcrthe case fOr 18 02 2015 for comments of Dcpa●ment of

Case No.:49/10/82‐

ALC4/2014 No/Datc:15/82‐ Re-indexed 12012015 醜孵Ю剣∞ "Ю 7隣缶 &∞2m5 :It was decided to deferthe case fOr 18 02 2015 for commcnts Of Deparment Of No.:73/S/82‐ ALC4/2014 Par″ Name:IPCA No/Date:15/82- ILABORATORIES LIMITED Name:MYLAN No/DateJ 5/82‐ TORIES LIMITED :It was dccidcd tO defcrthc case fOr 18 02 2015 for comments of Dcpaiment Of No.:38/10/82-

アル Cas€ No.:77l5/82-ALC4l20l4 Party Name:INDOCO Pharmaceuticals. Meet No/Date:15/82‐ Re-indexed Re-indexed ALC4/2014 12012015 :lt was decided to defcrthc casc for 18 02 2015 for commcnts ofI)cpartmcnt of ヽ/ Re-indexed 嘔鱈蕪認彙蕪烈燃‖鵬絆一澪ＦＩ ) Fit .- f RLA Ftl" J-" )8ZOSOlOOSlOlev t sl i:31/83/040/00015/AM l s/ r0 t \z+.ot ,"iaioo , ln the light of written comments received fron le their oM No. 35011/369/2014-Pl(Norms) dated 22'( rrms under Para 4.7 of HBP v1 as per details given below ot less: No/Date: ! 5/82- ,Staaus: ll2ol4 lAPProved .20t5 l o,oate:l t tor-6lss ibefer- loate: t g.0z.z0t 5 .2014 i n Department of Pharmaceuticals )1.2015, it was decided to ratifu r as applied bY the firm, whichever 119 Export Item S No Import Item For Export ol lNo Vlal 2ml vial 4ml宙al 1 469 gm Amikacin Sulfate lttCCtiOn uSP Amikacin Sulfate 734 459mg う ‘ Serum Stopper Relevant- As D(:r packing policY 3 Flip― off Seals IR tion as perthe decisiOn of Norm s commttee 1211霊漁ilハυ 82- Paty NamelBRUNDAVAN LABORATORIES PRIVATE No/Date:15/82‐ :It was dccided to deferthe casc fOr 18 02 2015 for commcnts of Department of No.:5375/82-ALC4/2014 Namc:UNIMAX B N∝θ 5慇2 ALC4たm4儒獣響IR No′Date:15/82‐

3｀ I LTD" ~ 112012015 1 MSdeCidedtodcfcrthecascfOr‖ ゝ022015 forcomments of Depmnent Of 「 1濶 m‐ W AM 15/~ 1蹴l&∞2m5 r18.02.2015 for comments ofI)epamentOf 鯰 3鵬 3月5∽ "∞鳳「 Ⅶ面蕊扇Ю I翻鼎α“Юη %∝臣蔦扁 )n:It was decidcd tO rcmind the■mntO fumish a copy of DML(Drug Manufacturing )Thc case was defcrrcd fOr 18 02 2015 Deffered Re-indexed ion : Committee considered the case as per agenda and in light of r ed from Department of Pharmaceuticals vide their OM No. 35011/401 22.01.2015 and in consultation with technical authority present in me( norms under para 4.7 of HBp as per details below or as applied by I ,vritten comme )/2014-PI(Nom :ting, decided ]rm whichever Export product 賄 ” SI No Import items Q" A‖owcd kυkg Aliskiren Hemifumarate l kg l Tert-Butyl( 1 S,3 S)- I -(2S,4S)-4- isopropyl-5 -oxotetrahydro furan-2- yl)-3-(4-methoxy-3-(3-methoxy propoxy)benzyl)-4-methyl penrylcarbamate (AKl l) 1.526 う ι 3-amino-2.2-dimcthyl prOpOnamide 061 RA concerned may take further action as per above decision of NC. 「墜主ンロm4[闊蒻,顧鮮… 田3鷺 "Ю"%/AM W~膨棚 ∽∞κ/AMЫ I蹴辮 Ю引 "“ %3 No■64/5/82-ALC4/2014隔NameSURVIVAL~陣 ea No/DateJ 5慇2‐ 悔mtu"DefFered 血赫赫「辮晰躙滉D No/Date;15/82‐

TECHNOLOGIES PVT LTD 3Ч Pa●y Name:VIVIMED LABS LIMITED ALC42014 12012015 眺顆 /m"Amy No.:46/10/82- 14 Re-indexed Re-iDdexed 18022015 Re-indexed ALC42014 12012015 Lic No/Date10910059887 つ7隔応蕊蕊 ly:蜃 ∽∞ "晨 Ⅲy ぱ群器 αのWの力"1麒L802期5 -一 ― ― ― ― ― ― ― ― ― ― ― ― ― ~ ; It ; d;id"d t" d"f.t tf," t" f l8'02'2015 for comments of Department of , IN" d."i;6d"f.. th" ;f ia'oz'zo t s for comments of Department of Mcct No/Date:15/82‐ '9爾薦蕊勇i'1夕_鵬ち鵬 υO∞りAmy l翻ち∬ W力… ∞′ 隣よ1&悦2∝5 -― ,Itfi;id;;;-fth"""f 18'02'2015 for comments of Department of :01/82/050/00707/AM15/ : Committee considered the case as per agenda and in:ight Of written comments from Department of PharmaceutiCals vide their OM No 350■1/360/2014-Pl(Norms) 22 01 2015 and in COnsultation with techniCal authority present in meeting′ decided to norms under para 4 7 of HBP as per detallS given beloW Or as applied by firm whiCheveris

Case No:41/10/82‐

ALC4/2014 Paty NameiVIVIMED LABS LIMITED

Case No.:51/10′ 82-

Pa,y Name:VIVIMED LABS ALC4ノ2014 LIMITED 12012015 No/Datel1 5/82‐ No′Date:15′ 82‐ Re-inde\ed No.:43/8′82-ALC4′ 2014 Name:COVALENT TORIES PRIVATE :It was dccidcd tO defcrthc Casc fOr 18 02 2015 for comments Of Departmcnt of

一　 ‐ ３ ‐ 35 Export product Exp Qty SI No lmport items Qty allowed kg/kg Cefixime Kg 1 7-Phenylacetamideo-3 - Chloromethyl Cephalosporonic Acid Para Methoxybenzyl Ester (GCLE) 150 2 Triphenyl Phosphine 082 3 Activated Carbon 005 4 Dimethyl Formamide 280 5 Methylene Chloride 1000 6 Mica Ester 082 may take appropriate action as per the decision of Norms Committee, :It was decidcd tO dcferthc case for 18 02 2015 for comments of Dcpartmcnt of Norms Committee. 日囮而=~1鵠柵翌 D∝

鵬 ∬ 詢2岡蹴脚 | | ~~
「獅昴丁 F"u_Ш uじλW 田脇5∽ "9は Ⅲ夕陽蹴 OЮ鰤9/AM W囲辮以 ∞И “ 91器 8"洲 5 Decision:ln the light Of written comments received from Department Of Pharmaceuticais vide their OM No 35011/214/2014‐ PINorms)dated 20 01 2015,l was decided tO ratify norms under Para 4 7 of HBP vl as per deta‖ s given below or as applied by the firm,whicheveris less: !tem of ExpOrt Qty S,No Item of lmport Quantity allowed 2-Mercapto-i(1-Pyrrolyl) Benzimidazole KG 1 2,5-DimethOxy Tetrahydrofllran 1 88 kνkg may take appropriate action as per the decision of プ

Case No.:75/8/82‐ ALC4/2014

1器V… 12012015 HQ File :01/82/050/00739/AM15/ RLA File t09 124 I 0/Ol0003 4 I AM I 5 / Lic No/Date:0910o59927 29042014 IDefer Date: / No:77/10/82- Name:NECTAR No′Date:15/82-

36 :It、vas dccidcd to dcferthc Casc fOr 18 02 2015 for commcnts of Dcpartrncnt of

case No.:20/10/82-

ALC4/2014 Party Name:INCHEM Meet No/Date:15782‐ LAIIORATORTES PRIVATE lALC4/20I4 135 lHq rite :01/82/050/00934/AM15/ :09/24/040/00044′ AM15/ ALiIANCEDYE-CHEM ALC4I2OI4 Mcct No/Datc:15/82‐ Meet No/Datei15/82‐ ALC42014 12012015 File Lic No/Date:0510385706 ―――――――――――――――――― ― 10mments ofI)eparmCnt of :It was decided to deferthe case for 18 02 2015 for c Party Name:NEW Meet No/Datcl1 5/82- Lic No/Date:0910059969 01052014 Re-indexed Re-indexed Re-indexed Deffered Re-indexed 雪覇錨悔|か需i調:鵠しdd ALC4/2014 12012015 ,6iiir;soroossrieMrsr :oe24tBot0o02otAMt5t ffi f;t-02.2015 for comments of Department of Meet No′Date:15/82‐ F渕~膠呂y PHARMACEUTICALS \ALC4/20I4

case No:375/82-ALC4/2014

Case No.:43/10′ 82-

ALC4/2014 12012015 cnse No.:9/5/82-ALC4/2014 Party Name:DHANUKA LABORATORIES LTD :0523ノ040/00041/AM15/ 101/82/050/00326/AM15/ 05052014 堀部隠黒粥詢 No.:61/10/82- Filc :It was dCCidcd tO deferthc Casc fOr 18 02 2015 for comments of Departmcnt of [[::::,1::::::::::l:1:][::1:11:場:ち下 1!|!::II:I[!l:[:憫 Filc TD, Name:SRINI Filc ―――――――――― ―――――一― ~~~― ――――― )。mments ofI)epartment of :It was decided to deferthe case for 18 02 2015 forc

⌒ 37 I F o■ o,2∝4 12012015 PVT LTD, NoDate■5/82‐ TORIES LTD 18022015 Re-indexed 18022015 Re-indexed :It was dccided to deferthe case for 18 02 2015 for comments ofDep― ent of No.:54/5/82-ALC4/2014 Ptt Name:NEW No/Datc:15/82‐ ALLIANCE DYE‐ CHEM 14 1臨蕊i戸脇 No.:12/5/82-ALC4/2014

多g

Case No.:57′ y82‐ALC4/2014 Patt Name:NEW

PHARMA ALLIANCE DYE― CHEM IALC4/2014 PVT LTD, :Ol/82IO5O/OO374tAMl5l i:03/95/040i00085/AMl5/ Partv Name:ELIXIR Mcct No/Datc:15/82- Meet No/Date:15/82‐ ALC42014 12012015 Re-indexed Re-indexed Re-indexed 1
冊磁2 : It was dccided to defcr the casc for 18 02 2015 for commcnts of Departinent of

Case No.: t 5/5/82-4LC4lzOl4 Party Name:PARABOLIC

Meet No/Date:15/82‐ DRUGS LTD, ALC472014 Re-indexed 12012015 :05724/040/00036/AM15/ 認辮ЮЯ 03861%躊 l&022∝5 Lic No/Date:0310780627 No.:35/5/82-ALC4/2014 : It was decided to defer the case for 18.02.201 5 for comments of Department of 摯平L・

: ltwas decided to defer the case for 18.02.2015 for comments of Department of IBOLIC I濶 m‐ W 蔦Ⅷ洒面臨蕊 r18 02 2015 forcomments of Depament Of 脚等羅訊糀点1温点“中胤蕊謀鵬 1・ udJoq Bna"va'r' ; No/Date:15/82‐ No.:18ん/82‐ALC4/2014 Name:RECKITT No/Date:15/82‐ THCARE INDIA 12 01 2015 M8F33児 5∽ ""AⅢ y厩蹴 OЮ∞2ハⅢy l認辮 6Ю ・ 6"3 :It was decided to deferthe casc fOr 18 02 2015 for commcnts of Dcpartment of :It was dccided tO defcrthc case for 18 02 2015 for commcnts OfI)cparlment of :it was dccided tO dcferthc casc fOr 18 02 2015 for comments Of Dcpartinent Of

イθ ン :01/82/050/00931/AM15/ 109/247040/00054/AM15/ Meet No′つatc■5/82‐ ALC4/2014 12012015 Re-indexed

Case No.:52/10/82-

ALC4/2014 凝〆・ E0 File trA Fll. [-ic.t to/oate:0910060o32 ]Defer Date: l:01/82/050/00951/AM 15/ :09l24lM0t00062tAMl5t 109.05.2014 I lD""iaioo .-Th" co.nrittee consi<i..ed ttt" ".r" ^ p". "g"@"no lreceived from Department of Pharmaceuticals vide their OM No. 3501 l/341/2014-PI(Norms) ldated 28.11.2014 and in consultation with technical authority present in meeting, decided to lratifo norms under para 4.7 of HBP as per details below or as applied by firm whichever is Export product Export Qty SI No Import items Qty a‖owcd kg/kg (2S,3S)1,2-cpoxy‐ 3‐ (butOF/CarbOnyl)aminO-4- phcnylbutanc[(S,S)― BOC Epoxide] l kg l (3 S)-3 -(tert-Butoxycarbonyl) amino- I -chloro-4-phenyl-2 - butanone (Chloroketone) 160 may take appropriate action as per the decision of Norms Committee.

Case No.:5/10/82-ALC4n0l4 Party Name:MYLAN

LABORATORIES LIMITED ALC4/2014 12012015 lon:in the light of written comments received from Department of Pharmaceuticals vide OM No 35011/553ノ2014-P(Norms)dated 20 01 2015,■ was decided to ratify norms

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

Piperacillin & Tazobactam 8:1 For Injection No.:17/10′ 82- Name:HETERO LABS IMectNo/Datc:15/82-

″ く 3 Activated carbon 00090 4 Aluminium Canisters Relevant, As per Packing Policy A may take appropriate action as per the decision of Norms Committee. 「[萱翌:J2[篤柵蝠:D勝鱚市 :It was dccided tO defcrthe case for 18 02 2015 for comments of Depaiment Of 18022015 :It was dccided tO dcfcrthe case for 18 02 2015 for commcnts Of Departmcnt of | ~W 日]孫赫 and Re‐ indexed l

Case No.:59/10/82-

‐ALC4/2014 ICase No.:14/10/82- ALC4/2014 “9鵬疏50/m23/AMⅣ I猟棚l1/KxXl"ムmy l冨辮劇Ю “"%暦薦戸 the ‖ght Of written comments received frOm Department of Pharmaceuticals I their OM No 35011/369/2014-PI(Norms)dated 22 01 2015′ たwas decided tO ratify No.:3/10/82-ALC4/2014 Name:GLAND No/Date:15/82‐ LIMITED No.:44/10/82- NamelMYLAN No′つate:15/82‐ Re-indexed Re-indexed :lt was decidcd tO deferthe case for 18 02 2015 for commcnts Of Departincnt of Namc:EMCURE No/Date:15/82- LTD 12012015

Цン under Para 4.7 of HBP v1 as per details Siven below or as applied by the firm' whichever RA@the decision of Norms committee. Export Item S No Import Item For Export of lNo. vial. 2ml vial 4ml宙al 1 469 gm Amikacin Sulfate lttCCtiOn uSP 1 Anlikacin Sulfate 734 459mg う ‘ Serum Stopper Relevant, As per Packing PolicY ，Ｄ Flip-off Seals 一 ―

Case No.:39/10′ 82‐

ALC4/2014 Re-indexed 18022015

mmcntS OfI)epartmcnt of
:It was dCCidcd to dcferthe casc fOr 18 02 2015 for c
Pa″ Name:PREGNA
INTERNAT10NAL LTD
INTRA UTERINE
CONTRACEPTiVE
DEVICE― CU 200 AG
SOLID ROD MADE OF
POLYPROPYLENE CRANULES
Re-indexed
@edecision 
of Norms committee'
Name:MYLAN
TORIES LIMITED
No.:10176/82-ALC4ノ2014
No/Date:15/82‐
5
19052014
lptte
I t ,tt" r,gfn "i ;*r"" ."r.*rt lleived from Petrochemical Division of oepartment of
and Petrochemicals vide their v o io' a6OtLl22l2oO8-PC- ll dated 10'12'2014' it ii:-l"^*l
emにas ano rcuυ ur‖に
0。・‐‐・
:.tittI::lei:iξξ
vei bdowora s app‖ ed by the firm,Whichever is
rajfy no「ms under Para 4 7 of HB`
l no
No.:120/8/82-

1蠣
el・l
Ч3
鵬3月5∽
"“晨MI「隔蕊蕊薦y面面戸Ю割
・離蕊蕊
No.:9/10/82-ALC4/2014
Namc:EMCURE
Filc
1/83/040/00032/AM15/
No:35/10/82‐
Name:MYLAN
No/Date:15/82-
Re-indexed
Re-indexed
Re-indexed
5
5/
:It was decidcd tO dcferthc case for i8 02 2015 for cOmments of Departmcnt of
`V■
●●
`:ヽU7υ
`
LTD ALC4/2014
112012015
: It was decided to defer the case for 18.02.2015 for comments of Department
:It、vas dccided tO dcfcrthe case for 18 02 2015 for commcnts of Depanrnent Of

uЦ
Pharmaceuticals.
Meet No/Datcl1 5/82‐
ALC42014
12012015
UU,JO′ AIVI I′ ′     
・Vン
“
マ′―
V′ Vυ Oノ0ハ■●●●´′     1‐ ´・‐´ ~‐ ●             |~~‐

:It was decided to deferthe casc for 18 02 2015 for commcnts of DepaJけnent of Party Name:GLAND Meet No/Date:15782- PHARMA LIMITED ALC4/2014 !2012015 Meet No/Datc■ 5/82‐ 耐| 1閻め狙 ALC4ノ2014 12012015 | Meet No/Datel1 5/82‐ Pa,y Name:ALMELO PVT

Case No:16′ 8/82-ALC4/2014

Case No:114/8′ 82-

Party Name:INDOCO ALC4/2014 REヽ〔EDIES LIMITED Decision : lt was decided to defer the case for I 8.02.2015 for comments of NυDate:15/82‐ Re-itrdexed Re-indexed MAmy :It was dcCided to defcrthe casc for 18 02 2015 for commcnts of Deparmcnt Of : It was decided to defer the case for I 8.02.2015 for comments of Department of Re-indexed

Ч5 4 r7鵬島児50Ю “ 98/Amy 膨鵬 OЮm"ハmy l器鼎 e091∞ω 郎7B府 1&∞2m5 Party Name:SYMBIOTEC Meet Nυ Date:15/82‐ PHARMALAB LTD, ALC4/2014 12012015 174 HQ F‖ e :01/82/050/00985/AM15/ 鷺ち馬器∽∞醐Am夕伊謳 1“ a∞ “ 2o躊ほは矧 5 : It was decided to defer the case for I 8.02.201 5 for comments of Depadment of CHEMICALS PRIVATE IALC4′2014 Partv Name:MY[,AN Meet No/Date:15/82‐ LA30RATORIES LIMITED ALC4/2014 12012015 No:29/10/82- LABORATORIES PRIVATE IALC4ノ2014

Case No.:38/8/82-ALC4/2014 Par"Namc:MYLAN

Meet No/Date:15/82‐ LABORATORIES LIMITED IALC42014 12012015 口8鵬 3鷺5∽ "鬱ハm夕彫鵬じo∝∝AM w

Case No.:71/10/82‐

ALC4/2014

Case No:145/6/82-

ALC4/2014

Case No:34/8/82-ALC4/2014

,3鵬児 5∽ "お蕊戸岡脇蕊蕊戸囲需画面 No.:H5/8/82‐ Re-indexed Name:INDOCO IMeet No/Date:15/82‐

々ε No.:51/8/82‐ ALC4/20:4 Pa●y Name:PVS Meet No/Datc■5/82‐ LABORATORIES LTD ALC4/2014 12012015 Re-indexed 18022015 3 It was decided to defer the case for I 8.02.2015 for comments of Department of tr." Nil0t/s/82- lFu.ty ltuln"rNculti.'---Mt firD;t"15/E] istat,rs: App-*d \LCANOI4 ETHICALS PVT LTD ALC4I2OI4 I I ie.ot.zots l {a Fit. lRtA Fit" -t-i"torout.'oj t o't tia: [oefer oate: Ot18-21050100765/AMl5l i:01/94iM0l00154/AMl5/ 5 . 29'05'2014 .l .. . - -

Decision : In the light of written comments received from Department of Pharmaceuticals vide their f,M No. 35011/541/2014-PI(Norms) dated 20.01.2015, it was decided to rati! the norms under Para {.7 ofHBP vl as per details given below or as applied by the firm, whichever is less: [Al For Export of Clotrimazote 17o Vasinal Cream 35em. 2yo Vaginal Cream 20ems 180 S No Import Item For Export of 1 No. Clotrimazole Vaginal Cream. 1%,35 gm 20/0,20脚 l0%,5gm 1 Clotrimazole 0.357 gn 0.408gm 0.51gm つ４ Octyldodecanol 4.725 gm 2.70 gm NIL ● Ｊ Cetvl Palmated 1.05 gm 0 60 gm 0.15 gm 4 Cetostearvl Alcohol 3503m 20gm 0 175 gm 5 Isopropyl Myristate NIL NIL 0675即 6 Empty Aluminium collapsible Tube Relevant, As per packing policy 7 Plastic Applicator S No Import Item For Exportofl No.Clodmazole l%Crealn,100gm Tube Clotrimazole 1.02 gm うん Octyldodecanol 13.50 gm つＪ Cetyl Palmated 3.0 gm . 4 Cetostearyl Alcohol 10 0 gm ′ 5 Empty Aluminium collapsible Tube Relevant, As per packing policy Note:- For different packsize, nonns can be worked out on pro-rata basis. [C] For Export of Clortimazole 17o Cream 10gm Tube with Fluconazole Capsule ..* -%M ″ ″ ●●V。・ r9鵬島鬼mЮm5/AMЫ 膨棚 OЮ∞″ AM″ 1蹴辮 Ю "∞ ω%7

Ч7 S No Import Item For Export of I No. Clotrimazol e l%o Cream, l0 gm Tube. Clotrimazole 0.102 gm/tube う ‘ Octyldodecanol I .3 5 gm/tube つＤ Cetyl Palmated 0.30 gr/tube 4 Cetostearyl Alcohol l 00 gmltube ξ υ Empty Aluminium collapsible Tube Relevant, As per packing policy RA may take appropriate action as per the decision of Norms Committee.

Case No.:100/8/82-

ALC4/2014 PttNmdPCA蔦薦 ~殴獅面西 LABORATORIES LIMITEl Lic No/Date:0310783592 J:01182/osOtOOT64lAMtst :03/94tMO/OOt2g/AMt5t 29.Os.2Ot4 Decision:It was decided tO dcferthe casc fOr 18 02 2015 for cOmments ofDepartmcnt of Pharmaceuticals. 埓 2目霊頭麗扇話再π :「」 ~~障携肥∽ mB晨話戸 1露¶ 31TЮ釧∞“ 22 Pharmaceuticals. ― 闊1棚児50/009“ 晨m夕膨鵬∽∞97/AMЫ F繭需繭而臣罵]扁 112012015 ■3鵬島鬼 "Ю"“ 晨m夕厖肥 oЮ∞柳Am夕 1器孵 ЮЯ∞ω "8B為 &鬱2∝5

Case No.:87/8/82-

ALC4/2014 : It was decided to defer the case for 18.02.2015 for comments ofDepartment of ~~[恵恐億高耐毬 RK IHQFile 悶 … No.:30/10/82- Name:EYTAN LABS No Datc:15/82‐ No.:37l8/82-ALC4l20l4PartyName:MSN MeetNo/Date:15/82- PRIVATE IALC4/2014 and Re― indexed

Case No.:68/6/E2-ALC4l20l4 Party Name:SUN

( .N tlrrsotoffi 5t t ^Mt st- [ir,r4to4u(rits6l l;rrt 5/ Fl,oo:ot+ |fi", t 8Jrr0t5 Re-indexed Re-indexed Re-indexed PHARMACEUTICAL NDUSTRIES LTD, : Itwas decided to defer the case for 18.02.2015 for comments of Department of No.:47/8/82‐ ALC4/2014 Party Name:HETERO LABS Meet No Date:15/82- LIMITED ALC42014 12012015 RLA File llic.No,Date:091006038 t :O9l24lH0l00l22lAMIS/ 05.06.2014 No.:49/8/82-ALC4/2014 Party Name:HETERO LABS Meet No/Date:15/82‐ LIMITED ALC4/2014 120!2015 Lic No/Date:0910060380 05062014 :It was decided to deferthe case for 18 02 2015 for comments of Department of Meet NolDate:15/82- ALC4/2014 12012015 :It was dccided to defer the case for 18 02.2015 for comments OfI)cpanlncnt Of Meet No′Date:15/82‐

Case No.:15/8/E2-ALC4DOIA Party Name:ALMELO PVT

File

レ4 191 器疏 "Юm8ハmy 彫糀 OЮ昭ハmy ttme似∞ 6m3 Lic No/Datc:0310785223 18022015 Re-indexed 5]lu"Deffertd landR← indexed 18022015 193 1HQ File :01/82Ю50/00770/AM15/ Ю3/94040/00131/AM15/ 112062014 Pharmaceuticals.

Case No:10578/82‐

ALC4/2014 ~匿画面而面戸~~P詢ド型宅IP匹9 REMEDIES LIMITED IALC4/2014 ■nd「ヒ■indexed 「続m4
ド ME〕昴HMTED I器鰐

「祠Mmα “ 12012015 : lt was decided to defer the case for I 8.02.201 5 for comments of Department of 開厩脇罵而 ~1需脇面蕊¬悦辮憫Ю Tη穏鴨矧 5 珈響1千ヘ No.:106/8/82- NametBAYER No/Date:15/82‐ No.:54/8/82-ALC4/2014 Pary Namc:GLAND Meet No/Datc:15/82‐ No/Date:15/82‐ Name:AUROBINDO

5。ハ R評淵長「期胤::規1堀1酬3朧:甲ぶl跡智橿龍柵殿蹴滞 norllnsunderPara47ofHBPvl asperdetailsgivcnbeloworasappliedbythefllll,whichcvcr is lcss: S No Import Item Qty. allowed kg/kg. 1. 7-aminocephalosporanic acid (7 A C A) 0769 う ‘ chlorosulphonyl isocynate 04754 3 (z)-2-methoxy imino(furyl-2-yl) acetic acid ammonium salt (smia) 06152 4 acetone 1611 ξ リ methylene chloride 3369 6 activated carbon 0093 7 n,n-dimethyl acetamide 402 8 potassium carbonate 0043 9 cyclohexane 1733 10 methanol 278 RA concerned may take further necessary action as per above decision of NC. ― F り6岡 Ptt Nallle:BIO‐ TECH IM( Case No■60/10/82- Paり Nallle:BIO‐ TECH IMeet N″ Date:15/82‐ I・硫~ P語贔縞昴h瞬鶯仏 Ⅲ 夕 | :It was dccided tO dcferthc case for i8 02 2015 for commcnts of Dcpattment of :ItwasdecidcdtOdcfcrthecascfor18022015forcommcntsOfI)epartinent of 百 Pa″ NamelMOREPEN Meet No/Date:15/82‐ LABORATORIES LTD, ALC4/2014 12012015 RLA File :05/24/040/00132/AM15/ :01/82/050/00974/AM15/

Case No.:149/6/82-

ALC4/2014 Pa●y Name:INDO PHYTO CHEMICALS PVT LTD ALC4/2014 12012015 Lic No/Date:0510388673 13062014 1漑蕊扁中品

1蹴I:lil:‖『:decidCd t° deferthe casc fOr 18 02 2015 for comments of Dcpartment of ' 1 1・～ ‐・ ¨ ‐・ ´ | 1鵬児 5∽%%晨my膨臆∽側 "晨Ⅲy F璃繭繭蹴蕊蔦 :It was decided tO defcrthe casc fOr 18 02 2015 for commcnts of Depa●ment of Decision:It was decidcd tO call from the n‖ :I copy of Ccrtincatc of Analysis The case is defcll,d fOr 18 02 2015 ::It was dccided tO defcrthe casc fOr 18 02 2015 for commcnts Of Departrnent of 堰窺鷲灘報｀ f 齋覇鎖当諦 5, No.:30/8/82‐ ALC4/2014 Name:INDIAN No/Date:15/82- LTD, 1棚鷺 "Ю"。AⅢy Name:HETERO LABS No/Date:15/82- Re-indexed No:160/6/82- No/Date:15/82- ＤＭ」ＴＡＬＣＨＥ ‐ ＯＮＡＬＮａｍｅ ‥ 岬 Re-indered File Lic No/Date:0310785501 : It was decided to defer the case for 18.02.2015 for comments ofDepartment of No.:20/8/82-ALC420l4 lParty Name:SRINI il4eer NolOate: I SISZ- 15/ 卜097724/040/00139/AM15/ 117062014 Dなo18022015 No:19/8/82-ALC4/2014 File 12012015 Re-indexed

ダγ

Case No.:73/8/82-ALC4/2014 Pa"Narne:METROCHEM

Meet No/Date:15/82- APIPVT LTD ALC4/2014 12012015

Case No:68/10/82‐

No/Date:15′ 82- ALC4/2014 ハ一Ｆ 12012015 Meet No Date:15/82- ALC4/2014 12012015 Lic No/1)ate:0410158822 Re-indexed Defrered Re-indexed Re-indexed Re-indexed 12012015 ::It was decided to defcrthc casc for 18 02 2015 for commcnts of Departmcnt of

Case No:230/6/82-

PaけNameiSYMB10TEC Deffered ALC4/2014 PHARMALAB LTD, Re-indexed ::ItwasdecidedtodeferthccascfOr18022015forcommentsOfI)epartment of

case No.:111/8/82‐

Party Name:THINQ Meet No/Date:15/82‐ ALC4ノ2014 PHARMA―CRO LIMITED ALC4/2014 Re-indexed 12012015

Case No.:107/8/82-

ALC4/2014 iarw Name:l-UpN LIMITED Meet No/Date: l5/82- ' ltLc4tzot4 : : It was decided to defer the case for 18.02.2015 for comments of Department of 鵬脱5∽ ""ハ my l競脱υ剛触 M耐 1蹴器 1
躙辮倒∞ωЯ5囲8回5 Uυ ′,′ ′AIVII′ ′
「Uフ尾 "′ ~V′ VV■υ l'^`'■'´ 1 1● ´ ‐‐ ~マ・ l~ ~~~ ::It was decided to defcrthe case for 18 02 2015 for comments ofI)cpartment of LABORATORIES Meet No/Date:15/82-

case No.:170/6/82-

HEALTH CARE PVT LTD, ALC4/2014 :04/24/040/00032/AM15/ 24062014 18022015 Name:LEBEN LTD, 2015 :01/82/050/00632/AM15/ :01/82/050/00775/AM15/ ::It was decided to dcferthe case for 18 02 2015 for commcntS Of Department of ::It was dccidcd to deferthe case for 18 02 2015 for commcnts of DcpartFnent Of

5メ Decision:It was decidcd to dcfcrthc casc for 18 02 2015 for comments of De「耐ment Of Pharmaceuticals. PHARMACEUTICALS LTD No.:231/6/82‐ 14 :01t8210s0t00633/AMt5t ):34t24t040/00055tAMt5/ :it was decided tO defcrthe casc fOr 18 02 2015 for comments ofI)epartment of :It was decided tO deferthe casc fOr 18 02 2015 for commcnts Of Department Of Mcct No/Date:15/82‐ 1蹴l&022∝5 ALC4/2014 112012015 Re-indexed Re-indexed :It was decidcd tO dcferthe casc fOr 18 02 2015 for commcnts ofI)epaltment of :It was dccidcd tO dcferthc casc fOr 18 02 2015 for commcnts ofI)cpartmcnt of aこ蘭 32/8/82■LC犠∝ 41蔦囮下 File No/Date:15/82- F‖e No:87/6/82-ALC4/2014 Namc:DIVIS Re-indexed Re-indexed 腋 Te15/82 No.:89/6/82‐ ALC4/2014 Namc:DIVIS No/Date:15/82- 1躙児5∽ “ 釧晨m夕「 M蕊蕊 ¨いC4/2014骨椰臨匿『嗜1澁|

`Ч (Petrochemical Div).

Case No.:63/10′ 82-

Paty Name:SAVVY CARE&IMect No Date:15/82- ALC4/2014 COSMETICS PVT LTD IALC4/2014 112012015 Re-indexed Pharmaceuticals.

Case No.:219/6/82‐

Meet NげDate■5/82- ALC4/2014 ALC4/2014 Re-indexed 12012015 3 It was decided to defer the case for 18.02.2015 for comments of Department of Pa“y Namc:HJ AROCHEM PVT LTD, 2り 1器3児5υO“O1/AMl夕 18022015 No.:202/6/82- :4 Re-indexed : It was decided to defer the case for 18 02 2015 for commcnts of Deparment of (Petrochemical Div).

Case No.:6218/82-ALC4l2Ol4 lParty Name:ADCOCK

Re-indexed lNGRAM LTD, :It、vas dccided to dcferthe casc for 18 02 2015 for comments of Depa“ mcnt of Party Name:DMS Meet No Date:15/82‐ PHARMACEUTICALS ALC4/2014 PRIVATE LIMITED 12012015 F■c Lic No Date10910060578 一 ― Ｆ ‐ ２２２ ‐

Case No:199/6/82‐

Meet No/Date■5/82‐ ALC4/2014 Mcct No/Date:15/82-

Case No.:29/8/82‐ ALC4/2014

:09/24/040/00181/AM15/ 1/82/050/00693/AM15/ 04072014 Re-index€d 062014 File l5l l:O3D5l040l0022llAMls/ 27.06.2014 Name:FORACE No/Date:15/82‐ YMERS(P)LTD

ダ∫ ⌒ ＦＬＦＩ 1
脇 Mect No/Datc:15/82- ALC4/2014 12012015 Re-indexed Re-indexed 18022015 Re-indexed 18022015 Re-indexed : lt was decided to defer the case for I 8.02.2015 for comments of Department of HQ File RLA Filc :Ol′ 82/050/00978晨M15/ Lo3/95/040/00303/AM15/ : It was decided to defer the case for 18.02.2015 for comments ofDepartment of P″ッName:UNICHEM IMeet No/Datel1 5/82- :It was decidcd tO dcfcrthc casc fOr 18 02 2015 for commcnts ofI)cpartincnt of 鱚 12012015 浙 | 鵬星児5K1/OID唸/AM Ы ]協肥卿 И3ムm夕 1脚鼎 α酬 ∞ “ “ 9 : It was decided to defer the case for 18.02.2015 for comments ofDepartment of It was decided to defer the case for I 8.02.201 5 for comments of Department of

Case No:18/8/82-ALC4/2014

Party Name:RA CHEM PHARMA LIMITED P征りName:SATYAJIT CHEMICALS PVT LTD, Lic No/Datc:0310786462 07072014 Casc No:218/6/82- ALC4/2014

Case No.:28/10/82-

ALC4/2014

Case No.:84/8/82-ALC4/2014

18022015 No.:83/8/82-ALC4/2014 吻 ~ [1liiillllili『こ 1長要 I[:[罵31長75Fl属『こ :ξξ 73「TI]テFうo15 for comments ofDepartment of Re-indexed Name:NAPROD LIFE PVT LTD No/Date:15/82‐

メル No.:62/10/82- Party Name:STERLING Meet No/Date:15/82‐ 14 AUXILIARIES PVT LTD ALC4ノ2014 12012015 : lt was decided to defer the case for I 8.02.201 5 for comments of Department of Re-indexed Re-indexed 1
厩 :It was dccidcd tO dcferthc case for 18 02 2015 for commcnts of Depaltrnent of

Case No.:194/6/82-

Meet No Date:15/82- ALC4/2014 ALC4/2014 12012015 Lic No′ Date:051038965

Case No.:44/15/82-

ALC4/2014 ;No.:3?t0l8r-AtC420H FartvNa."SIJROBIIiDO FtN"D"I"'I5/S'?- ISt't"t lnHmur LlMlrED tALc4D0-14 lAPProvcd, r ll2'ol 2ols ) FiL __- ptcN"ID"tto'g t 0060655 Ptftt D"t" )gzosoloogloleu t sl l:09D4t040t00182tAMl5/ 1 1 1.07.2014 L raiiry no, ,naer-para 4.7 of HBp vl as per details given below or as applied by the frm, whichever is less: Export Product Quantity SI No Import items Quantity allowed k&/ks Meropenem for l■eCtiOn l kg | MeroDenem Trihydrate (Non-sterile) つ４ハＵ 2 Acetone MethanOl 201 4 ActiYated Carbon 0065 concerned may taFe furttrer necessary action as per above decision of Nc. Party Name:MOREPEN LA30RATORIES LTD, :01/82/050/00596/AM15/ 4 F‖e 2014 No/Date:15/82-

ダつ ^ sion : In the light of written comments received from Department of pharmaceuticals vide OM No. 3501 l/3 89/2014-PI(Norms) dated 20.01 .2015, it was decided to ratifo the norms r Para 4.7 of HBP v I as per details given below or as applied by the firm, whichever is less S No Import Item Qty. Recommended kdke. 1 (S)-(E)-2-t2-t3-(7-chloro-2-quinolinyl)-ethenylphenyll- 3 -hydroxypropyll -phenyll -2-propanol 1.24 _ 2 Mcthanol 2325 3 N,N-Diisopropylethylamine 030 4 Tetrahydrofuran 315 ξ υ Acetonitrile 295 6 2-[ -(Mercaptomethyl)Cyclopropyt] Acetic Acid 040 concerned may take further action as per above decision of NC.

Case No.:36/8/82-ALC4/2014 P征″Namc:RA CHEM

PHARMA LIMITED 1造:1輝摯。 15お2-~唐 12012015 ICaseNo.:27/8/82‐ ALC4/2014 1器3鷺50Ю0691AMl夕 ~鵬角棚0側 “ 晨Ⅲ夕 1悧辮側∝ “"6「面 PなりName:SHILPA MEDICARE LTD, 1徴『1盤F 1235 | | Decision : committee .o*id"r"d case as per agenda and in light of earrier decision taken in lll82 meeting held on 26.11.2014 and in consultation with technical authority present in meeting' decided to ratifi norms under para 4.7 ofHBp as per details below or as apptied by firm whichever is lower:- Export product 恥 ” Si No Import items aty. allowed AmbroxO:HcL ∬ l kg l Liquid Brominc 1 32 kg ´ う ‘ Trans Para Amino Cyclohexanol 0 80 kg ´ Sodium Borohydride 0 583 kg ´ 4 Tetra Hydrofllran 2 15 kg 5 Methanol 2 58 kg ´ 6 Mcthylcnc Dichio」dc 3 225 kg uご声・Ohawan. Re-index€d :It was decidcd tO dcferthc casc fOr 18 02 2015 for commcnts OfDeparment Of

concemed may take further necessary action as per above decision ofNC.

Case No.:200/6/82-

Party Name:PANACEA BIOTEC LTD, ちらドMED ALC4/2014

Case No.:214/6/82‐

ALC4/2014

Case No.:103′ 8′82-

ALC4/2014 Party Name:CLOBAL Meet No Date:15/82‐ Re-indexed Re-indexed 18022015 Re-indexed 18022015 Date: 18022015 No:70/8782-ALC4/2014 Pary NamciSHANPAR ヽ4eet No/Date:15/82‐ CALCIUM PRIVATE ALC4/2014 LIMITED, 12012015 ALC4/2014 12012015 INDUSTRIES PVT LTD ALC4/2014 12012015 :It was dccidcd tO dcfcrthc case for 18 02 2015 for commcnts Of Departrnent of Meet NolDate:15/82‐ :It was dccided to defcrthe case for 18 02 2015 for comments of Dcpaltrncnt of ParりNamciSHIVAM OILS& Meet No′ Datel1 5/82- PROTEINS INDUSTRY, ALC4/2014 F継鷲

Case No.:72/10/82-

ALC4/2014 LABORATORIES LIMITED

Case No.:25/:5′ 82-ALC4/2014

:01/82/050/O1312/AM15/ :56/24ノ040/00019/AM15/ 12012015 1器耽 50/00602晨m夕匪危糀 OЮ∝68ハⅦ夕 No′つate:15/82‐ Re-indexed | .2014 lDate:1E.02.2015

5, Decision : It was decided to defer the case for 18.02.2015 for comments ofDepartment of C&PC (Petrochemicals Div.).

Case No.:2/6/82-ALC4/2014

ド服 RttLQ踪榊日地 ~ DeFFered Re-indexed Re-indexed 「…… ALC4/2田 | |

Case No.:3/6/82-ALC4/2014

Pary Name:CADILA HEALTHCARE LTD, 匝け IALC4/2014 112012015 跳蹴∽∝“ハm夕 ~1器辮m""0 IPHARMACEUTICALS LTD | :ision : ln the light ofearlier decision taken in meeting no. l6182 dated 16.0g.2012, it r decided to ratify norms under Para 4.7 of HBp vl as per details given below or as lied by the firm, whichever is [ess: Export Product ExpOrt Qty SI No import items Quantity allowed Tamsulosin Hcl 0.4 mg Capsule l No 1 Tamsulosin Hydrochloride 0 408 mq 2 Methacrylic Acid Copolymer Dispersion NF 170.0'12 mg 3 Microcrysta‖ ne Ce‖ ulose(Acicel PH 102) 233 mg 4 lmportnems at sl No 4to 10 As per packing policy may take apfrropriate action as per the decision of Norms ＦＬＦ ‐ 1246 || 印に~| 1躙… 1晰麗児 5ν∞■α Am夕匿死祗扇肩冨蔦薦戸 scfortt15forco : Deffered 1 ン↑― lDv Direaor Ceneral ol「ore10n lra‐ 叫欄%累震 r)計戯曇議ぼI 脚辮 Re-indexed File IRLA File Lic.No/Date:0410159058

6。 Mcct No/Datc:15/82- ALC42014 器疏 50Ю0987AMI夕陽ち蹴 OЮ037αAMI夕 12012015 ALC4/2014 12012015 Re-indexed 248 Mcct No/Datc:15/82‐ ド爾藤蔦蔦肩~膨鵬 OЮ∝∞ハ my l悧辮ЮЯ 03901S酵 18Ю2節“ Parw Name:ADCOCK INGRAM LTD,

Case No.:73/10′ 82-

ALC4/2014 Lic No/Date:0710106215 Case lio.:26i 10182-AIC4/r0H F"rty N"In.JNDO PHYTO iM."t N"/D"te, t 5/82- Status ICHEMICALS PVT LTD ALC4l20t4 lApproved i 1r2.or.20rs | ' Ha Fil"-[RLA F.tt"

E"N"/D"t.o5103r0068 trf.r D"t. :01/82/050/00940/AM l5/ :05l23l040l00l70lAMlsl 101.08.2014 I Decision : Committee considered the case as per agenda and in liEht of written comments received from Department of Pharmaceuticals vide their OM No. 35011/333/2014-Pl(Norms) dated 22.01.2015 and in consultation with technical authority present in meetinS, decided to ratify norms under para 4.7 of HBP as per details Siven below or as applied by firm whichever is Export product 恥餌 SI No lmport items Qty A‖ owed Kqノkq I 9-Norandrostenedione 997o Intermediate l kg 1 Sitolactone 140 2 5-Chloro-2- Pentanone 130 3 Tetrahydrofuran 3 50 1it/kg concerned may take further necessary action as per above decision of NC. ll宏0■2釧5 | ILic No/Date:0910060837 Re-indexed

`| l:01/E2loso/o1001/AMr5/ lfist24/o4o/oo2s8/AMt5t lrr.os.zor+ Dal面8022015 :111111llil:」liSdCCidedtodeferthccascfor18022015forcommcntsofDepattmentof Re-indexed 劉鵬3鷺 "畑 ∞5ハШ "膨鵬0側η Am夕 1蹴辮 Ю4劇 "22浙 %2階厩蕊而而 ~障 λ乳。 Ю∝露ハ m」 ~1躙鼎αω Ю ・8И : It was decided to remind the firm to fumish a copy of Master Batch Formula duly by Quality Control lncharge. The case was deferred for 18.02.2015. P征りName:SURVIVAL Meet No/Date:15/82- TECHNOLOGIES PVT LTD ALC4/2014 Re-indexed 12012015 18022015 No.:2/8182-ALC4l20l4 Party Name:SAURAV Deffered CHEMICALS LTD, Re-indexed 腰「 1珈百 :01/82Ю50/01342/AM157 109/24/040/00274ノAM15/ 1蹴鼎α酬∞ω明 u tr+ztA'- t)t f.uytz4/wu/oo2 t4/AMt5t 105.09.2014 i19.02.201 : It was decided to d.f", th" "^"E, I 8.022015 fo. .orr*.r,t, of O"p"rt "nt of ― Meet No/Date:15/82- ALC4/2014 Re-indexed 12012015 Decision:It was dccided tO dcferthc casc for 18 02 2015 for commcnts of Departmcnt of Pharrnaceuticals ― 鱚 ~IRLARL

Case No.:18/1_5/82-

ALC4/2014 Meet No/Date:15/82- 12012015

Case No.:17/15/82-

ALC4/20:4

Case No.:55/15/82-

ALC4/20:4

Case No:16/10/82-

ALC4/2014

Case No.:45/1_5/82-

ALC4/2014 雌棚rd銘2:譜蹴脚 |12012015 1 rLic.No/Date:09 t0060957,Defer Date: 1器3児5900666AMЫ 陽棚 ∽∞ "/AM剛

f/ l:0 | I 82/050 t0 t 3321 AM t s t Itz.os.zotq 18022015 Party Name:HONOUR LAB LIMITED Re-indexed C“eN∝6/8/82ALC4/2m41m柵 °HONOllR LAB | Meet No/Date:15/82- ALC4ノ2014 12012015 Lic No/Date:0910060964 Re-indexed 18022015 Re-indexed Re-indexed :01/82/050/00670/AM15/ :09/24/040/00314/AM15/ 12092014 LIMITED 12012015 : lt was decided to defer the case for 18.02.201 5 for comments of Department of 109/24/040/00305/AM15/

Case No.:4/8/82-ALC4/2014

F―れ¨41 1滲… : [t was decided to defer the case for 18.02.2015 for comments of Department of Pary Name:HONOUR LAB ヽ4eet No/Date:15/82‐ ALC4/2014 %0鵬 3児5∽0672晨my 隔翻蕊瓢蔦~囲盟両画面 B宥1搬2m5

Case No.:8ノ8/82-ALC4/2014

Case No.:9/8/82-ALC4/2014

Pa“y Name:HETERO LABS LIMITED

Case No:12′ 15/82-

ALC4/2014 Pary Name:JNDAL DRUGS LIMITED ILic No/Date:0310789265 Status:Deffered and Re-indexed

ギ CE 陽鮒 rd y紛~岡出圏而¬需需而面1離 18 02 2015 for comments of Department of 1棚掲5¨ ハ剛夕「競蕊薦戸 1協脱 : 1棚児5∽∝η ハm夕鮨蹴 o畑 "4ハ Ⅲy聞辮側 ∞ “ %9開蕊蔦 1蹴盤 li誌濯 S dttdedぉdet“hecase b BЮ22∝5おrcommcms of Deptte■of 鵬 3児5鳳福9ハm夕膨鵬 υ∞贅5/AMl,TI I冊辮: 顆聴 Ⅲ 満高。おr BЮ22m5おrcommems ofhpartmem of 「 c No/Date 0910061001 IHQ Πb
面謳 `多 No:54/15/82- Name:DRREDDYS ]MeetNo/Date:15/g2- LIMITED 12012015 : [t was decided to defer the case for I 8.02.201 5 for comments of Department of No.■25/8/82‐ Namc:HETERO No/Date:15/82- LIMITED, No.:13/8/82_ALC4/2014 Name:HETERO LABS ｍ２０ ‐ 晰馳 Re-indexed Re-indexed ALC4t20t4 lrz.or.zors No.:9/15/82-ALC4/20l4,Parry Name:VtRCHOW lMeer NolDare:15182_ PV T LTD, ALC4/2014 and Re― indexed

6h l:011821050101296lAMlsl l:o9D4l040l00327lAMtsl l19092014 18022015 ALC4/2014 ― |

Case No:60/15/82‐

ALC4/2014 Re-indexed LIMITED ALC4/2014 Re-indexed 12012015 Lic No/Date:0910061002 Date: 22092014 18022015

Case No.:127/8/82-

Party Name:HETERO LABS Meet No/Date:15/82‐

Case No.:123/8782-

ALC4/2014 Pary Name:HETERO LABS Meet No Date:15/82- LIMITED ALC4/2014 12012015 : lt was decided to defer the case for I 8.02.201 5 for comments of Department of Re-indexed 劉1繭曰蕊薦司渕蕊111ly躙辮働∞ a∞3脇辮 : ALC4/2014

Case No.:129/8/82-

Pa●y Namc:HETERO LABS LIMITED Re-indexed Lic No/Date:0910061004 Date: 22092014 18022015 No.:130ノ3/82‐ 14 Re-indexed : It was decided to defer the case for l8'02.2015 for comments of Department of | 1脇糀∽""ハmy l淵鼎醐∞ a∞51需蔦 Meet No/Date■ 5/82‐ Meet No/Date:15/82‐ 12012015

Case No.:131/8/82-

ALC4/2014 FQme~~~~画 RL におNo/Dateb'l Name:HETERO LABS

ι5

Case No.:61/15/82‐

Case No.:10/15/82-

ALC4/2014 ll8.o2.2ors Re-indexed 師 :It was decidcd tO dcferthc case fOr 18 02 2015 for comments of Deparment Of 「 … 脇ALC4/21114甲鱚 ~腰謂 " 1蕊脇面蔦丁 1脇鵬∽∝ 3仏my 日辮"Ю 061068 :In the‖ght ofca‖tr decヽbnttkcn by NC h is H/82 meethg dated 26 H 2014 and r consultation with technical authority present in meeting, decided to ratifo norms under para .7 ofHBP as per details below or as applied by firm whichever is lower:_ [A]For Export ofRocurOnium BrOmide lniection 10mg/ml.5mi Vial USP_― ¨――――‐lNo. S No lmport ltem (1) Norms Applied t2t As per Central Excise Certificate (3) Batch Logsheet (4) Lovvest of (2)to{4) 〔 5) 1 RCB Diol 71 5mg As perS:ON 57 .75mg ＾２ Glass Vials 1 064nos. 10617 10565 1 0565nos ＾３ Rubber Stoppers 1 076nos 10832 10794 1 076nos 4 Seals, Plastic and Rubber 1 064nos 1048 10310 1 031nos ＥＪ Sodiunn chioride BP 0 000022kg Excipients & Consumables. Relevant′ Netto Net 6 Benzyl alcohol BP 0 0000441it 7 Sodium hydroxide USP 0 0000001kg 8 Hydrochloric USP 0 0000oo41it 9 Tubing, Plastic 0 0006731it |:09/2477040/00353/AM15/ 12092014 Name:EMCURE .、■|(U`´ ハlR 慨鯖 e

6' 10 Filters, Plastic 0 000181nos 11 An■ factor xa test kits 0 000101nos 12 Antl factor lla test kits 0 000101nos 13 Analytical columns 0 000022nos 14 Analytical guard columns 0 000022nos. [B [g:- These norns are specific to US FDA project' The higher norms for packing Gials shall be permissible only in respect of export to USA and will not be applicable repeat basis. I For Export of Rocuronium Bromide Iniection 10me/ml. 10ml Vial USP--------- -lNo, S No lmport ltem (1} Norms Applied (2) As per Central Excise Certificate (31 Batch Logsheet (4) Lowest of (2)to(4) (5) 1 RCB Diol 142mg As per SION 115 5mg 2 G lass Vials 1.07nos. 10927 10922 1.07nos 3 Rubber Stoppers 1.10nos. 11067 11053 1.10nos 4 Plastic Seals 1.05nos. 10643 1.0413 1.0413nos 5 Sodium chloride 0 000022kg Excipients & Consumables. Relevant, Netto Net 6 Benzyl alcohol 0 0000441it 7 Sodium hydroxide 0 0000001kg 8 Hydrochloric 0 00000041it 9 Tubing 0 0006731it 10 F‖ ters 0 000181nos. 11 Anti factor xa test kits 0 000101nos 12 Anti factor lla test kits 0 000101nos 13 Ana lytica I columns 0 000021nos 14 Analytical guard columns 0 000021nos jg:- These norns are specific to US FDA project. The higher norms for packing ierials shall be permissible only in respect ofexport to USA and will not be applicable repeat basis. E霰酬乱器 1 F躙

`¬ 蕊L~腋∬辮"Ю061067厩需 For 18 02 2015 for commcnts ofI)epaJLnent of : Comminee considered case as per earlier decision taken by NC in its 4/82 meeting dated .07.2014 and in consultation with technical authority present in meeting, decided to rati! norms under 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp Qty S No Impon items Qty. aUowed 7‐ PHENYLACETAMIDEO‐ 3‐CHLOROMETHYL CEPHALOSPORONIC ACID PARA METHOXY BENZYL ESTER(CJCLE) l kg l PENICILLN C‐ POTASS:UM FIRST CRYSTAL 2 81 kg つ４ ACETONE 1 971 kg ISOPROPYL ALCOHOL 0 66 kg 4 DIMETHYL FORMAMIDE 1 314 kg METHYLENE CHLORIDE 3 29 kg ´ ０ 2 MERCAPTO BENZO THIAZOLE 0 51l kg 7 METHANOL 1 971 kg concemed may take fuflher necessary action as per above decision ofNC. :審ざ臨V圏踏T[顕甲可薦 1躙児5∽BηttMЫ I協乳 ∽ "“ 晨M「 ~囲鼎 “ 釧∞att PettD配「冨脚酬静照 ~甲閻瓢穏『 ″鱚器島児59m"3ムmy l協北 υ∞ "2/AMl夕階 ∬辮 Ю釧∞御 "21協辮:

Case No.:35/15/82‐

ALC4/2014 ― ▲ ＦＬ円 ― ‥て応ｒｐｌＤ ‐ に ― ‐ ２ TD IQ File )1/82/050/01323/AM15/ ecision : Committee considered case as per earlier decision t k", by NC i, it. ;, .0'1.2014 and in consultation with lechnical aurhority present in meeting, decided to n ra 4.7 ofHBP as per details below or as applied by firm whichever is lower:- No:36/1_R/82- 3/2014 Name:VIRCHOW OCHEMICAL PVT Meet No/Date■5/82‐ ALC472014 112012015 Status: Approved o-erer o"te: 82 meeting dated atiry norms under Export product Exp OW S No Impon items Qty. allowed 7‐ PHENYLACETAMIDEO‐ β‐CHLOROMETHYL CEPHALOSPORONIC ACID PARA METHOXY BENZYL ESTER(CCLE) rl l kg l PENICILLIN C―POTASSIUM FIRST CRYSTAL 2 81 kg 2 ACETONE 1 971 kg 3 ISOPROPYL ALCOHOL 0 66 kg 4 DlMETHYL FORMAMIDE 1 314 kg 5 METHYLENE CHLORIDE 3 29 kg 鮨′ 聰翻蟷岬I

6 2N4ERCAPTO BENZO THIAZOLE 051lk負 7 ヽlETHANOし 1 971 kg concemed may take further necessary action as per above decision ofNC. Cr ecision : Comminee considered case as per earlier decision taken by NC in its 4/82 meeting dated -0'1.2014 and in consultation with technical authority present in meeting, decided to ratiry norms under 4.7 ofHBP as per details below or as applied by hrm whichever is lower:- concemed may take further necessary action as per above decision ofNC.

Case No:42/15/82‐

Meet No/Date:15/82- ALC4/2014 ALC4/2014 Re indexed 12012015 丁 | Re-indexed 戸 51辮蕊薦戸脇糀∽“餅 A剛夕 ud菫準織議mlЫ Lic No/Datc:0910061H4 Date: :09/24/040/00385/AM15/ 17102014 18022015

Case No:47/15/82-

Export product Exp Oty S No Import items Qty. allowed 7‐ PHENYLACETAMIDEO― 3‐CHLOROMETHYL CEPHALOSPORONIC ACID PARA METHOXY BENZYL ESTER(CCLE) l kg 1 PENICILLIN G‐ POTASSIUM FIRST CRYSTAL 2 81 kg 2 ACETONE 1 971 kg ISOPROPYL ALCOHOL 0 66 kg 4 DIMETHYL FORN4AMIDE 1 314 kg ヽ4ETHYLENE CHLORIDE 3 29 kg 6 2 MERCAPTO BENZO THIA20LE 0 511 kg MEIHAN01 1 971 kg Par"Name:PVS AGRO VET Party Name:VINS Pharmaceuticals. 105 1Derer Datc: 15/ No:13/15/82- No/Date:15/82‐ Re-indexed 1器3児50Ю 1300晨」 [; 11l Defer Date:

Case No.:58/15/82-

ALC4/2014

Case No.:78/10/82-

ALC4/2014 Date: 18022015 `ィ Paty Name:HETERO LA3S ,Meet No/Date:15/82- LIMITED ALC4/2014 112012015 1輛臨脇蕊戸嚇

「 ~けだ辮¨a30厩需~ :It was decidcd tO deferthe casc fOr 18 02 2015 for cOmmcnts Of Dcpartment of 趾 2~ Re-indexed Status: Deffered and Re-indexed ＦＬＦ ‐ 鵬脇 50Ю ""ハ my l協北 ∽ "釧 AM15/ 騰 ∬鼎醐 ∞aH厩雛 : :It、vas decided to dcferthc case for 18 02 2015 for comments of Dcpartment of |
四 HETERO Lぶ 1濶 "TM l* grqR/ N 躙野雪輩′ 零譜編「 ° 器晰 ::::1誕f鶴習朧 Lic No/Datc:0910061113 17102014 PHARMACEUTICALS Ha Fit" -FtA F " Et".No/Drt.s9l0o6l lz lD"fb, Drr* :01/82t05OtO134OtAutst l:Ogtz4tO4OtOO3}OtAMt 5/ ),Zt.tO.ZOt+ l D""ltt"" r Th" C.r.ln"" "o*iao"a . "" ". p", ,g"na" -a ln tigt t of *rln"n comments received fiom Department of Pharmaceuticals vide their oM No. 35ol l/341/2014-pl(Norms) d^ted 28.11.2014 and in consultation with technical authority present in meeting, decided to rati! norms under para 4.7 of HBP as per details below or as applied by firm whichever is No.:53/1y82- 3/2014 潔監ムLDttF産 Export product Export Qty. SI No lmport items Qty. allowed kg/kg l,l-Cyclohexane Diacetic Anhydride l kg l l,l -Cyclohexane Diacetic Acid 1.188 RA may take appropriate action as per the decisio n of Norms Committee. ud霊嘉轟謀誡 l嗜 Name:SUVEN LIFE No Datc:15/82‐ Name:HETERO LABS No′つate:15/82‐

40 Mect No/Date:15/82- ALC42014 12012015 Lic No/Date10910061133 1Defcr Date: :09′24/040/00407/AM15/ 122102014 18022015 14

Case No:84/10/82-

Party Name:HETERO ALC4/2014

Case No:85/10′ 82-

ALC4/2014 No.:82/10/82- Lic No/Datei3 H0065004 1Defer Date: 27102014 18022015 | DRUCS LIMITED Meet No/Date:15/82- 鵬編 ~ 囲蕊諦 ~ Deffered Re-indexed Deffered Re-indexed Lic No71Date:0510391738 1Defer Date: 27102014 18022015 Meet No/Date:15/82‐ IALC4/2014 ALC4/2014 Re-indexed 12012015 Lic No/Date:091006H41 1Defer Date: 27102014 18022015 :It was dcCided to dcfcrthc casc for 18 02 2015 for commcnts of Departmcnt of :It was decided to defcrthe case for 18 02 2015 for comments ofI)epartment of ~Case No劇た開多浄 LC4/2014
「 IMFED Party Name:DEEPAK Meet No/Date:15/82 TECHNOLOGIES LTD 12012015

Case No:64/15/82-

ALC4/2014 Meet No7Date:15/82-

Case No.:40/15/82-

ALC4/2014 … |!2012015 File 1/837040/00151/AM15/ Re-indexed File

7/ :o I / 82tL5o I O t327 I AM I 5 / i09/24tM0/0M14/AMts/ lze.ro.zort necessary per above decision of NC. 「匡港鵬ハル [辮ビ躙S槽鮮 e15/82‐ "7日3脇500"8/AMly彫膳 OЮ鬱09Am夕囲鼎 C04101"“5 :It、vas dccided tO dcferthc casc fOr 18 02 2015 for comments of Dcpartmcnt Of Re-indexed Decision : In the light ofearlier decision taken by NC in its l2lg2 meeting dated 10.12.2014 and in consultation with technical authority present in meeting, decided to ratifo norms under para 4.7 ofHBP as per details below or as applied by firm whichever is lower:- Export product Exp Qty SI No lmport items Qty AIlowed Kgノkg (lS,4R)-4-[(2‐ AMNO-6- CHLORO-5-FORMAMIDO-4- PYRIMIDINYL)AMNO]_2- CYCLO PENTENE‐ 1‐ METHANOL l kg 1 N― (2‐AMINO-4,6‐ DICHLORO-5- PYRIMIDINYL) FORMAMIDE 0764 2 (+)-2- AZABICYCLO[221]HEPT‐ 5-EN‐ 3‐ ONE(VNCELACTAM) 141 3 D(―)TARTARIC ACID 078 4 SODIUM BOROHYDRIDE 0226 5 ISOPROPYL ALCOHOL 470 6 METHANOL 423 7 L(+)TARTARIC ACID 123 concerned may take further action as P¨/NalnaViVIMED LAB「靡面面高面 5/82‐ 1而Fa“ No■5715/82‐ No:6/15/82-ALC4/2014 Name:SMILAX No/Date:15/82‐ :It was decided tO dcferthe case fOr 18 02 2015 for comments OfI)cpaiment of

1レ昭

Case No.:31/15/82-

Party Name:BELCO ALC4/2014 PHARMA Party Name:EYTAN LABS Re-indexed Deffered Re-indexed LIMITED In was decided to defer the case for l8'02'2015 for comments of Departrnent of I )CiSiOn : ln the light of written comments received from Department of Pharmaceuticals vide their 4 No. 35011/23l2013-Pl(Norms) dated 1.4.2013, it was decided to ratifY norms under Para 4'7 of HBP as per details given below or as applied by the firm, whichever is less: 1 Export Product Ｖ興Ｑｕａｎｔｉ S No lmport Product Quan●tv A‖ oWed Kg/kg Losartan Potassium (or) Losartan Potassium USP Methanol 051 Toluene 059 2o‐ ButVり‐4てhlor●5 Fomvl lmidazolc 050 4 2でyano4-McthJ BlphCnメ 068 Chlorofonn 120 6 Sodillm BorohydridC 0048 7 Sodium Azidc 035 8 Iso Propyl Alcohol 080 mav take approp●ate acion as perthe ded●on of Norms Commttee Meet No Date:15/82‐

case No.:49715/82-

Meet No/Date:15/82- ALC4/2014 PなりName:VENUS ,日高 ●■,、/NlRYttL KU 楽曇薫肇撃理愛 : 酬ょ翻鴨冊de Directorat€ Generd ot tor€'qo rraoe slFr.q F{,{r.vDopadment ol commorc€ 島面聾譜駐瓢誡 ,Ⅲ | No.:43/15/82- Name:VASUDHA CHEM LTD No/Datc:15/82‐ Re-indexed :It was decided to deferthc Casc fOr 18 02 2015 for comments of Departmcnt of HQ File :01/827050/Oi336/AM15/

田 3児5∽BttAmy 膨棚 90鯰 “ /AM,「 ∬鼎 α04101"η6協雛 : 1棚児 mm ttmy層競薦蕊戸囲辮鮒∞ 044681硼州 : 鵬星掲5∽B∝ハm夕 1湯棚 OЮttπttmy
階駿雛 : 51モF「『え厖「う 5Fモ「五要comments of Deparmcnt Of No.:20/15/82- フア NametMALLADI & No/Date:15/82‐ Re-ind€xed 鵬 3掲5∽B"ハmy l脇淵 OЮ鯰 "ハ m夕「 F∬器 α腑∝ "η 5 2015 No.:14/15′ 82- Ntte:STERICON No/Datel1 5/82‐ PVT LTD, Ｍ２。 ‐ No.:19/15/82- Party Name:MALLADI IMeet No Date:15/82- 3 It was decided to defer the case for 18.02.2015 for comments ofDepartment of No:56/15/82- No7Date:15/82- 5/ Re-indexed : It was decided to defer the case for I 8.02.201 5 for comments of

`｀

Case No.:65/15/82-

ALC4/2014 Party Name:ABEERS Meet No/Date:15/82‐ ALC4/2014 Re-indexed LTD 12012015 : It was decided to send a copy ofapplication to Department ofAYUSH. The case dcfcrrcd for 18 02 2015 Re-indexed : It was decided to defer the case for 18.02.2015 for comments ofDepartment of PHARMACEUTICALS PVT Deffered Re-indexed Date: 18022015 Meet No/Date:15782- ALC4/2014 12012015 ■3鵬疏 50畑 "α AM y 隔酬蕊ふ蔦 ~酵慨 TЮ 釧剛 %51協器 Meet No Date:15/82‐ ALC4/2014 12012015 Lic No/Date:0910061256 1Dcfcr Datc:

Case No.:3/15/82‐ ALC4/2014 Partv Name:NATCO

PHARMA LIMITED Re-indexed

Case No.:62/15/82-

ALC4/2014 LABORATORIES LTD, ALC4/2014 12012015

Case No.:59/15/82-

ALC4/2014 Lic No/Datc1041 0159756 17112014

Case No.:39/15/82-

ALC4/2014 LABORATORIES LIMITED

Case No:41/15/82-

ALC4′ 2014 LABORATORlES LIMITED Mcct No/Date:15/82‐ Name:DIVIS No/Date:15/82‐ File NamelMYLAN NamclMYLAN : It was decided to defer the case for I E.02.201 5 for comments of Department of … F‖ e κuMAR Dy 雨ギ蒲|・

０２ ‐ ‐ ‐ ＬＰＩＩＩＩ渕口p effered Rl-ioo"*"0 FW欄郡補榊椰蕊繭面:iぽ酬肥釉器 Quinoline Bascd Alkaloid― CamptOthecin(Chemical) OMT95%) QuinOlinc BaSed Alka10id‐ CamptOthCCin( chemical) HPLC PuriりNot Less Than 98 5% .ryt"k" app.pr'Et" action as per the decision of Norms Committee' 驚諄 :違sゴD No.:5′ 15′82‐ALC4′ 2014 c1338/AMr 5i :09/24l040i 0{Ja:+"'r', , rr.r,1 , for .omm.nts of Depanment of : lt was decided to deler the case rut I o v- -" lffrfffeP 謳 :稲CaSC f°r io6-ate:tsttz- No:51 ′15732- No′Datc:15/82‐

7` 発さ蹴海 PttI洒Ⅲ13磁 IALc4/2o17 Ⅲ■ 2И 5/82_ fOr c。 ln 場
轟能 :『 fOr Cm蔦:聴卍 ⊆疏誼雛靴め鋏 fOr cornmcnts ofDep濫 01.12.2014 Party Name:AMINES & Meet No/Date: t5/82- ALC42014 Date: 18.02.20t5 獣1岬 i∬ concemed may take funhernecessav eCtOn as perabove dedgon of NC lmpOrt tems For"rpon of r N-6iEEiE

Case No.:32/1_5/82-

3251ALC4/2014 PLASTIclzERS LIMlTED 12012015 Re-indexed

マン鵬 3児501ら88/AM Ⅳ 障危北。Ю “ 90/AM W 階らg冊°°Я 00° 407匿橿辮 ξ :It was decided to deferthc case for 18 02 2015 for comments of Department Of 孵脚面 FT面雨 l孵「げ :It was decidcd tO dcfcrthc case for 18 02 2015 for commcnts ofI)epartmcnt of 椰誉 :乳計。 i量滉詔轟謂臨 d。 ■,、o簿T7oepa“ment of Conlmerco ud菫緊轟話瓢 !日 No.:2/1_5/82_ALC4/2014 Name:HETERO LABS No/Date:15/82- 12012015 1棚児 5∽鯰"¨ Ｄａｔ２０ ‐ 缶０２Ｄｅは LIMITED :,ALC4/2014 land Re-indexed No.:27/15/82- Name:HETERO LABS No/Date:15/82‐ Re-indexed Re-indexed Re-indexed :Itwasdccidedtodcferthccasefor 18022015forcOnlmcntsofDcpartmentOf :It was decided to dcfcrthc casc fOr 18 02 2015 for comments of Dcpartment Of 5 防２０ ‐ 缶０２＞ｅ＆鵬脇5∽BИ/AMⅣ I脇肥∽法 46/AM Ы :It was decided tO defcrthc case fOr 18 02 2015 for comments of Dcparment Of Ｄａｔ２。 ‐ ｂ鯰Ｄｅは

■5 鵬3月50畑闘Am夕陽ち糀 ∽0502晨my l淵鼎 C酬∞a″9厩飛 : 1鼈:淵° 1'82- Irz.ot.zots I Status:Deffered Re-indexed υ 「"鵬 3児5剛3耐Amy厩蹴 OЮ “`ハ my囲器 α酬0061知 1需需

Case No.:29/15′ 82-

ALC4/2014 Pa●y Name:HONOUR LAB LIMITED sion : ln the light of earlier decision taken in meeting no. ll/82 dated 26.11.2014, it was ed to ratifi norms under Para 4.7 ofHBP v I as per details given below or as applied by the whichever is less: Export product Export Qty. SI No Import items Qけ al10Wed kノkg 2‐Chloromcthy卜3,5 Dimcthyl‐ 4 N4cthoxy Pツridinc Hydrochloridc l Kg 1 3 5 Lutidinc 104 うん Toluene 520 Methanol 414 4 Acetone 207 5 Activated Carbon 0100 6 Ammonium Persulphates 1 80 may take appropriate action as per the decision of Norms Committee. ~
開ご甲霊 "41 1脚鼎° 091∞°m71協器 υ d霊兜臨議駐籍高 No.:30/15/82‐ Name:ONEIRO LTD 012015 File Name■ODAS EXPOIM IMeet No/Datc:15/82- 12012015 Date:

Date:12.01.2015 Place:New Delhi Nirmal Kumar Dy. Director General of Foreign Trade

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