DGFT Committee Minutes
^ Office of Directorate General of Foreign Trade New Delhi -0 MEETINC NUMBER Para 4 7 Decislon :4/82-ALC4′2015 MEETING DATE:12062015 Meeting No. 0418212015 of 2015-16, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, was scheduled tot |L.06.2015 but actually held on 18.06.2015 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFTinRoom No.11, Udyog Bhawan, New Delhi. Following members were present:- Shri A.K. AgaMal, Dy. lnd. Adviser, Department of C&PC Shri O.P. Sharma, Joint lndustrial Adviser, Department of C&PC Dr. Nitin Jain, Scientist "D" D/o Biotechnology Shri D.N. Mathur, Consultant, Department of Pharmaceutical Shri Mahendra Vikram Singh, Foreign Trade Development Officer The committee went through the minutes of earlier NC-lll meeting No. 03/82 was scheduled for 20.05.2015 but actually held on 18.06.2015 and approved the same. The following cases/issues were discussed and the committee took the decision as mentioned against each case. Case tlo.:lglllAZ-n LC4t2Ol5 Party Name:ONEIRO frfiei No/Date:4i82- Staaus: CHEMICALS LrD i:::';:t': Dererred 1 HQ File nl,c iit. Lic.No/Date:3410028761 Deier Date: :01/82l050/00088/AM l6l :34124/O4OlOo224lAMt t t 09. 12.2010 24.07.20t5 Decision: lt was decided to defer the case for want of comments of O/o ptrarmaceuticats- 「 r面語頂簡面雨/4/82‐ALC4/2015[吾 ,蕊:更悪需 『 7百三]~ |1 1 IMeet No/Datc:4/82‐ Status:Dererred lALC4/2015 lt2.o6.2ots I HQF‖e RLA F‖ c Lic No/Datc:3410031902 1DcfcrDate: |:01/82/050Ю 0057/AM16/ :34/24/040/00130/AM12/ 1121020H 24072015 Decision : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals). 路お掲 50/Ol"2晨my脇∬OЮ%"AMW I器離αψ Wの勿: 隣群基 | Decision : lt was decided to defer the case for want of comments of D/o Pha rmaceuticals.
Case No:79/1/82-
ALC4/2013 IPatty NameiSTERICAT Meet No/Date14/82-ALC4/2015 1GUTSTRINGS PVT LTD 112 062015 Status:Deferred― | 「鵬蕊蕊扇1漑麒蕊百配需画面 「 Ⅷ蘊「鴨
ヽ
Case No.:20/7/82-
ALC4t2ot4 : lt was decided to send a copy of application to Dlpp and defer the case for want of 屁 隔琲
- Past production vis-d-vis actual consumption ofall important inputs for last three years luly certified by Central Excise Authorities. Batch log Sheet and its summarized statement in tabular form for each batch for the 5 batches in continuity duly certified by Production Head.
- Inputs to be imported should be indicated by their generic names instead ofusing brand rames or code names. RLA F‖ c 10056000 Date: :09/24/040/00041/AM14/ 15052013 072015 : In the light of writlen comments received from Department of pharmaceuticals vide their OM 350t t /456/2014-pl(Norms) dated 02.02.20t5, it was decided to remind the firm to fumish the ing information: Mcct No/Datc:4/82- Deferred ALC4/2015 12062015 10037475 Date: 072015 : It was decided to send a copy of application to D/o pharmaceuticals and defer case for want of comments. No:1/10/82- 4/2013 Paty Name:MICRO LABS LTD Meet No/Date:4/82- Deferred ALC4/2015 12062015 10097180 Date: 072013 072015 : lt was decided to defer the case for want of comments of D/o Pharmaceuticals Bhavan, New Delhi. : lt was decided to defer the case for want of comments of D/o C&pC (Chemicals). No:32/4/82-ALC4/2015 ParりName:KLJ ド淵"~騨鰈Ⅷ趾″「…高 8厩曰蕊薦脇脇蕊 「 厩P両翻離 Meet No7Date:4/82- ALC42015 12062015 OdV00 PLASTICIZERS LTD, 障 ~ No.:68/17/82‐
1器島掲 5νO∞71AMl;~~ Decision : lt was decided to defer the case for want of comments of D/o C&pC (Chemicals). :ln the light of wrnten cOmments received from D/o PharmaceuJcais vide their OM No35011/87/2014‐ PI(Norms)dt OctOber,2014′ the COmmittee has decided to ca‖ for cOpy Of DMLfrom the■rm : The committee OeciAeJ io -ratifvlh";r^ brr"d;;lh" ,*"rr""d.ti.^ .f Department of pharmaceuticars vide r.D.No. 3507L/20212074-pr (Norms) dt. october, 2o14as per details give below or as applied by the firm whichever is lower:_ Ｌ Ｅ Ｔ Ｎ Ａ 」 Ｏ Ｓ Ａ Ｓ Ｅ Ｃ Ｂ PARA cHLoRo BeNzit_ cvetuoe RA may take further actiOn accOrdingly No:9/30/83‐ : lt was decided to defer the case for want of comments of D/o pha rmaceuticals. No:17/4/82‐ALC4/2015 NameJUBILANT LIFE No/Date:4/82‐ LIMITED 12062015 1蹴鼎α“Ю 3“%3 No.:22/17/82- Namc:ATHENA No/Date:4/82- DELiVERY PRIVATE No.:9/47/83‐ ALC1/2013 NυDate:4ノ82‐
Case No.:140/23/82-
ALC4/2013 Pary NamclllNITED PHOSPHORUS LTD ALC4'015 12062015 : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals) PaロッName:AKZO NOBEL INDIA LIMITED Partv Name:VIVIMED LABS LIMITED
Case No:203/3/82-
ALC4/2014 Partv Name:OGENE SYSTEMSINDIA PVT Ｆ ‐ ‐ ‐ ９ ‐ ‐ 隔 ∽02麟MW所 角鵬 OЮO,5ムMW Date: 072015 : lt was decided to defer the case for want of comments of D/o C&Pc (chemicals). ALC4/2015 12062015 Lic No/Datc:0910059155'DeFer Date: Partv Name:VIVIMED LABS LIMITED 製聯:ふ欝 was decided to defer the case for want of comments of D/o C&PC (Chemicals). 1器3泥50/O1417晨Ml夕 No/Datc:4/82‐ 187/Aヽ414/ No:181/3/82- No Date:4/82- 5 12062015 NameiViVIMED Llヽ41TED No.:204/3/82- No/Datc:4/82- Filc : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals) %器 3児5∽創8扁跳ち鵬oЮ0053晨MW IDecision:t was decided to deferthe case for want ofcomments of D/oC&PC{Chemに als) ２ ８ ４ Ｍ ‐ ５ 耐 開 4 1器島鬼 5υ00091AM I夕 パィ
: lt was decided to defer the case for want of comments of D/o C&PC (Chemicals). ２ ８ ６ ５ ８ ‐ ４ 眈 囲 1器星児 50Ю“ 6αAMly E * N". t 106/3/81 fpurty Wur**enrBCr v-*t N"lo"i.altz-- Ｆ ‐ ‐ ‐ ２ ４ ‐ ‐ ， ‐ 1器3児50Юm 10/Amシ鷺λ馳∽"60AM W lDecision : lt was decided to defer the case for want of comments of D/o c&Pc (chemicals). Decision : The committee decided to ratiry the norms based on the recommendation of Department of Pharmaceuticals video.M.No350f1/438/2014-Pl (Norms) dt. 27.1.2015 as per details given below or as applied by the firm whichever is lower:- Export product Qty lmport items Qty Cefetamet Pivoxil Hcl 500mg tab:ets Ｘ ０ Ｖ Ｐ ｅ ｄ ｅ ｔ ｂ ¨ Ｈ ｙ ｄ ｒ ｏ ｃ ｈ 510m9 RA may take further action accordingly. Party Name:VMMED No.:86/3/82- Date: 2015 Name:BAYER No Datc:4/82- LIMITED PVT LTD 5 12062015 Date: 2015 Ｅ Ｊ
ド¨4~阿 Pa●y Name:JUBILANT LIFE SCIENCES LIMITED :L was decided tO deferthe case fOr want ofcOmments Of D/o Pharmaceutに aに | ALC4つ015 Meet No/Date:4/82‐ 12062015 :[was decided tO deferthe case fOr want of cOmments Of D/oC&PC{Chemicals) :09/24/040/Oo644/AM14/ :忙was decided tO deferthe case fOr want ofcOmments Of D/o PharmaceuJcaL 囲脱 : ―― 不 ¨ … 枷・ epannent o,Cornmerce ud菫聾轟謀誡 [" Name:BEST VALUE IMeet NげDate:4′ イPVT LTD ALC472015 112062015 Declsio■The commttee decded tO ratify the nOrms`二 E」■l Department of c&Pc vide U O No 14010/58/2011-Ch‐ ll dt 17 6 2015 a or as appiied by the firm whicheveris lower:― 182‐ IApprl ∞"翻1面 the recommer S per details gi Date: rdataon of ven below Export product Qty lmport item Qty Kg/kg Methyl octine Carbonate lkg 1-Octyne 0 834kg l pentanol/N Amyl alcohOI 0 795 kg rA may raKe turther action accordingly. sion : The committee decided to ratify the ,o-t Lr"u * ," iuionuna"tion or rtment of pharmaceuticars vide r.D.No35o11 r500/20.,4-pr (Norms) dt. March 2015 as per given below or as applied by the firm whichever is lower:- RA may take further actiOn accOrdingly No.:180/6/82‐ Filc No:826/82‐ Name:KOPRAN
Case No.:51/5/82‐
Meet No/Date:4/82- ALC4/2015 12062015 Date: 2015 ~甲 7藤 Meet No/Date14/82‐ ALC42015 12062015 Meet No/Date:4/82- ALC4/2015 12062015 Date: 072015 同 ｀:扁CADILA IHEALTHCARELTD, Mcct No/Datc:4/82‐ ALC4/2015 12062015 HQ File RLA File Lic No/Datc:0810130534 1Dcfer Date: :01/82Ю50/00003んヽM15ノ :08/24/040/00008/AM15/ 11042014 24072015 IDecision:L was decided to deferthe case for want ofcomments of D/o Pharmaceujcals "鵬3月 "Ю““ハ剛ダ隔臨蕊7[蹴鼎α "Юη“%1辮辮 : ~1猾 | Pa●y Name:ALEMBIC PHARMACEUTICALS LTD : ln the light of written comments received from D/o Pharmaceuticals vide their OM No3s9tf/4fi 12o14-Pl(Norms) dL.22.1.2015, it was decided to call for the copy of Master-Batch ula for each strengths of export product duly certified by the qC Incharge, showing net of APls and each of the excipients from the firm. Meet No/Date:4/82- ALC4/2015 12062015 %1爾薦蘊罵丁膨淵OЮ∝器ハⅦ″1需鼎α酬∞""51辮辮: IDecision:L was dedded to deferthe case for want ofcomments of D/o Pharmaceu■ caL ud話染織話韓 |ロ Lic No/Datc:0310776087
Case No:22/10/82-
ALC4/2014 Lic No/Date:0910059697 Mcct No/Datc:4/82-
Case No.:21710/82-
ALC4′2014 Name:JINDAL LIMITED File 15/ 1:03/94/040Ю 1098/AM14/ 032014 Namc:UPL LTD Name10GENE SYSTEヽlSINDIA PVT LTD File 12062015 Date: 14ノ Filc
Case No.:48/10/82‐
ALC4ノ2014
LABORATORIES
Mcct No7Date:4/82‐
1淵鰍∵
37器
3児5900962AM I夕1蕩脇蕊下
厭
Decision : : Reply of deficiency letter received from the firm. The case was deferred for
12.06.20t5
Lic No/Date:0510384810
Date:
24042014
072015
: In the Iight of written comments received from Department of Pharmaceuticals vide
OM No. 3 501 I /42012014-PI(Norms) dated 22.01.2015, it was decided to call from the firm
ofvalid Drug Manufacturing License (DML) from the firm for both ofthe above export
items.
[榊品冨ⅣAL~ Meet No/Date14/82‐
ALC4/2015
12062015
Date:
:01/82/050/00381/AM15ノ
072015
File
RLA File
:09724/040Ю 0028/AM15/
Date:
1/82/050/00955/AM15/
072015
: ln the light of written comments received from D/o pharmaceuticals vide their OM
No35011/618/2014‐ PI(Norms)May 2015′
the Commlttee decided to call past production vis―
a‐vis
consumption of all imported inputs duly certified by Central Excise authorities from the
|
File
Defer Date:
1/82/050/00960/AM15/
:09/24/040/00029/AM15/
072015
: ln the light of written comments received from D/o pharmaceuticals vide their OM
No3501U618/2014-Pl(Norms) dt. May 2015, the committee decided to ca past production vis-
actual consumption of all imported inputs duly certified by central Excise authorities from
囮
i「「輛雖画面
Party Name:UNITED
B10TECH PVT LTD
101/82/050/00323/AM15/
:05/24/040/00034/AM15/
Case No:64/5/82-
ALC4/2014
Case No.:41/10/82-
ALC4/2014 0059852 :091 蘭 加 い 獅
Case No.:46/10/82-
ALC4/2014 Party Name:VMMED LABS LIMITED firm: Name:MYLAN No.:6/5/82- 腰謂鯉 ~ 膨 No/Date14/82‐ 12062015 File 8
石 1旧器に″ "― ~ 1 12062015 鵬肌 50Ю "釧 /鰤Ⅳ 陽蔦薦話肩~け DttC劉∞И 88 Date: 072015 : The committee decided to ratify the norms based on the recommendation of Department of C&PC No 14010/138/2011-Ch‐ Fll dated 27 5 2015 as per details given below or as by the firm whichever is lower:- Export Product Qty lmpot items Qty Kg/kg TCC OR VIVILIDE OR 3,4,4- TRICHLOROCARBANILIDE lkg PARA CHLORO ANILINE 0546 3,4-DICHLORO PHENYL ISOCYANATE 0627 TOLUENE 200 METHANOL 0500 No.:51/10′ 82- 4/2014 1翻器° "Ю“%"1辮器 : lt was decided to defer the case for want of comments of D/o (Pha rmace utica ls) m淵凛儡π 2畷∬α 朝2 F面 :2( ILic No/Date:0310779831 de on: The committee de ment of Pharmaceutica l: given below or as applied cided to「aufy the norms based on the recommendaJon of s vide l D No35011/30/2015‐ PI(Norms)dt 29 05 2015 as per i by the firm whicheverisloWer: Export product Qty ● ０ Ｓ ‐ Ｎ lmport items Qty Kg/kg Sulbactam Sodium Sterile lkg Sulbactam Acid 09733 2 Soidum Carbonate 0076
Case No:61/10/82‐
ALC4′2014 :01/82/050/00975/AM15/ 13/AM:4′ 129042014 Name:ViVIMED No/Datc:4′ 82‐ LIMITED
:lt was decided to deferthe case for want ofcOmments Of D/oC&PC(chemicals) Case No;20/10/82- :lt was decided to deferthe case for want ofcOmments of D/oc&PC(Chemicals} Meet No/Date:4/82‐ ALLIANCE DYE― CHEM ALC42015 :t was decided tO deferthe case fOr want OfcOmments Of D/oC&PC(chemicals) e case br waハ:屏comments Of D/o lPharmaceutlcalsl :lt was decided to defer th Mcet No/Date:4/82‐ ALC42015 12062015 :01/82/050/00957/AM15/ sion : The committee decided to ratifi/ the nor^ tar"O "; th; ;;rr;;;a;; rtment of pharmaceuticals vide t.D.No. 3507t/SOBl2Ot3-pt (Norms) dt. May 2015 as ls given below or as applied by the firm whichever is lower:_ Qty lmport items Qty Kg/kg 1軸灘鶉&3, CHLOROPHENYL)ACETATE HYDROCHLORIDE(CPc_20) lkg 郡鴇St出製W羅:N離2 (CPC‐ 10) 074 MEIHYLIso BuTYL KETONE (MIBK) ETHYLENE DIcHLORIDE/DI CHLORO ETHANE 1092 2508 XA mav take furthpr a.ti^n ---^-)i--t. ul‖ じ[y Lic No′ つate:o91oo59968 O1052014 No.:3/5/82_ Name:NEW LTD, 1両脇 憂面市 ~ PHARMACEUTICALS ILTD, NO:43/10ノ82-ALC4/2014 NamciSRNI LTD,
Ｆ ‐ ‐ ‐ ‐ ‐ ５ ‐ Ｆ ‐ ‐ ‐ ‐ : lt was decided to defer the case for want of comments of D/o c&PC (Chemicals). IDecision:L was decided to deferthe case for want ofcomments of D/oC&PC(ChemiCak) F… 9嘘・К伽戸 孵雉lttD臓鮮 纂 Fr° Ved 厩扇蕊薦」~膨鵬 0加036/AM15/ 開鼎 3°91°° 600061~~ | 1 蔦 Export product Qty lmport items Qty Kg/kg 2-CHLOROMETHYL4‐METHOXY‐ 3,5-DIMETHYLPYRIDINE HCL lkg 3,5 Lutidine 104 Hydrogen peroxide (50%) Chloroform 520 Ammonium per Sulphate 180 Thionyl Chloride 080 5 3 : The committee decided to ratify the norms based on the recommendation of ment of Pharmaceuticals vide O.M.No35O11/36/2015-Pl (Norms) dt. iune 2015 as per given below or as applied by the firm whichever is lower:- I I LEVETIRACETAM つ ４ ４ Ｍ ‐ ５ ５Ｗ 卿 洲 HQ F‖ e 101/82/050/00931/AM15/
^ 0n: The committee decided to ratify the norms based on the recommendation of ment of Pharmaceuticals vide l.D. No35011/3412075-Pl (Norms) dt. June 2015 as per given below or as applied by the firm whlchever is lower:- Export product Qty Sl. no. lmport items Qty Kg/kg Ticagrelor lkg 1 2‐((3aR,4S,6R,6aS)‐ 6-amino-2,2‐ dimethyl‐ tetrahydro‐ 3aH―cyclopenta[d][1,3]diox01‐4‐ yloxy)ethan01‐ L‐tartarate salt (OR)Cyc10pentyl‐ethoxy‐amine‐ L‐tartrate 320 2 ( I R,2S)-2-(3,4-difl uorophenyl) cyclopropanamine HCI (OR) Difluoro cyclopropyl amine 208 Tetrahydroluran 541 4 Methanol 312 Ｃ υ Dichloromethane (or)Methylene Chloride 683 ´ ０ Toluene 1462 7 Hexanes 1052 8 Acetone 416 9 IsopropyI alcohol 131 ~骨 鮒鵬 N 厩蕊蕊蔦l戸蹴鼎α酬∞ω“ 8 囮 鸞 Date: 072015 : ln the light of written comments received from D/o Pharmaceuticals vide their OM No35011/104/2014-Pl(Norms) dt. September 2014 decided to call for following information from firm:
- Stepwise % Yield on moral basis alongwith copy of technical literature in support of yield envisaged and molar ratio of diethanolamine
- Past production vis-a-vis Actual consumption of input duly certified by Central Excise Authorities in respect of another advance authorisation taken by Matrix in 2010-11 No/Date:4/82- 1囲辮Ю釧∞ω“ 7 窯臨W競:「露de 回Department oF Ccmmerco
Case No.:59/10/82-
ALC4/2014
Party Name:MYLAN
LABORATORIES
ALC42015
12062015
;~
」
I)ate:
2015
: In the light of written comments received from Department of Pharmaceuticals vide
OM No. 3501 I /568/2014-PI(Norms) dated 05.05.2015, it was decided to remind the firm to
Past production vis-a-vis actual consumption of all imported inputs duly certified by
Excise Authorities.
No:39/10慇2-
鵬
星児5∽
""晨
MW脇
肥
oЮ∞翻AM W
: lt was decided to defer the case for want of comments of D/o (Pharmaceuticals).
Ψ
げ
%鵬星児
"Ю"4吸my隔ち乳
OЮO蕊話肥需Ю“
m“
Date:
4072015
: : lt was decided to defer the case for want of comments of D/o (Pharmaceuticals)
Meet No/Dttc:4/82-
ALC42015
12062015
Lic No/Date:0910060165
21052014
Decision : : lt was decided to defer the case for want of comments of D/o (Pharmaceuticals)
Party Name:ALMELO PVT
LTD
Lic No/Date:0910060207
Defer Date:
23052014
24072015
The representative of Pharmaceuticals has informed that reply fi,unished by the
is incomplete. Only production data given. Consumplion data not given. It was
Lic No/Date:0910060084
13052014
Party Name:MYLAN
LA30RATORIES
Case No:35/10/82‐
ALC4/2014 Meet No7Datc:4/82‐ LABORATORIES
Case No:41/5/82-
Meet No Date:4/82- ALC4/2014 :09/24/040/00096/AM15/ :01/82/050/00358/AM15/ to remind the firm to fumish the same immediatelv. No/Date:4/82‐ No/Date:4/82‐ 5 12062015 Ｍ ２ ０ ‐ Namc:MYLAN 12062015 No.:36′ 10/82- Name:MYLAN TORIES
Case No.:119/8/82‐
Partv Name:KtIStlMA ALC4/2014 Mcct Nυ Date:4/82‐ ALC4/2015 12062015 RLA File :03/94/040/00115/AM15ノ Lic No/Datc:0310782930 Defer Date: 26052014 24072015 It was decided to defer the case for want of comments of D/o C&PC Chemicals. Def'er Date: 24072015 IDecision:L was decided to deferthe case for want ofcomments of D/o Pharmaceuucals Meet No/Date:4/82- ALC472015 12062015 1133児50/00985/AM15/ RLA F‖ c :56/24/040/00009/AM15/ : The committee decided to ratify the norms based rtment of Pharmaceuticals vide O.M.No3501L|564/2074-pt given below or as applied by the firm whichever is lower:- on the recommendation of (Norms) dt. 26.2.2015 as per
Case No:71/10ノ82-ALC4/2014
Partv Name:SYMBIOTEC PHARMALAB LTD, Lic No/Date:5610004240 27052014 Dn: The committee decided to ratify the norms based on the recommendation of ment of Pharmaceuticals vide O.M.No3501L/4t/zOLS-Pl (Norms) dt. 29.5.2015 as per given below or as applied by the firm whichever is lower:- Export product Qty lmport items Qty Kg/kg Prednisolonc Acetate IP/BP/EP/USP l kg Prednisolone lP 0943 Prednisolone Sodium Phosphate BP/EPruSP l kg Prednisolone lP 0857 Prednisolone Hemisuccinate USP l kg Prednisolone lP 0850 Export product lmport items Qty Losartan Potassium 12.5 mg Film Coated Tablcts LOSARTAN POTASSIUM 12.75 mg Losartan Potassium 25 mg Film Coated LOSARTAN POTASSIUM 255 mg 14 Namc:MSN No′lDate:4/82- TORIES ATE LIMITED 62器 疏5ν0094νAM W みまFglЫ tt T格と 0 File 10/AM15/ 052014 …Dy oG品｀ dFα ttnTrat
Tablets Losartan Potassium 50 mg Film Coated Tablets LOSARTAN POTASSIUM 51 00 mg Losartan Potassium 100 mg Film Coated Tablets LOSARTAN POTASSIUM 102 mg Ｆ ‐ ‐ ６ ６ ‐ ‐ Decislon:にwas decided to deferthe case for want ofcOmments of D/o Pharmaceuticak コ Ｆ Ｉ 赫 ¨ 正 鯰 :3島児5υO“98/AMW I‰ ち鵬 υOm03法h Decision :~The comF7ttee detted~tottatifv the nOrms based on the recommendatiOn of )epartment of pharmaceu■cals vide i.D No35011/567/2014-PI(NormS)dt ∞4.2015 as per 」eta‖ s given below or as app‖ ed by the lrm whiCheverislower:― 7 Export product Qty SI No lmport items Qty Kg/kg LOPINAVIR lkg 1 L-Phenylalanine 0710 2 pSy I -tetrahydropyrimid-2-onyl)-3- methylbutanoic acid
0656 3 NN-Carbonyl diimidazole (CDl) 053 4 2,6-Dimethyl phenol 0618 Ｃ Ｊ Potassium carbonate 1368 6 Sodium borohydride 0819 ¨ ／ (L)-Pyroglutamic acid 0316 8 Tricthanolamine 100 9 Citric acid monohydrate 411 10 Methane sulfonic acid 1867 11 n-Heptane 190 12 Acetonitrile 064 Ｅ Ｊ No.:13/2782-ALC4/2015 NameJUBILANT LIFE 鵬疏 50Ю∞ 28/AM附 画面高孫面10 defer¨萱三mments of F"e蘭 .45/6/82■Lα″ "4騨臨
13 TctrahydrOfllran 263 14 120 Ｅ υ 1,2-DimethOxyethane 1016 16 Ｅ υ 一 ５ 17 -ldC 196 18 Toluene 215 29 Methylcnc dich10」de 157 20 IsoprOlly!JcOhd 050 bn: It was dedded tO deferthe case forwant ofcOnlment OfD/o Ph赫 Date: 072015 slon:ln the‖ ght Of w‖ tten comments received frOm D/o Pharmaceu■cak vide their oM 011/14/2014‐ PI(Norms)dt 08 06 2015, l was decided to call fOr fOIIowing information the firm: 1' A copy of appropriate Drug License issued by State Drug contror Administration in appropriate form. 盟世 =[二 1幌52 / 1ヽ「■●『 :_ 趙 鶉 鰺 lyQTir.ourzrosoroozoar lir-e lAMf 5/ _ l:03t9a 'Decision : the committee decid, Department of pharmaceuticals vir details given below or as applied by常」梢wi∬χ ttβ 伸∝ m.止Ap 蘇 | mmendation 。 「 ri1 2015 as perl Export product Etodolac Qty lmport tems Qty Fg/kg lkg /― Lthyl l ryptOphol 072 054 Mctllanol 114 ), C 16 No.:51/8/82‐ ALC4/2014 Name:PVS No/Date:4/82‐
Case No.:8/18/82-ALC4/2014
Party Name:DEEPAK Meet No/Date:4/82- NITRITE LIMITED ALC4/2015 12062015 Lic No/Date:0910060403 Defer date 09062014 072015 informed that reply fumished by the ~F蔦 高面面扇=壼 雨面戸 | | 701 is incomplete. Only production data given. Consumption data not given' It was to remind the firm to fumish the same immediately. The representative of Pharmaccuticals has infolllled that reply furnished by the is incomplete. Only production data given. Consumption data not given' It was ded to remind the firm to fumish the same immediately' :t was decided tO deferthe case fOr want ofcommentS Of D/oC&PC(ChemiCak) 「翻暉 :09/24/040/00118/Aヽ115/ ゝ R諄認 当錯‐ 1出含R %躊雪お零辮 de ネ熙需踊潔聞蠅f懸聖l鵬麓 ud菫聾轟繍誡 IH
Case No.:15/8/82-ALC4/2014
Case No:106/8782-ALC4/2014
:01/82/050/00770/AM15ノ 17 10040192 1 Dcfer datc 2015 Namc:BAYER No/Datc:4/82- IALC4/2015 112062015
Case No.:77/8/82-ALC4/2014
Party Name:BENZO CHEM INDUSTRIES PRIVATE No/Date:4/82‐ 12062015 Lic.No/Date:0310785501 Deferdate 17062014 :忙was decided tO deferthe case fOr want Of cOmments Of D/oc&Pc(chemた ak) 1濶ル : ln the light of written comments received from DBT;;;;; dtJi.O:OrS, tt* r decided to callfor following information from tne firrn- I . Drug Manufacruring license 2' Consolidated Batch mmufacturing record showing material dispensing materiar used _jd .?!e]Ilrj"j9Iu11":g! ., qya uy ih. f ffi ;;; in charge. Meet No/Date:4/82-
- COA of the import items from foreign supplier. H鍛蹴鷺棚:器説常轄 L:]‖lふsLnmtt Jh"■hn
Case No:20/882‐ ALC4/2014
Paty Name:SRINI PHARMACEUTIcALS LTD, ALC42015 12062015 gO
Case No.:83/l8 /82_ALCt/2Ol I panyName:TNDIAN
rpriluNoloc'r-ceisrro., Xil,o).Jir,'".,r, l,"fnT.o t2.06.20 15 t4.1.2015 18 1/AM15/ 96/AM15/ F33児 "Ю∝脚 Amシ 7062014 No.:19/8/E2-A LC4IZO f a ?urty Nur.,tf efenO t-eAS LIMITED 2015 Defer date Defer date liSbn:The cOmmttee h‖ ght。 「 お罵孫昴::。fЪ昴轟罵訴i弓面赫
「 而 ` l No35011/676/2013-PI(Norms)dt 21 4 2014,decided tO call fOr fO‖ Owing information from nrm:_ No/Date:4/82- 12062015 血L In thelltt J面ttcnttmmms面 蕩 盪 8推濾騰 l鷺曽【 015-Hc
: ln the liBht of written comments received from DBT vide email dt.17.6.2015, the
mittee decided to call for followlng information from the firm:-
l. Drug Manufacturing license
2. Consolidated Batch manufacturing record showing material dispensing material used
and material reconciliation duly signed by the production in charge.
1濶"町
1辮辮:
: lt was decided to defer the case for want of comments of D/o Pharmaceuticals.
Meet No/Date:4/82-
ALC4/2015
12062015
鵬
3捻5υ∞■″Am夕
1脱
糀
。Ю∞辮A剛夕
1蹴鼎αmm“48
IDeferDate:
124072015
: lt was decided to defer the case for want of comments of D/o pharmaceuticals.
囲開
o“Ю
786143
Date:
072015
Decision : lt was decided to defer the case for want of comments of D/o C&pC (petro
Chemicals).
―
吻
Date:
072015
: ln the light of written comments received from D/o pharmaceuticals vide their oM
No35011/44l2014-Pl(Norms) dt. 17.6.201s, the committee decided to call for copy of approved
list of formulations with composition and size of ampoules of injections to be exported from the
Lic No/Datc:0910060517
20062014
Party NamelTHINQ PHARMA‐
Case No.:52/8/82‐ ALC4/2014
CHEMICALS PRIVATE
Case No.:80/8/82-ALC4/2014
Party Name:PREGNA INTERNAT10NAL LTD C“eN∝り 9/6/82AК4/2014医肩雷面蔽耐W需戸琥汗~阿 19 % No:111/8/82-ALC4/2014 78/AM15/ File Name:LAKE No/Date:4/82‐ 12062015 15/ 10786114 062014 File File
Defer date 072015 : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals)' ヽ4eet No/Date:4/82‐ ALC4/2015 12062015
Case No.:83′ 3/82-ALC4/2014
: ln the light of written comments received from D/o C&PC vide their OM No.14010/14l2015-Ch-ll dt. 23.4.2OL5, it was decided to call for following information from the 12062015 | | Technical specifications and certificate of analysis (coA) for Dipentene (Mixture of Monocylic Terpenes) to be exported along with copy of export order. Printed authentic technical literature/certified quantity of raw-materials required for the manufacture of Dipentene by NCL Pune. Details of By-products obtained during the manufacturing process along with their quantity & value. Details of production of Dipentene in the year 2ol3-14 and 2014-15 and corresponding consumption of Gum turpentine Oil duly certified by CA' Any other relevant information. No.:13/8/82‐ ALC4/2014 F出哭 嚇 FttM~ Lic No/Date:0910060577 04072014 3 The committee decided to ratify the norms based on the recommendation of dt. 29.5.2015 as Per ils given below or as applied by the firm whichever is lower:- Department of Pharmaceuticals vide O.M.No.35011/35/2015-Pl (Norms) ヽ 喘
Case No:202/6/82-ALC4′ 2014
Party Name:FORACE POLYMERS(P)LTD Lic No/Date:0510389232 :01/82/050/00604/AM15/ :05/23/040/00139/AM15/ 01072014 Meet No/Date:4/82‐ MEBEVERNE HCL 20 陽λ非∽m吸剛夕 | ｃ ５ 防 ２ ０ ‐
I .4-Dibromo Butane
057
4-Methoxy Benzaldehyde
0733
Sodium Mctal
030
Toluene
057
"棚児
5ν∞
"8ハmy
厩鱈繭蘇
1辮辮
陶
柵
志憔
uM‐
D鱚
~四
%2015 1
Case No.:28/10/82‐ ALC4/2014
~
甲Ⅲ前ⅧP西師
鯰
器星児mЮ B引晨剛y
膨
鵬υ剛ヮAmy
闘需
面
∞60“5鵬
雛
:
F5こ
こ晨こ
31「『扇
「罵層こ
1「]]3こ通
「品
「こ
[三]「『子
『[轟for want ofcomments of Dノ。Pharmaceutica應:
No.:64/9/82-ALC4/2014
Decision : The committee decided to ratiry the norms based on the recommendation of
Department of Pharmaceujcais vide O M No35011/578/2014-Pl(Norms)dt 5 5 2015 as per
1棚‰ Ю∝aAMv
障筋鵬OЮm"AMw l脚
辮
憫Ю電磁
1
:01/82/050/00976/AM15/
details given below or as applied by the firm whichever is lower:-
駈
No.:64/10/82-ALC4/2014
Name:SATYAJIT
No/Date:4/82‐
PVT LTD, :ALC4つ015
12062015
Namc:GLOCHEM
No/Date:4/82-
12062015
108072014
No:62/10/82-ALC4/2014
Namc:STERLING
臓鮮鯉
~
15/ 108072014
Date:
2015
くυ κlA
irlrcrq
21
…
。icOmmc
| 「M 諄鮮纂 鵬星児 "加ωttMy 開淋蕊蔦~脚 辮m""4 Date: 4072015 :The committee decided to send copy ofapplication to DBT and defer the case. Date: 072015 : lt was decided to defer the case for want of comments of D/o C&pC (Chemicals) Жh滲纂阿 喚m夕 ♭器 開 °箕Ю餌 "お 囲 需 r want ofcomments of D/oC&PC(ChemiCals) Export product Qty lmport item Qty Kg/kg ETHISTERONE lkg 4-AndЮ stene-3,17‐ Dione(AD) (or)Androst‐ 4‐enc-3,17 Dione(4 AD) 103 :The commttee declded to ratify the norms based on the recommendaJon of lt of Pharmaceuticals vide:D No35011/464/2013 PI(Norms)dt 21 10 2013 as per ,n below oras app‖ed by the firm whicheverislower:― Export product Qty lmport items Qty kg/kg Tadalafil lkg (lR,3R)-1,2,3,4 TETRAHYDRO-2- CHLORO ACETYL‐ 1(3,4- METHYLENED10XY PHENYL)― 9H―PYRIDO[3,4-Bl― NDOLE‐ 3- CARBOXYLATE(TAD40) 165
Case No.:200/6/82-ALC4/2014
Pa,y Name:PANACEA BIOTEC LTD, 22 No.:72/10/82‐ALC4/2014 1Pary Name:GLOBAL IMect No Date:4/82‐ 1棚 鷺 "Ю":6晨 m夕 陽ち棚 ∽m2晨、高
Ｆ
Ｉ
Ｉ
G"¨¨ 知41騨
:琳i3い
「
器3鬼5ν∞
"2魔my l協棚υ∞り
4/AMl夕 |ぶ鼎
e091∞ωηO「
Decision The comm■tee decided to raJ″
the nOrms based on the recommendatlon
Department of PharmaceuJcaL vide:D.No35011/82ノ2015-Pl{Norms)dt 25 6 2015 as
deta‖s given below or as applied by the firm whicheverislower:
Of
per
Export prod uct
Qty
lmport items
Qty kg/kg
Alpha‐ (2‐MethyI Amine) Ethyl
Benzene methanol
lkg
Benzaldehyde
172
Iso Propyl Alcohol
078
Palladium
0002
Parafollllaldehydc
040
Acetophenone
Sodium Boro Hydride
011
Case No.:25/15/82-
ALC4/2014 Party Name:SHIVAM OILS & PROTEINSINDUSTRY, Date: 072015 | 鵬星鬼 5ν∞■ 5ムm夕 既珈蕊蕊蔦¬鼎開°箕Ю““%閉需 3 ln the light of written comments received from D/o Pharmaceuticals vide their OM 35011/566/2014-PК Norms)dt 25 2 2015′ ■was dedded to ca‖ for fo‖ owing informaJon the firm:- py of master Batch formula for each strengths of export product duly certified by their Q'C in showing net content of APls and each of the excipients used a nd applied for import. 鵬 3児5温45ハ瓢ζ「蕩脇lぷmヌ 1孵鼎α 04101tt Ю 3 The committee decided to ratify the norms based Department of PharmaceuticaL vide O M No35011/649/2014‐ PI on the recommendation of (Norms) dt. May 2015 as per ffi grqrs/ NTRMAL KUrv.tAR sq <Frf++srz6 fraf ErIrrR Oy. Di€ctor General of Forei9n Trade f{isr qrqrq qtrfr*srrfrq Dnedorate General of Foreign Trade slFfq fttFuoepartnenl of commerce sdrn lrdar, Tg erd Udyog Bhawan. N6w Delhi Mcct No/Datc:4/82- Lic No/Datc:5610004338
Case No:48/9/82-ALC4/2014
23 12/AM15/ File
given below or as applied by the firm whichever is lower:_ Export product Qty lmport■ems Qty kg/kg rilヽih Aヽ 0しllヽυAlVI Iし1lN H Yυ КυCHLORIDE ACTIvE PHARMACEUTIcAL INGREDIENT LNcoMYCIN HYDROCHLORIDE ８ ２ Ｕ ２ ０ ｌ Ｂ KA may take further action accordingly. 帆 一 ¨ Date: 4072015 l :The committee noted that infOrmatiOn had been ca‖ ed fOr from the vide in its No 02/82 dated 29 4 2015 but no reply receⅣ ed from the nrm so far The cOmmttee rd to remind the firm to submit the requisite information within a period of 2 weeks fairing case will be decided on the basis of available information. :L was decided tO deferthe case fOr want ofcOmments Of D/o Pharmaceutにak [鮮U「1騨¨ 幽 1蘇 嚇麟 n *"r 0".'0"*t:tG, *-*rr"nt.o-fo *.-..ffi
Case No:18/15/82-
['鵠∫柵駆濯繕lt酔2露:紺1驚地肌t犠i聴:鳶鳳糠曽ォ孵 HBP vl as per details given below Or as applied by the firm′ whicheveris iess: Export product Exp Qty SI No lmpo咸tems Qty a‖owed 0 862 kg 磁Юna M「PШり l kg ０ ４ 鋭FЮ mahanem生P面″ 0 703 kg No.:66/8/82- Name:RECKITT No/Date:4/82‐ 1鑑盤ピ File No:21/9/82- Name:PIINDUSTRIES No/Date:4/82‐ TD, 5 Filc 1310047575 Date: 187AM 15/ 13/24/040/Ooo20/AM15/ No.:227/13/82- 105 ● 一 ´ ぎ 一 一 ， Ｖ ´
ヘ 3 Dimethylsulfoxide(Min Pu‖ ty 99%) 0 875 kg 4 Hexamine(Min Punty 96%) 1 000 kg 5 Toiuene(Min Purity 97%) 0 430 kq 6 lsoprOpyl Alcohol(Min Punty 99%) 0 220 kg may take appropriate action as per the decision of Norms Committee. )cision: committee considered the case as per agenda and in the light of earrier deci;io; (en by Nc in its 6/82 meeting dated 29.o8..zol4, it was decided to ratify norms under para 4.i 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 a‖owed Piperonal Min Purity 98% l kg 珈 in Punty 99%) 0 862 kg 2 Dichloromethane (Min. purity qe%) 0 703 kg 3 DimethyLulfOxide(Min Pu‖ ty 99%) 0 875 kg 4 Hexamine (Min. Purity 960/0) 1 000 kq 5 Toluene(M n Puttty 97%) 0 430 kg 6 鯰 り川∞旧仰h ttT 0 220 kg mりtakc appropHatc acuon as perthc dedJOn Of― ― 「莉淵‰T哨鮮"~ LDぼ 酬 T酬 移 F“ 晰 劇 107 :03/95/040/00428/AM15/ :忙was decided tO deferthe case for want ofcOmments Of D/oC&PC{chemicals) :01/82/050/01304/AM15/ 雪 酬 ｀ |ヽ "侶彗 『電需駕 11:|「 Dictorate Cenerel、,“ 赫 n― Dep3威nleni ud死聾 鳳 謀 Ｅ υ つ 乙 No.:228/13/82- NameiCROWN No Date:4/82- 隔舗 脱OЮ餌 “ 晨m夕 1蹴 開 ° "Ю ・ 8328 No.:2,4/13/82- PなりName:SEQUENT~~~~匝藻T雨35面3扇彊江 10788513 1Defer Date: :lt was decided to deferthe case for want of cOmments Of D/o PharmaceuJcals
~田に即吻 「 1濶m_ド¨ 1器3児5υ0220AMl夕 陽λ刷:餅00494M
No/Dat●0310788620
Date:
:03/94/040/00494/AM15/
‐02092014
072015
: ln the light of written comments received from D/o Pharmaceuticals vide their OM
No3501U633/2014-Pl(Norms) dt.10.4.2015, the Committee has observed discrepancies in the
quantities of various inputs applied for import and the certificate about past production of
export products and corresponding consumption of dlfferent inputs. lt was decided to
clarification/confirmation from the firm that the CA certified consumption /production
enclosed with the appllcation has correct figures.
Meet No/Date:4/82‐
ALC4/2015
12062015
: lt was decided to defer the case for want of comments of D/o Pha rmaceuticals.
No.:45/15/82‐
4/2014
Date:
4072015
FN¨
和
伽
4甲
酬
耐
腰
鮮
纂
胃
赫
: ln the light of written comments received from D/o Pharmaceuticals vide their OM
No35011/37/2014-P(Norms)dt∞062015, I was dedded to call for following informajon
l12
the firm:-
1. Specific use of Lithium metal and n-Butyl chloride is not given in the
However, these are consumed in the process may be
process/Reactions.
explained.
2. Past production vis-a-vis actual consumption of all imported inputs duly
|ヽヾごぅ
by Central Excise AuthoHtics
| |
|| |＼
蝉
鵬
島児5υ∞
“
拡MW
陽ち鵬
OЮ酬
靱
1蹴鼎
e。91∞ω%3[蔦
需
珈
「
lmttα
H銀°URLAB ttl囃
等
″
"‐
F“
DeFer"孟
繭
鼈
26
Lic No/Date:0910060921
05092014
Party Name:GLAND
PHARMA LIMITED
Meet No/Date:4/82-
:01/82/050/01332/AM15/
蹴辮側∞ω
%7
No:55/15/82-
Namc:COVALENT
^
鵬島児
50Ю%70/Amy l脇糀υ
00314AMЫ
Date:
072015
: ln the light of written comments received from D/o Pharmaceuticals vide their OM
No35011/664/2014‐ Pl{Norms)dt 20 5 2015, it was decided to ca‖
for production/conSumption
from the firm duly certified by Central Excise Authorities.
No.:8/8/82-ALC4/2014
: lt was decided to defer the case for want of comments of D/o Pha rmaceutica ls.
P征りName:ADCOCK
INGRAM LTD,
IMeet No/Date:4/82‐
ALC4つ015
12062015
: : In the light of earlier decision taken in meeting no.3182 dated 08.05.2014, il
decided to ratify norms under Para 4.7 of HBP vl as per details given below or as
by the firm, whichever is less:
Paracetamol 450m9
+ Codeine Phosphate
l0mg+ Caffeine
45mg + Doxylamine
Succinate 5mg
Tablets
‐
ｉ
ｏ
ｎ
‐
ｃｔ
ｓ
ｌ
ｍ
ｔ
ａ
l
Doxylamine Succinate USP/Ph.
Eur Grade
5 10 kg
う
ん
Codicnc Phosphatc
BP/EP/USP/PH EUR
10 2 kg
3
Colour Ycllow 14037 1 H
2 43 kg
4
Colour Quinoline Yellow WS
(spectracol)
4 56 kg
RA concemed may take necessary action accordingly.
PaFy Namc:JINDAL DRUCS
LIヽ41TED
Fne lRLA File
腰鮒ル
Date:
072015
: lt was decided to defer the case for want of comments of D/o C&PC (Chemicals)
ALC42015
12062015
Lic NυDate:0910060989
Party Name:HONOUR LAB
LIMITED
.ALC4/2015
112062015
## Case No:115/18/82-
ALC4/2014
## Case No:12/1S/82-ALC4/2014
1/82/050/00677/AM15/ :09/24/040/00324/AM15/
17092014
防
２
０
‐
H4棚
児
590“
"ハm夕 ~lucNo/Dat
/24/040/003 1577AM15/ 112092014
## Case No.:38/15/82‐ ALC4/2014 PaFy Name:SALICYLATES&IMeet No/Date:4/82‐
CHEMICALS PRIVATE
ALC4つ015
LIMITED
12062015
Paty Namc:HETERO DRUGS
Meet NげDate:4/82-
LIMITED,
ALC42015
12062015
I II lnqa;l"-
101/82/050/00789/AM15/
: lt was decided to defer the case for want of comments of O/o pharmaceuticals.
Mcct No/Date:4/82-
ALC4/2015
つ
‘
つ
４
12062015
3 lt was decided to defer the case for want of comments of D/o Biotechnology.
## Case No:60/15/82‐ ALC4/2014
Party Name:CLEAN SCTENCE lMeet No/Dare:4/82-
ALC4/2015
12062015
Date:
072015
Pa●y Name:HETERO LABS
Meet No/Date:4/82‐
LIMITED
ALC4/2015
12062015
:09/24/040/00339/AM15/
Paty Name:HETERO LABS
LIN41TED
File
109/24/040/00341/AM15/
×
## Case No.:125/8/82‐ ALC4/2014
ic No/Date:0910061000
19092014
## Case No:9/15782-ALC4′ 2014
Party Name:VIRCHOW
BIOTECH PV T LTD,
Lic No7Date10910061001
:01/82/050/01296/AM15/
:09/24/040/00327/AM15/
19092014
:01/82/050/01347/AM15/
Lic No/Datc:3‖ 0064915
:31/83Ю40Ю0136/AM15/
## Case No.:127/8/82‐ ALC4/2014
Lic No/Date:0910o61002
:01/82/050/00791/AM15/
## Case No.:128/8/82-ALC4/2014
Meet No/Date:4/82-
IALC4/2015
112062015
Lic No/Date:091oo61003
122092014
1/82/050/00792/AM15/
28
隧
円
3鷺50/O1325/Am夕 1協
棚
OЮ囲
ハmy
TECHNOLOGY
LTD
EROLABS ili]::「
~~
阻my 囲靡Ⅲ画面辮辮
:
)r want ofcomments of D/o Pharmaceuticals
…S
師
2晨my l淵鼎α酬∞
a∞5囲齋
or want ofcomments of D/o Pharmaceuticals
「F¨
/2/82‐AL∽帖
1鼈:w
「want ofcomments of D/o Pharmaceutica:s l
|
Ｆ
‐
‐
２
７
‐
‐
No■29/18/82‐ ALC4/2014 1PaッName:CAMPHOR& IMeet No/Date:4/82-
l lt was decided to defer the case for want of comments of D/o C&pC (Chemicals).
〒翻呼
~F薦而訂
M夕
爾
齋
戸
而
面
辮
器:~
r want ofcOmments of D/oC&PC〔ChemiCa:s).
mmul滲"師
蕊i戸階だ鼎
C“Ю
"∞"1需需
,r want ofcOmments of D/oC&PC(ChemiCa:s)
^
PRODUCTS
12062015
HQ File
:01/82/050/01395/AM15/
Date:
2015
¨
i
## Case No.:46/15/82-ALC4/2014
LABORATORIES PVT LTD
134
Meet Nυつate:4/82-
ALC4/2015
12062015
Lic No/Date10910061072
Date:
09102014
072015
: lt was decided to defer the case for want of comments of D/o C&pC (chemicals).
## Case No.:113/9/82-ALC4/2014 Pany NamelASTRIX
Mcet No/Date:4/82‐
LA30RATORIES LTD,
ALC42015
12062015
Meet No′Date:4/82‐
ALC42015
12062015
: lt was decided to defer the case for want of comments of D/o pha rmaceuticals.
Meet No/Date:4/82‐
ALC4/2015
12062015
: lt was decided to defer the case for want of comments of D/o Biotechnology.
Decision : lt was decided to defer the case for want of comments of D/o pha rmaceuticals.
Meet No Date:4/82-
ALC472015
12062015
Date:
2015
「51113晨「[1「F「:雇[「EEE屁「]『15「『E「:rthe case fbr want ofcomments of D/o pharmaceuticals.
Lic No/Date:0910061093
15102014
Casc No.:42/15/82‐ ALC4/2014
青∬鼎調釧∞aЮダ
1器辮:
## Case No.:13/15/82-ALC4/2014
Lic No/Date:091006H ll
16102014
F乱″¨ 叩ポ… 財¨ 町
鵬3児50Ю 鯰%/AM Ⅳ
膨
鵬
oЮ
“
85/AM W 囲
需
両
面
而
1辮辮:
## Case No:58/15/82‐ ALC4/2014
P征りName:SUVEN LIFE
SCIENCES LIMITED
## Case No.:152/13/82-
ALC4/2014
:01/82/050/01155/AM15/
30
Namc:PORUS
B3器
駆児50/O130ν AMl夕
1型狸JIwTJ,J型J空里里空型空た。mmmsJりo助計m“酬∞しコ
]Decision : lt was decided to defer the case for want of comments of D/o Pharmaceuticals.
IE*
Nr.St/I0/S]
F",ty N"..*lONOt R LAB E;r No,Dare/S2- Frrtrr0.f.*"d
I lALC420r4
lLrMrrED
ALC4/2015
I
I
i
t2.o6.2ots
Ea Fll.
IRI-A F,t.
Et.J.lr,D"r"o9l 006l lX [o"f", out*
140 l:01/82/050/00995/ AYtst t:Ogt24tO4OtOMOT lAMt Sl
22.10.2014
'24.07.2015
iDecision rln the light of written .o.tn"ntr ,"."ir"d from D/r Pt'a"";uticals vide their OM
I
lNo350rV664/2014-Pl(Norms) dt.20.5.2015, it was decided to call for production/consumption
lcertificate from the firm duly certified by Central Excise Authorities.
F万
円ご商品瀾PL ADDFIVE「中
Ξ IIml
31
〕ase No:78/10/82-
ヽLC4/2014
躙
淑
αHETEЮ LABS 腰麟ド″泌
IStatus:DeFerred
HQ File
:01/82/050/00992/AM15/
RLA File
:09/24/040/00393/AM15/
ILic No′ つate:0910061130
122102014
1辮辮:
File
No:79/10/82-
Namc:HETERO LABS
No.:36/18/82‐
Name:APEX
No/Date14/82-
File
10790531
Date:
2015
102014
No:84/10/82‐
NamelHETERO
No/Datc:4/82-
靡
万晨よ所0061 ИO日粟荷漂α
127.10.2014
124.07.2015
: lt was decided to defer the case for want of comments of O/o Pharmaceuticals.
No.:80/10/82‐ ParN Namc:HETERO LABS IMeet No′ Date:4/82-
Decision sThe committee decided to ratify the norrr b"r"o on the recommendation of
Department of c&pc vide u.o.No.1401o/7/2011-ch-[ dt. 29.5.2015 as per detairs given berow
or as applied by the firm whichever is lower:-
Qty
Azodicarbonamide
lkg
Hydrazine Hydrate(100%)
0 548 kg
Technical Grade Urei
1 316 kg
RA may take further action accordlngly.
ド……“知
4甲魃wT臥腰鮮¨
## Case No:38/18/82-ALC4/2014 Pary Name:CROヽ
ヤN
Lic No/Date:0510391738
105/23/040/00305/AM15/
27102014
CHEMICALS PVT LTD,
ALC4/2015
12062015
Date:
072015
ion : committee considered the case as per agenda and in the right of earrier decision
by Nc in its 6/82 meeting dated 29.09.2014, it was decided to ratify norms under para 4.7
ALC4/2014
Name:CROWN
ИICALS PVT LTD,
No/Date:4/82-
1/2015
「
~
)fer Date:
072015
――――――――――
~ 1■1 ~ ~I三 ´
・
・・・´′
14ン ,V4V■‐
lz4 u′
Zυ l)
ecision:cOmmtttee conJdered the case as per agend[Ъ
nd iTFhe lしht Of e『;籠rd配
`br
ken by NCin ts 6/82 meelng dated 29 08 2014,I was decided tO ratify norms under Para 4ラ
HBP vl as per deta‖ s given below Or as applied by the firm,whichever is iess:
144
Export product
ExP
Qty
SLNo
lmport items
Piperonal Min Pu百ty
98%
l kg
1
CateChol(Min Pに
0 862 kq
2
Dichloromethane (Min. purity
99%)
0 703 kg
3
歌
hJШ陥力“
mR Purty
0 875 kg
4
Hexamine(Min Pun[y960/Ol
1 000 kq
5
Toluene(Min Punty 97%)
0 430 kq
6
翁
pylA cmЩ Mn Purlty
0 220 kg
may take appropriate action as per the decision of Norms Committee-
Meet No/Date:4/82‐
Lic No′ つate:0310790589
29102014
1器3掲50Ю И
ttAMlシ
HBp vl as per details g:ven below Or as applied by the firm′ whichever is less:
2
Dichloromethane(Min Punty
99%)
0 703 kg
3
Dimethylsulfoxide(Min Punty
99%)
0 875 kg
4
Hexamine(Min Puntv 96%)
1 000 kq
5
Toluene(Min Puntv 97%)
0 430 kq
6
lsopropyl Alcohol
(Min Puntv 99%)
0 220 kg
may take appropriate action as per the decision of Norms Committee.
## Case No:141/13/82-
ALC4/2014
146
Party Name:YASHASHVI
Meet No/Date:4/82-
RASAYAN PVT LTD
ALC42015
12062015
HQ File
:01/82/050/01144/AM15/
Casc No:70/18782-
Party Name:GLENMARK
Mect No7Date:4/82‐
ALC4′ 2014
GENERICS LIMITED
ALC4/2015
12062015
IDecisio■:k was decided to deferthe case for want ofcomments of D/o Pharmaceu■
caL
No:86/10/82-
Party Name:SHM
Mcet No/Date:4/82‐
PHARMACHEM LTD,
ALC4ノ2015
И8鵬3鷺釧
∞。魔m"障
危鵬
OЮ釧%ハm夕
圏
辮
側
∞
“ “
4辮
雛
:
12062015
Meet No/Date:4/82-
LA30RATORIES LIMIT ALC4/2015
12062015
Decision : lt was decided to defer the case for want of comments of D/o Pharmaceuticals
No:57/15/82-
14
4
No.:6/15/82-
4/2014
bO鵬
島児5υ∝鉾4晨my隔
角鵬
υOm υAM夕
貯
∬鼎
°明
∞御応4囲
蕊
RLA Fne:09/24/040/00378/AM15/
Lic No/Datc:091006116
:01/82/050/01293/AMI
Party Name:VtVIMED LABS
LIMITED
ALC42015
;Case No.:45/18/82-
lN,ctnotq
鵬
先50畑4VAm y障
蹴
υ∞θ ttm夕
[ドだ鼎
醐釧
"∞
御3
Date:
072015
:The representative ofD/o C&PC(Chemicals) vide their letter No. 15022/1/2015‐ Ch― ||
from the firm and
16 06 2015 has informed that fo‖ owing information have been ca‖ ed
is awaited:-
of production of NA-CMTS in the year 2014-15 and 2015-16 and corresponding
ion of raw-materials duly certified by CA.
1. The basis of applied quantity of raw-materials for the manufacture of NA-CMTS.
2. Any other relevant information.
Accordingly, the Committee has decided to remind the firm to submit the above
information immediately.
Date:
2015
: lt was decided to defer the case for want of comments of D/o pharmaceuticals
Meet No/Date:4/82-
ALC4ρ 015
12062015
Date:
072015
Party Name:VENUS
Meet No/Date:4/82-
REMEDIES LTD,
ALC4/2015
12062015
Date:
072015
Party Name:CLENMARK
GENERICS LIMITED
1薇「に3"｀1■81/13/82ALC4/2014厚再NameRLFNECHEM IMedNα
Dat=″82-
卜mm" |
34
## Case No:31/15/82-
ALC4/2014
Lic NげDate:0510391872
Party Name:EYTAN LABS
LIMITED
Lic No/Date1091 006 1189
Lic No′ Date:2210015115
## Case No.:76/18/82-
Mect No/Date14/82‐
Name:BAYER VAPI
No Date:4/82‐
LTD
12062015
No.:49/15/82-
13AM15/ 07H2014
10790871 Defer Datc:
1器3月5∽1447ムmy l鶴ち棚900270ハmy
匿7盈F~ Peた
rred
囲瑯習面扉辮肌
:
lDecision : lt was decided to defer the case for want of comments of D/o Pharmaceuticals
## Case No.:19/15/82-ALC4/2014 Party Name:MALLADI
[F∬辮“
n,Ю6厭
Date:
072015
器3児5∽807ハ剛ヌ 膨鵬ν
00207AMW
Meet No/Date:4/82-
|り
Ю620b
Meet No/Date:4/82‐
´
０
Case NttИ錮猟LC4/2014ド
認淋
戸
腰
∬
~四
器
3泥50m“7Am y 厩淋蕊蕊~「
∬
ma"Ю""ω
l
Decision:The cOmmittee decided to ratify the norms based on the recommenda‖ on of
Department of C&PC vide U O No 14010/67/2011-Ch―
|ldt 22 6 2015 as per deta‖ s given below
or as applied by the firm whicheveris:ower:―
Export product
Qty
lmport item
Qty
EDTA Ferric Ammonium Liquid
lkg
脚器Fb輛m hmAはに0 460 kg
may take further action accordingly.
―
に
r■P→ス7
テ
i,
## Case No:100/4/82-
ALC4/2015
IHQ F‖ e
Ｅ
υ
つ
Ｄ
1710005978
&
No.:20′15/82-ALC4/2014
Name:MALLADl
&
~唇
[1'17RTよ
扇
籠
r
ゝ
「01/82/050/00139/AM16/
|:1724/041躊
112H2014
HQ Fne
l,:0 I I 82 l0 50 / 0 I 464 / AMt 5 /
No.:77/18/82-ALC4/2014 Parw Name:LAKELAND
Mcet No/Date:4/82-
CHEMICALS(INDIA)LTD
ALC4/2015
12062015
1器3児50畑443AMl夕
1鱚悩扁
: lt was decided to defer the case for want of comments of D/o C&pC (Chemicals)
## Case No.:24/15/82‐ ALC4/2014 1Pa■y Name:SHIVAM OILS&
Meet No/Date:4/82‐
PROTEINS INDUSTRY,
ALC42015
12062015
l“
器3月50畑311ttMlシ
Date:
072015
1面sion:lt was decttd to deferthe caseforwant ofcomments ofD/oC&PC{ChemiCa:s)
HQ File
:01782/050/01412/AM15/
RLA Fle
:03/94/040/00748/AM15/
Meet No/Date:4/82‐
ALC4/2015
12062015
境危鵬OЮ。
99ハMЫ
Lic No/Date13410040677
13112014
Date:
072015
Lic No/Datc103 10790966
12112014
Lic No Date:5610004468
:56/24/040/00046ノAM15/
12112014
Meet No/Date:4/82‐
Lic No/Datc:0310791014
13112014
Decision:The commttee decided to ra■
fy the norms
Department of C&PC vide U O No 14010/67/2011‐
Ch― |!dt
or as applied by the firm whicheveris lower:―
based on the recommendation of
22.6.2015 as per details given below
Export product
Qty
lmport item
Qtv
EDTA DlAMMONIUM POWDER
lkg
Ethvlene Diamine Tetra Acetic
Acid(EDTA)
0 825 kg
36
No:98/18/82-ALC4/2014
Name:KARNATAKA
No/Date:4/82-
&
LTD,
1鶴危棚υ
0027νAM剛
Name:AVA
PVT LTD,
12062015
No:65/18782-ALC4/2014
## Case No.:72/18/82‐ ALC4′ 2014
No:42/18/82-ALC4/2014
P″″Namc:LAKELAND
Meet No/Date:4/82‐
CHEMiCALS(INDlA)LTD
ALC42015
112062015
: lt was decided to defer the case for want of comments of D/o C&pC (Chemicals)
## Case No.:56/13/82-ALC4/2014P″ ″Name:MALLADl
DRUGS&
1棚児
m畑42晨myに
A Ⅲ
c
卜
04/24/040/OIX171/AM15/
Meet No/Date:4/82‐
:01/82/050/01301/AM15/
13112014
Meet No/Date:4/82-
ALC4ノ2015
12062015
Deferred
…
…
‐ALC4/2叩
淋
誦
可
鮮
纂
Date:
4072015
: lnformation had been called for from the firm in NC meeting No.02/82 dt. 29.4.2015
reply is awaited. Accordingly, it was decided to defer the case.
Lic No′ Date:0310791049
13 112014
Meet No/Date:4ノ82‐
PHARMACEUTICALS
LIMITED
Lic No7Date10410159730
13112014
## Case No.:14/15/82-ALC4/2014 Paty Name:STERICON
PHARMA PVT LTD,
ALC4つ015
12062015
Par″ NmeiVIVIMED LABS
LIMITED
Lic No Date:0510392011
14112014
## Case No.:119/13/82-
ALC420:4
ALC4/2015
10392008 DetrDate:
鼈
齢
ud,聾轟瓢誡
“
RLA File
37
PHARMACEUTICALS
Date:
2015
つ
４
４
Ｄ
ａ
‐
５
醐
脚
No/Date:4/82‐
:01/82Ю50/01122/AM15/
IИ H204
:L was dedded tO deferthe case fOr want ofcomments of D/o Pharmaceutに
ak
Party Name:MYLAN
LABORATORIES LIMITED
Date:
072015
Date:
4072015
Party Name:MYLAN
Mect No/Date:4/82‐
LABORATORIES LIMITED
ALC4/2015
12062015
## Case No.:62/15/82-ALC4ノ2014
Lic No/Datc:0910061248
Party Name:MALLADI
Mcet No/Date:4/82‐
DRUGS&
PHARMACEUTICALS
## Case No:39/15/82-ALC4/2014
Meet No/Date:4ノ82‐
Lic No/Date:0910061255
No.:41/15/82-ALC4/2014
l
■se No訓漉
ALC4/201万
1蘊繭
鰍
粗T,「
~顧
棚T酬"~1而
面
|
棚鬼
50/O138θ Am夕硼蹴蕊蔦~厭
蕊」面耐阿
Decision:Committee considered the case as per agenda and in the light of earlier decision
taken by NCin ts 6/82 meeJng dated 29 08 2014′ t was decided to raJfy norms under Para 4 7
of HBP vl as per details given below or as applied by the nrm′
whicheveris less:
Expoft product
Exρ
Qfソ
S′ Ⅳ0
lmpoft items
Qtv
allowed
Prpero″ al Ml17 ρυrlfy
98%
′kg
イ
carecゎο′rMl・
Pυ rlty 99%,
θ862 kg
2
Dlcわloromettane rA″ ル,Pυ″fy
99%リ
0 703 kg
3
Dllmettylsυ lfox′ de ttMln Pυ ″fy
99%リ
θ875 kg
`
月examlne 6И ρ Pυ″ry 96%,
イOθO ko
38
| ;
IDecision::t was dedded to deferthe case for want ofcomments of D/o Pharmaceu■cak
鵬
島児50Ю B87A岬
隔
糀
υ∞卿
AM W~~
| 1濶
磁
~ICaseNo.:24/18/82‐
ALC4/2014「
111ぽ
SHANT~~~~~
一
‐
８
０
IMeet No/Datc4/82‐
ALC4/2015
12062015
Decision : lt was (
((Pharmaceuticals)
5
To′υene rMlrl Pυ ″ly 97,つ
0 430 kc
6
lsopropylス′
cο力ο′(Min P41″ry
99%,
0 220 κg
may take appropriate action as per the decision of Norms Committee.
m21/18/82■LC4/2014P鱚踏D"
)cision : Committee considered the case as per agenda and in the light of earlier decision
(en by NC in its 5/82 meeting dated 29.Oa.2OL4, it was decided to ratify norms under Para 4.7
HBP vl as per details Biven below or as applied by the firm, whichever is less:
Exporl product
Exp
Q′y
SiⅣ0
′mpO″ ′fems
Qtv
allowed
aperora′ Ml●
Ptr″ry
98%
`kg
イ
Caわoわ0′ rMlll P″lfy 99%リ
0862た0
2
Dlchloromettane rMl17 P・″ty
99%,
0 703 κg
3
D力
"eめ
ylsυ lfoxlde rMllo Pυ″ry
99%リ
0 875 kg
`
Hexam′ne rMla ρυ″ry 96%,
イθOθ たo
5
To′υene rM1/1 ρυrlty 97%,
0430たo
6
Isopropylハlcoわ0′
`ん
″,Pυ″ry
99%リ
0 22θ kg
may take appropriate action as per the decision of Norms Committee.
## Case No:50/15/82‐ ALC4/2014
師
1辮器
「汀に薦τ雨諄百罰雨蔵ア画面ラ万olπ ¨
KELAND
No/Date:4/82-
Dcfcr Datc:
24072015
区おbn‐ wttdeclded to deferthe 3冨おrwantofcommeniof D/o Pharmateu■cJs
No/Date:4ノ82‐
Datc:
2015
D´ Ditti:ltil」:ご =
|-5 LTD昭
開
瓢
Ю
“"AM14/~Ⅵ
雨
鼎
C"Ю 期ら3
Date:
072015
Decision : lt was decided to defer the case for want of comments of D/o C&pC (Chemicals)
PaロッNamcMEDREICH
Meet No/Date:4/82-
LINIITED
ALC4/2015
12062015
1粉淵υ∞∞繁my
Meet No/Date:4/82‐
ALC42015
Deferred
12062015
Date:
072015
:L was dedded tO deferthe case for want Ofcomments of D/o Pharmaceutた
als
Meet No/Date:4/82-
ALC4つ015
12062015
Meet No Date:4/82‐
ALC4/2015
12062015
Lic No77Date:0310791309
21 112014
based on the recommendation of
18.6.2015 as per details given below
D:蕊混謂}轟電滞籠de
価
f=『ワDepanment oi Commerce
ud羹聾轟話誡
1ロ
:01/82/050/01389/AM15/
:01/82/050/01476/Aヽ415/
## Case No.:52/15/82‐ ALC4/2014
LABORATORIES LIMITED
Lic No/Date:0910061280
## Case No.:28/18/82‐ ALC4/2014
)●Ision:The cOmmltee decided to ratify
partment of C&Pc vide U O No 14010/85/20
as applied by the firm whicheveris lower:―
the norms based on the recommendation o,
12-Ch-ll dt. 18.6.2015 as per details given below
Export product
Qty
lmport item
Qty Kg/kg
Acetonitrile
lkg
Acetic Acid
1 766kg
ヽA may laKe Turtner ac tion accordi
40
NO.:5/15/82-ALC4/2014 Par●7Name:PVS
No/Date:4/82-
TORIES LTD
LTD
File
as applied by the firm whichever is lower:-
Export product
Qty
lmport item
Qty Kg/kg
Acetonitrile
lkg
Acetic Acid
1 766kg
189
嫌
¨
猟呻
田
F閻
面
「
1濶
m_7
器
島先50畑
“
眈
剛y
膨
鵬
OЮttvAmy
け
∬翻距
期
∞
“
η 5「
~
Decision:The committee decided to ra■fy the norms based on the recommendation of
Department of C&PC vide U.O No 14010/58/2011-Ch―
ll dt 17 6 2015 as per details g市en below
or as app‖ ed by the lrm whicheveris:ower:―
Export product
Qty
lmport item
Qty Kg/kg
Methy1 0ctine
Carbonate
lkg
1-Octyne
0 834kg
1-pentanol/N-Amvl alcohol
0 795 kg
Party Name:ENCUBE
ETHICALS PVT LTD
り2鵬
児5剛賀νAmy
隔
鵬
∽
"訂
Amy
囲
鼎
翻
"釧
ЮO囲
盤
No:34/18/82‐ ALC4/20:4
―
IDecision:t was decided to deferthe case for want ofcomments of D/oC&PC(ChemiCak)
Lic No7Date:0310791303
21 112014
No.:59/18′ 82‐ ALC4/2014
Mcct No/Datc:4/82‐
ALC4/2015
12062015
ハ
ン
41
Name:HEMA
No/Date14/82-
Date:
2015
¨
8/82 ALC4/2014孵
酬
面
可
鮮
"‐
Party Name:INDOCO
Mcet No/Date:4/82‐
REMEDIES LIMITED
ALC42015
12062015
Meet No/Date:4/82‐
ALC4/2015
12062015
Case No■9/18/82-ALC4′ 2014
Lic No/Date:0310791351
## Case No.:74/18/82‐ ALC4/2014
Partv Name:ADESHWAR
MEDITEX PVT LTD
Decision : lt was decided to defer the case for want of comments of D/o lPP.
No.:18/13/82-ALC4/2014 Pa●y Name:ANTHEA
AROMATICS PVT LTD,
Date:
4072015
: lt was decided to defer the case for want of comments of D/o C&PC (chemicals).
## Case No.:3211E/82-ALC4l20l4 Party Name:BDR
Mect No/Date:4/82‐
PHARヽ4ACEUTICALS
ALC42015
INTERNAT10NAL PVT LTD
12062015
Lic No/Date:0310791380
Date:
25112014
072015
CaseNo.:66/18/82-ALC4l20l4 PartyName:BENZOCHEM MeetNo/Date:4/82-
INDUSTRIES PRIVATE
ALC4/2015
LIMITED,
12062015
Date:
072015
IDecision:L was decided to deferthe case for want ofcomments of D/oC&PC{ChemiCab)
## Case No.:53/18/82-ALC4/2014 Parり
Name:CATAPHARMA
Meet No/Date:4/82-
CHEMICALS PVT LTD,
ALC4/2015
!2062015
Date:
2015
1)ecision:ITtlas decided t5:efe1lhe caseforwant ofcommentξ もfD/o Pharmaceuticals.
## Case No:1512/82-ALC4/2015 Pary NalneiSHALINA
Meet No7Date:4/82-
ALC4/2015
File
Mcct No/Datc14/82‐
Lic No/Date:0310791374
:0:/82/050/01398/AM15/
:03/94/040/00784/AM15/
:01/82/050/01432/AM15/
Lic No/Date:0310791375
:03/94/040/00739/AM15/
:01/82/050/01419/AM15/
:31/83/040ノ00057/AM15/
1/82Ю 50/00030/AM16/
LABORATORIES PVT LTD
12062015
ヘ
lDecision : lt was decided to defer the case for want of comments of D/o c&Pc (chemicals)
m2厩面高蔦~鵬
ち糀0濡3鳳ハ
=ζ 囲鼎°“Ю
"釧"囲辮
Ｆ
Ｐ
Ｉ
No:17/13/82-ALC4′2014
## Case No.:15/15/82-ALC4/2014
Party Name:RANBAXY
LABORATORIES LTD
Lic No/Date:0310791419
Date:
26112014
072015
:t was decided tO deferthe case for want ofCOmments Of D/oC&PC(ChemiCak)
1
厭
~
## Case No.:43/13/82‐ ALC4/2014
Party Name:YASHO
INDUSTRIES PVT LTD
## Case No.:103/18/82-
ALC4/2014
PHARMACEUTICALS LTD
鱚
112062∝5
Lic No/Datc:3410040726
1器疏50Ю`69AMЫ I蹴ち鵬ν剛97AⅢダ
Date:
072015
: lt was decided to defer the case for want of comments of D/o c&PC (chemicals)
:01/82/050700026/AM16/
:L was decided tO deferthe case for want ofcommentS Of D/o Pharmaceu■
Cals
畷
一
―
一
Ｆ
## Case No:10/2/82-ALC4/2015
Pa●y NamcJUBILANT
GENERICS LTD
Lic No/Date:0510392167
## case No.:11/2/82-ALC472015
Pary Name:JUBILANT
GENERICS LTD
:05/23/040/00370/AM15ノ
ALC472015
12062015
43
No/Date:4/82-
No/Date:4/82-
う
‘
８
４
Ｄ
ａ
‐
５
Ｗ
卿
ハ
2081器
疏50Ю p9vA剛夕 1跳危鵬OЮ0008ハMV
監孵辮:
断
cNoDac0310791516匿需
Date:
072015
: lt was decided to defer the case for want of comments of D/o C&Pc (chemicals).
No:64/18/82-ALC4/2014
Party Name:DEEPAK
Meet No/Date:4/82‐
NITRITE LIMITED
ALC4/2015
12062015
## Case No.:114/18/82-
Patt NamoIND‐SWiFT
ALC4/2014
LABORATORIES LTD,
芳∬鼎“
4∞“"31蹄雛
:
lDecision : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals).
## Case No.:11715/82-ALC4/2014
Nlcet No/Datc:4/82-
ALC42015
12062015
Date:
072015
:lt was decided tO deferthe case for want OfcOmments of D/oc&PC{Chemica:s)
一
Ｉ
Ｆ
Lic No7Date:0510392199
Partv Name:SWATI
MENTHOL&ALLIED
CHEMICALS LTD,
Lic No/Date:2910025174
ヽleet No/Date:4/82‐
Lic No′ Date:3410040732
## Case No.:89/18/82-ALC4/2014
Meet No/Date:4/82‐
No■90/18/82-ALC4/2014 ParりName:BALAJI AMINES
輯
F潔避鷲:=
螂
鉤
“融戚罵』譴i
|
12062015
No:26/18/82-ALC4/2014 Parv NameiSADHANA
CHEM LIMITED
No.:92/18/82‐ALC4/2014 Par″ NamelTATVA
No/Datc:4/82‐
AN PHARMA CHEM
LTD
12.06.2015
Name:BALAJI AMINES
F‖ e
1/83/040/00191/AM15/
1棚児
5品11蒸:′
一
７
Ｆ
‐
２
‐
‐
，
‐
ぼ器 腋訂∬輌‐胃
"7ムmy~匿ら辮“Ю勁"囲
e for want ofcomments of Dノo Pharmaceutlcals
Ｆ
Ｌ
Ｆ
Ｉ
r lt was decided to defer the case for want of comments of D/o Pharmaceuticals.
IDecision:t was decided to deferthe case for want ofcomments of Dノ。PharmaceuJcaゝ
篇
3 lt was decided to defer the case for want of comments of D/o C&PC (Chemicals).
No.:67/13/82-ALC4/2014 Pary Name:BENZO CHEM
０
４
４
Ｄ
ａ
‐
５
問
脚
No.:15/18/82-ALC4/2014 Par"Namc:CORAL
No/Date:4/82-
TORIES LTD,
IAUXILIARIES PVT LTD
|
ド鮮
te 4/82
Date:
2015
Date:
2015
No.:62/18/82‐ALC4/20:4
Name:MOREPEN
No/Date:4/82‐
LTD,
No:32/15/82-ALC4/2014
Name:AMINES&
No/Date:4/82‐
1識
ed
|
ハ
F釧酬
3/82‐ALC4/2014 PaりName」ACSONPAL
Mcct No/Date:4/82-
PHARMACEUTICALS LTD
ALC4/2015
12062015
Bhavan.
: Information had been call for from the firm in the NC meeting No.02l82 dt.
.4.201 5 and reply is awaited.
## Case No.:101/4/82-
ALC4/2015
PaゥName:ESTEEM
INDUSTRIES PVT LTD,
Meet No/Date:4/82-
ALC4/2015
12062015
Date:
072015
Meet No′1)atc:4/82-
ALC4/2015
12062015
Ｆ
Ｌ
Ｆ
Ｉ
## Case No:57/18/82-ALC4/2014
: lt was decided to defer the case for want of comments of D/o C&pC
(Petrochemicals).
## Case No.:97/18/82-ALC4/2014 1Pa●y Name:DYNAMIC
Meet No/Date:4/82-
SPECIALITY CHEMICALS 'ALC4つ
015
12062015
No/Date:4/82-
Lic No/Date:0510392349
;01/82/050/01446/AM15/
悧辮m鯰%8願
Lic No/Date:1710005998
10122014
## Case No:120/18/82‐
ALC4/2014
Party Name:C.G.CHEM ICA LS
&PHARMACEUTICALS
PVT LTD,
Lic No/1)ate:2210015143
10122014
IFi…
1辮器
:
No:119/18/82‐
15
Ｄ
ａ
２
０
No.:82/18/82‐ALC4/2014 PaⅢ′Name:ABEERS Mcct NolDate:4/82‐
No′Date:4/82‐
File
lnLe pite
15/ 10122014
^
|
|
1器3児50Ю И85AM Ⅳ
膿ち棚
OЮ∝リハ剛y
112062015
Ｆ
Ｌ
Ｆ
Ｉ
IDecision:L was decided to deferthe case for want ofcomments of D/oC&PC{ChemiCaК
)
Partv Name:ALEMBIC
## Case No.:116/18/82-
ALC4/2014
:t was decided tO deferthe case for want ofcOmments of D/o Pharmaceujcak
―
Party Name:H.J.AROCHEM
PVT LTD,
Decision:にwaS decided to deferthe case for Want ofCOmments of D/oC&PC(ChemiCals)
1器洲ざ躙器°匿/‐″
"‐
Deferred
12062015
Lic No/Datc:0510392439
16122014
:t was decided tO deferthe case fOr want ofCOmmentS Of D/o Pharmaceuticals
case was defened for want above information'
## case No.:104/18/82-
PaTty Name:SHREE GANESH
鑑獄F F“ "“
けら辮劃Ю““ω
l辮辮
:
躙
癬
## Case No.:102/18/82-
Pa●y Name:CAD:LA
HEALTHCARE LTD,
Lic No/Date:0810134056
16122014
## Case No.:113/18/82-
ALC4/2014
## Case No:100/:8/82-
ALC472014
i31Fs豆万勇万π瓦万罵
:」
~~~膨
爵親
0/00417/AM15/
ALC4ノ2014
REMEDIES PVT LTD
NυDate14/82-
12062015
Date:
2015
Date:
2015
15/
No7Date:4/82‐
r5t
ir6.12.20t4
No.:106/18ノ82-
Name:PANACEA
No/Date:4/82-
LTD,
12062015
16122014
:It was decided to request the fl.11lto mention the strength OfPertussis Bulk
一
３
４
一
―
‐
‐
‐
‐
，
‐
‐
‐
―
―
ム
″
ｒ
ｌ
‐
‐
―
―
―
―
―
―
―
―
## Case No.:2/18/82-ALC4nOl4 rParty Name:SWATI
MENTHOL&ALLIED
CHEMiCALS LTD,
Date:
072015
Party Name:AUCTUS
Mcct No/Datc:4/82-
PHARMA LIMITED
ALC4/2015
12062015
## Case No.:88/18/82-ALC4/2014 Paty NamelMETROPOLITAN
Mect No/Date:4/82-
EXIMCHEM LTD
Ｆ
‐
２
３
６
‐
Ｆ
Ｌ
Ｆ
‐
Ｆ
Ｐ
‐
ALC4つ015
12062015
:L was decided to deferthe case fOr want ofcOmments Of D/oC&PC(Chemicals)
眺′
喘
Meet No/Datc:4/82-
ALC4つ015
12062015
Date:
072015
:L was decided tO deferthe case fOr want ofcOmments Of D/o pharmaceuticaL
No.:2/15/82‐ ALC4/2014
Pa,y Name:HETERO LABS
Meet No Date:4/82‐
LIMITED
ALC4/2015
12062015
:t was decided tO deferthe case fOr want ofcomments of D/o Pharmaceuticals
Meet No/Date14/82‐
ALC4/2015
12062015
Meet No/Date:4/82-
## Case No:1/15/82-ALC4/2014
## Case No:69/13/82-ALC4ノ2014
P″″Name:NEヽV ALLIANCE
DYE―CHEM PVT LTD,
Lic No/Date:0310792132
18122014
:O1/82/050/01289/AM15/
Lic No′ Date:091oo61443
## Case No:105/18/82-
ALC4/2014
PLASTICIzERS LTD,
Lic No/Date:0510392586
:05/23/040/00436/AMi5/
26122014
12062015
File
17122014
File
15/
No:lo8/18/82-
15/ 19122014
一
―
一
―
F53cislon Jtwas dedded to deferthe case forwantofcomments ofD/oC&PC IChemiCals)~~~|
It was decided to defer the case for want of comments of D/o Pharmaceuticals.
甲
黙鮒路D
It was decided to defer the case for want of comments of D/o Pharmaceuticals.
Meet Noつate:4/82-
ALC4/2015
12062015
1器辮:
It was decided to defer the case for want of comments of D/o Pharmaceuticals.
## Case No.:99/13/82-ALC4/2014 Pa“ y Name:GLOBAL
1瞥贄ルッに″
82-
ALC4/2015
12062015
2“
1鵬
児wm“
5ハm夕
陽危馳
OЮω 鬱ハ剛夕
語ら鼎°
m∝
"∞
7
It was decided to defer the case for want of comments of D/o C&PC (Chemicals)
1躙
鞭
~
Date:
072015
iDecision : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals).
ヽ4eet No′Date:4/82‐
ALC4/2015
12062015
: ln the light of written comments received from D/o Biotechnology vide their letter
BT/1L/05/391/2013-PID dt 29 8 2013′ it was decided to ca‖ for the fo‖ owing information
the firm:-
## Case No.:27/15/82-ALC4/2014
Party Name:HETERO LABS
LIMITED
Case No■11/18/82-
ALC4/2014
CALCIUM PRIVATE
## Case No.:84/18/82‐ ALC4/2014
Party Name:HESTER
BIOSCIENCES LIMITED
1. Drug Manufacturing License for the export product.
No.:101/13/82-
Name:RANBAXY
TORIES LTD
No/Datc:4/82‐
Name:GLOBAL
Date:
2015
:01/82/050/01477/AM15/
2. Q.A.approved batch manufacturing Record.
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide l.D. No35011,/39812}74-pt (Norms) dt. January 2015 as per
details given below or as applied by the firm whichever is lower:-
Export product
Qty
lmport items
Qty
Kg/kg
MONTELUKAST
SODIUM
l kg
(S)‐ (E)-2-12‐ [3‐ [2-(7‐ CHLORO‐ 2‐QUINOLINYL)―
ETHENYLPHENYLl‐ 3-HYDROXYPROPYLl‐
PHENYL]-2‐ PROPANOL
124
METHANOL
2325
N,N‐ DⅡSOPROPYLETHYLAMINE
030
TETRAHYDROFURAN
315
ACETONITRILE
Ｅ
Ｊ
ｎ
フ
２
2‐ 1!‐(MERCAPTOMETHYL)CYCLOPROPYL]
ACETIC ACID
040
## Case No.:112′ 18/82‐
ALC4/2014 面‐ 甲閻
「
臓謂鯉‐
AM15/
円3児
"Ю
∞∬AⅢα
障ら鵬
oЮ
"鯰
ハmy躙
器
°
"Ю
792548
Ю3/94/040/00932/AM15/
072015
Date:
: lt was decided to defer the case for want of comments of D/o (pharmaceuticals)
Meet No/Date:4/82-
ALC4つ015
12062015
File
:01/82/050/01451/AMi5/
Date:
Lic No′ 1)atc:0510392619
30122014
:01/82/050701478/AM15/
## Case No.:19/4/82-
ALC4′ 2015
Meet No/Date:4/82‐
Lic No Date10510392654
01012015
: lt was decided to defer the case for want of comments of D/o C&pC
50
072015
No:86/18/82-ALC4ノ2014
ParりNamclMOREPEN
LABORATORIES LTD,
12062015
File
File Lic No′ Date:0510392620
1/AM15/
122014
鞭咆
町
Date:
072015
:01/827050/01315/AM15/
: lt was decided to defer the case for want of comments of D/o Pharmaceuticals'
## Case No:28/15/82-ALC4/2014
Pary Name:DR REDDYS
LABORATORIES LIMITED
c"* N;r{syls/s2.Al,C420H F"ttv N"."DIvlS
;-* No7p61s"asz-
lLAeoRAroRIEsuro., |ALC4/2015
I
I 12 06'20l s
Ho F "
-
RLA Frl.
.-ir-lt'Noro-
o9t00614'g2
,o iltzlosolo r+ ralerur t si
:09/24to40t00544lAMlSl _ -
106 01'2015 . -
6""t.tr" t Th".*..'ttt"" d".ided to ratify the norms based on the recomm
lO"O.nr"n, of Pharmaceuticals vide l'D No35O1L/8L12OL5-P| (Norms) dt' June :
ldetails given below or as applied by the firm whichever is lower:
endation of
2015 as per
Export product
Qtv
lmoort items
Qty kg/kg
HYDROBROMIC ACiD
159
…
λCETYLENE DI
CAR30XYLATE CRUDE
lkg
FUMARIC ACID
144
-ceusttcPoTASHFLAKES
395
METHANOL
300
RA may take further action accordingly'
## case No.:29/1y82‐ ALC4/2014
二怪王
Il二」
l=「
一
Ｉ
Ｆ
Pa,y Name:NUTRA
SPECIALITIES PVT LTD,
## case No.:96′ 18/82-ALC4/2014
## case No.:2/2/82‐ ALC4/2015
「
lcnseN::::::::::::[111::
Ｅ
′
11HQ File
Name:VIRUPAKSHA
No/Date:4/82‐
_=-
" f"' **t of cornrn"nts of D/o Pharmaceuticals'
: lt was decided to defer the cas
Name:HONOUR LAB
[Iま五ζ:こ11『πらs空JJttFd三王the Cl=f° r Want Ofおふmentsof Dノ。C&PC IChei輛Cals)
No/Date:4/82‐
15/
Irz.oo.zor s
Lic No/Datc:0910061502
## Case No.:33/15/82-ALC4/2014
Ｆ
Ｌ
Ｆ
‐
Pa■y Name:HETERO DRUGS
Meet No7Date:4/82-
LIMITED
ALC42015
12062015
IT麓掲
50/01320晨M15ノ |お;角5器0/005:8/AM15/
:t was decided tO deferthe case fOr want ofcomments Of D/o pharmaceuucaL
No. :78ll E/82-A LC4l201 4
| party Nam.bREEN SIGNAL M;.t No/D."te{/S}
ALC4つ015
12062015
:L was decided tO deferthe case fOr want ofcOmments oF D/o DBT
:lt was decided tO deferthe case fOr want ofcOmments Of D/o pharmaceuticals
## Case No.:34/4/82-4 LC4t20t5
Party Name:UNICHEM
Meet No/Date:4/82-
Deferred
LA30RATORIES LIMITED
ALC4/2015
12062015
Lic.No/Date:03 I079300i
Date:
Lic No/Datc:0910061507
## Case No:34/15/82_ALC4/2014
Mect NげDate:4/82‐
Party Name:JODAS EXpOIM
PVT LTD,
Party Name:LINICHEM
LABORA TORIES LIMITED
No/Date:
1/2015
iHeFite
E,4il-[t.Nr/D"te,u
:0t/82t050/00073tAM16t,:03/95t040/00832tAM:S/ l",ilo',.rr,,
Decision : tn the litht "f *rti", d".tri- t.t"" tn Nailtt"g N"lZ&
was decided to ratify norms under para 4.7 of HBp v1 as p"i iei"ifs gtuen
the firm, whichever is less:
4/82- lappr° Vt「
舶
"3町
|
2 dated o5.022015,it
beiow Or as applied by
Export product
Exp. Qty.
Si No
lmport items
Qty a‖owed/75 mg
tablet
CLOPIDOGREL
75MG TABLET
Number
1
CLOPIDOGREL
HYDROcENSULPHATE
99.82 mg
may take appropriate iaioiJs perthe decision of Norms Committee.
## Case No.:35/4/82-
ALC4/2015
52
16012015
072015
PHARMA PRIVATE
1棚帰
5凶
"νAmシ
匝面高喜T蔦面面話高面藻而雨藤吾扉扇雨冨:品1高,三P/。PiarmaCeu.caL I
Ｆ
Ｌ
Ｆ
Ｉ
## Case No.:9/18782‐ ALC4/2014
Meet No/Date:4′ 82‐
ALC4つ015
12062015
: lt was decided to defer the case for want of comments of D/o C&PC (Chemicals)
Paty Namc:SHREE BANKEY
BEHARI LAL BOARD MILLS
Meet No/Date:4/82‐
ALC4/2015
■2062015
3 lt was decided to defer the case for want of comments of D/o c&Pc (chemicals).
Party Name:JODAS EXPOIM
PVT LTD,
:k was decided tO deferthe case fOr want ofcomments of D/o PharmaceutlcaL
## Case No:1/2/82-ALC4ノ2015
願
## Case No.:1/18/82-ALC4/2014
12062015
## case No.:13/4/82‐
面
而
飛2ALC42∝4:畿
剛
l選儡
LTD,
澁
ハm夕
Mect Nαつate:4/82-
ALC4ノ2015
12062015
Lic No/Date:0410160068
28012015
072015
ヽ
Date:
―
一
―
―
一
―
一
―
一
―
―
一
―
一
―
一
―
―
- lt`Of D/o Pharmaceulcals
:lt was decided to deferthe case for Want of COmmer
Lic No/Date103 10793542
03022015
Date:
:01782/050/00059/Aヽ116/
:03/94/040/00759/Aヽ415/
4072015
―
―一一
―― ―
its Of D/oC&PC(ChemiCalS)
::t was decided to deferthe caSe for Want of cOmmer
Meet No/Date:4/82‐
ALC4/2015
## Case No:20/4/82-
ALC4′2015
12062015
F‖ e
Name:METROCHEM
No/Datc:4/82‐
PVT LTD
:lt was decided to deferthe case for Want ofCOmments of Dノ
。PharmaceutlCals
つ
４
０
０
４
Ｍ
‐
５
湘
卿
:01/82/050/01413/AM15/
No.:6/18/82‐ ALC4/2014
Name:GRANULES
Ｆ
Ｉ
貯
‐
‐
Date:
072015
Party Name:ARENE LIFE
Meet No/Date:4/82‐
SCIENCES LIMITED
ALC42015
12062015
Date:
072015
Mcct No/Date:4/82‐
ALC4つ015
12062015
::ln the‖ ght Of wntten comments received from D/o Pharmaceuucals vide ther OM
/2014-PI(Norms)dt 00 06 2015, ■was decided tO ca‖
fOr fO‖ Owing informatiOn
1器3掲50/O137αAMly
隔蒻扇蕊証
廟麗需
而而雨薫
繭麗語
the firm:-
1. Specific use of Lithium metal and
process/Reactions. However. these
explained.
n-Butyl chloride is not given in the
are consumed in the process may be
一
‐
７
‐
‐
2' Past production vis-a-vis actual consumption ofalr imported inputs duly certified
by Central Excise Authorities.
:ltwasdecided tO deferthe case forwantOfcommentsOfD/o pharmaceuticals
Case N∝B48/82-ALC42014と
Ψ NTeЮ DASEXPoM¨
駆
億
…
3/82‐ ALC4/2014阿
Ⅲ
繭
耐
腔躙
酬
2
堕こ謳匠』i…感
踵灘等″鯰。¬認
I配
躊
服脇
「
~隔
F蘊
「
LIMITED,
1濶輌‐
1墜墨叩οム
mα
Date:
072015
Lic No/Date:0910061577
## Case No.:11/18/82-ALC4/2014
Lic No/Date:0910061599
## Case No:10/18/82-ALC4/20:4
Pary Name:HONOUR LAB
LIMITED
Lic NO/Date103 1 0793769
11022015
′,lt w●dedded tO deferthe case fOr want ofcOmments Of D/oc&PC(chemicals)
―
54
## Case No:14/18/82-ALC4/2014
Lic No/Date:0310793763
11022015
Meet No/Date14/82‐
ALC4つ015
12062015
Date:
072015
Decision : lt was decided to defer the case for want of comments of D/o (Pharmaceutica ls)
## Case No.:33′ 4/82‐
ALC4/2015
PETROCHEM PRIVATE IALC4772015
12062015
: lt was decided to defer the case for want of comments of D/o C&PC
Petrochem icals).
: lt was decided to defer the case for want of comments of D/o (Pharmaceuticals)
No.:57/4/82‐
4/2015
Date:
4072015
: lt was decided to defer the case for want of comments of D/o C&PC (Chemicals)
lDecision : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals).
,Status:DeFerred
Casc NO.:62/4/82-
Pa●y Narne:RAKSHIT
Meet No/Date:4/82-
ALC4/2015
PHARMACEUTICALS LTD IALC4/2015
12062015
鵬3児
"Юtt mm α 開脇蕊正戸
‐
囲齋
## Case No.:121/13/82-
ALC4/2014
Pa●y Name:HETERO LABS
LIヽ41TED
Meet No/Date:4/82‐
Lic No/Datc10910061606
Party Name:SUNSHIELD
CHEMICALS LTD
Lic No/Date:0310793925
:01/82/050/00096/AM16′
## Case No.:24/4/82‐
ALC4/20:5
, IALC4/2015
## Case No.:63/4/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
ALC4/2015
12062015
Ｅ
Ｊ
Ｅ
υ
ヽ
⌒
NamelHEMMO
ATE LIMITED
File
躙器α“Ю
"3135
2015
Namc:PAYAL
No′つate:4/82‐
Date:
10794026 1DeFer Date:
α
´
う
Ｄ
ａ
ｔ
２
０
‐
Decision : lt was decided to defer the case for want of comments of D/o Pharmaceuticals
No.:54/4/82-
4′2015
## Case No:75/4/82‐
ALC4/2015
隔
0/00029/AM16/
## Case No:72/4′ 82‐
ALC4/20:5
Name:MAHARSHl
ヽleet No/Date:4/82‐
CHEM PVT LTD,
ALC42015
12062015
Lic No/Date:0810134665 1DeFer Date:
25022015
Meet No/Date:4/82-
12062015
Lic No/Date:0910061653 1Defer Date:
26022015
Meet NolDate:4/82-
ALC4/2015
12062015
ALC4ノ2015
1辮冊
Partv Name:LANTECH
PHARMACEUTICALS LTD
Lic No Date:0910061664 1Defer Date:
04032015
Pary NamelMETROCHEM
APIPVT LTD
Lic No/Date:0910061667
05032015
LABORATORIES LIMITED
## Case No.:14/2/82-ALC4/2015
:05/23/040/00499/AM15/
Mcet No/Date:4/82-
Case No■2/4/82‐ALC4/2015
: Committee considered the case as per agenda and ln the light of earlier decision
by Nc in its 4/82 meeting 03.07.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as
details given below or as applied by the firm, whichever is less:
may take appropriate action as per the decision of Norms Committee.
lmport items
Export product
mcthyl)‐ 3‐mcthy卜4‐(2,2,2‐
Trifl uoroethoxy)Pyridine.
Hydrochloride
56
F‖ e
No/Date:4/82-
:/2015
趙
:01/82/050/00051ノAM16/
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Decision : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals).
lhe case br want tt comments of D/o{Pharmaceutにau l
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No.:9/4/82-ALC4/2015
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「 HARMACEU■0 棉肌50/00076AM附 1跳発鵬:/0021去 Decision:The COmmittee decided tO ratify the norms based on the recommendaJon of Department of PharmaceutiCals vide l D No35011ノ 537ノ2015-Pl(Norms)dt Apri1 2015 as per detai:s given below Or as applied by the firm whicheveris10wer:‐ Export product Qty Si no lmport items Qty kg/kg ATAZANAVIR SULFATE lkg 1 EPOXIDE(BOC‐Epoxide) 0 49kg 2 T_BOC HYDRAZINE 0 50kg No.:26/4/82- Paw Name:GOPINATH IMeet No Date:4/82- File lRLA File Lic NυDate:0810134769 1Defer Date: Name:VIRUPAKSHA No/Date:4/82- Decision:t was decided to deferthe case for want ofcomments of D/o(Pharmaceu■cals) No.:85/4/82- Name:VIVIMED LABS No/Date:4/82‐ No:39/4/82- Namc:BALAJI No/Date:4/82‐ LIMITED
N‐METHOXYCARBONYL‐ L― TERT LEUCINE 0 77kg 4 EDAC‐ HCL l_(3‐ DIMETHYLAMINOPROPYL)‐ 3- ETHYLCARBODHMIDE HYDROCHLORIDE 0 79kg
Case No.:53/4/82‐
ALC4/2015 Party Name:MAHARSHI Meet No/Date:4/82‐ PHARMA CHEM PVT LTD, ALC4ノ2015 12062015 Date: 072015 Date: 072015 :t was decided tO deferthe case fOr want ofcOmments Of D/o(PharmaceuucaL) Paty Name:TIDE Meet No7Date:4/82‐ INDUSTRIES ALC42015 12062015 一 ― Ｆ Ｌ ｒ ‐ 1器脇50Ю0084/AM附 1助角 5脇OЮ0325晨my Date: 2015 :lt was decided to deferthe case for want ofcOmments of D/oc&PC(Chemicak) :忙was decided tO deferthe case fOr want ofcOmments Of D/o{Pharmaceuticals} Party Name:INTAS Meet No/Date:4/82‐ PHARMACEUTIcALS ALC4,015 LTD, 12062015 Lic No/Date:0810134851 19032015 comments of D/o (pharmaceuticals) IMeetNo/Date:4/82- ALC4/2015 112062015 Lic No/Date:0810134799 13032015
Case No:56/4/82-
Partv Name:MAHARSHI PHARMA CHEM PVT LTD, ALC4ノ2015
Case No.:45/4/82-
ALC4/2015 Lic No/Date:3410041050 16032015
Case No.:55/4/82-
ALC4/2015
Case No.:50/4/82_
Pafty Name:SENTISS PHARMA PVT LTD ALC4/2015 RLA F‖ e AM15/ Name:MAMTA No′Date:4/82- YCoATS File
I lDecision : lt was decided to defer the case for want of comments of D/o (Pharmaceuticals) I Case N∝47/4/82‐ALC42015~墜 、YttBfllIVALUE MelNolP,■ '″ 82‐ Approved ICHEMPVTLTD 299 111)3鬼50/00086/AM16/ 囲 0/0。333/AM15/
Case No:21/4/82-
ALC4/2015 HQ File :01/82/050/00060/AM16/ 障蹴 OЮ66νAM Ⅳ 囲 鼎 e051""洒τ 囲 州 「 ~ Decision : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals). 鵬 3児50Ю∞話蕊戸隔脇蘊蕊蔦 ~1用 器α“Ю """ ln the light of earlier decision taken by NC in its 14182 meeting dated 22.t2.20L4, it decided to ratiry norms under Para 4.7 of HBP vl as per details given below or as applied by firm, whichever is less: ヽ 憫軸手 1鑑箱 ~[:「 ::][]:「 FJ「 ]面 5こ 15面 J~ Decision: The comm■tee decided to ratify the norms based on the recommenda■on of Department of C&PC vide l D No 14010/58/2011-Ch‐ ll dated 12 6 2015 as per details g市en below or as the firm whichever is lower:- Undecavertol (Kakidinol ) l kg Propionaldehyde 0 842kg 1-Pentallo1/N Amyl Alcohol 0 639kg Export product Exp Qty SI No lmport items Qty a‖oWed kg/kg 3cnximc usP/1P/BP 7-Phenylacetamideo -3-Chloromethyl Cephalosporaflic Acid Para Methoxy Benzyl Ester (CCLE) ACETONE Dichloromethane 498 METHANOL ACTIVATED CAR30N 0100 MiCA ESTER 1112 RA may take appropriate action as per the decision of Norms Committee. 59 No.:46/4/82- Name:BEST VALUE PVT LTD No/Date:4/82- 12062015 1器3鬼50Ю0085ハMlα
「謎獅よ° 壺~ 1器3児590∞79/AMI″ Fttf畑 2~[誦 酬 鷺 LD臓 鮮 酬ル Date: 072015 Declsion:The cOmmittee decided to rajfy the norms based On the recomm Department of Pharmaceuticais vide l D No35011/537/2015‐ Pl(Norms)dt Ap‖ l detai:s given below Or as applied by the firm whicheverislower:― endation of 2015 as per Export product Qty Sl. no. lmport items Qty kg/kg ATAZANAVIR SULFATE lkg 1 EPOXIDE(BOC_Epoxide) 0 49kg 2 T‐BOC HYDRAZINE 0 50kg N―METHOXYCARBONYL― L― TERT LEUCNE 0 77kg 4 EDAC‐ HCL l_(3‐ DIMETHYLAMNOPROPYL)‐ 3‐ ETHYLCAR30DHMIDE HYDROCHLORIDE 0 79kg RA may take further action accord ¨ 1濶"|… 耐 1器鼎α“Ю""1器雛 m to mention the strength OfPertussis Bulk. ■11lation. :The committee decided to ra■fy the nOrms based on the recommendajOn Of rrtment of Pharmaceuticars vide o.M.No35017/480/zoLa-p\Norms) dt. March 2015 as per ils given below or as applied by the firm whichever is lower:- (lS,4R)‐4‐ 〔 (2‐AMINO‐ 6‐ N-(2-AMrN04,6-DTCHLORO_5- 60 :L was decided to deferthe case fOr want OfcOmments Of D/o Pharmaceuucals し パ
PYRIMIDrNYL)AMNOl-2- CYCLO PENTENE― l‐ METHANOL (+)-2- AZABICYCLO〔2 2 1lHEPT-5- EN‐3-ONE(VINCELACTAM) 1 41kg 3 D(‐ )TARTARIC ACID 0 78kg SODlUM BOROHYDRIDE 0 226kg 5 ISOPROPYL ALCOHOL 4 70kg 6 METHANOL 4 23kg 7 L(+) Tartaric Acid 123
Case No:30/4/82-
ALC4/2015
MeetNo/Date:4/82- Status:Deferied
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: ln the light of written comments received from D/o Pharmaceuticals vide their OM
No35OLt/273/2O14- (Norms) dt. November 2014 decided to call for copy of master batch
duly certified by Quality Control ln-charge.
:01/82/050/00069/Aヽ416/
Case No:38/4/82-
ALC4/2015 膨鵬OЮ0305晨MⅣ lDecision: ln the light of written comments received from D/o Pharmaceuticals vide their OM ffiffirzij;;ii:;;;;,rt November 2or4 decided to carrfor copy of master batch I formula duly certified by Quality Control ln-charge . l l lstatus: ~| | approved : : ln the light of earlier decided taken in NC meeting No.14/82 daled 22.12.2074, il decided to ratify norms under Para 4.7 of HBP vl as per details given below or as applied by firm, whichever is less: AROXETINE TABLETS RA concerned may take further necessary action as per above decision of NC 101/82/050/00077/Aヽ4 For export of 1 Million Tablets 雪辱鞘撃ft:∴:ド1ぎ D犠宰fcma棚辮 de 紺鶴ε ::話認f『習λ鷲鍵 ud霊男鳳話誡 lm 61 NaineiSHASUN No/Date:4/82- No.:41/4/82‐ ALC4/2015 NameiSHASUN Ｄ ａ ｔ ２ ０ ‐
Pary Name:BIOLOCICAL E Meet No/Date:4/82‐ LTD ALC4/2015 12062015 Date: 072015 No.:31/4/82‐ Meet No/Date:4/82‐ 5 ALC4/2015 12062015 Date: 072015 : lt was decided to defer the case for want of comments of D/o (Pha rmaceutica ls) Party Name:METROCHEM Meet No/Datc:4/82- Deferred APIPVT LTD ALC4/2015 12062015 Date: 2015 Partv Name:METROCHEM Mect No/Datc:4/82‐
Case No.:15/4/82-
ALC4/2015 No.:96/4/82- 4/2015 納 簿甲VDepamentOi commerce udy。婆轟話鮪■[Ы APIPVT LTD ALC4/2015 12062015 Date: 072015 Meet No/Date:4/82- ALC4/2015 12062015 B冊漑蕊面、 M16/ 脂ち馳υ∞″ 6ハm夕 [蹴鼎° "m"%8 Date: 072015
Case No:65/4/82-
Meet No/Date:4/82- ALC4/2015 ALC4/2015 12062015 Date: 072015 ヽ4eet No/Date:4/82‐ ALC42015 12062015 脇 証 Lic No/Datc:0410160375 Date: Lic No/Datc:0910061841 PHARMACEUTICALS LTD Lic No′ Date:3110065371
Case No.:14/4/82‐
ALC4/2015 Lic No/Date:0910061803 Lic No/Date:0910061802 LABORATORIES LIMITED しic No/Date:0910061843
Case No.:29/4/82-
ALC4/2015 Party Name:NUTRA SPECIALITIES PVT LTD, 62 31032015 072015 Name:EMCURE Name:MYLAN 1/83/040/00267/AM15/
ハ
I Decおbn.was dedded to deたr me case br wantofcommetts of D/oTharm:[暦3F冨百
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Decision : lt was decided to defer the case for want of comments of D/o (pharmaceuticals)
Mcct No Date:4/82‐
ALC42015
12062015
Date:
072015
Defer Date:
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Decision:The committee decided to ratify the norms based on the recommendation of
Department of PharmaceuJca:s vide O M No35011/267/2011-PI(Norms)dt 1 4 2014 as per
details given below or as app‖ ed by the■rm whicheverisiower:―
ExpOrt product
Qty
Sl. no.
lmport items
Qty kg/kg
2‐CHLOROMETHYL 3,5
DIMETHYl‐4 METHOXY
PYRIDINE HYDROCHLORIDE
lkg
3 5 LUTIDINE
104
TOLUENE
520
METHANOL
414
ACETONE
207
5
ACTIVATED CARBON
0100
6
AMMONIUM PERSULPHATES
180
No.:79/4/82_
:01/82/050/00118/AM16
)n : In the light Of
to rati～the nOnns ul
er is iess:
written earlier decision taken in meeting no. 16/g2 dated 23
rder Para 4.7 ofHBP vl as per details given below or as app
Export Product
Qッ
S No
Import ltems
Qty A‖owcd
kykg
I 23.01.2015, it was
applied by the firm,
No:36/4/82-
Name:NUTRA
PVT LTD,
10160376 1DeFer Datc:
5/ 131032015
No:78/4/82-
LABORATORIES L
No/Date:4/82-
LABORATORIES LI
:09/24/040/00584/AM15/
|
3‐lsobu,l Glutaric Acid[CMH Diacid] l kg l Isovelaraldehyde 06068 う ４ Ethyl Cyanoacetate 07814 3 Diethyl Malonate 09784 may take appropriate action as per the decision ofNorms Committee. 320器 3鬼5υOm25晨Mlσ li飩蕊蕊戸1辮亥面愕
Case No.:86/4/82‐
Party Name:SUVEN LIFE Meet No/Date:4/82‐ ALC4/2015 HQF‖ e RLA File Юル82/050/00050/AM16/ Ю9/24/“0700726/AM15/ り1032015 SCIENCES LIMITED ALC4/2015 12062015 Date: 072015 No.JO/4/82- 15 No.:11/4ノ82- 4/2015 Name:VIRUPAKSHA No/Date:4/82- LIMITED 1隠薦蕊蕊戸1脇鵬 OЮ "ηハ m夕 囲辮側∞ aЮ8厩 Date: 2015 : lt was decided to defer the case for want of comments of D/o (Pha rmaceuticals) Mect No/Date:4/82‐ ALC4/2015 12062015 "4囲応蕊蔦丁珊蒻扇罵蕊「圏鼎酬∞ 618211辮辮 : :lt was decided to deferthe case for want of comments of D/oC&PC(ChemiCak) Lic Nα Эate:0910061851 Date: Юル82/050/00103AM 16/ Ю9/24/040/00595/AM 15/ ,1032015 072015 : lt was decided to defer the case for want of comments of D/o c&PC (chemicals).
case No.:73/4/82‐
Party Name:VtVIMED LABS Meet No Date:4/82‐ ALC4/2015 LIMlTED ALC4/2015 12062015 Mect No/Date:4/82- ALC472015 Party Name:VIRUPAKSHA ORCANICS LIMITED Meet No/Date:4/82‐ 12062015
Case No:64′ 4/82-
ALC4/2015 Party Name:VIVIMED LABS LIMITED
Case No:52′ 4/82-
ALC4′ 2015 12062015 1,rrR下171.。 Name:PAYAL
~躊 颯 へ亀卜 lmttdNDOAMNES IALC4/2015 Date: 072015 ALC4/2015 12062015 Datc: 2015 Status:Deferred Pa●y Name:ADCOCK Meet No′ Date:4/82‐ rNGRAM LTD, ALC4/2015 12062015 Pary Name:SATYADEVA IMeet No/Date:4/82- Lic No/Date:0910061883 Date: 15042015 4072015 : lt was decided to defer the case for want of comments of D/o C&PC ヽleet No Date:4/82‐ ICaseNo■5Ⅳ4慇2- ~「 :5面高雨面甍面戸 ~| ALC4/2015 1HEALTHCAREPVT LTD¬ Meet No/Date:4/82‐ ALC4つ015 12062015 Date: 2015 Meet No/Date:4/82‐ ALC4つ015 12062015
Case No.:97/4/82-
ALC4/2015 Lic No/Date:0410160408 10042015 HEALTH CARE PVT LTD,
Case No.:60/4/82-
ALC4/2015
Case No.:81/4/82-
ALC42015 PHARMACEUTICALS/P/ LTD, RLA Fne :09/24/040/00728/AM 15/ Ptt Name:VINS B10PRODUCTS LTD, Ｅ υ ‘ υ IALC4/2015 ,12062015 15/ TT Date: No.:59/4/82- Name:SOFTGEL 10042015 D 10108024 1Defer Datc: No/Date:4/82- 5
| 1器島児50側り晨剛夕 陽 危棚 υ00657AMⅣ Date: 2015 : it was decided to forward a copy of application Department of Biotechnology. The was deferred. Party Name:ARENE LIFE Meet No/Date:4/82‐ SCIENCES LIヽ41TED ALC4/2015 12062015 悧辮醐∞a"41辮雛 : Decision : lt was decided to defer the case for want of comments of D/o (Pharmaceuticals). Casc No.:67′ 4/82- Party Name:STERMONE Meet No′Date:4/82‐ ALC4/2015 CHEMICALS PVT LTD ALC4つ015 12062015 Date: 072015 Meet No′つate14/82- ALC4/2015 12062015 Date: 072015
Case No.:77/4/82‐
Party Name:VMMED LABS ヽ4eet No/Datc:4/82- ALC4/20:5 L!MITED ALC4/2015 12062015 呼沈露」 0910061892F蒲需戸~ Decision : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals). Party Name:ALMELO PVT Meet No′つate:4/82- LTD ALC4/2015 12062015 r lt was decided to defer the case for want of comments of D/o Pharmaceuticals. Meet No′1)ate:4/82- ALC4/2015 Date: 1/AM16/ ' fq+ql qrqR rErR{r€{r Oirecto.alo G6neral ol For€,on Trado aFrq frr,voepanrnent or commerc€ selr.r .rc-r. TJ Rid Udyos Bhawan, New Delhl 112062015 Lic No/Date:0910061882 15042015
Case No.:52/82-ALC4/2015
Lic No/Datc:3410041147 17042015
Case No.:76/4/82‐
Party Name:VMMED LABS ALC4/2015 LIMITED Lic No/Date:0910061893 17042015
Case No:6/2/82-ALC4/2015
Case No:22/4/82-
ALC4/2015 HEALTH CARE PVT LTD, 66 12062015 10160421 072015 陣 |う °うHQ F‖ e :01/82/050/00020/AM16/ 鵬多‰,肌9ハ剛y 厩薦蕊蕊丁¬靡 Omハmα l躙鼎 e091∞a'9
ハ | 11)ecision:lt was decided to deferthe case for want of comments of Dノ o{Pharmaceutica:5) | 甲酉~甲鶉市臓鮮鯉 ~ 1器3児50Ю∞御AM附 陪 角拙 OЮ舵68晨Ⅲyレ |ザ辮 BH°065387 IDecision:L was decded to deferthe case for want ofcomments of D/oC&PC(Chemに alsl ~ 3 lt was decided to defer the case for want of comments of D/o C&pC (Chemicals). :L was decided tO deferthe case fOr want ofcOmments of D/oC&PC(ChemiCat) No:27/4/82- Name:BALAJI Llヽ41TED File 1/83/040/00269ノAM15/ 110065385 1Defer Date: 042015 124072015 l l猟艦∽鬱 7Am y♭蹴器α tt Ю %"“ No.:8/2/82-ALC4/2015 Filc No.:66/4/82- Namc:SHlvA No/Date:4/82‐ ‖57 1DeFer Datel No.:69/4/82‐ Name:SHIvA 10041158 1Defcr Date: 削 翻ETEЮ LAlllS I顆 酬 2 No/Date:4/82‐ 1/2015 Ｖ Ｅ Ｎ Ｕ 」 に ‐ Ｅ Ｓ Ｎ ａ Ｅ Ｄ No:84/4/82- No Datc:4/82-
Date: 072015 Pa●y NamelCONTINENTAL Meet No/Date:4/82- ALC4/2015 12062015
Case No.:83ノ4/82-
ALC4/2015 349 HQ File
Case No.:71/4/82-
ALC4/20:5 CHEMICALS Date: 4072015 Date: 072015 Meet No/Date:4/82- Name:GULBRAN DSEN ALC4/2015 CHEMICALS PVT LTD 12 06 2015 Date: 4072015 :L was decided tO deferthe case for want ofcomments of D/oC&PC(ChemiCak) Lic No/Date:3410041191 Date: :0ル82/050/00109ノAM16/ :34/24/040/00019/AM16/ p9042015 072015 :t was dedded to deferthe case fOr want ofcomments of D/o(Pharmaceu■ cak) ２ ８ ４ Ｎ ｏ ・ ‥ ６ ８ 瑯 Meet No/Date:4/82‐ ALC4/2015 12062015 Datc: 2015 Lic No/Date:0810135094
Case No:74′ 4/82-
Parw Name:RECKITT Meet No77Date:4/82‐ ALC4/2015 BENCKISER HEALTHCAREINDlA
Case No.:70/4′ 82-
Meet No/Date:4/82‐ ALC4/2015 PHARMACEUTICALS LTD 1靡臨 靡 蔦扁~涙 、蕊 2'Amα l淵器副∞ 4り2 … 墨鍵 : tt was decided to defer the case for want of comments of D/o (Pha rmaceuticals) Meet No/Date:4/82- ALC4′2015 12062015 Lic No/Date10910062041 Date: 20052015 072015
Case No:1/4/82‐ ALC4/2015
Party Name:HETERO DRUGS LIMITED :t was dedded tO deferthe case for want ofcomments of D/o(Pharmaceuucak) 68 | | Name:ALEMBIC
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No.:2/4/82‐ ALC4/2015 1Pa●y Namc:HEPTACHEM&
Mcct No Datc14/82-
PHARMA(INDIA)PVT LTD
ALC4/2015
12062015
: lt was decided to defer the case for want of comments of D/o (Pharmaceutica ls)
No:3/4/82-ALC4/2015
Ptt Nalne:HETERO LABS
Meet No/Date:4/82-
LIMITED
ALC4/2015
12062015
Meet No/Date:4/82-
ALC4/2015
12062015
No.:514182- ALC4/20I5 Party Name:HETERO LABS
Meet No7Date:4/82-
LIMITED
ALC4/2015
12062015
: lt was decided to defer the case for want of comments of D/o (Pharmaceutica ls)
Case No.:6/4/E2-ALC4l20l5 Party Name:AUROBINDO
PHARMA LIMITED Party Name:AUROBINDO ヽ4cet No/Datc:4/82‐ PHARMA LIMITED ALC42015 12062015 "鵬 星児5υ∞ “ 4ムM16/ 厩 棚 υtt κハmθ l蹴 鼎 C酬∞ω “ 61需 需 一 ３ ５ ６ 鵬3児590∞6細κ戸| 1脳鼎 e091∞θ"2囲需 ::蕊戸囲盟雨100620万 Date: Party Name:HETERO LABS LlトイITED Meet No/Date:4/82‐
Case No.:7/4/82-ALC4/2015
69
072015
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No.:4/4/82-ALC4/2015
Date:
2015
No.:3/4/82‐ ALC4/2015 Partv Name:INCHEM
TORIES PRIVATE
Dvl
v@ttsv frrnrvoeparr,
' ",, r
sdr.r .r!rr. Tg El.d
iJctyog Bhawan. N€w Dotiri
鵬3鬼50ЮID43ハmα
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的m。6/AMV
No/Date14/82‐
Case No.:16/4/82-
ALC4/2015
Case No:92/4/82-
ALC4/2015
Case No:93/4/82_
ALC4/20:5 ALC4/2015 Deferred Deferred recommendation of dt May 2015 as per Pa●y Name:AUROBNDO Meet No/Date:4/82- PHARMA LIMITED 12062015 Date: 072015 LTD ALC42015 12062015 Date: 2015 Pary Name:ALMELO PVT Meet No/Date:4/82‐ on the (Norms) Pady Namc:ARIHANTANAM LIFECARE PVT LTD Date: 072015 :t was dedded tO deferthe case for want Ofcomments of D/o{Pharmaceutた als) Meet No/Date:4/82‐ ALC42015 12062015 The committee decided to ratify the norms based rtment of Pharmaceuticals vide O. M. No35017/636/Z1t4_pt given below or as applied by the firm whichever is lower:_ No:90/4/82-ALC4/2015 Mect No/Date:4/82- ALC42015 12062015 : lt was decided to defer the case for want of comments of pha rmaceutica ls. Lic No/Date:0910062098 Lic No/Date:091oo62107 Lic No/Date:5210041536
Case No:89/4/82-ALC4/2015
LABORATORIES LTD, Lic NげDatc:091oo62100 Export product Qry lmport items Qty kg/kg FUMARALDEHYDE BIs (DIMETHYL ACETAL) FURAN 060 METHANOL 343 CHLOROFORM 100 LABORATORIES LTD, Lic No/Date:091oo62101 01062015 70 No/Datc:4/82‐ 12062015 16/ Name:DIVIS 1棚憾 "側η Att α 属飩
⌒ Decision : lt was decided to defer the case for want of comments of D/o (Pharmaceutica ls) Paty Name:ALMELO PVT Meet No/Datc:4/82‐ LTD ALC4/2015 12062015 Ъ 蹴 OЮtt И77AM l″ 1淵 鼎 e091∞つりODebDttα 丁 2015 124072015 :O1/82/050/00134/AM16/ Meet No/Date:4/82‐ ALC42015 12062015 Decision : lt was decided to defer the case for want of comments of D/o (Pharmaceuticals) Party Name:INTAS PHARMACEUTICALS LTD, HQ File :01/82/050/00138/AM16/ IDecislon:t was decided to deferthe case for want ofcomments of D/o(Pharmaceu■ caι ) Ｆ Ｉ Ｉ Ｉ Ｌ Ｆ Ｏ ｅ ｐ C".. Xo-SV4/S2-ALC420I5 Fany Na..DIVIS M."t N"/D"I.4S} hppr"" lleaonaronres lro., ALC4nots i I r 2.06.2015 I HQ File lnr-e nir" lLic.No/Date:09 t0062 t02 [ :01/82l0s0/00130/AMl6/ l:09t24t0/,0100D901A ll6l 01.06.2015 | D"a ed on the ,".on*"naition Department of Pharmaceuticals vide l.D.No35OlLl8ll2OL5-Pl (Norms) dt. 25.6.2015 as details given below or as applied by the firm whichever is lower: Export product Qty lmport items Qty kg/kg DIMETHYL ACETYLENE DI CARBOXYLATE CRUDE lkg HYDROBROMIC ACID 159 FUMARIC ACID 144 CAUSTIC POTASH FLAKES ０ フ METHANOL 300
Case No.:94/4/82-
ALC4/2015 Patty Name:ALMELO PVT LTD ALC4/2015 12062015
Case No:95/4/82-
ALC4/2015
Case No.:98/4/82-
ALC4/2015 LABORATORIES LTD,
Case No.:99/4/82-
ALC4/2015 Meet No/Date:4/82‐ 71 No/Datc:4/82‐
Manual Minutes of NC Meeting No.04ノ82′2015 dated 12.06.2015′ 24.6.2015
Case No B-6
Meeung No 4/AM16 dated 12 06 2015 M/s Survival Technology Pvt Ltd F No01/82/050/00133/AM12/DES― |‖ RAF No 03/95/040/00536/AM 14 Adv Lic No 0310678569 dated 25 01 2012 Decision: lt was decided to defer the case for want of comments of O/o C&eC (Ctremicats).
Case No B‐ 7
Meeing No 4/AM16 dated 12 06 Mノs Deepak NInte Limtted F No01/82/050/01000ノAM12/DES― |‖ RAF No 31/83′040′00137/AM 12 Adv Lic No 3110052056 dated 22 12 2011 Decision:k was decided to deferthe case for want ofcomments of D/oC&PC{ChemiCals)
Case No B-8
Meejng No 4/AM16 dated 12 06 2015 M/s Dorf Ketal Chemicals lndia Pvt Ltd F No01ノ82/050/01242/AM15/DES― |‖ RAF No 03/94′040/00390/AM 15 Adv Lic No 0310787602 dated 04 08 2014 Decision: The committee consider the case and decided to amend the desc.iption-iimportlG lol- from "PAC-2M (4,4-Methylenebi Scyclo Haxanamine), synonym: Bis (paraminocyclohexyl),, to ,,pACM-2M ((4,4-Methylenebi Scyclo Haxanamine), Synonym: Bis (pa ra-aminocyclohexyl),,.
Case No B‐ 9
Meelng No 4/AM16 dated 12 06 2015 M/s Dorf‐ Ketal Chemicals lndia P宙 Ltd F No01/82ノ050/01243/AM15ノDES― |‖ RAF No 03/94′040ノ00241′AM 15 Adv Lic No 0310787845 dated 08 08 2014 Decision: The committee consider the case and decided to amend the aescriptlon of irnport itern Nof from "Antipolymerant-Trade Name - 2656 (Blend of N-oxyl compound, Glycol and amine),, to "Antipolymerant-Trade Name-DA 2665 (Blend of N-oxyl compound, Glycol and amine),,.
Case No B-10
Meelng No 4/AM16 dated 12 06 2015 M/s lndo Phyto Chemicals Pvt Ltd F No01ノ84/050/00318ノAM13/DES‐ |‖ RAF No 05/23ノ040′ 00252′AM 13 Adv Lic No 0510336430 dated 04 10 2012 Decision: The committee decided to ratifo the norms based on the recommEndation oiDepirtmiit of Pharmaceuticals vide O.M.No.3501l/333/20L4-Pl (Norms) dt. January 2015 as per details given below or as applied by the firm whichever is lower:― Export product Qty lmport items Qty 19-Norandrostenedione 99Yo lntermediate lkg Sitolactone 1 40 Kg/kg 5-Chloro-2-Pentanone 1 30 Kg/kg Tetra hydrofuran 3 50 1it/kg Pyridine 0 62 1it/kg 72 αa00 Trado
Case No B-11
Meeung No 4/AM16 dated 12 06 2015 M/s Paramount Aromachem P宙 Ltd F No01/821050/01246/AM13/DES‐ l‖ RAF No 05/24/040/00381/AM 13 Adv Lic No 0510343720 dated 18 01 2013 Decision: The Commiftee consider the case for correction in description of import item and decided to amend the description of import item from "Limonene (Limonene, citrus terpene, orange Brazalian citrus terpene, branzalian citrus terpene, standard citrus terpene)" to "D- Limonene (Limonene, citrus terpene, orange terpene, brazalian citrus terpene, standard citrus terpene)'.
Case No B‐ 12
Meelng No 4/AM16 dated 12 06 2015 M/s∨市imed Labs Limted F No01/82/050/00019/AM15/DES― |‖ RAF No 09ノ24/040′00598/AM 14 Adv Lic No 0910059372 dated 21 02 2014 Decision: The Committee considered the case and decided to defer the case for want of comments of D/o C&PC (Chemicals).
Case No B‐ 13
Meelng No 4/AM16 dated 12 06 2015 Mノs Hindustan Polyamides&Fibres Limled F No01/82/050ノ00516/AM15/DES― |‖ RAF No 03/94/040/00132ノAM 15 Adv Lic No 0310783464 dated 29 05 2014 Decision:The Committee considered the case and decided to correct the description of export product and lmport tem No l as mentioned below: Export product: read as “HAMBER (7‐Acetyl,1,2,3,4,5,6,7,8‐ Octahydro-1,1,6,7,― Tetramethyl Naphtha:ene)" instead Of・HAMBER(7-Acety!,1,2,3,4,5,6,7,8-OctahydrO-1,1,6,7,― Tetramethyl Naphtha:ine)" lrnportitem No l read as “Methyl Ethyl Ketone Mek"instead of “Methyl Ethyl Ketone Mer" RA may take necessary action accordingly
Case No B-14
Meeung No 4/AM16 dated 12 06 2015 M/s Hindustan Polyamides&Fibres Limlted F No01/82ノ050/00182/AM15/DES― |‖ RAF No 03/94/040/00835′AM 14 Adv Lic No 0310765125 dated 08 01 2014 Decislon: The Committee considered the case and decided to correct the description of import item No.3 as mentioned below: lmport item No. 3 read as "Acetic Acid" lnstead of 'Acetic Anhydride". RA may take necessary action accordingly. ネ******拿 *****■+ 73 ヽ
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