DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi -0
Para 4.7 Decision(DRAFT)
MEETING NUMBER :18182-ALC412014 MEETING DATE : 18.02.2015 But actually held on 16.04.2015 Meeting No. 18182 of 2014-15, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, was scheduled for 18.02.2015 but actually held on 16.04.2015 under the Chairmanship of Shri Jaikant Singh, Addl. DGFT in Room No.11, 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 of earlier NC -lll meeting No. 17182 scheduled for 05.02.2015 but actually held on 17.03.2015 and approved lhe same. The following cases/issues were discussed and the committee took the decision as mentioned against each case. Decision :lt was decided to request the firm to fumish Production und Coni,r.npiion dutu duly certified by Central Excise Authority. The case is deferred for 29.04.2015.
Case No.:14/24/82- ParりName:SANOR Meet No/Datel1 8/82‐ status:DeFFered l
ALC4/2010 LABORATORIES PVT LTD ALC4つ014 and Re― indexed
_ 18022015 1
‐
12鷺3月1鳥8島lM∴・鴨ち魔鳥ふ
1↓1″
~認
嬬
C面血蒟4霊[1ふ島
5
L需諄
i島撰繋オ
ttti圭蝋庸吼1忠洩璃響虫認ら語赫品
nd農″
―
Case No.:17/19/82‐ ALC4/201l Pary Name:VIVIMED LABS
LIMITED HQ Filc RLA Filc :01/82/050/00531/AM12/ 109/24,040/00137/AM12/ Approved Lic No/Datc:0910047175 Defer Date: 20062011 Meet No/Date:18/82‐ ALC42014 18022015 Status: ヽオ ― | Decision 3 ln the light of written comments received fiom Departmenr of Pharmaceuticals vide their OM tNo. 3501 I /576/2013-PI(Norms) dated 07-04.2015, it was decided to ratify the norms under para 4.7 of HBp 議 ” 中 倉 ¨ 赫 “ vl as pcr details given bc10w Or as apphed by the flrm,、 vhichever is less: ⌒ 一
Export Product 嚇 ¨ S No lmport Item Qw AIlowed kノkg Triclosan Oral Grade l kg l 2,4 DiCHLORO PHENOL 180 2,5-DiCHLORO NITRO BENZENE NA 3 POTASSIUM HYDROXIDE NA 4 PERCHLORO ETHYLENE 300 5 MIXED XYLENE NA 6 SODlUM NITRITE 063 7 SODIUM HYDROXlDE NA 8 HEXANE 300 i per above written comments it has been advised by D/o Pharmaceuticals to 2517 for export ofTriclosan Oral Grade ofspecified Specifications as under: SI No Import Item Qty Allowcd kνkg 1 2,4 DlCHLORO PHENOL 180 2 PERCHLORO ETHYLENE 300 3 SODIUM NITRITE 063 4 ISOPROPYL ALCOHOL OR HEXANE 300 revise S10N RA may take appropriatc action as per thc dccisiOn ofNorlns Committec Pary NamelVIVIMED LABS LIMITED ヽ )ecision : ln the light of wrinen comments received llom Department of Pharmaceuticals vir lo.350ll/57612013-Pl(Norms) dated 07.04.2015, it was decided to ratifo rhe norms under para I as per delails given below or as applied by the firm, whichever is less: Export Product 嚇 ¨ S No lmport Item Qty. Allowed kp/ks l kg 1 2 4 DICHLORO PHEN01_ 180 2 25‐DICHLORO NITRO BENZENE NA 3 POTASSIUM HYDROXIDE NA 4 PERCHLORO ETHYLENE 300 MIXED XYLENE NA ― | No/Date:18/82‐ 1鷺ち刷:OЮ。 3187AM 1 2
j_ MIXED XYLENE NA 6 SODIUM NITRITE 063 7 SODIUM HYDROXIDE NA 8 HE〉銀 E 300 per above written eomments it has been advised by D/o Pharmaceuticals lo rel i517 for export ofTriclosan Oral Grade ofspecilied Specifications as under: may take appropriate action as per the decision of Norms Committee. ′ise S10N 1濶 " 1器島掲 50綱28ハmν Ъ危鵬OЮ0337AⅢν 口 '」 391beFerI)ate: )ecislon:In the light of writen comments received from Department of Pharmaceuticals vide their OM Io 35011/576ノ2013-PI(NollllS)dated 07 04 2015,it was decided to rati～ the n0111ls under Para 4 7 of HBP l as per details given below or as applied by the flrll,whichever is less: Export Product け ｎ ｔ ｉ 呻 Ｑ ｕ ａ ｎ S No Import Item QりAllowed k″蹂 Triclosan Oral Gradc l kg 1 2,4 DICHLORO PHENOL 180 2,5‐ DICHLORO NITRO BENZENE NA POTASSIUM HYDROXIDE NA 4 PERCHLORO ETHYLENE 300 MlXED XYLENE NA 6 SODIUM NITRITE 063 SODlUM HYDROXIDE NA 8 HEXANE 300 i per above written comments it has been advised by D/o Pharmaceuticals to revise SION 2517 for export ofTriclosan Oral Grade ofspecilied Specifications as under:
SI No lmport ltem Qty Allowed kυkg 1 2,4 DiCHLORO pHENOL 180 2 PERCHLORO ETHYLENE 300 SODIUM NITRITE 063 4 ISOPROPYL A■COHOL OR HEXANE 300 may take appropriate action as per the decision ofNorms Committee. Ｆ ト Meet No/Date:18/82‐ ALC4/2014 18022015 : lt was decided to reject the case as the firm has not fumished information despite reminders. No.:4/27/82-ALC4′ 2012 Name:PORUS No/Date:18/82‐ TORIES PVT LTD 18022015 : It was decided to reject the case as the firm has not furnished information despite reminders. No:16/3/85-ALC3/2013 Parw Name:RA CHEM Meet No/Date:18/82- PHARMA LIMITED ALC4/2014 18022015 : It was decided to reject the case as the firm has not furnished information despite reminders.
Case No:79/1/82-ALC4/2013 1Pa●y NameiSTERICAT
Meet No′つate:18/82‐ GUTSTRINCS PVT LTD ALC4つ014 18022015 18022013
Case No:28/28/82‐ ALC4/2012
LABORATORIES LIMITED Lic No/Date:0910053660 7 Status: Rejected HQ Flle 101/82/050/00959/AM13/ RLA File :09/24/040/00408/AM 13/ Lic No/Datc:0910054464 D7122012 Defer Date: Status:Deffered and Re-indexed HQ File 101/82/050/01437/AMi3/ RLA File 105/24/040/00420/AM13/ B誰ち 9042015 盛 4
―一―――― ―一― 一― 一 一一-29042015forcommentsofDepartmentofIPP I It was dccidcd to dcfcrthc casc for 29 04 2015 for commel P繭 繭 耐 肥 赫 面 市 瑕 =願 | | | | HQ Fllc ~~~~匝 Flle ~医蔦扇西59100554211語 | :O1/82/050/00163/AM14/ :09/24ノ040/00607/AM13/ 19032013 Decision:In the‖ ght of wntten cOmments received from Department of Blotechnology vide their oM No BT/IL/05/382/2013-PID dated 26 02 2015,lt was decided to ratify nOrms under Para 4 7 of HBP vl as per deta‖ s given below or as applled by the irm,whichever is less: Item of Export Quantity S No Item of lmport Quantity allowed per million vials DTP‐HEPB‐HlB (PENTAVALENT VACCNE) FULLY LIQUID CONIBINAT10N VACCNE SINCLE DOSE VIAL, PEDIATRIC DOSE DIPHTHERIA,TETANUS PERTUSSIS,HEPATITlS B RECOMBINANT AND HAEMOPHlLUS INFLUENZA TYPE B(HIB) Via15 1 POLYETHYLENE CLYCOL 6m (MACR¨ L) 76 848 kg 2 AEROSIし380V(COしLIDAL ANH SILiCA BP) 20 375 kg 3 GLYCEROL 122 841 1tr 4 TWEEN,0(POLYSORBATE 20) 7 685 1tr Ｃ υ POTASSIUM THYOCYNATE 169 742 gms 6 TRIS BUFFER 10 216 kg CO～螂lNED VACCINE WITH VACCINE VIAL MONITOR (VVM) 7 ALUMINlUM CHLORIDE 6 HYDRATE EXTRA 27 665 kg 8 YEAST EXTRACT 22 447 kg 9 DEXTROSE(GLUCOSE) 35 937 kg 10 L―CYS「lNE 0 437 kg 11 BACTO CASAMINO ACID 31 758 kg 12 THIOMERSOL 0 379 kg 13 SILICON EMULSION 16 5 kg 14 ADIPIC DIHYDRAZlDE (ハDH) 1 686 kg Ｃ Ｊ N3‐ DIMETHYLAMNOPROPYL‐ N―ETHYLCAR30DIMIDE HCL(EDC) 167 .545 gm 16 2(ゞ‐MORPHOLINO) ETHANE SULFONiC ACID (MES) 1 441 kg 17 CETAVLON 1537 gm 18 ALUM:NIUM PHOSPHATE CEL 2%(ADJU PHOS 2%) 76 991 kg 19 L‐TYROSINE 0 7841 kg 20 NZ CASE TT(CASEIN PEPTONE PLUS) 39 12 kg 21 VITAMN Bl HCL (THlAMNE HYDROCHLORIDE) 1 14gm 22 CLASS VIALS 1100000 nos 23 RUBBER STOPPERS 1095638 nos 24 ALUMlNIUM CAPS/SEALS 1088334 nos Ｅ Ｊ つ ‘ HEATMARKER VACCNE VIAL MONITOR(VVM LABELS) 1086508 nos 26 SHIPPNG INDICATORS(Q TAC 2 PLUSヽ 902 nos 〔 ●● ‘ ¨ 綱 」 刺 ― ・ υ て,
27
FILTERS&FILTER AIDS
250 nos
RA may take appropriate action as per the decision of Norms Committee.
「
¬
IH器3鬼5∽“ら/AMW I胤乳∽∝創
AM蔦
: It was decided to reject the case as the firm has not fumished information despite
reminders and no comments from DCGI was received.
「F謎辮加脱‐~~
1躙…
|
鵬3掲50畑∞
8晨m″
膨薦『蕊蔦;~鱚
6110
Defferrd
Re-indexed
sion :In the light of written comments received from Department of Pharmaceuticals
their OM No. 3501 I /7512014-PI(Norms) dated 18.02.2015,It was decided to remind
firm to furnish the following information:
i)
Literature reference about conversion of IUs to weight of various Low Molecular
Weight Heparins i.e. Nadroparin, Enoxaprin and Delteparin sodium.
ii)
Consumption data for all raw materials used in the production of Low Molecular
weight Heparin-Delteperin Sodium lnjections, duly certified from Central Excise
authorities for the year 2012 -13,2013-14 and April to December 2014.
Copies of batch log sheets for the last 5 consecutive batches for conversion
Heparin Powder into Delteparin sodium indicating the actual consumption of all
raw materials consumed for getting the API used in the Delteparin sodium
lnJectlons.
iu)
Copies of batch log sheets for last 5 consecutive batches indicating actual
consumption of 16 raw materials applied for import in all applications against
export of Low Molecular weight Heparin-Delteparin sodium injections in pre-
filled syringes.
The information sought vide Item No.2 and 3 above may be certified by
production in-charge of manufacturing unit ofthe firm.
case wers deferred for 29.04.2015
ParりNamelCALYX
CHEMICALS&
IPHARMACEUTICALS LTD
Meet No/Date:18/82-
ALC4l20l4
iRejected
IB田3掲50Ю Oη 9AM蔦
Decision : lt was decided to reject the case as the firm has not furnished information despite
repeated reminders.
P畿めに
Lic No Date:0310734494
115052013
Party Name:GLAND
PHARMA LINflTED
lCase N:ii34/14/82
ALC4/2013
r : It was decided to reject the case as the firm has not furnished information despite reminders. r r It was decided to reject the case as the firm has not furnished information despite reminders. :It was decided to deFerthe case for 29 04 2015 for comments of Deparment Of l : It was decided to reject the case as the firm has not fumished information despite reminders. r : It was decided to reject the case as the firm has not fumished information dffi reminders and no comments from DCGI was received. No.:183/10/82‐ P征″Name:ViVEK 13′24ノ040/00032/AM12/ 16 No.:111/10/82‐ Pa●y Name:STERICAT GUTSTRINGS PVT LTD Meet NO/Date:18/82- ALC4/2014 18022015 閾蹴脚 HQ Fne :01/82/050/00294/AM14/ RLA File :05/24/040/00091/AM14/ Lic NoノDate:0510358000 25062013 Defer Dateκ File lRLA File r : It was decided to reject the case as the firm has not furnished info.r"tion derpit" reminders. No.:24/12/82‐ Name:WocKHARDT No/Date:18/82‐ 7 20貯淵″脱‐ Pary Name:WocKHARDT LIMITED Meet No/Date:18/82‐ ALC4/20i4 18022015 istatu": Rejected IHQ File RLA F‖ e Lic No′Date:o310741992 Defer Date: Ⅷ
Ｆ Ｐ ffit osu Nqqs, t eut +t | :03/95/040/00306/AM I 4/ , It r"u. a""ia"a t reject the case as the firm has not furnished information despite reminders and no comments from DCGI was received'
Case No:68/17/82-
Pany Nalne:BHARAT ALC4/2013 PARENTERALS LTD,
Case No.:52/12′ 82‐
Pa¨ソNameitlNIttLES LIFE SCIENCES LTD Lic No/Date:0310742481 23072013 : It was decided to reject the case as the firm has not fumished information despite reminders.
Case No.:1/10/82‐
P征″Name:MICRO LABS Meet No71Date:18/82‐ Re-indexed ALC4/2013 LTD ALC4/2014 18022015 2904.2015.
case No.:17/13/82-
PなけName:PA3 0RCANICS Re-indexed ALC4/2013 PVT LTD, case is defcrred for 29 04 2015 ALC4/2013 Ｆ Ｐ Party Name:UNIVERSAL B10FUELS PRIVATE LlMITED Re-indexed 18072013 Mect No77Datel1 8/82- Meet No7Date:18/82‐ Meet No7Date:18/82‐ Lic No′ 1)ate:3410037541 Meet No′つate:18/82-
Case No.:34/13/82-ALC4/2013
:01/82/050/00510/AM14/ :03/95/040/00132/AM14/ Lic No Date:0310744838 . It .',as d""id"d to defer the case for 29 .04 .2ol 5 for comments of Department of :Reply received and sent to Department ofPharrnaceuticals The case is :It was decided to cali from thc f1111l complete technical details as per Appendix 33 RLA F‖ e :09/24/040/00155/AM14/ Lic No71Date:0910056959 31072013 1蹴18Ю22m5 Name:WANBURY ORGANICS LTD)
their oM No.35011/710/2013-Pl(Norms) dated 17.02.2015, it was decided to ratify norms under
Para 4.7 of HBP v1 as per details Biven below or as applied by the firm, whichever is less:
Case No:73/13′ 82-
ALC4/2013 ∫ IHQFile RLA Filc :01/82/050/00549/AM14/ :03/95/040/00133ノ AM14/ Lic No/Date:0310744832 Deた r Date: 12082013 Decision:ln the light of wntten cOmments received from Department of Pharmaceuticals vide their OM No 35011/705/2013‐ PI(Norms)dated 17 02 2015′ t 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: Export product Exp. Qty. SI No lmport items Qty al10Wed kg/kg MEFENAMIC ACID lkg ORTHOCHLORO BENZOIC ACID 1053 2 2,3,―XYLIDINE 0806 3 ISOPROPYL ALCOHOL 1763 4 METHANOL Not shown in the process may appropriate per 1 順∬"日 鵬先期∞鋼晨Ⅲ″ 隔扇高扁~囲 辮“Ю 7“田Pb眈 'Oaaiaioo : It was decided to reject the case as the firm has not furnished information despite repeated reminders and no comments from DCGI was received. Party may approach DCGI, the case will be reviewed upon the receipt ofthe comments from DCGI. 127 128 | | SERTRALNE HYDROCHLORIDE D MANDELIC ACID ICase No“ H7/14/82‐ 卜LC4/2013 | Party NamclMAC CHEM PRODUCTS(INDIA) PRIVATE LIヽ41TED IMし3tNo/Dato 18/82‐ 1艦盤r Status: Rejected udy。9 8haw.I“ ' 囲肝繭面 「 高 服19 HQF‖ c 101/82/050ノ00702/Alヽ414/ IRLA Filc :03/95/040/00407/AM14/ 写 Export product Exp Qty SI No lmport items Qty al10Wed kg/kg lkg METHANOL 378 ISOPROPYL ALCOHOL ξ υ ， ′ ０ 3 0392 4 TETRALONEIMINE ７ う ι り ， Ｃ Ｊ n-Hexane 047 IMeet No/Datel1 8/82- 1器鰍r :
: It was decided to reject the case as the firm has not fumished information despite
Case No:9/30/83-
ALC1/2013 : It was decided to reject the case as the firm has not furnished information despite reminders. Party Name:STERICON ヽ `eet No/Datc:18/82‐ PHARMA PVT LTD, ALC42014 Re-indexed 18022015 : It was decided to defer the case for 29.04.2015 for comments ofDepartment of Party Name:SHASLJN Meet No/Date:18/82‐ 1欄Ms w18/82‐ 脇 脇 BO/AMW~H¶ 鼎 α “ Ю И "4 : It was decided to reject the case as the firm has not furnished information despite rem inders. 「 師 F「 M釜 品 船 FD~ 34 Meet No/Datc:18/82- ALC4/2014 18022015 囮 葛i話戸鱚 m.%0 File ヽ 一 ” ﹈ Filc 1/82/050/00859/AM14/ No:38717/82‐ Filc
Case No.:47/16/82-
ALC4/2013
Case No.:46/16′ 82-
Meet No Date:18/82‐ ALC4/2013 PHARMACEUTICALS 1782/050/00900/AM14/ :09/24ノ040/00322/AM14/ reminders. 1器3児50/0餌27ハMW Date: r IDecision:It was dcci(lcd to rlCCtthe case as the■::::has not fumished infonnation despitc repeated reminders. IR露肌 』脳 面 “ d Ю ttCCtthe case as h im膿耐 =断 dh柿 “ ¨億p:_| 丁M｀
鴨
…
鰤
Departn,entor conmerce
ud羹嘉轟
^普
テ乱lЫ
~F璃フ而丁~1
「…
37 HQ Filc RLA F‖ e Lic No/Datc:3410038266 DcFcr Datc:
:01/82/050/00217/AM15/ :34/24/040/00184/AIヽ
414/ 21 102013
Decision : It was decided to reject the case as the firm has not fumished information despite
rcpcatcd rcmindcrs
: lt was decided to call from the firm following information:
The export product being an edible drink what is the justification for using HS code
30045039 in their application to denote the export product.
A copy of Master Biich Formula duly certified by the Quality Control lncharge of
manufacturer.
is deferred for 29.04.2015.
24102013
ヽ
´
ク
Decision : ln the light of written comments received from Department of Pharmaceuticals vide
:....^^,J^^il^,I
a^ .-+if., ^^rh< trn.lar
their oM No. 3501i/35u2014-pt(Norms) dated 22.01.2015, it was decided to ratify norms under
39'Para 4.7 of HBP vl 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
kg/kg
LAMIVUDNE
lkg
1
1Zn-Cis1l-amino-t -[2-
(hydroxymethyl)- 1,3-oxathiolane-5-yll-
2( I H)-plrimidinone monosalicylate
monohydIate
1866
nA r*y tat e,ppropriate action as per the decision of Norms Committee'
11
Decision : It was decided to reject the case as the firm has not fumished information despite
repeated reminders.
Defer
Date:29.04.2015
Decision:Reply rcceivcd and sentto Departmcnt of PhaH‖ accuticals for their comments The casc
is deferrcd for 29 04 2015
| | |`｀
▼^・
‐
し■■
'■■,ルレ
P
Case No.:22/17/82-
ALC4/2013 and Re-indexed | 1珈 | F廊雷戸 下再蘇蔦蕊面瓦::陸鮒 山 ・ν 2‐ 日出蹂: 1棚児 5∽舵ηハITF面繭耐而丁囲需而ラ 54848B麗漁: 「 F蕩 蕩T雨 「 T三[睡E,PIttACEU■ CttS朧 鮒 剛 2‐ 門 耀露露剛 | ― ― ― ― Ｉ Ｊ
40
:It was dccided tO defcrthe case for 29 04 2015 for commcnts Of Deparment OfC&Pc
I霊翌堅要
~羅
甲面直~m
′ 1脇鵬OЮ∝
38/Am″
澁
Case No.:26/24/82-
ALC4/2013 Paty Name:GLAND Meet No Date:18/82‐ PHARMA LIMITED 101/82/050/01225/AM14/ HQ F‖ e 101/82/050/01227/AM14/ Pars Name:PORUS LABORATORIES PVT LTD RLA File 10924/040/oo396/Aヽ114/ Re-indexed 饉高姦面1海戸~ 1織″盤F 語評霊があ iあ3823ダ顧 [霊π 1li: n : It was decided to remind the firm to fumish the following information: Consumption data of l6 raw materials used in manufaituring of Enoxaprin Sodium IttCCtiOns pre― ■lled Syringcs duly cenined by central Excise AuthoHけ fOrthC year 2012- 13,2013-14 and Apr‖ tO Dccember 2014 D鷺」静 1縫欄聯偶槙山艦臨]LttW柵 Enoxaprin Sodium illJcctiOns ⑪ 締轍:鮮鮒 ]¶ 棚 :驚鵠器T蹴冨 and 3 above may be celtifed by production in― chargc Of manufacturing unit Ofthe fl‖ :: Thc casc was deferred fOr 29 04 2015 142 sion:In the light Ofwrittcn comments rcceivcd frOm Departmcnt ofPhal:1:accuticals vide OM No 350‖ /2432014-PloOnns)datCd October 2014,it was decided tO cali from thc f‖ ‖ Re-indexed Re-indexed (a) Certificate of Analysis from Foreign supplier for the relevant consigrment of imported crude product. (b) COA ofExport product as per shipping Bill/purchase Order. ing information: case is deferred for 29.04.2015 ALC42014 18022015 43 n :, It was decided to remind the firm to fumish the lollowing information: l:::::r::.: l?3:t,lu raw,materiats.used in manufaiuring of Enoxaprin Sodium duけCC面■ `d百 こ j鳥島 i■I:蔦葛 I品群 |こ・慰サ :f冽輝 lllJccJOns prc― ■‖cd syrlnges 13,?O13-14 and ApriltO Deccmber 2014 of batch iOg shccts fOr thc last s consecutive batches fOr conversion of Hcparh No:51/18/82‐ 12
Powder into Enoxaprin Sodium indicating the actual consumption of all raw materials consumed for getting the API used in the Enoxaprin Sodium injections. Copies of batch log sheets for last 5 consecutive batches indicating actual consumption 16 raw materials applied for import in all applications against export of Enoxaprin Sodium Injections in pre-filled syringes. The information sought vide Item No. 2 and 3 above may be certified by production in- charge ofmanufacturing unit ofthe firm. Thc c、e was dcfcrrcd fbr 29 04 2015 「 44
Case No.:112/23/82-
ALC4/2013 Pary Namc:CADILA HEALTHCARE LTD, HQF‖ c 101/82/050/01159/AM14/ 「 到 ― コ rision :ln the light of written comments received from Department of Pharmaceuticals vide ir OM No. 35Olll776/2O74-Pl(Norms) dated 22.01.2015, it was decided to ratify norms under a 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less: port product Duloxetine Delayed Release Capsules USP 20mg Norms for I ks Duloxetine hcl S No Import ltem Norms for t kg Duloxetine hcl. (Qty in ke^s) l 1-Fluoro Naphthalene 268 つ ‘ 2-Acetyl Thiophene 3286 3 Acetone 366 4 Di Benzoyl-L-Tartaric Acid Monohydrate !43 Dimethyl Sulphoxide 3464 6 IPA (lso Propyl Alcohol) 3205 Dichloromethane,Methylene Chloride 401 recommend€d for I No, S No Impon ltem 20mg 30mg 60mg 1 Duloxetine Hcl 229 3435 6870 Dehydrated Alcohol USP(Ethanol 99.2%) 5948 89216 178432 Hypromellose l5 CPS USP 18133 2720 5440 4 Suger Spheres NF (Pharm-A) 53333 800 1600 Hypromellose Phthalate NF 1095 2190 ´ ０ Packing Materials Relevant, As packing policy. 13 lλ:危5器0/00387/AM14/
Case No.:66/3/82-
ALC4/2014 Partv Name:GLAND PHARMA LIMITED Re-indexed ― :lt was decided to remind the firm following information: i) Consumption data of 16 raw materials used in manufacturing of Enoxaprin Sodium Injections pre-filled Syringes duly certified by Central Excise Authority for the year 2012- 13,2Ol3-14 and April to December 2014. iD Copies of batch log sheets for the last 5 consecutive batches for conversion of Heparin Powder into Enoxaprin Sodium indicating the actual consumption of all raw materials consumed for getting the API used in the Enoxaprin Sodium injections. Copies of batch log sheets for last 5 consecutive batches indicating actual consumption 16 raw materials applied for import in all applications against export of Enoxaprin Sodium Injections in pre-filled syringes. The information sought vide ltem No. 2 and 3 above may be certified by production in- charge ofmanufacturing unit ofthe firm. Thc case was deferred for 29 04 2015 甲 蟄 ¨ 鵬 器 鮒 許D ttFd略 RLA File ~十 ~~ Lic No/Date:0510372635 |:05/23/040/00341/AM14/ : It was decided to reject the case as the firm has not fumished information despite reminders. ~「需需諏雨正芋麟ぽ・ν "~~ 1器脇 5υO∝85AMly 彫力棚υO∞53AMW [輛 需戸 爾98392日 蕩蕊蔦 IDecision:It was decidcd to defcrthe case for 29 04 2015 for comments of Dcpartment ofC&PC HQ File ~原EA File ~~~~~~F飛石豪面現姦雨ラlololo55 :01782/050/00688/AM15/ :07′ 24/040/00323/AM14/ 102012014 Date:29042015 : It was decided to defer the case for 29.04.201 5 for comments of Department of C&PC. [「 '77語 ・両 2‐ ~ 05122013 Re-indexed Re-indexed :01/82/050/00070/AM15/ 1/82/050/01163/AM14/ Case No::81/3/82- ALC472014 14 | 」 repeated rem inders.
r : It was decided to reject the case as the firm has not fumished information despite reminders. ision : It was decided to send a copy ofapplication again to c&pc for their comments. The was deferred for 29 .04 .2Ol 5 ision : I1 was decided to send a copy ofapplication again to c&pc for their comments. rhe was deferred for 29.04.2015 :It was decidcd tO dcferthe case fOr 29 04 2015 for comments of Department of ,ase for 29 04 2015 for cOmments ofDepartment ofC&Pc :It was dccided tO deferthe( :It was decided tO dcferthe case for 29 04.2015 for comments Of Department OfC&Pc ﹇ ｄ ｅ ｘ ｅ ｄ Ｄ ｅ ＾ｉ ｎ 峙 Ｒ ｅ P″″NalnciVIVIMED LABS LIMITED Name:MACLEODS 50
Case No.:186/3/82-
ALC4/2014 「器蝠剛恵 ｄ Ｓ ｔ ａ ｔ ｕ ｓ ぃ HQ File :01/82/050/00190/AM15/ RLA File :09/24/040/00484/AM14/ 1脚BRF Defer Date: No.:192l3/82- lparty Name:VlvtMab I_aeS Meet Nr,Dat.l S/82- rNDIA PVT LTD No.:873/82- lparty Name:VIVIMED LABS
Ｆ Ｉ Ｆ Ｐ 一 Ｉ Ｐ Ｆ Ｐ reminders. reminders. deferred for 29 04 2015 No.:131/3/82-ALC4/2014 10059230 Party Name:INCHEM Meet No/Date:18/82‐ LarioneromEs pRIvATE ]ALc4/2014 LIMITED Meet No/Date:18/82- ALC4/2014 18022015 Name:ASTRIX TORIES LTD, Re-indexcd 鴨 9/AM14ノ | 】需憫Ю %%"P山めに ,,tr ,a."i*a from Department of Pharmaceuticals vid dated 07.04.2015, it was decided to ratify norms und( lw or as applied by the firm, whichever is less: e :r lmport items Qty. allowed Export product [xp Qty Sl No 0 663kg/1000 No tablcts FAMCICLOVIR 500MG TABLETS Nos )―(4-ACETOXY-3- ACETOXYMETHYLBUT-1- YL)-2-AMNO-6- CHLOROPURINE decision of Norms Committee. may take aPProPriate action as Per th( PなりNalne:ASTRIX ILA30RATORIES LTD, Meet No Date:18/82-
case No.:5473/82-
ALC4′ 2014
case No.:64/3′ 82-
Party Name:ARENE LIFE Meet No′Date:18/82‐ ALC4ノ2014 sCIENCES LIMITED
case No.:61/3/82‐
ALC4′ 2014 18022015
case No.:73/3/82-
Party Name:ARENE LtFE
ALC4′ 2014
16
―――――――~――~~
:It was decidcd tO rCJect the caSC as the flln has nOt fbrnished inforlnatiOn desplte
: lt was decided to r";e"t th" ""s"
us th-e
f"- has not furnished information despite
: It was decided to reject
面=慕
藤面高蔦面面hmlshed mおmat10n
赫二――_―――――――一―――
「
――■
「
■
「鳥罵:葛福1:石面モFttmpお “ teChnにJ detJヽあlerAppendx33 Thec“ e
Ｆ Ｉ lrecision : Department of Pharmaceuticals vide their oM No. 3501 I /49212014-pl(Norms) dated 10.02.2015 have stated that they have examined the matter and it is noted that boih import and items are chemically same. Since the coA of the import item is not given from foreign r, it is felt that no manufacturing activity is involved which may account for 3 4.3yo wast{ge hence the Department of Pharmaceuticals does not support the proposal. In view ofthe aboie ments ofthe Department of Pharmaceuticals it has been decided to Reject the case. Date: Re-indexed 042015 :Deffered Re-indexed 042015 sion :ln the light of written comments received from Department of pharmaceuticals vide QM No, 350r r/492/20r4-pr(Norms) dated r0.02.2015, if was decided to ratifo the norms Para 4 7 ofHBP vl as pcr dctails given be10w Or as applied by the■ =:::,whichevcr is icss: may take appropriate action as per the decision of Norms Committee Meet No/Datel1 8ノ82‐ ALC4つ014 18022015 Meet No′Date:18/82- ALC42014 18022015 Mcet No′ Datel1 8/82‐ ALC4/2014 18022015 | IDecision:It was decided to defcrthe case for 29 04.2015 for comments of Department of C&pC. 「 3鵬 3‰Ю∞ 9。/AMⅣ 厩肥∽釧 "畑w “1棚児 "Ю∝。嗽m夕 脇馳∽∝ηttw : It was decided to defer the case for 29.04.2015 Lic Nα Date10910059289 14022014
Case No.:64/6/82-ALC4/2014
Ptt Name:FDC LTD S No Export Product Quantity Raw materials allowed Quantity allowed 1 SODIUM CROMOGLICATE EYE DROPS135 ML VIALS l Vials ISODIUM CROMOGLICAT 0.2753 gmlvial 2 POLYETHYLENE SYNTHETIC RESN (LDPE GRANULES) Relevant, as per packing policy 2 SODUM CROMOGLICATE EYE DROPS lo ML VIALS l Vials SODIUM CROMOGLICATE 0.204 gnlvial 2 POLYETHYLENE SYNTHETIC RESIN KLDPE GRANULES) Relevant, as per packing policy
Case No.:86/3/82-
ALC4/2014 Party Name:AKZO NOBEL INDIA LIMITED Lic No/Date:0210200380 21022014
Case No.:lo5/3/82-
ALC4/2014 PHARMA‐ CRO LIMITED Lic No′ Date:0310771596 24022014 17 for comments of Department of Name:THINQ
Case No.:16173/82‐ ALC4/2014
Party Name:tINIMAX CHEMICALS PVT LTD Meet No/Date:18/82‐ ALC4/2014 18022015 HQ File Lic No/Date:0310771527 Date: :01/82/050/00165/AM15/ 24022014 Export Product Quantity Import Product Quantity allowed ks/ks Azithromycin Dihydrate USP-36 Ikg Azithromycin Dihydrate IP 1061 @e decision of Norms commitee' Re-indexed HQ File 042015 :01/82/050700520/AM15/ ffi received from Department of Pharmaceuticals vide OftA N". 35}lit315t2}l4-Pl(Norms) dated l3'03'2015' it was.decided t:.t?tiry q",i:-ttt Para 4 7 ofl]BP vl as pCr dctails givcn bc10W Or as applicd by thC fl‖ 11,whichcver iS ICss: Drug Manufacturing Licence ;;6;J;;position of the expon p'6iu"t'tu "*" isdeferredl2.06.20 No■53/6/82‐ t4 HQ File :01/82/050700460/AM15/ 042015
Case No.:106/3/82-
ALC4/2014 Meet NolDate:18/82‐ ALC4/2014 118022015 Lic No Date:0310772503 28022014 No Date:18782‐ Re-indexed 042015 @ received from Department of pharmaceuticals vide i.or.aN".350l.|-617t2o|4-Pl(Norms)dated07.o4.2o]t5mentionedthatexportProductiSnota rg and hence Department of Pharma is not concemed' lt was decided to send a copy of plfi..o." to Department of C&PC for their comments' The case was deferred for Re-indexed 18022015 Lic No17Date:0310772411 28022014 042015 :It was dccidcd tO defcrthc case for 29 04 2015 for comments of Department ofC&PC' Ｆ ‐ ‐ ６ ９ ‐ ‐
Case No.:l t8/6/82-
Meet No/Date:18/82 ALC4/2014 SCIENCES PRIVATE 18022015 Lic No/Date:0410155675 :04724ノ040/00214/AM14/ CROPSCIENCE LIMITED :03/94/040700797/AM14/ Party Name:PERFECT VITAMINS PVT LTD 18022015 No.:119/6/82‐ALC4/2014 18 No/Datei1 8/82‐ Name:EMCURE
隔恵薦蕊丁~日 魔 OЮ己誠話T I悧鼎ぬЮ R3∞2 Defer Date: sion:In the light of writen comments rcceived from Dcpartmcnt of Pharmacctlticals vide OM No 35011/491/2014-PIいorms)dated March 2015,■ was dcddcd to rau″ thc no‖ 1ls Para 4.? ofHBP vl as per details given below or as applied by the firm, whichever is less: Export Product Qり SI No Import items Quantity allowed kg/kg Ritona、'ir USP l kg l Ritonavir Intermediate-ll [Carbonate] { Carbonic Acid-4- nitrophenyl-5 -thiazolyl methylester) 072 2 BDH Succinic Acid Salt {(2S,3S,5S)-2-Amino-3- hydroxy-5-(tert butyloxY carbonyl) amino -1,6-diPhenYl hexane succinate) 114 may takc appropriatc action as per thc decision of Noll=lS COmmittcc Decision : It was decided Pharmaceuticals. 理 | 1匠面面面画面高面高品画面面 : 101靡 図 19 一 Ｍ 一 ― ‐ ， 一
rion :ln the light of written comments received from Department of pharmaceuticals vide
o_M No, 350tv480t2014-pl(Norms) dated 25.032015, it was decided to ratifu the norms
Para 4 7 ofHBP vl as perde●Is」ven bdOw Oras ap口Ld by thc nrln,whthcvcrヽLss
may take appropriate uctioffi
∬lLttD I濶…
30644魔m″
陪辮Ю釧∞
"劇
Re-indexed
Re-indexed
: lt was dccidcd tO defer the case fOr 29 04 2015 for
comments of Department
:It was decidcd tO deferthc casc fOr 29 04 2015 for commcnts Of Departmcnt of
)ecision :lt was decided remindthe frrm to furnish complete technicar detairs as per Appendix
3. The case was deferred for 29.04.2015.
Export Product
Qサ
SI No
Impon items
Quantity
allowed kollto
Abacavir
Sulphate
l kg
l
( I S,4R)-4-[(2-Amino-6-chloro-9H-
purin-yl)-2-cyclopentene- I -
methanol Hydrochloride
1292
/
2
Cyclopropylamine
019
175
P枷
″
ん般‐
壁
螢
訟酬
路lD,11 朧淵tB慇2
|
1鵬澪"側2鳳w丁
1葬
贄
…
1轟
Decision :committee considered the case as per agenda and in right of *ritten comments received
lr.": .O^",0.11T"."1 of pharmaceuticats vide their OM No. 350,/251120t4_pl(Norms) dared
18 03 2015and in cOnsulaaon wih techntal authOri″
present in mec■ng, dccided tO rati″
ino‖ ‖s under para 4 7 of HBP as per deta‖ s givcn below Or as applicd by frrll 、vhichcver is
岡
蹴
脚
澁
l轟ご¨に
鰊
鰈
蒋請禽潔F■
Udr -_9 Bhi
.+ R,
赫
uざ ■[
辮3/3/82
lower:- Export product Exp Qty SI No Import items Qty in mg for export of I Pantoprazole tablet 20 mg Tabs 40 mg tabs Pantoprazole Tablet l kg l Pantoprazole Sodium 21571 43143 2 Mannitol USP (PearlitO1 25C) 4244 8488 3 Sucrose USNF 800 1600 4 Hypromellose (Pharmacoat 603 3cps) USP 1 86 372 RA concerned may take further necessary action as per above decision of NC. Export product Exp Qty SI No lmport items Qty. allowed ks/kc Meropenem for lnjection lКg 1 MAP 4R -53-65-3- diphenyloxy phosphoryloxy-6- lR -l - hydroxy ethyl -4-methyl-7 - oxo-l -azabicyclo 3- Z 0 hept-2- ene-2-carboxylate. ｎ υ 2 Meropenem Side Chain ( 25- 45 )-2- (dimethylaminocarbonyl) -4- mercapto-1-(P- nitrobenzyloxycarbonyl)- l - pyrrolidine. 3 Dimethvl Fonnamide 1051 4 Tetra Hvdrofuran 130 5 Acetone 956 RA mav take appropriate action as per the decision of Norms Committee. a ppropriate
Case No:57/10/82-
A LC4/2014 79 HQ Filc Pa●y Name:AUROBINDO PHARMA LIMITED File 171 Decision : ln the liBht of written comments received from Department of Pharmaceuticals vide their OM No 35011/432/2013‐ pl(Norms)dated 06 02 2015,■ was decided to ratify norms under .Para 4 7 of H8P vl as per details given below or as app‖ ed by the firm′ whicheveris less:
Ю1/82/050/00971/AM15/綺9/24/040/00628/AM14/,7032017
Meet No/Datc:18/82-
ALC4/2014
18022015
野
ぽ
~鵬
蹴∽Ю
%晨Ⅲ″
: lt was decided to defer the case for 29.04.2015 for comments of Department of C&pC.
:ln the light of written comments received from Department of pharmaceuticals vide
OM No 35011/550/2014‐ Pl{Norms)dated 07 04 2015,■was decided to ratify norms under
Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Case No.:51/5/82-
ALC4/2014 Paty Namc:JNDAL DRUGS LIMITED
Case No.:48/5/82- Pary Name:KOPRAN Meet No/Date:18/82
ALC4/2014 LIMITED ALC4/2014
18022015
HQ F‖ e RLA File
‐Lic No/Date103 1077
:01/82/050/00365/AM15/ :03/94/040/01168/AN414/ 27032014
Decision:in the light of wrltten comments received from Department Of
their OM No 35011/432/2013‐
PI(Norm5)dated 06 02 2015′
t was decided
Para 4 7 of HBP vl as per deta‖ s given below or as applied by the firm′
whicl
6170 iDefer Date:
I
-r__
Pharmaceuticals
to ratify norms u
lever is less:
ｖ
ｉ
ｄ
ｅ
ｎ
ｄ
ｅ
ｒ
|
|
|
|
|
|
|
Export product
Exp. Qty.
SI No
lmport items
Qty a‖ owed
kgノkg
Meropenem for
lnjection
lkg
1
MAP
4R -5S-6S-3- diphenyloxy
phosphoryloxy-6- IR-l-
hydroxy ethyl -4-methyl-7-
oxo-l -azabicyclo 3- 2 0 hept-Z-
ene-2-carboxylate.
ｎ
Ｕ
０
０
2
Meropenem Side Chain ( 23-
45 )-2-
(dimethylaminocarbonyl) -4-
mercapto- l -(P-
nitrobenzyloxycarbonyl)- I -
pynolidine.
つ
Ｄ
3
Dimethyl Formamide
1051
4
Tetra Hvdrofuran
130
Ｃ
Ｊ
Acetone
956
「1暉~| ~~
12田3児59∞Я2ハ〕薦
~鵬
ち棚
ν∞ω αAMW I蹴
辮
Ю釧∞
"“
2
:lt was decided to defer the case for 29.04.20'15 for comments of Department of
― ― ― ― ― ― ― ― ― ― ― ― | Export product Exp Qty Si No lmport items Qty a‖ OWed kg/kg (5S,6E)-7-[2‐ Cyclopropyl-4-(4- fluorophenyl)-3- quinolinyl]-5- hydroxy-3-oxo-6- heptcnOic acid ethyI ester(5S MOLE) lkg 2-Amino-4- Fluorobenzophenone 1 855 2 Methyl-3 -cyclopropyl-3 - oxoDroDionate 1 23 3 Diethyl(cyanomethyl) phosphonate 1 02 4 N-Methyl-N,N-dioctyloctan- I - ammonium chloride 0034 5 N-Heptane 670 ´ ｂ S‐ 3inol 0089 Fcase ttll12/6/82「 ~ IALC4/2014 FPac Name DIVIS lstatus: lApproved ILABORATORIES LTD, IALC4/2014 18022015 HQ F‖ e RLA File 101/82/050/00514/AMi5/ :09/24/040/00658/AM14/ 28032014 Decision :ln the light of written comments received from Department of Pharmaceuticals vide. the計OM No 35011/455/2014-Pl(Norms)dated 26 02 2015′ I was decided to ratify norms under para 4 7 of H8P vl as perdeta‖ s given below or as app“ ed bythe lrm′ whichever`less: | Export product Exp Qty SI No lmport items Qty. allowed kc/kc (Z)-2-(2,3- DICHLOROPHENYL)-2- LIQUID (GUANIDNOIMNO) ACETONITRILE l kg 1 AMINO GUANIDINE BI CARBONATE 1 06 2 ACETONITRILE 202 （ ３ 2,3-DICHLORO BENZOYL CYANIDE 1 23
Case No:44/5/82- Pa●y Namc:KOPRAN Meet No/Date:18/82- Status:
‐ALC4/2014 LIMITED ALC4/2014 1Approved .
■8022015
HQ File ‐RLA Fnc Lic No/Date:0310776372 Defcr Date:
‐
:O1/82/050/00361/AM15/ :03/94/040/01157/AM14/ 28032014
‐
Decision:ln the light of written comments received from Department of Pharmaceuticals vide
ther OM No 35011/443/2014-PI(Norms)dated February 2015′
l was decided to ratify norms
‐under Para 4 7 of HBP vl as per details given below or as applied by the firm′
whicheveris less:
84
| 23 ― ・ ｒ 」 |
ヾ Export product Exp Qty SI No lmport items Qty. allowed kg/kg Clarithromycin USP/EP/IP (90% Less than 80 Mesh 150 Micron) l kg Clarithromycin USP (90% Less than 40 Mesh 400 Micron) 100 C"." No.,4?/5/82- p*tv Nu,r,",f<OpneN lf"f..t flo,Out.,f 8l/A2- - lSiriri, ALc4notl lr-rnirreo ,ALC4t2ot4 hpproved I 1E.02.2015 I nOrit. -- - --IELA Fll.
- latc.M/D"t"o3 t0??635 r ]D.r.r out., .jr/g/059,003611I'5r :0324t049'or6et^Mt4t lzr.o:.zor+ Decision !ln the light of written comments received from Department of Pharmaceuticals vide their oM No. 35011/143/2014-Pl(Norms) dated February 2015, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp Qty SI No lmport items Qty a‖ OWed kgノkg Claithromycin USP/EP/1P (90%Less than 80 Mesh 150 Micron) l kg 1 Clarithromycin USP (90% Less than 40 Mesh 400 Micron) 100
Case No:8/10/82-
ALC4/2014 Ｆ Ｉ Ｉ Ｉ ＾ ´ Ｐ Ｉ ― 「71器 疏 50Ю餌 “ 薫 罵 ~卜 LA me~~~― ― Ю3/95/040/01043/AM 14/ 鵬脇5∽0922/Amy 陽危詰∽“ "ハ剛″ : lt was decided to defer the case for 29.04.201 5 for comments of Department of : It was decided to defer the case for 29.04.2015 for comments of Department of Lic No/Date:0910059684 01042014
Case No.:73/5/82-
ALC4/2014 File :01/82/050/00390/AM15/ 24 | Name:SATYADEVA No/Date:18/82- /P/ 」 f ●F"円鰤 つepamentoF Conlme疇 ud落鄭鳳絲誡 :ぃ
ハ Meet No/Date:18/82- ALC4/2014 18022015 lsion:in the light of written comments received from Department of Pharmaceuticals vide OM No 35011/427/2014 Pκ Norms)dated 06 02 2015,I was decided to rajfy norms under 4 7 of H8P vl as perdeta‖s given below or as applied by the■ rm′ whichever is less: Export product Exp Qty Si No lmport items Qty allowed kg/kg Alpha Beta Arteether (Arteether) l kg 1 Artemisinin l 149
Case No:47/10/82-
ALC4/2014 LABORATORIES LIMITED Lic No/Date:0910059694 02042014 ０ ― ― ― ― ― ― ― ― ― ― ― ― ― 慣 ッ ー ー ー ー ー ー ー ー ー ー … 4/10/82‐ 凡C4/2014P価 … dcALE I濶 … 「 器3場5υ00釧8ハMW IЪ 危棚 OЮ0670AMW 脇:淵 αO剣0°59706F Decision:in the nght of written comments received from Department of Biotechnology vide th No BIノIL/05/382/2013-PID dated 26 02 2015,it was decided to ratify norms under Para 4 7 of HI per deta‖ s given below Or as applied by the nrm′ whicheveris less: efer Date: eir oM 3p vl as Item of Export Quantity S′No Item of lmport Quantity allowed per million vials (PENTAVALENT VACCINE) FULLY LIQUID COMBINAT10N VACCINE SNCLE DOSE ViAL, PEDIATRIC DOSE DIPHTHERIA,TETANUS PERTUSSiS,HEPATITIS B RECOMBINANT AND HAEMOPHlLUS NFLUENZA TYPE B(HlB) COMBNED VACCNE WITH VACCNE VIAL MONITOR (VVM) Vial POLYETHYLENE CLYCOL 61XX“ACROCOL) 76 848 kg 2 AEROSIL 380V(COLLIDAL ANH SILICA BP) 20 375 kg 3 GしYCEROL 122 841 kg 4 TWEEN20(POLYSRBATE 20) 7 658 1tr 5 POTASSIUM THYOCYNATE !69.742 ems 6 TRIS BUFFER 10 216 kg 7 ALUMNlUM CHLORIDE 6 HYDRATE EXTRA 27 665 kg 8 YEAST EXTRACT 22 447 kg 9 DEXTROSE(CLuCOSE) 35 937 kg 10 L CYSTINE 0 437 kg 11 BACTO CASAMINO ACID 31 758 kg 12 TH10MERSAL 0 379 kg 13 SILICON EMULS10N 16 5 kg 14 ADIPIC D:HYDRAZIDE 國 1 686 kg 喘 Ｅ υ 89 HQ File :01/82/050/00961/AM15/ 鵬λ淵OЮ∞ 38AM W Defer Date:29042015
Ｅ Ｊ N‐ 3‐ DMETHYLAMINOPROPYL‐ N‐ETHYLCARBODBイ:DE HCL(EDC) ___ 167 545 gm 16 2ョN‐MORPHOLNO ETHANE SULFONIC ACID (MES) 1 441 kg 17 CETAVLON 1537 gm 18 ALUMINIUM PHOSPHATE CEL 2%(ADJU PHOS 20/.l 76 991 kg 19 L■YROSlNE 0 7841 kg 20 NZ CASE TT(CASEN PEPrONE PLuS) 39 12 kg 21 VITAヽ4N Bl HCL (THlAMlNE HYDROCHLORIDE) 1 14gm 22 OLASS VlALS 1100000 nos 23 RUBBER STOPPERS 1095638 nos 24 江UMNIUM CAPS′ SEALS 1088334 nos Ｅ リ HEATN4ARKER VACCINE VlAL MONITOR(WM LABELS)LABELS _ 1086508 nos 26 SH:PPNC nlDICATORS(Q TAG 2PLUS) 902 nos 27 FlLTERS&FlLTER AIDS 250 nos mav take approprlate action 3s perthe deciJon of No「 ms Commttee
Case No.:15/10/82‐
ALC4/2014 P征 "Name:B10LOGICAL E Meet No/Date:18/82‐ LTD given below or as applied by the firm, whichever is less: ALC4/2014 18022015 Lic No/Date:0910059705 03042014 042015 DecisiOn ln the light of written comments received from Department of Biotechnology vide their OM No' BllVOSl38zlzoL3-PlD dated 26.02.2015, it was decided to ratify norms under Para 4 7 of HBP v1 as per (PENTAVALENT VACCn■) FuLLY LIQUID CONIBANITA10N VACCNE 10 DOSE VIAL PEDIATRIC DOSE DIPHTHERlヘ lL:ANUS, PERTUSSIS,HEPATITIS B RECOMBlNANT AND HAEMOPHILLUS INFLUENZA TYPE B(HIB) coMBINED VACCINE WITH VACC■lE VIAL MONITOR (VVM) 26 ヘ Re-indexed
ヘ | 1脚 RA may take appropnate action as perthe dedJon of N ETHYLCARBODIMIDE HCL(EDC) 14 SiLICON EMULSION 165 00 kg ― 15 2くN―MORPHOLNO) ETHANE SULFONIC ACID (MES) 14 41 kg 16 CETAVLON 15 369 kg ‐ 17 ALUMINIUM PHOSPHATE CEL 2% 769 91 kg 18 L―TYROSINE 7 81 kg 19 NZ CASE TT(CASEIN PEPTONE PLUS) 391 2 kg 20 VITABIN Bl HCL (THIAMNE HYDROCHLORIDE) 11 45 gm 21 CLASS VIALS SILCONISED 5ML 1100000 nos 22 RUBBER STOPPERS 1085430 nos ALUMINltJヽ4 CAPS′SEALS 1076890 nos 24 HEATMARKER VACCNE ViAL MONITOR LABELS (VVM LABELS) 1100000 nos 一 Ｌ Ｊ つ 乙 SHIPPINC INDICATORS (OTAG 2 PLUS) 1790 nos 26 FILTERS&FlLIER AIDS 2500 nos. , 27 BACTO CASAMINO ACID 317 58 kg ‐ Decision : It was decided to defer the case for 29.04.2015 for comments of Department of C&PC. ― ― ― ― ∃ 「ほ需嗣菰~~ ~| 1締為“ | | | | |1脇蕊蕊話し~脇 鳳鳳i瓜 1囮謳脇 ら 3 Para 4 7 of HBP vl as perdetaiL given below oras applied by the lrm′ whicheverもless: 5%W′VOF1000ML 051 gm per lo mivial Pa,y Name:GLOBE TROTTERS PVT LTD Meet No/Date:18/82‐ ALC42014 118022015 Status: Approved 27 ― | Export product ” Ｑ ｔ ｙ SI No lmport items Qty. allowed kg/kg ノials 1 〕HLORAMPHENICOL つ ´ ´DPE CRANULES {s per packing policy
隔既蕊蔦蕊TI需蕊濡蔦罵π ~歴 蕊需面面扇 Decision:in the light of written comments received from Department of Pharmaceuticals their OM No 35011/453/2014‐ PI{Norms)dated 17 02 2015′ t was decided to raJfy norms u Para 4 7 of HBP vl as perdeta‖ 5 given beiow or as applied by the firm′ whicheveris less: Export product Exp Qty SI No lmport items Qty a:10Wed kg/kg AMPICILLIN SODIUM STERILE+SULBACTAM SODIUM STERILE(2:1) (STERILE,CRYSTALLINE AND APYROGENIC) l kg 1 SULBACTAM SODIUM USP/BULK(STEШLE) 034 2 AMPICILLIN TRIYHYDRATE IP 068 3 ACETO NITRILE 0959 4 DIETHYL ANIINE 01667
Case No:23/6/82-
ALC4/2014 Deffered Re-indexed Re-indexed The casc is deferred for 29 04 2015 Ｆ ト | 開蕊=蕊 戸「 1場危鵬υ∞Ю 7AM W Lic NoアDatc12210014787 09042014 Sion :ln the light of written comments received from Department of Pharmaceuticals vide OM No. 3 501 i/52312014-PI(Norms) dated 25.03.2015, it was decided to call from the firm information: (a)TeChnical Justiflcation fbr import of Sulphcr which is not shown in the pr∝ css/chemicals reactions. (b) Past production vis-a-vis Actual consumption ofinputs duly certified by central Excise Authority . The casc is defe“cd for 29 04 2015
Case No:24/6/82-
ALC4/2014 卿 舗 Namc:KUDOS CHEMIE No′Date:18/82‐ sion +In the light ofwritten comments received from Department of Pharmaceuticals vide OM No. 3501 l/489/2014-PI(Norms) dated March 2015, it was decided to call from the firm production vis-a-vis Actual consumption of inputs for last three years duly certified by Excise Authorities. IALC4/2014 118022015
ヘ ‐Case No.:68/5/82- IALC4/2014 Party Name:FDC LTD 1器3児50Ю038"AMIフ :01/82/050/00385/AM15/ | 町 Decision : ln the light ot written comments received from Department of Pharmaceuticals vide their oM No. 35011/499/2014-Pl(Norms) dated 1L.02.2015, it was decided to ratify norms under
Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
98 .=1----..-.---l Export product Exp Qty Si No lmport items Qty. allowed 3HLORAMPHENICOL EYE DROPS '5%ヽ ″V OF1000 ML l Vial 1 ごHしORAMPHENICOL 0.05 I gm per l0 ml vial う ‘ _DPE CRANULES As per packing policy ― ∃ 「冨て日剛MM匙堕 | 1臨 扇 蕊 蕊 戸 障蹴 OЮ圃9ハⅢy F面 。ccivcd from Dcpartmcnt of Pha‖ 1laceuticals vidC ated 25 03 2015,I was dccided tO rati″ n011llS un( ″orぉapplied by thc fll111,whichcver is less: | cision:in thc light( ir OM No 35011/54 a47 ofHBP vl asl of written comments received from Department of Pharmaceuticals vlde l2tZOl3-Pl (Norms) dated 25.03.2015, it was decided to ratift norms under per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. SI No lmport items Qty A‖owed kg/kg VORICONAZOLE l kg 1 4-chloro-6-ethyl-5-fl uoro- pyrimidine 330 2 l―(2,4-Difluoropheny!)-2-(lH― 1,2,4-triazolc― l‐yl)Cthanone 550 / 3 RC) l0 camphor su l&I!-qgid- 101 4 Acetone 1190 ‐ 長発]【■feneralざFII.P:J、 29 c i@l their comments. The case was defe rred for 29.04.2O15. 1 : It was decided to send a copy ofapplication again to Department of Pharmaceuticals 齋話陶Fd跳 2岡蹴脚 M夕 圏戸0039800π扁 : leived from Dcpartment of Pharlllaccuticals vide ' thcir OM No 35011/417/2014-PloヾOrms)datcd 22 01 2015,■was decidcd to can from the fll‖ l i cOpy OfMaster Batch Folulula for cach strcnghs Ofcxport prOduct duly ccrtifled by their Qualiツ |1程IWT∬∬山 Mtt and eac耐血… S
Ｃ υ Methanol 526 ′ 6 Dichloromethane (orlVethylene Chloride 398 ′ 7 Iso Propyl Alcohol 110 HA may take appropriate action as per the decision of Norms 「 F¨ 蝕 |∝鵬3先mЮ"%晨剛]~1麒 :It was decidcd tO deferthe casc fOr 29 04 2015 for comments of Dcpartmcnt Of ‐P脚ル 「ロ 102 lMeetNoDate 18/ 1器盤r ,Case No.:69/5/82- Party Name:FDC LTD Meet I lALC4nOl4 rALC4i Irr.oz.: EQ-.,E - -trA Fne - - -- ---llt".N" :01/8210-50100386/AMt5/ i:03/94/O4}/Ooo4ttAMtst lZt.Ot.: t.irio;;th.-.-ngr'tor*riti"n-r;;;;."irJt"rD; their OM No. 3SO7U4Sr/2014-pt(Norms) dated 28.01.2015, under Para 4.7 of HBp v1 as per details given below or as applie Ooわ凛o18/82- Statu" 蠍.:l lApproved ib… IDeFer Date: Ю14 1 Dartment of Pharmaceuticals l was decided tO ratify n( ld bythe irm,whichever is le ｖ ｉ ｄ ｅ ｍ ｓ Export product Exp Qty SI No lmport items Qty. allowed ′ OHLORAMPHENICOL EYE DROPS '5%W/V oF 10 00 ML vials υia l l ごHLORAMPHENICOL 9 051 gm pcrlo ml宙al つ ４ _DPE CRANULES As per packing policy may take appropriate action as per the decision of ttornrs Co mittee. ほon:ln the light Ofwntten comments received frOm Departmen1 6111:1品 acさitic:ls↓iしき OM No 35011/426/2014-PINorms)dated o6 02 2015′ l was decided tO ratify nOrms Para 4 7 of HBp vl as per deta‖ s given below Or as applied by the flrm,whichever is less: Export product Exp Qty SI No lmport items Qty allowed kg/kg Nandrolone Phenyl Propionate Kg 1 19 Nor Androst_4-ene-3, 17‐ 器躁出陽 :::翼電忠 :° 1008 :ldy taKe approprlate act lon as 叫 儀 It 鸞憮識f ヽ “ ・ “ per the decision of Norms Conrmittee. 104 Case No.:48/10/g2- party Name:MyLAN
ALC4/2014 甲 繭 輸 而 器 盤F 「 耐R蒟劇α d 1脇棚0/006"AMW
Case No.:49/10/82‐
ALC4/2014 042015 Re-indered efer ate:29042015 Ｄ Ｄ Decision : It was decided to defer the case fot 29.04.2015 for comments of Department of Pharmaceuticals. 「… 77/5/82‐ALC4/2014 1 ¬3〒π=~~~~~― ――一―――質 HQ File 101/82/0 101/82/050/00394/AM15/ appropriate RLA File Ю3つ47040/00997/AM14/ Meet No/Date:18/82‐ status: | ALC4772014 Approved 118022015 . | Lic No/Date:0310779207 .Defer Date:| 123042014 1 rtment of Pharmaceuticals vide their OM I d lo rad～the nOnns under Para 4 7 of ever is less: ntittce :01/82/050/00962/AM15/ ision:in thc light ofwrltcn 35011/505/2014-PloNonlns)da 'vl as per detans given be10、v( comments received from Department of Pharmaceuticals vide thr ied 12.02.2015, it was decided ro ratiry rhe norms under para )r as applied by the firm, whichever is less: Export Product Unl Import Item Qty. Allowed BIMATOPROST OPHTHALMIC SOLUTION 0 01%N3ML BOTTLE Onc3 ml bottlc BIMATOPROST 0.306 mg per bottle BIMATCPROST OPHTHALMIC SOLUT10N 0 01%lN 5ML BOTTLE Onc5 ml bottlc BIMATOPROST 0.5 l0 mg per bottle BIMATOPROST OPHTHALMIC SOLUT10N 0 01%IN 7 5ml Bottlc One 75 ml bottle BIMATOPROST 0.765 mg per bottle RA may take action as Der the decision of Norms Committee. 「冨続赫甲濡臨「~冊面=師 ~ ´ 81器 脇 “ 畑370ムm夕 隔頭罵膠 ξ丁 囲爾語 面而薫戸petrDaer Decision : ln the light of written comments received from Department of Pharmaceuticals vide their oM No.3501!/437/2014-pt(Norms) dated 06.02.2015, it was decided to ratify norms 31 /82/050/00963/AM15/ |
Para 4.7 of HBP vl 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ノkg
Azithromycin Monohydrate
USP
Kg
1
Azithromycin Dihydrate
ｎ
ｖ
1
甲
Lic No/Date:0510384810
109
24042014
:In the light of written comments received from Department of Pharmaceuticals vide
OM No 350H/420/2014-PI(Norms)datcd 22 01 2015,l was dccided to ca‖
from the flrrn
ofvalid Drug Manufacturing License(DML)from thC■1‖ i for both ofthc above cxpo■
casc is dcferred for 29 04 2015
1需扇蕊薦yl競面蕊Imy l躙鼎
C酬∞
"“O Fhm
|
Deffered
Re-indexed
Decision:ln the‖ ght of written comments received from Department of Pharmaceuticals vic
their OM No 35011/457/2014 PI(Norms)dated March 2015,I was decided to ratify norn
under Para 4 7 of HBP vl 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
kg/kg
ヾ‐BOC― ETHYLENEDlハИINE
kg
l
)1‐T‐3UTYL DICAR30NATE
17758
2
じTHYLENE Dl AMINE
26637
3
VETHYLENE CHLOR:DE
519
~囲面瓢需腰
y∬"
‐
ｓ
ｖ
ｉ
ｄ
ｅ
¨
ノ
Case No.:53/10/82-
lk―、 | 「厩面戸‰ ~~臨 需融儒田PITD殴蒻Te18/8r瑠蕗d~
「 P赫 繭 甲 閻 而 離蒻 " 118022015 1B鵬3児w∞mmy囲脇扁戸1翻辮側""5“ Party Namc:VIVIMED LABS Ｆ Ｉ
Case No:41/10/82-
ALC4/2014 I l4 ,HQ File :01/82/050/00955/AM15/ RLAtte ~~~~~~Ll訴面扇語両loo59852 「09/24/040/00028/AM15/ p5042014 lb田3児5υllle60/AMЫ ド‐ ・・ Lυ lI置猫 『 珊翻蕊=蔦 丁1翻鼎醐∞ "お 3 Re-indexed しlIⅥITED 藤面雨扇面8/82~ IALC4/2014 Re-indexed Deffered Pary Namc:VlVIMED LABS Meet No/Date:18/82- Deffered ALC4/2014 Re-indexed R€-ind€xed LIMITED 18022015 瑕 而蔽面高面高悪「悪万y昴1硫品g品扇勇fDcpttemof No:51/10/82- 「 | ~| 11&022∝ 5 ~| 器3鬼5υ∞■0ムⅢξ ~鵬 ら馳 υ鰤2鳳 1夕 囲 開 ° "Ю η9501PebD畿:~ Decision:ln the light of written comments received from Department of Pharmaceutica:s vide their OM No 35011/325ノ2014-P(Norms)dated 07.042015,■ was decided to ratify norms under Para 4.7 of H8P vl as per detai:s given below or as applied by the nrm,whicheveris less: Export product Exp Qty SI No lmport items Qty. allowed FAMCICLOVIR 500MG TABLETS Nos 1 9-(4-ACETOXY-3- ACETOXYMETHYLBUT-1- YL)‐ 2‐AMNO-6- CHLOROPURINE 0 663kg/1000 No tablcts Meet No/Date:18/82-
Case No:46/10/82-
ALC4/2014
Case No:54/10/82-
ALC4/2014 ]Party Name:VIVIMED LABS No/Date:18/82‐
「N血
2‐ 11群"
sion : In the light of written comments received from Department of pharmaceuticars vide
oM. No. 3501 l/489/2014-PI(Norms) dated March 20r 5, ii was decided to call from the firm
production vis-a-vis Actual consumption of inputs for rast three years duly certified by
ral Excise Authorities-
It was decided to defer the case for 29.04.2015 for comments of Department of
case is deferred for 29.04.2015
: It was decided tO defcr thc casc fOr 29 04 2015 for comments Of Dcpartment Of
Ｆ
Ｐ
1慧だ]朧酬器D
|
τ~鵬
乳∽酬強Mw
decided tO defer the case fOr 29.04
顧鮮"
囲辮劇Юη
%引
.2015 for comments of
「印渕=~[鮒肥
卜
劉
1鵬
鷺5∽
"3仏
m夕
陽
鵬
OЮ∞
“
″
:It was decidcd tO defcrthc case for 29 04 2015 for cOmmcnts OfDcpartment of
やデ由3 .
‐
、に ..
●町■:
ご: I
D零事篭(● ・]F Oiredorate Cone,dl oi l ´ ャ |aこo
…
―
Departnlent of Comme“ "
υ 嶽
い
品
話
mlm
Re-indered
No.:77/10/82‐
Name:NECTAR
No Date:18/82-
D器
3捻5∽
"釧
ハⅢシ 1賜
北
OЮ∞
"ム
m夕 1器
鼎
°2Ю 釧4"
Re-indexed
Re-indexed
34
「
∃
―
・
Decision: It was decided to defer the case for 29.04.2015 for comments of Department of
C&PC.
Re-indexed
042015
Decision : It was decided to defer the case for 29.04.2015 for comments of Department of
Pharmaceuticals.
「
「
霊躙
Ю脇
1
翻
F“
跳2日
蹴
悧
|
P鵬3児5剛%7ハm夕 膨鵬OЮ∞2ハmy 岡鼎α酬∞"%T躊ち
9“hJ
Decision : It was decided to defer the case for 29.04.20'15 for comments of Department of
lPharmaceuticals.
Case No.:19710/82-
‐ALC4/2014 「悧λ賛 ::皿A厖 ILTD, 町 | ~| 朧辮mめη 7冨 り3器 3児50Ю093ンAMI夕 陽角刷:OЮlll120AMl夕 :01/82/050/00329ノAM15/ Decision:ln the light of wr thelr OM No 35011/425/2( Para 4 7 of HBP vl as perd( ltten comments received from Department of Pharmaceuticals vide 〕14-P(Norms)dated06 02 2015′ I was decided to ratify norms under atalls given below or as applied by the firm′ whicheveris less: Item of Export Qty SI No Item of lmport Quantity allowed kg/kg CEFUROXlME AXETIL AMORPHOUS STEARIC ACID COATED 30% POWDER l kg 1 7 ACA (TAmino Cephalosporanic Acid ) 0253 2 Phosphorous Penta Chloride 03044 3 (Z)2‐ Methoxy imino―(Fuヮ1- 2yll Acclc Acid Ammonium Salt(SMIA) 0267 4 Methanol 0311 ′ Ｅ υ Methylene Chloride 1075 ′ ´ ｂ Chlorosulphonyl Isocyanate 0166 7 Acetone 0925 8 Tetra Methyl Guanidine 0064 , 9 N,N Dimethyl Acetamide 0574 / 10 Ethyl Acetate 0702 / 35
00151
⌒
|
〓
‐
Ｐ
|こ
:こ 『下
品
'1331Й豆
】
写
【
Eえラ
う
う
る
こ
万
器
3児5∽
"ηAM「
~開
脇蕊蔦
: It was decided to defer the case for 29.04.20[5 for comments of Department of
1
品
:fCrthe casc fbr 2免042015 for com=`1聰
~8fDepartm3蔦
of
1器星児
50Ю037″AMly[謳脇蕊y「 厩甑蕊『
卜
¨
蒻F…
5/5/82■LC″“
「甲
ARABOLIC
ALC4ノ2014
18022015
HQ File
ギ
ALLIANCE DYE‐ CHEM
PVT LTD,
レ
6
Lic No/Date:0310780621
05052014
Case No:57/5/82-ALC4/2014
Case No… ‐ALC4/20TttLIXIRPHARMA圏 町 ~1靡 器3児50Ю "52AMl夕 ~~圃 oЮo047AM15/~廠 Ю制∝釧И2F而 面 Decisioll:!n the light of written comments received from Department of pharmaceuticals vide the「OM No 35011/422/2014-P(Norms)dated 06 02 2015′ I was decided to ra■fy norms under para 4 7 of HBP vl as per detai:s given below Or as app:ied by the nrm′ whichever is iess: り ´ Item of Export Qty SI No Item of lmport Quanuty allowed kg/kg 3-Isobu″ IG:utaHc Acid (CMH Dlacid) l kg 1 Isovaleraldehyde 06068 2 Ethyl Cyanoacetate 07814 3 Diethyl Malonate 09784 「 Ю38035- No/Date:18/82- DYE‐CHEM 18022015
101/82/050/00332/AM15/ :05/24/040/00036/AM15/ 09052014 DecisioII:ln the light of written comments received from Department of Pharmaceuticals vide thelr OM No 35011/440/2014‐ PI(Norm5)dated 06 02 2015,た was decided to rajfy norms under Para 4 7 of HBP vl as per deta‖ s given below or as applied by the firm′ whicheveris:ess: Item of Export Qty Si No Item of lmport Quanjty a‖owed kg/kg CcfdinI l kg 7-Phenylacetamido-3 -Ch loromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 2263 2 CAEM(S-2-BenothiazOly(Z)‐ 2‐(2‐ Amino Thiazol-4-yl― )-2- AccけioXyimino Thioacetate 1397 3 Triethvlamine 0377 4 Acetone 624 Ｅ Ｊ Methanol 655 6 Methvlene Chloride 741 7 Activated Carbon 0055 8 Triphenyl Phospine 1234 9 N― Butyl Acctatc 085
Case No:21/5/82-
ALC4/2014 Paty Namc:PARABOLIC IDRUGS LTD, Lic No/Datc:0510386136.Defer Date: ~剛 Ⅱ ‐ HQ File :01/82ノ050/00338/AM15/ IRLA File :05/24/040/00039/AM15/ 516:ち昴 I‐ マ‐ ・~~~~― | 130 'Decision: in the light of written comments received from Department Of Pharmaceuticals vide their OM No 35011/408/2014-P(Norms)dated January 2015,l was decided to ratify norms under Para 4 7 of HBP vl as perdeta‖ s given below or as applied by the firm,whicheveris less: Item of Export Qty SI No Item of lmport Quanlty a‖owed kg/kg Bacampiciliin Hcl l kg 6-Amino Pencillianic Acid (6-APA) 1091 2 I -Chloroethyl Ethyl Carbonate 08575 3 D-alpha Phenylgycin Base 07045 4 Ethvl Aceto Acetate 0687 5 Iso Propyl Alcohol 0320 6 Methylene Chloride 1968 37 「
1器3児50Ю0334/AM「跳ち刷 :OЮ∞ 53AMly 1田辮“Ю "鬱Z Re-indexed : ln the light of written comments received from Department of Pharmaceuticals vide OM No 35011/414/2014‐ P【Norms)dated 21 01 2015,it was dccided to call from thc fl‖ ‖ information: Copy of Drug Manufacturing License (DML) indicating approved compositions of export products. ii) Pharmaceuticals specification for each ofthe export products. iiD Packaging /presentation of expo( products specifuing quantity of contents of export products in each ofthe packs iv) Master Batch Formula indicating quantitative requirement for each of the ingredients duly certified by the production and qualities control in charge. v) Manufacturing process involved in production ofthe export products indicating the level of wastage /recoveries ofvarious solvents / raw material during the process. The case was deferred for 29.04.2015 Ｆ Ｉ RLA File iLic.No/Date:0510366223 :05t24t040t0002yAM15t loe.os.zora Re-indexed :ln the light of written comments received from Department of Pharmaceuticals vide OM No 35011/414/2014 Pl(Norms)dated 21 01 2015,It was decided to call from the■ 1‖ l ins information: Copy of Drug Manufacturing License (DML) indicating approved compositions of export products. Pharmaceuticals specification for each ofthe export products. Packaging /presentation of export products specifling quantity of contents of export products in each ofthe packs Master Batch Formula indicating quantitative requirement for each of the ingredients duly certified by the production and qualities control in charge. Manufacturing process involved in production of the export products indicating the level of wastage /recoveries ofvarious solvents / raw material during the process. The case was deferred for 29 04 2015 ０ ０ ｍ ｌ ｖ ｖ＞ LIMITED :01/82/050/00335/AM15/ 38 7 Methvl Acetoacetate 0636 8 N,N-Dimethyl Acetamide 284 9 N-Butyl Acetate 200 10 Pivaloyl Chloride 055 11 Trietylamine ⌒
F雨 砺 /82‐ALC4/20141蒸 凛 評 ё耐 「 ' | ILIMITED IMeet No/Date:18ノ82‐ Status:Deffered iALC4/2014 and R←indexed 18022015 | | luq nit. |RLA File l:01/82/050/00336/AMl5/ ]:05t24t040t0D20tAMt5l 蜃需覇10386217臨π i∫ Decision : ln the light of written comments received from Department of Pharmaceuticals vide 33 ther OM No 35011/414/2014-PЩ Norms)dated 21 01 2015′ It was decided to lfOnOwing info‖ :=ation: (a) Copy of valid Drug Manufacturing License for the export approved composition of the product. produdct showing (b) Copy of Master Batch formula duly authenticated by Quality-Control Incharge. HQ Fne RLA File Lic No/Datc:0910060039 Dcfer Date: :01/82/050′00932/AM15/ :09′24/040/00064/AIヽ415/ 09052014 Decisioll :Committee considcrcd thc casc as pcr agenda and in light of written comments rcccivcd frolln Dcpartmcnt of Pharmaccudcals vidc their OM No 350H/480/20]4-PIoorms) datcd 25 03 2015and in consultation 、vith tcchnical authority prcscnt in meeting, dccided to ‐ raj″ nOI‖ ls undcr para 4 7 of HBP as pcr detans below or as applicd by lllll whiChCvcr is Export product Exp Q″ SI No Import items Qty A‖owcd Kg/kg 13 R.3aS.6aR)-hexahydroluro[2.3- bl furan-3-yl 4-nitrophenyl carbonate(Nitro Complex) l kg 1 (3aS,6aR)― Tetra hydro-4- mcthoxy furo[3,4-b]furan_ 2(3H)―one 1093 2 Potassium Boro Hydride 055 3 Tetra Hydro Furan 273 RA concerned may take further necessary action as per above decision of NC. ― ⑮ 鵬 3児5∽"31/Amy~厖鵬 l1/1xXlヌハ～ call from the firm ― ― ― ∃ f f"s" xo.rrellolez- lnarty Nanresefva - lrta".t f.roDut",l s/8i- lsutus:Approved )Al.,c{t2ot4 DEEPTHA l{Lc4lzol4 I leHnnueceurtcALs LTD ltt.oz.zot s l 134 田繭 繭 而 蔽 Wttr18/82貯 蹴 田 「 鯰 扁 霊碁霧鼎錯.器 D´網辮rttde 器欝鶴瀧器緊[:設濡織 υd菫男轟謀雨h 39
ヘ 1器3児50Ю "り晨Mb/ Lic No/Datc:0910060057 12052014 It was decided to defer the case for 29.04.2015 for comments of Department of Party Name:AUROBINDO Meet No/Date:18/82- PHARヽ4A LIMITED ALC4/2014 18022015 Re-indexed Re-indexed 1器3澪50Ю0966晨mヌ Ъ危棚OЮ。 055ムm夕 P8 Pharmaceuticals. F“ e蘭馴鹿 ・ Lα2∝4日 瀬 認 「 ¬ 甲 F面 戸 田 18022015 : It was decided to remind the firm to fumish the following information: ＞ Ｄ Copies of batch log sheets for the last 5 consecutive batches for conversion Literature reference about conversion of IUs to weight of various Low Molecular Weight Heparins i.e. Nadroparin, Enoxaprin and Delteparin sodium. Consumption data for all raw materials used in the production of Low Molecular weightHeparin-Delteperin Sodium Injections, duly certified from Central Excise authorities for the year 2012-13,2013-14 and april to December 2014. 器島児 50Ю "17/Am夕 IЪ角鵬。Ю∞65AM y Heparin Powder into Delteparin sodium indicating the actual consumption of all raw materials consumed for getting the API used in the Delteparin sodium injections. Copies of batch log sheets for last 5 consecutive batches indicating actual consumption of 16 raw materials applied for import in all applications against export of Low Molecular weight Heparin-Delteparin sodium injections in pre_ filled syringes. The information sought vide Item No. 2 and 3 above may be certified by production in-charge of manufacturing unit ofthe firm. case was deferred for 18.03.2015 い・ i g鶏、 活島 ` Dy嗜婚ご■] 剛 融 , 悧蠍ふ野LⅢ
Case No.:52/10/82-
ALC4′ 2014
Case No:34/10/82-
ALC4′ 2014 :01/82/050/00948/AN415/ u`y。9さいawan. Re-indexed :111111llil」IiSdecidedtodefcrthccasefor29042015forcommentsofI)cpa■ ment of No/Datc:18/82‐ Lic No/Date:0910060082 13052014 T臓鮮…
:0 l/821050/00958/AMl 5/ 画面而而画面ア ~11■ 0'2014 「 F需 需 /10/82‐ Decision : It was decided to defer the case for 29.04.2015 for comments of Department of 「 F高 而繭面画面 日需繭輛瓢 EにNo/DateЮ 310782171 ,0052014 Fヌ』 に I [ヌ品お : ４ ‐ ― レ イ ー ー ー ー ー ー lon:in the light of written comments received from Department of Pharmaceuticals vide OM No 35011/555/2014‐Pl(Norms)dated 26 02 2015,■ was decided to ratify norms Para 4 7 of HBP vl as per details given below Oras app‖ ed by the firm′ whicheveris less: Item of Export Qty Si No Item of lmport Quantty a‖ owed kg/kg LATANOPROST OPHTHALMIC SOLUT10N,0005% 25 ML l kg 1 LATANOPROST 0 1275 mg/25 ml vial 2 Eye Drop Bottle (Packing Material). l.0l numbers for each vial Net+ l o/o 3 Eye Drop Caps (Packing Material) 1.01 numbers for "u"1] ,i31 Pet+ I o/o 4 Eye Drop Insert (Packing Material) I .01 numbers for each vial Net+l%o l瓢蕊慇 4ムⅢ夕 脇脇而ξ RA may take appropriate action as per the decision of Norms Committee' 41 14「HQ F‖ e 101/82/050/00973/AM15/ ― ・ に ― ― ― 101/82/050/00953/AM15/ ALC42014 18022015 ,hanlnaccudcJs Nalnnc:INTAS No/Date:18/82‐ No/Date:18/82-
Decisioll:In the light Of wri the「OM No 35011/431/2 under Para 4 7 of HBP vl asI tten comments received from Department of Pharmaceuticais ll∬ll翼鷲鳳躍:踏譴∴胤悧鴇思里ll Item of Export Qty SI No Item of lmport Quantity allowed DOXEPIN HYDROCHLORlDE EAPSULES 10 MG l Nos 1 DOXEPN HcL EP/BP′ UsP/PH EUR H526 mg/10 mg capsu:c DOXEPIN HYDROCHLORIDE CAPSULES 25 MG 1Nos. DOXEPN HcL EP′ BP′ usP′ PH EUR 28 815 mg/25 mg capsulc DOXEPIN HYDROCHLORIDE CAPSULES 50 MC l Nos 1 DOXEPN HcL EP/BP/usP/PH EUR 57 630 mg/50 mg capsulc
Case No.:35/10/82‐
ALC4/2014 翌柵麒mm匿席"叩脚 :It、vas decided tO dcferthe casc fOr 29 04 2015 for conlmcnts OfI)epaltmcnt of .+:^^:^ Ｆ Ｉ 階
Case No.:36/10/82‐
ALC4/2014 Re-indexed 層¶開。明∞ω κ 5 ~ 1-“ ― `ン ヽ 一 ― :It was decided tO defcrthc case fOr 29 04 2015 for cOmmcnts Of Depannent Of 14:^_1^ 翌■_ITF~順鮮酬ル 147 ヽ| RA :09/24/040/ooo72ノAM15/ :d07042015′ たwas decided tO ratify nOrms ow oras apphed bythe■rm,whichever is iess: Item of Export Qty SI No Item of lmport Quantlty a‖owed k皮/kg BETANIETHASONE DIPROP10NATE l kg 1 Betamethasone 0885 42 ^
Case No.:79l8/E2-ALC4t2Ol4 Party Name:BDR
PHARMACEUTICALS INTERNAT10NAL PVT 042015 : It was decided to dcfer thc case for 29 04 2015 for comments of Department of Ptt Name:ALMELO PVT Mcet No7Date:18/82- LTD ALC42014 Re-indexed 18022015 : ln the light of written comments received from Department of pharmaceuticals vide OM No 35011/414/2014-PI(Norms)dated 21 01 2015′ It was decidcd tO call frOm the■ 1 lll produc●on vヽ― a― vls Actual consumpJon Of all thc inputs duly ccrincd by CCntral Excise oritics fOr thc pcriOd 20 13-2014 and 2014-15 casc was dcferred for 29 04 2015 Meet NげDate:18/82‐ ALC42014 Re-indexed 18022015 鵬3掲50/00“α Amy l脱棚 OЮ∞ %ハmy 042015 : ln the light of written comments received from Department of pharmaceuticars vide OM No 35011/221/2014‐ P(Norm5)dated 18 02 2015,It was dccided tO call from thc fli‖ : information: P″ッNme:INDOCO Meet Nυ Date:18/82- REMEDIES LIMITED ALC4/2014 18022015 Lic No/Date:0310782942 26052014 i) consumption data of 16 raw materials used in manufacturing of Enoxaprin Sodium Injections pre-filled Syringes duly certified by central ExcisJAuthority ior the year 2012-13,2013-14 and April to December 2014. iD copies of batch log sheets for the last 5 consecutive batches for conversion of Heparin Powder into Enoxaprin Sodium indicating the actuar consumption of all raw materials consumed for getting the Apl used in the Enoxaprin Sodium injections. iii) Copies of batch log sheets for last 5 consecutive batches indilating actual consumption 9f J.6 .ll materiars appried for import in all apprications againsr-export of Enoxlprin Sodiumlnjections in pre-filled syringes. The information sought vide Item No. 2 and 3 above may be certified by production in- charge of manufacturing unit of the firm. The case was defened for 29.04.2015 Meet No/Date:18/82-
Case No.:41/5/82‐ ALC4/2014
Lic No77Date:0910060207 23052014
Case No.:16/8/82-ALC4/2014 PaりName:GLAND
PHARMA LIMITED Lic No/Date1091 0060220 26052014 ion : rn the light of written comments received from oepa.trent of pharmaceuticals vide oM No' 35011/555/2014-pr(Norms) dated 2G.02.201s, it was decided to ratiry norms 43 149 HQ File :01/82/050/00358/AM15/ 1協棚∽∞ 96/A語 DeFer Datc:29042015
d bY the firm' whichever is less: Item of ExPort Qty SI No Item of lmport Quantity allowed ks/kc 0 1275 mg/25 mi vial LATANOPROST oPHTHALMIC SOLUTION,0005% 25 ML l kg 1 LATANOPROST 2 Eyc Drop Bo●le(PaCking MatcHal) 1.01 numbers for each vial Net+l o/o 3 Eye Drop CaPs (Packing Material) l.0l numb"rs for "u"5 u;u11r1st+l7o 4 Eye Drop lnsert(Packing Mate」al) l.0l numbers for each vial Net+l% f-lnn r.y trt " appropriate action as per the decision of Norms Committer
case No.:119/8/82-
ALC4/2014 ALC4′2014 Re-indexed 猪ぶ器°“Ю ・"Ю蹂ち %∝2m5 Party Name:MSN Mect No/Date:18/82 LAIioRAToPJES PzuvATE lALc4/2014 Re-indexed
Case No.:71/10/82-
Paty NameiSYMBIOTEC R€-indexed PHARMALAB LTD, Meet NO/Date:18/82- ALC4/2014 Re-indexed 18022015 Lic No/Date:0310783328 :03/94/040/00151ノAM15/ 28052014 for comments of Departrnent ロ ー Ｆ 一 ヽ 一 Party Name:KUSUMA Meet No′ Date:18/82‐ 18022015
case No.:29/10/82-
ALC4/2014 Mect No/Date:18/82-
case No:115/8/82-
Pafty Name:INDOCO ALC4/2014 REMEDIES LIMITED 101/82/050/00779/AM15/ 44 comments of DePartment of @ for comments of Department of lomments ofI)epartment Of :It was decided to deferthe caSe for 29 04 2015 for c
Case No.:145/6/82-
ALC4/2014 Partv Name:LAKE Mect No/つatc:18/82- CHEMICALS PRIVATE IALC4/2014 18022015 IRLA File tLic No/Date:0710104565 IRLA File tLic No/Date:0710104565 1:07/24/040/00003/AM15/ '8052014 Re-indexed Re-indexed Re-indexed |"目慨翫蕊蕊戸~ ~1燎 鼎・酬∞ω %7 : lt was decided to defer the case for 29.04.201 5 for comments of Department of 「 F¨ 腱 ALC4/2田 「 柵 総 sm躍 脚 ユ F“ em34/8/82■LC続"4 ALC4/2014
Case No:38/8/82-ALC4/201
`2014F面
テNalltcMYLAN~~~降
面輛面画面ア
~
「
ABORATONESЫ
MFED I億
″ 盤F
File RLA Fnc
:01/82/050′00702/AM!5′ :09′24/040/00108/AM15/
Lic No/Datc1091 0060267
28052014
160
輛辟直~「MM臨
籠FI
Re-indexed
HQ me
囲辮劇Ю霧""
Ю182Ю50/00764/AM15/ IЮ 3/94/040/00129晨M15/
: ln the light of written comments received from Department of pharmaceuticals vide
r OM No 35011/556/2014-PI(Norms)dated 07 04 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:
Item of Export Qty SI No Item of lmport Quantity allowed kc/ke Etodolac l kg 7-Ethyl Tryptophol 072 （ ２ Methyl-3 -Oxopentonoate 054 3 Methanol 114 ´ 45 b9鵬 島掲鰍∞.5晨my膨 鵬 ∽∞η “ 戸 ト
Re-indexed P棚 児5∽剛 晨m夕 厩 脇 蔦 蕊 戸 囲 辮 側 ∞ω 221胤 9回 5 Decision : lt u as decided to deler the case lor 29.04.20 I 5 for comments ol Depanment of Pharmaceuticals. ALC4/2014 18022015 躍鰊腰 叩濶 暇F面82F…nd 133月50Ю0708AMly Ъ 筋 ::υ00087/AMly 「 M町 Decisioll:ln the light of written comments received from Department of Pharmaceuticals vide their OM No 35011/561/2014-P(Norms)dated 07 04 2015,■ was decided to raJfy norms under Para 4 7 of HBP vl as per detalis given below or as app!ied by the■ rm′ whichever is less: ´ ０ 「 Item of Export Qty Sl No Item of lmport Quantity allowed kg/kg Bromo Ketorolac (OR) 5-Benzoyl, 3bromo- 2,3- Dihydro, l-H pyrrolizine- I - carboxylic acid l kg Pyrrole 079 2 Isopropenyl Acetate 090 3 Dimethyl sulphoxide 171 4 Dヽ4F ξ ， 5 Potassium Carbonate 416 6 Di-ethvl malonate 229 |“ 「 漑 59m"4/AMly下 而「 ~蔦 ~蹴 鼎 。鉾Ю “ m" |:34/24/040/OIX137/AM i5, 躙辮側∞ω鉾 0 |::慧:8° n:It Was decided to deferthe case for 29.04 2015 for comments ofDepartment of Re-indexed : lt was decided to defer the case for 29.04-2015 for comments ofDepartment of
Case No:30/10/82-
ALC4/2014 :09′24/040/00097ノAM15/ 46 |
町 PttDate: Decision : ln the li8ht of written comments received from Department of Pharmaceuticals vide their oM No.35O7L/527/2014-Pl(Norms) dated 26.02.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, Item of Export Qty SI No Item of lmport Quantity allowed FLUNISOLlDE NASAL SOLUT10N uSP 0 025% Bottle 1 FLUNISOLIDE USP (ANHYDROuS) 625 mg 2 10Z WHITE OPAQUE CYLNDRiCAL ROUND HDPE BOTTLE 20●OSCREWED NECK KERR 34296 1 0i numbers nct+1% 3 20 MM MKli CL 20 SCREV′ ED ONヽVHITE PUMP AND ACTUATOR WiTH BLUE CAP FOR FLUNISOLIDE NASAL SPRAY MヽVVV CALMAR A0040332 I .01 numbers nel + lo 隔扇再頭扇薫嘉高:Fこ而扇萬翼而肩as perthe d[[islon of Norms Comm■tee applied by the firm, whichever is less: 1165 / 「
Case No:47/8/82-ALC4/2014 i FPAName■i↑ERO EABS~M品
赫 i3/82 IPttName:HETERO LABS I ■66 ILIMITED ALC42014 ‐18022015 1器疏 50Ю07:「AM耐 ~F誘蕊高蕩罵 |「~|:mBR亥 Defer Date Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No 35011/535/2014-PI{Norms)dated 25 03 2015′ t was decided to rajfy norms under Para 4 7 of HBP vl as per deta‖ s given below or as applied by the firm′ whicheveris iess: Item of Export Qty SI No Item of lmport Quantity allowed kg,/kg FINASTERIDE l kg 3‐OXO●‐AZA‐ 5‐ ALPHA‐ ANDROSTANE 17‐ BETA CARBOXYLIC ACID 190 ´ 2 DIISOPROPYL ETHER 1017 _ 3 BIS(TRIMETHYL SILYL)‐ TRIFLUORO ACETAMIDE 147 ′ 4 2,3 DICHLORO‐ 5,6‐DiCYANO BENZOQUNONE 086 」 ICase No:49/8/82‐ ALC4′ 2014 |:i:i::':i:i〕 li::11二洒 醸 う 「 「
~~|
Llc No/Datc:0910060350 瞑fcr Date「
ヽ
47
105062014
No:68/6/82-ALC4/2014
Palty Name:SUN
PHARMACEUTiCAL
JNDUSTRIES LTD,
Palty Na
PHARM
t67 l'g1192195919s7l3/AM l s/
Decision: ln the light of written comments received from Department of Pharmaceuticals vide
their OM No 35011/540/2014-P【Norms)dated 25 03 2015,た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:
Item of Export
Qty
SI No
Item of lm port
Quantity
allowed KBlKg
RAMIPRlL
l kg
BENZYL‐ (CIS,ENDO)
OCTAHYDRO CYCLOPENTA
(3)PYRROしE‐2くS)‐
CARBOXYLATE
HYDROCHLORIDE
083
Ｅ
Ｊ
N‐ 〔l(S)でARBOETHOXY 3-
PHENYL PROPYL]‐ (S)‐
ALANNE
098
3
N,N‐ DiCYCLOHEXYL
CARBODIIMIDE
0858
「
IRAmavtakeappropnatiracti。ぉ
168
: ln the light of written comments received from Department of Pharmaceutlcals vide
OM No. 35011/414l2014-Pl(Norms) dated 21.01.2015, It was decided to call from the firm
production vis-a-vis Actual consumption of all the inputs duly certified Central Excise
ies for the period 2013-2014 and 2014- 15.
case was dcfcrrcd for 29 04 2015
as per the decision of Norms Committee.
ALC4/2014
「F“・
No`3/8/82AК42m4P……剛呼
Re-indexed
: ln the light of written comments received from Department of pharmaceuticals vide
OM No.35011/414/2014-Pl(Norms) dated 21.01.2015, It was decided to call from the firm
production vis-a-vis Actual consumption of all the inputs duly certified Central Excise
itics for the period 2013-2014 and 2014-15
casc was defcrrcd for 29 04 2015
甲渕~甲鱚副蓼市
|
: Committee considered the case as per agenda and in light of written comments
from Department of Pharmaceuticals vide their OM No. 35011125112014-PI(Norms)
18.03.2015 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
Lic No/Date:0910060402
09062014
48
No.:15/8/82-ALC4/2014
No/Date:18/82‐
Re-indexed
1器3児50Ю0717AMl,
１
０
IDeferDate:
1、cw■
J
Export product
Exp
Q″
SI No
Import items
Qty in mg for export of
lPantoprazole tablet
20 mg Tabs
40 mg tabs
Pantoprazole
Tablet
l kg
l
Pantoprazole
Sodium
2157]
43 143
う
ｚ
Mannitol USP
(PearII01 25C)
4244
8488
Sucrose USNF
800
1600
4
Hypromeilose
(PharmacOat 603
3cps)USP
1 86
372
RA concerned may take further necessary action as per above decision of NC.
１
１
１
１
コ
‐
一
一
‐
F画面■
4/2014甲濡繭
~甲
|
鶴
3児50Ю0718/1=「
1蕩蕊蕊L;Li「 丁
B為9解2語
becision¬「1籠igh[話而面葛1「品
Iξ高:吾高而T高扇罵:高面高高面高[ude thar~
10M No 35011/75/2014-P:{Norms)dated 18 02 2015,It Was decidcd to remind the flHn to lШ
"ish
thc follo、ving infonlnation:
:ヽ T:●^_^^、_o_o■ヽ_0ぃ´
1)
Literature reference about conversion of IUs to weight of various Low Molecular
Weight Heparins i.e. Nadroparin, Enoxaprin and Delteparin sodium.
ii)
Consumption data for all raw materials used in the production of Low Molecular
weightHeparin-Delteperin Sodium Injections, duly certified from Central Excise
authorities for the year 2012-13,2013-14 and April to December 2014
iii)
Copies of batch log sheets for the tast 5 consecutive batches for conversion of
Heparin Powder into Delteparin sodium indicating the actual consumption of all
raw materials consumed for getting the API used in the Delteparin sodium
injections.
iv)
Copies of batch log sheets for last 5 consecutive batches indicating actual
'
^^-^-.--.:^-
^c 1t -^--, *^+^-:^l^
^-^l:-,1
f^-;-^^-+
i- -ll
---li^-riano
aaain<t
consumption of 16 raw materials applied for import in all applications against
export of Low Molecular weight Heparin-Delteparin sodium injections in pre-
filled syringes.
The information sought videltem No. 2 and 3 above may be certified by
production in-charge of manufacturing unit of the firm.
:
The case was deferred for 29 .04.2015
爾謎脚剛2‐ ~
鵬酔18/821濡:回
鴨
鑑
計
No/Date:18/82‐
18022015
49
⌒
Ｆ
Ｉ
Ｉ
戸
―
―
LLC4/2014 1鮒"町
174
118022015
Case No■05/8/82-ALC4/201
鵬疏
50Ю
"θハ
m夕 F頭脇面蔦丁¬蹴辮Ю獅お
25階缶
Date:
lon:ln the light of written comments received from Department of Pharmaceuticals vide
OM No 35011/555/2014-PК Norms)dated 26 02 2015,I was decided to ratify norms
Para 4 7 of HBP vl as per details given below or as applied by the firm′ whicheveris less:
Item of Export
Qty
SI No
Item of lmport
Quanuty a‖ Owed
kgノkg
LATANOPROST
OPHTHALMIC
SOLUT10N,0005%
-125 micrograms/
25 ML
l kg
LATANOPROST(Relevant
Bulk Dnlg/s)
O1275 mg/25 ml
vial
2
Eye Drop Bottle (Packing
Material).
l.0l numbers for
each vial Net+ lolo
3
Eye Drop Caps (Packing
Material)
l.0l numbers for
each vial Net+ I o/o
4
Eye Drop lnsert(Packing
Matc●al)
l.0l numbers for
each vial Net+l oZ
「
~~IRAmaytakeappropnateactbnasperthedecisionofNortttcommttee
## Case No.:60/10′ 82-
ALC4/2014
師
¨
: It was decided to defer the case for 29.04.201 5 for comments of Department of
Re-indexed
「
176
lo■: ln the light Of written comments received from Department of Pharmaceuticals vi(
OM No 35011/510/2014‐ PI(Norms)dated 13 03 2015,■
was decided to ratify norn
Para 4 7 of H8P vl as per details given below or as applied by the firm,whicheveris less:
Item of Export
Qty
SI No
Item of lmport
Quantity
allowed
′ ・
AR
い●
■
靱鱈
:「
50
|:EIF扇
[・t Was dcdded to deferthe case for 29042015 for comments ofDepamcnt Of
い
|
No/Date■8/82-
1/Aヽ415/ :05/23/040/00108/AM15/ 13062014
Date:
kg/kg
Nandrolone Decanoate
l kg
1
I 9-Nor-4-Androstene-3, I 7-Dione
0982
「
~~IRAmaytakeappropriateactionasperthedecisionofNormsCommittee
Ｆ
Ｉ
Meet No7Date:18/82-
ALC472014
Re-indexed
Re-indexed
「
1赫
赫
繭
1揚
器躙
比Q腰
席
"
P9田
3月m畑.4ハmy l l蹴
辮
似
∞6餌η
lecision ilt was decided to defer th e c$e for zg.o4.z0l5 for comments of Department of
iotechnolos/.
## Case Nol154/6/82-ALC4/2014「
lBttЖ】浮鰈
:~~~~lliJ〕
I:「
酬8782
棚児
5∽ωttAm y 膨北
OЮm"晨m夕 1蹴鼎α凶"&
Decision:ln the‖ ght of wtttten comments received from Department of Pharmaceut
No 35011/463/2013-PI(Norms)dated 26 02.2015,■
was decided to ratify no「ms under
vl as per details given below or as applied by the nrm,whicheveris less:
,703 1Defer Date:
icals vide their OM
Para 4 7 of HBP
Item of Export
Quantity
S,No
Item of lmport
ｇ
′
′
ｇ
ｔ
ｉ
ｔ
ｙ
ｅ
ｄ
ｋ
ｕ
ａ
ｎ
‐
Ｏ
ｗ
Ｑ
ａｌ
OLMESARTAN
MEDOXOMIL
l kg
1
Ethyl-4-( I -hydroxy- l -methylethyl)-
2-propyl im idazole-5 -carboxylate
0 70 kg/kg
2
Dimethylacetamide
1 96 1it/kg
3
N―(tiphenylmcthyll‐ 5-[4-
(brOmomethyl)biphCnyl-2‐
JltetrazoL
1 786 kg/kg
4
N,N-Diisopropylethylamine
100‖t/kg
5
Ethyl acetate
1022‖ t/kg
6
4-(chloromethyl)-5-methyl-2-oxo-
1,3-dioxole
0 48 kg/kg
7
Acetonitrile
3 00 1it/kg
lA may take appropriate action as per the decision of Norms Committee.
## Case No.:72/8/82-ALC4/2014
LABORATORIES PVT LTD
18022015
Re-indexed
180
51
:ision :It was decided to call from the firm following information:
iay Certificate of Analysis from Foreign supplier foi the relevant consignment of imported
crude product.
G) COA;fExport product as per shipping Bill/Purchase Order'
case is deferred for 29.04.2015
胚X3:皿AS 鵬淵「
酬授
~
Re-indexed
18022015
:It was decided to call from thc f1111l copy of Certiflcatc of Analysis of import itcm
foreign supplier.
case is deferrcd for 29 04 2015
## Case No.:160/6/82-
Party Name:ALCHEM
Meet No/Date:18/82-
Re-indexed
ALC4/2014
NTERNAT10NAL LTD
ALC42014
18022015
case was deferred for 29 04 2015
C"r" f.to.,lglgl8Z-e LC4l2Ol4 ]Party Name:HETERO LABS
Meet NolDate:18/82-
Re―indexed
ALC4/2014
18022015
Lic No/Date:0910060486
18062014
, It .r^ d""id"d to defer the case for 29.04.2015 for comments of Department of
## Case No:73/8/82‐ ALC4/2014 Pa町
Meet No′ Date:18/82-
Name:METROCHEMAPI
ALC4/2014
Re-indexed
PVT LTD
18022015
Lic No/Date:0910060515
19062014
: It was decided to dcfer thc casc fOr 29 04 2015
for comments of Department ot
り
Ｏ
①
Jt 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 of Export Product
fusi "p.oau"iion vis-a-vis Actual consumption of leaves for the last 3years duly
certified by Central Excise Authorities.
No:83/18/82-
`/2014
## Case No.:20ノ8′82-ALC4/2014
Meet No Date:18/82-
IMMLNOLOGICALS LTD,
ALC4/2014
Re-indexed
顎
52
^
Decision: in the hght of written comments received from Department of Pharmaceuticals vide
their OM No 35011/521/2014-PI(Norms)dated 07 04 2015,■
was decided to ra」fy norms
under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is
Item of Export
Qty
Si No
Item of lmport
Ｑ
ｕ
ａ
ｎ
ｔ
ｉ
ｔ
ｙ
¨
晩
Betamethasone Dipropionate
l kg
1
Betamethasone
0885 ′
Betamethasone Sodium Phosphate
l kg
Betamethasone
078 ′
Clobetasole Propionate
l kg
Betamethasone
104
less:
## Case No.:111/8/82‐
2‐ PttNalncTHINQ
PHARMA―CRO LIMITED
IRLA■le~~~~~~~
Ю3/95/040/00178/AM15/
Decision : lt was decided to call from the firm the complete technical details as per Appendix
33 The case was deferred for 29 04 2015
1器疏50Ю07■AM Ы
M8/82甲
評
麗珈
10785804脇[
「
Ｆ
‐
―
岬
―
‐
‐
No.:10778/82‐ALC4/2014 1:]:,'::F屁蜀扁ラ屁ヌ
「
~~~「
[]Fl::『
~
53
## Case No.:68/10/82-
ALC4/2014
Party Namc:LEBEN
LA30RATORIES
PVT LTD,
186 隔靡
「
Ю1/82/050/00982/AM15/
「「M
面高蔦裏1両面而而而醗ξ而石mm J
Date:
to Department of Bio-technologr for
cision: In the light of written comr
ir OM No. 35011/48212014-PI(Nor
ler Para 4.7 ofHBP vl as per details
nents received from Department of Pharmaceuticals vide
ms) dated March 2015, it was decided to rati8/ norms
given below or as applied by the firm, whichever is less:
Item of Export
Quantity
S′No
Item of lmport
Quantty
allowed kg/kg
Levetiracetam
l kg
1
Activated Carbon
00128 ′
2
Methylene Chloride
312
3
Tetra Butyl Ammonium
Bromide
010
4
4-ChiOro Butyryl
Ch10ride
1050 ´
5
Potassium Hydroxide
Ｅ
Ｊ
6
S(+)-2-Amino
Bu″ramide HcI
Ｌ
Ｊ
Ｏ
フ
０
RA may take appropriate action as per the decision of Norms Committee
/
「甲酉~「MMFD
|
File
1/82/050/00633/AM15/
陽淵υ∞“
5ムm夕
1器3M
19
1
鴨
』
Decision :ln the light of written comments received from D
their OM No. 3501 I /47312014-pl(Norms) dated March 201
under Para 4.7 of FIBP vl as per details given below or as appt
Export Product Telmisartan 20mg, 40mg & 80mg tab.
[A] Norms allowed for Telmisartan
)epartment of Pharmaceuticals vide
5, it was decided to ratifo norms
ied by the firm. whichever is less:
S No
Import Item
Qty. allowed kg/kg.
1
2-N-Propyl-4-Methyl-6-( 1 -Methyl
benzimidazole-2-yl)Benzimidazole
082
う
乙
Methyl-4-(Bromomethyl)-Biphenyt-2-
Carboxylate
087
3
Acetone
098
54
No.:170/6/82‐
S
NameiSoFTCEL
CARE PVT LTD,
No/Datc:18/82‐
18022015
Re-indexed
Filc
15/
: It was decided to defer the case for 29.04.2015 for comments of Department
No/Date:18/82-
18022015
⌒
4
334
5
Activated Carbon
002
:
[B
|
|
| | ::::::::::::::::::::::::]l:チ
::ll::::|:|
RA may take appropriate action as perthe decision of Norms Committee
|
Ｆ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
|‥器瓢
1器3児5900489ハMly Ъ危刷
:OЮ0149^Mlヌ と
0620 И I _ _|
1器3児5900489ハMly Ъ危刷:OЮ0149 AM17 ■Ю,?Ψ l:liドIlli:|ツ
elil:]]__|
1:F淵長
:喘l躍駆洲器ド:∬器』現fi瞥1,1『駆1::L::讐:器i‖瑠l誌
|
Para 4 7 ofHBP vl as pcr deta‖ s givcn below or as applied by the flilli,WhiChcvcr is lcss l
nn ,"y t"f" "pp-priate
action as per the decision of Norms Committee'
Decision:In thc light of written commcnts receivcd from Dcpartment of Pha‖ ‖aceujcals vidc
り
3需FT席‖留滉賃魅tMr釜路′鯖げ滞寵Ⅷ鯉RWSm“
r
55
備
ヽこ
=習
nerdi。′F&こ
'I平
里_
輻
蛛
Decision :In the liSht of written comments recelveo rrom r-,,ePa
rheir oM No. 35Ot 11455/2014-pl(Norms) dated 26.02.2015, it was decided to ratiry norms under
puru n.Z otHSp vl as per details given below or as applied by the firm, whichever is less:
Item of Export
QuantitY
S,No
Item of lmport
Quantity
allowed kg/kg
TELMISARTAN
l kg
2CYAN04‐ METHYL
BIPHENYL
0576
METHYし【
'NE C H1 0RIDE
1334
Telmisartan… …………‐¨―……20 40mg/20mg tablet
――――……………-40 80mg/40mg tablet
………………………‐81 60mg/80mg tablct
4-CHLOROINDOLE
(GW604389X)
N,N―DIMETHYL
FORMAMIDE DI
METHYL ACETAL
Ｅ
リ
PYRROLIDINE
0733
3
METHぶol
450
4
2‐ N‐PROPYL●‐METHYL‐ 6‐
CARBOXYLATE‐ lH‐
BENZIトイIDAZOLE
075
Ｅ
Ｊ
N.METHYL ORTHO
PHENYLENE DIAMINE
DIHYDRO CHLORIDE
074
´
０
PHOSPHOROUS PENTOXIDE
1425
7
1,2‐DI METHOXY ETHANE
042
⌒
~「需湘
l淵附俎
S
Mcet No′Datc:18/82‐
ALC4つ014
18022015
Lic No/Date10910060539
25062014
cislon :In thc light Of v
ir OM No 35011/533/20
a47 ofHBP vl as pcr dl
/ritten comments received from Department of pharmaceuticals vide
l4-PI(Norms) dated 25.03.2015, it was decided to rarifl norms under
etails given below or as applied by the firm, whichever is less:
Item of Export
Quantity
S′ No
Item of lmport
Quantity
allowed kelks
ABACAVIR SULPHATE
l kg
(lS,4R)-4-[(2-amino-6-
ch!orO-9H puHn― yり_2-
cyc10pentcne]-1-mcthanol
町drOCllloHde
1292
2
…
019
xA may take appropriate action as per the decision of Norms Committee.
## Case No.:80/8/82-ALC4/2014
Ｆ
‐
Ｐ
‐
‐
:It was decided tO defcrthc case for 29 04 2015 for cOmments Of Dcparmcnt Of
層鮮畑2~
[響器1総駆
&1覇F産
Re-indexed
「1鰊
RLA File
56
Lic No/Date:0310786114
Re-indexed
No.:52/8/82-ALC4/20:4
File
:It was decided tO dcferthe casc fOr 29 04 2015 for cOmmcnts OfI)cpa■mcnt of
.`:^_1_
Namc:PRECNA
T10NAL LTD
Name:LAKE
41CALS PRIVATE
1田
島児5∽
“
劉/AM b戸
~賠
λ乳
OЮOη 鳳剛夕
囲
鼎
°
"Ю
・
°
・
匪面扇百
:01/82/050/00977/AM15′
「03/95/040/00254AM 15/ '7062014
IDate:18022015
Party Name:UNICHEM
Mcet No/Datc:18/82-
LABORATORIES LIMITED
ALC4/2014
18022015
sion :In the light of writen comments reccivcd from Dcpartment of PhaH‖ aceuticals vide
OM No 35011/487/2014-PIcヽ
。:::IS)dated 06 02 2015,it was dccided to rati″
nOnlls undcr
4 7 ofHBP vl as pcr dctans given bclow or as applicd by the fll‖
:,WhiChever is lcss:
Item of Export
Quantity
S,No
Item of lmport
Quantity
allowed
3LOPIDOGREL 75MG
「ABLET
l kg
1
Clopidogrel Hydrogen
sulphate
99.8146 mg
## Case No.:199/6/82-
Partv Name:H-J.AROCHEM
Meet No Date■
8/82‐
ALC4/2014
PVT LTD、
ALC42014
Re-indexed
18022015
## Case No.:202/6/82-
Partv Name:FORACE
Status: Deffered
and Re-indexed
ALC4/2014
POLYMERS(P)LTD
(P.C. Division).
## Case No.:29l8/82-ALC4l20l4 Party Name:DIVtS
Mect Nυ Datel18/82-
PHARMACEUTICALS
ALC4/2014
PRIVATE LIMITED
18022015
:In the light of written comments received from Department of Pharmaceuticals vide
OM No 350H/455/2014-PIぃorms)dated March 2015,I was decided to raJ″
nollllS
Para 4 7 ofHBP vl as pcr dcmils given below or as applicd by thc■
::‖,whiChever is less:
P9厩
脇
屁。ハm夕
膨
棚
∽
“
69/AMW臓
辮
創Ⅲ
"'OB為
"佗
∝5
201
ALC4/2014
57
⌒
File
1淵鼎α
"Ю
%“可面面
⌒
kg/kg
Alpha-(2-Methyl Amine)
Ethyl Benzene Methanol
l kg
1
Benzaldehyde
1 72
（
２
呻
嗣
０
・
ｌ
Ｃ
‐
ｓ
Ａ
078
3
Pa‖adium
0002
4
Paraformaldehyde
040
一
Ｌ
Ｊ
Acetophenone
‘
υ
6
Sodum Boro
Hydride
011
「P赫繭 1濶馳―
れ鯰鵬児
5∽077ハMy myl翻
器劇"8m8
: Itwas decided to defer the case for 29.04.2015 for comments ofDepartment of
1203
## Case No:64/10/82-
ALC4/2014
Re-indexed
## Case No.:21El6/82 - ALC4l20t 4 Parry Name:UNICHEM tM*i-N",O"t", l8l/iZ- -Lt"t*i-
LABORATORIES LIMITED 'ALC4/2014
Approved
I
:rs.o2.2ol;
Ha Fit. -
- lRLAFilt- -
l-r-ic.NoTout"oiiozs6ae6 -]oii;ilt
,0rtry0s0ly620!!Mly :03/95 /o4o/00246/AMtst 07.07.2014
i
Decision : In the light or *.itt"n "o.t*r,tr ."""i*a-r.om rj"p".tr*r,t or pr,u.rn"..uti""lr rrc
their oM No. 35ol l/48712014-Pl(Norms) dated 06.02.2015, it was decided to rati& norms under
## Para 4.7 ofHBP vl as per details given below or as applied by the firm, whichever is less:
Item of Export
Qty
S,No
Item of lmport
Quantity
allowed
58
NαDatel18/82-
^
昭
―
―
| |
「
ISCIENCES PVT LTD
IRLA File
:03/95/040/00258/AM15/
08072014
FFτ,7こF5層品
「テテ]『テ顧ζ長3ζ
~lDeferDate:
ALC42014
18022015
isr"tu.i
lApproved
208
調器躙
噸 1翻岬0岬
lon as per above decision of NC
)XlCiLLN&POTASS10M
VULANATE TABLETS 250/125MC
ber
POTASSIUM CLAVULANATE
AND MICROCRYSTALLNE
CELLULOSE(11)
303 770 mg
AN40XICILLN&pOTASSIUM
3LAVULANATE TABLETS SIXl′ 12SMG
\umber
POTASSIυ M CLAVULANATE
AND MICROCRYSTALLNE
CELLULOSE(1:1)
303.770 mg
け
‐
‐
‐
‐
‐
‐
嚇
ド
‐
‐
RLA File
Lic.No/Date:0910060609
:0924l040l00l43lAvlst 08.0'7.2014
: lt was decided to defer the case for 29.04.201 5 for comments of Department of
|~lCaSe高184/8慇簾ALC42“ 4「憂
'NalncNAPROD uFE
Meet No/Date:18/82‐
:01/82/050/00942/AM15/
Decision :ln the light of written comments received from Department of Pharmaceuticals vide
their oM No. 35011/483/2014-Pl(Norms) dated January 2015, it was decided to ratify norms
under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product
Exp
Qtv
SI No
lmport items
otv.
allowed
IPECACUANHA EXTRACT
Concentrate 9%
l Kg
IPECACUANHA R00TS
4 091 kg
concerned may take further necessary action as per above decision of NC.
rion 3ln the light of written comments received from Oepartment of Pharmaceuticals vide
OM No. 35011/551/2014-Pl(Norms) dated 26.02.2015, it 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:
Export product
Exp
Qty
SI No
lmport items
Qty a‖owed
VANCOMYCN 500 MC INJECT10N
l Kgぃ。
1
VANCOMYCIN
HYDROCHLORIDE
561 mg/10 ml vial
RA concerned may take further necessary action as per above decision of NC.
209 Case No.:62/10/82‐
PaFy Name:STERLING
Meet No/Dtte:18/82-
Status:Deffered
⌒
鵬3月50Ю"7餘my障
蹴
0/002■ハm夕
1癬辮
“
Ю
・
6523
18022015
AUXILIARIES PVT LTD
ALC4/2014
18022015
:05/24/040/00168/AM15/
Re-indexed
Re-indexed
Re-indexed
Re-ind€xed
Re-indexed
Party Name:MYLAN
Meet No7Datel18/82-
LA30RATORIES LIMITED iALC4/2014
一
‐
‐
‐
２
‐
‐
‐
1脚辮Ю剣∞ω“
2蹴ち
9餌2m5
:01/82/050/00685/AM15/
:In the light of written comments received from Department of Pharmaceuticals vide
OM No. 3501l/54712014-Pl(Norms) dated 25.03.2015, it was decided to call from the firm
following technical details:
Norms applied per kg for each export product separately alongwith relevant technical details."
case was deferred for 29.04.2015.
田
疏
50佃ηttmy
隔ち糀
υ剛銘ハmy
悧
鼎
醐
∞ω 饂
## Case No:44/15/82-
Paty Name:HETERO LABS
LIヽ41TED
ALC42014
## Case No.:21/8/82-ALC4′ 2014
## Case No.:50/18/82-
Meet No′つatc:18/82‐
ALC4/2014
PHARMACEUTICALS
18022015
P21器3月50Ю И κttmy lЪ
ち棚
∽
“
89晨M膨
隔
ALC4/2014
18022015
## Case No.:200/6/82-
ALC4/2014
60
悧鼎αいЮ錦
"箕躊ち
9“ 2創5
No.:36/8/82-ALC4/2014
Name:RA CHEM
,Meet No/Date:18/82‐
LIMITED
|
^
icase No.:214l61E2-ALC4nU4 Party Name:ALCHYMARS Meet No/Date: 18/82- lStatus:
I
]lcM sM pzuvArE LIMITED )evc+tzor+
lapproveo
i
lE.o2.2ol5
I
tHa Fir; --'-"
Eie lir"
---'ii..r.rorotCn,ial5e026
D;reioate:'
t0l/821050100616lAMl5l :04/24/040100O67/AMl5l 18.07.2014
Decision : ln the liSht of written comments received from Department of Pharmaceuticals vide
their OM No. 35011/465/2014-Pl(Norms) dated March 2015, it was decided to ratify norms
under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever is less:
Export product
Exp. Qty.
SI No
lmport items
otv.
allowed
ko/ko
S‐ACETYL‐ 3CHLORO IMINODIBENZYL
INTERMEDIATE
l Kg
1
IMINODIBENZYL
222
concerned may take
necessary action as per above decision
「「面戸藤~~
博席溜諄
れ“ 鵬3泥50Ю
"86/AM W
厩
鵬
OЮ∝リハmy l悧
鼎
酬
m“ 器4
ALC4/2014
Deffered
Re-indexed
Re-indexed
042015
Re-indexed
摯
7隔
3児50Ю
"34/A剛
夕 1賜
鵬
OЮ醐7/AMW H盤
階
34°餌
"お
: lt was decided to defer the case for 29.04.2015 for comments of Department of
「
甲
酉
~IM8憔
ЫMFED
1181器3児5900767ハMly囲脇扁戸
Mcct No′Date:18/82-
18022015
Lic No/Date:0310787202
22072014
: lt was decided to defer the case for 29.04.201 5 for comments of Oepartment of
No/Date:18/82‐
18022015
田:胤面薦」~ 1鼎
鼎α朔∞“
"8
品
`朧
瓶,臨識『
## Case No:25/15/82-
ALC4/2014
Pa●y Namc:SHIVAM OILS
61
Re-indexed
No.:70/8/82-ALC4′ 20:4 P征ッName:SHANPAR
nNDUSTRIES PVT LTD
ハ
Decision : In the light of written comments received from Department of Pharmaceuticals vide
their OM No. 350111484/2014-Pl(Norms) dated 03.02.2015, it was decided to call from the firm
copy ofvalid Drug Manufacturing Licence for both ofthe export product.
Thc casc was defercd for 29 04 2015
辮辮m"“8躊ち
9“測
5
Ψ
ttC親田
[蹴賛酬
腺
「D脚
¨
F剛
直
/6/82‐ALC4/2014甲
呂
需
博席
"
import.
Re-indexed
|
摯
|
Re-indexed
: In the light of written comments received from Department of Pharmaceuticals vide
OM No. 3 501 I /566/2014-PI(Norms) dated 25.02.2015, it was decided to call from the firm
of Master Batch Formula for each strengths of export product duly certified by their Quality
in charge showing net content of APIs and each ofthe excipients used and applied for
case was dcferred for 29 04 2015
[霰継晰ピHttD
瑞允馳OЮ∝0鳳M戸囲肝繭耐
222
F万Fttτ雨
=164/8/82‐
ALC4/2014
ALC4/2014
:01/82/050/00786/AM15/
ision :ln the light of witten comments received from Department of Pharmaceuticals vide their OM
350111537/2014-Pl (Norms) dated 07.04.2015, ir was decided to ratiry the norms under Paru 4.'l of
vl as per details given below or as applied by the firm, whichever is less::-
Export product
Export
Qty.
SI No
Import items
Q″ al10Wed
(kg/kg)
ATAZANAVIR SULFATE
l kg
1
EPOXIDE
CHEM!CAL
049
う
Ｚ
T‐BOC HYDRAZINE
050
N‐METHOXWCARBONVL‐ L‐TERT
LEUCNE
077 ´
4
EDAC‐ HCL l‐ (3‐
DlMETHYLAMNOPROPVL)3‐
ETHYLCARBODIIMlDE
HYDROCHLORIDE
079 ′
Party Name:MOREPEN
Status:
鵬
3鬼mЮ餌餌晨m夕
膨
鵬
oЮ∞釧ハ蔦
1輛面高蕊戸障蹴∽∞"AM[戸囲辮“
No.:122/8/82-ALC4/2014
No/Date:18/82-
|
「
A10RATOMES LTD, 1借
″ 盤」 Fppr"“
器
3児50Ю
"盤
ハⅢシ
厖
淵
υ剛
"/AM耐 1鼎
鼎
α
“
Ю翼
"%PhDatc
鷺
電:親1戒Lぶ鼎
|バ認
∬l肥
『
0捻
r〕
譜
1駿
思
譜
″ L潟留
i漑
鴇
鮮
∬IP予
HBP vl as per details given below or as applied by the rrm,whichever is less:‐
Export product
Export
Qty.
Si No
Import items
Q″ al10WCd
(kgkg)
SITAGLIPTIN
PHOSPHATE
MONOHYDRATE
lk
1
R-3-((tert‐
butOxycarbonyl)amin。)`―
(2,4,5‐
dfluorophenyl)butanOic acid
(SG04)
100k3/kg
つ
４
3-(trifl uoromethyl)-5,6,7,8-
tetrahydro-[ 1,2,4]triazolo[4,3 -
alpyrazine hydroch loride
0 80 kg/kg
3
N‐
Hydroxybenzotriazoに(HOBT)
0 50 kνkg
4
Methanol
3 65 1it/kg
5
Isopropyl alcohol
6 10 1it/kg
6
Mcthylcne Dichioridc
15251t/kA
## Case No.:73/10/82‐
ALC4/2014
Pa●y Name:ADCOCK
INGRAM LTD,
鱚席"
Re-indexed
124 1鶴危脇OЮ037υAMⅣ
Pharmaceuticals specification for each ofthe export products.
Packaging /presentation of export products specifing quantity of contents of export
products in each ofthe packs
Master Batch Formula indicating quantitative requirement for each of the ingredients
duly certified by the production and qualities control in charge.
Manufacturing process involved in production of the export products indicating the level
of wastage /recoveries of various solvents / raw material during the process.
Lic No/Datc:0710106215
28072014
042015
## Case No.:66/8/82-ALC4aU4 lParty Name:RECKITT
BENCKISER
042015
: ln the light of written comments received from Department of pharmaceuticals vide
OM No 35011/414/2014-PI(Norms)dated 21 01 2015,It、vas dccidcd to ca‖
from the inln
information:
Copy of Drug Manufacturing License (DML) indicating approved compositions of
export products.
０
０
面
Ⅳ
ｖ＞
HEALTHCARE INDIA
LIトイITED
Meet No′Date:18/82‐
Lic No/7Datc:0510390158
06082014
63
The casc was deferrcd fOr 29 04 2015
1鷺「£肥露
:留ギ
l捌認!鴇r常∬191
e frm,whichever is less:
Export Product
Export
OualltiV
＆
、
Import Item
Q″ Allowcd
kg/kg
N―Me■vI NaphthyI MethyI Amine
HcI(oo N― Mcthyl-lNaphthyl
ヽIethyl Amine Hcl
(。っN― ―Methyl NaphthyI Methyl
Amine Hc1/TER‐ A
l kg
l
I Chloro Methyl
Naphthalene
ｎ
υ
2
Toluene
123
may take appropriate action as Per the decision of Norms Committee.
## Case No.:18/15/82-
ALC4/2014
Party Name:SHASUN
Mect No/Date:18782‐
PHARMACEUTICALS
'ALC4I2OI4
18022015
by Quality Control Incharge. The case was defeo"d !t 29 04'2015'
## Case No.:89/9/32-,lLCA l21l 4 lParty Name:KARNATAKA
ALC4/2014
ANTIB10TICS&
PHARMACEUTICALS
:It was decidcd to dcferthe casc for 29 04 2015 for commcnts ofI)epartmcnt of
## Case No.:17ノ15/82‐
ParりName:SURVIVAL
Mcet No′つatcl1 8/82-
Re-indexed
Re-indexed
Re-indexed
TECIINOLOGIES PVT LTD
ALC4/2014
18022015
:Itwasdecidcdtodcferthccascfor29042015forcommcntsofI)epartment of
Name:ANUPAM
No/Date:18/82‐
Кυ MAR
…■ .“ de
Meet No/Date:18/82‐
## Case No.:4/18/82‐ ALC4/2014
YAN(lNDIA)LTD
18022015
¬■ 1、く、1
■ New Delhi
1器島児
50畑370AMl戸跳ち馳OЮ0029AMⅣ
petrDに
126082014
Decision:ln the light of written comments received from Department of Chemicals and
Petrochemicals vide their U O No 14010/3/2015-Ch ll dated 16 03 2015, it was decided to
ratify norms under Para 4 7 of H8P vl as per details given below or as applied by the firm′
whicheveris less:
Export product
Exp. Qty.
SI No
lmport items
Qty. allowed
2-Chioro-4-(4-Chloro
Phenoxy)Acetophenone
l kg
1
Para Chloro Phenol
0 9670 kg
2
Meta Dichloro
Benzene
1 3500 kg
3
DimcthyI Sulfoxidc
0 8000 kg
Ｉ
Ｈ
Ｉ
コ
「
“
臨齋戸面5079
Defre"ed
Re-indexed
IHQ F‖ e
101/82/050/00666/AM15/
;Decision : It was decided to defer the case for 29.04.2015 for comments of Department of
iPharmaceuticals.
B鳶ち
,m矧5
脇淵ν
lxxlЯハ
T百
Partv NamciCOVALENT
LABORATORIES PRIVATE
LIMITED
RLA Filc
:09/24/040/00274/AM15/
瑕
Re-indexed
18022015
B寛ち知″鰤
1ヽprie:nn・
in ttha lioh十nfl″ rit,on rnmmpntく
rρr●lv●d frnm nenartment of pharmaceuticals vide
Decision : ln the light of wrltten comments received from Department of Pharmaceuticals vide
their oM No.3517l/22r12114-Pl(Norms) dated 18.02.2015, It was decided to call from the firm
following information :
i)
Consumption data of 16 raw materials used in manufacturing of Enoxaprin Sodium
233
Injections pre-filled Syringes duly certified by Central Excise Authority for the year
:
2012-13, 2013-14 and April to December 2014.
r
ii)
Copies of batch log sheets for the last 5 consecutive batches for conversion of Heparin i
Powder into Enoxaprin Sodium indicating the actual consumption of all raw materials
ro、vocr inlo LnOXaprin ooo:um inolca11【lg tilc aじtual oυ llbulllPι :υll υ■ 4‖ :`W ll141Clia13
consumcd for gcting thc APl used in thc Enoxaprin Sodium ittcctiOns l
面) COpにS Of batch log shccts for hst 5 consccudve ba¨ hcs indicadng actual consumption
of 16 raw matcrials applied for import in al applications against export of Enoxaprin‐
z
Sodium Injections in pre-filled syringes.
The information sought vide Item No. 2 and 3 above may be certified by production in-
charge ofmanufacturing unit ofthe firm.
:●●
「ヨ■ ‐
## Case No.:55/15/82-
The casc、vas dcferred for 29 04 2015
Casc No.:45/15/82‐
ALC4/2014
Pa●y Namc:GLAND
PHARMA LIMITED
ALC4/2014
鵬3鬼50畑
"2/AM Ы
FnseN∝
4/3/82‐ALC4/2m4
臨
靱
: ln the light of written comments received from Department of pharmaceuticals vide
OM No 35011/221/2014‐ P(Norms)dated 18 02 2015′
It was dccided tO call fbm the fll川
I
inq information:
i)
consumption data of 16 raw materials used in manufacturing of Enoxaprin Sodium
lnjegtiors pre-filled Syringes dury certified by centrar ExcisJ Authority ior the year
2012-13,2013-14 and April to December 2014.
ii)
copies of batch log sheets for the last 5 consecutive batches for conversion of Heparin
Powder into Enoxaprin Sodium indicating the actual consumption of all raw matirials
..
consumed for getting the API used in the Enoxaprin Sodium injections.
iii)
Copies of batch log sheets for last 5 consecutive batches indilating actual consumption
9f l_6 oy materials applied for import in all applications againstlxport of Enoxaprin
Sodium Injections in pre-filled syringes.
The information sought vide ltem No. 2 and 3 above may be certified by production in-
charge ofmanufacturing unit ofthe firm.
The case was deferred for 29.04.2015
|
Re-indexed
042015
Re-indexed
:29042015
1協鵬OЮ“埓ハmy
:It was decided tO defcrthe case for 29 04 2015 for commcnts of Departrnent of
「Fお
em:7/3/82ALC伽4甲ポ耐
|
P7鵬‰∽鰤1/AM15/M蕊戸囲亥耐
Decision: It was decided to defer the case for 29.04.2015 for comments of Department of
Pharmaceuticals.
:O1/82/050/00668/AM15/
1235
## Case No.:6/8/82‐ ALC4/2014
FN眈
¨
“
m4[岬
繭
前
階Te18/82‐
w
鵬脇
50Ю∝
70/Am夕 厖珈蕊蕊肩
1蹴鼎醐∞ω
9“ 1胤9_2m5
66
Name:HONOUR LAB
No/Date:18/82‐
defer the case for 29.04.2015 for comments of Department of
18022015
^
1趙
ge:H°NOUR LAB~騨
嚇
語
1蹴鼎ε
: It was decided to defer the case for 29-04.2015 for comments of Department of
ICaseNo.:9′
3/82‐ ALC4/2014 1 Paty Name:HETERO LABS
LIMITED
Re-indexed
囮
話3AMЫ I協棚υ∞
"0ハ剛夕圏鰊繭翻瓢蕊
‐Case No.:11_1/18/82-
,ALC4/2014
劉| ~鵬霧朋
OЮ“ω″
脇
冨百
Status: Deffered
and Re-indexed
:07/24/040/00207/AM15/
## Case No:12/15/82-
Party Name:JINDAL DRUGS
Meet No/Date:18/82‐
ALC4/2014
LIMITED
## Case No.:13/3/82-ALC4′2014 Pary Name:HETERO LABS
Meet No′Date:18/82-
LIMITED
ALC42014
18022015
## Case No.:38/15/82‐
ALC4/2014
躙謡:語R器
諄
棚TI而
67
「
|
No/Date:18/82-
「
File
|1
滸
「お鵬疏50/O132'Am夕
膨扁蕊蕊「
躙辮翌
ω%8E誰ち9"J
P3隔
File
5
1囲戸
面高瓢面面高teてぉ詢
賀
42劇5おrcommemsofDepartmemof l
## Case No:54/15/82-
ALC4/2014
:It was dccided tO deferthe case for 29 04 2015 for cOmments of Depaltmcnt of
Re-indexed
Re-indexed
鵬疏5∽"9mm夕 1協馳∽∞
69/Amy
Lic No/Date:0310789468
19092014
18022015
:ln the nght of written comments received frOm Petrochemical Division of Department of
and Petrochemicals vide their u o No 46011/91/2008-PC‐
|l dated 20 04 2015,it was decided
ratify norms under Para 4.7 of HBp vL as per details given below or as applied by the firm, whichever is
:It was decided to defcrthc casc fOr 29 04 2015 for cOmments Of Departmcnt Of
Party Name:HETERO
DRUGS LIMITED,
## Case No.:125/8/82-
ALC4/2014
25鵬
星鬼50Ю
"89/A剛
シ
]協
鵬
。Юω もハmy l翻
鼎
醐
∞a∞OB為
9脳2m5
:lt was decided to deferthc case fOr 29 04 2015 for commcnts of Dcpartmcnt of
## Case No.:126/8/82-
Pa●y Name:RELIANCE
INDUSTRIES LTD
Importitcms
## Case No:9/15/82-ALC4/2014
。調Ъ∴ニ
吻
Re-indexed
Namc:VIRCHOヽv
PV T LTD,
戸
「F繭面
「
~麗覇頭耳丁朧辮Ψ
&‐ 日ぱ訛翻
控8圃
r(Lll rl|e
rlic.No/Date:31 10064915 lDefer
t:31t83/040/00t36lAMt5t 2Z.Og.2Ot4
OiiZg.U.ZOtS
⌒
一
２
４
９
ほ謎胤響
7/8/82
|
|
lm柵
oHETEROLABS ttNの
に
18/82-
IALC4/2014
118022015
Lic No′ Date:0910061002
22092014
ICase No.:128/3/82‐
PttNalncHETEROLABS tte“ Noわate:lν 8】
「
~卜
彎,Pettrel
IALC4/2014
|
|億″盤F 「
nd Re‐mdex“
LIMITED
陽ち鵬
OЮ"4^mシ
囲耐面雨MS
1250
IHQ File
l:01/82/050/00792/AM15/
Pa●y Name:HETERO LABS
No/Date:18/82‐
Deffered
Re-indexed
Ｆ
‐
‐
‐
２
５
‐
‐
## Case No.:129/8/82-
ALC4/2014
囮
LIMITED
18022015
F咄
聴
αttEttЁ ROLABS ttlT=lν
"‐
「
M‐D
1脇棚υ∞
"2ハmy l淵辮Ю釧∞a∞5
Re-indexed
18022015
: ln the light of written comments received from Department of Pharmaceuticals vide
Parw Name:HONOUR LAB
LIMITED
Lic No/Date:0910061007
69
eir oM No. 35orLl4r4/zol4-pr(Norms) dated 21.01.2015, It was decided to call fro, tr," n,,
llowing information:
ヽ
り
ｈ
り
一
Ш
‐
Ｖ
ヽ
，、
リ
copy of Drug Manufacturing License (DML) indicating approved compositions of
export products.
Pharmaceuticals specification for each ofthe export products.
Packaging /presentation of export products specifring quantity of contents of export
products in each ofthe packs
Master Batch Formula indicating quantitative requirement for each of the ingredients
duly certified by the production and qualities control in charge.
Manufacturing process involved in production ofthe export products indicating the level
of wastage /recoveries ofvarious solvents / raw material during the process.
The case was defcrred for 29 04 2015
Case No.|
ALC4′ 20
ALC4′ 2014
## Case No.:61/15/82‐
Re-indexed
|
51器
3児50/OB48/AM15/
Filc
1/83/040/00148/AMi5/
Lic No/Datei3 11 0064931
126092014
:It was dccided tO dcferthe casc fOr 29 04 2015 for cOmmcnts of DcpartFnCnt Of
Casc No:10/15/82-ALC4/2014
1256
sion :in thc light of ν
OM No 35011/533/2C
4 7 ofHBP vl as pcrd
yritten comments received from Department of ptrarmaceuticals viae
ll4-PI(Norms) dated 25.032015, it was decided to ratifo norms under
etails given below or as applied by the firm, whicheveris less:
Item of Export
Quantity
S′No
Item of lmport
Quantity
allowed kslks
ABACAVIR SULPHATE
l kg
(lS,4R)-4‐ [(2-amino-6-
ch10rO_9H_pu‖ n―yリー
2-
cycIOpentcne]― 卜methanol
…
ridC
1292
2
Cyclopropylam ine.
019
may take apprOp“ ate acJOn as perthe dec`i。●Of Norms COmmittee
258 Case No.:37/t5/82-
parry Name:GLA\D
Meer No Dale:lg 82_
Starus:Deffered
乙Joしasc l、o.:●″15/じZ― Par,Namc:GLAND Mect No/Datc:18/82- status:Defrered
・
■ ~‐ ,■′｀
「 ::
70
gtFr6q fn"
rsql ' I
Udyog lrr
Name:SRIAM LABS
ATE LIMITED
No7Datel18/82-
Π マ
r llじ
101/82/050/O1297/AM15/
――
― |…
面TED~
|
ALC4′2014
Re-indexed
18022015
HQ HL RLA RL
匠
疏
荘
0910061067
109102014
':Ol/82/O5OlOl324/AMl5l :O9/24/M0100354/AMl5l
042015
: ln the light of written comments received from Department of Pharmaceuticals vide
OM No 35011/221/2014-PI(Norms)dated 18 02 2015′
lt was dccidcd to call iom the inll
ing information:
Consumption data of 16 raw materials used in manufacturing of Enoxaprin Sodium
Injections pre-filled Syringes duly certified by Central Excise Authority for the year
2012-13,20 l3- l4 and April to December 2014.
Copies of batch log sheets for the last 5 consecutive batches for conversion of Heparin
Powder into Enoxaprin Sodium indicating the actual consumption of all raw materials
consumed for getting the API used in the Enoxaprin Sodium injections.
Copies of batch log sheets for last 5 consecutive batches indicating actual consumption
of l6 raw materials applied for import in all applications against export of Enoxaprin
Sodium lnjections in pre-filled syringes.
The information sought vide ltem No. 2 and 3 above may be certified by production in-
charge of manufacturing unit ofthe firm.
The case was defe rred for 29.04.2015
に,se N∝4015/82‐
「
呵
NamcPORUS~~lMedNo/Dacly82‐
ALC4/2014
|
LA30RATORIES PVT LTD ALC4/2014
1 118022015
| | 118022015
%9鵬
3掲m"3ハmy 開
囲需
RLA Fne
:31/83/040/00149/AM15/
―
Li".t totort"iiiooo+goz D"r".
09.10.2014
l,Date:29.04.2015
「a鵬
島児
"Ю
O射肱「
i「
顧
蹴
∽
"7蕊
圏癬
0910061093臨高ξ
一
‐
‐
２
６
２
‐
‐
Mcet No/Date:18/82‐
ALC4つ014
18022015
It was decided to defer the case for 29-04-2015 for comments of Department of
Party Name:PVS AGRO VET
## Case No.:49/18/82‐
ALC4/2014
## Case No.:113/9/82-
Party Name:ASTRIX
ALC4/2014
LABORATORIES LTD,
Meet No/Date:18/82‐
18022015
Status:Deffered
and Re-indexed
臨嘉蕊菰蔦~膨
棚
OЮυ“晨Ⅲy 階だ鼎α醐∞“Ю
5
042015
Re-indexed
15/AM15/
!
: lt was decided to defer the case for 29.04.201 5 for comments of Department of
肥
~「
Partv Name:VINS
BIOPRODUCTS LTD,
Meet No/Datc:18/82-
Re-indexed
18022015
: It was decided to defer the case for 29.04.2015 for comments of Department
## Case No.:7/1_9/82-ALC4/2014 Pary Namc:NATCO
Meet No Date:18/82‐
PHARMA LIMITED
ALC4/2014
Re-indered
18022015
Meet No/Date:18/82-
ALC4/2014
Re-iIldexed
18022015
RLA Fne
:01/82/050/01345/AM15/ 1:0924/040/00392/AM15/
Pa●y Namc:HETERO LABS
Meet No/Date:18/82‐
LIMITED
ALC4/2014
Re-indexed
18022015
ALC4/2014
2“
田
疏
50Ю 2%ハ剛y
脇
鵬
OЮ
"“
ムmy「
∬鼎
e091∞a H4
淵鼎
C"Юm BO厩ち
9“2釧5
## Case No:79/10782-
ALC4′ 2014
Partv Name:HETERO LABS
Meet No/Date:18/82‐
LIMlTED
ALC42014
Re-indexed
18022015
f'
つ,
‐｀
Aヽ
ド
■
ktt」い
・
## Case No:58/15/82-
Paty Name:SUVEN LIFE
SCIENCES LIMITED
Lic No/Date10910061 113
17102014
## Case No:78/10/82-
ALC4/2014
:01/82/050/00992/AM15/
RLA File
:09/24/040/00393/AM15′
## Case No:80/10/82‐
ALC4/2014
ALC4/2014
鸞鶴
:‐
ヘ
田3万鳳Ll↓ly
72
: lt was decided to defer the case for 29.04.20151or comments of Department of
「
ALC4/2014
## Case No:81/10/82-
Partv Name:HONOUR LAB
N4cct No/Date:18/82-
LIMITED
ALC42014
Re-indered
18022015
3 It was decided to defer the case for 29.04.2015 for comments of Department of
Party Name:APEX PHARMA, Meet No/Date: l8/82-
ALC42014
Re-indexed
18022015
## Case No:82/10/82‐
## Case No:85/10/82-
ALC4/2014
Partv Name:HETERO
PaりName:HPL
朧魃
ヽ
ER
Mect No/Date:18/82‐
DRUGS LIヽ41TED
ALC4/2014
18022015
:lt was decided to defer the case for 29.04.2015 for comments of Department of
Meet No/Datel1 8/82-
ALC4/2014
18022015
Re-indexed
Re-indexed
: It was decid€d to defer the case for 29.04.2015 for comments of Department of
Meet No/Date:18/82‐
ALC42014
18022015
Partv Name:HETERO LABS
LIMITED
## Case No.:64/15/82-
ALC4/2014
RLA F‖ c
73
Lic.No/Date:05 1039t738
Re-indexed
Pa●y Nalne:DEEPAK
NOVOCHEM
ITECHNOLOGIES LTD
F‖ e
15/ :31/83/040/00151/AM15/
Date129 04 2015
Nalne:DEEPAK 隔
No Date118/82-
η
31棚児
5υ∞
"9ハⅢ夕膨淵∽∝
"ハm夕
|
l:O t lazOsOTo r rS Verr,fl V
Date:29042015
Re-indexed
042015
Decislom:It was decided to dcferthc case for 29 04 2015 for cOmments ofDepartment of
Meet No/Date:18/82‐
ALC4/2014
18022015
Meet No′1)ate:18/82-
ALC4/2014
18022015
per above decision of NC.
駆∬叫 ~
Mcct No/Date:18/82-
ALC472014
18022015
Re-indexed
:It was dccided tO defcrthe case for 29 04 2015 for comments Of Dcpartmcnt of
AM15/ レ7102014
## Case No.:38/18/82-
ALC4/2014
PaりNamciCROWN
CHEMICALS PVT LTD,
Lic No/Date103 10790589
## Case No:22/18/82-ALC4/2014
浙
面鮮
Lic No/Date:0310790576
:03/95/040/00453/Alヽ415/
29102014
slon :In thc light Of writ
OM No 35011/142′ 201`
Para 4 7 ofHBP vl as p(
len comments received from Department of pharmaceuticals vide
4-PI(Norms) dated October 2014, it was decided to ratifo norms
:r details given below or as applied by the firm, whicheveris less:
Export product
ExpOrt
Qty
Si No
lmport items
Quant■y Allowed
kg/kg
Poviodne Iodine Topical
solution USP
l kg
Povidone lodine
powderlP/uSP
0098
RA concerned may take further necessary action as
Lic No/Datc:0310790636
74
Name:SIRMAX0
vIICALS PVT LTD
IDeFerDate:
^
Ｆ
Ｉ
|
1鵬掲5¨8¨
118022015
1野∬
gttα0410159655
:04/24/040/00200/AM15/
necessary
ヽ
ヽ
ヽ
′
´
´
may
per
tion :ln the Iight of written comments received from Depanment of Pharmaceuticals
OM No. 3501l/410/2014-PI(Norms) dated January 2014, it was decided ro ratiry n
' Para 4.7 of HBP v I as per details given below or as applied by the firm, wh ichever is l,
Export product
Exp. Qty.
SI No
lmport items
Oty. allowed
PAROXETINE TABLETS
20 MG
l kg
1
PAROXETINE
HYDROCHLORIDE
22 20 mg/20 mg
Tablet
PAROXETNE TABLETS
30 MG
l kg
1
PAROXETINE
HYDROCHLORIDE
33 30 mg/30 mg
Tablet
PAROXETINE TABLETS
40 MG
l kg
1
PAROXETINE
HYDROCHLORIDE
44 40 mg/40 mg
Tablet
concerned
take further
action as
above
「F腑叫
れ“
戸
―
貯
LABS
1鶴角鵬
OЮ餌1。/AM W
042015
Status: Deffered
and Re-indexed
|¨
1躙、
F
R€-indexed
042015
Date:29042015
嚇
戸肝∬辮“Ю
"∝"
to dcferthe casc for 29 04 2015
Lic No/Date:0910061161
30102014
Ｅ
υ
一
ノ
forcommcnts ofDepartment of i
NamcSHiVA
LTD,
Re-indexed
C&PC.
Meet No Date:18/82-
ALC4/2014
18022015
囮
冽
Amy
:O1/82/050/O1401/AM15/
Re-indexed
Re-indexed
F躙“ ~甲¨下階∬"
2861器
疏50/O1336/AM W
「
群ZttЮ
9Ю
“
H8913L9脳
2m5
C".. Xo"rvralS2-ALC4Z0H lFu.ty Nu."l(RISHt,lA M""t N./D"t., t S/81 Frrtrsr
-
,ANrroxrDANrs
Pvr. LrD. iLtjf.l,r.
'Approved
Ea Fi[
inr-a pit"
lLic.No/Date:03 10790837 lDefer Date:
:01/82/050/01439/AM l5/
l:$t94t040t00723tAutst loz.tt.zor+
I
tD""t.t", , l^ tf" iigfrt of *ritt"r' .on r*ntt r"."ir"a t.rn O"p..tr*nt of Ch"ri."lt ."d
lPetrochemicals vide their U.O No. 14010/1OOlzO1.i}-Ch.ll dated 26.03.2015, it was decided to
lratifu norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,
lwhichever is less:
Export product
Export
Quantity
S No
Import items
Quantity
Allowed
TRIS TRIDECYL
l kg
1
YELLOヽV PHOSPHORUS
0 050 kg
Lic No Date:0310790719
03 112014
ion::n the:ight of written comments received from Department of Pharmaceuticals
OM No 35011/548/2014-P(Norms)dated 07 04 2015,lt was decided to ratlfy n(
Para 4 7 of HBP vl as per details given below or as applied by the firm′ whicheveris l(
Item of Export
Qty
SI No
Item of lm port
Quantlty a‖owed
kg/kg
Betamethasone
Sodium Phosphate
l kg
Betamethasone
078
「ぱ
Party Name:BELCO
76
No/Date:18/82-
1器3児5υ01318AM lシ
Date:29042015
: It was decided to defer the case for 29.04.2015 for comments ofDepartment of
―
Lic No′ 1)ate:3110065034
:01/827050/01421/AM15/
31/83/040/00171/AM15/ 110H2014 1
: In the light of written comments received from Department of Pharmaceuticals vide
OM No. 3501 I /491/2014-PI(Norms) dated March 2015, it was decided to ratiry the norms
## Para 4.7 ofHBP vl as per details given below or as applied by the firm, whichever is less:
Partv Name:EMCtJRE
Export Product
Q″
SI No
Import items
ｇ
飲
¨
¨
Ｑ
ａｌ
Ritonavir USP
l kg
1
Ritonavir IntermediateJ I
[Carbonate] {Carbonic Acid-4-
nitrophenyl-5 -thiazolyl
methylester)
072
2
BDH Succinic Acid Salt
{(2S,3S,5 S)-2-Amino-3-
hydroxy-5-(te( butyloxy
carbonyl) amino -1,6-diphenyl
hexane succinate)
114
う
ι
PHENOL
0 469 kg
TRIDECYL ALCOHOし
1 06 kg
Pa“y Name:VENUS
REMEDIES LTD,
|
No/Datel1 8/82‐
289
No.:71/18/82-ALC4/2014
Name:GLENMARK
No/Date:18/82-
お
3ハ剛y匿∬鼎α
"Ю"0%9
:The Committee considered the case as per agenda, in the light of written
^
ノ
|
Lic No/Datc:0310790871
::01/82t050/01442/AMt5t :03/94t040/00734/AMt5/ ltO.tt.zot+
: It 、vas dccided to defcr the case fOr 29 04 2015 for commcnts Of Department
Meet No/Date:18/82-
ALC4/2014
18022015
Date:29042015
:It was decidcd tO defcrthe casc fOr 29 04 2015 for cOmments ofI)epa■inent of
Meet No/Datc:18/82-
ALC4/2014
18022015
HQ File
:01/82/050/01427/AM15/
RLA Filc
1斃1猾
"畑“
7ムⅢy脂
角棚
OЮttηハⅢy爾
∬鼎
Cmm%鯰
41蕊
蕊
|1鶉正
illr dCCidedゎ
detr tte c～おr"042創5おr∞mmetts Of Departmm d
No:19/15/82-
4
:it、vas dccided tO dcferthc case for 29 04 2015 for comments of Dcpartment of
器
3児59m薦厩淋蕊y貯∬開Cm m"η 5
轟J勲・
1.「:踊
財
害馨塘
i響毬ざ
Qty
Ciclopirox Gel
0.77Vo,30 sm
Packs
1
Ciclopirox USP
235.62 mgl30 gm
Ciclopirox Gel
0.77%o, 45 sm
Packs
1
Ciclopirox USP
352.967 mg/45 gm
Cic10pirox Gel
0770/0,100 gm
Packs
1
Ciclopirox USP
785.0 mg/l00 gm
## Case No:76/13/82‐
ALC4/2014
PaりName:GLENMARK
GENERICS LlMITED
## Case No.:81/18/82-
ALC4/2014
P征,Name:R L FINE CHEM
P錮りNamcMALLADI
DRUCS&
PHARMACEUTICALS
## Case No:20/1_7/82-
ALC4/2014
Meet No7Date:18/82‐
## Case No:61/18/82‐
ALC4/2014
Lic NげDate134 10040676
11 112014
駆朧孵dい
:34/24/040/00198′しへM15/
Re-indexed
Re-indexed
Re-indexed
Name:MALLADI
&
Re-indexed
Namc:TATVA
AN PHARMA CHEM
LTD
Re-indered
９
う
‘
∠
Ｕ
Re-indexed
:03/94/040/00747/AM15/
042015
:ln the light of wriften comments received from Petrochemical Division ofDepartment
Chemicals and Perochemicals vide their OM No. 14010167l20l I -CH-l I dated 29.03.2015, it
decided to call from the firm the following technical details:
i) Detailed manufacturing process along with balanced chemical reaction indicating number of
of all the reactions, products and by-products with corresponding molecular Formulae,
formulae, molecular weight and process flow diagram.
ii) Stage-wise percentage yield with respect of each ofthe reactants and products and the relevant
enclosing therewith authentic printed technical literature in support ofyield or
of items for import.
Detail ofby-products formed during the process and their recovery in terms ofquantity and
) Details of production of export product under reference and corresponding consumption
material in the year 2013-14 and 2014-15 (April to October) duly certified by CA may
If the production has not commenced in the past, the details from commencement
may be fumished duly certified by CA.
casc、vas dcfcrrcd for 29 04 2015
Re-indexed
:29042015
decided to defer the case for 29.04.2015 for comments of Department
ｂ
ｃ
ｏ
ｆ
It was decided to defer the case for 29.04.2015 for comments of Department of
## Case No:33/18782-ALC4/2014
Party Name:ARIHANTANAM
LIFECARE PVT LTD
:01/82/050/01399/AM15/
:03/94/040/00770/AM15/
12112014
sion :ln the light of written comments received from Department of Pharmaceuticals vide
OM No. 350lll2l2l20l4-Pl(Norms) dated October 2014, it was decided to ratify the norms
r Para 4.7 of HBP v I as per details given below or as applied by the firm, whichever is less:
Export product
Exp.
Qtv.
SI No
lmport items
Qty. allowed (kg)
Lumefantrine
1kg
(Dibutylamine Methyl)-
2, 7-Dichloro-4-Fluoren
Methanol (DBA)
0.8691 kg
## Case No:41/13/82-
ALC4/2014
:01/82/050/01407/AM15/
79
Name:AVA
No/Date:18/82‐
PVT.LTD.,
18022015
Namc:KARNATAKA
No/Date:18/82‐
ヽ
¨
Ｓ
ぬ
一
Ｍ
６
１
０
い
¨
¨
―
ぃ
ヽ
ヽ
１
ヽ
ヽ
⌒
Pharmaccuticals
Re-indexed
of Department of
ヽ4eet No/Date:18/82‐
ALC4/2014
18022015
剛囮扁戸腋∬器。鋼∞四“
Date:29042015
:It was decided to defer the case for 29.04.2015 for comments of Department of
~P知
りNalne:AVA IMcctNo/Datα 18/82-
Defrered
R€-indexed
Paw Name:DEEPAK
NITRITE LIMITED
Mect No/Date:18/82‐
ALC4/2014
Re-indexed
18022015
躙
児5∽剛
ハmy
陽
乳0側99/AM V
階伴鼎
α卸∞
“
θ 7
Re-indexed
: It was dccidcd tO defcr the casc fOr 29 04 2015 for comments of Dcpartmcnt of
## Case No.:24/15/82-
ALC4/2014
:O1/82/050/01311/AM15/
PaりName:SHIVAM OILS
&PROTEINSINDUSTRY,
## Case No:46/18/82‐
1302
## Case No.:72/18/82-
Meet No/Datel1 8/82-
ALC4/2014
PHARMACEUTICALS
No:77/18/82‐
File
Re-indexed
1棚
鷺5∽Ⅲ2晨my脇
鵬
∽
"駕
ハⅢy階
∬鼎
“
釧
"Я
m4
¨
¨
80
顧而
RLA F‖ e
:01/82′ 050/01301/Aヽ415/
:07/24/040/00274/AM15/
| |:i:iili::ii::li[三
二妥
]遍爬晃
「晨
『毛厖
7E17EEl勇ここ
「晨Л
「59o42015 for comments of Dcpament Of
: [t was decided to defer the case for 29.04.2015 for comments of Department of
Ｆ
舞
308
'"" Decision : tn the light of written comments received from Department of AYUSH vide
communication no. T.l20l61212015-DCC (AYUSH) dated 23.03.2015, it was decided to request
the firm to provide at the earliest details ofthe herbal extracts used in formulation as required in
provide at the earliest details ofthe herbal extracts used in formulation as required in
& Cosmetics Rule 158 B for consideration offixation of norms. The case was deferred for
15042014
| 1顆
面デ
甲
酉
~1需
ド
amcHNDUSTkES ttα
W"~
器
耽5剛424/AMЫ M28ハ
剛y~囲
慨T而
面
″
: ln the light of written comments received from Depanment of Chemicals and
vide their U O No 15022/6/2010-Ch‖
dated 20 03 2015,it was decided to ratify
under Para 4.7 of HBP vl as per details Siven below or as applied by the firm, whichever
## Case No.:56/18/82‐
ALC4/2014
Lic No/Date:0710106972
13112014
降
淵
/15/82‐
附
柵
副
Ⅵ剛D LABS雁
ルr副
田2
1ALC4/2014
1 1
０
０
器3児5∽И
22Am y 彫扁話71/AMW 囲需°“幽""0開蕊蔦
|
1剰
酬
~~1財
面
が
Name:STERICON
IALC4/2014
ヽ
喘
鑑
Export prod uct
Exp
Qty
Sl No
lmport items
Qty. allowed
2-methyl- I -methylthio-2-
propanamine (SAA)
l kg
1
2-Amino-2-Methyl― l―
Propanol(AMP)
1 006 kg
2
TOLUENE
0 307 kg
## Case No.:107/18/82-
ALC4′ 2014
P鉗りName:PRECNA
INTERNAT10NAL LTD
澁
|
|
「Ю棚児
5∽`"¨
脇馳
OЮ“
aハm夕
14112014
N(ゾDate:0310791082
Decision r It was decided to defer the case for 29.04.2015 for comments of Department of
C&PC.
ALC42014
## Case No.:25/18/82-
ALC4/2014
~甲織評~
Re-indexed
浙
蔦瀞
~1鵬
馳OЮ““晨
m夕
1313f謎)littA5/82-
D-ecision :ln the light of written comments received from Petrochemical Division of Department
]of Chemicals and Petrochemicals vide their oM No. 140 t 0/6 41201l-cH-ll dated 25.03.2015, it
lwas decided to call from the firm the following technical details:
I
I i) Detailed_ manufacturing process along with balanced chemical reaction indicating number of
,^ ]moles ofall the reacrions, products and by-products with corresponding molecularlormulae,
rz lstructural formulae, molecular weight and process flow diagram.
lii) Stage-wise percentage yield with respeit ofeach of the;actants and products and the relevant
fiustificatior. enclosing therewith authentic printed technical literature in support ofyield or
quantity of items for impon.
]iii) Detail ofby-products formed during the process and their recovery in terms ofquantity and
]value.
1liv) Details of. production of export product under reference and corresponding consumption of
raw.material^in the year 2013-14 and 2014-15 (April to october) duly certifiei by CA may be
furnished. If the production has not commenced in the past, the detaiis f.om commencement of
lproduction may be fumished duly certified by CA.
i
lThe case was deferred for 29.04.2015
―
璃繭繭蕊T tt18/82~厩面需|
No/Date■8/82‐
悔静
騨醐
湯
ヘ
Ｆ
Ｉ
iHO Fu"
l:0ll82l0s0l0t349l AMt5t'1:09D4/0401004381 AMlSl
Partv Name:MYLAN
Meet No/Date:18/82‐
LABORATORIES LIMITED IALC4/2014
[b鵬
星掲50/Ol"αAmy l協
棚
ν00379ハm夕
18022015
Re-indexed
042015
Re-indexed
Re-indexed
: [t was decided to defer the case for 29.04.201 5 for comments of Department of
Meet No/Date:18/82-
LABORATORIES LIMITED
ALC4/2014
1171器疏
50Ю B8αAMⅣ I鷺λ鵬
OЮ0787AM「
~語
B需
面面万
B鮨ち9Ю42m5
18022015
Mcct No/Datc:18/82‐
ALC4/2014
18022015
18022015
Lic No/Date:0,10061248
17112014
IXl遷獅認
/15/82‐
1
Lic No/Date:0910061256
17112014
## Case No.:20/18/82-
ALC4′ 2014
Party Name:CROWN
CHEMICALS PVT LTD,
Meet No/Datel1 8/82‐
18022015
Party Name:CROWN
CHEMICALS PVT LTD,
Lic No/Date:0310791201
18112014
∴瀧胤尉避T°
No:8/15/82-
Name:NATCO
IMeet Noわate:18/82‐
Deffered
No.:59/15/82-
Re indexed
File RLA File
17112014
File
No.:41/1982‐
Name:MYLAN
No.:21/18/82‐
Re-indexed
Mcct No/Date:18/82‐
ALC4/2014
18022015
P鵬
3児5剛
"0ハ
m5戸
隔
蹴
0畑
“
2晨M15/階
∬辮
“
Ю
"0
: Case was considered as per agenda and it was decided to advise the firm to speciry
quantiけOf BP and uSP scparately Thc case is deferrcd for 29 04 2015
Meet No/Date:18/82-
ALC4/2014
Re-indexed
18022015
Lic No Date:0910061263
:01/82Ю50/01337/AM15/ 1:09/24/040/00448/AM15/ 118H2014
Meet NげDate:18/82-
ALC4/2014
18022015
## Case No.:110/18/82‐
Mect No′Date:18/82‐
ALC4/2014
ALC42014
Re-indexed
18022015
Re-indexed
Re-indexed
## Case No.:24/18/82-
ALC4/2014
―
|
## Case No:50/15/82-
ALC4/2014
Pary Nallte:SUVEN LIFE
SCIENCES LIMITED
P
## Case No.:23/18/82-
ALC4/2014
Party Name:LAKELAND
CHEMICALS(lNDIA)LTD
1323
|
「22 1鷺
念監υ。
“
97AM W厩
鱈
繭
面
B誰ち,“2m5
HQ Ⅲe ~~1鴨棚OЮ
"“
AM Ⅳ
Ю182Ю50/0`76/AM15/ Ю7/24/040Ю 0305/AM15/
: It was decided to defer the case for 29.04.2015 for comments of Department
Meet No/Datc:13/82‐
LABORATORIES LIMITED ALC42014
Re-indexed
18022015
Party Name:MEDREICH
LIMITED
## Case No.:52′ 15/82‐
ALC4/2014
F
## Case No.:5/15/82-
Party Name:PVS
84
Meet No/Date:18/82- 「
::illi;:i51:iii::i::i~|
Name:MYLAN
ALC4/2014
Re-indexed
Re-indexed
囲蕊ハ剛ヌ階ぶ鼎°酬∞
a"5
## Case No:28/18/82-
ALC4/2014
Party Name:ALKYL
Mect No/Date:18/82‐
AMINES CHEMICALS LTD ALC4ρ 014
## Case No:34/18′ 82-
ALC4′ 2014
1器疏50Ю И4靱
18022015
:lt was decided to call from the firm Details of production and consumption ofexport
in the year 2013-14 and 2014- lS(April-Dec) and corresponding consumption of the
materials duly certified by CA.
Re-indexed
飛蟄
厩黒蕉
1輛
霜
酬T~圏
孵
面
戸
甲
Paly Na“ oCLENMARK IMeetNo/Date:18/82- St31T:PeFFeぃ
s iALC4/2014
11802_2015
隔漱蕊高薦面
~11
瑕
―
閻
LiC INO′ υaI
‐21 112014
蘇躙罐甲
M夕
[ BttL9回5
11 卿理型興堅
## Case No.:94/18/82-
ALC4/2014
1328
Lic No/Date:0310791303
21 112014
## Case No.:75/18/82-
ALC4/2014
^
ICase No.:S9/18/82‐
.ALC4/2014
|¨
産
1織、
F
Re-indexed
: It was decided to defer the case for 29 04 2015 for comments of Department of
21112014
to defer the case for 29.04.2015 for comments of Department of
1胤9m狙5
: It 、vas dccided
1雇那夏面T
Lic NO′ 1)ate:3110065086
21 112014
Ψ
r卜,翌甲Pttca“On as per me dedsbn OfNonns cOmmhce
Meet No/Date:18/82‐
ALC4つo14
18022015
l10065085
1 112014
整
j農情報II瞳需
'呼
鳳壽蕎
s iess:
no. 8/82 dated 25.09.2014, it
per details given below or as
may take appropriate
「
## Case No.:93/t 8/82-
Import items
## Case No.:54/lE/82-
ALC4/2014
~簾
寝が
MPSE
86
No/Date:18/82‐
Status:Deffered
―鰈
NげDate:18/82-
File
l8/AMl5/ i:3t/83/M0/00t89tAMt5/
畷£認舞寵硼』鍵ξ
in meeting no. 8/82 dated 25.09.2014. it
{BP vl as per details given below or as
No.:52/18/82‐
:01/82/050/01459/AM15/
^
Namc:GULBRANDSEN
CHEMICALS PVT LTD
1艦鰍F
products and the relevant
in support of yield or
terms of quantity and
「| 1鶴皿器
136器3鷺50畑385ハMb/臨
|1需蕊罰齋高蒸面面高悪高
「 ~|
337
1躙児
5νm40ムmy「出儒蕊戸
Decision:In thc light Of writcn cOmments rcccivcd frOm Dcpartmcnt Of
Pctrochemicals vide thcir U O No 14010/64/2013-Ch II datcd 14 03 2015, it
rai″ norms under Para 4 7 of HBP v l as per dctails g市en below or as appl
whichcver is less:
Chemicals z
was decided
ed by the fir
Export Product
Qty
SI N
lmport Product
Quanity
STERO MEA(MONO ETHANOL
AMNE)
l kg
1
MONO ETHANOL
AMINE
1 10 kg
STERO MDEA (PIP) (Blends of
Piperazine and Methyl Di Ethanol
Amine)
l kg
MONO ETHANOL
AMINE
0 3630 kg
ETHYLENE OXIDE
0 2130 kg
PIPERAZINE 68%
0 5200 kg
STERO NC 300 (F) (Nonyl Phenyl
l kg
NONYL PHENOL
0 170 kg
,Decision :lt was decided to remind the firm to furnish the following information:
1. Detailed manufacturing process along with balanced chemical reactions indicating number of
moles of all the reactants, products and by-products with corresponding molecular formulae,
structural formulae, molecular weight and process flow diagram.
Stage-wise percentage yield with respect of each of the reactants and
justification enclosing therewith authentic printed technical literature
quantity of items for import.
Details of byproducts formed during the process and their recovery in
value.
4. Denials of production of export product under reference and corresponding consumption of raw
material in the year 2013-14 and 2014-15 (April to October) duly certified by CA may be
furnished duly certified by CA. lfthe production has not commenced in the past the details from
commencement of production may be furnished duly certified by CA.Any other relevant
information.
5. Any other relevant information, if any
The case was deferred for 29.04.2015.
Mcct No/Datc:18/82-
ALC4/2014
18022015
Re-indered
042015
87
Status:Approv€d
魃
⌒
Poly Glycol Ether)
2
ETHYLENE OXIDE
0 850 kg
STERO 1202 CIA (Lauryl Alcohol
Ethoxylate/Lauryl Alcohol 1.5 mole
l kg
1
LAURYL ALCOHOL
0 761l kg
Ethoxylated)
2
ETHYLENE OXIDE
0 2589 kg
STEROL 120G(BG)(Faty Aicohoi
Poly Glycol Ether/Lauヮl Alcoho1 4 5
molc Ethovlated)
l kg
1
LAURYL ALCOHOL
0 261l kg
2
ETHYLENE OXIDE
0 7589 kg
STERO C0 360(A)(
Polyoxycthylene THglyceridc
Ricinoleic Acid/THglyccridc
Ricinoleic Acid 36 molc Ethoxylate)
l kg
1
ETHYLENE OXIDE
0 7252 kg
STEROCARE SMS (Sorbitan Mono
Stearate)
l kg
1
STEARIC ACID
0 6738 kg
2
SORBITOL 70%
0 6167 kg
## Case No.:74/18/82-
ALC4/2014
Partv Name:ADFlSl-l WA R
MEDITEX PVT LTD
Mcet No/Datc:18/82-
ALC4/2014
18022015
Re-indexed
Re-indexed
Re-indexed
| ~明
10791翼0
I It was decided to defer the case for 29.04.2015 for comments of Department of
Pharmaceuticals.
ヽ
爾
腑
17‐
躙鰈
器M障蒻・か1編
|
「"
陽λ糀
OЮ“Иハmy圏鼎°
"Ю
791373
Decision : lt was decided to defer the case for 29.04.2015 for comments of Department of
Pharmaceuticals.
「
1339
Partv Name:ANTHEA
AROMATICS PVT LTD,
## Case No.:18/18′ 82-
ALC4/2014
Lic No/Date:0310791374
:01/82/050/01384/AM15/
:03/94040/00792 AM 15/
## Case No.:32718782-
ALC4ノ2014
PHARMACEUTICALS
INTERNAT10NAL PVT
:01/82/050/01398/AM15/
88
No/Date:18/82‐
「
~~~|
FLI雨,~~―
‐
― 一ll面22015
:03/94/040/00739/AM15/ 25H2014
1囮
五扁
## Case No.:53/18/82-
IALC4/2014
I
1憮聯輛τ潔囮輛―
悧下
:W響畳世型
Status: Deffered
and Re-indexed
: lt was decided to defer the case for 29-04.2015 for comments of Department of
「頸「
甲雫面1鰈耐~「蕗
~
属戸[翻需繭而FDate~
y淵lよl:艦T棚1猟‰
『
踏亀
T;
i whicheveris lower―
Export product
ExpOrt
Otv
SI No
lmport items
ot)/.
allowed
Compresso GEM 70
(Gemlbroz‖
Granules
DC 70%)
l Kg
Gemibro2‖ _
0 707 kg
2
Maize Starch
0 1485 kq
3
Povidone K-30
0 0270 kg
4
Sodium Starch Glyco‖ ate
0 030 kq
5
Sodium Lauryl SulPhate
0 00150 kg
6
Starch Preqelatinised
0 083 kg
7
Stearic Acid
0 0100 kg
concerned may take further necessary action as per above decisiOn of NC
冊罐
Re-indexed
レ
三
囮
5
1 鱚
fiflllll
for commcntS OfI〕epartment of
⌒
薦蔦蔦
~匿
ざ器
C"Ю期63躊
恐
Lic No/Datc:3110065095
1器3児5αO`り晨
Ml夕
125112014
Case N`:31/13/82‐ ~~~~~~
Party Name:GLENMARK
Mect No/Date:18/82‐
ALC4/2014
GENERICs LIMITED
ALC4/2014
18022015
Re-indexed
:It was decded o dctrthe casc fOr 29 04 2015 fOr comments~ ~===
,Omments OfDepa口Lnent of
lticals
Party Name:RANBAXy
Meet No/Date■8/82_
LABoRAToRIES LTD
ALC42o14
Re-indexed
Case No.:,13/18/82-
ALC″2o14
Meet No/Date; I8/8i-
ALC42014
Re-indexed
: It was decided to a"f". rf,
Re-indexed
## Case No.:I6115/82-
Pa●y Name:RA｀ёス文ヤ
Meet No/Date:18/82_
ALC4/2014
LABORATORIES LTD
ALC42o14
Re-indexed
: It was dccldcd tO defcr the casc for 2以042015 fOrcomments Ol言言::llilill:F
ticals
ililISdecttedt。こ
[屁1l131:ξ『五
I二]ヌ:'こ巧電Filiil:iii罵罵五
「5F三罷扁
:III鼻::11坐
構
0
1 1
認∬
S dCdded o defer]硫薇扇面嵩話薫瀧薦覇面」二繕
1みI
)Omments OfDeparment Of
## Case NO:39/18/82_
ALC4/2014
## Case No.:t5/tS/82-
ALC4/2014
Party Name:yASHO
INDUsTRIES PvT LTD
## Case No.:lo3/18/82-
ALC4/2014
18022015
Party Name:sient,n tc
AUxlLIARIES PvT LTD
18022015
Re-indexed
⌒
|
「8圃
18022015
Name:ALEMBIC
No/Date: I8/82_
90
## Case No.:11/15/82‐
ALC4/2014
⌒
C&PC
1麗頸冨]::~
Rc-indexed
匿面361e2910025174
,7112014
042015
甲瀑可席"
一
: lt was decided to remind the firm to furnish the following information:
1. Detailed manufacturing process along with balanced chemical reactions indicating number of
moles of all the reactants, products and by-products with corresponding molecular formulae,
structural formulae, molecular weight and process flow diagram.
2. Stage-wise percentage yield with respect of each of the reactants and products and the relevant
justification enclosing therewith authentic printed technical literature in support of yield or
quantity of items for import.
3. Details of byproducts =s formed during the process and their recovery in terms of quantity and
value.
4. Details of production of export product under reference and corresponding consumption of raw
material in the year 2OL3-L4 and 2074-15 (April to October) duly certified by cA may be
furnished duly certified by CA. lf the prod uction has not commenced in the past the details from
commencement of production may be furnished duly certified by CA. Any other relevant
information.
5. Any other relevant information, if any
case was deferred for 29.04.2015.
"4鵬3‰
畑毬0/AM Ⅳ
区囮
薦
ソAtty l
蹴
ち)“洲
5
RLA File
:29/24/040/00008/AM15/
Re-indexed
042015
Re-indered
「ぽ
Party Name:SADHANA
Meet No/Datc:18/82‐
NITRO CHEM LIMiTED
ALC42014
i18022015
靱
:舗
卿
網
]Iie
Meet No/Date:18/82‐
## Case No:64/18/82-
ALC4/20:4
Lic No/Date:3410040733
## Case No.:114/18/82-
ALC4/2014
LA30RATORIES LTD,
RLA Fne
:03ノ95/040/00714/AM15/
042015
356 Case No.:92i 18/82-
Party Name:TATVA
Meet No,/Date:18/82- Status:Deffered
ｎ
フ
18022015
吻
Re-indexed
12014
CHINTAN PHARMA CHEM ALC4IaOI4
18022015
Re-indexed
Decision : It was decided to defer the case for 29.04.201 5 for commenrs of Departmenr of
C&PC.
:蹴賛霊U柵:~開
1鷺ユ鷺く
n7n12n“ hrl″ 隔会理
'ハ
……▲…“
~PCパ
殴彎。
No.:22/15/82-
1/2014
€:18/82- Status:Deff€red
and Re-indered
---'--.
0410159798 lDefer
iDate:2g.04.2015
ent of Pharmaceuticals vide
vas decided to ratiry norms
the firm, whichever is less:
「υ
"′
AIVII D′ lυ l lZ Zυ 14
lion :ln the light of written comments received from Departm
OM No. 3501I/410/2014-PI(Norms) dated January 2014, it I
## Para 4.7 of HBP v I as per details given below or as applied by
Export product
Exp. Qty.
SI No
lmport items
Qty
PAROXETNE TABLETS
20 MG
l kg
1
PAROXETINE
HYDROCHLORIDE
22 20 mg/20 mg
Tablet
PAROXETINE TABLETS
30 MG
l kg
1
PAROXETINE
HYDROCHLORIDE
33 30 mg/30 mg
Tablet
PAROXETNE TABLETS
40 MC
l kg
1
PAROXETINE
HYDROCHLORIDE
44 40 mg/40 mg
Tablet
concerned may take further necessary actiOn as per above decision of NC
## Case No:89/18/82-
ALC4/2014
Pa■y Namc:BALAJl
AMINES LIMITED ―圃
1器疏5∽И55ハm夕 1瑞
角監
∽O191AM“ /~け
らり貯
3‖ 0065H6
Meet No/Date:18/82-
ALC42014
18022015
:lt was decided to defer the case for 29.04.2015 for comments of Department of
Meet NげDatel1 8/82-
ALC4/2014
18022015
duly certified by CA.
was decided to defer the case for 29.04.201 5 for comments of Department of C&pC.
Re-indexed
cision :lt was decided to call from the firm details ofproduction of N-Ethyl-2-pyrrolidone in
year 2013-14 and 2014-15 (April-September) and corresponding consumption of raw-
「「謎胤留
/18/82‐ ~~「
1358
## Case No.:90/18/82-
ALC4/2014
Pa●y NamelBALAJI
AMINES LIMITED
騰れ蕊ュ爪諦澳
lⅢ
Re-indexed
F‖ e
92
囲鼎α国
"釧°91蹴ち
%“2m5
I It was decided to defer the case for 29.04.2015 for comments of Department of
## Case No.:60/18/82-
ALC4/2014
ParサName:DHANUKA
Meet No′つate:18/82‐
LABORATORIES LTD
ALC4'014
Party Name:CORAL
Meet No′つatc:18/82‐
LABORATORIES LTD,
ALC4つ014
18022015
: It was decided to defer the case for 29 .04 .201 5 for comments of Department of
Re-indexed
Re-indexed
18022015
No.:68/18/82-
Meet No/Date:18/82‐
14
ALC42014
Filc
:01/82/050/O1434/AM15/
'い
キョ.・l:、′N[RMへL KuNlAR
協
鵬3鷺50Ю И%/AMW
膿ち北
ν∞"7AM剛
肝ら開
。いЮ
"",日窮ち9脳2∝5
362
畔
∬
面
圏
夢
篇
~躍
ぽ
正
甲
蘇
器3児50/O140″ Att y障
念馳
。Ю
“"晨m夕
階ら開
°ω Ю劉°5 PettDttα
Decision:ln the‖ ght of wntten cOmments received from Department of Chemicals and
petrochemica:s vide the「
uO No.14010/4/2015-Ch ‖dated 20.032015,it was decided to
ratify norms under Para 4 7 of H8P vl as per deta‖s given below or as applied by the nrm,
whicheveris less:
Export product
Export
Quantity
S No
Import items
Quantity
Allowed
WiCK CHAFING FUEL(DI
ETHYLENE CLYCOL)PACKED
ALUMNlUM CANS
l kg
1
DIETHYLENE CLYCOL
Nct+2%
Wastagc
2
FIBRE CLASS
STRNC1/ROPE
Net+2%
Wastage
3
ALMINIUM FOIυSHEETS
As per packing
Policy
## Case No.:15/18/82-
ALC4/2014
Lic No Date:0310791656
03122014
Party Name:CROWN
CHEMICALS PVT LTD,
93
18022015
Re-indexed
lt was decided to deferthe case for 29 04 2015 for comments of Dcpartment of
## case No.:87/18782-
ALC4/2014
Re-indexed
042015
じision:Commitee conddcred case as pCr agcnda and h‖ght ofWitten comments fOpardcd
Department of C&PC Vide their U O No 14010/64/2013/Ch H dated 29 03 2015 and in
, , , _^:▲
_^_^
・―
“^__^__
И 7
with tcchnical authori″ presCnt in meeting, dccidcd to rati″ nomlS under para 4 7
HBP as per details below or as applied by firm whichever is lower:-
concerned may take further necessary action as per above decision of NC'
Lic No′ 1)ate:0310791744
05122014
No/Date:18/82-
P額りNamc:STERLING
Meet No7Date:18/82‐
AUXILIARIES PVT LTD
STEROCARE TN 20 (Polyoxyethylen.
Sorbitan Mono taurate)
STERO BPA 083363(PolッmCr of
Bchcn,ac,latC and Es∞rcnc)
STERO PE 040(Phcn01 Ethoxylatcs)
Eth●●latcDCcyl Alcoh01 6 molcs
EいoO!atcd)
03160k9
Ethoxylatelso decanol Elhoxylat€,/D€cyl
alcohol I moles Elhoxylated)
STEROICARE TN 60(Sorbilall Mono
Stcaratc Edloxylatc)
Party Name:MOREPEN
LABORATORIES LTD,
94
18022015
⌒
: It was decided to defer the case for 29 -04-2015 for comments of Department of
:Committee considered the case as per agenda and in light of written comments
3 5 0 I 1 I 183 /20 | 4 -PI(Norms)
from Department of Pharmaceuticals vide their OM No.
Re-indexed
l2.l I .2014 and in
norms under para
consultation with technical authority present in meeting, decided to
4.7 of HBP as per details below or as applied by firm whichever is
Export product
Exp
Qty
SI No
lmport items
Qty
AIlowed
Kqノkg
Rosuvastatin Calcium
lkg
1
Tert-butyl-2-((4R,6S)-6-(E)-2-(4 (-
(4-fl uorophenyl)-6-isopropyl-2- [N-
methyl (methylsulphonyl) aminol
pyrimidin-5-yl) vinyl)-2,2-dimethyl-
1,3-dioxane-4-yl) acetate
1425
2
Methanol
253
3
Tc■―buけI mcthyl cthcr(MTBE)
079
concerned may take further necessary action as per above decision of NC.
## Case No.:82/18/82- Pan
70 ALC4/2014 PHA
I LTD
剛薦I葛罵」
~瑶
競3:語話
lJ百
~程
謎獅WBお多
|
LTD
No:63/13/82-
No′1)ate:18/82-
18022015
No■32′ 15/82-
Namc:AMNES&
NυDate:18/82-
出
Ｔ
Ｄ
¨
¨
Ｎ
ａ
ｍ
ｅ
ｍ
3691HQ File
Name:JACSONPAL
No/Datc:18/82-
18022015
IRLA Fi:e
l:0523/040Ю 0350/AM 15/
Name:ABEERS
No/Datc:18/82-
18022015
Ｅ
Ｊ
Ｏ
フ
PVT
18022015
Decision:In the‖ ght ofwritcn cOmments receivcd from Dcpartment OfAYUSH宙
de thcir
communication no.T.120161212015-DCC(AYUSH) dated 23.03.2015, it was decided to request
the firm to provide at the earliest details ofthe herbal extracts used in formulation as required in
Drug & Cosmetics Rule 158 B for consideration offixation of norms. The case was deferred for
15.04.20t4.
Pharmaceuticals.
Pharmaceuticals.
ParりName:PAYAL
PETROCHEM PRIVATE
LIMITED
:52/24ノ040/00049/AMi5/
Status:Deffered
and Re-indexed
「 ~
[7棚
児Ю 畑
“
3ハm夕
陽
ち棚
∽0“ vAmyけ
ら鼎
“
m m03261
Deffered
Re-indexed
Mcct No/Datel1 8/82‐
鵬島児
50ЮИ
%晨my l賜鵬∽∞
77/Amy 階ら鼎・"Ю∝Я
“
F
## Case No.:57/18/82‐
ALC4/2014
ALC4/2014
118022015
1372 :01/82/050/01423/AM15/
## Case No:109/18/82-
ALC4/2014
Party Name:ARl HANTANAM
LIFECARE PVT LTD
Lic No/Date:5210041348
11 122014
sion : In the light of written comments received from Department of Pharmaceuticals vide
OM No. 3501 l/212l2014-Pl(Norms) dated October 2014, it was decided to ratiry the norms
tP a4.7 of HBPvI as per details given below oras applied bythe firm, whichever is less:
Export product
Exp
Qtv
SLNo
lmport items
Qty. allowed (kg)
Lumefantrine
l kg
1
(Dibutviaminc McthyI)2,7‐
Dichloro 4‐ Fluorcn Mcthanol
(DBA)
0 8691 kg
Re-indexed
No/Date:18/82-
IHQ File
:O1/82/050/01475/AM15/
⌒
「に謎淵
9/18/82
鯰
鷹
~躇
戟鷲声"
|「 ~~ 「
~‐ ~~~― 一― F■:猫I
「Ъ田艦蔦扁~
階ら鼎Cm"鯰44
## Case No.:102/18/82‐
ALC4′ 2014
Pary Name:ALEMBIC IMeet No Datc:18/82-
PHARMACEUTICALS LTD ALC4/2014
18022015
Re-indexed
Status:Deffered
and Re-irdexed
Deffered
Re-indexed
176器
島児50/OИ6νAMlシ
既璃
蕊
蔦
い
Noわ
“
34Ю040787
116122014
: It was decided to defer the case for 29.04.2015 for comments of Departm€nt of
C:INo●116′18/8r~~ 而蔦蔽3面面戸~~IMeoNげ
D“α18/82‐
「「謎淵
8118/82‐
~甲ポ前
IHEALTHCARE LTD,
18022015
一
９
ｒ
ｌ
ｌ
‐
―
―
―
１
３
７
Ｆ
‐
: lt was decided to defer the case for 29.04.2015 for comments ofDepartment
## Case No.:106/18782‐
ALC4/2014
囲蕊蕊戸囲悩4晨M“/「M両面
B誰ち
)餌2015
Pharmaceuticals.
97
Status: Deffered
and Re-indexed
Name::NDO PHYTO
No/Date:18/82‐
Re-indexed
Pary Name:PANACEA
BIOTEC LTD,
⌒
HQ File
Meet No/Date:18/82‐
ALC42014
Re-indexed
18022015
Re-indexed
Lic No Date:2910025185
:01/82/050/01368/AM15/ :29′
24/040/00009/AM15/ ■7 122014
No/Date:18/82‐
Re-indexed
18022015
Pany
Meet No/Date:18/82‐
Name:METROPOLITAN ALC4/2014
Re-indexed
EXIMCHEM LTD
18022015
Partv Name:NEW
Mcct No/Datcl18/82-
ALLIANCE DYE― CHEM IALC42014
Re-indexed
PVT LTD,
18022015
Pa●y NameJUBILANT LIFE IMeet No Date:18/82‐
SCIENCES LIMITED IALC4/2014
18022015
: It was decided to defer the case for 29.04_201 5 for comments of Department of
「84鵬
3児50畑454/AMW ttλ
乳
OЮ0776ハmy BL9Ю
42創5
[%
彫脇蕊AⅢy l需鰊;甲1蘊
Lic No/Date:3410040803
:34′24/040/00245/AM15/
17122014
1382
## Case No:88/18/82-
ALC4/2014
## Case No.:69/18/82-
ALC4/2014
## Case No.:108/18/82-
A LC4/2014
Pharmaceuticals.
98
No:104/18/82-
1器3鬼50/O И
7υAMly
NamciSHREE
REMEDlES
LTD
File
No.:2718/82‐ ALC4/2014
No.:1/15/82-
Name:AUCTUS
LIMITED
隔
∽囲8ハm夕
鵬3鷺
"Ю
И,AⅣ戸
障ら馳
OЮO“
"Am夕
匿ら開
°
"Ю
792132
&ALLIED
「
甲
辟
西
~甲
了
面
耐
1
叩
|
「"鵬
3児50/O128"Am夕 1脇
鵬
∽
“ “
AM15/
け
ら鼎
C酬∞a“ 3B章
ち9Ю4劉5
eferthe casc for 29 04 2015 for commcnts of Dcparmcnt Of
Ｆ
Ｉ
Ｉ
1388
## Case No:117/18/82-
ALC4/2014
Party Namc:OTSUKA Meet No/Date:18/82‐
CHEMICAL(INDIA) ALC4/2014
1器島児
50/O1483AMlシ
decided to ratify norms
firm, whichever is lower:
Item of Export
Ouantity
S No
Item of lmport
Quanuty
AIlowed kg′kg
7-Phenylacetamideo-3-
Chlo「omethyl
Cephalosporanic Acid
Para Methoxybenzyl
Ester (GCLE)
lrvh‖ e′Light Yellow
Powder
l kg
1
Penicillin G Potassium
l"rCrystals
285
う
４
Methanol
200
3
Dimethyl Formamide
386
4
Methylene Chlonde
209
5
2-Mercaptobenzothiazole
0511
6
lsopropyl Alcohol
125
「厩w5/82‐
|
| |
1器3月50Ю 290ハMl夕
Decision : ln the light of earlier decision taken by Nc in its 10/82 meeting dated 12.11.2014, it was
decided to ratifo norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,
whichever is less:
Item of Export
Qty
S,No
Item of lm port
Quantity allowed kB,/kg
Cefuroxime Sodium
Sterile
l kg
Cefuroxime acid
1 056
2
Acetone
3437
3
Methanol
036
4
Activated carbon
0060
Ｅ
Ｊ
Aluminium Canisters
Relevant, As per packing
policy.
390 Case No.:105/18/82-
Party Name:KLJ
99
Meet No Date:18/82‐
…
MI
IALC4/2014
|
ALC4つ014
18022015
Re-indexed
1器3鬼50畑4ηハⅢヌ浙
6/AMⅣ
18022015
Mcct No/Date:18/82‐
ALC4/2014
Decision: It was decided to defer the case for 29-04.2015 for comments of Department of
Pharmaceuticals.
Re-indexed
:29042015
Re-indexed
Re-indexed
## Case No.:101/18/82-
ALC4/2014
## Case No:91/18/82-
ALC4/2014
Party Name:ALCHEM
INTERNAT10NAL LTD
Meet No7 Date:18/82‐
ALC472014
18022015
: It was decided to call from the firm to furnish following technical details:
Actual content of Digoxin in imported digitalis Lanata Leares supported by COA from
foreigner supporter
Assay of Export Product
Past production vis-a-vis Actual consumption of leaves for the last 3years duly
certified by Central Excise Aurhorities.
鵬3児5∽И
57ハⅢ夕
~隔
霜蕊面蔦ア
~[需
蕊雨面而
case is dcferred fOr 29 04 2015
ヽ
リ
ハ
‘
ｎ
Namc:HETERO LABS
No/Date:18/82-
18022015
:It was dccided to dcferthe case for 29 04 2015 for comments of Department Of
Meet No7Date:18/82‐
Status:Deffered
ALC4/2014
and Re-indexed
18022015
:It was decided to dcferthe case for 29 04 2015 for comments of Dcpaltmcnt of
No.:26/1_R/82‐
14
## Case No.:27/15/82-
ALC4/2014
Pttw Name:HETERO LABS
LIMITED
|IIil::i〕|||li:Fここ
:18/82‐
100
## Case No.:99/18/82-
395 ALC4/2014
395 ALC4,
厩縣蔦五訂~開
蕊蒜蔦
「
~Lse No■
117万ν82-~~~~FttNamcG10BAL
I冷
Lα″m4
脇wttVA‐
Ｆ
Ｉ
甲酉y順謝r溜泌
Ｆ
Ｉ
Ｐ
Meet No′ Date:18/82-
ALC4/2014
Re-indexed
18022015
3 It was decided to defer the case for 29.04.2015 for comments of Department of
Re-indexed
3 It was decided to send a copy of application to Department of Biotechnolory. The
is defcrred for 29 04 2015
Re-indexed
## Case No.:112/18/82-
Partv Name:MOREPEN
Mcet No/Date:18/82‐
ALC4/2014
LABORATORIES LTD,
ALC4/2014
Re-indexed
18022015
042015
Lic No/Datc:0710107307
30122014
ILic NげDate:0710107306
30122014
Lic No/Date:0810134170
30122014
## Case No:86/18/82-
Lic No/Date:0510392619
## Case No:95/18/82-
隔
脇
50Ю ИO/AM Ы
肝ち鵬
OЮω
"ハ
m"
101/82/050/01461/AM15/
:ln the light of earlier decision taken by NC in its 3/82 meeting date
05.2014, it was decided to ratify norms under Para 4.7 of HBP vl as per details given
Iow or as applied by the firm, whichever is less:
101
―
∃
Namc:MOREPEN
TORIES LTD,
No/Datc:18/82‐
ApproYed
Export Product
０
ｐ
Ｖ
Ｅ
ｘ
Ｑ
ｔ
SI No
lmport items
Qty. allowed
堺尉
1トリ■T
Clomipramine Hcl
l Kg
1
1 Bromo 3 Chloro Propane
0 85 kg
3 Chloro lminodibenzyl
0 91 kg
401 HQ File
:01/82/050/01451/Aヽ415/
「開け珊顆薦濶… 鱚
RLA F‖ c
Lic No/Date:0510392654
105/24/040/00412/AM15/ 101012015
Party Name:DR REDDYS
Meet No/Date:18/82‐
LABORATORIES LIMITED
~PttNmcDⅥS ttedNo/Daolν 82‐
「
ABORATONES LTEl,
Re-indexed
Re-indexed
## Case No.:28/15/82-
ALC4/2014
ALC4/2014
18022015
1402
## Case No:48/18/82‐
ALC4/2014
ALC4ノ2014
臨
m44晨my
Lic NげDate10910061492
Party Name:HONOUR LAB
Meet No/Datel1 8/82-
LIMITED
ALC4/2014
Re-indexed
18022015
Re-indexed
IDefer ~~
## Case No.:29/15/82-
ALC4/2014
[“ 棚児
5¨ 6ムmy陽ち鵬∽“
`ハ醐
Lic No/Date:0910061501
Ю9/24040/00543/AM15/ Ю7012015
RLA Fne
Lic No Datc:0410159987
:011821050/0l445lAMl5/ ):04/24/040/00255/AMl5/ 07.01.2015
ALC42014
102
5
Name:NUTRA
No/Datc:18/82-
PVT LTD,
No:79/18/82-
^ I Wtstosuot46r/^Mts/ Win4lo4uur4a^Mw -Ft.ot20l5
ltate.2ro420l5 |
l@."r.'
l
「
1珈脩
Mect No/Datc:18/82‐
||
ALC4/2014
18022015
'07い
,牧.…… … 1聖全11,
Lic No/Date:0910061507
:01/82/050/01320/AM15/
:09′24/040/00568/AM 15/
042015
Pharmaceuticals.
## Case No.:33/15/82-
ALC4/2014
Status:Deffered
and Re-indexed
F∝1瓢
Decision : It was decided to defer the case for 29.04.2015 for comments of Department of
Biotechnology.
## Case No.:34/15/82_
ALC4/2014
「
ヽlect No/Date:18/82‐
18022015
Status:Deffered
and Re-indexed
Pary Name:JODAS EXPOIM
PVT LTD,
F"
:52/24/040/00055/AM15/
:ln the li8ht of written comments received from Department of Chemicals and
petrochemicals vide their U O No 14010/3/2015-Ch ‖ dated 16 03 2015′ it was decided to
norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,
is less:
Export product
Exp Qty
SI No
lmport items
Qty. allowed
2-Chloro-4-(4-Chloro
Phenoxy) Acetophenone
l kg
1
Para Chloro Phenol
0 9670 kg
Meta Dichloro
Benzene
1 3500 kg
3
Dimethyl Sulfoxide
0 8000 kg
|
:01/82/050/01371/AM15/
Re-indexed
SURFACTANTS(P)LTD,
‐Mect No/Datel1 8/82‐
ALC4/2014
Status:Deffered
and Re-indexed
「 ~ll&022015
~ Lic No/Datc:5810134344
:08/24/040/00371/AM15/
Re-indexed
P3鵬
島児50畑4フAM Ы
鵬蹴
OЮ∞
“
/AMI夕 1獅
鼎
α°4101“
“
8B誰
ち9Ю4矧5
: lt was decided to defer the case for 29.04-2015 for comments of Department of
1濶…
鵬3月50Ю B"/AM Ⅳ
陽危鵬
OЮ。58ムmy
Re-indexed
P征″Name:AUROBINDO
PHARMA LIMITED
)n:ln the light of earlier decision taken by NC in its 7/82 meeting dated l1 09 2014′
lt was
to raJfy norms under Para 4 7 of HBP vl as per deta‖ s given below or as applied by the lrm′
er is less:
Item of Export
Quantity
S′No
Item of lmport
ｇ
′
′
ｇ
ｔ
ｉ
ｔ
ｙ
ｅ
ｄ
ｋ
ｕ
ａ
ｎ
Ш
Ｑ
ａｌ
PIPERACILLIN AND
TAZOBACTAM 8:1
STERILE
l kg
1
6-Amino Pcnicillanic Acid
(6-APA)
0455
2
4-Ethyl-2, 3 Dioxo
Piperazine
03323
3
Carbon Enoanticromos
(Activated Carbon)
0050
4
D(―)Alpha PhcnyI Glycinc
Base(PG BASE)
0359
5
Ethyl Acetoacetate
0346
6
Isopropyl Alcohol
04015
7
Methylene Chloride
2835
8
Pivalovl Chloride
0251
9
Potassium Carbonate
0164
10
Tazobactam acid
0112
11
Trimethvl chlorosilane
0.3069'
:01/827050/01375/AM15/
104
No.:47/18/82‐
ヘ
ITMCS)
Triphosgene
0281
13
Aluminium Canisters
As per packing
policy
Pa●y Name:HONOUR LAB
LIMITED
Mect No/Datel1 8/82‐
ALC4/2014
18022015
Re-indexed
:It was decidcd to dcfcrthc casc fOr 29 04 2015 for commcnts of Dcpaltmcnt of
| 1欄
ド鵬
2
Re-indexed
に話面而蔽面飛而面σ阪高=~~~
:It was dccided tO dcfcrthe case for 29 04 2015 for comments ofDcpartincnt of
Ｆ
‐
‐
４
‐
９
‐
霊柵
叫
~胃
戸
蔽
町
鮮
…
零
鱚
~~涵ハΠL 匠繭満繭σttls
И15/ :09/24/040/00605/AM15/ ■o o2 2015
HQ F‖ e
:01/82/050/01379/AM15/ :09/24/040/00605/AM15/ ■o o2 2015
~ ~ ― V VV‐ ν´′、
`●●
`´ ′ “o υZ 4Vlυ υdtじ:ιソυ
`
I)ecis10n:It was dccidcd tO dcfcrthc casc fOr 29 04 2015 for comments of Dcpartmcnt of
lPharmaccuticals
:0924/040/00604/AM15/
418
:01/82/050/01378/AM15/
田□
|
「冨~ド絆
P51鵬児
5υ釧釘
2ムmy膨淵∽“
%ん
||:誡il∫
d∝ded Ю
det“he¨cb
No.■0/18/82‐
File
105
PRIVATE LIMITED
Ｆ
Ｉ
[21日3児50Ю И
87/AMU~
: lt was decided to defer the case for 29.04.201 5 for comments of Department of
18022015
19既瑞高薦而
~障
倉鵬
OЮm2/AMW 目¶猾∫Ю釧
07"7“躊ち
9劇2m5
HQ File
Decision : It was decided to defer the case for 29.04.2015 for comments ofDepartment of
Pharmaceuticals.
^
霊脚劉冊~甲瀬謳百1爾
『
・群レ
胃
「
田頭面蔦菰薦
「~厩蕊蕊蕊蔦戸
~囲蒻戸
910061626PettDac
l濡蕊咄廃 1画面需面藷需濡
under Para 4 7 of HBP vl as per detaiヒ
g市en below or as apphed by the nrm,whicheveris less:
Export product
Exp
Qty
SI No
lmport items
Qty. allowed
kglkg
(Z)-2-(2,3-
DICHLOROPHENYL)-2-
LIQUID
(GUANIDNOIMNO)
ACETONITNLE
l kg
AMINO GUANIDINE BI
CARBONATE
106
2
2,3-DICHLORO BENZOYL
CYANIDE
123
may take appropriate actiorJ as per the decision of Norms Committee.
つ
ｚ
つ
た
′
や
Date:18022015
Placc:Nc、v Dclhi
actio( as per the decision of Norms Commi
I&
NirmaiKumar
Dy. Director General of Foreign Trade
106
Name:HETERO LABS
No Datei18/82-
IRLA File iしic No/Date:0910061606
Ю9/2477040/00645/AM15ノ 112022015Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.
No analysis has been generated for this document yet.