DGFT Committee Minutes

-1 ofrlce of Directorate Ceneral of Foreign Trade New Delhi‐ 0

Para 4.7 Decision(DRAFT)

MEETINC NUMBER :3/82-ALC4/2015 MEETING DATE:20052015 Meeting No. 0318212015 of 2015-16, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, was scheduled for 20.05.2015 but actually held on 18.06.2015 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.11, Udyog Bhawan, New Delhi- Following members were present:- Shri A.K. Agarwal, Dy. lnd. Adviser, Oepartment of C&PC Shri O.P. Sharma, Joint lndustrial Adviser, Department of C&PC 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. 02182 was scheduled lor 29.04.2015 but actually held on 21.05.2015 and approved the same. The following cases/issues were discussed and the committee took the decision as mentioned against each case. lhP薦

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Decision : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals).
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: it was decided to defer the case fOr want Of cOmments Of DeDartmen,。 f :忙was decided tO deferthe case for w:F73「comments Of D/oc&PC{Petro Chemttab) : !t was decided tO defer the case for want Of cOmments of Department Of ticals. 腑1%2~甲濡臨面1頸"w NO:29/19/82_ Name:AUCTus LIMITED No/Date:3/82‐ Re-indexed No.:38/19/82- Namc:PoRUS No/Date:3/82‐ Re-indexed Pharmaceutlcal has ln■mated that thei'are not able to locate a cOpy of the Date t3t lzt .os.zotz 'IR / NIFTMAL KUMAR l':, F f{tqr arrqri , ,,'., ot For€iCn Trad6 .rErRYIr€fq or Foreign Trads Decision:The D/o -2″

They requested for a copy of the application. tt was decided to forward a full list of pertaining to the said department, if found not traceable would be sent again. iCase No.:33/19/32- lALC4/2014 | iALC4t2ots 120.0s.201s Pa●NalnaViVIMED LABS Meet No/Date:3/82‐
卜tatuSAppЮ ved LIMITED : The committee decided to ratify the norms based of Chemical & Petrochemicals vide U.O.No. on the recommendation of 14010/138/2011‐ CH II Dated lever is less:― ~轟 馬面画面 「 IALC4/2014 「 1
面 : The committee decided to ratify the norms based on the recommendation of Department of Chemical & petrochemicals 宙de UONo 14010/138/2011‐ CH‐ 11 Dated 27.05.2015 as per detail given below or as a the firm which ever is less:- RA may take further action accordingly. Meet No/Date:3/82- 鵬 島児50Ю =蕊 y~膨 鵬 OЮ∞ヮAmy l冥 盤 e091∞ "%9 15 as per detail Riven below or as aDplied bv the firm whichever is Export Product lmport items Qty Hydroxy Methyl Methyl Phenldone (HPM lkg Dimethylol propionic Acid (DMPA) 1 203kg Phenyl Hydrazine (PH) 0 928kg Methanol 0 41lkg To lue ne 0 928kg Amberlyst (Resin) 0 171kg 鵬3児50Ю b郎ムm夕 陽蹴 oЮ∞9″AM W 圏 盤 ° "Ю 6ν “ 「 Reversacol Midnight Grey 4-Methyl aminO benzaldehyde (4-N′ N― Dimethyl aminO ― コー IALC4/2015 120052015 Name:ViVIMED LABS Export Product lmport items Qty lkg 1 600kg Dimethyl succinate 2 400kg Methanol 23 875kg Toluene 8 800kg 4-Fluoro benzophenone 1 500kg Trimethv:s‖ vl Acetate 1 500kg Piperidine 1 948kg Phenyl Boronic Acid 1 000kg

衛 す Oy ( Di. 前 嗜 U、 Lic No/Date:0910052816 29052012 : lt was decided to defer the case for want of comments of Department of Pharmaceutica ls.

Case No:27/19/82-

ALC4/2014 ALC42015 Party Name:HETERO LABS Meet NoノDatc:3/82‐ LIMITED Re-indexed 20052015 Date 072015 ls 1419島胤 :;:再j:IIi:; Pharmaceutica ls. 鶴危鵬OЮ∞ 89晨MB Mect No/Date:3/82‐ ALC472015 Re-indexed 20052015 Date 072015 Pha rmaceutica ls. Pha rmaceutica ls. Meet No/Date:3/82‐ ALC42015 Re-indexed 20052015 Pa●y Name:BIO‐ TECH Meet No/Date:3/82‐ OPHTHALMICS PVT LTD, IALC4/2015 20052015 曰 鵬島掲50畑つ4/AMW~彫 糀 OЮ蕊9ンAmン ~圃 齋 霜 而 而 Lic No′ 1)ate:0910052815 29052012

Case No:39/19/82-

ALC4/2014 Lic No/Date10910052842 Party Name:SUVEN LIFE SCIENCES LIMITED ‐Case No.:13/19/82- IALC4/2014 LABORATORIES LIMITED Lic No/Date1091 0052887

Case No:37/19/82-

ALC4/2014

Case No:6/19/82-

ALC4/2014 li葛謂需de toiCOmmrce .誡 :Ы ― Ч レ Date 2015 NamelMYLAN Date 2015 Re-indexed File RLA File

肥 | ~|[1:〕 :「:霰死 弄 蔑 F Pary Namc:VI」AYASRI ORCANICS LTD HQ File :01/82/050/01550/AM15ノ Date :09/71/040/00073/AM13/ 072015 Re-indexed Date 072015 : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals). Lic No/Date:0910053465 09082012 Decision:The representative of D/o PharmaceuJca:s handed over a copy of earlier norms in which certain quantities have been reduced in terms of present manufacturing practices lt was decided to ratify the norms based on these recommendaJons furnthed vide O M No 35011/317/2011-Pl(Norms)dt 27 2 2012 as per detans given below■ Export product Qty lmport items Qty 4-Fluoro-A-2-Methyl- 1-oxopropyl)-g-oxo-n- b-dlphenyl benzene butaneamide (diketone- intermediate for atorvastatin/DKT-3 lkg Fluorobenzene 0 52kg Methylene dichloride (MDC) 2 00kg Methγl iso butyryl acetate (MIBA) 0 76kg Methanol 0 50kg | ICaseNo.:7/3/82‐ ALC4/2015 1器島児 50Ю∞ 37AMIθ Mcct No/Datc:3/82‐ ALC4/2015 20052015 File 105/23/040/00042/AM14/ ― S― HQF‖ c 101/82/050/00045/Aヽ114/ No:4/4/82-ALC4/2013 Namc:SABERO GUJARAT つ ４ Ｄ ａ ‐ ５ Ｗ 卿

Case No:5/19/82-

Ｆ 」 Ｆ Ｉ NameiCOVALENT TORIES PRIVATE defer the case for want of comments of Department of Ｄ ａ ｔ ２ ０ ‐ Jttde 1e.al of Fororgn I rada -"oartment of comme.cs

Pharmaceutica ls. 一 ― Re-indexed 鵬 3掲5鳳蕊而¬麒 i薦薦~器鼎α“Ю翻“ 1腑辮 : 画 而 品 面 efer the而而 粽 :The committee noted that the ITCHS classification oflhe export product mentioned in the cation as 3004901 I is wrong. It has been decided to transfer the case to DES-vl section who is dealing the food products. ICase No.:25/1/82-ALC4/2biζ | | | 1脇鵬OЮm"/AMl″ 1麟¨ 鵬星鷺 50Ю bЯ /AM″ 温 :;'1言舌 : Date 072015 : lt was decided to defer the case for want of comments of D/o C&pC (Chemicals). iCase No:22′ 12/82- ALC4/2013 Decision : The represc which certain quantities decided to ratify t O M No 35011/317/201 Intative of D/o Pharmaceuticals handed over a copy of earlier norms in have been reduced in terms of present manufacturing practices. lt was he norms based on these recommendations furnished vide 1-Pl (Norms) dt. 27 .2.20\2 as per details Biven below:- Export product Qty llmpOn tems l Qty. 4‐Fluoro― A-2-Methyl‐ 1-oxopropyl)g―oxo― n b‐diphenyi benzene butaneamide {diketOne‐ intermediate for atorvastaln/DKT-3 lkg Fluorobenzene 0 52kg Methylene dichlonde(MDC) 2 00kg Methyl iso butyryl acetate (M IBA) 0 76kg Methanol 0 50kg ′NlFミMAL -6″ ＝ 一 NげDatei3/82- Re-indexed No.:47/14/82‐ NameiVIvIMED LABS Re-ind€xed 1/AMi4/ つ ４ Ｄ ａ ‐ ５ ５ 耐 脚 ｍ File

Pa●y Namc:DR REDDYS LABORATORIES LIMITED Decision : The committee decided to ratify the norms based on the recommendation of Department of Pharmaceuticals vide l.D.No. 350f7/644/2ot4-Pl (Norms) Dated 18.05.2015 as per details giv en below or as applied by the firm whichever is less:- Export product Qty lmport items Qty Atorvastatin Calcium (amorphous/Form- P/Crystalline/lCH/Trihydrate) lkg (4R-cis)-l, 1-dimethylethyl-6-(- 2aminoethyl-2,2-dimethyl-l, 3- dioxane-4-acetate 0 78kg Acetonitrile 5 37kg Methanol 3 01kg : lt was decided to defer the case for want of comments of D/o Bio technology. 甲蔽繭而腔棚言ツ "― 財= Re-indexed 一 ‐ ‐ ‐ Ｍ ド ー ー ー Re-indexed Lic NげDatc:0510372321 :01/82Ю50/OH51/AM14/ 1:0524Ю40/00201/AM14/ 29112013 It was decided to defer the case for want of comments of D/o C&PC (Petro Re-indexed 103/95/040/00791/AM14/ 雪ぶギ畿幽 鰈 椰 』 卿 翻T Case No■04/23/82- ALC4/2013

Case No:48/23782-

Partv Name:EXCEL Meet No′つate:3/82‐ ALC4′ 2013 lNDUSTRIES LIMITED

Case No.:55/23/82-

ALC4/2013 P肛りName:SATYAJIT CHEMICALS PVT LTD, Lic No/Date:0310763764 :01/82/050/O1102/AM14/ 3! 122013 _可´ No′lDatci3/82‐ 122013 Re-indexed Date 2015

】 )ecision:lt was decided to deferthe case fbr want ofcOmments of D/oC&PC(Chemicals) 一 ― X霊ガ l『″ 23β2- 肥 1濶 m~ Ш Am″ case for want ofcomments of D/oC&PC{C 「 on : It was decided to remind the firm to fumish following information within 2 weeks which case will be decided as per the available information: (a) Technical Justification for import ofsulpher which is not shown in the process/chemicals reactions. (b) Past production vis-a-vis Actual consumption ofinputs duly certified by Central Excise Authority . ICase No.:187/3/82- IALC4/2014 | Pharmaceuticals. ICaseNo.:108/3/82- IALC4/2014 1 ¨ ｄ ｅ ｘ ｅ ｄ Ｄ ｅ 　 ・ｉ ｎ 暉 Ｒ ｅ 離尤監"00805AM 4 「11漑T面薦石厩咄百~ 聾ジ戦賓 -8″ No.:12/21/82‐ Name:KUDOS CHEMIE TD, 34 ParりName:ALCHEM INTERNATIONAL LTD IMeet NoノDate13/82- IALC4つ015 20052015 Status:Deferred and Re-indexed HQ File :01/82/050/00191/AM15/ 鵬危監 OЮ04BAM W Lic No′ つate:0510376990 24012014 1路雛

1)ecision:lt was decided to deferthe case for want of comments of D/oC&PC{ChemiCals) |

Case No.:44/4/82‐

ALC42014 Party Name:CATAPHARMA Mcct No/Datei3/82- CHEMICALS PVT LTD, ALC4/2015 Re-indexed 20052015 圏辮剖Ю“2' was L decided to defer the case for want of comments of Department of Date 072015

Case No:177/3/82-

ALC4/2014 Par"Name:INDO AMINES LIヽ41TED ALC4/2015 20052015 "鵬 3鷺50Юm尉晨my l器 鼎 綱 "“ “ 61蹄 辮: 3/94/040/00958/AM14/ ,001つ No.:165/3/82‐ ALC4/2014 Re-ind€xed 障蹴∽四 8晨m″ |

Case No.:45/19/82-

ALC4/2014 Date 072015 decided to defer the case for want of comments of Department of 兵ぼ蹴 も=駐 ‐ 鵬 選 響 器 ザ 断 き∬ 酬"=顆 , ' 1~~~~~~‐ ― l 101器脇50Ю“ 48晨MW I鷺念馳OЮ0986/AM剛 ~
浙 ion : : It was decided to remind the firm to furnish following technical details within 2 failing which the case will be closed:- I r-.. ^ (a) Complete technical details as per Appendix-33 (b) % content of Buffering Agent in Export Product. 3 lt was decided to defer the case for want of comments of D/o C&pC (Chemicals). was :s Party Name:MANGALAM ALC4/2015 20052015 109/24/040/00600/AM14/ -4- No/Date:3/82- Re-indexed No/Datc:3/82- No/Date13/82- Re-indexed

casc is dcfcrrcd for 20 05 2015 Partv Name:INDOCO REMEDIES LIMITED Parfy Name:BELCO ALC4/2015 20052015 Date 072015 ls Ｆ ｌ ‐ ― ― 陣 ‐ ― ― ‐ ― 11霊 胤 ″ “ /82- Pa●y Namc:ND‐ SWIFT LABORATORIES LTD, ALC4つ015 20052015 Lic No/Date12210014691 Datc :22/24/040/00102/AM14/ 14032014 : It was decided to remind the firm to furnish complete technical details as per Appendix 3 Thc caseis deferred for 20 05 2015 Name:IND―SヽVIFT No Date:3/82- TORIES LTD, RLA File :22/24/040/00103/AM14/ Lic No′ 1)ate12210014692 14032014 of Pharmaceuticals vide l D No 35011/588/2014‐ Pl{Norms)Dated 18 05 2015 as details given below or applied by the firm whichever is less:- Export product Qty lmport items qty. Ks./ks Betamethasone Sodium Phosphate lkg Betamethasone 078 Methanol 216 Acetone 125 1器島児50Ю0304ハmy区 角鵬 OЮ。OνAm″ No.:58/4/82- Party Name:IND-SWIFT TORIES LTD, 072015 Lic No/Date:0510381658 12032014

Case No:57/4/82‐

ALC4/2014 :01/82/050/00305/AM15/ udy。鍋バ湿試懸蒐薫 14 一 l。 一 吻 ^ 10773‖ 2‐ Defer Date 2015 |:01/82/050/00034/AM15/ No Datei3/82‐

厩 It was decided to remind the firm The case is defened for 20.05.2015. to fumish complete technical details as per F聴甲百~~「 悧器響器 鵬 星‰ Ю “ η AM Ы 膨 棚 ν∞ “ 7AM四 1悧 辮 Ю舅 “ "餌 2 Pharmaceutica ls. Date 072015 ~F“ eN∝Wlm2ALC42∝4「 蕊 而 需諏 而 朧麟 伊 鯉‐ | Department of of C&PC Pharmaceuticals vide O.M.No. 35O7t/6O5lZOL4-Pt (Norms) Dated .04.2015 as per details given below or as applied by the firm whichever is less:- Export product Qty No lmpon ltem Name. Qty kg/ kg Imipenem and Cilastatin Sodium (l:l) for injection ０ ● Ｌ Ｋ l Carbon Enoanticromos I Activated Carbon l 0200 2 Acetone 764 Dowex TM 0020 4 cnastatln Acid 050 D Bicyclic Ketoester 156 6 Diphenyl Chlorophosphate 7 Cystamine Hydrochloride 056 8 4‐(Dimcthyl Amino)Pvridine 0015 9 Methanol 244 10 Isopropyl Alcohol 779 N-Methyl-2-Pyrrolidone 207 つ ‘ Acetonitrile 310 Methylene Chloride 1207 14 TetrahydrOfuran(THF) 120 HQ Fne:01/82Ю 50/00971/AM15/ 障ち鵬∽“露晨 m″ 1輔鮮似∞'6「 鰯 o 彊卸職軸見 ― |ト No:42/4/82- Name:RECKITT No/Date:3/82‐ HEALTHCARE Re-indexed

may take further action accordingly. ~F蕊 評 肩~~甲 聰 藤 諏 齋 「 諄i鮮菫 3慇2 Pha rmaceutica ls. Re-indexed Date 072015 Party Name:PERFECT Meet No/Date:3/82‐ INDUSTRIES PRIVATE IALC4/2015 LIMITED 120052015 "1瓢蕊蕊蔦丁隔乳0畑 "″AM W 蹴辮Ю "° 776%9 Re-indexed Date 072015 Meet No/Date:3/82- ALC4/2015 Re-indered 20052015 Meet No/Date:3/82‐ ALC4/2015 Re-indexed 20052015 Re-indexed Date 072015 : It was decided to remind the firm to fumish a copy of valid Drug Manufacturing for the export product namely Fomepizole Injection l.5gm/ml vial indicating volume and ition of each vials of export product. The firm is requested to fumish the requisite information within 2 weeks failing which the case will be closed. Lic No/Date:3110063312 28032014

Case No:51/6/82-

ALC4/2014

Case No.:50/6782-

ALC4/2014 |

Case No.:20/6/82-

ParッName:ADISHANK ALC472014 CHEMICALS PVT LTD 厩面高:話IT隔濡0畑И OハⅢ″ 1淵辮憫Юηη %1蹄辮 :

Case No:32/5′ 82-

ALC4/2014 Party Name:TIDE -12- No/Date:3/82- ― 一 File 15/ 131/83/040ノ00232/AM14/ Ｆ ‐ ‐ ‐ ‐ ５ ‐ ‐ ‥ ‐ ‘ ｉ ‐ Filc Name:EMCURE No/Datei3/82‐ File :01/82/050/00349/AMl5/ j:3ll83/040/00008/AMl5/ ll.O4.2Ol4

ハ 「 | 囲蕊扁戸跳ち鵬OЮ0005AM V Decision : lt was decided to defer the case for want of comments of D/o C&pC (Chemicals). 甲酉~甲渕 「 瞭謂ル胃吻 1蹴鼎引 ・∞“Ю 3階3辮: ALC4/2014 戸 雨53百〒買正玉 「

IALC4/20T
1艦盤F
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:
ALC42015
鵬疏5∽∞
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陽危淵∽鳥萩MЫ  
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Decision:!t was decided to deferthe case For want ofcomments of D/oC&PC{PetrOChemicals)
: lt was decided to defer the case for want of comments of Department of C&pC
ls)
Pa●y Name:ESTEEM
Meet No/Date:3/82‐
NDUSTRIES PVT LTD,
20052015
1鶴鵬OЮ∞
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I)ecision:lt was decided to deferthe case for want of comments of D/oC&PC{Petrochemicals):
: In the light of written comments received from Department of pharmaceuticals vide
OM No. 3501 I /4312013-PI(Norms) dated 29.05.2015, it was decided to ratif, norms under
4.7 of HBP v I as per details given below or as applied by the firm, whichever is less:
ud菫聾轟瓢mim
rNDUSTR:ES PVT LTD,
(4R-cis)- l,l -dimethyl ethyl-
-amino ethyl)-2,2-
(4R-cis)-1, l -dimethyl
ethyl-6-cyanomethyl-2,2-
dimethyl- 1,3-dioxane-4-
acetate
-13-
Re-indexed
File
17/24/040/00002/AM15/
No.:236/6/82-
Namc:ESTEEM
No71Date:3/82-
Re-indexed
No.:238/6/82-
Re-indexed
No.:88/13/82-
Name:MAITHRI
No Date:3/82‐
Export product
”
帥
SI No
lmport items
ｄ
ｅ
Ｗ
Ｏ
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1079

may take appropriate action as per the decision of Norms Committee.
## Case No.:5/10/82‐
ALC4/2014
Partv Name:MYLAN
LABORATORIES
LIMITED
Mcct No/Datc:2/82-
ALC4/2015
29042015
HQ File          RLA Filc
:01/82/050/00919/Aヽ415/ 109/24/040/00676/AM14/
Lic No/Date:0910060057 1Dcfcr
12052014
Datel12 06 2015
Meet No/Date:3/82-
Deferred
Re-indexed
Date
072015
was decided to defer the case for want of comments of D/o C&PC
●
●
　
ａ
ｕ
・
¨
　
ｒ
ｍ
ａ
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ｅ
Pha
I   TttF面
PHOSPHORUS LTD)     20052015
Lic No/Date:0310782129
:03/95/040/00033/AM15/     120052014
udPI¬ 鴻誡
|‖
sion : In the light ofwritten comments received from Department of Pharmaceuticals vide
OM No.350l l/34l2015-PI(Norms) dated 29.5.2015, it was decided to ratifr norms under
4.7 of HBP v I as per details given below or as applied by the firm, whichever is less:-
Export product
Oty
Import Item Name.
Qtykg/kg
Ticagrelor
lkg
2-((3 aR,4S,6R,6aS)-6-amino-2,2-dimethyl-
terahydro-3aH-cyclopentaId] [ 1,3 ]dioxol-4-
yloxy)ethanol-L-tartarare salt
(OR) Cyclopentyl-ethoxy-amine-L-tartrate
320
( I R,2S)-2-(3,4-difl uorophenyl) cyclopropanamine
HCI (OR) Difluoro cyclopropyl amine
208
Tetrahydrofllran(THF)
541
Methanol
つ
た
Dichioromethane(Or)Methylene Chloride(MDC)
683
Toluene
1462
Hexane
1052
Acetone
416
Isopropyl alcohol
may take appropriate action as per the decision of Norms Committee.
## Case No.:52/10/82-
ALC4/2014
Lic No/Date:0910060080
:O1/82/050/00966/AM15/
:09つ4/040/00055/Aヽ415/
13052014
Paty Name:AUROBINDO
PHARMA LIN41TED
ALC4ノ2015
20052015
## Case No:88/6/82-
ALC4/2014
_lИ
―
Re-indexed

Date
072015
: It was decided to remind the firm to fumish a copy of valid Drug Manufacturing
Licence for the export product namely Fomepizole Injection 1.5 gm/ml vial indicating volume and
composition of each vial of export product. The firm is requested to furnish the requisite
information within 2 weeks failing which the case will be closed.
Decision:: The committee decided to ratify the norms based on the recommendat
Department of PharmaceuJcals vide O M No35011/07/2015-PI(Norms)dt 20 6 2015そ
detail given below or app‖ ed by the firm whicheverisless:
ion of
ls per
Export Product
Qty
lmport item
Qty
Colistimethate Sodium for
injection BP 1 million
lnternational Units per vial
Vial up to
10ml
Colistimethate Sodium
for injection BP
96.65m9
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「
1麟¨
田脇蕊蕊~囲
;蕊079AM Ⅳ
Date
072015
3:lt
was decided to defer the case for want of comments of Department of
is
―匡
…
2薦
|
"1器3児50Ю003VAM附 IW蹴蕊蔦
顆
|…
―
1090720:5
decided to defer the case for want of comments of D/o C&pC (petro
Pa●y Name:BALAJI AMINES
LIMITED
ALC42015
20052015
## Case No.:165/6/82‐
ALC4/2014
Decision : tt was
― IJ一
IQ Filc
D1/82/050/00743/AM15/
F‖ e
10782569
4
Date:
No/Date:3/82‐
No/Date13/82-

Chemica s)
舗
“
N∝2/8/82‐ ALC4/2側41mttα
HETEROLABS tti猟
ド
ン鯰~Imm"A"Ю
“
器3児W∞
“
6ハ剛夕
厖
棚
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1蹴辮
Ю釧∞ω む81
Decision:The committee decided to ra■fy the norms based on the recommendaJon of
Department of Pharmaceuucals vide LD No 35011/36/2015-PI(Norms)Dated 05 06.2015 as per
detals given below or a s applied by the■
rm whicheverisless:―
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Ｅ
　
Ｐ
Qty
Import Item Name.
Qty
Kg/kg
Te rblnafine
Hcl
lkg
1
N-Methyl- I -naphthalene methanamrne
hydrochloride
l14
う
る
1 -Chtoro-6,6-dimethyl-2-hepten-4-yne
087
3
Methylene chloride
237
4
Dimethyl follllalnidc
ξ
ジ
Ｏ
Ｏ
０
5
Cyclohexane
Not shown in
process details in
reaction
6
Diisopropyl ether
130
喰霊獅
″
〃
"―   
靱
宵
ぎ
V PHARMA腔
き棚
Toフ"―
ALC4/2014
一
　
　
　
　
６
６
: lt was decided to defer the case for want of comments of D/o c&Pc (Chemicals).
Deferred
Rc-indexed
Meet No/Date:3/82-
## Case No.:71/9/82-
ALC4/2014
8隔鶏蕊蔦
風競蕊薦戸掘辮憫Ю
・""
ALC4/2015
20052015
Date
072015
3 lt was decided to defer the case for want of comments of D/o C&PC (Chemicals).
W尋翼畔鼎絆R
## Case No:164/6/82-
ALC4/2014
Party Name:VDH CHEM
TECH PVT LTD
Mcet No/Date:3/82-
Lic No/Datc:0510388792
CHEMICALS PVT LTD,
-te-
Re-indexed
5/     113062014

No.:170/6/82-
4/2014
Mcct No/Date:3/82‐
Mcct No/Date:3/82‐
ALC4/2015
20052015
Re-indexed
ALC4/2015
Re-indexed
20052015
Date
072015
Pha rmaceutica ls.
「謎鰈脇
岡蕩爾~
Party Name:BLISS GVS
Meet No/Date:3/82-
PHARMA LTD
ALC4/2015
Re-indexed
20052015
Dat€
072015
Pha rmaceutica ls.
## Case No.:69/4/82-
ALC4/2014
(Petrochemica ls).
## Case No.:204/6782-
ALC4/2014
File
Deferred
Re-indexed
Date
072015
Re-indexed
Party Name:RA CHEM
Meet No/Date13/82-
PHARMA LIMITED
A LC4/2015
20052015
: A copy ofthe application is to be sent to the Deptt. of Pharmaceuticals.
澁
藤蔦戸
~匿
蕊繭平而面而匿麗蕊
: lt was decided to defer the case for want of comments of Department of C&PC
1耶F蘊石
R、4躙
1
HEALTH CARE PVT LTD,
Lic No/Date:0410158822
24062014
Pa●y Name:BLISS GVS
PHARMA LTD
Lic No/Date:0310786049
26062014
## Case No.:74/9/82-
ALC4/2014
Lic No′ 1)ate:0310786144
27062014
Lic No/Date10910060550
27062014
## Case No.:73/9/82-
ALC4/2014
ParN Name:D- R. COATS
INK&RESNS PVT LTD
:01/82/050/00870/AM15/
105/24/040/00192/AM14/
1/82/050/00606/AM15/
-1,´
諄鮮鯉‐
Namc:SOFTGEL
15/
15/
Re-indexed

## Case No:211/6/82-
ALC4/2014
:01/82/050Ю 0613/AM15/
Partv Name:PAYAL
Meet NolDatei3/82‐
PETROCHEM PRIVATE
ALC4/2015
LIMITED
20052015
Date
105/24/040/00191/AM 14/
072015
Petroche m ica ls).
~に謎朗
i″
/9β2-
|
`1瓢蕊蕊i「
Mcct No/Date:3/82-
ALC4/2015
20052015
Pharmaceuticals.
Party Name:MAC CHEM
Meet No/Date13/82‐
PRODUCTS(INDIA)
ALC4/2015
PRIVATE LIMITED
20052015
Date
072015
: ln the light of written comments received from D/o Pharmaceuticals vide their OM
35011/661/2014-PI{Norms)dt 18 05 2015 k was decided to callfor following informa■
on
the firm:
(c) Complete technical details as per Appendix-33.
(d) % content ofBuffering Agent in the Export Product.
Mcct No/Datc:3/82-
ALC4/2015
20052015
Defer Date
072015
Lic No Datc:0510389447
08072014
Party Name:ALMELO PVT
:09/24/040/00188/AM 15/
悧辮側∞““r剛
「
―
:01/82/050ノ00885/AM15/
## Case No.:108/9/82‐
Party Name:NECTAR
ALC4/2014
LIFESCIENCES LIMITED,
Lic No/Date:2210015019
:22/24/040/00083/AM14/
15072014
: It was decide to remind the firm to fumish following information:
i) 
% of coating material in export product supported by COA of the export
consignment.
iD 
Copy of DML for relevant coated export product.
firm is requested to fumish the requisite information within 2 weeks failing which the case
be closed.
:01/82/050/00905/AM15/
_18-

貯淵3/13/82「M鑑涙
79器3掲50Ю 25VAMl夕
Lic No/Date:0310786993
17072014
ALC4/2015
20052015
## Case No.:1/6/82-ALC4/2014
Status:DeFerred
landR←indexed
|
隅¨
p9072015
Re-indexed
IMeetNo/Dato3/82-
1搬盤F
ALC4/2015
20052015
ЮI鵬児
5∽“"/AMly囮
61/AMЫ I悧鼎α°
410159021
~ヒ
ase No■79/9/82-   両
ALC4/2014
Date
18072014
072015
: A copy of application is to be sent to the Deptt. of Pharmaceuticals.
Party Name:PACE
PHARMATECH PVT LTD
Meet No/Date:3/82‐
ALC42015
20052015
Lic No/Date:0310787160
22072014
Name:METROPOLITAN
EXIMCHEM LTD
## Case No:24/9/82‐
ALC4/2014
:01/827050/00821/Aヽ415/
Ъ 蹴
OЮm“AMЫ  
囲
鼎
m釧∞
“
Ю3蹄
辮:
## Case No:78/9/82‐
ALC4/2014
Pharmaceuticals.
Mect No/Date:3/82‐
ALC4/2015
20052015
: The committee decided to ratify the norms based on the recom
## Case No:107/9/82‐ ALC4/2014
Party Name:lND-SWIFT
LABORATORIES LTD,
Lic No/Date:2210015039
‐23072014
-le -
Date
2015
No/Date:3/82‐
15/
Re-indexed
Date
5

artment of Pharmaceuticals vide O.M.No. 35011/588/2014_pt (
details given below or as applied by the firm whichever is less:_
JOrms)Dated 18 05 2015 as
ExpOrt product
Qty
lmport items
Qty kg/kg
Betamethasone
Sodium
P hosp hate
lkg
1. Betamethasone
078
2  Methanol
216
3. Acetone
125
貯淵
/9/82‐ ~[脚♀
祠LW厠7~厠
鵬
3児50ЮO脇
蔦
戸
隔
棚
OЮO102/Am夕 1器
器
°鉾Ю
“ “ “
躊
蕊
:It was dccided to send a copy ofapplicatiOn tO Department ofPhallllaceuticals
F脚馴ル~甲瓢腐蕊覗椰Ⅲ
「W
~隔
λ鵬
OЮω
2Am夕 薇漁°“Ю
7873,両飛
No.:7/6/82-ALC4/2014
Name:AARTI DRUGS
¨
‐
‐
‐
‐
‐
‐
‐
‐
＾
´
師
‐
‐
‐
―
―
‐
‐
‐
ICase No.:73/10/82-
:ALC4/2014
2015
Name:V&V PHARMA
No/Date13/82‐
1ハM15/
Ｍ
２
０
‐
No.:8/6/82-ALC4/2014
―
¨
一
5

Decided to send the copy of application to D/o c&PC (Chemicals).
## Case No.:209/13/82‐
ALC4/2014
Partu Name:AVA
Meet No/Date:3/82‐
ALC42015
Re-indexed
20052015
Date
072015
:In the light of written comments received from Department of Chemicals and
videthcir OM No 14010/67/2011-CH― II datcd 29 03 2015,it、vas dccidcd to ca‖
the firm the following technical details:
i) Detailed manufacturing process along with balanced chemical reaction indicating number of
ofall the reactions, products and by-products with conesponding molecular Formulae,
formulae, molecular weight and process flow diagram.
ii) Stage-wise percentage yield with respect ofeach ofthe reactants and products and the relevant
enclosing therewith authentic printed technical literature in support ofyield or
of items for import.
iii) Detail ofby-products formed during the process and their recovery in terms ofquantity and
iv) Details of production of export product under reference and corresponding consumption of raw
ial in the yeat 2013-14 and 2014-15 (April to October) duly certified by CA may be
lf the production has not commenced in the past, the details from commencement of
may be fumished duly certified by CA.
―
  
―
  |
Lic No/Date103 10787610
Datc
04082014
072015
Meet No/Date3/82-
ALC42015
20052015
: A copy of application is to be sent Deptt. of Pharmaceuticals.
師渕繭砺厩
Meet No/Date3/82-
IALC4/2015
120052015
103/94/040/00171/AM15/
:01/82/050/00855/AM15/
Lic No Date103 10787536
01082014
## Case No.:49/9/82-
ALC4/2014
ALC42015
120052015
## Case No.:31/9/82-
ALC4/2014
Paty Name:AMBERNATH
ORGANICS PVT LTD
_つ
メ
ー
PVT LTD,
Re-indexed
Re-indexed
10787473
5/

## Case No.:10/6/82-
ALC4/2014
1輻
:01/82/050/00412/AM15/
Lic No/Datc:0910060796
04082014
The committee decided to ratify the norms based on the recommendation of Department of
lsvide O M No 35011/477/2014‐ PI(Norms)Dated 05 03 2015 as perdeta‖
s
or as applied by the firm whichever is less:-
Export Product
Qty
Import items
Qり
K″kg
Cefoodoxim
Proxetil
lkg
7 Amino Cepha10sporonic Acid(7
ACA)
0956
2-Mercapto― BenzothiazOl‐
2‐
Aminothiazole‐
4yl― MethOxyimino
Acetatc(MAEM)
0956
Alpha-Chloroethyl Isopropyl
Carbonate (CEIPC)
055
1,1,3,3,― tctramethyl Guanidine
(TMG)
0223
Methanol
Methylene Chloride
232
Acetone
250
Tetra Hydro Furan
156
Sodium lodidc
028
Activated Carbon
0100
concerned may taken necessary accordingly.
94
## Case No.:15/9/82-
Mcct No Date:3/82‐
ALC4/2014
ALC42015
20052015
1器3児50Ю081νAm y鵬
角鵬
。Ю鯰03ハm夕
Department of Pharmaceujcals vide O M No 35011/606/2014‐ PI(Norms)Dated 29 04 2015 as
details given below or as applied by the firm whichever is less:-
Party Name:COVALENT
LABORATORIES PRIVATE
LIMITED
Status:ApproYed
Lic No′1)atc:0910060793
04082014
Item Name                 lQty Kν kg
Cefdinir
'2-hydroxylamino-2-(2-aminthiazole-4-y)
-Phenylacetamideo-3-Chloromethyl
Acid Para Methoxybenzyl Ester
may take further action accordingly.
一
γ
´
嚇
嚇
Qty
lkg
2263
1 397
Methylene Chloride
1487
Tetra Hvdro Furan
206
Methanol
412
Activated Carbon
0055

Ｆ
‐
‐
‐
９
７
‐
‐
Date
072015
: lt was decided to defer the case for want of comments of D/o Pharmaceutical.
Defer Date
072015
Lic NυDate:521004H80 1Defcr Date
05082014
072015
:L was dedded to deferthe case for want ofcomments of D/oC&PC(Chemに
als)
becis:。n::It was deci[cd t。再mllld the■nll to fumζh compittτ techntal dctがls
iimrnq rne rrrrn Io Iumlsn comptele Iecnnlcal detatls as per
Appendix 33 and (ii) past production vis-avis actual consumption of inputs duly certified by
Party Name:ANUPAM
RASAYAN(IND:A)LTD
1器3鬼50Ю“И
AMIS/ ~
Department of PharmaceuJcaにvide O M No 35011/42/2015 PI{Norms)Dated 29 05 2015 as
per deta:ls given below or as applied by the firm whicheveris less:―
Moranlel Citrate
_つ螂
―
No.:44/9/82-
NameilNTAS
NげDatei3/82-
Re-indexed
No.■47/13/82-
Name:SHiVAM OILS&IMeet No/Date:3/82‐
INDUSTRY,
Re-indexed
150/AM15/
No.:12/6/82-
No/Date:3/82‐
5
Re-indexed
No.:42/13/82-
Name:INCHEM
No/Date:3/82-
TORIES PRIVATE
Re-indexed
No.:205/13/82-
NamcllPCA
TORIES LIMITED

## Case No.:105/9/82-
ALC4/2014
躍織話需
f】L~諄
i勢ドツ
"~
Re-indexed
: ln the light of written comments received from D/o
No 35011/654/2014-PI(Norm5)dt 13 05 2015 1t was decided
the firm:
Pharmceuticals vide their OM
to call for following information
!
::.
:li
A copy of valid Drug Manufacturing License granted by concerned State Drug
Controller
Vial size of injection to be exported alongwith a copy of purchase order
Description (Chemical name) of the raw material to be imported indicating quantity
of any other material blended with the new materialto be imported.
Date
072015
Lic No/Date:2210015058
07082014
~甲¨ 甲閻‐ 1濶m_w
田開
o鉾Ю
0404%
:34/24/040/00111/AM15/
Decision : A copy of the application is to be sent to the Deptt. of Pharmaceuticals.
F釧∝棚和伽4甲鱚
「
諄鮮ル甲
Ю3鵬
3児
"Ю
∝鰯Am夕
陽角鵬
。Ю唸唸晨剛夕
田
開
°
“
Ю
"
lDecision 3 A copy of the application is to be sent to the Deptt. of Pharmaceuticals.
Party Name:SENTISS
Mcct No/Date:3/82-
PHARMA PVT LTD
ALC4/2015
p0052015
104
HQ File
:01/82/050/00850/AM15/
RLA Fne
臓器α“Ю
390257
Decision : The committee decided to ratify the norms based on the
Department of Pharmaceuticals vide l.D.No. 35011/09/201s-Pl (Norms)
per details given below or as applied by the firm whichever is less:-
recommendation
Dated 08 06 2015
ｄ
　
ａ
ｓ
冨濡鞘讃:等鼎綸R
ud霊甕鳥議棘
Export Product
Pack Size
lmport items
Qtv
Betaxolol Hc1 0 5%eve drops,
04m卜{Xonef BK Eye Drop)
04ml vial x 30
Nos
Betaxolol
Hyd rochloride
68 466mg
Betaxolol Hcl 0.5% , 5ml-
(Xonef Eye Drops)
5mivialx l
Betaxolol
Hydrochloride
28 52mg
― %Ч 一
No.:7′9/82-ALC4/2014

ｎ
ｕ
い話面雨扇=~~~
IALC4/2014
1
HQ File
:01/82/050/00820/AM15/
Deferred
Re-ind€xed
Date
072015
]胤棚υ剛%ハm夕 1蹴器酬∝"%51路脱
: ln the light of written comments received from D/o Pharmceuticals vide their OM
decided to call for following information
No 35011/19/2014-PI(Norms)dt 12 06 2015 k was
the firm:
Copy of valid Drug Manufacturing License for different composition of Sodium
Hyaluronate Opthalimic Solution and respective sizes of vials.
Exact number of vials of sodium hyaluronate opthalimic solution of different
compositions to be exported against this application.
Quantity of sodium hyaluronate MMW or LMW needed for production of each of
the composition of sodium hyaluronate opthalimic solutions.
Actual consumption data of sodium hyaluronate MMWLMW and different packing
component (applied for import) during last 3 years against production of sodium
hyaluronate opthalimic solutions of different composition and the justification of
wastage of each component. The figures of actual production and consumption may
be duly certified by an independent Chartered Accountant.
Department of Pharmaceujcals vide l D No35011/656/2014-Pi{Norms)dated 20 5 2015 as per
107
ils given below or as applied by the firm whichever is less:-
Export product
lmport item
Qty
Lincomycin lnjection
500mg/2ml vial
Lincomycin Hydrochloride
(Anhydrous)
0.612 BOU per 1000 vials of
Lincomycin injection 600mg/2ml
lV
~F:きが見常妻
35藤
Name:SRIAM LABS
ATE LIMITED
…
′N〔RMAL КυM^R
ud霊兜メ梶罫
:ヌム謀軌こ
F厩璃P面戸~~~
一γ ■
Name:B10‐ TECH    IMeet No/Date:3/82‐
10159215
No.:50/9/82-ALC4/2014 Paty Name:CAPLIN POINT  IMcet No/Datei3/82-

田:鷺続
厩蕊蕊:扁
「
1蹴鼎α酬∞ω%4Mゝ
Lic N(ノDate:0910060843
12082014
も
No/Date:3/82-
Deferred
15
Re-indexed
2015
ls
Meet No′Date:3/82‐
ALC42015
20052015
Date
072015
: lt was decided to defer the case for want of comments of Department
κ
Meet No Datei3/82‐
ALC42015
20052015
ls
Meet No′Эate:3/82‐
ALC4つ015
20052015
;ぶ岬
1諦辮
:
3 It was decided to send a complete set of application to the Deptt. o
Mect NげDate:3/82-
ALC4/2015
20052015
Lic No/Date:0410159266
宙辮暑緞袋翌賓
R
:憚寓拙鞘f
可n口q,■■oopartnent Or COmmerce
ud瘤聾轟謀誡
lⅢ
## Case No:55/13/82‐
Pary NamelHETERO
ALC4/2014
DRUGS LIMITED,
## Case No.:60/13/82‐
ALC4′ 2014
Pa,y Name:VERDANT LIFE
SCIENCES PVT LTD
Lic No Date:0910060869
20082014
## Case No.:37/9/82-ALC4/2014
P肛ッName:JAGSONPAL
PHARMACEUTICALS LTD
## Case No:41/9/82‐
ALC4/2014
Party Name:RANBAXY
LABORATORIES LTD
Party Name:UNILINK
PHARMA PVT LTD
:04724/040/001H/AM15/
_%く
 ´
21082014
師
F‖ e
2015
Re-indexed
Fne
Filc
Re-indexed
No:52/9′ 82-ALC4/2014

ヽ/
Dated 20.05.2015 as
Department of Pharmaceuticals vide l.D.No. 35077/ 665/ 1OL4-P| (Norms)
per details given below or as applied by the firm whichever is less:-
PartyName:HINDUSTAN iMeetNo/Date:3/82-
POLYAMIDES&FIBRES  IALC42015
Re-indexed
LIMITED
20052015
Date
072015
Department of Pharmaceujcals vide O M No 35011/675/2013‐ PI(Norms)Dated 01 04 2014 as
per deta‖ s given below or as applied by the firm whicheverisless:
Export product
Qty
lmport item
Qty
Yohimbine
Hydrocloride USP
lkg
Yohlmbine bark with Yohimbine content not
more than 1%
133 42kg
諄席ル
|
Lic No Datc:0310788279
Date
22082014
072015
3 lt was decided to defer the case for want of comments of Department of
Pa●y NameJNDOCO
REMEDIES LIMITED
rmaceuticals.
Meet No/Date 3慇2-
1錯殿盤∵
Re-indexed
Export product
lmport item
Qty
Penic‖‖n v 250 mg
Tablets
Phonoxy Methyl penicillin
Potassium
275mg/250mg Tab ets
## Case No.:242/13/82‐
ALC4/2014
## Case No.:245/13/82‐
ALC472014
## Case No:229/13/82-
Partv Name:AVA
CHEMICALS PVT LTD,
ALC4/2014
-2■
´
Lic No/Datc:0310788333
Defer Date
No:38/9/82-
Name:NDO
う
０
０
０
Ｄ
ａ
‐
５
Ｗ
卿
5/

| :0 I I 82 I 050 I 0 1232 I AM | 5 I
Ю3/94/040/00465/AM15/
lzs.oa.zot t
: lt was decided to remind the firm to furnish 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.
Stage-wise percentage yield with respect ofeach 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 be
If the production has not commenced in the past, the details from commencement
may be fumished duly certified by CA.
casc、vas deferred fOr 20 05 2015
1蹴器°“¨ "7
Decision : lt was decided to defer the case for want of comments of Department of
Date
072015
Re-indexed
Re-indexed
Date
~四酉~甲剰
「
厠町
的
RLA Flle
:08/24/040/00202/AM15/
Lic No/Date10810133096
Date
072015
:InthelightofO M No 35011/658/2014-PI(NoHlns)dated 20 05 2015 the
decided to forward a copy ofadvance authorization application to the Deptt.
f Pharmaceuticals.
Re-indexed
Date
072015
~口戸
「
ド鱚踪滞狙勤府耐ル
RLA F‖ e
:03/94/040/00358/AM15/
Pharmaceutica ls.
甲¨ 甲囮野1濶融
~
RLA File
:09/24/040/00275/AM15/
120
## Case No.:3579/82-ALC4/2014
:01/82/050700832/AMi5/
Partv Name:CADII-A
HEALTHCARE LTD,
Meet No/Date:3/82‐
:08′24/040/00203/AM15/
:01/82/050/01218/AM15/
Lic No/Date:0310788338
25082014
:01/82/050/01048/AM15/
Lic No/Date:0910060885
25082014
『
072015

: ln the light of written comments received from D/o Pharmaceuticals vide their OM
35011/630/2014‐ PI(Norms)dt 20 05 2015 ‖was decided to call for following informaJOn
the firm:
i. 
Justification for requirement of imported inputs in view of the CA certificate
furnished by the firm, and
ii. 
Past production vis-a-vis actual consumption of all imported inputs duly certified by
Central Excise Authorities.
No:46/13/82‐
4/2014
Re-indexed
yl蹴鼎
C酬∞ω器
`[需聴~
:01/82/050/01049/AM15/   1:0924/040Ю 0271ハM15/   25082014
Decision:比was decided to deferthe case for want ofcomments of Department of
Pharmaceuticals.
鯰
4田匝墨慕戸膨肥
OЮ∝
"ムⅢシ     1締獅ξ
1認え器
膠
rED腰
聴
続
Re-indexed
Re-indexed
20052015
: The Committee decided to remind the firm to furnish the information/documents
were earlier called for vide minutes of Norms committee meeting No.19/82 dt19.3.2o15.
On the DGFT website
F"血
2/7/82‐ALC伽
4M器
趾
♀DI鰍
r副
秘
Meet No/Date:3/82- status:
: The committee decided to ratify the norms based on the recommendation
Department Of PharmaceuJcals vide l D No 35011/03/2015-PI(Norms)dt 20 5 2015 as
ils given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty
216‐Methoxy-2‐
Naphthyl)
lkg
2-Acetyl-6-Methoxy Naphthalene
1 04 kg
Hydroxylamine Sulphate
0 48kg
Ｏ
　
ｅ
ｐ
P『りNalne:HETERO LABS
Meet No Date:3/82-
## Case No.:264/13/82‐
ALC4/2014
20052015
Meet Nυ Date:3/82-
Lic No/Date:091oo60892 1
26082014    1
『
_■9-
No:42/9/82-
NameiCADILA
Date
5

Propionic Acid (DL
Acid)
Activated Carbon
0 04kg
Caustic Potash Flakes
1 14kg
―
―
ト
イ
ー
No:255/13/82‐
`/2014
Name:THE
Meet No′1)ate13/82-
MORARJI   IALC4/2015
Re-indexed
Pary Name:SARV BIO
Meet No/Date:3/82-
1261器
3児50Ю こ
νAM15/~澁
lハMl夕
~      
日
麗
雨
## Case No.:43/9/82-
ALC4/2014
LABS PVT LTD,
ALC4/2015
Re-indered
り8鵬
3児5υ∝
"7晨
my ttλ
糀
OЮ
""ハ
my l撚
辮
Ю釧
"“
舅5躊
聴
20052015
: The Committee decided to remind the firm to furnish the information/documents
were earlier called for vide minutes of Norms Committee meeting No.01/82 dt. 15.4.2015
on the DGFT website.
## Case No.:224/13/82-
Meet No/Date13/82‐
ALC4/2014
ALC4/2015
Re-indexed
20052015
Meet No/Date:3/82-
Deferred
ALC4/2015
Re-indexed
20052015
RLA F‖ c
Lic No/Datc:0310788514 Dcfcr Datc
:01/82/050/01228/AM15/     :03/94/040/00397/AM15/
Partv Name:NAVIN
Meet No/Date:3/82‐
FLUORINE
ALC4/2015
INTERNAT10NAL LIMITED
20052015
File
Filc
1/82/050/01259/AM15/
Department of Chemical&Petro Chemicals vide U O No 14010/92/2011-Ch ll dt 17 6 2015
as per details given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty
Kg/kg
Party Name:DELTA
FINOCHEM PVT LTD
## Case No:225/13/82‐
Parw Name:DELTA
ALC4/2014
## Case No.:256/13/82-
ALC4/2014
- !o-
Date
2015
臨‰Ю“
4υttbノ丁鵬ち鵬
OЮttωttm y圏
of C、 `nerce
鴨酪Lttn

Z- 1,1,1,4′ 4,4-HEXAFLUORO-2-
BUTENE{HF0 1336 mz2)
lkg
1,1-DICHLORO‐2,2,2-TRIFLUORO
ETHANE(HCFC‐ 123)
530
/
N′ N―DIMETHYLFORMAMID[
430
## Case No:257/13/82-
Partv Name:NAVIN
ALC4/20:4
INTERNAT10NAL
ぼ譜胤琺認留
|
1蹴辮創Ю
・6“ 躊需
: lt was decided to defer the case for want of comments of D/o C&PC (Pharma).
Re-indexed
Lic No/Date:0310788560 1 Dcfcr Datc
072015
Partv Name:ANTHEA
Meet No/Date:3/82-
AROMATICS PVT LTD,   IALC4′ 2015
20052015
Defer Date
072015
ド““"Deた
rred
landRe‐
indexed
B3鵬
脇
5υm266/AMЫ  tttttυ
00967AMl″  
ぼ悧gttαO釧07田∬8
甲
留
/13/82‐
Re-indexed
Defer Date
072015
ι
ALC4/2015
Decision : lt was decided to defer the case for want of comments of D/o C&pC (Chemicals)
Meci No/D誠o3/82-
ALC4/2015
120052015
Fr+d grrrY/ Nr
もЧ
…
繊
日
…
Dy                       dO
器謝鶴騒::緊f:設λ驚瀧
ud菫嘉晟瓢誡
l“
## Case No:262/13/82-
ALC4/2014
Party Name:ANTHEA
AROMATICS PVT LTD,
## Case No:263/13/82-
ALC4/2014
Party Name:RA CHEM
## Case No:63/13/82-
ALC4/2014
Party Name:JUBILANT
GENERICS LTD
## Case No.:60/9/82-ALC4/2014
_gi″
B2鵬
3児
"畑
%5ハm夕
陽ら鵬
υ∞鯛A而
Name:SATYADEVA
/P/
TD,
File
No/Date:3/82-
No/Datc:3/82‐

V
Lic No/Date1051 0390923
02092014
dt 2 3 2015 as per
137
器3児5剛
η ttmy~鵬
棚
oЮ
“
鰤Att y~1蹴
鼎
α
“
Ю
・
8“7躊
需
of pharmaceujcals vide l D No 35011/573/2014-pl(Norms)
given below or as applied by the firm whichever is less:-
Export product
lmport item
Qty in mg for export of 1 tablet
250mg tablets
500mg tablets
Azithromycin Tablets
250m9 and 500m9
Azithromycin
Dihydrate
259 50mg
519 02mg
## Case No:223/13/82-
Party Name:KRISHNA
Meet No/Date:3/82-
ALC4/2014
ANT10XIDANTS PVT LTD IALC4/2015
Re-indexed
20052015
: lt was decided to defer the case for want of comments of D/o c&PC (chemicals)
Party Name:S V CHEM
ヽleet No/Date:3/82-
INTERMEDIATES P LTD
ALC4/2015
Re-indexed
20052015
Defer Date
072015
: : lt was decided to defer the case for want of comments of D/o C&pC (Chemicals).
Party Name:DANOPHARM lMeetNo/Date:3/82-
CHEMICALS PRIVATE   ALC4/2015
Re-indexed
20052015
: lt was decided to defer the case for want of comments of D/o C&pC (Chemicals)
Re-indexed
: The Committee decided to remind the firm to furnish the information/documents
were earlier called for vide minutes of Norms Committee meeting No.19/82 dt.18.3.2015
uploaded on the DGFT website.
Name:KUSUMA
No/Date:3/82‐
15
B9鵬
島泥50Ю 1262/AM Ⅳ 
鵬
臆
OЮ
“
ηハⅢ夕 1蹴
鼎
C"Ю
・
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齋
-9■
1、′NIRYAL
茸1臨
輛
d諦牲
・
                      li
…
D ttteCeおera of F6r60n Trade
価
枷
Depa山me■延COTrnerCe
## Case No:3/7/82-ALC4/2014
Lic No/Date:0410159328
02092014
## Case No.:259/13/82-
ALC4/2014
## Case No.:75/9/82-
ALC4/2014
HEALTHCARE(P)
## Case No:235/13/82‐
ALC4/2014
しd癬鷹黒ξ炉
lLlい
-3ヽ一
15
15/

V/
/
:01/827050Ю 1238/AM15/
Lic No/Datc:0310788804
05092014
Export product
Qry
lmport items
Qty kg/kg
Sodium saccharin (Pure
Dental Grade)
lkg
Sodium Saccha rin
1 02kg
may take further action accordingly.
15.4.2015 as per deta ils
Department Of PharmaceuJcals vide l D No 14010/32/2013-ChJl dt
below or as applied by the firm whichever is less:-
IDecision:t was decided to deferthe case for want ofcomments of D/oC&PC{ChemiCab)
Status:Deferred
and Re-indexed
И3鵬
星児50畑り9晨Ⅲy陽
ら鵬
OЮ
“
6ハm夕
1認開
°
"Ю
・
"勢
Defer Date
09072015
IDecision:t was decided to deferthe case for want ofcomments of D/oC&PC(Pharma)
: ln the light of written comments received from D/o Pharmaceuticals vide their OM
No 35011/633/2014‐ PI{Norms)dt 10 4 2015′
t was decided to call for followig informaJon
144
the firm:-
1. Detailed production of export product under reference in the year 2014-15 and
corresponding consumption of raw-materials duly certified by CA
2. Basis of applied quantity of raw materials including authentic printed literature in
support of the quantity raw material.
3. Any other relevant information.
## Case No:27/13/82-
1451ALC4/2014
Patt NameiSTERLING
IAUXILIARIES PVT LTD
RLA File
:03/95/040/00494/AM15ノ
顆
蕊
"0ハmy
Re-indexed
Defer Date
072015
常剰
坦藝
:
09072015
Party Name:KOPRAN
LIMITED
ALC4泡015
20052015
_らら一
No.:22/13/82-
Namc:MANGALAM
No′1)ate13/82-
Y DUJODWALA
1器3児50Ю Ю
25晨Mlシ
No.:201713/82‐
Name:KRISHNA
No/Datc:3/82‐
I Defer Date
109072015
No/Date:3/82-

lDecistt ltwasdec面高扇ざ薦藤醗F再孫dcttme薦
`fD/oC&PCに
hemにJ● |
## Case No.:23/13/82-
Party Name:YASHO
Meet NolDatc:3/82‐
ALC4/2014
PヾDUSTRIES PVT LTD
ALC4つ015
Re-indexed
20052015
И6鵬
島児50/O1026/AM Ы  
障蹴
υ∞の6ハⅢ夕 1蹴
開
°
"Ю
・
翻1画
需
И7器
3児5¨
3Amy ttλ
乳
OЮ餌∞AⅢy蹴
辮
“
Ю
・
“"顆
Decision : lt was decided to defer the case for want of comments of D/o C&PC (Chemicals)
Party Name:YASHO
Meet No Date:3/82‐
INDUSTRIES PVT LTD
ALC4/2015
Re-indexed
20052015
: lt was decided to defer the case for want of comments of D/o C&PC (Chemicals)
Meet No Date:3/82-
ALC4/2015
Re-indexed
20052015
: lt was decided to defer the case for want of comments of D/o C&PC (Pharma)
Re-indexed
: lt was decided to defer the case for want of comments of D/o C&PC (Pharma)
И8鵬
3児wm“ 5/AMЫ
陽角鵬
OЮ∞押AM夕
1悧辮
Ю釧∞ω 鯰4M
5°
鵬
島児50畑
“
67AM″ 
膨
鵬
OЮ鬱
“
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鼎
酬
∞ω %0[需
聴
町
~
Partv Name:MYLAN
Mcct No/Datc:3/82‐
LABORATORIES LIMITED :ALC42015
20052015
Re-indexed
Re-indexed
: lt was decided to defer the case for want of comments of D/o C&PC (Pharma)
No.:64/13/82-
Party Name:MYLAN
Meet No/Date:3/82-
4
LABORATORIES LIMITED IALC4/2015
20052015
: lt was decided to defer the case for want of comments of D/o C&PC (Pharma)
Namc:DiVIS
Meet No Date:3/82‐
TORIES LTD,
ALC4つ015
剛
港識:
::
u凛兜轟瓢誡
[面
## Case No.:250/13/82-
## Case No.:62/13/82‐
ALC4/2014
Party Name:EYTAN LABS
LIMITED
## Case No.:71/13/82-
ALC4/2014
## Case No:66/13/82-
ALC4/2014
-3Ч 一
20052015

鵬
3児50Ю  Ю69AM Ы  
隔角棚
OЮ0303晨m夕 |
: The committee decided to ratify the norms based on the
Department of PharmaceuticaL vide l D No 35011/636/2014-PI(Norms)
ils given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty
kg/kg
Fumaraldehyde BIS
(Dimethyl Acetal)
lkg
Furan
060
Methanol
343
Chloroform
100
Lic No/Datc:0910060941
11092014
recommendation of
dt 18 52015 as per
1濶
m‐
冨
## Case No.:69/13/82‐
ALC4/2014
LABORATORIES LTD,
Export product
Qty
lmport items
Qty
Kg/kg
B‐10NVLIDEN      ETHYL      TRI
PHOSPHONlUM   BROMIDE   (B―
CAROTENE WlTTIN6 SALT)
ETHYLENE DI BROMID=
120
TOLUENE
TRI PHENYL PHOSPHINE
HYDROBROMIC ACID 47%
TETRA HYDRO FURAN
115
METHANOL
METHYLENE CHLORIDE
: The committee decided to ratify the norms based on the
Department of Pharmaceu,cals vide l D No 35011/635/2014-Pl(Norms)
given below or as applied by the firm whichever is less:-
RA may take further action accordingly
recommendation of
dt 18 5 2015 as per
鷺ら鵬
OЮ0547AM Ы  
ヤ|¶器
CO釧0789054
to defer the case for want of comments of Oepartment of
~ 「謎ぶぉぱ
7/13/82-
Ы
Defer Date
072015
1習雷潔理丁冠菅面高悪而
ed
~日需需P直腑麟芦ル騨、
|1器3掲50/O1075AMⅣ IЪ危乳。Ю鬱
87晨Ⅲ
融
-3ゞ―
語:か鐘聾D。
Namc:DiVIS
Name:KOPRAN

/
P ha rmace utica ls.
Meet No/Date:3/82‐
ALC4/2015
20052015
RLA Flに         
圧たNo77Dac091oo60952
Ъち糀OЮ029ソAM耐 け」
;る品
: The committee decided to ratlfy the norms based on the recommendation of
157 Department of PharmaceuucaL vide l D No35011/29/2015-PI(Norms)dt 20 5 2015 as per
ils given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty Kg/kg
4-Hydroxy
Carbazole
lkg
1,2,3,9-Tetrahydrocarbazole-4-One
120
Fこ｀… … `｀「
1器星掲
50畑073AMly
匝
…
1錯殿盤∵
囲辮¨ω
%4
Defer Date
of Pharmaceuticais vide l D No 35011/33/2015‐ pl{Norms)dt 29 5 2015 as per
ls given below or as applied by the firm whichever is less:-
Export prod uct
Qty
lmport items
Qty
Kg/kg
2‐AMINO METHYL‐ 7‐
CHLORO‐ 1,3-
DIHYDRO-5(2-
FLUOROPHENYL) lH‐
1′ 4‐BENZO DIAZEPlNE′
DIMALEATE {AMINO
DIMALEATE)
lkg
2-AMINO‐ 5‐CHLORO-2-FLUORO BENZ0
PHENONE
0932
CHLORO ACETALDEHYDE DIMETHYL
ACETAL
0696
MANGANESE D10XIDE
0852
RANEY NICKEL
0089
DIMETHYL SULFOXIDE
0405
ACETONE
0405
## Case No:65713/82‐
ALC4/2014
lDecision : lt was decided to defer the case for want of comments of D/o C&PC (pharma)
## Case No.:61/13/82-ALC4/2014
Pa●y Name:SHODHANA
LABORATORIES LTD
:01/82/050/01064/AM15/
:09/24/040/00310/AM15/
鍬
躍幽
]
::
纂聯器拙Te
_3く一
Name:MSN
No/Datc:3/82‐
Re-indexed
15/     12092014

V/
## Case No:25/13/82-
ALC4/2014
Party Name:TITAN
Meet No/Datc:3/82-
LABORATORIES PVT
ALC4/2015
LTD
20052015
and Re-indexed
b9鵬
3児釧
唸8ハmy隔
馳
90“
“
ハmy l蹴
辮
Ю釧
"翔
∞
Defer Date
072015
IMeetNo/D江o3/82‐
Deferred
ヒ偲PRATORIESPVT    IALC47720F
Re-indexed
## Case No.:28/13/82-
ALC4/2014
: lt was decided to defer the case for want of comments of p ha rma ceutica ls.
「
"-3/82‐AL鍬田   
吻
嚇
戸   
圏P耐
: The committee decided to ratiry the norms based on the recommendation of
Department of Pharmaceuticals vide l D No 35011/627/2014-pl(Norms)Dated 20 5 2015 as per
given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty.kg,/kg
(2 R-Cis)-4-amino-1-[2-
(hydroxymethyl)-1,3-
oxathiolan-5-yll-2(1H)-
pyrimidinone
monosalicylate
monohydrate
lkg
GLYOXYLIC ACID-50%
08630
2,5 DIHYDROXY l,4 DITHIANE
03784
CYTOSiNE
05024
HEXAMETHYL DISILAZANE
08206
DlMETHYL FORMAMIDE
022
TRIETHYL AMINE
077
METHYLENE CHLORIDE
388
SAL CYL C ACID
044
SODIUM BOROHYDRIDE
026
DIPOTASSIUM      HYDROGEN
PHOSPHATE
0988
Re-indexed
HQ Fne
:01182/050/0l19llAMl5t l:B/94/040t00
戸1協器。
側面戸   M、
T
Defer Date
## Case No.:188/13/82-
ALC4/2014
_g¬ _
Name:TITAN
Name:DELTA
1翻言釧
2

Party Name:INDO PHYTO
CHEMICALS PVT LTD
No:9/3/82‐ ALC4/2015
Meet No/Date:3/82‐
ALC4/2015
20052015
RLA F‖e     
したNo/DaeЮ 510391194
Defer Date
:05/23/040/00262/AM15/
: lt was decided to defer the case for want of comments of Pharmaceutica ls.
Re-indexed
18092014
072015
1麟
¨
%4鵬
3鬼59mtt1/AMV I糀
鵬
OЮO152/Amy l蹴
器
3綱∞価
01需
聴
~甲¨ 甲ポ… 濶融‐5
%5器
3児59m060/AMW
袂ぱ
LAB LIMITED
墓璽壼雷理澪辱轟尋輩         -38-
Lic No/Date:0510391246 Defer Date
105/23Ю40/00277/AM15/     19092014
IMeetNo/Datc3/82‐
Deferred
“
6鵬
島児50Ю  ЮθttM W 
鵬蹴
OЮ
"7″
AM Ы  
囲
鼎
e l15 1""2¶
慨
宵
ALC4/2015
]zo.os.zo r s
Pary Nam●HONO■lR MeetNoわ
ate382‐
ALC4/2015
20052015
Re-indexed
: lt was decided to defer the case for want of comments of D/o C&PC (Chemical).
Party Name:YASHO
Meet No′つate:3/82‐
NDUSTRIES PVT LTD
ALC4/2015
20052015
~IRLA RL      uc No/DateЮ
310789471
:01/82/050/01252/AM15/
1:03/95/040/00518/AM15/
19092014
## Case No:59713/82‐
ALC4/2014
Pary Name:HELLO PAINTS
(P)LTD
## Case No:249/13/82-
ALC4/2014
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide l.D.No.140tll95/2OL].-Ch-ll Dated 30.4.2015 as per details
given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty kg/kg
YAPOX CL 30/10"HYDROQUINONE
BIS{2hydroxv ethyl ether)
l kg
HYDROQUINONE
0 61l kg
¨凛臨黒灘l
No.:18/13/82-
F‖ c

器島児
5mttAMl夕協鵬。Ю“
53/Amy l翻鼎°
"Ю¨7諦雛2,“ふ
:
: ln the light of written comments received from D/o Pharmaceuticals vide their OM
No 35011/37/2015-pl(Norma)dt 5 6 2015 t was decided to callforfollowing information from
firm:
a) Specific use of Lithium metal and n-Butyl chloride is not given in the
process/Reactions. How these are consumed in the process may be explained.
b) Past Production vis-a-vis Actual consumption ofall imported inputs duly certified
by Central Excise Authorities.
1鵬監∽鯰θハmy
Lic No/Date:0510391274
Defer Date
23092014
072015
ι
Meet No/Date:3/82-
ALC4/2015
20052015
Status:Deferred
and Re-indexed
Lic No/Date:3410040570 DeFer Datc
23092014
072015
Re-indexed
Lic No/Date:0510391308
Defer Date
24092014
072015
No/Dttc:3/82-
Re-indexed
,商ョ
ョ"l、
′NIRMAL KU～
## Case No.:75/13/82-
ALC4/2014
―
:01/82/050/01078/AM15ノ
## Case No.:17/13/82‐
ALC4/2014
~F蕊需面薦
## Case No.:74/13/82-
ALC4/2014
ALC4つ015
20052015
## Case No.:192/13/82‐
Pa●y NameINDOFIL
INDUSTRIES LTD
υd菫鴨品爪誡
|は
ALC4/2014
-3年
052015
口2器
3児5∽Ю77晨my陽
角慌
υ0028νAm夕
‖ 18ムM15/  
Ю2/24Ю 40/00097ハM15/
No/Date:3/82-

鵬3児59mり5晨剛
" 
脇
鵬
OЮ
“
りAMI夕 1用
ma"Ю
.%%B宥
獅F
Party Name:MICRO LABS
Mcct No/Datc:3/82-
LTD
ALC4/2015
Re-indexed
20052015
Defer Date
072015
Pha rmaceutica ls.
Meet No/Date:3/82‐
ALC4/2015
Re-indexed
20052015
Defer Date
:01782/050ノ01033/AM15/     107/24/040/00218/AM15/
072015
decided to defer the case for want of comments of Department of
ａ
Ｗ
　
Ｓ
Re-indexed
Lic No/Datc:0310789677
Defer Date
25092014
072015
蛛
T
Pha rmaceutica ls.
Defer Date
072015
К
Meet No/Date:3/82‐
ALC42015
20052015
0な/AM 15/
of FO,09n irade
## Case No.:148/13/82‐
ALC4/2014
Lic No/Datc:0710106752
24092014
## Case No:30/13/82-
Party Name:R L FINE CHEM
ALC4/2014
Lic NυDate:0710106755
24092014
## Case No:158/13/82‐
Meet No/Datc:3/82-
## Case No.:159/13/82-
ALC4/2014
PHARMACEUTICALS
INTERNATIONAL PVT
Lic No/Date:0310789678
25092014
## Case No.:20/13/82-ALC4/2014
Partv Name:PRC)LIFE
INDUSTRIES LINIITED
Lic No/Date1081 0133449
:08/24/040/00124/AM 15/
25092014
―Ч。一
Name:BDR
No/Date13/82‐
Re-indexed
162′りヽM15/

Decision:The commttee decided to ra■fy the norms based on the recommendation of
Department of Pharmaceutica:s vide l D No 14010/74/2014-Ch‐
li dt 30 4 2015 as per deta‖ s
given below or as apphed by the irm whicheverisless:
Export product
Qry
lmport items
Qty kg/kg
Dehydro Thio para toluidine
Solfonic Acid
lkg
Para Toluidine
1 85kg
Party Name:JUBILANT
GENERICS LTD
## Case No:21/13/82-
ALC4/2014
Pharmaceuticals.
Is)
Meet No/Datc:3/82-
ALC4/2015
Re-indexed
20052015
Defer Date
072015
“
0器3児50畑053AMl戸
戦角鵬
OЮO劉1/AM Ⅳ
目面
Ⅲ
爾
Defer Date
072015
It was decided to defer the case for want of comments of D/o C&pC (petro
Deferred
Re-indexed
一
　
‐
８
‐
鵬
星鷺50畑
“
仏M戸
罹
蹴
oЮ0444/AM14/1悧
辮
“
Ю391367
Defer Date
09072015
: lt was decided to defer the case for want of comments of D/o C&pC (petro
No.:52/13/82-
B2日扇蔦蕊戸1脇面高蕊戸1悧鼎劇Я
"釧"騰辮
|:‖l‖‖
1:li:t Was decided to deferthe case fbr want ofcomments of D/oC&PC{Petr。
―
4
No.:49/13/82-
4/2014
PETROCHEM PRIVATE   .ALC42015
Re-indercd
Lic No Date:0510391389
Defer Date
雪黒鞘機器
榔鋼憮獅』
卿
信
## Case No:50/13/82-
ALC4/2014
PaりName:PAYAL
PETROCHEM PRIVATE
LIMITED
Status: Deferred
and Re-indexed
ALC42015
20052015
Pa,y Namc:SENTISS
PHARMA PVT LTD
_崎l´
口9鵬3月50/O102仏m夕 
陽
乳
OЮttω/AMЫ I蹴
辮
ЮЯ0391"7
No/Date:3/82‐
No:51/13/82-
Name:PAYAL
No/Datei3/82‐
Name:PAYAL

囁1濶
納‐m
嗣夕1繭亥繭柵背
Dr want ofcomments of Department of
ン脚… 鱚
瀞
1器鼎α∝Ю
・%郡常獅ξ
)r want ofcomments of D/oC&PC(Chemicals).
l:0 I I 82 / 050 I 0 l0s2l AM I s /
Ю
5つ4/04ν00284/AM15/ レ6092014
Department of pharmaceuticals vide l D No35011/28/2015‐ Pl(Norms)dt18 5 2015 as per detans
below or as applied by the firm whichever is less:-
―」42-一
No.:19/13/82‐
Name:SANO
No77Date:3/82-
KITS PVT LTD,
Re-indexed
開掲Ю畑唸
2晨〕
肩
10159504 1 Defer Datc

2-(4-Cyanophenylamino)
Acetic acid
l kg
4-Amino Benzonitrile (or) 4-
Cyano Aniline
093
Ethyl Acetate
108
Causticsoda Lye
032
No.:15/13/82-
4/2014
博9器
3澪50畑∝8ハШ y障
角鵬
υOm6鳳剛夕
Mcct No/Date:3/82‐
ALC4/2015
20052015
Lic No/Date:0310789922
Re-indexed
Deferred
Re-indexed
jttt酬ふ翻駐冊de
詢
や円mワDepanment OF Commerce
## Case No.:19/1/82‐
Defer Date
072015
Re-indexed
Lic No Date:0310789905
Defer Date
01 102014
072015
眸淵:馴¨
1泰
『
産
Par& Name:TATVA
CHINTAN PHARMA CHEM
Lic No/Date:3410040594
30092014
蒻
―
―
―
―
鳳
服
濶
ル
 weALEMBIC諄
謂
"師
~
|
器3掲50畑Bνttly 
彫
棚υ側御A而
~~~囲
所
戸
繭
耐
「
~~
Decision:The commttee decided to raJfy the norms based on the recommendation of
Department of PharmaceuJca:s vide:D No 35011/40/2015/PI(Norms)dated 05 06 2015 as per
detai:s given below or as app:ied by the lrm whicheverisless:―
Export product
Qty
lmport items
Qty
Kg/kg
NITAZOXANIDE
l kg
2-AM:NO-5-NITROTHIAZOLE
059
METHYLENE CHLORIDE
248
ACETONE
275
ACTIVATED CAR30N
0100
## Case No.:157/13/82-
ALC4/2014
ALC4/2015
―Ч3-
01 102014
じdttlξ ELF百そ誡
l“
‐
‐
ノ
ｒ
‐
‐
‐
‐
―
―
―
Name:AVA
No′Date:3/82‐
朗鵬3児5m“0ムmy 厖乳υ∞ω
3晨my

ParyWToMALLAD
ｎ
ン
IALC4/2014            ii111liCEUTICALS
I器3鬼50ЮЮ
80晨M剛
障危鵬
OЮ創
64ムmy
Lic No/Date:0410159520
Defer Date
01 102014
072015
ls
一
　
９
## Case No.:160/13/82-
ALC4/2014
Deferred
Re-indexed
Defer Date
072015
: lt was decided to defer the case for want of comments of D/o C&PC (Chemlcals).
Meet No′1)atc:3/82-
Meet No/Date:3/82‐
CROPSCIENCE LIMITED
## Case No.:13/13/t2- ALC4l2Ol4 Party Name:FINE CURE
lV..r f.folOur":ttZ jSt"t*t
PHARMACEUTICALS LTD. IALC4/20 t 5 
jApprovr
- - libG.zors l"
He Fite 
l[aA Fitt 
Et.M/D."t"rsl0'33503 t-
:01/82/050/0t0t6/AMls/ :08t24t040t00233/AMt 5t 
107.t0.20t4 
I
Decision r it " .orritta" O".ia"a to ratify the ffi, 
U.r"A on tt " ,".ornrn*artion
Department of Pharmaceuticals vide t.D.No.35o1tl23l2075-ptlNorms) dt. 16.5.2015 as
details given below or as applied by the firm whichever is less:-
Export Product
Qty
lmport items
Qty
AMOXiCILLIN     AND
CLAVULANATE
POTASS:UM   TABLETS
625 MG
1
Tablet
AMOXICILLIN TRIHYDRATE
585 mg
POTASS:UM CLAVULANATE +
MICROCRYSTALLINE
CELLULOSE(1:1)
1518′ mg+1518=3036
mg
ALUMiNIUM    LAMINATED
PR!NTED F01L
As per packin8 policy
ALU ALU BOTTOM FO:L FOR
BLISTER PACK
As per packing policy
Party Name:HETERO
DRUGS LIMITED
:09/24/040/00362/AM 15/
Filc
ALC4/2015
20052015
Lic No′ Date:0910061060
Defer Date
07102014
109072015
_Ч Ч―
No:77/13′82-
|

り8器
疏
50Ю H37晨my 
区
ち棚
OЮ。0劉ムMЫ
I DeferDate
109072015
: ln the light of written comments received from D/o Pharmaceuticals vide their OM
No35011/631/2014-Pl(Norms) dt.20.5.2015. lt was decided to call for following information
n the firm:
i. 
Complete technical details as per Appendix-33 including Mol.wt. of reactants
and output product for each step.
ii. 
Copy of Technical Literature in support ofyields envisaged, and
iii. 
Past production vis-a-vis actual consumption of all imported inputs duly
certified by Central Excise Authorities.
Party Name:MAHAVIR
Meet No/Date13/82-
Deferred
SYNTHESIS PRIVATE
ALC4つ015
Re-indexed
LIMITED
♭0052015
: lt was decided to defer the case for want of comments of D/o C&PC(
Pha rmaceutica ls).
酔諧:懃
:
Defer Date
09072015
: The Committee decided to remind the firm to furnish the information/documents
ich were earlier called for vide minutes of Norms Committee meeting No.01/82/15 dt.
15 4 2015 uploaded on the DGFT website
‐RLA F‖ c
20052015
したNo/DateЮ 310790001
197
## Case No.:33/t3/82 -ALC4?(/'4learty Name:KLJ
lMeet No/Date:3/82- lsrrtrs
TPI,ASTICIZERS LTD.. 
I LC4t2015 
lApproved
I 
l2o.o5.2o 15 
|
Ha F,b 
lRtA Fll. 
E"No/Dare05 r039l4,5,
:0 t/82/o5o/o to36/AM t5/ 
l:o5/23t040too256tAM15/ lOZ.rO.ZOra 
I
D*M;.tlfy 
il" ."rrr b.t"d-on tt" ,".orrendation of
Department of Pharmaceuticals vide 14010/36/2011-Ch-ll dt. 03.3.105 as per details given
below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty
Kanato卜8080
lkg
Terephtha‖ c Acid
0 447kg
Ethyl Hexanol
0 740kg
## Case No.:134/13/82-
ALC4/2014
Lic No/Datc:5210041251
07102014
## Case No.:179/13/82-
ALC4/2014
ALC4/2015
20052015
## Case No.:182/13/82‐
ALC4/2014
CHEMICALS PVT LTD,
一Ч5■
Defer Datc
/
File              lRLA File             lLic No/Date:0310790000
182/AM15/     :03/94/040/00622/AM15/     108 102014

: The committee decided to remind the firm to furnish the information/documents
were earlier called for vide minutes of Norms committee meeting No.o1/82/15 dt.
4 2015 uploaded on the DGFT website
## Case No:29/13/82-
Paty Name:JUBILANT LIFE
Meet No/Date:3/82-
ALC4/2014
SCIENCES LIMITED
ALC4/2015
Re-indexed
20052015
3 lt was decided to defer the case for want of comments of D/o C&pC (Chemicals).
Pa●y Name:JuBILANT LIFE
Meet No Date:3/82‐
SCIENCES LIMITED
ALC4/2015
Re-indexed
20052015
Lic No′ Date10510391491 1 Defer Date
:01i82/050/01038/AM l5/ 
:05t23/040t00218/AM15/ lOt. t O.ZO ta
Pa“y Namc:NEULAND
Meet No Date:3/82‐
LABORATORIES LTD
ALC4/2015
Re-indexed
20052015
Lic No Date:0910061074
Defer Date
09102014
09072015
: lt was decided to defer the case for want of comments of D/o C&pC (petro
Re-indexed
節4M蕊
戸鵬允棚∽
"“ムmy
Lic No′ Date:0510391511
09102014
Pha rmaceutica ls.
Meet No/Date:3/82‐
ALC4/2015
20052015
dt. 18.5.2015 as per
## Case No:35/13/82-
ALC4/2014
## Case No:103/9/82-
ALC4/2014
## Case No.:146/13/82-
ALC4/2014
Pa●y Name:RECKI町
BENCKISER
HEALTHCARE INDIA
## Case No:275/13/82-
ALC4/2014
PHARMACEUTICALS LTD
Lic No/Date:0810133557
10102014
of Pharmaceuticals vide l D No35011/632/2014-PI{Norms)
No/Datc:3/82-
2015
―Чも一

ン
ls given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty Kg/kg
NATEGLiNIDE / NATEGLINIDE
FORM H
l kg
TRANS 4 1SOPROPYL CYCLOHEXANE
CAR30XYLIC ACID
069
D―PHENYLALAN:NE
070
HEXAMETHYL DISiLAZANE
075
ACETONITRILE
218
## Case No.:104/9/82-
ALC4/2014
|百肝ラName:NEUI´ AND   IMeetNo/Date:3/82-
「
AЁORATOkESLTD  I錯
殿盤F
Defer Date
072015
Re-indexed
鰹
腑
叫
 
「
   
翻
r纂
岡
蹴
脚
207      ~所蒻扁蔦覇而戸      瞬麗語
Pharmaceuticals.
## Case No:111/9/82-
ALC4/2015
20052015
208
Fttm面~|    |
1器3掲50/OIИ3AMly~
Lic No/Datc:0710106816
Defer Date
:07/24/040/002287AM 15/
13 102014
072015
: ln the light of the comments of Department of pharmaceuticals vide
1.D.No.35011/11l2015-pt(Norms) dt. 05.05.2015 , firm has furnished batch manufacturing
of amoxicillin tables only and other details not provided by the flrm. Therefore, it was
to call for complete information from the firm.
R.響幾撫
R
_Ч つ´
Name:HETERO LABS

## Case No.:184/:3/82-
Meet No/Date:3/82‐
ALC4/2014
PHARMACEUTICALS
Lic No/Date:0310790237 1 Defcr Date
:01/82/050/0 t 187/AM l5/ 
'':031941040/0067 5lAMl5/ ll4. t0.2014
: ln the light of written comments received from D/o Pharmaceuticals vide their oM
No35011/13/2014-Pl(Norms) dt.08.06.2015. lt was decided to call for followinB information
the firm:
A copy of valid Drug manufacturing License granted by concerned State Drug
Controller.
No.:272/13/82-
4/2014
4
Dy欄鼎
需
de
柵
需誌::器漏
:譜ぎλ鷲瀧
udy。聾轟謀尉乱in
NameiSAIBABA
Meet No Datc:3/82‐
ACTANTS(P)LTD,
ALC42015
Re-indexed
20052015
鷺ち棚υ∞
zッAⅦ夕腔∬鼎°囲∝
""7
Defer Date
072015
: lt was decided to defer the case for want of comments of D/o c&Pc (Petro
ls)
: ln the light of written comments received from D/o Pharmaceuticals vide their OM
No 35011/3712015-Pl(Norma) dt. 5.6.2015. lt was decided to call for following information from
firm:
a) Specific use of Lithium metal and n-Butyl chloride is not given in the
process/Reactions. How these are consumed in the process may be explained.
b) Past Production vis-a-vis Actual consumption of all imported inputs duly certified
by Central Excise Authorities.
## Case No.:115/9/82-
ALC4/2014
劉31器
3児50Ю
"12/AMⅣ 
隔ら鵬
∽0376/AMⅣ I青
∬」蹄
Ю剣∞a Ю6岡
爾
背
| 卜01/82/050/0"12/AM15/
1濶
m~
Re-indered
: lt was decided to defer the case for want of comments of D/o C&PC (Chemicals ).
No.:163/13/82‐
1造き腑
e3/82-
101/82/050/01275/AM15/
Party Name:NAGARILINA
AGRICHEM LTD
_Ч9-
Re-indexed
No.:114/9′ 82-
~爾
商
戸
両
面
恵
腑∬
3慇2

'aO,2015
HQ F‖ e
Defer Date
:01/82/050/01166ノAM15/
072015
P ha rmace utica ls.
Re-indexed
1器3児5υO H58/AMl夕
Defer Date
072015
: The Committee decided to remind the firm to furnish the information/documents
were earlier called for vide minutes of Norms Committee meeting No.01/82/15 dt.
4 2015 uploaded onthe DGF「
website
|
＾
Ｚ
´
０
## Case No.:155/13/82-
ALC4/2014
Meet No/Datc:3/82-
CHEMICALS PVT LTD,
Case No■83/13/82-
ALC4/2014
:01/82/050/01186/AM15ノ
Lic No/1)ate103 10790362
17102014
Dn : The committee decided to ratify the norms based on the recommendation of
ment of Pharmaceuticals vide l.D.No35011lL7 /2O75'Pl (Norms) dt. 10.6.2015 as per
given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty
Kg/kg
BLISS FAST PESSARY  EACH CONTAINING
NYSTATIN BP 100,0001U AND OTHER Apls
One Pessary
NYSTATlN BP
21 mg
GYNANFORT PESSARY  EACH CONTAINING
NYSTAT:N8P100′0∞IU AND OTHER APls
One Pessary
NYSTATIN BP
21 mg
GVGYL― N PESSARY   EACH CONTAINING
NYSTATIN BP 100,0∞lU AND OTHER APls
One Pessary
NYSTATIN BP
2tmg
WELLGYNAX PESSARY  EACH CONTAINING
NYSTATIN 8P 100,0001U AND OTHER APls
One Pessary
NYSTATIN BP
21 mg
GYNASTATIN PESSARY  EACH CONTA!NING
NYSTATIN BP 100′ 0001U AND OTHER APls
One Pessary
NYSTATIN BP
2l mg
~除
謎腸lν
3/82‐ ~~
|
2171器
3児50/OH39/A蔦夕
Status:Deferred
and Re-indexed
Defer Date
072015
inLl rile
t,:05 t23 t M)t 00309 I AM I 5 /
脚
地織:
百ξ嚢語
…
dO
卿
鐵
_Чq´
Name:DHANUKA
TORIES LTD
ｄ
ｍ
岬
Ｓ
　
ａ
い
ト

1躙先
5¨7Am夕
|「M蕊蕊戸陪般肥Я
"鈍°
3厩需
: lt was decided to defer the case for want of comments of D/o Biotechnology.
: lt was decided to defer the case for want of comments of D/o C&pC
鰯
珈
:
File
―
ヌ
ン
10790350 Detr Dae~
No.:154/13/82-
No Date:3/82‐
Re-indexed
157/AM15/
No.:117/9/82‐
Namc:INCHEM
No/Datc:3/82‐
Re-indexed
No.:124/13/82‐
Name:PANACEA
LTD,
Re-indexed
No.:135/13/82-
NameiSHREE
No/Date:3/82‐
BEHARILAL
Re-indexed
TICS
Ｄ
Ｔ
Ｌ
Ｔ
ｅ
‥Ｇ
Ｅ
Ｍ
‐
Ｃ
Ｓ
Ｐ
Ｖ
Ｎ
ａ
ｍ
Ｗ
田
3掲5∽
"И
ムmy膨
乳
0加3η嗣
夕
腔∬鼎
“ "∞
aH91腑
紺
1       鵬危棚υ
00306/Am夕

1器鰍F  I
Lic No/Date:05103916601
090■2∝5
Defer Date
25 i:0 I 182/050/0 I I 47 I AM I 5/
RLA F‖ e
:05/24/040/00293/AM15/
Ю1/82/050/OH68/AM15/  Ю3/95/“0/00594/AM13/
う
４
/
ICase No.:144/13/82‐       Partv Nme:PAYAL
咄
…
tzo.to.zott
072015
: lt was decided to defer the case for want of comments of D/o C&pC (petro
Deferred
Re-indexed
Lic No/Date:0510391659
Defer Date
Filc
4
Case wo.,l327l3il82- Farry Namen4OREPEN M..t N"/D"r"'3l82- Ltrt,*
ALC4I2OIA 
LABOMTORTES LTD., lAlCarZOrs 
l,lpprovea
I 
lzo.os.zori I *. - *
Ha Fr" 
iRLATle 
#r*;to"t"os ro:qronl 8"f". D"r"
:O l/82/050/01 135/AM l5/ 
l:05 t24tO4OtOO322tAMt5t 2O.tO.2Ol4 
I
Decision to ,i 
-
decided to ratiry the norms under Para 4.7 of HBP vl as per details given below or as applied by the firm,
whichever is less:
Export Product
■
”
呻
Ｑ
ｕ
ａ
ｎ
S No
Import Item
Q″
A‖owcd
kykg
Montelukast
Sodium
l kg
1
(S)―(E)-2-〔2-[3-(7-chiorO-2-
quinolinyl)― cthCnylphenyl]-3-
hydroxypropyI]―phCnyl]‐ 2-
propanoI
124
2
Methanol
2325
3
N,N-Diisopropylethylamine
030
4
Tetrahvdrofuran
3 15
5
Acetonitrile
０
ソ
う
乙
6
z-lt-
(Mercaptomethyl )Cyclopropyll
Acetic Acid
040
may take
action as per the decision of Norms Committee.
## Case No:145/13/82-
ALC4/2014
1ノ82/050/O1148/AM15/
-5)´
20102014
072015
: lt was decided to defer the case for want of comments of D/o C&PC (
No/Date:3/82-
Re-indexed

|:‖l‖‖
llliltWasdecidedtodeferthecaseforwantofcommentsofD/oC&PC(Petr。
        |
Re-indexed
Lic No/Date:0510391644
:01/82/050/OH41/AM15/   1:05/24/040/00330/AM15ノ
20102014
: ln liBht of the comments of Department of Pharmaceuticals vide
.N035011/436/2015-Pl (Norms) dt. 04.6.2015 decided to call for following information from
firm:-
1. Master batch Formula indicating the actual output of formulation in specified
pack sizes.
2. Net content of each ofthe ingredients (appfieA for import) in one bottle of 180 ml
size.
3. A copy of past consumption data of individual inputs vis-a-vis the actual
production in terms of specified packs of Mucinex Fast max severe congestion
and cough oral liquid, for the last 2 financial years.
Ｅ
睡
Re-indexed
:01/82/050/01142/AM15/
浙
/AⅢ
"
Defer Date
072015
HQ Filc
: ln light of the comments of Department of Pharmaceuticals vide
rr Np3.501u436/2015-Pl (Norms) dt. 04.5.2015 decided to call for following information from
:麗富算1=|「
薇
f●
『
″Depa●ment oi Cc●― _=
躍
糖
2/13/82ド
皿
躙
鴇
瞭麟
ギ
2 1粘
ed
鵬
児50い
ダAMⅣ I跳念鵬
OЮ069νAM Ы
芳∬辮
Ю釧0790392「
~~
Decおlon:The commltee decided to raJfy the norms based on the recommendaJon of
Department of Pharmaceu‖ cals vide O M No35011/12/2015-P!{Norm5)dt 08 06.2015 as per
deta‖s given below or as app‖ ed by the nrm whicheverisiess:―
Export prod uct
Qry
lmport items
Qty
Dorzolmaide
Hydrochloride+Timolol Maleate
Ophthalmic solutions - 10ml
l vial
Timolol Maleate
59.70mg
per vial
may take further action accordingly.
Meet No/Date:3/82‐
Party Name:RECKITT
BENCKISER
HEALTHCARE INDIA
ud瘤鴨轟話鯛
O‐
-52~
P征りNalte:RECKIT r
BENCKISER
No.:138/13/82-
Defer Date
2015
No:139/13′ 82-

firm:-
1. Master batch Formula indicating the actual output of formulation in specified
pack sizes.
2. Net content of each of the ingredients $nnliea for import) in one bottle of 180 ml
3. A copy of past consumption data of individual inputs
the actual
production in terms of specified packs of Mucinex Fast max severe congestion
and cough oral liquid, for the last 2 financial years.
ALC4/2015
20052015
~[葬鮮艦
rttL tti∬ル
冨
ル
Re-indexed
Defer Date
072015
IDecision:t was decided to deferthe case for want ofcomments of D/oC&PC iChemiCals)
|
1230
Defer l)ate
072015
committee decided to remind the firm to furnish the information/documents which were
called for vide minutes of Norms Comm■tee meeung No 01/82/15 dt 15 4 2015
雪酬
F
助囃選零電∫器5'「
`
Direcbrate cene
…
…
,
ud霊聾線
## Case No.:169/13/82-
ALC4/2014
P".tr NrrrVlSiO
Lic No/Datc:0310790376
20102014
## Case No:153/13′ 82-
ALC4/2014
ion: The committee decided to r
tment of Pharmaceuticals vide l.D.N(
below or as applied by the firm whict
aJfy the norms based on the recommendaJon of
)14010/176/2011‐ Ch‐ !l dated 4 5 2015 as per detai:s
lever is less:―
Export product
Qty
lmport items
Qty
Kg/kg
Polymer   Additives‐ N,N′ Dialkyamino―
Diphenyimethane                 
―
(UOPNo 225/Unilink       4200/CN―
2357/STOCK-2357)
l kg
4,4-Methylenedianinne/M DA
0642
Methyl EthyI Ketone/MEK
0700
Catalyst 3% Platinum on carbon
power(2020 Carbon Suinded/
CP RWS DOPED 43515)
000025
on the DGFT webslte
-53´
No/Date:3/82-

2
1謎淵‖ル
 
日躍i応蕊Ⅷ那甲=町
器3鷺50Ю ‖7νAMⅣ 
鵬λ馳
OЮO。0ハmy    l
Decision:The committee decided to ratify the norms based on the recommendation of
Department of PC LD No 46011ノ10/2015-PC‐ ll dt 14 5 2015 as per deta‖s given below or as
app!ied by the nrm whicheverisless:―
Export prod uct
Qty
lmport items
叫
Ｍ
INTRAUTERINE CONTRACEPTIVE DEVlCE
COPPER T 380 A
100 nos
COPPER WiRE (OF HIGH CONDuCTlVllγ
9999%PURE COPPER)
002
INSERT TUBE(MADE OF HDPE)
115 nos
POuCHES
110 nos
COPPER TUB!NG (OF H:GH CONDuCTIV lγ
9999%PURE COPPER)
001656
POLYPROPYLENE     GRANULES(GAMMA
RADIAT10N STABILISED POLYPROPELENE)
0165
COMPOuND OF LDPE RESN AND BARIUM
SULPHATE(GRANULES)
0049
PVC{GRANULES)
0125
F港淵m調2ド魃淋
D
|
234F麗願蔦扇蔦丁
~鵬念乳
OЮ0588ハmy l芳∬粛
「Ю劉
07904」1蹴管
Mcct No/Date:3/82‐
ALC4/2015
Re-indexed
20052015
Deferred
Re-indexed
Fttm源
was decided to defer the case for want
ls.
Party Name:ALEMBIC
Meet No/Datci3/82‐
PHARMACEUTICALS LTD IALC4/2015
20052015
Re-indexed
Defer Date
09072015
of comments of Department of
Meet No/Date:3/82‐
ALC4つ015
20052015
25日33児5m口5ハmy 
脇
乳∽0362/AMⅣ
~階
だ開
°
"Ю"“
“融
## Case No.:172/13/82-
ALC4/2014
Party Name:PRASOL
CHEMICALS LIMITED
― S~ナ
133/AM15/

Casc No.:170/13/82-
237隔
麗
願
薦
高
蔦
丁
~1助
角鵬
餅Om79AMW I芳
∬Z計
34Ю
“
0637出
品宵
1糀譜格D酉鮮ル
IDecision:t was decided to deferthe case for want ofcomments of D/oC&PC(Chemた
als)
Meet No Date:3/82‐
ALC42015
Re-indexed
20052015
Defer Date
88ノAM15/
109072015
Party Name:HETERO LABS
LIMITED
Re-indexed
Defer Date
072015
Decision : lt was decided to defer the case for want of comments of D/o Pharmaceutical.
鵬
島児5∽HB/AMW I賜
肥
。Ю創
ALC4/2015
Status:Deferr€d
and Re-indered
Defer Date
09072015
: ln the light of written comments received from D/o Pharmaceuticals vide their OM
No35011/6/2015-Pl(Norms) dt.20.5.2015. lt was decided to call for following information from
240
firm:
End-use ofthe export product indicating the API produced from it.
Complete technical details as per Appendix-33 including solvent charged and
recovered at each step.
Past production vis-a-vis actual consumption of all imported inprlts duly
certified by central Excise Authorities. 
ll t
鵬
島児50畑
"0/AMЫ  
障角鵬
OЮ釧9畝m夕 
けら鼎
°m∝
"94
## Case No:116/13/82-
ALC4/2014
## Case No:110713/82‐
ALC4/2014
Lic No/Date:3410040635
22102014
## Case No:87/13/82‐
ALC4/2014
PHARMACEUTICALS
_5s‐
173/AM15/
No.:83/10/82-
NげDatei3/82-
Name:MALLADI
No/Date:3/82-
&
PVT LTD   .ALC4/2015         and Re‐ indexed

PLASTICIZERS LTD,
Export product
Qty
lmport items
Qty
Kanato卜400
lkg
Phthalic andydride
0 560kg
Normalbutanol
0560kg
Meet No/Datc:3/82-
ALC4/2015
20052015
HQ File
~~RLA RL    ~~し
たNoDaeЮ 510391766
榊
:j局5υ
“
128/AM W 
騰ち描
oЮo313/AM Ы
 
ば
うち滞
of Chemicals vide 74O7O/36/2011-Ch-ll dt. 03.3.105 as per details given below or
applied by the firm whichever is less:-
Party Name:AMOL
Meet No/Date13/82-
PHARMACEUTICALS PVT
ALC42015
Re-indexed
LTD
20052015
Defer Date
072015
Party Name:ATUL LIMITED, Meet No/Date:3/82‐
ALC4/2015
Re-indexed
20052015
Defer Date
09072015
: lt was decided to defer the case for want of comments of D/o C&PC ( Petro
).
o'E so kt
22囮
mWム
m夕
Pha rmaceuticals.
P ha rm ace utica ls.
RLA File
105/23/040/00311/AM15/
Meet No/Date:3/82‐
ALC42015
20052015
Deferred
Re-indexed
Defer Date
Re-indexed
Defer Date
Lic No/Datc:0510391765
28102014
## Case No:104/13/82-
ALC4/20:4
Lic No Date:1310047687
05 112014
冨
… 1滲
m~
RLA File
:08/24/040/00283/AM15/
1器疏50Ю 271ハmy
_メ
ー
10133734
072015
No:125/13/82‐
∨
No■26/13/82‐
13′24/040/00029/AM15/
ζ蹴蠅憮漱囃
¬ρ
"円
0ロロにヽpartment oi Commerce
ud菫聾轟孫誡
lЫ

i lt was decided to defer the case for want of comments of D/o C&PC (Chemicals).
## Case No.:107/13/82‐
ALC4/2014
26鵬
星掲5m Hν AMy 
膨
鵬
0側96/A剛夕 
諸
∬鼎
α卸
∞
“ “
5再
棚
雷
Partv Name:SHIVA
Meet No Date13ノ82‐
PHARMACHEM LTD,
ALC4/2015
Re-indexed
20052015
ヒ
Meet No/Date:3/82-
ALC4/2015
Re-indexed
20052015
ヽ4cct No/Datc:3/82-
ALC4/2015
20052015
: The committee decided to ratii/ the norms based on the recommendation of
dt 18 5 2015 as per
Department of Pharmaceuticals vide l D No35011/625/2014-PI(Norms)
given below or as applied by the firm whichever is less:-
## Case No.:1/13/82‐
ALC4/2014
No.:121/13/82-
4/2014
7器
3月50畑鯰
4ハM膨
|:L危鵬υ
Om HノAMЫ  11:∬辮Ю
2Ю20,26蹄
Party Name:HETERO LABS
Meet No/Date:3/82-
LIMITED
ALC4/2015
Re-indexed
20052015
Defer Date
072015
も
Party Name:ATUL LIMITED,
No/Datc:3/82‐
:Deferred
15
Pa●y Name:AKZO NOBEL
INDIA LIMITED
## Case No.:267/13/82-
ALC4/2014
Lic No Date10810133743
07112014
3■sobutyl Glutanc Acid(CMH
Diacid)
Lic No/Date:091006H88
07112014
## Case No.:2/13/82-
ALC4/2014
_」ワー
2015
Re-indexed
ヘ
Namc:ELIXIR PHARMA
:01/82/050/01270/AM15/
Ku MAR

10133762
Defcr Date
10112014
072015
: lt was decided to defer the case for want of comments of D/o C&pC (petro
## Case No:3/13/82-
ALC4/2014
Pha rmace utica ls.
No:265/13/82-
4
## Case No.:151/13/82-
ALC4/2014
晰
ツ
:
D rectottte ceneral ci;          ,
…
'日
曖ワDepa■me,        O
udyttЪ凛頭葛尋ヽと
,.L… Ⅲ
Patty Name:AUROBINDO
PHARMA LIMITED
Meet No/Datc:3/82-
ALC4/2015
Re-indexed
20052015
Lic No/Date10910061197
Defer Date
10112014
09072015
Pa●y Name:HJ AROCHEM
ヽleet No/Date:3/82-
鵬角鵬
OЮ舵
“
AM Ⅳ
諸
∬開
°
“
剛
"%8旧
常
£雷
PVT LTD,
ALC42015
Re-indexed
20052015
Meet No/Date:3/82‐
Deferred
ALC4/2015
Re-indexed
20052015
Defer Date
072015
ゝ
Meet No/Date:3/82‐
Re-indexed
20052015
RLA F‖ e
Defer Date
:01/82/050/01354晨M15/   :22/24/040/00068/AM15/
072015
Pha rmaceutica ls.
PaゥName:VIRDEV
INTERMEDIATES PVT LTD
Meet No/Datc:3/82-
ALC4/2015
Re-indexed
20052015
ALC4/2015
2"器
3鬼50畑H7/AM Ы
陽ち鵬
OЮ∞42ハMЫ
賭
∬辮
5釧Om292脇
常
£ 雷
F533風「
31「「
TF二]::~5[[11晏「lto defer the case for want of comments of Department of
Lic No/Datc:0310790870
10112014
## Case No:2/16/82-
Party Name:VENUS
ALC4/2014
Lic No/Date:2210015116
10112014
_59_
No:114/13/82-
File             lRLA File
154/AM15/   1:03/95/“ 0/00631/AM15/

## Case No:111/13/82-
ALC4/2014
Pha rmaceutica ls.
## Case No:5/13/82-
ALC4/2014
Pharmaceutica ls.
## Case No.:108/13/82-
ALC4/2014
|
Re-indexed
Deler Date
072015
Re-indexed
Meet No/Date:3/82-
ALC4/2015
20052015
: lt was decided to defer the case for want of comments of D/o Ayush.
Defer Date
09072015
Party Name:ASTRIX
Mcct No/Date13/82-
LABORATORIES LTD,
ALC4/2015
Re-indexed
20052015
Defer Date
1l l1 2014
072015
る9鵬
島鷺5m H1/AMЫ
陽角糀
0/。。3″ハ剛y
~    
囲需雨
20052015
Defer Date
Decision : lt was decided to defer the case for want of comments of D/o C&pC (Chemicals).
Pany Name:SHREE
Meet No/Datc:3/82‐
BANKEY BEHARILAL
ALC4/2015
BOARD MILLS
20052015
: lt was decided to defer the case for want of comments of D/o C&pC (petro
一
　
２
６
０
Chemicals).
Ptt Namc:HETERO LABS
LIMITED
|
「
¨
112112014
iSt, t u. o"r".."4
iand Re-indexed
I
Defer Date
09072015
騨
翻T
PHARMACEUTICALS PVT
Lic No/Date:0510391927
ll 11 2014
## Case No.:4/13/82-
ALC4/2014
Lic No/Datc:0510391926
11 112014
Status:Deferred
and Re-indexed
## Case No:7/13/82-
ALC4/2014
:09/24/040/00446/AM15/
:01/82/050/01010/AM15/
―'9′
^
Name:ABEERS
1器3児50Ю H`ハⅢy陽
角鵬
∽。352晨MⅣ
Filc
No/Date13/82-
H5/AM15/
15/    111 l12014
2015

一
Ｉ
Ｉ
: lt was decided to defer the case for want of comments of D/o C&pC (chemicals).
3 ln the light of written comments received from D/o Chemicals. vide their OM
4010/2/2015 ChJl dt 27 5 2015 ‖was decided to call for following informaJon from the
:
r. The purity of sebacic Acid - standard grade to be imported and sebacic acid
refined grade to be exported is same i.e. 99.50%. How both the export and import
item can be differentiated? whether the export and import item contains any
specific technical characteristics. The detail may be furnished.
2. The details of production of sebacic acid refined grade from the commencement
of production till date may be fumished duly certified by cA. what is the basis
ofapplied quantity of import item for export ofsebacic acid refined grade.
Ｏ
一
　
ｅ
ｔ
ｃ
５
　
”
¨
ｍ
・
ｍ
Ｄ
０
９
　
０
― ζ。一
No.:120/:3/82-
Name:JUBILANT LIFE
No/Date13/82‐
LIMITED
Re-indexed
123/AM15/
No:3/16/82‐
Name:VENUS
No/Datei3/82-
LTD,
Re-indexed
1器3月5∽B55AMV I跳
ち棚
OЮ∞60晨MЫ
F港淵
1網2 甲囮呼
Defer Date
y
No′つate:3/82‐
10791095
Defer Date
No.:105/13/82- iparry Name:pAyAL lMeet No/D-ate:sls2_
PRIVATE   ALC4/2015         and Re―
indcxed

甲¨ 耶蟄… 1濶級‐鯰
1器脇50/O10BAM剛         
け∬gttC09Ю 06鯰69ミ
ゝ雷
鯰
鵬
3児5mm4ハ
m夕
陽
蹴
OЮttωハm夕
け
∬鼎
"剣
∞a劉
溺棚
雷
L
ICase No:5/16/82‐
ALC4/2014
階∬鼎α
"ЮЮηお日常身ξ
ι
F柵
劉ル    
戸願F万
F繭需
1器3月50/OH25AMl夕
厩
脇
蕊
yl頭
財
而
而
お宥
£管
: lt was decided to defer the case for want of comments of D/o C&pC
器計鶴寵:鋼魔f:設l鷲離
udT絆,■■‐
11:,■1.
: lt was
Pharmaceuticals.
Defer Date
5
decided to defer the case for want of comments of Department
Name:MEDREICH
No/Date:3/82-
Re-indexed
Re-indexed
No.:123/13/82‐
Namc:PAYAL
PRIVATE
器
3鷺50/Ol126/AM Ⅳ 
鵬
危淵
υ00376AM W
ID―
百戻西扇轟1要面謳rthetts3forwantofcOmmentsofDノoC&PC
{petrOChemicals)
瞭鮮ル
_`l´

## Case No.:269/13/82-
ALC4/2014
1器3児50畑277AMV I跳
ち棚
υ00劉夕A剛夕
: The committee decided to ratify the norms
Department of chemicals vide l D No14010/05/2015‐
ch―‖
14
Meet No/Datei3/82-
ALC4/2015
20052015
based on the
dt 20 03 2015
recommendation of
as per details given
or as applied by the firm whichever is less:-
may take further action accordingly.
No.:75/18/82-
Defer Date
072015
Pharmaceutica ls.
IEiMliED
脇
∞つVAmy[ド群辮"…囲Defer Date
072015
:01/827050/01094/AM15/
:lt was decided to defer the case for want of comments of Department of
ls
|
"侶暉F電需震
r、[     .
Di… rate Conera。
|
マF“口や翔PυOepanme l
ud冥熱轟語o請じ
LJ“
Party Name:SHREE
VALLABH CHEMICAL
Lic No/Date10810133875
20112014
Export product
Qty
lmport items
Qty
kykg
PE6400
DIETHYLENE GLYCOL WITH 106 MOLE EO
l kg
Ethylene Oxide
0750
Di Ethylene Glycol
0250
NP9 5
NONVLPHENOL WITH 9 5 MOLE EO
Ethylene Oxide
0660
Nonyl Phenol
0340
PEG40∞
DIETHYLENE CLYCOL WITH 106 MOLE EO
l kg
Ethylene Oxide
09731
Di Ethylene Oxide
00269
N P20
NONYL PHENOL WITH 20 MOLE E0
l kg
Ethylene Oxide
0800
Di Ethylene Oxide
0200
Party Name:GLENMARK
PHARMACEUTICALS
## Case No:91/13′ 82-
ALC4/2014
## Case No.:93/13/82-ALC4/2014
_ζ L―
No/Date:3/82‐
Re-indexed
Name:INCHEM
TORIES PRIVATE

:lt was decided tO deferthe case for want Of cOmments of Departrnent Of
Decision : rt was decided to defer the case for want of comments of oepartmeni of
Pha rm aceutica ls.
: lt was decided to defer the case for want of .or."nt. of Department of
Jticals.
: lt was decided tO defer the case for want of cOmments of Department Of
It was decided to defer the case for want of comments of D/o pharmaceuticals.
No.:99/13/82-
M2/AM15/
Name:HETERO
No/Date:3/82‐
LIM ITED
Re-indexed
18 1 Defcr Date
No.:4/16/82‐
1靡罵蕊蔦
107083 Dcfer Datc
2015
No:102/13/82-
Name:DR REDDYS
TORIES LIMITED
1躙湾
5剛Ю5扁戸
‐
― ζЧ一

: The Committee in light of the written commnets of D/o Pharmaceuticals
provided vide O M No.35011/36/2015-PI(Norms)dated 05 06 2015 decided to raJfy
norms as per details given below or as applied by the firm whicheverisless:―
Export product
Qty
Import items
Qty
Levofloxacin
Hemihydrate
l kg
Ethyl(S)-9, 10-d ifluoro-3-methyl-7-
oxo-2,3-dihydro-7H-pyrido( 1,2,3-
DE)-1,4-benzoxazine-6-
carboxylate
08571
kg
may take further necessary action accordingly
Status:Deferred
and Re-indexed
1器島児
5υ∝097AMlylЪ危刷:γ00469AMlyl指∬g嗣°
091006300
Defer Date
072015
Ph a rm aceutica ls.
No.:95/13/82‐
Status:Deferred
and Re-indexed
14
隔麒
46ヌAMlダ
|
ALC4/2014
Pharmaceuticals.
## Case No.:96/13/82-
Partv Name:HETERO
Mcet No/Datc:3/82-
DeFerred
LABS LIMITED
ALC4/2015
Re-indexed
20052015
Defer Date
072015
ヒ
Defer Date
09072015
n : lt was decided to defer the case for want of comments of Department of
2781器島児
5υm099ハMly隔源扇
=葛
IMIy
Namc:HETERO
Llヽ41TED
う
４
８
３
ｅ
防
‐
５
Ｍ
卿
_`3´

MedNo/Date3慇2-
1錯″盤F
Lic No/Datc1091 0061365
Defer Date
09122014
09072015
286    
鷺角鵬OЮ0505AMW厩鰊面面厩
No.:281/13/82-
4
P ha rmace utica ls.
Pharmaceuticals.
Pa●y Namc:HETERO LABS
LIMITED
## Case No:282/13/82-
ALC4/2014
Party Name:HETERO LABS
LIMITED
Meet No/Date:3/82-
## Case No:283/13/82-
ALC472014
Pharmaceuticals.
Parry Name:HETERO LABS
LIMITED
Re-indexed
Lic No/Date:0910061367
Defer Date
09122014
09072015
1濶“
~
## Case No:279/13/82‐
ALC4/2014
ParりNtte:HONOUR LAB
LIMITED
Meet No/Date13/82-
ALC4/2015
Re-indexed
20052015
1器3掲50Ю 鯰82AMlシ
「
y薦
蕊
戸
Defer Date
072015
: ln the light of written comments received from D/o pharmaceuticals vide their OM
No 35oLU37 /2o].5-Pl(Norma) dt. 5.6.2015. tt was decided to call for following information from
firm:
1. Specific use of Lithium metal and n-Butyl chloride is not given in the
process/Reactions. How these are consumed in the process may be explained.
2. Past Production vis-a-vis Actual consumption ofall imported inputs duly certified
by Central Excise Authorities.specific use of Lithium metal and n-Butyl chloride
is not given in the process/Reactions. How these are consumed in the process may
be explained.
## Case No.:284/13/82‐
ALC4/2014
_ζ S´
Re-indered
Re-indexed
Defer Date
No/Datei3/82-

: ln the liBht of written comments recelved from D/o Pharmaceuticals vide their OM
No 35011/37/2015‐ PI(Norma)dt.5 6 2015 t was decided to ca‖ for following informajon from
firm:
Meet No/Date:3/82‐
ALC42015
20052015
Specific use of Lithium metal and n-Butyl chloride is not given in the
process/Reactions. How these are consumed in the process may be explained.
Past Production vis-a-vis Actual consumption ofall imported inputs duly certified
by Central Excise Authorities.
F……¨甲閻¨ 1孵融‐町
1器3児5∽552晨MⅣ I鷺
危鵬
∽
“
44ハm夕 
けら辮
Ю釧00° 3851
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide l.D. No35017/3771z0f4,-Pl (Norms) dt. lanuary.2O15 as per
details given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty kg/kg
4-FLUORO― a-2‐ METHVL-1-
OXOPROPYL)― g―oXO― N― B―DIPHENVL
BENZENE BUTANEAMIDE(DIKETONE
FLUOROBEN2ENE
METHYLiSO BUTYRYL ACETATE(MIBA)
0フ6
INTERMEDlATE             FOR
ATORVASTATIN)/DKT‐ 3
POTASSIUM CARBONATE
ANIL NE O L
047
## Case No.:27/1/82‐ ALC4/2015
1器3児50Ю 1553魔MI夕
Lic No′ 1)ate:0910061386
:09/24/040/00443/AM15/
12122014
Decision:The cOmmttee decided to raJfy the norms based on the recommendation of
Department of Pharmaceu■caι vide l D No35011/377/2014 PI(Norms)dt January 2015 as per
deta‖s given below or as applied by the firm whicheverisless:―
Export product
Qty
lmport items
Qty kg/kg
4‐FLUORO‐ a‐2-METHYL-1-
OXOPROPYL)― g―oXO‐ N‐ B‐DIPHENVL
BENZENE BUTANEAMIDE(DIKETONE―
INTERMEDIATE              FOR
ATORVASTATIN)/DKT‐ 3
FLUOROBENZENE
METHYLiSO BUTYRVL ACETATE(MlBA)
POTASSIUM CAR80NATE
ANIL NE O L
Lic No/Date:0510392649
Name:VIJAYASRl
LTD
Name:JACSONPAL
No:3/1/82-ALC4/2015
―ζ
`一
No/Datc:3/82-

"4田
島児5υm"9/AM W 
鵬
監
OЮ釧4/AMl夕 1悧
鼎
∝
"Ю
7928ω
躊
需
卜01/82/050/00003/AM16/
:0523/040/00450/AM15/   01012015
Lic No/Date:0310792858 1 Defer Date
13012015
072015
Re-indexed
Re-indexed
: lt was decided to defer the case for want of comments of Petrochemicals.
Meet No/Date13/82‐
ALC4/2015
20052015
: lt was decided to defer the case for want of comments of Petrochemicals.
Meet No/Date:3/82‐
ALC4/2015
20052015
072015
Re-indexed
Defer Date
09072015
Lic No/Date:0310792863
13012015
: : lt was decided to defer the case for want of comments of Petrochemicals.
Patt Name:DR REDDYS   'Mcct No/Datc:3/82-
LABORATORIES LIMITED IALC4/2015
20052015
"6器
島児5剛%3AM15/ 
膨
肥
OЮ囲
ハMb/~    
踏
鷺
Decision=忙was decded to deferthe case for want ofcomments of D/o Pharma
Starus:Deferied
and Re-indexed
## Case No:6/16/82-
Meet No/Date:3/82-
ALC4/2014
## Case No.:7/16/82‐
Party Name:RELIANCE
INDUSTRIES LTD
## Case No.:8/16/82‐
Pady Name:RELIANCE
INDUSTRIES LTD
:03/95/040/00243/AM15/
## Case No:10/16/82-
ALC4/2014
Pa●y NameJODAS EXPOIM
PVT LTD,
ALC4/2015
20052015
Lic No/Date:0910061548
21012015
09072015
IDecision:t was decided to deferthe case for want ofcomments of D/o Pharma
吻
"8鵬3月5∽B“ハmy~厩面高蕊戸圏鼎“釧∞
a"2
Defer Date
Partv Name:RA CHEM
PHARMA LIMITED
## Case No.:12/16/82-
ALC4/2014
匹
## Case No:14/16ノ82-
_(,一
072015
Decision : lt was decided to defer the case for want of comments of D/o Pharma.
PartyName:HERBOCHEM Meet No/Date:3/82-
Vい
oたこ■■
…
…
 =:09rl Trad(
蜀
仄
Name:RELIANCE
:01/82/050/01358/AM15/
Re-indexed
No:11/16′82-
Re-indexed

ALC4/2015
: lt was decided to defer the case for want of comments of D/o Pharma.
Party Name:INDOCO
Meet No′1)ate:3/82‐
REMEDIES LIMITED
ALC4/2015
20052015
## Case No.:7/l/E2-ALCll2DlS Party Name:BDR
PHARMACEUTICALS
INTERNAT10NAL PVT
LTD
No:6/3782-ALC4/2015
Party Name:INDO PHYTO
No/Date:3/82‐
CHEMICALS PVT LTD
Re-indexed
鵬3児50/O1366AM Ы  
膨
鵬
υ∞
"2晨m夕 1州
鼎
e.091∞a"41需
薦
20052015
Decision : lt was decided to defer the case for want of comments of D/o Pharmaceutical.
Decision : lt was decided to defer the case for want of comments of D/o Pharma.
Meet No Date:3/82-
ALC4つ015
20052015
∞
0囲瓢蕊蔵而~膨
鵬
OЮ“
"/AMl夕 1獅鼎
e c191∞a"31需需
Defer Date
072015
Re-indexed
Defer Date
072015
Re-indexed
Defer Date
072015
Meet No′Date:3/82‐
ALC4/2015
F‖ e
1/82/050/00012/AM16/
風
:L]]::蔦  
『:蕊テ
~~~~
…
枷
Department oF Commerce
ud語聾轟話肌
1嗜
期
間
3児5血
∝4ムmα
障
蹴
OЮ
"ぉ
ハm夕
1器
辮
“
Ю
""“
Ｆ
‐
‐
‐
‐
‐
』
”
‐
‐
‐
‐
‐
‐
1133児50/00036/AM16/
## Case No.:12/1/82‐
ALC4/2015
跳蹴。Ю“ηハmy l総辮わЮ"期1諦辮:
## Case No.:13/16/82-
ALC4/2014
Party Name:HETERO
ALC4/2015
20052015
## Case No.:14/1/82-
ALC4/2015
Party Name:ANUH
Case No■3/1782-
ALC4/2015
Meet No/Date:3/82‐
Party Name:INDOCO
REMEDIES LIMITED
嚢
∂一
20052015
No Date:3/82‐
161

## Case No.:52/19/82‐
ALC4/2014
1   1)ecision: :t was decided to deferthe case fOr want Ofcomments of D/o Pharma.           |
Party Name:PCL OIL &
SOLVENTS LTD,
ALC42015
20052015
Pary Name:INDOCO
REMEDIES LIMITED
Defer Date
: lt was decided to defer the case for want of comments of D/o pharma.
Cr." ff o.':lVS2-A Lcal2oI5 fParty Name:AUROBIND(
IPHARMA LIMITED
HQ Fire 
trA Fil.
:0ll82l050l00032lAMl6l :09f241040/00632tAMl5t
D""i"io, , In tn" n-ght of ""rli* d""l.ion t"r.* i, tfr"
it was decided to ratifr the norms under Para 4.7 ofHl
applied by the firm, whichever is less:
「厩郵藁藤~日テ証
¬悧鼎
C酬∞
a。9路辮
:
NC.3 mecting no 15/82 datcd 12 01 2015
BP vl as pcr dctails given below or as
S No
Import Item
Qty. Recommended kglkg.
7-aminocephalosporanic acid (7 A C A)
0769
う
乙
chlorosulphonyl isocynate
04754
つ
Ｄ
(z)-2-methoxy imino(fury1-2-yl) acetic
acid ammonium salt (smia)
06152
4
acetonc
1611
5
methylene chloride
3369
6
activated carbon
0093
7
n,n-dimethyl acetamide
402
8
potassium carbonate
0043
9
cyclohexane
1733
10
methanol
278
lA concerned may take further necessary action as per above decision of NC.
## Case No.:11/1/82-
ALC4/2015
Meet No/Date:3/82‐
一
"一
072015
No′Date:3/82-
Re-indexed
File
10393248 Defer Date
15/     17022015
: lt was decided to defer the case for want of comments of D/o Petrochemicals.
一
゛
型

## Case No.:8/1/82-ALC4/2015 Pary Name:BDR
IMeet No/Date:3/82‐
1器鰍F
Deferred
PHARMACEUTICALS
Re-indexed
INTERNATIONAL PVT
Lic No/Date:0310793987
Defer Date
Ю1/82/050/00008/AM16/  Ю3/94040/00917/AM15/  119022015
Re-indexed
・
°
M畑
側
Am夕
## Case No:4/19782-
ALC4/2014
## Case No:46/19/82-
ALC4/2014
Pa■y Name:AUROBINDO
PHARNIA LIMITED
Meet No/Datc:3/82-
072015
Defer Date
072015
Deferred
Re-indexed
Re-indexed
Defer Date
072015
Deferred
Re-indexed
Defer Date
072015
Re-indexed
1躙鼎α
"Ю""“
Mcct No/Datc:3/82-
ALC4/2015
20052015
ALC4/2015
20052015
3 lt was decided to defer the case for want of comments of D/o Pharma.
F~棚な枷
5
: lt was decided to defer the case for want of comments of D/o Chemicals
Party Name:CADILA
Meet No/Date:3/82-
F轟
1/1/82‐ALC枷
5 1孵
級
―
1「
[傷1lFOЮ““ん
蕊; iF∫l」Rlα"Ю"3385
Defer Date
HEALTHCARE LTD,
ALC4/2015
20052015
## Case No.:2/19/82-
ALC4/2014
Meet No/Date:3/82‐
PHARMACEUTICAL
INDUSTRIES LTD,
:03′95/040/00916/AM15/
## Case No:3/19/82-
ALC4/2014
LA30RATORIES LTD,
Partv Name:GOPINATH
CHEM‐ TECH LTD,
ALC42015
20052015
― 可0-
072015
一
　
　
３
０
９
No/Datc:3/82‐
H鵬
星児ЮЮИ釧ハm夕
~陽
危棚
∽
“
2独my

|
[椰淵
VATE
Re―indexed
Lic No/Date:3510044692 1 Defer Date
:01/82/050/01535/AM15/   1:3524/040/00006/AM15/    27022015
Decision : lt was decided to defer the case for want of comments of D/o C PC (Chemicals).
Ｆ
Ｌ
ド
ー
Ｆ
‐
服
躙
叫
 
甲
了
繭
可
袂
副レ
平
需
器
3澪5剛鳳戸囮
057/AMly躙画面蹄
Decision : lt was decided to defer the case for want of comments of D/o pharma.
## Case No.:47/19/82-
一
ト
## Case No.:6/1/82-ALC4/2015
Decision : lt was decided to defer the case for want of comments of D/o pharma.
:01/82/050/000ls/AMl6/ i:04/241040/002721Alrirl5/
Decision : lt was decided to defer the case for want of comments of D/o pharma.
:響
Narne:MICRO LABS
Re-indexed
Defer Dttc
072015
Defer Date
Re-indexed
Defer Date
072015
鵬
疏
50畑
"7ハ
Ⅲ夕 1場
淵
ν∞Ю2ハmy l悧
鼎
硼
剛
"“
319
一
Ｆ
sion : In the light of "*ii., aeiiSon taken in meeting no. 6t82 dated 2g-n8.2014, it
decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as
ied by the firm, whichever is less:
Export product
Exp
Qty
SI No
Import items
Qty. allowed
Homatropine Methyl 
Bromide
Synonyms 
N,N-dimethyl-8-
Azoniabicyclo(3.2. I )octane-3-yl)2-
hydroxy-2-phenylacetate bromide
C.A.S. 
No.80-49-9 formula
C6H4CH2Bro2N Quality 99% Puriry
l kg
1
Tropine
0 718 kg
2
DL‐ Mandcnc Acid
0 862 kg
3
Mcthylcnc Dichloridc
5 20 kg
4
Acetone
5 37 kg
may take appropriate action as per the decision of Norms Committee.
_ヨメー
∴,熱鷹議誡
,ぃ
No:49/19/82-ALC4/2014
NamciSAURAV
No:15/1/82-
つ
‘
一
Ｄ
ａ
‐
５
一
Ｗ
脚
Status:
Approved

## Case No:50/19/82-
ALC4/2014
Partv Name:HETERO
Meet No/Datc:3/82‐
DRUGS LIヽイITED
ALC4′2015
20052015
ALC4/2015
LIMITED
Decision : : lt was decided to defer the case for want of comments of D/o Pharma.
Re-indexed
Defer Date
Re-indexed
Defer Date
072015
072015
Re-ind€xed
Defer Date
## Case No.:23/1/82-
翻     1脇
棚OЮ“
7りAMЫ I冨辮
e091∞a●3
Decision : : lt was decided to defer the case for want of comments of D/o pharma.
Pary Namc:HONOUR LAB IMeet No7Date13/82-
「剛πD   I器盤F
Lic No/Date:0910061695 1 Defer Date
Ю1/82Ю 50/01539/AM15/   :09/24Ю 40Ю0693/AM15/  112032015
: lt was decided to defer the case for want of comments of D/o Chemicals.
Pa●y Namc:ARENE LIFE
SCiENCES LIMITED
Meet No/Datei3/82‐
ALC4/2015
Re-indexed
20052015
膨
璃
Ю658/AMW I蹴
器
C酬∞a η4
Meet NolDate:3/82‐
ALC4/2015
20052015
Meet No/Datci3/82-
ALC4/2015
20052015
Lic No/Date:0910061716
Defer l)ate
:01/82/050/01542/AMl5/ :09/24/040100703/AMl5/ 17.03.2015
072015
3 lt was decided to defer the case for want of comments of D/o Pharma.
Mcct No/Datc:3/82‐
Deferred
ALC4/2015
Re-indexed
20052015
Lic No/Date:0810134879
Defer Date
:01/82/050/01546/AM15/     :08/24/040/00474/AM15/     123032015
## Case No:22/1/82-
Party Name:HETERO LABS
Re-indexed
Defer Date
## Case No:51/19/82-
ALC4/2014
## Case No:53/19/82-
ALC4/2014
:01/82/050/01541ノAM15/
## Case No.:16/1/82-
ALC4/2015
Party Name:HETERO LABS
LIMITED
## Case No:20/1/82-
ALC4/2015
Pary Namc:CADlLA
HEALTHCARE LTD,
_コ2-
ALC4′ 2015
09072015
No/Date:3/82-

^
,Decision : lt was decided to defer the case for want of comments of D/o Pharma.
Ｆ
Ｌ
Ｆ
Ｉ
Partv Name:MICRO LABS
¨
―
―
Statu,DeFerred
LTD
: : lt was decided to defer the case for want of comments of D/o Pharma.
Partv Name:DHANUKA
Defer Date
072015
Defer Date
09072015
## Case No.:28/1/82-
ALC4/2015
LABORATORIES LTD
Lic No/Date:0710107918
25032015
IDecision:L was decided to deferthe case for want ofcomments of D/o Pharma
|
Status:Deferred
and Re-indexed
|
Defer Date
072015
## Case No:29/1/82-
IDecision::t was decided to deferthe case for want ofcomments of D/o Pharma
Pa“y Name:HONOUR LAB  Mcet No/Date:3/82-   Status:DeFerred
LIMITED              ALC4/2015
鵬児
5剛“
5ムm夕
岡誦蕩蕊戸1器器“
%∞°
・9開需
: ln the liBht of written comments received from D/o Pharmaceuticals vide their OM
35Of!87 /2}15-Pl(Norma) dt. 5.6.2015. lt was decided to call for following information from
firm:
a) Specific use of Lithium metal and n-Butyl chloride is not given in the
process/Reactions. How these are consumed in the process may be explained.
b) Past Production vis-a-vis Actual consumption of all imported inputs duly certified
by Central Excise Authorities.
Re-indexed
Lic No/Date:0410160364
Defer Date
30032015
072015
ud霊兜織瓢誡
1“
## Case No:9/1/82‐ ALC4′ 2015
Pary NameiVIVIMED LABS
(ALATHUR)PRIVATE
:01/82/050/00009/AM16/
Pharmaceutica ls.
二毬
―
No:5/1/82-ALC4/2015
and Re-indexed
1193児50/000057AM 16/   1カ危漏脱
0/00457/AM15/ ~
No/Date:3/82‐
Re-indexed
No:30/1/82-
Re-indexed
No/Date:3/82‐

Meet No/Date:3/82‐
ALC4/2015
Re-indexed
20052015
Defer Date
072015
P ha rmace utica ls.
「
## Case No.:32ll/82-
A,LC4t2ol5
附柵器∫
LT:「
Meet No/Date:3/82‐
ALC4/2015
20052015
Re-indexed
t箕    
厩棚
OЮ"zttmy
Lic No′ つate:0910061849
Defer Date
31 032015
09072015
κ
Meet No/Date:3/82‐
ALC4/2015
20052015
|
Defer Date
072015
Ｆ
Ｉ
‐
Ｌ
げ
‐
‐
‐
337
Pha rmaceutica ls.
ICaseNo.:373/82‐
AL…
Pha rmace utica ls.
Pha rmaceutica ls.
…
oF Fore19n Traao
Paty Name:RA CHEM
PHARMA LIMITED
|
Meet No/Date:3/82-
ALC42015
20052015
Meet No/Date:3/82-
ALC42015
20052015
Date
072015
F―‐
ALC4/2015
円醜蕊面蔦戸¬膨棚
OЮ∞鍬
Amα
Date
Lic No/Date10910061 820
31032015
## Case No:33/1/82-
LABORATORIES LTD,
:01/82/050/01559/AM15/
ヨ
Ч ―
072015
Name:AUROBINDO
LIMITED
Name:DiVIS
Re-indexed
No:5/3/82-A LC4/2015
Name:HETERO LABS
No/Date:3/82‐
Filc

Case No.Br 
I Mis. Supriya Lifescience Ltd. Mumbai
Meeung No 3/AM16     1F No01/82/162/44/AM16/DES■
||
dated 20.05.20.1s 
I RAF. No o3/95/040/1085/AM 15
Decislon: The Comm ttee consider the case for ratificat on of Ad‐
hoc Norms for the export product
"MECOBALAMIN JP" under para 4.2.2 of HBP. The Committee in light of the written comments
forwarded by D/o pharmaceuticals vide O. M. No.35011/28/2013-P I (Norms) dated 00.4.2015 decided to
ratify the norms as per details given below or as applied by the firm whichever is less:-
Export product
Qty
lm port items
Qty
Methy Cobalamin JP
(Mecobalamin)
lkg
Vitamin B 12 (Cyanocoba lamin)
0 95 kg
RA may take further necessary action accordingly.
Manual Minutes of NC Meeting No.03′
82ノ2015
dated 20.05 2015 but actua‖ y he!d on18.6.2015
]
t凝暮藁黒蠅Te
case No. B, 
I M/s. Supriya Lifescience Ltd. Mumbai
Meeing No 4/AM16     1F No01/82/162/45/AM16/DESJll
RAF No 03′ 95′040/988′ AM 15
dated 20 05 2015          1｀ハ
「
 Nυ
Decision: The Committee consider the case for ratification of Ad―
hoc Norms for the export product
"MECOBAIAMIN JP" under parc 4.2.2 0f HBP. The Committee in light of the written comments
forwarded by D/o pharmaceuticals vide O.M. No.35011/28/2013-Pl (Norms) dated 00.4'2015 decided to
ratify the norms as per details given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty
Methy Cobalamin JP
{Mecobalamin)
lkg
Vitamin B 12 (Cya nocobala min )
0 95 kg
RA may take further necessary action accordingly.
M/s Supriya Lifescience Ltd Mumbai
F No01/82/162/46/AM16′ DES― l‖
RAF No 03′ 95/040′815′AM 15
## Case No B-3
Mee‖ ng No 4/AM16
dated 20 05 2015
Declsion: The Committee consider the case for ratification of Ad‐
hoc Norms for the export product
"MECOBALAMIN JP" under para 4.2.2 of HBP. The Committee in light of the written comments
forwarded by D/o Pharmaceuticals vide O. M. No.35011/28/2013-Pl (Norms) dated 00.4.2015 decided to
ratify the norms as per details given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty
Methy Cobalamin JP
(Mecobalamin)
lkg
Vitamin B 12 (Cyanoco ba lam in)
0 95 kg
RA may take further necessary action accordinBly.
_¬ 5~一

## Case No. B-4
] M/s. Supriya Lifescience Ltd. Mlrnbai
Meelng No 4/AM16     1F No01/82/162/47/AM16/DES■
||
dated 20.05.2015 
RAF. No. 03/95/040i 801/AM 15
Decision. The Committee consider the case for ratification of Ad-hoc ltormr foi-hJ "rpo.t p-a1,a
"MECoBALAMIN JP" under pata 4.2.2 of HBp. The committee in light of the written comments
forwarded by D/o Pharmaceuticals vide o. M. No.35011/2812013-Pt (Norms) dated 00.4.2015 decided to
ratify the norms as per details given below or as applied by the firm whichever is less:-
Export product
Qty
lmport items
Qty
Methy Cobalamin JP
(Mecobalamin)
lkg
Vitamin B 12 (Cyanocobalamin)
0 95 kg
RA may take further necessary action accordingly.
## Case No B-6         1M/s shiva Pharma Lid
Meeting No.4/AM16 
| F. No 01/821162/16/AM 13/DES-ttt
dated 20.05.2015 
I Adv.Lic 3410025487 dt.30.'10.2009
Adv Lic 3410025693 dt25 11 2009
Adv Lic 341002651l dt03 03 2010
Adv Lic 3410027522 dt16 07 2010
Decision: The Committee consider the case for revision of norms. the committee in hght of the
written comments of c&Pc (chemicals) forwarded vide U,o. No.14010/L64/2olL-cH- dt. 19.6.2015
decided to revise the norms as per details given below:-
Export prod uct
Qty
lmport items
Qtv
Neodecanoyl Chloride
lkg
Neo Deca noic Acid
0 970kg
RA may take further necessary action accordingly.
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