DGFT Committee Minutes
Document text
⌒
1
Of{icc of Directoratc Gcncral of Foreign Trade
Nclv l)clhi -0
Para 4,7 Dccision
MEETING NUMBER :19182-ALC4DOI4 MEETING DATE : I8.03.20I5
But actually held on29.04.2015
Meeting No. 19182 of 2014-15, to consider the cases/issues under Duty Exemption
Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Allied
products and falling under Chapter 29 and 30, was scheduled for 18.03.20.15 but actually
held on 29.04.2015 under the Chairmanship of Shri Jaikant Singh, Addl. OGFT in Room
No.1 1 , Udyog Bhawan, New Delhi.
Following members were presenti
Shri Nirmal Kumar, Deputy Director General of Foreign Trade
Shri A.K. Agarwal, Dy. lnd. Adviser, Department of C&pC
Ms. Swati Kumari, O/o DC (MSME)
Shri D.N. Mathur, Consultant, Department of Pharmaceutical
Shri Mahendra Vikram Singh, Foreign Trade Development Officer
The committee went through the minutes of earlier NC-lll meeting No. 1g/g2 was
scheduled for 18.02.2015 but actually held on 16.04.2015 and approved the same.
The following cases/issues were discussed and the committee took the decision as
mentioned against each case.
ICasc No:42′ 19/82-ALC4/20:4 ParりNamc:SMS
IPHARNIACEUTICAI´ S LTD
IMcct No/Datc:19/82‐
:ALC4/2014
118032015
Stalus:
,\pprovcd
| |
臨蕊LiIユ|「
l瓢而蔦薦丁~
Lお:｀6/Diおbうib65,60 DEfcr bat
130032012
Dccision : In the light ol written comments received from Department of pharmaceuticals vidc
'thcir oM No. 35011/486/2013-pl(Norms) dated 21.11.2013, it was decided ro rarifo the norms
under Para 4.7 ofHBP vl as per details given below or as applied by rhc firm, whichcver is lcss:
Il\pon Producr
Qty
SI No
Import Product
Quantity
allowed ke4(s
EI'avircnz
l kg
1
(S)-5-chloro-alpha-(cyclopropyl
ethylyl)-2-amino-alpha-(rri fl uoro
methyl) bcnzene mcthanol
0987
2
Triphosgene
0448
rtttl
RA may take appropriate action as per the decision of Norms Com,nittee.
|ヽ4cct No/Datc:19/82-
IALC42014
118032015
Status:Dcffercd
and llc-indcrcd
Lic No/Datc:0910052125 DclcSr
112042012
Datc:20052015
Dccision:It w¨
dccided to dcFcr thc casc for 20.05.2015 for comments ofDepartment ofC&pC.
ヘ 「 4 ICaSe耐 面I売玉tc4/20百 汗 濡 ご輌 … HQ Filc :01ノ82/050/01499/Alヽ415/ 簿源需蕊蕊扇五百 13042012 | IDccision:ln the light of eanier dedsion taken by NC in ts 7/82 meeung dated l1 09 2014,■ was dedded to ratfy nOrms under Para 4 7 of HBP vl as per detaiЬ given below or as applied by the firm′ whicheveris less: RA concerned may take furlher necessary action as per above decision of NC. Decision : It was decided to dcfer the case for 20.05.2015 for comments ofDepartment of Pharmaceuticals. Casc No:34/19/82-ALC4/2014 Party Namc:VEllNDIA IPHARNIACEUT!CALS 臣 ILIMITED | | 1脇蔦罵 =~ :RLA Fnc :0924/040/00655晨M12/ F需 10910°5茄 F聴 ~ Dccision : lt was decided to defer the case for 12.06.2015 .Pharmaceuticals. for comments of Department of Casc N o:43/19/82‐ ALC4/20141)arty Namc:AVON ヽ4cct No/Datc:19/82- Status: | 10RGANICS LID, ALC4/2014 1Approvcd 18032015 ‐ 1■ 6需 泉jmttIA剛シ ｀ 響 Ⅲ ツ lッ ザ 鼎 ず Юい郷 DcfcrT:‐ ‐ : ‐ ,「■′: : .'..-.,',. , ,' -,.r' Dccisir-rn : In thc lighl of rvritlen conlments reccivcd frotn Dcpartmcnt ol l)hanlaceuticais vidc Export product Export Qty Si No lmport ilems Qty. allowed Sodium Ascorbyl Phosphate or C-Vite l kg 1 (2R)-2-[(lS)-1,2- Dlmethoxyethyll-4,5- Dihvdroxyfuran-3-One 1 110 kg 2 Methanol 2 664 kq 3 Potassium Carbonale 4 610 kq N4cct No/Datc:19/82‐ ALC4/2014 18032015 Status: Approved Datc Casc No:14/19/82- Al.C4/2014
⌒ ⌒ / 8 / lheir OM No 35011/577/2014-PI(Norms)datcd ApH1 2015、 ■was decidcd tO rad″ the nOrms undcr Para 4 7 of HBP vl as pcr deta‖ s givcn bclow Or as applicd by the fnll,whichevcr is less: | Export product Exp Q″ SI No Import items Qty a‖owed kg/kg Valacyclovir Hydrochloride l Kg Acyc10vir 0758 つ た N-Benzyloxy Carbonyl -L- Valine (CBZ -L- Valine) 1 1824 3 Dicyclohexyl Carbodim ide lDCC) 1061 4 4-DimcthyI Amino Pyrldine(DMAPl 0028 5 Dimcthと!FollllamldC 3515 RA mりtake apprOp●atc ac●On as pcrthc dccヽiOn OfNorms Committcc :
Case No.:28/19/82-ALC4/2014
|| RLA Fnc Lic No/Date:091oo52229 :09/24/040/00027/AM13/ 18042012 P^":r:igl_: In the light of earlier decision taken by NC in its 09-08.2012, it was decided to ratify no*, d., Fr'C.i "f USp below or as applied by the firm, whichever is less: RA mayt■e3?PPPl摯ea“ On as pcr ic dcdsbn OfNorlns COm面tca Pary NameiVIvIMED LABS LIIヽ1lTED Meet No/Date■ 9/82‐ status: A[∫ ∫盤1:4 Approved m―雨」――― ――――― IЮ 1/82/050/01516/AM15/ Defer Date: 15/82~meeting~datcdl v1 as per details given Dt Drecror Generat ot f 聰 紺 υdy電陪織」ヽ KUMAR arqr< ei9n Trado Commeree 輛 ヽ ″ Dclhi Export product 恥 韓 SI No Import items Qty. allowed Octcnidinc Di HydrochlOridc or Octenidinc 2 HCL l kg … Hdhe 0 345 kg 2 I -Octanal (l.l-Octyt Aldehyde) 0 470 kg 3 Di ch10rO Methane (MDC) 0 374 kg 4 1,10-Dicanc Diol 0 496 kg 5 MCthyI Ethyl KctOne (MEK) 1 003 kg Export Product Qw SI No lmport Product GLYOXYLIC ACID Quantity a‖Owed kノkg 0376 L‐MLNlHYL CLYOXYLATE HYDRATE(MGH) l kg 1 rr.en` 1織t欄ぞ甚ξ蕊ま漱乳品計唱唆弔棚鳳I魂需震常潔語
the decision of Norms Committee' Import ProduCt Quanti" allowed墨望盤二_ Export ProduCt Qty 誂 ヽ 030 l kg 1 2,5 DIHYDKOXY l,4‐ DITHIANE _____ S薇瑠31照轡:tXY■ L到‐ | CAR30XYLATE, L― L‐ MENTHYL ESTER)ECE 2 GLYOXYLIC ACID‐ 50% 070 may take approPriate actiOn as p-decision of Norms Committee. |~に3"No■1ツ1り32‐ ALC4/2014 10 'Meet No/b-atelglEz- 1"tat*t . , ALC4/2014 lAPProYed I ,rt.or.zots I I
- tat"N"/D"t"orl0052316 loefer Date: 1 '25 .04 .20t2 _ _ _ '-- . .. .l from Deparlmen;f Pharmaceuticals vide I :mber 2012. it was decided to. ratlty th€l low or as applied by the firm' whtchever ts 1 I ffi NlTl響繋ビ 11■魃 rments received from Department of Pharmaceuticals vide t",;i,ll'l;,lili;Xi'':J';ilil:iFlHi([ffi ::[r:.i"""i-l#.:,fi'3":': )M No 35011′ b)0′ Zυ lZ‐ rl、1ヽυlll・。ノ ‐~・‐~ ~~「~ ),lied by the f11111,ヽ Vhichever is under Para 4 7 of HBP Vl as pcr detailS giVen be10ヽ V or as ar -tmport Product GLYOXALIC ACID IcYCLoHExANE Quantlty a1lowed kに Export Product Qty ０ Ｓ ‐ Ｎ 034 l kg ｌ 一 ２ 127 nつo DlHYDROXY!4‐ Dll HlANじ 0531 4 lEuonocvrostlE 854 5 ヽイFTHVI「NE CH1 0RIDL NollllSしOmlnlL‐ 。・ |1 1空2-一一一ぜ | 鰤 o鰤3/AM13/ 鸞鱗錢曲鯖窮熙鯛押憮業 26042012__ | __ 0メorec18:ё Di朧:『 嘲師口f r Ｒ “ ・ ¨ ¨ u udソ。しЬⅢ…._`、 1、.蒻 ｈ ｉ ｅ 「 Ｄ 4 rion : ln the light of written comments received from Department of Pharmaceuticals vide oM No. 3501l/4r 8/2013-Pr0orm'1"a"""4lo'os'20"1,1,y.';t^":':*0.:?':lt:Y"ff':."J"' 弾牌 :瑞『 lyflょ脱 Iξ 昴詰苗OT」慮apFilおd by mc■m,wh“ "σ もにS I
（ （ RA may take appropriate action as per the decision of Norms Committee. ICase No.:21/19/82- ALC4/2014 HQ File | :01/82/050/01509/AM15/ ¨ PHARヽ4A LIMITED 1造き l冽胃に 19/82- ■8032015 Status: Deffered and Rc-indexed RLA File Lic No/Date:0910052352 Defer :09/24/040/00002/AMi3/ 26042012 ,Datc:200520151 to dcfcr thc casc for 20 05 2015 for commcnts of Departmcnt of Decision : It rvas dccided Pharmaceuticals. Casc No.:29/19/82- Pa“y Namc:AUCTUS PHARMA LIMITED Mcct No/Date:19/82- ALC4つ014 18032015 Status: Deffered and Re-indexed ALC4/2014 卜1蕊脇蕊蕊戸開脇蕊而 ILic No/Date:0910052354 26042012 蔓 | B荒ち∞瑯 Decision : It was decided lo defer the Pharmaceuticals. case for 20.05.2015 for comments of Department of
Case No.:17/19/82-ALC4/2014
HQ Fne
:01/82/050/01505/AM15/
Parw Name:MEDCHL
CHEMICALS AND
PHARMACEUTICALS PVT
LTD
RLA Filc
:0924/040/00025/AM13/
1
餞
“
us
1儲
:『1盤F IApprα
ed
后百N875]置o91oo52341 betr Date:
26042012
|
IDecision:In thc light of wHtcn commcnts received from Department of Phallllaccujcals宙
de
thcir OM No 350H/206/2013-Plo(Orllns)dated 03 07 2013,l was decided to rati～
the n0111ls
!4‐ under Para 4 7 of HBP vl as pcr details givcn below or as applied by the fll‖
l,whichcver is!css:
Export Product
Qty
訛
Ｎ
。
Import Product
Quallti″
allowed kノkg
D2Aminobutanol
l kg
l
DL2Aminobutanol
22642 ´
Monosodium glutamate
100
つ
Toluene
060
「Fm∝釧鴨
2‐ALCψO14M配孫薦輝瀑
19/82‐~囲蕊
~
18032015
15器晶児
590151νAM ly 跳允
5:i。0063ンAMlν り脳出らα
0910052396 DeたrDac
1)ecision : In thc light of、vrittcn comments rcccivcd from Dcpartment of Phallllaceuticals vide
thcir OM No 35011/63/2014-PKNorms)datcd Scptcmber 2014,l was decided to rati″
thC noIIns
under Para 4 7 of H〔3P vl as pcr tletails givcn bclo、v or as applicd by thc flrlll
、vhichever is lcss:
（ （ Expon product Exp. Qq/. S No Import items Qty. allowed 7‐ PHENYLACETAMIDEO‐ 3‐CHLOROMETHYL CEPHALOSPORONIC ACID PARA METHOXY BENZYL ESTER(CCLE) l kg 1 PENICILLnゞ G‐POTASSIUM FIRST CRYSTAL 2 81 kg つ ‘ ACETONE 1 971 kg 3 ISOPROPYL ALCOHOL 0 66 kg 4 DIMETHYL FORMAMIDE 1 314 kg 5 METHYLENE CHLORIDE 3 29 kg 6 2 MERCAPTO BENZO THIAZOLE 0 51l kg 7 METHANOL 1 971 kg | [
Case No.:41/19/82-A LC4′2014
lPharmaceuticals. ´ ０ ~F蕊 霜=~~|:癬頭諏臨i蔦「 曰鵬星掲 59蕊輛面 L「 彫濡薦ふ蔦~ Meet No Date:19/82- ‐ALC4/2014 18032015 ,Defcr i bate200520151 ILic No/Date:0910052425 1Defer Date: .30042012 1 )ision : ln the light of earlier decision taken by NC in its 7/82 meeting dated 11.09.2014, it decided to ratify norms under Para 4.7 of HBp vi. as per details given below or as applied by firm, whichever is less: Export product Export Qty. SI No lmport items Qty a‖owed Sodium Ascorbyl Phosphate or C-Vite l kg 1 (2R)-2‐ [(lS)-1,2- Dimethoxyethy嗜-4,5- Dihydroxyfuran-3-One 1 110 kg 2 Methanol 2 664 kg 3 Potassium Carbonate 4 610 kg Lic No/Datc10910052628 16052012 [lii:::i:i:,:ir[「 [ξ:面cdto deferti]:case for 20 05.2015forcommcntsЪ fDepartmentof Status:Deffered and Re-indexed ¨ 嘘 ‐ALC4/2田 陣 閻 hⅦ D朧 鮮 ~ 18M蕊[肩 「 ~澁 烹И 13/ 胃源 | PetrDate 町 n : In the light ofearlier decision taken in meeting no. 8/82 dated 25.09.2014, it was to ratify nonns under Para 4.7 of HBP vl as per details given below or as applied by the is less: 劇 。醜 t詔 ″うしい l ffiq A.rrvr sdr'I ' Uclyog Bh- 6 M concerned may take further necessary action as per above decision of NC.
（ （ | Export product Exp Q″ SI No Import items Qty. allowed Rosuvastatin Calcium l kg l (4R― CIS)-6-[(acC″ loXy)methyI] 2,2-dimcthyl-1,3-dioxane-4- acctic acid,l,l― dimcthyl ethyI cstcr 1 871 kg 2 Methyl 4-(4-fl uorophenyl)-6- isopropyl -2-[(N-methyl-N- methylsulfonyl)amino pyrimidine-5-Carboxylate 1 871 kg RA concemed may take furttrer necessary action as per above decision ofNC. II語1顆 戸 甲 五」~~明 10052680B窮ち。ェ劉 5 | lDecision : It was decided to defer the case for 20.05.2015 for comments of Department of Pharmaceuticals.
Case No.:38/19/82- Pa■y Name:PORUS IMcCt No/Datc:19/82‐ Status:DeFFered
ALC4/2014 LABORATORIES PVT LTD ALC4/2014 and Re― indexed
18032015 1
101爾屁「
=罵
ζ
1爾屁「
=罵
」~甑
:温話Iy[EI〕抒テ雨面而誌
2706B席ち。
Ю剛5
臨繭輛戸画面高面e∽se for 20 0,2m5おrcommmおof Dcpartmm of
証
顆
面高扇蔦而而房2750 1Detr ~~~
1騰雖静
‰
詔
鮒
出:織監蘇
熙
蒜蒔11燎孵
狙
「F而赫画面ふ不
Pary NamciVANI PHARMA
‐LABS LTD
Status: |
Approved
118032015 1
悧鼎酬∞
"Ъ2F而
Mcct No/Datc:19/82‐
ALC42014
旧38澪5∽bH/AM剛
鵬危糀
OЮ
“ "AMW
Decision : In the light ofearlier decision taken in meeting no. 22182 dated 20.02.2014, it was
22 decided to ratiry norms under Para 4.7 ofHBP vl as per details given below or as applied by the
firm- whichever is less:
|
Export product
Exp
Qty
SI No
lmport ltems
Qty. allowed
kc/kg
Kg
Aminoguan id ine Bicarbonate
146
/
鰊
r、
駈
8",n,
AMBAZONA XH20
(SP TER)
2
Thi Scmi Carbazole
0916
3
Para Benzo Quinone
116 /
4
Dimethylformamide
020
Ｌ
Ｊ
Nltric Acid
Not
importable
items
6
CP HydrOchloric Acid
7
Toulene
0385
8
Methanol
140
9
Ammonia LQ
(on 100% basis)
020
may take appropriate action as per the decision of Norms Committee.
VIVIMED LABS
IDecision:It was dccidcd to deferthe case for 20 05 2015 for commcnts of Dcpartment ofC&PC
ξ
躙… 叩
囲飛繭万隔蕊
一
ｍ
ｄ
ｅ
ｘ
ｅ
ｄ
一
い
¨
．
８
２
・
９
24
臨
;:↓i」
ILic No/Datc:0910o52760
24052012
052015
つ
た
It was decided to defer the case for 20.05.201 5 for comments of Department of C&PC.
ICase No:20/:9/82‐ALC4/2014 Party NamciVIVIMED LABS Meet No/Datc:19/82‐
IStatus:
‐
LIヽ41TED ALC4/2014 1Approved l
18032015
1HQ F‖e RLA Filc lLic No/Datc1091 0052795 Defer Date:
:01/82/050/O1508/AN415/ :09/24/040/00100/AM13/ 25052012
1)ecision:In thc light Ofcarlicr dccision taken in mccting no 17/82 datcd 05 12 2013,it、
vas
decided to raj～
norms under Para 4 7 of HBP vl as per dctalls g市
cn below Or as app‖ ed by the
‐
■ll‖ ,、vhichcver is lcss: .
IRA may take appropriate action as per the decision of Norms Committee
:01/82/050/O1523/AM15/
Export prod uct
Exp
Qty
SI No
lmport items
Qty. allowed
TDS OR2,5
TOLUENE DIAM:NE
SULPHATE
l kg
1
ORTHO TOLUDINE(OT)
1 023 kg
2
SODIUM NITRITE
0 320 kg
3
VANISPERSE
0 01l kg ′
4
SODIUM SULFITE
0 056 kg
5
METHANOL
3325
8
（
（
## Case No:13/19/82-ALC4′ 2014 Pary Name:AUROBINDO
PHARMA LIMITED
|ヽ4cct No/Datc:19/82-
ALC4/2014
18032015
Status:
Approved
HQ Fife
RLA File
Llc.No/Date:09100528 li .Defer Date:
:01/82/050/01501/AM15/ :09/241040/0008llAMl3/ 29.05.2012
Decision : Committee considered the case as per agenda and in light of written .o.rn.nt.
received from Department of Pharmaceuticals vide their OM No. 35011/311/2014-PI(Norms)
dated 11.11.2014 and in consultation with technical authority present in meeting, decided to
ratifu norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp
Qty
Sl No
lmport items
Qty AIlowed
Koノkq
IRBESARTAN
l kg
1
Ortho Toluyl Benzonitrile / 2-
Cvano-4-Methyl Biphenyl
0891
3
Activated Carbon
0100
4
Di-isopropyl ether
125
一
ｂ
Dimethyl Formamidc(DMF)
167
6
Methyl alcohol(Methanol)
428
7
Methylene Chloride
135
RA concerned may take further necessary action as per above decision of NC.
## Case No.:26/19/82‐
ALC4/2014
HQF‖ e
:01/82/050/01514/Aヽ415/
Pary Name:AUROBINDO
PHARMA LIMITED
RLA Fnc
:09/24/040/00093/AM 13/
Meet No/Datc:19/82- Status:Defrered
′ヽLC4ノ2014 and Re‐ indexed
肥
0910052816臨
Decision : lt was decided to defer the case for 20.05.201 5 for comments of Department of
Phallllaccuticals
|
## Case No.:27′ 19/82-
ALC4′2014
28 HQF‖ c
:01/82/050/01515/AMi5/
Pharmaceuticals.
## Case No:39/19/82-
ALC4/2014
1291:,1';::li;i:;i;liil::
iParty Name:HETERO LABS
]I -IMITED
I
\:09 D4 I 040 t oo I 03 I AMt 3 I
Pary Namc:SUVEN LIFE
SCIENCES LIMITED
IM酪ヽ誦
"西
19/82
1ALC4/2014
―
―
|
Status:Deffcred
and Re-indered
Decision : It was decided to defer the case for 20.05.201 5 for comments of Department of
RLA Fnc
:09/24/040/00089ノAヽ413/
‐Lic No/Date:0910052842
30052012
Meet No/Datc:19/82-
ALC42014
1!8032015
Status: Deffered
and Re-indexed
1麒
|
Decision : lt was decided to
Pharmaceuticals.
ICase No:22/19/82-ALC4/2014
defer the case for 20.05.2015 for comments of Department of
匡
‐
３
０
Party Name:AUROBINDO
PHARMA LIMITED
Mcct No/Date:19/82‐
ALC4/2014
[に
|
Approved 町
10
18032015
,HQ File
,RLA File
,Lic.No, Date:0910052849 ,Defer Date:
l,oittzTosororsroraursr lwiir6iorcoro.ueuw l;;;i1;;;--""-'-- 1
Decision : Comminee considered lhe case as per agenda and in light of wriften comments
received from Department of Pharmaceuticals vide their OM No. 35Ol ll3l2l2}l4-pl(Norms)
dated November 2014 and in consultation with technical authority present in meeting, decided to
ratifo norms under para 4.7 ofHBP as per details below or as applied by firm whichever is lower:-
Export product
Exp
Q″
SI No
lmport items
QりA1lowed
Kノkg
EMTRICITABINE
l kg
l
5 Fluorocytoslnc
1348
つ
ι
Glyov‖ c Acid(aS 50%)
2234
Hexa McthyI Dお‖azanc(HMDS)
1 86
4
Methanesulfonic Acid
0029
2,5-Dihydroxy. 1,4-Dithiane
090
6
Sodium borohydride
0510
7
Activated Carbon (Carbon
Enoanticromos)
0100
Cyclohexane
1 042
9
Dimethylformamide ( D M F )
0431
10
Methanol
2308
ll
Methvlene chloride
9331
つ
´
Hexanes
8392
13
Toulene
1 806
14
Steam/Thermal Coal
As per fuel policy
||| | |
| IRAconcernedmaytakefurthernecessaryactiOnasperabovedecisionofNC
concerned may take further necessary action as per above decision of NC.
」
皿互歴田
rI{
;dated October 2014 and in consultation with technical authority present in meeting, decided to
31 ratifo norms under para 4.7 of HBp as per details below or as applied by firm whichever is lower:-
t:
（
（
File
4/040/00085/AM13/
Decision:It、vas dccidcd lo defer the case ftDr 20 05 2015
Pharmaceuticals.
1麒
=I―¬蕩
「
## Case No:8/19/82-ALC4/2014 Party Namc:VIVIMED LABS
Mcct No/Date:19/82-
|
「剛π
D
鵬疏5∽`%ハmy l膨棚o/001p/AMW
ALC4/2014
18032015
Status:
ApproYed
ILic No/Datc1091 0052937
08062012
続
―
|
| |
Decision : ln the
Petrochemicals vide
ratify norms under
whichever is less:
light of written comments received fronn Department of Chemicals and
thelr U O No 14010/138/2011‐ Ch ‖dated 04 04 2013, it was decided to
Para 4 7 of HBP vl as per deta‖ s given below or as applied by the firm′
34
Export product
Exp
Qty
Si No
lmport items
Qty. allowed
HYDROXY METHYL―
METHYL‐PHEN:DONE
(HMP)
l kg
1
METHANOL
0 41l kg
2
DIMETHYLOしPROP10NIC ACID
(DMPA)
1 203 kg
3
PHENYL ilYDRttINE(PH)
0 928 kg
4
TOLUENE
0 928 kg
5
ANIBERしYST(RESIN)
0 171 hters
RA mav take aooropriate action as per the decision of Norms Committee.
mav
appropriate
pe
「
## Case No:9/19慇2-A LC42014
Meet No/Date:19/82- Status:
ALC4/2014 Approved
118032015 1
函而戸~~
匡蔚√~
脈Noわ話091oo5j“5~pcたr Datc
Paty Name:AKTINOS
PHARMA PVT LTD,
Defer Date:
l6iiii6sororqzreNarsr _i,wiiiiioroor34/AMr3/ 'tn.oe.zotz 1
i
ffiat""*.*p"t"gffil
135
received from Department of Pharmaceuticals vide their oM No. 3501 l/163/2013-PI(Norms)
dated 09.05.2013 and in consultation with technical authority present in meeting, decided to
ratifl norms under para 4.? of HBP as per details below or as applied by firm whichever is lower:-
掛
い
concerned may take further necessary action as per above decision of NC
IMeet No/Date:19/82‐
IALC4/2014
118032015
m需
0810112513
「霊
T薄瓦
「
~
jn comments
3-PI(Norms)
, decided to
rer is lower:-
necessary
per above decision of NC.
0810112618
:01/82/050/01519/AM15/
:08′24/040/00o69/AM13/ 14062012
Decision:It、vas dccided tO re cctthe case as cxp。■and importitems arc same
Re-indexed
:01/82/050/00045/AM14/ :
LたNo/DateЮ310724136-
14022013
IDate:20052015
Decision :ItwasdecidedtOdefcrthecascfOr20052015forc01nnmentsofDcpartmentOfC&Pc
## Case No:57/10/82- Party Name:BIOLOGICAL E Mcct No/Date:19/82-
ξtatus: ~
ALC4/2013 tTD
ALC4/2014 1Approved
18032015
Lic No/Date10910055420 Defcr Datc:
;06/Aヽ413/ 19o32013
・ξttt∴t _
ion : Committee considered the case as per agenda and in light
ed from Department of Pharmaceuticals vide their OM No. 35011
October 2014 and in consultation with technical authority present in
norms under para 4.7 of HBP as per details below or as applied by fim
of、vritten co
/134/2013-PI(
mceting, de{
1、vhichever is
Export product
Exp
Q″
SI No
Import items
Q″ Aliowcd
Kg/7kg
PHTHALIMIDO
AMLODIPINE
l kg
l
ETHYL 4でHLORO ACETO ACETATE
0795
つ
４
METHANOL
1272
IPA(ISO PROPYL ALCOHOL)
3986
4
METHYLENE DI CHLORIDE ( MDC )
0612
RA concerned may take further
action as
NamciSヽVIss
PVT LTD
一
８
１
，
‐
⌒
Decision : ln the light of written comments received from Department of Biotechnology vide th eir OM
No. Sf/lL/O'138212013-PlD dated 26.02.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as
per details
below or as aDplied bv the
whichever is less:
Item of Export
Quantity
S′ No
Item of lmport
Quantity
allowed per
million vials
(PENTAVALENT VACCINE)
FULLY LIQU10
COMBANITAION VACCNE
10 DOSE VIAL PEDIATRIC
DOSE DPHTHERIA,
TETANUS,
PERTUSSIS,HEPATITIS B
RECOMBNANT AND
HAEMOPHILLuS
NFLUENZA TYPE B(H13)
COMBMD VACCINE Wl■H
VACCINE VIAL MONITOR
(V■/04)
l kg
1
POLYETHYLENE CLYCOL
6∞OrMACROCOL)
768 48 kg
2
AEROSiL 380 V(COLLIDAL
ANH SILICA BP)
203 75 kg
3
CLYCEROL
1228 41 1tr
4
pWEEN‐20(POLYSRBATE
20)
76 85 1tr
5
POTASSttM THYOCYNATE
1697 42 gms
6
TRIS BUFFER
102 16 kg
7
ALUMNRIM CHLORlDE 6
HYDRATE EXTRA
276 65 kg
YEAST EXTRACT
224 47 kg
9
DEXTROSE(GLUCOSE)
359 37 kg
10
LでYSTINE
4 37 kg
BACTO CASAMINO ACII)
317 58 kg
TIHOMERSAL
3 79 kg
SlLICON Eヽ4ULSION
165 00 kg
14
ADIPIC DШ YDRAZIDE
(ADH)
16 86 kg
N3-
DIMETHYLAMNOPROPYL‐
N ETHYLCARBODIMlDE
HCL(EDC)
1675.45 gm
21N‐ MORPHOLINO)
ETHANE SULFONIC ACID
(MES〕
14 41 kg
17
CETA VLON
15 369 kg
18
ALUMINШ M PHOSPriA‐
CEL 2%
769 91 kg
L‐TYROSIN E
7 81 kg
20
NZ CASE TT(CASElN
PEPTOllE PLUSヽ
391 2 kg
VITABIN BI HCL
(THIAMNE
HYDROCHLORIDEヽ
11 45 gm
GしヽSS VIALS SILCON:SED
5ML
1100000 nos
RUBBER STOPPERS
1085430 nos
24
ALUヽ41NIUヽ4 CAPS′SLへしS
1076890 nos
HEATMARKLR VACCINE
VIAL MONITORしヽBELS
(VVM LABELS)
1100000 nos
SIIIPPNC NDICATORS(Q
TAC 2 PLUS)
1790 nos
FILTERS&FILTER AH)S
2500 nos
阻
|:ヽ
雪器
D習篭
Lic.No/Datc:09 10055925 Deler
ハ
ヘ
14
:01/82/050/01493/AM 15/ :09/24/040/00633′ AM13/
Dccision : It was decided to defer the case for 20.05.2015
Pharmaceuticals.
Casc No:18/7′ 82-
ALC4′ 2014
HQ「ilc RI´ A FHc
:01/82/050/00662/Aヽ415/ :09/24/040/00624/AM13/
Dccision : Committee considered the case as per agenda and in light of written comments
received from Department of Pharmaceuticals vide their OM No. 3501 I /596/2014-Pl(Norms)
dated 29.04.2015 and in consultation with technical aulhority present in meeting, decided to
o, ratify norms under para 4.7 ofHBP as per details below or as applied by firm whichever is loweri
Export product
“
∝
SI No
Import items
QけAHowed
KノkR
(1ヽ2S,5R〉MENTHYL‐
5にACETOXY‐
l,3・
OXATH10LANE‐ 2R―
CARBOXYLATE(MAC)
l kg
1
CLYOXYLiC AClD‐ 50%
0865
う
Ｚ
2,5 Di HYDROXY 14 DI‐ THIANE
0356
CYCLOIIEXANE
162
4
I)lISOPROPYl´ ETHI:R
1 31
RA concerned may take further necessary action as per above decision of NC.
輻
雷… π眈場に
19/82
ICase No.:6/7/82‐ ALC4/2014 1Party Namc:RA CHEV
PHARMA LlMITED
蔦島児
5α∞“υ
Am5戸膨鵬α∞“
3ハm
lDccision:Committee considcrcd the case as
Party Namc:RA CHEM
PHARMA LlMITED
Nlcct No/Datc:19/82‐
ALC42014
18032015
Status:
Approvcd
received from Department of Pharmaceuticals vide their OM No. 3501 I /560/2014-PI(Norms)
dated 07.04.2015 and in consultation with technical authority present in meeting, decided to
ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
Export product
Exp
Qty
SI No
Import items
Q″ Allowed
Kg/kg
DIPYRIDAMOLE
l kg
1
2,6-DichiorO-4,8-Dipiperidino―
Pyrimido― (4,5-d)Pyrimidine
0 935 kg
RA concerned may take further necessary action as per above decision of NC.
Slatus:
Rcjected
“
鵬
島掲5υ∞
“
4/AM″
膨
鵬
α∞
“
1/AMW
露膨
酬
∞
“
∞O Fr嘘
\ i
l)ccision : lt rrrs decidcrl to close thc case as the firrn has not frrrnished infort:talion
I \iL
dcspite rcperlcd rctninticrs.
Il
.
.':
Iili:vi
.,-<i::
;,
'frtct qrqn 'r
Diredorate Genen
qFrrq fr'n voe',..
sdFr 1Iq l
Utlyog Bhawd,,.,\.,\/ te,hr
Casc No■20′7/82-ALC4/2014 Patt Namc:DR REDDYS IMeet No/Datc:19/82‐
‐ lLABORATORIES LINllTED iALC4/2014
1 1 118032015
Ｅ
Ｊ
ハ
^
「陣瓦面雨瓦蔵″
m4
卜晨ュ鷺……
匠画面漂耐而面圧
ILIMITED
|
隠源諏蕩話嘉薫蔦
「
~
Rejected
M｀
0056109「面
ALC4/2014
18032015
ICase No.:12/20/82-
ALC4′ 2013
:01/82/050/00416/AM15/
Decision : It was decided to reject the case as the firm has not furnished information despite
repeated reminders.
Paty Name:GLAND IMeet No/Datc:19/82- Status:R●ected
lPHARMA LIMITED .ALC4/2014
18032015
461HQ F‖ c lRLA F‖ e Lic No/Date10910056108 1DeFer Date:
101/82/050/00998/AM14/ :09/24/040/00061/AM14/ 23052013
Decision : It was decided to reject the case as the firm has not furnished information despite
repeated reminders.
## Case No.:22/12/82- PartD Name:INDOFIL Meet No/Date:19/82‐
Status:Deffered
lALC4/2013 11NDUSTRIES LTD ALC4/2014 and Re―
indexed
47 「「民再:^ ~~ ~~~
18032015
/ ng rit.
RLA Fite
Lic.No/Date:03 t0738404 Defer
::0UE2/050/00446lAMl4l :O3/941040/00t97 /AMt4/
20.06.2013
rDate:20.05.20 t5
Decision : It was decided ro defer the case for 20.05.201 5 lor comments of Department ofCapC.
## Case No:44/19/82‐
ALC4/2014
Party Name:WRIGLEY
lNDIA PVT LTD,
4嚇
」―脇靡
t―一
Mcct No/Datel1 9/82-
ALC4/2014
18032015
Lic No/Datc:0710096312
Defer
Status: Deffered
and Re‐ indexed
IDate:20052015
28062013
Decision : Comminee considered the case as per agenda and in consuhation with technical
authority present in meeting, it was decided to request the firm to clari$.,as to whether tlte export
item is medicament, if so, a copy of Drug Manufacturing License may be fumished by the firm.
The case was deferred for 20.05.201 5.
MeetNo/Date:19/82- Status:Deffered
AL.C4/2014
and Re-indexed
18032015
Lic No/Date:0910057280 DeFer
‐22 08 2013 1Date120 05 2015
Decislo■:lt was dccidcd tO dcFcrthc casc for 20 05 2015 for commcnts of Dcpa■mcnl ofC&PC
: lcaζ しヽこ63/iウ/j力: ~~■
an,NaおよDR REDbム
~Mcま
No'Dまさ:i98が
‐
暉晨[ζ 5efFettj l
ALC4/2013 LABORATORIES LIMITED ALC4/2014 and Re―
indexed l
18032015 1 1
501HQ File l良LA File l Lic｀8'Datc:b,166;154`「55[F ~~ ~ |
101/82Ю50/00925/AM14/ :09つ4/040/00261/AM14/ 13 092013 1Date:200520151
1 1Decision:ItwasdccidcdtodefcrthecascfOr20052015 forcommcntsofDcpaltmentof l
I Pharmacelltlcals I
)
16
Decision : lt was decided ro reject rhe case as lhe firm has not furnished information despire
repeated rem inders.
1需蕊
蕊雷t面而
ectthe case F面編
[高:高l面扁而覇
was decided to defer the case for 20.05.2015 for comments of Department of C&pC.
珈
「
~i
ud癖編Ll.、_v bLiⅢ
⌒
⌒
No:36/19/82-
Party Namc:SOHAM
ORGANICS PVT LTD
No/Date:19/82-
18032015
Rejected
眈
2確鵜猟
К 親田
1辮
T而
嚇
ARMAM
l18032015
17
^
^
|:01/82/050/OH51/AMi4/ 1:05つ47040/00201/AM 14/ 脚~圏叩
|
1碁櫻
議薫爺
|
Decision:It、vas decidcd lo defcrthc case for 20 05 2015
for comments of Department of C&PC.
HQ F‖ c
:01ノ82/050/00015/AM15/
RLA File
:07/24/040/00318/AM14/
necessary
per
置だ
gttЮη例
007"PetrDttα
of NC
Decision : Committee considered the case as per agenda and in light of *.in.n comments
received from Department of Pharmaceuticals vide their oM No. 35011126112014-pl(Norms)
dated 12.03.2015 and in consultation with technical authority present in meeting, decided to
ratify norms under para 4.7 of HBP as per details below or as applied by firm wh ichever is lower:-
Export product
Exp Qw
SI No
Import items
Qty. Allowed
AMOXYCILLN 250MG+
FLUCLOXACiLLlN 250MC
CAPSULES
Thousands
in Nos.
l
AN40XYCILLIN TRIHYDRATE
292 68 mg for One
capsule
2
FLUCしOXACILLIN SODIUM
267.34 mg for one
capsule
AMOXYCILLIN
125MC+FLuCLOXACILLIN
125MC ORAし
SUSPENS10N
Bottles
1
鰤OXYCILLIN TRIHYDRATE
755 mg fOr 100 ml
bottle
う
ι
FしUCLOXACiしLIN SODiUM
688 mg fOr 100 ml
bottle
concerned may take further
action as per above decision
「
Fttm1/3/82‐
ALC例
“
1翻
r醐
に
圧
「
「M戸
F9澁T蘊;蕊「
「蒟臨孤面
Mcct No/Datel1 9/82‐
ALC4/2014
!8032015
Status:DerFered
land Re‐ indexed
Derer
Date120 05 2015
INDUSTRIES LIMITED
RLA Filc
:03/94/040/00719/AMi4ノ
ILic No/Date:0310763628
‐30122013
, Decision : It was decided to deler the case for20052015forcommcntsofDepartmentofC&PC‐
1珈
「
平
~
:需
…
甲
has not furnished information despite
repeated reminders.
´
r―
_J
Status:
‐Mcct No/Datc:19/82-
―
|
IR●ected
肌
一
雪
器
腎
マ1 :「
'1｀(
6'`.じハ lrade
:亀滞
de
。,comlnerce
繭謡
』じ
|
「 而1澁:ECON~
ALC4/2014
18032015
3蕊麗蕊謀誡
:Ы
―
一
‐PHARMA LIMITED
1棚鬼
5∽∞略Ⅲ夕[競脇蕊I罵丁
肝
I而
: It was decided to reject the case as the firm has not fumished information despite
reminders.
: It was decided to defer the case for 20.05.2015 for comments of Department of C&PC
に
: Committee considered the case as per agenda and in light of written comments
6 received from Department of Pharmaceuicals vide their OM No 35011/382/2014‐
P(Norms)
07.o4.2O15 and in consultation with technical authority present in meeting, decided to
norms under para 4.7 of HBP as per details given below or as applied by firm whichever is
lower:―
ExPort tem No l:DMT―T
^
⌒
隔臨蕊蔦万「需
0310%"“ [蕩OЮ5 2015
mi憂亜憂亜≡
●
ｏ
ｅ
18
需蕊需面正~~[理
語癬蒼ξ面雨~~臨
翔需面漉T
卜
LC472014
「
FESαEhlCES I織
殿盤:
1祗薦蕊戸 Fド駆辮耐Ю
ttH9PttD配
3 It was decided to reject the case as the firm has not furnished information despite
reminders.
## Case No.:53′ 23/82‐ Pary Name:EXCEし
ヽ4eet No/Date:19/82- Status:Deffered
ALC4/2013 1NDUSTRIES LIヽ
1lTED ALC4/2014 and Re― indexed
18032015
19
（
（
ExpOrt lem No 2:DMT―
Bz―dc
ExpOrtltem No 3:DMT― Bz―dA
ExpOrtltem No 4:DMT― i8u―dG
IRAconcernedmaytakefurtherneCessaryactiOnasperabOVedeCiSionOfNC
1
Status:Deffered
land Re‐ lndexed
|
FDefer~~~~~~~
IDate:20052015
IDecision:lt was decided to deferthc casc fOr 20 05 2015 for commcnts of
Department of C&PC
S No
lmport ltem
Qtv. recommended ko/kq
THYMIDINE
0596
2
DMT― CI
0761
S No
lmoort ltem
Otv. recommended ko/ko
Deoxycytidine
0678
2
DMT― CI
065
S No
lmport ltem
Qtv. recommended ko/ko
DEOXYADENOSIN MONOHYDRATE
073
2
DMT― CI
068
S No
lmport ltem
Qtv. recommended kq/kq
DEOXYGUANOSINE MONOHYDRATE
0688
つ
４
DMT― CI
070
「7競
扁
蕊
鳳
i戸
LAⅢ
e~~蘇
~|
Ю3/95/040/00805/AM14/
| ICase No.:40/4/82- Pa“y Namc:NEW ALLIANCE McctNo/Datc:19/82‐
IALC4/2014 DYE‐
CHEM PVT LTD, IALC4/2014
Meet No/Date:19/82- Status: |
IALC4/2014 1R●ected :
118032015 1 1
RLA F‖ c
:03/94/040/00942/AM14/
l;:|::ii「::i;lil「
F:こ「
:「『
iテ;1:Fテi「il,「
~IDeferDate: |
to reject the case as the firm
21012014 1 1
蔽
~1浅~品面話:hぉrrnmon dcsp■a
following information:
(a) Technical Justification for import of Sulpher which is not shown in the process/chemicals
reactions.
(b) Past production vis-a-vis Actual consumption of inputs duly certified by Central Excise
Ψ
LC4/2014
Pa●y Name:BLISS GVS
IPHARMA LTD
」
「 IFT:Ψ 胃蕗面
|
. IHQ File lRLA F‖ e Lic No/Date:2210014544 1Defer
‐
. IHQ File lRLA F‖ e Lic No/Date:2210014544 1Defer
‐
| :01/82/050/01042/AM14/ :22/21/040/00096/AM14/ .23 01 2014 1Date120 05 2015 1
`9 1Decision:In the light ofwrltten commcnts rcceived from Depanmcnt OfPhallllaceuticals vide
‐
their OM No 35011/523/2014-Ploヾ。rms)dated 25 03 2015,I was dccided to ca‖
from the■rm l
Ⅷ
11]L恵耳活de
,nt Or commerce
ヽま再発hi
Authority
case is deferred for 20 05 2015
: It was decided to reject the case as the firm has not fumished information despite
20
Name:ALCHEM
Decision : Reply received and sent to
The case is deferred for 20.05.201 5.
No:108/3/82-
Decision : lt was decided to defer the case for 20.05.2015 for comments
」
No.:149/3/82-ALC4/2014 1Pary Name:MOREPEN
ILABORATORIES LTD,
|
reminders.
21
（
（
## Case No:150/3/82‐ ALC4/2014 Pary NamelMACLEODS Mcct No/Datc:19/82‐ Status:
PHARMACEUTICALS LTD ALC4′2014 1Approved
18032015
HQ File RLA File Lic No/Date:0310769509 Defer Date:
:01/82/050/00154/AM15/ :03/95/040/00879ノ
AM14/ 06022014
Decision:in the nght of written comments received from Department of Pharmaceuticals vide
the計OM No 35011/325/2014-Pl(Norms)dated 07 04 2015′
t was decided to rajfy norms under
Para 4 7 of H8P vl as per detalls given below or as applied by the firm,whicheveris less:
Export product
Exp
Qty
SI No
lmport items
Qty allowed
kg/kg
FAMCICLOVIR 500MG
TABLETS
Nos
l
)―(4-ACETOXY-3‐
ACETOXYMETHYLBUT-1-
YL)-2-AMNO‐ 6-
3HLOROPURNE
0 663kg/1000 No
tablets
## Case No:86/3/82-
ALC4/2014
Party Namc:AKZO NOBEL
INDIA LIMITED
|ヽ4ect No/Date:19/82‐ Status:Deffered
AI C4/2014 and Re‐ indexed
18032015
_| |
HQ File
RLA Filc
:O1/82/050/00090/AM15/ :02/24/040/00197/AM14/
Lic No/Date:0210200380 1Defer l
21022014
iDate:20.05.2015
]
Decision: It was dccidcd to dcfcrthc casc for 20 05 2015
for commcnts of Depaltmcnt ofC&PC I
781HQ File
:01/82/050/01533/AM15/
Pa口りNamelMYLAN
LABORATORIES LIMITED
RLA File
:0924/040/00600/AM14/
N4cct No/Datc:19/82‐
ALC4/2014
‐18032015
Lic No/Date,0910059428 DeFer
26 02 2014 1Date:20052015
## Case No:45719/82-
ALC4/2014
Status: Deffered
and Re-indexed
Decision : It was decided to defer the case for 20.05.2015 for comments of Department of
Pharmaceuticals.
|
鵬3月50/002"/AMW
「器躙説1麟
te 19 82附配
Decision : committee considered the case as per agenda and in light of written comments
received from Department of Pharmaceuticals vide their oM No. 35ol I l4j2l2ol4-pl(Norms)
79 dated February 2015 and in consultation with technical authority present in meeting, decided to
ratiry norms under para 4.7 of HBPas per details below or as applied by firm whichever is lower:-
ゝ
Fr+q I'
gq ,rait.' .._
,
tj.^
rrs Dkect(r Ge, 1.
- frr.r ?.q.rql{... i*-i..-I
rrk;6rats c€neral or , J'! ln rraoe
?rlFr.;q F{Fvoepadment of c.mmsrco
,oBEffi;"11.,ffi",n,
Methyl-2-[3(s)-[3-[2-(7-Chloro-
2-quinolinyl)ethenytlphenyll-3-
Export product
Exp
Q″
SI No
lmport items
Q″ A‖owcd
K」kg
Montelukast
Sodium
l kg
l
1489
22
hvdrate or HCP
つ
た
Methyl magnesium chloride
3317
3
Toluene
596
4
Ethyl acetate
380
5
Methanol
195
6
N,N-Diisopropylethylamine
030
7
Tetrahydrofuran
132
8
Dicyclohexylamine
0631
9
Acetonitrile
055
10
z-lt-
(Mercaptomethyl)Cyclopropyll
Acetic Acid/ 1,1 -Cyclopropane
Dimethanol
040
Methylene Chloride
146
concerned may take further necessary action as per above decision of NC.
Status:Deffered
and Re-indexed
Defer
Date:20.05.2015
:Decision:It was decided to cali fo1lowing technical dctalis from the■rm viz■
| (a)COmplCtc technical dctails as per Appendix-33
1 (b)%COntent of BuffcHng Agent h Expo■
Product
lThe casc is dcferred for 20 05 2015
~F雨
繭
蔽
繭
F薪
藷悟憂R西蕗
Meet No/Date:19/82-
ALC4/2014
18032015
Status:Deffered
and Re-indexed
]目漑
50Ю
“
%ハmダ
鵬蹴
υ∞
"νAMW
爾
鼎
翻"矧
百
BttQ“ 2m5
: It was decided to defer the case for 20.05.2015 for comments ofDepartment of
雪可R′ N,RMAし
,´ ・1 ■
|
Mcct No/Datc:19/82-
Status:Deffered
´
⌒
ICasc No.:56′ 4/82-
| ‐ALC4/2014
I)arty Namc:IND‐ SWIFT
LABORA『ORIES LTD,
靱
Status:Dcffcred
rtnd Rc-in(lcxed
83 HQ lllC RI′ A Filc Lic No/1Datc12210014691 1)citr
101/82/050/00304/AN115/ :22′ 24/040/00102/′ ヽlN4 14/ 14032014 1)●tc120 05 2015
Decision : It was decided to call from the firm complete technical details as per Appendix 33.
The case is deferred for 20.05.201 5.
CバcN∝57ただか ,a“yNamcNDSy獣 1造き淵腎にツ陀‐
l∬糧littI::
‐ALC4/2014
‐LABORATORIESi
118032015
84 HQ Filc RLA FHc ,IJC No′
つatc:2210014692 1Doたr
l 101/82/050Ю 0305んへM15/ 122724/040/00103/AM14/ 114 03 2014 Datc:18032015
1 1Dccision:It was dccidcd io ca‖ from thc nllll complctc tcchnical dctals as pcr Appendix 33
Thc case is dcfcrrcd for 20 05 2015
Casc No:58ノ4/82‐
ALC4/2014
IPa“yNamcND‐ SWIFT
LABORATORIES LTD,
:Mcct No/Datc:19/82‐ status:DcFlcrcd
:ALC4/2014 and Rc― indcxcd
118032015
:01/82/05α 00306 AM 15/ :22/24/040/00100/AM14/
2210014694 1DcFcr
lDatc:20052015
IDccisio■:I was decidcd tO call from the irm cOmplctc tcchnical dctaiζ
as pcr Appcndix 33
1Thc case is dcrcrrcd for 20 05 2015
| ICasc No■42たβ2‐ 'ary Nam∝
RECKltt IM8よ
ヽルbacl%8工
針
"iζ
bcrFcl`j
ALC4/2014 BENCKISER HEALTHCARE IAI C4/2014 and Re‐
indcxcd
‐ lNDLヽ
LIMITED 18 03 2015
86 HQ Filc RLA Fne lLic No/Datc:0510382032‐
Dctr
:01/82/050/00290/AM 15/ :05/24/040/00480/Aヽ
414/ 18 03 2014 Datc:20052015
1 1Dccision:Rcply rcccivcd from thc nrm and scntto dcpanmcnt Of Pharinlaccuticals. Thc
‐ casc was dcfcrrcd fOr 20 05 2015
24/6/82‐
臨蕊需聴
「
~聞
wF9/82‐
Status:Dcffercd
and Rc-indcrcd
ALC4/2014
HQ Filc RLA F‖ c lLic No/Datc:0510382042 1Dcttr
101/82/050/00526/AM15/ 1:0524/040/00467/AM14/ 118 03 2014 Datc:20052015
1Dccision:it was dccidcd tO dcFcrthe casc FOr 20 05 2015 for commcnts of Dcpartmcnt ofC&Pc
「
西感而
7/6/82‐ 巨ごV馬温
…
IALC4/2014 1CHEMICALS PVT LTD,
| |
SS rlQ Filc
RLA Filc
iot/8210s01005291AMt5/ t3U83/040tOO232tAMt4/
' Decision : It was decided to defer the case for 20.05.2015
Pharmaceuticals.
i14032014
IMcct No′ つatc:19/82‐ statusDcFrcrcd
lALC4/2014 1and Rc‐ indcxcd
118032015 1 1
for commcnts of Dcpartmcnt of
⌒
ヘ
24
Status:
Approvcd
| IRA may takc appropHatc
Lic No/Date:0310776326 1DeFerDatc:
28032014 1
IMcct No′ Datc:19/82- Status:Dcffcred
l盤盤F ,祠
k輸“辮
d
IHQ lllC
:01/82/050/004621ヽヽ115/
:03′り5漁D40/01035んヽヽ414/
Dccision : In thc light of、vriten commcnts receivcd from Depaimcnl of Pharmaccuticals vide
thcir OM No 350H/315/2014-PIいorms)dated 13 03 2015,it was decided to rati～
thC nOl‖ Is
underPara47ofH8Pvl asperdctailsgivenbclo、v or as applied by the rlrm,、vhichevcr is less:
Export Product
Quantity
Raw materials allowcd
Quantity allowcd
ke/kc
Azithromycin Dihydratc
USP‐ 36
l kg
Azithromycin Dihydrate IP
1061
as
thc
0
Clommittee.
pcr
:輛
聴
蔽
~ド
撚
隠
&VttARMAttF詢
薩
畢
画
面
9l HQ Filc
nl-,r fil"
lLic.No/Date:0310776760 Dcfcr
:01/82/O5O/00452/AM 15/
:01195lo40lolo6llAMl4l 02.04.2014
Date:20 05'2015
Dccision:ltwasdecidedtoscndacopyofapplication to Department of C&PC ior their
comments. The case was deferred for 20.05 2015 for comments of Departmenl ofC&PC.
‐Party Namc:PERFECT
INDUSTRIES PRIVATE
ILIMlTED
90 HQ rilc RI A Flc Lic No/1)atc:0310776759 Dclcr
:01/82/050/00453/′ヽ
|ヽ415/ :03/957040/01054/ノ｀M14/ 02042014 1).ltc120 05 2015
Dccision : lr was decided to defer lhe case for 20.05.2015 for comments ofDePartment ofc&PC.
Casc No.:183/6/82-
ALC4′ 2014
Rc-indexcd
2015
Dccision:It was dccidcd to dcferthc casc for 20 05 2015 for comments ofDcpartnnent orC&PC
Casc No:23776/82-
~“
I
NIcct No/D■c:19/82‐
ALC4/2014
‐18032015
Status:Dcffcrcd
and Re-indexcd
Casc No.:20/6/82-
Party NamC:ADISIIANK Mcct No/Date: l9182- Status: Dcffcrcd
Al,C4l2014
CIIEMICAI,S PVT.LTD. ,ALC4l20l4
8nd Rc-indcxcd
18.03.2015
92 Hq rit"
RLA File
,Lic.No/Date:03 1077 7786 Dcler
:01182/050/0(1422/AMl5l t}3lg4l}41l1ll4,lAMl4l 09.04.2014
Datc:20.05'2015
Decision : lt was decided to defer the case for 20.05.2015 for comments ofDepartment ofC&PC. r
¬n■可れ
。ep・
,.,., * iii,rnr
Ｃ
Ｊ
^
HQ F‖ c RLA Filc
:01/82/050/00639/AM15/ :17/24/040/00002/AM15/
DecЫon:■was d∝ded oこeferiお
`:悪
蔦蘭:6;面再for語nments of Dcpartment ofC&PC
## Case No.:9/9/82-ALC4/2014
脚
艦
:~
|
/
「F売繭丁
…
繭
Pharmaceuticals.
IDecision:It was decided tO deferthc case for 20 05 2015 for commcnts of Depanment OfC&PC
‐Mcct No/Date:19/82-
ALC4/2014
■8032015
ｄ
，
Ｏ
Ｖ
Ｓ
ｔ
ａ
ｔ
ｕ
柿
|‖
ilase No.:236/6/82-
Party Name:'EsteeU U"eiilofOare,t gltZ- -
Ert,rsD.ff"r"d
'6vcuzott
,lNousrntes pvr. lro,
ALAtzot
iand Re.indexeu
I
18.03.20 r 5
I
| l il&o■
2015 1
1HQ卜ile ~~ ~~~ 1ミ[rFile ~~ ‐
~~~~tlc、
67D猛よiilooo580g 15efer~~~~~~~
「01/82/05υ00638/AM15/ :17/24/040/00007/AM15/ 108 05 2014 1Date:20052015
951HQ File RLA File
‐
101/82/050/00806/Aヽ415/ 109/24/040/00036/Aヽ415/
1)ecislon : It 、vas decidcd tO defcr the casc fOr
|
匠
~~
IDate:14062015
for comments of Department
`HQ「lle
:01/82/050/00640/AM15/
Pary Name:ESTEEM
INDUSTRIES PVT LTD,
RLA Filc
Meet No/Date■9/82‐
ALC42014
18032015
Lic No/Date■710005810
09052014
117/24/040/00008/AM15/
IDecision:It was decided to defer the case for 20.05.201 5 for comments of Department of C&pC.
1/82/050/00625/AM15/
26
^
n comments
4-PI(Norms)
decided to
whichever is
comments
PI(Norms)
iecided to
richever is
100
~い
面
高
疏
直
面
扇
而
両
面
IA― OLIC
I PRllCSLTD,
Meet No/Date:19/82-
ALC4/2014
118032015
田
RLA File
:05′24/040/00070/AM15/
Lic No/Datc103 10783471 Defer Datc:
29052014
ion : Committee consic
ed from Department of
25.03.2015 and in const
norms under para 4.7 t
lered the case as per agenda and in light of written commet
Pharmaceuticals vide their OM No. 3501 l/545/2014-PI(Norn
lltation with technical authority present in meeting, decided
rf HBP as per details below or as applied by firm whichever
Export product
Exp
Q″
Sl No
Import items
QけA‖owed
KA/kg
BETAMETHASONE VALERATE
l kg
|
BETAMETHASONE
0915
concerned may take further necessary action as per above decision of NC.
No.:67/9/82-ALC472014
ion : Committee considered the case as per agenda and in light of written comment
ed from Department of Pharmaceuticals vide their OM No. 3501I/25112014-PI(Norms
18.03.2015 and in consultation with technical authority present in meeting, decided tr
norms under para 4.7 ofHBP as per details given below or as applied by firm whichever i
Export product
Exp
Q″
SI No
Import items
Qty in mg for export of
I Pantoprazole tablet
20 ms Tabs
40 mg tabs
Pantoprazoic
Tablet
l kg
1
Pantoprazole
Sodium
21571
43 143
つ
Mannitol USP
(PCarlitO1 25C)
4244
8488
3
Sucrose USNF
800
1600
4
Hyprome‖ osc
(Pha:‖ lacOat 603
3cps)USP
1 86
372
concerned may take further necessary action as per above decision of NC.
、 |∝ほ1lnl群席∬盤庶露』籠〔Wtttytr器l∬1拐:社∫熙WS
|
tc:0510388412 Defer Datc:
。蕊
t轟品ま黒|
、
■fヽマ呵枷
Depar O
ξlelttWT』珊LF£甜し1肥劉
|
―
―
―
―
―
一
― ―
―
―
―
―
―
一
―
―
―
―
―
―
―
―
―
―
―
―
― ~
sqtq at"in.
Udyog Bhawarr, ,.-', oerhl
~淋
蕊
1瓦薦j
27
^
ハ
Export product
Exp
Q″
SI No
Import items
Q″ Allowcd
Kg/kg
Praziquantel
l kg
1
2-Benzoyl-1,2,3,6,7,11-
bhexahydrO-4H― Pyrazino[2,1-al
isoquinolinc-4-onc
1703 ´
2
Acetone
060
3
Activated Carbon
0100
4
Cyclohexane
034
5
Cyclohexane Carboxylic acid
0714
6
Methvlene Chloride
319
7
Ortho Phosphoric acid
109 _
RA concerned may take further necessary action as per above decision of NC.
102133児
50Ю068αAMl夕
~辱
薦蕊;話11蔦
「
~臨
漱需画面而IB鑑ち
OЮ,2015
Decision : It was decided to defer the case for 20.05.2015 for comments of Department of
rPharmaceuticals.
|
Filc
輌面雨蔦~~~~~ におヽ61E面,Io388672
:01/82/050/00553/AM15/
105/23/040/00107/AM15/
13062014
sion : Committee considered ca5e as per agenda and in light of earlier decision taken
ing no. 6/82 dated 29.08.2014 and in consultation with technical authority present
ing, decided to ratil)/ norms under para 4.7 of HBP as per details below or as applied
whichever is lower:-
Export product
Exp
Q″
SI No
Import items
Qty Allowcd
Kノkg
ALLYLESTRENOL
BULK‐ DRUG API
l kg
1
I 9-Nor-Androstenedione
(Estr-4-ENE-3.1 T.Dione)
1 45 kg
concerned may take further necessary action as per above decision of NC.
necessary
ｎ
ｎ
ｙ
ｌ
ｌ
，
０
`lPa●
NalleHETERO LABS
ILIMITED
|
Name:INDO PHYTO
No′Date:19/82‐
IMcctNo/Data 19/82-
IALC42014
ヽN
珈
:A
28
ision:In the light of written comments received iom Depanlllent of Pharmaceuticals vide their OM
350H“ 95/2014‐ PI(Nonns)dated March 2015,I was decided to raJ″
thC n01lns under Para 4 7 of
)vl as per details given below or as applicd by the fl‖ ‖,whichever is less:―
Export product
Export
Qty.
SI No
Import items
Qけal10WCd
SITAGLIPTIN
PHOSPHATE
MONOHYDRATE
lk
1
R-3-((tert―
butoxycarbonyl)aminO)-4-
(2,4,5-
trifluorophcnyl)butanOiC acid
(SG04)
100kノkg
つ
ι
3-(tHnuoromethyD-5,6,7,8-
tctrahydro― [1,2,4]tHazO10[4,3-
alpyraJnc hydr∝hlo‖dc
0 80 kg/kg
つ
N-
Hydroxybenzotriazole(HOBT)
0 50 kgkg
4
Methanol
3 65 1it/kg
Isopropyl alcohol
6 10 1it/kg
´
０
Methylene Dichloride
15251プkg
may take appropriate action as per the decision of Norms Committee.
（
（
106
107印戸~甲閻庶可鮮
"/82
器耽5∽∝“/AMly隔脇瓶:蕊戸1獅鼎雨雨
厩
WaSdCttdedtoleferthecasefor20052015forcommentsofDepartmcntof
Ю81器
3児50ЮO釧7AMV IЪ
危糀
OЮ。75AMV
1造31輝T°
19/82‐
118032015
1Lic No′Date:0910060550
,■0620И
## Case No.:164/6/82-
ALC4/2014
: It was decided to defer the case for 20.05.2015 for comments of Department of
ｄ
“
Ｏ
Ｖ
ｔ
ｕ
ｐ
ｒ
Casc No:73/982-
A LC4′ 201■
1091HQ Fnc
:01/82/050ノ008707AM 15/
29
Party Namc:D R COATS IMcct No/Datc:19/82‐ ‐status:DcfFcrod
INK&RESINS PVT LTD ALC4ρ 014 and Rc― indexcd
18032015
賠λ
ttγ00755AMW
1撚鼎α∝Ю
tta創躊ち
032m5
I)ccision : It was decided to defer the case for 20.05.201 5 for commcnts of Department of
I C&PC
| :01轟ヽdi'16/6/8'lALё 4/'di`ぎヽヽ古
“
じ:wEXF6ib lMおよヽo/D::ぎti9/821 1Stititl l
10鳳le―
― 一-4翼
yttWrD器
盤F
け
ⅢⅢd l
― ~~~~・
満
悦面
蒟添瑞
IDcrcr面31
i Ю1/82/050/00612/AM15/ Ю7/24/040/00105/AM15/ 10062014 1 :
I DcciSon:It was dcdded lo●
ca the Case¨ the inln has not fumishcd hfonnttbn dcs●
tC I
I ICpCatcd rcmindcrs. I
Casc NO:63/9/82‐ ALC42014
Pary Namc:CORAL
LABORATORIES LTD,
諄醐す
19/82‐ ~~岡
nll
HQ Fi!c
:01/82/050 008607AM 15/
RLA Filc
:03/94/040/00177/Aヽ415/
Del'cr Datc:
agenda and in light of written comments
their OM No. 3 501 l/615/2014-Pt(Norrns)
aulhority prcsent in meeting, decided to
below or as applied by firm whichcver is'
Lic No/D"cЮ 310786480
i07072014
Decision : Committee considered the case as per
receivcd from Department ol Pharmaceuticals vide
|しししlVじu
“
ulll υcPこ11:11じ【
lι 01 rildrlnaccuIIcals vloc
ldatcd 27 03 2015 and in consultation with technical
lratl～n01uS undcr para 4 7 of HBP as pcr dctails
lower:-
may
necessary action as per above decision of NC.
llI
Export product
Exp
Qty
SI No
Import items
Qty Allowcd
DOFEC 50 TABLETS
Diclofcnac Sodium BP
Equivalcnt tO Dic10Fenac 50
Mg
l kg
1
DICLOFENAC
SODIUM BP
54 790 mg pcr
tablet Of 50
mg
concerned may take further
,Pa“y Namc:PAYAL
IPETROCHEヽ4 PRIVATE
ILIMITED
Mしまヽ。b“よ19/め: もtatit:bcrlcl`d
,AI´ C4/2014 and Rc indcxcd
118032015
圏需“お勧聴や各
I P4o200,2m5
1 1
IMcct N″ Datc:19/82‐ status DcfFcrcd
lAI.C4ノ2014 and Rc indcxcd
'18032015 1
I´ ic NoノI)atc:0510389447 1)crcr
For 20 05 2015 for cOmmcnts OfDepartmcnt Or
Party Namc:PAYAL
IPETROCHEM PRIVATE
ILIMITED
Mi:鳥
躍聯器拙I「
1 1)ccisiOn:It was dccided 10 defcr the casc
: IC&PC
jnue nire
ヘ
ヘ
30
:01/82/050/00613/AM15/
|
IDate:2005.2015
IDccision:It was dccidcd to dcfcr the casc for 20 05.2015 for comments of Department of
lC&PC
Casc No:64/9/82-ALC4/2014
Party Namc:IPCA
LABORATORIES LIMITED 博鐸面魏が琴漱霊
]
剛戸繭需蕊
1141品3児5000861ハMl夕
RLA Fnc
:03ノ94/040/00199Aヽ415/
Dccision : It was dccided
Pharmaceuticals.
ro defer the casc for 14.06.2015 for comments of Department of
一
Ｑ
Casc No:26/9/82-ALC4/2014
RLA FHc
:01/82/050/00823/AM157 :09724/040/00188/AM15/
Datc:20052015
l)ccision :lt was decided to call from the finn past production vis-a-vis actual
constlmption of an the inputs duly ccrtifled by Ccntral Excisc Authori" for thC pcriod o
2013-14 and 2014‐ 15 Thc casc iS dcfcrrcd for 20 05 2015
Dccision : Il was decided to defer the case for 20.05.2015 for comments ofDepartment of
Pharmaceuticals.
## Case No.:108/9/82- Party Name:NECTAR iMcct No/Dut"t tglAZ- -3Gt'"l6"ff"t"a l
ALC4]2O14
LIFESCIENCES LIMITED, ]ALC4/2O 1,4
and Rc'indcxcd l
118.03.2015
HQFilcn-r-e}ir"''-itic.t.ioroate:2zt00l50l9Dcr.er
:01/82/050/00e05/AM 15/ ,:r.tiituotooow eurct 'tts'ot'zotc
DaI?o9529]5
l
I l7 Dccision : It was decide to call from the firm following information:
I
i)
% ofcoating material in export product supported by COA ofthe export
I
consignment.
ii)
Copy of DML for relevant coated export product'
I
The case is deierrcd for 20.05'2015'
I
Casc No■108/9/82‐ Pa“y Namc:NECTAR IMCCtNollDatc:19/82‐ Status:Dcfrcrcd
ALC42014
ЫFESCENCES uN41TED,1常
殿盤F lndRttndcxcd
Mcct NolDatc:19/82‐
DcfFcrc(1
11072014
C:lsc No::′6/82‐ ALC4/2014
品
誦
両面
繭
面
1鼈
紺
MM日
鴨γ
酷
ぱ
棚
H6131」i:j:鳳ζ
l話ζ
ll痣鑑し
:∴:jl二ζ
ttF滉21`b3働ケ
8678'識ちょ
:よ」
:L
118‐ 責Q Filさ
101ノ82/050/00403/アヽM15/
（
３
ハ
′ ヽ
|
C&PC
|
~F嘘眈
7卿な伽4
猫鮮―
H9開
掲50Ю
“
7αAM 157脇
淵
OЮ
“ "ム
m夕
]W開
°
"Ю
・
η
"
Deffered
Re-indexed
:20052015
Decision : It was decided to defer the case for 20.05.2015 for comments of Department of
C&PC.
吻
Lic No/Date:0910060702
122072014
120
DTP― HEPB‐HIB
(PENTAVALENT VACCINE)
FULLY LIQUID
CONIB「ヾAT10N VACCNE
SINCLE DOSE VIAL,
PEDlATRIC DOSE
DIPHTHERIA,TETANuS
PERTUSSIS,HEPATITIS B
RECOMBlNANT AND
HAEMOPHILUS
nヾFLUENZA TYPE B(HIB)
COMBINED VACClNEヽVlTH
VACCnヾE VIAL MONITOR
(VVM)
Decision:In the light of wntten cOmments received from Department of Biotechnology vide their OM
No BT/1L/05/382/2013-PID dated 26 02 2015,it was decided to ratify norms under Para 4 7 of HBP vl as
per detalls given below or as apphed by the firm,whichever is less:
Qua ntity
allowed per
million via ls
POLYETHYLENE CLYCOL
ALUMNIUM CHLORIDE 6
HYDRATE EXTRA
167 545 gm
VITAMDヽ31 HCL
No.:18/9/82‐ ALC4/2014
Name:BIOLOGICAL E
つ
０
(THIAMlNE
HYDROCHLORIDE)
22
CLASS V:ALS
1100000 nos
23
RUBBER STOPPERS
1095638 nos
24
ALUMNIUM CAPS′SEALS
1088334 nos ´
Ｅ
Ｊ
HEATMARKER VACCINE
VIAL MONITOR(VVM
LABELS)
1086508 nos
26
SHIPPINC NDICATORS(Q
TAC 2 PLUS)
902 nos
27
FILTERS&FlLTER AIDS
250 nos.
No.:2419t82-ALC4/20t4 Party Name:BRUNDAVAN
LABORATORIES PRIVATE
LTD,
Decision : lt was decided to defer the case for 20.05.2015 for comments of Depaltment of
Pharmaceuticals.
Re-indexed
:18032015
ｍ
ｄ
ｅ
ｘ
ｅ
ｄ
ｅ
ｎ
ｎ
υ
・ｌ
嘔
Ｒ
ｅ
ｔ
ａ
ｔ
ｎ
ｄ
Ｓ
ａ
14062015
: It was decided to defer the case for 14.06.2015 for comments of Department of
諄席"
Re-indexed
「F需評而戸~~
り
4臨蔦扁瓶肩」~彫
蔦薦菰「」
~輛
霜P而而
Re-indexed
: lt was decided to call from the firm complete technical details as per Appendix 33.
casc is defcrrcd for 20 05 2015
F‖ e
IRLA Rた ~~~~
IЮ3/94/040/00321/AM15/
…
茄
「
町
ARTIDRUGS w
## Case No.:78/9/82-ALC4/2014
123爾脇蕊藷~MIIil:テ
囲濡繭繭
PHARMATECH PVT LTD
_frq qrt{r{ 'r
Dir€ctorato Gener:
<rFrq fit{r.voep,
sdFr qq:r
Udyog tshawar,
1/82/050/00409/AM15/
⌒
一
―
′ ヽ
|
|
33
⌒
ハ
| ICase No.:32/9/82‐ ALC4/2014 Ptt Name:CHEMCON IMeet N8′bまし:1'/愚2‐ lStifiζ :5tFfe:こdl
SPECIALITY CHEMiCALS ALC4/2014 and R←
indexed i
l l IP LTD 18 03 2015 1
| 1
臨
127 Decision:It was decidc to call from thc■
rm fo‖ owing information:
iii)
Complete application showing export quantity norms applied etc.
ir)
Complete technical details as per appendix 33 showing Molecular weights and
% yield on molar basis for each step.
r
u)
Technical literature in support ofyield envisaged in each step'
I
iThe case is deferred for 20.05.2015.
瑶
λ馳
OЮ圃
/鰤Ы
I辮辮
Ю引
"""2
「 O14
Statu"Dereredl
and Re-indered
|
浙
‐Case No.:20/9/82-ALC4/2014 P征りName:AUROBINDO Meet No/Date:19/82- Status:
PHARMA LIMITED ALC4/2014 1Approve(
18032015 ,
IHQ File RLA F‖ e Lic No/Date:0910060790 1Defcr Dal
101/82/050/00817/AM15′ :09/24/040/00202/AM15/ 01082014
Decision:In the light of writen comments received frOm Depa“
mcnt of Pha‖ llaccudcals vide thcI C
No 350Hκ 05/2014‐ P(Nomns)datcd 29 04 2015,l was decidcd lo rai～
the nOrms under Para 4 7
HBP vl as per details given bclow or as applicd by the frm,、vhichever is less:‐
ｄ
一
一
一
Ｍ
Ｏｆ
Export product
Export
Qty.
SI No
Import items
Qty al10WCd
(kg/kg)
CLlNDAMYCN
HYDROCHLORIDE
lk
1
Lincomycin Hydrochloride
Monohydrale
1 222 BOU/kg
つ
ι
N,N-Dimethylformamide I DMF ]
1 42 kg/kg
lsopropyl Alcohol (2-Propanol)
2 13 kυkg
4
8 10 kυkg
Carbon Enoanlicronros (Activated
0069Xノ聰
Decision : It was decided to defer
Pharmaceuticals.
thc casc for 20 05 201 5 for comments of Department of
Ⅷ
∫ ド
戦
:
34
（
（
No■58/9/82‐ ALC4/2014「
1111:111∫:]]『FΠ
13f'・
~~111:l::[:F319/82‐
BO鵬
3児5∽∝
"ムmy臨
蕊戸卜蹴開°
"Ю嚇
Re-indexed
Re-indexed
: It was decided to defer the case for 20.05.201 5 for comments of Department of
3 It was decided to defer the case for 20.05.2015 for comments of Department of
: It was decided to defer the case for 20.05.2015 for comments of Department of
彫蕊蕊
:蕊i蕊;~臨所燿面而
us:lrellered
Re-indexed
: It was decided to defer the case for 20.05.2015 for comments of Department of
P征りNameiCOVALENT IMeet No/Date:19/82‐
LA30RATORIES PRIVATE IALC42014
Re-indexed
134
LIヽ41TED 18 03 2015
淋
鳳
:′
~面高~~~~
Ю9/24/040/00203/AM15/
: It was decided to defer the case for 20.05.2015 for comments of Department of
No.■4/9/82-ALC4/2014 ParッName:GLAND
No/Date:19/82‐
udyO」百h通しЪ
「
Carbon)
6
Steam/Thermal Coal
As per fuel
policv
may take appropriate action as per the decision of Norms Committee.
¨
い
"田
―
BI珊
疏
50Ю 0846ムMV
所危鵬
υOmmMЫ
ほ¶ 鼎「
Ю40“ 9鯰5
## Case No.:10/6/82-
ALC4/2014
:01/82/050700412/AM15/
## Case No.:15/9/82‐
ALC4/2014
熱臨F遮g』l
PHARMA LIMITED
18032015
Re-indexed
No.:31/9/82-ALC4/2014
Namc:AMBERNATH
No/つatc:19/82‐
PVT LTD
File
^
^
35
HQ F‖ c RLA Fllc Lic No/Datc:0910060797
:01/82/050/00811/Alヽ415/ 109/24/040/00219/AM15/ 104082014
: It was decided to reject the case as the firm has not fumished information despite
reminders.
"6廟藤蕊4ムШ夕蔦珈蕊二」扁
~1蹴
辮Ю
tt m"“ 3
Deffered
Re-indexed
Re-indexed
Re-indexed
: It was decided to defer the case for 20.05.201 5 for comments of Department of
: lt was decided to defer the case for 20.05 -2015 for comments of Department of
: lt was decided to defer the case for 20.05.201 5 for comments of Department of
: It was decided to defer the case for 20.05.2015 for comments of Department of
140
Re-indexed
: It was decided to send a copy of application to Department of pharmaceuticals
their comments. The case is defened for 20.05.2015.
~……
汗
g6高品
Jζ高 揺語独
:
1嗣浙
1蘇ξ
~~~~圃
No.:7/9/82‐ ALC4/2014~FatyName:SENTISS
「
HARMA PVT LTD
ヽ
二
bi沼[〕こlnora」
縛嚇枷雲ギ
::e
~四
赫
赫「
騨
蜃
臨「珊ri9/82甲
B71麒蔦
「
~彫
濡蕊蔦Я孟;~浙面∞
4蟷OBttLOЮ珈5
囃瀾熱纂
,市
臨
“
/9/82‐ALC親O14囀
1~鱚
ILTD, 18032015
No.:105/9/82-
~ ~1靱
而
醇I“面Im蕊
需
~瑯
闊
雨
5/ :22′24/040/00035/AM 15/ 107082014
ヽ
い
い
い
い
岬
一
¨
一
¨
rEr<tT rzlTglq rrE
Dn€do.ata Gsn€r€t o'
slFrar ftqFyoepa.tdr,
ud凛
轟
iょ、_.:`h
田
肌
5∽08“ハm夕
陽ち棚
∽似
νAMly B為
OЮ卿
5
/24/040/00213/AM 15/ 11082
`2田
銑
50Ю089υAM W
隔危馳
υ00412Am y「
|¶辮
Ю釧0787釧0蹴
ち。0,2∝5
: It was decided to defer the case for 20.05.2015 for comments of Department of
18032015
Decision : It was decided to defer the case for 20.05.2015 for comments of Department of
C&PC s
Re-indexed
:01/82/050/00820/AM15/ :08/24/040/00176/AM15/
Lic No/Date:0810132955
12082014
: It was decided to defer the case for 20.05.2015 for comments of Department
Re-indexed
~「
おe蘭
“
0/9/82‐ALC4/20141蘊
蘊
瓢
需
FM｀
92‐
四
鵬
星鬼5∽∝47ハmy l鶴
糀
OЮ∞.ハmy
肥
“
明
5
145
: It was decided to defer the case for 20.05.2015 for comments of Department of
匝
A File
101/82/050/00858/AM15/ :08724ノ040/00186/AM15/
: ln the light of written comments received from Department of Pharmaceuticals
their OM No 35011/616/2014-PI(Norms)dated 29 04 2015,■was decided to ratify norms
under Para 4.7 of HBP v1 as per details given below or as applied by the flrm, whichever is less:
. Dir€ctor Goneral or
fr*q ::rrqrq srr
…
繭71蝠T¨
1顆
/82‐
No.:23/9/82-ALC4/2014
NamelBIO‐ TECH
No′1)ate:19/82-
PVT LTD,
No:21/9/82-ALC4/2014
Name:PIINDUSTRIES
No/Date:19/82‐
TD,
37
岬
一
Mycophenolic Mofteil
Powder Foam
lks
|
Mycophenolic Acid
Powder Foam
0941
旧雌里仄蛍h珈嗜
― ―
― ― ― ― ― ― ― ― ― ― -1=:~= _ ^´
.^^^^´
‐
●
## Case No:41/9/82-A LC4/2014
No:52/9/82-ALC4/2014
11/AM15/
Decision : It was decided to defer the case for 20.05.2015
lPharmaceuticals.
38
⌒
つ
‘
iDeCiSion : It was decided to call from the firm Past production vis-d-vis actual consumption of
imported inputs duly certified by Central Excise Authorities. It was decided to deferred the case
for 20.05.2015.
ICaseNo.:45/9/82‐
ALC4/2014
1瓢鳳霧蕊」
~圃
鸞蔦I[戸1璃酉¨
IStatus:
Approved
IDcfcrDatc:
154
Decision:ln the light of
their OM No 35011/616/
under Para 4 7 of HBP vl
written comments received from Department of Pharmaceuticals vide
2014‐ PINorms)dated 29 04 2015,t was decided to raify norms
as per detalis given below or as applied by the firm′
whicheverisless:
Item of Export
Qty
S,No
Item of lmport
Quantity allowed kglkB
Mycophenolic Mofteil
Powder Foam
l kg
l
Mycophenolic Acid
Powder Foam
0941
町
|
―
― ――
―
一
― ―― ――――― ―― ― 一
― ― 一
― ―― ― ―― ―「=●=_ ■~~■1l f=■
■■嘔=~~~~~~~~~ |
1器疏
5餅00840AM耐 1眺
ち鵬
oЮ020ンAM
F洒可書璽鋼研慕療
靴
cl費t盤喜聯誇
i下記鍔鳳蔦器撚洲面 |
1珈
19/82:硼
Re-indexed
: It was decided to defer the case for 20.05.2015 for comments ofDepartment of
Pa■y Name:CONCORD
BIOTECH LTD
瑕
118032015
No:60/9/82-ALC4/2014 Pa“ y Name:JUBILANT
GENERICS LTD
・
一
“
“
ハ
⌒
39
118032015
|
IHQ lllC RLA Filc lLic No/D●c:0510390923 Dcお
r
101/82/050700857/AIヽ4!5/ :05/23/040/00217′ Aヽ115/ 102092014 ‐Datc:20052015 1
IDccおlo■:It w¨ dcddcd to dcfer ttc cascおr2005.2015おr∞mmcnもofDcpartmc■群~~|
IPharmaccuticals.
## Case No:3/7/82-ALC4/2014 Pa“ v Namc:S V CHEM
「
―
j
Status:l)effcred
INTERMEDIATES P LTD IALC4/20!4
and Rc-indcxcd
i:
{18.03.2015
:
I
I
;--
ls7 Eq File
8LA r-lre
r0ls932i Trerei
:OllE2tO5OtOO647tAvlst ;:Ml24t040t00t39tAMtSl iOZ.OO.ZOT+ :Dare:20.05.20 l5 l
D"ci.ion r It *^ d
nt of
,
;C&PC.s
T搬
獅
″79/82 1鐵
網
漱C VeoNoD江
醐&T面
高Dem高
lBALTHCARE`P) ALC4/2014 ,nd Poin`l。
■OH
rLC4/2014
ぱ謝留3CAREc)
講01iお |'LA Ale
/ヽLC4/2014 and Rc indcxcd
18032015
講01iお |'LA Ale i由しヽしt)atc:0510390973 1Dcfcr l
lЮ 1/82/050Ю 0872/AM15/
Ю5/24/040/00235/AM15/ 04 09 2014 Dtte20 05 2015 1
Dccision : It was decide to call from the firm lollowing information:
i)
% ofcoating material in export product supported by COA ofthe export
consignmcnt.
ii)
Copy of DML for relevant coated export product.
casc is dcfcrrcd for 20 05 2015.
‐158
| IThc
ICasc No.:55/9′ 82‐ Al.C42014
Pa“y Namc:CONCORD
BIOTECH LTD
lheirOM No 35011/616/2014-PI{Norms)dated 29 04 2015,た
was dedded to ratify nOrms
mav
appropr
per
Norms Committee,
## Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Item of Export
Qty
S,No
Item of lmport
Quantity allowed kglke
Mycophenolic Mofteil
Powder Foam
l kg
1
Mycophenolic Acid
Powder Foam
0941
RA
take
ate adion as per the decision of
ICasc No■14/13/82-
IALC4/2014
IHQ Filo
101/82/050/010177Aヽ415/
IM`こtヽも
'bふ
i`lib,0,1 も二tus
lALC4′2014 1Approvcd
118032015
,Lic No/Datc:1310047642 1Dcrt・
r Datc:
126092014 1
「品:ホ面話面
ILTD,
INDUSIIヽlI,S
160:
い
一
RLA Fnc
113ノ24/040/00025/AM15/
:HQ Filc
RI.A Filc
118032015
Lic No′つatc0810133285 :Dclbr Datc
40
Dccision : ln lhe light of writtcn comments received from Petrochcm ical-' Division ol
Department of Chemicals and Petrochemicals vide their U.O No. 140221612010- Ch. ll datcd:
20.03.2015, it was decided to ratiry norms under Para 4.7 ofHBP vl as per details given below orl
as applied by the firm, whichever is less:
Erhyl 4-chlorc.2 Fluoro-
lrkg lr
l2-CHLoRo-4-FLUORO-5- lO.SlSkg
5l( | lisopropyl(mcthyllamino lsullonyl | |
|
I ntrnOBeNzorrucuuontoe I
I
laminorcarbonvltnhcnvlcarbcmarc I
l2
lMcthyl lso Propyl Aminc
l0.l22kg I
I...^..
l
Ir
INoRr.ysrrlr) p8086 \olot\ I0.006 kp I
|
|
14
lMcthanol
ll.95qkg I
I
I
l:
l totuene
lo.osotg I
I
I
lo
lEthvl chloroformare
10.370ke I
|
|
lt
lsulfi'rvt chloride
10.659ka
r
I
Ix
ln-ttcranc
ltl.38(rka
RA may take appropriate action as per the decision ofNorms Committee.
i
Ilxport product
Exp
Qty
SLNo
lmport itcms
Qty
A1lowcd
Ethy1 4‐ Chlorc・2 Fluoro‐
5〔({IsOpropyKmcthyりamin01sulfOnyl)
amino)carbOnyl]phCnyicarbamatc
(1)CM)
l kg
1
2‐CHLORO‐4-FLUORO‐ 5‐
NITROBENZOTШ CHLORIDE
0 599 kg
Methyl Iso Prooyl Aminc
0 322 kg
NOBLYST(lt)P80861%Pt
0 006 kg
Mcthanol
1 959 kR
う
'l oluene
0680k8
6
Ethyl Chloroformate
0 370 kR
7
sulrttryl Chloridc
0 659 kA
8
nl lexanc
0 386 kg
IDctr
lDate:200520151
lment oF
11&032015 1
剛
鶏
既
鳳
蔦
:「
脇
刷:α∞
"拡
M″
~ 1蹴
ちOЮ,知5
Dccision : lt was decided to defer the case for 20.05.201 5 for comments of Department of
Pharmaceuticals.
ち●｀ど林よ
IЁttkヽ Mcctヽ6/Diよi夕82: も1litibcFFclぬ
|
ICasc No.:2′ 9/82‐ ALC4/2014 1
LABORATORIES IALC42014
●nd Rc―indcxcd i
Casc No.:5/9/82-ALC4/2014 Party Name:tIETERO
DRUCS LIMITED
1 1
Mどま｀3/D西西断二~~
IALC4/2014
118032015
1).frcrcd
Rc-indcrcd
162 HQ rilc RI′ A Fnc Lic No/Datc:0910061060‐ Dctr
:01/82/050/00802/′ヽ
|ヽ415/ :09/24/040/00362/AM 15/ .07102014
‐Datc:20052015
Dccision : It was decided to defer the case for 20.05.2015 for comments ofDepartment of
Pharmaceuticals.
ICasc No■103/9782 Pary Namc:NEULAND IMeet No/Datc:1シ82‐ Statu“ DcFfercd l
lALC4/2014 1LA30RATORIES LTD IALC42014 and Rc‐
indcxcd l
‐18032015 1 1
|“3器漱温ふ誌萩II~陽万魔蕊::菰薦
'~顎
慨T画面面
B誰ち
OЮ,2∝5
‐ IDccision:It was decided to deFcrthe casc for 20 05 2015 for∞nlntcnts ofDepartment of
l lPharmaccuticals
ヽ
1警漱4/97821~「濡酬
|“4器
3児5∽"01AM″ 鵬ら臓α
00319/A
Dccision : It rvas decided to defer the casc for 20.05.201 5 for comments of Dcpartment of
rr -r
Pharnraceuticals.
18032015
ヘ
41
旧
肝
薦
~~町
HETEl
b浙
iπ「―澁
瓦λ
| ~~~~~~~ 1‐
‐ ・
‐ ~~・・ |ル
c●し`υ
υ」ιVlJ I
面
defcr the面繭両面温温I高而扁~|
for comments of Department of
1顆赫~ド蝠
‐KLA「llc Lic No/Datc:091oo61119
5/
Ю9/24/040/00374/AM15/ 117102014
1 濫淵鵠綱
=轟
発吉
:鞣高 |
―――― ――一――_
―――__―‐
―‐――――― _J
## Case No.:83/10/82_
ALC4/2014
Patty Name:HETERO LABS ,Meet No/Date:19/82‐
‐
LIMITED
ALC42014
118032015
Status: Deffered
| 1甲r繭
2~岡誦霊
]
| :γ
錮i」li∴した
Itl iⅢFT「電
L3
融
』
',iふ
+ボ
踊
辞獣〒
case No': I l519/82-
pany Name:NAGARJUNA Meer No/Dare: lglg2- status:Deffered
ALC4/2014
AGRICHEM LTD
ALC4t2Ot4
and Re-indexed
"… …
1而ご― ― 1鏑鰤
|
42
ハ
′
Pharmaceuticals.
霊脚爾 甲顎
1珀
: Deffered
No.:5/16′82-
貯淵
16/82‐ 圏r"1需蹴脚
一
― 一
―
一
`――
―
‐ ― ‐
ば
下
m隔蕊蘇~開藉 毛三型 :ざ践潤ぼ膚° 10708] ~臨翻薦瓢I「~囲嗣赫6 HQ Flle ,01/82/050/01357/AMi5/ Decision:It was dccidcd to deferthe case for 20 05 2015 for comments of Departrncnt of Decision:It was dccidcd to dCferthc casc for 20 05 2015 for commcnts of Departmcnt of Pharmaceuticals. 「「MP戸~胃繭ぽ TttЮ朧ぽ dttZ i需蹴脚 ―
― 囀面糀懃藝|「「W面鴨Oα for 20 05 2015 for commcnts Of Dcpartment of M ρP,No′Date:19/82- Status:Deffered ― i器 騨 :RI:::、 '´ Dソ醤 %♀風渇 rl: 、 → 膳臨椒鰍1 1 Udソ嗜81雪17』Fヽ.書bLl・ No.:3/16/82‐ No/Date:19/82- Pharmaceuticals. Ｓ Ｖ Ｅ Ｎ Ｕ Щ 耐 ‐ Ｅ Ｓ Ｎ ａ Ｅ Ｄ ヽ
43 ^ Meet No/Date:19/82- IALC4ρ014 118032015 Status:Deffered and Re-indexed 2015 HQ me 廠‖e~~~囲 … Ю1/82/050/111360/AMi5/ Ю3/95/040/00243/AM 15/ Ib""fut"" , I.r^;;"id"d i. d"f". th" ""." ro, iolr-ioii r"r ".n r*"i. .r o"p"rt "r,t "r lcarc 1nc Division). T~11麗渕 Paty Namc:DR RED5'S IMeさfヽルbatc ll蔑[ ILABORATORIES LIMITED ALC42014 1 118032015 178 ¨ S EXPOIM属属お面輌ラ5憂ET万蕊 「
「
V■LTD, ぃ
LC4/2m4
118032015
NamelRELIANCE
No:10/16/82-
Decision : It was decided to defer the case for 20.05.2015 for comments of D"pu.t."nt oi
Pharmaceuticals.
:It、vas decided 10 defcrthc casc fOr 20 05 2015 for coinments Of Dcpartmcnt of
ud羹鄭轟話誡
IЫ
No.:8/16/82-
IMeet No/Date■9/82‐
IALC4/2014
118032015
and Re-indexed
ヽ
No.:52/19/82-
14
44
ハ
|
Deffered
Re-indexed
Jt was decided to defer the case for 20.05.2015 for comments of Department of
;ay tak" app.opriate action as per the decision of Norms Committee.
:ltwasdecidedtodeferthecasefor20.05.20l5forcommentsofDepartmentof
Export Product
Q"
SI No
Import Product
Quantity
allowed kg&g
Efavirenz
l kg
1
-(s)-5-chloro-alpha-(cyclopropyl
ethylyl)-2-amino-alpha-(nifl uoro
methyl) benzene methanol
0987
2
Triphosgene
0448
str―
。,pⅢctOr cenera
No:1/19ノ82-ALC4/2014
コse No■2/19782-ALC4/2014falχ
lヽi路:UヽcAL
lNDUSTRIES LTD,
185諄Q HL ____ 1性全理:
F品:'お5υ0149υAM15ノ iあ
';;晟
υoo916/AMl夕
N∝3/19/"■La扇″浙
面:
博
6田蕊蕊罵|」
Status:Deffered
and Re-indexed
1
IMcet No/Date:19′ 82-
:ALC42014
118032015
雷
緬
面
繭
椰
繭
耐
戸
Ⅶ
蓼
而
45
^⌒
|
IPhallllaccutica:s
「
F璃諏面「
~~理
露恵翌瓢
|
F‖ e
IRLILお ~~~~~
IЮ824704900442/AMI夕
IALC4/2014
118032015
[漑甲繭
~印渕
2‐ ~鰈
「
F而
:01/82/050/01534/AM15/
2015
l111:111:fttiliSdecidedtodeferthccasefor20052015forcommentsofI)epartmcnt of
1891Rュ収々ハ^… “・…
… RLA RL ~「
おNo/Dao35 Ю04492
:01/82/050/01535/AM15/ :35/24/040/00006/AM15/ 27 02 2015 1Date:20052015
¨
“
菖dCCldCdご轟
Lどあ面
『
】δbttδ驀扇i温罵品s of Departmcm of
lC&PC
Re-indexed
Decision : In the light of earlier decision taken in meeting no. 6182 dated 29.OB.ZO|4, it
was decided to ratify norms under Para 4.7 of HBP v I as per details given below or as
applied by the firm, whichever is less:
‐Case No.:50/19/82- Patty Name:HETERO
192 ALC4/2014 DRUGS L!MITED
「0匹憂巫憂互Ⅲ國匝亜巫正1総器醐"%%常為。“
2釧5
rDecision : It was decided to defer the case for 20.05.201 5 for comments of Department of
Pharmaceuticals.
「「謎獅ノ19/82 に喘1肥営W
貯躙" W、
｀
1器3児50/O1537/AM“戸~囲
話蔦蕊
「
Homatropine Methyl Bromide
Synonyms
N,N-dimethyl-8-
Azon iabicyclo(3.2. I )octane-3 -yl)2-
hydroxy-2-phenylacetate bromide
C.A.S. No.80-49-9 formula
C6H4CH2Bro2N Quallty 99%
|
Re-indexed
## Case No.:48/19/82-
ALC4/2014
|
Paty Name:AARTI DRUGS
LIMITED
46
臨=扁
囲鸞勇
1「
「
圏こ
繭而
B為。ω
2m5
ハ
Dccision : It u'as decided to defer the case for 20.05.201 5 for comments of Department of
りCCiS1011:it Wd
‐Pharmaceuticals
Out Side agenda Part B-ll
M/s. Vital Laboratories Pvt Ltd
F No01/82/050/00670/AM13/DES‐ IH
Meeung No 19/AM15 dated-29042015
Adv Lic No 0310705409 dated 17 08 2012
RAF No 03/95/040/00254/AM 13
Decision: In the light of written comments received from Department of Pharmaceuticals vide their
OM No 35011/28/2013 PloOol‖
IS)datcd 07 04 2015,I was decidcd to rati″
nOnns under Para 4 7
0fHBP vl as per details given bclo、
v or as applied by thc fl1111,whichever is less:
the decision of Norms Committee.
Item of Export
Quantity
S,No
Item of lmport
Quanthv
allowed kg/kg
Methyl Cobalamin J.P.
(Mecobalamin)
l kg
1
Vitamin B l2
Cyanocobalamin
095
## Case No. B- 2
M/s Arudaa Vis Labs Pvt Ltd
Meeting No 19/AM15 dated-29042015
F No01/82/050/00385/AM14/DES-lII
RAF No 04/24/040/00067/AM 14
Adv Lic No 0410147616 dated 28 06 2013
47
⌒
ハ
Decision: Committee considered the case as per agenda and in light of written comments received
from Department of Pharmaceuticals vide their oM No. 3501L1392/2014-pt(Norms) dated
07.o4.2o75 and in consultation with technical authority present in meeting, decided to revise
norms under para 4.7 of HBP as per details given below or as applied by firm whichever is lower:-
Export ltem No. 'l : DMT-T
S No
lmport ltem
Qty a‖owed kq/kq
1
THYMIDINE
0596
う
‘
DMT― CI
0761
ExpOrtltem No 2:DMT― B2-dC
S No
lmport ltem
Qty alowed kq/kq
1
Deoxycyjd ne
0678
つ
４
DMT― CI
065
Exportitem No 3:DMT― Bz―dA
S No
lmpOⅢ lem
Qty a‖ owed kq/kq
1
DEOXYADENOSIN
073
2
DMT―CI
068
Exportltem No 4:DMT― IBu―dG
RA concerned may take further necessary action as per above decision of NC.
S No
lmport ltem
Qty. allowed kq/kq
1
DEOXYGUANOSINE MONOHYDRATE
0688
2
DMT― CI
070
## Case No. B- 3
M/s. Shiva Pharmachem Ltd
Meeting No.19/AM15 dated - 29.04.2015
F No01/82/162/00016/AM13/DES―
III
RAF No 34724/040/00117/AM 10
34′24/040/00136/AM 10
34/24/040/00206/AM 10
34′24/040/00086/AM ll
Adv Lic No 3410025487 datcd 30 10 2009
3410025693 datcd 25 11 2009
3410026511 datcd 03 03 2010
3410027522 dated 16 07 2010
Decision: lt was decided to defer the case for next Nc for comments of Department of c&rc
## Case No. B- 4
M/s. Chirag Enterprise
Meelng No 19/AM15 dated-29042015
F No01/82/050/00256/AMl1/DES― ⅡI
O1/82/050/01090/AMl1/DES― HI
48
RAF No 24/24/040/00009/AM ll
24/24/040/00014/AM ll
Adv Lic No 2410029974 datcd 27 10 2010
2410030871 dated 27 10 2010
Decis'lon, lt was decided to deferred the case for next Nc for comments of Department of c&Pc
⌒
^
## Case No. B-5
M/s Rohan Exports lndia Ltd
M77s Mahesh Rai ChCmiCals Ltd
Meeting No 19/AM15 dated-29042015
F No01/83/162/00654/AM12/DES― IH
Decision: Committee considered case as per agenda and in consultation with technical
authority present in the meeting it has been found that despite repeated reminders the
lnstitute of Chemical Technology Mumbai, has not given their opinion as to whether the
export product "4,4 Diamino Sulfanilide " is manufactured only of purity 93o/o on
commercial scale. Further, whether the product always contained 7% ot more of
impurities. lt was also decided to remind the Department of c&PC to take appropriate
action and furnish their comments as the case has been pending for long.
The case is defened for next NC.
## Case No 8-6
lWs. Gopinath Chem-Tech Ltd
Meeting No 19/AM15 dated-29042015
F No01/82/050/00562/AM14/DES― IH
RAF No 08/24ノ040/00231ノAM 14
Adv Lic No 0810124122 datcd 26 08 2013
O".i.ion' lt was decided to deferred the case for next NC for comments of Department of C&PC
## Case No B-7
N{/s. Sainor Laboratories Pr4 Ltd
Mee■ng No 19/AM15 dated-29042015
F No01/82/050/00350/AMl177DES-l11
RAF No 09/24/040/00040/AM ll
Adv Lic No 0910042075 dated 19 05 2010
Decision: lt was decided to deferred the case for next NC for comments of Department of C&PC
## Case No. B-8
iWs. Sainor Laboratories Pvt Ltd
Meeting No 19/AM15 dated-290420
F No01/82/050/00528/AM101DES-lH
F No01/82/050/00621/AM10/DES-lH
RAF No 09/24/040/00040/AM ll
RAF No 09′24/040700040/AM ll
Adv Lic No 0910039225 dated 01 09 2009
Adv Lic No 0910039590 datcd 14 10 2009
品謝
繭
udttLIttL膚ヽ計乱IH
49
⌒
Decision: lt was decided to deferred the case for next NC for comments of Department of C&pC
## Case No B-9
M/s. Alchymars ICM SM Pvt Ltd
Meeing No 19/AM15 dated-290420
F NoO1/82/050/00111/AM14/DES-lH
RAF No 0424/040/00279ノAM 13
Adv Lic No 0410144366 dated 25 03 2013
Decision: lt was decided to defer the case for next NC for comments of Department of
Pharmaceuticals.
## Case No B‐ 10
M/s Makson Llds Pvt Ltd
Mee■ng No 19/AM15 dated-290420
F No01/82/050/00889/AM13/DES― HI
RAF No 03/95/040/00394/Aヽ113
Adv Lic No 0310710561 datcd 26 09 2012
Decision: lt was decided to deferred the case for next NC for comments of O/o DC(MSME).
## Case No B‐ 11
Mノs Coral Labor江oHcs Ltd
Meeting No 19/AM15 dated-290420
F No01/82/162/00275/AM14/DES-lH
RAF No 03/94/040/00777/AM 14
Decision: lt was decided to defer the case for next NC for comments of Department of
Pharmaceutica ls.
## Case No B-12
M/s. Hiran Orgochem Ltd
Meelng No 19/AM15 dated-290420
F No01/82/050/01030/AM14/DES‐ II
RAF No 03/94/040700814/AM 14
Adv Lic No 0310692029 dated 25 04 2012
Decision: lt was decided to deferred the case for next NC for comments of Depa rtment of C&pC
## Case No 8-13
M/s RA Chem pharma Ltd
Meeting No 19/AM15 dated-290420
F No01/82/050/00219/AM12/DES―
|‖
RAF No 09/24/040/00071/AM 12
Adv Lic No 0910046667 dated o6 05 2011
Decision: lt was decided to deferred the case for next NC for comments of Department of
Pha rmaceuticals.
Ⅷ
f
50
## Case No 8-14
M/s. Lupin Limited
Meeung No 19/AM15 dated-290420
F NoO1/82/050/00933/AM12/DES-1■
RAF No03/95/040/00523/AM 12
Adv Lic No 0310657925 dated 04 10 2011
Decision: Committee considered case as per agenda and in light of earlier decision taken by NC in
irs 34/82 meeting dated L7.LL.2OI4 it was decided to allow import item at sl. No. 1 " sodium Rifa -
s " for manufacture of export product Rifampicin 450 mg capsules. Norms Committee in its
Meeting No. 49/82 dated 06.03.20112 has already recommended all import items except the
import item " Sodium Rifa - s". The committee recommend the item mentioned at Sl. No. 1 i.e. "
Sodium Rifa - s " and its respective quantity for duty free import as details glven below:
lmport itme at Sl. No.
Name of the lmport item
Quantity allowed ke/kg
1
Sodium Rifa― s
1 02 kg
RA concemed may take further necessary action as per above decision ofNC.
## Case No B‐ 15
M/s lndo Ge111lan Alkaloids
Meeting No 19/AM15 dated-290420
F No01/82/050/00856/AM15/DES-lH
01/82/050/00250/AM15/DES―
III
RAF No03/94/040/00305/AM 15
03/94/040701019/AM 14
Adv Lic No 0310786553 dated 08 07 2014
0310769858 dated 10 02 2014
Decision: Comminee considered the case as per agenda and in consultation with the technical authority present
in the meeting, it was decided to amend the description ofexport product in the minutes ofthe NC meeting no.
4182 dated 03.07 .2014 and l6182 dated23.0l.20l5 as details given below.
From
To
IPECACUANHA EXTRACT BP/USP
IPECACUANHA EXTRACT CONCENTRATE 9%
The rest ofthe minutes would remain same.
M/s SANOFIINDIA LIヽイITED
F No01/82/050/01125/Aヽ415/DES‐ IH
Meeting No 19/AM15 dated-290420
Adv Lic No 0310786553 dated 08 07 2014
RAF No,03/94/040/00465/AM 15
●iマ
Ｃ
υ
（
ヽ
Datc:20042015
Placc:New I)clhi
Decision: Committee considered the case as per agenda and in consultation with the
authority present in the meeting, it was decided to amend the description of import item and quantity
in the minutes of the NC meeting no. 16/82 dated 23.01.2015 as details given below:
From
To
Description of import item
Qty. allowed
Description of import item
Qty. allowed
MNOCYCLINE
HYDROCHLORIDE PH
EUR
100kノkg
CLEXANE 60MG
INJECT10N 2s
1.00 packs
(net to nel)
The rest of the minutes would remain same.
RA may take appropriate action as per the decision of Norms Commi ee.
Nirr.nal Krurlar
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