DGFT Committee Minutes
Document text
Office of Directorate General of Foreign Trade New Delhi -0
Para 4.7 Decision
PIEETING NUMBER :14/82-ALC4/2014 MEETING DATE:22.12.2014 But actuaHy held on 07.01.2015 Meeting No. 14ノ82 of 2014-15,to conslder the casesAssues under Duty Exemption Scheme (Chapter_4)of Foreign Trade Policy,2009-14 pertaining to Chemical and AIlied products and falling under Chapter 29 and 30, was schedule for 22.12.2014 but actua‖ y held on 07.01.2014 under the Chairmanship of Shn Jalkant Singh,Addl.DGFTin Room No ll,Udyog Bhawan,New Delhi. Fo‖owing rnembers were present:… Shri Nirmal Kumar,Deputy Director General of Foreign Trade Ms.SwaI Kuma画,Oノo Dc(MSME) Shri D.N.Mathur.Consunant,Department of Pharmaceutical Sh百Mahendra Vikram Singh,Foreign Trade Development Officer The commtttee went through the minutes of earlier NC一 ‖l meeting No.11ノ82 scheduled for 26.11 2014 but actua‖ y held on 01.12.2014 and approved the same The fo‖ owing casesAssues were discussed and the cornrnittee took the decision as mentioned against each case | ‐
Case No.:4/16/82-ALC4/2011 1Pa“ y Name:BOSTIK lNDIA
I I :OD■ ■′ATE TTヽ イIT口n | | IPRIVATELIMITED IHQ File l:01/82/050/00462/AM12/ 画 File .:07/24/040/00073/AM12/ for comments of Petrochemicals Division of iDepartment of Chemicals and Petrochemicals. 24.11.2011 1 ‐ Decision:ln the light of earlier decision taken by NC in its 32′ 82 rneeting dated 08.11 201l and in lconsultation with technical authority present in meeting,it was decided to ratify norrns under para 4 7 of HBP as per details below or as applied by ttrm whicheveris lower:― Export product Export Qty. SI No lmport items Qty. allowed Dipyridamole Extended Release and Acetyl Salicylic Acid Capsules (200m9+ Nos. DipyttdamolePH EUR 2.50 kg 「 ⌒ No/Date:14/82- 4 Re-indexed 12.2014
concerned may take further necessary action as per above decision of NC.
Case No.:196/10/82…
ALC4/2013 Status:Deffered and Re-indexed 1瓢1鳳鳳 Decision : lt was decided to remind the firm to furnish the following information:
- Technical specifications, % composition (by weight), alongwith specific end use/application and the copy of export order for the export product i.e. Polysocyanate Solution-7'Yo solid may be furnished.
- Details and quantity of other indigenous inputs to be used in the manufacture of the export product may be indicated. Detailed manufacturing process along with balanced chemical reactions indicating %yield/wastages along with technical justification for wastages at each stage and also on each of the raw material may be furnished. Complete material balance indicating input and output material at each stage of manufacturing process. Details of production of export product under reference and corresponding consumption of raw material in the year 2Ot2-L3 and 2013-14 duly certified by CA may be furnished. lf the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA. Any other relevant information. The case was deferre d for 22.01,.201,5 一 ５
「 ~「面 | | o.:4/3/82¨ ALC4/2012 卿 黒酬T Name:BOSTIK INDIA ATE LIMITED No/Date:14/82‐ 122.12.2014 0085024 ′AM12/ No.:32/51/83- Flle 1/83/050/00929/AM12/ Name:JINDAL DRUGS No/Date:14/82- 4 10679441 AM12/ 1.01.2012 File Re-indexed 1.2015 IDecision:It was dccided tO dcfer the case for 22.01.2015forcommentsofDepartmentofPhalIIlaceuticals. Name:SATYA No/Datc:14/82- 4 丁囲霊雷面7呼 ision : In the light of written comments received from Department of pharmaceuti";G;id; iililOM 35011126812014-PI(Norms) dated 28.11.2014, it was decided to ratif,z the norms under para 4.7 of HBp I as per details given below or as applied by the firm, whichever is less:
1-(3‐CHLORO
PHENYL)
PIPERAZINE HCL
l kg
1
DIETHANOLAMINE
0.83
2.
ACETONE
0.64
●
Ｄ
ⅥIX XYLENE
0.95
may take
action as per the decision of Norms Committee
ALC4/2014
22.12.2014
Lic.No/Date:0310692029 1Defer
l:0y82t050t01030/AMl4/ l:$t94/040too8t4tAMtz/ lZS.O.t.ZO|Z
Date:22.01.2015
IDecision:It was decided to ca‖
fronn the firm the cOmplete technical deta‖ s as per Appendix 33.The case
was deferred fbr 22.01.2015.
~
・~~~~^~~r―
■―
=―
,一一――
―― ― 一――
,,::,^:^'Itwasdecidedtorejectthecaseasthefi'.d;-,"tf,.,Gh.di,f"',@
n:It was decided tO deferthe case for 22.01.2015 for conllnents ofDepartment OfIPP.
iStatus:Deffered
tiand Re-indexed
i
Case No.:44/20/82‐
Party Name:HIRAN ORGOCHEM LIMITED Status:Deffered ParけName:CADILA Status:Deffered HEALTHCARE LTD.,
Case No.:85/31/82-
111ALC4/2012 |^ No/Date:14/82- Re-indexed No.:18/20/82- No/Date:14/82‐ Re-indexed File File 1/82/050/01004/AM14/ AM13/ 114.06.2012 :It was decided to deferthe case for 22.01.2015 for comments ofDepartment ofPha111laceuticals. No.:19/1/82‐ALC4/2013 Name:CDYMAX No/Date:14/82- PHARMA PVT. NameiSANOFIINDIA
14.12.2012 : In the light of written comments received from Department of Pharmaceuticals vide their OM 35011/160/2014‐ PIcヾOHHS)dated 26.11.2014,Inentioned that they have exalnined the case and noted the flHll has stated that they will be importing Clexane 60 mg inJection from their group ofcsompany in rance and after carrying out certain relabeling and repacking export the injections to Sri Lanka Govt. encies. No wastage claimed. Since there is no manufacturing activity involved except certain relabeling I repacking. It wis decided to advise the firm to take NOC from DCGI. The case was deferred for 01.2015. HQ File :01/82/050/01125/AM13/ HQ File :01/82/050/01312/ANI11 3/ for 22.01.2015. RLA File :03/95/040/00465/AM13/ ParサName:CADILA HEALTHCARE LTD., RLA File :08/24/040/00257/AM13/ ParりName:MOREPEN LABORATORIES LTD.& Lic.No/Date:0310717240 1Defer Date:22.01.2015 ALC4/2014 22.12.2014 22.01.2015 Date: Meet No/Date:14/82‐ Status:Deffered ALC4/2014 Deffered Re-indexed Lic.No/Date:0510345208 07.02.2013 12 Decision:It was decided to call iom the f1111l a copy ofMaster batch Follllula duly certifled by Quality一 In charge. The case was deferredfor22.0l.2015 Meet No/Date:14/82‐ ALC4/2014 RLA File :09/24/040/00495/Aゝ413/ firm has not furnished information despite repeated reminders. MOREPEN INTERNATION 122.12.2014 Meet No/Date:14/82- IRLA File l:03/94/040/00945/AM13/ Lic.No/Date:0310722715 01.02.2013 reject the case as the firm has not furnished information despite repeated ヽ4ect No/Date:14/82- 「 ド HQ File :01/82/050/01298/ANI11 3/
Case No.:165/33/82‐
Status:Deffered
Case No.:13ノ12/82‐ ALC4/2013
ParサName:HETERO DRUGS 22.12.2014 1淵器 C"Ю“″"
Case No.:2/30/82-
ALC4/2012 Date:22.01.2015
Case No.:9/4/82‐ ALC4/2013
Patty Name:GOPALDAS VISRAM&CO.LTD. Status: Rejected ALC4/2014 22.12.2014 HQ File i :0 I /82/050/0005O/AM I 4/ Decision : It was decided to
Case No.:151/33/82…
ALC4/2012 Party Name:FORACE POLYMERS(P)LTD. ALC4/2014 22.12.2014 Date:22.01.2015 :05/23/040/00459/AM13/ No/Date:14/82‐ Re-indexed Re-indexed File 10343975 1/82/050/01038/AM13/ ′AM13/ 1.2013 putt*tnt of Pharmaceuticals' The case is Date: File 4
「 B略漁榔盤需潔鳳撻胤:胤 『 劇2∝5お“ ommentsofhЮぬettds D宙dm」
Case No.:7/3/82‐ ALC4/2013
Meet No/Date:14/82‐ ALC4/2014 22.12.2014 :01/82/050/00040/AⅣl14/ 1:03/95/040/00886/AM13/ I Lic.NolDat e:03 107 23 636 11.02.2013 :It was decided to send a copy ofapplication again to lD(〕GI fbr their conllnents. for 22.01.2015 Paty Name:WOCKHARDT LIMITED Status:Deffered
Case No.:4/4/82¨ ALC4/2013
Pa●y Name:SABERO ORGANICS GUJARAT Mcet No/Date:14/82- Status:Deffered and Re-indexed Ｆ 卜 ‐ ‐ ９ ‐ ‐ 181HQ File :01/82/050/00045/AM14/ 1:03/95/040/00880/AM13/ 114.02.2013 Decision : It was decided to defer the case for 22.01.2015 for comments of Department of Chemicals and Petrochemicals. Mcet No/Date:14/82‐ ALC4/2014 Deffered Re-indexed Status:Deffered and Re-indexed Decision : lt was decided to give last reminder to the firm to furnish the following technical details: . Complete technical details as per Appendix -33 including%Yield on molar basis for each step and solvent Recovery etc. . Past Production vis-d-vis Actualconsumption of raw materials duly certified by Central Excise Authorities. The case was deferred for 22.01.2015. 鵬 島児50m■7ハⅢν 陽ち鵬 υ∞蜆はⅢν l需 鼎 αいЮ鉾 “"B魔 ち2劇2創5 師落吾面肩百T百五嘉蔦面画面石醍面る面西肩FttEI五嘉吾5託憂薫両三蒟百了五I13面語正面西罵下5百藤喜面渓蔦丁面両下下 「
Patt Name:MYLAN ~MttNo/Date 14/82-
LABORATOⅢESЫMFED I分
"盤
Υ
器3児5γttαAMイ
膨淵υ∞"7/AMW I悧
器
α酬∞
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ち2劇わm5
ALC4/2014
22.12.2014
## Case No.:79/1/82¨
Pa●y Name:STERICAT
IGUTSTRINGS PVToLTD.
## Case No.:31/8/82¨
ALC4/2013
Paty Name:BIOLOGICAL E
LTD
## Case No.:57ノ10/82‐
ALC4/2013
Mcet No/Date:14/82‐
ALC4/2014
22.12.2014
tus:Deffered
Re-indexed
Lic.No/Date:0910055420 1Defer
:01/82/050/00240/AM14/ :09/24/040/00606/AM13/ 119.03.2013
Date:22.01.2015
ision : It was decided to give last reminder to the firm to furnish copy of Batch production record of
plete Manufacturing process (up stream, down stream, formulation, filling etc.) showing quantities and
of import inputs".
case was deferred for 22.01.2015
Re-indexed
File
File
File
~~ICaSeNo.:6/10/82-ALC4/2013
Lic.No/Date:0510350030
22.03.2013
:It was decided to reject the case as the firm has not furnished information despite repeated
Mcet No/Date:14/82‐
LABORATORIES LTD.& IALC4/2014
Lic.No/Date:0510350279 1Defer
:01/82/050/01480/AⅣl13/ 1:05/24/040/00481/AM13/ 126.03.2013
Date:22.01.2015
ParりName:CHIRAG
ENTERPRISE
Ｃ
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Ａ
Ｌ
Ｃ
一
町
側
Ｆ
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|
醜
一
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‐
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¨
一
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熙
22.12.2014
Lic.No/Date:0310730905
fer
:01/82/050/00303/AM14/ :03/95/040/00020/AM14/ 109.04.2013
22.01.2015
:Reply received from the firm and sent to Department of Pharmaceuticals for their comments.
case is defelTed for 21.04.2015
No.:43/10/82‐
No/Date:
14
14
HQ File
:01/82/0
04.2013
ofanal、
/82/050/00226′
ParサName:MEHTA APIPVT
LTD
Mcet No/Date:14/82-
Status:Deffered
ALC4/2014
o/Date:
Ｍ
ｅ
ｅ
ｔ
Ｎ
。
／
¨
２
２
．
‐
２
．
２
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‐
一
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剛
繭
唯
一
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１
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。
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¨
一
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一
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一
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一
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Ⅲ
一
・
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ase No.:18ノ7/82‐
Party Name:VIVIN
Meet No/Date:14/82-
4/2014
LABORATORIES PRIVATE IALC4/2014
## Case No.:33/2/82‐
Decision : It was decided to defer the case for 22.01.20 I 5 for comments of Department of Chemicals and
Petrochemicals.
## Case No.:120/10/82-
and Re-indexed
CI
ALl
Status:Deffered
iDecision : It was decided to defer the case for 22.0L 20l5 for r:omments of Department of Pharmaceuticals.
111)13:):50/00189/AM14/
Name:MOREPEN
Re-lndexed
INTERNAT10N
File
Re-indexed
File
Name:SRINI
Re-indexed
12.2014
File
1/82/050/00662/ANI11 5/
## Case No.:6/7/82¨ ALC4/2014
ParけName:RA CHEM
PHARMA LIMITED
Meet No/Date:14/82‐
:Deffered
ALC4/2014
Re-indexed
22.12.2014
Lic.No/Date:0910055932 1Defer
:011821050/00650/AMls/ i:0912410401000431AM141 103.05.2013
:22.01.2015
Decision : It was decided to defer the case for 22.01.2015 for comments of Department of Pharmaceuticals.
Paty Name:LUPIN LIMITED
## Case No.:157ノ10/82‐
臓鮒…
Lic.No/Date:0310733961
:01/82/050/00340/AM14/ 1:03/95/040/00098/AM14/ 110.05.2013
Date:22.12.2014
IDecision:It was decided to withdnw the case as the exportitem is Non… infringing。
Ｆ
‐
:諦晶児
50/00120/AM14/ IЪ ち刷10/00023/AM14/
ision : It was decided to remind the firm to furnish the following information:
1. Complete technical details as per Appendix 33
Past production vis-i-vis actual consumption of input duly certified by Central Excise Authorities.
case was defelTed for 22.01.2015
PartyName:MYLAN
LABORATORIES LINIIITED
## Case No.:2/5/82¨ ALC4/2013
Status:Deffered
and Re-indexed
ALC4/2014
22.12.2014
Date:22.01.2015
Status:Deffered
Status:Deffered
Date:22.01.2015
Decision : It was decided to call from the firm Copy of relevant DML for the export product. The case was
for 22.01.2015.
Pany
Name:SRINIPHARNIACEUTICALS
LTD.,
Mect No/Date:14/82-
ALC4/2014
22.12.2014
## Case No.:11/7/82-
LicoNo/Date:0910056024
17.05.2013
113:1):50/00655/ANI11 5/
RLA File:09/24/040/00062/AM14/
一
８
Ｆ
Ｉ
Ｉ
ｌ
ｈ
Ｆ
Ｉ
Ｉ
Ｉ
Ｉ
File
File
No/Date:14/82‐
No.:20/7/82¨
Name:DR REDDYS
No/Date:14/82‐
TORIES LINIIITED
14
File
1/82/050/00664/AM15/
1/AM14/ 115.05.2013
:It was decided to send a copy of application to Department of Pharmaceuticals for their
and deferred the case for 2 I .0 I .2015.
No.:10/7/82‐
Party Name:RA CHEM
No/Date:14/82-
PHARMA LIMITED
14
File
File
1/82/050/00654/AM15/
′AM14/ 116.05.2013
:鷺嶽看判T
12.2014
Decision :In the light of written comments received from Department of Bharmaceuticals, it was decided
ratifu the norrns under Para 4.7 of HBP vl as per details given below or as applied by the firm, whichever
less:
Export Product
Export
OuantiW
S.No
Import Product
Quantity Allowed
Valacyclovir Hydrochloride
Monohydrate
l kg
1
Carbobenzyloxy-L-Valine
(CBZ-L-Valine)
1.1824 kg
2.
N,N‐
E)icyclohexylcarbodHrnide
(DCC)
1.061 kg
つ
Ｄ
4-Dimethyl amino
ovridine (DMAP)
0.028 kg
4.
Dimethyl Formamide
3.515k只
ξ
υ
Acyclovir
0.758 kR
RA may take appropriate action as per the decision of Norms Committee.
## Case No.:52/13/82-
ALC4/2013
Paty Name:STERICON
PHARMA PVT.LTD。,
Meet No/Date:14/82-
ALC4/2014
22.12.2014
HQ File
:01/82/050/00528/AM14/
Defer Date:
:07/24/040/00039/AM14/
Lic.No/Date:0710095454
17.05.2013
Decision:IIIhe light ofearlier declsion takさ
n by NC in ls7/82 meeting dated H.09.2014,it was decided
to ratitt norrns under Para 4.7 ofHBP vl as per details given below or as applied by the flm,whichever is
less:
1記乳需
糖IsTШ zⅢG AND COMFOM EYEDROPS
Ｌ
Ｏ
Ｓ
Ｎ
lmport ltem
For Export of l No.Bottle
ｍ
ｅ
威
０
“
１
ｘ
ｐ
Ｏ
・
Ｅ
Ｎ
Export ltem
No.2
Export ltem
No. 3
ｍ
ｅ
ｍ
４
Ｘ
ｐ
Ｏ
．
Ｅ
Ｎ
SOFT BOWLE
7906/0007
Relevant as per packing Policy
2
WHITE CAP 8417/0001
3
DROPPER 6049/0001
4
SODIUM
HYALURONATE
0.01 gm
0.03 gm
N.A.
N.A
concerned may take further necessary action aS per above decision of NC.
冊
´
UdV°9
No.:8/7/82‐ALC4/2014
Name:SUVEN LIFE
No/Date:14/82‐
AM l4l
it z.os.zot r
ision:ln the light of written comrnents received from Departrnent of Pharmaceuticals vide their OM
35011/503/2013-P!(Norms)dated 21.10.2013′
k was decided to ratify norms under Para 4.7 of HBP vl
per
or as
rnn′
Item of Export
Quantity
S′ No
Item of lmport
Quantity
allowed kglkg
DOXOFYLLINE
l kg
1.
TⅢOPHYLLINE
0.80
2.
CHLOROACETAL
DEHYDE DIMETHYL
ACETAL
0.80
3.
POTASSIUM
CARBONATE
0.61
4.
METHANOL
0.63
5.
DIMETHYL
FORMAMIDE
0.40
36
details given below
applied by the fi
whichever i
1悧辮JЮ056017
:In the light of earlier decision taken by NC in its 18/82 mecting dated 19.12.2013 and in
' norrns under para 4.7 of
tation with technical authority present in meeting, it was decided to ratify
as per details below or as applied by firm whichever is lower:
Item of Export
Quantity
SI.No
Item of lmport
Quantity
allowed ke/ke
EMΘ-7(OR)2‐
(CHLOROMETHYL)‐ 4¨
METHOXY‐ 3,5-
DIMETHYLPYRIDINE OR(2-
CHLORO METHYL3,5-
DIMETHYL 4 METHOXY
PYRIDINE HCL)
l kg
1.
3,5 LUTIDINE
1.04
2.
METHYLENE
CHLORIDE
0.92
3.
N―HEXANE
0.65
4.
METHANOL
4.14
5.
CAUTIC SODA
FLAKES
1.55
6.
TOLUENE
7.83
7.
THIONYL CHLORIDE
0.80
8.
ACETONE
0.50
9.
AⅣIMONIUM PER
SULPHATE
1.80
9
T ~~ |
1器航5γ00416AMly lЪが浙υ
0006yAMl“
藤理鵬ぶ瓢電戸
## Case No.:12/7ノ82¨
Party Name:VIVIMED LABS
LIMITED
lrttTC
p2.12.2014
:01/82/050/00656/AR415/
:09/24/040/00060/Aヽ/114/
1⌒
File
## Case No.:12/20ノ82-
Pany
Name:GLANDPHARMA IALC4/2014
:It was decided to cali frorn the flilllto furnish Central Excise Data and also Batch Log Sheet for
last 5 batches.The case was deferred for 22.01.2015
:Oll82lO5OlO0390/AM14l t;24124l040/00008lAMl4l
Paty Name:SCOTT‐ EDIL
PHARMACIA LTD.,
Lic.No/Date:2410038996
27.05.2013
Meet No/Date:14/82-
t ft *. O""iaid to defer the case for 22.01.2015 for comments Petrochemical Division of
tofC&PC
140
lD*kirr, C".*itt". considered the case as per agenda and in consultation with technical authority present
iln tt. meeting, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as
iapplied by the firm, whichever is less:
Paty Name:CALYX
ICHEMICALS&
PHARMACEUTICALS LTD.122.12.2014
:01/82/050/00718/AM14/ :03/94/040/00537/AM13/
Meet No/Date:14/82‐
ド∬ぱ憮1
|
ision :It was decided to call the following information from the firm :
l. Complete technical details as per Appendix 33
2. past production vis-i-vis actual coniumption of input duly certified by Central Excise Authorities.
case was deferred for 22.01.2015
Meet No/Date:14/82‐
ALC4/2014
22.12.2014
Status:Defferedan
Status:Deffered
## Case No.:207/10/82‐
ALC4/2013
ALC4/2014
22.12.2014
LicoNo/Date:2210013890
28.05.2013
Export product
Exp. Qty.
SI.No.
lmport items
Qty.AIlowed
kg/kg
Cefalexin Capsule BP 500mg
(each hard gelatin capsule contain:
Cefalexin Monohydrate BP equivalent to
Anhydrous Cefalexin 500mg) packed in
40000 Boxes
Numbers
1.
Cefalexin
Monohydrate IP
500 mg/500
mg capsule
may take appropriate action as per the decision of Norms committee.
## Case No.:133/14/82‐
ALC4/2013
Date:22.01.2015
## Case No.:96/10ノ82‐
421ALC4/2013
39
No/Date:14/82‐
File
1/82/050/00998/AM14/
NameiCHIRAG
No/Date:14/82‐
14
Re-indexed
File
4
File
:08/24/040/00085/AM14/
|:SI〕):50/00279/Aヽ414/
:Committee considered the case as per agenda and in consultation with technical
to ratify norms under para 4.7 of HBP as per SION A412
present in meeting decided
2% wastage.
concerned may take further necessary action as per above decision of NC.
Party Name:SMILAX
Mcet No/Date:14/82-
tus:Deffered
LABORATORIES LIMITED
ALC4/2014
Re-indexed
22.12.2014
RLA File
:09/24/040/00113/AM14/
lDecision : It was decided to defer the case for 22.01.2015 for comments of Departmint of Pharmaceuticals.
PrけName:INDOFIL
Meet No/Date:14/82‐
INDUSTRIES LTD.
HQ File
:01/82/050/00446/AM14/
RLA File
:03/94/040/00197/AM14/
## Case No.:40/12/82‐
:01/82/050/00464/AM14/
## Case No.:22/12/82‐
Status:Deffered
ALC4/2014
122.12.2014
## Case No.:203/10/82-
45
IDecision:It was decided to deferthe case for 22.01.2015 for comments ofDepartment ofC&PC.
ParけName:SHASUN
PHARⅣlACEUTICALS
LITИ ITED
HQ File
Decision : It was decided to reject the case as the firm has not furnished
repeated
ParりName:SHASUN
PHARMACEUTICALS
11;:ち帰:10/00065/AM14/
ⅣIeet No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:0410147559
27.06.2013
:ision:Itwasdecidedtorejectthecaseasthefirmhasnotfurnishedi;.@
inders
Mect No/Date:14/82‐
R4eet No/Date:14/82‐
## Case No.:204/10/82-
:01/82/050/00387/Aヽ414/
## Case No.:64/13/82‐
P征けName:EAGLE
ICHEMICAL WORKS
釘| 1鵬淵υ∞
O19/A鳥
~1器
鼎α“Юれ"
ffitb* It ** o..io"a t" r"ffio th" ffi t" fr;^itr,-th.f"l"*irg C.h"i..tA..itrr-
lComplete technical details as per Appendix 33.
lcopy of technical literature in support of yield envisaged in the process
iPast Froduction vis-a-vis Actual consumption of all inputs duly certified by central Excise Authorities.
Status:Deffered
ALC4/2014
22.12.2014
Date:22.01.2015
11
File
Re-indexed
4
1/82/050/00386/Aヽ414/
File
Re-indexed
case was deferred for 22.0L.20L5.
## Case No.:41/13/82‐ ALC4/2013
Ｆ
Ｉ
Ｌ
ギ
ー
ー
Ｆ
Ｌ
Ｆ
Ｉ
Pa●y Name:JAGSONPAL
PHARNIIACEUTICALS LTD.
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
:It was decided to reJect the case as the fli11l has not ibnlished infoHilation desplte repeated
Mcet No/Date:14/82-
Re-lndexed
ALC4/2014
,2.12.2014
HQ File
LにNo/Dttα 0510360180 1Detr
:01,1821050100504/AMl4l't:05124/040/001 l4lAMl4l
18.07.2013
Date:22.01.2015
tofurnishacopyofMasterBatchFormuladulycertifiedby
Control Incharge. The case was deferred fot 22.01.2015 '
RLA File
:09/24/040/00185/AM14/
Lic.NoノDate:0910056909 1Defer
:01/82/050/00631/AR/114/
Date:22.01.2015
n again to department of Pharmaceutical for their
The case was defelTed for 22.01.2015.
## Case No.:43ノ12/82-
ParサName:AMI ORGANICS
ALC4/2013
PVT LTD.
Meet No/Date:14/82¨
ALC4/2014
22.12.2014
Lic.No/Date:0910057007
02.08.2013
t.it" t ia was decided to reject the case as the firm has not hHlished infollllation desplte repeated
Mcet No/Date:14/82‐
ALC4/2014
Ll″
## Case No.:28ノ13ノ82-
ALC4/2013
Party Name:RANBAXY
LABORATORIES LTD
Parly Name:MYLAN
ⅣIcet No/Date:14/82‐
Status:Deffered
Status:Deffered
Party Name:HETERO DRUGS
LIMITED,
Status:Rejected
## Case No.:61ノ14/82‐
ALC4/2013
Case No。:22/13/82‐
Patty Name:PROMED
EXPORTS PVT.LTD.
ALC4/2013
:01/82/050/00498/AM14/
:05/24/040/00171/ANI114/
22.12.2014
File
1/82/050/00517/AM14/
Re-indexed
File
Re-indexed
File
1/82/050/00467/AM14/
i iot "ottents
of Department of C&PC'
10362268
.08.2013
: It was decided to reject the case as the firm has not furnished information despite repeated
Mect No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:0710097664 1Defer
:01/85/050/00H3/AM14/ 1:07/24/040/00150/AN114/ 122.08.2013
Date:22.01.2015
htteet No/Date:14/82‐
ALC4/2014
22.12.2014
Lic.No/Date:0910057280 1Defer
:0l1821050100632lAMl4l i:0912410401002511AM141,22.08.2013
Date:22.01.2015
## Case No.:10/17/85‐
PaゥName:BEL00R BAYIR
BIOTECH LTD,
ision : It was decided to call from the acopy of Drug Manufacturing Licence for the export product. The
was defelTed for 22.01.2015.
## Case No.:47/14/82‐
ALC4/2013
Paty Name:VIVIMED LABS
LINIIITED
Status:Deffered
|
156
lDecision : It was decided to defer the case for 22.01 .201 5 for comments of Department of C&PC.
Paty Name:SHASUN
PHARMACEUTICALS
LIMITED
: ln the light of written comments received from Department of Pharmaceuticals vide their OM
. 35011/369/2013-Pl(Norms) dated 11.09.2013, it was decided to ratify norms under Para 4.7 of HBP v1
per details given below or as applied by the firm, whichever is less:-
AROXETINE TABLETS
S.NO.
lmport ltems
For export of l M‖ ‖onTab:ets
(Quantky in kg)
興
¨
塾
Ｔ
ａ
ｂ
‐
ｅ
ｔ
ｓ
塾
Ｔ
ａ
ｂ
‐
ｅ
ｔ
ｓ
1
PAROXETINE HCL
11.10
22.20
33.30
concerned may take further necessary action as per above decision of NC
## Case No.:4/4/82‐ ALC4/2014
Mcet No/Date:14/82‐
Status:
Approved
Lic.No/Date:0410148932
23.08.2013
Defer Date:
蔦戸
:27.08.2013
:27.08.2013
:01/82/050/00701/AM14/ 1:03/95/040/002
li"E.i- rit *ui a".ia"a to "uirf.ornirr. n., r"rl"*ing into.rnution'
D
Complete description of export product showing the content of API in the Injection, and
管
ョ"べ′
赫
effereF
landRe―
indexed
Date:22.01.2015
II)
Copy of relevant DML along with the list of approved items.
Re¨lndexed
File
Re-indexed
File
4
No.:116ノ14/82¨
Name:UNIJULES LIFE
No/Date:14/82‐
LTD.
14
File
case was deferred for 22.01.2015
## Case No.:53ノ14/82‐ALC4/2013
## Case No.:2ノ12/82‐
ALC4/2013
@iu'.*thefirmhasnotfurnishedinformationdespiterepeated
Party Name:VIVEK
Meet No/Date:14/82-
PHARMACHEM(INDIA) IALC4/2014
LTD.,
22.12.2014
HQ File
RLA File
Lic.No/Date:1310044274
Defer Date:
:0118210501004261 AMl4t l:r312410401000221 AMr4l
09.09.2013
:υ
l′ 04′ V」υ ′υ υ
'4υ
′
`ヽ
■V■1‐′ 1.■
フ′んπ ′V‐ V′ VVV“
“
′ムヽ工▼■■
=′ |‐
′ ●V′・~V^―
|
―――一――――――――――――――――――――一―――――一ニーーー_____― ――――― ―――――――――‐―――
Decision::It was decided to reJect the case as the f1111l has not furnished infollllatiOn desplte repeated
## Case No.:56ノ14/82‐
Party Name:VIVEK
Mcet No/Date:14/82-
ALC4/2013
PHARNIIACHEM(INDIA) IALC4/2014
LTD.,
22.12.2014
Decision::It was decided to reJect the case as the f1111l has not fumished infollllation desplte repeated
reminders.
Meet No/]Date:14/82‐
ALC4/2014
22.12.2014
HQ File
:01/82/050/00846/AM14/
HQ File
:01/82/050/00797/ANI114/
RLA File
:09/24/040/00278/AM14/
"iit,.caseasthefirmhasnotfurnishedinformationdespiterepeated
reminders.
‐
## Case No.:63/17/82‐
Parly Name:DR REDDYS
ⅣIcet No/Date:14/82-
us:Denereo
Re-indexed
ALC4/2013
LABORATORIES LINIIITED
ALC4/2014
22.12.2014
Decision :It was decided to send a copy for application to Department of Pharmaceuticals for their
ts. The case is dcfelTed for 22.01.2015
Mcet No/Date:14/82-
tus:Deffered
ALC4/2014
Re‐indexed
22.12.2014
Lic.No/Date:0310749439
13.09.2013
## Case No.:33/16/82-ALC4/2013
ParサName:I‐IETERO DRUGS
LIMITED,
Lic.No/Date:0910057537
12.09.2013
## Case No.:35/15/82-
ALC4/2013
Parw Name:KOPRAN
LIMITED
:03/94/040/00472/AN4114/
:22.01.2015
Name:STERILE INDIA
No/Date:14/82‐
ATE LIMITED
12.2014
File
File
1/82/050/00638/AM14/
HQ File lRLA File
1310044273 1Defer Date:
:0.1/82/050/0O64tlAMl4l i:13l24l040l0002tlAMt4l
File
1/82/050/00925/ANI114/
1/AM14/ 113.09.2013
14
: it was decided to call from the firm the complete technical details as per Appendix 33. The case
deferred for 22.01.2015.
## Case No.:151/14/82‐
Party Name:THINQ PHARMA-
Decision : It was decided to reject the case as the firm has
reminders.
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
Defer Date:
not furnished information despite repeated
113::):50/00736/ANI114/ 1:::念5::0/00432/ANI114/
~「
謎淵
/17/82‐
冊甲漑蘇朝邪ジ戸
ド蹴脚
粥
3島児5γ∞
"ν型
イ
膨
鵬ν0028νAⅢ″
貯∬器
α酬∞鋼4日
本ち222∝2m5
rision : It was decided to reject the case as the firm has not furnished information despite repeated
inders.
ヽ4eet No/Date:14/82‐
ALC4/2014
22.12.2014
Status:Deffered
Lic.No/Date:0310751325
:01182/050t00966tAM14t i:03t94/O4OtOO5O2tAMl4t lZA.Oq.ZO|Z
: it was decided to remind the firm to furnish following technical details :
l. Export should be in No. Of Bottles and not in kgs.
2. The import item should match the description and type given in DML and be supported by Supplier's
Brochure.
3. Net content of Cod Liver Oil (Type B), Both in quantitative and volumetic term, in each bottle of 170
4. Copy of technical literature in support of density of import item. COA from foreign supplier may be
given.
The case was deferredfor 22.01.2015.
Decision:Itwasdecidedtoremindthefirmtofurnishcompletetechnicald"@and
(ii) past production vis-avis actual consumption of inputs duly certified by Central Eicise Authority. The
was defelTed fOr 22.01.2015.
## Case No.: 18 I 4182- ALC4l20l4 I Party Name: SHASUN
PHARMACEUTICALS
LINIIITED
RLA File
:04/24/040/00137/AM14/
PaゥName:INCHEM
LABORATORIES PRIVATE
LIⅣIITED
Lic.No/Date:0410150092
19.09.2013
NIleet No/Date:14/82‐
ALC4/2014
22.12.2014
lLic.No/oate:09 I ooi 778s D"r.;
Lic.No/Date:0310749651
16.09.2013
Meet No/Date:14/82-
:01/82/050/00266/ANI11 5/
## Case No.:21/19/82‐
ALC4/2013
Pa●y Name:GOPALDAS
VISRAM&CO.LTD.
and Re-indexed
Date:22.01.2015
## Case No.:48/17/82‐
ALC4/2013
Status:Deffered
juq rite
IRLA 116
Ｆ
●
12.2014
File
File
File
15
@ttwtosot0o9l0/AMl4/ l:09Dafiao/00287/AMlt4t lot.to.zot:
lDate:22.01.20t i-
t,
: It was decided to remind the firm to furnish complete technical details as per Appendix 33 and
ii) past production vis-avis actual consumption of inputs duly certified by Central Excise Authority. The
was deferred for 22.01.2015.
Party Name:SANMAR
SPECIALITY CHEMICALS IALC4/2014
Decision:It was decided to reJeCt the case as the f1111l has not fumished infollllation desplte repeated
reminders.
‐Case No.:26/17/82-
Status:Deffered
ALC4ノ2013
and Re-indexed
ffiii.inothefirmtofurnishfollowingtechnicaldetails:
陽淵
:υ00302/AMW
騰∬器
α
"Ю“
獅
B蕩
劇2m5
__
― ¨
Molecular weight of each reactant and output product at eagh step of manufacturing process.
yield claimed by the firm appears to be very low. Copy of Technical Literature /Patent may be
furnished in support of yield, claimed.
Past production vis-a-vis actual consumption of inputs duly certified by Central Excise
The case was deferred for 22.01.2015.
No.:137/23/82‐
Pu,tyNil":MANGALAM ]MeetNo/Date:14182-
ALC4/2013
DRUGS&ORGANICS
LIⅣlITED
RLA File
:03/95/040/00454/AM14/
HQ File
:01/82/050/01184/AM14/
甘∬辮憫Ю
%剛匿…
~ d infol11latiOn despite repeated
:L was decided to racctthe case as the■
111l has not fumishα
Meet No/Date:14/82-
ALC4/2014
22.12.2014
LicoNo/Date:0910057908
11.10.2013
O".i.ion : it was decided remind the firm to furnish following information:
l)
Stepwise % yield on molar basis alongwith copy of technical literature in support of yield
envisaged and molar ratio of Diethanolamine, and
ll)
past production vis-a-vis Actual consumption of lnput duly certified by central Excise Authorities
in respect of another Advance authorization taken by Matrix in 2010-11'
ニ
ICase No.:39/16/82‐ ALC4/2013
Lic.No/Date:0410150519
Party Name:MYLAN
ALC4/2014
‐22.12.2014
## Case No.:37ノ17/82‐
Party Name:MYLAN
Status:Deffered
ALC4/2013
Date:22.01.2015
case was deferred for 22.OL.2OLS
16
No/Date:14/82-
12.2014
File
146/AM14/
10.2013
No/1Date:14/82-
12.2014
Re-indexed
File
File
1/82/050/00899/ANI114/
16/AM14/
:01/82/050/00852/AM14/
Paty Name:NAPROD LIFE
SCIENCES PVT.LTD.
## Case No.:17/4/82‐
ALC4/2014
## Case No.:17/24/82ぃ
ALC4/2013
Pa●y Name:EYTAN LABS
LIⅣIITED
芽鮒…
Mcet No/Date:14/82-
HQ File
RLA File
:01/82/050/00265/ANI11 5/ 103/95/040/00563/AM14/
Decision : It was decided to call following technical details from the firm viz:-
(a) Complete technical details as per Appendix-33
(b) % content of Buffering Agent in Export Product.
The case is deferred for 22.01.2015.
Lic.No/Date:0910057998 1Defer
24.10.2013
Date:22.01.2015
lDecision :It was decided to defer the case for 22.01-201 5 for comments of Department of Pharmaceuticals.
Pa口けName:MANGALAM
DRUGS&ORGANICS
LIMITED
HQ File
RLA File
:01/82/050/00296/AM15/ :03/95/040/00571/AM14/
ⅣIcet No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:0310755274 1Defer
l∬蹴脚
Date:22.01.2015
Date:22.01.2015
ALC4/2014
22.12.2014
## Case No.:48/4/82-
ALC4/2014
一
７
６
.01.2015.
HQ File
:01/82/050/01202/Ah414/
Ptt NamcMIDAS CAu~IMedNo/Dttα
14/82‐
PHARMACEUTICALS PVT IALC4/2014
LTD
1器疏
5υm18yAm″ 隔λ
ttυ00599晨MW
Lた。No/Dttα 0310755504 Detr
25.10.2013
Date:22.01.2015
:It was decided to callfrom the firm copy of DML (Drug Manufacturing Licence), and copy of
Batch Formula duly authenticated by Quality Control Incharge. The case was deferred for
Status:Deffered
## Case No.:3/24/82‐
ALC4/2013
障ち臆∽醐AⅢ″ 囲辮側∞
"∝
4
ParりName:SANZYME LTD
Status:Deffered
and Re-indexed
ALC4/2014
22.12.2014
Date:22.01.2015
Decision : It was decided to send a copy of application to Department of Biotechnology. The case is
deferred for 22.01 .201 5.
HQ File
:01/82/050/00981/AM14/ :31/83/040/00124/AM14/
lDecidoFTllttaξ なさ
bdedto callfromthenrm thecOmpbtetechn111_111更生
1llFfIAppe喫雪聖
:;iliヨ:1[lli【「
11:[言lili:li:°
晏
i:ス■呂d]
じ」丁j …i.= “
## Case No.:36/19/82‐
ALC4/2013
ParlyName:SOHAM
ORGANICS PVT LTD
Status:Deffered
Lic.No/Date:3110060943
29.10.2013
Date:22.01.2015
Re-indexed
17.10.2013
Re-indexed
File
1/82/050/01216/AM14/
55/AM14/
: It was decided to defer the case for 22.01.2015 for comments of Depaftment of Pharmaceuticals.
No/Date:14/82‐
No/Date:14/82-
Re-indexed
File
IWaSdeferredfor22.01.2015.
⌒
_|
## Case No.:78/23/82-
Pa“y Name:AMI ORGANICS
PVT LTD.
Meet No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:5210040368 1Defer
us:DerIere(l
Re-indexed
Date:22.01.2015
:01/82/050/01125/AR414/ 1:52/24/040/00031/AM14/
## Case No.:19/24/82‐
IDecision:It was decided to defer the case for 22.01.2015 for comments of Department ofC&PC
Party Name:SMILAX
ision : It was decided to withdraw, as the case was already approved in lll82 meeting dated
。11.2014.
Mcet No/Date:14/82‐
ALC4/2014
Re-indexed
22.12.2014
Lic.No/Date:0910058221
:01/82/050/01225/Aヽ414/ 1:09/24/040/00392/AM14/ 113.11.2013
22.01.2015
Decision :It was decided to call from the firm to furnish Central Excise Data and also Batch Log Sheet for
last 5 batches . The case was deferred for 22.01.2015
Meet No/Date:14/82-
Lic.No/Date:0910058239
Decision : It was decided to call from the firm following information:
(a) Certificate of Analysis from Foreign supplier for the relevant consignment of imported crude
product.
(b) COA of Export product as per shipping Bill/Purchase Order.
case is deferred for 1 2.01.2015
ALC4/2014
22.12.2014
Decision : It was decided to defer the case for 22.01.201 5 for comments of Department of C&PC.
Paty Name:ACEBRIGHT
Meet No/Date:14/82-
us:lrellered
Re-indexed
ALC4/2014
嘱1
ALC4/2014
22.12.2014
## Case No.:26/24/82‐
ParりName:GLAND
PHARMA LINIIITED
## Case No.:28/24/82…
ALC4/2013
Party Name:PORUS
LABORATORIES PVT LTD.
ALC4/2014
22.12.2014
Date:22.01.2015
## Case No.:140/23/82‐
ParりName:UNITED
PHOSPHORUS LTD.
Status:Deffered
ICase No.:101/23/82¨
ALC4/2013
(INDIA)PHARNIIA PVT LTD,
22.12.2014
Ｆ
卜
‐
７
９‐
‐
‐
File
No/Date:14/82-
No/Date:14/82‐
14/ 121.11.2013
Ｆ
Ｉ
ｌ
ｏ
・
Ｆ
Ｉ
Ｉ
AM14/ 18.H.2013
Lic.No/Date:0710099923
25.11.2013
Date:22.01.2015
lDecision : lt was decided to call from the firm the complete technical details as per Appendix 33. The case
lwas deferre d for 22.01..2015.
## Case No.:20/24/82-
ALC4/2013
Pa=y Namc:GLAND
PHARMA LIMITED
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
Decision :lt was decided to call from the firm to furnish Central Excise
,last 5 batches . The case was deferred for22.01.2015
Data and also Batch Log Sheet for
ParサName:SHASUN
PHARⅣIACEUTICALS
Mcet No/1Date:14/82‐
ALC4/2014
22.12.2014
器
3月5υmり4ハ剛″
~競
が
精υ剛83/AMW
け∬器
α0410152258
Status:Deffered
Defer
IDate:22.01.2015
## Case No.:77/23/82‐
Defer
Date:22.01.2015
IDecision:It was decided to deferthe case for 22.01.2015 for comments of Depa■
ment ofC&PC.
Decision : It was aeciaea to Oefer ttre "ur" foiiZOf ZfilS fo. *rnn"r,t. "f O.purtr*nt of pnurru"ruti*li
(Reply of DL received and sent to Department of Pharmaceuticals).
## Case No.:18/23/82…
ALC4/2013
89
一――躍嚇
而¨
」―断爵蔦読流罰4/82‐
酬選露嶺ヽ
|
HQ File
:01/82/050/01065/AA414/
D""i.io, : It was decided tocall following technical details from the firm viz:-
I
(u) Complete technical details as per Appendix-33
r
(b) oZ content of Buffering Agent in Export Product.
lThe case is defened for 22.01.2015.
ド
CIENCES PVT.LTD。
1分
野盤
Υ
間蔦蔦蕊扁
~諸
ぢ鼎α“Ю
%"“
Status:Deffered
and Re-indexed
:
瓢
.蔦
」
;Party Name:CHIRAG
阿lCase No.:146123182-
19
Mcct No/Date:14/82-
1148/AM14/
Re-indexed
1219/AM14/
: It was decided to reject the case as the firm has not furnished information despite repeated
No/Date:14/82-
14
Re-indexed
File lRLA File
1/82/050/01151/Aヽ/114/ :05/24/040/00201/AM14/
No。:112/23/82…
Name:CADILA
THCARE LTD.,
Name:PCL OIL&
ALC4/2013
Decision:It was decided to defer the case for 22..01.2015 for cominents of Petro chenlical E》
ivision of
Department of C&PC.
1錯
"盤
Υ FindeXed
~
面丁聞需繭而
"6B荒ち
2劇洲
5
necision : ln the light of written comments received from Department of Pharm
No. 3501-1/3 6g/2}73-Pl(Norms) dated 11.09 .2Ot3, it was decided to ratify norms I
as per details given below or as applied by the firm, whichever is less:
jExport Product
ipmoxBuNE TABLBTS
S.NO.
lmport ltems
For export of L Million Tablets
(QuantitY in kg)
20 mg Tablets
40 mg Tab:ets
1
PAROXETINE HCL
22.20
44.40
RA concerned may take further necessary action as per above decision of NC
NIleet No/Date:14/82‐
ALC4/2014
22.12.2014
for comments of Department of Pharmaceuticals.
raceuticals vide their OM
under Para 4.7 of HBP v1
ｒ
‐
‐
‐
‐
‐
‐
‐
‐
」
眠
ｒ
‐
‐
~~需
薄輛蔦瓢I
ALC4/2014
22.12.2014
Status:Deffered
and Re-indexed
Status:Deffered
and Re-indexed
HQ File
:01/82/050/00145/AM15/
trtment ofPhallllaceuticals.
け例器α酬∞男%7厩m?m5
:01/82/050/01056/AM14/
賠蹴
0畑侶″AMイ
~
面面
## Case No.:47/4/82‐
Patty Name:VISION DRUGS
PVT LTD
## Case No.:9/23/82-
ALC4/2013
|
20
鱚
膜れ欝鴛師
雪馬髪続輌d鐸
ま
::
Di鰯
脚
癬rry吊おヽお
・
r:鍵
糖師轡彎砕製Te
No.:4/5/82‐ALC4/2014
Name:SHASUN
File
10152693
Date:
:01/82/050/00321/AM15/
198/ANI114/
12.2013
4
Re-indexed
File
10058477
1/82/050/00295/AM15/
AM14/
12.2013
1.2015
No/Date:14/82-
12.2014
File
18/AM14/
Mcet No/Date:14/82¨
File
つ
乙
ｎ
ソ
File
.LTD.,
:It was decided to remind the firm to furnish the following information:
Separate weight of DI Ethylene Glycol, Fibres Glass String / Rope and Aluminium can in one
number of final one number of export product i.e. AL cans with components may be furnished
along with the copy of the export order.
Details and quantity of other indigenous inputs to be used in the manufacture of the export product
may be indicated.
Detailed manufacturing process along with justification for wastages at each stage and also on each
of the raw material may be furnished.
Complete material balance indicating input and output material at each stage of manufacturing
process.
Standard /Authentic technical literature in support of the raw material requirement formulation for
the manufacture of export product.
You have applied for the import of aluminium foiUsheets as 1.30 kg/kg content in the Aluminium
can which seems to be on gross weight basis and not on net content basis. The details of production
of Aluminium cans and corresponding consumption of Aluminium foiUsheets may be furnished for
the year 2012-13 and,2013-14.
The commercial sale value of the aluminium sheets scrap generated in the process may be furnished
along with the documentary evidence. In addition, earlier NC decision for the import of Aluminium
foil/sheets against the export of Aluminium can for your similar export product may also be
furnished.
Details of production of export product under reference and corresponding consumption of raw
material in the year 20ll-12 and,2012-13 (Aprilto December) duly certified by CA may be
furnished. If the production has not commenced in the past, the details from commencement of
production may be furnished duly certified by CA.
Any other relevant information.
case was defelTed for 22.01.2015.
Meet No/Date:14/82‐
ALC4/2014
22.12.2014
鷺ユ収ξ～…′
^… … 1■りや
にお。
NoDttco510373480赫
Юν82Ю5γOH62/AMlイ
トo5泡3Ю4γ00365/AMl″
膵Iある高
…
・Vυ ~° υ
ドxち2Ю ■2015
2.
3.
6.
8.
9.
istatus:Deffered
land Re-indexed
― _________―
――――ユーー
ロ:It was decided renlind the■111l to furnish fOHOwing technical details from the r1111l Viz:
(a)%content ofTabersonine in the imported seeds and its%recOvery in each step.
rh、 rハn,ハn`ハF^`■^_■_,^___」___4 ・ ′■ ● ● . ^
(b) content of other bye-products in the seeds, their %o.""or",fiiilitu".""" ""''
I
(c) Copy of technical ]iterature in support of (a) and (b).
' i'J E re 'e!sv'
i
(d) Past production of Vinpocetinevis-avis A.i"ut
"onrurnption of imported seeds for lart 3 v"ar.l
duly certified by Central Excise Authorities.
u'rvr rvv ovwu'
-
|
:*1lj:tr"{f".22.ot.zots.
I
----.--_-__-* *J
HQ File
RLA File
:09/24/040/Oo441/AM14/
deferthe case for 22.Ol.2015 for cOmments OfDepa■mttt OfPhallllaceuticals.
階淵…
萄1胤劉洲:
## Case No.:115/23/82‐
ParサName:ALCHEM
INTERNATIONAL LTD.
## Case No.:139/3/82‐
:01/82/050/00143/Aヽ/115/
21
Name:SMILAX
No/Date:14/82‐
Re-indexed
TORIES LIMITED
12.2014
## Case No.:7ノ18/82¨ALC4/2013
Patty Name:SWISS EXPORTS
ALC4/2014
22.12.2014
HQ File
:01/82/050/00942/ANI114/
## case No.:11/3/82‐
ALC4ノ2014
RLA File
:08/24/040/00400/AM14/
Party Name:PARENTERAL
DRUGS(INDIA)LTD.,
t82to5ol0ll32lAMll4l l:561241040100033/AMl4/ lzv'tL'zv t)
tvqLv''e'e "-
lision:Departmentol|ll6ol2ol4-PI(Norms)dated
ll.2[l4,has mentioned that thev have examined the case and stated *:9lT
lf f*'X*,r6i3'*
packing inputs as per packingpoligy'-
The caie was deferred for 22.01'2015'
i) Complete set of aPPlication
ii) Pack size of oral susPension'
ii(ゞ[;iЙご爵
及:Ul iteAs showingCOmpOSition ofeachexport
case Was deferred for 22.01.2015.
RLA File
:09/24/040/00439/AM14/
Ⅳlect No/Date:14/82‐
tatus:Deffered
ALC4/2014
Re‐indexed
122.12.2014
Lic.No/Date:0910058708
鷲 i
Lic.No/Date:0810127123
16.12.2013
cinit'10/82meetingdatet2.Ll.2oL4,itwasdecided
to ratifu nonns under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
ExpOnprOdud l諦
.
SI.No.
lmport items
Qty.AIlowed
Kqノkg
Arnoxicillin and
Clavulanate Potassium
Tablet USP 625 mg
l kg
Potassium
Clavulanate
Diluted IP with
Microcrystalline
Cellulose (1:1)
300。90 1ng/625
mg tablet
concerned may take further necessary action aS per above decision of NC'
## case No.:85ノ23/82‐
Ⅳlect No/Date:14/82-
Status:Deffered
Status:Deffered
Date122.01.2015
## case No.:142/3/82‐
Parけヽ五me:sRIAM LABS
PRIVATE LIⅣIITED
:01/82/050/00146/AM15/
124.12.2013
12.2014
Name:MICRO LABS
No/Date:14/82‐
4
12.2014
Re-indexed
Re-indexed
1.20
Decision : It
Pharmaceuticals.
decided to defer the case for 22.01.2015 for comments of Department
司
ヨ
―
TI
IHQ File
l:0r 1821050100 I 48/AM 1 5/
Defer Date:
iO""i.ioo , l" th" lisht;f;arlier de.iri", trk* b, Nb i, itr 2l
Itation with technical authority
the light of earlier decision taken
aken by NC in its 21182 meeting
in the meetins. it was decided to ra
per
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
田既鳳鳳百
臨漱温atO deferthe case繭
ｎ
７
ｅｄ
Ⅸ
伽
的
04.10.2012 and
沖
'Status:Deffered
and Re-indexed
~賠λ
ttυ∞η鉄剛″ けら器α“Ю燿"
nsultatlon wltn technlcal aul
HBP v1 as per details given
honty present rn the meetrng, rt was decided to ratify norrns under Para 4
below or as applied by the firm, whichever is less:
Export Product
Export
Ouantiw
S.No
Import Product
Quantity A1lowed
KノkA
Valacyclov ir Hydroch loride
Monohydrate
l kg
l
Carbobenzyloxy-L-Val i ne
(CBZ-L-Valine)
1.1824
う
ん
N,N―
E)icyclohexylcarbodHnlide
(DCC)
1.061
り
，
4-Dimethyl amino
pyridine (DMAP)
0.028
4.
Dimethyl Formamide
3.515
5.
Acyclovir
0.758
6.
Palladium Sponse
0.0032
## Case No.:38/4/82-
ALC4/2014
Ｆ
Ｌ
ド
ー
~甲濶而~ ぽド聴
|
| | 122.12.2014 1
剛蕊蔦蕊戸1競扁勉Ⅲ″開需画面
|
Defer
l:011821050/0109s/AMl4l l:03/94t040/007t9lAMt4l lzo.tz.zotZ
lDate:22.01.2015
rDecision : It was decided to defer the case for 22.01.201 5 for comments of Department of C&PC.
: It was decided to call from the firm to furnish Central Excise Data and also Batch Log Sheet for
5 batches. The case was deferredfor22.0l.2015
ョ町■7fキたョ7: fli t、, 、
“
,Ч lマ
Dypirector Geno「al of Eofagn Trade
-frisr EEnqrc
Directorato General of Foreron Trade
qrFlsq BqFvp6parrment of c;mmerce
04
23
u凛兜轟瓢誡
:日
Namc:SRINI
Parfy Name:CLAND
Mcet No/Date:14/82‐
PHAMA L1lИITED
Re-indexed
２
β
ん
Ｎ
ｏ
・
‥
２
２
”
105
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
:01/82/050/00092/AM15/ 1:09/24/040/00451/AⅣl14/ 31.12.2013
IRl
iOS
RLA File
Defer
Date:22.01.2015
HQ File
Lic.No/Date:0910058792
Decision :It was decided to call from the firm following information:-
(a) % yield on molar basis for each step of manufacturing process
(b) Requirement and Recovery of solvent of each step.
(c) Copy of technical literature in support of yields envisaged in the process.
(d) Past production vis-a-vis Actual consumption of lnput duly certified by Central Excise Authorities
case was deferred for 22.01.2015
ヽ〔eet No/Date:14/82-
Status:Deffered
and Re-indexed
106 HQ File
:01/82/050/00004/AM15/
RLA File
:61/24/040/00033/AM14/
Iぢ器
Ca Ю剛鯰
0匿麗m2m5
: It was decided to defer the case for 22.01.2015 for comments of Department of
ls.
:01/82/050/00248/AM15/
臨蔦
## Case No.:88/3/82-
Party Name:MYLAN
Status:Deffered
ALC4r2014
LABORATORIES LIⅣIITED
ALC4/2014
22.12.2014
## Case No.:244/3/82-
ALC4/2014
Pa●y NameiSAFECON
LIFESCIENCES
to defer the case for 22.01.2015 for commentss of Department of
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:03 10763764 1Defer
:01/82/050/01102/AM14/ 103/95/040/00791/AM14/ i31.12.2013
Date:22.01.2015
lDecision : It was decided to defer the case for 22.01.2015 for comments of Department of C&PC.
1躙下轟
1‐D‐
NIleet No/Date:14/82‐
Status:Deffered
ALC4/2014
22.12.2014
and Re-indexed
109
鵬
児5剛ЮttM″
稀t臆0り4晨M″
囲
鼎
酬聾
"“
%ダ
瞬ち2劇洲5
]Decision : It was decided to defer the case for 22.01.2015 for comments of Depurt*ent of C&PC.
ParサName:PARENTERAL
DRUGS(INDIA)LTD。
,
Meet No/Date:14/82‐
## Case No.:55/23/82…
ALC4/2013
Status:Deffered
## Case No.:53/23/82‐
ALC4/2013
## Case No.:38/3/82¨
RLA File
24
22.12.2014
Status:Deffered
ALC4/2014
No/Date:14/82-
4
Re‐lndexed
107.HQ File
Name:SATYAJIT
PVT.LTD。,
Re-indexed
File lRLA File
Party Name:SAFECON
|:01/82/050/00042/AM15/ :56/24/040/00036/AM14/ 102.01.2014
lDate:22.01.2015
Decision : Department of Pharmaceuticals vide their OM No. 350lll160120l4-PI(Norms) dated
11.2014, has mentioned that they have examined the case and stated that the firm has applied 64.92%
wastage on LDPE granules and23Yo wastage on craft paper on the net requirement. No API/RM raw
materials and applied for import. It was decided to take a decision on the relevant grade lspecification of
packing inputs as per packing policy.
case was defelTed for 22.01.2015.
ⅣIcet No/Date:14/82‐
ALC4/2014
Lic.No/Date:5610003471
102.01.2014
:It was decided to defer the case for 22.01.2015
for comments of Department of
ls.
ParけName:MYLAN
LABΘRATORIES LINIIITED
RLA File
:09/24/040/00484/Aヽ/114/
Decision :lt was decided to request the firm to furnish the following
. Complete technical details as per Appendix -33 showing % Yield on molar basis.
o Requirement and recovery of solvent of each stage.
. Past Production vis-d-vis Actual consumption of inputs duly certified by Central Excise
case was deferred for 22.01.2015.
Deffered
## Case No.:118/3/82¨
ALC4/2014
Party Name:PARENTERAL
DRUGS(INDIA)LTD。
,
Status:Deffered
Date:22.01.2015
22.12.2014
## Case No.:186/3/82-
ALC4/2014
ALC4/2014
22.12.2014
:01/82/050/00190/Aヽ江15/
Lic.No/Date:0910058825
06.01.2014
se No.:2/22/82‐ALC4/2013
)File
/82/050/01045/AR414/
rcision : Committee considered the case as per written comments of department of Pharmaceuticals
d in consultation with technical authority present in meeting, decided to ratify norms under para 4.7
HBP as per details given below or as applied by firm whichever is lowe.r:-
圏F西町「
P畿…
Export product
Exp.
Qty.
SI.No.
lmport items
Qty.AIlowed
Kg/kg
2-Mercapto-5 -( I -Pyrrolyl)
Benzimidazole
l kg
1
2, 5-Dimethoxy Tetrahydrofu ran
1.88
concerned may take further necessary action as per above decision of NC.
25
⌒
Re-indexed
No/Date:14/82-
Re-indexed
File
13
ハ
Ｗ
代
## Case No.:116/3/82¨
ALC4/2014
Party Name:VIJAYASRI
ORGANICS LTD
NIleet No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:0910058840 1Defer
:01/82/050/00120/AM15/ 1:09/24/040/00402/Aヽ
414/ 107.01.2014
Date:22.01.2015
Decision : Committee considered the case as per written comments of department of Pharmaceuticals
and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7
HBP as per details given below or as applied by firm whichever is lower:-
Export product
Exp.
Qty.
SI.No.
lmport items
Qty.AIlowed
Kg/kg
4-FLUORO― a-2‐METHYL‐ 1‐
OXOPROPYL)‐ g‐OXO‐N―B‐
DIPHENYL BENAENE
BUTANEAMIDE
(DIKETONE
INTERMEDIATE FOR
ATttRVASTATIN)DKT‐3
l kg
1
FLUOROBENZENE
0.58
2.
METHYLISO BUTYRYL
ACETATE(ヽlIBA)
0.80
3.
POTASSIUM CARBONATE
1.00
concerned may take further necessary action as per above decision of NC.
Paty Name:VISION DRUGS
PVT LTD
RLA File
:09/24/040/00426/ANI114/
Lic.No/Date:0910058839 1Defer
Date:22.01.2015
Pharmaceuticals.
Meet No/Date:14/82‐
ALC4/2014
Lic.No/Date:0910058863
Defer
Date:22.01.2015
:01/82/050/00207/AM15/
:09/24/040/00362/ANI114/ 108.01.2014
to defer the case for 22.01.2s015 for comments of Department of
Status:Deffered
ParサName:VINS
BIOPRODUCTS LTD.,
Decision : [t was decided
Pharmaceuticals.
:01/82/050/00204/AM15/ :07/24/040/00333/AM14/
Decision : It was decided to defer the case for 22.01.2015 for comments of Department of
Pharmaceuticals.
## Case No.:180/3/82‐
ALC4/2014
Status:Deffered
ALC4/2014
22.12.2014
:01/82/050/00184/AM15/
## Case No.:203/3/82‐
IALC4/2014
Status:Deffered
22.12.2014
ICase No.:200/3/82‐
IALC4/2014
Pa“y Name:WEXFORD
LABORATORIES P LTD
ic.No/Date:071010H86 1Defer
Date:22.01.2015
26
Re… lndexed
Re‐ lndexed
No/Date:14/82¨
4
Re-indexed
Party Name:SHASUN
PHARNIACEUTICALS
Ｆ
Ｉ
Ｉ
１
１
１
１
１
１
## Case No.:134/3/82¨ ALC4/2014
Mcet No/Date:14/82-
RLA File
:04/24/040/00226/AM14/
: It was decided to reject the case as the firm has not furnished information despite repeated
inders.
ALC4/2014
22.12.2014
Decision : [t was decided to defer the case for 22.01.2015 for comments of Department of
Pharmaceuticals.
Meet No/Date:14/82-
ALC4/2014
Lic.No/Date:0310766431 1Defer
RLA File
:04/24/040/00219/AM14/
RLA File
:03/95/040/00805/ANI114/
RLA File
:03/94/040/00942/Aヽ414/
16.01.2014
Defer
Date:22.01.2015
Date:22.01.2015
Ｆ
Ｉ
レ
ー
ー
Decision : It was decided
Pharmaceuticals.
HQ File
:01/82/050/00107/AM15/
Decision : It was decided to defer the case for 22.01.2015 for comments of Department of C&PC.
No/Date:14/82-
Status:Deffered
LC4/2014
Re-indexed
.12.2014
RLA File
:56/24/040/00041/AM14/
to defer the case for 22.01.2015 for comments of Department of
ヽ4eet No/1Datel14/82-
ALC4/2014
22.12.2014
Status:Deffered
Lic.No/Date:0310767119 Defer
Date:2Z.01.2015
Decision : it was decided to call from the firm following technical details:
1. COA for foreign supplier indicating Potency of Nystatin imported under present A.A
2. Detailed calculation of arriving at the quantity of API applied.
case was deferred for22.01.2015.
Mect No/Date:14/82-
ALC4/2014
22.12.2014
RLA File
:22/21/040/00096/AM14/
Lic.No/Date:2210014544
Hq
grqrqzNtRMAL KUMAR
_g_q qErft<cro Biqr qrqrrr
Dy._Dir€ctor Gon€ral of Foroign Trade
ft<sl qrsrq qErrr<prrdrr
Direclorate Gen€ral of Foreign Trade
rfiPffiI f?rTfrl/Department of commerce
seirrr qqq. Tg R=d
Udyog Bhawin. I'i,;1y pg16i
ALC4/2014
122.12.2014
Lic.No/Date:0410154220
13.01.2014
Case No。:196/3/82‐
ALC4/2014
ParサName:ARUDAA VIS
LABS PRIVATE LIMITED
Status:Deffered
Lic.No/Date:0410154292
15.01.2014
:01/82/050/00200/AMi5/
## Case No.:40/4/82-
ALC4/2014
ALLIANCE DYE¨ CHEM
22.12.2014
:01/82/050/00288/Aヽ415/
## Case No.:202/3/82‐
111)lll):50/00206/AM15/
Parly Name:PARENTERAL
DRUGS(INDIA)LTD.,
Lic.No/Date:5610003580
16.01.2014
Date:22.01.2015
## Case No.:103/3/82‐
ALC4/2014
Pa=y Name:BLISS GVS
PHARNIA LTD.
and Re-indexed
PartyName:KUDOS
CHEMIE LTD.,
Status:Deffered
Date:22.01.2015
ICase No.:12/21/82‐
27
123.01.2014
No/Date:14/82-
Re-indexed
File
Name:NEW
.LTD.,
'0飾
: It was decided to send a copy of application again to Department of Pharmaceuticals for their
.The case was defelTed fbr 22.01.2015
## Case No.:187/3/82‐
ALC4/2014
ParサName:ALCHEM
INTERNATIONAL LTD.
NIleet No/Date:14/82‐
ALC4/2014
22.12.2014
HQ File
:01/82/050/00191/AR415/
RLA File
:05/23/040/00413/AM14/
Lic.No/Date:0510376990 1Defer
Decision : It was decided remind the firm to furnish following technical details from the firm viz:-
(a) o/o content of Tabersonine in the imported seeds and its oZ recovery in each step.
(b) Content of other bye-products in the seeds, their o/o recovery and value.
(c) Copy of technical literature in support of (a) and (b).
(d) Past production of Vinpocetinevis-avis Actual consumption of imported seeds for last 3 years
duly certified by Central Excise Authorities.
case is deferred for 22.01.2015.
No.:108/3/82‐
Party Name:CROPNOSYS
Mcet No/Date:14/82‐
14
(INDIA)PRIVATE LIMITED ALC4/2014
22.12.2014
Defer
Date:22.01.2015
Decision : It was decided to defer the case for 22.01.2015 for comments of Department of C&PC.
NIteet No/Date:14/82‐
Date:22.01.2015
Status:Deffered
Status:Deffered
LicoNo/Date:0310767733
:01/82/050/00112/Aヽ115/
24.01.2014
Case孵淵
0/3/82‐
「辮滞D。
1躍F産冨
鵬
3児5υ∞郎4ハⅦy
蕊
戸
|ぶ
鼎
α∝Ⅲ
露り8P
I榊電ふitl鳳lr冨育7詰Ъギ:里it甜∬It轟出号織瑠
rpproved
tte:
ｗ
ａ
．
ｅ
ｒ
‐
．
ｉ
ｔ
ｅ
ｖ
ｈ
ｌ
′
Ｃ
Export product
Exp.
Qtv.
SI.No.
lmport items
Qty.AIlowed
Kg/kg
Arnoxicillin and
Clavulanate POtassium
Tablet USP 625 mg
l kg
1
Potassium
Clavulanate
Diluted IP with
Microcrystalline
Cellulose (l :1)
300。90 1ng/625
mg tablet
RA concerned may take further necessary action as per above deci
per above decision of NC.
## Case No.:44/4/82¨
ParサName:CATAPHARMA
CHEMICALS PVT.LTD。
,
ALC4/2014
22.12.2014
lHq rite
lnle rle
ILic.No/Date:3H0062387 1Defer
Status:Deffered
Re-indexed
Re-lndexed
File
126
l:0v82t050too2s2tAMlts/ lsvs3fia)/ootss/AMt4t l:o.or.zor+
Date:22.01.2015
Decision : It was decided to call from the firm COA of import item from the foreign supplier for the
relevant consignment . The case was deferred for 22-01.2015.
Mcet No/Date:14/82-
ALC4/2014
Lic.No/Date:0310768616 1Defer
:01/82t05010018I/AMls /
l:$D4lo4oto}ss}tAMt4l i:o.ot.zOr+
Date:22.01.2015
lDecision : It was decided to defer the case for 22.0L2015 for comments ;fb"pad;nt of CApC.
Mcet No/Date:14/82-
Status:Defferedand
ALC4/2014
22.12.2014
Re-indexed
Pharmaceuticals.
IMedNo/Dttα 14/82-
1錯
"盤
∵
111)i[:):50/00227/AM15/ lli;チら:λ10/00867/AM14/ [11::]11lF百
百
「面百爾百面こ壼テ
13荒ち2.01.2015
1翻器α“Ю
%8928B鳶ち
2劇2m5
:01 1821050100 I 69lAM I 5 /
i:03194/0401004481 AMl4l
128
CaseNo.:20gl3ts2-ALc4t2or
@Ft"tr-
-
ILABORATORIES LIMITED iALC4l2014
lApproved
I
|22.tz.2ot4
I
HaFtl.
@D"fe.D"te
:0t182/050l002t3lAMtsl l:09/24/0401005401AM141 130.01.2014
i
D".
No.350ll/29312014-Pl(Norms) dated26.ll.2014, it was decided to ratifu the norms under Para 4.7 of
FIBP vl as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Ouantiw
S.No.
Import Item
Qty. Allowed
ks/ks
Capecitabine
l kg
1
2,3 -Di-O - acetyl-5 -deoxy-
5-fluorocytidine
1.19
2.
N-PentylC h loroFormate
0.813
り
，
Methylene Chloride
4.20
may take appropriate action as per the decision of Norms Committee.
## Case No.:177/3/82-
ALC4/2014
Party Name:INDO AMNES
LINIIITED
Status:Deffered
and Re-indexed
22.12.2014
ICase No.:223/3/82¨
ParサName:UNIJULES
LIFE SCIENCES LTD.
Party Name:MANGALAM
10RGANICS LINIIITED.
Status:Deffered
lDecision : It was decided to defer the case for 22lL 2015 for comments of Department of C&PC.
⌒
No.:165/3/82¨
Re-indexed
File
132
## Case No.:111/3/82‐
ALC4ノ2014
Pa●y Name:SRIAM LABS
PRIVATE LIMITED
Ⅵeet No/Date:14/82-
へLC4/2014
22.12.2014
29
:01/82/050/00115/AM15/
RLA File
:09/24/040/00509/AM14/
LicoNo/Date:0910059150 1Defer
Date:22.01.2015
iCase No.:149/3/82‐
Paty Name:MOREPEN
LABORATORIES LTD.,
Pharmaceuticals.
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:0510378413 1Defer
:01/82/050/00153/AM15/ :05/24/040/00420/AM14/ 105.02.2014
Date:22.12.2014
Decision : it was decided to call from the firm the complete technical details as per Appendix 33. The case
was deferred for 22.01.2015.
No.:150/3/82-
Lic.No/Date:0310769509 1Defer
:0U821050t00154/AM1s/ l:03t95t040t00879tAM14t lOA.OZ.ZOtq
Date:22.01.2015
Decision :It was decided to call from the firm Copy of relevant DML for the export product. The case was
for 22.01.2015..
Mect No/Date:14/82-
Status:DeffOred
ALC4/2014
and Re-indexed
fer
:01/82/050/00012/ARだ15/ 卜09/24/040/00548/AM14/
22.01.2015
Pharmaceuticals.
ALC4/2014
Pharmaceuticals.
Pa●y Name:ARENE LIFE
SCIENCES LIⅣIITED.
ParサName:MACLEODS
PHARNIIACEUTICALS LTD.
Mcet No/Date:14/82-
Status:Deffered
ALC4/2014
ヽ4cet No/Date:14/82-
ALC4/2014
22.12.2014
Status:Deffered
and Re-indexed
B6器
3月期∞∝″Amy陽
ち臆
υ∞
"″
Amイ
け
ど鼎
α酬
∞
"犯
7B鳶
ち2m2∝
5
B7器
3月5剛%3/AMlζ
障
ち非
υ∞551/AM″ 1蹴
器
α酬
∞
"鯰
2B荒
ち2劇2m5
: It was decided to defer the case for 22.01.20 I 5 for comments of Department of
Mcet No/Date:14/82‐
Status:Deffered
ALC4/2014
and Re-indexed
122.12.2014
Status:Deffered
and Re-indexed
22.12.2014
## Case No.:8/3/82‐ ALC4/2014
ParサName:ALEKHYA
DRUGS PVT LTD.
22.12.2014
## Case No.:10/3ノ82¨
## Case No.:59/3/82‐
Party Name:ARENE LIFE
SCIENCES LINIIITED.
ヽleet No/Date:14/82-
IB8猥霊胤f1/3/82
Party Name:CIPLA LIMITED
鱚
ギ鶏拝Ⅲ
・ぼ
Re-indexed
File
30
lzz.tz.zot+
:011821050100155/AMl5/'t:03l94l040l01\22lAMl4l
Lic.No/Date:0310769755 1Defer
Date:22.01.2015
: ln the light of written comments received from Department of Pharmaceuticals vide their OM
lo. 35011/155/20L5-Pl(Norms) dated January 2015, it was decided to ratify norms under Para 4.7 of HBP
1 as per details given below or as applied by the firm, whichever is less:
ParりName:KREATIVE
ORGANICS(P)LTD.,
RLA File
:09/24/040/00577/AM14/
Party Name:VIJAY
~IMeetNo/Date:14/82-
1錯″盤Υ
u駅兜臨爪棘
!け
S.NO.
Import Items
For export of 1000 No. Pack
75 1nl
100 1nl
150 nll
l
AmoxycillinTrihydrate
4.200
5.649
8.274
2
Clavulanate Potassium Syloid
mix
2.3444
3.126
4.6888
り
，
Silicon Dioxide(Sy10id AL―
lFP)NF
1.500
2.00
3.00
4to 7
Packing Materials
Relevant as per packing policy
## Case No.:21/4/82-ALC4/2014
Mect No/Date:14/82‐
ALC4/2014
22.12.2014
Lic.No/Date:0910059237 1Defer
11.02.2014
Date:22.01.2015
:01/82/050/00269/AM15/
cision :In the light of written comments received from Department of Pharmaceuticals, i
ratifu the norns under Para 4.7 of HBP vl as per details given below or as applied
ichever is less:
was decided
by the firm,
Export Product
■
的
師
Ｑ
ｕ
ａ
ｎ
So No.
Import Item
Qty. Allowed
ks/ke
GLIPIZIDE
l kg
1
S-Methyl Pyrazine-2-
Carboxylic Acid
0.54
2.
4-2-Amino Ethyl Benzene
Sulfonamide
0.67
3.
yclohexyllsocyanate
0。97
RA may take appropriate action as per the decision of Nornrs C.,--i
## Case No.:166/3/82-
Status:Deffered
PERFUMES PVT.LTD.
70/AM15/
16/AM14/ 118.02.2014
:It was decided to deferthe case for 22.01.2015 for comments OfIDepartinent of
Re-indexed
ICase No.:65/3/82‐
HQ File
:01/82/050/00069/AA415/
## Case No.:46/6/82‐
ALC4/2014
HQ File
:01/82/050/00436/Aヽ415/
Patty Name:NAPROD LIFE
SCIENCES PVT.LTD.
ParサName:INDOCO
REMEDIES LIMITED
RLA File
:03/94/040/00973/AM14/ 105.03.2014
Mcet No/Date:14/82‐
ALC4/2014
Re-indexed
Defer
Date:Z2.01.2015
2.01.2015
Meet No/Date:14/82‐
Status:Deffered
ALC4/2014
and Re-indexed
Pa■y Name:I‐IETERO LABS
LIIИITED
RLA File
:09/24/040/00595/AA414/
ParりNameiVENUS
REMEDIES LTD.,
Meet No/Date:14/82‐
Status:Deffered
ALC4/2014
22.12.2014
Lic.No/Date:0910059337
19.02.2014
Defer
Date:22.01.2015
1431131〕
):50/00282/AM15/ 1::ち刷
:0/00455/ANI114/ 1:::∫〕器
e:0510380668
ticals.
Mcet No/Date:14/82‐
IALC4/2014
22.12.2014
Decision : [t was decided to defer the case for 22.01.2015 for comments of Department of
Pharmaceuticals.
ision : It was decided to defer the case for 22.01.2015 for comments of Department of
И5日
33月5γ∞おyAmy
脇
刷10Ю
"%晨
Mイ
諸譜鼎
α
“
ЮηW
22.12.2014
icals.
## Case No.:132/3/82‐
Status:Deffered
Date:22.01.2015
22.12.2014
Lic.No/Datei2210014635
126.02.2014
## Case No.:34/4/82‐
ALC4/2014
Party Name:MOREPEN
LABORATORIES LTD.,
Status:Deffered
and Re-indexed
ALC4/2014
122.12.2014
## Case No.:33ノ6/82-
ALC4/2014
Date:22.01.2015
## Case No.:34/6/82‐
ALC4/2014
Pa●y Name:INDOCO
REMEDIES LIMITED
ALC4/2014
22.12.2014
D;trtr. r It *u, OEia"a to defer the case for 22.01.2015 for comments of Department of
Status:Deffered
File
36/A〕И15/
No/Datci1 4/82-
File
1/82/050/00448/ANI11 5/
No/Date:14/82-
中
Re-indexed
i詰i掲e
（
‐
lPharmaceuticals.
―
|
## Case No.:32/6/82‐
ALC4/2014
Pa●y Name:INDOCO
REⅣlEDIES LINIIITED
Status:Deffered
ALC4/2014
22.12.2014
RLA File
Lic.No/Date:0310774050
:011821050/00434/AMl5t l:$/94/O4\/0fi04/AMt4/ lt r.Or.zol+
ticals.
Defer
Date:22.01.2015
RLA File
:04/24/040/00258/AR414/
:L was decided tO ttect the case as the nII1l has not fumished
NIleet No/Date:14/82-
ALC4/2014
22.12.2014
:It was decided to deferthe case lbr 22.01。2015 for comments OfI〕epartment Of
Patty Name:SNIIILAX
ALC4/2014
:It was decided to deferthe case for 22.01.2015 for comments OfI)epartinent of
)uticals.
ParりName:IND― SWIFT
LABORATORIES LTD.,
:It was decided tO deferthe case for 22.01.2015 for comments ofIDepartinent of
、..●:^^1^
RLA File
despite repeated
Status:Deffered
and Re-indexed
Defer
Date:22.01.2015
ⅣIeet No/Date:14/82‐
Status:]Deffered
ALC4/2014
and Re.indexed
町
## Case No.:3/3/82‐ A]LC4/2014
ParサName:SHASUN
PHARNIACEUTICALS
LINIIITED
:01/82/050/00007/ARだ15/
Lic.No/Date:0410156078
11.03.2014
ICase No.:30/3/82¨
ALC4/2014
## Case No.:11/9/82‐
## Case No.:56/4/82-
ALC4/2014
## Case No.:57/4/82-
ALC4/2014
22.12.2014
:01/82/050/00305/AM15/
:22/24/040/00103/AM14/
No/Date:14/82‐
Re-indexed
Name:BELCO
Re-indexed
AM14/ 112.03.2014
No/Date:14/82‐
File
1/82/050/00808/AM15/
t8/AMt4/ ltt.ot.zotq
No/Date:14/82-
Re-indexed
File
1/82/050/00304/ANI11 5/
102/AMt4/ fiq.ot.zotq
File
: It was decided to defer the case for 22.01.201 5 for comments of Department of
Party Name:IND‐ SWIFT
LABORATORIES LTD。,
Status:Deffered
and Re-indexed
ゝ4eet No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:2210014694 Defer
Date:22.01.2015
:22/24/040/00100/AⅣl14/ 114.03.2014
Party Name:RECKITT
us:lrellered
Re-indexed
HQ File
LicoNo/Date:0510382032 1Defer
:01/82/050/00290/AM15/ 1:05/24/040/00480/AM14/
18.03.2014
Date:22.Ol.2015
:[t was decided to call from the firm copy of DML (Drug Manufacturing Licence), and copy of
Batch Formula duly authenticated by Quality Control lncharge. The case was defened for
Meet No/]Date:14/82-
ALC4/2014
22.12.2014
was deferred for 22.01.2015.
‐Case No.:124/6/82-
ALC4/2014
## Case No.:15/6ノ82¨
ALC4r2014
ParサName:UNITED
BIOTECH PVT.LTD.
Mcet No/1Date:14/82-
ALC4/2014
122.12.2014
Party Name:KOPRAN
Mcet No/Date:14/82-
LIMITED
ALC4/2014
22.12.2014
piitt t""t'nical details as per Appendix 33' The
was defelTed for 22.01.2015.
Meet No/Date:14/82-
Status:Deffered 帥
ALC4/2014
and Re-indexed
罐∬袋》
嘔
°ソ織ヨャ
翼藤:ri■tti
調臨r榔
陽
D詢色覧ギ尋3:3鋼
::||:;i:::i l 「ヨ
F口
n 「
rり
|
灘悧榔か
HQ File
:01/82/050/00306/AM15/
## Case No.:42/4/82‐
ALC4/2014
HEALTHCARE INDIA
## Case No.:43/24/82-
Party Name:THINQ
Status:Deffered
ALC4/2013
PHARMA― CRO LIゝ江ITED
Status:Deffered
156119島〉
;50/00526/AM15/ 11七tfl10/00467/AM14/ 「『蕊再
ITie:0510382042B荒ち
2012015
Decision:It was decided to deferthe case for 22.01.2015 for comlnents ofDepartment ofC&PC.
Status:Deffered
and Re-indexed
## Case No.:116/6/82‐
Party Name:PARENTERAL
DRUGS(INDIA)LTD.,
34
22.12.2014
=識
静ら｀
.2015。
Re-indexed
ffirmtofurnishcompletetechnicaldetailsasperAppendix33.The
Re-indexed
File
1/82/050/00417/Aゝ415/
1159/AM14/
２
８
４
Ｎ
ｏ
・
‥
５
８
卿
⌒
鵬3月5υ∞Я 8ハmy
膿が
浙υ∞
“
3/AMI″ 1器
鼎
α知∞
“
%6 Defer
Date:2Z.01.2015
Mect No/Date:14/82‐
Status:Deffered
and Re-indexed
Decision : It was decided to call from the firm COA of import item from the foreign supplier for the
relevant consignment . The case was deferred for 22.01.2015
Status:Deffered
and Re-indexed
Defer
Date,,Z2.01.2015
Date:22.01.2015
Decision : It was decided to defer the case for 22.01.201 5 for comments of Department of
Pharmaceuticals.
1591器
星児5γ00529ハMlダ
陽が
精υ00232ハMW L::ど
鰍TC3H00633りB鳶ち20.2∝5
ision :It was decided to remind the firm the following technical details:
i) Copy of certificate of Analysis of Imported Azithromycin Dihydrate IP grade on Actual content basis
is specifications under Indian Pharmacopia.
ii) A similar COA of the Export Product vis-avis the specifications laid down in USP -36
iii) Justification / Reasons for Reprocessing.
case was deferred for22.01.2015.
ParサName:VEGESNA
ヽ4eet No/Date:14/82‐
LABORATORIES PRIVATE IALC4/2014
LIⅣIITED
22.12.2014
剛
鵬
児剛∞欄υA剛ダ
膨
鵬
υ∞
“
6触Ⅲ″
購ザ
鼎
α酬
∞
"“
8開
Pa●y Name:AGIO
PHARMACEUTICALS LTD
RLA File
腰鮒…
Lic.No/Date:0310776774 Defer
Date:22.01.2015
“
3臨
蔦
蕊
蔦
yttλ
ttυ鋭
“
″AM″
1淵器
醐引
"%万
9靡
:01/8210501004371AM151 l:$/94l040l}O9t4lAMt4l 02.04.2014
Pharmaceuticals.
ParサName:PERFECT
Meet No/Date:14/82‐
INDUSTRIES PRIVATE IALC4/2014
LIMITED.
22.12.2014
lDecision : It was decided to defer ttrJ Caie for 22.ol.zolif;r comiln;fD"p".t."rt "f
CE pC
瑚
:
## Case No.:127/6/82-
Party Name:CATAPHARMA
CHEMICALS PVToLTD。
,
ALC4/2014
22.12.2014
ICase No.:60/6/82-
Party Name:UNIMAX
CI‐IEMICALS PVT LTD.
ALC4/2014
22.12.2014
## Case No.:83/5/82‐
ALC4/2014
## Case No.:35/6/82¨
Status:Deffered
## Case No.:51/6/82…
No/Date:14/82-
File
1/82/050/00462/AR415/
1035/AMi4/
Re-indexed
Re-indexed
Re-indexed
ICase No.:50/6/82¨
Mcet No/Date:14/82¨
ALC4/2014
22.12.2014
Decision:It was decided to deferthe case for 22.01.2015 for conlments of Department of
Pharmaceuticals.
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
HQ File
:01/82/050/00549/Aヽ415/
RLA File
:07/24/040/00490/AM14/
Date:22.01.2015
their OM
7 of HBP
iil;;;D;rd;d
land Re-indexed
I
Mect No/Date:14/82-
ALC4/2014
電ョ票経ゼ≒:IS・
Status:Deffered
Lic.No/Date:0310776760
02.04.2014
## Case No.:147/6/82-
ALC4/2014
Pa●y Name:R L FINE CHEM
:07/24/040/00489/AM14/
Lic.No/Date:0710103377
03.04.2014
D"@oe.i'iontakeninmeetingno.t/82dated04.04.2oL3,itwasdecidedt
ratify ndrms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever
less:
０
・
Ｉ
Ｓ
Export product
Exp. Qty.
Si.No.
lmport items
Qty.al10Wed
rkO、
Nort百ptyline HCL
BP′USP
l kg
1
l,Bromo 3 Chloro
Propane
0.96
2
Tetra Hydro Furan
0.71
3
EthyI ChloroFormate
0.46
rnay take appropriate action as per the decision of Norms committee.
## Case No.:137ノ6/82…ALC4/2014
|:Ъ I〕):50/00539/AM15/
CHEMICALS PRIVATE
LINIIITED,
ALC4/2014
22.12.2014
LicoNo/Date:0710103378
03.04.2014
cision:ln the light of written comments received from Department of Pha
.35011/314/2013-PI(Norms)dated 13.09.2013′
仕was decided to ratify no:
as per deta‖ s given below or as apphed by the firm′ whichever is less:
rmaceuticals vide t
'ms under Para 4.7
Item of Export
Quantity
S′ No
Item of lmport
QuantitY
allowed kg/kg
DOTHIEPIN HCL
l kg
1.
lBROM0 3 CHLORO
PROPANE
0.92
2.
TETRA HYDRO FURAN
0.50
3.
ACETONE
Not required in
the process
4.
THIOPHENOL
0.65
may take appropriate action as per the decision of Norms committee.
iCase No.:20/6/82‐
ALC4/2014
36
^
164
File
Name:V&V PHAFWIA
Re-indexed
File
AM15/
'AM14/
Date:
166
匹12.2014
gd to deferthe case fOr 22.01.2015 for comments OfDepartment ofC&PC.
:01/82/050/00422/AM15/
## Case No.:156ノ6/82…
1盪躙TR諄♯…
|::;,〕:λ10/00483/AM14/
Status:Deffered
and Re-indexed
:01/82/050/00558/AM15/
## Case No.:183/6/82‐
Party Name:TIDE
INDUSTRIES
Status:Deffered
IRLA FHe ~~
:09/24/040/00047/AM15/
臓鮮…
:
¨
P畿』配
・
ｍ
ａ
ｓ
170
Status:
:ision, :ln the tigrrt oi *.itt"n "o-r"nir ieceived from department of pnarmaceuii.;,;' ila
sultation with technical authority present in meeting decided to iatif, norrns unde, pa.a 4.7 of HBp
details below or as applied by firm whichever is lower:_
Export product
Export
Qtv.
SI.No.
lmport items
Qty.allowed
(kg/kg)
Ceftibuten
旺
l kg
1
3-MEttHYL-2-BUTEN-1-OL
3.114
2
ACETONE
1.51
3
ACE丁ONITRILE
10.62
4
ACTIVATED CARBON
0.200
5
DIMETHYL FORMAM!DE
4.38
6
GHYH[7-PHENYLACETAMIDE―
3-HYDROXY-3‐ CEPHEM-4-
CARBOXYLiC ACID
DIPHENVLMETHYL ESTERI
2.977
7
lSO PROPYL ALCOHOL
14.16
1140/AM14/
|
No/Date:14/82-
4
4
File
1/82/050/00585/AM15/
扇
ζttW再菖蔦3ded to defeFthett for茄「うo15お高
imments ofDepartment ofC&Pc.
8
METHANESULFONIC ACID
0.913
9
METHANE SULFONVL
CHLORIDE
0.968
10
MEttHANOL
24.81
11
METHYL 4-CHLORO
ACETOACETATE
1.661
12
METHYL-3-
METHOXYACRYLAttE
1.620
13
METHYLENE CHLORIDE
108.00
14
SODIUM BOROHYDR:DE
0.344
15
TRIETHYLAMINE IttEAl
3.214
RA may take appropriate action as per the decision o Norms Committee.
## Case No.:51/10/82‐
ALC4/2014
Paty Name:VIVIMED LABS
LIMITED
ALC4/2014
22.12.2014
Defer Date:
ision :ln the light of written comments received from Department of Chemicals and Petrochemicals
their U.O No.14010/138/2011/Ch ll dated 12.12.2014′
it was decided to ratify norms under Para 4.7
HBP v1 as per details given below or as applied by the firm, whichever is less:
Export Product
Export
Ouantitv
S.No
Import Product
Quantity
Allowed
DANTUFF―C
(CLIMBAZOLE)
l kg
1
CHLORO ETHER
KETONE or
(1,CHLORO,(4-
CHLOROPHENOXY
3,3-DIMETHYL 2-
BUTANONE)
110 Kg
2.
Iヽ41DAZOLE
0.289 Kg
3.
POTASSIUM
CARBONATE
0.600 Kg
may take appropriate action as per the decision of Norms committee.
Pa“y Name:ESTEEM
INDUSTRIES PVT.LTD,
扇3雨而証1″ 82-
IALC4/2014
122.12.2014
隔 1ダ
:01/82/050/00639/AM15/
Defer
Date:22.01.2015
1赫
五百蔑百五而
8丁高百酔grthe case for 22.01.2015 for comments ofDepaltment ofC&PC
11:EII〕
Ilil'7/6/82-
Status:Deffered
and Re-indexed
中
「
「
I｀1. 11■。
く,ヤ ｀
輸
38
ヘ
No/Date:14/82-
臨
## Case No.:9/9/82‐ ALC4/2014
（
け
‐
‐
‐
‐
‐
‐
し
い
‐
‐
‐
‐
‐
―
―
Pa●y NameiSHREE JAYA
LABORATORIES PVT LTD.
Mcet No/Date:14/82-
Status:Deffered
and Re-indexed
HQ File
RLA File
Lic.No/Date:1710005806 1Defer
:0v82t050t00638/AMl5/ l:17t24t040/00007/AMl5/ iOt.OS.ZOr+
Date:22.01.2015
lDecision : It was decided to defer the case for 22.01.2015 for comments of Department of C&PC.
HQ File
:01/82/050/00642/AM15/
Pa口けName:MICRO LABS
LTD
RLA File
:07/21/040/00092/ANl15/
ParけName:ESTEEM
INDUSTRIES PVT.LTD,
Meet No/Date:14/82-
ALC4/2014
22.12.2014
ⅣIcet No/Date:14/82‐
ALC4/2014
Decision :Committee considered the case as per agenda and in consultation with technical
present in meeting decided to ratify norms under para 4.7 of HBP as per SION A-412
2% wastage.
RA concerned may take further necessary action as per above decision of NC.
122.12.2014
: It was decided to defer the case for 22.01.20 I 5 for comments of Department of C&pC.
Mcet No/Date:14/82‐
ALC4/2014
22.12.2014
RLA File
:09/24/040/00093/AM15/
Lic.No/Date:0910060176
Defer
Date:22.01.2015
ALC4/2014
‐22.12.2014
## Case No.:236/6/82…
ParサName:ESTEEM
Status:Deffered
INDUSTRIES PVT.LTD,
ALC4/2014
22.12.2014
Lic.No/Date:0710103970
## Case No.:238/6/82-
ALC4/2014
## Case No.:88/6/82‐
ALC4/2014
: [t was decided to defer the case for 22.01.2015 for comments of Department of C&PC.
## Case No.:17/9/82-
IALC4/2014
:01/82/050/00814/AM15/
ParサName:AUROBINDO
PHARMA LIA41TED
39
22.05.2014
No/Date:14/82-
4
Re-indexed
No.:240/6/82-ALC4/2014
Re-indexed
1710005810
Name:UPL
No/Date:14/82-
TD。(FORMERLY UNITED
Re-indexed
LTD.)
A
Decision:ln the‖ ght of writ
No.35011/225/2014‐ PI(Norr
vl as per deta‖ s given below
ten comments received from Department of Pharmaceuticals vide tht
ns) dated o2.og.2ot4, it was decided to ratify norms under Para 4.7 o'
or as applied by the firm, whichever is less:
ir OM
HBP
Item of Export
QuantitY
S′No
Item of lmport
QuantitY
allowed kg/kg
Lamivudine.
l kg
1.
Glyoxalic Acid 50%
1.738
2.
2,5‐lDihydroxy,1,4-
E)ithiane
0.739
3.
Acetone
0.39
4.
Activated Carbon
0.100
5.
Cyclohexane
1.781
6.
Cytosine
0。955
7
Dimethyl Formamide
0.41
8
HexamethylDisilazane
1.89
9
Methanol
1.235
10
Methylene Chloride
10.43
11
Sodium Borohydride
0.48
12
Triethylamine
2.00
13
Steam/Thermal Coal
As per fuel
policy.
G"lih^^^- P,4l/-
駈
40
lne may take appropriate action as per the decision of Norms Committee.
## Case No.:223/6/82‐
PaゥName:ANUH
PHARMA LTD.
ALC4/2014
122.12.2014
Lic.No/Date:0310783471
29.05.2014
Decision : It was decided to defer the case for 22.01.20 I 5 for comments of Department of
Pharmaceuticals.
Mcet No/Date:14/82‐
ALC4/2014
122.12.2014
Lic.No/Date:0310783793
30.05.2014
Decision:Itwasdecidedtodeferthecasefor22.0l.20'
Pharmaceuticals.
NIlect No/Date:14/82‐
Status:Deffered
and Re-indexed
ALC4/2014
22.12.2014
RLA File
ic.No/Date:2210014962 Defer
:22/24t040/0oot7tAMt5/ los.oe.zot+
22.01.2015
Defer
Date:22.01.2015
Ｆ
ほ
Ｆ
Ｉ
‐
Decision : It was decided to defer tt " "ur" rffi;f
D"p"rt.".t "f
Pharmaceuticals.
n : It was decided to call from the n., "
In charge. The case was deferredfor22.122014.
Status:Deffered
## Case No.:86/8/82-
ALC4/2014
ParサName:GLENMARK
GENERICS LINIIITED
Status:Deffered
Date:22.01.2015
## Case No.:165/6/82‐
ALC4/2014
Patty Name:HALDIA
PETROCHEⅣIICALS LTD.
ALC4/2014
22.12.2014
## Case No.:228/6/82‐
ALC4/2014
Status:Deffered
LIFESCIENCES LIMITED,
:01/82/050/00630/AM15/
## Case No.:90/6/82-
Date:22.01.2015
ll::li;lI1/00075/AlИ 15/
No/1Date:14/82‐
tus:Deffered
ALC4/2014
Re-indexed
.12.2014
HQ File
:01/82/050/00492/AM15/
ffi
gfqrcl NlPMAl lrl'\.4AR
a{tf r-'
r-'
Di'
!'
l,
I
Dirstoraic uJr ru,d ..
-, tr'Ji) Irade
qlprtq frirrruDgpartment of commerco
15dFr srq=r. q-g Cd
uaioei eniw6n' New Delha
41
⌒
No/Date:14/82-
File
1/82/050/00625/Ahだ15/
149/ANI11 5/
160/AM15/
1/82/050/00567/AM15/
10203844
Name:NECTAR
No/Date:14/82-
: It was decided to defer the case for 22.01.2014
rnt of Chemicals and Petrochemicals.
Re-indexed
Re-indexed
Re-indexed
Re-indexed
Name:WANBURY
No/Date:14/82‐
′Y
14
ORGANICS LTD)
10784601
:01/82/050/00750/ANI11 5/
: [t was decided to call from the firm a copy of Master Batch Formula duly certified by Quality
In charge. The case was deferred for 22.12.2014.
## Case No.:92/6/82‐
Status:Deffered
ALC4ノ2014
:01/82/050/00494/AM15/ 1:03/95/040/00072/AM15/
r It *;a decided to call from the firm a copy of Master Batch Formula duly certified by Quality
In charge. The case was deferred for 22.12.2014-
PaゥName:WANBURY IMeetNo/Dttα
14/82‐
LIMITED(FORMERLY
ALC4/2014
PEARL ORGANICS LTD) lZZ.tZ.ZOt+
acopyofMasterBatchFormuladulycertifiedbyQuality
In charge. The case was deferredfor 22.12.2014.
## Case No.:98ノ6/82‐
;RY I呼讐vP,α 14/82-
ALC4/2014
L1lИITED(FORMERLY
ALC4/2014
HQ File
HQ File
:6):,7650/00552/AM15/ 1:05/23/040/00099/A哩
Lに.No/D江o03107846951Detr
06.06.2014
Date:22.01.2015
PEARL ORGANICS LTD) 122.12.2014
I In charge. The case was deferredfor22J22014'
" *py "f M"tt* Batch Formula duly certified by Qualiff
In charge.The case was defer,df°
r22.12.2014.
Ⅳleet No/Date:14/82-
ALC4/2014
nd Re-indexed
22.12.2014
調器α“Ю賀
8492B寛ち
2]川5
De孫lon:■was deoded tO detrthe ctte for 22.01.2015 for co語
“
ents ofDepartment of
Mcet No/Date:14/82-
IALC4/2014
22.12.2014
Lic.No/Date:0510388491
## Case No.:96/6/82‐
Status:Deffered
Status:Deffered
ICase No.:100/6/82‐
Status:Deffered
ALC4/2014
## Case No.:150/6/82‐
Patty Name:DHANUKA
LABORATORIES LTD.
Status:Deffered
Party Name:DHANUKA
LABORATORIES LTD。
Pharmaceuticals.
Name:WANBURY
No/Date:14/82‐
Y
14
Re-indexed
ORGANICS LTD)
12.2014
File
Re-indexed
Re-indexed
1871器疏5υ0050υAM y 雌ら鯛
:υooo7″AMly
atch Formula duly certified by Quality
Re-indexed
Re-indexed
馴
器
3月5υ∞%″AMy
膿ち荒0側∝晨my l淵
鼎
α
“
Ю賀8394B鳶
ち2劇2m5
l:0vs2l050l00sss/AMls/ l:05/8fia0/00098/AMl5/ los.oa.zot+
lDate.Z2.01.2015
NIteet No/Date:14/82-
Status:Deffered
and Re-indexed
ALC4/2014
:lt was decided to call from the firm copy of DML (Drug Manufacturing Licence)for the export
and copy of Master Batch Formula duly authenticated by Quality Control Incharge. The case was
for 22.01.2015.
No.:148/6/82¨
A4eet No/1Date:14/82-
ALC4/2014
22.12.2014
Deffered
ALC4/2014
Re-indexed
HQ File
Lic.No/Date:0510388412 Defer
Date:22.01.2015
:01/82/050/00550/AMl5/ i:051241040100070/AMl5/ t09.06.2014
Pharmaceuticals.
Mcet No/Date:14/82-
HQ File
:01/82/050/00686/Aヽ415/
RLA File
:09/24/040/00146/AN(15/
り
5圏胤蕊蔦
「
T翻蕊蕊蔦TI悧鼎副Ю
%“・B荒ち
2劇2鋭5
Decision : It was decided to reject the case as the firm has not furnished information despite repeated
reminders.
|
|
Defer
Date:22.01.2015
Pharmaceuticals.
P".ty N"m.:KORES(NDIA)
tus:Deffered
LTD.
Re¨indexed
@dedtodeferthecasefor22.ol.2ol5forcommentsofDepartmentofC&PC.
## Case No.:61/4/82‐
Status:Deffered 肛
## Case No.:67/9/82‐
ALC4/2014
Party Name:JUBILANT LIFE
SCIENCES LINIIITED
22.12.2014
ParりName:PARABOLIC
DRUGS LTD.,
## Case No.:22/8/82-ALC4/2014
Pa●y Name:HETERO LABS
Ln41TED
ALC4/2014
22.12.2014
Lic,No/Date:0910060438
13.06.2014
## Case No.:151/6/82‐
ALC4/2014
Paty Name:INDO PHYTO
CHEMICALS PVT LTD
ALC4/2014
22.12.2014
Case No。:166/6/82-
ALC4/2014
22.12.2014
ALC4/2014
and Re-indexed
ハ
File
No/1Date:14/82‐
13.06.2014
Name:V&V PHARMA IMcetNo/Date:14/82-
ハALレくψY
HQ File
:01/82/050/00309/AM15/
RLA File
:03/95/040/00190/ANI115/
Pharmaceuticals.
Meet No/Date:14/82-
Lic.No/Date:0510388704 1Defer
:01182/050100554/AMl5/ t:051241040100133/AMl5/ t\6.06.2014
Date:22.01.2015
: It was decided to defer the case for 22.01.20 I 5 for comments of Department of
Pharmaceuticals.
Lic.No/Date:0510388792 1Defer
:011821050t00566/AM l5 I
l:05t24/040/00085/AM I 5/
lt g.OO.ZO r +
Date:22.01.2015
lDecision : It was decided to defer the case for 22.0L2015 for .ornr.nii of O"p".t.*nt of C&PC.
1聾
BΨ
KALAЮ MT話
Status:Defferedan
d Re…lndexed
fer
22.01.2015
ICaSe
RLA File:05/23/040/00105/Aヽ115/
「出
200
ICase No.:152/6/82-
ParサName:MOMPEN
LABORATORIES LTD.,
Status:Deffered
ALC4/2014
22.12.2014
Status:Deffered
## Case No.:142/6/82‐
ALC4/2014
Lic.No/Date:05103889
:01/82/050/00544/AMl
## Case No.:6414t82-ALC4l20l4 lfarry Name:AUROBINDO -M."t NolO"t*r+lg2- Ft"tr-
IPHARMA LTMTTED letc+tzot+
japprove
I
l22.tz.2ot4
I
Ha Fl"
m-Ei"N"/D"t.o910060520
-D.f".D",
:01182/050/003t2t{Mtst i:09Dafi40t001s4lAMl5/ lZl.OA.ZOt+
i
Department of Pharmaceuticals and in consultation with technical authority present in meeting decided
ratiff norms under para 4.7 of IIBP as per details below or as applied by firm whichever is lowir:-
ｄ
一
ほ
一
ｂ
ｙ
”
Export product
Export
Qty.
Sl.No.
Import items
Qty.al10Wed
(kg/kg)
/
MEROPENEM FOR
INJECTION
(MEROPENEM
STERILE)
l kg
1
MeropenemTrihydrate (Non-
sterile)
0.987
2.
Carbon
Enoanticormos(Activated
Carbon)
0.049
●
Ｄ
Acetone
z.so
I
44
13.06.2014
File
No.:164/6/82-
Name:VDH CHEM
No/Date:14/82‐
PVT.LTD.
4
Re-indexed
4.
Methanol
0.096
Pafty Name:AVA
ヽ4cet No/Date:14/82‐
Status:Deffered
IALC4/2014
,^^.^^^´
´
and Re-indexed
訓
HQ File
:01/82/050/00880/A1415/
: It was decided to defer the case for 22.01.2015 for comments of Department of C&pC.
Paty Name:IPCA
Mcet No/Date:14/82‐
購臣璽
=II田
漱甲面~閉聯面戸
~ド蹴脚
RLA File
Defer Date:
:03/94/040/00223/AR415/
:ln the light of written comments received from Department of Pharmaceuticals vide their OM
' 35011/591/2013-Pl(Norms) dated 24.L2.2oL3, it was decided to ratifli norms under para 4.7 of HBp
as per details given below or as applied by the firm, whichever is less:
Export product
Exp.
Qtv.
SI.No.
lmport items
Qty.
AIlowedkoノko
HYDROXY
CHLOROQUINE
SULPHATE
l kg
Acetobutyrolactone(ABL)
1.4538
2.
2-Ethylamino-Ethanol(Mono
Ethyl Ethanolamine)
1.8463
3.
Ethoxy Methylene Malonic
Acid Ester I EMME ]
1.1481
4.
Metachloro Aniline
0.6756
5.
S.B. Toluene
1.6799
6.
Methanol
3.48
7.
Iso Propyl Alcohol
1.49
8.
Methylene Chloride ( Methylene
DiChloride )
5.18
may take appropriate action as per the decisioffi
3製、′N:Ry^L KUMAR
ICase No.:71/9/82¨
## Case No.:83/9/82‐ALC4/2014
ALC4/2014
22.12.2014
45
PVT.LTD.,
File
10785955
1.2015
10785911
「
## Case No.:74′9/82¨
ALC4/2014
Paty Name:BLISS GVS
Meet No/Date:14/82‐
ALC4/2014
Re-lndexed
22.12.2014
RLA File
Lic.No/Date:0310786144 1Defer
:03/94/040/00277/Aヽ/115/ 127.06.2014
Date:22.01.2015
@ioair"ith"cas"for22.0|.20l5forcommentsofDepartmentofPharmaceuticals.
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
HQ File
RLA File
Lic.No/Date:0910060550 1Defer
:01l82l050l01317lAMl51 1:091241040100175/AMl5/
127.06.2014
Date:22.01.2015
: It was decided to defer the case for 22.01.20 I 5 for comments of Department of
ticals.
No/Date:14/82‐
:Deffered
ALC4/2014
and Re-indexed
HQ File
:01/82/050/00870/Aヽ/115/
22.12.2014 1
Lic.No/Dttα0310786181 5etr
:03/94/040/00755/AM14/ 130.06.2014
Date:22.01.2015
'20l5sforcommentsofPetrochemicalsDivisionof
of Chemicals and Petrochemicals.
Meet No/Date:14/82-
IALC4/2014
122.12.2014
HQ File
:01/82/050/00612/Aヽ江15/
:It was decided to deferthe case for 22.01.2015 for comments ofI)epartrnent of
Mcet No/Date:14/82‐
Status:Deffered
and Re-indexed
ALC4/2014
■2.2014
RLA File
Defer
Date:22.01.2015
:01/82/050/00860/AM15/ 1:03/94/040/00177/AM15/
:It was decided to defer the case for 22.01.2015 for comments ofDepartment of
ticals.
Meet No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:0310786553
RLA File
HQ File
HQ File
RLA File
:03/94/040/00305/AM15/
Defer
Date:22.01.2015
評百理製暮
R牲飾:蠣
奮羅鐵齢襲鰤
Ъi畷鴬y
I量曇鰭雹籠
r憂]I揚蕊漱
:梶
聰
3:軋響
Te
製鷲黒蘇発い
Trade
碑
## Case No.:69/4/82¨
ALC4/2014
Party Name:RA CHEM
Status:Deffered
and Re-indexed
## Case No.:73/9/82-
Paty Name:D.R.COATS
INK&RESINS PVT.LTD.
‐Case No.:210/6/82,
Party Name:WEXFORD
LABORATORIES P LTD
Status:Deffered
Lic.No/Date:0710105465
:07/24/040/00105/AM15/
30.06.2014
## Case No.:63/9/82-
Party Name:CORAL
LABORATORIES LTD.,
Lic.No/Date:0310786480
## Case No.:59/9ノ82-
Party Name:NDO GERMAN
Status:Deffered
ALC4/2014
:01/82/050/00856/Ah江15/
46
108.07.2014
L」預聾濯raII、eW
LTD.
HQ File
LIMITED
Re-indexed
RLA File
Re-lndexed
: It was decided to defer the case for 22.01.2015
for comments of Department of
Pharmaceuticals.
HQ File
:01/82/050/00606/AM15/
Decision : It was decided to defer the case for 22.01.2015 for comments of Department of C&pC.
ALC4/2014
22.12.2014
Lic.No/Date:0510389448 1Defer
08.07.2014
Date:22.01.2015
Deffered
Re-indexed
Pa●y Name:PAYAL
PETROCHEM PRIVATE
LINIIITED
Meet No/Date:14/82-
ALC4/2014
22.12.2014
Ｆ
Ｌ
Ｆ
‐
Decision : It was decided to defer the case for 22.01.2015 for comments of Department of C&pC.
諄鮒…
Decision:Itwasdecidedtodeferthecasefor22.0l.20|5fo'"o,,ffi
Pharmaceuticals.
HQ File
:01/82/050/00823/ANl11 5/
Pary Name:ALMELO PVT
LTD
ヽ/1cet No/Date:14/82-
Status:Deffered
and Re-indexed
Defer
Date:22.01.2015
…
8P"]ヽ′N:Pヽパハ!レてヽ・14｀lR
―
¬
`1「
・bミ受■l,i,(t tl ■lfЧR
Dy欄鼎
囀
de
紺臨輩累瀧F:ilき11盤:
u駅兜肌謀棘
:h
ision : It was decided to defer the case for 22.01.2015 for comments of Department of C&pC.
Mcet No/Date:14/82‐
RLA File
:03/95/040/00302/AM15/
Lic.No/Date:0310786782
14.07.2014
:It was decided to deferthe case for 22.01.2015 for comments ofI〕epartment of
|:SI〕):50/00905/ANI11 5/ 1:」Lち帰liO/00083/AM14/
B諸ち知洲
5
## Case No.:204/6/82‐
ALC4/2014
Paty Name:PAYAL
PETROCHEM PRIVATE
Status:Deffered
:05/24/040/00192/Aヽ114/
## Case No.:211/6/82‐
ALC4/2014
## Case No.:64/9/82‐
## Case No.:26/9/82¨
ALC4/2014
ALC4/2014
22.12.2014
:09/24/040/00188/AM15/
Case No。388/9/82‐
ALC4/2014
ParサName:MAC CHEM
PRODUCTS(INDIA)
PRIVATE LIMITED
Status:Deffered
ALC4/2014
22.12.2014
:01/82/050/00885/ANI11 5/
‐
## Case No.:108/9/82¨
ALC4/2014
Status:Deffered
ALC4/2014
22.12.2014
47
No/Date:14/82‐
Re-indexed
Re-indexed
File
10786631
199/AM15/ 109.o7.2014
Name:NECTAR
No/Date:14/82‐
LINIIITED,
Re-indexed
File
10389447
1/82/050/00613/AR415/
191/AM14/
Name:IPCA
TORIES LINIIITED
10060660
Re-indexed
File
Ｆ
Ｌ
ド
ー
## Case No.:87/9/82‐
IALC4/2014
Pharmaceuticals.
HQ File
:01/82/050/00403/Aヽ415/
HQ File
:01/82/050/00876/Aヽだ15/
HQ File
HQ File
:01/82/050/00821/AM15/
ParッName:UNIJULES LIFE
SCIENCES LTD.
ヽ4eet No/Date:14/82-
Status:Deffered
ALC4/2014
and Re-indexed
Meet No/Date:14/82-
ALC4/2014
122.12.2014
Lに。No/Dttα 04101590211Detr
18.07.2014
:22.01.2015
18.07.2014
Date:22.12.2014
22.12.2014
122.12.2014
:It was decided to defer the case for 22.01.2015 for comments ofIDepartment of
sefor22.0l.20l5forcommentSofDepartmentofC&PC.
Pamy
Mcet No/Date:14/82-
Natte:METROPOLITAN IALC4/2014
EXIIИ CI‐IEM LTD.
22.12.2014
Lic.No/Date:0310787073 1Defer
RLA File
:04/24/040/00061/Aヽ415/
RLA File
:03/95/040/00337/AM15/
LTD.,
RLA File
:09/24/040/00104/AM15/
霊繭諏:脳E匿き淵d鵜か
Ｆ
Ｌ
Ｆ
Ｉ
:It was decided to defer the case for 22.01.2015 for comments ofDepartment ofC&PC.
Mect No/Date:14/82¨
tatus:Deffered
ALC4/2014
Re-indexed
22.12.2014
RLA File
Lic.No/Date:0310787172 1Defer
1/82/050/00895/AM15/
Date:22.01.2015
:It was decided to defer the case for 22.01.2015 for comments ofI)epartment of
Pharmaceuticals.
ParサName:BIOLOGICAL E
LTD
HQ File
:01/82/050/00815/Aヽ/115/
RLA File
Lic.No/Date : 09 1 0060702 lDefer
:09/24/040/00197/AM15/ p2.07.2014
Date:22.01.2015
‐
―
―
―
―
:It was decided to defer the case for 22.01.2015 for comments ofI〕
epartment ofB10technology.
~~ onllnents ofDepartment of
:It was decided to deferthe case for 22.01.2015 for c(
Date:22.01.2015
## Case No.:1/6/82‐ ALC4/2014
CHEMICALS PVT.LTD。
,
## Case No.:79ノ9/82-
Status:Deffered
ALC4/2014
## Case No.:98ノ9/82‐
Party Name:AGIO
PHARMACEUTICALS LTD
‐Case No.:18/9/82-
ヽ4eet No/Date:14/82‐
Status:Deffered
ALC4/2014
22.12.2014
‐
## Case No.:24/9ノ82¨
Status:Deffered
LicoNo/Date:0910060703
Date:22.01.201
Re-indexed
Re-indexed
File
1/82/050/00884/AM15/
AM15/ 115.07.2014
Name:ARJUN
Re-indexed
Re-indexed
|
Pharlnacettcふ
ICase No.:25/9/82¨
IALC4/2014
Pa●y Name:DIVIS
PHARNIACEUTICALS
PRIVATE LIMITED
RLA File
:09/24/040/00194/AM15/ 122.07.2014
Pa●y Name:PACE
PHARNIATECH PVT.LTD.
RLA File
:03/95/040/00347/AM15/
RLA File
:22/24/040/00033/ANI11 5/
Meet No/Date:14/82‐
ALC4/2014
22.12.2014
ic.No/Date:0310787160
2.07.2014
tus:Deffered
Re‐indexed
Defer
Date:22.01.2015
Defer
Date:22.01.2015
Status:Deffered
Date:22.01.2015
ゝ江eet No/Date:14/82‐
:01/82/050/00822/AM15/
## Case No.:78/9/82‐
ALC4/2014
:01/82/050/00875/AM15/
ion : It was decided to defer the case for 22.01.2015 for comments of Department of
## Case No.:107ノ9/82…
IALC4/2014
ParりName:IND― SWIFT
LABORATORIES LTD.,
ALC4/2014
22.12.2014
:01/82/050/00904/AM15/
Lic.No/Date:2210015039
23.07.2014
Decision: It was decided to defer the case for 22.01.2015 for comments of
Pharmaceuticals.
Department of
Ｆ
Ｉ
Ｌ
Ｆ
Ｉ
Ｉ
Ｆ
Ｌ
Ｆ
Ｉ
## Case No. : 1 0 0 I 9 182- ALC 4 l20l 4
| Party Name : INDOCO
Meet No/Date:14/82‐
REMEDIES LINIIITED
ALC4/2014
: Committee considered the case as per agenda and in consultation with technical
present in meeting decided to ratify norms under paru 4.7 of HBP as per SION A412
2olo wastage.
concerned may take further necessary action as per above decision of NC.
Meet No/Date:14/82‐
ALC4/2014
22.12.2014
Lic.No/Date:0310787378
128.07.2014
Date:22.01.2015
122.12.2014
## Case No.:7/6/82-ALC4/2014
Party Name:AARTI DRUGS
LIMITED
″資謎胤f/9/82
Deffered
Re-indexed
Meet No/Date:14/82-
IALC4/2014
File
Re-lndexed
Re-indexed
1器疏
5υ00897/AMy 所念臆
No/Date:14/82-
Re‐lndexed
Name:ALCHYMARS
SM PRIVATE
lLrrralreo
HQ File
Lic.No/Date:0410159110 Defer
:0U821050100845/AMlsl l:0aD4rc40rc0062lAMl5/ lZt.Ol.ZOt+
icals.
Party Name:CHEMCON
ヽ4eet No/1Date:14/82-
Status:Deffered
and Re-indexed
PaJりName:V&V PHARMA
INDUSTRIES
122.12.2 ()14 1
ヽ4eet No/Date:14/82-
ALC4/2014
Meet No/1Date:14/82‐
ALC4/2014
ヽ江eet No/Date:14/82‐
ALC4/2014
22.12.2014
:22.01.2015
Date:22.01.2015
Status:Deffered
:22.01.2015
Status:Deffered
and Re-indexed
T鵬
島児5υ∞授9触Ⅲダ
障ち臆
υ剛
"ハ
剛ダ 1孵
器
副
∞鵜
“
6B寛
ち2混2鋭4
SPECIALITY CHEMICALS iALC4I2OI 4
22.12.2014
: It was decided to defer the case for 22.01.2015 for comments of Department of C&PC.
22.12.2014
Defer
Date:ZZ.12.2014
Decision : It was decided to defer the case for 22-01.2015 for comments of Department of
Mcet No/Date:14/82‐
ALC4/2014
22.12.2014
HQ File
Lic.No/Date:0410159122 1Defer
:01/82/050/00827/AM15/ :04/24/040/00033/AM15/
30.07.2014
Date:22.01.2015
:it *as decided to defer the case for 22.01.2015 for comments of Department of Pharmaceuticals'
22.12.2014
HQ File
Lic.No/Date:0910060790 1Defer
:01/82/050/00817/AM15/ 1:09/24/040/00202/AM15/
01.08.2014
: It was decided to defer the case for 22.01.201 5 for comments of Department of
ticals.
Patty Name:AUROBINDO
PHARNIA LIMITED
Pa」けName:G AMPHRAY
LABORATORIES,
ision : It was decided to defer the case for 22.01.2015 for comments of Department of
肌
／
## Case No.:32/9/82‐
IALC4/2014
## Case No.:8/6/82-ALC4/2014
Status:Deffered
and Re-indexed
Lic.No/Date:0310787382
28.07.2014
## Case No.:30/9ノ82‐
ALC4/2014
HEALTH CARE PVT.LTD.,
## Case No.:20/9/82-
Status:Deffered
Pharmaceuticals.
ヘ
Name:SOFTGEL
Re-indexed
File
Re‐lndexed
No.:58/9/82-
Re-indexed
File
71/AM15/
No.:49l9/82-
lPafi Name:SANMAR lMeet No/Date:14182-
50
|
lLuranro,
鵬
児50/00譴σ劇
Ⅳ
膨
臆
υ剛鰤AMダ
ロ¶ 鼎
α餌Ⅲ59125
2.01.2015
lDecision: Itwasdecidedtodeferthecase for22.OL2015 forcommentsof Departmentof C&PC.
ParサName:SHASUN
PHARNIIACEUTICALS
LIMITED
RLA File
:04/24/040/00117/AM15/
Ⅳlect No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:0410159129
01.08.2014
|
1234
: ln the light of written comments received from Department of Pharmaceuticals vide their OM
lo. 35011/359/2013-Pl(Norms) dated 11.09.2013, it was decided to ratify norms under Para 4.7 of HBP
1 as per details given below or as applied by the firm, whichever is less:
AROXETINE TABLETS
concerned may take further necessary action as per above decision of NC
## Case No.:31/9/82-
ALC4/2014
19RGANICSPVT.LTD.
RLA File
Lic.No/Date:03107876101Defer
:0U82t050t00828/AMl5/ i:03t94t040tooo74tAMtst lo+.ot.zor+
Date:22.01.2015
Decision : It was decided to defer the case for 22.01.2015 for comments of Department of C&PC.
Status:Deffered
and Re-indexed
Pharmaceuticals.
ParサName:COVALENT IMectNo/Date:14/82‐
LABORATORIES PRIVATE IALC4/2014
LIMITED
HQ File
RLA File
Lic.No/Date:0910060793
:01/82/050/00812/AM15/ 1:09/24/040/00203/AM15/ 104.08.2014
: It was decided to defer the case for 22.01.201 5 for comments of Department of
戸 1蹴器酬Я∞“
"6開蕊蔦
Defer
Date:22.01.2015
'日
蔵F3■ド′N:RMALレ(UMハR
ぃЧ ¬副fデ拳“TFヽ｀ .T
lzz.tz.zot+
## Case No.:29/9/82‐ALC4/2014
:01/82/050/00826/AR415/
For export of 1 MillionTablets
PAROXETINE HCL
Status:Deffered
## Case No.:10/6/82‐
## Case No.:15/9/82‐
Status:Deffered
51
Name:AMBERNATH
No/Date:14/82-
14
File
Name:COVALENT
No/1Date:14/82-
TORIES PRIVATE
Re-indexed
Re¨lndexed
S.NO.
lmport ltems
Ｓ
堕
Ｔ
ａ
ｂ
ｉ
ｅ
ｔ
範
ｍ
Ｓ
鉤
Ｔ
ａ
ｂ
‐
ｅ
ｔ
1
11.10
22.20
33.30
## Case No.:14/9/82‐
ALC4/2014
Party Name:GLAND
PIIARMA LIMITED
Mcet No/Date:14/82-
Status:Deffered
ALC4/2014
‐22.12.2014
5 batches.The case was defelTed for 22.01.2015
Party Name:INTAS
Mect No/Date:14/82-
pHenUecEUTICALS lALC4lzDt4
ision:It Was decided to defer the case for 22.01.2015 for comments OfDepartment of
Pharmaceuticals.
## Case No.:12ノ6/82‐
ALC4/2014
HQ File
:01/82/050/00824/AM15/
Party Name:ANUPAM
RASAYAN(INDIA)LTD
ParサName:GRANULES
INDIA LINIIITED
Par[ Name:MANGALAM
諄鮒酬秘
and Re-indexed
Defer
Date122.01.2015
Deffered
Re-indexed
町
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
鯖
晰醐静
Status:Deffered
## Case No.:44/9ノ82‐
ALC4/2014
## Case No.:27/9/82‐ALC4/2014
O".irio, :ln the light of earlier decisio
consultation with technical authority p
HBP as per details below or as applie
n taken I
resent ir
d by firm需臨盟著Л∫棚棚ξ
ttβ踏脚
l whlcheveris 10Weri―
・
ｌ
ｎ
ｏ
ｆ
lmport items
Qtv.
allowed
Export product
ExpOrt
Cゝtv
SI.No.
Gemfibrozil
0.707 kg
…
GEM 70
(GemttbrOZil Granules
DC 70%)
l Kg.
2.
Maize Starch
0.1485 kg
3.
Povidone K-30
0.0270 kg
4
SoOium Starch Glycollate
0.030 kg
5.
Sodium Lauryl SutPhate
o.00150 kg
6.
Starch Pregelatinised
0.083 kg
7.
Stea面c Acid
0.0100 kg
concerned may take further necessary action as per above decision of NC'
Mcet No/Date:14/82‐
匪FtteN∵1輩:土II
DRUGS&ORGANICS
Ｆ
Ｌ
Ｆ
Ｉ
Re-indexed
LTD.,
12.2014
器耽5υ0084ソAMlダ 跳ち洲
:αom77AMly
~ ents ofDepartment ofC&PC.
:It was decided to deferthe case for 22.01.2015 for conlln
Ir.rurreo
:03/95/040/00344/Aヽ115/
:01/82/050/00891/AM15/
lzz.tz.zot+
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
RLA File
:22/24/040/00035/AM15/
Decision:It was decided to deferthe case for 22.01.2015 for conlments ofDepartment of
Pharmaceuticals.
Meet No/Date:14/82-
ALC4/2014
22.12.2014
Lic.No/Date:3410040436 1Defer
HQ File
:01/82/050/00850/ARだ15/
HQ File
Pharmaceuticals.
RLA File
:34/24/040/00111/AM15/
Paty Name:RANBAXY
LABORATORIES LTD
RLA File
ParサName:SENTISS
PHARMA PVT.LTD.
11.08.2014
Meet No/Date:14/82-
ALC4/2014
22.12.2014
NIteet No/Date:14/82-
ALC4/2014
Defer Date:
Date:22.01.2015
Defer
Date:22.01.2015
Defer
Date:22.01.2015
l3t"t*b;ff"""d
land Re-indexed
,tt *ur decided to defer the case for 22.01.2015 for comments of Department of C&PC.
PattName:YAS面0~~~~輌
面雨面五百扇薫
22.12.2014
irir, ; ii *ur decided to defer the case for 22.01.2015 for comments of Department of
Pharmaceuticals.
ｎ
／
Lic.No/Date:0310787716
06.08.2014
Decision :ln the light of earlier decision taken by NC in its 7/82 meeting dated 27.06.2013 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
Expo Qtv.
SI.No.
lmport items
Qtv. allowed
Lumefantrine
lkg
1
2,7-Dichloro― A―{Dibutylamino)
Methyl-9H―Fluorene-4-Methanol
(DBA)
0.974 kg
2.
4-Chlrorobenzadehyde
0.3478 kg
## Case No.:105/9/82¨
ALC4/2014
Pa●y Name:SCOT「¨EDIL
PHARMACIA LTD.,
:01/82/050/00902/Aヽ415/
LicoNo/Date:2210015058
07.08.2014
Date:22.01.2015
## Case No.:53/9/82¨
Parly Name:ONEIRO
Status:Deffered
CHEMICALS LTD
and Re-indexed
## Case No.:8/9/82-ALC4/2014
Status:Deffered
Lic.No/Date:0510390250
## Case No.:7/9/82-ALC4/2014
Status:Deffered
F丁|
INDUSTRIES PVT.LTD. :ALC4/2014
Re-indexed
Re-indexed
:It was decided to deferthe case for 22.01.2015 for comments ofIDepartment of
File
1/82/050/00804/AM15/
13/AM15/
ll.08.2014
|
鵬
掲剛∞
"0晨
my脇
監
υ∞綱2晨Ⅲy H悧
鼎
α
“
Ю 賀
"Ю B鳶ち2m2鋭
5
ision : It was decided to defer the case for 22.01.2015 for comments of Department of C&PC.
## Case No.:23/9/82-
Party Name:BIO-TECH
ⅣIcet No/Date:14/82-
Status:Deffered
ALC4/2014
OPHTHALⅣIICS PVT.LTD。,lALC4/2014
and Re-indexed
22.12.2014
: It was decided to defer the case for 22.01-2015 for comments of Department of
icals.
## Case No.:50/9/82…
Party Name:CAPLIN POINT
Meet No/Date:14/82‐
ALC4/2014
LABORATORIES LTD。,
ALC4/2014
22.12.2014
NIleet No/Date:14/82‐
ALC4/2014
22.12.2014
HQ File
Lic.No/Date:1310047575 1Defer
:01/82/050/00818/AM15/ :13/24/040/00020/AM15/ 112.08.2014
Date:22.01.2015
Decision : It was decided to defer the case for 22.01.20 1 5 for comments of Department of C&pC. -
NIteet No/Date:14/82‐
ALC4/2014
,2.12.2014
HQ File
:01/82/050/00825/Aヽだ15/
RLA File
:04/24/040/00123/AM15/
Lic.No/Date:0410159219
13.08.2014
Defer Date:
: It was decided to reject the case as the firm has not furnished information despite repeated
:ision : It was decided to reject the case as the firm has not furnished information despite repeated
inders.
Ｆ
Ｌ
暫
―
ICaseNo.:51/9/82‐
ALC4/2014 1:illl!ll霊
[:吉lLlls
FN画
面
硫
1僻
霊躙
S臓
鮒
d他~F嚇
1器晶児59Ю0848ハMlダ
障危刷iα00鯰″AMly
鵬:∬盤γ
α04m59220PetrDttα
lzz.tz.zott
Status:Deffered
and Re-indexed
Lic.No/Date:0410159215
12.08.2014
Date:22.01.2015
## Case No.:21/9/82-
ALC4/2014
ParサName:PIINDUSTRIES
LTD。,
Status:Deffered
and Re-indexed
## Case No.:28/9/82‐ALC4/2014
Parly Name:SHASUN
西
I Case No. :4 6tg 182- ALC4/2014 lParty Name:ADCOCK
lMeet No/Date:14182-
Ｆ
Ｌ
Ｆ
Ｉ
鵬晶児5υ∞
"0ハ
Ⅲy
膨
臆υ叩7銀剛y l撚
鼎
α∝嘘
%5
File
AM15/
File
54
INGRAM LTD,
鵬鴛 Pご
Lic.No/Date:0710106458
19.08.2014
r : ln the light of earlier decision taken by NC in its 30182 meeting dated 07.02.2OL3, it was
to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,
er is less:
Export product
Exp.
Qty.
SI.No.
Import items
Qty. allowed
Norflex 100 mg
tablets (Orphenadrine
100 mg+ Lactose 167
mg_Aerosol 200-8
mg Ethyl Cellulose
20 mg)
1
tablet
1
Orphenadrine Citrate
BP/EP/USP/PHoEUR
102.0 mg
2.
Lactose USP/NF/BP/EP/PH.
EUR
167.0 mg
3.
Aerosol BP/EP/USP/PH.EUR
8.O nlg
4.
EhtyI Cellulosc N 100-
BP/EP/USP/Ph.EUR
20.0 mg
## Case No.:61/9/82-
ALC4/2014
Pa●y Name:CONCORD
BIOTECH LTD
I
IRA may take appropriate action as per the decision of Norms Committee.
Lic.No/Date:0810133062 1Defer
:01/82/050/00858/AM15/ 1:08/24/040/00186/AM15/
20.08.2014
Pharmaceuticals.
LicoNo/Date10510390634 1Defer
21.08.2014 1Date:22.01.2015
Decision : [t was decided to defer the case for 22.01.2015 for comments of Department of
Pharmaceuticals.
Date:22.01.2015
ParりName:RANBAXY
LABORATORIES LTD
R4eet No/Date:14/82‐
ALC4/2014
‐22.12.2014
: It was decided to defer the case for 22.01 .201 5 for comments of Department of
ff.a E-.Tr</NIRMAL KUMAR
sq ffiqsro
E-qvr aqrqrq
Ov. Direaor General o, Foreign Trad€
'fritcr qrqrq q-ErF-<{nd-q
Dirbit6rate General of For€ign Trad€
qlpfq BtqFVoepartment of co'rimerco
e;€irrl t{'q=T. q-€ frft,fi
Uavog Bhawan, New Delhi
Status:Deffered
ALC4/2014
22.12.2014
## Case No.:37ノ9/82-
ALC4/2014
## Case No.:41/9/82…
Status:Deffered
55
File
1/82/050/00843/AM15/
No/Date:14/82-
Re-indexed
File
NamelJAGSONPAL
No/Date:14/82-
LTD.
4
111)i3:児50/00834/AM15/
Re-indexed
Re-indexed
17/AM15/ 121
## Case No.:52/9/82‐
ALC4/2014
ParけName:UNILINK
PHARMA PVT LTD
'571職晶掲5υ00849ハⅢダ
障危臆υOm H/AM15/際悧器
α04Ⅲ59266B鳶
ち2∝2創5
Status:Deffered
and Re-indexed
!4!qJ.yurtvt
9u
nd Re-indexed
Ｆ
購
Ｆ
‐
: It was decided to defer the case for 22.01.201 5 for comments of Department of
ticals.
hだect No/Date:14/82-
DIATUS:UEII
Re-indexed
Name : INDOPHYTOCHEM I ALC4 I2o 1 4
PHARMACEUTTCALS lZZ.tZ.ZOru
RLA File
Lic.No/Date:0510390704 1Defer
:0U82/050t00835/AMl5 I
l:05t23tO4OtOO2OgtAMt5t lzz.oe.zo4
Date:22.01.2015
HQ File
Pharmaceuticals.
22.12.2014
Decision : It was decided to defer the case for 22.0L2015 for comments oiO"pu.t.*t of
Pharmaceuticals.
ParサNameiCADILA
HEALTHCARE LTD.,
Paty Name:CADILA
HEALTHCARE LTD.,
Meet No/Date:14/82‐
Status:Deffered
ALC4/2014
and Re-indexed
Defer
Date:22.01.2015
Mcet No/Date:14/82-
Status:Deffered
and Re-indexed
ALC4/2014
Defer
Date:22.01.2015
Ｆ
Ｌ
Ｆ
‐
器3月5υ∞
83晨Ⅲy 所需蕊藤蔦¬淵鼎α∝“"6
22.12.2014
ision:It was decided to deferthe case for 22.01.2015 for conllnents ofDepartment of
ParサName:KARNATAKA
ANTIBIOTICS&
PHARMACEUTICALS
:22t24t040/00048/AM1st lzs.ot.zot+
: It was decided to defer the case for 22.0r.2015 for comments ;aD"prrt."rt "f
ruticals.
Ｆ
Ｌ
Ｆ
‐
:It was decided to defer the case for 22.01.2015 for conllnents OfDeparment OfPhallllaceuticals.
NIleet No/Date:14/82-
Status:Deffered
nd Re-indexed
RLA File
Defer
Date:22.01.201
ALC4/2014
22.12.2014
## Case No.:38ノ9/82‐
ALC4/2014
## Case No.:35/9/82¨
ALC4/2014
## Case No.:36/9/82‐
IALC4/2014
## Case No.:89/9/82‐
IALC4/2014
Meet No/Date:14/82-
:01/82/050/00886/AM15/
## Case No.:109ノ9/82-
IALC4/2014
ParサName:VENUS
REMEDIES LTD.,
ALC4/2014
22.12.2014
:01/82/050/00906/AM15/
UdyOg
No/Date:14/82-
111)13:):50/00832/AM15/ 1::'I;:i
4
File
」
一
」
Ａ
Ｆ
ｉ
‐
ｅ
## Case No.:42/9/82‐
ALC4/2014
Ｆ
Ｌ
Ｆ
Ｉ
Ｄ
Ｔ
Ｌ
Ｓ
Ｃ
Ａ
Ｄ
‐
Ｌ
Ａ
Ｅ
Ｕ
Ｔ
‐
Ｃ
Ａ
Ｌ
α
〈
じ
¨
¨
Ｐ
Ｐ
２
ｒ
２
畿
山
Ｄ
Ｄ
3103
.01.2015
ALC4/2014
22.12.2014
:01/82/050/00842/Aヽ/115/
Pharmaceuticals.
Paty Name:COVALENT
LABORATORIES PRIVATE
LIMITED
NIteet No/Date:14/82‐
:ln the !ight of earlier decision taken by NC in its 20/82 meeting dated 16.01.2014′
it was
to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,
is less:
Mcet No/Date:14/82-
ALC4/2014
22.12.2014
RLA File
:05/23/040/00221/ANI11 5/
Lic.No/Date:0510390763
26.08.2014
: ln the light of earlier decision taken by NC in its 18/82 meeting dated L9.t2.2O13, it was
to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,
Paty Name:DHANUKA
LABORATORIES LTD.
阻
Status:Deffered
## Case No.:45/9/82-
Party Name:CONCORD
B10TECH LTD
Status:Deffered
and Re-indexed
may take appropriate action as per the decision of Norms Committee
## Case No.:1/7/82‐ ALC4/2014
ALC4/2014
22.12.2014
Lic.No/Date:0910060890
26.08.2014
Export product
Exp.
Qty.
S:.No.
lmport items
Qty. allowed
ke/ke
Ihioester
(g
1.
ethy卜(Z)‐ 2‐hydroxylanlino‐ 2‐(2‐
aminthiazole-4‐ y)acetate
(EHATA)
1.155
2.
Methylene Chloride
1.94
3.
Acetone
1.94
4.
Triphenyl Phosphine
0.60
5。
MBTS
1.157
## Case No.:84/9/82‐A]LC4/2014
町
Peお
r Date:
ichever is less:
Re-indexed
File
File
1/82/050/00839/ANI11 5/
97/AM15/
No/Date:14/82¨
File
AM15/
4 1Date:22.01.2015
1/AM15/
Export product
Exp.
Qty.
SI.No.
lmport items
Qty.a:10Wed
kg/kg
Ceflxime USP/1P/BP
くg
1.
7-Phenylacetamideo‐3-
ChloromethyI Cephalosporanic
Acid Para Methoxy Benzyl Ester
(GCLE)
1.555
2.
ACETONE
1.18
3.
Dichloromethane
4.98
4.
METHANOL
6.16
5.
ACTⅣATED CARBON
0.100
6.
MICA ESTER
1.112
ICase No.:2/7/82‐ALC4/2014
may take appropriate action as per the decision of Norms Committee
122.12.2014
RLA File
:09/24/040/00263/AM15/
Lic.No/Date:0910060892 1Defer
:01/82/050/00646/AM15/
Date:22.01.2015
Pharmaceuticals.
NIleet No/Date:14/82‐
ALC4/2014
22.12.2014
Re-indexed
RLA File
:05/24/040/00203/Ahだ15/
Lic.No/Date:0510390783 1Defer
:01/82/050/00840/AM15/
27.08.2014
Date:22.01.2015
ヽ4cet No/Date:14/82-
ALC4/2014
22.12.2014
Status:Deffered
and Re-indexed
ParサName:DR REDDYS
Meet No/Date:14/82-
Status:Deffered
ALC4/2014
Defer
Date:22.01.2015
Status:Deffered
and Re-indexed
%9鵬
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"""
ision : It was decided to defer the case for 22.01.2015 for comments of Department of
## Case No.:76/9/82‐
Party Name:KLJ
ⅣIcet No/Date:14/82-
ALC4/2014
22.12.2014
ALC4/2014
PLASTICIZERS LTD.,
: It was decided to defer the case for 22.01.2015 for comments of Department of C&PC.
## Case No.:43/9/82…
Pa●y Name:SARV BIO
LABS PVT.LTD.,
## Case No.:60/9/82¨
ALC4/2014
Patty Name:JUBILANT
6o人p∩
Re‐ lndexed
File
Ｆ
Ｌ
ド
ー
1/82/050/00873/Aヽだ15/
Defer
Date:22.01.2015
４
／
８
２
．
一
的
帥
一
側
4/2014
Decnslon
Ｆ
Ｌ
Ｆ
‐
Ｆ
ト
ト
ー
:It was decided to deferthe case for 22.01.2015 for comments ofDepartrnent ofC&PC.
lf謎胤fF渇
2‐
[撚軸寧
O
RLA File
:08/24/040/00177/AM15/
HQ File
:01/82/050/00649/Aゝ415/
Decision : :Committee consider the case as per agenda and in consultation with technical authority
present in the meeting , it was decided to ratify norms under Para 4.7 of HBP v1 as per SION with l%
wastage as per details given below or as applied by the firm, whichever is less:-
Export product
恥
Ｑ
ｔ
ｖ
．
Ｌ
ｏ
Ｓ
Ｎ
lmport items
Qty. allowed
PARACETAMOL DIRECT
COMPRESSABLE GRADE
CONTAINING90%
PARACETAMOL
l kg
PARACETAMOL
POWDER DRUG
0.909 kg/kg
concerned may take further necessary action as per above decisi
necessary
decision of NC.
Status:Deffered
ALC4/2014
22.12.2014
Lic.No/Date:0810133217
03.09.2014
and Re-indexed
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器計闘寵庸稲「1恕需糞
ud霊兜臨話誡
:‖
Name:S V CHEM
TES P LTD
4
Re-indexed
12.2014
No/Date:14/82‐
Date:
No.:75/9/82-
Name:NEUTEC
No/1Date:14/82-
THCARE(P)
Re-indexed
12.2014
10390973
.2015
:It was decided to deferthe case fbr 22.01.2015 for comments ofI)epartment of
No.:55/9/82¨
Name:CONCORD
No/Date:14/82-
LTD
12.2014
10133285
10.09.2014
1.2015
:It was decided tO deferthe case fbr 22.01.2015 for comments ofI〕epartment of
59
decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,
whichever is less:
Export product
Exp.
Otv.
Sl.No.
Import items
Qty. allowed
G-
tr
Misoprostol Tablets
l kg
2.
Misoprostol
鮒ょ甲200T
concerned may take further necessary action aS per above decision of NC.
276
3"*W
P".tyN"."AIJROBNDO il\'l""tNuD"t-t+'8} gt"
lprmnva LIMITED ltLc4tzot4
lApr
I
122.t2.2014
I
HaFtre
@Per
o1/82/Oso/00798/AMl5/ l:09l24l0a0l00329lAMtsl 129.09.2014
i
No. 3501 ll283l2}l4-Pl(Norms) dated October 2014, it was decided to ratiff the norms under Pa
FIBP vl as per details given below or as applied by the firm, whichever is less:
tus:
proved
br Date:
h.ir OM
ra 4.7 of
Export product
Export Qty.
Sl.No.
lmport items
Qtv.
allowed
ke/ke
RAMIPRIL
l Kg.
1.
(S,S,S)- 2- Azabicy clo(3,3,0)-
Octane-Carboxylic Acid
Bezylester HCL ( BAOCH
Intermediate )
0.83
2.
1,3-Dicyclo Hexyl Carbodiimide
0.858
3.
Activated Carbon)
0.054
4.
ECPP-Alanine ( 1 -N-(S)-
Ethoxycarbonyl-3 -Phenyl-Propyl-
L-Alanine)
0.98
5.
Triethylamine
0。767
6.
Di Isopropyl Ether (Iso Propyl
Ether)
2.62
7.
Methanol (Methyl Alcohol)
3.32
8.
NItethylene Chloride
1.65
## Case No.:2/9/82-ALC4/2014
Party Name:PERKIN
LABORATORIES
:09/24/040/00358/Aヽ415/
Ｆ
Ｌ
Ｆ
Ｉ
Mcet No/Date:14/82‐
ALC4/2014
22.12.2014
;It rlllas decided to defer the case for 22.01.2015 for comments of Department of
Deffered
Re-indexed
S.
60
雪署尋1lil■f lr_11,
…
【r'I堅デ1ヽ,1
6謁i温}幌λゴ亀J奮■iお
de
臨
諒記霜事空
of COminerce
:瀬弱I醜ふ誡
1雨
## Case No.:5/9/82-ALC4/2014
一
８
Ｆ
Ｉ
Ｌ
Ｆ
Ｉ
‐
Mcet No/Date:14/82‐
ALC4/2014
22.12.2014
h4eet No/Date:14/82‐
ALC4/2014
Pharmaceuticals.
Status:Deffered
and Re-indexed
Defer
Date:ZZ.01.2015
Deffered
and Re-indexed
Defer
Date:22.01.2015
## Case No.:103/9/82‐
ALC4/2014
Party Name:NEULAND
LABORATORIES LTD
22.12.2014
ICase No.:104/9/82¨
IALC4/2014
ParサName:NEULAND
LABORATORIES LTD
Status:Deffered
ALC4/2014
22.12.2014
:01/82/050/00901/AM15/
1鷺角鵬υ
00m9/AMy
ruticals.
Meet No/]Date:14/82-
HQ File
:01/82/050/00908/AM15/
RLA File
:09/24/040/00346/AA415/
to defer the case for 22.01.2015 for comments of Department of
: It was decided
uticals.
No/Date:14/82-
ALC4/2014
.12.2014
用れ
)
吼
醍響懸
:l章|ご:#」
電螂掛瓶よ
哺
慧
:i聯
般崚ゴ尋旨謝号
融職
臨
Lic.No/Date:0910061076
10.10.2014
## Case No.:111/9/82‐
ALC4/2014
Paty Name:HttTERO LABS
Status:Deffered
Date:22.01.2015
ALC4/2014
22.12.2014
Lic.No/Date:0910061084
13.10.2014
## Case No.:113/9/82‐
ALC4/2014
PaゥName:ASTRIX
LABORATORIES LTD.,
:01/82/050/0091o/AM15/
Status:Deffered
and Re‐indexed
Date:22.01.2015
υ喘′
L趣編冬
Name:HETERO
LIⅣIITED
File
060
AⅣl15/
.10.2014
10061074
.10.2014
No/Date:14/82‐
Re-indexed
File
File
0061093
5/
15.10.2014
.2015
: It was decided to defer the case
for
Re-indexed
1.2015
Re-indexed
comments of Department of
22.01.2015 fOr
No.:114/9/82¨
Name:HONOUR LAB
No/Date:14182-
14
12.2014
ittdeCiddb“ bぬette b″吻5bc
10.2014
ICase No.:115ノ9/82‐
IALC4/2014
ド5
陽分臆0/00374/AMy冊酬
%00611り
ParサName:NAGAⅢUNA
AGRICHEM LTD
HQ File
RLA File
Lic.No/Date:0910061106
16.10.2014
:01/82/050/00912/AM15/ 1:09/24/040/00376/AM15/
: It was decided to defer the case for 22.01.20 I 5 for comments of Department of
icals.
Party Name:INCHEM
Mcet No/Date:14/82-
LABORATORIES PRIVATE IALC4/2014
22.12.2014
Decision:It was decided to defer the case for 22.01.2015 for comments ofIDepartment of
Pharmaceuticals.
Mcet No/Date:14/82‐
ALC4/2014
22.12.2014
Lic.No/Date:0910061139
27.10.2014
:It was decided to defer the case for 22.01.2015 for cominents ofDepartment of
話ζ
Defer
Date:22.01.2015
fer
Date:22.01.2015
Date:18.12.2014
Place:New Delhi
Nillュニal Kumar
Dy.Director General ofForeign Trade
ALC4/2014
22.12.2014
町悪鸞I
|
iCase No.:117ノ9/82-
ALC4/2014
Status:Deffered
## Case No.:83/10ノ82‐
ALC4/2014
62
No/Date:14/82‐
Re-indexed
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