DGFT Committee Minutes
Document text
t
Government of India
Ministry of Commerce and Industry
Directorate General of Foreign Trade
Maulana Azad Road, New Delhi 110011
Norms Committee-III
Para4.7 Decision
Meeting No. 13 & l4 of Agenda No.llr82/ of 2017-18 dated 24.01.2018 (actually held on 19.04.2018 and
20.04.2018) considered the cases/issues rrnder Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy,
2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the
Chairmanship of ShriJ.V. Patil, Addl. DGFT in Room No.l1, Udyog Bhawan, New Delhi.
Following members were present:-
Shri Nirmal Kumar, Dy. Director General of Foreign Trade
Consultant, Technical expert Pharmaceuticals
Consultant, Technical expert Chemicals
The committee went through the minutes of earlier meeting No. l0/82 dated 10.01.2018 actually held on
03.04.2018 and 12.04.201.2018 and approved the same.
Note:
In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations /
Deficiencies received from the concet'ned 't'echnical authorily in the same case or a dffirent case of another
firm with the same product. A scanned copl' of such document is placed at the end of the Minutes. In some cases,
the scanned copy uploaded may be un.signcd. In both these instances, the scanned copy uploaded is to be
accepted. The Committee does not approve ,SCOMET items and all applicants are understood.
11/82¨ ALC4/2017ルlEETING DATE:24.01.2018
MEETING NUⅣlBER
|ICase No.:60/17/82-
ALC4/2016
1山
0 1ile
ll:01/82/050/01021/AM17/
1‐ Decision:Deferred
Status:Deferred
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Case No.:40/1/82‐ ALC4/2017 Palty Name:ONEIRO
CHEMICALS LTD
脇嗣ぼ~珈
Approved
124.01.2018
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:Decision:Commi"ee considered case as per agenda and deliberated on the matter in the presence of thel
technical expens and l was decided lo ratitt the ad¨ hOc input output norms under para 4.7 of HBP as peri
2 details bclow or as applied by flrm wllicllcveris lower:
ParりNalnelMYLAN IMeet No/Date:H/82‐
ILABORATORIES LIMITED:ALC4/2017
鴨鍬
0鳳I鳥葛
~継
驀
面血5945[温
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―
― ――一 ― : | 4,5,6,7‐ Tetrahydro (3,2‐C)ThiOnO Pyridine Hcl. IRA concemed may take further necessar/ action as per above decision of NC. Export product Exp. Oty. Sl.No. Import items Otv. allowed ke/ke 2125.000 Kg Thiophene -2 Ethvlarnine 0.87 kg つ ４ Methanol 1.49 kg Methyene Chloride 079k負
「1姉 面 面 高1而 | iHa F,l. l:0 t I 821 050 I 0028 8/AM I 5/ 2 PrりNamelNEW ALLIANCE DYE―CHEM PVT.LTD., Meet No/Date:11/82¨ ALC4/2017 24012018 Lic.No/Date:0310766431 16012014 Status: Approved 乱 'お お:ざhil ee meetingl hichever is l Decision : Committee considered the case as per agenda and in consultation with technical authority in meeting, it was decided to ratiflz norrns as per the earlier decision taken in norms committee No.13/82 held on 03.10.2013 under para 4.7 of HBP as per details below or as applied by firm whic lower:- Export product Exp Qty. SI.No. lmport items Qty.allowed kg/kg EDTA FERR!C SODi∪M Fe content 13%(+/‐ 0.5) l kg 1 ETHYLENE DIAN41NE TETRA ACETIC ACID 0.730 kg RA may take approprlate action as per the decision of Norms Committee Fe岬 r麟К 4可 HQ File :01/82/050/00966/AM17/ 聞 い.耐 ~ : 1腑 Mcet No/Date:11/82‐ AlンC4/2017 24012018 Status: Deferred Lic No/Date:2610012456 1Defer 27 02 2014 1Date:05.06。2018 ― | 「震胤ノα &‐ 丁臨 翌S 離静 16′Dtteli/82-~~~IstatI:lDeferredl 2017 1 : 「 ~…… F… ルν…ル ・レ, I捕「猫 tノ | 5■ =■ ― =11… …二 一二ヽ………、__ _― ‐一― 「
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おじ星児
59/09718/AM18/ 1跳ち刷
:0/00016ハM15/ 1星:どg品讐α
22100149098i龍
15.06.20181
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lDecision : Deferred
luq rile
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Lic.r\-olDati,ZZtOOtqgog roere.
t1:0'lls2/050/00718/AMl8/ t:22t24t040t00016/AMl5/ ,zs.os.20tq
6u,.,0,
Mcet No/Date:l1/82-
Status:Deferred l
ALC4/2017
24.01.2018
HQ File
i01/82/050/00702/AM15/
瓢IRL薦
~
,Decision : Deferred
|
IMcet No/Date:11/82¨
IA lンC4/2017
24012018
Lic No/Date10310787982 1Defer l
12 08 2014 1Date:05.06。
20181
Status: Deferred
,
一
６
面1吻
|
「振霊淵
4/13/82‐ ~丁
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I t:01/821050t0t217/AM15t l:$/94t}4ot}o386tAM15/
1ffi
IRLA File
i:03/95/040/00805/AM14/
IL′ ic No/Date:0910060258
‐28052014
IDefer l
‐Date:05.06。20181
ICase No.:42/15/82‐
ALC4/2014
Partv Name:PVS AGRO VET
IRLA File
:09/24/040/00246/AM15/
IHQ File
101/82/050/01329/Aν l15/
Lic.No/Date:0910061105
16.10.2014
oecision r iornrnitt"" considered case as o*;t.;A;a a.iiu.*i.a
.technical experts and it was decided to ratif,i the ad-hoc input output
,details below or as applied by firm whichever is lower:
on the matter in the presence of the
norms under para 4.7 of HBP as per
Export
product
Exp.
Oty
Sl.No.
Import items
Qty. allowed
1
AGROMOX―CSD
Asper DML
Kg
1
Toltrazuril
As applied
2
AGROFLOR‐ 100
Asper DML
litre
つ
‘
Doxycycline
As applied
AGROFLOR‐ 200
Asper DML
4
AGRO‐ DOX―TT
Asper DML
K3
Florfenicol
As applied
5
AGRO‐DOX―G
Asper DML
Kg
6
AGRO¨ DOX‐N
Asper DML
Kg
4
Diclazuril
As applied
TIACARE‐ 10
Asper DML
Kg
AGROTRIM-25
Asper DML
Kg.
Tiamulin Hydrogen
Fumarate
As applied
9
ACEPINE-75
Asper DM L
Kg
10
AGROLI‐ 10
Po、vder
Asper DML
Kg
6
Diclazuril
As applied
11
AGROCLAZ
Liquid
Asper DML
Amoxycillin
Trihydrate
As applied
AGROMOX‐50
Asper DML
Kg
AGROMOX‐20
As per DⅣlL
Kg
Tiamulin Hydrogen
Fumarate
As applied
14
AGROMOX‐C
Asper DML
Kg
AGROTART‐
62.5
As per DⅣlL
Kg
9
Tvlosin Tartrate
As applied
3
No/Date:11/82‐
16
AGROTIL‐ L
Asper DML
litre
AGROTIL WSP
As per DⅣIL
kg
10
cephalexin
monohydrate
As applied
LESSCOX-25
Asper DML
19
LESSCOX‐ 5.0
As per DⅣlL
litre
11
Colistin sulphate
As applied
RA concerned may take further necessary action as per above decision of NC
necessary
爾百馬蔦■由ERS
per
::01/82/050/01114/AM15/
PHARMACEUTICALS PVT
LTD
翻蕊勇扁
翻予品∵品高
卜
F斜鸞ぎお而動驚臨島
:11
IDecislon:Deferred
―
‐
…一
―
一
ヽ
一
一
―
―
一
一
一
_―
__…
_―
―
-1
:LTD
ヽMeet No/Date:11/82-
IALC4/2017
124012018
IRLA File l ILic Nルbittbrbj"bli Defer~ ‐
::05/23/040/00360/AM15/
)14.11.2014
10392011 1Defer
IDate:05。06.2018:
IMe`i｀8'biお:il滝,1~~ISIlil::b`felttL I
IALC4/2017 1
12401 2018 1
‐
廿ぢ鼎α“Ю助“雌L5Ю6珈
Case No。:111/13/82‐
ALC4/2014
01/82/050/01352/AM15/
Decision : Deferred
１
１
Decisio■ : COmmittee considered case as per agenda and delibcrated
に
d expeis and h was decHed tO ratしth`ad」i語1
iStatus:
Approved
L on the matter in ttre fiesence of ttre
norms under para 4.7 of HBp as per l
■■■να■しAPolし。01lu lL WOS uCclaca lo ratily tne ad― hoc input output
il,be10W Or as applied by f1111l whichever is 10wcri
4
|
iCase No。:65/15/82¨
IALC4/2014
lStatus: Deferred
IDecision:Deferred
File
Export product
Exp. Qty.
Sl.No.
Import items
Oty.allowed
(卜PHENYLMETHYL)‐ lH―
INDENO[2,卜b〕PYRIDINE‐
6-CARBONITRILE
l Kg
1
TRIS(DIBENZYLIDENE
ACETONE)
DIPALLADIUM(0)
0 075 kgkg
IRA concemcd may take further necessal・)I actiOn as per above decision ofNC
## Case No.:149/5/82-ALC4/2015
Party Name:ALCHEMIE
ILABORATORIES
IMeet No/Date:H/82-
lALC4/2017
P4.91.2018
『
匡
14
FA Ftt.-
inr-r iire
諸ざ鼎α∝Ю"%"
:01/82/050/00289/AM16/
:03/94/040/00813/AM15/
Decision : Committee considered the case as per agenda and in consultation with technical authority present
in meeting, it was decided to ratifl nonns as per the earlier decision taken in norms committee meeting
No.7/82heldon l3.05.2008underpara.1.7of HBPasperdetailsbeloworasappliedbyhrmwhicheveris
llower:-
RA concerned may take furlher necessary action as per above decision of NC.
Export product
Export
Qty.
Sl.No.
Import items
Qty. allowed per
unit of export
product
N-Ethyl Ortho Toluidine
l Kg
l
Ortho Toluidine
0.932kノkg
つ
４
Denatured Ethyl Alcohol
0460kノkg
|
.Case No.:112/5/82-
ALC4/2015
15白。lilc
:01/82/050/00252/AM16/
Decision: Deferred
Pa“y Nanle:lJNIMAX
ICHEMICALS PVT LTD.
1孵… ‐ 1
RLA File
:03/95/040/00812/AM15/
ILic No/Date:0310793039 1Defer
‐
19.01 2015 1Date:05.06.20181
16
ICase No.:88/5/82-
‐ALC4/2015
HQ Filc
:01/82/050/00228/AM16/
Decisio■: Deferred
## Case No.:91/7/82-
lALC4/2015
Party Name:ABEERS
PHARMACEUTICALS PVT
LTD
RLA Filc
:05/23/040/00486/AM15/
諄鮒
d虚‐
ILic.No/Date:0510392949
121.01.2015
Istatus:Deferred
:Defer
iDate:05.06.2018‐
IPalty NanleiSHME GANESH
IREMEDIES PVT.LTD
IRLA Filc
HQ File
101/82/050/00696/AM16/
Decision: Deferred
:34/24/040/00295/AM15/
ICase No.:61/17/82‐
ALC4/2016
ParりNanleiMYLAN
ILABORATORIES LIMITED
|
IMcet No/Date:11/82‐
ALC4/2017
12401.2018
冨1
Status:Deferred l
な減[iiti:|
5
,HQ File
IRLA File ~
l
1:09 124 I 040 I 00607/AM I 5/
2602.2015
Lic No/Date:0910061652 1Defer
Date:05.06.2018
:01/82/050/01022/AM17/
il;r'i;;,- D"i;;;;;
「
,Decision : Deferred
ICase No.:72/4/82‐
IALC4/2015
1器3児5υOm HttMl″
瓢
鳳鳳
Meet No/Date:H/82‐ IStatus:Deferred l
ALC4/2017
124.012018 '
ILic No/Date:0910061664 1Defer
04032015
IDate:05.06.2018
Status:Deferred l
|
ICase No.:447/5/82‐
lALC4/2015
HQ File
:01/82/050/00587/AM16/
Pa=y Name:AARTI
INDUSTRIES LIMITED
Mcet No/Datc:11/82-
ALC4/2017
24.01.2018
L′ ic.No/Datei0310794543 1Defer l
1203.2015 Date:05.06。20181
IDecision:Deferred
1群脚"脱‐
1 1
孵
話が
Mcct No/Dateil 1/82‐ Status:Deferred
ALC4/2017
24012018 1
Defer
l
Date:05.06.2018
21
~開
麒ち扁
Lic No/Date:0310794612
1603.2015
IHQ File
:01/82/050/00711/AM16/
―
一
Decision : Deferred
1猥薔槻∬″
8年
12機■
『
―……
| :01/82/050/00104ハM16/
Paty NameiMYLAN
ILABORATORIES LIMITED
McetNo/Date:l1182- Status:Deferred
ALC4/2017 1
24.01.2018 1
Liciヽ3/D派雨死面石面r5藁
「
―一―一
31032015
IDate:05.06.201
1曰鳳扁
一
８
一
:Decision:Deferred
甲動…
Mcet No/Dateil 1/82‐ status:Deferred l
ALC4/2017
2401.2018 ‐ |
Lic.ヽも
,5読もうOibb`182f Deふ… … 1
3103.2015 1Date:05.0`.20181
:~い面高面百~~~隔
ぃ温Ъ■iNS~~~~~McまNoあ滉よ丁iた,~itti:5`僣Fたこ
| ド
LC4/2015 1BЮ
PRODUCTSLTD。,
針:〃鶴7 1
141隧、葛I 漁
:λttj鳳瀞~協
策赫
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||
IPaty Name:NATIONAL
iTUBE INDUSTRIES,
Mcet No/Datell
A LC4/2017
2401.2018
1/82- status:Deferred
6
lru-n ptte
l iCase No。:73/4/82‐
1 1ALC4/2015
卜01/82/050/00H2/AM16/
iDecision : Deferred
HQ File
:01/82/050/00734/AM16/
Decision : Deferred
| ICase No.:97/8/82- ‐Pally Nallle:ASCENT
' IALC4/2015 FIN ECHEM PVT.LTD.,
Mcet No/Date:11/82‐
ALC4/2017
IRLA File
:01/82/050/00893/AM16/
Decision:Deferred
:08/24/040/00051/AM 16/
## Case No.: ll0l1l82-
Partr Narne:RISHABH
RLA Filc
:03/95/040/00073/AM16/
ILic.No/Date:0310795930,Defer
l14.05.2015 :Date:05。
06。2018
261。
File
Lic.No/Date:0810135338
22.05.2015
IALC4/2015
IMETALS&CHEMICALS
PVT LTD
巨Q File ~~~~~~~匡A由だ
Lic.No/Datci03 10796383
:01/82/050/00715/AM16/ :03195/040/00051/AM16/ 103.06.2015 1
27‐ beciti。1:ёommiice toAζ iderea casc as per agenda and deliberated on thc matter in the prescnce ofthe
technical representative of Departrnent of Industrial Policy & Promotion (DIPP, Chemical) and it was
decided to allow the ad-hoc input output norms in respect of import item at serial No. I to 5 as applied and
import item at serial no 6 is deleted / not allowed
I lnn concerned may take further necessarv action as per above decision of NC.
「
28 uq nit.
ALC4/2015
ICase No.:17/7/82-
Pany Na11leiSUN
PHARMACEUTICAL
INDUSTRIES LTD,
IMeet No/Date:11/82‐
IALC4/2017
124.01.2018
:01/82/050/00622/AM16/
'Decision : Deferred
RLA F‖ e
105/24/040/00078/AM16/
ICase No。:60/4/82‐
‐ALC4/2016
Paltv Nanle:ADCOCK
INGRAM LTD,
Mcet No/Dtte:l1/82-
ALC4/2017
.01.2018
29
IHQ File
:01/82/050/00123/AM17/
RLA F‖ e
:07/24/040/00071/AM16/
:Lic.No/Date:0710108351
110.06.2015
124.01.2018
111
:
一
J
Decision : Deferred
‐ ICase No.:24/13/82-
IALC4/2016
30青。「ilさ
Party Na11le:ARENE LIFE
SCIENCES LIMITED.
:01/82/050/00652/AM17/
RLA File
109/24/040/00034/AM16/
Decision : Deferred
J
1壼調需よ
ii′ 82‐
:ド
:」tiまbι“
rita
12401.2018 1
1
臨
嘉y
:O1/82/050/01529/AM16/ :24/24/040/00007/AM16/
Decision : Deferred
|
7
IDefer l
:Date:05,06。20181
卜4eet No/1Date:11/82-
lALC4/2017
124.01.2018
lstatus:
lApproved
iStatus:Deferred
|
|
IDate:05,06.2018
諄蝋7酬繋ず…綺К
d
ILiも1ヽも
'5it81601o6`う
i`ζ
15きfef
10.062015
lDate:05.06.2018
I
ICase No。:48/19/82‐
IALC4/2015
Partv NanleiRA」
‐DHANVANTRY
PHARMACY
31 hOFil`
1眠霊
=胤
/13/82‐
,32l" lrro pi
IHQ File
1 1:0ル82/050/01004/AM16/
IRLA File
l:03/94/040/00H1/AM16/
Lic.No/Date:0310796667
1606.2015
IStatus:Deferred
lDefer l
:Date:24.01.20181
8
~臨
獅霊総驚雷
「
監き漱需
il 1/8'―
ILTD.
24012018
'
rDecision : deferred
Mcct No/Date:11/82- Status:Deferred l
ALC4/2017 1 1
2401.2018 1 1
Lic.Nルbiま061003818ダ5嘉i~~~~~
1:0118210501008461AM't6l l:06DafiaU00014lAM16/
0907.2015
IDate:24.01.2018
Bttbn:dettrred Commhee conddered tte case ttd tt was d``語
き品而面蔽燕面comments of~
1姉
T乱
7TT品
由dbGICALE ttr磁
獅脇高蔦i「~I蹴
:1庶:蕊1戸
1需需
b蒟“磁メ
:status:
Approved
1i
lDecision : ln the light of earlier decision taken by NC in its 2/82 meeting Zg.O4.2OtS, it was decided to
lratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is
i
i I ess:
I
134
Item of Export
Quantity
S.No.
Item of lmport
Quantity
allowed per
million vials
DTP―HEPB‐ HIB
(PENTAVALENT
VACCINE)FULLY
LIQUID
COMBINATION
VACCINE SINGLE
DOSE VIAL,
PEDIATRIC DOSE
DIPHTHERIA,
TETANUS
PERTUSSIS,
HEPATITIS B
RECOMBINANT AND
HAEMOPHILUS
INFLUENZA TYPE B
(HIB)COMBINED
VACCINE WITH
VACCINE VIAL
MONITOR(VVM)
lm‖ ‖on
Vials
1
POLYETHYLENE GLYCOL
6000(MACROGOL)
76 848 kg
AEROSIL 380V(COLLIDAL
ANH SILICA BP)
20.375 kg
3.
GLYCEROL
122 841 1tr
4
TWEEN-20(POLYSORBATE
20)
7.685 1tr
Ｃ
υ
POTASSIUM THYOCYNATE
169.742 gms
6
TRIS BUFFER
10.216 kg
7
ALUMINIUM CHLORIDE 6
HYDRATE EXTRA
27.665 kg
8
YEAST EXTRACT
22 447 kg
9
DEXTROSE(GLUCOSE)
35 937 kg
10
L―CYSTINE
0.437 kg
BACTO CASAMINO ACID
31.758 kg
THIOMERSOL
0.379 kg
13
SILICON EMULSION
16.5 kg
14
ADIPIC DI}IYDRAZIDE
(ADH)
1 686 kg
N‐3-
DIMETHYLAMINOPROPYL―
N‐ETHYLCARBODIMIDE
HCL(EDC)
167 545 gm
2-(N―MORPl10LINO)
ETHANE SULFONIC ACID
1.441 kg
(MES)
17
CETAVLON
1537 gm
18
ALUMINIUM PHOSPHATE
GEL 2%(ADJU.PHOS2%)
76.991 kg
19
L‐TYROSINE
0.7841 kg
20
NZ CASE TT(CASEIN
PEPTONE PLUS)
39.12 kg
VITAMIN Bl HCL
(THIAMINE
HYDROCHLORIDE)
1.14 gm
GLASS VIALS
1100000 nos
23
RUBBER STOPPERS
1095638 nos
24
ALUMINIUM CAPS/SEALS
1088334 nos
HEATMARKER VACCINE
VIAL MONITOR(VVM
LABELS)
1086508 nos
26
SHIPPING INDICATORS(Q
TAG 2 PLUS)
902 nos
FILTERS&FILTER AIDS
250 nos.
RA may take appropriate action as per the decision of Norms Committee
faseNo59/14/82‐
ALC4/2015{響
ヽlneBI° LOGICAL Ё
~1需
》メ|「
l1/82‐ ~~11:iれ
島
責
Q liた RLA li13~… ……~ 百お
:ヽ。
/5猛86うi5oわ蕊
「
「~~~ ~
101/82/050/01195/AM16/ 1:09/24/040/00525/AM15/ 115.07.2015 1
1Decision:in the light of earlier decision taken by NC in ts 2/82 meeting 29.04.2015′
■was decided to
lratify norms under Para 4.7 of HBP vl as per detal:sg市
en below or as applied by the nrm′ whicheveris
less:
Item of Export
Quantity
S.No.
Item of lmport
Quantity allowed
per million vials
DTP‐ HEPB―HIB
(PENTAVALENT
VACCINE)FULLY
LIQUID
COMBANITA10N
VACCINE 10 DOSE
VIAL PEDIATRIC
DOSE DIPHTHERIA,
TETANUS,
PERTUSSIS,
HEPATITIS B
RECOMBINANT AND
HAEMOPHILLUS
INFLUENZA TYPE B
(HIB)COMBINED
VACCINE WITH
VACCINE VIAL
MONITOR(VVM)
lm‖ 1lon
∨ials
1
POLYETHYLENE GLYCOL
6000(MACROGOL)
768.48 kg
2
AEROSIL 380 V(COLLIDAL
ANH SILICA)
203.75 kg
GLYCEROL
1228.41!tr
4.
TWEEN‐ 20
(POLYSORBATE)
76.58:tr.
POTASSIUM THYOCYNATE
1697.42 gms
6.
TRIS BUFFER
102.16 kg
7
ALUMINIUM CHLORIDE 6
HYDRATE EXTRA
276.65 kg
8
YEAST EXTRACT
224.47 kg
9
DEXTROSE(GLUCOSE)
359.37 kg
10
L―CYSTINE
4.37 kg
TH10MERSOL
3.79 kg
12
ADIPIC DIHYDRAZIDE
(ADH)
16.86 kg
N‐ 3‐
DIMETHYLAMINOPROPYL―
N ETHYLCARBODIMIDE
HCL(EDC)
1675.45 gm
9
10
SILICON EMULSION
2‐(N‐MORPHOLINO)
ETHANE SULFONIC ACID
14 41 kg
ALUMINIUM PHOSPHATE
GEL 2%
NZ CASE TT(CASEIN
PEPTONE PLUS
391.2 kg
VITABIN BI HCL
(THIAMINE
HYDROCHl,ORIDE
GLASS VIALS SILCONISED
5ML
RUBBER STOPPERS
ALUMINIUM CAPS/SEALS
HEATMARKER VACCINE
VIAL MONITOR LABELS
VVM LABELS
SHIPPING INDICATORS
AG 2 PLUS
FILTERS&FILTER AIDS
BACTO CASAMINO ACID
may take appropriate action as per the decision of Norms Committee.
謳ご湿嵩ざM'LAN~ ~~Meよヽレbiよii滝ダ
ILABORATORIES LIMITED ALC4/2017
,Status: Deferred
Date:24.Ol.2018
I
z4.ol.2ol8
IRLA File Lic No/Date:0910062338:Defer
1/82/050/01340/AM16/
i:09/24/040/00032/AM16/ 15072015
MectNo/Date:]t1182-,status:Deferred
r
|
37「両て
FF百3~~~~~~~~~
IRLA File
Lic No/Date:0310797355 1Defer
17 07 2015 1Date:24.01.2018
t:011821050100985/AMl6/ t:03t94t040t0O282tAMt6t
iDecision : deferred
NTA
鷲
認
需
面
y~田
面DeferredI
124.012018 1 :
―
‐麟もヽ0/D駐
`蔦
10,976ガ1蘭島7~~~…
:
| 101/82/050/01078/AM16/ 1:03/94/040/00038/AM16/ 24072015
| lb`とiζ iもI:18fer「
`む
胚
瓶
Ｆ
一
Case No。:22/13/82-
ALC4/2015
臨
:訃
~
1
ALC4/2017
24012018
IDate:24.01.2018
Mも∝No51ttl1/82-~statu赫
こ
|
ALC4/2017 1 1
24.012018 1 :
Lic.No/Date:0s I 0395 I 02 iDefer
28072015
I)ate:24012018
14
16500k只
16
CETAVLON
15.369 kR
17
769.91 kg
18
L―TYROSINE
7.81 kg
19
20
11.45 gm
1100000 nos
1085430 nos
1076890 nos
24
1100000 nos
1790 nos
26
2500 nos.
27
317.58 kg
iCase No.:20/16/82‐
lALC4/2015
,Decision : deferred
11
## Case No.:127/13/82‐
ALC4/2015
辮ぷ藉:1孵ryIF赫
|
“器既11ふ:巖語」1協璃篤1品二II I
"“
iζion f‐deferred~~~~~~~~一一―
一 |
## Case No.:34/14/82¨
ALC4/2015
Palty Na11lc:TRANSPEK
INDUSTRY LIMITED
‐ALC4/2017
12401.2018
|
41
HQ File
RLA File
ILiciNo/Diよjイloo41464「
~~¨
:01/82/050/01170/AM16/
34t24to4otoot44tAMt6t jiz.os.zor s
I
Decision : Committee considered case as per agenda and deliberated on the matter in tfr. p[r.n.t;i ih;
'technical experts and it was decided to ratifu the ad-hoc input output norms under para4.7 of HBP os p€r:
tdetails below or as applied by firm whichever is lower:
I
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed ke/ke
ISOPHTHALOYL
CHLORIDE/TEREPHTHALO
YL CHLORIDE MIXTURE
(93%/7%)
L kg
1.
ISOPHTHALIC ACID
0 845 kg
IRA may take appropriate action as per the decision of Norms Committee.
ICase No.:126/13/82¨
IALC4/2015
12鵠轟月
::篤れ
;I話:~胤tili1/蕊鳥1鳳;
‐一
―
― ―
一―
―
―
:
Pal‐ 1、Nanlc:ASTEC
LIFESCIENCES LTD.,
IMeet No/Date:H/82‐
IALC4/2017
,4.01.2018
U週雨3b岳3…
sti苗::Б[ferLa
l l
l l
PO.08.2015
1.2018 I
___*l
I
IDecお
lon:deferred
凛
__ __一
―
―
一
―
―
一
―
一
―
一
―
一
―
一
―
一
―
一
―
一
―
一
一
|
:絣
赫
多
審
需濡
=~1熙
占
1/82‐
洋
品
1
`1協諾蕊1扁
~胤ち漏脇0囲ハⅢα
l覆驚鼎… 9面B為4回
1
1Decision:deferredCommittee considered the case
l
lDBT
l食癬析が Rぼ1詰船温: 難調需而下汗蒜b漢満
:
ALC4/2016 1NDUSTRIES LIMITI
器3掲5υ0029VAM17
雌
λ』::OЮ 0424/AM
Decision : deferred
:
Date:24.01.2018
## Case No.:157/14/82‐
ALC4/2015
Party Name:AETHER
INDUSTRIES LIMITED
IMcet No/Date:11/82-
:ALC4/2017
F面
蔦而通群Ldi
45
‐Mcet No/Date:H/82‐ IStatus:
Approved
::01/82/050/01293/AM16/
12
24.01.2018
Lic No/Date:5210041630
10.09.2015
: |
'Defer l
lDatei24.01.20181
1 lCase No.:118/14/82¨ ,ParサNameiSHAStlN
Meet No/Date:11/82‐ Status:Deferred
ALC4/2017 1
24012018 1
rDefer
I
,Date.24.01.20 I 8
蹴
蕊辮
Lic No/Date:0410161045
2209.2015
tDecision : deferred
147
:
|
iCase No.:79/14/82‐
IALC4/2015
嚇
:ABEERS
il¥舎
RMACEUTICALS PVT
IHQ File
101/82/050/01215/AM16/
RLA File
::05/23/040/00274/AM16/
30.092015
MeetNoiDate:l1182- iStatus:Deferred
AL´C4/2017
24.01.2018
Lic No/Date:0510395773 1Defer
IDate:24.01.2018.
lDecision : deferred
## Case No.:164/14/82‐
ALC4/2015
Party Name:AASHA
BIOCHEM
Meet No/Date:H/82‐
ALC4/2017
2401.2018
Status:
Deferred
IHQ File
i:01/82/050/01300/AM16/
Lic No/Date:1010059293 1Defcr l
12.10.2015 1Date:2401.20181
―
|
:Case N∝771α跡
Meet No/Date:11/82‐
ALC4/2017
2401.2018
諄Q FHe ~~lRLA RL
1ンic No/Date:0310799561 ‐Defer
|:01/82/050/01397/AM16/ 1:03/95/040/00481/AM16/
20.10 2015 1Date:24.01.20181
19:
1 lALC4/2015
:Decision:deferred
'Status: Deferred
|
1 lCase No.:116/13/82‐
| IALC4/2016
:Ю
蕊瀞
~
Party Name:SOFTGEL
HEALTH CARE PVT.LTD.,
Meet No/Date:11/82‐ Status:Deferred l
ALC4/2017 1 :
24.012018 1 1
Lic No/Date:0410161132 1Defer
20 10.2015 ,Date124.01.2018
:跳ち刷iO/00143/AM16/
1 洒き
cおion:committee considUred the case ind iwas decided t6とも｀r iIど
`鳳
もforЪ6品話BIt 615百十
「
[蕊
蒲FF~~
鷲:N/82-~~平
面5面
サ
:018 1 :
『1瓢高詰~翻
鬼
1蕊綜
~甘
漱赫0062831紘蕊
1 拝【IIIIIr二-11111111lIIrilrilt「
1-1 1 1 ~~~~ ‐―- 1■‐~~~~~■■―■二f~■~ 1 ■ 「
‐~ ~~■ ~~~~ ‐
■
「
F面
蔽覇而π 賣覇面
Party Name:AIMSIMPEX
PVT.LTD.,
i isQ rite
1跳ち刷
iOЮ0042ハMlα
lParty Name:LACTOSE
t(rNDrA) LTD.,
i
;RLA File
IMeet No/Date:11/82‐
.ALC4/2017
24.01.2018
1澪:I:ted
13
HQ File
101/82/050/01587/AM16/
RLA File
:03/94/040/00656/AM16/
け∬鼎α“Ю
"T“
Decision : Committee considered case as per agenda and deliberated on the matter in the presence
under para 4.7 of HBP
Itechnical experts and it was decided to ratify the ad-hoc input output norms
details below or as applied by firm rvhichever is lower:
53 1110 Fi18 ~ ~
‐ |:01/82/050/01776/AM16/
IRLA File
:03/95/040/00632/AM16/
IRA may take appropriate action as per the decision of Norms Committee
## Case No.:2/1/82-ALC1/2016 Pariv Name:UNI」
ULES LIFE
SCIENCES LTD.
IMも
`:ヽ
6′ bitもliiた2‐~ ‐
な
IItuξ:Defelred i
l針∬獄V l l
靡評策τ
6n面0416BttI託∴
|
Export Product
Export
Quantity
S No
lmport Product
Quantity
Allowed kelke
ISOPHTHALOYL
3HLORIDE/TEREPHTHALOYl
OHLORIDE MIXTURE
(93%/7%)
l kg
ISOPHTHALIC ACID
0.845 kg
Decision : deferred
541責。lli8
## Case No.:5/1/82-ALC1/2016 Partv NallleiNEOGEN
CHEMICALS LlMITED
1卿面
7~Feferred
瞬霊PT∞剛睡14m2詳:
:01/82/050/01779/AM16/ :03′ 95/040/00239/AM15/
1Decision:deferred
## Case No.:36/19/82-
ALC4/2015
551責
O Fi18
101/82/050/01517/AM16/
Deferred for want of conrments of DBT
IRLA File
Party NameiPANACEA
BI()1‐ EC LTD.,
IRLA File
l:05/24/040/00439/AM16/
IMcet No/Datc:11/82‐
.ALC4/2017
124.01.2018
ILic.No/Date105 10396670
118.12.2015
Decision :
‐
Case No。:2/17/82¨
ALC4/2015
56.HQ File
101/82/050/01462/A～116/
Partv Nal■e:ARENE LIFE
SCIENCES LIMITED.
RLA File
:09′ 24/040/00571/AM16/
IMeet No/Date:H/82¨
IALC4/2017
.2401.2018
:Lic.No/Date:0910063114
10801.2016
攣
善:“
|
| |
雛謳|ム
ICase No.:66/1/82‐
ALC1/2016
571山
0 1ilも
RLA File
103194/040/00831/AM16/
Party NamelBTL EXPORTS
PV′「LTD.,
McetN3'Date:l1/82 1
針∫
1鰍V I
Lic.No/Date:03 | 0801 850 Oefer
r18.01.2016
lDate:24.01.2018
:O1/82/050/01840/AM16/
Decision:deferred
1~cali両面而百
1 1ALC1/2016
||F8
耐
i l:01/82/050/01842/AM16/ 1:03/94/040/00834/AM16/
14
~
罰薮資焉再~
|
Meet No/Date:H/82- Status:Deferred
ALC4/2017 1
24012018 ‐
ILic No/Date:0310801927 1Defer
120.Ol.2016 1Date:2401.2018
Ｆ
Ｉ
lCase No.:17110182-
―
¨
F画面― 下IMeよヽm_I1/82‐
lALC4t20t6
ALC4/2017
24012018
1591IHO Fil●
Status:Deferred
:HQ File
i101/82/0
/82/050/00363/AM17/
ILABORATORIES LTD.,
IRLA File Lic No/Date:2210015407 1Defer l
l:22/24/040/00104/,vl,/ 10102.2016 Date:24.0120181
i101.
IDel
Decision : deferred
IMect No/Date:11/82¨ Istatus:Deferred
lALC4/2017 1
124012018 ‐
ILic No/Date:0310802261 1Defer
160
照正Xl誦ぼ
"" Hq rite
| 101/82/050/01817/AM16/ 1:03/94/040/00882/AM16/
i}s.02.20t6
‐ IDecision:deferred
Date:2401.2018
汗1瓢絆~呻δ
蔽計
rCase No.:26/21/82-
jlarry Name:RoNAK
veet No/Iiat., frzs2_ * - jStutus
irt-ctrzors
lcnenarcnr_S e iitioti'- " "'
iipp.or.o
I
24.01 .20t8
HQ File
RLA Fite
Lic.Noi Date:34 t004 1857
':011821050/01731/AMl6l 1,:341241040100273tAM16t 05.02.20r6
oeclion : otr.t*a committee considered case.a-s p.i ug.nau and cleliberated on the matter in the presence
iof the technical experts and it was decided to ratifi tt " ul-no. input output norms under oara 4.7 of HRp ac. ,
が
典
航ξ高:」艦
淵
島tittW黒
霧Rl稲lmclllp瞑
∞やI Юrms m“ rpara 47 J HBPぉ
|
| |
1 1
Export Product
Export
Quantity
S No
lmport Product
Quantity
A‖ ntA7ndレ0ノL
SODIUM 2‐ ETHYL
HEXONATE
L kg
2-ETHYL HEXONIC
ACID
1.01 kg
iRA may take appropriate action ,r p", t* o".irion of r,lormicoffitte".
胚
Ｉ
Ａ
Ｉ
Ｉ
ase No.:69/1/82‐
[害淵ξ
:り器3
難漱需摘か~1温ζ鵡Ⅲ
2401.2018 ‐
‐
|二十
cN(｀
'51iき
:6bibをb,うOi bきfel
08.02 2016 1Date124.01.2018‐
Status:DeFerred
124012018
Lic.No/Date:0'lo06j,46.bきfer
‐
10022016 ‐Date:24.01.2018
ALC1/2016
に
2揮
Q ΠL
…
…
|:01/82/050/01843/AM16/
|:03/94/040/00922晨M16/
Decision : deferred
## Case No.:79/7/82‐
ICase No.:43/1/82-
ALC1/2016
15
ICase No.:13/10/82‐
IALC4/2016
Palty Name:IND― SWIFT
LABORATORIES LTD,
IALC4/2017
12401.2018
ILic.No/Date:2210015417
117.022016
1511 「
IIモFlll'IE1lF:モri
64 HQ File
:01/82/050/00359/AM17/
RLA File
:22/24/040/00109/AM16/
Date:24.01.2018
Decision : deferred
４
υ
ICase No.:82/7/82‐
IALC4/2016
1HQ File
101/82/050/00256/AM17/
Decislon:deferred
Pa“y Name:OPTIⅣIUS
DRUGS PRIVATE LIMITED
RLA File
109/24/040/00721/AM16/
ILic.No/Date:0910063357 1Defer l
03.03.2016 1Date:24.01.20181
ICase No.:50/2/82‐
IALC4/2016
ParりName:PANERA
B10TEC PVT.LTD
~Mお高硯¨
1辮篤
66 HQ File
101/82/050/00050/AM17/
Decision : deferred for comments of DBT
RLA File
:05/24/040/00597/AM16/
:Lic No/Date:0510397827
104.03.2016
Datei24 01 2018
## Case No.:66/4/82‐
.ALC4/2016
671百01i18
‐
:01/82/050/00129/AM17/
Decision:deferred
Pary Name:STRIDES
SHASUN LIMITED
RLA File
:04/24/040/00257/AM16/
ICase No.:67/4/82‐
:ALC4/2016
68‐ HQ Fii` ~
:01/82/050/00130/AM17/
Party Name:STRIDES
SHASUN LIMITED
RLA File
:04/24/040/00256/AM16/
|::|:|:li::lil::||||llillilil:i:ii~i「
;i:::':::~~~~～―
―
li:iii:i::lil:::li:;i:i:::|::::::|:::|
澁面赫障鶏il
1691
Decision : deferred
ICase No.:55/4/82‐
IALC4/2016
HQ File
:01/82/050/00118/AM17/
Decision:deferred
Patty Name:ENCUBE
ETHiCALS PVT LTD
RLA Filc
:03/94/040/01044/AM16/
ICasc No.:3/2/82‐ ALC4/2016 ‐Party Name:RONAB
CHEMICALS
:01器3児590000ν AM17 )舗
::研Oo,2りA
I IDecision:Committee considered case as per agenc
‐technにd expens and l was decded Ю
rtti～山ea,十
"hPYt°
IPT'PTS'1空I_P賀1″ 工Itt T甲
:
燈棚Ψ tt PttШttbК dl
124.01.2018
16
P面
高
品
而
満
heverI満
i*n
Export Product
Export
Quantity
S No
lmport Product
Quantity
Allowed kelke
30DIUM 2‐ ETHYL
IEXONATE
l kg
2-ETHYL HEXONIC
ACID
1.01 kg
I鵠……鼎」黒4菫摯婆
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed kelke
N―McthyI Piperazine NLT
'9.8%
L kg
N‐Methyl Piperazine
NMT995%
1 02 kg
1 1臨濡蘊辮需
~臨
瀬膏
/82‐
~statuζb蒜ぬ
24012018 1
^ 饉■1■~■■~¨ ~―
――――― ‐― ‐―― ― | _ __
72 1HQ File ~~~~:良LA門iし ~~~~~
,O ν82Ю 50Ю0532/AM17 134ρ 4Ю4υ0029υAMlα
計譜究
1ま
j4ib64'6'i3:[:
燻構鼻認群淋軋稿面淵i器y
~1輛
渕
声
~~輛
漏
・
ARTl~~‐ 臨よヽル5晶hたメ
lζ温k浜薔高
絆LC4/2016 ,NttSTⅢ
ES LI面TED I足
どルお育
ち il籾聯硫雌‐
轟
:
1
量1 1ッ
Z明。 Dttα 2劇.矧8
lStatus:Deferred r
―
―
―
一
―
―
一
―
―
…
… …
…
―
__
I
1甲渕ぼ丁1鰤需攣
IMeet No/Date:H/82‐
:ALC4/2017
12401.2018
lStatus:
lApproved
HQ File
鍮キ角慌OЮm π
ttmα
‐Lic No/Date:3110066051
:01/82/050/00274/AM17/
1403.2016
| IDecおbn:COmmittee cOn雨derea`基ざ驚ぃざ
1竃8面」
:lld ttiお辞
atecl on the matter in the presence Ofthe
111棚異認Tlξ露出胤州枷認i比甘∝h四mtt mms m‐ 釘
a47 J HBPぉ
"r
「~l IF聯
存耐~晋ふ満
鮒1鴛1冊1誌
17
「
…
IHQ File
i01/82/050/00297/AM17/
Decision : deferred
面雨Ъ75猛駈面面雨IDefer
:03/94/040/01038/AM16/
Date:24.012018
## Case No.:45/7/82-
‐ALC4/2016
761南。lli`
:01/82/050/00219/AM17/
Decision:deferred
Partv Name:ASTRAL
STERITECH PVT.LTD.
IRLA Filc
134/24/040/00009/AM17/
ゆ4.01.2018
1Lic.No/Date:3410042064
113.042016
ICase No.:164/10/82‐
‐ALC4/2016
Party Name:GLAND
IPHARMA LIMITED
IMectNo/Date:H/82-
IALC4/2017
,40●2018
Lic.No/Datc:0910063540
122.04.2016
‐77.
//1責
O Fii`
|:01/82/050/00510/AM17/
IDecision:deferred
IRLA Filc
:09/24/040/00767/AM16/
Defer
Date:24.01.2018
ICase No.:7/6/82¨ ALC4/2016 Pattv Nallle:MANGALAM IMeet No/Date:11/82-
| 10RGANICS LIMITED :ALC4/2017
1 (FORMERLY DUJODWALA 124.01.2018
1HQ File lRLA File lLic.No/Date:0310804365
1:01/82/050/00174/AM17/ 1:03/95/040/00013/AM17/ 103.05.2016
Decision : Comminee considered case as per agenda and deliberated on the matter in
Itechnical expefts and it was decided to ratify the ad-hoc input output norms under para
details below or as applied by firm whichever is lower:
IRA may take appropriate action as perthe decision of Norms Committee.
ICase No.:174/10/82¨
:ALC4/2016
ILic.No/Date:0510398377
101/82/050/00520/AM17/ 1:05/23/040/00038/AM17/
04.052016
Decision : deferred
the presence of the
' 4.'7 of HBP as per
」
閉扇蕊萬
II
|
106.04.2016
JI
Defer
Date:24.01.2018
1
Export Product
Export
QuantitY
S.No
lmport Product
Quantity
Allowed ke/ke
DIPENTENE
(M破ture Of Monocylic
Terpenes)
GUM TURPENTINE
OIL
1.05 kg
| ICase No.:181/10/82-
‐ IALC4/2016
80 1HQ Flle
IRLA File
124.01.2018
~~匝
馬扇蘭而而面万
Party Name:ALEMBIC IMeet No/Date:11/82‐
lα :り
1｀
`ι
ll■V・
`■ロロ1●■ν`V `^~~‐
‐~― ―
IPHARMACEUTICALS LTD IALC4/2017
:01/82/050/00527/AM17/ 1:34/24/040/00021/AM17/
05052016
firm Master Batch Formula
一――
-1
178
for each exporl and imPort item.
18
iCase No.:8/7/82‐ ALC4/2016
画
101/82/050/00182/AM17/
IMcct No/Datc:H/82‐
IALC4/2017
12401.2018
Status:Deferred l
l r‐
I IDecislon:deFerred
IRLA Πに
Lic No/Date:0410161871
Defer
Date:24.01.2018
:04/24/040/000091AM 17/
05.05.2016
■8&No/biまii′わ: も
titiζ bttritd
lALC4/2017 1
:24012018 1
1Li`:ヽ3応:お16イ16itijラケlb`fel~ ~ ~
0505.2016 1Date:24012018
IMeぎヽ6,D爵8111′恵
,: iSiltuξ ibtfeir`む
ALC4/2017 1
2401.2018 1
Li`:｀ル5五18ibOib6`b`,315さ各
‐… ‐
17.05.2016 1Date:24.01.2018
11薔胤∬
7解秘
| :
183●。File
1 1:01/82/050/00331/AM17/
iCase No.:86/11/82-
‐ IALC4/2016
:Party Name:ALMELO
IPttVATE LIMITED
:
841 1赫
:RLA File
101/82/050/00620/AM17/ ::o9つ4/040/Ooo56ハM17/
IDecおlon:deFerred ~~
C:ζe Ntti69/10/82:~~1島■、
1品ょЁb二6ё i私LЁ r
iAI′ r4/,olκ lI Tハ
Иeet NO/Date:l1/82- lstatus
IALC4/2016 tT5 ~~~~V~…
~…
し
kl■
11に
J17° Z~ 11::|:ted
=______し、__ 24.01.2018
揮Q tte ~~~~漱■
iお
~~‐~~~‐
‐
品、ル
Datきもす
100ああ|~
■n1/oっ/Aくハ′
^ハ
ξl=′ A■″■″′
〔
「｀‐~ 叫ArHC I甘ごち品を
e:09100636291
1:01/82/050/00515/AM17/ 1:o924/040/00oo7ハ
M17/
扇萬ζF覇蔦墓雨凛覇ier&鵡tak訴5而下さI″ゎ枯ど島古費636Jう6LI「↓薫■1
l"-""'"" ' rrr rrrE rrE'rrt ur edlrrer oeclslon taken by NC in its 11/82 meeting 05.09.2013, it was decided to
iratify norms under Para 4'7 of HBP v1 as per details given below or as applied by the firm, whichever is
; I ess:
Item of Export
Quantity
S′ No
item ofl
Quantity allowed kglke
ADSORBED TETANUS
VACCINE
BP/TETANUS ToxoID
VACCINE
ADSORBED-5ML 10
DOSES
l kg
1
L‐CYSTINE
As per A 2302 of HBp-il
THIOMERSAL
As per A 2302 of HBP_l!
3.
N Z cASE TT―
PEPToNE PLUS)
As per A 2302 of HBP― ll
4
L―TYROSINE
As per A 2302 of HBp-il
ALUMINIUM
CHLORIDE 6
HYDRATE EXTRA
As per A 2302 of HBP_‖
6
SILICON EMUlンS10N
0 043 kg
7
Tzu SODIUM ORE_O
PHOSPHATE
As per/ヽ2302 of HBP_||
8
GLASS vIALS
As per A 2302 of HBP_!|
iCase No.:9/7/82‐ ALC4/2016
|
|
IPatt NameiSTRIDES
SHASUN LIMITED
IRLA File
i:04/24/040/00010/AM17/
甲2面
19
9
RUBBER STOPPERS
As per A 2302 of HBP― ll
10
ALUMINIUM
CAPS/SEALS
As per A 2302 of HBP‐ il
SHIPPING
INDICATORS(Q TAG
2 PLUS)
As per A 2302 of HBP‐ ||
VVM LABELS
(HEATMARICER
VACCINE VIAL
MONITOR LABELS)
10010 Nos.
FILTERS AND FlLTER
AIDS
5 Nos
IRA may take appropriate action as per the decision of Norms Committee
iCase No.:71/17/82‐
‐ALC4/2016
f6■。由
`
| |:01/82/050/01032/AM17/
Palty Nanle:GLOBAL
CALCIUM PRIVATE
LIMITED,
RLA File
107/24/040/00385/AM16/
IMcet No/Date:11/82‐
lALC4/2017
124.01.2018
ILic.No/Date:0710109823
117.05.2016
ドはuttDettred
|
厩蕊ち
:キ:
Decision : deferred
## Case No.:126/10/82-
ALC4/2016
,7品ビ
1 101/82/050/00472/AM17/
Decision : deferred
Patty Namc:BIOLOGICAL E
LTD
RLA Fi!e
:09/24/040/00306/AM15/
IMcet No/Date:11/82‐
IALC4/2017
124.01.2018
ic.No/Datei0910063657
:19.05.2016
瞬LIII:|二
|
## Case No.:149/10/82-
ALC4/2016
Pal■y NanlelBIOLOGICAL E i卜leet No/Datell 1/82-
LTD IALC4/2017
12401.2018
HQ iite
RLA Fi'i; -- -- -
[il.N"lo"t.'oqrooo:osq
I
:0t/82/050/00 4g5lAMr1l :091241040100546lAMl6l :tg.os.zorc
l
rDecision : ln the lieht of earlier decision taken by NC in its 3/82 meeting 08'05.2014, it was decided to
,ratify norms under para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is
188
less:
Item of Export
Quantity
S,No
Item of lmport
Quantity allowed kg/kg
ADSORBED TETANUS
VACCINE
BP/TETANUS TOX01D
VACCINE
ADSORBED-10ML 20
DOSES
l kg
1.
L‐CYSTINE
As per A 2304 of HBP― ll
THIOMERSAL
As per A 2304 of HBP― ||
N Z CASE TT(CASEIN
PEPTONE PLUS)
As per A 2304 of HBP― ll
4.
L―TYROSINE
As per A 2304 of HBP― ll
Ｃ
υ
ALUMINIUM
CHLORIDE 6
HYDRATE EXTRA
As per A 2304 of HBP‐ ll
SILICON EMULS10N
0.043 kg
TRISODIUM ORTHO
PHOSPHATE
As per A 2304 of HBP‐ !l
8
GLASS VIALS
As per A 2304 of HBP― ll
20
9
RUBBER STOPPERS
As per A 2304 of H8P‐ 11
10
ALUMINlUM
CAPS/SEALS
As per A 2304 of HBP‐ ll
SHIPPING
INDICATORS(Q TAG
2 PLUS)
As per A 2304 of HBP― ll
VVM LABELS
(HEATMARKER
VACCINE VIAL
MONITOR LABELS)
5005 Nos.
FILTERS AND FILTER
AIDS
2.5 Nos
IRA may take appropriate action as per the decision of Norms Committee
:「霊ザl甘「M…
IMeet No/Date:H/82‐
:ALC4/2017
12401.2018
Status:Deferred l
ILic No/Date:0910063658 1Defer
19 05 2016 1Date:24.012018
| IDecislon:deferred
iCase No.:102/10/82‐
lALC4/2016
押響皿・
∵
:"寿蝋r…
1血…劇
「
IHQ File
l:01/82/050/00448/AM17/
瓢
蕊
i;I鳳嵩
I‐
~1身
蕊」
RfittibD862慧
,Defer
,Date:24.01.20 I 8
b`[i`i詳長おおiII
IFE蕩評而而
「
~~~
192洋
=夕
「
手
:ソ
Z IIQFile
: |:01/82/050/00458/AM17/
脇
鳳薦′
ILic.No/Datc10510398655
IParty Name:FRESENIUS IMcet No/Date:11/82- Status:Deferred
lKABI ONCOLOGY LIMITED IALC4/2017
124012018 1
12705.2016
IDefer
lDate:24.012018
|IDecision:deferred
ICase No.:129/10/82‐
Decision : committee considered case as per agenda and deliberated on the
l iteChnにd expeis and it was decded to ratitt the ad― hOc mput Output norms
%器3掲50Ю“Ъttm 7~1悩:蕊:Л詳
~~臨
策繭6“輌
:-f
lParty Name:MYLAN iMeet No/Date:lll82-
LABORATORIES LIMITED ALC4I20I7
'li
i24.0t.2018
IStatus:Approved
|
matter in the presence of the ,
under para 4.7 of HBP as per
ils below or as applied by firm whichever is lower:
90 HQ File
File
|:01/82/050/00308/AM17/
|:03/95/040/00069/AM17/
124.05.2016
IMcet No/Date:H/82- Status:Deferred
IALC4/2017 1
12401.2018 1
IDefer
IDate:2401.2018
:Case No。:134/7/82¨
IALC4/2016
怒鑑縦晋
;8祝Tど
FE
I
ｎ
乙
Export Product
Export
Quantity
S.No
lmport Product
Quantity
AIlowed kg/kg
DOLUTEGRAVIR SODIUM
L kg
(3R)‐3‐Amino butan‐
1‐
01
0.445 kg
Acetonitrile
3.33 kg
Amino Acetaldehyde
dimethylacetal
2.065 kg
4
Citric acid Monohydrate
0.425 kg
Dimethylformamide
dimethvlacetal
2.34 kg
6
Dimethyl oxalate
2.33 kg
7
Mcthane Sulfonic acid
(Or)Methanesulphonic
Acid
0.16 kg
8
Methyl-4-methoxy
Acetoacetate
2.873
9
Potassium Carbonate
2.166
RA may take appropriate action as per the decision of Norms Committee.
194
ICase No。:134/10/82‐
IALC4/2016
IHQ File
l:01/82/050/00480/AM17/
Palty Name:ALPHAMED
FORMULAT10NS P LTD
RLA File
:09/24/040/00087/AM17/
'Mcet No/Date:H/82¨
IALC4/2017
124.01.2018
|
鏡高J
Lic No/Date:0910063771
08.06.2016
IDecision:deferred
## Case No.:121/10/82‐
ALC4/2016
q(
Patty Name:OPTIMUS
‐DRUGS PRIVATE LIMITED
RLA File
i09/24/040/00032/AM17/
ソ
DI責0「ii`
| |:01/82/050/00467/AM17/
Decision:deferred
Case No。:151/10/82-
ALC4/2016
Patty Name:TNCHEM
LABORATORIES PRIVATE
IMeet No/Date:H/82- iStatus:Deferred l
lALC4/2017 1 1
124.01.2018 1 1
1Lic.No/Date:0910063778 1Defer l
09 06 2016 1Date:24.01.20181
| :LIMlTED
'6競
Q File ~~~~~rRL蕊
101/82/050/00497/AM17/ 1:09/24/040/00123/AM17/
1 瞬cis高薫面蒲証~~~~~― ―――
iCase No.:61/11/82‐
ALC4/2016
Palty NameiKEKULE
PHARMA LTD
Meet No/Dateil 1/82-
‐ALC4/2017
.24.01.2018
97 ‐
HQ File
101/82/050/00595/AM17/
IRLA File
t:09/24/040/00017/AM17/
ILic.No/Date:0910063781
109.06.2016
Decision : deferred
F眈識が
,響埋ツI曹躍軍IttT
多: 11111
1HQ File lR
‐ 101/82/050/00358/AM17/ 1:0
Date:24.012018
「納¨
1
22
「
199
icase高面扇面源
IALC4/2016
|
Fフ1器3児5υ0036αAM17
F:も｀品もそ人ILIN ldNT
:LABORATORIES LTD.,
IMect No/Datcil 1/82- Status:Deferred
IALC4/2017
124012018
IDecision:deferred
kLrrile ― ――~~~‐
|二十
`ヽ
。
/Date:0410162041 Defer
:04/24/040/00049/AM17/ 14 06 2016 Date:24.01.2018
IMeet No/Date:11/82- Status:Deferred
lALC4/2017 .
124012018 1
―
r―
## Case No.:25/10/82‐
ALC4/2016
・VVIHQ File
1 1:01/82/050/00371/AM17/
囮
:L扁
:Lic.No/Date103 1 0805494:Defer
1506.2016
IDate:24012018
ド
レ
‐
，
ヽ
，
‐
，
に
Ｉ
Ｉ
ヽ
ヽ
Ｆ
1100
IDecision:deferred
lDecision : It was decided to call from the firm
leach export import items.
MeetNo/Date:lll82-,Status:Deferred
:ALC4/2017
124012018
ヾo/Date:0510398826 1Defc
Lic.No/Date:0510398826 1Defer
11606.2016
IDate:2401.2018
copy of DML and copy Master Batch Formula for
iCase No.:29/10/82‐
:ALC4/2016
ド嬬藤臨
l「
~
MeetNo/Date lll82-,Status:Deferred
:ALC4/2017
12401.2018
|
ド
2
IHQ File
l:01/82/050/00375/AM17/
RLA File… …~~~~―…….Lお
:ヽも
'5れ
ま031086ζ
`力
ibefeF~… ……
1
1:03/94/040/00208/AM17/ 2106.2016 1Date:2401.20181
,Decision : deferred
「甲汗~「雉濡臨1鋼げ‐
r品∵
ポ
31需応蔦菖蕊~励
濡蕊鳥辮
…
11曲赫繭:温鳳
|
1 洒語 ~~~~~~~― ―‐ ―――――――― ― ――…―――一‐… ―
……‐―
|
l iCase No.:78/10/82‐ ParりName:AMOL
「備赫語蹴i
,ALC4/2016 1PHARMACEUTICALS PVT
…
高
再
高
IMeet No/Date:H/82‐ Status:Deferred iALC4/2017 1 12401.2018 1Lic No/Date:13 10048295 1Defer 12206.2016 1Date:24.012018 IMeet No/Date:11/82‐ istatus:Deferred lALC4/2017 124.01.2018 1Lic.No/Date:0910063814 1Defer 12206.2016 1Datei24 01 2018 =~casewtty~~~臨出憶鷺語篤 105'LC42m6 1 Decision : deferred IParty Name:RECKlTT IBENCKISER(INDIA) l0l ,HQ File jru-e rire
23 ――-1 | 106
Case No.:109/10/82‐
ALC4/2016
Partt Name:DSM
SINOCHEM
PHARMACEUTICALS
INDIA PVT.LTD.
1造き』輝ν
tell慇2‐
14.01.2018
|
IHQ File
:01/82/050/00455/AM17/
RLA File
:22/24/040/00022/AM17/
Date:24.01.2018
Decision : deferred
107
‐Case No.:5/11/82-
ALC4/2016
1HQ Flle
l:01/82/050/00539/AM17/
Pany Name:ASCENT
FINECHEM PVT.LTD.,
IRLA File
108/24/040/001041AM17/
‐Case No.:92/16/82‐ Pally NameiHETERO LABS
ALC4/2016 LIMITED
I Wl
誡策励0063品‐
3れ鳳猟
:
1081青。Fil`
RLA File
:09/24/040/00157/AM17/
:01/82/050/00909/AM17/
IDecisio■:deferred
1食
癬
赫証
ザ
抒
雨
乱恩
lhΨ
げ
~ツ
赫
:
Ю9青Q File RLA品
~~LL~計
沈密
&面耐
面
BttL鳥i」1こ
|:01/82/050/01159/AM17/ 1:09/24/040/00172/ハ
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
‐
― ~~~~―
一
―
――
一
一
―
― 一
―一
一
―
― 一 一 ~ ~1 1謳両deferred~~~■li l「T丁: | ICase No.:7/11/82¨ :ALC4/2016 HO山 O Filc 101/82/050/00541/AM17/ IDecision:deferred Party Name:PANERA BIOTEC PVT LTD. RLA Fllc :05/24/040/00136/AM17/ 琴桜F而丁胃品1 iCase No.:185/17/82- :ALC4/2016 HQ File 101/82/050/01146/AM17/ IDecision:deferred RLA File :09/24/040/00147/AM17/ 124.01.2018 1Lic.No/Date10910063885 104.07.2016 Defer Datei24.01.2018 Pa■yNttα AUROttNDδ ~V“ tNふ .11慇2‐ IPHARMA LIMITED IALC4/2017 ICase No.:5/14/82- ‐ALC4/2016 IParty Name:ASTRAL ISTERITECH PVT.LTD. HQ File lRLA File Mcct No/Date:11/82‐ Ted Defer Date:2401.2018 IALC4/2017 124.01.2018 ILic No/Date:3410042324 .05.07.2016 112 :01/82/050/00803/AM17/ :34/24/040/00099/AM17/ Decision : deferred 1胚 冨TI ‐Lic No/Date1081 0138218 B鮨ち 4.01.20181 128.06.2016
24
iDecision : It was decided to call from the firm copy of DML .
IMeet No/Datell 1/82‐
:ALC4/2017
12401.2018
1Lic No/Date:3410042325
105.072016
iStatus:DeFerred
Defer
Date:24.Ol.2018
tDecision : [t was decided to call from the firm copy of DML .
IMeetNo/Date:1
lALC4/2017
ll82-
rStatus:Deferred,
24.01.2018
Lic No/Date:0310805960 Defer
105072016
Date:24.012018
Name:J.B.
CHEMICALS&
RMACEUTICALS
| |
“田既蕊蔦薦T~蹴鳳濡
/Am7
||
[鍛鶴鷺::縞正
IINDUSTRIES LTD.,
IRLA File
l:05/24/040/00143/AM17/
IMcetNo/Date:H/82-
IALC4/2017
Status: Deferred
IHO Fi
IHQ File
|:01/82/050/00631/AM17/
124.01.2018
Lic.No/Datei051 0399022 1Defer
106.072016
Date:24.01.2018
, ユ′ιL■ミ
Decision : deferred
lase No.:42/11/82‐
IMeet No/Date:H/82- Status:Deferred
lALC4/2017 1
124012018
ILic No/Date:0310806121 1Defer
11207.2016 Datei24 01.2018
1116
1
1
:…「翔蒋而=~…
1濡選需鮮
……
監漱摯議磁‐中蔽漢齢
“
|
124.012018
‐
l口1浙:蕊蔦「
~影
濡鳳11語茅~需
需Йあ
423443親ふふ
11
IDecislon:it was decided to caH from the nrm copy ofCAO ofimport and export showing particle
islze.
rDO確嘲rd1/82-ドは画断腱
di
04.01.2018 1 1
-一―― -1二
だ、。
'b品
もう1665,雨ざ~~~~|
ゝM17/ 114 07 2016 Date:24.01.20181
1 1Dedsbn:deLrred ~~~~~~~一
一
一‐
― 一――
―
‐
Status:Deferred l
FMきさ
INo/Dat8面/82]
1針∬鰍了
Case No.:10/11/82‐
IHQ File IRLA File | IALC4/2016 IHQ File IRLA File Decision : deferred IHQ File RLA File
25 :01/82/050/00544/AM17/ 103/95/040/00304/AM17/ 114.07.2016 いお】bibbij Decision : lt was decidecl to call from the firm copy of production and consumption data duly ] certified by jurdistional Central Excise Authority /Customs Authority |
Case No.:43/16/82‐
ALC4/2016 Party Name:OPTIMUS ‐DRUGS PRIVATE LIMITED Meet No/Date:11/82‐ ALC4/2017 120 12401.2018 HQ File :O1/82/050/00860/AM17/ RLA File :09/24/040/00213/AM17/ .ui. ur pii ig.nai ira deliberated "; ih;;"ti; in tr," ptii.nce of the ..1 +^ -^+14, +L^ ^,1 L^^ ia*,r nrrhrrt -^*o 'rnrlpr nqrq /, 1 nf IJEIP ac ner l ltCChnical expcrts andれ was decidcd to rati″ the ad_hoc input output no:11ls under para 4.7 ofHBP as peri ,details below or as applied by firm whichever is lower: Export Product Export Quantity S No lmport Product Quantity Al!owed kg/kg 30FOSBUVIR‐ IH L kg 2-deoxy‐ 2‐ fluoro‐ 2-C‐methyluridine (or)(2R)‐ 2‐ Deoxy‐ 2‐Fluoro-2‐ Methvluridine 0.91 kg 2 N-[(S)-(2,3,4, 5,6-Pentafl uorophenoxy) phenoxyphosphinyll-L-alanine I - methylethyl ester (O R) propan-2-y l(25)-2- { [(pentafl uorophenoxY) (ohenoxy)phosphoryllamino ) propanoate 1.60 kg .RA may take appropriate action as per the decision of Norms committee. ICase No.:32/16/82‐ lALC4/2016 Party Name:AUROBINDO PHARMA LIMITED 121 111Q Filざ :01/82/050/00849/AM17/ RLA File i09/24/040/00218/AM17/ Decision : deferred J
Case No.:35/lll82-
Party Name:AARTI lMeet No/Date"l 1162- lstatus: ,ALC4l20l6 INDUSTRIES LIMITED lALC4l20l7 iApproved l'--- -'---- ) i./ n 1 .n1o i |~~~~~~~~ | 124.01.2018 、, ● い1 11:^｀ I^′ ぃ。十 o・A21090κ 五つ7 RLA File ‐~~ ILic.No/Date:0310806427 1HQ File , :01/82/050/00569/AM17/ :03/94/040/00283/AM17/ 120072016 Export Product Export QuantitY S.No lmport Product Quantity AIlowed kg/kg 2,4 DIFLUORO NITRO BENZENE(2,4 DFNB) L kg META DICHLORO BENZENE 1.14 kg POTTASSIUM FLUORIDE(KF) 0.81 kg 3 SULFOLANE ANHYDROUS 0.10 kg 1 1lLA lたら1 6,計 vヽЯふIIIÅミ■i~ M``tヽ も 'Dat`lil'82-~iStatuま Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the I rechnical experts and it was decided to ratify thi ad-hoc input output norrns under para4'7 of HBP as perl details below or as applied by firm whichever is lower: 122 糟ざ鼎α醐∞“ %81 IMeetNo/Datc:H/82‐ lALC4/2017 124.01.2018 FmDeFer劇 | liしヽ誦面再琶薫面盃面列Detr ~~~~ 1907.2016 IDate:24.01.2018
26 ~lCaseNo。 :27/16/82‐ IALC4/2016 つ ４ 'RA may take appropriate action as per the decision of Norms Committee. ′AM17/ IRLAFile~~~~~― ―― .iしヽルDaおbうib6`396り:De誌f… … … |:09/24/040/00132/AM17/ 21 07 2016 1Date:24.012018 IjRA may take appropriate actionis per tlre decision of Norms committee. | ~~ ~~‐ ^~^^:′
・v、 わLcisiltt」耐
,Mect No/Date:‖ /82‐ lstatus:Deferred‐
IALC4/2017 1
124.012018 1 1
~LitiヽルDatこb510399202 Defer~~~~~
12207.2016
iDate:24.01 .201 8
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allnrrrad
I
ISOPHTHALOYL
CHLORIDE/TEREPHTHALOYL
CHLORIDE MIXTuRE
p3%/7%)
l kg
ISOPHTHALIC ACID
0.845 kg
F雨
ぶ雨迅
茄Jド
総漁1鶴漱
だ~1漱
r磁
導鷺1‐
1瓢鳳鳳…
|1嚇浙
j詰:蕊
「
ぶ需M而為ガ■
|
露
押
鋼綱
椰
・
編
橘
ざ品J語語諄ょ昴ぉ品
loc input output nOrms under para 4.7 of HBP as per
126
「
r7
,ltryI":'oPTRlx
Meet No/Date:l l/82- Status:Deferred
;LABORATORIES PRIVATE ALC4/2017
ILIMITED
t2q.Ot.ZOlB
I
--
r* -*-*" "* -
l1lll,t
--**-rt;c.NoTDaie:osi0063r,D;r.i-- -
i
'];ogtztto+o/Oo23s/AMt7/',zs.ot.zotZ-' " i""^r|,ro.ot.20l8
l
1 lDecision:deferred
,:尋ヽ五ふぎЁttiLLiÅ員FB16 1Me`tヽ6′ bit`li i′ jう:
iStatus: Deferred
E魃図VATE
IALC4/2017
124012018
Meet No/Date:11/82‐
iStatus: Deferred
IALC4/2017
124.01.2018
ILic No/Date:0310806482:Defer
i21.07.2016
IDate:24.01.2018
| ICase No.:20/13/82-
: IALC4/2016
iParty Name:FRESENIUS
IKABIoNCoLoGY
jLtvrrpo
11251
|´ν
lHQ File
, 「01/82/050/00648/AM17/
1職ち」
liO/00211晨M17/
,
1
27
ICase No.:77/11/82‐
ALC4/2016
128
‐
HQ File
Pa●y Name:ASIATIC
DRUGS
&PHARMACEUTICALS
PVT.LTD.
IRLA File
:05/23/040/00124/AM17/
Prred
|
:01/82/050/00611/AM17/
Decision : deferred
Date:24.01.2018
## Case No.:78/11/82-
ALC4/2016
11291 ______´
_一―
| IHQ File
Pany Name:ASIATIC
DRUGS
&PHARMACEUTICALS
PVT.LTD.
:01/82/050/00612/AM17/
RLA File
:05/23/040/00123/AM17/
‐Decision:deferred
130
ICase No.:79/11/82‐
IALC4/2016
1HQ Flle
i01/82/050/00613/AM17/
Party Name:ASIATIC
DRUGS
&PHARMACEUTICALS
PVT LTD.
`RLA File
:05/23/040/00119/AM17/
″回8
-閉
B温i五百
1
Decision : deferred
: _
iCase No.:80/11/82-
‐ALC4/2016
Palty Name:ASIATIC
DRUGS
&PHARMACEUTICALS
PVT LTD.
RLA File
:05/23/040/00125んヽⅣl1 7/
IHQ File
101/82/050/00614/AM17′
IDecision:deferred
## Case No.:64/13/82¨
ALC4/2016
Patty Name:AARTI
INDUSTRIES LIMITED 可
う
ι
IHQ File
101/82/050/00692/AM17/
IRLA File
103/94/040/00177/AM17/
|;:::サザ
:1管
e:0310806697
Date:24.01.2018
Decision : deferred
‐Case No.:85/16/82‐
ALC4/2016
HQ Filc
iO 1/82/050/00902/AM17/
率鍔鶴鳥脚ご冨1
… 1孵
呼臨
i.狙1
鴨ら
'lil孟
:漁↓
Li… 猥ぶ
|
Decision : deferred
iCase No。:31/16/82-
ALC4/2016
HQ File
:01/82/050/00848/AM17/
Patty Name:OPTRIX
LABORATORIES PRIVATE
LIヽイITED
RLA File
湾咄燿
~´
腎派Defe品
|
24.01.2018 1 1
134
09/24/040/00236/Aヽ417/ 灘杵甲Ⅲ轟面」
匿き棚ツα
H/82‐
12401.2018
ド
mDefer“d
|
Li`:ヽも
'5五
:まo5103b52411bきた
r
27.07.2016
IDatei24.01.2018
IStatus:Deferred
|
1
28
「
|
IHQ File
iCase No.:93/6/82‐
IALC4/2017
|
||:rty7｀:ふさ
ISAヽD02
1PRIVATE LIMITED
:ALC4/2017
'4.01.2018
Lic No/Date:03 10806790 1Defer
~IRLA File
101/82/050/00663/AM18/ 1:03/95/040/00312/AM17/
02082016
Date:24.012018
「
~|
ド
6打
33月50/0080独Ⅲ
7
‐ IDecision:deferred
閉蔦蕊i扁
MeetNo/Date:|1182- Status:Deferred
,ALC4/2017
124.012018
ILic No/Datei341 0042403 1Defer
104082016
Datei24 01.2018
|~ lcaζもヽ3:■力i3/821
1 :ALC4/2016
r Status:
,Approved
:
presence of the
' of HBP as per
24012018
Liciヽ6, 1
11082016
:Decision:COmmittee considered case as per agenda andと
も
Hberated On the matter in the i
iteChnical experts and it was decided tO ratitt the ad‐ hOc input Output nOrms under para 4 7
:ЯO+_:1^k^1^.. ^_^^__ 1・
11 ～ |・ . _
IRA maytake
Export Product
Export
Quantity
S No
lmport Product
Quantity
A1lowed kg/kg
THYMOL
iABOVE 95%PURITY)
l kg
1
META CRESOL
(ABOVE 95%
PURITY)
0.72 kg
c3sg N9t:2r fi6/82-
parry Name:ARENE LIFE Meet NoiDat e:r ug2- Sratus:Deferred
ALC4I2OI6
SCIENCES LIMITED.
ALCqD.OTI
'.^-l
I
;24.01.20t8
'
ド鑢
繭
赦
淵
品EI鱗繭碗
・鏡
蔦
IDecおbn:deLired ――――――――――――――
ICase No.:78/13/82‐
ALC4/2016
1需聴 ~監漱需
・・
/782-~|も高横儡
`
|
り4012018 1
聯昴Ⅲ:品,11写郷11TTTFI華¨
|“ |
39
|1続編
1140x従棚
;育
一
Ｃ
Ａ
## Case No.:190/17/82‐
融 ~~ 世
`躍
■11露普111
29
lz+.ot.zott
101/82/050/01151/AM17/ :09/24/040/00223/AM17/
Lic.No/Date:0910064041
16.08.2016
## Case No.:40/13/82¨
ALC4/2016
141 1HO lile
:01/82/050/00668/AM17/
Pany Name:AETHER
INDUSTRIES LIMITED
IRLA File
:52/24/040/00036/AM17/
Defer
Date:24.01.2018
Decision : deferred
J
ICase No.:19/13/82¨
ALC4/2016
Palty Name:FRESENIUS
KAB1 0NCOLOGY
LIMITED
1142■Oiぉ
~
| |:01/82/050/00647/AM17/
IRLA File
105/23/040/00234/AM17/
Nlcct No/Date:11/82‐
ALC4/2017
2401.2018
tus:Deferred
Decision : deferred
ICase No.:15/16/82-
ALC4/2016
143 uq nit.
Pany Name:GRANULES
INDIA LIMITED
Tvleet No/Date:11/82-
101/82/050/00832/AM17/
IRLA F‖ e
:09/24/040/00264/AM17/
'ALC4/2017
124.Ol.2018
'Lic.No/Date:0910064057
:19.082016
Defer
Date:24.0120181
,Decision : deferred
1441H。lile
‐ |:01/82/050/00778/AM17/
RLA File
:05/24/040/00201/AM17/
,Case No.:150/13/82‐
‐ALC4/2016
145
Party NamciSUN
IPHARMACEUTICAL
INDUSTRIES LTD,
IMeet No/Datei H/82‐
:ALC4/2017
124.01.2018
IDecision:deferred
ICase No.:156/13/82- Pany Name:MAHIMA LIFE IMeetNo/Datei H/82-
IALC4/201` SCIENCES PVT.LTD. :ALC4/2017
124.01.2018
偽濡
l蕊」萩諦~ぶ策e面面
「
~~|
IHQ File RL
101/82/050/00784/AM17/ :Of
● ■ , 1, , J __人L^_^``^‐
:―
+ス0^■・0●o‐ρO Afth●
|
Decision : Committee considered .ur" u, f.i ugenda and deliberated on the matter in the presence of the
technical experts and it was decided to ratii' the ad-hoc input output norms under para 4'7 of HBP as per
details below or as applied by firm whichever is lower:
Export Product
Export
Quantity
S No
lmport Product
Quantity
AIloWed kg/kg
BETAMETHASONE
DIPROPINATE
L kg
BETAMETHASONE
0.868 kg
IRA may take appropriate actiOn as perthe decislon of Norms Committee.
Decision : deferred
IMeet No/Date:H/82‐
:ALC4/2017
2401.2018
rLic.N o/Date : 05 I 0399 492 iDefer
11908.2016
IDatc:24.01.2018
lstatus:Deferred
ILic.No/Date:0510399507 1Defer
Status:Deferred l
:19082016
IDate:24.01.2018
ICase No.:163/13/82‐
:ALC4/2016
30
臨
癬
面
耐
耐
猛漱
需E而:~輌
高
満
:
124012018
1Lic NO/Date:0910o64084
101 092016
‐Defer
‐Date:24.012018
''-Ilcase No':164/liu'-
lTy Nime:HETEnoless Meet No/Dar e:|tg2- status:Deferred
irrctrzorc
llilriil'
iALC4/20t7
i
i24.01.2018
;
l:01/82/050100792/AMr7 r
i:09r24r040/0o31u AM17 r
o i .oq.zo ro
:Date:24.0t.2018
Decisionl a"r".."a ll
「
~昨脇∬
m3β多 臨
IHQ File
-ALA Fil.
i:01/821050100796/AM|Zt ti}g124IO4O/OO30UAMtl/
「8 1 剛
鷺漱需
1/82-~ド品ふ晶轟Ⅲ
124.012018 1
1Liciヽ8′5:おibOib684bbζ 158fel
‐
‐
O1092016 1Date124.O12018‐
Date:24.01.2018
,
1壼漱需ま
iiた
'1~,ltiζ
b`拠IFLI
'4012018 1 1
■ヽ6晟
`65丁
oo6408'1幌孫~~~:
101092016
‐
Date:24.0120181
i
i:}t/82/050/Ott57/AMt7/
i
r:--
漏聯あ掲50Юo737/AM17
満統ガ:,OЮ04841」i;戸
~
1藻[耐II萬落:蔦詭面ぉlall I語LЪ 轟
:話雨ξFDML
1面「餃1,9Nlilf黎堕2, ~｀
~FI再
面高蔽雨ご
IMeet No'D`181i iた,:
:ALC4/2017
2401.2018
ⅢcNルbiよbbib恵oウ
`i」
,06092016
IStatus:Deferred l
158fer l
lDate:24.O12018 1
一
一
,Meet No/Date,, I
f Ztil
,status:Oefer.eA
1461青。llit
:01/82/050/00791/AM17/
jDecision : deferrea
| ICase No.:196/17/82¨
| IALC4/2016
F"臨
31
ALC4/2016
HQ File
/82/050/01344/AM17/
LIFESCIENCE
IRLA File
l:34/24/040/00154/AM17/
IALC4/2017
124.01.2018
Case No。:100/16/82‐
ALC4/2016
Party Name:DHANUKA
LABORATORIES LTD.
154 ug nit.
:01/82/050/00917/AM17/
IRLA File
:05/23/040/00272/AM17/
けぉ」識`範
496臨蕊i漁:
lzq.or.zots
I
.Lic.No/Date:0510399660 1Defer ‐
0809.2016 1Date:24.01.20181
Decision : deferred
| ,Case No.:167/13/82‐
‐ ‐ALC4/2016
155‐ 白Q Fil`
| :01/82/050/00795/AM17/
Party Name:HETERO LABS
LIMITED
Decision : deferred
156
‐Case No。:169/13/82‐
ALC4/2016
.HQ File
:01/82/050/00797/AM17/
Decision : deferred
|
「
iCase No.:209/17/82‐
IALC4/2016
157.HQ File
.:01/82/050/01170/AM17/
Decision:lt was decided to call from the firm copy of DML for each export product.
一
一
論きまヽル島Iξ而慧ダ
ICase No.:159/13/82-
IALC4/2016
Party Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
158 110 File
RLA File
:05/24/040/00264/AM17/
101/82/050/00787/AM17/
IDecision:deferred
ICase No.:208/17/82‐
IALC4/2016
159‐ HQ File
SCIENCES LIMITED
‐RLA File
109/24/040/00256/AM17/
:諄運墨i縣聡ぎFE I造ご器に
1782-
:01/82/050/01169/AM17/
:ALC4/2017
'401.2018
08.09.2016
:ALC4/2017
124.01.2018
iLおi｀Ъ′
5:181o5而繭
108.09.2016
Datci24.01.2018
Decision:deferred
1601霊漁l:α
13/82‐
Palty Name:HETERO LABS
ILIⅣllTED
性咄Ⅲ碗」t'サす
|
Decision : deferred
RLA File
:09/24/040/00300/AM17/
IMeet No/Datei H/82‐ IStatus:Deferred
l折饂了 |
.Lic.No/Datc:0910064112 1Defer
108.092016
IDate:24.01.2018
Pa●y NamciHETERO LABS
LIM ITED
RLA Filc
:09/24/040/00302/AM17/
1造き』邸印
tα ll慇2-ドtatttDettrred
壼!コ: |_…
…
ILic.No/Date:0910064113 1Defer
10809.2016
IDatc:24.01.2018
,Status:Deferred l
32
~~1
「
,HQ File
::01/82/050/00794/AM17/
,RLA FiIC
1;09 I 24 / 040 I 003 1 4 I AM ti I
2401.2018
1Lic.No/Date:0910064123 1Defer
109.092016
IDate:24.01.20181
ase No。:105/13/82‐
LC4/2016
Q Flle
1/82/050/00733/AM17/
1P".tv Nurn.,IARTi
llrvrrpo
IMeet No/Date:H/82-
ALC4/2017
24012018
,Status: Deferred
DRUGS
Lic No/Date103 10807836 1Defer
‐16092016
IDate:24012018
i
la;;; M:;iutitu--*- - -iii.ry N;.'MAHiMAiiFi iM..iNozo,uii,tr/b:- *-
iStatus:Dererred
. IALC4/2016
]SCIENCES PVT.LTD.
ALC4I2OII
il
t6)
24.0 t .2019
'"- HQ File
Rle Fite
Lic.No,Dare:0510399749 Defer
i
l;0118210:9f"9?9llAy_r7t- ::05t24t040to022etAMt7t ro os.zoro
Date:24.0r.20r8
1 lDecislon:It was decided tO cali from the nrm for Personal Hearing to explain their case.
a_
_-_ '_ -
__'.-.."-
Parry Name:MAHIN4A LIFE Meet No/Dat e:l llg2_ Status:Deferred
iSCIENCES PVT.LTD.
ALC4I2OI1
IRLA File
i:03/94/040/00487/AM17/
ase No.:95/16/82‐
‐ALC4/2016
%4耐
101/82/050/00912/AM17/
IDecisiOn:deferred
124.01.2018
:¨ ″
で¨
聯憂
:―=
| IALC4/201`
11651HQi蔦
1辮諄聴
稿
|
脇
:源蕊
IMeet｀0'Diteii 1 7821 ■Statiζ ibefellea
lALC4/2017 1 1
124012018 ‐ |
101/82/050/00914/AM17/
‐
…
deferred
ILic No/b`iもibもibjう0ウ
`,IDeお
:
11609.2016
Date:24.01.2018
IMeきiヽ6′ b:iも:ii/8う―
|ぶ1ltisibtferFι3‐
IALC4/2017 1
:2401.2018 1 ‐
ILたヽ3/5晨8:o3ibな0う力415Ъ高 |
1609.2016 1Date:240120181
1鋼}赫
~∵
∵
:DecisiOn:deferred
:~~にase No。:94/16/82‐
| IALC4/2016
憑誂舶露:躙粘Ы
FE
MeetNo/Date:1t/82- :St"iriiO.f..."A
IALC4/2017 1
協
熙掲
5∽酬鳳
m■_肝西蕊~~~~《熙儡i05103碗締~~~
05/24/040/00230/AM17/ 11609.2016 :Date:24.01.2018
IDecision:It was deciaきJto tili fr`品IIどIItt f。,|さ:ξぎお
li leil・ing tO explain their case.
Lic.No/Date:05 I 0399746 Defer
|:05/24/040/00222/AM17/
:
¨
16.092016
Date:24.01.2018
|
ICase No.:70/16/82‐
iParty Name;tNDO pHyTO
ICHEMICALS PvT LTD
|
1671ALC4/2016
33
IHQ File
101/82/050/00887/AM17/
IRLA Flle
105/23/040/00237/AM17/
魏頸甲
厩渦
1/82/050/00889/AM17/
ParりName:ASIATIC IMeetNo/Date:H/82‐
‐DRUGS ,ALC4/2017
1&PHARMACEUTICALS i24 01.2018
PVT LTD. 1
性あ棚υ
0021″AM口 1翻鼎α∞Ю
399816
ICase No.:72/16/82-
IALC4/2016
′
υ
Q File
Ｈ
Ю
‐Case No.:56/17/82‐
‐ ‐ALC4/2016
1169‐
| IHQ File
l :01/82/050/01017/AM17/
Party NameiJ.B.
CHEMICALS&
PHARMACEUTICALS
ILIMITED
IRLA File
:03/94/040/00582/AM17/
IM8Ct｀0/D:お:li/8':~ ド仏
titi5もfe'I`む
:ALC4/2017 1 1
「4飢川8 1 1
|
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
1170
,Decision ; deferred
No.:13/17/82-
4/2016
170 1110 Fil`
Decision : deferred
Party Namc:GUJARAT
10RGANICS LIMITED
IRLA File
IMeet No/Date:H/82-
lALC4/2017
124.01.2018
1面と｀3/D:18:δI而面面死
27.09.2016
1 101/82/050/00974/AM17/
103/94/040/00585/AM17/
171
‐Case No.:113/13/82-
ALC4/2016
Pary Namc:HETERO LABS
‐LIMITED
RLA File
:09/24/040/00342/AM17/
‐
HQ File
101/82/050/00741/AM17/
Mcet No/Datc:l1/82‐
‐ALC4/2017
124.012018
Date:24.01.2018
Decision : deferred
## Case No.:114/13/82‐
ALC4/2016
1172‐責
O ri18‐
Pary Name:HETERO LABS IMcetNo/Date:11/82‐
LIMITED IALC4/2017
)
iALC4l20l7
Po.ol,T,1
聡需繭而臨温
‐
隅I蔽5こferrぬ
1
1 1
RLA File
:09/24/040/00341/AM17/
:01/82/050/00742/AM17/
.Decision:deferred
Case No。:109/16/82‐
ALC4/2016
173 HQ rile
:01/82/050/00926/AM17/
Decision : deferred
Patty Namc:PANERA
IB10TEC PVT.LTD.
IRLA File
105/24/040/00307/AM17/
IMeet No/Date:l1/82‐ IStatus:Deferred
iALC4/2017 1
24012018
ぢ
F∬%躍α
0510399924B:lち
4Ю L2018
174 Case No.:140/20/82‐
Paltv Name:SRINI
PHARMACEUTICALS
Meet No/Date:11/82-
IALC4/2017
ALC4/2016
Status:Deferred l
lstatus:Deferred
I
IDate:24.01.2018
34
IPRIVATE LIMITED
:24012018
IHQ File
t:01/82/050/01317/AM17/
「RLA Fne ~‐
~
卜09/24/040/00348/AM17/
Lic.No/Date:09 1 0064 I 96 lDefer
128092016
IDate:24012018
IDecision:deFerred
| ICase No.:194/17/82‐ ,Par″ Name:SUVEN LIFE lMeet No/Date:H/82- Status:Deferred
1 lALC4/2016 1SCIENCES LIMITED ALC4/2017
15器既扁鳳
「
協胤鳳Li↓汚
…
1難藁赫064206:諸」鳳t∴
1 lDecision:deferred
|「霊胤響たン
82
1曰6嵩而~―一―
1 1:01/82/050/00718/AM17/
鰐
湘
αAⅦ ORGANCS賞
[棚
ν
ttν 紗‐
:ね
nSDeたrd
1 24.01.2018 1
鑢鍬:鳳L罵愕
……
1嬬ル島は】b磁轟わ書……
2016 1Date:24.01.2018
1 lDecislon:deFerred
## Case No.:69/16/82‐
IALC4/2016
101/82/050/00886/AM17/
IPaty Name:DHANUKA
ILABORATORIES LTD
IMeet No/Date:11/82- status:Deferred
iA LC4/2017
12401.2018
:Lic No/Date:0510399960 1Defer
103102016
Date124.01.2018
1177嵩
## Case No.:200/17ノ82‐
ALC4/2016
iCase No.:98/16/82‐
IALC4/2016
Pa農ジ馬ふも
IINb6 1iヤi6
1CHENttICALS PVT LTD
IMeet No/Date:H/82‐ status:DeFerred
,ALC4/20!7 1
124.012018 ‐
:Lic No/Date:0510400012 1Defer
10410.2016 1Date:24.01.2018
Dedζion¬II品百
Parry Name:AUROBINDO
iPHARMA LIMITED
lMc81ヽ。/5駈さ
il l‐′j2-~~lstit轟:DefelL五
:ALC4/2017
124.012018
:Lic.No/Date:0910o64252
106102016
tDefer
lDate:24.012018
IMeet No/Date:H/82‐
IALC4/2017
12401.2018
1赫
―
―
|へしハ
Γ ‖。
|:03/94/040/00617/AM17/
106.10.2016
Lic No/Date103 10808312 Defer
Status: Deferred
IDate:24012018
IM`も:ヽルb姦勇「i/82-~~~1;Status: Deferred
## Case No.:49/17/82‐
181 IALC4/2016
| ~~
|
Ｆ
ハ
ー
IALC4/2017
124.012018
:01/82/050/00972/AM17/
|
IHQ File
101/82/050/00915/AM17/
IRLA File
l:05/23/040/00293/AM17/
iCase No.:11/17/82‐
lALC4/2016
Palty Name:CIPLA
ILIMITED
35
IHQ File
:01/82/050/01010/AM17/
IRLA File
103/94/040/00622/AM17/
囲
Datc:24.01.2018
Decision : deferred
ICase No.:9/17/82-
ALC4/2016
Party Namc:CLARIANT
INDIA LIMITED
182責。Fil`
:O1/82/050/00970/AM17/
.Decislon:deferred
RLA File
:03/94/040/00629/AM17/
Date:24.012018
Mect No/Date:11/82‐
Lic No/Date:0310808422
117 102016
## Case No.:31/17/82‐
Party Name:REANNON
M“ 1‐ヽあ藤再1/82-
lALC4/2017
12401.2018
PHARMACEUTICALS
HQ F‖e RLA File iLic No/Datei0310808412
:01/82/050/00992/AM17/ :03/95/040/00540/AM17/ 117.10.2016
101/82/050/00992/AM17/
Ю4ν0054υAm7 11■
102顎
詰
而
「
LIII.TTI
Decision : Committee considered case as per agenda and deliberated on the matter in the presence of thel
technical experts and it was decided to ratifl the ad-hoc input output norms under para4.7 of HBP as peri
ldetailsbeloworasappliedbyfirmwhicheverislower:
I
Export Product
Export
Ouantity
S No
Import Product
Quantity
Allowed ke/ke
REANONTRIKAL INJECT10N
:APROTININ 10000 1U)
LYOPHILIZED INJECTION
′EACH COMBIPACK CONTAINS
10 VIALS OF APROTININ 10,000
lU,EACH AMPOULE CONTAINS
SODIUM CHLORIDE BP O.9%W/V
WATER FORINJECTION BP Q S
l rnillion vials
1
APROTININ
2.244 kg pcr
million
RA may take appropriate action as per the decision of Norms Committee.
ALC4/2016
― ――
―
- 1
184
ICase No.:25/17/82¨
:ALC4/2016
Party Name:CLARIANT
INDIA LIMITED
Meet‐雨読漂而而
「
~
1辮鶴V
雨
118.10.2016
…
lII
臨高:
,HQ Filc
101/82/050/00986/AM17/
IRLA File
i03/94/040/00648/AM17/
Decision : deferred
ICase No.:107/16/82‐
IALC4/2016
Party Name:DALAS
BIOTECH LTD.
118511。File~~‐
IRLA File
:05/23/040/00474/AM16/
Defer
Date:24.01 .20 I 8
101/82/050/00924/AM17/
Decision : deferred
Case No。:54/16/82-
ALC4/2016
Party Name:IND― SWIFT
ILABORATORIES LTD.,
Ⅳleet No/Datell 1/82-
IALC4/2017
124.01.2018
Status: Deferred
11861
F‖ e
ILic No/Date:2210015580
IHQ File
RLA
lstatus:Deferred
I
|
,Meet No/Date:H/82‐
:ALC4/2017
IStatus:Deferred
:01/82/050/00871/AM17/
36
―
ゎ2/24/040/00065/AM17/ 18 102016
jDecision : deferred
: |:01/82/050/013H/AM17/ 1:09/24/040/00390/AM17/
‐20102016
I
,Decision : deferred
1壼漱曽
311たメ ドあ
tiまbefellさ|
,40L2018 1 1
ILic No/Dat`ib0166`4うなケibもお
:
‐Date:24.012018
IDate:24.01.2018
‐Meet No/Date:H/82- status:Deferred
1針∫
1鶴了 |
■
`.ヽ
ルbiざo916δ
`4う
な
7‐ Defer~
21.10.2016
lDate:24.01.2018
l~‐
1188熊
1・
υυ
lHQ File ~~~
| 101/82/050/01293/AM17/
ase No.:116/20/82‐
ALC4/2016
IParty Name:OPTIMus
IDRUGS PRIVATE LIMITED
1~腸
ら艦iふ応じ
~
IDecis10n:deferred
| ,Case No.:51/16/82‐ IParty Name:IND‐ SヽVI
IParty Name:IND‐
SヽVIFT
,Case No.:51/16/82‐
IALC4/2016
Meet No/Date:11/82‐
ALC4/2017
Status:DeFerred
押9臨
漁
9「……W i
ILABORATORIES LTD,
嚇
24012018 1
1Lic.N8/bat`12'10biS3b3 1befer l
t
l:01/821050t00868/AM17/ l:|:22/24/040/00067/AM17/
「
~
IMeet N6′ 5爵
`ffた
2‐
~ istttijibeFe'ユ
j‐
IALC4/2017 1 ‐
12401.2018 1 1
190
|おいお掲
50Ю 1302/AM17/
| HQ File
~Ⅲよ｀ルbttk
ILi`:ヽ8′ bat`ibうibb`4joO lbきfel ‐ ~
Defer
1,/Av17/ 26.10.2016
,Date:24.01.20181
IDecisiOn:deferred
1 1 ・
` V・4V i V I・ノ
atC:Z i:.U l .ZU 1 6 1
「~狩
,,1,1:1,12υ
82‐ |¨
薇疏両満
lMさ
`iヽ
6′biおli iた,1 1もiムtiζ ib`felita
lALC4/2017 .
124012018
二i`:ヽ6,bit`:6o16b84ib意lb`fel
―
~簿雨蔦面死面扇
「
~~~IPa再
面扁も
IA通ヽ百LI穐
:ALC4/2016
` SCIENCES LIMITED.
126102016
iDate:24.01 .201g
| IDecisiOn:deferred ~=~~
1語
濡P薦
~~町
Nallaよ罰6あ配ALЁ
壼湿
ルDatcIЙ メ~島
赫
品高
,
′2017 1 1
‐24012018 ‐
り21HQ而―~~~~~―――無LAhお~~~~‐
m ν Rν O、Ⅳm2っ
∝△M口
IA__相
^一
一
一
―
Ⅲ
｀ルbiよ
σうibbヒ4bbbう
も感
織 l鷲
“
IW響全聖7__ザ出TギTTT奪:レP=
omments frOm DBT
## Case No.:126/20/82‐
ALC4/2016
N/1eet No/Date:11/82‐
IALC4/2017
2401.2018
Lic No/Date:091oo64311
26 10.2016
IStatus:Deferred l
Defer
lDate:24.01.2018
漏
38掲5υ“
3:蕊蔦
125.10.2016
:Date:24.01.2018
37
Decision : deferred
## Case No.:15/17/82‐
ALC4/2016
Party Name:HARMoNY ''..
lM."t Nolbui.,iilsz-
LIFESCIENCEPRIVATE,ALC4I2OIT
r --- . -- -'
LTMTTED
124.01.2018
IStatus:Deferred l
l l
l l
臨蕊L轟
194
IHQ File
101/82/050/00976/AM17/
鷺ら刷:OЮ0672/AM17 1猪∬ぢ認α
0310808773
Decision : deferred
０
ソ
ICase No。:19/16/82‐
ALC4/2016
1HQ File
101/82/050/00836/AM17/
PartyName:DHANUKA - lMeetNoloate:ills2-' [Status:Deferred
LABORATORIES LTD. IN-CqDOTI
I
124.01.20t8
|
RLA File
-ll-i..Nolouti,os ro+oozx lD.f*
::o5t23l040l0o355lAl.4l7l
]l27 .10.2016
lDate:24.01.2018
Decision : deferred
196
## Case No.:130/16/82-
ALC4/2016
1HQ File
:01/82/050/00947/AM17/
Party Name:10L
CHEMICALS AND
PHARMACEUTICALS
IMeet No/Datei H/82‐
IALC4/2017
24.01.2018
LIMITED
RLA File
:30/24/040/00027/AM17/
Lic.No/Datei3010103875
,7.10.2016
IDefer
lDate:24.OL2018 1
Status:Deferred
197
Decision : deferred
た1:`ヽも.:i“たレ鹿_ latty｀
:品eもuR雨LABS… Ⅲさまヽルbttli/821~隅
IIこま
‐~
IALC4/2016 1ALC4/2017 1Approved
124.012018 1
1器星掲5νOB42AM17 )が
liυOo20%AM17
″
∬り認
α34100426301
1Decision:Commi■ee considered case as per agenda and deliberated on the matter in the presence of the
lteChnical experts and it was decided to ratltt the ad‐ hoc input output norms undcr para 4.7 of HBP as per
ldetails belo、v or as applied by nrm、
vhichever is lo、ver:
Export Product
Exporl
Ouantity
S No
Import Product
Quantify
Allowed
Haemodialysis B icarbonate
;artridge, Sodium Bicarbonate
t.P. -500 grams
l12704
ヽos.
l
Emotv Bicartridges
235031 Nos
つ
ん
Sodium Bicarbonate
117515 kg
laemodialysis Bicarbonate
:artridge, Sodium Bicarbonate
I.P. - 650 grams
19392 Nos.
1
Emotv Bicartridges
19585 Nos.
2
Sodium Bicarbonate
12731 kg
r{aemodialysis B icarbonate
:artridge, Sodium Bicarbonate
t.P. - 720 grams
19392 Nos
1
Empty Bicartridges
19585 Nos.
つ
‘
Sodium Bicarbonate
14102 kg
Dry Citrapure 45 X Dextrose.
)54 Nos.
l
Sodium Bicarbonate
15303 kg
38
rRA may take appropriate action as per the decision of Norms Committee.
汗
8
:
|
ICase No。:95/17/82‐
lALC4/2016
|
闘
l :01 1 821 050 1 0 1056 1 AM|T I
留器営
8讐lttNC°
RD
|
膨塀
::OЮ舵“ハm7
IMeet No/Dateil 1/82‐ Status:Deferred
:ALC4/2017
124.012018
:Lic.No/Date:0810138997 1Defer
12810.2016
IDate:24.01.2018
(15.882 Kgs.)
Citrapure 35 X Dextrose,
(15.882 Kgs.)
Sodium Bicarbonate
Decision : deferred
I Case No.:11/16/82‐
| IALC4/2016
IParty Name:EMCURE
IPHARMACEUTICALS LTD
IMeet No/Dateil 1/82- Status:Deferred
lALC4/2017
12401.2018
tLic.No/Date:3 I I 0066388 rDefer
Date:24.012018
loo,---
-
'" lHq rite
面
"
‐
師
| IALC4/2016
:01/82/050/00828/.AM17/
131/83/040/00094/AM17/
:31.10.2016
IDecislon:deferred
ICase No.:18/16/82-
~~~~降
吻Name:HONOUR LAB IMeetNo/Date:11/82- status:Deferred
lALC4/2017
124012018 '
IDate:24.01.2018
ILIMITED
|
発
:ち濡話蔦蕊;
Lic.No/Date:091oo64330,Defer
31 10.2016
||五■Na轟
=面
iёRO LAjζ IMお1ヽルbiおlii′め
:
ILTD
｀ALC4/2017
臨
υ剛弘m7RLr乱
~~~一
― 餞珈品面品歯ヴ
ト07/24/040/00255/AM17/ 102.H.2016
"S、
i葛絲ⅢⅢ品ξ百詭8古∬Fttagendl and deiお
`1貌`ど
もA“g蔦品も11
層聯ilぶ肥∬i磐
1∬
:ぶ:詠野
t龍猟∬器Wil思謂∬
:『富|
iCase No。:15/14/82‐
IALC4/2016
norms under para
Status:
Approved
the presence of the r
t 4.7 of HBP as per:
ldetailS be10wOras appliedby nrm whichevgr is lower:
1201
1
Export Product
Export
Ouantitv
S.No
Import Product
Quantity
Allowed
AMOXICILLIN TABLETS 500
MG(BP/EP/USP/1P)
l Nos
l
AMOXIcILLIN
TRIHYDRATE
BP/EP/USP/1P
146.34
mg/tablet
へMOXICILLIN TABLETS 250
ⅥG(BP/EP/USP/1P)
l Nos.
l
AMOxlcILLIN
TRIHYDRATE
BP/EP/USP/1P
29268
mgたablet
へMOXIcILLIN TABLETS 500
ⅥG(BP/EP/UsP/1P)
NOs
1
AMOXICILLIN
TRIHYDRATE
BP/EP/USP/1P
585.35
mg/tablet
RA may take appropria
揚
33泥5υ∞
"夕AM7
39
| ICase No.:158/20/82‐
| :ALC4/2016
2021責0 1il` ~
101/82/050/Oi335/AM17/
Pa●y Name:ENAL DRUGS
‐PVT LTD.,
RLA File
:09/24/040/00411/AM17/ 珈続
断と｀JDa落¨
p3.11.2016
Decision : deferred
轟
Decision : deferred
1204
ICase No.:157/20/82‐
IALC4/2016
IHQ File
:01/82/050/01334/AM17/
Decision : deferred
ICase No。:150/20/82‐ Patty Name:EYTAN LABS MCet No/Date:11/82-
| ■LC42016 」MrED I針
『盤了
ICase No.:148/20/82‐
lALC4/2016
Patty Name:LEE PHARMA
LIMITED
IRLA File
109/24/040/00399/AM17/
iMeetNo/Date:H/82-
:針∬鰍了
12051
2° 51HQ Filも
:01/82/050/01325/AM17/
|
Decision : deferred
|
‐Case No.:160/20/82-
ALC4/2016
206
Lic.No/Date:0910064336
J
## Case No.:25/20/82‐
ALC4/2016
Decision : deferred
Party Name:ALKALOIDS
CORPORATION
rStatus:Deferred
ilirl
|
つ
‘
一
ｅ
ｔ
Ｎ
。
／
Ｄ
ａ
¨
０
‐
・
２
０
‐
８
Ｍ
ｅ
Ａ
Ｌ
２
４
．
1207.責011i8 ~ ~ ~
1 101/82/050/01202/AM17/
IRLA File
102/24/040/00145/AM17/
開
―
一
|
‐Case No.:16/14/82-
‐ALC4/2016
Party NamelMALLADI
DRUGS&
PHARMACEUTICALS
LIMITED
‐
HQ File
:01/82/050/00814/AM17/
RLA File
:04/24/040/00133/AM17/
Status:Deferred ,
＾
υ
う
ん
I)ecision:deferred
iStatus:Deferred '
lr
I
:01/82/050/O1327/AM17/
IRLA File
109/24/040/00410/AM17/
ILic.No/Date:0910064338:Defer
10311.2016 :Datei24.01.2018
Patty Nanle:HETERO LABS iMeCtNo/Date:H/82- iStatus:Deferred
ЫMITED I針∬鰍了 |
肺
語
i
IRLA File
109/24/040/00426/AM17/
iLi".No/Dute:09 I 0064340 lDefer
103.11.2016
lDate:24.01.2018
Palty NallleiVIRUPAKSHA IMeet No/Date:11/82‐
.ORGANICS LIMITED :ALC4/2017
. 124.01.2018
IStatus:Deferred
|
‐103.11.2016 1Datei24.01.20181
lMeet No/Datell182'
tALC4l2017
i24.01.2018
需需而面臨高L
40
IM`よ出
/82‐
ISta tus:Deferred I
IALC4/2017
124012018
Lic.No/Date:0310809129
111 112016
IDefer
lDate:24012018
|~FaseNo。:101/17/82‐
| :ALC4/2016
| |
′
10 HQttF
| ,・1叉r ll。
l i:01/82/050/01062/AM17/
FP
Meet No/Date:11/82-
ALC4/2017
2401.2018
Status:Deferred
IRLA File
l:05/23/040/00372/AM17/
Lic No/Date105 10400404 1Defer
ll l1 2016 1Date:24.012018
:
12H
lcase No':14 4/20/82- iilftvn"r"MYlAN lrra..t No/bii "rll/si:-
- jsirtrr,ueferred
r
iALC4/2016
LABORATORIES LIMITED ALC4I2OII
:
,, _*_* _
24.01.2019
luq nile
-- lRlA Fii;
Lic.No/Date:0910064386 ]b;i;r
i0y!_?1T0191:2:ry:M]/ ,:0et24t040/oo43o/AMtlt rs. u.r0 r6
:Date:24.0r.20r 8
Decision : deferred
:1需癬編声
~~¨
1鳳濡繁熙吾:姓漱需輌が~~い高b轟高
'4.01.2018 1
:趾11す1鴇|ず,十∵
1譲石二
:|
Decisi蒜=朦
礁
Meet NoiDate:ll/82- Status:Deferred
:針『1鶴了 |
「
~お
38掲5υttνAⅦj~顧W~~……
1109/'4/040/0042つ
/△ヽ/117′
′B面
|たヽo'5`iさlo9r66843j,IDeLf~
:09/24/040/00432んへM17/
15 11 2016 1Date:24.012018
9::l):t:ils/20t82- l,TY.1iy'.151ryos Meet No/Dat e:nt82- Starus:Deferred
|iALC4l20l6jHeAr,rrrcaREPRIVATE.oiiiiii,ii.c,ll/oz-
)14 t
iLIMITED
i24.01.2018
i
l
''- :HQ Fite
'RLA Fit; -
^
f_ic.NoZOate:0910064399 Defer
illll'z]-qry0tTg11Ml7t :0et24t040/0044s/aMt7t ir.,,.rr, 6
:Date:24 0r.20r8
「慶堂三
「略芋 ~
## Case No.:127/20/82-
rbi臨
蛉
91.M17 1鶴
A ΠL~~~…
…… … ~.`、
も,5品boi66&jぅゲDe籠1‐
09/24/040/Oo459/AM17/ 11811,01κ l、
^`^ハ′
IRLA ΠL
1
戯IZttVlΨ Uイン4MI乃_111・T2016
わ誠α240L2018
iDecisiOn:deferred
41
IHQ File lRLA File
101/82/050/01189/AM17/ 109/24/040/00419/AM17/
‐
## Case No.:12/20/82¨
‐ALC4/2016
iCase No。:121/20/82‐
Party Name:AUROBINDO
PHARMA LIMITED
IMeet No/Date:H/82‐
lALC4/2017
124.01.2018
譜∬鼎α醐∞“
1"
216
Decision : Committee considered case as per agendffid aeliberateO on the matter in the preiin.. olifl.
technical experts and it was decided to ratifo the ad-hoc input output norms under para 4.7 of HBP as per
details below or as applied by fir,. whichever is lower:
Export Product
Export
Ouantity
S No
Import Product
Quantity
Allowed ke/ke
VALACYCLOVIR
HYDROCHLORIDE
l kg
1
Acyclovir
0.758 kg
つ
４
50/O Palladium On
Charcoa1/Carbon
(Catalyst‐type 5T39
Paste)
0.0079 kg
1,3-Dicyclo Hexyl
Carbodimide(DCC)
1.061 kg
4
4-Dimethyl
Aminopyridine
0.028 kg
Carbobenzyloxy -L-
Valine (CBZ-L-Valine)
1.112 kg
6
Dimethylfollllamide(D
MF)
4.25 kg
7
Methanol(Methyl
Alcohol)
3.25 kg
Steam/Thermal Coal
(Non-Cooking) in Bulk
( Limiting factor is
value only, the eligible
CIF value is 5% of FOB
Value.) Due to non
acceptance ofzero
decimalby DGFT EDI
System, we have
mentioned estimated
Qty. Only.
As per packing
policy
‐RA may take appropriate action as perthe decisiOn of Norms Committee
|
|
1217
:ALC4/2016
t需聴よ責Ё
fЁる
・扇も匿」漱摯
8・7"‐
|・
lV・`・レレ :う万612018
IRLA File iLic.No/Date:0910064401
:09/24/040/00461/AM17/ 118.H.2016
IHQ File
薫、
1葛|:
:01/82/050/01298/AM17/
Declslon i deferred
I Case No.:122/20/82¨
‐ ALC4/2016
Patty Name:HETERO LABS
LIMITED
IMeet No/Date:H/82‐
lALC4/2017
124012018
ILic No/Date10910064402
118112016
|
IDefer
lDate:2401.2018
?1810116 ~
. :01/82/050/01299/AM17/
IRLA File
109/24/040/00451/AM17/
Decision : deferred
,191従漁キ
182υ
82‐
Party Name:HETERO LABS
ILIMITED
IMeet No/Date:H/82-
IALC4/2017
istatus:Deferred‐
Status:Deferred l
42
~|~
IHQ File
t:01/82/050/01305/AM17/
取LA FI「~~
卜
0924/040/00436んへM17/
124.01.2018
Liti｀6′ bit`16うibb`446615`庭r
18 11 2016 1Datc:24.O12018
,Decis10n:deferred
IM881ヽ6′b:iもlli,82:~ も1lti`:5tFeiled l
lALC4/2017 1
124012018 1
Lic No/Date:63ib:b0216 158fer
「振謎脇∬た
7慇多 1鳳
| |
1211 :蔦
K ~踊需硫メ
~~1儡臨再
:こ:警l厳FΨ爾叫ぉ昴
|
鷲漱需衝″ Ⅲ赫ferredl
|¨
面満面高ギ縣軋
鮮| ′劉囲
6
om the rlrm copy of DルlL.
I R`“ .:… 。.`…■J_..T… Ⅲl_I二
1~lドγγ
``1中・1ん
Name:MEGHMANI
ISTRIES LTD,
~~薇
LA百お
~‐~~~～‐‐~
1:08//24/040/00293/AM17/
22 112016
ueetuoloaierlttt$- btrtri,.o;i.;;.;
ALC4t20t7
24.01.2018
Lic.No/Date:O8 I 0 I i9050 Defer
22.11.2016
Date:24.01.201g
lDecision r it.f..*d
|~ ~ltrr i__."=""-...-
I
i--" HQ File
_-_-..-.--.-..--.-.-.--__-*t
IHQ File
~IRI A File ~~…
1
1 101/82/050/01o81/AM17/
103/95/040/Oo602AM17/
castN品蒟17/8メ~… …
11arty/ヽ」島3■↓輸ё…
lALC4/2016
2401.2018
Lic.No/Date;031
:6」ib恵0026315さぉ:
Meet No/Date:11/82-
:Datei24 01.2018
Status: Deferred
:ALC4/2017
124.012018
|ヽ出す
:11警妻」
:ふ」
:L
122
'Meet No/Date:H/82‐
rStatus: Deferrecl
:ALC4つ017
124.01.2018
Lic.No/Date;OS f O+OO+3: iO.fe,
24.11.2016
,Date:24.01.201g
IMきさ
iヽ8,5五i`liiツを
,:
,ALC4/2017
IStatus:DeFerred l
ZzAtg?tfNo.:86/lils2_ ,eu.ry NareeICHW
IALC4/2016
jnT'anNarroNAl. PVT.
iCase No.:99/17/82‐
lPafiy Name:SAURAV
誓
41
:ALC4/2016
iCHEMICALS LTD,
IRLA File
|:22/24/040/Ooo73/AM17/
43
|
IHQ File
:01/82/050/01047/AM17/ :05/23/040/00358/AM17/
.Decision : deferred
師Lう前8 「
¬
購 B施ち
4劇洲:
:LTD.
RLA File
i∵「
〔
|
1
ICase No.:155/17/82‐
ALC4/2016
Patty Name:CIPLA
LIMITED
1227 HQ File
101/82/050/01116/AM17/
RLA File
:03/94/040/00757/AM17/
Decision : deferred
Deler
Datc:24.01.2018 ‐
ICase No.:129/17/82‐
IALC4/2016
128濃Fi「~一―
Patty Name:DELTA
FINOCHEM PVT.LTD.
101/82/050/01090/AM17/
IRLA Filc
:03/94/040/00675/AM17/
Defer
Date:24.01.2018
Decision : deferred
ICase No。:180/17/82‐ Patty Name:ENCUBE IMeet NO/Date:11/82- lStatus:Deferred l
lALC4/201` IETHICALS PVT LTD IALC4/2017 1 1
. ( 124.Ol.2018 1 1
:29脇覇:i鳳耳稀分
jlil蕊肝
~欧
」需
『豆再雨蕊百万
B霊元
10L2018
'Decision ; deferred
‐Case No.:84/17/82-
‐ALC4/2016
2301百0「i18
101/82/050/O1045/AM17/
ICase No.:36/20/82‐
ALC4/2016
今
‘
HQ Filc
'Party Name:SENTISS
PHARMA PVT LTD.
:01/82/050/O1213/AM17/
IDecision:deferred
‐Case No.:116/17/82‐
ALC4/2016
232‐ 青。rilさ
IRLA F‖ e
105/24/040/00423/AM17/
IRLA File
l:52/24/040/00053/AM17/
―
―
一
:01/82/050/01077/AM17/
Meetヽ。/5轟i1/82‐
~~
IALC4/2017
1ぅヵ^1ぅAlo
l case No.:128/1/82- ‐Party Namc:STRIDES
SHASUN LIヽ41TED
233‐ ALC4/2017
諄‖¨
:mDeFerred
125.112016
IMeet No/Date:H/82-
IALC4/2017
124.012018
♭8.l L2016
IStatus:Deferred
Palty Name:MOREPEN
ILABORATORIES LTD。
, 渉‖
d虚~ド恥
md
RLA File
- -llii.No/Date:0510400507l?tft'^.
^. ^
',:052464060415/AMl7/ lZA.t t.ZOtO
lDate:24.01.2018 i
Decision : deferred
IMeet No/Date:H/82-
:ALC4/2017
2401.2018
Status:Deferred
101.122016
ILic No/Date:0510400571 1Defcr
iDate:24.01.2018
,
Party Nalnc:AETHER
INDUSTRIES LIMITED
IMect No/Date:11/82-
IALC4/2017
124.012018
lstatus:Deferred
44
沈策ぎ面前話比‐
3量虫まふ
1計
Meet No/Date:11/82- Stituζ :b`felita
ALC4/2017 1
124012018 1
―
―
―
―
―
|
.
--'t
-*.'
## Case No.:3t/ltg2-ALC4/20t7 party Name:RONef
Meet No/Dat e:t t/g2_ Srarus:
ral-tEnrI-^r
o
i , -
ICHEMIcALS
■lr"L7 1Approved
HQ File
~~猥
己万百肩
Export Product
Export
Quantity
S.No
lmport Product
Quantity
AIlowed kg/kg
SODIUM 2- ETHYL
{EXONATE
l kg
2-ETHYL HEXONIC
ACID
1.01 kg
may take
罐為瀞~俳3410042719ギ≒
/11 ウ′ |
ヽM17/ lo5.122016 1 1
鴇器蠅譜∝
“
Ш協1濡濡温|
RA
appropriate
ction as per the deci`iOn of Norms COmmittee.
|:01/82/050/01482/AM17/ 1:o4/24/040/Oo145晨M17/
２
８
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湘
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Ｌ
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一
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「136稀蔦
|~´ VIHQ Fi
| 101/82/050/01o39/AM17/
1 1Decislon:deFerred
'`●
ヽ品品:INDIA~~‐
IGLYCOLS LTD.,
1
匠A Rb l
:05/23/040/00412/AM17/
IMeet No/Dateil 1/82‐ status:Deferred
,ALC4/2017
124.01.2018
1Lic.No/Date:0510400608 1Defer
106.122016
:Date:24.012018
iCase No.:79\n/n:
,larty Nu,,,_:Aeee nS
: iALC4/2016
lpHanvacEUTrcALS pvr
."_,,,_
|LTD
｀ 1 1LTD
「7 甕 1_1
IMeet No/Date:H/82-
IALC4/2017
124.01.2018
:Lic.No/biteibζ ib40b`ζう15さfer ‐
107.12.2016 1Datc:24.01.2018
Status:Deferred
一
―
―
一
―
―
一
一
二__壼
漁襄1聴:癬｀
1扇」
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:
24.01.2018 1 1
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ttAB
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|ぶi:tit:b`feltta l
ふ
;穣食鳳憎あ碗メ
2341青。
「ile
ICase No.:128/17/82‐
IALC4/2016
IParty Name:GLENMARK
IPHARMACEUTICALS
、LTD,
IRLA File
Lic｀も
'bitき
ibbibttbうと
bずb`お「
:01/82/050/01089/AM17/
|:03/94/040/00801/AM17/
05 12.2016
:Date:24.01.2018
IDecisio■:deFerred
45
IHQ File lRLA File
::01/82/050/01319/AM 17/ :09/24/040/00492/AM17/
oecision : deferred
124012018
魏需繭繭Defer
Date:24.0 I .201 8
## Case No.:21/20/82‐
Palty Name:JUBILANT
GENERICS LTD
MさdN´5五百而:ア ~
:ALC4,2017
124012018
IStatus:Deferred‐
ALC4/2016
語ら蛹蔀而
400685開蕊:if
難き漱TTル
82‐ ~,而ぎ
儡乱
d
,4012018 1
ν
l 10百お~ ~ 協jlij:lili話
~~~~~瀞だぢ鹿よ
b蒟瑞
bg意
`開LIふ|:
|:01/82/050/O H 99/AM17/ :
‐RLA Fllc
105/23/040/00402/AM17/
ICase No.:22/20/82-
Pany Namc:」UBILANT
GENERICS LTD
ALC4/2016
ICase No.:81/17/82‐
ALC4/2016
242‐ HQ File
Par57 Name:BIO TECH
OPHTHALMICS PVT LTD
IRLA File
]Meet No/Date lll82-
istatus:Deferred
ALCI l0l7
I
24 g | .lr)lg
it-ic Noioatioaior:qiia ib;i;"-- -
loe.tz.:oto
lDate:24.ot.2otr
|:01/82/050/01042/AM17/
:08/24/040/00360/AM17/
Decision : deferred
243
ICase No.:37/20/82‐
‐ALC4/2016
1HQ File
|:01/82/050/01214/AM17/
Paty Name:lOL
ICHEMICALS AND
IPHARMACEUTICALS
LIMITED
IRLA File
:30/24/040/00026/AM17/
Status: Deferred
諄岬而
:
‐ ICase No.:118/20/82‐
I ALC4/2016
ParりName:SUVEN LIFE
ISCIENCES LIMITED
IMeet No/Datc:H/82‐
lALC412017
124012018
1Lic No.Datei091 0064464
109 122016
244 uq rit.
―――一――
―
―
J
Defcr l
Date:24.01.20181
:01/82/050/O1295/AM17/
IRLA Filc
:09/24/040/00472/AM17/
Decision : deferred
J
Case No。:7/20/82‐
ALC4/2016
245
ILic,No/Datei0810139274 1Defer l
HQ File RLA File
Юν
"Ю
5υ剛″AM口 Юν
2″04υO“4'AML__IPJ,2い
'____」
聖:型望里
11
Declslo■:deferred
ぅ"∠ICase No.:9/20/82‐ ParりNameiBIO TECH
~需
濡絆
1魔牌滞戦咄需h麓
124.012018
12461x懸3ォ}こじ〔と
… ′~ 161舌
THALMICS PVT LTD
1 1 _ _ ______―
‐
―
―
― ― ｀― ・ ‐ __ _
―― …… ‐ ‐^― ―
・― ―__― ‐―″ 一― 殴調需nし
'II価
す11
24011。lile
1 101/82/050/01198/AM17/
:Decision : deferred
Lic No,Date:3010103898 1Dcfer
.09 122016
IDatei24.012018
46
| |
陣01.2018
~| |
IHQ File
i:0 I 182/050/01 1861 AMI'7 I
RLA File
:08/24/040/00355/AM17/
ILiも｀o/bitき:6をibl」0うケ
`bさ
fel
13.12 2016 Datc:2401.2018
Decision : deferred
監:激Pttr麓丁¨
―
24.01.2018
「
つ
４
iCase No。:146/17/82‐
:ALC4/2016
1
|ん
‐
′ |
1
・′
IHQ File
‐ 101/82/050/01107/AM17/
‐Decision i deferred
Party Name:CIPLA
ILIMITED.
RLA Filc
:03/94/040/00835/AM17/
iStatus:Deferred l
ILiも｀o/5,tと10bibttb9,な1158籠:
1312.2016 1Date:24012018
r
lror
ICase No.:19/1/82‐
IALC4/2017
HQ Fiに
‐~~~~
,Party Name:IND―SWIFT
ILABORATORIES LTD,
RLA File Lic.｀も
,b五お:"1001``bうbefel~‐
~…
Datei24 01.2018
101/82/050/01373/AM17/
:22124/040/00081/AM17/ 113122016
「
|
249
ICase N ().:142/17/82‐
~
IALC4/2016
IParty Name:Л NDAL DRUGS
IPRIVATE LIMITED
RLンA File
:03194/040/00818/AM17/
11::概需よ責麓: ■
iζbざL存
`|
'4.01.2018 1 1
1Lたヽ
6′b:i`:6」ibj6"もゥb8庭| |
13 122016 1Date:24.01.20181
IHQFile ~~~~~~~
|:01/82/050/O H03/AM17/
ICase No.:143/17/82‐
lALC4/2016
Party Name:JINDAL DRUGS
PIくiVATE LIMITED
1250
1
IRIンA Filc
103/94/040/00819/AM17/
IDate:24.01.2018
1251
IHQ File
i:01/82/050/O Ho4/AM17/
below or as applicd by the firm, whichever is less:
Export product
Exp Qty
SI No
lmport items
Qty allowed
kg/kg
ABHAYARAB O.5
ML(HttMAN
RABIES VACCINE
WITH
DISPOsABLE
1000∨ials
TRYPAN BLUE
0 001 gm
2
ADULT BOvINE SERU,0.2
MICRON FILTERED
0.76 Ltr
3
L―GLUTAMINE
0 0547 gm
4
MINIMuM ESSEN¨
｀VITH PEPTONE
0 413 kg
鵬島胤鳥
1」:鳥|;~1晩隧LsI↓∴~僣
穆″
b品訪轟
6演´鮨I~~
12.2016 1
lDecislon:!n thoith,ハ
f lA′ ri●●△h´ ´ ~~~~~~一
‐――、
一――´ __ _ _ _ _‐ ― ― ‐ _
## Case No.: l4il}0lg2-
I,.rrty Name:INDIAN
Meet No/Dat e:l llg2_
Status:
;ALC4/2016
TMMUNOLOGICALS LTD., ALC4t2Otl
Approved
24.01.2018
,Decision : rn the light of written .orr.nt, **ir;; ir;; oepartment of Biotechnorogy vide their oM
:No' BTl1105/34012o13-PlD dated 13.06.2011, it was decided to ratify norms under para 4.7 of HBp v1 as
,per details given below or as aoolicd bv thp firm rrrhirha,ar ic r^...
IMeet No/Date:H/82-
lALC4/2017
124.01.2018
Status:Deferred
47
SYRINGE AND
DILUENT)1
DOSE/1 VIAL
5
POLYMIXIN B SULPIIATE
0.396 gm
6
KANAMYCIN SULI)IIATE
4 37gm
7
NEOMYCIN SULPHATE
3.216 gm
8
HUMAN SERUM Al′ 13UMIN 25%
0.84 Ltr
9
2ML VIAL CLEARI＼JECTION
F13
1100 Nos.
10
13 MM FLIP‐ OFF‐ SEAL 3769
(ALUMINIUM SEAl´
)
1100 nos
RUBBER STOPPER V 50 4405/50
GREY
1100 Nos
12
THIMERSOL/TH10MI〕RSAL
015 gm
13
PS ROLLER CULTURE BOTTLE
4250(DISPOSABLE) ______
1408
14
SYRINGES 2 ML VVll H NEEDLE
24 GUAGE MAKEIBD
1000 8 Nos
RA may take appropriate action as per the decision of Norms Committee
‐252
ICase No.:18/20/82-
ALC4/2016
1HQ File
101/82/050/01195/AM17/
Pary Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD。
,
RLA File
i05/24/040/00429/AM17/
IPaty Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD。
,
RLA File
i05/24/040/00445/AM17/
非郎蔀ぼ師
~
IIぢЪ
ttα
0510400788 1
IMcct NO'Date:1
:ALC4/2017
12401.2018
1412.2016
Decision : Committee considered case as per agenda and deliberated orl the matter in the presence of the
technical experts and it was decided to ratifi the ad-hoc input outpLrt norms under para4.7 of HBP as per
details below or as applied by firm whichever is lower:
Export Product
Expott
Ouantity
S No
Import l)rodtrct
Quantity
Allowed kg/kg
Ketorolac Trometham ine
)phthalmic Solution 0.5o/o w lv
l0 ml, (Each ml contains
Ketorolac Tromethamine 5 mg
(Equivalent to 0.952 Kg of Bulk
Drue)
19047 Nos.
1
KETOROLAC
TROMETHAMINE
4 97 kg
Ketorolac Tromethamine
)phthalmic Solution 0.5oh wlv 3
ml, (Each ml contains Ketorolac
Iromethamine 5 mg
(Equivalent to 0.952 Kg of Bulk
Drus)
;3484 Nos.
l
(etorolac Tromethamine
)phthalmic Solution 0.5oh wlv 5
nl, (Each ml contains Ketorolac
fromethamine 5 mg
iEquivalent to 2.830 Kg of Bulk
Drug) (Equivalent to 4.735 Kg
cf Bulk Drug) Drug
Formulation/ Formulation Grade
113200
Nos.
1
RA@tionasperthedecisionofNormsComlrrittec.
ICase No。:42/20/82‐
IALC4/2016
1HQ Flle
101/82/050/01219/AM17/
ll82-
istatus:Deferred
Lic No11)ate:0510400789 1Defcr
253
IDate:2401.2018
48
‐ IDecision:deFerred
Party Name:CADILA
HEALTHCARE LTD
RLA File
:08/24/040/00321/AM17/
…
1荒漱常hが沖ζ
Defer品
り4.01.2018 1
ILic No/Datei0810139295'Defer i
115.122016 ‐Date:2401.2018
Ｆ
‐
‐
‐
２
５
５
IHQ File
101/82/050/01137/AM17/
IDecision:deferred
Party Name:GITANJALI
CHEMICALS PVT LTD
RLA File
:03/94/040/00741/AM17/
IMさet｀6′baお:i1/慧2‐ IStitiζ ibeferttd.
1針∫
1鶴了 | |
lLic No/Date:0310809851 1Defer
1512.2016 1Date:240120181
Party Name:FRESENIUS iMeet No/Date:l1/82‐ status:
KA131 0NCOLOGY IALC4/2017 1Approved
LIMITED 24 01.2018 :
256
RLA ΠL ~~~画
面。/DII蒟面雨藤琢| ~~|
05/23/040/00446/AM17/ 16.12.2016
: Comlnittee cOnsidercd case as per agenda and de‖
berated On the matter in the presence of the
ical experts and it was decided to ratify the ad-hoc i
ruat cxpcrts anq lt was oecldecl to ratlty the ad-hoc input output norms under para4.7 of HBp as per
s below or as applied by lir.rn rvhichever is lower:
RA may take apprOpHate act10n as perthe declsお
n ofNorms COmmitee
, E,s" il,trizuaz;-i.Lcirzoro
t2s7l
,l
rl
Party Name:HONEST BIo_
VET PVT.LTD
IN`cet NO/Date11 1/82-
lStatus:
lApproved
IALC4/2017
124.01.2018
## Case No.:176/17/82‐
## Case No.:18/1/82-
ALC4/2017
HQ File
:01/82/050/01372/AM17/
Export Product
Export
Quantitv
S.No
Import Product
Quantity
Allowed ke/ke
Methotrexate Injections
l5mg/3ml.
3500 Nos.
l
Methotrexate IPruSP.
57.75 gm
つ
４
Rubber Stoppers for
Pharmaceutical Articles
Use.
Rubber Stoppers 20mm
Bromobutyl S- 127
4405/50 EPP.
As per Packing
Policy
Mcthotrexate ltteCtiOns
50mg/2ml.
75600 Nos.
1
Methotrexate IP/USP
4358.00g m
つ
４
Rubber Stoppers for
Pharmaceutical Articles
Use.
Rubber Stoppers 20mm
Bromobutyl S- 127
4405/50 EPP.
As per Packing
Policy
Methotrexate I nj ections
500mg/20m1.
32200 Nos
1
Methotrexate IP/USP.
16905.00 gm
2
Rubber Stoppers for
Pharmaceutical Articles
Use.
Rubber Stoppers 2Omm
BromobutylS-127
4405/50 EPP.
As per Packing
Policy
|
1254
iCase No.:213/17/82-
lALC4/2016
|
IHQ File
101/82/050/01174/AM17/
:Decision:deferred
49
IHQ File lRLA File Lic N()IDate10810139328 : |
:01/82/050/01218/AM17/ :08/24/040/00383/AM17/ 19122016 1 ‐
IDecision:Committee considered case as per agenda and as per carlicr dccision taken by NC in its 27/821
meeting 05 10.2010, ■was decided to ratitt norms under pa薇147o「HBP as pcr details below or as
apphed by Arm、vhichever is lo、veri‐
Export product
Exp. Oty.
Sl.No
Import itenrs
Qty. allowed
Menadione
Nicotinamide
Bisulphite
l Kg.
1
Menadionc
Sodium
Bisulphite 9-l'l'o
0.917 kg
つ
４
Niacirramidc
0.40 kg
RA concerned may take further
action as per above decision ol'NC.
」
neccssary
per
ёiseヽも
::44/'o/恵う_ALё4た016 1alty N五島ざ
:南6ヽビ毯↑BIo_~ Mcctヽ()/b:t`:iiた
'1 ~lζ
iltiζ :~ ‐
IVET PVT LTD ALC‐
|‐2017 :Approved
24012018 1 ‐
1責0+li8
‐
l良
=Å
li` ~
‐ ‐~｀一―
Lic No‐ Di`16恵ibiUOjうケ |~‐
~~… … |
|:O1/82/050/01221/AM17/ :08/24/040/00382/AM17/ 19122016 1
・
IDecision:Committee considcred case as per agenda and as per earlicr dccision taken by NC in its 5/82 1
meeung 24.07.2014,it was decided to rati″ nOrmsunderpara47ofHBPasperdetailsbeloworas l
applied by firm whichever is lower:-
258
Export product
Exp
Qty
Sl.No.
lmport items
Qty a!10Wed
kg/kg
MENAD10NE
DIMETHYL
PYRIMIDINOL
BISULPHITE
(FEED SUPPLEMENT)
lkg
1
MENADIONE SODIUM
BISULPHATE
0.918
ACETYL ACETONE
0.40
3.
N一BUTANOL
0.40
RA may take appropriate action as per the declsion of Norms committee..
ICase No.:30/1/82- ParりName:SRIAM LABS IMeet No[)atc:H/82‐ IStatus:DeferreC
l tiζЪ ttb.1レi慇
'_ latt N話
よS血AM tABs
■ed No D試よi1/8が
ヽ江uttDeたrred
l ‐ALC4/2017 PRIVATE LIMITED IALC4/2017 1
124012018 1
759■0~iお‐~
長LA Fl`~~~~「
~‐
lFi、りvO%0064488曖
e「
lヵ_… 。
:01/82/050/0t 384lAM17l :091241040100508/AM17/ '20.12.20tt,
Date:24'01'2018
I Decision:deferred
.Case No.:53/20/82‐
IALC4/2016
?601QF正~~~~~
101/82/050/01230/AM17/
Pany Namc:TORIN
IRLA File
::35/24/040/00011/AM17/
may
10RGANICS PVT LTD
ICase No.:124/1/82-
IALC4/2017
Party Name:TORIN
10RGANICS PVT LTD
２
ｈ
‐
７
８
山
呻
０
‐
・２
＜
‐
Ｍ
Ｃ
Ａ
Ｌ
χ
3510045080
１１
６
Ｄ
Ｏ
‐
♂
２
・
Ｎ
‐
２
・
‐
Ｃ
・
」
一
Ｉ
Ｌ
２
261
IHQ File
:01/82/050/01478/AM17/
IRLA Flle
l:35/24/040/00070/AM16/
Date:24.01.2018
Decision : deferred
)l,tcqizott
lz+.0 r.zo t s
121 122016
IDefer
iDate:24.01.2018
Decision : deferred
50
~‐｀
籠蕊酔薦~~漱
腰蘊蕊~TI胚
「
而
・T孫芹面
|
262 HQ― File…… … … …
良二人File~~~ 240L2018 1 1
lLic No/Date:0810139351 1Defer l
l:01/82/050/01231/AM17/ :08/24/040/00320/AM17/ 22.12.2016 Date:24.Ol.2018
1Decisioll deFei:ぬ~~ ~二
~~一― ――― ―‐―― 一― ―― ‐
ICase No.:50/1/82¨
1263
:ALC4/2017
IHQ File
101/82/050/01404/AM17/
IDecision:deferred
Party Name:CLARIANT
INDIA LIMITED
RLA File
:03/94/040/00881/AM17/
Party Name:BIo TECH
OPHTHALMICS PVT LTD
IMb`t｀o'bliき:ii/82- ISittitib`feFた西
:ALC4/2017 1
:24.01.2018 1
lLic.No/Dite:0310j10o991b8fe:
123 12 2016 1Date:24.012018
Status:Deferred
IDefer
IDatei24.01.2018
,Meet No/Date:H/82‐
IStat us:Deferred
1鷲:」湯rtα
'4012018
,Case No.:125/1/82‐
IALC4/2017
′“赫
101/82/050/01479/AM17/
IDecision:deferred
l iCase No。:56/20/82‐
| IALC4/2016
?651QF蔦~~~~~
| 101/82/050/01233/AM17/
1 lbetiζ ibi l a`feFl`む
Patty Namα T6RIN ~~~~｀郷Iどき:ヽも面
てヽたふ
… ‐
ORGANICSPvTLTD I,ぉ
『1式、了
RLA File
3y24Ю4υ0004夕AM17 易
:ど鰍慧∝
3510045085
RLA File
i08/24/040/00401/AM17/
犯鸞蒟面街
Lわ53爵…… ~|
IDate:240120181
′
66 FHQ File
: -"
i-'^ --"**
-
lCase No.: 4/1/82¨ALC4/2017
||
F~椰13児5∽団A話;
IDecisiOn:deferred
ICase No.:60/1/82‐
lALC4/2017
1HQ lile~~… …
:01/82/050/01414/AM17/
| IDecision:deFerred
: IDecisiOn:deFerred ~‐
RLA File
:03/94/040/00836/AM17/
Party Name:AGIO IMeさiNo/btti`:il,なう: ~lstitiζ ib`fellta
PHARMACEUTICALS LTD IALC4/2017 .
12401.2018 1
~におヽ
6′bit`:6b16意ib10b 158fer ■
12912.2016 1Date:24.01.2018‐
|
1267
|
Part1,,Name:INFINITy -,V..tNo/D,arc)1lg)_
Stutri,OeierreU
LABORATOzuES i/.tcqtzon
PVT.LTD.,
lz+.ot.zott
,:
nla Cire---._-.*.-.-._'- --* "*lti".N"roui"l)zioorjG)iin"r* ,*- -
,
t22/24t040/00!87!.y1v lzo.tz.zorc -- io"i",24.0t.2018
## Case No.:58/1/82‐
:ALC4/2017
12691責ё
rilき
4VノIHQ File
1 101/82/050/01412/AM17/
51
Palty Name:GITANJALI IMeet Nol)ate:11/82-
ICHEMICALS PVT LTD IALC4/2017
1 124012018
協濡j:鳳;話1…諸ざ嘱ド“
bttbう充
Status:Deferred‐
IDefer l
lDatei24 01.2018 1
Decision : deferred
―」
## Case No.:32/1/82¨
ALC4/2017
12701責011i`
‐
:01/82/050/01386/AM17/
Patt Name:ALEMBIC
IPHARMACEUTICALS LTD
:RLA File
134/24/040/00268/AM17/
IMect No l)ate:H/82‐ IStatus:Deferred l
,ALC4/2017 1 1
,4 01 201S I I
清ぶぢ肥
品血
山
B壺甥ふ島ニ
Decision : deferred
|
## Case No.:22/1/82-
ALC4/2017
Pa"y Name:ASCENT
FINECHEM PVT LTD,
1271 ‐
HQ File
:01/82/050/01376/AM17/
IRLA File
i08/24/040/00388/AM17/
| IDecislon:deferred
Case No。:32/20/82‐
‐ ALC4/2016
:72 10 1ie
l :01/82/050/01209/AM17/
Decision : deferred
la●ヽ
:“8:1晨ЁζЁヽlus~~‐ Mも∝N01)aにH/82‐ IStatusDeたrred l
KABI ONCOLOGY
IALC4/2017
LIMITED
24'0l l(t I S
RLA File
Lic.No t)l'e :0510401 159 Defer
:0512310401004't 4lAM17l ]os.o r .:o r ;
lDate:24'01'2-018
―
「
| ICase No.:53/1/82-
Palty Name:CIPLA
LIMITED
RLA File
|:03/94/040/00915/AM17/
酵きま｀
o‐ Date:H/82-
1針∫
l発キビ
Status:Deferred l
IALC4/2017
2731青0「iiも ~
‐ :01/82/050/O1407/AM17/
Lic No/1)tllci0310810380 1Defer
106 01 2011 1Datc:2401.2018 1
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274
ICase No.:170/20/82‐
IALC4/2016
2751百
0 11ig
:01/82/050/01347/AM17/
1)eclslo■:deferred
,Pany Name:RONAK lMeet No l)rte:l l/82-
lcnpvrrcer-s i!y?!,:,?,,1
124.01 .20I I
IRLA llic ~~~~~ILic N。/Dttlci34 1 0042830 1Defer l
134/24/040/00277/AM17/ 10 01 2017 1Date:24.01.20181
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一
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一
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一
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2761Case No.:55/1/82‐
Party Name:AARTI DRUGS
Mect NolI)ate:11/82-
rstatus: Deferred
IMeet No I)atei H/82-
:A LC4/2(り17
12401.2018
,Status: Deferred
諸ざ喘彎
c0810139477B鮨ち
4Ю L2018
52
‐ :ALC4/2017
1 ,HQ File
、 |:01/82/050/01409/AM17/
‐ lDecislon:deferred
LIMITED
RLA File
103/94/040/00900/AM17/
,Lic.No/Date:03 108 l0a6a ,Deier
111.01.2017
:ALC4/2017
124012018
¨
|
IDate:24.01.2018
iCase No.:54/1/82‐
lALC4/2017
ら
771
IHQ File
■01/Qつ/nくn/nl′ n。
:01/82/050/01408/AM17/
ICase No.:27/1/82-
IALC4/2017
127811Qlilさ
| 101/82/050/O1381/AM17/
1 1DecisiOn:deFerred
「躊概″而~
179嵩―
百
F…………
…
101/82/050/01382/AM17/
IDecisiOn:deferred
iCase No.:52/1/82‐
:ALC4/2017
lb`tiζ i`1:at籠Flea
jDecision : deferred
HQ File
:01/82/050/01388/AM17/
¨
僣品
「
… …
Panyヾ五me:AARTl~
‐
IMeよヽ。/75■&ii′82「
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fitiζ 面酢|[ふ
|
lNDUSTRIES LIMITED IALC4/2017 1
b4.012018 、
RLA File ~~ ‐
‐ ~ ILitヽ
。
/Date:63ib8ib483 15`fer ‐
:03/94/040/00805/AM17/ 12.01 2017 1Datei24.012018
Palty Name:CADILA
HEALTHcARE LTD
RLA File
108/24/040/Oo323/AM17/
Pal■y Name:CADILA
HEALTHcARE LTD
RIンA File
:08/24/040/00430/AM17/
IMeet No/Date:H/82-
lALC4/2017
124.012018
IStatus: Deferred
ILたNo/Dac:bttibljう
`bi bき
感
12 01 2017 1Date:24.01.2018
「…甲
ILic.No/Date:08101」0`jO 158fei
113.01.2017
',Date:24.01.201g
80
う
ι
Party Name:CIpLA
LMi品i……ハ |「んW背にH慇2¨
ドぬmsDeたrred l
嘴醍
編∫
路Ⅷ
賢l器鍵]Nb♂‖
漱
需
・
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品
面
高
1:ち石蕊ユ|:,II謝幕よ面疏
4590建
[曳ふ
:∴
―
Party Name:SUN
:Meet No/Datei H/82‐
lALC4/2017
'Status: Deferred
|::魔藷濡′
iたが
PHARMACEUTIcAL
r
IHQ File ~‐
~
|:01/82/050/01406/AM17/
|を」
:`Ndi34'i′jうL
53
| ~~~~~~~~~―
一一一IINDUSTRIES LTD.
1 :
HQ File
:O1/82/050/01378/AM17/
Decision:deferred
IRLAFii3‐
~‐… ~~… …………
LiこN8/Dtltci05ibムOf520 5t
1320 1Defer
)5/24/040/00508/AM17/ 17 01 2017 Date:24.01.20181
:05/24/040/00508/AM17/
|
IParty Name:RUSAN
IPHARMA LTD.
り41012018
~| |
IDefer l
Date:24.01.20181
## Case No.:86/20/82-
ALC4/2016
2841HQ Fllざ
:01/82/050/01263/AM17/
~~面
I Fil」~~~~
:Lic No/Dt11ビ103 10810600 1Defer
i18012()17 1Date:24.01.2018
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一
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¨
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０
‐
．
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:03/95/040/00823/AM17/
285
Decision : deferred
iCase No.:38/1/82-ALC4/2017 1ParりName:BELCHEM INDS.I McCtヽ0,Date:11/82- Status:
I INDIA PVT.LTD. .ALC4.2017 :Approved l
t , 24012018 , 1
■Oiお
~ ~~ lRLAlile~~~~~一
― 一 Lic No Daお:0316恵ib`j恵
~「~~~~|
101/82/050/01392/AM17/ 1:03/94/040/00699/AM17/ 123012017 1 1
Decisioni Committee considered case as per agenda and in light of dec siOn taken in meeting no.21/821
dated 06 04.2014′ decided to ratify norms under para 4.7 of HBP as p(,「
deta‖ s below or as app!ied byl
firm whichever is lower:-
Export product
Exp.
Qty.
SI.No.
lmport itenrs
Qty. allowed
1.3 DIMETHYLOL‐ 5-5‐ DIMETHYL
HYDANTOIN(DMDM
HYDANTOIN 52%-55%)ASSAY
55%MAX
BELGUARB DMDMH
l kg
5.5 DIMEIIIYL
HYDANTOIN ASSAY
99%MIN C.OLOUR
PUREヽVI‖ 丁E
0.382 kg
l deCiSiOn ofNorms Committcc
286 1HO lile ‐
101/82/050/O1253/AM17/
Pany Name:WANKSONS
‐CHEMICAL INDUSTRIES
PVT.LTD
RLA File
:03/95/040/00807/AM17/
IMCet N0 1)ate:11/82- lStatus:Deferred
l針∫l£ |マ |
Lic.No/1)titci0310810695 1Defcr
123.01 2017
Date:24.01.2018
ICase No.:76/20/82-
ALC4/2016
Decision : deferred
iCase No.:97/20/82¨
:ALC4/2016
287 1HQ File
:01/82/050/O1274/AM17ノ
I)eclslon:deferred
′ iCase No.:3/1/82‐ ALC4/2017
288‐
HQ File
:01/82/050/O1357/AM17/
Party Name:RESONANCE
ISPECIALTIES LTD
RLA File
i03/95/040/00781/AM17/
IMCet NO Date:11/82‐
:ALC4/2017
'4.012018
1Lic.No/1)(1l c:0310810742
124.012017
lstatus:Deferred i
l l
‐Defer l
Date:24.01.20181
」
1麓漱濡ど器
~監
滉:ド
H慇}
. 124012018
―――一一―一――…………
:Litiヽ3/1)ale10510401381
1RLA File
l:05/23/040/00507/AM17/ 125.O12017
Defer l
lDatei24.01.20181
:status:Deferred
54
|~澄IINolL′ iた,_AEを4/2617
1 1
189鰤
…… …
1 1:01/82/050/01356/AM17/
l ibecisi3五:むき
feritj
l lCase No。:113/1/82-
| :ALC4/2017
′∞loh籠
| 101/82/050/01467/AM17/
: ICase No.:13/1/82¨
1 lALC4/2017
1 1
?91lHQ百1も ~
| |:01/82/050/01367/AM17/
IDecision:deたrred
IDecision:deFerred
IDecision:deferred
Party Name:ALKAL01DS
CORPORAT10N
IMcet No/Date:H/82‐ status:Deferred l
:ALC4/2017 1 1
124.01.2018 1 1
Party Name:CORONA
REMEDIES PRIVATE
I′ Iヽ41TED
RLA File
i08/24/040/00387/AM17/
RLA File
:02/24/040/00216/AM17/
ILic No/Date:021020ケ
'恵
ケ158fer ~ |
27.01.2017 .Date:2401.20181
匿漱攣僣
I1/82‐ ~~Fttζ
Defe品|
124.01.2018 1 1
Lたヽ
8′ b五iよ6恵ibijう
`b`IDefer‐
‐
130012017
IDate:2401.2018
ILic｀6′ bらtさlo4ibi`う,3な15ざfeF
岬冨TWtt「T,
RLA File
-1
05t)4'040/00543/AMt7t 3t.01.2017
Date:24.Ol.2018
1~~lё aseNJli｀bJ】bた,1
1 1ALC4/2016
′斃loF13-―
―
1:01/82/050/01282/AM17/
, IDecisiOn:deFerred
|~~1む基ざヽ」:o夕i/8'1 ‐
| IALC4/2017
1 1
193鵬既嘉
:Lili↓|,
rDecision : deferrecl
RLA File
i04/24/040/00186/AM17/
I)arty Name:CADILA
PHARMACEUTIcALS LTD
RLA Flle
:08/24/040/00449/AM17/
珈
帥
l聴慧
~孵
貯
面ル壺
・
~:漁
品臨
■
131.01.2017
IDatei24 01.2018
1Status:Deferred
IMeet No/Datel H/82‐
:ALC4/2017
124.012018
Ii`:ヽ6/bit`16恵ibl」0`bj 158fei ‐
101 02 2017 1Date:24.01.20181
1 嬌霊胤″
m/82-
12941:1::111;:i:::::」|:|
Party Name:CADILA iMeet No/Date:t1/g)_ rst;tu;:Deferred
HEALTHCARE LTD
ALC4I2OIl
24.01.2018
RLA Fi[.-
i ----''--'----*--
:08/24t040t004s | / AMt., / _ l,';X):ii,?''08
I 0 I 3e644 m5.;; ;,,
ICase No.:lo8/1/82-
1295
IALC4/2017
|
: 101/82/050/01462/AM17/
: ぶ1■■■■1■111三: :
Party Name:CADlLA
HEALTHcARE LTD
RLA File
:08/24/040/Oo450/AM17/
: IDecis10n:deFerred
1造:」冽琴
tC llお2‐
fね
tu::beたIIed
i24.01.2018 1
ILiti｀6′bilさ1081bijう
`4b lbe庭
|
102.02 2017 1Date:24.01.2018
55
l iCase No.:10/1/82-
| IALC4/2017
‐296.
響P誌
赫
孵
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″
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|
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…―一‐一――― ― … …… …‐一―…
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一
~~~1
1 24.01.2018 1 1
聴需品1而~臨鶴彎面面И制臨4劇.嘉
IHQ File
101/82/050/01364/AM17/
‐Decislon:deferred
## Case No.:117/1/82‐
‐ .ALC4/2017
ParりNameiCADILA
‐HEALTHCARE LTD
Mcet No l)ttlc
iALC4/2017
124.01.201S
ILic No/1)alc108
106.022017
?97●。由3 -~~ IRLA「iぎ… ‐…
. :01/82/050/O1471/AM17/ 108/24/040/00452/AM17/
IDecision:deferred
lCase No.1161/20/82-
IALC4/2016
Patty Name:ARVEE lMeet N0 1)atビ
:11/82-
ILABORATORIESINDIA IALC4/2017
PRIVATE LIMITED 24 01.2018
## Case No.:116/1/82-
ALC4/2017
299‐ l101i18
‐ |:01/82/050/01470/AM17/
Party NameiCADlLA
HEALTHCARE LTD
‐RLA Filc
108/24/040/00453/AM17/
MeetNo l):ir.:l l/82-
iStatus:Deferred'
1瓦こあO17 1 1
う西」1:2018 1 1
i続臨
五
:~
赫臨蔦1181
」
Defer
Date:24.01.2018
「げ
隔
…
1
1 1
1 :
‐298
IHQ File
101/82/050/01338/AM17/
IRLA File
l:08/24/040/00315/AM16/
Decision : deferred
Case No。:41/1/82¨
ALC4/2017
10010「iさ
| |:01/82/050/01395/AM17/
ParりName:GODAVARI
IDRUGS LTD
‐RLA Flle
109/24/040/00607/AM17/
1需鸞
副山雨
"6誌隣L4劇猛:
t出用
'J
ν
2‐ ~'L品:Defe■
124.01.201S l l
IDe彙
IDat(
Lic No/D(1lc t)910064654 1Defer
Lic No/D(1lc t)910064654 1Defer i
07.02.2017 1Date:24.01.20181
le:24.01.20181
Decision : deferred
## Case No.:3/20/82‐
ALC4/2016
301‐ 白
O File
101/82/050/Ol180/AM17/
IDecision:deferred
ParりName:INCHEM
LABORATORIES PRIVATE
LIMITED
RLA File
Lic.No I)rtte , '() I0064656 Defer
Meet No.I)al、
'
ALC4/2017
24012018
:09/24/040/00497/AM17/
107.02.2017
11‐′
`1し。
・
Z3‐・・ヽ
′
・
・
Zしヽ
′
・
V I
ICase No.:98/1/82‐
ALC4/2017
3021責
O Filも
| :01/82/050/01452/AM17/
Pany Namc:IN D‐ SWIFT
LABORATORIES LTD,
IRLA File
122/24/040/00101/AM17/
耐や玉絲品
|
| :
|∬どり計
:・
2210015648B:lち
4.01.2018
IMcet NolI)alC
'ALC4/2()17
124012018
Decision : deferred
lぼ貯蔽醜油
ILic No/1)atcl
107022017
Decision : deferred
56
I
lCase No.:11/l/82-
',tLC4l2ol7
i01
- -- HQ File
1:01/821050/01365 ,A Vt I 7
r
jDecision : deferred
Prrty Name:SUN
Meet No/Date: I l/g2-
Status:Deferred
PHARMACEUTICAL ALC4I2OI7
iNDUSTRIES LTD.
24.01.2018
It I-A File
Lic.No/Date:05 10401 5g2 Defer
:05/24/040/00557/AM17/ 1o8.02.2017 1Date:24.01.20181
l iCase No.:107/1/82‐
IALC4ガ617 ~~
1面0百1e~―
|:01/82/050/01461/AM17/
RLA File
i22/24/040/00105/AM17/
Lic NO/Date:2210015655
115.022017 1
燿繹11訛鳳募
ittr磁
:澪憔
|
:DecisiOn:COmmittcc cOnsi(lcrcd case as pei ttL`五
di ttAa atiiもeratea。,n the matter in thc prescnce ofthcl
itCChnical expens and it was dccided tO ratitt thC ad_hOc input output norms undcr Dara 4_7 of HRP,ミ
ぃ。r:
"ぬ
面山perts動鴫劇∝
dettl議露i胤1°ざ
I高温稿:淵ξ∬
:∫[罪」肌聯∬欝
|
ldetailS be10w Oras applicd by n「
nl l
'304
I rara
feacrr
[ParacL
IRA may
Export Product
Export
Quantitv
S No
Import Product
Quantity
Allowed
r4rduErarilol I aolgl .)Ut)n)q
lach uncoated tablet corrrrrirr::
aracetamol 500mg. ErciIierrrs
.s.
naV take aooronriAtA arrian ,
ヽos
1
Paracetamol
5 l0 mg per tablet
appropriate action as per the aecisioffi
I ICase No.:122/1/82- Panyヽ
aふも:A由百
A↑ヾT ‐Meet No/Date・11/
rvl.LtD
,,24.01.201g
HQ File
RLA File
ir i^ ii^,..,^-
:~“。し1｀υ
・・・4るノ
1′ 0″ rany Name:AШ HANT
‐Meet No/Datei H/82‐ lζtitiζ :
:ALC4/2017 sIDDHAR LABORATORIES IALC4■
、17 1Approved .
I PVT.LTD う401´
re r,rre
RLA File
- ^it_ic.NouDate:3
1t0066602
,
0t/82t0s0/01476tAMt7t :3U83t040t00162tAM17/ ,ii.$)on
i
Pttdm:COm面
te∞雨ほ
dあx基討
導品
ふb面高
おa品品
続
rふ品
品s品ぉ編
"Chた
al expCrts ttd I賂
“
d“
I胤講
1樅
T“
叩輌mtt mrms m“ r“n47 J HBPぉ
"「
idetailS be10w Or as al)plied lぃ
11「1111
Export Product
Export
Quantity
S No
Import Product
Quantity
Allowed
LUMEFANTRINE
may take
lkg
1
(DIBuTY耐
METHYL)‐ 2,7-
DICHLORO‐ 4-
FLUREN
METHANOL(DBA)
0.869 kg
apprOp
tron as per the decision of Normstomm-itEEl
II剰″
5/20/82‐
1lhジヽ品僣■両面ANTANAM~勲
`さ
iヽルb滸811/82-~~
LIFECARE PVT LTD. :ALC4/2017
124.012018
器既
::λ l上:lMP
RLA File
:52/24/040/00o81/AM17/
Lic No/Date:5210o42188
28022017
57
Decision : Committee considered case as per agenda and deliberated on llr.
technical experts and it was decided to ratifl the ad-hoc input output norrrr:.
details below or as applied by firm whichever is lower:
matter in the presence of the
under para 4.7 of HBP as per
RA may take appropriate action as per the decision of Norms Committee
Export Product
Export
Ouantitv
S.No
Import Product
Quantity
Allowed
Florfenicol 20oh W lv Oral
iuspension
96850
1iters
l
Florfenico
197.57 kg
307 Hq nit.
ICase No。:121/1/82-
:ALC4/2017
IParりName:CLEAN
SCIENCE AND
ITECHNOLOGY PVT.LTD
Mcet No/Dalcil 1/82-
:ALC4/2017
124.01.2018
1Lic No/Dat、ヽ13110066608
‐02.032017
Defer
Date:24.01.2018
:01/82/050/O1475/AM17/
‐Decision:deferred
RLA File
i31/83/040/00168/AM17/
.Case No.:8/6/82‐ ALC4/2017 ParりName:PANACEA
IBIOTEC LTD,
30811。lli`
RLA File
i05/24/040/00092/AM18/
101/82/050/00578/AM18/
‐Decision:deferred
芳蕊鸞・6…睡琉|:∴:
IMeet No/Dtltc:11/82-
.ALC4/2017
124.01.2018
ICase No.:27/6/82‐
ALC4/2017
309‐責。rilc
:01/82/050/00597/Aン118/
Patty NameiCLEAN
SCIENCE AND
:TECHNOLOGY PVT・LTD.
IRLA Flle
l:31/83/040/00035/AM18/
1鋼rCFFξ赫
1
1諸蕊」品ツ
`i10066777B壺甥
II::|:
Decision : deferred
ICase No.:1/6/82‐ ALC4/2017
13101 _ … _ _ _
1 lHQ File
‐ 101/82/050/00571/AM18/
‐Party Name:DSM
SINOCHEM
PHARMACEUTICALS
INDIA PVT LTD
RLA File
:22/24/040/00094/AM17/
Meet N()/1)tltc:11/82-
IALC4/2017
124012018
‐
Lic.No/Dat、ヽ2210015738
123062017
一
ｄ
一
た
一
Ｄ
ｕ
一
ａ
一
Ｓ
Date:24.01.2018
1311
Decision:deferred
Case No。:49/6/82-
ALC4/2017
IHQ Filc
101/82/050/00619/AM18/
ParりName:J.B.
CHEMICALS&
PHARMACEUTICALS
iLIMITED
IRLA File
103/94/040/00260/ANl18/
Meま｀JD■tcil 1/恵2‐
lStatiζ :5`ユ「iti
lticヽ6′ Dat●10」10814635 1Dc
Decision : deferred
曽ぶら路
il°814635彫
[ぅふち∴
|
は
12
ICase No.:32/6ノ82‐
.ALC4/2017
IHQ File
101/82/050/00602/AM18‐
‐Decision:deFerred
ICase No.:2/7/82¨ ALC4/2｀17
13締
101/82/050/00724/AM18
1Decision:deferred
iCase No.:6/`/82‐ ALC4/2`}17
58
Party Name:VERDANT LIFE
SCIENCES PVT LTD
RLA File
:09/24/040/00117/AM18/
,Meet No/Date:H/82‐ status:Deferred
i針∫
1鰍「 |
ILic.No/Datei0910065276 1Defer
17.07 2017 1Date124.01.2018
IMもし
i■。
,bite11 1た,1 もiitiζ :bι felたd
IALC4/2017 .
24.012018 1
:ti`:ヽ6′ bat81」iibb`七恵
iウ:5もfel
118.07・2017
Palty Name:DEEPAK
NOVOCHEM
.TECHNOLOGIES LTD
RLA File
:31/83/040/00051/AM18/
Pal‐ly Name:NEOGEN
CHEMICALS LIN41TED
IMeet No/Date:11/82‐
.ALC4/2017
124.012018
Status: Deferred
314満、
5υ00576ハML′
'Decision:deFerred
ICase No.:7/6/82‐ ALC4/2()17
-|
kLA Fi18~~¨ ~ ~~… …
ILENo′ bitも:6jibtti4ウjど58fei ~
|:03/95/040/00731/AM15/ 21.07.2017 1Date:24.01.2018
Palty Name:NEOGEN
CHEMICALS LIMITED
‐
lMgetN8/bit811 iた,1 1stitisibι fel「ιむ
IALC4/2017 1
124.01.2018 1
‐
lticiヽお′
bli`:Obib§ i4念ij 15`fef
125.072017 :Date:24.Ol.2018
RLA File
103/95/040/00700/AM17/
iCase No.:40/6/82‐
lALC4/2017
Patty NameiCIPLA
LIMITED.
匿漱需
・患
'あ
ふferredl
124.01.2018 1 1
RLA Fi18 ~ ~IE18:ヽルbtti8:bbibな14う0恵15`fer l
:03/94/040/00295/AM18/ 131.07.2017 1Datc:24.012018‐
ギ
61脇
::薦蕊L
I lbtt撼i`i:deferred~
1 堀霊胤″682
3171。
Fiお
~‐~~~～
| :01/82/050/00593/AM18
1 lDecislon:deferred
需
雨
kFMINド
~鵬
帝
赫
タ
'4.01.2018
rstatus: Deferred
RLA File
:05/24/040/00194/AM18/
臨需赫血ぬ
"麓[14ふ悦1
:Lic No/Date:0310815019 1Defer
Palty Name:KOPRAN Meet No/Date:11/82- statiζ
:btfer「
`a
RESEARCH IALC42017 1
LABORATORIES LTD. 124012018 1
RLA File
:03/94/040/00385/AM18/
臨
: deferred
104.08.2017
Date:24012018
Me∝Nυb品11/8'1~ヽ1『面ζbefefttb
319icase No.:95/6/82‐
Party Name:KOPRAN
:Date:2401.2018
|:01/82/050/00577/AM18
59
:ALC4/2017
RESEARCH
LABORATORIES LTD.
IHQ File RLA File
:01/82/050/00665/AM18/ 103/94/040/00383/AM18/
‐ALC4 2017
.2401.201S
「酵til鳳11
Declslo■:deferred
## Case No.:136/6/82-
.ALC4/2017
Party Name:NEOGEN
CHEMICALS LIMITED
3201。li18
RLA Filc
:03/95/040/00240/AM15/
|
|
1:01 1821050100706/AM I 8/
‐Decision:deferred
lCase No.:137/6/82-
IALC4/2017
Palty Name:P.K.
PHARMATECH PVT LTD
Mcct)ヽo/1)tlteil 1/82‐
ALC4 2017
124.01.201S
1321「
P21面
「
~~~~~‐
~一
―
IRLAFile
| :01/82/050/00707/AM18/ 103/95/040/00036/AM18/
IDecision:deferred
lCase No.:108/6/82‐
IALC4/2017
3221面h1liぎ
‐
IRLA F‖ e
■03/95/040/00393/AM18/
IHQ File
l:01/82/050/00678/AM18/
Party Name:LUPIN LIMITED
|「蕊Ъ黒
1血ЮЫЯ“雛汎ち
:穐
|
Party Name:USV PRIVATE Meet hrr I '.rre:l l/8)-
lstatus:Deferred
LTMTTED (FORMERLY ALC4 lo 1 7
I
usv LIMITED)
24.01.1018
I
Lic N(,I)(ltci0310815158'Defer l
1608P()1「 IDate:24.01.2018‐
ICase No。:111/6/82‐
IALC4/2017
3231責。lii`
101/82/050/00681/AM18/
RLA File
103/95/040/00341/AM18/
MeetヽolI)tltc:11/82-
ALC4 20「
7
24011101ヽ
ILic N().Dalci0310815236
118.082017
iStatus:Deferred
i
|
lDe庭|~~
IDatei24.01.2018‐
‐Case No。:134/6/82-
A LC4/2017
324‐ 由
O Fil`
Parfy Name:NEOCEN
CHEMICALS Llヽ41TED
IRLA Flle
103/95/040/01044/AM17/ 非曲Frrぶ
Deferl
l∫:雌::lillざ
0310815235[II:::lI::|:|
MもまNc D誠も
:i v82‐ ~陣
itζ53111tal
ALC4 201ア |
‐
2401.1101ド | |
ヤ∫脳
::品
(lC051040373313寛ち
40120181
:O1/82/050/00704/´ tM 18/
IDecision:deferred
## Case No.:16/6/82‐
ALC4/2017
325‐ HQ File
101/82/050/00586/AM18/
IDecision:deferred
Pa●y Name:SUN
IPHARMACEUTICAL
lNDUSTRIES LTD.,
IRLA File
105/24/040/00219/AM18/
も
261従胤ツツα路
Paty Name:THEON
IPHARMACEUTICALS
Meet N o,1)そlteil 1/82‐
ALC4 2017
Status:Deferred
|
60
「
| ~Lf帆~~~~~~~レ4m20TI
|
:HQ File
101/82/050/00719/AM18/
IDecision:deferred
iCase No。:106/6/82‐
IALC4/2017
HQ File
101/82/050/00676/AM18/
IDecislon:deferred
## Case No.:107/6/82-
ALC4/2017
iCase No.:110/6/82‐
:ALC4/2017
HQ File
:01/82/050/00680/AM18/
|ヽLA File
i22/24/040/00030/AM18/
|)alty Name:SPAK
ORGOCHEM(lNDIA)PVT.
1ンTD.
RLA File
103/95/040/01038/AM17/
ILic.No/Date:2210015752 1Defer
18.08.2017 1Datei24 01.2018
1)any Name:ROYAL
l)HARMA
ltLA File
i03/95/040/00424/AM18/
Palty Name:USV PRIVATE
LIMITED(FORMERLY USV
LIMITED)
IMeet No/Date:H/82- Status:Deferred‐
IALC4/2017
124.01.2018 1 1
1Lic.No/Date:0310815337 1Defer l
IMcet No/Date:H/82¨
IALC4/2017
り4.01.2018
ILic.No/Date:0310815299 1Defer
22.08 2017 1Datei24 01.2018
12308.2017
Date:24.01.2018
rStatus: Deferred
,
ir
,Meet No/Date:H/82‐
lALC4/2017
124.012018
Status:
Approved
1329
|
|
|
|
|
|
|
Ъ λ蠍
OЮ幽
/AMly '蹴
辮
α
“
Ю田
"η
l
loegisjol : committee consicle'cd iase;ffi;s;d;;;d d;iib..;iil;, ir.,. rutt.iin iiie fiesence ortne
Itechnical experts and it was clec ided to rati0/ the ad-hoc input output norms under para 4.7 of HBp as per
ldetails below or as applied l,r' fir.rn whichever is lower:
Export Product
Export
Quantity
S No
Import Product
Quantity
Allowed
Griseomlvin Tablets USI)500
2000 BOttles x loo Per B()ttlc=
100,000 Tablets)(Net C()lltcllt
Veight loo kg)
Nos.
1
Griseofulvin USP
510.00 mg per
tablet
RA may take appropriate action as per the decision of t,torri corr*itteu.
ICase No。:109/6/82‐
Patty Name:RUSAN
隕
l1/82‐
,Status: Deferred
IALC4/2017
PHARMA LTD.
24012018
。∞Io由ぉ
Ｆ
Ｐ
IHQ File
Party Name:SHREE LIFE
SCIENCES PVT LTD
101/82/050/00679/AM18/
,Decision : deferred
ICase｀No::123/6/82‐
IALC4/2017
RLA File
103/95/040/00431/AM18/
ILic.No/Datei03 10815403 1Defer
28 08 2017 1Date:24012018
IMcet No/Date:H/82‐ istatus:Deferred l
lALC4/2017 1 1
12401.2018 ‐ |
:Lic No/Date:0310815404‐ Defer
, |
128器既
5υ00677/Ami
RLA File
61
:01/82/050/00693/AM18/
:03/95/040/00437/AM18/
128082017
bliも:24.6il'blを
Decision : deferred
I Case No.:112/6/82-
‐ALC4/2017
Parry Narne:USV PRIVAia
ILIMITED(FORMERLY
USV LIMITED)
332‐ 責。lile
IRLA File
:03/95/040/00383/AM18/
,331HQ hぉ
‐RLA File
104/24/040/00110/AM18/
:01/82/050/00682/AM18/
Decision:deferred
lCase No.:30/6/82¨
ALC4/2017
Pa■y NamciCAPLIN P01NT
ILABORATORIES LTD,
‐Meet No/Date:11/82‐
ALC`|,.2017
.24012018
tおNo'bic:64101634'j
130082017
lStitiξ
:Defelledl
l l
lD3■|
‐
lDate124.012018
. :01/82/050/00600/AM18/
Decision:deferred
l lCase No.:68/6/82‐
| .ALC4/2017
3341責011i`
| :01/82/050/00638/AM18/
Declslo■:deferred
. Case No。:150/6/82‐
ALC4/2017
1351。ハぉ
l i:01/82/050/00720/AM18/
Decision : deferred
336
Pary Name:NECTAR
LIFESCIENCES LIMITED
IRLA File
:22/24/040/00009/AM18/
‐
Lic N。/5icOグloo15762 D8fer ~ ‐
30 08 2017 1Date:24.01.20181
Parry Name:NECTAR Meet \o/Date:11182' ]Status:Deferred
LIFESCIENCES LIMITED ALC'| 2017
i
24.011018
l
ilA iiii
,Lic.Nr,/Ditc .22toors7661D.i.;
:2a2afia0fi901-2/AMl8/ 30.08 2011
-pate:24'01
20J8
i
## Case No.:17/6/82-ALC4/2017
IHQ File
101/82/050/00587/AM18/
Party NameiCADILA
‐HEALTHCARE LTD
IRLA File
l:08/24/040/00153/AM18/
AL(14/2017
24()12018
Lic No/Date:08101408541
3108.2017 1
,Decision : Committee conriaer.aiui" ^ p.i ugenda and deliberatc.l on tfr. rrrutt", i., tt.lres.nce of the
technical experts and it was decided to ratifu thi ad-hoc input outptrt nornts under para4.7 of HBP as per
details below or as applied by tirm whichever is lower:
Export Product
Exporl
Ouantity
S,No
Import Product
Quantity
AHowed
ACICLOVIR TABLETS 200
ⅥG(ACICLOVIR ZYDUS 200
ⅥG TABLETS)
(ACTIVE INGREDIENT:
ACYCLOVIR PH EUR‐ NET
WT 200000 KGS)
Nos
1
ACICLOVIIt PH
EUR
(THIS LICENCE IS
ISSUED AS PER
POLICY
CIRCULAlくN09
DTD 30()()2003
AND POl′ ICY
CIRCULAIヽNO.15
DTD.17092003
204 mgper tablet
62
AND AS PER PARA
4.07 0F HBP 2015-
20 SUBLECT TO
FIXAT10N OF
NORMS BY ALC,
NEW DELHl)
RA may take appropriate action as per the decision of Norms Cor,mitte*
|
iCase No。:151/6/82‐
:ALC4/2017
[溌語」籍幣ξ
l蕊|::~~Meet Nレ
b農よ
iiた2-~|
IALC4/2017 1
124.01.2018 1
RLA File Lic.No/Datei22 100 15767 1Defer
iP2/24/040/00034/AM18/ 3108.2017 Date:240120181
IHQ Flle
:01/82/050/00721/AM18/
tDecision : deferred
た
Iζ
`N」
■3/6/82‐
lALC4/2017
HQ File
101/82/050/00653/AM18/
IDecision:deferred
Palty Name:SHIVA
PHARMACHEM LTD
R LA File
IM8ttNルbiteii iた0: も1ltiζ :btFeliきa
:ALC4/2017 1
‐
12401.2018 1
‐
:Lic.No/Datei3410043429 1Defer
:34/24/040/00121/AM18/ 131.08.2017
‐Date:24.01.2018
| |
lhれ,ヽ
`品
よ
1良Ё
SЁNI」S~ lMebiヽ。
,b農よilたう
_
lくAB1 0NCOLOGY IALC4/2017
たIMITED 124.01.2018
RLA「iig―~~~~~――蘭蒸而萌:蒟510403920
:05/23/040/00218/AM18/ 1o4.09.2017
I｀atty Name:JODAS EXPOIM
PVT LTD
IヽLA File
05/23/040/00227/AM18/
柵納:出
LAヽ十 雑漱需麗―摯品ferred‐
124.01.2018 1 1
lt'昴,1111,轟|=:暇11111711素111ふ:
1鼎r滋‐拌Ⅲ
け漉
Rりよ
b`ib4bjうと
o3i[11:1.嘉
:|
Defer
ICase No。:78/6/82‐
IALC4/2017
340
IDecislon:deferred
|
I)arty Name;JODAS EXpOIM Meet No/Dat e:ll/g2_
IALC4/2017
.24012018
IStatus:Deたrred
PVT.LTD
P‖ 。 ~1-
|:01/82/050/00648/AM18/
## Case No.:79/6/82‐
IALC4/2017
RLA Filc
ILic No/Date105 1 0403959 1Defer
l iCase No.:143/6/82‐
| IALC4/2017
1 1
1381。T百ど~
| |:01/82/050/00713/AM18/
1 0こti;iol‐ :deferred…
iStatus: Deferred
ICase No.:76/6/82‐
lALC4/2017
HQ File
IЮ 1/82/050/00646/AM18/
1漂ision:deferred ~
‐
HQ File
63
101/82/050/00649/AM18/
:05/23/040/00226/AM18/
07092017
'Decision : deferred
lDaわ4bibbi恵
|
iStatus: Deferred
l
I
O.f.,
l
lDate:24.01 .201 8
343
## Case No.:121/6/82-
ALC4/2017
Pa■y Name:TITAN
LABORATORIES PVT
LTD.
Mcct N()/Date:11/82‐
AI C4/2017
2401.2018
Llc No/Date:0310815607
07()92()17
IHQ Flle
:01/82/050/00691/AⅣl18/
IDecisio■:deferred
RLA File
:03/95/040/00462/AM18/
ICase No.:72/6/82‐
| IALC4/2017
344 1nO lil`
| :01/82/050/00642/AM18/
Pa●y NamciSTRIDES
SHASUN LIMITED
Mcct N()/Date:H/82‐
AI C4/2017
2401 2018
IRLA File
104/24/040/00112/AM18/
Lic.No/1)ate:0410163499
08092017
・
ｅ
ｄ
一
‐
８
一
ｍ
一
４
．
０
‐
．
２
０
一
Ｓ
ｔ
ａ
ｔ
ｕ
ｓ
一
晰
Ｄ
ａ
ｔ
ｅ
…
２
Decision : deferred
ICase No.:77/6/82‐ ALC4/2017 1Party Name:JUBILANT
GENERICS LTD
l
iStatus:
l.lpproveo
HQ File
:O1/82/050/00647/AM18/
RLA File
:05/23/040/00233/AM18/
ヽlcet No/Date:11/82‐
Al′C412017
21012018
l´ ic No/Date:0510403990
1209.2017
345
Decision : Committee considered case as per agenda and deliber.rted on the matter in the presence of the
Itechnical expefts and it was decided to ratib/ the ad-hoc input output norms under para4.7 of HBP as per
ldetails below or as applied by firm whichever is lower:
Export Product
Export
Ouantity
S.No
lmport I)r'oduct
Quantity
Allowed
lelecoxib Capsu le/Tablets
50mg
ヾos.
l
Celecoxitr
51mノtablet
Celccoxib Capsule/Tablets
100mg
ヽos.
1
Celecox ib
102 mytablet
3elecoxib Capsule/Tablets
200mg
Celecoxib
204 1ng/tablet
3elecoxib Capsule/Tablets
100mg
ヽos
l
Celecor ib
408 mytablet
IRA may take appropriate action as per the decision ofNorms Conlmittec
‐ ‐Case No.:120/6/82-
ALC4/2017
346.Ho File
:01/82/050/00690/AM18/
‐ IDecision:deferred
Party Name:YASH0
1NDUSTRIES PVT.LTD
Mect N(プDate:H/82- Status:Deferred l
AL('4/2017 1
24012()18 1 1
|ボ%需α
0310Ы 5731彫[::蔦鳥
RLA File
:03/95/040/00481/AM18/
3471霊漁キ
11/6/82-
Palty Name:YASHO
lNDUSTRIES PVT.LTD
Mcet N(プDate:11/82‐
ALC4/2017
駈itiζ :53拠:縄a
64
「
~[勧
3481
lёl:しヽ6::90落張
「
~~‐~
:ALC4/2017
|
「
~で
IユNl亜茨両F~~~
: IALC4/2017
: |
:49爾既輛蔦薫蔦
1 lDecislon:deferred
Party Namc:PCL OIL&
SOLVENTS LTD.
RLA File
i05/24/040/00258/AM18/
Partゝ′Name:PCL OIL&
SOLVENTS LTD.
'Meet No/Date:11/82‐ status:Deferred
lALC4/2017
24012018
1Lic.No/Date:0510404050,Defer
120.09.2017 ‐Date:24012018
IMきさ
iヽb′ bi`li iた,1 ‐
stitiζ ibtFerita
l針『1鰍了 | ‐
~~~,45両面恵~~~~~1~~~~~―
|
疑λ丼品二|「1霞輩
,11■7摯瓢1品|
1基と｀ま拓ウ商
力
'前
ケh崎`嶋heそAttAI責AttMA■きまNレbttα Hたふ
も品蔽
[_____ FHEMCA田
Ⅳ■rD I辮
鶴了 1叩
Ю℃d
iHQ File RLA 1118 ~ ~ ~ ~に
面くも7D滸浜bri66`68カ:~~~‐
~~
1:01/82/050/00726/AM18/ :31183/040/00032晨M17/ 120.092017 1
:撫繊聯紺
1薔1鍛部需需恵鳶虫漱輻r譜
Expoft Product
l-xpo11
Quantitv
S No
Imporl Product
Quantity
Allowed
N―MethyI Piperazinc(pharma
yade)Ofpurity not less than
'9.50/0.
l kg
1
N― MethyI Piperazine
ofpurity not mOre
than 989る。
1.02 kg
i^o r.,
50
IRLA File
:05/24/040/00259/AM18/
Lic.No/Date:0510404051
.Defer
Datei24 01 2018
|しlC.IN O/υ at
120092017
m
|:01/82/050/00667/AM18/
‐Declslo■:deferred
## Case No.:97/6/82‐
ALC4/2017
PartゝName:GLOBAL
CAI′CIUM PRIVATE
LIヽ41TED,
IRLA F‖ e
i07/24/040/00166/AM18/
Iヽ「t,Name:MEGHMANl
INDUSTNES LTD,
RLA File
i~閉轟
~雨:続
| ぃLC″2"7
:52¨ Filg
l 101/82/050/00657/AM18/
1 DecisiOllT高面高訂~~
一
一
HQ File
:01/82/050/00660/AM18/
:08/24/040/Ooo99/AM18/
IMcet No/Dateil 1/82-
Status:Deferred
:ALC4/2017 1
124.01.2018
一
一
1翻r"
Status: Deferred
ILic No/Date:0810140981 158fef
121.09.2017 ,Date:24.01.2018
65
ICase No。:75/6/82¨ IPaty Name:STRIDES
IALC4/2017 SHASUN LIMITED
153■。hl― ~~ itÅ
i籠~~~ ~
| 101/82/050/00645/AM18/ 1:04/24/040/00124/AM18/
′Decision:deferred
Case No。:119/6/82-
IALC4/2017
3541責。「iiも
101/82/050/00689/AM18/
非麟
r面般‐―ド患趾面
errel
嬬」
:1翌Ю
%"4監,品、
1
ParりName:UPL
LTD(FORMERLY UNITED
PHOSPHORUS LTD。
)
IRLA File
103/95/040/00482/AM18/
ヽlcet No/Date:11/82‐ Status:Deferred l
】fi獄了 | |
:ドぶ安、
彎ざ
031081588不
[|:[tilll:|:
ICase No.:125/6/82‐
ALC4/2017
355 1HQ File
101/82/050/00695/AM18/
Pa■y Name:USV PRIVATE
LIMITED(FORMERLY
USV LIMITED)
ヽlcet No/Date:11/82‐
Al´C4/2017
21012018
静
Ltiζ Deferi島
|
|
RLA File
:03/95/040/00460/AM18/
:「蕊ぢ評而而酵tittL
Decision : deferred
ICase No.:86/6/82‐
ALC4/2017
356 110 rii`
ParりNameiCADILA
HEALTHCARE LTD
IRLA File
108/24/040/00151/AM18/
Ⅳ
F=独||・ν
"‐
~~摯轟
:Deferred
21012018 1
:ぶ喘彎∝
08ЮИ
0994B:[ち
4Ю L2018
:01/82/050/00656/AM18/
Decision : deferred
‐Case No.:118/6/82-
IALC4/2017
3571山。lil`
:01/82/050/00688/AⅣl18/
IDecision:deferred
IName:METROPOLITAN
IEXlMCHEM PRIVATE LTD
IRLA File
103/95/040/00446/AM18/
## Case No.:122/6/82-
IALC4/2017
Pa■y Name:RELIANCE
INDUSTRIES LTD
ヽlcet No/Date:11/82‐
Al,C4/2017
2101.2018
iStatus: Deferred
I
I
I
IHQ File
:01/82/050/00692/AM18/
Decision:deferred
RLA File
103/95/040/00246/AM18/
:ぶ」品りα∞Ю
81589び
B:[ti籠:|:
## Case No.:129/6/82‐
ALC4/2017
Paty NameiRELIANCE
INDUSTRIES LTD
3591責。
liiど ―
RLA File
101/82/050/00699/AM18/ :03/95/040/00371/AM18/
IPa口y
lic No,Date:0310815895 1Defer
22092017
IDate:24012018
I閣7酬鵬ド画衛К
d
l icヽo‐ Date:0310815896 1Deた
r
IDate:24.01.2018
ヽlcet No/Date:11/82- Status:Deferred
Decision : deferred
22092017
66
懸
ぽυ
l
ICase No.:127/6/82- Pa11、
Name:USV PRIVATE ,Meet No/Date:11/82‐
status:
:ALC4/2017 L´ IMII｀ED(FORMERLY USV IALC4/2017 1Approved
‐
i l′
lM11・ED) 124.01.2018 1 1
1HQ File RL′ A File lLic.No/Date:03108158931 1
:01/82/050/00697/AM18/ 1031t)5`040/00483/AM18/ 122.09.2017 1 1
1Decヽlon:Committee cOnsidered case as per agenda and deliberated on the matter in the presence ofthel
lteChnical experts and it was decide(1 lo ratitt the ad― hOc input Output norms under para 4 7 of HBP as perl
details below Or as applicd by flHlぃ、hichever is lower:
Export Product
I:xport
t)uantity
S No
Imporl Product
Quantity
Allowed
Desipramine Hydrochloridc
「ablets,USP 10 MG
i10,000 BOttles x 100 Per
3ottles=10,00,000 Tablcts)(
Net Content Weight=10.000
くgs)
1000000
(os
l
Desipramine HCL
106.59 kg
)esipramine Hydrochloride
lablets, USP 150 MG
.12,600 Bottles x 50 Per Botrles
= 6,30,000 Tablets) ( Net
lontenr Weight : 94.500 Kes)
ヽ30000
Nos.
ICase No.:73/6/82‐ ALC4/2017 Panv Name:ARIHANTANAM IMcet No/Date:11/82‐ S,Status:
Pariv Name:ARIHANTANAM
l′ II'IiCARE PVT LTD
IALC4/2017
Approved
lDecision : Committee considered case as per agenda and deliberated on the matter in the presence of the
itechnical experts and it was deciclcd to rati0/ the ad-hoc input output norms under para4.7 of HBP as per
ldetails below or as applied by firnr rr hichever is lower:
l
I
l
Export Product
Export
Ouantitv
S.No
Import Product
Quantity
Allowed
LUMEFANTRINE
０
●
し
Ｋ
1
(DIBUTYLAMINE
METHYL)-2,7‐
DICHLORO‐ 4-
FLUREN
METHANOL(DBA)
0.869 kg
||
L二1よIWぶ進ちオ
.蝋Kg9 1_ | |
RA may take appropnate action as perthe decision of Norms Committee.
貯
ICase No.:70/6/82‐
IALC4/2017
| |
PallゝNameiCAPLIN POINT IMeetNo/Date:11/82‐
Status:Deferred l
LA130RATORIES LTD., IALC4/2017 1 1
124.01.2018 1 1
良
lンA Filざ ~ ｀
~~″ ^Litiヽ
b′bateib4ibi6j`ζ ё 158fer ‐
|
162卜R,li`― 一
| :01/82/050/00640/AM18/
:04124/040/00128/AM18/ 125.09.2017
Date:24.01.2018
IHQ File RI′ A File
翻辮α
"Ю
M2386 1
Ina may take appropriate action as per the decision of Norms Committee.
Decision : deferred
67
ICase No.:3/7/82-A LC4/2017
363 uq nit.
:0 | I 82 I 0 50 I 007 25 I AM I 8 I
ICase No.:96/6/82‐
IALC4/2017
1HQ File
101/82/050/00666/AM18/
Paty Name:CLEAN
SCIENCE AND
TECHNOLOGY PVT.LTD.
RLA File
:31/83/040/00080/AM18/
It te t No/Dat,",.llin:- - istatus:Deferred
Al_C4/2017
2101.2018
11c No/Datc:31100668801Defcr
25 09 2017 1Date:24.01.2018
364
Pa■y Name:NEOGEN
ICHEMICALS LIMITED
RLA File
:03/95/040/00403/ANl18/
I‖…
~F品餌
Deferred
:ギリ認α
03108159368:僧ち
4Ю●
2018
Decision:deたrred
lCase No。:115/6/82‐
IALC4/2017
ParりName:MEHK
‐CHEMICALS PVT LTD λ
l洲ν酬鵬戸町薇“
Ferred
:ぶ」評…
8:[らf訴ふ
i:
3651青
O riiも
:O1/82/050/00685/AM18/
Decislon:deferrcd
RLA File
:03/95/040/00500/ANl18/
ICase No。:117/6/82-
.ALC4/2017
1HQ File
101/82/050/00687/Aヽ418/
Pa●y Name:S.KANT
IHEALTHCARE LTD.
:RLA File
103/95/040/00440/AM16/
'Decision : Committee considered case as per agenda and delibr
technical experts and it was decided to ratifo the ad-hoc input tr
details below or as applied by firm whichever is lower:
lrnpori
ヽlcct No/]Date:11/82‐
ヽ
1′C4/2017
]1012018
|lc No/Date:0310815971
1(ヽ092017
irrcd on the matter in the presence of the I
,il)ut norms under para 4.7 of HBP as per,
2、7-l,(HLORO‐ A‐
(DIBt lヽ
′LAMINO)
N/1ET11ヽ′1_-9H‐
FLU01く
l〕NE‐4‐
MET1lrヽNl10L(DBA)
99ツ6ヽH｀
Status:
Approved
tl
"
:'
:.-.-:-
.nn rnay t^ate appropriate action as per the decision of Norms Corrrrnittee'
I Case No.:114/6/82-
ALC4/2017
167責Oiぉ
| :01/82/050/00684/ANl18/
I IDecisio■:deferred
## Case No.:116/6/82‐
ALC4/2017
IPalty Namc:NEOGEN
‐CHEMICALS Llヽ41TED
RLA F‖ e
:03/95/040/00039/Aヽ418/
卜
.1、'ct No/Dateil 1/82- IStatus:Deferred
′
^、l(14/2017
?101.2018
::樹需ざ
雨而b"7駐協∴ふ
:
Pa“y NamelNEOGEN
ICHEMICALS LIMITED
LUMEFANTRINE
368
Export Product
Export
Orrantitv
S No
Quantity
Allowed
lkg
0.869 kg
1366
68
‐
RIンA「‖e
103/()5040/00474/AM18/
一
９
６
lcase No': l/7/82-ALc4l20l7 I'artr "lame:cLEAN
,Meet No/Date: I l/g2-
Status:Deferred
,
j
scil \ctE AND
,ALC4t20t7
rl
:1.7o,:__* -
.fECri\OLOGy PVT.LTD. :24.01.2018
,
","HQFileRLAI]ile;Li".Noloat":31l0066885iD;fe.
,:0tr82r0sot0w?3/ANfi8t _ :i r,s. oqorooosz/AMr8/ 6i.i;;;,;-
Date:24.0r.20r8
,Decision : deferred
"''l
ICase No.:152/6/82‐
IALC4/2017
面
File
101/82/050/00722/AM18/
Part)Name:SCOTT_EDIL
ADヽ'IヽNCE RESEARCH
ILAB へND EDUCAT10N
‐LTD
IRLA「ile
:22/21.040/00038/AM18/
12401.2018
Lた。
｀ルbitよOjibなi3"うIDefer… … ‐‐
27.09.2017 1Date:24.01.2018
Lic No/Date:2210015780
27.092017
IHQ F‖ e
Decision : deferred
MeetNo/Dare:lll82- Status:Deferred
,ALC4|20t7
'24.0t.20t8
‐Date:24.012018Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.
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