DGFT Minutes

Government of India Ministry of Commerce and Industry Directorate General of Foreign Trade Maulana Azad Road, New Delhi I l00l I Norms Committee-Ill

Para 4.7 Decision

Meeting No. 1218212017 of 2017-18 dated20.03.2018 (actually held on 26.04.2018 and 04.05.2018) considered the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreigrr Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.l l, Udyog Bhawan, New Delhi. Following members were present:- ShriNirmal 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. ll/82 dated20.03.2018 (actually held on 19.04.2018 and20.04.2018) and approved the same. Note: In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations / Deficiencies received from the concerned Technical authority in the same cose or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned. In both these instances, the scqnned copy uploaded is to be accepted. The Committee does not approve SCOMET items and all applicants are understood. MEETING NUMBER 112/82‐ALC4/2017 ⅣIEETING DATE:20.03.2018 (aCtuaHy held on 26.04.2018 and 04.05.2018) ~西 面 画 面 而 雨[T繭 繭 面 「 ~ 1聯 為dl 需漱鷲#腑鮮l肝‰器 州 「eChniCal experts and it was decide( "etJ｀ bebw or as apメた d by arln v ils below or as app Export product Exp.oty. Import items Qty.

018 and 04.05.2018) ~西 面 画 面 而 雨[T繭 繭 面 「 ~ 1聯 為dl 需漱鷲#腑鮮l肝‰器 州 「eChniCal experts and it was decide( "etJ｀ bebw or as apメた d by arln v ils below or as app Export product Exp.oty. Import items Qty. allowed Dicloxacillin 500mg Capsules (Dicloxacillin Altemova 500mg) (2070000)=1035 KG l No. Dicloxacillin Sodium BP/EP/USP/1P 535.0 mg/capsule lr i lp.e concemed may take further necessary action a:lel above rlecision of NC 「甲腑ん蔑‐丁丁目 NttαⅢ CЮ郎囲rdル麗レI iir"'* -iffi i^ I'oyszloso/01045/AMl8 t l:o7t24to4otoo37ttAMl6/ 1,04.02.20t6 I 12 ','-' -- -- - - - l' mrrid.*dias;;ip.-€;ffithe matter in the_presence of the I I ll.frrrc"f experts and it was decided to ratiry the ad-hoc input output norms under para 4.7 of HBP as per I I laetaits below or as applied by firm whichever is lower: I ll---'-l lt 一 |″

Export product Exp. Otv. Import items Qty.a110Wed DICLOXACILLIN 500MG CAPSULES (DICLOXACILLIN ALTERNOVA 幽 G)(1510000 Nos)=750KG l No. E)icloxacillin Sodium BP/EP/USP/1P 535.0 mg / 500 mg capsule DICLOXACILLIN 250MG CAPSULES (DICLOXACILLIN ALTERNOVA 250MG)(390000Nos)=97.50KG l No. Dicloxacillin Sodium BP/EP/USP/1P 26750 mgl250 mg capsule RA concemed may take further action as above | 'Case No.:92/12/82‐ ‐ :ALC4/2017 Mcet No/Date:12/82- ALC4/2017 Decision : committee considered case as per agenda and deliberated experts and it was decided to ratifu the ad-hoc input ouput on the matter in the presence of the norms under para 4.7 of HBP as per ils below or as applied by firm whichever is lower: 2003.2018 Lic.No/Date:0710109368 04.02.2016 Export product Exp.Qty. Ｓ ‐ ． Ｎ 。

the matter in the presence of the norms under para 4.7 of HBP as per ils below or as applied by firm whichever is lower: 2003.2018 Lic.No/Date:0710109368 04.02.2016 Export product Exp.Qty. Ｓ ‐ ． Ｎ 。 Import items Qty. allowed AMOXICILLIN 250 MG十 FLUCLOXACILLIN 250 MG CAPSULES (95000xlx100)-4750 KG l No. 1 AMOXICILLIN TRIHYDRATE BP/EP/USP/1P 292.68 mg /capsule 2 FLUCLOXACILLIN SODIUM BP/EP/USP/1P 267.34 mg / capsule AMOXICILLIN 125 MGttFLUCLOXACILLIN 125 MG/5ML ORAL SUSPENSION (BOttLES) (100000XlX100 ml)500 KG l No. 1 AMOXICILLIN TRIHYDRATE BP/EP/USP/1P 3012.83 mg /bottle 2 FLUCLOXACILLIN SODIUM BP/EP/USP/1P 2.752mglbottle RA concerned may take further necessary action as per above decision of NC 「FE源蔦而面源 RLA File :26/24/040/00019/AM16/ Paty Name:VERDANT LIFE SCIENCES PVT LTD ALC4/2017 20.03.2018 Lic.No/Date:2610012744 02.03.2016 Decision : Committee considered case as per agenda and deliberated on the matter in the presence of the technical experts and it was decided to ratift 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 Exp. Otv. Import items Qty. Allowed kglkg CARISOPRODOL Nos. 1 Propionaldehyde Liquid 1.024 2 DimathyI Carbonate Liouid 0.80 3 Mono Isopropylamine Liouid 0.737 4 Para Formaldehyde 0.390 -2´ ヘ

product Exp. Otv. Import items Qty. Allowed kglkg CARISOPRODOL Nos. 1 Propionaldehyde Liquid 1.024 2 DimathyI Carbonate Liouid 0.80 3 Mono Isopropylamine Liouid 0.737 4 Para Formaldehyde 0.390 -2´ ヘ

SoHd Methanol Liquid 0.121 6 Caustic Soda Flakes Liouid ， ′ ｎ ン ０ 7 Chloroform Liquid 0.183 Panadiunl carbon Solld 0.164 gm/kg 9 Trichloro Acetic Acid Solid 1.28 kttg 10 Sodium Cyanate Solid 0.508 kgkg Toluene Liquid 0.664 kgkg ICase No。:94/12/82‐ IALC4/2017 | HQ File :01/82/050/01049/AM18/ Mcet No/Date:12/82‐ RLA File :07/24/040/00027/AM17/ Parfy Name:MICRO LABS Status: Approved ALC4/2017 120.03.2018 Lic.No/Date:0710109714 26.04.2016 Decision : Committee considered case as per agenda and deliberated on the matter in the presence technical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP rf the N per Export product Exp. OW. Import items Qty. allowed AMOXICILLIN lgm tablet (40000X1000S) 40000.00KG l gm tablet AMOXICILLIN TRIHYDRATE BP/EP/USPAP 1170.558 mg/tabtt ALC4/2017 Paty Name:MICRO LABS TD RLA File :07/24/040/00162/AM17/ Mect No/Date:12/82- ALC4/2017 20.03.2018 Lic.No/Date:0710110234 10.08.2016 ffidcu,easperigendaanddeliberatedonthematterinthepresenceofthe technical experts and it was decided to ratiff the ad-hoc input output norms under pata 4.7 of HBP as per details below or as applied by frm whichever is lower: Item of Export Quantity Item of ImPort Quantity A1lowed DOXYCYCLINE 100MG DISPERSIBLE TABLETS (Eq.

put output norms under pata 4.7 of HBP as per details below or as applied by frm whichever is lower: Item of Export Quantity Item of ImPort Quantity A1lowed DOXYCYCLINE 100MG DISPERSIBLE TABLETS (Eq. to anhydrous doxycycline100mg) 1028278 Tabs(102.83 Kg) numbers DOXYCYCLINE MONOHYDRATE BP/EP/USP/1P 106.17 mg/tablet @n as perthe decision of Norms Committee' :91/12/82‐ )17 師 ILTD S ヘ No.:99/12/82‐

貯淵舵脱 ~ 押 ｀鵬Mた良ё LABS 1器3児5υOЮ46晨Mlν 1鶴角刷 :OЮ0226晨↓ iT 囲鼎α "朋ЮЯ 7 Lic.No/Date:0710110717 30.11.2016 1器島児 5υOЮ53ハMlν 1鶴λ馴 ,OЮ02571豆i' 諄鮮"隅 圏鼎α mmЮ "川 1濶" | Decision:Committeeconsideredcaseasperagendaanddeliberatedonthe.ittery technical experts and it was decided to ratift the ad-hoc input output norms under para 4.7 of HBp as per Export product Exp. OW. Import items Oty.a1lowed DICLOXACILLIN 500MG CAPSULES 1035 KG l No. Dicloxacillin Sodium BP/EP/USP/1P 535.0 mg / 500 mg capsule DICLOXACILLIN 250MG CAPSULES 90 kg l No. Dicloxacillin Sodium BP/EP/USP/1P 267.50 m!250 mg capsule concerned may take further action as per above decision of NC ision : Committee considered case as per agenda and deliberated on the matter in the presence of the nical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per .ils below or as applied by firm whichever is lower: ltem of Export Quantity Item of Import Quantity Allowed DOXYCYCLINE HYCLATE TABLETS 100 MG numbers DOXYCYCLINE HYCLATE BP/EP/USP/1P 117.70 mg/tabLt RA may take appropriate action as per the decision of Norms Committee. 1附 NamcMCЮ LABS

rt Quantity Allowed DOXYCYCLINE HYCLATE TABLETS 100 MG numbers DOXYCYCLINE HYCLATE BP/EP/USP/1P 117.70 mg/tabLt RA may take appropriate action as per the decision of Norms Committee. 1附 NamcMCЮ LABS technical experts and it was decided to ratiS the ad-hoc input output norms under para 4.7 of HBP as per Item of Export Quantity Item of Import Quantity Allowed DOXYCYCLINE 100MG TABLETS(EDっ l No. DOXYCYCLINE MONOHYDRATE BP/EP/USP/1P 106.17 mg/tablet may take appropriate action as per the decision of Norms Committee. ● ´ ８ ２ Ｎ ｏ ・ ‥ ９ ５ ” ａ ｓ ｃ Ｌ Ｃ Ｃ Ａ Ｆ Ｌ ド ー 1附 NmcMCRO LABS liiII::|:IIIi:ii:i:ili~~~~‐

―
|
タ
けら鼎α
07101Ю■21   1
No.:100/12/82‐
File
1/82/050/01055/AM18/
File
1/82/050/01050/AM18/

ision : Committee considered case as per agenda and deliberated on the matter in the presence of the
nical experts and it was decided to ratiff the ad-hoc input output norms under para 4.7 of HBP as per
ils below or as applied by hrm whichever is lower:
Export product
Exp.OtV.
Import items
Oty. allowed
AMOXICILLIN 1000 MG
TABLETS      (DT)
l No
AMOXICILLIN
TRIHYDRATE
BP/1P/EP/USP
H70.558 mg/tablet
concerned may take further necessary action as per above decision of NC
Case No。:96/12/82‐
Meet No/Date:12/82-
ALC4/2017
20.03.2018
i.i* t Corrnittee considered case as per agenda and deliberated on the matter in the presence of the
nical experts and it was decided to ratify the ad-hoc input output norms under para4.7 of HBP as per
ils below or as applied by frm whichever is lower:
Export product
Exp.o～
.
Import items
Otv.

f the
nical experts and it was decided to ratify the ad-hoc input output norms under para4.7 of HBP as per
ils below or as applied by frm whichever is lower:
Export product
Exp.o～
.
Import items
Otv. allowed
AMOXICILLIN l GM
DISPERSIBLE TABLETS
/  1  GM  TABLETS
BP/1P/EP/USP ( 40000
KG)
Nos.
AMOXICILLIN
TRIHYDRATE
BP/1P/EP/USP
1170.558 mg/tablet
「
 
「
li:1'11lF百三
′
82‐
圏蕊
/m48/AMIν
良ё LABS
i1118/
12
ALC4/2017
20.03.2018
Lic.No/Date:0710111565
09.05.2017
sion : Committee considered case t
rical experts and it was decided to t
ls below or as apPlied bY firm which
@ed 
on the matter in the presence of the
ratin, ttri ad-hoc input output norms under para 4'7 of HBP as per
rever is lower:
Export product
Exp.
Otv.
Ｓ
‐
．
Ｎ
。
Import items
Qty. allowed
AMOXICILLIN 125
MG+FLUCLOXACILLIN 125
MG/5ML ORAL SUSPENSION 100
ML BOttLES
BP/EP/USP/1P(500 KG)
Ｎ
。
．
硫
ｌ
ｂ
1
AMOXICILLIN
TRIHYDRATE
BP/EP/USP/1P
3012.83   mg   /
bottle
2
FLUCLOXACILLIN
SODIUM
BP/EP/USP/1P
2856.33  mg  /
bottle
AMOXICILLIN 250 MG十
FLUCLOXACILLIN 250 MG
CAPSULES
BP/EP/USP/1P(4750 KG)
lNo.
Capsules
1
AMOXICILLIN
TRIHYDRATE
BP/EP/USP/1P
292.68
mg/capsule
2
FLUCLOXACILLIN
SODIUM
BP/EP/USP/1P
277.47
mg/capsut
conccmed may take mrther necessary action as per above decision ofNC
0111537
No/】Date:12/82-

OXICILLIN
TRIHYDRATE
BP/EP/USP/1P
292.68
mg/capsule
2
FLUCLOXACILLIN
SODIUM
BP/EP/USP/1P
277.47
mg/capsut
conccmed may take mrther necessary action as per above decision ofNC
0111537
No/】Date:12/82-

「貯淵舵脱‐
1需
NamcMCЮ LiBS 1濶"
1冥器α囲∝H“31
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ision : Committee considered case as per agenda and deliberated on the matter in the presence of the
nical experts and it was decided to ratifu the ad-hoc input output norms under para4.7 of HBP as per
Export product
Exp.oty.
lmport items
Oty,a110wed
AMOXICILLIN 750 MG
TABLETS
BP/1P/EP/USP 5625 KG
Nos
AMOXICILLIN
TRIHYDRATE
BP/1P/EP/USP
878.025 mg/tablet
14
甲賛ず∞脚"町
Export product
Exp.
Oty.
Import items
Qty. Allowed kg/kg
TENOFOVIR
DISOPROXIL
FUMARATE
l kg
1
Adenine
0.8011
2
Diethyl-p-
ToluenesulfonyloxymethYl
Phosphonate
2.025
Chloromethyl IsoproPYl
Carbonate
1.3527
4
Methane sulfonic Acid
0.0569
Triethylamine
0.4477
6
N-Methyl-2-Pyrrolidone
1.4878
7
(R)― (十)―Pr
0.6960
Activated Carbon
(Enoanticromos)
0.016
9
Dimethyl FollllamidC(DMF)
3.61
10
Iso Propyl Acetate
2.28
Iso Propyl Alcohol
4.02
12
Methylene ChloHde(MDC)
6。90
Toluene
1.19
14
Hydrobromic acid - 48oh
6.54
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
decimal by DGFT EDI
System, we have mentioned
estimated Qtv. OnlY.
As per fuel policy
RA concemed may takc hrther necessary action as per above decision ofNC
」
ι

Value.) Due to
non acceptance ofzero
decimal by DGFT EDI
System, we have mentioned
estimated Qtv. OnlY.
As per fuel policy
RA concemed may takc hrther necessary action as per above decision ofNC
」
ι

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「
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IALC4/2017
20.03.2018
1器島児
5υOЮ9νAMlν
1鷺ち』
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technical experts and it was decided to ratify the ad-hoc input ouput norms under para 4.7 of HBP as per
Export product
Exp.
Otv.
Import items
Qty. Allowed kg/kg
N¨BENZYL     3(S)―
HYDROXY
PYRROLIDINE(BHP)
l kg
1
L‐MALIC ACID
2.69
2
BENZYL AMINE
2.28
TETRAHYDRO FURAN
3.77
4
SODIUM BORO HYDRIDE
2.26
R‐MANDELIC ACID
1.60

## Case No.:109ノ12/82-
ALC4/2017
PTけName:VIVIMED LABS
LIMITED
Meet No/Date:12/82‐
Decision : [t was decided to call the firm for PH along with the following information:
i) 
The past consumption coefficient data in C. A Certilicate for the period 2015-l6and 2016'17
are confusing and do not match with applied norms
ii) 
The firm may be advised to explain the above and produced production consumption data
for the period 2015-16,2016-17 and 2017-18duly certified by Central Excise Authorities.
２
８
２
２
Ｎ
。
。‥．
０
如
ａ
Ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
「蹴賛
Ⅷ湯∞
ALC4/2017
20.03.2018
Meet No/Datei12/82-
:09/24/040/00185/AM18/
Lic.No/1Date:0910065255
Ю7.07.2017
technical experts and it was decided to ratif, the ad-hoc input output norms under para 4.7 of HBP as per
Export product
Exp.
Oty.
Import items
Qty. Allowed kg/kg
ZIPRASIDONE
HYDROCHLORIDE
l kg
1
Piperzine Derivative (or) 3-
(l -Piperazinyl)- I,2-
benzisothiazole hydrochloride
1.10
2
Chloroxindole(or)6¨Chloro―
5‐(2‐Chloroethyl)‐ 1,3‐
dihvdro-2H‐ indolc‐ 2‐one
0.94
Activated Carbon (Carbon
Enoanticromos)
0.022
4
Isoproovl Alcohol(IPA)
4.23
Methanol(Methyl AlcohoD
6.73
6
Tetrahydrofuran
16.69
7
Steam/Thermal Coal (Non-
As per fuel policy
No.:136ノ12/82-
No/Date:12/82¨
Re-indexed
0065247
Date:
.2017
17
8
File
File
:01/82/050/01057/AM18/

「盪賛
Ⅷ膵
:°
Ｆ
‐
‐
‐
８
‐
ト
1濶" |
Lic.No/Date:0910065254 1Defer Date:
Ｆ
‐
‐
‐
９
巨
‐
PartyName:DISCOVERY lMeetNo/Date:12182-
INTERMEDIATES PVT LTD.IALC4/2017
Defer Date:
19.05。2018
:01/82/050/01159/AM18/

## Case No.:137/12/82-
ParりName:NASENSE LABS
PVT LTD
撥霊淵″Иν秘
|
印
需IttM
IHQ Flle
澁
島
1剛ν
1066/AM18/
Ｆ
‐
‐
２
２
‐
‐
|:i:i::i':ii;:「
5712/82‐
1
鵬
:15νAⅦν
lDe面高而」蔵汗ed~~
ALC4/2017
20.03.2018
Lic.No/Date:0910065267
13.07.2017
Defer Date:
19.05。2018
Decision : Deferred
1
01/82/050/01066/AMIU/ liu9lzt+tuqvtvulvl/Amro/ 
11r'vt'Lwt t 
I
o""i.i"" : Committee considered case as per agenda and deliberated on the matter in the presence o
technical experts and it was decided to ratiry thi ad-hoc input output norms under para4.7 of HBP a
ｔ
ｈ
ｅ
阿
Export product
Exp.Qty.
Import items
Qty・
kg/kg
Allowed
DIPYRIDAMOLE
l kg
2:6‐Dichloro‐4,8-Dipipもridino―Pyrimido‐
(4、5‐d)Pvrilnidine            _
0.935 kg
‐
1濶
翻2
「 
が
?
No.:110/12/82‐
No.:204/12/82‐
.07.2017
1認辮α酬∞“劉
No/Date:12/82‐
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
Re-indexed
10065298
Date:

ヘ
鵬mm醐
陽ち描ぃΨ摯叩ν [皿躍図甲理
IDecision:Deferred
Ｆ
‐
‐
２
４
‐
‐
RLA File
:09/24/040/00208/AM18/
Paty Name:SUVEN LIFE
SCIENCES LIMITED
Mcet No/Date:12/82¨
lilll:|||||!i:iili:ili~~～‐
~~~~―
|
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Ｅ
Ｔ
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Ｌ
Ｃ
Ｃ
Ａ
raF,b 
m@
0l/821050/01109/AMl8/ l:0912a10a010023'llAMtSl 101.08.2017 
I
Decision : Committee considered case as per agenda and deliberated on the matter in the presence of
:echnical experts and it was decided to ratiry the ad-hoc input ouput norms under para 4.7 of HBP as
Jetails below or as applied by firm whichever is lower:
一
　
　
　
一
ｔ
ｈ
ｅ
阿
Export product
Exp.Qty.
Ｓ
‐
．
Ｎ
。
Import items
Qty.

s decided to ratiry the ad-hoc input ouput norms under para 4.7 of HBP as
Jetails below or as applied by firm whichever is lower:
一
　
　
　
一
ｔ
ｈ
ｅ
阿
Export product
Exp.Qty.
Ｓ
‐
．
Ｎ
。
Import items
Qty. Allowed
ke/ke
SOFOSBUVIR‐ IH
l kg
1
2-deoxy-2-fl uoro-2-C-methyluridine
(or) (2R)-2-Deoxy-2-Fluoro-2-
Methyluridine
0.90 kg
2
N- [(S)-(2,3,4,5,6-Pentafl uorophenoxy)
phenoxyphosphinyll-L-alanine 
I -
methylethyl ester
(OR) propan-2 -y l(25)'2 -
{ [(pentafluorophenoxY)
(phenoxy)phosphoryll amino ) propanoate
1.60 kg
tion as Per above decision of NC
Party Name:SAPTAGIR
CAMPHOR LIMITED
Lic No/Date:0910065322
02.08.2017
Ｆ
‐
‐
２
７
‐
‐
町¨
Party Name:SATYA
PHARMACEUTICALS LTD
Lic.No/Date:0910065323 iDefer Date:
No.:155/12/82‐
Flle
/82/050/01110/AM18/
No.:181/12/82‐
File
File
/82/050/01136/AM18/
:09/24/040/00239/AM18/
18
.2017
No/Date:12/82‐
7
.2018
No/Date:12/82-
17
.2018
7
Name:AURORE LIFE
No/1Date:12/82‐

1蹴器α
"Ю%""1訛紺
:
Ｆ
‐
‐
３
０
‐
‐
貯
脚
mル
 
躊
響
揺
輛
LIFE
1器星泥
5υOH26ハMlν  lЪ危刷
,OЮ∝
33ハ↓
18;
Mcet No/Date:12/82‐
Ｆ
‐
‐
３
‐
‐
‐
ParりNamciINCHEM
LABORATORIES PRIVATE
LIMITED
1蹴器“
%∞“"51躙紺
:
Ｆ
‐
‐
３
２
‐
‐
「
li:淵″
0ノ12/82-
|
|:鮒
∬
快PRIVATE
1器島児5υOH3ヌAMlν  lЪ
ち刷:OЮ0230ハMlν
|
lDecision : Deferred
Lic.No/Date:0910065349 1Defer Date:
IDecision:Deferred for comments of DBT
Case No。:178/12/82‐
Lic.No/Date:0910065348 1Defer Date:
F;.tri* t D"f*."dio..o.r"rts of DBT
No.:170/12/82‐
7
File
1/82/050/01125/AM18/
Name:AURORE LIFE
No/Date:12/82‐
17
8
123/AM18/
17
18
7
No/Datc:12/82‐
7
No/Datel12/82‐
7
18
Name:BIOLOGICAL E
No/Date:12/82‐
8
No/Date:12/82‐
No.:1`9/12/82‐
No。:130/12/82‐

7
File
1/82/050/01125/AM18/
Name:AURORE LIFE
No/Date:12/82‐
17
8
123/AM18/
17
18
7
No/Datc:12/82‐
7
No/Datel12/82‐
7
18
Name:BIOLOGICAL E
No/Date:12/82‐
8
No/Date:12/82‐
No.:1`9/12/82‐
No。:130/12/82‐
Pa●y Name:BIOLOGICAL E
File
No.:166/12/82‐
NamclMYLAN
7

Ｆ
Ｉ
ト
ー
ー
ALC4/2017
HQ File
:01/82/050/01122/AM18/
P霞りName:MYLAN
LABORATORIES LIMITED
Mcet No/Datc:12/82-
IALC4/2017
IⅧ辮“
9100653501需紺
:
20.03.2018
:09/24/040/00250/AM18/
両蔽粟面T両瓦fef穐通
證謎胤ツ“ν泌
|
lmttα
HETEROLABS
|
1麟lT‐ 町
1淵鼎α醐∞“
%91
1鷺ち刷
:0/00269/AM18/
Ｆ
‐
‐
３
８
‐
ト
Mcet No/Datei12/82‐
ALC4/2017
HQ File
:01/82/050/01071/AM18/
RLA File
:09/24/040/00234/AM18/
blcision : Committee considered case as per agenda and deliberated on the matter in the presence of the
technical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per
Export product
Exp.Qty.
Ｓ
‐
．
Ｎ
。
Import items
Qty. Allowed
ke/ke
Capecitabine
l kg
1
2,3‐Di-0‐ Acetyl‐ 5‐Deoxy‐ 5‐
Fluorocytidine
1.19 kg
2
n-Pentyl Chloro Formate
0.813 kg

## Case No.:116/12/82-
Paty Name:VIVIMED LABS
20.03.2018
Lic.No/Date:0910065373
‐23.082017
Defer I)ate:
19.05。2018
Decision : Deferred

## Case No.:134/12/82-
ALC4/2017
ParりName:VIVIMED LABS
LIMITED
Ｆ
‐
‐
‐
３
９
‐
‐
Ｆ
‐
‐
４
０
‐
‐
Ｆ
‐
‐
‐
４
‐
‐
‐
‐
HQ File
:01/82/050/01089/AM18/
ICase No.:157/12/82‐
Paty NameiVIVIMED LABS
LIMITED
ミ＼TE
ALC4/2017
20.03.2018
Lic.No/Date10910065370
123.08.2017
tus:Deffered
Re-indexed
Lic.No/Date:0910065372
:09/24/040/00233/AM18/
23.08.2017
し
|
ヘ
No.:167/12/82‐
File
1/82/050/01131/AM18/
File
/82/050/01112/AM18/
No/Date:12/82‐
8
File
No/Date:12/82‐

ヘ
２
β
２
０
Ｎ
ｏ
・
‥
‐
５
州
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
Ｆ
‐
‐
４
２
‐
‐
1柵柵
eTIEЮ Liii
Meet No/Date:12/82‐
1鷺ち刷:900268晨Mlν
ALC4/2017
120.03.2018
Lic.No/Date:0910065388
2408.2017
Defer Date:
19.05。2018
Case No。:182/12/82‐
ALC4/2017
Party Name:KREATIVE
ORGANICS(P)LTD.,
Ｆ
‐
‐
４
３
‐
‐
Ｆ
卜
‐
４
４
卜
‐
Meet No/Date:12/82‐
HQ File
:01/82/050/01137/AM18/
Decision : Deferred
HQ File
:01/82/050/01134/AM18/
us:Deffered
nd Re-indexed
RLA File
i09/24/040/00254/AM18/
ALC4/2017
120.03.2018

## Case No.:179/12/82-
ALC4/2017
20.03.2018
Lic.No/Date:0910065378
24.08.2017
c"*N*H9l12t82- W@Ftrt*'
ALC4t20l7 
ILASORATORIES lALC4l20l7 
lApproved
I 
lzo.or.zota I
mry@
1:0 I /82i050/0 I I 04/AM I 8/ 
l:09/2410a0t002441 AM|S/ '124.08.2017 
I
ltechnical experts and it was decided to ratiff the ad-hoc input output norms under para 4.7 of HBP as per
ldetails below or as applied by firm whichever is lower:
Export product
Exp.Qty.
Sl.
No.
Import items
Qty. Allowed
ks/ke
Bromo Ketorolac
(or) 5-Benzoyl,
3bromo-2,3-
Dihydro, l-H
pyrrolizine-l-
carboxylic acid
l kg
1
Pyrrole
0.79 kg
つ
４
Isonropenyl Acetate
0.90 kg
Dimethyl sulphoxide
1.71 kA
4
DMF
1.53 kg
Potassium Carbonate
4.16k負
6
Di-ethyl malonate
2.29 kg
concerned may takt further necessary action as per above decision of NC
Case No。:158/12/82‐
PTりName:VIVIMED LABS
Ｆ
‐
‐
４
６
‐
ト
Meet No/Date:12/82
陽ち鵬υ¨Amy鵬
Defer Date:
Decision : [t was decided to call the for PH atong with Central Excise production consumption data.
lFurty Nd;'VNrNaso r-ess
西しご雨面而ラl'1
1 )
7
No/Date:12/82-

Meet No/Date:12/82
陽ち鵬υ¨Amy鵬
Defer Date:
Decision : [t was decided to call the for PH atong with Central Excise production consumption data.
lFurty Nd;'VNrNaso r-ess
西しご雨面而ラl'1
1 )
7
No/Date:12/82-

Ｆ
Ｉ
Ｉ
Ｉ
Ｉ
Ｉ
ALC4/2017
HQ File
:01/82/050/01086/AM18/
RLA File
:09/24/040/00238/AM18/
Lic.No/Date:0910065396
128.08.2017
Ｆ
‐
‐
４
８
‐
‐
ALC4/2017
HQ File
:01/82/050/01087/AM18/
RLA File
:09/24/040/00235/AM18/
Meet No/Date:12/82‐
ALC4/2017
20.03.2018
Lic.No/Date:0910065398
28.082017
Pa●y Name:VIVIMED LABS
LIMITED
ICase No.:141/12/82‐
２
８
２
６
Ｎ
ｏ
・
‥
２
‐
”
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
Ｆ
‐
‐
４
９
‐
‐
Ｆ
‐
‐
５
０
‐
‐
HQ Filc
:01/82/050/01096/AM18/
P釘りName:VIVIMED LABS
LIMITED
RLA File
:03/94/040/00423/AM18/
Mcet No/Date:12/82‐
1器3児5υ∝
17VAMlν
ALC4/2017
20.03.2018
Defer Date:
19.05。2018
Party Name:GLOBE
TROTTERS PVT LTD
ALC4/2017
120.03.2018
Lic.No/Date:0310815413
29.08.2017
,Decision : Deferred
Ｆ
Ｉ
Ｉ
Ｉ
Ｉ
貯糖班ル
1器星児
5υOЮ8VAMlν
1鴨刷
:OЮ舵のハ
mν
1麟"町
|   |
押柵濫N
D".iti"n , C..rritt.. ."*iO.iia i*. as per agenda and deliberated on the matter in the presence of the
technical experts and it was decided to ratiry the ad-hoc input output norms under para4.7 of HBP as per
details below or as applied by f,rrm whichever is lower:
Export product
Exp.Qty.
Ｓ
ｌ
．
Ｎ
。
Import items
Qty.

rts and it was decided to ratiry the ad-hoc input output norms under para4.7 of HBP as per
details below or as applied by f,rrm whichever is lower:
Export product
Exp.Qty.
Ｓ
ｌ
．
Ｎ
。
Import items
Qty. Allowed
ke/ke
Bromo Ketorolac
(or) 5-Benzoyl,
3bromo-2,3-
Dihydro, l-H
pynolizine-l-
carboxylic acid
l kg
1
Pyrrole
0.79 kg
2
Isopropenyl Acetate
0.90 kg
Dimethyl sulphoxide
1.71 kg
4
DMF
1.53 kg
Potassium Carbonate
4.16 kg
6
Di-ethyl malonate
2.29 kg
concerned may takt further necessary action as per above decision of NC
巫
No。:132/12/82‐
No/Date:12/82‐
1躙鼎α
"Ю“""
No■13ツ12だ2‐
  P]需
Namα HETEROLABS I鼈
:l冽愕
tα 12/82- E需
糧littI::

1撚鼎“Я∞““61器紺
:
‐

## Case No.:138/12/82-
Ｆ
‐
‐
５
３
‐
‐
P釘
"Name:BRILLIANT BIO
PHARMA PRIVATE
LIMITED
IMcet No/Date:12/82‐
IALC4/2017
20.03.2018
:0 I /82/050/0 1093/AM I 8/ 
l:091241040100267 lAMlSl
r Date:
19.05。2018
Lic.No/Date:0910065419
31.08.2017
lDecision : Deferred for comments of DBT
Ｆ
‐
‐
５
４
‐
‐
Ｆ
‐
‐
５
５
‐
‐
Pa“y Name:COVALENT
LABORATORIES PRIVATE
LIMITED
RLA File
:09/24/040/00251/AM18/
tus:Deffered
nd Re-indexed
HQ File
i01/82/050/01138/AM18/
圏器“釧∞“の
21器紺
:

## Case No.:183/12/82-
ALC4/2017
20032018
画面雨高面
F
No.:122/12/82‐
4/2017
IPattNamc:DIⅥS
ILABORAT:RIES LTD
1麟"
|:計;)We:0910065142 町
区分璃為
00283ハMlν
ision : Committee considered case as per agenda and deliberated on the matter in the presence of the
nical experts and it was decided to ratii/ the ad-hoc input output norms under para 4.7 of IIBP as per
Lils below or as applied by hrm whichever is lower:
Export product
Exp.Qty.
Ｓ
ｌ
．
Ｎ
。
Import items
Qty.Allowed
kJkg
NABUMETONE
l kg
1
2‐ACETYL‐ 6‐METHOXY
NAPHTHALENE
1.71 kg
2
METHANOL
3.16 kg
Ｆ
卜
‐
５
７
‐
‐
函
ド
貯灯‐甘騨賛Ⅷ湯T
醜ち刷
:υ00273ハMlν

## Case No.:126/12/82‐
Party Name:NASENSE LABS
t 7
ALC4/2017
PVT LTD
File
No/Date:12/82-
20.03.2018

:01/82/050/01081/AM18/
Date:
19.05。2018
RLA File
:09/24/040/00289/AM18/

## Case No.:113/12/82‐
P額りNameiSUVEN LIFE
Mcet No/Date:12/82‐
ALC4/2017
SCIENCES LIMITED
ALC4/2017
20.03.2018
:09/24/040/00271/AM18/
Lic.No/Date:0910065448
11.09.2017
ICase No.:163/12ノ82‐
Party Name:RA CHEM
ALC4/2017
20.03.2018
:01/82/050/01118/AM18/
Lic.No/Date:0910065456
14.09.2017
Decision : Committee considered case z
technical experts and it was decided to r
details below or as applied by firm which
n per agenda and deliberated on the matter in the presence
:ati$ the ad-hoc input ouQut norms under para 4.7 of HBP
Lever is lower:
Export product
Exp.Qty.
Import items
Qty. Allowed
kp/ke
Orlistat PcHcts 50%
l kg
ORLISTAT
0.505 kg
Case No。:112/12/82…
ALC4/2017
‐20.03.2018
Lic.No/Date:0910065453
14.09.2017
Lic.No/Date:0910065455
14.09.2017
ind deliberated on the matter in the presence of the
tical experts and it was decided to rati$'the ad-hoc input output norms under para4'7 of HBP as per
ls below or as applied by firm whichever is lower:
Export product
Exp.Qty・
Ｓ
‐
．
Ｎ
。
Import items
Qty. Allowed
ks./ks.
DOXOFYLLINE
l kg
1
THEOPHYLLINE
0.80 kg
2
CHLOROACETAL DEHYDE
DIMETHYL ACETAL
0.80 kg
3
POTASSIUM CARBONATE
0.61 kg
4
METHANOL
0.63 kg
DIMETHYL FORMAMIDE
0.40 kg
concerned may takt further necessarl action as per above decision of NC
ICase No.:162/12/82‐
Ｆ
卜
‐
６
２
‐
‐
RLA Flle
:09/24/040/00296/AM18/
Lic.No/Date:0910065454
14.09.2017
P釘りNameiSUVEN LIFE
SCIENCES LIMITED
Meet No/Date:12/82‐
:01/82/050/01117/AM18/
15
No//Date:12/82‐
LIMITED
File
Re-indexed
File
1/82/050/01068/AM18/
File

00296/AM18/
Lic.No/Date:0910065454
14.09.2017
P釘りNameiSUVEN LIFE
SCIENCES LIMITED
Meet No/Date:12/82‐
:01/82/050/01117/AM18/
15
No//Date:12/82‐
LIMITED
File
Re-indexed
File
1/82/050/01068/AM18/
File

Ｆ
卜
降
―
‐
―
Pa"Name:AUROBINDO
PHARMA LIMITED
Mcet No/Date:12/82‐
ALC4/2017
lzo.or.zot s
E」
Ｆ
卜
‐
６
４
‐
‐
Party Name:MYLAN
LABORATORIES LIMITED
Lic.No/Date:0910065479
18.09.2017
:Deffered
nd Re-indexed
Ｆ
Ｉ
ト
ー
ト
lCase No.:l6lll2l82-
llALC l20r1
I
孵甲や
IπD 1麟"
1需辮“
%∞“″01器紺
:
1器3泥50Ю HlαAMlν  
陽ち刷iυ00294ハMlν
Ｄ
Ｅ
Ｔ
Ｕ
Ｓ
」
‐
Ｍ
　
・
Ｍ
Ｅ
¨
¨
Ｎ
ａ
Ｇ
Ｓ
切
脚
２
８
２
５
Ｎ
ｏ
・
‥
‐
６
州
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
Ｆ
‐
‐
６
６
卜
‐
1鷺ち刷
:OЮ0292ハMlν 1濶酬
T多
1悧器α
"Ю“
'・麗紺
:
Case No。:164/12ノ82‐
ALC4/2017
Parfy Name:OPTIMUS
DRUGS PRIVATE LIMITED
Ｆ
‐
‐
６
７
‐
‐
Decision : Deferred
Lic.No/Date10910065492
.2017
:Deffered
Re-indexed
Defer I)ate:
19。05。2018
Par″ Name:DR.REDDYS
LABORATORIES LIMITED

## Case No.:173/12/82‐     IPartyName:OPTRIX
LABORATORIES PRIVATE
Mect No/Date:12/82‐
西画面面面而而う
:
No。:160/12/82‐
7
File
1/82/050/01115/AM18/
119/AM18/
File
18/
Ｆ
‐
‐
６
８
‐
‐
脚辮α酬∞“
5万麗裏I

Ｆ
ト
ー
ー
IALC4/2017
HQ File
:01/82/050/01130/AM18/
|[舎品呂lttT°
RIES PRIVATE
RLA File
i09/24/040/00307/AM18/
Party Name:PORUS
LABORATORIES PVT LTD
Ｆ
‐
‐
７
‐
‐
‐
ALC4/2017
HQ File
:01/82/050/01075/AM18/
ALC4/2017
20.03.2018
Defer Date:
19.05。2018
:09/24/040/00315/AM18/
Lic.No/Date:0910065521
29.09.2017
Ｆ
‐
‐
７
２
‐
‐
IDecision:DeFerred
HQ File
:01/82/050/01080/AM18/
P征けName:SATYADEVA
PHARMACEUTICALS PVT
LTD
RLA File
:09/24/040/00328/AM18/
Mcet No/Date:12/82-
1翻辮“Я∞“"61蹄紺
:
IALC4/2017
120.03.2018
1甲器焉T
|;計;)We:0910065525 町
彫顧
j"η7叩γ
Oecision : Committee considered case as per agenda and deliberated on the matter in the presence of the
technical experts and it was decided to rati$ the ad-hoc input output norms under para4.7 of HBP as per
details below or as applied by frm whichever is lower:
Export product
Exp.Qty・
Import items
Qty. Allowed
ks/ks
(4R-Cis)- l, I -Dimethylethyl-6-(2-
aminoethyl)-2,2-Dimethyl- 1,3 -
Dioxane-4-acetate (OR) Amino ketal
l kg
(4R‐Cis)‐ 1,1‐
Dirnethylethyl-6-
cyanomethyl‐ 2,2‐
Dimethyl‐ 1,3-
dioxane‐4-acetate
(ATS‐ 8)
1.01 kg
RA concemed may take further necessary action as per above decision of NC
Ｆ
Ｌ
ド
ー
藤
I■
;il:/
: Deferred
No.:120/12/82‐
No.:125ノ12/82‐
Name:SRINI
ATE LIMITED
No/Date:12/82‐
File
No/Date:12/82-

.01 kg
RA concemed may take further necessary action as per above decision of NC
Ｆ
Ｌ
ド
ー
藤
I■
;il:/
: Deferred
No.:120/12/82‐
No.:125ノ12/82‐
Name:SRINI
ATE LIMITED
No/Date:12/82‐
File
No/Date:12/82-

technical experts and it was decided to rati$/ the ad-hoc input output norms under para4.7 of HBp as per
Export product
Exp.Qty.
Ｓ
‐
．
Ｎ
。
Import items
Qty. Allowed
ks/ks
FLUVOXAMINE
MALEATE
l kg
1
1‐CHLORO¨ 4-METHOXY BUTANE
1.01 kg
０
４
4‐(TRIFLUORO METHYL)
BENZONITRILE
0.93 kg
TETRA HYDROFURAN
1.985 kg
4
2‐CHLOROETHYLAMINE HCL
0.48 kЯ
SODIUM HYDROXIDE MICRO
PEARLS
1.313 kg
Case No。:1/12/82…
Parry Name:UPL LTD.
Meet No/Date:12/82¨
ALC4/2017
20.032018
Lic.No/Date:0310816059
10310.2017

## Case No.:174/12/82‐
PTりName:OPTIMUS
DRUGS PRIVATE LIMITED
腸ち鵬
∽
"剛
AMν
圏
辮
JЮ
“"%1器
紺
:
ALC4/2017
20.03.2018
:01/82/050/O1129/AM18/
Case No。:115ノ12ノ82‐
Party Name:SATYADEVA
PHARMACEUTICALS PVT
Mcet No/Date:12/82‐
ALC4/2017
Lic.No/Date:0910065537
RLA File
:09/24/040/00337/AM18/
05.10.2017
Party Name:AKTINOS
HEALTHCAREPRIVATE lALC4l2ol7
79119∫
:|:50/01073/A卜1lj   llttiλ:0/00334/AM18/    ■
_i慾We:0910065542剛
20.03.2018
:01/82/050/01070/AM18/
Casc No。:118/12/82…
Ｋ
Ａ
Ｄ
Ｐ
Ｅ
Ｅ
Ｔ
飢
Ｍ
・
¨
¨
Mcet No/Date:12/82-
ALC4/2017
20.03.2018
Lic.No/Date:3410043535
11.10.2017
lζ
7
: Deferred
Flle
No/Date:12/82‐
: Deferred
: Deferred
No.:27/12/82‐
No/Date:12/82‐
File

Ｆ
‐
‐
８
‐
‐
‐
lf霊ガ島″
/12/82…
HQ File
:01/82/050/00984/AM18/
Decision : Deferred
２
８
２
３
“
・
７
Ｎ
。
．
例
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
[榊鑑盟g 1琲~‐
町
圏器α鋼∞咽
1器3潟5υ∝10VAMlν
醍角刷
:υ00057AMly
町1麟"
訂
日辮“ЮΨ劉
1器紺
:
Decision : Committee considered case as per agenda and deliberated on thi ;"tt* t" th. p*"."c. "f th"
technical experts and it was decided to ratiry the ad-hoc input ouput norms under para 4.7 of HBp as per
details below or as applied by frm whichever is lower:
Export product
Exp.Qty.
Import items
Qty. Allowed
ke/ke
Methylprednisolone Sodium
Succinate for Injection USP for
manufacturers 
use
Succinate Buffered 3% sterile
l kg
Methylprednisolone
Hemisuccinate USP
Organic Chemicals
0.966
貯糖・ル
躊淋躙惧
V 1麟"
椰
3星児
5剛既ハmj
1鷺ら男
iO/00558/AM18/
圏器α∞Ю
&卸6
84
technical experts and it was decided to ratifu the ad-hoc input output norms under para4.7 of HBP as per
Export product
Exp.Qty.
Import items
Qty.

V 1麟"
椰
3星児
5剛既ハmj
1鷺ら男
iO/00558/AM18/
圏器α∞Ю
&卸6
84
technical experts and it was decided to ratifu the ad-hoc input output norms under para4.7 of HBP as per
Export product
Exp.Qty.
Import items
Qty. Allowed
ke/ke
Griseomlvin Tablets USP 500 mg
(2000 Bottles x 100 Per Bottle =
200,000  Tablets) Net  COntent
Weight 100.000 kgs)
l Nos.
Griseofulvin USP
510 mg/tabtt
Ｆ
Ⅳ
猥薔淵r"/82‐
lη
Name:DEEPAK
No/Date:12/82-
17
Re-indexed
10043536
1.10.2017
1器紺
:

Ｆ
Ｉ
Ｉ
ト
「
|       |       
レ
00■2∝8   1
鵬
掲5∽
""晨
my陽
蹴
oЮ
“"晨
my 
圏
辮
“
Я ∞
“ “
51器
紺
:
２
８
２
Ｎ
ｏ
。
‥
８
‐
州
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
Paty Name:SYMBIOTEC
PHARMALAB PRIVATE
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
Mcet No/Date:12/82‐
ALC4/2017
町
岬路響瞥
:"
1器3児5υOЮ36/AMly
1跳t刷:0/00580/AM18/
87

## Case No.:142/12/82‐
ALC4/2017
Lic.No/Date:5610005238
24.10.2017
ision : Committee considered case as per agenda and deliberated on the matter in the presence of the
nical experts and it was decided to rati! the ad-hoc input output norms under para4.7 of HBP as per
Export product
Exp.Qty.
Import items
Qty. Allowed
kelke
Methylprednisolone Hemisuccinate
USP
Orsanic Chemical
l kg
Methylprednisolone
IP/BP/EP/USP
Organic Chemicals
0.86 kg
RA concemed may take further necessary action as per above decision of NC
20.03.2018
Lic.No/Date:0310816516
25.10.2017
technical experts and it was decided to ratify the ad-hoc input output norms under pata 4.7 of HBP as per
Export product
Exp
Otv.
Ｓ
‐
．
Ｎ
。
Import items
Qty. Allowed
Momat Rino Advance (AZ) NS
150MD RU/ Mometasone Furoate
& Azelastine HCL Nasal Spray
(rsOMD)
(Mometazone furoate 50 mcg,
Azelastine hydrochloride 140
mcgXNet Wt. of Mometasone
Furoate BP is 1500.00 Grams &
Net Wt. of 
Azelastine
Hydrochloride BP 4200.00 Grams)
Ｎ
ｕ
ｍ
ｂ
ｏ
ｆ
山
1
Mometasone Furoate
BP ( Micronized)
7.65 m{pack
2
Azelastine
Hydrochloride BP
2l.42mglpack

## Case No.:108/12/82‐
Lic.No/Date:5610005240
25.10.2017
:01/82/050/01063/AM18/
P征りName:SYMBIOTEC
Meet No/Date:12/82‐
PHARMALAB PRIVATE
LIMITED
ALC4/2017
120.03.2018
RLA File
:56/24/040/00068/AM15/
2フ
Re-indexed
Date:

２
８
２
３
Ｎ
ｏ
。
‥
‐
４
州
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
[趙賛誠首躙器
ILIMITED
Meet No/Date:12/82-
ALC4/2017
20.03.2018
囲辮α知∞“
25
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
町
1器3泥5υ01098ハMlν
:01/82/050/01099/AM18/
1跳ち刷:OЮ0006/AMlν
町
|しよだら
11彎
e:5610005248
technical experts and it was decided to ratifu the ad-hoc input output norms under para4.7 of HBP as per
Export product
Exp.Qty.
Import items
Qty. Allowed
ke/ke
Succinate for injection USP for
manufacturers 
use
Succinate 3% Buffered Sterile
l kg
Methylprednisolone
Hemisucciante IP/BP
0.966

## Case No.:144/12/82‐
ALC4/2017
P額けNameiSYMBIOTEC
PHARMALAB PRIVATE
LIMITED
:56/24/040/00004/AM16/
technical experts and it was decided to ratifu the ad-hoc input output norms under para4.7 of HBP as per
details below or as applied by frm whichever is lower:
Export product
Exp.Qty.
Import items
Qty. Allowed
ks./ks.
Methylprednisolone
Succinate for Injection
manufacturers
Methylprednisolone
Ｓ
ｏ
ｄ
ｉ
ｕ
ｍ
¨
ｕ
ｓ
ｅ
Ｓ
ｏ
ｄ
ｉ
ｕ
ｍ
Ｕ
Succinate Buffered 3oZ sterile
l kg
Methylprednisolone
Hemisuccinate USP
Organic Chemicals
0.966
| [欄
警下
lda and deliberated on the matter in the presence o
ld‐ hoc mput output nolllls under para 4.7 ofHBP a
ver:
一
　
　
一
袖
叩
Export product
Exp.Qty
Import items
Qty. Allowed
ke/ke
Succinate for Injection USP for
manufacturers 
use
Succinate Buffered 37o sterile
l kg
Methylprednisolone
Hemisuccinate USP
Organic Chemicals
0966
21

concemed may take further necessary action as per above decision of NC
「霊以
I″
6/12′ 82‐   ~|:脚
に3島掲5υ01101/AM18/1跳
ち刷:OЮ0044晨M17
1濶~ |
Lic.No/Date:5610005243 1Defer Date:
ParりName:SYMBIOTEC
PHARMALAB PRIVATE
LIMITED
ｎ
ン
Ｆ
ト
ー
ー
ー
ー
貯灯
mル
[榊鑑躙稽1濶]"町
囲辮αηTT響
|
暦需悪蔦
=菰
蔦戸
~「
隈分刷
:OЮ0021ハMlα
ision : Committee considered case as per agenda and deliberated on the matter in the presence of the
nical experts and it was decided to ratify the ad-hoc input ouput norms under para4.7 of HBP as per
Export product
Exp.Qり.
Import items
Qty.

genda and deliberated on the matter in the presence of the
nical experts and it was decided to ratify the ad-hoc input ouput norms under para4.7 of HBP as per
Export product
Exp.Qり.
Import items
Qty. Allowed
ke/ke
Succinate for Injection USP for
manufacturers 
use
Succinate Buffered 3% sterile
l kg
Methylprednisolone
Hemisuccinate USP
Organic Chemicals
0.966
technical experts and it was decided to rati! the ad-hoc input output norms under para4.7 of HBP as per
Export product
Exp.Qty.
Import items
Qty. Allowed
ke/ke
Succinate for Injection USP for
manufacturers 
use
Succinate Buffered 37o sterile
l kg
Methylprednisolone
Hemisuccinate USP
Organic Chemicals
0.966
|
22
No.:147/12/82‐
No/Date:12/82-
7
8
File
Flle
1/82/050/01102/AM18/
10.2017
No。:82/12/82‐

Ｆ
‐
‐
９
６
‐
‐
Case No。:107/12/82‐
tus:Deffered
nd Re-indexed
DeFer Date:
19.05。2018
OXYGEN&INDUSTRIAL
GASES PVToLTD.,
ALC4/2017
20.03.2018
Lic.No/Date:5610005253
2610.2017
Party Name:KAIRAV
CHEMOFARBE
INDUSTRIES LTD.
Ｆ
Ｌ
Ｆ
Ｉ
HQ File
:01/82/050/01035/AM18/
RLA File
:03/94/040/00582/AM18/
Meet No/Date:12/82‐
Lic.No/Date:0310816608
30.10.2017
ALC4/2017
120.03.2018
Ｆ
‐
‐
９
８
‐
‐
jDecision : Deferred
ALC4/2017
HQ File
:01/82/050/01033/AM18/
Deffered
nd Re-indexed
田辮∝∞Ю譴“γ師
Pa●y Name:CIPLA LIMITED.
ALC4/2017
20.03.2018
:03/94/040/00588/AM18/
ICase No。:53ノ12/82‐
Lic.No/Date:0310816693
01.11.2017
Patt Name:INDO AMINES
LIMITED
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
Defer Date:
19.05。2018
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
Case No。:26/12/82‐
Party Name:DEEPAK
ALC4/2017
NITRITE LIMITED
ALC4/2017
120.03.2018

S
LIMITED
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
Defer Date:
19.05。2018
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
Case No。:26/12/82‐
Party Name:DEEPAK
ALC4/2017
NITRITE LIMITED
ALC4/2017
120.03.2018
Lic.No/Date:3410043582 1Defer Date:
Decision : Deferred
町
r f n tfr" light of written comments received from Department of Pharmaceuticals vide their OM
.350tu34g12017-pl(Norms) dated December 2077,it was decided to ratify norms under Para 4.7 of

## Case No.:79/12/82‐
ALC4/2017
Party Name:CIPLA
:01/82/050/01034/AM18/
:03/94/040/00496/AM18/
23
101
No/Date:12/82‐
No.:80/12/82‐
7
No.:78/12/82‐
No/Date:12/82‐
: Deferred
: Deferred
No/Date:12/82‐
File
1/82/050/00981/AM18/
112017
No.:31/12182 - ALC4l2Ot7 iParty Name:ALEMBIC
PHARMACEUTICALS LTD
File
1/82/050/00986/AM18/

BP v1 as per details given below or as applied by the firm, whichever is less:
Export product
ExpOrt
Ouantitv
S.No
Import items
Quantity
Allowed ke/ke
AZITHROMYCIN
STEP 4
l KGA
1
EMhromycin Base USP
1.58 kg
2.
Hydroxylamine Hydrochloride
0.714 kg
Methanol
2.24k貪
4
Methane Sulfbnvl Chloride
0.47k2
Acetone
6.45 kg
6.
Ethvl Alcohol
2.81 Ltr.
7
Platinum Metal
0.05 gm
may take appropriate action as per the decision of Norms Committee.

## Case No.:54ノ12/82‐
ALC4/2017
1鶉鶴W軋
ALC4/2017
20.03.2018
:01/82/050/01009/AM18/
:03/94/040/00590/AM18/
Lic No/Date:0310816824
06.11.2017
Defer Date:
19.05.2018
Meet No/Date:12/82‐
ALC4/2017
2003.2018
106.11.2017
Lic.No/Date:0310816812
1器紺
:
鰤
貯ν麓脱‐
W軋
一
‐
‐
０
６
‐
一

## Case No.:56/12/82‐
ALC4/2017
CHEMICALS PVT.LTD.,
:03/94/040/00584/AM18/
107
ユk
No.:60/12/82-
1015/AM18/
Name:AVA
File
No/Date:12/82‐
No/Date:12/82‐
7
fficaSeaSperagendaandinconsultationwithtechnicalauthoritypreSent
meeting, it was decided to rati! norns as per the earlier decision taken in norms committee meeting No.
held on 19.12.2014 under para 4,7 of HBP as per details below or as apphed by f1111l WhiChever is
Party Name:ENALTEC

ROSUVASTATIN CALCIUM
(R‐ 10 ROUTE)
6 -l(lB)-z-t4 -(4-Fluorophenyl)-6-( I -
Methylethyl)-2- [Methyl
(Methylsulfonyl)Aminol -5 -
Pyrimidinyll Ethenyll -2,2-Dimethy-L- 1,3 -
Dioxane-4-Acetic Acid l, l -Dimethylethyl
Ester
RA concerned may take further necessary action as per above decision of NC.
Case No。:61/12/82-
ALC4/2017
ParりNamc:ENALTEC LABS
PVT.LTD.
ALC4/2017
20.03.2018
Lic.No/Date:0310816850
:03/94/040/00619/AM18/   07.11.2017
ical experts and it was decided to ratify the ad-hoc input output norms under para 4.1 of HBP as per
ils below or as applied by firm whichever is lower:-
@cessary 
action aS perabove decision of
F霞
血
62/12/82‐ 凡釧
狙71躙
器
ぶ
尋FttК
1器島児
59ЮЮ
17AMlν
剛温扁
日孵
C“Ю制御"「
戸F而
而而正画面
[鑑縦露
:舗
|キど
ЫF:匿
き淵
α282
|:illlll:|lii:::lililll::III:llll
(4R―CIS)-1,1‐ DIMETHYLETHYL‐ 6-
CYANOMETHYL-2,2-DIMETHYL-1,3‐
DIOXANE-4‐ ACETATE
ATORVASTATIN
CALCIUM
4‐FLUORO‐ALPHA― (2‐METHYL‐ 1‐
OXOPROPYL)‐ GAMA‐OXO―N,BETA‐
DIPHENYL BENZENEBUTANAMIDE
Mcet No/1Date:12/82‐
casezrSperagendaandinconsultationwithtechnicalauthority
.esent in meeting, it was decided to rati$ norrns as per the earlier decision taken in norms committee
eeting No.

TANAMIDE
Mcet No/1Date:12/82‐
casezrSperagendaandinconsultationwithtechnicalauthority
.esent in meeting, it was decided to rati$ norrns as per the earlier decision taken in norms committee
eeting No. l4l8, held on 24.10 .2013 under para 4.7 of HBP as per details below or as applied by firm
hichever is lower:-
Export product
Exp.
Qty
S:.No.
lmport items
Qty. allowed
STEARYL ERUCAM:DE
l kg
ERUC:C ACID
0.592 kg
STEARYL AM!NE
0.471 kg
may take appropriate action as per the decision of Norms Committee'
25
Export product
恥
Ｑ
ｔ
ｙ
lmport items
ｄ
ｅ
ｒ
ｏ
ｗ
ｈ
Ｑ
ｔ
Ａ
‐
‐
ｋ
ａ
l kg。
1.425 kg
No/Datc:12/82‐
17
18

lzo.o:.zora
I
Lic.No/Date:0510404542
08.11.2017
:01/82/050/00963/AM18/
RLA File
:05/23/040/00276/AM18/
Defer Date:
19.05。2018

## Case No.:58/12/82‐ ALC4/2017
P釘りName:ENALTEC LABS
PVT.LTD.
Mcet No/Date:12/82‐
ALC4/2017
鵬
児剛mmνAmy ttλ
刷:υ∞。αAttν
田
器
α
"Ю
別の2
Decision : Committee considered the case as per agenda and in consultation with technical authority
in meeting, it was decided to ratify norms as per the earlier decision taken in norms committee
meeting No. 5/82 held on 25.06.2015 under para 4.7 of HBP as per details below or as applied by firm
whichever is lower:-
Export product
Oty.
Import items
Oty.kノkR
DEXKETOPROFEN
TROMETAMOL
lkg
2‐ (3‐BENZOYLPHENYL)PROP10NITRILE
99%MIN(KETOPROFEN NITRILE)
1.82 kg
N¨OCTYL¨ D‐GLUCAMINE
0.36 kg
may take appropriate action as per the decision of Norms Committee.
Mcet No/Date:12/82‐
ALC4/2017
|
20.03.2018

## Case No.:59/12/82‐ ALC4/2017
Pa●y Name:ENALTEC LABS
PVT.LTD.
20.03.2018
:01/82/050/01014/AM18/
:03/94/040/00617/AM18/
112
Export product
Oty.
Import items
Otv.kg/k負
Nitazoxanide
lkg
2‐Amino‐ 5-Nitro Thiazole
0.50

## Case No.:28/12/82‐
ALC4/2017
:01/82/050/00983/AM18/
Party Name:PRISM
INDUSTRIES LTD.
Mcet No/Date112/82‐
RLA File
Defer Date:
19.05。2018
Lic.No/Date:3410043610
09.11.2017
:34/24/040/00197/AM18/
Paty Name:TRANSPEK
INDUSTRY LIMITED
HQ File
:01/82/050/01181/AM18/
RLA File
:34/24/040/00204/AM18/
Meet No/Datei12/82‐
ALC4/2017
Lic.No/Date:3410043615
10.11.2017
Decision:Committec considered the casc as per agenda and in consultation with technical authority
present in mecting,lt Was decided to rati″
norlnS as per the earlier decision taken in nol11ls cOmmittee
ing No. 6/82 held on 10.05.201l under para 4.7 of HBP as per details below or as applied by fll111
20.03.2018
hichever is lower:
2ん
: Deferred
File
;i-d1n1nit1ge-""*id;;a the case as per agenda and in consultation with technical authoriry
in meeting, it was decided to ratifu norms as per the earlier decision taken in norms committee
No. 7/82 held on 24.07.2015 under para 4.7 of HBP as per details below or as applied by f11111
is lower:-
may take further action accordingly.
Re-indexed
8
File
No.:226/12/82‐
7

ハ
Export Product
Export
Quantitv
S.No
lmport Product
Quantity
Allowed ke/ke
「EREPHTHALOYL
3HLORIDE
L kg
PURIFIED
TEREPHTHALIC
ACID
0.833 kg
may take appropriate action as per the decision of Norms Committee.

## Case No.:50/12/82‐
ParりName:AARTI
LIMITED
HQ File
RLA File
:01/82/050/01007/AMl8/ 1:8/941040100631/AMl8/
Meet No/Date:12/82‐
ALC4/2017
20.03.2018
Lic.No/Date:0310816993
13.11.2017
Decision : Committee considered cz$e as per agenda and deliberated on the matter in the presence of the
ical representative of Department of Industrial Policy & Promotion (DIPP, Chemical) and it was
ed to ratifo the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
firm whichever is lower:
. allowed
concerned may take further necessary action as per above decision of NC.
Meet No/Date:12/82‐
ALC4/2017
20.03.2018
RLA File
Defer Date:
19.05。2018
118貯腑″脱‐
Mcet No/Date:12/82-
ALC4/2017
Lic.No/Date:0510404598
14.11.2017
Decision : Deferred
:01/82/050/01005/AM18/
:03/94/040/00564/AM18/
Lic.No/Date:0310817004
13.11.2017

## Case No.:52/12/82‐
ALC4/2017
Party Name:AMINES &
PLASTICIZERS LIMITED
ALC4/2017
20.03.2018
:01/82/050/01006/AM18/
:03/94/040/00603/AM18/
Lic.No/Date:0310816992
13.11.2017
孵
:鵠IⅧ
THFE
:05/23/040/00269/AM18/
20.03.2018

## Case No.:200ノ12/82‐
ORGOCHEM(INDIA)PVT.
LTD
ALC4/2017
120.03.2018
陣Q ΠL
IRLA RL
21
[Li..NolDut.:03 I o8 1 7028 Defer Date:
Ｆ
Ｌ
打
―
File
No/Date:12/82-
File
Deffered
Re-indexed
Name:SPAK
No/1Date:12/82‐
Re-indexed

|
F53こ玉
[。n:Deferred
「
1器3児5υOЮ2νAMlν
ision : Deferred
RLA File
:03/94/040/00583/AM18/
Mcet No/Date:12/82‐
ALC4/2017
Lic.No/Date:0310817075
15.11.2017
Party Name:AVA
ICHEMICALS PVT.LTD.,
No.:49/12/82‐ALC4/2017
町
局
3島児
5∽Ю“ハⅢν
120
¨12/82-AК州押淵ΨttN隠
Meet No/Date:12/82-
1器3児5υOЮ3νAMlν
1碗λ刷:OЮ0612/AMlν
Decision : ln the light of earlier decision, it was decided taken by NC in its 4182 meeting dated 12.06.2015
and in consultation with technical expert present in the meeting , it was decided to ratify norms under

## Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product
Exp.Qty.
SIoNo.
lmport items
Qtv.Allowed
EDTA Diammonium(POヽfr)
l kg
1
ETHYLENE DIAMINE
TETRA ACETIC ACID
0.825 kg
RA may take appropriate action as per the decision of Norms Committee.
ALC4/2017
120.03.2018
Lic.No/Date:0310817077
15.11.2017
Decision: Committee considered case as per agenda and in light of decision taken in meeting no.2!182
dated 06.04.2014, decided to ratify norms under para 4.7 of HBP as per details below or as applied by
firm whichever is lower:-
Export product
Exp.
Qty.
S!.No.
lmport items
Qty. allowed
1‐3,DIMETHYLOL-5,5‐ DIMETHYL
江YDANTOIN(DMDM Hydantoin
52%‐55%)Assay 55%Max.
〔BELGUARD DMDMH)
l kg
5,5】Dilnethyl
Hydantoin Assay
min。99%ColourPure
nttite
0.382 kg
may take appropriate action as per the decision of Norms Committee'
[II】二
'票
至Л
liξR&
Meet No/Date:12/82-
ALC4/2017
Defer Date:
19.05。2018
fer Date:
20.03.2018
Lic.No/Datei031 0817078
15.11.2017
Par"Name:JODAS EXPOIM
PVT.LTD.,
ALC4/2017
20.03.2018
:05/23/040/00312/AM18/
Lic.No/Datei0510404611
15。11.2017
:01/82/050/00957/AM18/
RLA File
2r
19.05。2018
18
No.:2/12/82‐ ALC4/2017
No/Date:12/82‐
File

Mect No/Date:12/82-
ALC4/2017
20.03.2018
RLA File
:03/94/040/00595/AM18/
P額けName:ENALTEC LABS
Mcet No/Date:12/82‐
PVT.LTD.
ALC4/2017
‐
20.03.2018
RLA File
:03/94/040/00660/AM18/
う
乙

## Case No.:67/12/82-ALC4/2017
Party Name:KRISHNA
ANT10XIDANTS PVTo LTD.
1器島泥
5剛022ハMlν
Lic,No/Date:0310817117
16.11.2017
Decision: Committee considered case as per agenda and in light of earlier decision taken in Meeting No.
16182 dated 2l.ll,2Ol3 and also and in consultation with technical authority present in meeting, decided
to ratiS 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 Allowed
DIPHENYL ISODECYL
PHOSPHITE
l kg
PHENOL
0.558 kg
2.
ISODECYL ALCOHOL
0.419 kg
3.
YELLOW PHOSPHORUS
0.09 kg
RA may take appropriate action as per the decision of Norms Committee.

## Case No.:66/12/82‐ ALC4/2017
:01/82/050/01021/AM18/
Lic.No/Date:0310817157
20.11.2017
deliberated on the matter in the presence of the
technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per
details below or as applied by frm whichever is lower:-
Export product
Exp.
Qty.
S:.No.
lmport items
Qty.a‖ OWed
kg/kg
LYMECYCLINE EP
l kg
TETRACYCLINE
HYDROCHLORIDE
1.00 kg
A ,ry tak" app.priate action as per the decision of Norms committee.
Case No.:`9/12/82‐
ParりName:GODREJ
INDUSTRIES LTD.,
Meet No/Date:12/82‐
Defer Date:
19.05。2018
Defer】Date:
19.05。2018
]Att ν
Lic.No/Date10310817159
20.11.2017
ALC4/2017
120.03.2018
Lic.No/Date:0310817161
20.11.2017
Decision : Deferred
2η
ALC4/2017
‐
20.03.2018
|:iIIIIIIIil:|:liilll::il:||||
|    |
17
/82/050/01024/AM18/
No/1Date:12/82‐
Re-indexed
File
No.:39/12/82‐
No/Date:12/82-

⌒
:01/82/os0l0rl53/AMl8/ l:031951040100688/AMl8/
Defer Date:
19.05.2018
Defer Date:
19.05.2018
Lic.No/Date:0510404646
20.11.2017

## Case No.:198/12/82…
Party Name:ZYTEX
BIOTECH PVT.LTD.
ALC4/2017
20.03.2018
Lic.No/Date:0310817180
21.11.2017
IDecision:Deferred for comments of DBT
貯柵脱脱‐
1孵"町
け∬辮α“Ю譴η
130
: Committee considered case as per agenda and deliberated on the matter in the presence of the
experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed kelke
EEFOTAXIME SODIUM
STERILE
L kg
CEFOTAXIME ACID
0.989 kg
RA may take appropriate action as per the decision of Norms Committee..
ffiasperagendaandinlightofearlierdecisiontakeninMeetingNo.
dated25.09.2014 and also and in consultaiion with technical authority present in meeting, decided to
iS norms under para 4.7 of HBP as per details below or as applied by hrm whichever is lowers:
may take appropriate action as per the decision of Norms Committee'
Ｆ
‐
‐
３
２
ト
剛¨
鵠
.
圏111醐Mν
澁
:誌1剛ν
TSN HYDROCHLORIDE(3,7‐
DIAMIN0 2,8‐
DIMETHYLDIBENZOTH10PHENE
5,5‐D10XIDE
DIHYDROCHLORI
スク
: Deferred
No/Date:12/82‐
7
Re-indexed
Name:GLOBE
PVT LTD
File
1019/AM18/
No.:199/12/82‐
Name:METROPOLITAN
No/Date:12/82‐
PRIVATE LTD.
7
8
10817218
154/AM18/
112017

HENE
5,5‐D10XIDE
DIHYDROCHLORI
スク
: Deferred
No/Date:12/82‐
7
Re-indexed
Name:GLOBE
PVT LTD
File
1019/AM18/
No.:199/12/82‐
Name:METROPOLITAN
No/Date:12/82‐
PRIVATE LTD.
7
8
10817218
154/AM18/
112017

technical representative of Department of Indushial Policy & Promotion (DIPP, Chemical) and it was
decided to ratify 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
Exp, QW.
Sl.No.
Import items
Qty.alloWed
INTRA    UTERINE
CONTRACEPTIVE
DEVICE ―COPPER T
380A
I Number
1
COPPER VV:RE(99.99%
PURIW)
0.000204 kg
2.
HDPE GRANULES
(Moulding grade)
0.001202 kg
POUCHES(PLASTiC)
Net+10%
4.
COPPER TUBE(99.99%
PURITY)
0.000169 kg
POLYPROPYLENE
GRANULES
0.0015543 kg
6.
COMPOUND OFLDPE
RESIN&BAR:UM
SULPHATE
0.000415 kg
7.
PVC GRANULES
0.000658 kg
HDPE GRANULES{OR
NYLON RES:N)MEDICAL
GRADE
0.000177 kg
1器蹴
乳習ヾ
E
Meet No/Date:12/82‐
ALC4/2017
120.03.2018
剛
,0岬御晨剛ν
Defer Date:
19。05。2018
Lic.No/Date:0310817258
23.11.2017
ICase No.:190/12/82‐
Decision : Deferred
Mcet No/Date:12/82‐
ALC4/2017
Meet No/Date:12/82‐
ALC4/2017
20.03.2018
Defer Date:
19.05.2018
Defer Date:
19.05。2018
SPECIALITIES PVT.LTD.
レ0.03.2018
Lic.No/Date:0310817246
:03/95/040/00701/AM18/
23.11.2017

## Case No.:208/12/82¨
P征りName:ATUL LIMITED,
Lic.No/Datei0810141364
:01/82/050/01163/AM18/
gl
24.11.2017

## Case No.:73/12/82‐
ALC4/2017
Re-indexed
File
1028/AM18/
: Deferred
Re-indexed
Re-indexed
File
1/82/050/01145/AM18/
: Deferred

## Case No.:65/12/82‐ ALC4/2017
ParりName:CIPLA LIMITED.
Meet No/Date:12/82-
師
陽λ
51,OЮ“76/Amy 隣∬器醐Ю
81728
ALC4/2017
120.03.2018
:01/82/050/01020/AM18/
technical experts and it was decided to ratify 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
Exp.Qty.
SI.No.
lmport items
Qty. allowed
Cipcox 2.5%Solution Toltrazlril
Solution 2.5%w/v Pack size:l Ltr
Each 100 ml contains:Toltraztri1 2.5
興
1 litre pack
Toltrazuril
25.5gm
may take appropriate action as per the decision of Norms Committee.

## Case No.:189/12/82-
Party Name:PRIVI ORGANICS
INDIA LIMITED
Meet No/Date:12/82‐
ALC4/2017
20.03.2018
Lic.No/Datei0310817286
:01/82/050/01144/AM18/
:03/95/040/00585/AM18/
24.11.2017
Decision : Committee considered case as per agenda and in light of earlier decision taken in 21182 meeting
held on 23.08.2011 and in consultation with technical authority present in meeting, decided to ratifu
norms under para 4.7 of HBP as per details below or as applied by frm whichever is lower:-
Export product
Exp.
Oty.
Sl.No.
Import items
Qty. allowed
Amber Fleur
l Kg.
1
Myrcene 80%o
0.90 kg
2
Methyl Ethyl Ketone
0.53 kg
Phosphoric Acid
0.025 kg
Case No。:224/12/82‐
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
Lic.No/Date:3410043655
27.11.2017
Par"Name:ASTRAL
STERITECH PVT.LTD.
Defer Date:
19.05.2018
Ｄ
皿
Ｔ
・Ｌ
Ｔ
　
一
Meet No/Datc:12/82‐
ALC4/2017
20.03.2018
匿源需翫瓶面蕉|118/
Lic.No/Datei3410043654
lzt.tt:on
g,
⌒
File
File
Re-indexed
File
No.:225/12/82‐
Re-indexed
Flle
1/82/050/01180/AM18/
File
: Deferred
Date:

Ｔ
　
一
Meet No/Datc:12/82‐
ALC4/2017
20.03.2018
匿源需翫瓶面蕉|118/
Lic.No/Datei3410043654
lzt.tt:on
g,
⌒
File
File
Re-indexed
File
No.:225/12/82‐
Re-indexed
Flle
1/82/050/01180/AM18/
File
: Deferred
Date:

FalT“
IttZALα
側
7「
ば
隈
摺
轟洋
"鮮
i鮮
翻鯛2
鵬
児"畑
∞腋mν
脇
刷:υ∞
"0件
叩ν
階∬鼎
α
“
Ю尉
"“
|
F猥¨2/82‐AL鋤鰤卜
鵬掲剛∝∞ν
Attν      
圏郷α
TT田"T
師
Decision: Committee considered case as per agen
19/82 meeting held on 02.01 .2014 and in consultation with technicalauthority present in meeting,
:ided to ratify norms under para 4.7 of HBP as per details below oi as applied by firm
ichever is lower:-
Export product
ｐ
　
ｙ
欧
Ｑ
S:.No.
lmport items
Qty. allowed
ヽ―METHYL
ⅥORPHOLINE O対de‐
50%
[kg
2
Morpholine
0.391 kg
may take appropriate action as per the decision of Norms Committee.
Ⅳ【ect No/Date:12/82‐
ALC4/2017
20.03.2018
ion: Committee considered case as per agenda and in light of earlier decision taken in
19/82 meeting held on 02.01 .2014 and in consultation with technicalauthority present in meeting,
ided to ratify norms under para 4.7 of HBP as per details below or as applied by firm
Export product
Exp.
Qtv.
SI・No.
lmport items
Qty. allowed
ヽ‐METHYL
ⅥORPHOLINE O対dc‐
500/O
L kg
2.
Morpholine
0.391 kg
RA may take appropriate action as per the decision of Norms Committee
Meet No/Date:12/82-
142
ALC4/2017
120.03.2018
Lic.No/Date:0310817368
28.11.2017
Decision : Committee considered the case as per agenda and in consultation with technical authority
present in meeting, it was decided to ratifu norTns as per the earlier decision taken in norms committee
meeting No.

tee considered the case as per agenda and in consultation with technical authority
present in meeting, it was decided to ratifu norTns as per the earlier decision taken in norms committee
meeting No. l4l87 dated24.10.2013 under para4.7 of HBP as per details below or as applied by firm
whichever is lower:-
Export product
Exp.
Qtv.
S:.No.
lmport items
Qty.al10Wed
kg/kg
STEARYL ERUCAM:DE
l kg
1
ERUCiC AC!D
0.592 kg
STEARYL AM:NE
0.471 kg
may take appropriate action as per the decision of Norms Committee.
翠

Ｆ
Ｌ
Ｆ
Ｉ
貯淵錮猜′
IШ賓よ艦
HQ File
:01/82/050/01143/AM18/
RLA File
:03/95/040/00721/AM18/
Lた。No/DateЮ 3108173661DeLr Date:
ALC4/2017
20.03.2018
iDecision : Deferred
ICaseNo。
:63/12/82‐ALC4/201711]|1絆
81:|∫:¥ξ
R&
|
1麟~町
|
Ｆ
鷹
Ｆ
Ｉ
貯淵旭脱
~
梓搬α
IP:A
1器星鬼
5υOЮO"AMlν
1鷺ち刷
:0/00686晨M18/ 欝鰈"
け∬器α∞Ю制7T蹂語:
144
器晶泥型Ш
^mγ
 
陽らぶ:OρΨ 2.叩γ
階剛
:"∵
譴
"鯰
「
~
ALLIED PRODUCTS
LIMITED,
Decision: Committee considered case as per agenda and in light of earlier decision taken in Meeting No.
4182 dated I 6.05.20 I 3 and also and in consultation with technical authority present in meeting, decided to
ratif norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:
Export product
Exp.
Qty.
SI No.
lmport items
Qtv.
allowed
Camphor EP
l kg
1
Alpha Pinene
1.146 kg
RA may take appropriate action as per the decision of Norms Committee
146
IDecision:Deferred
!
ion : Committee considered the case as per agenda and in light of earlier decision taken in norms
ittee meeting No.

appropriate action as per the decision of Norms Committee
146
IDecision:Deferred
!
ion : Committee considered the case as per agenda and in light of earlier decision taken in norms
ittee meeting No. l3l82 held on lg.l2.2}l4 and in consultation with technical authority present in
rg, decided to ratifu norms under para 4.7 of HBP as per details below or as applied by firm
is lower:-
hAm…
kさappお
"夏
こacti5Rぉ5酢
“
eaさd面3A J雨6rmsこOmmはea
Ψ ¨ ¶ 珊FI濶"町
鵬
掲Wm∽61my ttλ
刷:υ∞
“
νAmν
囲
郷
α
“
Ю譴
"%|
Export Product
Export
Quantity
S.No
lmport Product
Quantity
Allowed
2-Alkyl Isophoronediamine
(Trade Name - Clearlink 1080)
L kg
Iso Phorone Diamine/1PDA
0.680 kg
2.
3% Platinum on carbon
0.0003 kg
Ｆ
‐
‐
４
７
‐
貯癬″脱
~
|:霧当ご罷質」』品馴
IIミ:ド
E
囮
面
L'Amν
gソ
No/Date:12/82-
Re-indexed
19.05。2018
1鷺痣ガ
::OЮ0630/AM18/
Re-indexed

IDecision:Deferred
Paty Name:HUBERGROUP
INDIA PRIVATE LIMITED.
IDecision:Deferred
Case No。:45/12/82‐
Paty Name:HUBERGROUP
INDIA PRIVATE LIMITED.
fer Date:
19.05.2018
P額りName:HUBERGROUP
INDIA PRIVATE LIMITED.
Case No。:196/12/82‐
ALC4/2017
Meet No/Date:12/82‐
Party Name:CORAL
Lic.No/Date:03108174601DeferDate:
LABORATORIES LTD.,
囲鳥蕊
4VAtt ν
メ5

## Case No.:44/12/82‐
ALC4/2017

## Case No.:75/12/82‐
ALC4/2017
File
1/82/050/01030/AM18/
151 1HQFlle
:01/82/050/01151/AM18/
No.:13/12/82‐
HQ File
:01/82/050/00968/AM18/
No。:19/12/82‐
7
Re-indexed
10817408 1Defer Date:
Re-indexed
No/Date:12/82‐
17
18
No/Date:12/82-
File
Name:MATRIX FINE
No//Date:12/82‐
PVToLTD。
,
Name:TRION
17
Name:NECTAR
No/1Date:12/82¨
154
1:01/82/050/00974/AM18/
7

## Case No.:184ノ12/82‐
ParりName:lJNIMAX
LABORATORIES PVToLTD
Mcet No/Datei12/82‐
ALC4/2017
20.03.2018
:hnical experts and it was decided to ratiff the ad-hoc input output norms under para4.7 of HBP as per
ls below or as applied by firm whichever is lower:
「
N“Mν"・
LC42∝7
Meet No/Date:12/82‐
隔
10%νAmy
156
Prednisolone (Prednisolone Base )
Tech Spec. : Pharmacoepial Grade.
叩
鯉キ
3
:08/24/040/00243/AM18/
ALC4/2017
120.03.2018
Lic.No/Date:0810141444
01.12.2017
ffiih..us.asperagendaandinthelightofearlierdecisiontakeninnorms
Lmittee meeting No, I I /82 held on 05.0r.201 3 and in consultation with technical expert present in the
rting, it was deiided to ratifo norms under para4J of HBP as per details below or as applied by firm
chever is lower:-
Item of Export
Quantity
S′No
Item of lmport
Quantity allowed
k」kg
PAROXETINE HCL
l kg
1
PIPERIDINE ALCOHOL[(‐ )
ALCOHOL]OR
(‐)TRANS-1‐ N‐METHYL-3‐
HYDROXY METHYL-4‐ (4-
FLUORO PHENYL)PIPERIDINE
0.810
2.
SESAMOL
0.55
3.
DIMETHYL SULFOXIDE
2.9293
4.
ISOPROPYL ALCOHOL(IPA)
327
METHANOL
310
6.
ACETONE
THIS LICENCE ISSUED AS PER

## PARA 4.7[NO‐NORMS]OF HBP‐
2009‐14 WITH NORMAL
CONDITION AS PER T.NOTICE
NO.5 DT.08.10.2003 FOR EXPORT
PRODUCT SUB.TO
COND.FIXATION OF NORMS BY
ALC N.DELHI.
3.58
may take appropriate action as per the decision of Norms Committee'

## Case No.:15/12/82‐
ParりNameiCADILA
HEALTHCARE LTD
Mcet No/Date:12/82‐
ALC4/2017
丞
`
20.03.2018
ハ
7
File
File
10817451
/82/050/01139/AM18/
11.2017
Quantity
allowed kg&g
7
Re-indexed

臨… 岬脇
Mttγ l
11),cislon:pe,rrel
ICase No。:32/12/82-
Pa●y NameiCADILA
HEALTHCARE LTD
Mcet No/Date:12/82-
Defer Date:
19.05。2018
ALC4/2017
120.032018
:01/82/050/00987/AM18/
:08/24/040/00261/AM18/
Lic.No/Date:0810141442
01.12.2017

## case No. :30/ t2 t82- ALc 4t2on @
@ 
fstrtr.t
j euanvncEuTlcAls LTD iaLC4/2017 
lApproved
I 
l2o.o3.2ot8 
|
EaFtl. 
m[-i..Noroutt:34t0043673 
I
l:01/82l050/0098s/AMl8/ l:34/2at040l0024tt{Mt8t |04.12.2017 
I
I
lruo. aSOff7S49/2017-Pt(Norms)dated December 2O!7,it was decided to ratify norms under Para4.7 of
lHee ,r as per details given below or as applied by the firm, whichever is less:
Export product
Export
OuantiW
S.No
Import items
Quantity
Allowed kg/kg
AZITHROMYCIN
STEP 4
l KGA
1
EMhomycin Base USP
1.58 kg
2.
Hydroxylamine Hydrochloride
0.714 kg
Methanol
2.24 kA
4
Methane Sulfonyl Chlgride
0.47 kg
Acetone
6.45 kg
6.
Ethyl Alcohol
2.81 Ltr.
7.
Platinum Metal
0.05 gm
Rn may tat<e appropriate action as per the iecision of Norms Commlttee.
p..iii", : beferred
ICaSe
貯腑脱
l多     囲冨ずか霊距II
ぱ
]‖]IЮ“
31
一
一
一
ニ
ー
ニ
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
ー
T一
三
百
蔦
~TT3n the matter h the presence ofme
Decision:Conlmittee considered case as per agenda and deliberated(
technical experts and h was decided to ratitt the ad_hoC mput output norlns under para 4.7 of HBP as per
Quantity
a1lowed
ils below or as applied by frm whichever is lower:
CITRIC ACID
TRIETHYL CITRATE(TEC)
(ESTER OF CITRIC ACID)
n as Per above decision of NC
Filc
1/82/050/00988/AM18/
No/Date:12/82‐
87

Ｆ
ト
ー
レ
00■2∝8   1
Meet No/つate:12/82‐
Deffered
IALC4/2017
nd Re-indexed
120.03.2018
Lic.No/Date:0310817504 1Defer Date:
Party Name:YASHO
INDUSTRIES PVT.LTD.

## Case No.:197/12/82…
ALC4/2017
Par"Name:ARVEE
LABORATORIES INDIA
PRIVATE LIMITED
RLA File
:08/24/040/00167/AM18/

## Case No.:6/12ノ82‐ALC4/2017
ALC4/2017
20.03.2018
:01/82/050/00961/AM18/
|
HQ File
:01/82/050/00962/AM18/
RLA File
:08/24/040/00242/AM18/
Lic.No/Date:0810141468 1DeferDate:
濶~
２
８
２
Ｎ
Ｏ
・
‥
７
４
州
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
Ｆ
Ｌ
Ｆ
Ｉ
1器島泥
5υ0102りAMlν
隔刷
'υ
鳳
`α
Amγ
陣柵皿焉1脚酬
T2
賭ぉ器“
31081%節
1出紺
:
¨
肩Fi「:百
Party Name:SHREE
BANKEY BEHARILAL
AROMATICS
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
ic.No/Date:0510404723 1Defer Date:
Lic.No/Date: 04 l0 I 6377 5 i Defer Date:
HQ File
:01/82/050/00971/AM18/
:05/24/040/00339/AM18/

## Case No.:16/12/82‐
Mcet No/Date:12/82‐
:04/24/040/00175/AM18/
6S
Decision : Deferred
ハ
%21器
3泥50Ю H52ハMlν
:01/82/050/00991/AM18/
7
File
No/1)ate:12/82‐
２
８
２
Ｎ
ｏ
・
‥
３
‘
四
Re-indexed
Date:
19。05。2018
甲蔦
２
８
２
Ｎ
Ｏ
・
‥
‐
７
卿
17

1器肌5υ00977AMlν
諸ら器“
4飢“η71器紺
:
Decision : Deferred
ParりName:STRIDES
SHASUN LIMITED
Meet No/Date:12/82‐
tus:Deffered
ALC4/2017
Re-indexed
120.03.2018
Defer Date:
19.05。2018
Case No。:20/12/82…
:01/82/050/00975/AM18/

## Case No.:37/12/82‐
ParU Name:STzuDES
SHASUN LIMITED
ALC4/2017
20.03.2018
:01/82/050/00992/AM18/
RLA File
:04/24/040/00181/AM18/
Defer Date:
19。05。2018
Lic.No/Date:0410163778
106.12.2017

## Case No.:10/12/82‐
ALC4/2017
Party Name:CADILA
HEALTHCARE LTD
RLA File
:08/24/040/00244/AM18/
Paty Name:CADILA
HEALTHCARE LTD
Mcet No/1)ate:12/82‐
ALC4/2017
20.03.2018
Lic.No/Date:0810141483
107.12.2017
us:Deffered
nd Re-indexed
Defer Date:
19.05。2018
1器粘
:
Mcet No/Date:12/82¨
:01/82/050/00965/AM18/
Party Name:CADILA
HEALTHCARE LTD
‐
Case No。:213/12/82‐
Mcet No/Date:12/82-
Lic.No/Date:0810141484
07.12.2017

## Case No.:23/12/82‐
Party Name:JUBILANT
GENERICS LTD
ALC4/2017
20.03.2018
Lic.No/Date:0510404765
07.12.2017

## Case No.:3/12/82-ALC4/2017
ParサName:JUBILANT LIFE
SCIENCES LIMITED
Mcet No/Date:12/82‐
Deffered
ALC4/2017
nd Re-indexed
20.03.2018
luq rit.
回
ご含
lLに。
No/D年,0510,94760
File
No/Datel1 2/82‐
7
File
No/Datc:12/82‐

107. 12.20 17                                    119。
9,。
2018              1
:Deffered
nd Re-indexed
Lic.No/Date:0510404755 1Defer Date:
:Deffered
nd Re-indexed
Lic.No/Date:0510404751 1Defer Date:
CaseNo.:12112182- ]PartyName:JUBILANTLIFE lMeetNo/Date:12182-
IDecision:Deferred
PaコけName:JUBILANT LIFE IMeetNo/Date:12/82‐
13aseNo.:5/12ノ
82…ALC4/2017
Ｆ
Ｌ
Ｆ
Ｉ
Ｆ
Ｌ
ド
ー
田
晶児
"Ю"“
ハmν
陽危酬:υ∞
"7晨
mν
け
ら辮
α
“
Ю404753師
Ｆ
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ほ
げ
―
―
Ｅ
Ｆ
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Ｔ
Ｊ
Ｕ
Ｂ
」
Ｉ
Ｍ
ｍ
ｅ
Ｅ
Ｓ
Ｎ
ａ
Ｎ
Ｃ
Paty Name:JUBILANT LIFE
SCIENCES LIMITED
:05/23/040/00295/AM18/
Ｆ
‐
‐
８
２
‐
馴
liル
|
阿訥認ド
1鷺λ馴:0/003?9/4M10/
1器島掲
5叩040/AMlγ
りθ
| :0 I /821050/00958/AM I 8/
No/Date:12/82-
17
No/Date:12/82‐
File
1/82/050/00960/AM18/
No/Date:12/82‐
17
18

## Case No.:87/12/82‐
No/Date:12/82‐
ALC4/2017
Flle
File
1/82/050/01042/AM18/
13/24/040/00041/AM18/
Re-indexed
1310048799
Date:
File

２
８
２
Ｎ
ｏ
。
‥
８
６
如
ａ
ｓ
ｅ
Ｌ
Ｃ
Ｃ
Ａ
Lた。No/DateЮ 310817555 DeLr Daほ
ALC4/2017
20.03.2018
ICasc No.:121/12/82‐
P霞りName:RELIANCE
INDUSTRIES LTD.
:01/82/050/01076/AM18/
RLA File
:03/95/040/00625/AM18/
ALC4/2017
20.03.2018
Meet No/Date:12/82-
ALC4/2017
120.03.2018

## Case No.:140ノ12/82‐
Party Name:RELIANCE
INDUSTRIES LTD.
Lic.No/Date:0310817601
07.12.2017
Defer Date:
19.05。2018
Case No。:159/12/82-
:01/82/050/01114/AM18/
P霞りName:RELIANCE
INDUSTRIES LTD.
l
RLA File
:03/95/040/00624/AM18/
Party Name:RELIANCE
INDUSTRIES LTD.
RLA File
:03/95/040/00747/AM18/
ALC4/2017
20.03.2018
ALC4/2017

## Case No.:185/12/82‐
ALC4/2017
20.03.2018
Case No。:195ノ12/82‐
ParりName:ROYAL
PHARMA
:01/82/050/01150/AM18/

## Case No.:38/12/82‐
Party Name:V.D.H.
iORGANICS PVToLTD
Decision : Deferred
クノ
120.03.2018
7
File
1/82/050/01095/AM18/
ALC4/2017
Flle
140/AM18/
: Deferred
ALC4ノ2017
File
Flle
Ｅ
Ｃ
Ｎ
Ｉ
Ｓ
No/Date:12/82-
No/Date:12/82‐
No/Datei12/82‐
17
18
Re-indexed
Ｆ
Ｌ
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Ｉ
Ｆ
Ｉ
・
ｏ
。
ド
ー
File
1/82/050/00993/AM18/
File
No/Date:12/82-

貯柵Иル
HQ File
:01/82/050/01078/AM18/
SPECIALITY CHEMICALS
PVT.LTD.
ALC4/2017
20.03.2018
Lic.No/Date:0310817629
:03/95/040/00623/AM18/
08.12.2017
Decision : Committee considered the case as per agenda and in light of earlier decision taken in norms
committee meeting No. 1/82 held on 10.04.2014 and in consultation with technical authority present in
meeting, decided to ratifu norms under para 4.7 of HBP as per details below or as applied by firm
whichever is lower:-
Export product
Exp.
Qty
S!.No.
lmport items
Qty. allowed
4,4-BIPHENOL
l kg
ISOBUTYLENE
0.700 kg
2.
PHENOL
1.50 kg
3.
METHANOL
1.00 kg
RA may take appropriate action as per the decision of Norms Committee.
ICase No.:11/12ノ82‐
IALC4/2017
「鑑縦露棚
|キぶ
T Ы
FE
Meet No/Date:12/82-
191
1器島児
5υ0096αAMlν
1性た男
,OЮ0323ハMlν

## Case No.:22/12/82‐
ALC4/2017
P釘りName:JUBILANT LIFE
SCIENCES LIMITED
Mect No/Date:12/82-
HQ File
:01/82/050/00977/AM18/
鵬危棚υ∞鯛Amν
[ドら辮α“Ю“鶴
"
Defer lDate:
19.05.2018
ALC4/2017
20.03.2018
IDecis10m:DeFerred
P釘りName:TITAN
LABORATORIES PVToLTD.
Meet No/Date:12/82-
鵬
児WmИりAmν ttλ ttiυ∞%υAttγ Fドお器
CTЮ譴%6:
rion : Committee considered case as per agenda and deliberated on the matter in the presence of the
ical experts and it was decided to ratifu the ad-hoc input output norms under para 4.7 of HBP as per
ICase No.:194ノ12/82‐
ALC4/2017
ALC4/2017
120.03.2018
Export Product
Qty.
Sl.No.
Import items
Quantity
aHowed
DIPYRIDAMOLE SR
PELLETS 40 0/0
l kg
1
DIPYRIDAMOLE
0.404 kg
llu.ty Na*e:USV PRIVATE lMeet No/Date:12182-
画
ICase No.:186/12/82‐
7フ
Name:MELOG
No月Date:12/82-
17
Re-indexed
18

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:03/95/040/00719/AM18/  111.12.2017
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9/12/8年二こ
4/2017
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nd Re-indexed
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離
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D鰤
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琴
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tus:Deffered
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ParりName:KLJ
PLASTICIZERS LIMITED
rion : Committee considered case as per agenda and deliberated on the matter in the presence of the
ical experts and it was decided to rati! the ad-hoc input output norms under para 4.7 of HBP as per
ils below or as applied by frm whichever is lower:
:05/24/040/00384/AM18/
ase No。:215/12/82‐
Mcet No/Date:12/82‐
AMODIAQUINE
HYDROCHLORIDE(HCL)
Ethoxy Methylene Malonic Acid
Ester ( EMME )
(FORMERLY USV IALC4/201 7
2003.2018
No.:25/12/82‐
File

lower:
:05/24/040/00384/AM18/
ase No。:215/12/82‐
Mcet No/Date:12/82‐
AMODIAQUINE
HYDROCHLORIDE(HCL)
Ethoxy Methylene Malonic Acid
Ester ( EMME )
(FORMERLY USV IALC4/201 7
2003.2018
No.:25/12/82‐
File
1/82/050/00980/AM18/
No/Date:12/82‐
No/Date:12/82‐
7
18
Name:MANGALAM

Ｆ
鷹
鮮
‐
貯滞И原眸淵凛
I続編
:22/24/040/00047/AM18/
1躙
答
炉
°CHET諄
謙
『
秘
‐
Lic.No/Date:0610038759 1Defer Date:
Decision : Deferred
RLA File
:31/83/040/00126/AM18/
technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per
Ｆ
Ｌ
ド
ー
貯淵“ル
HQ File
Paty Name:FRESENIUS
KABI ONCOLOGY
LIMITED
[榊勢
:瑞:ユI蔦
SODIIЛVI BENZOATE
MICRONISED
SODIUM BENZOATE
POWDER
貯脚‐ル
luq rite
ЧЧ
No.:240/12/82‐
No/Date:12/82‐
1器3児5υOH95晨Mlν
２
８
２
湘
‐
７
Ｎ
。
．
例
12.2017
No/Date:12/82‐
17
File
1/82/050/00995/AM18/
allowed kg/kg

@@Wnon
technical experts and it was decided to ratiS the ad-hoc input output norms under para 4.7 of HBP as per
ils below or as applied by frm whichever is lower:
Mcet No/Date:12/82‐
ALC4/2017
20.03.2018
鵬3掲。
υ∞叫響ν膿瑞υ叩"岬ν岡鼎“Я““
"2
experts and it was decided to ratit/ the ad-hoc input output norms under para 4.7 of HBP as per
Export Product
Qty.
Sl.N
O.
Import items
Quantity allowed
Misoprostol Tablet 200
mcg
I Number
1
Misoprostol
204.0 mcg
@furthe'neceSSaryactionasperabovedecisionofNC
DeFer Date:
19.05。2018
Export Product
Qty.
Sl.No.
Import items
Quantity
allowed
Griseomlvin Tablets USP
500 ing
(2000 Bottles x 100 Per
Bottle=200,000 Tablets)
l No.
1
Griseomlvin usP
510 mg per
tablet
concemed may take further necessary action as per above decision of NC
ICase No.:35/12/82‐

ablets USP
500 ing
(2000 Bottles x 100 Per
Bottle=200,000 Tablets)
l No.
1
Griseomlvin usP
510 mg per
tablet
concemed may take further necessary action as per above decision of NC
ICase No.:35/12/82‐
Party Name:NAAN
PHARMA PRIVATE
P釘りName:RELIANCE
INDUSTRIES LTD.
ALC4/2017
120.03.2018
:01/82/050/01156/AM18/
:03/95/040/00727/AM18/
Lic.No/Date:0310817858
18.12.2017
Case No。:41/12/82‐
Party Name:CLEAN
SCIENCE AND
Meet No/Date:12/82‐
Decision : Deferred
RLA File
:31/83/040/00124/AM18/
囮
お農
/AⅢν
Lic.No/Date:3110066937
19.12.2017
1麟
:■
曜
血

## Case No.:43/12/82‐
ALC4/2017
Lic.No/Date:0810141548
19.122017
Decision : Deferred
Ч5
No/1Date:12/82-
Re-indexed
7
Re-indexed
Fllc
1/82/050/00996/AM18/

Ｆ
Ｌ
計
ト
:Deffered
:ALC4t2otT
nd Re-indexed
120.03.2018
Lic.No/Date:0310817908 1Defer Date:
Party Name:YASHO
INDUSTRIES PVT.LTD.
Ｆ
Ｌ
Ｆ
Ｉ

## Case No.:209/12/82‐
Party Name:CADILA
HEALTHCARE LTD
ALC4/2017
20.03.2018
Ｆ
卜
鮮
―
Pa■y NameiCADILA
HEALTHCARE LTD
:08/24/040/00269/AM18/
貯淵Иル
1濶" |
IHQ File
'01/82/050/01166/AM18/
IDecision:Deferred
Pa●y Name:YASHO
INDUSTRIES PVT・LTD.
Ｆ
Ｌ
Ｆ
Ｉ
ALC4/2017
Lic No/Date:0310817953 1Defer Date:
:03/95/040/00790/AM18/
貯∬Ⅵル
1躙隠柵TD
1器品掲
5υm 15VAMlν
1鷺λ爵
:,0/00789/AM18/
IDecision:Deferred
躍
マι
Flle
1/82/050/01165/AM18/
Flle
File
File
Re-indexed
1576 1Defer Date:
18
Re-indexed
141575 1Defer Date:
Re-indexed

Pa●y Name:AMI ORGANICS
PVT LTD.
Mcet No/Date:12/82¨
ALC4/2017
20.03.2018
:01/82/050/01177/AM18/
Defer Date:
19,05。2018
区而百
~Deferred
Pa●y Name:AM1 0RGANICS
PVT LTD.
Mcet No/Date:12/82‐
ALC4/2017
岬恵
Defer Date:
19.05.2018
120.03.2018
Lic.No/Date:5210042463
122.12.2017

## Case No.:84/12/82-
Party Name:BALAJI
AMINES LIMITED
Mcet No/Date:12/82-
RLA File
:31/83/040/00130/AM18/
Lic.No/Datei3 11 0066946
22.12.2017
fer Date:
19.05。2018

## Case No.:114/12/82‐
ALC4/2017
ParりName:MANGALAM
DRUGS&ORGANICS
1鷺λ
ttiυ00564/AMlν
l:01/82/050/01069/AM18/
ision : Committee considered case as per agenda and deliberated on the matter in the presence of the
nical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per
Export Product
Qty.
Sl.No.
Import items
Quantity allowed
kdkg
ARTESUNATE
l kg
1
ARTEMISININ
0.80 kg
2
SODIUM
BOROHYDRIDE
0.14 kg
―
ヨ

## Case No.:106/12ノ82‐
ALC4/2017
Party Name:CADILA
HEALTHCARE LTD
ALC4/2017
20.03.2018
:01/82/050/01061/AM18/
RLA File
:08/24/040/00284/AM18/
Case No。:207/12/82‐
ALC4ノ2017
Par″ Name:MAHIMA LIFE
SCIENCES PVT LTD
ALC4/2017
20.03.2018
1器島児
5:lH62晨Mlν
‐翫翻漏::鳥il
Lic.No/Date:0510405091
26.12.2017
夕7
No.:223/12/82‐
concerned may take funher necessary
Decision : Deferred
２
８
２
２
Ｎ
ｏ
・
‥
２
２
州
No/Date:12/82-
No/Date:12/82-
No/Date:12/82‐
File
action as
decision ofNC

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|]「iド|:]il:111‖ :|:ξ il:11:雪11:::iSeanditWasdecidedtocantherlrmfOrpersonalhearing(  |
貯脚mル
us:Deffered
POLYPLAST PRIVATE    IALC4/2017
nd Re-indexed
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:
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Ｉ
:Deffered
nd Re-indexed
Defer I)ate:
19.05。2018
Party Name:SWISS
PARENTERALS LTD
ALC4/2017
120.03.2018

## Case No.:128/12/82‐
ALC4/2017
Party Name:YASHO
INDUSTRIES PVT.LTD.
leLcqtzon
lzo.o:.zor t
Lic,No/Date:0310818011
126.12.2017
IDecision:Deferred
２
８
２
９
Ｎ
Ｏ
・‥・
２
”
ａ
ｓ
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1鷺λ
]:,0/00795ハM18/
1躙艦拙TD 1濶"
囲器α“Ю蜘3
us:Deffered
IDecisio■:Deferred
Case No。:220/12/82…
Pa●y Name:RELIANCE
INDUSTRIES LTD.
1濶"
IDecislom:Deferred
ν ζ
Name:PAYAL
No/Date:12/82‐
Re-indexed
File
Date:

^
貯淵釧ル
Party Name:STRIDES
SHASUN LIMITED
貯淵欄ル
Party Name:STzuDES
SHAStIN LIMITED
Lic.No/Date:0510405241 1Defer Date:
Lic.No/Date:0610038783 1DeFer Date:
71
File
Re-indexed
10405200 1Defer Date:
Re-indexed
163851 1Defer Date:
19.05。2018
Re-indexed
10163850 1Defer Date:
Deffered
Re-indexed
Ｆ
Ｌ
Ｆ
Ｉ
No.:218/12/82‐
7
File
1/82/050/01173/AM18/
No。:241/12/82‐
7
File
1/82/050/01196/AM18/
File

was decided to can certirlcate of Analysis(CoA)of
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ト
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‐
Ｆ
」
Ｆ
‐
貯粽鮒源ド潤紐i3 鰐T動か
HQ File
:01/82/050/01184/AM18/
Decision : Deferred
RLA File
:08/24/040/00285/AM18/
Lic.No/Date:0810141772
15.01.2018
fer Date:
19.05。2018
lLic.NotDate: o8l o I 4tj 7 4 Defer Date:
19。05。2018
15.01.2018
Lic.No/Date:0810141775 1Defer Date:
1麟ず‐
ド柵鰤
貯罵″
胃柵継総 
囲∬
動2澤面需
臨ちう脱υ0028卿W I冨
鼎
硼m4η31躙
紺
:
HQ File
:01/82/050/01187/AM18/
Decision : Deferred
Decisio■ :COmmittee considered the case as per agenda and decided to ask the rlr.l to furnish the
information on following points:
i) Yield at each stages of manufacturing
ii) Clari$ whether the input item is 65Yo or 100% purity
iii) Certificate of Analysis of import items
~  1欝膨骨鵬醇滞了秘甲聴
Z2鵬塾2聖2竺里_騰t描OЮ∝35/Attγ l獅鼎:“
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:
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File
File

ing
ii) Clari$ whether the input item is 65Yo or 100% purity
iii) Certificate of Analysis of import items
~  1欝膨骨鵬醇滞了秘甲聴
Z2鵬塾2聖2竺里_騰t描OЮ∝35/Attγ l獅鼎:“
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¶ 器紺
:
5つ
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File
File
File
1/82/050/01185/AM18/
腸
33泥5呻6晨my

沖
esANOFIINDIA
。
あ:ふb′    rndRe■ndexed
1/82/050/0n97/AMt8/
5′
No.:242/tid
File
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NorDateilEll
Date: