DGFT Committee Minutes
1
Government of India
Ministry of Commerce and Industry
Directorate General of Foreign Trade
Maulana Azad Road, New Delhi 110011
Norms Committee-III
Para 4.7 Decision
Meeting No. 02/82/2016 of 2016-17, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, held on 26.04.2016 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.107, Udyog Bhawan, New Delhi.
Following members were present:-
Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. Shri M.V. Singh, FTDO, DGFT
The committee went through the minutes of earlier meeting No. 01/82 held 07.04.2016 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 case
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 scanned copy uploaded is to be accepted. The Committee does
not approve SCOMET items and all applicants are understood to have furnished a declaration
to RA that the items of import/export are not SCOMET items.
MEETING NUMBER
: 2/82-ALC4/2016 MEETING DATE : 26.04.2016
1
Case
No.:132/8/82-
ALC4/2014
Party Name:PROVENTUS
LIFE SCIENCES PRIVATE
LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00796/AM15/
RLA
File
:04/24/040/00395/AM08/
Lic.No/Date:0410094357
12.03.2008
Defer
Date:24.05.2016
Decision : The Committee noted that information had been called for from the firm in NC meeting
No.05 dated 25.6.2015 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
2
Case
No.:15/2/82-
ALC4/2016
Party
Name:PERFECT
INDUSTRIES
PRIVATE
LIMITED.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00015/AM17/
RLA
File
:03/95/040/00554/AM12/
Lic.No/Date:0310659678
14.10.2011
Defer
Date:24.05.2016
Decision : Deferred.
3
Case
No.:36/19/82-
ALC4/2014
Party
Name:ALKALI
METALS LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
2
HQ
File
:01/82/050/01524/AM15/
RLA
File
:09/24/040/00503/AM12/
Lic.No/Date:0910052125
12.04.2012
Defer
Date:24.05.2016
Decision :Deferred.
4
Case
No.:38/19/82-
ALC4/2014
Party
Name:PORUS
LABORATORIES
PVT
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01526/AM15/
RLA
File
:09/24/040/00050/AM13/
Lic.No/Date:0910052706
21.05.2012
Defer
Date:24.05.2016
Decision :Deferred.
5
Case
No.:18/19/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01506/AM15/
RLA
File
:09/24/040/00085/AM13/
Lic.No/Date:0910052887
05.06.2012
Defer
Date:24.05.2016
Decision : The Committee noted that information furnished by the firm is incomplete. The
Committee decided to call for Central Excise Certificate for production consumption of export
product and deferred the case.
6
Case
No.:173/5/82-
ALC4/2015
Party
Name:FORACE
POLYMERS (P) LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00313/AM16/
RLA
File
:05/23/040/00069/AM14/
Lic.No/Date:0510356983
13.06.2013
Defer
Date:24.05.2016
7
Case
No.:31/4/82-
ALC4/2014
Party
Name:UNIVERSAL
BIOFUELS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00279/AM15/
RLA
File
:09/24/040/00155/AM14/
Lic.No/Date:0910056959
31.07.2013
Defer
Date:24.05.2016
Decision :Deferred.
8
Case
No.:41/16/82-
ALC4/2013
Party Name:KARNATAKA
ANTIBIOTICS
&
PHARMACEUTICALS
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00854/AM14/
RLA
File
:07/24/040/00188/AM14/
Lic.No/Date:0710098283
16.09.2013
Defer
Date:24.05.2016
Decision : The Committee decided to send copy of application to DoP.
9
Case
No.:62/2/83-
ALC1/2014
Party
Name:STERICON
PHARMA PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/83/050/00019/AM15/
RLA
File
:07/24/040/00279/AM14/
Lic.No/Date:0710099790
20.11.2013
Defer
Date:12.05.2016
Decision :The Committee decided to call for DML from the firm and deferred the case.
10 Case No.:140/23/82- Party Name:UNITED Meet No/Date:2/82- Status:Case
3
ALC4/2013
PHOSPHORUS LTD.
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/01187/AM14/
RLA
File
:03/95/040/00495/AM14/
Lic.No/Date:0310758627
21.11.2013
Defer
Date:24.05.2016
Decision :Deferred.
11
Case
No.:48/13/82-
ALC4/2015
Party
Name:BELCHEM
INDS. INDIA PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01011/AM16/
RLA
File
:03/94/040/00860/AM14/
Lic.No/Date:0310766718
17.01.2014
Defer
Date:24.05.2016
Decision :Deferred.
12
Case
No.:208/3/82-
ALC4/2014
Party
Name:OGENE
SYSTEMS
INDIA
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00212/AM15/
RLA
File
:09/24/040/00515/AM14/
Lic.No/Date:0910059017
22.01.2014
Defer
Date:24.05.2016
Decision :Deferred.
13
Case
No.:108/3/82-
ALC4/2014
Party
Name:CROPNOSYS
(INDIA)
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00112/AM15/
RLA
File
:03/94/040/00908/AM14/
Lic.No/Date:0310767733
24.01.2014
Defer
Date:24.05.2016
Decision :Deferred.
14
Case
No.:177/3/82-
ALC4/2014
Party
Name:INDO
AMINES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00181/AM15/
RLA
File
:03/94/040/00958/AM14/
Lic.No/Date:0310768616
30.01.2014
Defer
Date:24.05.2016
Decision :Deferred.
15
Case
No.:58/6/82-
ALC4/2014
Party
Name:BAYER
CROPSCIENCE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00460/AM15/
RLA
File
:03/94/040/00797/AM14/
Lic.No/Date:0310772503
28.02.2014
Defer
Date:24.05.2016
Decision :Deferred.
16
Case
No.:106/3/82-
ALC4/2014
Party
Name:PERFECT
VITAMINS PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00110/AM15/
RLA
File
:03/95/040/00960/AM14/
Lic.No/Date:0310772411
28.02.2014
Defer
Date:24.05.2016
Decision :Deferred.
17 Case No.:58/4/82- Party Name:IND-SWIFT Meet
4
ALC4/2014
LABORATORIES LTD.,
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/00306/AM15/
RLA
File
:22/24/040/00100/AM14/
Lic.No/Date:2210014694
14.03.2014
Defer
Date:24.05.2016
Decision : The Committee decided to send copy of application again to DoP.
18
Case
No.:57/3/82-
ALC4/2014
Party
Name:JUBILANT
LIFE SCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00061/AM15/
RLA
File
:05/23/040/00506/AM14/
Lic.No/Date:0510382053
18.03.2014
Defer
Date:24.05.2016
Decision : The Committee noted that information called for from the firm in NC meeting
No.17/AM16 dt. 27.01.2016 is awaited. The Committee accordingly decided await the reply and
deferred the case.
19
Case
No.:26/5/82-
ALC4/2014
Party
Name:ACEBRIGHT
(INDIA) PHARMA PVT LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00343/AM15/
RLA
File
:07/24/040/00469/AM14/
Lic.No/Date:0710103055
20.03.2014
Defer Date:
12.05.2016
Decision : The Committee decided to defer the case for want of comments of DoP.
20
Case
No.:51/5/82-
ALC4/2014
Party
Name:JINDAL
DRUGS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00368/AM15/
RLA
File
:03/94/040/01098/AM14/
Lic.No/Date:0310776087
27.03.2014
Defer
Date:24.05.2016
No.13/AM16 dt. 27.11.2015 is awaited. The Committee accordingly decided await the reply and
deferred the case.
21
Case
No.:51/6/82-
ALC4/2014
Party
Name:PERFECT
INDUSTRIES
PRIVATE
LIMITED.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00453/AM15/
RLA
File
:03/95/040/01054/AM14/
Lic.No/Date:0310776759
02.04.2014
Defer
Date:24.05.2016
No.17/AM16 dt. 27.01.2016 is awaited. The Committee accordingly decided await the reply and
deferred the case.
22
Case
No.:50/6/82-
ALC4/2014
Party
Name:V
&
V
PHARMA INDUSTRIES
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00452/AM15/
RLA
File
:03/95/040/01061/AM14/
Lic.No/Date:0310776760
02.04.2014
Defer
Date:24.05.2016
No.17/AM16 dt. 27.01.2016 is awaited. The Committee accordingly decided await the reply and
deferred the case.
23 Case
No.:20/6/82-
ALC4/2014
Party
Name:ADISHANK
CHEMICALS PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Deferred
5
26.04.2016
HQ
File
:01/82/050/00422/AM15/
RLA
File
:03/94/040/01140/AM14/
Lic.No/Date:0310777786
09.04.2014
Defer
Date:24.05.2016
No.17/AM16 dt. 27.01.2016 is awaited. The Committee accordingly decided await the reply and
deferred the case.
24
Case
No.:1/2/82-
ALC4/2014
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00003/AM15/
RLA
File
:08/24/040/00008/AM15/
Lic.No/Date:0810130534
11.04.2014
Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its
meeting No.28/82 dated 10.01.2013, uploaded at the end of these minutes or as applied by the
firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as
per decision of NC.
25
Case
No.:49/13/82-
ALC4/2015
Party
Name:BELCHEM
INDS. INDIA PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01012/AM16/
RLA
File
:03/94/040/01118/AM14/
Lic.No/Date:0310779215
23.04.2014
Defer
Date:24.05.2016
Decision :Deferred.
26
Case
No.:183/6/82-
ALC4/2014
Party
Name:TIDE
INDUSTRIES
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00585/AM15/
RLA
File
:34/24/040/00005/AM15/
Lic.No/Date:3410039854
23.04.2014
Defer Date:
Decision : Approved in Meeting No.21 dated 22.3.2016
27
Case
No.:237/6/82-
ALC4/2014
Party
Name:ESTEEM
INDUSTRIES PVT. LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00639/AM15/
RLA
File
:17/24/040/00002/AM15/
Lic.No/Date:1710005803
05.05.2014
Defer
Date:24.05.2016
28
Case
No.:13/2/82-
ALC4/2015
Party
Name:JUBILANT
LIFE SCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00028/AM16/
RLA
File
:05/23/040/00080/AM15/
Lic.No/Date:0510387607
28.05.2014
Defer
Date:24.05.2016
No.17/AM16 dt. 27.01.2016 is awaited. The Committee accordingly decided await the reply and
deferred the case.
29
Case
No.:38/8/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0910060258 Defer
6
:01/82/050/00702/AM15/
:09/24/040/00108/AM15/
28.05.2014
Date:24.05.2016
Decision : The committee decided to send copy of application again to DoP.
30
Case
No.:165/6/82-
ALC4/2014
Party
Name:HALDIA
PETROCHEMICALS LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00567/AM15/
RLA
File
:02/24/040/00037/AM15/
Lic.No/Date:0210203844
05.06.2014
Defer
Date:24.05.2016
Decision :Deferred.
31
Case
No.:106/8/82-
ALC4/2014
Party
Name:BAYER
CROPSCIENCE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00770/AM15/
RLA
File
:03/94/040/00131/AM15/
Lic.No/Date:0310785223
12.06.2014
Defer
Date:24.05.2016
Decision :Deferred.
32
Case
No.:60/10/82-
ALC4/2014
Party
Name:BIO-TECH
OPHTHALMICS
PVT.
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00974/AM15/
RLA
File
:08/24/040/00116/AM15/
Lic.No/Date:0810132332
13.06.2014
Defer
Date:24.05.2016
No.11/AM16 dt. 28.10.2015 is awaited. The Committee accordingly decided await the reply and
deferred the case.
33
Case
No.:77/8/82-
ALC4/2014
Party
Name:BENZO
CHEM
INDUSTRIES
PRIVATE LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00741/AM15/
RLA
File
:03/94/040/00196/AM15/
Lic.No/Date:0310785501
17.06.2014
Defer
Date:24.05.2016
No.19/AM16 dt. 25.02.2015 is awaited. The Committee accordingly decided await the reply and
deferred the case.
34
Case
No.:20/8/82-
ALC4/2014
Party
Name:SRINI
PHARMACEUTICALS
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00684/AM15/
RLA
File
:09/24/040/00139/AM15/
Lic.No/Date:0910060467
17.06.2014
Defer
Date:24.05.2016
No.04/AM16 dt. 12.06.2015 is awaited. The Committee accordingly decided await the reply and
deferred the case.
35
Case
No.:19/8/82-
ALC4/2014
Party Name:HETERO LABS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00683/AM15/
RLA
File
:09/24/040/00153/AM15/
Lic.No/Date:0910060486
18.06.2014
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o
Pharmaceuticals forwarded vide O.M.No. 35011/580/2014-PI(Norms) dated 26.4.2016, uploaded
7
at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
36
Case
No.:202/6/82-
ALC4/2014
Party
Name:FORACE
POLYMERS (P) LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00604/AM15/
RLA
File
:05/23/040/00139/AM15/
Lic.No/Date:0510389232
01.07.2014
Defer
Date:24.05.2016
Decision :Deferred.
37
Case
No.:44/15/82-
ALC4/2014
Party Name:HETERO LABS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01331/AM15/
RLA
File
:09/24/040/00192/AM15/
Lic.No/Date:0910060635
09.07.2014
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o
Pharmaceuticals forwarded vide O.M.No. 35011/144/2015-PI(Norms) dated 11.4.2016, uploaded
38
Case
No.:72/10/82-
ALC4/2014
Party
Name:GLOBAL
CALCIUM
PRIVATE
LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00986/AM15/
RLA
File
:07/24/040/00112/AM15/
Lic.No/Date:0710105884
18.07.2014
Defer
Date:24.05.2016
Decision :Deferred.
39
Case
No.:32/9/82-
ALC4/2014
Party
Name:CHEMCON
SPECIALITY
CHEMICALS P LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Deffered
HQ
File
:01/82/050/00829/AM15/
RLA
File
:34/24/040/00102/AM15/
Lic.No/Date:3410040406
28.07.2014
Defer
Date:12.05.2016
Decision :Deferred.
40
Case
No.:203/5/82-
ALC4/2015
Party Name:ALKALOIDS
CORPORATION
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00343/AM16/
RLA
File
:02/24/040/00080/AM15/
Lic.No/Date:0210204732
07.08.2014
Defer
Date:24.05.2016
Decision :Deferred.
41
Case
No.:21/9/82-
ALC4/2014
Party
Name:PI
INDUSTRIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00818/AM15/
RLA
File
:13/24/040/00020/AM15/
Lic.No/Date:1310047575
12.08.2014
Defer
Date:24.05.2016
Decision :Deferred.
42 Case
No.:48/5/82-
ALC4/2015
Party
Name:VISION
DRUGS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Deferred
8
26.04.2016
HQ
File
:01/82/050/00188/AM16/
RLA
File
:09/24/040/00260/AM15/
Lic.No/Date:0910060860
18.08.2014
Defer
Date:12.05.2016
No.18 dated 10.02.2016 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
43
Case
No.:245/13/82-
ALC4/2014
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01248/AM15/
RLA
File
:03/94/040/00300/AM15/
Lic.No/Date:0310788279
22.08.2014
Defer Date:
Pharmaceuticals forwarded vide O.M.No. 35011/300/2015-PI(Norms) dated November 2015,
uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07
of HBP Vol.1. RA concerned may take necessary action as per decision of NC.
44
Case
No.:264/13/82-
ALC4/2014
Party
Name:BAYER
CROPSCIENCE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01267/AM15/
RLA
File
:03/94/040/00405/AM15/
Lic.No/Date:0310788397
26.08.2014
Defer
Date:24.05.2016
Decision :Deferred.
45
Case
No.:37/7/82-
ALC4/2015
Party
Name:DR
J
PHARMACHEM
(INDIA)(PROP.ADITYA
PRAMOD JOGDEO)
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00642/AM16/
RLA
File
:31/83/040/00125/AM15/
Lic.No/Date:3110064792
28.08.2014
Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its
meeting No.01/82 dated 10.04.2014, uploaded at the end of these minutes or as applied by the
firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as
per decision of NC.
46
Case
No.:254/13/82-
ALC4/2014
Party
Name:SEQUENT
SCIENTIFIC LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01257/AM15/
RLA
File
:03/95/040/00459/AM15/
Lic.No/Date:0310788513
28.08.2014
Defer
Date:24.05.2016
Decision : The Committee noted that information has been called for from firm by NC in its
meeting No.09/82 dated 30.09.2015 is awaited. The Committee accordingly, decided to defer the
case.
47
Case
No.:263/13/82-
ALC4/2014
Party
Name:ANTHEA
AROMATICS PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01266/AM15/
RLA
File
:03/94/040/00962/AM14/
Lic.No/Date:0310788558
01.09.2014
Defer
Date:24.05.2016
9
48
Case
No.:217/13/82-
ALC4/2014
Party
Name:ENCUBE
ETHICALS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01220/AM15/
RLA
File
:03/94/040/00494/AM15/
Lic.No/Date:0310788620
02.09.2014
Defer
Date:24.05.2016
Decision : It was noted that fraudulent CA certificates have been submitted in this case.
Committee decided to defer the case.
49
Case
No.:6/8/82-
ALC4/2014
Party
Name:HONOUR
LAB LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00670/AM15/
RLA
File
:09/24/040/00314/AM15/
Lic.No/Date:0910060964
12.09.2014
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of DoP.
50
Case
No.:28/13/82-
ALC4/2014
Party
Name:TITAN
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Rejected
HQ
File
:01/82/050/01031/AM15/
RLA
File
:03/95/040/00398/AM15/
Lic.No/Date:0310789099
12.09.2014
Defer Date:
Decision : Rejected in meeting No.21 dated 22.3.2015.
51
Case
No.:380/5/82-
ALC4/2015
Party
Name:THEON
PHARMACEUTICALS
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00520/AM16/
RLA
File
:22/24/040/00054/AM15/
Lic.No/Date:2210015086
16.09.2014
Defer
Date:24.05.2016
No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
52
Case
No.:188/13/82-
ALC4/2014
Party
Name:DELTA
FINOCHEM PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01191/AM15/
RLA
File
:03/94/040/00102/AM15/
Lic.No/Date:0310789322
17.09.2014
Defer
Date:24.05.2016
Decision : Deferred
53
Case
No.:57/13/82-
ALC4/2014
Party
Name:HELLO
PAINTS (P) LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01060/AM15/
RLA
File
:05/23/040/00277/AM15/
Lic.No/Date:0510391246
19.09.2014
Defer
Date:24.05.2016
Decision : The Committee noted that information has been called for from firm by NC in its
meeting No.19/82 dated 25.02.2016 is awaited. The Committee accordingly, decided to defer the
case.
54
Case
No.:59/13/82-
ALC4/2014
Party
Name:HELLO
PAINTS (P) LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0510391245 Defer
10
:01/82/050/01062/AM15/
:05/23/040/00276/AM15/
19.09.2014
Date:24.05.2016
Decision : The Committee noted that information has been called for from firm by NC in its
meeting No.18/82 dated 10.02.2016 is awaited. The Committee accordingly, decided to defer the
case.
55
Case
No.:9/15/82-
ALC4/2014
Party
Name:VIRCHOW
BIOTECH PV T LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01296/AM15/
RLA
File
:09/24/040/00327/AM15/
Lic.No/Date:0910061001
19.09.2014
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of DoP.
56
Case
No.:131/8/82-
ALC4/2014
Party Name:HONOUR LAB
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00795/AM15/
RLA
File
:09/24/040/00353/AM15/
Lic.No/Date:0910061007
22.09.2014
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/692/2015-PI(Norms) dated 26.02.2016 uploaded
57
Case
No.:17/13/82-
ALC4/2014
Party
Name:GRASIM
INDUSTRIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01020/AM15/
RLA
File
:34/24/040/00155/AM15/
Lic.No/Date:3410040570
23.09.2014
Defer
Date:24.05.2016
Decision :Deferred.
58
Case
No.:49/5/82-
ALC4/2015
Party
Name:VISION
DRUGS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00189/AM16/
RLA
File
:09/24/040/00336/AM15/
Lic.No/Date:0910061013
23.09.2014
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/759/2015-PI(Norms) dated April 2016 uploaded
59
Case
No.:115/13/82-
ALC4/2014
Party
Name:WEST
BENGAL
CHEMICAL
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01118/AM15/
RLA
File
:02/24/040/00097/AM15/
Lic.No/Date:0210205008
23.09.2014
Defer
Date:24.05.2016
60
Case
No.:74/13/82-
ALC4/2014
Party Name:CONSTECH
ENTERPRISES PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01077/AM15/
RLA
File
:05/23/040/00282/AM15/
Lic.No/Date:0510391308
24.09.2014
Defer
Date:24.05.2016
11
Decision :Deferred.
61
Case
No.:9/2/82-
ALC4/2015
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00024/AM16/
RLA
File
:05/23/040/00261/AM15/
Lic.No/Date:0510391358
26.09.2014
Defer
Date:24.05.2016
Decision : The Committee noted that information called for from the firm in NC meeting No.15
dated 30.12.2015 is awaited. The Committee accordingly decided to await the reply and deferred
the case.
62
Case
No.:19/13/82-
ALC4/2014
Party
Name:SANO
MEDICAL
KITS
PVT.
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01022/AM15/
RLA
File
:04/24/040/00171/AM15/
Lic.No/Date:0410159504
29.09.2014
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of DoP.
63
Case
No.:160/13/82-
ALC4/2014
Party
Name:BAYER
CROPSCIENCE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01163/AM15/
RLA
File
:03/94/040/00544/AM15/
Lic.No/Date:0310789976
07.10.2014
Defer
Date:24.05.2016
Decision :Deferred.
64
Case
No.:5/9/82-
ALC4/2014
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00802/AM15/
RLA
File
:09/24/040/00362/AM15/
Lic.No/Date:0910061060
07.10.2014
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of DoP.
65
Case
No.:35/13/82-
ALC4/2014
Party
Name:JUBILANT
LIFE SCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01038/AM15/
RLA
File
:05/23/040/00218/AM15/
Lic.No/Date:0510391491
08.10.2014
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of DoP.
66
Case
No.:76/13/82-
ALC4/2014
Party
Name:CAPLIN
POINT LABORATORIES
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01079/AM15/
RLA
File
:04/24/040/00163/AM15/
Lic.No/Date:0410159566
13.10.2014
Defer
Date:24.05.2016
Decision : The Committee noted that information called for from the firm in NC meeting No.13
dated 27.11.2015 is awaited. The Committee accordingly decided to await the reply and deferred
the case.
67 Case
No.:114/9/82-
ALC4/2014
Party Name:HONOUR LAB
LIMITED
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Approved
12
26.04.2016
HQ
File
:01/82/050/00911/AM15/
RLA
File
:09/24/040/00386/AM15/
Lic.No/Date:0910061094
15.10.2014
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/692/2015-PI(Norms) dated 26.2.2016 , uploaded
68
Case
No.:42/15/82-
ALC4/2014
Party Name:PVS AGRO
VET
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01329/AM15/
RLA
File
:09/24/040/00246/AM15/
Lic.No/Date:0910061105
16.10.2014
Defer
Date:24.05.2016
Decision : Based on the recommendation of D/o Pharmaceuticals forwarded vide
O.M.No.35011/368/2015-PI(Norms) dated 27.11.2015 uploaded at the end of these minutes ,
committee decided to call for information from the firm.
69
Case
No.:154/13/82-
ALC4/2014
Party
Name:GEM
AROMATICS PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01157/AM15/
RLA
File
:03/94/040/00680/AM15/
Lic.No/Date:0310790351
17.10.2014
Defer
Date:24.05.2016
Decision :Deferred.
70
Case
No.:12/20/82-
ALC4/2015
Party
Name:STERICON
PHARMA PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01595/AM16/
RLA
File
:07/24/040/00255/AM15/
Lic.No/Date:0710106853
17.10.2014
Defer
Date:24.05.2016
Decision :Deferred.
71
Case
No.:80/10/82-
ALC4/2014
Party Name:HETERO LABS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00994/AM15/
RLA
File
:09/24/040/00394/AM15/
Lic.No/Date:0910061132
22.10.2014
Defer Date:
Decision : The Committee received the recommendation of D/o Pharmaceuticals forwarded vide
O.M.No.35011/145/2015-PI(Norms) dated 11.04.2016 and after deliberation the Committee
decided to ratify norms as per details given below or as applied by the firm whichever is less under
para 4.07 of HBP Vol.1.
Export product Qty Import Item Qty. Lamivudine 1kg (2R-CIS-4-amino-1,2-(hydroxymethyl-1,3- oxathiolan-5yl)-2-(1H)-pyrimidinone (Technical Grade) 1.05kg
RA concerned may take necessary action as per decision of NC.
72
Case
No.:81/10/82-
ALC4/2014
Party Name:HONOUR LAB
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Rejected
13
HQ
File
:01/82/050/00995/AM15/
RLA
File
:09/24/040/00407/AM15/
Lic.No/Date:0910061133
22.10.2014
Defer Date:
Decision : Based on the firm’s letter dated16.4.2016 and RA Secunderabad dated 29.09.2015,
both the letters uploaded at the end of these minutes, Committee decided to withdraw the case.
RA may take further necessary action as per decision of NC.
73
Case
No.:110/13/82-
ALC4/2014
Party
Name:TATVA
CHINTAN
PHARMA
CHEM PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01113/AM15/
RLA
File
:34/24/040/00188/AM15/
Lic.No/Date:3410040635
22.10.2014
Defer
Date:24.05.2016
Decision :Deferred.
74
Case
No.:86/10/82-
ALC4/2014
Party
Name:SHIVA
PHARMACHEM LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01000/AM15/
RLA
File
:34/24/040/00194/AM15/
Lic.No/Date:3410040644
30.10.2014
Defer
Date:24.05.2016
Decision :Deferred.
75
Case
No.:266/13/82-
ALC4/2014
Party
Name:ATUL
LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01269/AM15/
RLA
File
:08/24/040/00289/AM15/
Lic.No/Date:0810133735
05.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
76
Case
No.:268/13/82-
ALC4/2014
Party
Name:ATUL
LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01271/AM15/
RLA
File
:08/24/040/00283/AM15/
Lic.No/Date:0810133734
05.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
77
Case
No.:39/7/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00644/AM16/
RLA
File
:09/24/040/00371/AM15/
Lic.No/Date:0910061181
05.11.2014
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/725/2015-PI(Norms) dated April 2016 , uploaded
78
Case
No.:107/13/82-
ALC4/2014
Party
Name:SHIVA
PHARMACHEM LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01110/AM15/
RLA
File
:34/24/040/00196/AM15/
Lic.No/Date:3410040655
05.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
14
79
Case
No.:114/13/82-
ALC4/2014
Party
Name:VIRDEV
INTERMEDIATES
PVT
LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01117/AM15/
RLA
File
:52/24/040/00042/AM15/
Lic.No/Date:5210041292
10.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
80
Case
No.:111/13/82-
ALC4/2014
Party
Name:ABEERS
PHARMACEUTICALS
PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01114/AM15/
RLA
File
:05/23/040/00352/AM15/
Lic.No/Date:0510391927
11.11.2014
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of Ayush.
81
Case
No.:393/5/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00533/AM16/
RLA
File
:09/24/040/00387/AM15/
Lic.No/Date:0910061210
11.11.2014
Defer
Date:24.05.2016
No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
82
Case
No.:61/18/82-
ALC4/2014
Party
Name:TATVA
CHINTAN
PHARMA
CHEM PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01427/AM15/
RLA
File
:34/24/040/00198/AM15/
Lic.No/Date:3410040676
11.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
83
Case
No.:100/4/82-
ALC4/2015
Party
Name:ESTEEM
INDUSTRIES PVT. LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00139/AM16/
RLA
File
:17/24/040/00125/AM15/
Lic.No/Date:1710005978
12.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
84
Case
No.:120/13/82-
ALC4/2014
Party
Name:JUBILANT
LIFE SCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01123/AM15/
RLA
File
:05/23/040/00325/AM15/
Lic.No/Date:0510391947
12.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
85
Case
No.:77/18/82-
ALC4/2014
Party
Name:LAKELAND
CHEMICALS
(INDIA)
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01443/AM15/
RLA
File
:03/95/040/00629/AM14/
Lic.No/Date:0310790966
12.11.2014
Defer
Date:24.05.2016
15
86
Case
No.:65/18/82-
ALC4/2014
Party
Name:DEEPAK
NITRITE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01431/AM15/
RLA
File
:34/24/040/00199/AM15/
Lic.No/Date:3410040677
13.11.2014
Defer
Date:24.05.2016
87
Case
No.:42/18/82-
ALC4/2014
Party
Name:LAKELAND
CHEMICALS
(INDIA)
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01408/AM15/
RLA
File
:03/95/040/00628/AM14/
Lic.No/Date:0310791049
13.11.2014
Defer
Date:24.05.2016
88
Case
No.:65/15/82-
ALC4/2014
Party
Name:ABEERS
PHARMACEUTICALS
PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01352/AM15/
RLA
File
:05/23/040/00360/AM15/
Lic.No/Date:0510392011
14.11.2014
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of Ayush
89
Case
No.:52/15/82-
ALC4/2014
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01339/AM15/
RLA
File
:09/24/040/00408/AM15/
Lic.No/Date:0910061280
20.11.2014
Defer
Date:24.05.2016
No.09 dated 30.09.2015 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
90
Case
No.:16/18/82-
ALC4/2014
Party
Name:KAIRAV
CHEMOFARBE
INDUSTRIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01382/AM15/
RLA
File
:03/94/040/00789/AM15/
Lic.No/Date:0310791300
21.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
91
Case
No.:74/18/82-
ALC4/2014
Party Name:ADESHWAR
MEDITEX PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01440/AM15/
RLA
File
:03/94/040/00814/AM15/
Lic.No/Date:0310791373
25.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
92
Case
No.:18/18/82-
ALC4/2014
Party
Name:ANTHEA
AROMATICS PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01384/AM15/
RLA
File
:03/94/040/00792/AM15/
Lic.No/Date:0310791374
25.11.2014
Defer
Date:24.05.2016
16
Decision :Deferred.
93
Case
No.:15/2/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00030/AM16/
RLA
File
:03/95/040/00639/AM15/
Lic.No/Date:0310791416
25.11.2014
Defer
Date:24.05.2016
No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
94
Case
No.:11/2/82-
ALC4/2015
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00026/AM16/
RLA
File
:05/23/040/00370/AM15/
Lic.No/Date:0510392171
27.11.2014
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of DoP.
95
Case
No.:32/2/82-
ALC4/2016
Party
Name:STERLING
AUXILIARIES PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00032/AM17/
RLA
File
:03/95/040/00617/AM15/
Lic.No/Date:0310791470
27.11.2014
Defer
Date:24.05.2016
Decision :Deferred.
96
Case
No.:114/18/82-
ALC4/2014
Party
Name:IND-SWIFT
LABORATORIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01480/AM15/
RLA
File
:22/24/040/00073/AM15/
Lic.No/Date:2210015135
28.11.2014
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/162/2015-PI(Norms) dated 19.02.2016 ,
97
Case
No.:26/18/82-
ALC4/2014
Party
Name:SADHANA
NITRO CHEM LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01392/AM15/
RLA
File
:03/95/040/00714/AM15/
Lic.No/Date:0310791516
28.11.2014
Defer
Date:24.05.2016
No.13 dated 27.11.2015 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
98
Case
No.:92/18/82-
ALC4/2014
Party
Name:TATVA
CHINTAN
PHARMA
CHEM PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01458/AM15/
RLA
File
:34/24/040/00224/AM15/
Lic.No/Date:3410040732
28.11.2014
Defer
Date:24.05.2016
17
Decision :Deferred.
99
Case
No.:154/5/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00294/AM16/
RLA
File
:03/95/040/00740/AM15/
Lic.No/Date:0310791735
05.12.2014
Defer
Date:24.05.2016
No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
100
Case
No.:82/18/82-
ALC4/2014
Party
Name:ABEERS
PHARMACEUTICALS
PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01448/AM15/
RLA
File
:05/23/040/00413/AM15/
Lic.No/Date:0510392368
10.12.2014
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of Ayush.
101
Case
No.:101/4/82-
ALC4/2015
Party
Name:ESTEEM
INDUSTRIES PVT. LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00140/AM16/
RLA
File
:17/24/040/00144/AM15/
Lic.No/Date:1710005998
10.12.2014
Defer
Date:24.05.2016
Decision :Deferred.
102
Case
No.:97/18/82-
ALC4/2014
Party
Name:DYNAMIC
SPECIALITY
CHEMICALS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01463/AM15/
RLA
File
:30/24/040/00041/AM15/
Lic.No/Date:3010103261
11.12.2014
Defer
Date:24.05.2016
Decision :Deferred.
103
Case
No.:119/18/82-
ALC4/2014
Party
Name:V.D.H.
ORGANICS PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01485/AM15/
RLA
File
:05/24/040/00419/AM15/
Lic.No/Date:0510392414
15.12.2014
Defer
Date:24.05.2016
Decision :Deferred.
104
Case
No.:224/5/82-
ALC4/2015
Party Name:SUVEN LIFE
SCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00364/AM16/
RLA
File
:09/24/040/00531/AM15/
Lic.No/Date:0910061427
22.12.2014
Defer
Date:24.05.2016
Decision :Deferred.
105
Case
No.:2/15/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File RLA
File Lic.No/Date:0910061443 Defer Date:
18
:01/82/050/01289/AM15/
:09/24/040/00545/AM15/
23.12.2014
Pharmaceuticals forwarded vide O.M.No.35011/246/2015-PI(Norms) dated Sept. 2015, uploaded
106
Case
No.:91/18/82-
ALC4/2014
Party
Name:ALCHEM
INTERNATIONAL LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01457/AM15/
RLA
File
:05/23/040/00449/AM15/
Lic.No/Date:0510392602
29.12.2014
Defer
Date:24.05.2016
Decision : The Committee noted that information had been called for from the firm in NC
meeting No.18 dated 18.2.2015 is awaited. The Committee accordingly decided to await the
reply and deferred the case.
107
Case
No.:27/15/82-
ALC4/2014
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01314/AM15/
RLA
File
:09/24/040/00546/AM15/
Lic.No/Date:0910061457
29.12.2014
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/246/2015-PI(Norms) dated Sept. 2015, uploaded
108
Case
No.:84/18/82-
ALC4/2014
Party
Name:HESTER
BIOSCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01450/AM15/
RLA
File
:08/24/040/00362/AM15/
Lic.No/Date:0810134170
30.12.2014
Defer
Date:24.05.2016
meeting No.04 dated 12.06.2015 is awaited. The Committee accordingly decided to await the
109
Case
No.:3/1/82-
ALC4/2015
Party Name:JAGSONPAL
PHARMACEUTICALS
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00003/AM16/
RLA
File
:05/23/040/00450/AM15/
Lic.No/Date:0510392649
01.01.2015
Defer
Date:24.05.2016
meeting No.11 dated 28.10.2015 is awaited. The Committee accordingly decided to await the
110
Case
No.:96/18/82-
ALC4/2014
Party
Name:NUTRA
SPECIALITIES
PVT.
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01462/AM15/
RLA
File
:04/24/040/00248/AM15/
Lic.No/Date:0410159986
07.01.2015
Defer
Date:24.05.2016
meeting No.13 dated 27.11.2015 is awaited. The Committee accordingly decided to await the
19
111
Case
No.:239/5/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00379/AM16/
RLA
File
:09/24/040/00555/AM15/
Lic.No/Date:0910061520
09.01.2015
Defer
Date:12.05.2016
112
Case
No.:119/5/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00259/AM16/
RLA
File
:03/95/040/00843/AM15/
Lic.No/Date:0310792869
13.01.2015
Defer
Date:12.05.2016
meeting No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the
113
Case
No.:92/5/82-
ALC4/2015
Party Name:ALKALOIDS
CORPORATION
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00232/AM16/
RLA
File
:02/24/040/00203/AM15/
Lic.No/Date:0210205448
14.01.2015
Defer
Date:24.05.2016
Decision :Deferred.
114
Case
No.:59/5/82-
ALC4/2015
Party
Name:ANTHEA
AROMATICS PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00199/AM16/
RLA
File
:03/94/040/00793/AM15/
Lic.No/Date:0310792911
14.01.2015
Defer
Date:24.05.2016
Decision :Deferred.
115
Case
No.:243/5/82-
ALC4/2015
Party Name:SUVEN LIFE
SCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00383/AM16/
RLA
File
:09/24/040/00589/AM15/
Lic.No/Date:0910061530
14.01.2015
Defer
Date:12.05.2016
Decision :Deferred for want of comments from DoP.
116
Case
No.:72/5/82-
ALC4/2015
Party Name:MICRO INKS
PRIVATE LIMITED.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00212/AM16/
RLA
File
:03/95/040/00658/AM15/
Lic.No/Date:0310793017
16.01.2015
Defer
Date:24.05.2016
Decision :Deferred.
117
Case
No.:112/5/82-
ALC4/2015
Party
Name:UNIMAX
CHEMICALS PVT LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
20
HQ
File
:01/82/050/00252/AM16/
RLA
File
:03/95/040/00812/AM15/
Lic.No/Date:0310793039
19.01.2015
Defer
Date:24.05.2016
Decision : The Committee observed that CA certificate furnished by the firm in two applications
reflects contradictory production and consumption data for the year 2013-14. Further ITCHS
code of import and export product also needs to be corrected.
118
Case
No.:10/16/82-
ALC4/2014
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01362/AM15/
RLA
File
:09/24/040/00529/AM15/
Lic.No/Date:0910061548
21.01.2015
Defer
Date:24.05.2016
meeting No.09 dated 30.09.2015 and meeting no. 14 dated 16.12.2015 is awaited. The
Committee accordingly decided to await the reply and deferred the case.
119
Case
No.:12/16/82-
ALC4/2014
Party Name:RA CHEM
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01364/AM15/
RLA
File
:09/24/040/00592/AM15/
Lic.No/Date:0910061552
21.01.2015
Defer
Date:24.05.2016
120
Case
No.:86/5/82-
ALC4/2015
Party
Name:SENTISS
PHARMA PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00226/AM16/
RLA
File
:05/24/040/00489/AM15/
Lic.No/Date:0510392966
22.01.2015
Defer
Date:24.05.2016
121
Case
No.:204/5/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00344/AM16/
RLA
File
:09/24/040/00596/AM15/
Lic.No/Date:0910061555
23.01.2015
Defer
Date:24.05.2016
122
Case
No.:1/18/82-
ALC4/2014
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01367/AM15/
RLA
File
:09/24/040/00601/AM15/
Lic.No/Date:0910061562
27.01.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/ 339/2015-PI(Norms) dated 12.4.2016 ,
123
Case
No.:31/7/82-
ALC4/2015
Party
Name:V.D.H.
ORGANICS PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00636/AM16/
RLA
File
:05/24/040/00498/AM15/
Lic.No/Date:0510392987
27.01.2015
Defer
Date:24.05.2016
21
124
Case
No.:32/7/82-
ALC4/2015
Party
Name:V.D.H.
ORGANICS PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00637/AM16/
RLA
File
:05/24/040/00499/AM15/
Lic.No/Date:0510392988
27.01.2015
Defer
Date:24.05.2016
Decision :Deferred.
125
Case
No.:25/7/82-
ALC4/2015
Party
Name:DEEPAK
NOVOCHEM
TECHNOLOGIES LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00630/AM16/
RLA
File
:31/83/040/00144/AM15/
Lic.No/Date:3110065235
28.01.2015
Defer
Date:24.05.2016
Decision :Deferred.
126
Case
No.:230/5/82-
ALC4/2015
Party
Name:R.K.INDUSTRIES,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00370/AM16/
RLA
File
:08/24/040/00394/AM15/
Lic.No/Date:0810134414
28.01.2015
Defer
Date:24.05.2016
Decision :Deferred.
127
Case
No.:163/5/82-
ALC4/2015
Party
Name:RANBAXY
LABORATORIES LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00303/AM16/
RLA
File
:05/24/040/00503/AM15/
Lic.No/Date:0510393026
29.01.2015
Defer
Date:24.05.2016
meeting No.12 dated 12.11.2015 is awaited. The Committee accordingly decided to await the
128
Case
No.:166/5/82-
ALC4/2015
Party
Name:CADILA
PHARMACEUTICALS LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00306/AM16/
RLA
File
:08/24/040/00386/AM15/
Lic.No/Date:0810134454
30.01.2015
Defer Date:
24.05.2016
Decision : The committee decided to defer the case for want of comments of DoP.
129
Case
No.:138/8/82-
ALC4/2015
Party
Name:HEMMO
PHARMACEUTICALS
PRIVATE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00934/AM16/
RLA
File
:03/94/040/01099/AM14/
Lic.No/Date:0310793426
30.01.2015
Defer
Date:12.05.2016
Decision :Deferred.
130
Case
No.:284/5/82-
ALC4/2015
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
22
HQ
File
:01/82/050/00424/AM16/
RLA
File
:03/94/040/01053/AM15/
Lic.No/Date:0310793620
05.02.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/ 383/2015-PI(Norms) dated 17.03.2016,
131
Case
No.:169/5/82-
ALC4/2015
Party
Name:TIDE
INDUSTRIES
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00309/AM16/
RLA
File
:34/24/040/00290/AM15/
Lic.No/Date:3410040927
05.02.2015
Defer
Date:24.05.2016
Decision :Deferred.
132
Case
No.:333/5/82-
ALC4/2015
Party Name:MEHTA API
PVT LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00473/AM16/
RLA
File
:03/95/040/00903/AM15/
Lic.No/Date:0310793861
12.02.2015
Defer Date:
Decision :Approved in Meeting No.01/AM17
133
Case
No.:91/7/82-
ALC4/2015
Party
Name:SHREE
GANESH
REMEDIES
PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00696/AM16/
RLA
File
:34/24/040/00295/AM15/
Lic.No/Date:3410040965
16.02.2015
Defer
Date:24.05.2016
Decision :Deferred.
134
Case
No.:52/19/82-
ALC4/2014
Party Name:PCL OIL &
SOLVENTS LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01540/AM15/
RLA
File
:05/24/040/00273/AM15/
Lic.No/Date:0510393248
17.02.2015
Defer
Date:24.05.2016
Decision :Deferred.
135
Case
No.:38/7/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00643/AM16/
RLA
File
:09/24/040/00640/AM15/
Lic.No/Date:0910061628
18.02.2015
Defer
Date:24.05.2016
Decision :Deferred.
136
Case
No.:283/5/82-
ALC4/2015
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00423/AM16/
RLA
File
:03/94/040/01084/AM15/
Lic.No/Date:0310793953
18.02.2015
Defer Date:
Decision :Approved in meeting No.01/AM17
23
137
Case
No.:285/5/82-
ALC4/2015
Party Name:CAMPHOR &
ALLIED
PRODUCTS
LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00425/AM16/
RLA
File
:03/94/040/01092/AM15/
Lic.No/Date:0310793985
19.02.2015
Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in
its meeting No.4/82 dated 16.5.2013 , uploaded at the end of these minutes or as applied by the
firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action
as per decision of NC.
138
Case
No.:332/5/82-
ALC4/2015
Party
Name:O
C
SPECIALITIES PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00472/AM16/
RLA
File
:03/95/040/00991/AM15/
Lic.No/Date:0310794000
19.02.2015
Defer
Date:24.05.2016
Decision :Deferred.
139
Case
No.:280/5/82-
ALC4/2015
Party Name:FERMENTA
BIOTECH LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00420/AM16/
RLA
File
:03/94/040/01110/AM15/
Lic.No/Date:0310794101
24.02.2015
Defer
Date:24.05.2016
meeting No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the
140
Case
No.:1/1/82-
ALC4/2015
Party
Name:PARAMOUNT
AROMACHEM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00001/AM16/
RLA
File
:05/24/040/00563/AM15/
Lic.No/Date:0510393385
26.02.2015
Defer
Date:08.06.2016
Decision : The Committee decided to defer for seeking details regarding the various item of
import and content of export product Carvacrol.
141
Case
No.:298/5/82-
ALC4/2015
Party
Name:MEDICEF
PHARMA,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00438/AM16/
RLA
File
:22/24/040/00095/AM15/
Lic.No/Date:2210015200
27.02.2015
Defer
Date:24.05.2016
142
Case
No.:47/19/82-
ALC4/2014
Party
Name:RUBY
FRAGRANCE
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01535/AM15/
RLA
File
:35/24/040/00006/AM15/
Lic.No/Date:3510044692
27.02.2015
Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decided taken by NC in
its meeting No.06/AM14 dated 13.06.2013, uploaded at the end of these minutes or as applied
by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
action as per decision of NC.
24
143
Case
No.:444/5/82-
ALC4/2015
Party
Name:AARTI
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00584/AM16/
RLA
File
:03/94/040/01132/AM15/
Lic.No/Date:0310794412
09.03.2015
Defer
Date:24.05.2016
Decision :The Committee decided to send copy of application to DoP.
144
Case No.:50/19/82-ALC4/2014 Party Name:HETERO DRUGS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01538/AM15/
RLA
File
:09/24/040/00679/AM15/
Lic.No/Date:0910061693
12.03.2015
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals
forwarded vide O.M. No.35011/823/2015-PI(Norms) dated April 2016, uploaded at the end of these minutes
or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take
necessary action as per decision of NC.
145
Case
No.:413/5/82-
ALC4/2015
Party
Name:INDO
AMINES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00553/AM16/
RLA
File
:03/94/040/01145/AM15/
Lic.No/Date:0310794545
12.03.2015
Defer
Date:24.05.2016
Decision :Deferred.
146
Case
No.:106/7/82-
ALC4/2015
Party
Name:ALCHEMIE
LABORATORIES
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00711/AM16/
RLA
File
:03/94/040/00812/AM15/
Lic.No/Date:0310794612
16.03.2015
Defer
Date:24.05.2016
147
Case No.:16/1/82-ALC4/2015 Party Name:HETERO LABS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01542/AM15/
RLA
File
:09/24/040/00703/AM15/
Lic.No/Date:0910061716
17.03.2015
Defer
Date:24.05.2016
148
Case
No.:103/7/82-
ALC4/2015
Party
Name:VADIVARHE
SPECIALITY CHEMICALS
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00708/AM16/
RLA
File
:03/95/040/01041/AM15/
Lic.No/Date:0310794641
17.03.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/717/2015-PI(Norms) dated 29.3.2016 ,
149
Case
No.:407/5/82-
ALC4/2015
Party
Name:WANBURY
LIMITED(FORMERLY
PEARL ORGANICS LTD)
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:
Deferred.
HQ
File RLA
File Lic.No/Date:0310794735 Defer
25
:01/82/050/00547/AM16/ :03/95/040/00934/AM15/ 20.03.2015 Date:12.05.2016
150
Case
No.:427/5/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00567/AM16/
RLA
File
:03/95/040/01071/AM15/
Lic.No/Date:0310794916
26.03.2015
Defer
Date:24.05.2016
meeting No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to await the
151
Case
No.:431/5/82-
ALC4/2015
Party
Name:EUROLIFE
HEALTHCARE
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00571/AM16/
RLA
File
:03/94/040/01086/AM15/
Lic.No/Date:0310794964
27.03.2015
Defer
Date:24.05.2016
meeting No.18 dated 10.02.2016 is awaited. The Committee accordingly decided to await the
152
Case
No.:9/1/82-
ALC4/2015
Party
Name:VIVIMED
LABS
(
ALATHUR)
PRIVATE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00009/AM16/
RLA
File
:04/24/040/00292/AM15/
Lic.No/Date:0410160364
30.03.2015
Defer
Date:24.05.2016
meeting No.13 dated 27.11.2015 is awaited. The Committee accordingly decided to await the
153
Case
No.:448/5/82-
ALC4/2015
Party
Name:AARTI
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00588/AM16/
RLA
File
:03/94/040/01211/AM15/
Lic.No/Date:0310795048
31.03.2015
Defer
Date:24.05.2016
meeting No.08 dated 16.09.2015 is awaited. The Committee accordingly decided to await the
154
Case
No.:16/5/82-
ALC4/2015
Party Name:ARENE LIFE
SCIENCES LIMITED.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00156/AM16/
RLA
File
:09/24/040/00736/AM15/
Lic.No/Date:0910061856
31.03.2015
Defer
Date:12.05.2016
Decision :Deferred for want of comments of DoP.
155
Case
No.:405/5/82-
ALC4/2015
Party
Name:CTX
LIFESCIENCES PVT LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00545/AM16/
RLA
File
:03/94/040/00521/AM15/
Lic.No/Date:0310795052
31.03.2015
Defer Date:
26
Decision :Approved in Meeting No.01/AM17
156
Case
No.:26/5/82-
ALC4/2015
Party
Name:CONTINENTAL
CHEMICALS
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00166/AM16/
RLA
File
:08/24/040/00470/AM15/
Lic.No/Date:0810134992
07.04.2015
Defer
Date:12.05.2016
Decision :Deferred.
157
Case
No.:411/5/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00551/AM16/
RLA
File
:03/95/040/01033/AM15/
Lic.No/Date:0310795186
08.04.2015
Defer
Date:12.05.2016
meeting No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to await the
158
Case
No.:12/7/82-
ALC4/2015
Party
Name:SHILPA
MEDICARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00617/AM16/
RLA
File
:07/24/040/00002/AM16/
Lic.No/Date:0710108028
15.04.2015
Defer
Date:24.05.2016
Decision :Information has been received and sent to DoP on 19.4.2016
159
Case
No.:5/5/82-
ALC4/2015
Party Name:MAHARSHI
PHARMA
CHEM
PVT.LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00145/AM16/
RLA
File
:08/24/040/00003/AM16/
Lic.No/Date:0810135051
17.04.2015
Defer
Date:12.05.2016
Decision : : The Committee noted that information had been called for from the firm in NC
meeting No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to await the
160
Case
No.:32/5/82-
ALC4/2015
Party
Name:LANTECH
PHARMACEUTICALS
LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00172/AM16/
RLA
File
:09/24/040/00011/AM16/
Lic.No/Date:0910061900
20.04.2015
Defer
Date:24.05.2016
meeting No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to await the
161
Case
No.:8/2/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00023/AM16/
RLA
File
:09/24/040/00043/AM16/
Lic.No/Date:0910061906
21.04.2015
Defer
Date:24.05.2016
Decision
:
The
Committee as per recommendation of DoP forwarded vide O.M.No.35011/543/2015-PI(Norms) dated December 2015, uploaded at the end of these minutes, decided to call for information from the firm and deferred the case.
27
162
Case
No.:147/7/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00752/AM16/
RLA
File
:03/94/040/00036/AM16/
Lic.No/Date:0310795446
21.04.2015
Defer
Date:24.05.2016
163
Case
No.:153/7/82-
ALC4/2015
Party
Name:DR.
ACHARYA
LABORATORIES
PVT.
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00758/AM16/
RLA
File
:03/94/040/00039/AM16/
Lic.No/Date:0310795534
24.04.2015
Defer
Date:12.05.2016
164
Case
No.:174/7/82-
ALC4/2015
Party
Name:S
M
B
CORPORATION
OF
INDIA
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00779/AM16/
RLA
File
:03/95/040/00039/AM16/
Lic.No/Date:0310795601
28.04.2015
Defer
Date:24.05.2016
Decision :Deferred.
165
Case
No.:151/7/82-
ALC4/2015
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
approved
HQ
File
:01/82/050/00756/AM16/
RLA
File
:03/94/040/01216/AM15/
Lic.No/Date:0310795663
30.04.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/708/2015-PI(Norms) dated 17.03.2016,
166
Case
No.:62/8/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00858/AM16/
RLA
File
:09/24/040/00028/AM16/
Lic.No/Date:0910061955
01.05.2015
Defer
Date:24.05.2016
meeting No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the
167
Case
No.:111/7/82-
ALC4/2015
Party
Name:ZIM
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00716/AM16/
RLA
File
:03/95/040/00058/AM16/
Lic.No/Date:0310795699
05.05.2015
Defer
Date:12.05.2016
Decision :The Committee noted that information had been called for from the firm in NC meeting
No.18 dated 10.02.2016 is awaited. The Committee accordingly decided to await the reply and
deferred the case
28
168
Case
No.:50/7/82-
ALC4/2015
Party Name:ARENE LIFE
SCIENCES LIMITED.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00655/AM16/
RLA
File
:09/24/040/00041/AM16/
Lic.No/Date:0910061976
06.05.2015
Defer
Date:24.05.2016
meeting No.19 dated 25.2.2016 is awaited. The Committee accordingly decided to await the
169
Case
No.:75/8/82-
ALC4/2015
Party
Name:PORUS
LABORATORIES
PVT
LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00871/AM16/
RLA
File
:09/24/040/00051/AM16/
Lic.No/Date:0910061986
06.05.2015
Defer
Date:12.05.2016
Decision :The Committee based on the written comments forwarded by the D/o
Pharmaceuticals forwarded vide O.M.No.35011/660/2015-PI(Norms) dated 12.2.2016, uploaded
at the end of these minutes decided to call for COA of import and export items from foreign
supplier to show that some activity is involved. The Committee accordingly decided to defer the
case.
170
Case
No.:4/7/82-
ALC4/2015
Party
Name:POSY
PHARMACHEM
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00609/AM16/
RLA
File
:08/24/040/00006/AM16/
Lic.No/Date:0810135194
06.05.2015
Defer
Date:24.05.2016
171
Case
No.:65/8/82-
ALC4/2015
Party
Name:VIRCHOW
BIOTECH PV T LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00861/AM16/
RLA
File
:09/24/040/00052/AM16/
Lic.No/Date:0910061973
06.05.2015
Defer
Date:12.05.2016
Decision :The Committee noted that information had been called for from the firm in NC meeting
No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
172
Case
No.:11/7/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00616/AM16/
RLA
File
:08/24/040/00016/AM16/
Lic.No/Date:0810135204
07.05.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/603/2015-PI(Norms) dated 21.3.2016, uploaded
173
Case
No.:23/7/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00628/AM16/
RLA
File
:08/24/040/00028/AM16/
Lic.No/Date:0810135220
07.05.2015
Defer Date:
29
Pharmaceuticals forwarded vide O.M.No.35011/730/2015-PI(Norms) dated 28.3.2016, uploaded
174
Case
No.:3/3/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00033/AM16/
RLA
File
:09/24/040/00077/AM16/
Lic.No/Date:0910061994
07.05.2015
Defer
Date:24.05.2016
175
Case
No.:108/7/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00713/AM16/
RLA
File
:03/95/040/00003/AM16/
Lic.No/Date:0310795745
07.05.2015
Defer
Date:24.05.2016
meeting No.13 dated 27.11.2015 is awaited. The Committee accordingly decided to await the
176
Case
No.:7/5/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00147/AM16/
RLA
File
:05/23/040/00037/AM16/
Lic.No/Date:0510394177
08.05.2015
Defer
Date:12.05.2016
Decision :The Committee noted that information had been called for from the firm in NC meeting
No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
177
Case
No.:38/8/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00834/AM16/
RLA
File
:09/24/040/00060/AM16/
Lic.No/Date:0910061998
08.05.2015
Defer
Date:12.05.2016
Decision :The Committee noted that information had been called for from the firm in NC meeting
No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
178
Case
No.:7/7/82-
ALC4/2015
Party
Name:SWISS
PARENTERALS PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00612/AM16/
RLA
File
:08/24/040/00017/AM16/
Lic.No/Date:0810135225
08.05.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/700/2015-PI(Norms) dated 26.3.2016, uploaded
179
Case
No.:8/7/82-
ALC4/2015
Party
Name:SWISS
PARENTERALS PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
30
HQ
File
:01/82/050/00613/AM16/
RLA
File
:08/24/040/00018/AM16/
Lic.No/Date:0810135226
08.05.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No. 35011/700/2015-PI(Norms) dated 26.04.2016,
180
Case
No.:117/7/82-
ALC4/2015
Party
Name:ZIM
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00722/AM16/
RLA
File
:03/95/040/00079/AM16/
Lic.No/Date:0310795788
08.05.2015
Defer
Date:24.05.2016
181
Case
No.:15/7/82-
ALC4/2015
Party
Name:MAHAVIR
SYNTHESIS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00620/AM16/
RLA
File
:52/24/040/00007/AM16/
Lic.No/Date:5210041517
11.05.2015
Defer
Date:24.05.2016
Decision :Deferred.
182
Case
No.:129/7/82-
ALC4/2015
Party
Name:NATIONAL
TUBE INDUSTRIES,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00734/AM16/
RLA
File
:03/95/040/00073/AM16/
Lic.No/Date:0310795930
14.05.2015
Defer
Date:24.05.2016
Decision :Deferred.
183
Case
No.:6/7/82-
ALC4/2015
Party
Name:SIMPEX
PHARMA PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00611/AM16/
RLA
File
:05/24/040/00564/AM15/
Lic.No/Date:0510394266
15.05.2015
Defer
Date:014.06.2016
Decision : The Committee noted that the export product, Cefanorm, is seen to contain
Cefpirome Sulphate with Sodium Carbonate. The import is of Cefpirome Sulphate with Sodium
Carbonate sterile. If this is the case, wastage applied would need further justification. The
application mentions export as 19718 vials, each containing Cefpirome 1gm. The net content of
bulk drug is stated in the application as 27.877kg (bulk drug is Cefpirome). These figures are
contradictory. The case was deferred and applicant has to furnish a reply.
184
Case
No.:164/7/82-
ALC4/2015
Party
Name:ETERNIS
FINE
CHEMICALS
LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00769/AM16/
RLA
File
:03/94/040/00026/AM16/
Lic.No/Date:0310795971
18.05.2015
Defer
Date:24.05.2016
meeting No.17 dated 27.01.2016 is awaited. The Committee accordingly decided to await the
185
Case
No.:109/7/82-
ALC4/2015
Party
Name:ZIM
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
31
HQ
File
:01/82/050/00714/AM16/
RLA
File
:03/95/040/00103/AM16/
Lic.No/Date:0310795994
18.05.2015
Defer
Date:24.05.2016
186
Case
No.:133/7/82-
ALC4/2015
Party
Name:AARTI
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00738/AM16/
RLA
File
:03/94/040/00085/AM16/
Lic.No/Date:0310796048
20.05.2015
Defer
Date:24.05.2016
187
Case
No.:102/7/82-
ALC4/2015
Party
Name:DYNAMIC
SPECIALITY
CHEMICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00707/AM16/
RLA
File
:30/24/040/00006/AM16/
Lic.No/Date:3010103498
21.05.2015
Defer
Date:24.05.2016
188
Case
No.:199/5/82-
ALC4/2015
Party
Name:SHASUN
PHARMACEUTICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00339/AM16/
RLA
File
:04/24/040/00040/AM16/
Lic.No/Date:0410160570
21.05.2015
Defer
Date:24.05.2016
189
Case
No.:200/5/82-
ALC4/2015
Party
Name:SHASUN
PHARMACEUTICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00340/AM16/
RLA
File
:04/24/040/00038/AM16/
Lic.No/Date:0410160569
21.05.2015
Defer
Date:12.05.2016
Decision :The Committee noted that information had been called for from the firm in NC meeting No.12
dated 18.11.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case.
190
Case
No.:55/13/82-
ALC4/2015
Party
Name:GLOBAL
CALCIUM PRIVATE LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01018/AM16/
RLA
File
:07/24/040/00036/AM16/
Lic.No/Date:0710108251
22.05.2015
Defer
Date:24.05.2016
Decision :Deferred.
191
Case No.:3/4/82-ALC4/2015
Party
Name:HETERO
LABS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ File :01/82/050/00042/AM16/
RLA File :09/24/040/00104/AM16/
Lic.No/Date:0910062064
25.05.2015
Defer Date:
Decision
:
The
Committee
received
the
recommendation
of
D/o
Pharmaceuticals
forwarded
vide
O.M.No.35011/145/2015-PI(Norms) dated 11.04.2016 and after deliberation the Committee decided to ratify norms as per
details given below or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
Export product Qty Import Item Qty. Lamivudine 1kg (2R-CIS-4-amino-1,2-(hydroxymethyl-1,3-oxathiolan-5yl)-2- (1H)-pyrimidinone (Technical Grade) 1.05kg
RA concerned may take necessary action as per decision of NC.
32
192
Case
No.:4/4/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00043/AM16/
RLA
File
:09/24/040/00106/AM16/
Lic.No/Date:0910062065
25.05.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/693/2015-PI(Norms) dated 02.3.2016, uploaded
193
Case
No.:5/4/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00044/AM16/
RLA
File
:09/24/040/00116/AM16/
Lic.No/Date:0910062066
25.05.2015
Defer
Date:24.05.2016
Decision :The Committee decided to defer the case for want of comments of DoP.
194
Case
No.:45/8/82-
ALC4/2015
Party
Name:MOREPEN
LABORATORIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00841/AM16/
RLA
File
:05/24/040/00073/AM16/
Lic.No/Date:0510394342
25.05.2015
Defer
Date:12.05.2016
Decision :The Committee based on the written comments forwarded by the D/o
Pharmaceuticals forwarded vide O.M.No.35011/657/2015-PI(Norms) dated 12.2.2016, uploaded
at the end of these minutes decided to call for information from the firm and deferred the case.
195
Case
No.:176/7/82-
ALC4/2015
Party
Name:GLOBE
TROTTERS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00781/AM16/
RLA
File
:03/94/040/00124/AM16/
Lic.No/Date:0310796194
26.05.2015
Defer
Date:24.05.2016
Decision :Deferred.
196
Case
No.:124/7/82-
ALC4/2015
Party
Name:PRIVI
ORGANICS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00729/AM16/
RLA
File
:03/95/040/00114/AM16/
Lic.No/Date:0310796233
27.05.2015
Defer
Date:24.05.2016
Decision :Deferred.
197
Case
No.:100/7/82-
ALC4/2015
Party
Name:SHREE
GANESH
REMEDIES
PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00705/AM16/
RLA
File
:34/24/040/00024/AM16/
Lic.No/Date:3410041261
28.05.2015
Defer
Date:24.05.2016
Decision :Deferred.
198
Case
No.:90/4/82-
ALC4/2015
Party
Name:DIVIS
LABORATORIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File RLA
File Lic.No/Date:0910062101 Defer Date:
33
:01/82/050/00129/AM16/
:09/24/040/00089/AM16/
01.06.2015
Pharmaceuticals forwarded vide O.M.No.35011/610/2015-PI(Norms) dated December 2015,
199
Case
No.:188/7/82-
ALC4/2015
Party
Name:ATUL
LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00793/AM16/
RLA
File
:08/24/040/00034/AM16/
Lic.No/Date:0810135421
02.06.2015
Defer
Date:24.05.2016
Decision :Deferred.
200
Case
No.:5/7/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00610/AM16/
RLA
File
:05/24/040/00090/AM16/
Lic.No/Date:0510394416
02.06.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/588/2015-PI(Norms) dated 21.3.2016, uploaded
201
Case
No.:98/4/82-
ALC4/2015
Party
Name:DIVIS
LABORATORIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00137/AM16/
RLA
File
:09/24/040/00092/AM16/
Lic.No/Date:0910062128
03.06.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/586/2015-PI(Norms) dated December 2015,
202
Case
No.:142/7/82-
ALC4/2015
Party
Name:GLOBE
TROTTERS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00747/AM16/
RLA
File
:03/94/040/00159/AM16/
Lic.No/Date:0310796401
03.06.2015
Defer
Date:24.05.2016
Decision :Deferred.
203
Case
No.:110/7/82-
ALC4/2015
Party
Name:RISHABH
METALS & CHEMICALS
PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00715/AM16/
RLA
File
:03/95/040/00051/AM16/
Lic.No/Date:0310796383
03.06.2015
Defer
Date:24.05.2016
Decision :Deferred.
204
Case
No.:16/7/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File RLA
File Lic.No/Date:0510394419 Defer Date:
34
:01/82/050/00621/AM16/
:05/24/040/00084/AM16/
03.06.2015
Pharmaceuticals forwarded vide O.M.No.35011/734/2015-PI(Norms) dated April 2016, uploaded
205
Case
No.:17/7/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00622/AM16/
RLA
File
:05/24/040/00078/AM16/
Lic.No/Date:0510394418
03.06.2015
Defer
Date:24.05.2016
Pharmaceuticals forwarded vide O.M.No.35011/734/2015-PI(Norms) dated April 2016, uploaded
at the end of these decided to call for information from the firm and deferred the case.
206
Case
No.:67/7/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00672/AM16/
RLA
File
:09/24/040/00105/AM16/
Lic.No/Date:0910062138
05.06.2015
Defer
Date:24.05.2016
meeting No.21 dated 22.3.2016 is awaited. The Committee accordingly decided to await the
207
Case
No.:13/9/82-
ALC4/2015
Party
Name:SHILPA
MEDICARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00949/AM16/
RLA
File
:07/24/040/00081/AM16/
Lic.No/Date:0710108327
05.06.2015
Defer
Date:24.05.2016
Decision :Information has been received and sent to DoP on 19.4.2016
208
Case
No.:121/7/82-
ALC4/2015
Party
Name:UNIMARK
REMEDIES LIMITED.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00726/AM16/
RLA
File
:03/95/040/00715/AM15/
Lic.No/Date:0310796458
05.06.2015
Defer
Date:24.05.2016
meeting No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the
209
Case
No.:123/7/82-
ALC4/2015
Party
Name:UNIMARK
REMEDIES LIMITED.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00728/AM16/
RLA
File
:03/95/040/00582/AM15/
Lic.No/Date:0310796457
05.06.2015
Defer
Date:24.05.2016
meeting No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the
210 Case
No.:59/7/82-
ALC4/2015
Party
Name:GRANULES
INDIA LIMITED
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Approved
35
26.04.2016
HQ
File
:01/82/050/00664/AM16/
RLA
File
:09/24/040/00149/AM16/
Lic.No/Date:0910062152
10.06.2015
Defer Date:
Pharmaceuticals
forwarded
vide
O.M.No.35011/624/2015-PI(Norms)
dated
21.03.2016,
211
Case
No.:14/9/82-
ALC4/2015
Party
Name:SHILPA
MEDICARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00950/AM16/
RLA
File
:07/24/040/00078/AM16/
Lic.No/Date:0710108349
10.06.2015
Defer
Date:24.05.2016
Decision : Information received and sent to DoP on 19.4.2016 for comments.
212
Case
No.:65/7/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00670/AM16/
RLA
File
:09/24/040/00164/AM16/
Lic.No/Date:0910062163
10.06.2015
Defer
Date:24.05.2016
213
Case
No.:66/7/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00671/AM16/
RLA
File
:09/24/040/00162/AM16/
Lic.No/Date:0910062162
10.06.2015
Defer
Date:24.05.2016
214
Case
No.:20/13/82-
ALC4/2015
Party
Name:JAYANT
AGRO ORGANICS LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00983/AM16/
RLA
File
:03/94/040/00169/AM16/
Lic.No/Date:0310796563
11.06.2015
Defer
Date:24.05.2016
meeting No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the
215
Case
No.:159/7/82-
ALC4/2015
Party
Name:VIJAY
PERFUMES PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00764/AM16/
RLA
File
:03/95/040/00985/AM15/
Lic.No/Date:0310796576
11.06.2015
Defer
Date:24.05.2016
meeting No.15 dated 30.12.2016 is awaited. The Committee accordingly decided to await the
216
Case
No.:87/7/82-
ALC4/2015
Party
Name:VISION
DRUGS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0910062168 Defer
36
:01/82/050/00692/AM16/ :09/24/040/00102/AM16/ 11.06.2015 Date:24.05.2016 meeting No.13 dated 27.11.2016 is awaited. The Committee accordingly decided to await the
217
Case
No.:42/13/82-
ALC4/2015
Party
Name:BTL
EXPORTS PVT. LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01005/AM16/
RLA
File
:03/94/040/00177/AM16/
Lic.No/Date:0310796604
15.06.2015
Defer
Date:24.05.2016
218
Case
No.:48/19/82-
ALC4/2015
Party
Name:RAJ
DHANVANTRY
PHARMACY
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01529/AM16/
RLA
File
:24/24/040/00007/AM16/
Lic.No/Date:2410041748
15.06.2015
Defer
Date:24.05.2016
219
Case
No.:41/13/82-
ALC4/2015
Party
Name:DANOPHARM
CHEMICALS
PRIVATE
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01004/AM16/
RLA
File
:03/94/040/00111/AM16/
Lic.No/Date:0310796667
16.06.2015
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of DCPC.
220
Case
No.:52/7/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00657/AM16/
RLA
File
:05/23/040/00107/AM16/
Lic.No/Date:0510394590
17.06.2015
Defer
Date:24.05.2016
Decision : The Committee based on the written comments forwarded by the D/o
Pharmaceuticals forwarded vide O.M.No.35011/696/2015-PI(Norms) dated 22.03.2016,
uploaded at the end of these minutes decided to call for technical information from the firm and
deferred the case.
221
Case
No.:43/13/82-
ALC4/2015
Party
Name:BTL
EXPORTS PVT. LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01006/AM16/
RLA
File
:03/94/040/00178/AM16/
Lic.No/Date:0310796712
18.06.2015
Defer
Date:24.05.2016
222
Case
No.:15/9/82-
ALC4/2015
Party Name:KDAC CHEM
PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00951/AM16/
RLA
File
:34/24/040/00069/AM16/
Lic.No/Date:3410041310
22.06.2015
Defer
Date:24.05.2016
37
Decision :Deferred.
223
Case
No.:26/13/82-
ALC4/2015
Party
Name:KOPRAN
RESEARCH
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00989/AM16/
RLA
File
:03/94/040/00164/AM16/
Lic.No/Date:0310796757
23.06.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/724/2015-PI(Norms) dated 4.4.2016 , uploaded
224
Case
No.:27/13/82-
ALC4/2015
Party
Name:KOPRAN
RESEARCH
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00990/AM16/
RLA
File
:03/94/040/00197/AM16/
Lic.No/Date:0310796759
23.06.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/724/2015-PI(Norms) dated 4.4.2016 , uploaded
225
Case
No.:28/13/82-
ALC4/2015
Party
Name:KOPRAN
RESEARCH
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00991/AM16/
RLA
File
:03/94/040/00162/AM16/
Lic.No/Date:0310796761
23.06.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/724/2015-PI(Norms) dated 4.4.2016 , uploaded
226
Case
No.:31/13/82-
ALC4/2015
Party
Name:KOPRAN
RESEARCH
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00994/AM16/
RLA
File
:03/94/040/00198/AM16/
Lic.No/Date:0310796762
23.06.2015
Defer
Date:26.04.2016
Pharmaceuticals forwarded vide O.M. No.35011/724/2015-PI(Norms) dated 4.4.2016 , uploaded
227
Case
No.:83/13/82-
ALC4/2015
Party
Name:RIDDHI
PHARMA
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01046/AM16/
RLA
File
:34/24/040/00087/AM16/
Lic.No/Date:3410041313
23.06.2015
Defer
Date:24.05.2016
228 Case No.:15/13/82- Party Name:ALIVIRA Meet
38
ALC4/2015
ANIMAL
HEALTH
LIMITED
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/00978/AM16/
RLA
File
:03/94/040/00219/AM16/
Lic.No/Date:0310796797
24.06.2015
Defer
Date:24.05.2016
229
Case
No.:82/19/82-
ALC4/2015
Party Name:SIDDHARTH
CARBOCHEM
PRODUCTS LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01563/AM16/
RLA
File
:03/95/040/00667/AM15/
Lic.No/Date:0310796830
24.06.2015
Defer
Date:24.05.2016
Decision :Deferred.
230
Case
No.:72/7/82-
ALC4/2015
Party Name:PCL OIL &
SOLVENTS LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00677/AM16/
RLA
File
:05/24/040/00104/AM16/
Lic.No/Date:0510394704
25.06.2015
Defer
Date:24.05.2016
meeting No.09 dated 30.09.2015 is awaited. The Committee accordingly decided to await the
231
Case
No.:76/7/82-
ALC4/2015
Party Name:PCL OIL &
SOLVENTS LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00681/AM16/
RLA
File
:05/24/040/00103/AM16/
Lic.No/Date:0510394703
25.06.2015
Defer
Date:24.05.2016
meeting No.09 dated 30.09.2015 is awaited. The Committee accordingly decided to await the
232
Case
No.:75/7/82-
ALC4/2015
Party
Name:SENTISS
PHARMA PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00680/AM16/
RLA
File
:05/24/040/00122/AM16/
Lic.No/Date:0510394696
25.06.2015
Defer
Date:24.05.2016
233
Case
No.:78/7/82-
ALC4/2015
Party
Name:WEST
BENGAL
CHEMICAL
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00683/AM16/
RLA
File
:02/24/040/00028/AM16/
Lic.No/Date:0210205920
25.06.2015
Defer
Date:24.05.2016
meeting No.15 dated 30.12.2015 is awaited. The Committee accordingly decided to await the
234
Case
No.:109/8/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0310796997 Defer
39
:01/82/050/00905/AM16/ :03/95/040/00038/AM16/ 01.07.2015 Date:24.05.2016 meeting No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the
235
Case
No.:108/14/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01244/AM16/
RLA
File
:09/24/040/00183/AM16/
Lic.No/Date:0910062267
01.07.2015
Defer
Date:24.05.2016
Decision : The Committee noted that information called for from the firm in NC meeting No.17
dated 27.01.2016 is awaited. The Committee accordingly decided await the reply and deferred
the case.
236
Case
No.:10/13/82-
ALC4/2015
Party Name:AMINES &
PLASTICIZERS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00973/AM16/
RLA
File
:03/94/040/00229/AM16/
Lic.No/Date:0310797018
02.07.2015
Defer
Date:24.05.2016
Decision :Deferred.
237
Case
No.:11/13/82-
ALC4/2015
Party Name:AMINES &
PLASTICIZERS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00974/AM16/
RLA
File
:03/94/040/00228/AM16/
Lic.No/Date:0310797020
02.07.2015
Defer
Date:24.05.2016
Decision :Deferred.
238
Case
No.:39/13/82-
ALC4/2015
Party
Name:GLENMARK
PHARMACEUTICALS
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01002/AM16/
RLA
File
:03/94/040/00260/AM16/
Lic.No/Date:0310797052
03.07.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/703/2015-PI(Norms) dated 26.4.2016 ,
239
Case
No.:105/14/82-
ALC4/2015
Party
Name:PORUS
LABORATORIES
PVT
LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01241/AM16/
RLA
File
:09/24/040/00191/AM16/
Lic.No/Date:0910062299
03.07.2015
Defer
Date:24.05.2016
meeting No.20 dated 09.032016 is awaited. The Committee accordingly decided to await the
240
Case
No.:24/13/82-
ALC4/2015
Party
Name:DANOPHARM
CHEMICALS
PRIVATE
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
40
HQ
File
:01/82/050/00987/AM16/
RLA
File
:03/94/040/00226/AM16/
Lic.No/Date:0310797092
07.07.2015
Defer
Date:24.05.2016
241
Case
No.:32/13/82-
ALC4/2015
Party Name:FDC LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00995/AM16/
RLA
File
:03/94/040/00263/AM16/
Lic.No/Date:0310797090
07.07.2015
Defer
Date:24.05.2016
242
Case
No.:82/13/82-
ALC4/2015
Party
Name:PAB
ORGANICS PVT.LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01045/AM16/
RLA
File
:34/24/040/00084/AM16/
Lic.No/Date:3410041360
07.07.2015
Defer
Date:24.05.2016
meeting No.15 dated 30.12.2015 is awaited. The Committee accordingly decided to await the
reply and deferred the case..
243
Case
No.:162/14/82-
ALC4/2015
Party Name:MICRO LABS
LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01298/AM16/
RLA
File
:07/24/040/00100/AM16/
Lic.No/Date:0710108505
14.07.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/777/2015-PI(Norms) dated 11.4.2016, uploaded
244
Case
No.:23/13/82-
ALC4/2015
Party Name:K V AROCHEM
PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00986/AM16/
RLA
File
:03/94/040/00284/AM16/
Lic.No/Date:0310797268
15.07.2015
Defer
Date:24.05.2016
Decision : The Committee noted that information had been called for from the firm in NC meeting No.17
dated 27.01.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case.
245
Case
No.:20/16/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01340/AM16/
RLA
File
:09/24/040/00032/AM16/
Lic.No/Date:0910062338
15.07.2015
Defer
Date:24.05.2016
246
Case
No.:49/8/82-
ALC4/2015
Party
Name:M.L.A.
INDUSTRIES
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00845/AM16/
RLA
File
:06/24/040/00015/AM16/
Lic.No/Date:0610038193
16.07.2015
Defer
Date:12.05.2016
41
Decision :The Committee noted that information had been called for from the firm in NC meeting No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case.
247
Case
No.:120/8/82-
ALC4/2015
Party
Name:PERFECT
VITAMINS PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00916/AM16/
RLA
File
:03/95/040/00304/AM16/
Lic.No/Date:0310797293
16.07.2015
Defer
Date:12.05.2016
Decision :The Committee noted that information had been called for from the firm in NC meeting
No.18 dated 10.02.2016 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
248
Case
No.:22/13/82-
ALC4/2015
Party
Name:BLISS
INDASI LIFESCIENCES
PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00985/AM16/
RLA
File
:03/94/040/00282/AM16/
Lic.No/Date:0310797355
17.07.2015
Defer
Date:24.05.2016
Decision : The Committee based on the written comments forwarded by the D/o
Pharmaceuticals forwarded vide O.M. No.35011/707/2015-PI(Norms) dated 11.4.2016
uploaded at the end of these minutes decided to call for technical information from the firm and
deferred the case.
249
Case
No.:93/8/82-
ALC4/2015
Party
Name:DR
J
PHARMACHEM
(INDIA)(PROP.ADITYA
PRAMOD JOGDEO)
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00889/AM16/
RLA
File
:31/83/040/00050/AM16/
Lic.No/Date:3110065541
17.07.2015
Defer Date:
Decision : The Committee decided to ratify norms in light of the written comments of D/o C&PC
forwarded vide U.O.No.14010/52/2011-Ch-II dated 02.04.2014, uploaded at the end of these
minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned
may take necessary action as per decision of NC.
250
Case
No.:119/8/82-
ALC4/2015
Party Name:SI GROUP
INDIA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00915/AM16/
RLA
File
:03/95/040/00322/AM16/
Lic.No/Date:0310797595
23.07.2015
Defer
Date:24.05.2016
Decision :Deferred.
251
Case
No.:115/13/82-
ALC4/2015
Party Name:FERMENTA
BIOTECH LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01078/AM16/
RLA
File
:03/94/040/00038/AM16/
Lic.No/Date:0310797627
24.07.2015
Defer
Date:24.05.2016
252 Case
No.:73/8/82-
ALC4/2015
Party
Name:RECKITT
BENCKISER
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Deferred
42
HEALTHCARE
INDIA
LIMITED
26.04.2016
HQ
File
:01/82/050/00869/AM16/
RLA
File
:05/24/040/00213/AM16/
Lic.No/Date:0510395102
28.07.2015
Defer
Date:24.05.2016
253
Case
No.:69/13/82-
ALC4/2015
Party
Name:PI
INDUSTRIES LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01032/AM16/
RLA
File
:13/24/040/00016/AM16/
Lic.No/Date:1310047933
29.07.2015
Defer
Date:24.05.2016
Decision :Deferred.
254
Case
No.:92/13/82-
ALC4/2015
Party
Name:INFINITY
LABORATORIES
PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01055/AM16/
RLA
File
:22/24/040/00027/AM16/
Lic.No/Date:2210015273
31.07.2015
Defer
Date:24.05.2016
255
Case
No.:116/13/82-
ALC4/2015
Party
Name:JINDAL
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01079/AM16/
RLA
File
:03/94/040/00215/AM16/
Lic.No/Date:0310797864
31.07.2015
Defer
Date:24.05.2016
256
Case
No.:49/19/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01530/AM16/
RLA
File
:05/23/040/00185/AM16/
Lic.No/Date:0510395140
31.07.2015
Defer
Date:24.05.2016
257
Case
No.:114/13/82-
ALC4/2015
Party
Name:BLUE
CIRCLE
ORGANICS
PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01077/AM16/
RLA
File
:03/94/040/00258/AM16/
Lic.No/Date:0310797898
03.08.2015
Defer
Date:24.05.2016
Decision :Deferred.
258
Case
No.:113/13/82-
ALC4/2015
Party
Name:K
V
AROCHEM PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01076/AM16/
RLA
File
:03/94/040/00335/AM16/
Lic.No/Date:0310797897
03.08.2015
Defer
Date:24.05.2016
Decision :Deferred.
259 Case
No.:112/13/82-
ALC4/2015
Party
Name:K
V
AROCHEM PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Deferred
43
26.04.2016
HQ
File
:01/82/050/01075/AM16/
RLA
File
:03/94/040/00345/AM16/
Lic.No/Date:0310797937
04.08.2015
Defer
Date:24.05.2016
meeting No.17 dated 27.01.2016 is awaited. The Committee accordingly decided to await the
260
Case
No.:75/13/82-
ALC4/2015
Party
Name:SENTISS
PHARMA PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01038/AM16/
RLA
File
:05/24/040/00215/AM16/
Lic.No/Date:0510395160
04.08.2015
Defer
Date:24.05.2016
261
Case
No.:78/13/82-
ALC4/2015
Party
Name:SENTISS
PHARMA PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01041/AM16/
RLA
File
:05/24/040/00219/AM16/
Lic.No/Date:0510395169
04.08.2015
Defer
Date:24.05.2016
262
Case
No.:109/13/82-
ALC4/2015
Party
Name:KOPRAN
RESEARCH
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01072/AM16/
RLA
File
:03/94/040/00170/AM16/
Lic.No/Date:0310797954
05.08.2015
Defer
Date:24.05.2016
Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded
vide O.M.No.35011/773/2015-PI(Norms) dated 26.4.2016, uploaded at the end of these minutes
decided to call for information from the firm and deferred the case.
263
Case
No.:12/18/82-
ALC4/2015
Party
Name:OMTECH
CHEMICAL INDUSTRIES
PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01477/AM16/
RLA
File
:03/95/040/00345/AM16/
Lic.No/Date:0310797967
05.08.2015
Defer
Date:24.05.2016
meeting No.20 dated 09.03.2016 is awaited. The Committee accordingly decided to await the
264
Case
No.:50/13/82-
ALC4/2015
Party
Name:ARJUN
CHEMICALS PVT. LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01013/AM16/
RLA
File
:04/24/040/00095/AM16/
Lic.No/Date:0410160884
06.08.2015
Defer
Date:24.05.2016
Decision :Deferred.
265
Case
No.:2/21/82-
ALC4/2015
Party Name:AUROLAB
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01707/AM16/
RLA
File
:35/24/040/00022/AM16/
Lic.No/Date:3510044782
06.08.2015
Defer
Date:24.05.2016
44
266
Case
No.:166/13/82-
ALC4/2015
Party
Name:PARAMOUNT
AROMACHEM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01129/AM16/
RLA
File
:05/24/040/00235/AM16/
Lic.No/Date:0510395245
07.08.2015
Defer
Date:08.06.2016
267
Case
No.:68/13/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01031/AM16/
RLA
File
:05/24/040/00230/AM16/
Lic.No/Date:0510395244
07.08.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/588/2015-PI(Norms) dated 21.3.2016 ,
268
Case
No.:110/13/82-
ALC4/2015
Party
Name:ELPPE
CHEMICALS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01073/AM16/
RLA
File
:03/94/040/00350/AM16/
Lic.No/Date:0310798096
12.08.2015
Defer
Date:24.05.2016
Decision :Deferred.
269
Case
No.:106/13/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01069/AM16/
RLA
File
:03/94/040/00379/AM16/
Lic.No/Date:0310798101
12.08.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/597/2015-PI(Norms) dated 21.3.2016, uploaded
270
Case
No.:111/13/82-
ALC4/2015
Party Name:HEMA DYE
CHEM PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01074/AM16/
RLA
File
:03/94/040/00305/AM16/
Lic.No/Date:0310798134
13.08.2015
Defer
Date:24.05.2016
Decision :Deferred.
271
Case
No.:91/13/82-
ALC4/2015
Party
Name:VENUS
REMEDIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01054/AM16/
RLA
File
:22/24/040/00016/AM16/
Lic.No/Date:2210015282
13.08.2015
Defer
Date:24.05.2016
45
272
Case
No.:79/13/82-
ALC4/2015
Party
Name:AMI
ORGANICS PVT LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01042/AM16/
RLA
File
:52/24/040/00034/AM16/
Lic.No/Date:5210041610
14.08.2015
Defer
Date:24.05.2016
Decision :Deferred.
273
Case
No.:57/13/82-
ALC4/2015
Party
Name:VENUS
REMEDIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01020/AM16/
RLA
File
:22/24/040/00013/AM16/
Lic.No/Date:2210015284
14.08.2015
Defer
Date:24.05.2016
meeting No.17 dated 27.01.2016 is awaited. The Committee accordingly decided to await the
274
Case
No.:127/13/82-
ALC4/2015
Party
Name:ASTEC
LIFESCIENCES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01090/AM16/
RLA
File
:03/94/040/00878/AM15/
Lic.No/Date:0310798205
17.08.2015
Defer
Date:24.05.2016
275
Case
No.:60/13/82-
ALC4/2015
Party
Name:HELLO
PAINTS (P) LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01023/AM16/
RLA
File
:05/23/040/00204/AM16/
Lic.No/Date:0510395351
18.08.2015
Defer
Date:24.05.2016
meeting No.17dated 27.01.2016 is awaited. The Committee accordingly decided to await the
276
Case
No.:99/14/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01235/AM16/
RLA
File
:09/24/040/00231/AM16/
Lic.No/Date:0910062516
18.08.2015
Defer
Date:12.05.2016
Decision :The Committee noted that information had been called for from the firm in NC meeting
No.20 dated 09.03.2016 is awaited. The Committee accordingly decided to await the reply and
deferred the case.
277
Case
No.:126/13/82-
ALC4/2015
Party
Name:ASTEC
LIFESCIENCES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01089/AM16/
RLA
File
:03/94/040/00879/AM15/
Lic.No/Date:0310798319
20.08.2015
Defer
Date:24.05.2016
Decision : Deferred
278
Case
No.:61/13/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
46
HQ
File
:01/82/050/01024/AM16/
RLA
File
:05/23/040/00218/AM16/
Lic.No/Date:0510395388
20.08.2015
Defer
Date:24.05.2016
279
Case
No.:62/13/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01025/AM16/
RLA
File
:05/23/040/00212/AM16/
Lic.No/Date:0510395383
20.08.2015
Defer
Date:24.05.2016
280
Case
No.:161/13/82-
ALC4/2015
Party
Name:STERLING
AUXILIARIES PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01124/AM16/
RLA
File
:03/95/040/00274/AM16/
Lic.No/Date:0310798374
21.08.2015
Defer
Date:24.05.2016
Decision :Deferred.
281
Case
No.:125/13/82-
ALC4/2015
Party Name:FDC LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01088/AM16/
RLA
File
:03/94/040/00364/AM16/
Lic.No/Date:0310798396
24.08.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/772/2015-PI(Norms) dated 11.4.2016 ,
282
Case
No.:130/13/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01093/AM16/
RLA
File
:03/94/040/00413/AM16/
Lic.No/Date:0310798392
24.08.2015
Defer
Date:24.05.2016
283
Case
No.:54/13/82-
ALC4/2015
Party
Name:AARTI
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01017/AM16/
RLA
File
:03/94/040/00089/AM16/
Lic.No/Date:0310798493
26.08.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/760/2015-PI(Norms) dated April 2016, uploaded
284
Case
No.:77/13/82-
ALC4/2015
Party
Name:ARKRAY
HEALTHCARE PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01040/AM16/
RLA
File
:52/24/040/00038/AM16/
Lic.No/Date:5210041620
27.08.2015
Defer
Date:24.05.2016
47
Decision : : The Committee decided to send a copy of application to DBT
285
Case
No.:120/13/82-
ALC4/2015
Party
Name:ENCUBE
ETHICALS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01083/AM16/
RLA
File
:03/94/040/00279/AM16/
Lic.No/Date:0310798629
03.09.2015
Defer
Date:24.05.2016
286
Case
No.:84/14/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01220/AM16/
RLA
File
:05/24/040/00262/AM16/
Lic.No/Date:0510395506
03.09.2015
Defer
Date:24.05.2016
Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded
vide O.M. No.35011/781/2015-PI(Norms) dated 26.4.2016, uploaded at the end of these minutes
decided to call for information from the firm and deferred the case.
287
Case
No.:7/9/82-
ALC4/2015
Party Name:DR REDDYS
LABORATORIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00943/AM16/
RLA
File
:09/24/040/00312/AM16/
Lic.No/Date:0910062574
08.09.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/722/2015-PI(Norms) dated 31.3.2016, uploaded
288
Case
No.:8/9/82-
ALC4/2015
Party
Name:BEST
VALUE CHEM PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00944/AM16/
RLA
File
:34/24/040/00155/AM16/
Lic.No/Date:3410041496
09.09.2015
Defer
Date:24.05.2016
Decision :Deferred.
289
Case
No.:10/9/82-
ALC4/2015
Party
Name:ALKYL
AMINES CHEMICALS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00946/AM16/
RLA
File
:03/94/040/00355/AM16/
Lic.No/Date:0310798806
10.09.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.14010/85/2012-CH-II dated 08.12.2015, uploaded at
the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP
290
Case
No.:125/14/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Approved
HQ
File
:01/82/050/01261/AM16/
RLA
File
:09/24/040/00345/AM16/
Lic.No/Date:0910062589
10.09.2015
Defer Date:
48
Decision :Approved in NC meeting 01/AM17
291
Case
No.:64/21/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01769/AM16/
RLA
File
:08/24/040/00137/AM16/
Lic.No/Date:0810136085
22.09.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/730/2015-PI(Norms) dated 28.3.2016, uploaded
292
Case
No.:20/9/82-
ALC4/2015
Party
Name:SUPREET
CHEMICALS PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00956/AM16/
RLA
File
:03/95/040/00424/AM16/
Lic.No/Date:0310798995
22.09.2015
Defer
Date:24.05.2016
Decision :Deferred.
293
Case
No.:51/19/82-
ALC4/2015
Party
Name:SHALINA
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01532/AM16/
RLA
File
:03/95/040/00430/AM16/
Lic.No/Date:0310799076
28.09.2015
Defer
Date:24.05.2016
meeting No.19 dated 25.02.2016 is awaited. The Committee accordingly decided to await the
294
Case
No.:12/19/82-
ALC4/2015
Party
Name:ARJUN
CHEMICALS PVT. LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01492/AM16/
RLA
File
:04/24/040/00154/AM16/
Lic.No/Date:0410161070
01.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
295
Case
No.:45/16/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01365/AM16/
RLA
File
:03/94/040/00529/AM16/
Lic.No/Date:0310799266
07.10.2015
Defer
Date:12.05.2016
Decision :Deferred.
296
Case
No.:130/14/82-
ALC4/2015
Party
Name:V.D.H.
ORGANICS PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01266/AM16/
RLA
File
:05/24/040/00317/AM16/
Lic.No/Date:0510395874
09.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
297 Case No.:56/2/82- Party Name:GLOBAL Meet
49
ALC4/2016
CALCIUM
PRIVATE
LIMITED,
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/00056/AM17/
RLA
File
:07/24/040/00123/AM16/
Lic.No/Date:0710108886
13.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
298
Case
No.:135/13/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01098/AM16/
RLA
File
:09/24/040/00408/AM16/
Lic.No/Date:0910062740
14.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
299
Case
No.:24/16/82-
ALC4/2015
Party
Name:SALICYLATES
&
CHEMICALS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01344/AM16/
RLA
File
:09/24/040/00380/AM16/
Lic.No/Date:0910062727
14.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
300
Case
No.:136/13/82-
ALC4/2015
Party
Name:ATUL
LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01099/AM16/
RLA
File
:08/24/040/00207/AM16/
Lic.No/Date:0810136320
16.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
301
Case
No.:65/21/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Approved
HQ
File
:01/82/050/01770/AM16/
RLA
File
:08/24/040/00240/AM16/
Lic.No/Date:0810136319
16.10.2015
Defer Date:
Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its
meeting No.28/82 dated 10.01.2013, uploaded at the end of these minutes or as applied by the
firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action
as per decision of NC.
302
Case
No.:46/19/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01527/AM16/
RLA
File
:09/24/040/00438/AM16/
Lic.No/Date:0910062744
19.10.2015
Defer
Date:24.05.2016
303
Case
No.:138/13/82-
ALC4/2015
Party
Name:ARCHIMEDIS
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01101/AM16/
RLA
File
:09/24/040/00320/AM16/
Lic.No/Date:0910062756
20.10.2015
Defer
Date:24.05.2016
50
304
Case
No.:140/13/82-
ALC4/2015
Party
Name:SURVIVAL
TECHNOLOGIES
PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01103/AM16/
RLA
File
:03/95/040/00503/AM16/
Lic.No/Date:0310799583
21.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
305
Case
No.:141/13/82-
ALC4/2015
Party
Name:SURVIVAL
TECHNOLOGIES
PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01104/AM16/
RLA
File
:03/95/040/00504/AM16/
Lic.No/Date:0310799629
23.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
306
Case
No.:142/13/82-
ALC4/2015
Party
Name:SYNTHO
CHIRALS PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01105/AM16/
RLA
File
:09/24/040/00443/AM16/
Lic.No/Date:0910062774
27.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
307
Case
No.:146/13/82-
ALC4/2015
Party
Name:COVALENT
LABORATORIES PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01109/AM16/
RLA
File
:09/24/040/00413/AM16/
Lic.No/Date:0910062785
28.10.2015
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o
Pharmaceuticals forwarded vide O.M.No.35011/745/2015-PI(Norms) dated April 2016, uploaded
308
Case
No.:45/19/82-
ALC4/2015
Party Name:LEE PHARMA
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01526/AM16/
RLA
File
:09/24/040/00451/AM16/
Lic.No/Date:0910062778
28.10.2015
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o
Pharmaceuticals forwarded vide O.M.No.35011/840/2015-PI(Norms) dated April 2016, uploaded
309
Case
No.:3/21/82-
ALC4/2015
Party Name:LEE PHARMA
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01708/AM16/
RLA
File
:09/24/040/00452/AM16/
Lic.No/Date:0910062779
28.10.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/840/2015-PI(Norms) dated April 2016, uploaded
51
310
Case
No.:29/21/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01734/AM16/
RLA
File
:09/24/040/00448/AM16/
Lic.No/Date:0910062788
28.10.2015
Defer
Date:24.05.2016
311
Case
No.:73/19/82-
ALC4/2015
Party
Name:GALAXY
SURFACTANTS LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01554/AM16/
RLA
File
:03/94/040/00575/AM16/
Lic.No/Date:0310799849
29.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
312
Case
No.:147/13/82-
ALC4/2015
Party
Name:GOPINATH
CHEM-TECH LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01110/AM16/
RLA
File
:08/24/040/00241/AM16/
Lic.No/Date:0810136382
29.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
313
Case
No.:152/13/82-
ALC4/2015
Party
Name:ARCHIMEDIS
LABORATORIES
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01115/AM16/
RLA
File
:09/24/040/00319/AM16/
Lic.No/Date:0910062806
30.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
314
Case
No.:151/13/82-
ALC4/2015
Party
Name:DIVIS
LABORATORIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01114/AM16/
RLA
File
:09/24/040/00439/AM16/
Lic.No/Date:0910062803
30.10.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/695/2015-PI(Norms) dated January 2016 ,
315
Case
No.:64/19/82-
ALC4/2015
Party
Name:INDO
AMINES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01545/AM16/
RLA
File
:03/94/040/00240/AM16/
Lic.No/Date:0310799907
30.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
316 Case No.:65/19/82- Party Name:INDO Meet
52
ALC4/2015
AMINES LIMITED
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/01546/AM16/
RLA
File
:03/94/040/00059/AM16/
Lic.No/Date:0310799906
30.10.2015
Defer
Date:24.05.2016
Decision :Deferred.
317
Case
No.:44/19/82-
ALC4/2015
Party
Name:MSN
PHARMACHEM
PRIVATE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01525/AM16/
RLA
File
:09/24/040/00424/AM16/
Lic.No/Date:0910062805
30.10.2015
Defer
Date:24.05.2016
318
Case
No.:153/13/82-
ALC4/2015
Party
Name:BEST
VALUE CHEM PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01116/AM16/
RLA
File
:34/24/040/00199/AM16/
Lic.No/Date:3410041644
02.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
319
Case
No.:66/21/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01771/AM16/
RLA
File
:08/24/040/00257/AM16/
Lic.No/Date:0810136405
02.11.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/730/2015-PI(Norms) dated 28.3.2016, uploaded
320
Case
No.:67/21/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01772/AM16/
RLA
File
:08/24/040/00258/AM16/
Lic.No/Date:0810136406
02.11.2015
Defer Date:
Decision : The Committee decided to ratify norms based on earlier decision taken by NC in its
meeting No.11/82 dated 05.09.2013, uploaded at the end of these minutes or as applied by the
firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action
as per decision of NC.
321
Case
No.:66/19/82-
ALC4/2015
Party
Name:ELPPE
CHEMICALS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01547/AM16/
RLA
File
:03/94/040/00582/AM16/
Lic.No/Date:0310799943
02.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
322
Case
No.:54/19/82-
ALC4/2015
Party
Name:ENCUBE
ETHICALS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0310799952 Defer
53
:01/82/050/01535/AM16/ :03/94/040/00590/AM16/ 02.11.2015 Date:24.05.2016
323
Case
No.:67/19/82-
ALC4/2015
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01548/AM16/
RLA
File
:03/94/040/00553/AM16/
Lic.No/Date:0310799932
02.11.2015
Defer
Date:24.05.2016
324
Case
No.:70/19/82-
ALC4/2015
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01551/AM16/
RLA
File
:03/94/040/00481/AM16/
Lic.No/Date:0310799926
02.11.2015
Defer
Date:24.05.2016
325
Case
No.:154/13/82-
ALC4/2015
Party Name:DR REDDYS
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01117/AM16/
RLA
File
:09/24/040/00460/AM16/
Lic.No/Date:0910062821
03.11.2015
Defer
Date:24.05.2016
326
Case
No.:156/13/82-
ALC4/2015
Party Name:SUVEN LIFE
SCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01119/AM16/
RLA
File
:09/24/040/00464/AM16/
Lic.No/Date:0910062832
03.11.2015
Defer
Date:24.05.2016
327
Case
No.:38/21/82-
ALC4/2015
Party
Name:VINS
BIOPRODUCTS LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01743/AM16/
RLA
File
:09/24/040/00442/AM16/
Lic.No/Date:0910062831
03.11.2015
Defer
Date:24.05.2016
328
Case
No.:159/13/82-
ALC4/2015
Party
Name:CHEMCON
SPECIALITY
CHEMICALS P LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01122/AM16/
RLA
File
:34/24/040/00205/AM16/
Lic.No/Date:3410041650
04.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
329
Case
No.:53/19/82-
ALC4/2015
Party
Name:INDOCO
REMEDIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
54
HQ
File
:01/82/050/01534/AM16/
RLA
File
:03/94/040/00557/AM16/
Lic.No/Date:0310800023
04.11.2015
Defer
Date:24.05.2016
330
Case
No.:9/19/82-
ALC4/2015
Party
Name:PAB
ORGANICS PVT.LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01489/AM16/
RLA
File
:34/24/040/00204/AM16/
Lic.No/Date:3410041654
04.11.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/731/2015-PI(Norms) dated 13.04.2016 ,
331
Case
No.:57/19/82-
ALC4/2015
Party
Name:BAYER
CROPSCIENCE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01538/AM16/
RLA
File
:03/94/040/00443/AM16/
Lic.No/Date:0310800060
05.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
332
Case
No.:108/16/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01428/AM16/
RLA
File
:05/23/040/00330/AM16/
Lic.No/Date:0510396254
05.11.2015
Defer
Date:24.05.2016
333
Case
No.:163/13/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01126/AM16/
RLA
File
:09/24/040/00479/AM16/
Lic.No/Date:0910062838
06.11.2015
Defer
Date:24.05.2016
334
Case
No.:18/21/82-
ALC4/2015
Party
Name:BHAGIRADHA
CHEMICALS
&
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01723/AM16/
RLA
File
:09/24/040/00487/AM16/
Lic.No/Date:0910062841
06.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
335
Case
No.:55/19/82-
ALC4/2015
Party
Name:BDR
PHARMACEUTICALS
INTERNATIONAL
PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01536/AM16/
RLA
File
:03/94/040/00600/AM16/
Lic.No/Date:0310800148
09.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
55
336
Case
No.:23/21/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01728/AM16/
RLA
File
:09/24/040/00481/AM16/
Lic.No/Date:0910062849
10.11.2015
Defer
Date:24.05.2016
337
Case
No.:165/13/82-
ALC4/2015
Party
Name:ATUL
LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01128/AM16/
RLA
File
:52/24/040/00050/AM16/
Lic.No/Date:5210041688
12.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
338
Case
No.:71/19/82-
ALC4/2015
Party
Name:AVA
CHEMICALS PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01552/AM16/
RLA
File
:03/94/040/00613/AM16/
Lic.No/Date:0310800272
17.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
339
Case
No.:72/19/82-
ALC4/2015
Party
Name:AVA
CHEMICALS PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01553/AM16/
RLA
File
:03/94/040/00612/AM16/
Lic.No/Date:0310800271
17.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
340
Case
No.:74/19/82-
ALC4/2015
Party
Name:ENCUBE
ETHICALS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01555/AM16/
RLA
File
:03/94/040/00641/AM16/
Lic.No/Date:0310800285
17.11.2015
Defer
Date:24.05.2016
341
Case
No.:167/13/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01130/AM16/
RLA
File
:09/24/040/00493/AM16/
Lic.No/Date:0910062862
19.11.2015
Defer
Date:24.05.2016
342
Case
No.:58/19/82-
ALC4/2015
Party
Name:JINDAL
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01539/AM16/
RLA
File
:03/94/040/00572/AM16/
Lic.No/Date:0310800324
19.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
343 Case No.:77/19/82- Party Name:KOPRAN Meet
56
ALC4/2015
RESEARCH
LABORATORIES LTD.
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/01558/AM16/
RLA
File
:03/94/040/00653/AM16/
Lic.No/Date:0310800320
19.11.2015
Defer
Date:24.05.2016
344
Case
No.:75/19/82-
ALC4/2015
Party
Name:BENZO
CHEM
INDUSTRIES
PRIVATE LIMITED,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01556/AM16/
RLA
File
:03/94/040/00450/AM16/
Lic.No/Date:0310800347
20.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
345
Case
No.:60/19/82-
ALC4/2015
Party
Name:ELPPE
CHEMICALS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01541/AM16/
RLA
File
:03/94/040/00661/AM16/
Lic.No/Date:0310800340
20.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
346
Case
No.:11/19/82-
ALC4/2015
Party Name:SURNI LABS Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01491/AM16/
RLA
File
:34/24/040/00214/AM16/
Lic.No/Date:3410041688
20.11.2015
Defer
Date:24.05.2016
347
Case
No.:28/21/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01733/AM16/
RLA
File
:09/24/040/00507/AM16/
Lic.No/Date:0910062899
24.11.2015
Defer
Date:24.05.2016
348
Case
No.:20/19/82-
ALC4/2015
Party Name:VDH CHEM
TECH PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01500/AM16/
RLA
File
:05/24/040/00369/AM16/
Lic.No/Date:0510396413
24.11.2015
Defer
Date:24.05.2016
Decision :Deferred.
349
Case
No.:24/19/82-
ALC4/2015
Party
Name:EMCURE
PHARMACEUTICALS
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01504/AM16/
RLA
File
:31/83/040/00115/AM16/
Lic.No/Date:3110065769
26.11.2015
Defer
Date:24.05.2016
350 Case
No.:6/19/82-
ALC4/2015
Party
Name:MALLADI
DRUGS
&
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Deferred
57
PHARMACEUTICALS
LIMITED
26.04.2016
HQ
File
:01/82/050/01486/AM16/
RLA
File
:04/24/040/00193/AM16/
Lic.No/Date:0410161352
27.11.2015
Defer
Date:24.05.2016
351
Case
No.:59/19/82-
ALC4/2015
Party
Name:EXCEL
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01540/AM16/
RLA
File
:03/94/040/00251/AM16/
Lic.No/Date:0310800536
01.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
352
Case
No.:62/19/82-
ALC4/2015
Party
Name:EXCEL
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01543/AM16/
RLA
File
:03/94/040/00252/AM16/
Lic.No/Date:0310800539
01.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
353
Case
No.:61/19/82-
ALC4/2015
Party
Name:K
V
AROCHEM PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01542/AM16/
RLA
File
:03/94/040/00440/AM16/
Lic.No/Date:0310800529
01.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
354
Case
No.:81/19/82-
ALC4/2015
Party
Name:J.B.
CHEMICALS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01562/AM16/
RLA
File
:03/94/040/00660/AM16/
Lic.No/Date:0310800594
02.12.2015
Defer
Date:24.05.2016
355
Case
No.:19/19/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01499/AM16/
RLA
File
:05/23/040/00370/AM16/
Lic.No/Date:0510396479
02.12.2015
Defer
Date:24.05.2016
356
Case
No.:27/19/82-
ALC4/2015
Party
Name:S.M.
HERBALS PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01507/AM16/
RLA
File
:05/24/040/00373/AM16/
Lic.No/Date:0510396496
02.12.2015
Defer
Date:24.05.2016
357 Case No.:79/19/82- Party Name:ALKYL Meet
58
ALC4/2015
AMINES CHEMICALS LTD ALC4/2016
26.04.2016
Approved
HQ
File
:01/82/050/01560/AM16/
RLA
File
:03/94/040/00632/AM16/
Lic.No/Date:0310800627
03.12.2015
Defer Date:
Pharmaceuticals forwarded vide O.M. No. 14010/85/2012-CH-II dated 08.12.2015, uploaded at
the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP
358
Case
No.:16/19/82-
ALC4/2015
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01496/AM16/
RLA
File
:05/23/040/00362/AM16/
Lic.No/Date:0510396503
03.12.2015
Defer
Date:24.05.2016
359
Case
No.:17/19/82-
ALC4/2015
Party
Name:JUBILANT
LIFE
SCIENCES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01497/AM16/
RLA
File
:05/23/040/00002/AM16/
Lic.No/Date:0510396500
03.12.2015
Defer
Date:24.05.2016
360
Case
No.:38/19/82-
ALC4/2015
Party
Name:AMI
ORGANICS PVT LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01519/AM16/
RLA
File
:52/24/040/00062/AM16/
Lic.No/Date:5210041707
04.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
361
Case
No.:63/19/82-
ALC4/2015
Party
Name:ENCUBE
ETHICALS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01544/AM16/
RLA
File
:03/94/040/00673/AM16/
Lic.No/Date:0310800674
04.12.2015
Defer
Date:24.05.2016
362
Case
No.:14/19/82-
ALC4/2015
Party Name:MEDICAMEN
ORGANICS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01494/AM16/
RLA
File
:05/24/040/00428/AM16/
Lic.No/Date:0510396544
07.12.2015
Defer Date:
Decision :The Committee decided to ratify norms based on the recommendation of D/o
Pharmaceuticals
forwarded
vide
O.M.No.35011/771/2015-PI(Norms)
dated
11.04.2016,
363
Case
No.:22/21/82-
ALC4/2015
Party Name:NIFTY LABS
PVT LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0910062938 Defer
59
:01/82/050/01727/AM16/ :09/24/040/00519/AM16/ 07.12.2015 Date:24.05.2016
364
Case
No.:90/19/82-
ALC4/2015
Party
Name:VENUS
REMEDIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01571/AM16/
RLA
File
:22/24/040/00082/AM16/
Lic.No/Date:2210015359
07.12.2015
Defer
Date:24.05.2016
365
Case
No.:1/15/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01312/AM16/
RLA
File
:09/24/040/00529/AM16/
Lic.No/Date:0910062940
08.12.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/823/2015-PI(Norms) dated April 2016, uploaded
366
Case
No.:46/21/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01751/AM16/
RLA
File
:09/24/040/00537/AM16/
Lic.No/Date:0910062946
08.12.2015
Defer
Date:24.05.2016
Decision :Deferred
367
Case
No.:27/21/82-
ALC4/2015
Party
Name:OPTIMUS
DRUGS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01732/AM16/
RLA
File
:09/24/040/00482/AM16/
Lic.No/Date:0910062947
08.12.2015
Defer
Date:24.05.2016
368
Case
No.:43/21/82-
ALC4/2015
Party Name:SUVEN LIFE
SCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01748/AM16/
RLA
File
:09/24/040/00518/AM16/
Lic.No/Date:0910062943
08.12.2015
Defer
Date:24.05.2016
369
Case
No.:89/19/82-
ALC4/2015
Party
Name:DSM
SINOCHEM
PHARMACEUTICALS
INDIA PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01570/AM16/
RLA
File
:22/24/040/00085/AM16/
Lic.No/Date:2210015363
09.12.2015
Defer Date:
24.05.2016
Decision : Deferred
370 Case No.:5/15/82- Party Meet
60
ALC4/2015
Name:GULBRANDSEN
CHEMICALS PVT LTD
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/01316/AM16/
RLA
File
:34/24/040/00215/AM16/
Lic.No/Date:3410041722
10.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
371
Case
No.:3/15/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01314/AM16/
RLA
File
:09/24/040/00553/AM16/
Lic.No/Date:0910062954
10.12.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/823/2015-PI(Norms) dated April 2016, uploaded
372
Case
No.:4/15/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01315/AM16/
RLA
File
:09/24/040/00545/AM16/
Lic.No/Date:0910062955
10.12.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/823/2015-PI(Norms) dated April 2016, uploaded
373
Case
No.:40/19/82-
ALC4/2015
Party
Name:JUBILANT
LIFE
SCIENCES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01521/AM16/
RLA
File
:05/23/040/00240/AM16/
Lic.No/Date:0510396587
10.12.2015
Defer
Date:24.05.2016
374
Case
No.:87/19/82-
ALC4/2015
Party
Name:SAURAV
CHEMICALS LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01568/AM16/
RLA
File
:22/24/040/00087/AM16/
Lic.No/Date:2210015368
10.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
375
Case
No.:88/19/82-
ALC4/2015
Party
Name:THEON
PHARMACEUTICALS
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01569/AM16/
RLA
File
:22/24/040/00081/AM16/
Lic.No/Date:2210015365
10.12.2015
Defer
Date:24.05.2016
376
Case
No.:94/19/82-
ALC4/2015
Party
Name:THEON
PHARMACEUTICALS
LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:2210015366 Defer
61
:01/82/050/01575/AM16/ :22/24/040/00080/AM16/ 10.12.2015 Date:24.05.2016
377
Case
No.:42/21/82-
ALC4/2015
Party
Name:NATCO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01747/AM16/
RLA
File
:09/24/040/00520/AM16/
Lic.No/Date:0910062967
11.12.2015
Defer
Date:24.05.2016
378
Case
No.:50/21/82-
ALC4/2015
Party
Name:PORUS
LABORATORIES
PVT
LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01755/AM16/
RLA
File
:09/24/040/00490/AM16/
Lic.No/Date:0910062966
11.12.2015
Defer
Date:24.05.2016
Decision : The committee noted that both import and export products are one and the same
chemical compounds and the firm has not given COA of imported item from foreign supplier and
the export product to show that some manufacturing activity is involved. The Committee
according decided to call for COA f of imported items from foreign supplier and deferred the
case.
379
Case
No.:43/19/82-
ALC4/2015
Party Name:U SQUARE
LIFESCIENCE PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01524/AM16/
RLA
File
:08/24/040/00306/AM16/
Lic.No/Date:0810136712
11.12.2015
Defer
Date:24.05.2016
380
Case
No.:56/21/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01761/AM16/
RLA
File
:09/24/040/00523/AM16/
Lic.No/Date:0910062965
11.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
381
Case
No.:30/19/82-
ALC4/2015
Party
Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01510/AM16/
RLA
File
:05/24/040/00401/AM16/
Lic.No/Date:0510396611
14.12.2015
Defer
Date:24.05.2016
382
Case
No.:31/19/82-
ALC4/2015
Party
Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01511/AM16/
RLA
File
:05/24/040/00375/AM16/
Lic.No/Date:0510396609
14.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
383 Case No.:32/19/82- Party Name:PAYAL Meet
62
ALC4/2015
PETROCHEM PRIVATE
LIMITED
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/01513/AM16/
RLA
File
:05/24/040/00381/AM16/
Lic.No/Date:0510396610
14.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
384
Case
No.:10/19/82-
ALC4/2015
Party
Name:TATVA
CHINTAN
PHARMA
CHEM PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01490/AM16/
RLA
File
:34/24/040/00223/AM16/
Lic.No/Date:3410041732
14.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
385
Case
No.:18/19/82-
ALC4/2015
Party
Name:AMI
ORGANICS PVT LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01498/AM16/
RLA
File
:52/24/040/00064/AM16/
Lic.No/Date:5210041711
15.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
386
Case
No.:48/21/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01753/AM16/
RLA
File
:09/24/040/00508/AM16/
Lic.No/Date:0910062971
15.12.2015
Defer
Date:24.05.2016
387
Case
No.:39/19/82-
ALC4/2015
Party
Name:JUBILANT
LIFE
SCIENCES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01520/AM16/
RLA
File
:05/23/040/00360/AM16/
Lic.No/Date:0510396634
16.12.2015
Defer
Date:24.05.2016
388
Case
No.:41/19/82-
ALC4/2015
Party
Name:JUBILANT
LIFE
SCIENCES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01522/AM16/
RLA
File
:05/23/040/00001/AM16/
Lic.No/Date:0510396632
16.12.2015
Defer
Date:24.05.2016
389
Case
No.:42/19/82-
ALC4/2015
Party
Name:JUBILANT
LIFE
SCIENCES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01523/AM16/
RLA
File
:05/23/040/00192/AM16/
Lic.No/Date:0510396633
16.12.2015
Defer
Date:24.05.2016
390 Case
No.:29/19/82-
ALC4/2015
Party
Name:SUN
PHARMACEUTICAL
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Approved
63
INDUSTRIES LTD.,
26.04.2016
HQ
File
:01/82/050/01509/AM16/
RLA
File
:05/24/040/00360/AM16/
Lic.No/Date:0510396645
16.12.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/734/2015-PI(Norms) dated April 2016, uploaded
391
Case
No.:6/15/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01317/AM16/
RLA
File
:09/24/040/00540/AM16/
Lic.No/Date:0910062982
17.12.2015
Defer
Date:24.05.2016
392
Case
No.:7/15/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01318/AM16/
RLA
File
:09/24/040/00531/AM16/
Lic.No/Date:0910062983
17.12.2015
Defer
Date:24.05.2016
393
Case
No.:8/15/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01319/AM16/
RLA
File
:09/24/040/00536/AM16/
Lic.No/Date:0910062985
17.12.2015
Defer
Date:24.05.2016
394
Case
No.:9/15/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01320/AM16/
RLA
File
:09/24/040/00530/AM16/
Lic.No/Date:0910062986
17.12.2015
Defer
Date:24.05.2016
395
Case
No.:45/21/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01750/AM16/
RLA
File
:09/24/040/00392/AM16/
Lic.No/Date:0910062991
17.12.2015
Defer
Date:24.05.2016
396
Case
No.:91/19/82-
ALC4/2015
Party
Name:IND-SWIFT
LABORATORIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01572/AM16/
RLA
File
:22/24/040/00093/AM16/
Lic.No/Date:2210015386
18.12.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/735/2015-PI(Norms) dated 29.3.2016, uploaded
64
397
Case
No.:36/19/82-
ALC4/2015
Party
Name:PANACEA
BIOTEC LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01517/AM16/
RLA
File
:05/24/040/00439/AM16/
Lic.No/Date:0510396670
18.12.2015
Defer
Date:24.05.2016
Decision :The Committee based on the recommendation of DBT forwarded vide letter
No.BT/IL/05/316/2010 dated 29.02.2016 uploaded at the end of these minutes, decided to call for
information from the firm and deferred the case.
398
Case
No.:35/19/82-
ALC4/2015
Party
Name:HELLO
PAINTS (P) LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01516/AM16/
RLA
File
:05/23/040/00396/AM16/
Lic.No/Date:0510396751
21.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
399
Case
No.:37/19/82-
ALC4/2015
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01518/AM16/
RLA
File
:05/23/040/00388/AM16/
Lic.No/Date:0510396753
21.12.2015
Defer
Date:24.05.2016
400
Case
No.:41/21/82-
ALC4/2015
Party
Name:RA
CHEM
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01746/AM16/
RLA
File
:09/24/040/00527/AM16/
Lic.No/Date:0910063006
21.12.2015
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/682/2015-PI(Norms) dated 22.3.2016, uploaded
401
Case
No.:33/19/82-
ALC4/2015
Party
Name:V.D.H.
ORGANICS PVT. LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01514/AM16/
RLA
File
:05/24/040/00448/AM16/
Lic.No/Date:0510396777
21.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
402
Case
No.:54/21/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01759/AM16/
RLA
File
:09/24/040/00525/AM16/
Lic.No/Date:0910063015
21.12.2015
Defer
Date:24.05.2016
65
403
Case
No.:61/21/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01766/AM16/
RLA
File
:09/24/040/00547/AM16/
Lic.No/Date:0910063018
21.12.2015
Defer
Date:24.05.2016
404
Case
No.:93/19/82-
ALC4/2015
Party Name:CURETECH
SKINCARE
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01574/AM16/
RLA
File
:22/24/040/00051/AM16/
Lic.No/Date:2210015392
23.12.2015
Defer
Date:24.05.2016
405
Case
No.:132/16/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01452/AM16/
RLA
File
:09/24/040/00563/AM16/
Lic.No/Date:0910063042
28.12.2015
Defer
Date:24.05.2016
406
Case
No.:55/21/82-
ALC4/2015
Party
Name:PORUS
LABORATORIES
PVT
LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01760/AM16/
RLA
File
:09/24/040/00573/AM16/
Lic.No/Date:0910063035
28.12.2015
Defer
Date:24.05.2016
407
Case
No.:21/19/82-
ALC4/2015
Party
Name:HPL
ADDITIVES
LIMITED(FORMERLY
KNOWN
HIGH
POLYMER
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01501/AM16/
RLA
File
:05/23/040/00391/AM16/
Lic.No/Date:0510397095
29.12.2015
Defer
Date:24.05.2016
Decision :Deferred.
408
Case
No.:86/19/82-
ALC4/2015
Party
Name:RUBY
FRAGRANCE
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01567/AM16/
RLA
File
:35/24/040/00048/AM16/
Lic.No/Date:3510044853
29.12.2015
Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decided taken by NC in
its meeting No.06/AM14 dated 13.06.2013, uploaded at the end of these minutes or as applied
by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
action as per decision of NC.
409
Case
No.:34/21/82-
ALC4/2015
Party
Name:DEEPAK
NOVOCHEM
TECHNOLOGIES LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:3110065816 Defer
66
:01/82/050/01739/AM16/ :31/83/040/00128/AM16/ 30.12.2015 Date:24.05.2016 Decision :Deferred.
410
Case
No.:32/21/82-
ALC4/2015
Party
Name:EMCURE
PHARMACEUTICALS
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01737/AM16/
RLA
File
:31/83/040/00135/AM16/
Lic.No/Date:3110065815
30.12.2015
Defer
Date:24.05.2016
411
Case
No.:22/19/82-
ALC4/2015
Party Name:FRESENIUS
KABI
ONCOLOGY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01502/AM16/
RLA
File
:05/23/040/00244/AM16/
Lic.No/Date:0510397137
30.12.2015
Defer
Date:24.05.2016
412
Case
No.:23/19/82-
ALC4/2015
Party Name:FRESENIUS
KABI
ONCOLOGY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01503/AM16/
RLA
File
:05/23/040/00260/AM16/
Lic.No/Date:0510397138
30.12.2015
Defer
Date:24.05.2016
413
Case
No.:13/19/82-
ALC4/2015
Party
Name:MALLADI
DRUGS
&
PHARMACEUTICALS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01493/AM16/
RLA
File
:04/24/040/00213/AM16/
Lic.No/Date:0410161479
30.12.2015
Defer
Date:24.05.2016
414
Case
No.:40/21/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01745/AM16/
RLA
File
:09/24/040/00559/AM16/
Lic.No/Date:0910063056
30.12.2015
Defer
Date:24.05.2016
415
Case
No.:49/21/82-
ALC4/2015
Party
Name:MYLAN
LABORATORIES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01754/AM16/
RLA
File
:09/24/040/00560/AM16/
Lic.No/Date:0910063055
30.12.2015
Defer
Date:24.05.2016
416
Case
No.:47/21/82-
ALC4/2015
Party
Name:BHAGIRADHA
CHEMICALS
&
INDUSTRIES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
67
HQ
File
:01/82/050/01752/AM16/
RLA
File
:09/24/040/00570/AM16/
Lic.No/Date:0910063087
01.01.2016
Defer
Date:24.05.2016
Decision :Deferred.
417
Case
No.:35/21/82-
ALC4/2015
Party
Name:DEEPAK
NOVOCHEM
TECHNOLOGIES LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01740/AM16/
RLA
File
:31/83/040/00094/AM16/
Lic.No/Date:3110065843
01.01.2016
Defer
Date:24.05.2016
418
Case
No.:33/21/82-
ALC4/2015
Party
Name:BALAJI
AMINES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01738/AM16/
RLA
File
:31/83/040/00117/AM16/
Lic.No/Date:3110065848
05.01.2016
Defer
Date:24.05.2016
Decision :Deferred.
419
Case
No.:137/16/82-
ALC4/2015
Party
Name:DEEPAK
NITRITE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01457/AM16/
RLA
File
:34/24/040/00245/AM16/
Lic.No/Date:3410041783
05.01.2016
Defer
Date:24.05.2016
Decision :Deferred.
420
Case
No.:68/21/82-
ALC4/2015
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01773/AM16/
RLA
File
:08/24/040/00350/AM16/
Lic.No/Date:0810136965
06.01.2016
Defer Date
24.05.2016
421
Case
No.:2/17/82-
ALC4/2015
Party Name:ARENE LIFE
SCIENCES LIMITED.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01462/AM16/
RLA
File
:09/24/040/00571/AM16/
Lic.No/Date:0910063114
08.01.2016
Defer
Date:24.05.2016
422
Case
No.:1/17/82-
ALC4/2015
Party Name:COVALENT
LABORATORIES
PRIVATE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01461/AM16/
RLA
File
:09/24/040/00565/AM16/
Lic.No/Date:0910063113
08.01.2016
Defer
Date:24.05.2016
423
Case
No.:44/21/82-
ALC4/2015
Party Name:SUVEN LIFE
SCIENCES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File RLA
File Lic.No/Date:0910063107 Defer
68
:01/82/050/01749/AM16/ :09/24/040/00588/AM16/ 08.01.2016 Date:24.05.2016
424
Case
No.:4/17/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01464/AM16/
RLA
File
:09/24/040/00598/AM16/
Lic.No/Date:0910063124
11.01.2016
Defer
Date:24.05.2016
425
Case
No.:5/17/82-
ALC4/2015
Party
Name:DYNAMIC
SPECIALITY
CHEMICALS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01465/AM16/
RLA
File
:30/24/040/00035/AM16/
Lic.No/Date:3010103695
11.01.2016
Defer
Date:24.05.2016
Decision :Deferred.
426
Case
No.:3/17/82-
ALC4/2015
Party
Name:INCHEM
LABORATORIES PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01463/AM16/
RLA
File
:09/24/040/00590/AM16/
Lic.No/Date:0910063122
11.01.2016
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/608/2015-PI(Norms) dated December 2015,
427
Case
No.:52/21/82-
ALC4/2015
Party Name:METROCHEM
API PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01757/AM16/
RLA
File
:09/24/040/00612/AM16/
Lic.No/Date:0910063118
11.01.2016
Defer Date:
24.05.2016
428
Case
No.:58/21/82-
ALC4/2015
Party Name:METROCHEM
API PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01763/AM16/
RLA
File
:09/24/040/00613/AM16/
Lic.No/Date:0910063119
11.01.2016
Defer Date:
24.05.2016
429
Case
No.:33/2/82-
ALC4/2016
Party
Name:UPL
LTD.(FORMERLY
UNITED PHOSPHORUS
LTD.)
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00033/AM17/
RLA
File
:03/95/040/00737/AM16/
Lic.No/Date:0310801688
11.01.2016
Defer
Date:24.05.2016
Decision :Deferred.
430 Case No.:6/21/82- Party Name:COVALENT Meet
69
ALC4/2015
LABORATORIES
PRIVATE LIMITED
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/01711/AM16/
RLA
File
:09/24/040/00602/AM16/
Lic.No/Date:0910063139
13.01.2016
Defer
Date:24.05.2016
431
Case
No.:60/21/82-
ALC4/2015
Party
Name:SALICYLATES
&
CHEMICALS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01765/AM16/
RLA
File
:09/24/040/00581/AM16/
Lic.No/Date:0910063135
13.01.2016
Defer
Date:24.05.2016
Decision :Deferred.
432
Case
No.:37/2/82-
ALC4/2016
Party Name:ALKALOIDS
CORPORATION
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00037/AM17/
RLA
File
:02/24/040/00181/AM16/
Lic.No/Date:0210206452
19.01.2016
Defer
Date:24.05.2016
433
Case
No.:36/21/82-
ALC4/2015
Party
Name:AMOL
PHARMACEUTICALS
PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01741/AM16/
RLA
File
:13/24/040/00038/AM16/
Lic.No/Date:1310048100
20.01.2016
Defer
Date:24.05.2016
434
Case
No.:4/21/82-
ALC4/2015
Party
Name:SHREE
BANKEY BEHARI LAL
AROMATICS
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01709/AM16/
RLA
File
:05/24/040/00521/AM16/
Lic.No/Date:0510397403
22.01.2016
Defer
Date:24.05.2016
435
Case
No.:31/21/82-
ALC4/2015
Party
Name:BALAJI
AMINES LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01736/AM16/
RLA
File
:31/83/040/00148/AM16/
Lic.No/Date:3110065887
25.01.2016
Defer
Date:24.05.2016
436
Case
No.:24/21/82-
ALC4/2015
Party
Name:BEST
VALUE CHEM PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01729/AM16/
RLA
File
:34/24/040/00267/AM16/
Lic.No/Date:3410041832
28.01.2016
Defer
Date:24.05.2016
437 Case No.:21/21/82- Party Name:CLEAN Meet
70
ALC4/2015
SCIENCE
AND
TECHNOLOGY PVT.LTD.
ALC4/2016
26.04.2016
Approved
HQ
File
:01/82/050/01726/AM16/
RLA
File
:31/83/040/00149/AM16/
Lic.No/Date:3110065900
01.02.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC
forwarded vide U.O.No.14010/3/2012-Ch-II (Vol-1)dated 13.1.2016, uploaded at the end of these
minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned
may take necessary action as per decision of NC.
438
Case
No.:37/21/82-
ALC4/2015
Party
Name:CLEAN
SCIENCE
AND
TECHNOLOGY PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01742/AM16/
RLA
File
:31/83/040/00147/AM16/
Lic.No/Date:3110065899
01.02.2016
Defer Date:
Decision : The Committee decided to ratify norms as per the details given below or as applied
by the firm whichever is less under para 4.07 of HBP Vol.1.
Export product Qty Import item Qty Anisole (Purity 99.50% Min.) 1kg Anisole (Purity 93% Maximum.) 1.065kg
RA concerned may take necessary action as per decision of NC.
439
Case
No.:8/21/82-
ALC4/2015
Party
Name:JUBILANT
GENERICS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01713/AM16/
RLA
File
:05/23/040/00438/AM16/
Lic.No/Date:0510397455
01.02.2016
Defer
Date:24.05.2016
440
Case
No.:39/21/82-
ALC4/2015
Party
Name:VISCUS
OILS PVT. LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01744/AM16/
RLA
File
:56/24/040/00042/AM16/
Lic.No/Date:5610004823
01.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
441
Case
No.:19/21/82-
ALC4/2015
Party
Name:EMCURE
PHARMACEUTICALS
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01724/AM16/
RLA
File
:31/83/040/00153/AM16/
Lic.No/Date:3110065906
03.02.2016
Defer
Date:24.05.2016
442
Case
No.:13/21/82-
ALC4/2015
Party
Name:JUBILANT
LIFE
SCIENCES
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01718/AM16/
RLA
File
:05/23/040/00439/AM16/
Lic.No/Date:0510397481
03.02.2016
Defer
Date:24.05.2016
71
443
Case
No.:1/19/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01481/AM16/
RLA
File
:09/24/040/00634/AM16/
Lic.No/Date:0910063213
04.02.2016
Defer
Date:24.05.2016
444
Case
No.:12/21/82-
ALC4/2015
Party
Name:SENTISS
PHARMA PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01717/AM16/
RLA
File
:05/24/040/00543/AM16/
Lic.No/Date:0510397506
04.02.2016
Defer
Date:24.05.2016
445
Case
No.:4/19/82-
ALC4/2015
Party Name:ALPHAMED
FORMULATIONS P LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01484/AM16/
RLA
File
:09/24/040/00628/AM16/
Lic.No/Date:0910063226
05.02.2016
Defer
Date:24.05.2016
446
Case
No.:25/21/82-
ALC4/2015
Party
Name:RONAK
CHEMICALS
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01730/AM16/
RLA
File
:34/24/040/00274/AM16/
Lic.No/Date:3410041858
05.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
447
Case
No.:26/21/82-
ALC4/2015
Party
Name:RONAK
CHEMICALS
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01731/AM16/
RLA
File
:34/24/040/00273/AM16/
Lic.No/Date:3410041857
05.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
448
Case
No.:14/21/82-
ALC4/2015
Party
Name:DHAMPUR
SUGAR MILLS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01719/AM16/
RLA
File
:05/23/040/00456/AM16/
Lic.No/Date:0510397521
08.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
449
Case
No.:5/19/82-
ALC4/2015
Party
Name:GOPINATH
CHEM-TECH LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01485/AM16/
RLA
File
:08/24/040/00291/AM16/
Lic.No/Date:0810137155
08.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
450 Case No.:11/21/82- Party Name:SUN Meet
72
ALC4/2015
PHARMACEUTICAL
INDUSTRIES LTD.,
ALC4/2016
26.04.2016
Deferred
HQ
File
:01/82/050/01716/AM16/
RLA
File
:05/24/040/00534/AM16/
Lic.No/Date:0510397525
08.02.2016
Defer
Date:24.05.2016
451
Case
No.:85/19/82-
ALC4/2015
Party
Name:ANUPAM
RASAYAN (INDIA) LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01566/AM16/
RLA
File
:52/24/040/00076/AM16/
Lic.No/Date:5210041759
09.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
452
Case
No.:84/19/82-
ALC4/2015
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01565/AM16/
RLA
File
:09/24/040/00654/AM16/
Lic.No/Date:0910063231
09.02.2016
Defer
Date:24.05.2016
453
Case
No.:95/19/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01576/AM16/
RLA
File
:09/24/040/00639/AM16/
Lic.No/Date:0910063233
10.02.2016
Defer
Date:24.05.2016
454
Case
No.:96/19/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01577/AM16/
RLA
File
:09/24/040/00638/AM16/
Lic.No/Date:0910063234
10.02.2016
Defer
Date:24.05.2016
455
Case
No.:20/21/82-
ALC4/2015
Party
Name:EMCURE
PHARMACEUTICALS
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01725/AM16/
RLA
File
:31/83/040/00155/AM16/
Lic.No/Date:3110065933
10.02.2016
Defer
Date:24.05.2016
456
Case
No.:8/2/82-
ALC4/2016
Party
Name:GULBRANDSEN
CHEMICALS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00008/AM17/
RLA
File
:34/24/040/00284/AM16/
Lic.No/Date:3410041870
10.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
457 Case
No.:30/21/82-
ALC4/2015
Party
Name:JODAS
EXPOIM PVT.LTD.,
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Deferred
73
26.04.2016
HQ
File
:01/82/050/01735/AM16/
RLA
File
:05/23/040/00467/AM16/
Lic.No/Date:0510397580
10.02.2016
Defer
Date:24.05.2016
458
Case
No.:97/19/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01578/AM16/
RLA
File
:09/24/040/00652/AM16/
Lic.No/Date:0910063248
11.02.2016
Defer
Date:24.05.2016
459
Case
No.:36/2/82-
ALC4/2016
Party
Name:STERLING
AUXILIARIES PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00036/AM17/
RLA
File
:03/95/040/00870/AM16/
Lic.No/Date:0310802475
11.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
460
Case
No.:2/2/82-
ALC4/2016
Party
Name:AMI
LIFESCIENCES P LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00002/AM17/
RLA
File
:34/24/040/00287/AM16/
Lic.No/Date:3410041875
12.02.2016
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/544/2015-PI(Norms0 dated December 2015,
461
Case
No.:13/2/82-
ALC4/2016
Party
Name:AMI
LIFESCIENCES P LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00013/AM17/
RLA
File
:34/24/040/00289/AM16/
Lic.No/Date:3410041874
12.02.2016
Defer
Date:24.05.2016
462
Case
No.:101/19/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01582/AM16/
RLA
File
:09/24/040/00668/AM16/
Lic.No/Date:0910063275
16.02.2016
Defer
Date:24.05.2016
463
Case
No.:5/2/82-
ALC4/2016
Party
Name:MAMTA
POLYCOATS
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00005/AM17/
RLA
File
:34/24/040/00293/AM16/
Lic.No/Date:3410041887
16.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
74
464
Case
No.:10/2/82-
ALC4/2016
Party
Name:ENVEE
DRUGS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00010/AM17/
RLA
File
:34/24/040/00297/AM16/
Lic.No/Date:3410041896
17.02.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/686/2015-PI(Norms) dated 23.2.2016 ,
465
Case
No.:55/2/82-
ALC4/2016
Party Name:MAHARSHI
PHARMA
CHEM
PVT.LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00055/AM17/
RLA
File
:08/24/040/00392/AM16/
Lic.No/Date:0810137224
17.02.2016
Defer
Date:24.05.2016
466
Case
No.:35/2/82-
ALC4/2016
Party
Name:STERLING
AUXILIARIES PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00035/AM17/
RLA
File
:03/95/040/00868/AM16/
Lic.No/Date:0310802660
17.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
467
Case
No.:102/19/82-
ALC4/2015
Party
Name:VIVIMED
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01583/AM16/
RLA
File
:09/24/040/00666/AM16/
Lic.No/Date:0910063280
17.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
468
Case
No.:52/2/82-
ALC4/2016
Party
Name:HPL
ADDITIVES
LIMITED(FORMERLY
KNOWN
HIGH
POLYMER
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00052/AM17/
RLA
File
:05/23/040/00426/AM16/
Lic.No/Date:0510397651
18.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
469
Case
No.:54/2/82-
ALC4/2016
Party
Name:INDO
PHYTO
CHEMICALS
PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00054/AM17/
RLA
File
:05/23/040/00487/AM16/
Lic.No/Date:0510397639
18.02.2016
Defer
Date:24.05.2016
470
Case
No.:1/2/82-
ALC4/2016
Party
Name:ALEMBIC
PHARMACEUTICALS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
75
HQ
File
:01/82/050/00001/AM17/
RLA
File
:34/24/040/00283/AM16/
Lic.No/Date:3410041911
19.02.2016
Defer Date:
Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in
its meeting No.09/82 dated 20.10.2014, uploaded at the end of these minutes or as applied by
the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary
action as per decision of NC.
471
Case
No.:34/2/82-
ALC4/2016
Party
Name:STERLING
AUXILIARIES PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00034/AM17/
RLA
File
:03/95/040/00888/AM16/
Lic.No/Date:0310802715
19.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
472
Case
No.:9/2/82-
ALC4/2016
Party
Name:DEEPAK
NITRITE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00009/AM17/
RLA
File
:34/24/040/00161/AM16/
Lic.No/Date:3410041915
22.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
473
Case
No.:28/2/82-
ALC4/2016
Party Name:MAC CHEM
PRODUCTS
(INDIA)
PRIVATE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00028/AM17/
RLA
File
:03/95/040/00858/AM16/
Lic.No/Date:0310802836
24.02.2016
Defer Date:
474
Case
No.:27/2/82-
ALC4/2016
Party
Name:PRIVI
ORGANICS LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00027/AM17/
RLA
File
:03/95/040/00874/AM16/
Lic.No/Date:0310802827
24.02.2016
Defer
Date:24.05.2016
Decision :Deferred.
475
Case
No.:22/2/82-
ALC4/2016
Party
Name:SANJIVANI
PARANTERAL LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00022/AM17/
RLA
File
:03/95/040/00897/AM16/
Lic.No/Date:0310802826
24.02.2016
Defer
Date:24.05.2016
476
Case
No.:11/2/82-
ALC4/2016
Party
Name:ENVEE
DRUGS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00011/AM17/
RLA
File
:34/24/040/00309/AM16/
Lic.No/Date:3410041919
25.02.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/686/2015-PI(Norms) dated 23.2.2016 ,
76
477
Case
No.:12/2/82-
ALC4/2016
Party
Name:ENVEE
DRUGS PVT LTD
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00012/AM17/
RLA
File
:34/24/040/00310/AM16/
Lic.No/Date:3410041920
25.02.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/686/2015-PI(Norms) dated 23.2.2016 ,
478
Case
No.:53/2/82-
ALC4/2016
Party
Name:CADILA
PHARMACEUTICALS
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00053/AM17/
RLA
File
:08/24/040/00409/AM16/
Lic.No/Date:0810137314
26.02.2016
Defer
Date:24.05.2016
479
Case
No.:4/2/82-
ALC4/2016
Party
Name:RIDDHI
PHARMA
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00004/AM17/
RLA
File
:34/24/040/00301/AM16/
Lic.No/Date:3410041924
26.02.2016
Defer
Date:24.05.2016
480
Case
No.:41/2/82-
ALC4/2016
Party
Name:VADIVARHE
SPECIALITY CHEMICALS
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00041/AM17/
RLA
File
:03/95/040/00926/AM16/
Lic.No/Date:0310802905
29.02.2016
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/717/2015-PI(Norms) dated 29.3.2016, uploaded
481
Case
No.:43/2/82-
ALC4/2016
Party
Name:YASHO
INDUSTRIES PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00043/AM17/
RLA
File
:03/95/040/00948/AM16/
Lic.No/Date:0310802906
29.02.2016
Defer
Date:24.05.2016
482
Case
No.:6/2/82-
ALC4/2016
Party
Name:BEST
VALUE CHEM PVT. LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00006/AM17/
RLA
File
:34/24/040/00308/AM16/
Lic.No/Date:3410041932
01.03.2016
Defer
Date:24.05.2016
Decision :Deferred.
77
483
Case
No.:42/2/82-
ALC4/2016
Party
Name:NEW
ALLIANCE
DYE-CHEM
PVT. LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00042/AM17/
RLA
File
:03/95/040/00939/AM16/
Lic.No/Date:0310802934
01.03.2016
Defer
Date:24.05.2016
484
Case
No.:14/2/82-
ALC4/2016
Party
Name:SHIVA
PHARMACHEM LTD,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00014/AM17/
RLA
File
:34/24/040/00221/AM16/
Lic.No/Date:3410041935
01.03.2016
Defer
Date:24.05.2016
Decision :Deferred.
485
Case
No.:38/2/82-
ALC4/2016
Party
Name:WANBURY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00038/AM17/
RLA
File
:03/95/040/00920/AM16/
Lic.No/Date:0310802986
02.03.2016
Defer Date:
24.05.2016
486
Case
No.:1/21/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01706/AM16/
RLA
File
:09/24/040/00702/AM16/
Lic.No/Date:0910063354
03.03.2016
Defer
Date:24.05.2016
487
Case
No.:50/2/82-
ALC4/2016
Party
Name:PANERA
BIOTEC PVT.LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00050/AM17/
RLA
File
:05/24/040/00597/AM16/
Lic.No/Date:0510397827
04.03.2016
Defer
Date:24.05.2016
Decision : The Committee decided to defer the case for want of comments of DBT
488
Case
No.:44/2/82-
ALC4/2016
Party
Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00044/AM17/
RLA
File
:05/24/040/00592/AM16/
Lic.No/Date:0510397826
04.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M.No.35011/734/2015-PI(Norms) dated April 2016, uploaded
at the end of these decided to call for information from the firm and deferred the case.
489
Case
No.:16/2/82-
ALC4/2016
Party
Name:WANBURY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00016/AM17/
RLA
File
:03/95/040/00918/AM16/
Lic.No/Date:0310803063
04.03.2016
Defer Date:
78
Pharmaceuticals forwarded vide O.M. No.35011/524/2015-PI(Norms) dated March 2015 ,
490
Case
No.:17/2/82-
ALC4/2016
Party
Name:WANBURY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00017/AM17/
RLA
File
:03/95/040/00916/AM16/
Lic.No/Date:0310803065
04.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/805/2013-PI(Norms) dated June 2015 ,
491
Case
No.:18/2/82-
ALC4/2016
Party
Name:WANBURY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00018/AM17/
RLA
File
:03/95/040/00913/AM16/
Lic.No/Date:0310803067
04.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/805/2013-PI(Norms) dated June 2015 ,
492
Case
No.:19/2/82-
ALC4/2016
Party
Name:WANBURY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00019/AM17/
RLA
File
:03/95/040/00912/AM16/
Lic.No/Date:0310803062
04.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/805/2013-PI(Norms) dated June 2015 ,
493
Case
No.:20/2/82-
ALC4/2016
Party
Name:WANBURY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00020/AM17/
RLA
File
:03/95/040/00919/AM16/
Lic.No/Date:0310803068
04.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/710/2013-PI(Norms) dated February 2015 ,
494
Case
No.:21/2/82-
ALC4/2016
Party
Name:WANBURY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00021/AM17/
RLA
File
:03/95/040/00917/AM16/
Lic.No/Date:0310803064
04.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/524/2015-PI(Norms) dated March 2015 ,
79
495
Case
No.:39/2/82-
ALC4/2016
Party
Name:WANBURY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00039/AM17/
RLA
File
:03/95/040/00915/AM16/
Lic.No/Date:0310803069
04.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/805/2013-PI(Norms) dated June 2015 ,
496
Case
No.:40/2/82-
ALC4/2016
Party
Name:WANBURY
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
approved
HQ
File
:01/82/050/00040/AM17/
RLA
File
:03/95/040/00908/AM16/
Lic.No/Date:0310803066
04.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/805/2013-PI(Norms) dated June 2015 ,
497
Case
No.:26/2/82-
ALC4/2016
Party Name:MANGALAM
DRUGS & ORGANICS
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00026/AM17/
RLA
File
:03/95/040/00672/AM16/
Lic.No/Date:0310803128
08.03.2016
Defer
Date:24.05.2016
498
Case
No.:23/2/82-
ALC4/2016
Party
Name:MERCK
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00023/AM17/
RLA
File
:03/95/040/00936/AM16/
Lic.No/Date:0310803135
08.03.2016
Defer
Date:24.05.2016
499
Case
No.:7/2/82-
ALC4/2016
Party Name:SONGWON
SPECIALTY
CHEMICALS INDIA PVT.
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00007/AM17/
RLA
File
:34/24/040/00323/AM16/
Lic.No/Date:3410041954
08.03.2016
Defer
Date:24.05.2016
Decision :Deferred.
500
Case
No.:49/2/82-
ALC4/2016
Party
Name:DHANUKA
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00049/AM17/
RLA
File
:05/23/040/00532/AM16/
Lic.No/Date:0510397864
09.03.2016
Defer Date:
80
Pharmaceuticals forwarded vide O.M. No.35011/643/2015-PI(Norms) dated 1.2.2016 , uploaded
501
Case
No.:30/2/82-
ALC4/2016
Party
Name:NEW
ALLIANCE
DYE-CHEM
PVT. LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00030/AM17/
RLA
File
:03/95/040/00940/AM16/
Lic.No/Date:0310803176
09.03.2016
Defer
Date:24.05.2016
Decision :Deferred.
502
Case
No.:31/2/82-
ALC4/2016
Party
Name:NEW
ALLIANCE
DYE-CHEM
PVT. LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00031/AM17/
RLA
File
:03/95/040/00931/AM16/
Lic.No/Date:0310803177
09.03.2016
Defer
Date:24.05.2016
Decision :Deferred.
503
Case
No.:3/2/82-
ALC4/2016
Party
Name:RONAK
CHEMICALS
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00003/AM17/
RLA
File
:34/24/040/00329/AM16/
Lic.No/Date:3410041957
09.03.2016
Defer
Date:24.05.2016
Decision :Deferred.
504
Case
No.:29/2/82-
ALC4/2016
Party
Name:RUSAN
PHARMA LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00029/AM17/
RLA
File
:03/95/040/00924/AM16/
Lic.No/Date:0310803186
09.03.2016
Defer
Date:24.05.2016
505
Case
No.:58/2/82-
ALC4/2016
Party
Name:CHIROS
PHARMA
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00058/AM17/
RLA
File
:22/24/040/00115/AM16/
Lic.No/Date:2210015444
11.03.2016
Defer
Date:24.05.2016
506
Case
No.:59/2/82-
ALC4/2016
Party
Name:CHIROS
PHARMA
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00059/AM17/
RLA
File
:22/24/040/00112/AM16/
Lic.No/Date:2210015443
11.03.2016
Defer
Date:24.05.2016
507
Case
No.:45/2/82-
ALC4/2016
Party
Name:DHANUKA
LABORATORIES LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File RLA
File Lic.No/Date:0510397903 Defer Date:
81
:01/82/050/00045/AM17/
:05/23/040/00534/AM16/
11.03.2016
Pharmaceuticals forwarded vide O.M. No.35011/643/2015-PI(Norms) dated 1.2.2016 , uploaded
508
Case
No.:25/2/82-
ALC4/2016
Party
Name:PREGNA
INTERNATIONAL LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00025/AM17/
RLA
File
:03/95/040/00953/AM16/
Lic.No/Date:0310803237
11.03.2016
Defer
Date:24.05.2016
Decision :Deferred.
509
Case
No.:24/2/82-
ALC4/2016
Party
Name:SCOPE
CHEMICALS
PRIVATE
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00024/AM17/
RLA
File
:03/95/040/00955/AM16/
Lic.No/Date:0310803229
11.03.2016
Defer
Date:24.05.2016
Decision :Deferred.
510
Case
No.:51/2/82-
ALC4/2016
Party
Name:CADILA
PHARMACEUTICALS
LTD.
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00051/AM17/
RLA
File
:08/24/040/00440/AM16/
Lic.No/Date:0810137433
15.03.2016
Defer
Date:24.05.2016
511
Case
No.:46/2/82-
ALC4/2016
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00046/AM17/
RLA
File
:08/24/040/00431/AM16/
Lic.No/Date:0810137474
21.03.2016
Defer
Date:24.05.2016
512
Case
No.:48/2/82-
ALC4/2016
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00048/AM17/
RLA
File
:08/24/040/00430/AM16/
Lic.No/Date:0810137473
21.03.2016
Defer
Date:24.05.2016
513
Case
No.:47/2/82-
ALC4/2016
Party
Name:CADILA
HEALTHCARE LTD.,
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00047/AM17/
RLA
File
:08/24/040/00444/AM16/
Lic.No/Date:0810137475
22.03.2016
Defer
Date:24.05.2016
514 Case
No.:60/2/82-
ALC4/2016
Party
Name:AUROBINDO
Meet
No/Date:2/82-
ALC4/2016
Status:Case
Deferred
82
PHARMA LIMITED
26.04.2016
HQ
File
:01/82/050/01863/AM16/
RLA
File
:09/24/040/00710/AM16/
Lic.No/Date:0910063454
29.03.2016
Defer
Date:24.05.2016
515
Case
No.:61/2/82-
ALC4/2016
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01864/AM16/
RLA
File
:09/24/040/00771/AM16/
Lic.No/Date:0910063461
30.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/748/2015-PI(Norms) dated 3.3.2016 , uploaded
516
Case
No.:62/2/82-
ALC4/2016
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01865/AM16/
RLA
File
:09/24/040/00770/AM16/
Lic.No/Date:0910063462
30.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/748/2015-PI(Norms) dated 3.3.2016 , uploaded
517
Case
No.:63/2/82-
ALC4/2016
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/01866/AM16/
RLA
File
:09/24/040/00769/AM16/
Lic.No/Date:0910063463
30.03.2016
Defer
Date:24.05.2016
518
Case
No.:65/2/82-
ALC4/2016
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01868/AM16/
RLA
File
:09/24/040/00763/AM16/
Lic.No/Date:0910063465
30.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/36/2015-PI(Norms) dated June 2015 , uploaded
519
Case
No.:64/2/82-
ALC4/2016
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/01867/AM16/
RLA
File
:09/24/040/00772/AM16/
Lic.No/Date:0910063464
30.03.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/823/2015-PI(Norms) dated April 2016 ,
83
520
Case
No.:57/2/82-
ALC4/2016
Party
Name:HETERO
DRUGS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Approved
HQ
File
:01/82/050/00057/AM17/
RLA
File
:09/24/040/00773/AM16/
Lic.No/Date:0910063490
04.04.2016
Defer Date:
Pharmaceuticals forwarded vide O.M. No.35011/823/2015-PI(Norms) dated April 2016 ,
521
Case
No.:66/2/82-
ALC4/2016
Party
Name:ENCEE
AROMATICS
PVT.
LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00060/AM17/
RLA
File
:32/24/040/00043/AM16/
Lic.No/Date:3210077862
13.04.2016
Defer
Date:24.05.2016
Decision :Deferred.
522
Case
No.:67/2/82-
ALC4/2016
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00061/AM17/
RLA
File
:09/24/040/00014/AM17/
Lic.No/Date:0910063515
19.04.2016
Defer
Date:24.05.2016
523
Case
No.:68/2/82-
ALC4/2016
Party
Name:HETERO
LABS LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00062/AM17/
RLA
File
:09/24/040/00019/AM17/
Lic.No/Date:0910063520
19.04.2016
Defer
Date:24.05.2016
524
Case
No.:69/2/82-
ALC4/2016
Party
Name:ALMELO
PRIVATE LIMITED
Meet
No/Date:2/82-
ALC4/2016
26.04.2016
Status:Case
Deferred
HQ
File
:01/82/050/00063/AM17/
RLA
File
:09/24/040/00739/AM16/
Lic.No/Date:0910063533
21.04.2016
Defer
Date:24.05.2016
84
Manual Agenda of NC Meeting No. 2/82/2017 Scheduled to be held on 26.04.2016
Case No. B- 01
M.No.2/AM-17 Date 26.04.2016
M/s. Paramount Aromachem Pvt Ltd File No. 01/82/171/00377/AM16 RLA No 05/24/040/00230/AM14 Adv. Auth. No. 0510367036 dated 27.09.2013
Decision: The Committee considered this case for amendment in the description of import item from “LIMONENE (LIMONENE CITRUS TERPENE, ORANGE TERPENE, BRAZILIAN CITRUS TERPENE, STANDARD CITRUS TERPENE, ORANGE OIL)” to “D-LIMONENE (LIMONENE CITRUS TERPENE, ORANGE TERPENE, BRAZILIAN CITRUS TERPENE, STANDARD CITRUS TERPENE, ORANGE OIL) as per agenda.
The Committee noted that in this case, the export product is Carvacrol, a constituent found naturally in certain oil. It was discussed that the content of Carvacrol may vary from source to source, and a common norm of 3.2kg import against 1kg export as presently allowed may have to be revisited, after examining each of the following import items :
“D-Limonene” “Limonene Citrus Terpene, Orange Tarpene, Branzilian citrus Tarpene, Standard citrus terpene, Orange Oil”.
It was also observed that the items stated in brackets may have to be stated separately, as D-Limonene is a constituent of the items(s) stated in brackets. The applicant may accordingly furnish the information in their fresh application, also under consideration in this meeting. In the instant case, since imports are already over, the firm is to provide the details of imports actually made, separately for each item, and the quantity ‘carvacrol’ manufactured from the respective items of import, as it will have a bearing on their fresh application. The amendment in import description at this stage does not appear necessary, as import period is already over.
Case No. B- 02
M.No.2/AM-17 Date 26.04.2016
M/s. Indo Phyto Chemicals Pvt Ltd. File No. 01/82/050/00553/AM15 RLA No 05/23/040/00107/AM15 Adv.Auth. No. 0510388672 dated 13.06.2014
Decision: The Committee considered this case for amendment in the description of import item as per agenda. The Committee decided to defer the case.
Case No. B- 03
M.No.2/AM-17 Date 26.04.2016
M/s. SMB Corporation of India File No. 01/82/050/01016/AM13 RLA No 03/95/040/00568/AM13 Adv.Auth. No. 0310713614 dated 25.10.2012
Decision: The Committee considered this case for amendment in UOM as per agenda. The Committee decided to defer the case.
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Case No.:77/4/82-ALC4/2012
Nleet No/Datc:28/82‐ ALC4/2012 ino.rn, uncler para 1.7 of HBP vl as per cletails given belo*/ or as applied by the firm. n'hicl-rever is less: RAl■a)′ take appropriate actioll as per the decision ofNonlls Col■ 1■ittce. :HQ Fi!e lRLA File Lic.No/Date:0810109993 1Defer Date: ::01/82/050/00157/AM13/ 1108/24/040/00304/AM12/ 122.03.2012 1 Oeci.io" r i; ih; figfri of ri,ritt"n ionrrn"nts received from Department of Pharmacellticals vide their OM No. 350il/531/2012-PINorms) clated 21 .12.2012. it u'as decided to ratify 67 / Palty NanlciCADILA HEALTHCARE LTD、 ‐10012013 Export Product Export Qty. Si No lmport items Qtv. allowed Atorvastatin Condensation Product l kg 1 Methyl lsobutyl Acetate 0 981 kg 2 Toluene 1 08 kg 3 Thiazole Base 0 120 kg 4 Acetone 1.77 kg 5 IPA (lso Propyl Alcohol) 5 97 kg 6 (4R,CIS)1,1-Dimethylethy卜6 Cynomethyl-2,2-Dimethy卜1,3- Dloxane-4-Acetate 0763k9 7 Methanol 163
or,lL') ヘ F. No.3501 1 /58012014-Pl (Norms) Government of lndia Ministry of Chemical & Fertilizers Department of Pharmaceuticals Udyog Bhawan, New Delhi, Dated: 26 April, 2016 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501683lAM-1S/DES- 3/846 dated lhe 24111114 vide which application from Mis Hetero Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Tenofovir Disoproxil Fumarate (Purity 99.5%). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14- S.No. lmport ltem Norms Recommended for 1kq Expo( 1 Tenofovir Disoproxil Fumarate (Purity 95%) 1.025kq 2 This issues with the approval of competent authority. Under Secretary to the Government of lndia PH.- 23071162 Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi
^ F. No.3501'l /1 441201 s-Pl (Norms) Government of lndia Dated: 1'1 April,20'16 Office Memorandum Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O No 01l82l50l1331lAM- 15/DES-3/1291dated the 413115 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Nevirapine (Purity 99%). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- Export Product:- Nevirapine (Purity 99%) - 1kg 2 PH.- 23071162 S.No. lmport ltem Norms Recommended for 1 kq Export 1 Nevirapine (Purity 93%) 1 025kq
F. No.3 50 1 | 130012015-PI Qrlorms) Government of India Department of Pharmaceutical s UdYog Bhawan, New Delhi, the November,2015 Office Memorandum
Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Indoco Remedies Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501200/AM-16/DES-3/139 dated the 11106115 vide which application from M/s. Indoco Remedies Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Trifluoperazine lmg and 5mg tablets. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- (Raj Kumar) Phone:23071162 (Shri M.V. Singh, FTDO). ′ ／ ′ ′ メ S. No. Import Itern Qty. Recommended. l Irifluoperazine Hcl l.224mgllmg tablet And 6)2mgl5mg tablet /
2 レ5/ユケ9 Mcet No/Date:1/82- ALC4/2014 10.04.2014 悧辮引Ю剛 %8P畿のた 187 :01/82/050/01173/AⅣ【14/ 131/83/040/00134/AⅣ114/ : ln the light of written comments received from Department of Chemicals and Petrochemicais vide their u.O No. 14010/52/2011-Ch ll dated 02.04.2014′ it was decided to ratify norms under Para 4.7 of HBP vl as per details g市 en be:ow or as applied by the nrm′ whicheveris less: Export product Exp.Qty. Si.No. lmport items Qty. allowed Sodium Benzoate Micronised SF Grade l kg 1 Sodium Benzoate 1.01 kg may take appropriate action as per the decision of Norms Committee.
Case No.:126/23/82‐
ALC4/2013 Party Name:TRIGON CHEMICALS PVT.LTD. File iRLA File ノ ∨
タレ |′ ト F. No.350 1 1 16921201 s-Pl (Norms) Government of lndia ″好 Udyog Bhawan,New Delhi, Dated:26 February,2016 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-
14 Case of M/s Honour Lab Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501953/AM- 16/DES-3/1021 dated the 28110115 vide which application from M/s Honour Lab Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of 4- Chloro-2trifluoro acetyl aniline hydrochloride hydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol. l) 2009-1 4:- 2 (Rajkumar) PH:- 23071162 (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi S.No. lmport ltem Norms Recommended for 1kq Export p-Chloroaniline 0 626kq 2 Pivalovl chloride 0 652kq 3. Ethyl trifluoro acetate 0.681kg 4 n-Butvl chloride 1 133kq 5 Lithiunn metal 0.168kq χ6. Methvl tertiarv butvl ether 2.45k9 ヽ ⌒
cz.)t7 4-- ,{ F. No.350 1 1 I 7 591201 s-Pl (Norms) Government of lndia F\a^^-r: ^^L ^t nL^-._^^^.,r:^-t^ LJvpdtLt ilst rt ut rtlaii IIiaueUtiUaiS Dated: April, 2A16 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14
Case of M/s Vision Drugs pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. O1tB2t5Ol1285lAM- 16/DES-3/1228 dated the 15112115 vide which application from M/s Vision'Drugs Pvt. l-td. was sent to iiris Deparlment for fixation of norms under para: 4.7 for the expc,rt i,f Homo Veratronitrile(HVN). This department has examined tl're matter and the foliowing 2. 1''ajktii-' "'-) PH.- 23071162 r S.No. lmport ltem 1kg Export 1 Veratrole 1.231kq 2 Sodium Cyanide 0.90kq 3 Paraformaldehyde 0.423ks 4 Methanol 0.46kq 5 Chloroform '1 385kq
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F No.35011/368/2015_PI(Norrns) Governmen1 0flndia Ministry Of chemical&Fertilizers Department Of Pharmaceuticals The undersigned is directed to refer to DGFT U o No 01rY2rsor132g/A[-1s/DEs- 31259 dated 01/0712015 vide which ,. ipli"Jtion from Mis pvs Agrovet was sent to this Department for fixation of norms for the ;b;;;i veterinarfJorrltrtions in powder or riquirr forms' This department has examined the ,rti.i ood.fu;;cwing ;::;crnlation may be cared for 1rr':r ihe appricant to enabie this Depart-"ni ;;;;u the request:_ i) complete set of applicatione for fixation or norr, *ii *,"vant detairs of eiport t productSalongwith "orru"ponding imported inputs. ii) Valid Drug Manufacturinq License for all the export produclagainst this apprication. iii) Data about past prod"-tlon of the veterinary formuration, io be exported arongwith ;:ffi:,T|tt consumption of imported inputs, duly certified by a charrered Shastri Bhawan, New Delhi, Dated the 27th November , ZOl S Office Memorandum subiect: ;5ili::?:J[[iil: #3i#: ,iuro, of Hand Book of procedures (Vor r) 2oos_14 iv)Details Of any ea「|!er advancea authorizatiOn recelved by the cOmpatty a10ngwith the norrns apprOved by Norrns cOrllrrltttee_ 2. This issues with the approval of competent authority C ( Unde;.secretary to the oouu,nnl3;i 5,iffi3 Phone:-23 071162 ~‐ ‐ V/ ＼ '
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RヽアXNもヽЧζ。まつ毎QI″ ハ ― HONOUR Reg. Off : H.No.8-3-166/7/1 , Hetero House, Erragadda, Hyderabad - 500 018 , A P" lndia Tel:+91-40-23710405, Fax:+91‐ 40‐23700405 April 16, 2016 To The Director General of Foreign Trade I/inistry of Commerce, Udyog Bhavan, New Delhi. Dear Sir, Sub:Requestfor notto fix norms for Advance Authorzation N6 0910061133 dated 22 10 2014 Rer RLA F No 09/24/040/00407/AM15 We have taken Advance Authorization No.0916061 133 dated 22.i0.2014 for export 50,000 kgs of S (+)-2-Amino Butanamide HCL under Para 4.7 of HBP. ln thls connection, we wish to inform you that due to many changes in manufacturing process, we have not utilized the Iicence and surrendered the same to RLA. The RLA has cancelled the unutilized Advance Authorization on 29..09.2015. Copy of the cancellation letter is enclosed for your reference. This is for your information and not to fix the norms for the above authorization. Thanking you, ly, R LAB LIMITED REDDY g"♂ 0- 脇 . Factory:Sy No 202,Bonthapally V‖ lage,」innaram Mandal Medak Dist-502313,A P Tel:(08458)274009 “鍮鷹画.臨、 .‐゛ 1 2 I APR t,lili 撫 Ш \oi cr(o7X. g 1. N● | | | κ RA
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F. No.350 11 17251201 5-Pi (Norms) Government of lndia Flanarlm^n+ ^f Dh^.*^^^,,+;^^l^ uvpst Lr I tst rL \Jt I I tol I llouEuLludl> Dated: April, 2016 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14
Case of M/s Mylan Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82t5Ot644tAM-16/DES- 31765 dated the 1018115 vide which application from M/s Mylan Labs Ltd. was sent to this Departfirelri fc,r fixation of norms under para: 4.7 for the exp:)rr :f Arteinether. l-hir department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. i indor SeCretary i.o the Gover'nn ...t 6f l;':. ::- i PH:- 23071162 S.No. lmport ltem 1kg Export Artemisinin 1.235kq 2 Sodium borohydride 0.1 88kq 3 Methanol 2.667k 4 Methylene dichloride 1 358kq /
F No.35011/162/2015-PI(Norrns) Government oflndia Ministry of Chemical&Fertilizers Department of Pharrnaceuticals Dated: 19 February, 2016 Office Memorandum 14 Case of M/s lnd-Swift Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501148014M- 15/DES-3/1452 dated the 17t3115 vide which application from M/s lnd-Swift Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clarithromycin Granules 33% (Suspension Grade). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of (Rajkumar) 2 Procedures(Vol.|)2009-14:― S No lmport ltem 1kg Export Clarithromvcin 0 3333kg 2 Carbopol 0.25kg 3. HPMC Phthalate 0.44kq y ハ θンl17~ O
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F. No.3 501 I 124612015-PI (Ir{orms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Dated the September. 2015 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011289/AM-15/DES-3/38 dated the l2l05l1i vide which application from M/s. Hetero Labs Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Darunavir Amorphous. This department has examined the matter and the following norns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item Qty. Recommended kg/kg. 1 (2 S,3 S)-3 -(Tert. Butoxy Carbonyl Amino)- 1,2-Epoxy- 4-Phenyl Butane 0.854 2. i3 R,3 aS,6aR)-Hydroxy Hexahydrofuro [2,3 -b] Furanyl Succinimidyl Carbonate 0.598 (Barnali Khastgir) Under Secretary to the Government of India Phone:23071162 /
ハ ム F. No.3 50 I | 124612015-PI Qllorms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Datedthe September,2015 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50ll314lAi|d-ll1DES-3/37 dated the l2l15ll5 vide which application from M/s. Hetero Labs Ltd was sent to this Department for fixation of norms under para:4.7 for the export of Valsartan. This department has examined the matter and the following norrns are furnished under para 4.7 of Hand Book of Procedures (Vo1.l) 2009 -1 4:- (Barnali Khastgir) Phone:23071162 S. No. Import Item 1 N-Valine,N-( 1 -Oxopentyl)-N- [[2-(2H-T etrazol-5 - yl)[ l, 1 -Biphenyl]-4-yllMethyll-Methyl Ester 1.15 2. Methylene Dichloride 2.075 う Ｄ Diisopropyl Ether 0.287 y
ハ 牲 ´ 、 11乙 現 L″ / ^ F No 35011/339′ 2015-PI(NorrYls) Govemment oflndia Ministry of Chemi9al&Fertilizers りepa「Lmen1 0T rnarmaceullcals Udyog Bhav,ran, NevY Delhi, Daieo . 12 APrii,2016 Office Memorandum Case of M/s Jodas ExPoim Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01t12l50l147\AM-16|DES- 3lZZ3 dated tne ZUA;l5 vide which application from M/s Jodas Expoim Pvt. Ltd. was sent to this Department for iixatlcn rrf norms unde; para 4-7 for the expotl of Meropenem lnjection 1gm/500mg.This department has examined the matter and the following norms are furniihed under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 - 2. This issues with the approval of competent authority' under Secretary to the Covernment oflndia PH:-23071162 (Shri M.V Singh, FTDO), UdyoE Bhawan, New Delhi S No lmport ltem Norms Recommended 1 filteropenem and sodium carbonate (sterile bulk) 1255.01 mg/1 grn vlal & 627 505mg/500mq型 /
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F No 35011/383/2015-PI(Norms) GoVernment oflndia Ⅵ :騒篤綺T認麻彙11雪ξ ShaSЬ:瞥糧ぶ群 ,現l: 劇面mび WSよBい 面∞僣& subi ― Fixation of nOrrlns under para 4 PharrrlaceutiCalS Ltd. 14:― Lozenges ln RaspberrY/ EucalYPtus & Menthol/Honey & D而lam Sugar Free 0.306 i-somalt ST-M 257 Cetylpy百dinium chlonde BenzYdamine hydrochloride 0.306 (Ral Kumar) under Secretary tO the COVernment oflndia PhOnei 23071162 usp13-Pharma@niC・in 100 1ozenges 100 10zenges LemOn′ ,Orange′ Doubte Mint flavours AndOleX LozengeS Sugar Free Mint 岡 t型 TAiζ lζζ :きξ with theム||「6va1 0Fうlreさtc:`lharma lndustry) Directorate Cenera1 0f Foreign Trade 籠∬塞ittuil さExported Raw mateHals tO be lmported DescriPtion Qυ an″ν′ng“ BenzYdamine hydrochloride Not needed as Per 一
No/Date:4/82¨ : In the light of written comments received from Department of Chemicals and nicals vide their u.o No. r40r0r20r2012-ch. II dated n3.20r3,it was decided ICase No。:2/4/82‐ ALC4/2013 ratify norms under Para 4.7 of HBP vl as pcr details given below Or as applied by thc m,■7hichcvcr is less: RA may tuk. upp.op 16052013 F"rty N"*.CAMPHOR & HQ File :01/82/050/00043/AM14/ 103/94/040/00937/AM13/ Export product 恥 叫 SI No rmport ttems Qtv allowed Camphor USP l kg 1 1.146 kg
966/AM 12 F No 01/82/50/00295/Am 12 Meeung n0 6/AM 14 Dated 13 06 2013 3510035931 dated 25.05.2011 3510034005 dated 25.052011 Advance Licence Nos. 35/24/40/00045/AM 12 35/24/40/00025/AM 12 Decisioni Committee considered case as per agenda and in light of written comments fon″ arded by Deptt of C&PC Vide their U O No 14010/100/2010-Ch‖ dated 21 02 2013 and in consu:tation with technica!authority present iふmeeting,decided to revise the norms under para 4 7 of HBP as per detal:s below or as applied by Export product Exp Qty SI No lmport items Qty. allowed (i) Eugenol in Liquid form packed in PVC Drums' l kg Clove Leaf Crude oil 20 kg (Only relevant packing material as per packing Policy) (ii) Caryphyllene in Liquid form packed in PVC Drums. l kg 1 Clove Leaf Crude Oil 1 120 kg (Only relevant packing materialas per packing Policy) R decision of NC ο」lh si百らM%| http://dgft. gov.irvexim 12000 I committee/meet adv4 06 I 4.htm 07¨ 04… 2016 is lower:-
F. No.3501 1 18231201 5-Pl (Norms) Government of lndia Dated: April, 2016 Office Memorandum Case of M/s Hetero Drugs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011326/AM- 16/DES-3/1564 dated the 1511116 vide which application from M/s Hetero Drugs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of 2,3,4,i-Bas-O-(1-methylethylidene)-, -D-fructopyranose. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. PH'.- 23071162 ( 11h S.No. lmport ltem 1kq Export 1 D(-)Fructose 1 434kq 2 Acetone 1.85kq 3 Toluene 1.565kq
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⌒ F. No.350 I 1 17 17 12015-Pl (Norms) Government of lndia ′ι 4 Dated: 29 March,2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Vadivarhe Speciality Chemicals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l708iAM-16IDES- 31741 dated the 2612116 vide which application from M/s Vadivarhe Speciality Chemicals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of 2-amino-4-hydroxy acetophenone Hcl. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol. l) 2009-1 4.- 2. Under Secretary to the(3overnment oflndia PH:-23071162 / ″声ト ～ S No. lmport item 1ko Export 1 Amino Acetonitrile Hcl 0.628 kq 2 Nitromethane 0.708 kg 3 Phenol 0.70 kq 4 lsopropyl alcohol 3.139 kq
F. No.350 1 1 I 543 12015-PI (Norms) Government of India Office Memorandum
Subject: - Fixation of norms under puru43 of H*d Book of Procedures (vol'l) 2009-14 Case
of IWs Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. Oll82l5Ol23lAM-161DES-31824 dated the 2ll1Sl;^i vide which application from M/s. Hetero Labs Ltd was sent to this Deparrment for fixation of norms und". para: 4.7 for the export of 1-((2R,3R:1R'5R)-3-fluoro- 4-hydroxy-S-(Hydroxymethyl)-3-Methyltetrahydrofu.ran-2-yl) Pyrimidine-2'4(1H'3H)- Dione. This department has- examined ihe matier and it is requested that DGFT may call following technical details from the firm viz:- (a) End-use ofthe exPort Product. (b) Technical justification for a low yield Literature. imported items dulY certified bY (c) Past production vis-il-vis Actual consumption of Central Excise Authorities. 2.Thisissueswithtlreapprovalofcompetentauthority. (Raj Kumar) Phone:23071162 (Shri M.V. Singh, FTDO). New Delhi, the Udyog Bhawan, December. 2015 of 39.3o/oin step II supported of copy of Tecl-r'
（ 一 ＾ 謬I F. N0.3501 1170812015-Pt (Norms) Government of lndia il/inisiry of Chemical & Feriiiizers Shastri Bhar,nran, New Delhi, Dated: llarch 17,2010 SLrb:-Fixationofnormsuncjerp,,,4m/sJ.B.ChemicaIs&PharmaceuticaIs Ltd The undersigned is directed to refer to DGFT U.O. irlo. 01t82lsotO098ilAiV-16/DES-3 11126 dated the2611112015 vide which an applicaiion from lfl/s J.B. Chemicals & Pharmaceuticals Ltd r,nras sent io this Department for fixation of norms against export of Sugar Based Medi-Keel A Medicated Throat Lozenges Black Current/Honey & Lemon flavours. This department has examined the matter and the foilowrng norms are furnished under para 4.7 of Hand tsook of Procedures ('ci,l) 2009-1 4.- Product to be Exported Raw materials to be Imported Description Quantity Description Quantity Sugar Based Medi-Keel A Medicated Throat Lozenges Black CurrenUHoney & Lemon flavours. 100 lozenges Benzocaine 1.224 gm This issues r,nriih the approval of Director (Pharma lndusiry). (Ral Ku (RaJ Kumar) Phone: 23071162 Directorate Generar of Foreign Trade, Uspi3-Pharnta@nic'in (Shri MVSingh,FTDO), Udyog Bhawan, New Delhi. y つ 」
F. No.350 1 1 16031201 5-PI (Norms) Government of lndia Dated: 21 March, 2016 Office Memorandum Case of M/s Cadila Healthcare Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501616/AM-'16/DES- 31778 dated the 1018115 vide which application from M/s Cadila Healthcare Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Rivastigmine Zydus 1.5m9 Capsules. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. lmport ltem Norms Recommended 1 Rivastigmine ' 2.45mql1.Smq capsule 2 Rivastigmine' 4.90mq/3mq capsule 3 Rivastigmine ' 7.35mol4.5mq capsule 4 Rivastiqmine 9.80mq/6.Omq caosule 2. PH:- 23071162
F. No.3501 1 /7301201 s-Pl (Norms) Government of lndia Dated: 28 March, 2016 Office Memorandum Case of M/s Cadila Healthcare Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l82l50l62BlAM-16/DES- 3/780 dated the 10/8i15 vide which application from M/s Cadila Healthcare Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Atorvastatin Calcium. This department has examined the matter and the following S.No. lmport ltem Norms Recommended for 1 kq Export 1 (4R,ClS) 1, 1 -dimethylethyl-6cyanomethyl-2,2- dimethvl-1,3-dioxane-4-acetate 0.70Bkg 2 lso propyl alcohol 1 406ks 3 methanol 6.734kq 2 PH:- 23071162 (ShriM.V Singh, FTDO),
Gzlt 1- F. No.350'1 1170012015-Pl (Norms) Government of lndia \1Y Dated: 26 April, 2016 Office Memorandum Case of M/s Swiss Parenterals Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l612lAM-16/DES- 3/733 dated the7l8l15 vide which application from M/s Swiss Parenterals Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Cefoperazone Sodium & Sulbactam Sodium for lnjection 1gm. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. lmport ltem Norms Recommended 1 Cefoperazone + Sulbactam 1.1 1.12gmlvial ０ ４ PH:- 23071162
■ １ １ ^ ヘ Government oflndia Ministry of Chemical&Ferti‖ zers Dated: 26 April, 2016 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-1a
Case of M/s Swiss Parenterals Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501613lAM-16/DES- 3/734 dated the 7l$l15 vide which application from M/s Swiss Parenterals Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Cefoperazone Sodium & Sulbactam Sodium for lnjection 1.59m. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S No lmport ltem Norms Recommended 1 Cefoperazone + Sulbactam 2:1 1 663gm/vial 2 Under Secretary to the Government ofindia PH:-23071162 Depanment Of Commerce, (Sh面M V Singh,FTDO), Udyo9 Bhawan,New Delhi
F. No.3501 1 /693/201 5-Pl (Norms) Government of lndia l1u Udyog Bhawan, New Delhi' Dated: 2 March, 2016 Office Memorandum
subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (vol.l) 2009-
14 Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82/50/606/AM- 16/DES-3/1027 dated the 28110t15 vide which application from M/s Hetero Labs Ltd' was sent to this Department for fixation of norms under para'. 4.7 for the export of . Efavirenz. This department has examined the matter and the following norms are tulnisned unO et paru 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. lmport ltem Norms Recommended for 1 kq Export (S)-5-chloro-a-(cyclopropylethynyl)-2-amino-a- (trifluoromethyl)-benzene methanol. 0.987kg 2 (Rajkumar) PH:- 23071162
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F. No.350 1 I I 61012015-PI (Norms) Government of India New Delhi, the Udyog Bhawan, December.20l5 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Divi's Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. O1l82l50ll29lAM-16/DES-3/832 dated the Zll11lli vide which application from M/s. Divi's Labs Ltd was sent to this Department for fixation of norrns urd.. para: 4.7 for the export of N-Hydroxy Succinimide' This department has examined the matter and the following norrns are furnished under pata 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. This issues with the approval of competent authority' (Raj Kumar) Phone:23011162 S. No. Import Item l Acetone 1.59 う 乙 Hydroxylamine Hcl t.l4 3. Succinic Anhydride t.43 y
o" li7- Wq F. No.3501 1 /5881201 s-Pl (Norms) Government of lndia Dated: 21 March, 2016 Office Memorandum Case of M/s Sun Pharma lndustries Ltd' The undersigned is directed to refer to DGFT U.O.No. 0118215016101AM-'l6/DES- 31771 dated the 10/8i15 vide which application from M/s Sun Pharma lndustries Ltd. was sent to this Department for fixation of norms under parc 4.7 for the export of Amoxycillin Trihydrate & Glavulanate Potassium+Avicel 1:1. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. lmport ltem For Export of 1No. TableUCaPsule 375mq 625m9 1000m9 1 Amoxycillin Trihydrate 289.017m9 578.03m9 101156m9 2 Clavulanate Potassium+Avicel 1.1 303.60m9 303.60m9 303.60m9 2 PH:- 23071162 ゾ
F. No.350 1 1 I 5861201 5-PI (Norms) Government of India New Delhi. the Udyog Bhawan. December, 2015 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Divi's Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50ll37lAM-L61DES-3/769 dated the 10/0S/1i vide which application from M/s. Divi's Labs Ltd was sent to this Department for fixation of norms under para:4.7 for the export of 3-O-Acetyl-1,6-Anhydro-2- nziAo-Z-leoxy-4-O-(Methyl 2,3-Di-O-Benzyl-Beta-D-Glucopyranosyluronate)-Beta-D- Glucopyranose. This department has examined the matter and the following norms are furnished under para4.7 of Hand Book of Procedures (vol.l) 2009-14:- 2. (Raj Kumar) Under Secretary to the Govemment of India Phone:23071162 Department of Commerce. S. No. Import Item l Acetonitrile 4.37 つ ４ Beta-D-G I ucopyranose, 1,6-Anhydro -2- Azido-4-O-!z,3 - B is-O-(Pheny tmethyl)-4,6-O-Phenyl methylene)-Beta-D- G lucopyranosyll -2-Deoxy-3-Acetate 2.47 り ， 2,2,6,6-T etramethy I p i peri dine- I -Oxy I (TEM PO) 0.019 /
F. Nc.350 1'l I i 341201 s-Pl (i.tt-rrms) Government of lndia DPnartmoni af Dharmaaar rtin^l- vr i i iqrttiuv9utrvclto Dated: April, 2016 Office Memorandum
Subject: - Fixation_9j n_orms under para 4.7 of Hand Book of procedures (Vol.l) 2OOg-14
Case of M/s Sun pharma Ltd. The undersigned is directed to refer to DGFT U.o.No. 01tg2l5ot622tAM-16/DES- 31736 dated the 718116 vide which application from M/s Sun Pharma Ltd. was sent to this Department for fixation of norms uncje r para: 4.7 for the e.xport of S-:iraline Hcl API and its Tablets/Capsules, 50mg. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of procedures (Vol.l) 2009-14:- S No. lmporl ltem 1kg Export Activated carbon 0.029kg 2 Methanol 2 50kg 3 Palladium 0 631grr1/kg 4 (R)Mandelic acid 0.392kq 5 4-(3' 4'-dichlorophenyl) 1 -Tetralone 3.27kg 6 Toluene 2 50kq つ 」 Under Secretary to the Government oflndia PH:-23071162 V/ | (編
F. No.3501 1173412015-Pl (Norms) Government of lndia n--^ -J.-- ---L ^t nl- -.-.--
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- l- rJtrpdr r.r iler rI ut rilitil ilaiueuUUill5 Udyog Bhavran, Nelv Delhi, Dated: April, 2016 Office Memorandum Case of M/s Sun Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215016211AM-16/DES- 31737 dated the 718115 vide which application from M/s Sun Pharma Ltd. was sent to this Deparlment for fixation of norms under para: 4.7 for ti,e expod of Clarithromycin Carbomer Granules 43.5o/o I 43.75% I 44%. This department has examined the matter and the following norms are furnished under paru 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- DGFT is advised to call following details from the firm viz:-
- Complete technical details as per appendix-33.
- Copy of valid DML for above exporl product.
- Copy of master-Batch formula for above export. nil
;l ,,y+ (RaJkumar) PH'.- 23071162
/ ダ Ziθ F No.3501 1t624t\Oj5-pt (Norms) Government of lndia Department of pharmaceuticals Udyog Bhawan,New Delhi〕 Datedi 21 March,2016 0ffice Memorandum Sutte∝理さす踊♀ :nttl憶慰鑢.d Hand B00kぴ PЮceduЮ s Ⅳ d⇒200"4 1o DGFT U.o.No.o1/82/50/664/AM‐ 16′DES― lon from M/s Granules lndia Ltdo was sentto b』請し亀i鳳幌f霧ξ魔ぷ鮮穏 : 3留解r盤ぼ職.:鶏劃Thg n∝ ms are ttmもhed under paa 47 J Hand Norms Recommended ' for 1 0.150k __0.043kg __ 0.7 」盪聟短 0.006kcI _ 0.001kg _ _ 0.01 2. This issues with the approval of competent authority 0J- Under Secretary to the cor"rnSl,|',Til PH:- 23A71$Z υ sulfamethoxazole i Trimethoprim sulfate
θリノ リ )tIヽ ^ F No 35011ノ696/2015-PI(Norms) Government ofindia Ministry Of Chemical&Fertilizers Department of Pharmaceulcals Dated: 22 March, 2016 Office Memorandum
subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14
Case of M/s Jodas ExPoim Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501657lAM-16/DES- 3/798 dated the 1418/'15 vide which application from M/s Jodas Expoim Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 fot the export of Drugs Formulations lnjections(Ampules/Vails above 20ml) imipenem+cilastatin injection 1gm. This department has examined the matter and the following norms and furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call copy of drug manufacturing licence from the firm for the above export product & working on requirement of imported APl. 2. Under Secretary to the Government ofindia PH:-23071162 Depanment Of Commerce, (Sh百M∨Singh,FTDO), ∪dyog Bhawan,New Delhi ツ
F. No.350 11 17241201 5-Pl (Norms) Government of lndia Dated. 04 April, 2016 Office Memorandum Subjeet: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s Kopran Research Laboratories Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501989/AM- 16/DES-3/1127 dated the 26t11t15 vide which application from M/s Kopran Research Laboratories Ltd. was sent to this Department for fixation of norms under para'. 4.7 for the export of Azithromycin dihydrate. This department has examined the matter and the foliowing norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2. (Rajkumar) PH'.- 23071162 S.No. lmport item 1kq Export Azithromycin amine 1.00kg 2 Acetone 0.90kg
十ご⊃ F. No.350 11 17241201 5-Pl (Norms) Government of lndia Dated: 04 April, 2016 Office Memorandum 14 Case of M/s Kopran Research Laboratories Ltd. The undersigned is directed to refer to DGFT U.O.No. OllB2tSOtggliAM- 16/DES-3/1122 daled the 26111115 vide which application from M/s Kopran Research Laboratories Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Cefepime for injection. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- 2. (Raikumar) PH:-23071162 ⌒ S.No lmport item 1kg Export 1 Cefepime Hcl (non-sterile) 0 655kg 2 Acetone 1 816kg 3 LArginine (non-sterile) 0.37kq 4 lso-propyl alcohol 0.392kg 5 Packing material : aluminium canister As per packinq policv ノ
（ （ 2:4 F No.3501 1/70312015-Pl (Norms) Government of lndia Dated: 26 APril, 2016 Office Memorandum Case of M/s Glenmark Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501100214M- 16/DES-3/1 1 13 dated the 26111115 vide which application from M/s Glenmark Pharmaceuticals Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Mometasone Furoate Monohydrate Nasal Spray 60MD and 120MD. This department has examined the matter and the following norms are furnished under
para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:-
S No. lmport ltem Norms Recommended 1 Mometasone Furoate BP (Micronized) 3.06m9/60MD Pack And 6.12msl120MD Pack (Rajkumar) PH.- 23071162 (Shri M.V Singh, FTDO), /
04qn*t? F.No.35011/777/2015¨ PI(Norms) Government ofindia Ministry of Chemical&Fertilizers て死万西 ~´ Dated: 11 April, 2016 Office Memorandum Case of M/s Micro Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011298/AM- 16iDES-3/1226 dated the 15112115 vide which application from M/s Micro Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Ciprofloxacin Tablets 250m9 and 500m9. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.- 2. Under Secretary to the(3overnment oflndia PHi-23071162 S No lmport ltem 1kq Export 1 Ciprofloxacin Hcl 277.5mg/250mg tablet And 555.Omg/500mg tablet /
.t*'., l') F. No.35011/70 7t2o1s-pt(Norms) '{qq Government of lndia Dated: 11 April, 2016 Office Memorandum Case of M/s Bliss lndasi Lifesciences Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215019851AM-16/DES- 3/1 132 dated Ihe 26111115 vide which application from M/s Bliss lndasi Lifesciences Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Vancomycin for injection 500m9. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call from the firm copy of valid DML alongwith list of items and composition approved by FDA for manufacturing. 2. PH- 23071162
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ル ・ ' F. No.350'1 1/7731201s-Pl (Norms) Government of lndia Dated: 26 April, 2016 Office Memorandum Case of M/s Kopran Research Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01l12l50l1072lAM- 16/DES-3/1 '180 dated the 9112115 vide which application from M/s Kopran Research Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clarithromycin Granules 43%. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call copy of Master-Batch formula from the firm for the above export item duly Certified by their Q.C. lncharge. 2. PH: 23071162
F. No.350 11 15881201 5-Pl (Norms) Government of lndia Dated: 21 March, 2016 Office Memorandum 14 Case of M/s Sun Pharma Industries Ltd. The undersigned is directed to refer to DGFT U.O.No. O1tB2tSOt610lAM- 16|DES-31771 dated the 1018115 vide which application from M/s Sun Pharma lndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Amoxycillin Trihydrate & Ctavulanate Potassium+Avicel 1:1 TableUGapsule. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of procedures (vol.l) 2OOg-14:- 2. (Rajkumar) PH:-23071162 S,No. lmport ltem For Export of 1No. Tablet/Capsule 375mg 625mq 1000mq Amoxycillin Trihyd rate 289.017mq 578 03mq 1011.56mq 2 Clavu lanate Potassium+Avicel 1:1 303.60m9 303.60m9 303.60mg 00
F. No.350 1 1 t\gt t201 S-pt (Norms) Government of lndia Department of pharmaceuticals Dated: 2'l March, 2016 Office Memorandum
Subject: - Fixation__of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14
Case of M/s lndoco Remedies Ltd. The undersigned is directed to refer to DGFT U.o.No. 01tg2l5o/753/AM-16/DES 3l t'A1 'iated thc 10/8/15 vide which application from M/s lndocc R.emedies LiC was sent to this Department for fixation of norms under para: 4.7 for the export of lbuprofen Tablets 200m9. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of procedures (Vol.l) 2oog-14.- S No lmport ltem Norms Recommended , '' -, - , . 1 lbuprofen 200m9 204.Omg/200m9 丁ablet 2 lbuprofen 400m9 408.Omg400mg Tablet 3 lbuprofen 600m9 612.Omg/600mg 丁ablet 4 lbuprofen 800m9 816.Omg/800mg 丁ablet 2 PH:-23071162 √
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F. No.3501 1177212015-Pl (Norms) Government of lndia Dated: 11 April,2016 Office Memorandum Case of M/s FDC Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82l50/1088/AM- 1 6/DES-3/1 1 83 dated the 9112115 vide which application from M/s FDC Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of iAzithromycin tablets 250m9 & 500m9. This department has examined the matter and the following 2 PH:- 23071162 S.No. lmport ltem Norms Recommended 1 Azithromycin (as Azithromycin dihydrate) 250m9/250m9 Tablet & 500mq/500mq Tablet
F. No.350 1 1 t76ot2tol s_pl (Norms) Government of lndia l-lana.t*^^+ ^r nt- ry,pdi i.i iieni oi i,nafillaceuticais Office Memorandum subject: - Fixation .oJ n^orm: under para 4.7 of Hand Book of procedures (vol.l) 2oog-14 Case of M/s Aarti lndustries Ltd. The undersigned is directed to refer to DGFT U.o.No. o1lg2l5ol1o17/AM- 16/DES-3/1157 dated the 8112115 vide which ,ppr,rrtion from M/s Aarti lndustries Ltd. was sent to this Deparlment for fixation of norms under ;.aroi a.z fir thl export of Budesonide' This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of procedures (vor.r) 200g_14:_ 2. Dated: April, 2016 Under Secretary to the cou"rnr$fly,ffi? pH:-23071162 t,,e.:toiaie Gerlerar of Foreign frade, (Shri MV Singh,FTDO), ノ Norms RecornnrenOeO for
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⌒ F. No.3501 1/781 12015-Pl (Norms) Government of lndia Dated: 26 April, 2016 Office Memorandum Case of M/s Sun Pharmaceutical lndustries Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501122014M- 16/DES-3/1319 dated the 16112115 vide which application from Mis Sun Pharmaceutical lndustries Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Valacyclovir Hcl Tablets 500m9 and 1000m9. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- DGFT is advised to call DML from the firm. 2. PH.- 23071162
（ ノ F. No.350 1 1 17221201 5-Pl (Norms) Government of lndia Dated: 31 March, 2016 Office Memorandum Case of M/s Dr. Reddys Laboratories Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501943/AM-16/DES- 3/1096 dated the 18i11/15 vide which application from M/s Dr. Reddys Laboratories Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Moxifloxacin HCL. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- PH'.- 23071162 2 S.No. lmport item 1kq Export 1 Methoxv difluoro l CPA quinoline ester 0.978kq 2 (S,S)-2, B-d iazabicyclo-(4.3.0) Nonane 0.37kg 3 Methvlene chloride 3.41ks 4 Methanol 4.28ks 5 acetonitrile 1.00ks げ
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⌒ ＾ ヽ Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals SubjectAdvance Authorization application from M/s. Alkyl Amines Chemicals Ltd. for the import of raw material against the export of Acetonitrile Ref: DGFT U. 15 (Adv ttt/s. Alkyl Amines Chemicals Ltd. have submitted present applications for the import of raw material against the export of Acetonitrile The application have been examined based on the addition information furnish by the firm. The Depirtment recommends the following norms for the present Advance Authorization application. 1.ltem of Exoort Qty. Item of lmport Qty Acetonitrile l kg. 1.AceJc Acid 1.766 kg This issues with the approval of competent authority' Addl.industrial Adviser Tel.No.011‐ 23381430 SR缶鶴ヽ 7gナ 嘉 ｀スヽヂ (A.K.AGARWAL) Deptt.of C&PC U.0.No. コl dated 8..12.2015 ノ
少多 働〇 F. No.350 1 1 17301201 5-Pl (Norms) Government of lndia Dated: 28 March, 2016 Office Memorandum 14 Case of M/s Cadila Healthcare Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501628/AM- 16iDES-3/780 dated the 1018115 vide which application from M/s Cadila Healthcare Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Atorvastatin Calcium. This department has examined the matter and the following (Ralkumar) Under Secretary to the(3overnment oflndia PH:-23071162 311 2. √ S No. lmport ltem Norms Recommended for 1kq Export /1 (4R,CIS)1,1-dimethylethyl-6cyanomethyl-2,2- dirnethyl-1,3-dioxane-4¨ acetate 0.708kg ノ3. methanor 6734 閻 6kq
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F. No.3501 1tT41t2o15_pt (Norms) Government of lndia Department of pharmacer,rtica ls Office Memorandum
subject: - Fixation of n9rls. under para 4.7 of Hand Book of procedures (Vol.l) 2oog-14case of
M/s Covatent Labs pvt.'Ltd. The undersigned is directed to refer to DGFT U.o.No. o1tg2tsot11o9/AM-16/DES- 311294 dated the 1671215 vide ilil application from M/s'covarent Labs pvt. Ltd. was sent to this Deparlment for fixation "i;#; u"no", prrr, i.i ioi in" export of Gefditoren pivoxit. This department has examined the ,rtt"rlno ttre fottowing *rr. are furnisi::..cf under para 4.T cl I rand Book of procedures gor.ry idOS.i+:_ Under Secretary to the Cor"rnr$i.l}',ffi? PH:- 23071162 D_epartment of Commerce, Norms necomnrenOeO ior tt<g Export 4-methyl-5-fo Chtoromethyl pivalaG Activated carOon Dimethyl formamiOe Chloroform Tetrabdrofuran(TH Methytene ahtoride 2912k MAEM ′
% F. No.3501 1 lB40l2O15-Pl (Norms) Government of lndia n^+^.{: A,pr-il.2ue Office Memorandum Case of M/s Lee Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011526/AM- 16/DES-3/1675 dated the 1912116 vide which application from M/s Lee Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of (S)-1-ttt1- [2(E)-(7-chloro-2-quinolynyl)ethenyl{{-3 -12-11-hydroxy-1-methylethyl)phenyl]-1- propanol. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S No lmport ltem lkq Expoft ( S, E ) - m et h y I 2 - ( 3 - ( 3 - (2 - (7 -chl o ro q u i n o I i n - 2 - yl)vinyl) p henyl)-3-hyd roxypropyl)benzoate 1.1lkg 2. (Raikumar) Under Secretary to the Goverhment oflndia PH:‐ 23071162 Depaftment of Commerce, ハ ⌒ ν
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⌒ μ ′δ8 F No.35011/840/2015-PI(Norms) Government oflndia Ministry 6f chё mical&Fertilizers Depattment of Pharmaceuticals Dated: April, 201O Office Memorandum
Subject: - Fixation._of norms under para 4.7 of Hand Book of procedures (Vol.l) 2OOg-14
Case of M/s Lee pharrna Ltd. The undersigned is directed to refer to DGFT U.O.No. O1tB2tSOt1708lAM- 16/DES-3/1895 dated the 30/3/16 vide which application from M/s Lee Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the exporl of (2-(((3- methyl-4-(2,2,2'trifluoroethoxy)pyridin-2-yl)methyl)thio)-1H-benzo[D]imidazoie."' This department has examined the matter and the iollowing norms are iurnished under
para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14:-
S No lmpoft ltem 1kq Export 2,3-lutidine 0.65kq 2 Methylene chloride 0 81kq 3 2,2,2-lrifluo ro eth a n o l/trif I uo ro eth a nol 0.65kq 4 Potassium carbonate powder 0 612kq 5 Methyliso butyl ketone(N/11BK) 0 41kq 6 Acetone 0 27kq 7 Toluene 0.54k0 8 2-mercapto bezimidazole 0 54kq 9 lso propyl alchohol 0.44k 2 Under Secretary to the(3overnment oflndia PH:-23071162 ノ
ヘ
ラ)h Ir. l{,,.i50 I I i(r95/2015-Pl (Norrns) (irlr.,crn lnent ol' I nd ia Ministrl' ol'('hcnticals & Irertilizers I)ipartnrcrr t ol' [)harrnaccut icals Llci-r r-rq []hlrrr un.\eu l)ellri. I)atcrl thc .llnrtrr'', . l() I (r !l ll qc t'.,1_q1 o1q4rl u r rr SLrh.ice t: - [ixlttiorl ttl' rltri'ttl; tttttler' plrtrr -].7 ol'llurrd LJool, oi' l)r'gectlrr;cs (/61.1; 2{)g()- lJ ('asc ol'M/s I)ir i': Lubs l_tti. 'lltc tlltcjersignerl is tiirccl.crl to rclL'r to I)Clr"l- il.O.No 0llW50ll I ll/AN,l-16,,1)l - l/ll-i(r tiatcd the ()Bll?ll5 ricle rihiclr lp;rlicution lionr M/s. Divis l.irtrs l-tci rvus sclr r. tlris l.)eparttllettt 1bI llxation ol'norrrrs trrrcld'1;lt[ir: -{.7 lirr tlre cx;lo11 ol'13-Wing (1,-/illirrc (]rclic Ilrea).-l'his departrl]cllt ltlt5 e\artlincti llre nratlcr urrcl the Iollorvin-l lr()r'nrs ale lirrnishc| Lrrrilcr. pura 4.7 ol'l'lancl llook trl'l)r'ocgllu;.s-5 (/trl.l) l()(.)9- l-l:- ヾ ()「11ls ltcconl!1]cndc(1 lk)「 [:-xport |.837k2 2 25kQ 11,lon itrile 0.951くЦ ustic Potetsh l-iakes 4.055k8 2.251く望 so Pr()p)ノI AlcohOI 092k望 'l'his issues u,itlr thc approvarl ()f c()ntpetetrt atrthor.it1,. Under Secretarv to the Covenlltenl ol'lnciia Phone:2307 I I 62 D irectol'atc Cenera I o I' Fc'rrc i grr'l'raclc. Departrnerr t ol' (lorrr rncrcc. (Shri M.V. Sirrgh. irTDO). Ud1,og Blrawan. Ner.r, Dclhi lenc'('hloriclc Int ltort Ilt-nt LC ('h ltlrrr Ijornrale ⌒ つ 一 S.No. |. ν
多2p ハ f歴概青したシ jが~1漱 聴 ヒ :`, 1 fuffi,'r-- Decision ' r, ,r.," richi;i*;** ;;;;;,;;1,g;;;;;;;;;..,,."L,r, uia",r,"i,. oM No' 35o1'1'/370/2013-Pl(Normrt art"J ii.o g.2o73,it was aeJoeiio ,rtiry norms under para 4.7 of HBP v1 as per details given below ";rr ,;;by the firm, whichever is less: 腔漑戸雨 RA may take apprOpriate actiOn as perthe decisiOn of Norms COmmittee PAROXETINE HCL F麒ざ島 1尭F° H°L[← (‐)TRANS‐ 1_N‐ METHYL― 3-HYDROxY METHYL-4- 絆爛 :肌 PHENYL) ⊇IMETHYL SULFOxIDE rsopRopyillffi THIS LICENCE ISSuED AS PER PARA 47[NO_ NORMS]oF HBP_2009_14. WITH NORMAL CONDITloN AS PER T.NOTIcE NO.5 DT.o8.10.2003 FOR EXPORT PRODUCT suB. TO COND.FIXATION OF NORMS BY ALC N.DELHI ノ
oz/t? I 7go F. No.3501 1 /73 I 1201 s-Pl (Norms) Government of lndia Dated: 13 April, 2016 Office Memorandum Case of M/s PAB Organics Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215016981AM-16/DES- 31729 daled the 6i8l15 vide which application from M/s PAB Organics Pvt. Ltd. was sent to this Department for fixation of norms under para'. 4.7 for the export of 2,3 dichlorobenzoyl cyanide (2,3 dichloro benzoyl nitrile). This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S No. lmport ltem Norms Recommended for 1 kq Export 1 2,3 dichloro benzovl chloride t.zvtKq / ) Directora/e General of Foreign Trade, PH.- 23071162 ⌒ ′
ヘ ^
F. No.350 I 1 177 1 12015-Pl (Norms) Government of lndia Dated: '11 April, 2016 Office Memorandum Case of M/s Medicamen Organics Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011178/AM- 16/DES-3/1332 dated the 18112115 vide which application from M/s Medicamen Organics Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Ferrous Sulfate 300mg + Folic Acid Tablet. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol. l) 2009'1 4.- 2 (Ralkumar) PH'.- 23071162 S.No. Export Product lmport ltem Norms Recommended for 1 No. Tablet 1 Tablet Ferrous Sulfate 300mq + Folic Acid 1mg Folic Acid 1.02m9 2 Tablet Ferrous Sulfate 200mq + Folic Acid 0.4m9 Folic Acid 0 408m9 ツ
r. No.3501 1 182312015-Pl (Norms)
Government of lndia
Depariment of Pharmaceuticais
Udyog Bhawan. New Delhi,
Dated: April, 2016
Office Memorandum
Case of M/s Hetero Labs Ltd.
The undersigned is directed to refer to DGFT U.O.No. 01182150113121AM-
16/DES-3/1831 dated the 1513116 vide which application from M/s Hetero Labs Ltd. was
sent to this Departrnent for fixation of norms under para: 4.7 for t\e export :f
Olmesartan Medoxomil. This department has examined the matter and the following
norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14'.-
2
(Rajkumar)
PH'.- 23071162
S.No.
Import ltem
1kg Export
1
Ethyl-4-( 1 -hyd roxy- 1 -methylethyl)-2-propyl
im idzole-5-carboxylate
0.70k9
2
N-(triphenyl methyl)-5-(4-bromomethyl biphenyl-
2-yl)tetrazole
1.35k9
3
Methyl ethyl ketone
0 50kq
4
Ethyl acetate
6.07kq
5
Methylene chloride
1 38kq
6
Methanol
1.85kq
7
Toluene
2.76kq
,-
/
ハ F. No.350 1 1 18231201 s-Pl (Norms) Government of lndia Department of Pharmaceuiicais Dated: April, 2016 Office Memorandum Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011314/AM- 16/DES-3/1808 dated the 1513116 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixaticn of norms urrder para: 4.7 foi the export of Daclatasvir dihydrochloride. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14.- S.No. lmport ltem 1 rt 1, 1 -(['1, 1 -biphenyl]-4,4-diyl)bis(2-bromoethane-1 - one) 1.303kg 2 N-(tert-butoxv carbonvl )-L-proli ne 1 481kg 3 Methoxvcarbonvl-l-val i ne 0 771kq 4 1 -(3-d imethylam i nopropyl)-3-ethyl carbod im ide hydrochloride 0 60kg 2. ρ 1/ 侭橘 PH:-23071162 ン
‐
^ F. No.350 1 1 18231201 s-Pl (Norms) Government of lndia Department of P harmaceuiicais Dated: April, 2016 Office Memorandum Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011315/AM- 16/DES-3/1824 dated the 1513116 vide which application from M/s Hetero Labs Ltd. was sent to this Department for fixation of norm.s unc'er para: 4.7 f ct the export c.rf (4R, i2aS)- 7-methoxy-4-methyl-6,8-d ioxo-3,4,6,8, 1 2,12a-hexahydro-2H- pyrido[1 ,2,4,5lpyrazinol2,1b][1,3]oxazine-9-carboxylic acid. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- S No lmport ltem 1kq Export Dimethyl oxalate 2.21kq 2 Lithiurll hydroxide 1 84kq 3 (3R)-3-amino butanol 0 47kq 4 Methvl-4-meth oxv aceto acetate 1.59kq 5 Methane sulphonic acid 0 13kq 6 Methylene chloride 5.44kq 7 methanol 2.73kq 2 （ 一 「 「 ＝ 日 Ⅳ Ｖ ｒ ′ ‐ ‐ (Rttumaり PH:-23071162 ⌒
∂Zlll F. No.350 1 1 17351201 s-Pl (Norms) Government of lndia Dated: 29 March,2016 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol'l) 2009-14
Case of M/s lnd-Swift Laboratories Ltd' The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1572lAM- 16/DES-3/1647 dated the 1gt2l16 vide which application from M/s lnd-swift Laboratories Ltd. was sent to this Department for fixation of norms under para: 4'7 for the export of Glarithromycin Granuies 275% (suspension grade)' This department has examined the matter and the following norms are furnished under para 4'7 of Hand Book of Procedures (Vol.l) 2009-14"- 2 Thisissueswiththeapprovalofcompetentauthority. PH'.- 23071162 'e1-$ 0.2777 HPMC Phthalate υ -,
~71切 戯 ′^L https://mail.gov.ir/iwc_staticflayouVshell.html?lang=sn-9ata.0.1.2.0_15121607 App‖ cation of Mノs Panacea Biotec Ltd,DGFT Ref: 01′ 82ノ050′01517ノAM‐ 16/DES‐ :‖/652 dated 16.02.2016 Mahendra∨ikram Sin9h FTDOくnc3 dgft@niC in> Date: 02/29/1604:34 Ph/1 From: "NIin Kumar」ain DBT"くntink iain@niC.in> nitink iain VC「(1 80bytes) BT/!L/05/316/2010 街← Dated:2902.2016 Dear Mr. Singh This has reference to DGFT U. O. No.0118210501015'17/AM-16/DEs-lll/1652 dated 16.02.2016. The application of M/s Panacea Biotec Ltd., New Delhi for the export of " DTwP-HepB-Hib-Pentavalent vaccine (Easy five-TT) (Each Vial of 0.5 rnl contains 1 dose)" has been examined and DGFT is requested to seek information from the firm on following points:. 1 . Potency of Pertusis Bulk in terms of OU/IU 2. Portion of Batch Production Record showing dispensing, use and reconciliation of Pertusis Bulk. 3. Detailsof itemssoughttobeimporteddutyfreeundertheauthorizationas5importinputsarementionedinpointl6,Part B of ANF 44 whereas only 03 import inputs are mentioned at point 1 (a) of Appendix 11. Kindly acknowledge the receiPt. Thanks and regards Nitin Ktinl〔rJ■:1プ潟千自興 J隋 ヽc:gtilt"E」r.き難:書薔事‐ l■P■rこTRせ■ l tir■itIはchnt〕:いざJバ圭潤柚雨薫和衡岬岡 Hiマ "、 lrド● i・Stiこllcc&1｀cclln●:=予ごヴ青可目 =i歯翻誦備面キ]由π円 BIIIr1 2、 6-ドlh FlF,()「ゴEttl■l-1.6-ヽ 1芋:Fヨマ可 〔l“ _口 (■日1ドをκJざkf「]i ttTF薫キT耳 Lゅ馴R●■ご`Neゃhlh卜11中003メメ裁 亀.→齢裁-110 oo3 ンだの5ψ脅′クに https:〃mail govi″ iwq staticハayodノshell html?lang=en― US&30120_15121607 ノ
⌒
F. No.350 1 1 16821201 s-Pl (Norms) Government of lndia Dated: 22 March,2016 Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 Case of M/s RA Chem Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501839/AM- 16/DES-3/923 dated the B/9/15 vide which application from M/s RA Chem Pharma Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Entacapone. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14.- 2. (Rajkumar) PH'.- 23071162 S.No. lmport ltem Norms Recommended for 1kq Export 1 Vanillin 2.306k9 2 Pvridine 1.02kq 3 Diethvl Amine 1 437kq 4 Toluene 1.35kg 5 Methanol 0.62ks 6 Ethyl Acetate 2.56ks 7 Ethyl Cyano Actate 0.95ks ン A
〆 F. No.350 1 1 I 60812015-PI (Norms) Government of India Udyog Bhawan, New Delhi, the December, 2015 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Inchem Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l47lAM-|6|DES-3/830 dated the 27108115 vide which application from M/s. Inchem Labs Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Ractopamine Hcl. This department has examined the matter and the following noffns are furnished under paru 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item 1 Amino Acetonitrile Hcl 1.19 2. Aluminium Chloridc 1.717 3. Phenol t.2t 4. 4(4-Hydroxyphenyl)-2-Butanone 0.70 5. \itromethane No tech justification is given in Reaction/Process. 2. (Raj Kumar) Phone:23071162 ノ
ヽ ヘ
″レ|ハ^― )η‐ し5,一 Governttent oflndia l PHENOXY METHANE/ANISOLE 1287 k9 PURITY 93%lvlAXIMUM 2 HYDROGEN PEROXIDE(60%) Ministry of Chemicals and Fertilizers lL*"--,* Departmeni of Chemicals and Petrochemi cals -tr-
Subject: Advance Authorization appiication from M/s. Clean Science and Technology Pvt. Ltd.
for the inrport of raw material against the export of GUAIACOL 99% PURITY. (Advance Authorization No. 3110065521 dated 01 'A7 'z}fi) (Advance Authorization No. 3110065626 dated 08.09'2015) Ref: u.o. No. 01/82/050/01059/AM16/DES-|ll/1194 dated I 12.2015 Ivl/s. Clean Science and Technology Pvt. Ltd. have submitted present applications for the import of raw rnaterial against the export of GUAIACOL 99% PURITY' The application haye been examined based on the addition information furnish by the firm. The Department recommends the following norms for the present Advance Authorization application. Item of 二豊型9f FXp91____ :GUAIACOL 99%PURITY 13 ACETONE This issr,ie ulith the approval of competent authority' 件 Addl lndustrial Adviser 丁el No.011‐23381430 Deptt of C&PCU O^ No ハ V
⌒ F. No.350I II54412015-PI Q{orms) Government of India O ttι ∂ New Delhi,thc Udyog Bhawan, December.2015 Office Memorandum
Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s AMI Lifesciences Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501700/AM-16/DES-3/821 dated the 20108115 vide which application from M/s. AMI Lifesciences Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the expott of Diacerein. This department has examined the matter and the following norns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S,No. Import Item 1 へloc Emodin-950/0 1.05 2. (Raj Kumar) Phone:23071162 ノ
F. No.350'1 1/686/201s-Pl (Norms) Government of lndia Dated: 23 February, 2016 Office Memorandum 14 Case of M/s Envee Drugs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01i82/50/1399/AM- 16/DES-3/10't2 dated the 27110115 vide which application from M/s Envee Drugs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Clobetasole Propionate. This department has examined the matter and the following 2 (Rajku ma r) PH:- 23071162 S.No. lmport ltem Norms Recommended for 1 kq Export Betamethasone 1.00kq
ハ i iurty N urn.'. AL-.E I\4 B rc - PHARMACEUTICALS LTD No/Datc:9/82‐ HQ Filc :01/82/050/00579/AN415/ : Committee considered case as per agenda and in the light Of written comments received rm Department of Pharmaceuticals vide their OM No. 35OLLl665l2O13-Pl(Norms) dated .OL2OL4, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below as applied by the firm, whichever is less: ヘ S No lmport item For l No Tablet 75 mg L50 mg 300 mg IRBESARTAN 75 mg 150 mg 300 mg LACTOSE MONOHYDRATE(GRANULAC‐ 20Clゝ 62.375 L2475 24950 CROSCARMELLOSE SODIUM(Ac DiSoり 14.00 28.00 4 MAGNESIUM STEARATE 1.125 4.50 may take appropriate action as per the decision Committee. ノ 314 ExpOrt productIRBESARTAN HEllMANN 75 M2,150 Mgand 300 MG FILMTABLE口 「EN
F No 35011/686/2015-Pi(Norms) Government ofindia Minlstry of Chemical&Fertilizers Dated: 23 February, 20'16 Office Memorandum 14 Case of M/s Envee Drugs Pvt. Ltd. The undersigned is directed to refer to DGFT U.O.No. 01lB2l50l1399lAM- 16/DES-3/1012 dated the 27110115 vide which application from M/s Envee Drugs Pvt. Ltd. was sent to this Department for fixation of norms under para: 4.7 for lhe export of Clobetasole Propionate. This department has examined the matter and the following 2 (Ralkumar) PH: 23071162 Directorate Ceneral of Foreign Trade, (Shtt M∨Singh,FTDO), Udyog Bhawan,New Delhi S No lmport ltem Norms Recommended for 1 kq Export 1 Betamethasone 1 00kg ν 00
0斗の F. No.350 1 I I 52412014-PI Qtrorms) Government of India Udyog Bhawan. New Delhi, the March, 2015 Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s. Wanbury Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501471/AM15/DES-3/585 dated the O5l0gll4 vide which an application from M/s. Wanbury Ltd was sent to this Department for fixation of norms under parul. 4.7 for the export of Tramadol Hydrochloride. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- つ 乙 This issues with the approval of Director (PI). (Barnali Khastgir) Phone- 23071162 Department of Commerce. S.No. Import Item /1. yclohexanone 1.00kg/kg /2. M-Bromo Anisole 1.93'' /3. Ietrahydrofuran 1.57'' 4. sopropyl Alcohol 1.18'' 5. n-Hexane 0.58'' 6. Paraformaldehyde 0.29'' /7. Methanol 1.66'' 8. foluene 0.51' 9. Dimethyl Amine Hydrochloride 0.81' /
F. No.350 1 I 1805 12013-PI Qllorms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Dated the June. 2015 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Wanbury Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501505/AM-15/DES- 311212 dated the 03/03/15 vide which application from M/s. Wanbury Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Metformin Hcl. This department has examined the matter and the following norms are fumished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S. No. Import Item l Dicyanodimide 0.567 つ ４ DMA Hcl (Di-Methylamine Hydrochloride) 0.60 3. Methanol 0.237 2. This issues with the approval of Director (PI). (Barnali Khastgir) Phone:23071162 ノ
F. No.350 1 | 17 1012013-PI (Norms) Government of India Udyog Bhawan, New Delhi, the February, 2015 Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s. Wanbury Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150120/AMl51DES-31612 dated the 08/09114 vide which an application from M/s. Wanbury Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Sertraline Hydrochloride. This department has examined the matter and the following comments are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- つ ４ This issues with the approval of Director (PI). (Barnali Khastgir) Phone- 23071162 S. No. Import Item -.'1 . Methanol 3.78 kg/kg J sopropyl Alcohol 0.75 " --2. D Mandclic Acid 0.392'' -4. Ietraloneimine 3.27 " 5. r-Hexane 0.47 " ノ
F. No.350 l 1 1 643 12015-PI Qrlorms) Government of India Ministry of Chemicals & Fertilizers Deparlment of Pharmaceuticals Udyog Bhawan,New Delhi, Dated: 1 February,20l6 Office Memorandum
Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Dhanuka Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182150110491AM-161DES- 311347 dated the l8ll2ll5 vide which application from M/s. Dhanuka Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Q.!Ug,-. ,{ryltt Amorphous Stearic acid coated 15% powder. This department has examined the matter and the つ ん (Rajkumar) Phone:23071162 fo110wi norms are fumished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- S.No. Import Item Norms Recommended for 1ke Export 1 D-7ACA (Desacetyl-7-amino cephalosporanic acid) 0.118kg 2. Phosphorous penta chloride 0.123ke 3. (Z) -2 -Methoxy imino - (Furyl -2 -yl )Ac eti c ac id ammonium salt. 0.1 1 0kg 4. Methanol 0.491ke 5。 Methylene chloride 0.413ke 6. Chlorosulphonyl isocyanate 0.0832ke 7. Acetone 0.283kg 8. 1, 1,3,3,Tetra Methyl Guanidine 0.0337kg 9. N,N Dimethyl Acetamide 0.314kg 10. Ethyl Acetate 0.296ke Stearic acid 0.843ke う 乙 Activated Carbon 0.016kR 13. 1 -Acetoxyethyl Bromide 0.0923kg ノ
0 F. No.350 I I I 643 12015-PI Qllorms) Govemment of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Dated: 1 February,2076 Office Memorandum
Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Dhanuka Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l1048lAM-16|DES- 311346 dated the 2l09l15 vide which application from M/s. Dhanuka Labs Ltd. was sent to this DepartmentforfixationofnorrnSunderpara:4.7fortheexportof@ Amorphous Stearic Acid Coated 30o/o. This department has examined the matter and the ハ 1)2009- followil norms are furnished under para 4.7 of Hand Book of'Procedures (Vol.t) 20tJ9-14:- S.No. Import ltem Norms Recommended for 1ks Export 1 DL-7‐ACA 0.236kg 2. SIⅥIA 0.2195kg 3. Phosohorous pentachloride 0.245kg 4. Chlorosulfonvl isocyanate 0.166kg 5. Activated Carbon 0.032kg 6. 1, 1,3,3-Tetramethyl guanidine 0.0675kg 7. I -Acetoxyethyl bromide 0.185kg 8. Stearic acid 0.6849kR 9. Methylene chloride 0.826kg 10. Dimethyl acetamide 0.624k只 Methanol 0.982kg つ 乙 Acetone 0.562kg う Ｄ Ethyl acetate 0.592kg 2. (Rajkumar) Phone:23077162 Dircctoratc Gcncral of Foreign Tradc, Dcpaltincnt of Commercc, (Shri M.V.Singh,FTDO), Udyog Bhawan,Ncw Delhi
F. No.350 1 1 17 481201 5-Pl (Norms) Government of lndia Dated: 3 March, 2016 Office Memorandum 14 Case of M/s Hetero Drugs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501930/AM- 16/DES-3/'1336 dated the 18112115 vide which application from M/s Hetero Drugs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Montelukast sodium. This department has examined the matter and the following 2 (Rajkumar) PH.- 23071162 S.No. lmport ltem Norms Recommended for 1kg Export 2-(2-3S-3, 2,7 -chloro-2-q u i n ol i nyl)-ethynylp henyl )-3- hvd roxv propyl )-phenyl-2-propanol 1.24k9 2 1 -(mercapto methyl)-1 -cyclopropane acetic acid 0.40ks V
F. No.350 1 1 17481201 5-Pl (Norms) Government of lndia Dated: 3 March, 2016 Office Memorandum 14 Case of M/s Hetero Drugs Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501966iAM- 16/DES-3/1340 dated the 18112115 vide which application from M/s Hetero Drugs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Esomeprazole magnesium dihydrate. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- 2 (Rajkumar) PH.- 23071162 S.No. lmport ltem Norms Recommended for 1kq Export 1 5-methoxy-2-[[(a-methoxy-3, 5-d imethylpyrid i n-2-yl) methyll thiol- 1 H-benzimidazole 1.22k9 2 Vanadvl acetyl acetonate 0.0122ks ガ (S)-(1 )1, 1 -bi-2-naphthol 1.38kg 4 Acetone 6 1lkq ″ Methanol 2 07kq y Methylene chloride 6.22kq ν
F. No.350 1 1 1361201 5-PI (I'Jorms) Government of India Ministry of Chemicals & Fertilizers Udyog Bhawan,New Delhi, Dated the June.20l5 Office Memorandum
Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case
of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215011058/AM-15/DES- 31962 dated the 06/01/15 vide which application from M/s. Hetero Labs Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Levofloxacin Hemihydrate. This department has exarnined the matter and the following norrns are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- つ ４ This issues with the approval of Director (PI). (Barnali Khastgir) Phone:23071162 S. No. Import Item 1 Ethyl(S )-9, 1 0-Difl uoro-3 -Methyl- 7 -Oxo -2,3 - Dihydro-7H-Pyrido( 1,2,3 -DE)- 1,4 -Benzoxazine-6- Carboxylate 0.8571 y
」 ， ′ uuf r'7 5t1 F. No.3501 1182312015-Pt (Norms) Government of India Department of Pha rmaceuticals Dated: April, 2016 Of[ice Memorandum
Subject: - Fixation-of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2OOg-14
Case of M/s Hetero Labs Ltd. The undersigned is directed to refer to DGFT U.o.No. o1lg2t5ol1312lAw- 16/DES-3/1831 dated the 1513t16 vide which application from Mis Hetero Labs Ltd. was sent to this Department for fixation of norms under para: 4.7 for the export of Olmesartan Medoxomil. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 20Og-14.- PH:- 23071162 2. Ethyl-4-( 1 -hyd roxy- 1 -m ethytethytl-Z-propl im idzole-5-ca rboxylate N-(triphenyt methyt)-s-14-or@ 2-vl)tetrazole Methanol ′ ⌒
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一 二 Lニ ユ. 己__ ._ ⌒ ザ θ 3//矛 gゎ F. No.3501 1t823t2015-Pt (Norms) Government of lndia l/inistry of Chemical & Fertilizers Department of pharrnaceuticals Udyogl::麟 :n'哭:H,TI: Office Memorandum SutteCt:― F破ation of norms under para 4.7 of Hand B00k of PЮ cedureS(VOI・|)2009-14 Case of M′ s Hetero Drugs Ltd. 丁he undersigned is directed to refer tO DGFtt U.〇.No.01/82/50/1326/AM― 16/DES-3/1564 dated the 15/1/16 vide、 vhich application from Allノs HeterO Drugs Ltd. vvas sent to this Department for fixation of norrns under para: 4.7 fOr the export of 2,3,4,5‐ Bis… 0‐ (1‐methyiethylidene)― β― D‐fructopyranose. 丁his department has exanη ined the matter and the fo‖ owing norrrns are furnished under para 4 7 of Harld Book of Procedures(Vol.り2009-14:― 2. PH:-23071162 S.No. Import ltem 1ks Export D(-)Fructose 1.434kg 2 Acetone 1.85kq 3 Toluene 1 565kg υ
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