DGFT Committee Minutes
Office of Directorate General of Foreign Trade
New Delhi -110011
Para 4.7 Decision
MEETING NUMBER
: 8/82-ALC4/2015 MEETING DATE : 16.09.2015
Meeting No. 08/82/2015 of 2015-16, 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, was scheduled for 16.09.2015 but actually held on 21.09.2015
under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.11, Udyog Bhawan, New Delhi.
Following members were present:-
Shri Nirmal Kumar, Dy.DGFT
Shri D.N. Mathur, Consultant, Department of Pharmaceutical
Shri Mahendra Vikram Singh, Foreign Trade Development Officer
The committee went through the minutes of earlier NC –III meeting No. 07/82 was scheduled for 24.07.2015 but actually held on 26.08.2015 and approved the same.
The following cases/issues were discussed and the committee took the decision as mentioned against each case.
1
Case No.:132/8/82-
ALC4/2014
Party Name:PROVENTUS
LIFE SCIENCES PRIVATE
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
Decision : The committee noted that information called for from the firm is awaited. The
Committee accordingly decided to defer the case.
2
Case No.:353/5/82-
ALC4/2015
Party Name:STERLING
AUXILIARIES PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00493/AM16/
RLA File
:03/95/040/00130/AM11/
Lic.No/Date:0310575673
24.05.2010
Defer
Date:15.10.2015
Decision : The Committee considered the case for ratification of norms and decided to defer the
case for want of comments from DEPARTMENT OF C&PC
3
Case No.:14/24/82-
ALC4/2010
Party Name:SAINOR
LABORATORIES PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00814/AM11/
RLA File
:09/24/040/00210/AM11/
Lic.No/Date:0910043414
08.09.2010
Defer
Date:15.10.2015
4
Case No.:42/20/82-
ALC4/2013
Party Name:GLAND
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
RLA File
Lic.No/Date:0910056110 Defer
:01/82/050/01028/AM14/
:09/24/040/00058/AM14/
23.05.2013
Date:15.10.2015
Decision : The committee noted that information called for from the firm is awaited. The
Committee accordingly decided to defer the case.
5
Case No.:173/5/82-
ALC4/2015
Party Name:FORACE
POLYMERS (P) LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
6
Case No.:25/1/82-
ALC4/2015
Party Name:VIJAYASRI
ORGANICS LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/01551/AM15/
RLA File
:09/24/040/00152/AM14/
Lic.No/Date:0910056835
19.07.2013
Defer Date:
Decision : The committee decided to ratify the in light of the earlier decision taken by NC in its
meeting No.05/AM16 as per details given below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg/kg
4-FLUORO-a-2-METHYL-1-
OXOPROPYL,)-G-OXO-N-B-
DIPHENYL
BENZENE
BUTANEAMIDE
(DIKETONE-
INTERMEDIATE
FOR
ATORVASTATIN)/DKT-3
1kg
FLUOROBENZENE
0.52
METHELENE DICHLORIDE (MDC)
2.00
METHYL ISO BUTYRYL ACETATE
(MIBA)
0.76
METHANOL
0.50
RA may take further action accordingly.
7
Case No.:43/16/82-
ALC4/2013
Party Name:SYMBIOTEC
PHARMALAB LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00856/AM14/
RLA File
:56/24/040/00017/AM14/
Lic.No/Date:5610002765
03.09.2013
Defer
Date:15.10.2015
Decision : In the light of written comments received from D/o Pharmaceuticals vide their OM
No35011/364/2014-PI(Norms) January, 2015, it was decided to call for information from the firm:
- The mol.wt. of import item shown in the chemical reaction does not match with literature therefore advised to furnish correct information and revise the chemistry.
- % Yield on molar basis may be furnished based on the actual plant data.
- Past –production vis-à-vis actual consumption of import item duly certified by Central Excise Authorities. The Committee accordingly decided to defer the case.
8
Case No.:82/23/82-
ALC4/2013
Party Name:DEEPAK
NITRITE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01129/AM14/
RLA File
:34/24/040/00212/AM14/
Lic.No/Date:3410038711
12.12.2013
Defer
Date:15.10.2015
9
Case No.:374/5/82-
ALC4/2015
Party Name:SURVIVAL
TECHNOLOGIES
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00514/AM16/
RLA File
:03/95/040/01015/AM14/
Lic.No/Date:0310775114
20.03.2014
Defer
Date:15.10.2015
10
Case No.:92/8/82-
ALC4/2015
Party Name:YASHASHVI
RASAYAN PVT.LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00888/AM16/
RLA File
:52/24/040/00055/AM14/
Lic.No/Date:5210040903
02.04.2014
Defer
Date:15.10.2015
11
Case No.:33/8/82-
ALC4/2015
Party
Name:METROCHEM API
PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Approved
HQ File
:01/82/050/00829/AM16/
RLA File
:09/24/040/00035/AM15/
Lic.No/Date:0910059900
28.04.2014
Defer Date:
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide letter No.35011/169/2015-PI (Norms) dt. Sept. 2015 as per
details given below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg/kg
2-Chloromethyl-4-(3-
methoxy propoxy)-3-methyl
pyridine Hydrochloride
1kg
1
2,3 Dimethylpyridine (2,3
Lutidine)
1.00
2
3-Methoxy-1- propanol
1.187
12
Case No.:76/10/82-
ALC4/2014
Party Name:KUDOS
CHEMIE LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00990/AM15/
RLA File
:22/24/040/00099/AM14/
Lic.No/Date:2210014839
29.04.2014
Defer
Date:15.10.2015
Decision : The committee in light of the written comment of D/o Pharmaceuticals forwarded vide
O.M.No.35011/642/2014-PI(Norms) dated May 2015 decided to call for Past Production vis-à-vis
Actual Consumption of all the imported inputs year wise for last 3 years duly certified by Central
Excise Authorities from the firm and defer the case.
13
Case No.:238/6/82-
ALC4/2014
Party Name:ESTEEM
INDUSTRIES PVT. LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00640/AM15/
RLA File
:17/24/040/00008/AM15/
Lic.No/Date:1710005810
09.05.2014
Defer
Date:15.10.2015
14
Case No.:383/5/82-
ALC4/2015
Party Name:DR REDDYS
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00523/AM16/
RLA File
:09/24/040/00019/AM15/
Lic.No/Date:0910060081
13.05.2014
Defer
Date:15.10.2015
case for want of comments from D/o Pharmaceuticals.
15
Case No.:14/5/82-
ALC4/2015
Party Name:YASHASHVI
RASAYAN PVT.LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00154/AM16/
RLA File
:52/24/040/00009/AM15/
Lic.No/Date:5210041040
13.05.2014
Defer
Date:15.10.2015
16
Case No.:15/5/82-
ALC4/2015
Party Name:ASCENT
FINECHEM PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00155/AM16/
RLA File
:08/24/040/00055/AM15/
Lic.No/Date:0810131405
19.05.2014
Defer
Date:15.10.2015
17
Case No.:88/6/82-
ALC4/2014
Party Name:UPL
LTD.(FORMERLY
UNITED PHOSPHORUS
LTD.)
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00490/AM15/
RLA File
:03/95/040/00033/AM15/
Lic.No/Date:0310782129
20.05.2014
Defer
Date:15.10.2015
18
Case No.:9/10/82-
ALC4/2014
Party Name:EMCURE
PHARMACEUTICALS
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00923/AM15/
RLA File
:31/83/040/00032/AM15/
Lic.No/Date:3110064004
21.05.2014
Defer
Date:15.10.2015
Decision : The Committee noted that information called for from the firm is awaited. Accordingly
decided to defer the case.
19
Case No.:1/3/82-
ALC4/2015
Party Name:BALAJI
AMINES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00031/AM16/
RLA File
:31/83/040/00006/AM15/
Lic.No/Date:3110064305
05.06.2014
Defer
Date:15.10.2015
20 Case No.:61/4/82- Party Name:V & V Meet No/Date:8/82- Status:Case
ALC4/2014
PHARMA INDUSTRIES
ALC4/2015
16.09.2015
Deferred
HQ File
:01/82/050/00309/AM15/
RLA File
:03/95/040/00190/AM15/
Lic.No/Date:0310785305
13.06.2014
Defer
Date:15.10.2015
21
Case No.:364/5/82-
ALC4/2015
Party Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00504/AM16/
RLA File
:09/24/040/00124/AM15/
Lic.No/Date:0910060469
17.06.2014
Defer
Date:15.10.2015
22
Case No.:164/6/82-
ALC4/2014
Party Name:VDH CHEM
TECH PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00566/AM15/
RLA File
:05/24/040/00085/AM15/
Lic.No/Date:0510388792
18.06.2014
Defer
Date:15.10.2015
23
Case No.:68/10/82-
ALC4/2014
Party Name:LEBEN
LABORATORIES
PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00982/AM15/
RLA File
:03/95/040/00230/AM15/
Lic.No/Date:0310785856
23.06.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/53 /2015-PI (Norms) dt. 14.09.2015 as per
Export product
Qty.
Import items
Qty.
Doxycycline
Capsules
100mg BP
1
capsule
Doxycycline Hydrochloride/Hyclate BP 117mg/Capsule
24
Case No.:170/6/82-
ALC4/2014
Party Name:SOFTGEL
HEALTH CARE PVT.
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00572/AM15/
RLA File
:04/24/040/00032/AM15/
Lic.No/Date:0410158822
24.06.2014
Defer
Date:15.10.2015
25
Case No.:69/4/82-
ALC4/2014
Party Name:RA CHEM
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00317/AM15/
RLA File
:09/24/040/00175/AM15/
Lic.No/Date:0910060550
27.06.2014
Defer
Date:15.10.2015
26
Case No.:73/9/82-
ALC4/2014
Party Name:D. R. COATS
INK & RESINS PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00870/AM15/
RLA File
:03/94/040/00755/AM14/
Lic.No/Date:0310786181
30.06.2014
Defer
Date:15.10.2015
27
Case No.:204/6/82-
ALC4/2014
Party Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00606/AM15/
RLA File
:05/24/040/00192/AM14/
Lic.No/Date:0510389448
08.07.2014
Defer
Date:15.10.2015
28
Case No.:211/6/82-
ALC4/2014
Party Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00613/AM15/
RLA File
:05/24/040/00191/AM14/
Lic.No/Date:0510389447
08.07.2014
Defer
Date:15.10.2015
29
Case No.:370/5/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00510/AM16/
RLA File
:09/24/040/00193/AM15/
Lic.No/Date:0910060634
09.07.2014
Defer
Date:15.10.2015
30
Case No.:26/9/82-
ALC4/2014
Party Name:ALMELO PVT
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00823/AM15/
RLA File
:09/24/040/00188/AM15/
Lic.No/Date:0910060660
11.07.2014
Defer
Date:15.10.2015
31
Case No.:375/5/82-
ALC4/2015
Party Name:NECTAR
LIFESCIENCES LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00515/AM16/
RLA File
:22/24/040/00023/AM15/
Lic.No/Date:2210015018
12.07.2014
Defer
Date:15.10.2015
3 2
Case No.:88/9/82-
ALC4/2014
Party
Name:MAC CHEM PRODUCTS (INDIA) PRI
VATE LIMITED
Meet
No/Date:8/82-
ALC4/2015
16.09.2015
Status:Cas
e Deferred
HQ File
:01/82/050/00885/
AM15/
RLA File :03/95/040/00302/AM15/
Lic.No/Date:03107
86782
14.07.2014
Defer
Date:15.10.
2015
33
Case No.:365/5/82-
ALC4/2015
Party Name:NECTAR
LIFESCIENCES LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00505/AM16/
RLA File
:22/24/040/00028/AM15/
Lic.No/Date:2210015020
15.07.2014
Defer
Date:15.10.2015
34
Case No.:108/9/82-
ALC4/2014
Party Name:NECTAR
LIFESCIENCES LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00905/AM15/
RLA File
:22/24/040/00083/AM14/
Lic.No/Date:2210015019
15.07.2014
Defer
Date:15.10.2015
35
Case No.:94/5/82-
ALC4/2015
Party Name:SHREE
BANKEY BEHARI LAL
BOARD MILLS
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00234/AM16/
RLA File
:05/24/040/00126/AM15/
Lic.No/Date:0510389737
16.07.2014
Defer
Date:15.10.2015
36
Case No.:248/13/82-
ALC4/2014
Party Name:REANNON
PHARMACEUTICALS
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Deffered
HQ File
:01/82/050/01251/AM15/
RLA File
:03/95/040/00325/AM15/
Lic.No/Date:0310786993
17.07.2014
Defer
Date:15.10.2015
Decision : The Committee considered the case for ratification of norms. The representative of
D/o Pharmaceuticals stated that quantity of import items is not correct. Therefore the Committee
decided advise the firm to correct the import quantity applied by the him.
37
Case No.:1/6/82-
ALC4/2014
Party Name:ARJUN
CHEMICALS PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00403/AM15/
RLA File
:04/24/040/00061/AM15/
Lic.No/Date:0410159021
18.07.2014
Defer
Date:15.10.2015
38
Case No.:79/9/82-
ALC4/2014
Party
Name:METROPOLITAN
EXIMCHEM LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00876/AM15/
RLA File
:03/95/040/00337/AM15/
Lic.No/Date:0310787073
18.07.2014
Defer
Date:15.10.2015
39
Case No.:24/9/82-
ALC4/2014
Party Name:BRUNDAVAN
LABORATORIES
PRIVATE LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00821/AM15/
RLA File
:09/24/040/00104/AM15/
Lic.No/Date:0910060703
22.07.2014
Defer
Date:15.10.2015
40
Case No.:78/9/82-
ALC4/2014
Party Name:PACE
PHARMATECH PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00875/AM15/
RLA File
:03/95/040/00347/AM15/
Lic.No/Date:0310787160
22.07.2014
Defer
Date:15.10.2015
Decision : The committee in light of the comments of D/o Pharmaceuticals forwarded vide
O.M.No.35011/583/2014-PI(Norms) dt. 09.3.2015 decided to call for following information from the
firm:
- The description of export product along with the quantity and FoB value of the export consignment.
- The pack size of export product
- The master batch Formula for the Export Product.
- In case the export product is Lincomycin Hcl Rolls, relevant copy of DML for this product may be furnished.
41
Case No.:396/5/82-
ALC4/2015
Party Name:ESTEEM
INDUSTRIES PVT. LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00536/AM16/
RLA File
:17/24/040/00047/AM15/
Lic.No/Date:1710005887
24.07.2014
Defer
Date:15.10.2015
42
Case No.:8/6/82-
ALC4/2014
Party Name:V & V
PHARMA INDUSTRIES
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00410/AM15/
RLA File
:03/95/040/00331/AM15/
Lic.No/Date:0310787382
28.07.2014
Defer
Date:15.10.2015
43
Case No.:209/13/82-
ALC4/2014
Party Name:AVA
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01212/AM15/
RLA File
:03/94/040/00379/AM15/
Lic.No/Date:0310787473
31.07.2014
Defer
Date:15.10.2015
44
Case No.:58/9/82-
ALC4/2014
Party Name:G AMPHRAY
LABORATORIES,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Deffered
HQ File
:01/82/050/00855/AM15/
RLA File
:03/94/040/00171/AM15/
Lic.No/Date:0310787536
01.08.2014
Defer
Date:15.10.2015
45
Case No.:49/9/82-
ALC4/2014
Party Name:SANMAR
SPECIALITY
CHEMICALS LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00846/AM15/
RLA File
:04/24/040/00106/AM15/
Lic.No/Date:0410159125
01.08.2014
Defer
Date:15.10.2015
46
Case No.:31/9/82-
ALC4/2014
Party Name:AMBERNATH
ORGANICS PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00828/AM15/
RLA File
:03/94/040/00074/AM15/
Lic.No/Date:0310787610
04.08.2014
Defer
Date:15.10.2015
47
Case No.:44/9/82-
ALC4/2014
Party Name:INTAS
PHARMACEUTICALS
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00841/AM15/
RLA File
:08/24/040/00173/AM15/
Lic.No/Date:0810132883
04.08.2014
Defer
Date:15.10.2015
Decision : The Committee considered the case for ratification of norms and decided to decided to
call for following information from the firm:
- COA of the imported API from the foreign Supplier for the relevant consignment
- The applied norms do not match with CA certificate furnished. Justification for the same may be furnished.
48
Case No.:373/5/82-
ALC4/2015
Party Name:NECTAR
LIFESCIENCES LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00513/AM16/
RLA File
:22/24/040/00039/AM15/
Lic.No/Date:2210015055
06.08.2014
Defer
Date:15.10.2015
49
Case No.:203/5/82-
ALC4/2015
Party Name:ALKALOIDS
CORPORATION
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
50
Case No.:42/13/82-
ALC4/2014
Party Name:INCHEM
LABORATORIES
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01045/AM15/
RLA File
:09/24/040/00242/AM15/
Lic.No/Date:0910060833
07.08.2014
Defer
Date:15.10.2015
51
Case No.:105/9/82-
ALC4/2014
Party Name:SCOTT-EDIL
PHARMACIA LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00902/AM15/
RLA File
:22/24/040/00035/AM15/
Lic.No/Date:2210015058
07.08.2014
Defer
Date:15.10.2015
52
Case No.:53/9/82-
ALC4/2014
Party Name:ONEIRO
CHEMICALS LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00850/AM15/
RLA File
:34/24/040/00111/AM15/
Lic.No/Date:3410040436
11.08.2014
Defer
Date:15.10.2015
53
Case No.:8/9/82-
ALC4/2014
Party Name:RANBAXY
LABORATORIES LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00805/AM15/
RLA File
:05/24/040/00202/AM15/
Lic.No/Date:0510390250
11.08.2014
Defer
Date:15.10.2015
54
Case No.:93/9/82-
ALC4/2014
Party Name:YASHO
INDUSTRIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00890/AM15/
RLA File
:03/95/040/00412/AM15/
Lic.No/Date:0310787910
11.08.2014
Defer
Date:15.10.2015
55
Case No.:23/9/82-
ALC4/2014
Party Name:BIO-TECH
OPHTHALMICS PVT.
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00820/AM15/
RLA File
:08/24/040/00176/AM15/
Lic.No/Date:0810132955
12.08.2014
Defer
Date:15.10.2015
Decision : In the light of written comments received from D/o Pharmceuticals vide their OM No.
35011/19/2014-PI (Norms) dt. 12.06.2015 It was decided to call for following information from the
firm:
i. Copy of valid Drug Manufacturing License for different composition of Sodium Hyaluronate
Opthalimic Solution and respective sizes of vials.
ii. Exact number of vials of sodium hyaluronate opthalimic solution of different compositions to be
exported against this application.
iii. Quantity of sodium hyaluronate MMW or LMW needed for production of each of the
composition of sodium hyaluronate opthalimic solutions.
iv. Actual consumption data of sodium hyaluronate MMW/LMW and different packing component
(applied for import) during last 3 years against production of sodium hyaluronate opthalimic
solutions of different composition and the justification of wastage of each component. The figures
of actual production and consumption may be duly certified by an independent Chartered
Accountant.
56
Case No.:21/9/82-
ALC4/2014
Party Name:PI
INDUSTRIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
57
Case No.:211/13/82-
ALC4/2014
Party Name:AVA
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01214/AM15/
RLA File
:03/94/040/00423/AM15/
Lic.No/Date:0310788032
14.08.2014
Defer
Date:15.10.2015
58
Case No.:48/5/82-
ALC4/2015
Party Name:VISION
DRUGS PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00188/AM16/
RLA File
:09/24/040/00260/AM15/
Lic.No/Date:0910060860
18.08.2014
Defer
Date:15.10.2015
59
Case No.:378/5/82-
ALC4/2015
Party
Name:CATAPHARMA
CHEMICALS PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00518/AM16/
RLA File
:31/83/040/00115/AM15/
Lic.No/Date:3110064753
19.08.2014
Defer
Date:15.10.2015
60
Case No.:60/13/82-
ALC4/2014
Party Name:VERDANT
LIFE SCIENCES PVT
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01063/AM15/
RLA File
:09/24/040/00238/AM15/
Lic.No/Date:0910060869
20.08.2014
Defer
Date:15.10.2015
61
Case No.:41/9/82-
ALC4/2014
Party Name:RANBAXY
LABORATORIES LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00838/AM15/
RLA File
:05/24/040/00217/AM15/
Lic.No/Date:0510390638
21.08.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 60 /2015-PI (Norms) dt. 15.09. 2015 as per
Export product
Qty.
Import items for one Tablet
LAMIVUDINE 150 MG+NEVIRAPINE
200
MG+ZIDOVUDINE
300
MG
Tablets
Lamivudine
Nevirapine
Zidovudine
153.0mg
204.0mg
306.omg
LAMIVUDINE 150 MG+ZIDOVUDINE
300 MG Tablets
153.0mg
Nil
306.omg
62
Case No.:240/5/82-
ALC4/2015
Party Name:VIC
INDUSTRIES,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00380/AM16/
RLA File
:17/24/040/00054/AM15/
Lic.No/Date:1710005896
22.08.2014
Defer
Date:15.10.2015
63
Case No.:229/13/82-
ALC4/2014
Party Name:AVA
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01232/AM15/
RLA File
:03/94/040/00465/AM15/
Lic.No/Date:0310788333
25.08.2014
Defer
Date:15.10.2015
64
Case No.:215/13/82-
ALC4/2014
Party Name:GOLD STAR
CHEMICALS PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01218/AM15/
RLA File
:03/94/040/00358/AM15/
Lic.No/Date:0310788338
25.08.2014
Defer
Date:15.10.2015
65
Case No.:45/13/82-
ALC4/2014
Party Name:HETERO
DRUGS LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Rejected
HQ File
:01/82/050/01048/AM15/
RLA File
:09/24/040/00275/AM15/
Lic.No/Date:0910060885
25.08.2014
Defer Date:
Decision : It was decided to reject the case as the firm has not furnished the requisite information
despite reminder.
66
Case No.:46/13/82-
ALC4/2014
Party Name:HETERO LABS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/01049/AM15/
RLA File
:09/24/040/00271/AM15/
Lic.No/Date:0910060886
25.08.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/580/2015-PI (Norms) dated May, 2015 as
per details given below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
Tenofovir Disoproxil
1kg
(R)-9-[2-(phosphono
methoxy)propyl]-adenine
Monohydrate
0.80
67
Case No.:368/5/82-
ALC4/2015
Party Name:MICRO LABS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00508/AM16/
RLA File
:07/24/040/00108/AM15/
Lic.No/Date:0710106537
25.08.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 499 /2014-PI (Norms) dt. 09.2.2015 as per
Export product
Import items
Qty.kg
CIPROFLOXACIN
250
MG
TABLETS
CIPROFLOXACIN BP/EP/USP/IP
296.9 mg / 250 mg tablet
CIPROFLOXACIN 500 MG TABLETS
CIPROFLOXACIN BP/EP/USP/IP 593.8mg/500mg Tablet
68
Case No.:264/13/82-
ALC4/2014
Party Name:BAYER
CROPSCIENCE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
69
Case No.:42/9/82-
ALC4/2014
Party Name:CADILA
PHARMACEUTICALS
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00839/AM15/
RLA File
:08/24/040/00197/AM15/
Lic.No/Date:0810133103
26.08.2014
Defer
Date:15.10.2015
70
Case No.:255/13/82-
ALC4/2014
Party Name:THE
DHARAMSI MORARJI
CHEMICAL CO LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01258/AM15/
RLA File
:03/95/040/00431/AM15/
Lic.No/Date:0310788373
26.08.2014
Defer
Date:15.10.2015
71
Case No.:382/5/82-
ALC4/2015
Party Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00522/AM16/
RLA File
:34/24/040/00129/AM15/
Lic.No/Date:3410040491
27.08.2014
Defer
Date:15.10.2015
72
Case No.:377/5/82-
ALC4/2015
Party Name:ENCUBE
ETHICALS PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00517/AM16/
RLA File
:03/94/040/00493/AM15/
Lic.No/Date:0310788472
27.08.2014
Defer
Date:15.10.2015
73
Case No.:43/9/82-
ALC4/2014
Party Name:SARV BIO
LABS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00840/AM15/
RLA File
:05/24/040/00203/AM15/
Lic.No/Date:0510390783
27.08.2014
Defer
Date:15.10.2015
Decision : The Committee decided to remind the firm to furnish the information/documents which were
earlier called for vide minutes of Norms Committee meeting No.01/82 dt. 15.4.2015 uploaded on the DGFT
website.
74
Case No.:456/5/82-
ALC4/2015
Party Name:CLARION
DRUGS LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00596/AM16/
RLA File
:50/24/040/00006/AM15/
Lic.No/Date:5010002152
28.08.2014
Defer
Date:15.10.2015
75
Case No.:224/13/82-
ALC4/2014
Party Name:DELTA
FINOCHEM PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01227/AM15/
RLA File
:03/94/040/00391/AM15/
Lic.No/Date:0310788515
28.08.2014
Defer
Date:15.10.2015
76 Case No.:225/13/82-
ALC4/2014
Party Name:DELTA
FINOCHEM PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
Status:Case
Deferred
16.09.2015
HQ File
:01/82/050/01228/AM15/
RLA File
:03/94/040/00397/AM15/
Lic.No/Date:0310788514
28.08.2014
Defer
Date:15.10.2015
77
Case No.:256/13/82-
ALC4/2014
Party Name:NAVIN
FLUORINE
INTERNATIONAL
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01259/AM15/
RLA File
:03/95/040/00371/AM15/
Lic.No/Date:0310788509
28.08.2014
Defer
Date:15.10.2015
78
Case No.:257/13/82-
ALC4/2014
Party Name:NAVIN
FLUORINE
INTERNATIONAL LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/01260/AM15/
RLA File
:03/95/040/00369/AM15/
Lic.No/Date:0310788508
28.08.2014
Defer Date:
Department of DEPARTMENT OF C&PC letter No14010/92/2011-Ch-II dt. 11.09. 2015 as per
Export product
Qty.
Import items
Qty.kg
1-BROMO-3,4,5-
TRIFLUORO BENZENE
(Purity Minimum 99.90%)
1kg
1-BROMO-3,4,5-TRIFLUORO
BENZENE (Purity Maximum
99.50%)
1.04
79
Case No.:262/13/82-
ALC4/2014
Party Name:ANTHEA
AROMATICS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01265/AM15/
RLA File
:03/94/040/00971/AM14/
Lic.No/Date:0310788560
01.09.2014
Defer
Date:15.10.2015
80
Case No.:263/13/82-
ALC4/2014
Party Name:ANTHEA
AROMATICS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
81
Case No.:223/13/82-
ALC4/2014
Party Name:KRISHNA
ANTIOXIDANTS PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01226/AM15/
RLA File
:03/94/040/00508/AM15/
Lic.No/Date:0310788647
02.09.2014
Defer
Date:15.10.2015
82
Case No.:3/7/82-
ALC4/2014
Party Name:S V CHEM
INTERMEDIATES P LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00647/AM15/
RLA File
:04/24/040/00139/AM15/
Lic.No/Date:0410159328
02.09.2014
Defer
Date:15.10.2015
83
Case No.:75/9/82-
ALC4/2014
Party Name:NEUTEC
HEALTHCARE (P)
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00872/AM15/
RLA File
:05/24/040/00235/AM15/
Lic.No/Date:0510390973
04.09.2014
Defer
Date:15.10.2015
case for want of comments from d/o Pharmaceuticals.
84
Case No.:401/5/82-
ALC4/2015
Party Name:ONEIRO
CHEMICALS LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00541/AM16/
RLA File
:34/24/040/00141/AM15/
Lic.No/Date:3410040510
04.09.2014
Defer
Date:15.10.2015
case for want of comments from d/o Pharmaceuticals.
85
Case No.:71/13/82-
ALC4/2014
Party Name:INCHEM
LABORATORIES
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01074/AM15/
RLA File
:09/24/040/00313/AM15/
Lic.No/Date:0910060931
10.09.2014
Defer
Date:15.10.2015
case for want of comments from d/o Pharmaceuticals.
86
Case No.:25/13/82-
ALC4/2014
Party Name:TITAN
LABORATORIES PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/01028/AM15/
RLA File
:03/95/040/00465/AM15/
Lic.No/Date:0310789100
12.09.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 58/2015-PI (Norms) dt. 14.09. 2015 as per
Export product
Qty.
Import items
Qty.kg
ORLISTAT PELLETS 50 %
1kg
1
ORLISTAT
0.505
2
STARLAC (Compound of
Maize Starch USP/NF,EP &
Lactose Monohydrate
USP/NF,EP)
Does not
match
with
control of
materials furnished by firm 3 POLYVINYL PYROLIDONE K-30 (PVPK-30) 0.05
87
Case No.:81/5/82-
ALC4/2015
Party Name:RUCHI
INFRASTRUCTURE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00221/AM16/
RLA File
:56/24/040/00034/AM15/
Lic.No/Date:5610004407
15.09.2014
Defer
Date:15.10.2015
Decision : The committee in light of the written comment of D/o DEPARTMENT OF C&PC
forwarded vide O.M.No.14010/17/2014-CH-II dated 23rd July 2015 decided to call for following
information from the firm:-
- Copy of the Advance Authorisation issued by theDGFT for the export of 7000MT Bio diesel.
- Specific chemical name and technical specifications of Bio Diesel to be exported along with copy of export order.
- It is noted that procurement of RBD Stearin is being done by Ruchi Infrastructure Ltd., Kakinada from Ruchi soya Industries ltd., Kakinada for supply to the supporting manufacturer i.e. Universal Biofuel Pvt. Ltd.. Please indicate the details for eligibility for procurement of RBD Strearin under duty Exemption Scheme.
- Detailed manufacturing process with balance chemical reactions indicating number of moles of all reactants, products and by products with corresponding molecular formulac, structural formulae, molecular weight and process flow diagram.
- Stage wise percentage yield with respect of each of the reactant and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import.
- Details of by products formed during the process and the recovery of solvents in terms of quantity and value.
- Details of production of Standard soya Lecithin food Grade and corresponding consumption of soya lecithin Industrial Grade in the year 2013-14, 2014-15 and 2015-16 (April to June ) duly certified by CA. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA.
- Any other relevant information, if any.
88
Case No.:391/5/82-
ALC4/2015
Party Name:TIDE
INDUSTRIES
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00531/AM16/
RLA File
:34/24/040/00138/AM15/
Lic.No/Date:3410040551
15.09.2014
Defer
Date:15.10.2015
Decision : The committee in light of the written comment of D/o C&PC forwarded vide
O.M.No.14010/40/2011-CH-II dated 28 July 2015 decided to call for following information from the firm:-
- Detailed manufacturing process with balanced chemical reactions indicating number of moles of all the reactants, products and by-products with corresponding molecular Formula structural formula molecular weight and process flow diagram. 2. Stage wise percentage yield with respect of each of the reactant and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import. 3. Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process. 4. Details of by products formed during the process and the recovery of solvents in terms of quantity and value. 5. Details of production of export product under reference and corresponding consumption of raw material in the year 2014-15, 2015-16 (April to June) 6. Any other relevant information, if any.
89
Case No.:398/5/82-
ALC4/2015
Party Name:YASH
RASAYAN & CHEMICALS
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00538/AM16/
RLA File
:34/24/040/00122/AM15/
Lic.No/Date:3410040555
15.09.2014
Defer
Date:15.10.2015
Decision : The Committee decided to remind the firm to furnish the information/documents which were
earlier called for vide minutes of Norms Committee meeting No.05/82 dt. 25.06.2015 uploaded on the
DGFT website.
90
Case No.:400/5/82-
ALC4/2015
Party Name:YASH
RASAYAN & CHEMICALS
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00540/AM16/
RLA File
:34/24/040/00120/AM15/
Lic.No/Date:3410040554
15.09.2014
Defer
Date:15.10.2015
91
Case No.:12/15/82-
ALC4/2014
Party Name:JINDAL
DRUGS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01299/AM15/
RLA File
:03/94/040/00460/AM15/
Lic.No/Date:0310789265
16.09.2014
Defer
Date:15.10.2015
92
Case No.:380/5/82-
ALC4/2015
Party Name:THEON
PHARMACEUTICALS
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
case for want of comments from Pharmaceuticals.
93
Case No.:399/5/82-
ALC4/2015
Party Name:ALCHEM
INTERNATIONAL LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00539/AM16/
RLA File
:05/23/040/00235/AM15/
Lic.No/Date:0510391191
18.09.2014
Defer
Date:15.10.2015
case for want of comments from Pharmaceuticals.
94
Case No.:381/5/82-
ALC4/2015
Party Name:ASCENT
FINECHEM PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00521/AM16/
RLA File
:08/24/040/00207/AM15/
Lic.No/Date:0810133388
19.09.2014
Defer
Date:15.10.2015
Decision : The committee in light of the written comment of D/o DEPARTMENT OF C&PC
forwarded vide O.M.No.14010/1/2012-CH-II dated 13rd August, 2015 decided to call for following
information from the firm:-
-
Detailed manufacturing process with balance chemical reactions indicating number of moles of all reactants, products and by products with corresponding molecular formulae, structural formulae, molecular weight and process flow diagram.
-
Stage wise percentage yield with respect of each of the reactant and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import.
-
Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process.
-
Details of by products formed during the process and the recovery of solvents in terms of quantity and value.
-
Details of production of Standard soya Lecithin food Grade and corresponding consumption of soya lecithin Industrial Grade in the year 2014-15 and 2015-16 (April to June ) duly certified by CA. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA.
-
Any other relevant information, if any.
95
Case No.:390/5/82-
ALC4/2015
Party Name:ATUL
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00530/AM16/
RLA File
:08/24/040/00225/AM15/
Lic.No/Date:0810133394
19.09.2014
Defer
Date:15.10.2015
96
Case No.:376/5/82-
ALC4/2015
Party
Name:R.K.INDUSTRIES,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00516/AM16/
RLA File
:08/24/040/00231/AM15/
Lic.No/Date:0810133412
23.09.2014
Defer
Date:15.10.2015
97
Case No.:49/5/82-
ALC4/2015
Party Name:VISION
DRUGS PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00189/AM16/
RLA File
:09/24/040/00336/AM15/
Lic.No/Date:0910061013
23.09.2014
Defer
Date:15.10.2015
98
Case No.:176/13/82-
ALC4/2014
Party Name:BDR
PHARMACEUTICALS
INTERNATIONAL PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01179/AM15/
RLA File
:03/94/040/00361/AM15/
Lic.No/Date:0310789985
07.10.2014
Defer
Date:15.10.2015
99
Case No.:179/13/82-
ALC4/2014
Party Name:AVA
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01182/AM15/
RLA File
:03/94/040/00622/AM15/
Lic.No/Date:0310790000
08.10.2014
Defer
Date:15.10.2015
100
Case No.:372/5/82-
ALC4/2015
Party Name:DR J
PHARMACHEM
(INDIA)(PROP.ADITYA
PRAMOD JOGDEO)
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00512/AM16/
RLA File
:31/83/040/00154/AM15/
Lic.No/Date:3110064948
08.10.2014
Defer
Date:15.10.2015
101
Case No.:29/13/82-
ALC4/2014
Party Name:JUBILANT
LIFE SCIENCES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01032/AM15/
RLA File
:05/23/040/00268/AM15/
Lic.No/Date:0510391490
08.10.2014
Defer
Date:15.10.2015
102
Case No.:356/5/82-
ALC4/2015
Party Name:GLAND
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
deferred
HQ File
:01/82/050/00496/AM16/
RLA File
:09/24/040/00350/AM15/
Lic.No/Date:0910061069
09.10.2014
Defer Date:
15.10.2015
103
Case No.:350/5/82-
ALC4/2015
Party Name:AMBE
PHYTOEXTRACTS
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00490/AM16/
RLA File
:05/23/040/00238/AM15/
Lic.No/Date:0510391555
13.10.2014
Defer
Date:15.10.2015
104
Case No.:124/5/82-
ALC4/2015
Party Name:DORF-
KETAL CHEMICALS
INDIA PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00264/AM16/
RLA File
:03/94/040/00684/AM15/
Lic.No/Date:0310790248
14.10.2014
Defer
Date:15.10.2015
105
Case No.:369/5/82-
ALC4/2015
Party Name:GLAND
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00509/AM16/
RLA File
:09/24/040/00344/AM15/
Lic.No/Date:0910061096
15.10.2014
Defer Date:
Decision : Committee considered the case as per agenda and in light of the comments of
Department of Pharmaceuticals present in meeting, decided to ratify norms under para 4.7 of
HBP as per details given below or as applied by firm whichever is lower:-
Export Product : Adenosine Injection USP Prefilled Syringe 3mg/ml, 4ml in a PFS
Sl.No.
Import Item
(1)
Norms
Applied
(2)
As per Central
Excise
Certificate
(3)
Batch
Logsheet
(4)
Lowest of
(2) to (4)
1
Adenosine
0.0132
gm/vial
N.A.
NIL
0.0132
gm/vial
2
Barrel Syringes (Glass)
1.28 Nos.
1.1095
NIL
1.1095
Nos.
3
V-OVS 10.6 Tip Caps
(Plastic)
1.2942
Nos.
1.03 Nos.
NIL
1.03 Nos.
4
Plunger
Stoppers
(Rubber)
1.28 Nos.
1.1481
NIL
1.1481
Nos.
5
Plunger Rods (Plastic)
1.08 Nos.
1.03 Nos.
NIL
1.03 Nos.
6
Filters (Plastic)
Consumable, on Net to Net basis
7
Tubing (Plastic)
8
Reference Standards
In accordance with the earlier decisions of Norms-Committee, present case may be considered specific to USFDA project and Export to USA only.
RA may take appropriate action as per the decision of Norms Committee.
106
Case No.:384/5/82-
ALC4/2015
Party Name:SATYADEVA
PHARMACEUTICALS /P/
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00524/AM16/
RLA File
:09/24/040/00382/AM15/
Lic.No/Date:0910061123
20.10.2014
Defer
Date:15.10.2015
107
Case No.:125/5/82-
ALC4/2015
Party Name:DORF-
KETAL CHEMICALS
INDIA PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00265/AM16/
RLA File
:03/94/040/00605/AM15/
Lic.No/Date:0310790441
21.10.2014
Defer
Date:15.10.2015
108
Case No.:352/5/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00492/AM16/
RLA File
:09/24/040/00398/AM15/
Lic.No/Date:0910061128
22.10.2014
Defer
Date:15.10.2015
109
Case No.:387/5/82-
ALC4/2015
Party Name:SUVEN LIFE
SCIENCES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00527/AM16/
RLA File
:09/24/040/00412/AM15/
Lic.No/Date:0910061152
29.10.2014
Defer
Date:15.10.2015
110
Case No.:70/18/82-
ALC4/2014
Party Name:GLENMARK
GENERICS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/01436/AM15/
RLA File
:03/94/040/00557/AM15/
Lic.No/Date:0310790636
30.10.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/66/2015-PI (Norms) dt.16.09. 2015 as per
Export product
Qty.
Import items
Qty.kg
Colesevelam
Hydrochloride
for
oral
suspension
1kg
Clesevelam Hydrochloride
1.97gm /2.5gm pack 3.94gm/5.0gm pack
111
Case No.:388/5/82-
ALC4/2015
Party Name:MYLAN
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00528/AM16/
RLA File
:09/24/040/00396/AM15/
Lic.No/Date:0910061183
05.11.2014
Defer
Date:15.10.2015
Decision : The Committee in light of comment of D/o Pharmaceuticals forwarded vide
O.M.No.35011/197/2015-PI(Norms) dated 24th July, 2015 decided to call for following information
from the firm:-
a) Complete technical details as per Appendix-33 showing % yield on molar basis for each
step of manufacturing process
b) Past production vis-à-vis Actual comsumption of all the imported inputs duly certified by
Central excise Authorities.
112
Case No.:1/13/82-
ALC4/2014
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01004/AM15/
RLA File
:09/24/040/00417/AM15/
Lic.No/Date:0910061188
07.11.2014
Defer
Date:15.10.2015
113
Case No.:386/5/82-
ALC4/2015
Party Name:SRINI
PHARMACEUTICALS
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00526/AM16/
RLA File
:09/24/040/00416/AM15/
Lic.No/Date:0910061191
07.11.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 178/2013-PI (Norms) dt. 09.05.2013 as per
Export product
Qty.
Import items
Qty.kg
HYDROXY
CHLOROQUINE
1kg
1
4,7-DICHLORO QUINOLINE
0.77
2
4-AMINO-N-ETHYL-(2
1.06
SULFATE USP HYDROXY ETHYL)-PENTY LAMINE 3 SODIUM HYDROXIDE MICRO PEARLS 0.75
114
Case No.:76/18/82-
ALC4/2014
Party Name:GLENMARK
GENERICS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/01442/AM15/
RLA File
:03/94/040/00734/AM15/
Lic.No/Date:0310790871
10.11.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/66/2015-PI (Norms) dt. 16.09. 2015 as per
Export product
Import items
Qty.kg
Azelaic Acid Gel 15%
Azelaic Acid (Dermaz 99)
4.59gm /30 gm pack
And
7.65 gm 50 gm pack
115
Case No.:359/5/82-
ALC4/2015
Party Name:NECTAR
LIFESCIENCES
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00499/AM16/
RLA File
:22/24/040/00067/AM15/
Lic.No/Date:2210015119
10.11.2014
Defer
Date:15.10.2015
116
Case No.:358/5/82-
ALC4/2015
Party Name:SHEETAL
CHEMICALS PVT LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
deferred
HQ File
:01/82/050/00498/AM16/
RLA File
:09/24/040/00422/AM15/
Lic.No/Date:0910061196
10.11.2014
Defer
Date:15.10.2015
117
Case No.:393/5/82-
ALC4/2015
Party Name:MYLAN
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
118
Case No.:198/5/82-
ALC4/2015
Party Name:SHASUN
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00338/AM16/
RLA File
:04/24/040/00205/AM15/
Lic.No/Date:0410159704
11.11.2014
Defer
Date:15.10.2015
119
Case No.:392/5/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00532/AM16/
RLA File
:09/24/040/00405/AM15/
Lic.No/Date:0910061222
13.11.2014
Defer
Date:15.10.2015
120
Case No.:126/8/82-
ALC4/2015
Party Name:BAYER
CROPSCIENCE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00922/AM16/
RLA File
:03/94/040/00710/AM15/
Lic.No/Date:0310791177
18.11.2014
Defer
Date:15.10.2015
121
Case No.:129/5/82-
ALC4/2015
Party Name:INDOCO
REMEDIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00269/AM16/
RLA File
:03/94/040/00740/AM15/
Lic.No/Date:0310791183
18.11.2014
Defer
Date:15.10.2015
122
Case No.:366/5/82-
ALC4/2015
Party Name:MYLAN
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00506/AM16/
RLA File
:09/24/040/00424/AM15/
Lic.No/Date:0910061281
20.11.2014
Defer
Date:15.10.2015
123
Case No.:75/18/82-
ALC4/2014
Party Name:GLENMARK
PHARMACEUTICALS
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/01441/AM15/
RLA File
:03/94/040/00799/AM15/
Lic.No/Date:0310791311
21.11.2014
Defer Date:
Decision :
The committee decided to ratify the norms based on the recommendation of Department of
Pharmaceuticals vide letter No.35011/ 67 /2015-PI (Norms) dt. 11.09.2015 as per details given
below or as applied by the firm whichever is less:-
Export product
Import items Qty. MOMATE AZ NASAL SPRAY / Mometasone Furoate & Azelastine HCL Nasal Spray (150MD)
1
Mometasone Furoate
7.5mg /pack
2
Azelastine
Hydrochloride
21.42mg/pack
124
Case No.:371/5/82-
ALC4/2015
Party Name:MYLAN
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00511/AM16/
RLA File
:09/24/040/00463/AM15/
Lic.No/Date:0910061295
24.11.2014
Defer
Date:15.10.2015
125
Case No.:357/5/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00497/AM16/
RLA File
:09/24/040/00435/AM15/
Lic.No/Date:0910061305
25.11.2014
Defer
Date:15.10.2015
126
Case No.:355/5/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00495/AM16/
RLA File
:09/24/040/00433/AM15/
Lic.No/Date:0910061297
25.11.2014
Defer
Date:15.10.2015
127
Case No.:94/13/82-
ALC4/2014
Party Name:HETERO
DRUGS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01097/AM15/
RLA File
:09/24/040/00469/AM15/
Lic.No/Date:0910061300
25.11.2014
Defer
Date:15.10.2015
128
Case No.:367/5/82-
ALC4/2015
Party Name:MYLAN
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00507/AM16/
RLA File
:09/24/040/00476/AM15/
Lic.No/Date:0910061308
25.11.2014
Defer
Date:15.10.2015
129
Case No.:126/5/82-
ALC4/2015
Party Name:IND-SWIFT
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00266/AM16/
RLA File
:22/24/040/00074/AM15/
Lic.No/Date:2210015136
28.11.2014
Defer
Date:15.10.2015
130
Case No.:362/5/82-
ALC4/2015
Party Name:KLJ
PLASTICIZERS LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00502/AM16/
RLA File
:05/23/040/00377/AM15/
Lic.No/Date:0510392211
28.11.2014
Defer
Date:15.10.2015
131
Case No.:247/5/82-
ALC4/2015
Party Name:SHREEGEN
PHARMA LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00387/AM16/
RLA File
:09/24/040/00467/AM15/
Lic.No/Date:091006132
3
28.11.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 84 /2015-PI (Norms) dt. Sept. 2015 as
Export product
Qty.
Import items
Qty.kg
ROSUVASTATIN
CALCIUM
1kg
1 (4R-Cis)-6-[(ACETYLOXY)-
Methyl]-2,2-Dimethyl-1,3-Dioxane-
4-Acetic Acid-1, 1-Dimethylethyl
Ester
1.87
2 4-(4-Fluorophenyl)-6-Isopropyl-2- [(N-Methyl-N- Methylsulphonyl)Amino]Pyrimidine- 5-YL-Methanol 1.87
132
Case No.:257/5/82-
ALC4/2015
Party Name:STERLING
AUXILIARIES PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00397/AM16/
RLA File
:03/95/040/00706/AM15/
Lic.No/Date:0310791534
28.11.2014
Defer
Date:15.10.2015
133
Case No.:360/5/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00500/AM16/
RLA File
:05/23/040/00386/AM15/
Lic.No/Date:0510392229
01.12.2014
Defer
Date:15.10.2015
134
Case No.:361/5/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00501/AM16/
RLA File
:05/23/040/00380/AM15/
Lic.No/Date:0510392228
01.12.2014
Defer
Date:15.10.2015
135
Case No.:245/5/82-
ALC4/2015
Party Name:GLAND
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00385/AM16/
RLA File
:09/24/040/00470/AM15/
Lic.No/Date:0910061327
02.12.2014
Defer
Date:15.10.2015
136
Case No.:264/5/82-
ALC4/2015
Party Name:GLAND
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00404/AM16/
RLA File
:09/24/040/00471/AM15/
Lic.No/Date:0910061328
02.12.2014
Defer
Date:15.10.2015
137
Case No.:128/5/82-
ALC4/2015
Party Name:STERLING
AUXILIARIES PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00268/AM16/
RLA File
:03/95/040/00733/AM15/
Lic.No/Date:0310791625
02.12.2014
Defer
Date:15.10.2015
138
Case No.:68/18/82-
ALC4/2014
Party Name:CROWN
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01434/AM15/
RLA File
:03/94/040/00838/AM15/
Lic.No/Date:0310791657
03.12.2014
Defer
Date:15.10.2015
139
Case No.:50/5/82-
ALC4/2015
Party Name:RAJ
PIONEER
LABORATORIES INDIA
PRIVATE LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00190/AM16/
RLA File
:56/24/040/00040/AM15/
Lic.No/Date:5610004489
03.12.2014
Defer
Date:15.10.2015
14 0
Case No.:261/5/82-
ALC4/2015
Party
Name:SMILAX LABORATORIES LI
MITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00401/A
RLA File :09/24/040/00493/AM15/
Lic.No/Date:0910061
345
Defer
Date:15.10.20
M16/
04.12.2014
15
141
Case No.:207/5/82-
ALC4/2015
Party Name:SRINI
PHARMACEUTICALS
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00347/AM16/
RLA File
:09/24/040/00474/AM15/
Lic.No/Date:0910061343
04.12.2014
Defer
Date:15.10.2015
142
Case No.:385/5/82-
ALC4/2015
Party Name:AMI
ORGANICS PVT LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00525/AM16/
RLA File
:52/24/040/00044/AM15/
Lic.No/Date:5210041339
05.12.2014
Defer
Date:15.10.2015
Decision : The committee in light of the written comment of D/o DEPARTMENT OF C&PC
forwarded vide O.M.No.14010/2/2012-CH-II dated 16.09.2015 decided to call for following
information from the firm:-
- Detailed manufacturing process with balanced chemical reactions indicating number of moles of all the reactants, products and by-products with corresponding molecular Formula structural formula molecular weight and process flow diagram.
- Stage wise percentage yield with respect of each of the reactant and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import.
- Details of byproducts formed during the process and the recovery of solvents in terms of quantity and value.
- Details of production of export product under reference and corresponding consumption of raw material in the year 2013-14, 2014-15 dully certified by CA
- Any other relevant information, if any.
143
Case No.:154/5/82-
ALC4/2015
Party Name:SHALINA
LABORATORIES PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
144
Case No.:265/5/82-
ALC4/2015
SCIENCES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00405/AM16/
RLA File
:09/24/040/00479/AM15/
Lic.No/Date:0910061351
05.12.2014
Defer
Date:15.10.2015
145
Case No.:244/5/82-
ALC4/2015
Party Name:VIVIN
LABORATORIES
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00384/AM16/
RLA File
:09/24/040/00420/AM15/
Lic.No/Date:0910061353
05.12.2014
Defer
Date:15.10.2015
146
Case No.:248/5/82-
ALC4/2015
Party Name:VIVIN
LABORATORIES
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00388/AM16/
RLA File
:09/24/040/00483/AM15/
Lic.No/Date:0910061354
05.12.2014
Defer
Date:15.10.2015
147
Case No.:280/13/82-
ALC4/2014
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01283/AM15/
RLA File
:09/24/040/00498/AM15/
Lic.No/Date:0910061364
09.12.2014
Defer
Date:15.10.2015
148
Case No.:279/13/82-
ALC4/2014
Party Name:HONOUR
LAB LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/01282/AM15/
RLA File
:09/24/040/00510/AM15/
Lic.No/Date:0910061362
09.12.2014
Defer
Date:15.10.2015
Decision : The Committee decided to remind the firm to furnish the information/documents which were
earlier called for vide minutes of Norms Committee meeting No.03/82 dt. 20.05..2015 uploaded on the
DGFT website.
149
Case No.:146/5/82-
ALC4/2015
Party Name:IPCA
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00286/AM16/
RLA File
:03/94/040/00852/AM15/
Lic.No/Date:0310791848
09.12.2014
Defer
Date:15.10.2015
150
Case No.:139/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00279/AM16/
RLA File
:03/94/040/00872/AM15/
Lic.No/Date:0310791890
10.12.2014
Defer
Date:15.10.2015
151
Case No.:153/5/82-
ALC4/2015
Party Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
RLA File
Lic.No/Date:3410040785 Defer
:01/82/050/00293/AM16/ :34/24/040/00244/AM15/ 12.12.2014 Date:15.10.2015
152
Case No.:260/5/82-
ALC4/2015
Party Name:MYLAN
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00400/AM16/
RLA File
:09/24/040/00488/AM15/
Lic.No/Date:0910061381
12.12.2014
Defer
Date:15.10.2015
153
Case No.:206/5/82-
ALC4/2015
SCIENCES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00346/AM16/
RLA File
:09/24/040/00511/AM15/
Lic.No/Date:0910061382
12.12.2014
Defer
Date:15.10.2015
154
Case No.:246/5/82-
ALC4/2015
Party Name:RAKSHIT
DRUGS PVT LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00386/AM16/
RLA File
:09/24/040/00426/AM15/
Lic.No/Date:0910061387
15.12.2014
Defer
Date:15.10.2015
155
Case No.:145/5/82-
ALC4/2015
Party Name:JINDAL
DRUGS PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00285/AM16/
RLA File
:03/94/040/00877/AM15/
Lic.No/Date:0310792112
17.12.2014
Defer
Date:15.10.2015
156
Case No.:130/5/82-
ALC4/2015
Party Name:NAVIN
FLUORINE
INTERNATIONAL
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00270/AM16/
RLA File
:03/95/040/00652/AM15/
Lic.No/Date:0310792103
17.12.2014
Defer
Date:15.10.2015
157
Case No.:127/5/82-
ALC4/2015
Party Name:EMAMI
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00267/AM16/
RLA File
:02/24/040/00183/AM15/
Lic.No/Date:0210205355
18.12.2014
Defer
Date:15.10.2015
158
Case No.:217/5/82-
ALC4/2015
Party Name:LEE PHARMA
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00357/AM16/
RLA File
:09/24/040/00513/AM15/
Lic.No/Date:0910061406
18.12.2014
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 274/2015-PI (Norms) dt. 21.09. 2015 as
Export product
Qty.
Import items
Qty.kg.
-1-(4,5-Diamino-10-aza-
tricyclo[6.3.1.0]dodeca-
2,4,6-trien-10-yl)-2,2,2-
trifluoro-ethanone
1 kg
2,3,4,5-Tetrahydro-7,8-
dinitro-3-(trifluoroacetyl)-1,5-
methano-1H-3-benzazepine
1.451
159
Case No.:133/5/82-
ALC4/2015
Party Name:AARTI
INDUSTRIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00273/AM16/
RLA File
:03/94/040/00883/AM15/
Lic.No/Date:0310792178
19.12.2014
Defer
Date:15.10.2015
160
Case No.:99/5/82-
ALC4/2015
Party Name:FDC LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00239/AM16/
RLA File
:03/94/040/00674/AM15/
Lic.No/Date:0310792173
19.12.2014
Defer Date:
Decision : The committee decided to ratify the norms based on the earlier dec as per details
given below or as applied by the firm whichever is less:-
Export product
Import items
Qty.
Brimonidine Eye Drops 5ml.
Brimonidine L-Tartrate
0.0102gm/vial
161
Case No.:143/5/82-
ALC4/2015
Party Name:FDC LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00283/AM16/
RLA File
:03/94/040/00834/AM15/
Lic.No/Date:0310792175
19.12.2014
Defer
Date:15.10.2015
162
Case No.:97/5/82-
ALC4/2015
Party Name:INDOFIL
INDUSTRIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00237/AM16/
RLA File
:03/94/040/00896/AM15/
Lic.No/Date:0310792172
19.12.2014
Defer
Date:15.10.2015
163
Case No.:205/5/82-
ALC4/2015
Party
Name:SALICYLATES &
CHEMICALS PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00345/AM16/
RLA File
:09/24/040/00517/AM15/
Lic.No/Date:0910061414
19.12.2014
Defer
Date:15.10.2015
164
Case No.:123/5/82-
ALC4/2015
Party Name:CADILA
HEALTHCARE LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00263/AM16/
RLA File
:08/24/040/00347/AM15/
Lic.No/Date:0810134112
22.12.2014
Defer
Date:15.10.2015
165
Case No.:144/5/82-
ALC4/2015
Party Name:INDOCO
REMEDIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00284/AM16/
RLA File
:03/94/040/00892/AM15/
Lic.No/Date:0310792262
22.12.2014
Defer
Date:15.10.2015
166
Case No.:224/5/82-
ALC4/2015
SCIENCES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
case for want of comments from D/o Pharmaceuticals.
167
Case No.:262/5/82-
ALC4/2015
Party Name:VARAHI
PHARMA PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00402/AM16/
RLA File
:09/24/040/00481/AM15/
Lic.No/Date:0910061416
22.12.2014
Defer
Date:15.10.2015
168
Case No.:216/5/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00356/AM16/
RLA File
:09/24/040/00538/AM15/
Lic.No/Date:0910061424
22.12.2014
Defer
Date:15.10.2015
case for want of comments from DEPARTMENT OF C&PC
169
Case No.:136/5/82-
ALC4/2015
Party Name:AVIGNON
EXIM PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00276/AM16/
RLA File
:03/94/040/00843/AM15/
Lic.No/Date:0310792314
23.12.2014
Defer
Date:15.10.2015
170
Case No.:96/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00236/AM16/
RLA File
:03/94/040/00912/AM15/
Lic.No/Date:0310792310
23.12.2014
Defer
Date:15.10.2015
171
Case No.:221/5/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00361/AM16/
RLA File
:09/24/040/00537/AM15/
Lic.No/Date:0910061442
23.12.2014
Defer
Date:15.10.2015
172
Case No.:329/5/82-
ALC4/2015
Party Name:CAMPHOR
& ALLIED PRODUCTS
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00469/AM16/
RLA File
:03/94/040/00899/AM15/
Lic.No/Date:0310792365
24.12.2014
Defer
Date:15.10.2015
Decision : The committee in light of the written comment of D/o DEPARTMENT OF C&PC
forwarded vide O.M.No.14010/47/2014-CH-II dated 7th August 2015 decided to call for following
information from the firm:-
- Detailed manufacturing process with balanced chemical reactions indicating number of moles of all the reactants, products and by-products with corresponding molecular Formula structural formula molecular weight and process flow diagram.
- Stage wise percentage yield with respect of each of the reactant and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import.
- Details of by products formed during the process and the recovery of solvents in terms of quantity and value.
- Details of production of export product under reference and corresponding consumption of raw material in the year2013-14. 2014-15 & 2015-16, (April to June) duly certified by CA. If the production has not commenced in the past, the details from commencement of of production may furnished duly certified by CA.
- Any other relevant information, if any.
173
Case No.:114/5/82-
ALC4/2015
Party Name:NATIONAL
TUBE INDUSTRIES,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00254/AM16/
RLA File
:03/95/040/00756/AM15/
Lic.No/Date:0310792363
24.12.2014
Defer
Date:15.10.2015
Decision : The Committee in light of written comments of DEPARTMENT OF C&PC provided vide letter No.46011/92/2015-PC-II dt. 07.09.2015 decided to call for following information from the firm:-
- Technical specifications, % composition (by weight) along with specific end use/application and the copy of export and imports products and corresponding inputs consumed.
- Details and quantity of other indigenous inputs to be used in the manufacture of the export products.
- Detailed manufacturing process along with justification for wastages at each stage and also on each of the raw material needs to be furnished.
- Complete material balance indicating input and output material at each stage of manufacturing process duly certified by CE specially weight of the export products.
- Whether the waste generated in the manufacturing process is being reused, if not, the technical reasons for the same may be furnished duly certified by CE.
- Details of production of export product under reference and corresponding consumption of inputs in the last three financial year duly certified by CA.
- Small sample of export product and import products, if feasible.
- Any other relevant information.
174
Case No.:108/5/82-
ALC4/2015
Party Name:AVA
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00248/AM16/
RLA File
:03/94/040/00908/AM15/
Lic.No/Date:0310792384
26.12.2014
Defer
Date:15.10.2015
175
Case No.:115/5/82-
ALC4/2015
Party Name:YASHO
INDUSTRIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00255/AM16/
RLA File
:03/95/040/00816/AM15/
Lic.No/Date:0310792387
26.12.2014
Defer
Date:15.10.2015
176
Case No.:271/5/82-
ALC4/2015
Party Name:AARTI
INDUSTRIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00411/AM16/
RLA File
:03/94/040/00882/AM15/
Lic.No/Date:0310792412
29.12.2014
Defer
Date:15.10.2015
Decision : The committee in light of the written comment of D/o DEPARTMENT OF C&PC
forwarded vide O.M.No.14010/1/2012-CH-II dated 13rd August, 2015 decided to call for
following information from the firm:-
-
Technical specifications, certificate of analysis (COA) and copy of export order for Ortho Phenylene diamine to be exported.
-
Technical specifications, certificate of analysis (COA) and copy of invoice for Crude Ortho Phenylene Diamine to be imported.
-
Detailed manufacturing process with balance chemical reactions indicating number of moles of all reactants, products and by products with corresponding molecular formulae, structural formulae, molecular weight and process flow diagram.
-
Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process.
-
Details of production of Standard soya Lecithin food Grade and corresponding consumption of soya lecithin Industrial Grade in the year 2013-14 and 2014-15 duly certified by CA.
-
Any other relevant information, if any.
177
Case No.:241/5/82-
ALC4/2015
Party Name:ASTRIX
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00381/AM16/
RLA File
:09/24/040/00516/AM15/
Lic.No/Date:0910061461
29.12.2014
Defer
Date:15.10.2015
178
Case No.:90/5/82-
ALC4/2015
Party Name:BEST
VALUE CHEM PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00230/AM16/
RLA File
:34/24/040/00254/AM15/
Lic.No/Date:3410040841
29.12.2014
Defer
Date:15.10.2015
179
Case No.:215/5/82-
ALC4/2015
Party Name:EYTAN
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00355/AM16/
RLA File
:09/24/040/00530/AM15/
Lic.No/Date:0910061459
29.12.2014
Defer
Date:15.10.2015
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide letter No.35011/ 83 /2015-PI (Norms) dt. September 2015
as per details given below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
(2R-Cis)-4-amino-1-[2-
(hydroxymethyl)-1,3-
oxathiolan-5-yl]-2(1H)-
pyrimidinone
monosalicylate
monohydrate
1kg
1
4-Amino-2-Oxo-Pyrimidinyl-
Oxathiolane-2-Carboxylic
Aicd-Isopropyl-Mentyl-
Cyclohexyl Ester (Cyclohexyl
Ester)
1.16
2
SODIUM BOROHYDRIDE
0.266
3
DIPOTASSIUM HYDROGEN
PHOSPHATE
0.988
180
Case No.:218/5/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00358/AM16/
RLA File
:09/24/040/00552/AM15/
Lic.No/Date:0910061462
29.12.2014
Defer
Date:15.10.2015
181
Case No.:120/5/82-
ALC4/2015
Party Name:YASHO
INDUSTRIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Approved
HQ File
RLA File
Lic.No/Date:0310792428 Defer Date:
:01/82/050/00260/AM16/ :03/95/040/00820/AM15/ 29.12.2014
DEPARTMENT OF C&PC U.O.No.14010/95/2011-Ch-II dt. 11.09 2015 as per details given
below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
Yantq 2020 (20% Solution
of
Tertiary
Butyl
Hydroquinone)
1 kg
1 Hydroquinone 0.282 2 Tertiary Butanol 0.208 3 Propylene Glycol 0.700
182
Case No.:142/5/82-
ALC4/2015
Party Name:FDC LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00282/AM16/
RLA File
:03/94/040/00923/AM15/
Lic.No/Date:0310792455
30.12.2014
Defer Date
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide letter No.350113/147/2015-PI (Norms) dt. Sept. 2015 as per
Export product
Qty.
Import items
Qty.kg
Sodium Cromoglicae Eye
drop in 13.5 ml vial
1 vial
1
Sodium Cromoglicate
0.2835
gm/vial
Sodium Cromoglicae Eye
drop in 10 ml vial
1 vial
Sodium Cromoglicate
0.2142
gm/vial
183
Case No.:65/5/82-
ALC4/2015
Party Name:CLEAN
SCIENCE AND
TECHNOLOGY
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00205/AM16/
RLA File
:31/83/040/00204/AM15/
Lic.No/Date:3110065167
31.12.2014
Defer
Date:15.10.2015
184
Case No.:222/5/82-
ALC4/2015
Party Name:SATYA
DEEPTHA
PHARMACEUTICALS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00362/AM16/
RLA File
:09/24/040/00553/AM15/
Lic.No/Date:0910061469
31.12.2014
Defer
Date:15.10.2015
185
Case No.:134/5/82-
ALC4/2015
Party Name:BDR
PHARMACEUTICALS
INTERNATIONAL PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00274/AM16/
RLA File
:03/94/040/00712/AM15/
Lic.No/Date:0310792545
01.01.2015
Defer
Date:15.10.2015
186
Case No.:226/5/82-
ALC4/2015
Party Name:EYTAN LABS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Deferred
HQ File
:01/82/050/00366/AM16/
RLA File
:09/24/040/00554/AM15/
Lic.No/Date:0910061471
01.01.2015
Defer
Date:
15.10.2015
Decision : The Committee considered the case for ratification of norms and decided to defer the
187
Case No.:137/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00277/AM16/
RLA File
:03/94/040/00931/AM15/
Lic.No/Date:0310792547
01.01.2015
Defer
Date:15.10.2015
188
Case No.:138/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00278/AM16/
RLA File
:03/94/040/00920/AM15/
Lic.No/Date:0310792544
01.01.2015
Defer
Date:15.10.2015
189
Case No.:214/5/82-
ALC4/2015
Party Name:LEE PHARMA
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00354/AM16/
RLA File
:09/24/040/00418/AM15/
Lic.No/Date:0910061472
01.01.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/210 /2015-PI (Norms) dt. 21.09.2015 as per
Export product
Qty.
Import items
Qty.kg
2-chloromethyl-3-methyl-4-
(2,2,2-trifluoroethoxy)pyridine
hydrochloride
1kg
1
2,3-Lutidine
0.76
2
Methylene Chloride
0.24
3
Trifluoro Ethanol
0.76
4
POTASSIUM
CARBONATE POWDER
0.45
5 ACETONE 0.87 6 METHYL ISO BUTYL KETONE ( M.I.B.K ) 0.16 7 ISO PROPYL ALCOHOL (IPA) Not used in the process
190
Case No.:225/5/82-
ALC4/2015
Party Name:LEE PHARMA
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00365/AM16/
RLA File
:09/24/040/00419/AM15/
Lic.No/Date:0910061473
01.01.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 210 /2015-PI (Norms) dt. 21.09. 2015 as
Export product
Qty.
Import items
Qty.kg
(2,4
Dihydro-4(4(4-
Hydroxyphenyl)-1-
Piperazinyl)Phenyl-2-(1-
Methyl
Propyl)-3h
1,2,4
Triazol-3-One
1kg
1
Palladium Charcoal 5%
0.03
2
Dimethyl Formamide
4.02
3
Pyridine
0.90
4
Phenyl Chloro Formate
1.16
5
Hydrazine Hydrate 80%
1.443
6
Dimethyl Sulfoxide
1.34
7
Hydro Bromic Acid 48%
2.50
8
Chloroform
2.67
9
Triethyl Orthoformate
2.79
10
Acetone
0.50
191
Case No.:69/5/82-
ALC4/2015
Party Name:LUPIN
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00209/AM16/
RLA File
:03/95/040/00807/AM15/
Lic.No/Date:0310792533
01.01.2015
Defer
Date:15.10.2015
192
Case No.:70/5/82-
ALC4/2015
Party Name:LUPIN
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00210/AM16/
RLA File
:03/95/040/00606/AM15/
Lic.No/Date:0310792532
01.01.2015
Defer
Date:15.10.2015
193
Case No.:84/5/82-
ALC4/2015
Party Name:SHIVA
PHARMACHEM LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00224/AM16/
RLA File
:34/24/040/00259/AM15/
Lic.No/Date:3410040852
01.01.2015
Defer
Date:15.10.2015
194
Case No.:105/5/82-
ALC4/2015
Party Name:CROWN
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00245/AM16/
RLA File
:03/94/040/00864/AM15/
Lic.No/Date:0310792569
02.01.2015
Defer
Date:15.10.2015
195
Case No.:106/5/82-
ALC4/2015
Party Name:CROWN
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00246/AM16/
RLA File
:03/94/040/00863/AM15/
Lic.No/Date:0310792568
02.01.2015
Defer
Date:15.10.2015
196
Case No.:68/5/82-
ALC4/2015
Party Name:POLYDRUG
LABORATORIES
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00208/AM16/
RLA File
:03/95/040/00810/AM15/
Lic.No/Date:0310792570
02.01.2015
Defer
Date:15.10.2015
197
Case No.:45/5/82-
ALC4/2015
SCIENCES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00185/AM16/
RLA File
:09/24/040/00558/AM15/
Lic.No/Date:0910061483
05.01.2015
Defer
Date:15.10.2015
198
Case No.:102/5/82-
ALC4/2015
Party Name:ALTA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00242/AM16/
RLA File
:03/94/040/00836/AM15/
Lic.No/Date:0310792635
07.01.2015
Defer
Date:15.10.2015
199
Case No.:107/5/82-
ALC4/2015
Party Name:AVA
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00247/AM16/
RLA File
:03/94/040/00933/AM15/
Lic.No/Date:0310792634
07.01.2015
Defer
Date:15.10.2015
200
Case No.:74/5/82-
ALC4/2015
Party Name:NEW
ALLIANCE DYE-CHEM
PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00214/AM16/
RLA File
:03/95/040/00833/AM15/
Lic.No/Date:0310792647
07.01.2015
Defer Date:
Decision : The committee decided to ratify the norms based on the recommendation of
Department of C&PC vide letter No.14010/67/2011-Ch-II dt. 2.9.2015 2015 as per details given
below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
Disodium Zinc EDTA (Zinc
content 15% (+/-0.5%)
1kg
EDTA
(Ethylene
Diamine
Tetra Acetic Acid)
0.690
201
Case No.:149/5/82-
ALC4/2015
Party Name:ALCHEMIE
LABORATORIES
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00289/AM16/
RLA File
:03/94/040/00813/AM15/
Lic.No/Date:0310792673
08.01.2015
Defer
Date:15.10.2015
202
Case No.:62/5/82-
ALC4/2015
Party Name:INDO
AMINES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00202/AM16/
RLA File
:03/94/040/00928/AM15/
Lic.No/Date:0310792678
08.01.2015
Defer
Date:15.10.2015
203
Case No.:63/5/82-
ALC4/2015
Party Name:INDOCO
REMEDIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00203/AM16/
RLA File
:03/94/040/00936/AM15/
Lic.No/Date:0310792676
08.01.2015
Defer Date:
Decision : In the light of the earlier decision taken by NC in its meeting No.18/82 dated
28.02.2015, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below
or as applied by the firm, whichever is less:
Item of Export Qty. Sl.No. Item of Import Quantity allowed kg/kg LATANOPROST OPHTHALMIC SOLUTION,0.005% 2.5 ML.
1 kg
1.
LATANOPROST
0.1275 mg/2.5 ml vial
2.
Eye Drop Bottle (Packing
Material).
1.01 numbers for
each vial Net+1%
3.
Eye Drop Caps (Packing
Material)
1.01 numbers for
each vial Net+1%
4.
Eye Drop Insert (Packing
Material)
1.01 numbers for
each vial Net+1%
204
Case No.:122/5/82-
ALC4/2015
Party Name:NEW
ALLIANCE DYE-CHEM
PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00262/AM16/
RLA File
:03/95/040/00682/AM15/
Lic.No/Date:0310792689
08.01.2015
Defer
Date:15.10.2015
205
Case No.:121/5/82-
ALC4/2015
Party Name:UNIJULES
LIFE SCIENCES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00261/AM16/
RLA File
:03/95/040/00835/AM15/
Lic.No/Date:0310792685
08.01.2015
Defer
Date:15.10.2015
206
Case No.:220/5/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00360/AM16/
RLA File
:09/24/040/00560/AM15/
Lic.No/Date:0910061516
09.01.2015
Defer
Date:15.10.2015
207
Case No.:219/5/82-
ALC4/2015
Party
Name:BHAGIRADHA
CHEMICALS &
INDUSTRIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00359/AM16/
RLA File
:09/24/040/00549/AM15/
Lic.No/Date:0910061517
09.01.2015
Defer
Date:15.10.2015
Decision :
The Committee considered the case for ratification of norms and decided to defer the case for want of
comments from DEPARTMENT OF C&PC
208
Case No.:80/5/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00220/AM16/
RLA File
:05/23/040/00465/AM15/
Lic.No/Date:0510392782
09.01.2015
Defer
Date:15.10.2015
209
Case No.:239/5/82-
ALC4/2015
Party Name:MYLAN
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
210
Case No.:150/5/82-
ALC4/2015
Party Name:ALKYL
AMINES CHEMICALS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00290/AM16/
RLA File
:03/94/040/00866/AM15/
Lic.No/Date:0310792839
12.01.2015
Defer
Date:15.10.2015
211
Case No.:152/5/82-
ALC4/2015
Party Name:AVA
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00292/AM16/
RLA File
:03/94/040/00943/AM15/
Lic.No/Date:0310792841
12.01.2015
Defer Date:
Department of Pharmaceuticals vide letter No.14010/67/2011-Ch-II dt. 2.9.2015 2015 as per
Export product
Qty.
Import items
Qty.kg
Disodium Zinc EDTA (Zinc
content 15% (+/-0.5%)
1kg
EDTA
(Ethylene
Diamine
Tetra Acetic Acid)
0.690
212
Case No.:141/5/82-
ALC4/2015
Party Name:AARTI
INDUSTRIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00281/AM16/
RLA File
:03/94/040/00746/AM15/
Lic.No/Date:0310792870
13.01.2015
Defer
Date:15.10.2015
case for want of comments from DEPARTMENT OF C&PC.
213
Case No.:151/5/82-
ALC4/2015
Party Name:AGIO
PHARMACEUTICALS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00291/AM16/
RLA File
:03/94/040/00902/AM15/
Lic.No/Date:0310792875
13.01.2015
Defer
Date:15.10.2015
214
Case No.:119/5/82-
ALC4/2015
Party Name:SHALINA
LABORATORIES PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
215
Case No.:92/5/82-
ALC4/2015
Party Name:ALKALOIDS
CORPORATION
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
216
Case No.:59/5/82-
ALC4/2015
Party Name:ANTHEA
AROMATICS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
217
Case No.:64/5/82-
ALC4/2015
Party Name:CLEAN
SCIENCE AND
TECHNOLOGY
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00204/AM16/
RLA File
:31/83/040/00200/AM15/
Lic.No/Date:3110065202
14.01.2015
Defer
Date:15.10.2015
218
Case No.:66/5/82-
ALC4/2015
Party Name:EMCURE
PHARMACEUTICALS
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00206/AM16/
RLA File
:31/83/040/00219/AM15/
Lic.No/Date:3110065206
14.01.2015
Defer
Date:15.10.2015
219
Case No.:243/5/82-
ALC4/2015
SCIENCES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
220
Case No.:51/5/82-
ALC4/2015
Party Name:UNIMAX
LABORATORIES PVT.LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00191/AM16/
RLA File
:03/95/040/00860/AM15/
Lic.No/Date:0310792918
14.01.2015
Defer Date:
Department of Pharmaceuticals vide letter No. 35011/218/2015-PI (Norms) dt.11.09. 2015 as per
Export product
Qty.
Import items
Qty.kg
Prednisolone
Sodium
Phosphate
1kg
Prednisolone
0.839
221
Case No.:60/5/82-
ALC4/2015
Party Name:INDOCO
REMEDIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00200/AM16/
RLA File
:03/94/040/00963/AM15/
Lic.No/Date:0310793006
16.01.2015
Defer
Date:15.10.2015
222
Case No.:78/5/82-
ALC4/2015
Party Name:LAXMI
ORGANIC INDUSTRIES
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00218/AM16/
RLA File
:03/95/040/00814/AM15/
Lic.No/Date:0310793011
16.01.2015
Defer
Date:15.10.2015
Decision : The committee in light of the written comment of D/o DEPARTMENT OF C&PC
forwarded vide O.M.No.14010/1/2012-CH-II dated 13rd August, 2015 decided to call for
following information from the firm:-
- Detailed manufacturing process with balance chemical reactions indicating number of moles of all reactants, products and by products with corresponding molecular formulae, structural formulae, molecular weight and process flow diagram.
- Stage wise percentage yield with respect of each of the reactant and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import.
- Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process.
- Details of production of export product and corresponding consumption of
Acetoactxyethy methacrylate and corresponding consumption of raw materials in the year 2013-14, 2014-15 and 2015-16 (April to June ) duly certified by CA. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA. - Any other relevant information, if any.
223
Case No.:72/5/82-
ALC4/2015
Party Name:MICRO INKS
PRIVATE LIMITED.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
224
Case No.:111/5/82-
ALC4/2015
Party Name:MICRO INKS
PRIVATE LIMITED.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00251/AM16/
RLA File
:03/95/040/00648/AM15/
Lic.No/Date:0310792988
16.01.2015
Defer
Date:15.10.2015
225
Case No.:89/5/82-
ALC4/2015
Party Name:CADILA
HEALTHCARE LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00229/AM16/
RLA File
:08/24/040/00253/AM15/
Lic.No/Date:0810134341
19.01.2015
Defer
Date:15.10.2015
226
Case No.:242/5/82-
ALC4/2015
Party Name:OPTIMUS
DRUGS PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00382/AM16/
RLA File
:09/24/040/00577/AM15/
Lic.No/Date:0910061545
19.01.2015
Defer
Date:15.10.2015
227
Case No.:249/5/82-
ALC4/2015
Party Name:PERKIN
LABORATORIES
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00389/AM16/
RLA File
:09/24/040/00588/AM15/
Lic.No/Date:0910061539
19.01.2015
Defer
Date:15.10.2015
228
Case No.:79/5/82-
ALC4/2015
Party Name:UNIJULES
LIFE SCIENCES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00219/AM16/
RLA File
:03/95/040/00877/AM15/
Lic.No/Date:0310793058
19.01.2015
Defer
Date:15.10.2015
229
Case No.:110/5/82-
ALC4/2015
Party Name:UNIMAX
CHEMICALS PVT LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00250/AM16/
RLA File
:03/95/040/00811/AM15/
Lic.No/Date:0310793038
19.01.2015
Defer
Date:15.10.2015
230
Case No.:112/5/82-
ALC4/2015
Party Name:UNIMAX
CHEMICALS PVT LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Approved
HQ File
:01/82/050/00252/AM16/
RLA File
:03/95/040/00812/AM15/
Lic.No/Date:0310793039
19.01.2015
Defer Date:
Decision :
231
Case No.:52/5/82-
ALC4/2015
Party Name:INDOCO
REMEDIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00192/AM16/
RLA File
:03/94/040/00953/AM15/
Lic.No/Date:0310793104
20.01.2015
Defer
Date:15.10.2015
232
Case No.:147/5/82-
ALC4/2015
Party Name:INDOCO
REMEDIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00287/AM16/
RLA File
:03/94/040/00964/AM15/
Lic.No/Date:0310793105
20.01.2015
Defer Date:
15.10.2015
233
Case No.:55/5/82-
ALC4/2015
Party Name:IPCA
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00195/AM16/
RLA File
:03/94/040/00975/AM15/
Lic.No/Date:0310793123
20.01.2015
Defer
Date:15.10.2015
234
Case No.:88/5/82-
ALC4/2015
Party Name:ABEERS
PHARMACEUTICALS
PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00228/AM16/
RLA File
:05/23/040/00486/AM15/
Lic.No/Date:0510392949
21.01.2015
Defer
Date:15.10.2015
235
Case No.:132/5/82-
ALC4/2015
Party Name:BDR
PHARMACEUTICALS
INTERNATIONAL PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00272/AM16/
RLA File
:03/94/040/00947/AM15/
Lic.No/Date:0310793170
21.01.2015
Defer
Date:15.10.2015
236
Case No.:56/5/82-
ALC4/2015
Party Name:IPCA
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00196/AM16/
RLA File
:03/94/040/00973/AM15/
Lic.No/Date:0310793182
21.01.2015
Defer
Date:15.10.2015
237
Case No.:131/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00271/AM16/
RLA File
:03/94/040/00988/AM15/
Lic.No/Date:0310793181
21.01.2015
Defer
Date:15.10.2015
238 Case No.:87/5/82- Party Name:SHREE Meet No/Date:8/82- Status:Case
ALC4/2015
BANKEY BEHARI LAL
BOARD MILLS
ALC4/2015
16.09.2015
Deferred
HQ File
:01/82/050/00227/AM16/
RLA File
:05/24/040/00454/AM15/
Lic.No/Date:0510392955
21.01.2015
Defer Date:
15.10.2015
239
Case No.:86/5/82-
ALC4/2015
Party Name:SENTISS
PHARMA PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
240
Case No.:170/5/82-
ALC4/2015
Party Name:ALEMBIC
PHARMACEUTICALS LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00310/AM16/
RLA File
:34/24/040/00278/AM15/
Lic.No/Date:3410040893
23.01.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/104/2015-PI (Norms) dt. Sept. 2015 as per
Export product
Qty.
Import
items
Qty.tablet
Valsartan
+
Hydrochlorothiazide
tablets 80 mg +12.5mg
One tablet
Valsartan
81.6mg/tablet
Valsartan
+
Hydrochlorothiazide
tablets 160 mg +12.5mg
One tablet
Valsartan
163.2/tablet
Valsartan
+
Hydrochlorothiazide
tablets 160 mg +25mg
One tablet
Valsartan 163.2/tablet Valsartan + Hydrochlorothiazide tablets 320 mg +12.5mg One tablet
Valsartan 326.4mg/tablet Valsartan + Hydrochlorothiazide tablets 320 mg +25mg One tablet Valsartan 326.4mg/tablet
Norms for one kg.
Export product
Qty.
Import items
Qty.kg.
Valsartan
One
kg.
Methyl (2S)-2-{[2Cyano-1,1-biphenyl-
4-yl)Methyl]amino)-3-methyl
butanoate ethanedioate (Bi
phenylvaline oxalate)
1.455kg/kg
Methanol
0.637 lit/kg
Methylene Chloride ( or
Dichloromethane)
9.409 Lit/kg
241
Case No.:165/5/82-
ALC4/2015
Party Name:IND-SWIFT
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00305/AM16/
RLA File
:22/24/040/00091/AM15/
Lic.No/Date:2210015173
23.01.2015
Defer
Date:15.10.2015
242
Case No.:76/5/82-
ALC4/2015
Party Name:MELOG
SPECIALITY
CHEMICALS PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00216/AM16/
RLA File
:03/95/040/00891/AM15/
Lic.No/Date:0310793255
23.01.2015
Defer
Date:15.10.2015
243
Case No.:77/5/82-
ALC4/2015
Party Name:THINQ
PHARMA-CRO LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00217/AM16/
RLA File
:03/95/040/00857/AM15/
Lic.No/Date:0310793256
23.01.2015
Defer
Date:15.10.2015
244
Case No.:204/5/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
245
Case No.:229/5/82-
ALC4/2015
Party Name:ATUL
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00369/AM16/
RLA File
:08/24/040/00391/AM15/
Lic.No/Date:0810134402
27.01.2015
Defer
Date:15.10.2015
246
Case No.:269/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00409/AM16/
RLA File
:03/94/040/01006/AM15/
Lic.No/Date:0310793301
27.01.2015
Defer
Date:15.10.2015
247 Case No.:85/5/82-
ALC4/2015
Party Name:V.D.H.
ORGANICS PVT. LTD
Meet No/Date:8/82-
ALC4/2015
Status:Case
Deferred
16.09.2015
HQ File
:01/82/050/00225/AM16/
RLA File
:05/24/040/00500/AM15/
Lic.No/Date:0510392989
27.01.2015
Defer
Date:15.10.2015
248
Case No.:58/5/82-
ALC4/2015
Party Name:JINDAL
DRUGS PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00198/AM16/
RLA File
:03/94/040/00980/AM15/
Lic.No/Date:0310793360
28.01.2015
Defer
Date:15.10.2015
249
Case No.:230/5/82-
ALC4/2015
Party
Name:R.K.INDUSTRIES,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
250
Case No.:168/5/82-
ALC4/2015
Party Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00308/AM16/
RLA File
:34/24/040/00277/AM15/
Lic.No/Date:3410040906
29.01.2015
Defer
Date:15.10.2015
251
Case No.:163/5/82-
ALC4/2015
Party Name:RANBAXY
LABORATORIES LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
252
Case No.:166/5/82-
ALC4/2015
Party Name:CADILA
PHARMACEUTICALS
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
253
Case No.:274/5/82-
ALC4/2015
Party Name:ELPPE
CHEMICALS PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00414/AM16/
RLA File
:03/94/040/01017/AM15/
Lic.No/Date:0310793439
30.01.2015
Defer
Date:15.10.2015
254
Case No.:138/8/82-
ALC4/2015
Party Name:HEMMO
PHARMACEUTICALS
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
255
Case No.:211/5/82-
ALC4/2015
Party Name:LEE PHARMA
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00351/AM16/
RLA File
:09/24/040/00602/AM15/
Lic.No/Date:0910061571
30.01.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 210 /2015-PI (Norms) dt. 21.09. 2015 as
Export product
Qty.
Import items
Qty.kg
5-(Difluoro
Methoxy)-2-
(3,4-Dimethoxy-2-Pyridinyl
Methyl
Thio
-1H-
Benzimidazole
1kg
1
Maltol
0.628
2
Acetone
2.62
3
Potassium Carbonate
0.711
4
Toluene
0.874
5
5-Difluoromethoxy-2-
Mercapto-1H-
Benzimidazole
0.69
6
Methylene Chloride
2.53
7
Chloroform
2.84
256
Case No.:212/5/82-
ALC4/2015
Party Name:LEE PHARMA
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00352/AM16/
RLA File
:09/24/040/00606/AM15/
Lic.No/Date:0910061572
30.01.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/274/2015-PI (Norms) dt. 21.09. 2015 as per
Export product
Qty.
Import items
Qty.kg
ATORVASTATIN
CALCIUM
1kg
1
tert-butyl2-((4R,6R)-6-(2(2-(4-
fluorophenyl)-5-isopropyl-3-phenyl-4-
(phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-
2,2-dimethyl-1,3-dioxan-4-yl)acetate
1.337
2 Toluene 1.54
3 methyl tertiary butyl ether (MTBE) 0.57
257
Case No.:181/5/82-
ALC4/2015
Party Name:R L FINE
CHEM
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00321/AM16/
RLA File
:07/24/040/00387/AM15/
Lic.No/Date:0710107544
02.02.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/203/2015-PI (Norms) dt. Sept. 2015 as per
Export product
Qty.
Import items
Qty.kg
ORPHENADRINE
CITRATE
BP/EP/USP
1kg
1
2 METHYL
BENZOPHENONE
0.70
2
ACETONE
1.25
258
Case No.:209/5/82-
ALC4/2015
Party Name:TRIMAX BIO
SCIENCES PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Deferred
HQ File
:01/82/050/00349/AM16/
RLA File
:09/24/040/00442/AM15/
Lic.No/Date:0910061573
02.02.2015
Defer
Date:15.10.2015
259
Case No.:343/5/82-
ALC4/2015
Party Name:YASHO
INDUSTRIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00483/AM16/
RLA File
:03/95/040/00905/AM15/
Lic.No/Date:0310793484
02.02.2015
Defer Date:
Department of DEPARTMENT OF C&PC U.O.No.14010/95/2011-Ch-II dt. 11.09. 2015 as per
Export product
Qty.
Import items
Qty.kg
YAPOX
CL
30/10
"HYDROQUINONE
BIS(2hydroxy ethyl ether)
1kg
HYDROQUINONE
0.611
26 0
Case No.:162/5/82-
ALC4/2015
Party Name:ALKALOIDS
CORPORATION
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00302/AM16/
RLA File
:02/24/040/00205/AM15/
Lic.No/Date:021020550
4
03.02.2015
Defer Date:
Decision : The Committee in light of earlier decision taken by NC in its meeting No.13/13 dated
17.7.2012 decided to ratify norms under para 4.7 of HBP as per details below or as applied by
firm whichever is lower:-
Export product
Qty.
Import items
Qty. in kg.
Noscapine BP/Noscapine Hcl
BP
1 kg
Noscapine crude 95%
1.158
RA concerned may take further necessary action as per above decision of NC.
261
Case No.:208/5/82-
ALC4/2015
Party Name:ASTRIX
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00348/AM16/
RLA File
:09/24/040/00534/AM15/
Lic.No/Date:0910061583
03.02.2015
Defer
Date:15.10.2015
262
Case No.:275/5/82-
ALC4/2015
Party Name:BAYER
CROPSCIENCE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00415/AM16/
RLA File
:03/94/040/00930/AM15/
Lic.No/Date:0310793539
03.02.2015
Defer
Date:15.10.2015
263
Case No.:158/5/82-
ALC4/2015
Party Name:DYNAMIC
SPECIALITY
CHEMICALS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00298/AM16/
RLA File
:30/24/040/00051/AM15/
Lic.No/Date:3010103361
03.02.2015
Defer
Date:15.10.2015
264
Case No.:233/5/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00373/AM16/
RLA File
:05/24/040/00525/AM15/
Lic.No/Date:0510393079
04.02.2015
Defer
Date:15.10.2015
265
Case No.:234/5/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00374/AM16/
RLA File
:05/24/040/00526/AM15/
Lic.No/Date:0510393080
04.02.2015
Defer
Date:15.10.2015
266
Case No.:164/5/82-
ALC4/2015
Party Name:SENTISS
PHARMA PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00304/AM16/
RLA File
:05/24/040/00513/AM15/
Lic.No/Date:0510393078
04.02.2015
Defer
Date:15.10.2015
267
Case No.:157/5/82-
ALC4/2015
Party Name:IND-SWIFT
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00297/AM16/
RLA File
:22/24/040/00100/AM15/
Lic.No/Date:2210015187
05.02.2015
Defer
Date:15.10.2015
268
Case No.:284/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00424/AM16/
RLA File
:03/94/040/01053/AM15/
Lic.No/Date:0310793620
05.02.2015
Defer
Date:15.10.2015
269
Case No.:238/5/82-
ALC4/2015
Party Name:KLJ
PLASTICIZERS LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00378/AM16/
RLA File
:05/23/040/00504/AM15/
Lic.No/Date:0510393099
05.02.2015
Defer
Date:15.10.2015
270
Case No.:182/5/82-
ALC4/2015
Party Name:MICRO LABS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00322/AM16/
RLA File
:07/24/040/00398/AM15/
Lic.No/Date:0710107559
05.02.2015
Defer Date:
Department of Pharmaceuticals vide O.M.No.35011/261 /2014-PI (Norms) dt. 12.03.2015 as per
Export product
Import items
Qty.
AMOXICILLIN
125MG
AND
FLUCLOXACILLIN 125MG PER
5ML
ORAL SUSPENSION
Amoxicillin
trihydrate
755mg for 100 ml bottle
Flucloxacillin
Sodium
688mg for 100 ml bottle
AMOXICLLIN
250MG
AND
FLUCLOXACILLIN
250MG
CAPSULES
Amoxicillin
trihydrate
292.68mg
for
one
capsule
Flucloxacillin
Sodium
267.34mg
for
one
capsule
AMPICILLIN
250MG
AND
FLUCLOXACILLIN
250MG
CAPSULES
Ampicillin trihydrate
294.5mg
for
one
capsule
Flucloxacillin
Sodium
267.34mg
for
one
capsule
271 Case No.:155/5/82- Party Name:ONEIRO Meet No/Date:8/82- Status:Case
ALC4/2015
CHEMICALS LTD
ALC4/2015
16.09.2015
Approved
HQ File
:01/82/050/00295/AM16/
RLA File
:34/24/040/00291/AM15/
Lic.No/Date:3410040925
05.02.2015
Defer Date:
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide letter No.35011/ 430 /2012-PI (Norms) dt. September 2012
and as per earlier decision taken by NC in its meeting No.07/AM16 as per details given below or
as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty. in kg.
4,7-Dichloro Quinoline
1 kg
1
Di Ethyl Ethoxy Methylene
Malonate
1.65
2
Meta Chloro Aniline
0.97
3
Light Liquid Parafin
0.97
4
Tolune
0.88
5
Phosphorous Oxychloride
0.97
6
Methanol
1.13
272
Case No.:169/5/82-
ALC4/2015
Party Name:TIDE
INDUSTRIES
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
273
Case No.:268/5/82-
ALC4/2015
Party
Name:CATAPHARMA
CHEMICALS PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00408/AM16/
RLA File
:31/83/040/00209/AM15/
Lic.No/Date:3110065261
06.02.2015
Defer
Date:15.10.2015
274
Case No.:227/5/82-
ALC4/2015
Party Name:MICRO LABS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00367/AM16/
RLA File
:07/24/040/00378/AM15/
Lic.No/Date:0710107574
09.02.2015
Defer Date:
Department of Pharmaceuticals vide O.M.No35011/52 /2013-PI (Norms) dt. 30.7. 2015 as per
Export product
Qty.
Import items
Qty.kg
PREMIX
FOR
NIFUROXAZIDE
CAPSULES OF 362 MG
Containing
200
mg
Nifuroxazide
1kg NIFUROXAZIDE EP 0.5775
275
Case No.:342/5/82-
ALC4/2015
Party Name:NAVIN
FLUORINE
INTERNATIONAL
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00482/AM16/
RLA File
:03/95/040/00585/AM15/
Lic.No/Date:0310793707
09.02.2015
Defer
Date:15.10.2015
276
Case No.:344/5/82-
ALC4/2015
Party Name:NAVIN
FLUORINE
INTERNATIONAL
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00484/AM16/
RLA File
:03/95/040/00445/AM15/
Lic.No/Date:0310793706
09.02.2015
Defer
Date:15.10.2015
277
Case No.:161/5/82-
ALC4/2015
Party Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00301/AM16/
RLA File
:05/24/040/00472/AM15/
Lic.No/Date:0510393118
09.02.2015
Defer
Date:15.10.2015
278
Case No.:346/5/82-
ALC4/2015
Party Name:YASHO
INDUSTRIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00486/AM16/
RLA File
:03/95/040/00947/AM15/
Lic.No/Date:0310793722
09.02.2015
Defer
Date:15.10.2015
279
Case No.:319/5/82-
ALC4/2015
Party Name:EXEMED
PHARMACEUTICALS
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00459/AM16/
RLA File
:34/24/040/00297/AM15/
Lic.No/Date:3410040950
10.02.2015
Defer
Date:15.10.2015
280
Case No.:190/5/82-
ALC4/2015
Party Name:HONOUR
LAB LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00330/AM16/
RLA File
:09/24/040/00629/AM15/
Lic.No/Date:0910061597
10.02.2015
Defer
Date:15.10.2015
281 Case No.:290/5/82- Party Name:IND-SWIFT Meet No/Date:8/82- Status:Case
ALC4/2015
LABORATORIES LTD.,
ALC4/2015
16.09.2015
Deferred
HQ File
:01/82/050/00430/AM16/
RLA File
:22/24/040/00098/AM15/
Lic.No/Date:2210015190
10.02.2015
Defer
Date:15.10.2015
282
Case No.:231/5/82-
ALC4/2015
Party Name:MAHARSHI
PHARMA CHEM
PVT.LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00371/AM16/
RLA File
:08/24/040/00403/AM15/
Lic.No/Date:0810134561
10.02.2015
Defer
Date:15.10.2015
283
Case No.:167/5/82-
ALC4/2015
Party Name:FRESENIUS
KABI ONCOLOGY
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00307/AM16/
RLA File
:05/23/040/00435/AM15/
Lic.No/Date:0510393162
11.02.2015
Defer
Date:15.10.2015
284
Case No.:171/5/82-
ALC4/2015
Party Name:FRESENIUS
KABI ONCOLOGY
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00311/AM16/
RLA File
:05/23/040/00434/AM15/
Lic.No/Date:0510393163
11.02.2015
Defer
Date:15.10.2015
285
Case No.:286/5/82-
ALC4/2015
Party Name:GALAXY
SURFACTANTS LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00426/AM16/
RLA File
:03/94/040/01054/AM15/
Lic.No/Date:0310793796
11.02.2015
Defer
Date:15.10.2015
286
Case No.:348/5/82-
ALC4/2015
Party Name:NEW
ALLIANCE DYE-CHEM
PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00488/AM16/
RLA File
:03/95/040/00895/AM15/
Lic.No/Date:0310793791
11.02.2015
Defer
Date:15.10.2015
287
Case No.:159/5/82-
ALC4/2015
Party Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
RLA File
Lic.No/Date:0510393136 Defer
:01/82/050/00299/AM16/ :05/24/040/00484/AM15/ 11.02.2015 Date:15.10.2015
288
Case No.:160/5/82-
ALC4/2015
Party Name:PCL OIL &
SOLVENTS LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00300/AM16/
RLA File
:05/24/040/00389/AM15/
Lic.No/Date:0510393132
11.02.2015
Defer
Date:15.10.2015
289
Case No.:127/8/82-
ALC4/2015
Party Name:CAMPHOR
& ALLIED PRODUCTS
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00923/AM16/
RLA File
:03/94/040/01056/AM15/
Lic.No/Date:0310793858
12.02.2015
Defer
Date:15.10.2015
290
Case No.:333/5/82-
ALC4/2015
Party Name:MEHTA API
PVT LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00473/AM16/
RLA File
:03/95/040/00903/AM15/
Lic.No/Date:0310793861
12.02.2015
Defer
Date:15.10.2015
291
Case No.:345/5/82-
ALC4/2015
Party Name:NAVIN
FLUORINE
INTERNATIONAL
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00485/AM16/
RLA File
:03/95/040/00909/AM15/
Lic.No/Date:0310793856
12.02.2015
Defer
Date:15.10.2015
292
Case No.:347/5/82-
ALC4/2015
Party Name:ROYAL
PHARMA
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00487/AM16/
RLA File
:03/95/040/00958/AM15/
Lic.No/Date:0310793866
12.02.2015
Defer
Date:15.10.2015
293
Case No.:201/5/82-
ALC4/2015
Party Name:AKZO
NOBEL INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00341/AM16/
RLA File
:02/24/040/00178/AM15/
Lic.No/Date:0210205557
13.02.2015
Defer
Date:15.10.2015
294
Case No.:330/5/82-
ALC4/2015
Party Name:SURVIVAL
TECHNOLOGIES
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00470/AM16/
RLA File
:03/95/040/00901/AM15/
Lic.No/Date:0310793891
16.02.2015
Defer
Date:15.10.2015
295
Case No.:42/5/82-
ALC4/2015
SCIENCES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00182/AM16/
RLA File
:09/24/040/00633/AM15/
Lic.No/Date:0910061619
16.02.2015
Defer
Date:15.10.2015
case for want of comments from D/o Pharmaceuticals..
296
Case No.:331/5/82-
ALC4/2015
Party Name:YASHO
INDUSTRIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00471/AM16/
RLA File
:03/95/040/00971/AM15/
Lic.No/Date:0310793898
16.02.2015
Defer Date:
Department of DEPARTMENT OF C&PC U.O.No.14010/95/2011-Ch-II dt 11.09. 2015 as per
Export product
Qty.
Import items
Qty.kg
AROMATIC
DERIVATIVE
OF DIPHENYLAMINE(ADA)
1kg
DIPHENYLAMINE
0.447
ALPHA METHYL STYRENE
1.23
ACTIVATED CLAY
0.200
297
Case No.:253/5/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00393/AM16/
RLA File
:05/24/040/00548/AM15/
Lic.No/Date:0510393250
17.02.2015
Defer Date:
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide letter No.35011/ 495 /2014-PI (Norms) dt. March 2015 as
Export product
Qty.
Import items
Qty.
SITAGLIPTIN
PHOSPHATE
MONOHYDRATE
1kg
1
(R)-3-((tert-butoxycarbonyl)amino)-4-
(2,4,5-trifluorophenyl)butanoic acid
(SG04)
1.00kg
2
3-(trifluoromethyl)-5,6,7,8-tetrahydro-
[1,2,4]triazolo[4,3-a]pyrazine
hydrochloride
0.80kg
3
N-Hydroxybenzotriazole(HOBT)
0.50kg
4
Methanol
3.65 lit./kg
5
Isopropyl alcohol
6.10 lit/kg
6
Methylene Dichloride
15.25 lit/kg
298
Case No.:235/5/82-
ALC4/2015
Party Name:AMANTA
HEALTHCARE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00375/AM16/
RLA File
:08/24/040/00413/AM15/
Lic.No/Date:0810134610
18.02.2015
Defer
Date:15.10.2015
case for want of comments from D/o Pharmaceuticals..
299
Case No.:281/5/82-
ALC4/2015
Party Name:IPCA
LABORATORIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00421/AM16/
RLA File
:03/94/040/01069/AM15/
Lic.No/Date:0310793943
18.02.2015
Defer Date:
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide letter No.35011/106 /2014-PI (Norms) dt. August 2015 as
Export product
Qty.
Import items
Qty.kg
Prednisolone
sodium
phosphate
1kg
Prednisolone
0.839
300
Case No.:283/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00423/AM16/
RLA File
:03/94/040/01084/AM15/
Lic.No/Date:0310793953
18.02.2015
Defer
Date:15.10.2015
case for want of comments from D/o Pharmaceuticals..
301
Case No.:349/5/82-
ALC4/2015
Party Name:PREGNA
INTERNATIONAL LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00489/AM16/
RLA File
:03/95/040/00984/AM15/
Lic.No/Date:0310793937
18.02.2015
Defer Date:
Department of DEPARTMENT OF C&PC U.O.No.46011/22/2008-PC-II dt. 25.08.2015 as per
Export product
Qty.
Import items
Qty.kg.
INTRA
UTERINE
CONTRACEPTIVE
DEVICE -COPPER T 380
A
One number 1 Copper Wire with ( 99.99% Purity) 0.000204 kg. 2 HDPE GRANULES (MOULDING GRADE) 0.001202 kg. 3 Pouches (Plastic) Net+10% 4 COPPER TUBE ( 99.99% PURITY) 0.000169 kg. 5 POLYPROPYLENE GRANULES 0.0015543 kg.
6 COMPOUND OF LDPE RESIN & BARIUM SULPHATE 0.000415 kg.
7 PVC GRANULES 0.000658 kg. 8 HDPE GRANULES / NYLON RESIN MEDICAL GRADE 0.000177 kg.
302
Case No.:285/5/82-
ALC4/2015
Party Name:CAMPHOR
& ALLIED PRODUCTS
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00425/AM16/
RLA File
:03/94/040/01092/AM15/
Lic.No/Date:0310793985
19.02.2015
Defer
Date:15.10.2015
Decision : The committee in light of the written comment of D/o DEPARTMENT OF C&PC
forwarded vide O.M.No.14010/47/2014-CH-II dated 18th July 2015 decided to call for following
information from the firm:-
- Detailed manufacturing process with balance chemical reactions indicating number of moles of all reactants, products and by products with corresponding molecular formulac, structural formulae, molecular weight and process flow diagram.
- Stage wise percentage yield with respect of each of the reactant and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import.
- Details of by products formed during the process and the recovery of solvents in terms of quantity and value.
- Details of production of export product under reference i.e. Camphor USP and corresponding consumption of raw materials in the year 2013-14, 2014-15 and 2015-16 (April to June ) duly certified by CA
- Any other relevant information, if any.
303
Case No.:279/5/82-
ALC4/2015
Party Name:CROWN
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00419/AM16/
RLA File
:03/94/040/01088/AM15/
Lic.No/Date:0310793983
19.02.2015
Defer
Date:15.10.2015
304
Case No.:288/5/82-
ALC4/2015
Party Name:CROWN
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00428/AM16/
RLA File
:03/94/040/01089/AM15/
Lic.No/Date:0310793982
19.02.2015
Defer
Date:15.10.2015
305
Case No.:237/5/82-
ALC4/2015
Party Name:INTAS
PHARMACEUTICALS
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00377/AM16/
RLA File
:08/24/040/00423/AM15/
Lic.No/Date:0810134636
19.02.2015
Defer
Date:15.10.2015
case for want of comments from D/o Pharmaceuticals..
306
Case No.:332/5/82-
ALC4/2015
Party Name:O C
SPECIALITIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
307
Case No.:317/5/82-
ALC4/2015
Party Name:AMI
LIFESCIENCES P LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00457/AM16/
RLA File
:34/24/040/00305/AM15/
Lic.No/Date:3410040974
20.02.2015
Defer
Date:15.10.2015
308
Case No.:38/5/82-
ALC4/2015
Party Name:MYLAN
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00178/AM16/
RLA File
:09/24/040/00591/AM15/
Lic.No/Date:0910061638
20.02.2015
Defer
Date:15.10.2015
309
Case No.:335/5/82-
ALC4/2015
Party Name:PRIVI
ORGANICS LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00475/AM16/
RLA File
:03/95/040/00978/AM15/
Lic.No/Date:0310794038
20.02.2015
Defer
Date:15.10.2015
310
Case No.:320/5/82-
ALC4/2015
Party
Name:GULBRANDSEN
CHEMICALS PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00460/AM16/
RLA File
:34/24/040/00313/AM15/
Lic.No/Date:3410040975
23.02.2015
Defer Date:
Department of DEPARTMENT OF C&PC U.O.No.14010/49/2011-Ch-II dt. 10.09.2015 as per
Export product
Qty.
Import items
Qty.kg
Tetra Butyl Tin (TBT)
1kg
1
Tin Ingots
0.364
2
Aluminium Grit/Granules
0.119
3
Butene-1
0.869
311
Case No.:31/5/82-
ALC4/2015
Party Name:SRIAM LABS
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00171/AM16/
RLA File
:09/24/040/00630/AM15/
Lic.No/Date:0910061641
23.02.2015
Defer
Date:15.10.2015
312
Case No.:318/5/82-
ALC4/2015
Party Name:TIDE
INDUSTRIES
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00458/AM16/
RLA File
:34/24/040/00310/AM15/
Lic.No/Date:3410040978
23.02.2015
Defer
Date:15.10.2015
Decision : The D/o DEPARTMENT OF C&PC vide letter No.14010/85/2010-CH-II dt.11.8.2015
has informed that information called for from the firm is awaited. The committee accordingly
deferred the case.
313
Case No.:280/5/82-
ALC4/2015
Party Name:FERMENTA
BIOTECH LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
314
Case No.:293/5/82-
ALC4/2015
Party Name:MAHARSHI
PHARMA CHEM
PVT.LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00433/AM16/
RLA File
:08/24/040/00426/AM15/
Lic.No/Date:0810134657
24.02.2015
Defer
Date:15.10.2015
315
Case No.:250/5/82-
ALC4/2015
Party Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00390/AM16/
RLA File
:05/24/040/00528/AM15/
Lic.No/Date:0510393339
24.02.2015
Defer Date:
Department of 46011/79/2014-PC-II dt. 26.8.2015 as per details given below or as applied by the
firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
Di-Octyl
Teraphthalate
(DOTP)
1kg
1
Pure Tere Phthalic Acid
0.400
2
2-Ethyl Hexanol
0.613
316
Case No.:251/5/82-
ALC4/2015
Party Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00391/AM16/
RLA File
:05/24/040/00538/AM15/
Lic.No/Date:0510393340
24.02.2015
Defer Date:
Department of 46011/79/2014-PC-II dt. 26.8.2015 as per details given below or as applied by the
firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
Di-Octyl
Teraphthalate
(DOTP)
1kg
1
Pure Tere Phthalic Acid
0.400
2
2-Ethyl Hexanol
0.613
317
Case No.:252/5/82-
ALC4/2015
Party Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00392/AM16/
RLA File
:05/24/040/00544/AM15/
Lic.No/Date:0510393341
24.02.2015
Defer Date:
Department of 46011/79/2014-PC-II dt. 26.8.2015 as per details given below or as applied by the
firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
Di-Octyl
Teraphthalate
(DOTP)
1kg
1
Pure Tere Phthalic Acid
0.400
2
2-Ethyl Hexanol
0.613
318
Case No.:232/5/82-
ALC4/2015
Party Name:RANBAXY
LABORATORIES LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00372/AM16/
RLA File
:05/24/040/00560/AM15/
Lic.No/Date:0510393348
24.02.2015
Defer
Date:15.10.2015
319
Case No.:334/5/82-
ALC4/2015
Party Name:UPL
LTD.(FORMERLY
UNITED PHOSPHORUS
LTD.)
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00474/AM16/
RLA File
:03/95/040/00862/AM15/
Lic.No/Date:0310794100
24.02.2015
Defer
Date:15.10.2015
320
Case No.:277/5/82-
ALC4/2015
Party Name:INDO
AMINES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00417/AM16/
RLA File
:03/94/040/01024/AM15/
Lic.No/Date:0310794134
25.02.2015
Defer
Date:15.10.2015
321
Case No.:308/5/82-
ALC4/2015
Party Name:PAYAL
PETROCHEM PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00448/AM16/
RLA File
:05/24/040/00511/AM15/
Lic.No/Date:0510393355
25.02.2015
Defer
Date:15.10.2015
322
Case No.:309/5/82-
ALC4/2015
Party Name:SHREE
VALLABH CHEMICAL
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00449/AM16/
RLA File
:08/24/040/00417/AM15/
Lic.No/Date:0810134670
25.02.2015
Defer
Date:15.10.2015
323
Case No.:259/5/82-
ALC4/2015
Party Name:VIRDEV
INTERMEDIATES PVT
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00399/AM16/
RLA File
:52/24/040/00067/AM15/
Lic.No/Date:5210041437
25.02.2015
Defer
Date:15.10.2015
Decision : The committee, in light of the written comment of D/o Pharmaceuticals forwarded vide
O.M.No.35011/92/2015-PI (Norms) dated September 2015 decided to call for complete technical
details from the firms as per Appendix-33.
324
Case No.:41/5/82-
ALC4/2015
Party Name:DR REDDYS
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00181/AM16/
RLA File
:09/24/040/00657/AM15/
Lic.No/Date:0910061651
26.02.2015
Defer
Date:15.10.2015
325
Case No.:314/5/82-
ALC4/2015
Party Name:R L FINE
CHEM
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00454/AM16/
RLA File
:07/24/040/00416/AM15/
Lic.No/Date:0710107713
26.02.2015
Defer
Date:15.10.2015
326
Case No.:325/5/82-
ALC4/2015
Party Name:SWISS
EXPORTS PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00465/AM16/
RLA File
:08/24/040/00401/AM15/
Lic.No/Date:0810134676
26.02.2015
Defer
Date:15.10.2015
327
Case No.:273/5/82-
ALC4/2015
Party Name:BHARAT
SERUMS & VACCINES
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00413/AM16/
RLA File
:03/94/040/01055/AM15/
Lic.No/Date:0310794262
27.02.2015
Defer
Date:15.10.2015
case for want of comments from DBT.
328
Case No.:452/5/82-
ALC4/2015
Party Name:BLUE
CIRCLE ORGANICS
PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00592/AM16/
RLA File
:03/94/040/01091/AM15/
Lic.No/Date:0310794261
27.02.2015
Defer
Date:15.10.2015
329
Case No.:297/5/82-
ALC4/2015
Party Name:HPL
ADDITIVES
LIMITED(FORMERLY
KNOWN HIGH
POLYMER
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00437/AM16/
RLA File
:05/23/040/00510/AM15/
Lic.No/Date:0510393404
27.02.2015
Defer
Date:15.10.2015
330
Case No.:298/5/82-
ALC4/2015
Party Name:MEDICEF
PHARMA,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
331
Case No.:312/5/82-
ALC4/2015
Party Name:R L FINE
CHEM
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00452/AM16/
RLA File
:07/24/040/00415/AM15/
Lic.No/Date:0710107728
27.02.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/203/2015-PI (Norms) dt. Sept. 2015 as per
Export product
Qty.
Import items
Qty.kg
ORPHENADRINE
CITRATE
BP/EP/USP
1kg
1
2 METHYL
BENZOPHENONE
0.70
2
ACETONE
1.25
332
Case No.:414/5/82-
ALC4/2015
Party Name:KRISHNA
ANTIOXIDANTS PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00554/AM16/
RLA File
:03/94/040/01090/AM15/
Lic.No/Date:0310794291
02.03.2015
Defer
Date:15.10.2015
333
Case No.:337/5/82-
ALC4/2015
Party Name:MANGALAM
DRUGS & ORGANICS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00477/AM16/
RLA File
:03/95/040/01001/AM15/
Lic.No/Date:0310794280
02.03.2015
Defer
Date:15.10.2015
334
Case No.:341/5/82-
ALC4/2015
Party Name:MANGALAM
DRUGS & ORGANICS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00481/AM16/
RLA File
:03/95/040/01002/AM15/
Lic.No/Date:0310794281
02.03.2015
Defer
Date:15.10.2015
335
Case No.:316/5/82-
ALC4/2015
Party Name:ALEMBIC
PHARMACEUTICALS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00456/AM16/
RLA File
:34/24/040/00280/AM15/
Lic.No/Date:3410041005
03.03.2015
Defer
Date:15.10.2015
336
Case No.:295/5/82-
ALC4/2015
Party Name:PROLIFE
INDUSTRIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00435/AM16/
RLA File
:08/24/040/00395/AM15/
Lic.No/Date:0810134703
03.03.2015
Defer
Date:15.10.2015
337
Case No.:294/5/82-
ALC4/2015
Party Name:ATUL
INTERMEDIATES
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00434/AM16/
RLA File
:08/24/040/00264/AM15/
Lic.No/Date:0810134727
04.03.2015
Defer
Date:15.10.2015
338
Case No.:326/5/82-
ALC4/2015
Party Name:ATUL
INTERMEDIATES
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00466/AM16/
RLA File
:08/24/040/00429/AM15/
Lic.No/Date:0810134726
04.03.2015
Defer
Date:15.10.2015
339
Case No.:415/5/82-
ALC4/2015
Party Name:BDR
PHARMACEUTICALS
INTERNATIONAL PVT.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
LTD.
HQ File
:01/82/050/00555/AM16/
RLA File
:03/94/040/01111/AM15/
Lic.No/Date:0310794368
04.03.2015
Defer
Date:15.10.2015
340
Case No.:422/5/82-
ALC4/2015
Party Name:ENCUBE
ETHICALS PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00562/AM16/
RLA File
:03/94/040/01120/AM15/
Lic.No/Date:0310794347
04.03.2015
Defer
Date:15.10.2015
case for want of comments from D/o Pharmaceuticals. The Committee considered the case for
ratification of norms and decided to defer the case for want of comments from D/o
Pharmaceuticals.
341
Case No.:451/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00591/AM16/
RLA File
:03/94/040/01097/AM15/
Lic.No/Date:0310794354
04.03.2015
Defer
Date:15.10.2015
342
Case No.:324/5/82-
ALC4/2015
Party Name:SWISS
PARENTERALS
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00464/AM16/
RLA File
:08/24/040/00439/AM15/
Lic.No/Date:0810134729
04.03.2015
Defer
Date:15.10.2015
343
Case No.:20/8/82-
ALC4/2015
Party Name:VEGESNA
LABORATORIES PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00816/AM16/
RLA File
:09/24/040/00660/AM15/
Lic.No/Date:0910061662
04.03.2015
Defer Date:
Decision : The committee decided to ratify the norms based on the recommendation of
Department of Pharmaceuticals vide letter No.35011/609/2013-PI (Norms) dt.24.12.2013 as per
Export product
Qty.
Import items
Qty.kg
Magnesium
salt/Magnesium
Mono-p-
Nitro Benzyl malonate
1kg
1
Para Nitro Benzyl alcohol
0.874
2
Malonic acid
1.044
3
Toluene
1.00
344 Case No.:340/5/82-
ALC4/2015
Party Name:YASHO
INDUSTRIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
Status:approved
16.09.2015
HQ File
:01/82/050/00480/AM16/
RLA File
:03/95/040/01027/AM15/
Lic.No/Date:0310794375
04.03.2015
Defer Date:
The committee decided to ratify the norms based on the recommendation of DEPARTMENT OF
C&PC U.O.No.14010/95/2011-Ch-II dt. 11.09 2015 as per details given below or as applied by
the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
Yantq 2020 (20% Solution
of
Tertiary
Butyl
Hydroquinone)
1 kg
1 Hydroquinone 0.282 2 Tertiary Butanol 0.208 3 Propylene Glycol 0.700
345
Case No.:303/5/82-
ALC4/2015
Party
Name:ASSOCIATED
DYESTUFF PVT. LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00443/AM16/
RLA File
:08/24/040/00422/AM15/
Lic.No/Date:0810134739
05.03.2015
Defer
Date:15.10.2015
346
Case No.:304/5/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00444/AM16/
RLA File
:05/23/040/00538/AM15/
Lic.No/Date:0510393485
05.03.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/79/2015-PI (Norms) dt. Sept. 2015 as per
Export product
Qty.
Import items
Qty.kg
CEFDINIR USP/BP/IP/EP
POWDER
1kg
1
7-Phenylacetamideo -3-
Chloromethyl
Cephalosporanic Acid
Para Methoxy Benzyl
Ester (GCLE)
2.263
2
TRIPHENYL
PHOSPHINE
1.234
3
SODIUM IODIDE
0.11
4
PHENOL
2.42
5
METHYLENE
CHLORIDE
12.556
6
TETRA HYDRO
FURAN(THF)
2.425
7
METHANOL
4.414
8
FORMALDEHYDE
2.74
9
CAEM
1.397
10
TRIETHYLAMINE
0.155
11
n-BUTYL ACETATE
1.659
347
Case No.:306/5/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00446/AM16/
RLA File
:05/23/040/00537/AM15/
Lic.No/Date:0510393484
05.03.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/79/2015-PI (Norms) dt. Sept. 2015 as per
Export product
Qty.
Import items
Qty.kg
CEFDINIR USP/BP/IP/EP
POWDER
1kg
1
7-Phenylacetamideo -3-
Chloromethyl
Cephalosporanic Acid
Para Methoxy Benzyl
Ester (GCLE)
2.263
2
TRIPHENYL
PHOSPHINE
1.234
3
SODIUM IODIDE
0.11
4
PHENOL
2.42
5
METHYLENE
CHLORIDE
12.556
6
TETRA HYDRO
FURAN(THF)
2.425
7
METHANOL
4.414
8
FORMALDEHYDE
2.74
9
CAEM
1.397
10
TRIETHYLAMINE
0.155
11
n-BUTYL ACETATE
1.659
348
Case No.:39/5/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00179/AM16/
RLA File
:09/24/040/00650/AM15/
Lic.No/Date:0910061669
05.03.2015
Defer
Date:15.10.2015
349
Case No.:11/5/82-
ALC4/2015
Party Name:LEE PHARMA
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00151/AM16/
RLA File
:09/24/040/00670/AM15/
Lic.No/Date:0910061666
05.03.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/274 /2015-PI (Norms) dt. 21.09.2015 as
Export product
Qty.
Import items
Qty.kg
2’3’DI-O-ACETYL-5-
DEOXY-5’-FLUORO-
1kg
1
1,2,3-TRIACETYL-5-
DEOXY-D-RIBOSE
1.05
CYTEDINE
2
5-FLUORO CYTOSINE
0.437
3
METHYLENE
CHLORIDE
2.00
350
Case No.:444/5/82-
ALC4/2015
Party Name:AARTI
INDUSTRIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:
Decision The Committee considered the case for ratification of norms and decided to defer the
351
Case No.:323/5/82-
ALC4/2015
Party Name:ADCOCK
INGRAM LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00463/AM16/
RLA File
:07/24/040/00444/AM15/
Lic.No/Date:0710107772
09.03.2015
Defer Date:
15.10.2015
352
Case No.:299/5/82-
ALC4/2015
Party
Name:G.G.CHEMICALS
& PHARMACEUTICALS
PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00439/AM16/
RLA File
:22/24/040/00106/AM15/
Lic.No/Date:2210015206
09.03.2015
Defer
Date:15.10.2015
353
Case No.:423/5/82-
ALC4/2015
Party Name:INDOCO
REMEDIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00563/AM16/
RLA File
:03/94/040/01116/AM15/
Lic.No/Date:0310794418
09.03.2015
Defer
Date:15.10.2015
354
Case No.:445/5/82-
ALC4/2015
Party Name:ELPPE
CHEMICALS PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00585/AM16/
RLA File
:03/94/040/01143/AM15/
Lic.No/Date:0310794485
10.03.2015
Defer
Date:15.10.2015
355
Case No.:13/5/82-
ALC4/2015
Party Name:MYLAN
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
RLA File
Lic.No/Date:0910061674 Defer
:01/82/050/00153/AM16/ :09/24/040/00343/AM15/ 10.03.2015 Date:15.10.2015
356
Case No.:402/5/82-
ALC4/2015
Party Name:POLYDRUG
LABORATORIES
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00542/AM16/
RLA File
:03/95/040/01024/AM15/
Lic.No/Date:0310794467
10.03.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/220/2015-PI (Norms) dt. September 2015
as per details given below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
Ferrous Fumarate BP/USP
1kg
Fumaric Acid
0.769
357
Case No.:434/5/82-
ALC4/2015
Party Name:POLYDRUG
LABORATORIES
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00574/AM16/
RLA File
:03/95/040/01025/AM15/
Lic.No/Date:0310794472
10.03.2015
Defer
Date:15.10.2015
358
Case No.:300/5/82-
ALC4/2015
Party Name:ADVANCE
PETROCHEMICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00440/AM16/
RLA File
:08/24/040/00448/AM15/
Lic.No/Date:0810134768
11.03.2015
Defer
Date:15.10.2015
359
Case No.:450/5/82-
ALC4/2015
Party Name:J.B.
CHEMICALS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00590/AM16/
RLA File
:03/94/040/01114/AM15/
Lic.No/Date:0310794517
11.03.2015
Defer
Date:15.10.2015
360
Case No.:447/5/82-
ALC4/2015
Party Name:AARTI
INDUSTRIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00587/AM16/
RLA File
:03/94/040/01131/AM15/
Lic.No/Date:0310794543
12.03.2015
Defer
Date:15.10.2015
361
Case No.:412/5/82-
ALC4/2015
Party Name:BDR
PHARMACEUTICALS
INTERNATIONAL PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00552/AM16/
RLA File
:03/94/040/00983/AM15/
Lic.No/Date:0310794539
12.03.2015
Defer
Date:15.10.2015
362
Case No.:301/5/82-
ALC4/2015
Party Name:CADILA
HEALTHCARE LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00441/AM16/
RLA File
:08/24/040/00460/AM15/
Lic.No/Date:0810134780
12.03.2015
Defer
Date:15.10.2015
363
Case No.:305/5/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00445/AM16/
RLA File
:05/23/040/00555/AM15/
Lic.No/Date:0510393548
12.03.2015
Defer
Date:15.10.2015
364
Case No.:413/5/82-
ALC4/2015
Party Name:INDO
AMINES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
365
Case No.:34/5/82-
ALC4/2015
Party Name:ASCENT
FINECHEM PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00174/AM16/
RLA File
:08/24/040/00397/AM15/
Lic.No/Date:0810134800
13.03.2015
Defer
Date:15.10.2015
366
Case No.:425/5/82-
ALC4/2015
Party Name:BENZO
CHEM INDUSTRIES
PRIVATE LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00565/AM16/
RLA File
:03/94/040/01126/AM15/
Lic.No/Date:0310794611
16.03.2015
Defer
Date:15.10.2015
367 Case No.:33/5/82-
ALC4/2015
Party Name:CADILA
HEALTHCARE LTD.,
Meet No/Date:8/82-
ALC4/2015
Status:Case
Deferred
16.09.2015
HQ File
:01/82/050/00173/AM16/
RLA File
:08/24/040/00466/AM15/
Lic.No/Date:0810134816
16.03.2015
Defer
Date:15.10.2015
368
Case No.:421/5/82-
ALC4/2015
Party Name:INDOCO
REMEDIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00561/AM16/
RLA File
:03/94/040/01151/AM15/
Lic.No/Date:0310794615
16.03.2015
Defer
Date:15.10.2015
369
Case No.:409/5/82-
ALC4/2015
Party Name:NOCIL
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00549/AM16/
RLA File
:03/95/040/00974/AM15/
Lic.No/Date:0310794587
16.03.2015
Defer
Date:15.10.2015
370
Case No.:302/5/82-
ALC4/2015
Party Name:STERILE
INDIA PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00442/AM16/
RLA File
:05/24/040/00589/AM15/
Lic.No/Date:0510393585
16.03.2015
Defer
Date:15.10.2015
371
Case No.:9/5/82-
ALC4/2015
SCIENCES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00149/AM16/
RLA File
:09/24/040/00671/AM15/
Lic.No/Date:0910061707
16.03.2015
Defer
Date:15.10.2015
372
Case No.:429/5/82-
ALC4/2015
Party Name:YASHO
INDUSTRIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00569/AM16/
RLA File
:03/95/040/01056/AM15/
Lic.No/Date:0310794585
16.03.2015
Defer Date:
Department of DEPARTMENT OF C&PC U.O.No.14010/95/2011-Ch-II dt. 11.09. 2015 as per
Export product
Qty.
Import items
Qty.kg
YAPOX
CL
30/10
"HYDROQUINONE
BIS(2hydroxy ethyl ether)
1kg
HYDROQUINONE
0.611
373
Case No.:6/8/82-
ALC4/2015
Party Name:YELURI
FORMULATIONS
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00802/AM16/
RLA File
:09/24/040/00690/AM15/
Lic.No/Date:0910061710
16.03.2015
Defer
Date:15.10.2015
374
Case No.:289/5/82-
ALC4/2015
Party Name:HPL
ADDITIVES
LIMITED(FORMERLY
KNOWN HIGH
POLYMER
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00429/AM16/
RLA File
:05/23/040/00560/AM15/
Lic.No/Date:0510393593
17.03.2015
Defer
Date:15.10.2015
375
Case No.:44/5/82-
ALC4/2015
Party Name:SRIAM LABS
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00184/AM16/
RLA File
:09/24/040/00666/AM15/
Lic.No/Date:0910061718
17.03.2015
Defer
Date:15.10.2015
376
Case No.:291/5/82-
ALC4/2015
Party Name:JUBILANT
LIFE SCIENCES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00431/AM16/
RLA File
:05/23/040/00544/AM15/
Lic.No/Date:0510393616
18.03.2015
Defer
Date:15.10.2015
377
Case No.:426/5/82-
ALC4/2015
Party Name:ENCUBE
ETHICALS PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00566/AM16/
RLA File
:03/94/040/01162/AM15/
Lic.No/Date:0310794710
19.03.2015
Defer
Date:15.10.2015
378
Case No.:420/5/82-
ALC4/2015
Party Name:KUSUMA
PHARMA
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00560/AM16/
RLA File
:03/94/040/01175/AM15/
Lic.No/Date:0310794718
19.03.2015
Defer
Date:15.10.2015
379
Case No.:156/5/82-
ALC4/2015
Party Name:MALLADI
DRUGS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00296/AM16/
RLA File
:04/24/040/00266/AM15/
Lic.No/Date:0410160309
19.03.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 265/2014-PI (Norms) dt. October 2015 as
Export product
Qty.
Import items
Qty.kg
Phenylepherine Base
1kg
1
3-Hydroxy Acetophenone
2.95
2
Methanol
4.063
3
L(+)Tartaric acid
1.84
4
Methyl Isobutyl Ketone
0.857
5
Bromine
3.69
6
Iso Propyl Alcohol
3.47
7
Causticsoda Flakes
2.33
8
Acetic Anhydride
2.70
380
Case No.:192/5/82-
ALC4/2015
Party Name:MALLADI
DRUGS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00332/AM16/
RLA File
:04/24/040/00009/AM15/
Lic.No/Date:0410160310
19.03.2015
Defer
Date:15.10.2015
381
Case No.:292/5/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00432/AM16/
RLA File
:05/24/040/00598/AM15/
Lic.No/Date:0510393647
19.03.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 495 /2014-PI (Norms) dt. March 2015 as
Export product
Qty.
Import items
Qty.
SITAGLIPTIN
PHOSPHATE
MONOHYDRATE
1kg
1
(R)-3-((tert-butoxycarbonyl)amino)-4-
(2,4,5-trifluorophenyl)butanoic acid
(SG04)
1.00kg
2
3-(trifluoromethyl)-5,6,7,8-tetrahydro-
[1,2,4]triazolo[4,3-a]pyrazine
hydrochloride
0.80kg
3
N-Hydroxybenzotriazole(HOBT)
0.50kg
4
Methanol
3.65 lit./kg
5
Isopropyl alcohol
6.10 lit/kg
6
Methylene Dichloride
15.25 lit/kg
382
Case No.:311/5/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00451/AM16/
RLA File
:05/24/040/00597/AM15/
Lic.No/Date:0510393646
19.03.2015
Defer
Date:15.10.2015
383
Case No.:315/5/82-
ALC4/2015
Party Name:ACEBRIGHT
(INDIA) PHARMA PVT
LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
approved
HQ File
:01/82/050/00455/AM16/
RLA File
:07/24/040/00461/AM15/
Lic.No/Date:0710107895
20.03.2015
Defer Date:
384
Case No.:407/5/82-
ALC4/2015
Party Name:WANBURY
LIMITED(FORMERLY
PEARL ORGANICS LTD)
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00547/AM16/
RLA File
:03/95/040/00934/AM15/
Lic.No/Date:0310794735
20.03.2015
Defer
Date:15.10.2015
385
Case No.:408/5/82-
ALC4/2015
Party Name:SHIRDI
CHEMICALS PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00548/AM16/
RLA File
:03/95/040/01059/AM15/
Lic.No/Date:0310794798
23.03.2015
Defer
Date:15.10.2015
386
Case No.:183/5/82-
ALC4/2015
Party Name:SPAK
ORGOCHEM (INDIA)
PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00323/AM16/
RLA File
:03/95/040/00964/AM15/
Lic.No/Date:0310794811
23.03.2015
Defer
Date:15.10.2015
387
Case No.:310/5/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00450/AM16/
RLA File
:05/23/040/00562/AM15/
Lic.No/Date:0510393721
24.03.2015
Defer
Date:15.10.2015
388 Case No.:410/5/82-
ALC4/2015
Party Name:INDO
AMINES LIMITED
Meet No/Date:8/82-
ALC4/2015
Status:Case
Deferred
16.09.2015
HQ File
:01/82/050/00550/AM16/
RLA File
:03/94/040/01184/AM15/
Lic.No/Date:0310794835
24.03.2015
Defer
Date:15.10.2015
389
Case No.:191/5/82-
ALC4/2015
Party Name:MALLADI
DRUGS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00331/AM16/
RLA File
:04/24/040/00309/AM15/
Lic.No/Date:0410160331
24.03.2015
Defer
Date:15.10.2015
390
Case No.:193/5/82-
ALC4/2015
Party Name:MALLADI
DRUGS &
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00333/AM16/
RLA File
:04/24/040/00310/AM15/
Lic.No/Date:0410160332
24.03.2015
Defer
Date:15.10.2015
391
Case No.:178/5/82-
ALC4/2015
Party Name:WINTAC
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00318/AM16/
RLA File
:07/24/040/00437/AM15/
Lic.No/Date:0710107914
24.03.2015
Defer
Date:15.10.2015
392
Case No.:29/5/82-
ALC4/2015
Party
Name:ASSOCIATED
DYESTUFF PVT. LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00169/AM16/
RLA File
:08/24/040/00483/AM15/
Lic.No/Date:0810134917
25.03.2015
Defer
Date:15.10.2015
393
Case No.:427/5/82-
ALC4/2015
Party Name:SHALINA
LABORATORIES PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
394
Case No.:431/5/82-
ALC4/2015
Party Name:EUROLIFE
HEALTHCARE PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
395
Case No.:448/5/82-
ALC4/2015
Party Name:AARTI
INDUSTRIES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
Decision : The committee in light of the written comment of D/o C&PC forwarded vide
O.M.No.14010/137/2011-CH-II dated 14.08 2015 decided to call for following information from the firm:-
- Detailed manufacturing process with balanced chemical reactions indicating number of moles of all the reactants, products and by-products with corresponding molecular Formula structural formula molecular weight and process flow diagram. 2. Stage wise percentage yield with respect of each of the reactant and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield or quantity of items for import. 3. Complete material balance indicating input and output material on weight to weight basis at each stage of manufacturing process. 4. Details of production of export product under reference and corresponding consumption of raw material in the year 2014-15, 2015-16 (April to June) 5. Any other relevant information, if any.
396
Case No.:16/5/82-
ALC4/2015
Party Name:ARENE LIFE
SCIENCES LIMITED.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
397
Case No.:405/5/82-
ALC4/2015
Party Name:CTX
LIFESCIENCES PVT
LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00545/AM16/
RLA File
:03/94/040/00521/AM15/
Lic.No/Date:0310795052
31.03.2015
Defer
Date:15.10.2015
398
Case No.:438/5/82-
ALC4/2015
Party Name:ENCUBE
ETHICALS PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00578/AM16/
RLA File
:03/94/040/01196/AM15/
Lic.No/Date:0310795049
31.03.2015
Defer
Date:15.10.2015
399
Case No.:19/5/82-
ALC4/2015
Party Name:MAHARSHI
PHARMA CHEM
PVT.LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00159/AM16/
RLA File
:08/24/040/00485/AM15/
Lic.No/Date:0810134977
31.03.2015
Defer
Date:15.10.2015
400
Case No.:27/5/82-
ALC4/2015
Party Name:POSY
PHARMACHEM PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00167/AM16/
RLA File
:08/24/040/00449/AM15/
Lic.No/Date:0810134978
31.03.2015
Defer
Date:15.10.2015
401
Case No.:28/5/82-
ALC4/2015
Party Name:RUCHI
SOYA INDUSTRIES LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00168/AM16/
RLA File
:56/24/040/00064/AM15/
Lic.No/Date:5610004573
31.03.2015
Defer
Date:15.10.2015
402
Case No.:24/5/82-
ALC4/2015
Party Name:SATYADEVA
PHARMACEUTICALS /P/
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00164/AM16/
RLA File
:09/24/040/00729/AM15/
Lic.No/Date:0910061845
31.03.2015
Defer
Date:15.10.2015
403
Case No.:40/5/82-
ALC4/2015
Party Name:VASUDHA
PHARMA CHEM LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00180/AM16/
RLA File
:09/24/040/00691/AM15/
Lic.No/Date:0910061852
31.03.2015
Defer
Date:15.10.2015
404
Case No.:12/5/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00152/AM16/
RLA File
:09/24/040/00627/AM15/
Lic.No/Date:0910061822
31.03.2015
Defer
Date:15.10.2015
405
Case No.:432/5/82-
ALC4/2015
Party Name:AVA
CHEMICALS PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00572/AM16/
RLA File
:03/94/040/01212/AM15/
Lic.No/Date:0310795110
06.04.2015
Defer Date:
Department of DEPARTMENT OF C&PC U.O.no.14010/67/2011-Ch-II dt. 2.09. 2015 as per
Export product Qty. Import items Qty.kg DISODIUM MANGANESE EDTA (Manganese Content 12.5% +/- 0.5) 1kg Ethylene Diamine Tetra Acetic Acid (EDTA) 0.690
406
Case No.:419/5/82-
ALC4/2015
Party Name:FDC LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00559/AM16/
RLA File
:03/94/040/01173/AM15/
Lic.No/Date:0310795100
06.04.2015
Defer
Date:15.10.2015
407
Case No.:449/5/82-
ALC4/2015
Party Name:INDOFIL
INDUSTRIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00589/AM16/
RLA File
:03/94/040/01208/AM15/
Lic.No/Date:0310795116
06.04.2015
Defer
Date:15.10.2015
408
Case No.:416/5/82-
ALC4/2015
Party Name:BLUE
CIRCLE ORGANICS
PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00556/AM16/
RLA File
:03/94/040/01197/AM15/
Lic.No/Date:0310795139
07.04.2015
Defer
Date:15.10.2015
409
Case No.:26/5/82-
ALC4/2015
Party
Name:CONTINENTAL
CHEMICALS
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
410
Case No.:411/5/82-
ALC4/2015
Party Name:SHALINA
LABORATORIES PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
411
Case No.:424/5/82-
ALC4/2015
Party Name:UNICHEM
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
RLA File
Lic.No/Date:0310795220 Defer
:01/82/050/00564/AM16/ :03/95/040/01083/AM15/ 09.04.2015 Date:15.10.2015
412
Case No.:406/5/82-
ALC4/2015
Party Name:ENCUBE
ETHICALS PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00546/AM16/
RLA File
:03/94/040/01225/AM15/
Lic.No/Date:0310795279
13.04.2015
Defer
Date:15.10.2015
413
Case No.:139/8/82-
ALC4/2015
Party Name:S.M.
CHEMICALS
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00935/AM16/
RLA File
:03/95/040/01120/AM15/
Lic.No/Date:0310795271
13.04.2015
Defer
Date:15.10.2015
414
Case No.:124/8/82-
ALC4/2015
Party Name:GUJARAT
ORGANICS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00920/AM16/
RLA File
:03/94/040/00664/AM15/
Lic.No/Date:0310795311
15.04.2015
Defer
Date:15.10.2015
415
Case No.:5/5/82-
ALC4/2015
Party Name:MAHARSHI
PHARMA CHEM
PVT.LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
416
Case No.:6/5/82-
ALC4/2015
Party Name:MAHARSHI
PHARMA CHEM
PVT.LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00146/AM16/
RLA File
:08/24/040/00004/AM16/
Lic.No/Date:0810135050
17.04.2015
Defer
Date:15.10.2015
417
Case No.:10/5/82-
ALC4/2015
Party Name:PI
INDUSTRIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00150/AM16/
RLA File
:13/24/040/00056/AM15/
Lic.No/Date:1310047840
17.04.2015
Defer
Date:15.10.2015
418
Case No.:35/5/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00175/AM16/
RLA File
:09/24/040/00739/AM15/
Lic.No/Date:0910061891
17.04.2015
Defer
Date:15.10.2015
419
Case No.:32/5/82-
ALC4/2015
Party Name:LANTECH
PHARMACEUTICALS
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
420
Case No.:64/8/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00860/AM16/
RLA File
:09/24/040/00006/AM16/
Lic.No/Date:0910061905
21.04.2015
Defer
Date:15.10.2015
421
Case No.:22/5/82-
ALC4/2015
Party Name:KLJ
PLASTICIZERS LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00162/AM16/
RLA File
:05/23/040/00587/AM15/
Lic.No/Date:0510393920
23.04.2015
Defer
Date:15.10.2015
422
Case No.:36/5/82-
ALC4/2015
Party Name:KLJ
PLASTICIZERS LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00176/AM16/
RLA File
:05/23/040/00597/AM15/
Lic.No/Date:0510393894
23.04.2015
Defer
Date:15.10.2015
423
Case No.:115/7/82-
ALC4/2015
Party Name:YASHO
INDUSTRIES PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Deffered
HQ File
:01/82/050/00720/AM16/
RLA File
:03/95/040/00042/AM16/
Lic.No/Date:0310795524
24.04.2015
Defer
Date:15.10.2015
424 Case No.:40/8/82-
ALC4/2015
Party Name:SYNTHO
CHIRALS PVT. LTD
Meet No/Date:8/82-
ALC4/2015
Status:Case
Deferred
16.09.2015
HQ File
:01/82/050/00836/AM16/
RLA File
:09/24/040/00042/AM16/
Lic.No/Date:0910061937
27.04.2015
Defer
Date:15.10.2015
425
Case No.:35/8/82-
ALC4/2015
Party Name:EYTAN
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00831/AM16/
RLA File
:09/24/040/00068/AM16/
Lic.No/Date:0910061940
28.04.2015
Defer
Date:15.10.2015
426
Case No.:36/8/82-
ALC4/2015
Party Name:EYTAN
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00832/AM16/
RLA File
:09/24/040/00067/AM16/
Lic.No/Date:0910061939
28.04.2015
Defer
Date:15.10.2015
427
Case No.:17/5/82-
ALC4/2015
Party Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00157/AM16/
RLA File
:05/24/040/00030/AM16/
Lic.No/Date:0510394006
28.04.2015
Defer
Date:15.10.2015
428
Case No.:135/8/82-
ALC4/2015
Party Name:SATYA
DEEPTHA
PHARMACEUTICALS LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00931/AM16/
RLA File
:09/24/040/00035/AM16/
Lic.No/Date:0910061944
29.04.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/341 /2014-PI (Norms) dt. November 2014
as per details given below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
(1S,4R)-4-[(2-AMINO-6-
CHLORO-5-FORMAMIDO-4-
PYRIMIDINYL)AMINO]-2-
CYCLO
PENTENE-1-
METHANOL
1kg
1
N-(2-AMINO-4,6-DICHLORO-5-
PYRIMIDINYL) FORMAMIDE
0.764
2 (+)-2- AZABICYCLO[2.2.1]HEPT-5- EN-3-ONE(VINCELACTAM) 1.41
3 D(-)TARTARIC ACID 0.78 4 SODIUM BOROHYDRIDE 0.226 5 ISOPROPYL ALCOHOL 4.70
6 METHANOL 4.23 7 L(+) Tartaric Acid 1.23
429
Case No.:47/8/82-
ALC4/2015
Party Name:SHODHANA
LABORATORIES LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Approved
HQ File
:01/82/050/00843/AM16/
RLA File
:09/24/040/00012/AM16/
Lic.No/Date:0910061943
29.04.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/29/2015-PI(Norms) dt. May, 2015 as per Export product Qty. Import items Qty.kg 4-Hydroxy Carbazole 1kg 1,2,3,9-Tetrahydrocarbazole- 4-One 1.20
430
Case No.:34/8/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00830/AM16/
RLA File
:09/24/040/00014/AM16/
Lic.No/Date:0910061946
29.04.2015
Defer
Date:15.10.2015
431
Case No.:174/5/82-
ALC4/2015
Party Name:GLOBAL
CALCIUM PRIVATE
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00314/AM16/
RLA File
:07/24/040/00393/AM15/
Lic.No/Date:0710108142
01.05.2015
Defer
Date:15.10.2015
432
Case No.:176/5/82-
ALC4/2015
Party Name:GLOBAL
CALCIUM PRIVATE
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00316/AM16/
RLA File
:07/24/040/00389/AM15/
Lic.No/Date:0710108141
01.05.2015
Defer
Date:15.10.2015
433
Case No.:177/5/82-
ALC4/2015
Party Name:GLOBAL
CALCIUM PRIVATE
LIMITED,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00317/AM16/
RLA File
:07/24/040/00390/AM15/
Lic.No/Date:0710108143
01.05.2015
Defer
Date:15.10.2015
434
Case No.:62/8/82-
ALC4/2015
Party Name:OPTIMUS
DRUGS PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
435
Case No.:60/8/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00856/AM16/
RLA File
:09/24/040/00063/AM16/
Lic.No/Date:0910061971
01.05.2015
Defer Date:
Decision :
The committee decided to ratify the norms based on the recommendation of Department of
Pharmaceuticals vide letter No.35011/ 99 /2015-PI (Norms) dt. Sept. 2015 as per details given
below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
RACTOPAMINE HCL
1kg
1
1-(4-Hydroxy Phenyl)-2-
Amino Ethanol
(OCTOPAMINE HCL)
0.77
2
4-(4-Hydroxy Phenyl)-2-
Butanone
0.91
3
Methanol
1.87
4
Ethyl Acetate
2.44
436
Case No.:61/8/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00857/AM16/
RLA File
:09/24/040/00045/AM16/
Lic.No/Date:0910061970
01.05.2015
Defer
Date:15.10.2015
437
Case No.:63/8/82-
ALC4/2015
Party Name:SATYA
DEEPTHA
PHARMACEUTICALS LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00859/AM16/
RLA File
:09/24/040/00737/AM15/
Lic.No/Date:0910061968
01.05.2015
Defer Date:
Decision : Committee considered the case as per agenda and in light written comments
provided by D/o Pharmaceuticals vide O.M.No.35011/480/2014-PI (Norms) dated March, 2015
decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm
whichever is lower:-
Export product
Exp.
Qty.
Sl.No.
Import items
Qty.
Allowed
Kg/kg
(3R,3aS,6aR)-hexahydrofuro[2,3-
b] furan-3-yl 4-nitrophenyl
carbonate(Nitro Complex)
1 kg
1 (3aS,6aR)-Tetra hydro-4- methoxy furo [3,4-b] furan-2 (3H)-one 1.093
2 Potassium Boro Hydride 0.55 3 Tetra Hydro Furan 2.73
RA concerned may take further necessary action as per above decision of NC.
438
Case No.:7/6/82-
ALC4/2015
Party Name:VIRUPAKSHA
ORGANICS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00603/AM16/
RLA File
:09/24/040/00069/AM16/
Lic.No/Date:0910061966
01.05.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/179/2015-PI (Norms) dt.14.09. 2015 as per
Export
product
Qty.
Import items
Qty.kg
Sofosbuvir
1kg
1
(2R)-2-Deoxy-2-fluoro-2-methyl-D-erythro
pentonic acid gamma-Lactone3,5 -
dibenzoate
4.235
2
N-[(S)-(2,3,4,5,6-Penta fluorophenoxy)
Phenoxy phosphinyl]-L-Alanine 1-
Methylethyl Ester
1.92
3
N4 Benzoyl Cytosine
3.573
439
Case No.:8/6/82-
ALC4/2015
Party Name:VIRUPAKSHA
ORGANICS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00604/AM16/
RLA File
:09/24/040/00070/AM16/
Lic.No/Date:0910061965
01.05.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/179/2015-PI (Norms) dt. 14.09.2015 as per
Export
product
Qty.
Import items
Qty.kg
Sofosbuvir
1kg
1
2-Deoxy-2-Fluoro-2-c-Methyluridine
0.90
2
N-[(S)-(2,3,4,5,6-Penta fluorophenoxy)
Phenoxy phosphinyl]-L-Alanine 1-Methylethyl
Ester
1.92
440
Case No.:21/5/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00161/AM16/
RLA File
:05/23/040/00003/AM16/
Lic.No/Date:0510394100
05.05.2015
Defer
Date:15.10.2015
441 Case No.:20/5/82- Party Name:MOREPEN Meet No/Date:8/82- Status:Case
ALC4/2015
LABORATORIES LTD.,
ALC4/2015
16.09.2015
Deferred
HQ File
:01/82/050/00160/AM16/
RLA File
:05/24/040/00040/AM16/
Lic.No/Date:0510394095
05.05.2015
Defer
Date:15.10.2015
442
Case No.:37/5/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00177/AM16/
RLA File
:05/24/040/00039/AM16/
Lic.No/Date:0510394094
05.05.2015
Defer
Date:15.10.2015
443
Case No.:77/8/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00873/AM16/
RLA File
:09/24/040/00022/AM16/
Lic.No/Date:0910061978
06.05.2015
Defer
Date:15.10.2015
444
Case No.:78/8/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00874/AM16/
RLA File
:09/24/040/00021/AM16/
Lic.No/Date:0910061977
06.05.2015
Defer
Date:15.10.2015
445
Case No.:75/8/82-
ALC4/2015
Party Name:PORUS
LABORATORIES PVT
LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
446
Case No.:65/8/82-
ALC4/2015
Party Name:VIRCHOW
BIOTECH PV T LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
case for want of comments from DBT.
447
Case No.:39/8/82-
ALC4/2015
Party Name:NEULAND
LABORATORIES LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
RLA File
Lic.No/Date:0910061987 Defer Date:
:01/82/050/00835/AM16/
:09/24/040/00030/AM16/
07.05.2015
Department of Pharmaceuticals vide letter No.35011/608/2012-PI (Norms) dt. 27.12.2012 as per
Export product
Qty.
Import items
Qty.kg
Entacapone
1kg
1
3-4
Dihydroxy
5
Nitrobenzaldehyde
1.40
2
N,N-Diethyl
2
Cyano
Acetamide
1.90
448
Case No.:3/5/82-
ALC4/2015
Party Name:S.M.
HERBALS PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00143/AM16/
RLA File
:05/24/040/00014/AM16/
Lic.No/Date:0510394126
07.05.2015
Defer
Date:15.10.2015
Decision : In the light of written comments received from D/o Pharmaceuticals vide their OM
No.35011/388/2013-PI(Norms) dt.26.9.2013, it was decided to remind the firm to furnish the
following information.
- COA from foreign Supplier for relevant import consignments for the imported input.
- COA from independent & Approval Testing laboratory for export product
- Stepwise process with wastage envisaged in the process.
449
Case No.:7/5/82-
ALC4/2015
Party Name:JODAS
EXPOIM PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
450
Case No.:38/8/82-
ALC4/2015
Party Name:OPTIMUS
DRUGS PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
451
Case No.:69/8/82-
ALC4/2015
Party Name:SRINI
PHARMACEUTICALS
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00865/AM16/
RLA File
:09/24/040/00742/AM15/
Lic.No/Date:0910061999
08.05.2015
Defer
Date:15.10.2015
452
Case No.:2/5/82-
ALC4/2015
Party Name:UNITED
BIOTECH PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00142/AM16/
RLA File
:05/24/040/00009/AM16/
Lic.No/Date:0510394187
11.05.2015
Defer
Date:15.10.2015
453
Case No.:76/8/82-
ALC4/2015
Party Name:AKTINOS
PHARMA PVT LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00872/AM16/
RLA File
:09/24/040/00062/AM16/
Lic.No/Date:0910062007
12.05.2015
Defer
Date:15.10.2015
454
Case No.:91/8/82-
ALC4/2015
Party Name:MEDREICH
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00887/AM16/
RLA File
:07/24/040/00025/AM16/
Lic.No/Date:0710108182
12.05.2015
Defer
Date:15.10.2015
455
Case No.:94/8/82-
ALC4/2015
Party Name:PI
INDUSTRIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00890/AM16/
RLA File
:13/24/040/00005/AM16/
Lic.No/Date:1310047866
12.05.2015
Defer
Date:15.10.2015
456
Case No.:95/8/82-
ALC4/2015
Party Name:PI
INDUSTRIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00891/AM16/
RLA File
:13/24/040/00004/AM16/
Lic.No/Date:1310047865
12.05.2015
Defer
Date:15.10.2015
457
Case No.:31/8/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00827/AM16/
RLA File
:09/24/040/00083/AM16/
Lic.No/Date:0910062012
13.05.2015
Defer
Date:15.10.2015
458
Case No.:32/8/82-
ALC4/2015
Party Name:ARENE LIFE
SCIENCES LIMITED.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00828/AM16/
RLA File
:09/24/040/00040/AM16/
Lic.No/Date:0910062015
14.05.2015
Defer
Date:15.10.2015
459
Case No.:30/8/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00826/AM16/
RLA File
:09/24/040/00058/AM16/
Lic.No/Date:0910062018
14.05.2015
Defer
Date:15.10.2015
460
Case No.:41/8/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00837/AM16/
RLA File
:09/24/040/00074/AM16/
Lic.No/Date:0910062016
14.05.2015
Defer
Date:15.10.2015
46 1
Case No.:46/8/82-
ALC4/2015
Party
Name:SMILAX LABORATORIES LI
MITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00842/A
M16/
RLA File :09/24/040/00027/AM16/
Lic.No/Date:0910062
040
19.05.2015
Defer
Date:15.10.20
15
462
Case No.:42/8/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00838/AM16/
RLA File
:09/24/040/00097/AM16/
Lic.No/Date:0910062057
21.05.2015
Defer
Date:15.10.2015
463
Case No.:43/8/82-
ALC4/2015
Party Name:RA CHEM
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00839/AM16/
RLA File
:09/24/040/00095/AM16/
Lic.No/Date:0910062053
21.05.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/376/2012-PI (Norms) dt.1.4.2014 as per
Export product
Qty.
Import items
Qty.kg
ENTACAPONE
1kg
1
Vanillin
2.306
2
Pyridine
1.02
3
Diethyl Amine
1.437
4 Toluene 1.35 5 Methanol 0.62 6 Ethyl Acetate 2.56
464
Case No.:67/8/82-
ALC4/2015
Party Name:S M S
PHARMACEUTICALS LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00863/AM16/
RLA File
:09/24/040/00008/AM16/
Lic.No/Date:0910062055
21.05.2015
Defer Date:
Decision : In the light of the earlier decision taken by NC in its meeting No.19/82 dated
18.03.2015, it was decided to ratify the norms on repeat basis under Para 4.7 of HBP v1 as per
details given below or as applied by the firm, whichever is less:
Export Product
Qty.
Sl. No.
Import Product
Quantity
allowed kg/kg
Efavirenz
1 kg
1
(S)-5-chloro-alpha-(cyclopropyl
ethylyl)-2-amino-alpha-(trifluoro
methyl) benzene methanol
0.987
2
Triphosgene
0.448
465
Case No.:199/5/82-
ALC4/2015
Party Name:SHASUN
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
466
Case No.:200/5/82-
ALC4/2015
Party Name:SHASUN
PHARMACEUTICALS
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
467
Case No.:66/8/82-
ALC4/2015
SCIENCES LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00862/AM16/
RLA File
:09/24/040/00084/AM16/
Lic.No/Date:0910062054
21.05.2015
Defer
Date:15.10.2015
468
Case No.:97/8/82-
ALC4/2015
Party Name:ASCENT
FINECHEM PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
RLA File
Lic.No/Date:0810135338 Defer
:01/82/050/00893/AM16/ :08/24/040/00051/AM16/ 22.05.2015 Date:15.10.2015
469
Case No.:140/8/82-
ALC4/2015
Party Name:SAIBABA
SURFACTANTS (P)
LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00936/AM16/
RLA File
:08/24/040/00015/AM16/
Lic.No/Date:0810135345
22.05.2015
Defer
Date:15.10.2015
470
Case No.:29/8/82-
ALC4/2015
Party Name:COVALENT
LABORATORIES
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00825/AM16/
RLA File
:09/24/040/00734/AM15/
Lic.No/Date:0910062067
25.05.2015
Defer
Date:15.10.2015
471
Case No.:45/8/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
472
Case No.:136/8/82-
ALC4/2015
Party Name:SEBACIC
INDIA LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00932/AM16/
RLA File
:34/24/040/00049/AM16/
Lic.No/Date:3410041253
28.05.2015
Defer
Date:15.10.2015
473
Case No.:86/8/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00882/AM16/
RLA File
:09/24/040/00131/AM16/
Lic.No/Date:0910062091
29.05.2015
Defer
Date:15.10.2015
474
Case No.:125/8/82-
ALC4/2015
Party Name:BLUE CIRCLE
ORGANICS PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00921/AM16/
RLA File
:03/94/040/01219/AM15/
Lic.No/Date:0310796353
01.06.2015
Defer Date:
Decision : The committee decided to ratify the norms repeat basis as per earlier decision taken
by NC in its meeting No.05/Am16 dt. 25.6.2015 as per details given below or as applied by the
firm whichever is less:-
Export product
Qty.
Import items
Qty.kg/kg
5-NITRO
ISOPHTHALIC
ACID DIMETHYL ETSER
1kg
Isophthalic Acid
0.90
47 5
Case No.:53/8/82-
ALC4/2015
Party
Name:ARIHANTANAM
LIFECARE PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00849/AM16/
RLA File
:52/24/040/00014/AM16/
Lic.No/Date:521004153
8
02.06.2015
Defer Date:
Decision : In the light of earlier decision taken in meeting no. 05/82 dated 25.06.2015, it was
decided to ratify norms on repeat basis under Para 4.07 of HBP v1 as per details given below or
as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Lumefantrine 1 kg (Dibutylamine Methyl)-2,7-Dichloro- 4-fluoren Methanol (DBA) 0.8691 kg
476
Case No.:8/8/82-
ALC4/2015
Party Name:VIRUPAKSHA
ORGANICS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00804/AM16/
RLA File
:09/24/040/00119/AM16/
Lic.No/Date:0910062125
03.06.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/179/2015-PI (Norms) dt. 14.09.2015 as per
Export
product
Qty.
Import items
Qty.kg
Sofosbuvir
1kg
1
2-Deoxy-2-Fluoro-2-c-Methyluridine (or) (2R)-2-
Deoxy-2-Fluoro-2 Methyluridine
0.90
2
N-[(S)-(2,3,4,5,6-Penta fluorophenoxy)
Phenoxy phosphinyl]-L-Alanine 1-Methylethyl
Ester
1.92
477
Case No.:90/8/82-
ALC4/2015
Party Name:UNITED
BIOTECH PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00886/AM16/
RLA File
:05/24/040/00072/AM16/
Lic.No/Date:0510394446
04.06.2015
Defer
Date:15.10.2015
478
Case No.:7/8/82-
ALC4/2015
Party Name:RAMPEX
LABS PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00803/AM16/
RLA File
:09/24/040/00139/AM16/
Lic.No/Date:0910062135
05.06.2015
Defer
Date:15.10.2015
479
Case No.:5/8/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
approved
HQ File
:01/82/050/00801/AM16/
RLA File
:05/23/040/00094/AM16/
Lic.No/Date:0510394514
10.06.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 403/2014-PI (Norms) dt. January, 2015 as
Export product
Qty.
Import items
Qty.kg
CEFUROXIME
AXETIL
AMORPHOUS STEARIC
ACID
COATED
15%
POWDER
1kg
1
7 ACA (7 Amino
Cephalosporanic Acid )
0.1265
2
PHOSPHOROUS PENTA
CHLORIDE
0.1522
3
SMIA(Z) 2- Methoxy imino -
(Furyl -2-yl ) Acetic Acid
Ammonium Salt.
0.1310
4
METHANOL
0.156
5
Methylene Chloride
0.537
6
CHLOROSULPHONYL
ISOCYANATE
0.0832
7
ACETONE
0.462
8
TETRA METHYL GUANIDINE
0.0322
9
N,N DIMETHYL ACETAMIDE
(DMAC)
0.287
10
ETHYL ACETATE
0.351
11
STEARIC ACID
0.8455
12
Acetic acid
0.00753
13
ACTIVATED CARBON
0.016
480
Case No.:59/8/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00855/AM16/
RLA File
:09/24/040/00140/AM16/
Lic.No/Date:0910062148
10.06.2015
Defer
Date:15.10.2015
481
Case No.:68/8/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00864/AM16/
RLA File
:09/24/040/00156/AM16/
Lic.No/Date:0910062147
10.06.2015
Defer
Date:15.10.2015
482
Case No.:74/8/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00870/AM16/
RLA File
:09/24/040/00127/AM16/
Lic.No/Date:0910062151
10.06.2015
Defer
Date:15.10.2015
483
Case No.:128/8/82-
ALC4/2015
Party Name:ENALTEC
LABS PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00924/AM16/
RLA File
:03/94/040/00181/AM16/
Lic.No/Date:03107966
29
15.06.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/619/2015-PI (Norms) dt. April, 2015 as per
Export product
Qty.
Import items
Qty.kg
ROSUVASTATIN
CALCIUM
(R-10
ROUTE)
1kg
6-[ (1E)-2-[4-(4-FLUROPHENYL)-6- (1-
METHYLETHYL)-2-[METHYL
(METHYLSULFONYL)AMINO]
-5-PYRIMIDINYL]ETHENYL] -2,2-DIMETHY L-1,3-
DIOXANE-4-ACETIC ACID 1,1-DIMETHYLETHYL
ESTER
1.425
484
Case No.:88/8/82-
ALC4/2015
Party Name:CLEAN
SCIENCE AND
TECHNOLOGY
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00884/AM16/
RLA File
:31/83/040/00005/AM16/
Lic.No/Date:3110065476
16.06.2015
Defer
Date:15.10.2015
485
Case No.:185/5/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00325/AM16/
RLA File
:09/24/040/00161/AM16/
Lic.No/Date:0910062185
16.06.2015
Defer
Date:15.10.2015
486
Case No.:87/8/82-
ALC4/2015
Party Name:SOHAN
HEALTHCARE PVT. LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00883/AM16/
RLA File
:31/83/040/00029/AM16/
Lic.No/Date:3110065477
16.06.2015
Defer Date:
Decision : The committee decided to ratify the norms on repeat basis as per the earlier decision
taken by NC in its meeting No.05/AM16 dt. 25.06. 2015 as per details given below or as applied
by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg/kg
Metformin
Hydrochloride
BP/EP/USP
1kg
Dicyandiamide
0.567
Di Methyl Amine Hcl
0.60
Mix Zylene
0.027
methanol
0.237
487
Case No.:186/5/82-
ALC4/2015
Party Name:DR REDDYS
LABORATORIES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00326/AM16/
RLA File
:09/24/040/00150/AM16/
Lic.No/Date:0910062206
17.06.2015
Defer
Date:15.10.2015
48 8
Case No.:51/8/82-
ALC4/2015
Party
Name:ARIHANTANAM
LIFECARE PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00847/AM16/
RLA File
:52/24/040/00017/AM16/
Lic.No/Date:521004155
2
19.06.2015
Defer Date:
Decision : In the light of earlier decision taken in meeting no. 05/82 dated 25.06.2015, it was
decided to ratify norms on repeat basis under Para 4.07 of HBP v1 as per details given below or
as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Lumefantrine 1 kg (Dibutylamine Methyl)-2,7-Dichloro- 4-fluoren Methanol (DBA) 0.8691 kg
489
Case No.:189/5/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00329/AM16/
RLA File
:09/24/040/00163/AM16/
Lic.No/Date:0910062218
19.06.2015
Defer
Date:15.10.2015
490
Case No.:454/5/82-
ALC4/2015
Party Name:CADILA
HEALTHCARE LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00594/AM16/
RLA File
:08/24/040/00081/AM16/
Lic.No/Date:0810135519
22.06.2015
Defer Date:
15.10.2015
491
Case No.:455/5/82-
ALC4/2015
Party Name:CADILA
HEALTHCARE LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Deferred
HQ File
:01/82/050/00595/AM16/
RLA File
:08/24/040/00082/AM16/
Lic.No/Date:0810135520
22.06.2015
Defer
Date:315.10.2015
492
Case No.:108/8/82-
ALC4/2015
Party
Name:METROPOLITAN
EXIMCHEM LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00904/AM16/
RLA File
:03/95/040/00041/AM16/
Lic.No/Date:0310796749
22.06.2015
Defer
Date:15.10.2015
493
Case No.:2/6/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00598/AM16/
RLA File
:09/24/040/00165/AM16/
Lic.No/Date:0910062242
23.06.2015
Defer
Date:15.10.2015
494
Case No.:1/6/82-
ALC4/2015
Party
Name:HERBOCHEM
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00597/AM16/
RLA File
:09/24/040/00148/AM16/
Lic.No/Date:0910062238
23.06.2015
Defer
Date:15.10.2015
495
Case No.:121/8/82-
ALC4/2015
Party Name:NEW
ALLIANCE DYE-CHEM
PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00917/AM16/
RLA File
:03/95/040/00190/AM16/
Lic.No/Date:0310796766
23.06.2015
Defer
Date:15.10.2015
496
Case No.:6/6/82-
ALC4/2015
Party Name:LAKE
CHEMICALS PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Approved
HQ File
:01/82/050/00602/AM16/
RLA File
:07/24/040/00075/AM16/
Lic.No/Date:0710108415
24.06.2015
Defer Date:
Decision : In the light of earlier decision taken in meeting no. 28/82 dated 10.01.2013, it was
decided to ratify norms on repeat basis under Para 4.7 of HBP v1 as per details given below or
as applied by the firm, whichever is less:
Export product
Export
Qty.
Sl.No.
Import items
Qty. in kg.
Midazolam Hcl
1 Kg.
1.
2-Aminomethyl
7-chloro-2,3
Dihydro-5(2-Flurophenyul)1H-1,4
4.59
Benzodiazepine Di maleate 2. Triethyl ortho acetate 3.42
49
7
Case
No.:110/8/82-
ALC4/2015
Party
Name:MAC CHEM PRODUCTS (INDIA) PRI
VATE LIMITED
Meet
No/Date:8/82-
ALC4/2015
16.09.2015
Status:Cas
e Deferred
HQ File
:01/82/050/00906/
AM16/
RLA File :03/95/040/00205/AM16/
Lic.No/Date:03107
96822
24.06.2015
Defer
Date:15.10.
2015
498
Case No.:107/8/82-
ALC4/2015
Party Name:NAVIN
FLUORINE
INTERNATIONAL
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00903/AM16/
RLA File
:03/95/040/00084/AM16/
Lic.No/Date:0310796841
24.06.2015
Defer
Date:15.10.2015
499
Case No.:111/8/82-
ALC4/2015
Party Name:NEW
ALLIANCE DYE-CHEM
PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00907/AM16/
RLA File
:03/95/040/00184/AM16/
Lic.No/Date:0310796820
24.06.2015
Defer
Date:15.10.2015
500
Case No.:100/8/82-
ALC4/2015
Party Name:REANNON
PHARMACEUTICALS
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00896/AM16/
RLA File
:03/95/040/00134/AM16/
Lic.No/Date:0310796838
24.06.2015
Defer Date:
15.10.2015
501
Case No.:56/8/82-
ALC4/2015
Party Name:TRIMAX BIO
SCIENCES PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00852/AM16/
RLA File
:09/24/040/00718/AM15/
Lic.No/Date:0910062245
24.06.2015
Defer
Date:15.10.2015
502
Case No.:3/6/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00599/AM16/
RLA File
:09/24/040/00179/AM16/
Lic.No/Date:0910062259
30.06.2015
Defer
Date:15.10.2015
503
Case No.:4/6/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00600/AM16/
RLA File
:09/24/040/00188/AM16/
Lic.No/Date:0910062261
30.06.2015
Defer
Date:15.10.2015
504
Case No.:89/8/82-
ALC4/2015
Party
Name:CATAPHARMA
CHEMICALS PVT. LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00885/AM16/
RLA File
:31/83/040/00027/AM16/
Lic.No/Date:3110065523
01.07.2015
Defer
Date:15.10.2015
505
Case No.:5/6/82-
ALC4/2015
Party
Name:GULBRANDSEN
CHEMICALS PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00601/AM16/
RLA File
:34/24/040/00091/AM16/
Lic.No/Date:3410041336
01.07.2015
Defer
Date:15.10.2015
506
Case No.:109/8/82-
ALC4/2015
Party Name:SHALINA
LABORATORIES PVT.
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00905/AM16/
RLA File
:03/95/040/00038/AM16/
Lic.No/Date:0310796997
01.07.2015
Defer
Date:15.10.2015
507
Case No.:112/8/82-
ALC4/2015
Party Name:UNIMAX
CHEMICALS PVT LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00908/AM16/
RLA File
:03/95/040/00243/AM16/
Lic.No/Date:0310797015
02.07.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/437/2014-PI (Norms) dt. February, 2015 as
Export product
Qty.
Import items
Qty.kg
Azithromycin Monohydrate
USP
1kg
Azithromycin dihydrate
1.05
508
Case No.:101/8/82-
ALC4/2015
Party Name:ZENITH
DYEINTERMEDIATES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00897/AM16/
RLA File
:03/95/040/00085/AM16/
Lic.No/Date:0310797037
02.07.2015
Defer Date:
Decision : In the light of earlier decision taken by NC in its meeting No.3/82 dated 2.5.2013 on
the basis of written comments of Department of Chemicals and Petrochemicals vide their U.O
No. 14010/99/2011-Ch. II dated 11.4.2013, it was decided to ratify norms on repeat basis under
Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed NAS-5 (2-Diazo-1- Napthol-5 Sulfonic Acid, Sodium Salt 1 kg Tobias Acid 97% Min.
Or 1.618 kg Sulfo Tobias (Purity 65% min on 100% basis) 1.798 kg
50 9
Case No.:48/8/82-
ALC4/2015
Party
Name:ARIHANTANAM
LIFECARE PVT. LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00844/AM16/
RLA File
:52/24/040/00019/AM16/
Lic.No/Date:521004156
9
03.07.2015
Defer Date:
Decision : In the light of earlier decision taken in meeting no. 05/82 dated 25.06.2015, it was
decided to ratify norms on repeat basis under Para 4.07 of HBP v1 as per details given below or
as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Lumefantrine 1 kg (Dibutylamine Methyl)-2,7-Dichloro- 4-fluoren Methanol (DBA) 0.8691 kg
510
Case No.:9/6/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00605/AM16/
RLA File
:09/24/040/00176/AM16/
Lic.No/Date:0910062314
07.07.2015
Defer
Date:15.10.2015
511
Case No.:130/8/82-
ALC4/2015
Party Name:CONCORD
BIOTECH LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00926/AM16/
RLA File
:08/24/040/00107/AM16/
Lic.No/Date:0810135624
07.07.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/70/2015-PI (Norms) dt. Sept. 2015 as per
Export product Qty. Import items Qty.kg Mycophenolate Mofteil Powder Foam 1kg Mycophenolic Acid 0.941
512
Case No.:98/8/82-
ALC4/2015
Party Name:HONEST
BIO-VET PVT. LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00894/AM16/
RLA File
:08/24/040/00109/AM16/
Lic.No/Date:0810135630
07.07.2015
Defer
Date:15.10.2015
513
Case No.:104/8/82-
ALC4/2015
Party Name:POLYDRUG
LABORATORIES
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00900/AM16/
RLA File
:03/95/040/00219/AM16/
Lic.No/Date:0310797101
07.07.2015
Defer
Date:15.10.2015
514
Case No.:129/8/82-
ALC4/2015
Party Name:SUPREET
CHEMICALS PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00925/AM16/
RLA File
:03/95/040/00237/AM16/
Lic.No/Date:0310797113
08.07.2015
Defer
Date:15.10.2015
515
Case No.:57/8/82-
ALC4/2015
Party Name:JAGSONPAL
PHARMACEUTICALS
LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00853/AM16/
RLA File
:05/23/040/00114/AM16/
Lic.No/Date:0510394864
09.07.2015
Defer
Date:15.10.2015
516
Case No.:54/8/82-
ALC4/2015
Party Name:JODAS
EXPOIM PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Deferred
HQ File
:01/82/050/00850/AM16/
RLA File
:05/23/040/00150/AM16/
Lic.No/Date:0510394862
09.07.2015
Defer
Date:15.10.2015
517
Case No.:50/8/82-
ALC4/2015
Party Name:PUSILIN
BIOTECHNOLOGY
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00846/AM16/
RLA File
:06/24/040/00014/AM16/
Lic.No/Date:0610038189
09.07.2015
Defer
Date:15.10.2015
case for want of comments from DBT.
518
Case No.:103/8/82-
ALC4/2015
Party Name:SUNSHIELD
CHEMICALS LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00899/AM16/
RLA File
:03/95/040/00266/AM16/
Lic.No/Date:0310797135
09.07.2015
Defer
Date:15.10.2015
519
Case No.:106/8/82-
ALC4/2015
Party Name:LUPIN
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00902/AM16/
RLA File
:03/95/040/00149/AM16/
Lic.No/Date:0310797161
10.07.2015
Defer
Date:15.10.2015
520
Case No.:105/8/82-
ALC4/2015
Party Name:ZIM
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00901/AM16/
RLA File
:03/95/040/00281/AM16/
Lic.No/Date:0310797177
10.07.2015
Defer Date:
DEPARTMENT OF C&PC vide letter No.35011/375/2014-PI (Norms) dt. January, 2015 as per
Export product
Qty.
Import items
Qty.kg
Nicardipine Hcl SR Pellets
50mg
1kg
Nicardipine Hcl
0.2196
521
Case No.:58/8/82-
ALC4/2015
Party Name:INDO
PHYTO CHEMICALS
PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00854/AM16/
RLA File
:05/23/040/00069/AM16/
Lic.No/Date:0510394892
14.07.2015
Defer
Date:15.10.2015
522
Case No.:72/8/82-
ALC4/2015
Party Name:INDO
PHYTO CHEMICALS
PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00868/AM16/
RLA File
:05/23/040/00068/AM16/
Lic.No/Date:0510394891
14.07.2015
Defer
Date:15.10.2015
523
Case No.:85/8/82-
ALC4/2015
Party Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00881/AM16/
RLA File
:05/24/040/00167/AM16/
Lic.No/Date:0510394902
15.07.2015
Defer
Date:15.10.2015
524
Case No.:113/8/82-
ALC4/2015
Party Name:UNIJULES
LIFE SCIENCES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00909/AM16/
RLA File
:03/95/040/00299/AM16/
Lic.No/Date:0310797251
15.07.2015
Defer
Date:15.10.2015
525
Case No.:70/8/82-
ALC4/2015
Party Name:ZEISS
PHARMACEUTICALS
PVT.LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00866/AM16/
RLA File
:22/24/040/00024/AM16/
Lic.No/Date:2210015267
15.07.2015
Defer
Date:15.10.2015
526
Case No.:52/8/82-
ALC4/2015
Party Name:AMI
ORGANICS PVT LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00848/AM16/
RLA File
:52/24/040/00026/AM16/
Lic.No/Date:5210041581
16.07.2015
Defer
Date:15.10.2015
527
Case No.:49/8/82-
ALC4/2015
Party Name:M.L.A.
INDUSTRIES
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
528
Case No.:120/8/82-
ALC4/2015
Party Name:PERFECT
VITAMINS PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
529
Case No.:116/8/82-
ALC4/2015
Party Name:PRASOL
CHEMICALS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00912/AM16/
RLA File
:03/95/040/00216/AM16/
Lic.No/Date:0310797284
16.07.2015
Defer
Date:15.10.2015
530
Case No.:93/8/82-
ALC4/2015
Party Name:DR J
PHARMACHEM
(INDIA)(PROP.ADITYA
PRAMOD JOGDEO)
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Deferred
HQ File
:01/82/050/00889/AM16/
RLA File
:31/83/040/00050/AM16/
Lic.No/Date:3110065541
17.07.2015
Defer
Date:15.10.2015
Decision : The Committee considered the case for ratification of norms and decided to call for
COA from foreign supplier and deferred the case.
531
Case No.:55/8/82-
ALC4/2015
Party Name:JUBILANT
LIFE SCIENCES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00851/AM16/
RLA File
:05/23/040/00142/AM16/
Lic.No/Date:0510394969
17.07.2015
Defer
Date:15.10.2015
case for want of comments from D/o Pharmaceuticals
532
Case No.:44/8/82-
ALC4/2015
Party Name:SUBHASH
CHEMICAL INDUSTRIES
PVT LTD
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00840/AM16/
RLA File
:31/83/040/00057/AM16/
Lic.No/Date:3110065540
17.07.2015
Defer
Date:15.10.2015
533
Case No.:84/8/82-
ALC4/2015
Party Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00880/AM16/
RLA File
:05/24/040/00121/AM16/
Lic.No/Date:0510394909
17.07.2015
Defer
Date:15.10.2015
534
Case No.:102/8/82-
ALC4/2015
Party Name:LUPIN
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00898/AM16/
RLA File
:03/95/040/00297/AM16/
Lic.No/Date:0310797490
21.07.2015
Defer
Date:15.10.2015
535
Case No.:122/8/82-
ALC4/2015
Party Name:LUPIN
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00918/AM16/
RLA File
:03/95/040/00300/AM16/
Lic.No/Date:0310797471
21.07.2015
Defer
Date:15.10.2015
536
Case No.:123/8/82-
ALC4/2015
Party Name:LUPIN
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00919/AM16/
RLA File
:03/95/040/00298/AM16/
Lic.No/Date:0310797489
21.07.2015
Defer
Date:15.10.2015
537
Case No.:71/8/82-
ALC4/2015
Party Name:KLJ
PLASTICIZERS LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00867/AM16/
RLA File
:05/23/040/00161/AM16/
Lic.No/Date:0510395027
22.07.2015
Defer
Date:15.10.2015
538
Case No.:83/8/82-
ALC4/2015
Party Name:VARUN
MEDIMPEX INC.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00879/AM16/
RLA File
:05/24/040/00195/AM16/
Lic.No/Date:0510395044
22.07.2015
Defer
Date:15.10.2015
Decision : The Committee considered the case for ratification of norms. The Committee noted
that DEPARTMENT OF C&PC vide letter No.46011/104/2009-PC-II dated 10.9.2015 has sought
following information from the firm:
- Detailed manufacturing process, material balance, steps involved in the manufacturing process, wastage at each level of step involved in the manufacture with its justification and documentary evidence/back up calculation duly certified by CE.
- Chartered Accountant certified production of export products and corresponding consumption of inputs (both indigenous and imported) for the last three financial years.
- If feasible, sample of the products
- Any other relevant information.
539
Case No.:1/8/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00797/AM16/
RLA File
:09/24/040/00236/AM16/
Lic.No/Date:0910062367
23.07.2015
Defer
Date:15.10.2015
540
Case No.:2/8/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00798/AM16/
RLA File
:09/24/040/00246/AM16/
Lic.No/Date:0910062368
23.07.2015
Defer
Date:15.10.2015
541 Case No.:3/8/82- Party Name:HETERO Meet No/Date:8/82- Status:Case
ALC4/2015
LABS LIMITED
ALC4/2015
16.09.2015
Deferred
HQ File
:01/82/050/00799/AM16/
RLA File
:09/24/040/00235/AM16/
Lic.No/Date:0910062369
23.07.2015
Defer
Date:15.10.2015
542
Case No.:4/8/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00800/AM16/
RLA File
:09/24/040/00237/AM16/
Lic.No/Date:0910062370
23.07.2015
Defer
Date:15.10.2015
543
Case No.:80/8/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00876/AM16/
RLA File
:05/24/040/00192/AM16/
Lic.No/Date:0510395055
23.07.2015
Defer
Date:15.10.2015
544
Case No.:81/8/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00877/AM16/
RLA File
:05/24/040/00197/AM16/
Lic.No/Date:0510395053
23.07.2015
Defer Date:
Department of Pharmaceuticals vide letter No.35011/ 495 /2014-PI (Norms) dt. March 2015 as
Export product
Qty.
Import items
Qty.
SITAGLIPTIN
PHOSPHATE
MONOHYDRATE
1kg
1
(R)-3-((tert-butoxycarbonyl)amino)-4-
(2,4,5-trifluorophenyl)butanoic acid
(SG04)
1.00kg
2
3-(trifluoromethyl)-5,6,7,8-tetrahydro-
[1,2,4]triazolo[4,3-a]pyrazine
hydrochloride
0.80kg
3
N-Hydroxybenzotriazole(HOBT)
0.50kg
4
Methanol
3.65 lit./kg
5
Isopropyl alcohol
6.10 lit/kg
6
Methylene Dichloride
15.25 lit/kg
545
Case No.:82/8/82-
ALC4/2015
Party Name:MOREPEN
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00878/AM16/
RLA File
:05/24/040/00198/AM16/
Lic.No/Date:0510395056
23.07.2015
Defer Date:
Decision : Committee considered the case as per agenda and in light of earlier decision taken
by NC in its meeting No.10/82 dated 12.11.2014 on the basis of written comments received from
Department of Pharmaceuticals vide their OM No. 35011/183/2014-PI(Norms) dated 12.11.2014 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Exp. Qty. Sl.No. Import items Qty. Allowed Kg/kg Rosuvastatin Calcium
1kg
1
Tert-butyl-2-((4R,6S)-6-((E)-2-(4 (-(4-
fluorophenyl)-6-isopropyl-2-[N-methyl
(methylsulphonyl) amino] pyrimidin-5-
yl) vinyl)-2,2-dimethyl-1,3-dioxane-4-
yl) acetate
1.425
2 Methanol 2.53 3 Tert-butyl methyl ether (MTBE) 0.79
RA concerned may take further necessary action as per above decision of NC.
546
Case No.:119/8/82-
ALC4/2015
Party Name:SI GROUP
INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
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:15.10.2015
547
Case No.:79/8/82-
ALC4/2015
Party Name:SUN
PHARMACEUTICAL
INDUSTRIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00875/AM16/
RLA File
:05/24/040/00110/AM16/
Lic.No/Date:0510395084
24.07.2015
Defer
Date:15.10.2015
548
Case No.:9/8/82-
ALC4/2015
Party Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00805/AM16/
RLA File
:09/24/040/00147/AM16/
Lic.No/Date:0910062382
27.07.2015
Defer Date:
Decision : Committee considered case as per agenda and in light of earlier decision taken by
NC in its meeting No.14/82 dated 22.12.2014 and in consultation with technical authority present
in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or
as applied by firm whichever is lower:-
Export product
Export
Qty.
Sl.No.
Import items
Qty. allowed
(kg/kg)
MEROPENEM FOR
INJECTION
(MEROPENEM
STERILE)
1 kg
1.
MeropenemTrihydrate (Non-
sterile)
0.987
Carbon Enoanticormos(Activated Carbon) 0.049
Acetone 2.50
549
Case No.:10/8/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00806/AM16/
RLA File
:09/24/040/00215/AM16/
Lic.No/Date:0910062383
27.07.2015
Defer
Date:15.10.2015
550
Case No.:115/8/82-
ALC4/2015
Party Name:MERCK
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00911/AM16/
RLA File
:03/95/040/00321/AM16/
Lic.No/Date:0310797685
27.07.2015
Defer
Date:15.10.2015
551
Case No.:117/8/82-
ALC4/2015
Party Name:PRASOL
CHEMICALS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00913/AM16/
RLA File
:03/95/040/00250/AM16/
Lic.No/Date:0310797677
27.07.2015
Defer
Date:15.10.2015
552
Case No.:114/8/82-
ALC4/2015
Party Name:ZENITH
DYEINTERMEDIATES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Approved
HQ File
:01/82/050/00910/AM16/
RLA File
:03/95/040/00318/AM16/
Lic.No/Date:0310797689
27.07.2015
Defer Date:
Decision : In the light of earlier decision taken by NC in its meeting No.3/82 dated 2.5.2013 on
the basis of written comments of Department of Chemicals and Petrochemicals vide their U.O
No. 14010/99/2011-Ch. II dated 11.4.2013, it was decided to ratify norms on repeat basis under
Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed NAS-5 (2-Diazo-1- Napthol-5 Sulfonic Acid, Sodium Salt 1 kg Tobias Acid 97% Min.
Or 1.618 kg Sulfo Tobias (Purity 65% min on 100% basis) 1.798 kg
553
Case No.:137/8/82-
ALC4/2015
Party Name:ZENITH
DYEINTERMEDIATES
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Approved
HQ File
:01/82/050/00933/AM16/
RLA File
:03/95/040/00291/AM16/
Lic.No/Date:0310797692
27.07.2015
Defer Date:
Decision : In the light of earlier decision taken by NC in its meeting No.04/AM13 dated
24.4.2012 and written comments then received from Department of Chemicals and
Petrochemicals vide their U.O No. 14010/99/2011-Ch. II dated 4.4.2012, it was decided to ratify norms on repeat basis under Para 4.7 of HBP v1 as per details given below or as approved by the firm, whichever is less:
Export Product Export Quantity Import Product Quantity allowed Sulfo Tobias Acid Purified-65% Min 1 kg Sulfo Tobias Acid 1.230 kg
554
Case No.:11/8/82-
ALC4/2015
Party Name:INTER LABS
(INDIA)PVT LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00807/AM16/
RLA File
:09/24/040/00249/AM16/
Lic.No/Date:0910062391
28.07.2015
Defer
Date:15.10.2015
555
Case No.:118/8/82-
ALC4/2015
Party Name:ORION
CHEM PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00914/AM16/
RLA File
:03/95/040/00337/AM16/
Lic.No/Date:0310797764
28.07.2015
Defer
Date:15.10.2015
556
Case No.:73/8/82-
ALC4/2015
Party Name:RECKITT
BENCKISER
HEALTHCARE INDIA
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00869/AM16/
RLA File
:05/24/040/00213/AM16/
Lic.No/Date:0510395102
28.07.2015
Defer
Date:15.10.2015
557
Case No.:12/8/82-
ALC4/2015
Party Name:COVALENT
LABORATORIES
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00808/AM16/
RLA File
:09/24/040/00250/AM16/
Lic.No/Date:0910062397
29.07.2015
Defer
Date:15.10.2015
558
Case No.:13/8/82-
ALC4/2015
Party Name:HETERO
DRUGS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00809/AM16/
RLA File
:09/24/040/00243/AM16/
Lic.No/Date:0910062398
29.07.2015
Defer
Date:15.10.2015
559
Case No.:14/8/82-
ALC4/2015
Party Name:HETERO
DRUGS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00810/AM16/
RLA File
:09/24/040/00241/AM16/
Lic.No/Date:0910062399
29.07.2015
Defer
Date:15.10.2015
560
Case No.:15/8/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00811/AM16/
RLA File
:09/24/040/00261/AM16/
Lic.No/Date:0910062400
29.07.2015
Defer
Date:15.10.2015
561
Case No.:99/8/82-
ALC4/2015
Party Name:SURVIVAL
TECHNOLOGIES
PVT.LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00895/AM16/
RLA File
:03/95/040/00313/AM16/
Lic.No/Date:0310797796
29.07.2015
Defer
Date:15.10.2015
562
Case No.:16/8/82-
ALC4/2015
Party Name:AKTINOS
PHARMA PVT LTD,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00812/AM16/
RLA File
:09/24/040/00229/AM16/
Lic.No/Date:0910062415
30.07.2015
Defer
Date:15.10.2015
563
Case No.:37/8/82-
ALC4/2015
Party Name:DHANUKA
LABORATORIES LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00833/AM16/
RLA File
:05/23/040/00183/AM16/
Lic.No/Date:0510395134
30.07.2015
Defer
Date:15.10.2015
564
Case No.:17/8/82-
ALC4/2015
Party Name:VIVIMED
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00813/AM16/
RLA File
:09/24/040/00251/AM16/
Lic.No/Date:0910062426
03.08.2015
Defer
Date:15.10.2015
565
Case No.:96/8/82-
ALC4/2015
Party Name:OTSUKA
CHEMICAL ( INDIA )
PRIVATE LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00892/AM16/
RLA File
:05/24/040/00216/AM16/
Lic.No/Date:0510395233
06.08.2015
Defer
Date:15.10.2015
566
Case No.:19/8/82-
ALC4/2015
Party Name:HETERO
DRUGS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00815/AM16/
RLA File
:09/24/040/00267/AM16/
Lic.No/Date:0910062455
07.08.2015
Defer
Date:15.10.2015
567
Case No.:18/8/82-
ALC4/2015
Party Name:HONOUR
LAB LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00814/AM16/
RLA File
:09/24/040/00270/AM16/
Lic.No/Date:0910062454
07.08.2015
Defer
Date:15.10.2015
568
Case No.:23/8/82-
ALC4/2015
Party Name:ALPHAMED
FORMULATIONS P LTD.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00819/AM16/
RLA File
:09/24/040/00091/AM16/
Lic.No/Date:0910062478
11.08.2015
Defer
Date:15.10.2015
569
Case No.:21/8/82-
ALC4/2015
Party Name:DIVIS
LABORATORIES LTD.,
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Approved
HQ File
:01/82/050/00817/AM16/
RLA File
:09/24/040/00265/AM16/
Lic.No/Date:0910062463
11.08.2015
Defer Date:
DEPARTMENT OF C&PC vide letter No.35011/636/2014-PI (Norms) dt. 2015 as per details
given below or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg
Fumaraldehyde
BIS
(Dimethyl Acetal)
1kg
1
Furan
0.60
2
Methanol
3.43
3
Chloroform
1.00
570
Case No.:22/8/82-
ALC4/2015
Party Name:GRANULES
INDIA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00818/AM16/
RLA File
:09/24/040/00287/AM16/
Lic.No/Date:0910062467
11.08.2015
Defer
Date:15.10.2015
571
Case No.:25/8/82-
ALC4/2015
Party Name:ARENE LIFE
SCIENCES LIMITED.
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00821/AM16/
RLA File
:09/24/040/00112/AM16/
Lic.No/Date:0910062498
13.08.2015
Defer
Date:15.10.2015
572
Case No.:24/8/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00820/AM16/
RLA File
:09/24/040/00262/AM16/
Lic.No/Date:0910062490
13.08.2015
Defer
Date:15.10.2015
573
Case No.:27/8/82-
ALC4/2015
Party
Name:AUROBINDO
PHARMA LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00823/AM16/
RLA File
:09/24/040/00271/AM16/
Lic.No/Date:0910062515
18.08.2015
Defer
Date:15.10.2015
574
Case No.:26/8/82-
ALC4/2015
Party Name:HONOUR
LAB LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00822/AM16/
RLA File
:09/24/040/00292/AM16/
Lic.No/Date:0910062510
18.08.2015
Defer
Date:15.10.2015
575
Case No.:28/8/82-
ALC4/2015
Party Name:HETERO
DRUGS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00824/AM16/
RLA File
:09/24/040/00313/AM16/
Lic.No/Date:0910062532
25.08.2015
Defer
Date:15.10.2015
576
Case No.:133/8/82-
ALC4/2015
Party Name:AKTINOS
HEALTHCARE PRIVATE
LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00929/AM16/
RLA File
:09/24/040/00227/AM16/
Lic.No/Date:0910062545
28.08.2015
Defer
Date:15.10.2015
577
Case No.:131/8/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:deferred
HQ File
:01/82/050/00927/AM16/
RLA File
:09/24/040/00324/AM16/
Lic.No/Date:0910062542
28.08.2015
Defer
Date:15.10.2015
578
Case No.:132/8/82-
ALC4/2015
Party Name:HETERO
LABS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00928/AM16/
RLA File
:09/24/040/00325/AM16/
Lic.No/Date:0910062543
28.08.2015
Defer
Date:15.10.2015
579
Case No.:134/8/82-
ALC4/2015
Party Name:HETERO
DRUGS LIMITED
Meet No/Date:8/82-
ALC4/2015
16.09.2015
Status:Case
Deferred
HQ File
:01/82/050/00930/AM16/
RLA File
:09/24/040/00336/AM16/
Lic.No/Date:0910062550
03.09.2015
Defer
Date:15.10.2015
Manual Agenda for NC Meeting No.08/82/2015 Scheduled to be held on 16.09.2015 but actually held on 21.09.2015
Case No. B- 01
M.No.08/AM 16 Date 16.09.2015
M/s. Deepak Nitrite Ltd. File No.01/82/50/01000/AM-12 Adv.Auth. No. 3110052056 dt. 22.12.2011
Decision: The Committee consider the case for ratification of norms and decided to defer the case for want of comments from D0/o C&PC.
Case No. B- 02
M.No.08/AM 16 Date 16.09.2015
M/s. Naprod Life Sciences Pvt Ltd File No.01/82/50/01065/AM-14 Adv.Auth. No. 0310760768 dt. 05.12.2013
Decision: The Committee consider the case for ratification of norms and decided to defer the case for want of comments from DIPP.
Case No. B- 03
M.No.08/AM 16 Date 16.09.2015 M/s. Wanbury Ltd File No.01/82/50/00492/AM-12 Adv.Auth. No. 0310641073 dt. 07.07.2011
Decision: The committee decided to ratify the norms based on the recommendation of Department of
Pharmaceuticals vide O.M.No. 35011/35 /2014-PI (Norms) dt. February, 2015 as per details given below or
as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.
PAROXETINE
HYDROCHLORIDE EP
1kg
1
(3S,4R(-4-FLUOROPHENYL)-3-
HYDROXYMETHYL-1-
METHYLPIPERDINE(S-
CARBOINOL)
0.810 kg /kg
2
TOSYL CHLORIDE
0.98 kg /kg
3
TRIETHYLAMINE
0.68 kg /kg
4
DIMETHYL AMINO PYRIDINE
0.017 kg /kg
5
DICHLOROMETHANE
7.95 lit./kg
6
SESAMOL
0.55 kg./kg
7
TOLUENE
4.65 lit./kg
8
PHENYL CHLOFORMATE
0.64 lit/kg
9
METHANOL
0.40 lit/kg
Case No. B- 04
M.No.08/AM 16 Date 16.09.2015
M/s. Scitech Specialities Pvt Ltd File No.01/82/50/00667/AM-10 Adv.Auth. No. 0310543476 dt. 30.10.2009
Decision: The Committee consider the case for correction in the name of export product and decided to defer the case for want of comments from DEPARTMENT OF C&PC
Case No. B- 05
M.No.08/AM 16 Date 16.09.2015
M/s. Sanofi India Ltd File No.01/82/50/01125/AM-13 RLA File No.03/95/040/00465/AM13 Adv.Auth. No. 0310717240 dt. 14.12.2012
Decision: The Committee consider the case for correction in file number and UOM of export product from 1kg to 1 Pack as per agenda.
The Committee decided to correct the file number, authorisation number as mentioned above. The Committee also amend the UOM of export product from “1kg to 1 Pack” without any change in the norms already ratified in respect of above Authorisation.
RA may take further necessary action as per decision of NC.
Case No. B- 06
M.No.08/AM 16 Date 16.09.2015
M/s. RA Chem Pharma Ltd File No.01/82/50/00219/AM-12 Adv.Auth. No. 0910046667 dt. 06.05.2011
Decision: The Committee in light of written comment of D/o Pharmaceuticals forwarded vide
O.M.No.35011/358/2011-PI(Norms) dated 31.3.2012 decided to call for production vis-à-vis actual
consumption data duly certified by Central Excise Authorities from the firm.
Case No. B- 07
M/s. Pharmazell (India) Pvt Ltd
M.No.08/AM 16 Date 16.09.2015
File No.01/82/162/00138/AM-15
Decision: The Committee consider the case for correction in the name of export product and decided to defer the case for want of comments from D/o Pharmaceuticals.
Case No. B- 08
M.No.08/AM 16 Date 16.09.2015
M/s. Makson Inds. Pvt Ltd File No.01/82/050/00889/AM-13 Adv.Auth. No.0310710561 dt 26.09.2012
Decision: The Committee consider this case for correction in the description of import items under Para 4.07 of HBP. The Committee noted that O/o Development Commissioner MSME vide letter No.23(2)/2014- Chem dated 30.07.2015, 09.09.2015 and 15.09.2015 has requested firm to provide copy of the approved formulation by the concerned Drug Authority of the export items. Firm vide letter dated 14.09.2015 has submitted copy of export order dated 1.7.2012. The Committee decided send a copy said letter to MSME and defer the case for want of comments of MSME.
Case No. B- 09
M.No.08/AM 16 Date 16.09.2015
M/s. Lotus Enterprise
File No.01/82/050/01148/AM-07
Adv.Auth. No.0310403889 dt 12.09.2006
Decision: The Committee consider the case for correction in the name of export product and decided to
Case No. B- 10
M.No.08/AM 16 Date 16.09.2015
M/s. Sterling Auxiliaries Pvt Ltd
File No.01/82/050/00996/AM-11
Adv.Auth. No.0310599495 dt. 01.11.2010
Decision: The Committee consider the case for correction in the description of import items and decided to
Case No. B- 11
M.No.08/AM 16 Date 16.09.2015
M/s. Pramod Exports Pvt Ltd File No.01/82/050/00531/AM-11 Adv.Auth. No.0510267798 dt. 08.07.2010
Decision: Committee considered case as per agenda and in light of the earlier decision taken by NC in its meeting No.32/82 dt. 08.11.2011 decided to ratify the norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-
Export product
Export Qty.
Sl.No.
Import items
Qty. allowed
Kombinil-Duo
Ear/Eye
Drops 5 ml pack containing
Ciprofloxacin
0.3%
and
Dexamethasone 0.1%
1 pack
1.
Dexamethasone
5.1 mg/5 ml pack
RA concerned may take further necessary action as per above decision of NC.
Case No. B- 12
M.No.08/AM 16 M/s. Adcock Ingram Ltd File No.01/82/050/00734/AM-13
Date 16.09.2015
Adv.Auth. No.0710090488 dt. 30.08.2012
Decision: The Committee considered the case for revision of norms as per agenda under Para 4.07 of HBP.
The Committee in light of comments of the representative of D/o Pharmaceuticals in the meeting decided to revised the norms as details given below:-
Sl.No. Export item
Import item Qty. 1
Calcium Carbonate 1250 mg Glycine 537.7mg tablets 1 number tablet Glycine USP/BP 535.7mg (net to net ) Calcium Carbonate Dense BP/USP 1275mg
RA may take further necessary action as per decision of NC.
Case No. B- 13
M.No.08/AM 16 Date 16.09.2015
M/s. Adcock Ingram Ltd File No.01/82/050/00597/AM-13 Adv. Auth. No.0710083853 dt. 11.11.2011
The Committee considered the case for revision of norms as per agenda under Para 4.07 of HBP.
The Committee in light of comments of the representative of D/o Pharmaceuticals in the meeting decided to revised the norms as details given below:-
Sl.No. Export item
Import item Qty. 1
Calcium Carbonate 1250 mg Glycine 537.7mg tablets 1 number tablet Glycine USP/BP 535.7mg (net to net ) Calcium Carbonate Dense BP/USP 1275mg
RA may take further necessary action as per decision of NC.
Case No. B- 14
M.No.08/AM 16 Date 16.09.2015
M/s. Camphor & Allied Products Ltd File No.01/82/050/01098/AM-14 Adv.Auth. No.0310762311 dt. 18.12.2013
Decision: The Committee consider the case for correction in the description of import items and decided to
Case No. B- 15
M.No.08/AM 16 Date 16.09.2015
M/s. Camphor & Allied Products Ltd File No.01/82/050/00950/AM-14 Adv.Auth. No.0310754842 dt. 22.10.2013
Decision: The Committee consider the case for correction in the description of import items and decided to
Case No. B- 16
M.No.08/AM 16 Date 16.09.2015
M/s. Camphor & Allied Products Ltd File No.01/82/050/00741/AM-13 Adv.Auth. No.0310706272 dt. 24.08.2012
Decision: The Committee consider the case for correction in the description of import items and decided to
Case No. B- 17
M.No.08/AM 16 Date 16.09.2015
M/s. Camphor & Allied Products Ltd File No.01/82/050/00623/AM-13 Adv.Auth. No.0310704836 dt. 10.08.2012
Decision: The Committee consider the case for correction in the description of import items and decided to
Case No. B- 18
M.No.08/AM 16 Date 16.09.2015
M/s. Camphor & Allied Products Ltd File No.01/82/050/01071/AM-13 Adv.Auth. No.0310712193 dt. 09.10.2012
Decision: The Committee consider the case for correction in the description of import items and decided to
Case No. B- 19
M.No.08/AM 16 Date 16.09.2015
M/s. Indo Phyto Chemicals Pvt Ltd File No.01/82/050/00047/AM-15 Adv.Auth. No.0510376464 dt. 17.01.2014
Decision: The committee decided to ratify the norms based on the recommendation of Department of
Pharmaceuticals vide letter No.35011/166/2014-PI (Norms) dt. October, 2014 as per details given below
or as applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg/kg
Testosterone Enanthate
1kg
1
Etherified AD (3-Ethoxy-
androsta-3,5-diene-17
one)
1.00
Case No. B- 20
M.No.08/AM 16 Date 16.09.2015
M/s. Indo Phyto Chemicals Pvt Ltd File No.01/82/050/00514/AM-14 Adv.Auth. No.0510358451 dt. 02.07.2013
Decision: The committee decided to ratify the norms based on the recommendation of Department of
Pharmaceuticals vide letter No.35011/688/2013-PI (Norms) dt. 1.4.2014 as per details given below or as
applied by the firm whichever is less:-
Export product
Qty.
Import items
Qty.kg/kg
Nandrolone
Phenylpropionate
1kg
1
19-Nor-4-Androstene-
3,17-Dione
1.008
2 Sodium Borohydried 0.108 3 Triethyl Orthoformate 0.857 4 Piridine 0.433
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