IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग

Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Jan/202324/21 DATED: 24/01/2024

Please Note

I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in
II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.
III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.

Meeting No. NC/3/MEET/Jan/202324/21 dated 24/01/2024 of Norms Committee - III for the year 2023-24 was held on 24/01/2024 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

cations for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	UTTAM SARKAR,Assistant Section Officer	DGFT(HQ)
2	Raman Kumar,Deputy DGFT	DGFT(HQ)
3	NAND Lal,Technical Consultant	DPIIT
4	SHAISH KUMAR,Technical Consultant	DGFT
5	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT
6	Nand Lal,Technical Consultant	DGFT

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 14-02-2024 17:40:35.

UDIN00482959AM24

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00004451AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	2 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007476AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending Personal<br>Hearing<br>before Norms Committee to explain its case along with following information / documents from the firm:-<br>Catalogue for import item 3 & 4.<br>1.<br>2. Master Batch Formula showing net content of inputs in the export.

Case No.	3 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	BIOLOGICAL E. LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007891AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The case is under consideration for want of comments from Deptt. of Bio-Technology.

NORM APPLY 00007891AM24|| |RA File Number|NA|| |Licence No and Date|NA|| |Norms Committee Decision: The case is under consideration for want of comments from Deptt. of Bio-Technology.|||

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 14-02-2024 17:40:35.

UDIN00482959AM24

Case No.	4 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM REVIW00008030AM24
RA File Number	522104000061 AM20
Licence No and Date	5210043148/14/08/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>2-CHLOROBENZOIC ACID<br>Not required<br>2<br>2-CHLOROBENZONITRILE<br>1.235 kg.<br>3<br>PARA CHLOROTOLUENE<br>1.340 kg.<br>4-BROMOMETHYL-2-<br>CYANOBIP HENYL<br>1 kg.<br>4<br>TETRAHYDROFURAN<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

PARA CHLOROTOLUENE 1.340 kg. 4-BROMOMETHYL-2- CYANOBIP HENYL 1 kg. 4 TETRAHYDROFURAN 1.00 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	5 / NC/3/MEET/Jan/202324/21	5 / NC/3/MEET/Jan/202324/21	5 / NC/3/MEET/Jan/202324/21	5 / NC/3/MEET/Jan/202324/21	5 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM REVIW00008019AM24
RA File Number		522404000044 AM20
Licence No and<br>Date		5210043258/12/12/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>PARA CHLORO TOLUENE<br>1.340 kg.<br>ORTHO TOLYL BENZO NITRILE<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	ORTHO TOLYL BENZO NITRILE		1 kg.	1	PARA CHLORO TOLUENE	1.340 kg.

This document has been digitally signed by Raman Kumar, Deputy DGFT on 14-02-2024 17:40:35.

UDIN00482959AM24

	2	TETRAHYDROFURAN	1.00 kg.
	3	2-CHLOROBENZONITRILE	1.235 kg.

RA concerned may take further necessary action as per above decision of NC.

17:40:35.

UDIN00482959AM24

	2	TETRAHYDROFURAN	1.00 kg.
	3	2-CHLOROBENZONITRILE	1.235 kg.

RA concerned may take further necessary action as per above decision of NC.

Case No.	6 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00002221AM23
RA File Number	07AX04000559 AM23
Licence No and<br>Date	0711004755/23/07/2022
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
To give chemical reaction of the process.

Case No.<br>7 / NC/3/MEET/Jan/202324/21
Case Status<br>Case Approved
Party Name<br>ARCH PROTECTION CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number<br>HQRNORM APPLY 00006341AM23
RA File Number<br>03AX04004385 AM23
Licence No and<br>Date<br>0311021465/15/02/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para			4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product	Qty.	**Sl. No.

da and it was decided to fix ad-hoc norms under Para||||4.07 of HBP||| |Vol. I as per details given below or as applied by the firm, whichever is less:-||||||| |Export Product|Qty.|**Sl. No. **|Import Items||Qty.|| ||||||allowed.|| |BIT 84 PERCENTAGE 400KG BB IN 1-2|1 kg.|1|2- CHLOROBENZ ONITRILE||0.968 kg.|| |Benzisothiazoline-3-One (Net Content 0.974||||||| |kg and 2.273 kg respectively)||2|SODIUM METHYL||2.418 kg.|| ||||MERCAPTIDE 20%|||| ||||||||

UDIN00482959AM24


RA concerned may	take further necessary action as per above decision of NC.


Case No.		8 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024

HQ File Number		HQRNORM APPLY 00000742AM24

RA File Number		08AX04000208 AM24

Licence No and Date		0811008135/10/05/2023

Norms Committee Decisio		:
<br>The Committee conside		<br>red the case as per agenda and taking cue from the earlier decision for same export
product/import product in		meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization
No. 0811008079 dated 0<br>		3/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

/MEET/Jun/202324/8** dated 30/06/2023against advance authorization||||||||| |No. 0811008079 dated 0 |||3/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details ||||||||| |given below or as applied|||by the firm, whichever is less:-||||||||| ||||||||||||| ||Export Product||||Qty.||Sl. No.|Import Items||Qty. allowed.|| ||PROPAFENONE HYDROCHLORIDE TABLETS 150 MG(EACH FILM ||||1 Nu|mber|1|PROPAFENONE HYDROCHLORIDE EP / ||153 mg/tablet|| ||COATED TABLET CONTAINS: PROPAFENONE HYDROCHLORID |||E||||BP / IP / USP / PH. EUR.|||| ||PH. EUR. 150 MG)||||||||||| ||PROPAFENONE HYDROCHLORIDE TABLETS 300 MG(EACH FILM COATED TABLET CONTAINS: PROPAFENONE HYDROCHLORIDE PH. EUR. 300||||1 Nu||||||| |||||||mber|2|PROPAFENONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR.||306|mg/tablet| ||||||||||||| || MG [IN WHICH ACTIVE INGREDIENT PROPAFENONE HYDROCHLORIDE ||||||||||| ||USED IS 48.000 KGS.])||||||||||| ||||||||||||| ||||||||||||| |RA concerned may take fu|||rther necessary action as per above decision of NC.||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |Case No.||9 / NC/|3/MEET/Jan/202324/21||||||||| ||||||||||||| |Case Status||Case D|eferred||||||||| ||||||||||||| |Party Name||INTAS|PHARMACEUTICALS LIMITED||||||||| ||||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024|||||||||| |HQ File Number||HQRNORM APPLY 00000743AM24|||||||||| |||||||||||||

HARMACEUTICALS LIMITED||||||||| ||||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024|||||||||| |HQ File Number||HQRNORM APPLY 00000743AM24|||||||||| |||||||||||||

Case No.	9 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000743AM24

UDIN00482959AM24

RA File Number	08AX04000207 AM24
Licence No and<br>Date	0811008136/10/05/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	10 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	MEDICLONE HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000746AM24
RA File Number	04AX04000118 AM24
Licence No and<br>Date	0411005383/10/05/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Y 00000746AM24| |RA File Number|04AX04000118 AM24| |Licence No and Date|0411005383/10/05/2023| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|

Case No.		11 / NC/3/MEET/Jan/202324/21
Case Status		Case Deferred
Party Name		MEDREICH LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000768AM24
RA File Number		07AX04000187 AM24
Licence No and<br>Date		0711007535/11/05/2023
Norms Committee	Decision:
The committee	considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
Justification for higher wastage (400.8%) in manual.<br>1.
2. Master Batch Formula (MBF) certified by Q.C. In-charge.

Case No.	12 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	SATYADEVA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000775AM24
RA File Number	09AX04000090 AM24
Licence No and<br>Date	0911005025/11/05/2023

6 This document has been digitally signed by Raman Kumar, Deputy DGFT on 14-02-2024 17:40:35.

UDIN00482959AM24

Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No.<br>13 / NC/3/MEET/Jan/202324/21
Case Status<br>Case Approved
Party Name<br>FDC LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202324/ 21 and	24/01/2024
HQ File Number<br>HQRNORM APPLY 00000782AM24
RA File Number<br>03AX04000570 AM24
Licence No and Date<br>0311023542/12/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue		from the earlier decision	for same export
product/import product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization
No. 0311022327 dated 21/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
CHLORAMPHENICOL EYE DROPS 10<br>1 Number	1	CHLORAMPHENICOL	51.00 mg/vial
ML((EACH VIAL CONTAINS		MICRONIZED
CHLORAMPHENICOL MICRONIZED
0.050GM NET WT OF BULK DRUG IS
15.95 KGS))
RA concerned may take further necessary action as per above	decision of NC.

IAL CONTAINS||MICRONIZED||| |CHLORAMPHENICOL MICRONIZED||||| |0.050GM NET WT OF BULK DRUG IS||||| |15.95 KGS))||||| |RA concerned may take further necessary action as per above|decision of NC.||||

Case No.<br>14 / NC/3/MEET/Jan/202324/21
Case Status<br>Case Approved
Party Name<br>HONOUR LAB LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number<br>HQRNORM APPLY 00000789AM24
RA File Number<br>09AX04000030 AM24
Licence No and<br>Date<br>0911005027/12/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization
No. 0911004841 dated 19/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.

UDIN00482959AM24

of HBP Vol. I as per details|||| |given below or as applied by the firm, whichever is less:-|||| |Export Product Qty. Sl. No.|Import Items|Qty.||

UDIN00482959AM24

				allowed.
(2R,3R,4R,5S,6S)-2-(acetoxymethyl)-6-	1 kg	1	5-Bromo-2-chlorobenzoic Acid	1.105 kg.
(4-chloro-3-(4-ethoxybenzyl)
phenyl)tetrahydro-2H-pyran-3,4,5-triyl<br>Triacetate (Diloxanide furoate, Cimetidine,		2	Trimethyl silyl chloride	2.60 kg.
Oxyclozanide, Famotidine: Other)
		3	(3R,4S,5S,6R)-3,4,5-Trihydroxy-6-	0.707 kg.
			(hydroxy methyl) tetrahydro-2H-pyran-
			2-one (THO)/Glucono-Delta-Lactone
		4	Triethyl silane	2.11 kg.
		5	Tetra hydro furan	5.00 kg.
		6	Ethyl phenyl ether/Phenetole	0.707 kg.
		7	n-Methylmorpholine	3.00 kg.

Case No.<br>15 / NC/3/MEET/Jan/202324/21
Case Status<br>Case Approved
Party Name<br>MICRO LABS LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number<br>HQRNORM APPLY 00000802AM24
RA File Number<br>07AX04000198 AM24
Licence No and Date<br>0711007559/12/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue	from the earlier decision	for same export
product/import product in meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023		against advance
authorizationNo. 0711004103 dated 26/05/2022, it was decided to fix	ad-hoc norms under Para 4.07 of HBP Vol.

meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023||against advance|| |authorizationNo. 0711004103 dated 26/05/2022, it was decided to fix|ad-hoc norms under Para 4.07 of HBP Vol. I||| |as per details given below or as applied by the firm, whichever is less:-|||| |Export Product Qty. Sl. No.|Import Items|Qty. allowed.|| |PHLOROGLUCINOL 160 MG OD 1 Number 1|PHLOROGLUCINOL|163.20 mg.|| |TABLETS|DIHYDRATE Ph.Eur||| |RA concerned may take further necessary action as per above decision of NC.||||

UDIN00482959AM24

Case No.	Case No.	16 / NC/3/MEET/Jan/202324/21	16 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000803AM24
RA File Number		07AX04000199 AM24
Licence No and<br>Date		0711007560/12/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided					to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as			applied by the firm, whichever is		less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	COLCHICINE 0.6MG		1500010 Numbers	1	COLCHICINE USP	0.9 kg.
	CAPSULES (0.90 KG)
RA concerned may take further necessary action as per above				decision of NC.

|Qty. allowed.|| ||COLCHICINE 0.6MG||1500010 Numbers|1|COLCHICINE USP|0.9 kg.|| ||CAPSULES (0.90 KG)||||||| |RA concerned may take further necessary action as per above||||decision of NC.||||

Case No.	Case No.	17 / NC/3/MEET/Jan/202324/21	17 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000807AM24
RA File Number		30AX04000059 AM24
Licence No and<br>Date		3011003543/12/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	DEXKETOPROFEN TROMETAMOL		1 kg.	1	KETOPROFEN	1.00 kg.
				2	N OCTYL D GLUCAMINE	0.36 kg.

UDIN00482959AM24

	3	TRIS AMINO BUFFER	0.36 kg.
		TROMETHAMINE
	4	ETHYL ACETATE	1.00 kg.

MOL||1 kg.|1|KETOPROFEN|1.00 kg.|| |||||2|N OCTYL D GLUCAMINE|0.36 kg.||

UDIN00482959AM24

	3	TRIS AMINO BUFFER	0.36 kg.
		TROMETHAMINE
	4	ETHYL ACETATE	1.00 kg.

Case No.	Case No.	18 / NC/3/MEET/Jan/202324/21	18 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00001093AM24
RA File Number		NA
Licence No and<br>Date		0711007560/12/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided					to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as			applied by the firm, whichever is		less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	COLCHICINE 0.6MG		1500010 Numbers	1	COLCHICINE USP	0.9 kg.
	CAPSULES (0.90 KG)
RA concerned may take further necessary action as per above				decision of NC.

|Qty. allowed.|| ||COLCHICINE 0.6MG||1500010 Numbers|1|COLCHICINE USP|0.9 kg.|| ||CAPSULES (0.90 KG)||||||| |RA concerned may take further necessary action as per above||||decision of NC.||||

Case No.	19 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000836AM24
RA File Number	08AX04000216 AM24
Licence No and<br>Date	0811008181/15/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product
in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance authorizationNo. 0811004069 dated 15/02/2022
, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever

UDIN00482959AM24

is less:-

** dated 15/02/2022|| |, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever||

UDIN00482959AM24

is less:-

ess:-
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BUSPIRONE HYDROCHLORIDE<br>TABLETS USP 5 MG (EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE HYDROCHLORIDE USP 5<br>MG)	1 Number	1	BUSPIRONE HYDROCHLORIDE<br>EP / BP / IP / USP / PH. EUR.	5.1 mg / tablet
BUSPIRONE HYDROCHLORIDE<br>TABLETS USP 7.5 MG (EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE HYDROCHLORIDE USP<br>7.5 MG)	1 Number	2	BUSPIRONE HYDROCHLORIDE<br>EP / BP / IP / USP / PH. EUR.	<br>7.65 mg / tablet
BUSPIRONE HYDROCHLORIDE<br>TABLETS USP 10 MG (EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE HYDROCHLORIDE USP<br>10 MG)	1 Number	3	BUSPIRONE HYDROCHLORIDE<br>EP / BP / IP / USP / PH. EUR.	<br>10.2 mg / tablet
BUSPIRONE HYDROCHLORIDE<br>TABLETS USP 15 MG (EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE HYDROCHLORIDE USP<br>15 MG)	1 Number	4	BUSPIRONE HYDROCHLORIDE<br>EP / BP / IP / USP / PH. EUR.	<br>15.3 mg / tablet
BUSPIRONE HYDROCHLORIDE<br>TABLETS USP 30 MG (EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE HYDROCHLORIDE USP<br>30 MG [IN WHICH ACTIVE<br>INGREDIENT BUSPIRONE<br>HYDROCHLORIDE USED IS 98.100<br>KGS.])	1 Number	5	BUSPIRONE HYDROCHLORIDE<br>EP / BP / IP / USP / PH. EUR.	<br>30.6 mg / tablet

Case No.	20 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	ANUH PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000838AM24
RA File Number	03AX04000593 AM24
Licence No and<br>Date	0311023591/15/05/2023

UDIN00482959AM24

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. 3/82-ALC4/2020 dated 07/08/2020 against advance authorization No. 0310831894 dated 27/09/2019 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Triamcinolone Acetonide<br>IP/BP/USP/EP	1 kg.	1	9 11B-Epoxidetriamcinolone(5TR)	1.00 kg.

Case No.	21 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000842AM24
RA File Number	08AX04000116 AM24
Licence No and<br>Date	0811008184/15/05/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>To give molecular weight of both reactants and products indicating yield of reaction.<br>1.<br>Stoichiometric Material balance of the reaction.<br>2.<br>3.End use of export item.

To give molecular weight of both reactants and products indicating yield of reaction. 1. Stoichiometric Material balance of the reaction. 2. 3.End use of export item.||

Case No.	22 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000845AM24
RA File Number	50AX04000007 AM24
Licence No and<br>Date	5011000884/15/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00482959AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sunflower Lecithin (Liquid)<br>1 MT<br>1<br>Crude Sunflower Lecithin Liquid<br>1.01 MT<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Sunflower Lecithin (Liquid)	1 MT	1	Crude Sunflower Lecithin Liquid	1.01 MT

decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Sunflower Lecithin (Liquid)	1 MT	1	Crude Sunflower Lecithin Liquid	1.01 MT

Case No.	23 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000849AM24
RA File Number	08AX04000108 AM24
Licence No and<br>Date	0811008186/15/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNC/3/MEET/Dec/202324/17 dated 20/12/2023against advance authorization<br>No. 0810145127 dated 30/04/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>IMIDAZOLE<br>0.712 kg.<br>2<br>SODIUM METHOXIDE POWDER<br>1.00 kg.<br>N-(3-AMINOPROPYL) IMIDAZOLE<br>WHITE OR OFF WHITE CRYSTAL<br>1 kg.<br>3<br>ACRYLONITRILE<br>0.500 kg.<br>RA concerned may take further necessary action as per above decision of NC.

r>1.00 kg. N-(3-AMINOPROPYL) IMIDAZOLE WHITE OR OFF WHITE CRYSTAL 1 kg. 3 ACRYLONITRILE 0.500 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	24 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000850AM24
RA File Number	34AX04000113 AM24
Licence No and<br>Date	3411003716/15/05/2023
Norms Committee Decision:

UDIN00482959AM24

The case is under consideration for want of comments of TE.

Case No.	25 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	AVA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000858AM24
RA File Number	03AX04000650 AM24
Licence No and<br>Date	0311023611/16/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 2/82-ALC4/2018 dated 16/05/2018against advance authorizationNo.<br>0310810275 dated 03/01/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ZINC<br>DIAMMONIUM<br>EDTA<br>(LIQUID) - Zinc Content 9% (? 1)<br>1 kg.<br>1<br>ETHYLENE DIAMINE<br>TETRA ACETIC ACID<br>0.422 kg.<br>RA concerned may take further necessary action as per above decision of NC.

IUM EDTA (LIQUID) - Zinc Content 9% (? 1) 1 kg. 1 ETHYLENE DIAMINE TETRA ACETIC ACID 0.422 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	26 / NC/3/MEET/Jan/202324/21	26 / NC/3/MEET/Jan/202324/21	26 / NC/3/MEET/Jan/202324/21	26 / NC/3/MEET/Jan/202324/21	26 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		AVA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000859AM24
RA File Number		NA
Licence No and<br>Date		0311023611/16/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 2/82-ALC4/2018 dated 16/05/2018against advance authorizationNo.<br>0310810275 dated 03/01/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Case No.	Case No.	26 / NC/3/MEET/Jan/202324/21	26 / NC/3/MEET/Jan/202324/21	26 / NC/3/MEET/Jan/202324/21	26 / NC/3/MEET/Jan/202324/21	26 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		AVA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000859AM24
RA File Number		NA
Licence No and<br>Date		0311023611/16/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 2/82-ALC4/2018 dated 16/05/2018against advance authorizationNo.<br>0310810275 dated 03/01/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00482959AM24

ZINC<br>DIAMMONIUM	EDTA	1 kg.	1	ETHYLENE DIAMINE	0.422 kg.
(LIQUID) - Zinc Content 9%	(? 1)			TETRA ACETIC ACID

ems**|Qty. allowed.|

UDIN00482959AM24

ZINC<br>DIAMMONIUM	EDTA	1 kg.	1	ETHYLENE DIAMINE	0.422 kg.
(LIQUID) - Zinc Content 9%	(? 1)			TETRA ACETIC ACID

Case No.	27 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	SARAL CHEMTECH LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000865AM24
RA File Number	33AX04000105 AM23
Licence No and<br>Date	3311001206/16/05/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	28 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	MAXCURE NUTRAVEDICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000872AM24
RA File Number	05AX04000388 AM24
Licence No and<br>Date	0511018844/16/05/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	29 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000876AM24
RA File Number	08AX04000284 AM24
Licence No and<br>Date	0811008214/16/05/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

UDIN00482959AM24

Number|08AX04000284 AM24| |Licence No and Date|0811008214/16/05/2023| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|

UDIN00482959AM24

Case No.<br>30 / NC/3/MEET/Jan/202324/21
Case Status<br>Case Approved
Party Name<br>SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number<br>HQRNORM APPLY 00000884AM24
RA File Number<br>05AX04000392 AM24
Licence No and<br>Date<br>0511018851/17/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from		the earlier decision		for same export
product/import product in meetingNC/3/MEET/Nov/202324/16 dated 17/11/2023against advance authorization
No. 0511013171 dated 13/06/2022, it was decided to fix ad-hoc norms under		Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.		Import Items	Qty. allowed.
Tobramycin 300mg / 5 ml Nebuliser Solution<br>1 Number	1		Tobramycin	306 mg.
((Each ml contains Tobramycin Ph. Eur. 60 mg)
(Equivalent to 504.000 Kg of Bulk Drug))
RA concerned may take further necessary action as per above decision of NC.

in|306 mg.|| |((Each ml contains Tobramycin Ph. Eur. 60 mg)|||||| |(Equivalent to 504.000 Kg of Bulk Drug))|||||| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	31 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	SANDOZ PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000890AM24
RA File Number	03AX04000516 AM24
Licence No and<br>Date	0311023636/17/05/2023
Norms Committee Decision:
The committee considered the case as per agenda and it was decided to fix ad-hoc norms as per SION A-412.

Case No.	32 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000891AM24
RA File Number	03AX04000467 AM24
Licence No and<br>Date	0311023637/17/05/2023

UDIN00482959AM24

Norms Committee Decision:

The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-

Sl. No	Export Product	Quantity
1	Azelaic Acid 15% Gel 50 Gm (Medical Creams & Ointments)	1 Number

S. No	Import Product	Quantity allowed.
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

i. 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.
ii. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.
iii. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.		33 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000892AM24
RA File Number		03AX04000417 AM24
Licence No and<br>Date		0311023638/17/05/2023
Norms Committee	Decision:
The Committee	considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Sep/202223/8 dated 23/09/2022against advance authorization
No. 0311008443		dated 11/11/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as		applied by the firm, whichever is less:-

17 This document has been digitally signed by Raman Kumar, Deputy DGFT on 14-02-2024 17:40:35.

UDIN00482959AM24

I as per details| |given below or as||applied by the firm, whichever is less:-|

17 This document has been digitally signed by Raman Kumar, Deputy DGFT on 14-02-2024 17:40:35.

UDIN00482959AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Methyl-Monoethanolamine (MMEA)	1 kg.	1	Ethylene Oxide	0.6453 kg.
		2	Monomethyl Amine 40%	0.4257 kg.

Case No.	34 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000897AM24
RA File Number	05AX04000410 AM24
Licence No and<br>Date	0511018871/17/05/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
Get the license amended to show content of API in the export product as per DML.

fixation of ad-hoc norms and it was decided to call for|| |following information/documents from the firm:-|| |Get the license amended to show content of API in the export product as per DML.||

Case No.	35 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000905AM24
RA File Number	34AX04000124 AM24
Licence No and<br>Date	3411003726/17/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Nov/202223/14 dated 07/12/2022			against advance
authorizationNo.	3411001604 dated 29/12/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.		Import Items		Qty.
				allowed.

UDIN00482959AM24

r details given below or as applied by the firm, whichever is less:-|||||| |Export Product Qty. Sl. No.||Import Items||Qty.|| |||||allowed.||

UDIN00482959AM24

Duloxetine<br>Caps.20<br>mg(Duloxetine<br>Caps.20 mg (Net content of active<br>ingredients 60.000 kgs ))	1 Number<br>Capsule	1	Duloxetine Hydrochloride<br>Ph,Eur.	22.88 mg
		2	Sugar Spheres (30-35<br>PHARM-A-SPHERES)	20.33 mg
		3	Hypromellose (Pharmacoat<br>606)	20.00 mg
		4	Talc (Luzenac Pharma Ultra<br>Micronised grade)	12.63 mg
		5	Sucrose (Compressuc PS)	15.67 mg
		6	Hypromellose Phthalate (HP<br>55)	12.07 mg
		7	Triethyl Citrate	1.21 mg
Duloxetine Caps. 30 mg(Duloxetine<br>Caps. 30 mg (Net content of active<br>ingredients 210.00 kgs ))	1 Number<br>Capsule	1	Duloxetine Hydrochloride<br>Ph,Eur.	34.36 mg
		2	Sugar Spheres (30-35<br>PHARM-A-SPHERES)	30.50 mg
		3	Hypromellose (Pharmacoat<br>606)	30.00 mg
		4	Talc (Luzenac Pharma Ultra<br>Micronised grade)	18.94 mg
		5	Sucrose (Compressuc PS)	23.50 mg
		6	Hypromellose Phthalate (HP<br>55)	18.10 mg
		7	Triethyl Citrate	1.81 mg
Duloxetine Caps. 40 mg(Duloxetine<br>Caps. 40 mg (Net content of active	1 Number<br>Capsule	1	Duloxetine Hydrochloride<br>Ph,Eur.	45.76 mg

UDIN00482959AM24

||7|Triethyl Citrate|1.81 mg| ||Duloxetine Caps. 40 mg(Duloxetine Caps. 40 mg (Net content of active|1 Number Capsule|1|Duloxetine Hydrochloride Ph,Eur.|45.76 mg|

UDIN00482959AM24

ingredients 120.000 kgs ))	2	Sugar Spheres (30-35<br>PHARM-A-SPHERES)	40.67 mg
	3	Hypromellose (Pharmacoat<br>606)	40.00 mg
	4	Talc (Luzenac Pharma Ultra<br>Micronised grade)	25.26 mg
	5	Sucrose (Compressuc PS)	31.34 mg
	6	Hypromellose Phthalate (HP<br>55)	24.14 mg
	7	Triethyl Citrate	2.41 mg
Duloxetine Caps. 60 mg(Duloxetine<br>Caps.

a Micronised grade)|25.26 mg| ||||5|Sucrose (Compressuc PS)|31.34 mg| ||||6|Hypromellose Phthalate (HP 55)|24.14 mg| ||||7|Triethyl Citrate|2.41 mg| ||Duloxetine Caps. 60 mg(Duloxetine Caps. 60 mg (Net content of active ingredients 450.00 kgs ))|1 Number Capsule|1|Duloxetine Hydrochloride Ph,Eur.|68.71 mg| ||||2|Sugar Spheres (30-35 PHARM-A-SPHERES)|61.00 mg| ||||3|Hypromellose (Pharmacoat 606)|60.00 mg| ||||4|Talc (Luzenac Pharma Ultra Micronised grade)|37.88 mg| ||||5|Sucrose (Compressuc PS)|47.00 mg| ||||6|Hypromellose Phthalate (HP 55)|36.20 mg| ||||7|Triethyl Citrate|3.62 mg|

Case No.	36 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred

UDIN00482959AM24

Party Name	AZAKEM LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000910AM24
RA File Number	09AX04000127 AM24
Licence No and<br>Date	0911005042/17/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	37 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000920AM24
RA File Number	08AX04000086 AM24
Licence No and<br>Date	0811008233/18/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00000920AM24| |RA File Number|08AX04000086 AM24| |Licence No and Date|0811008233/18/05/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	38 / NC/3/MEET/Jan/202324/21	38 / NC/3/MEET/Jan/202324/21	38 / NC/3/MEET/Jan/202324/21	38 / NC/3/MEET/Jan/202324/21	38 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000947AM24
RA File Number		05AX04000412 AM24
Licence No and<br>Date		0511018894/18/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNC/3/MEET/Sep/202324/14 dated 27/09/2023against advance authorization<br>No. 0511019932 dated 19/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Brinex / Brinex-M / Brinarga / Brinera<br>(Brinzolamide Opthalmic Suspension 1%)- 5ml<br>1 Vial<br>1<br>Brinzolamide<br>Micronized Sterile<br>51.00 mg / vial
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

rinera (Brinzolamide Opthalmic Suspension 1%)- 5ml 1 Vial 1 Brinzolamide Micronized Sterile 51.00 mg / vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Brinex / Brinex-M / Brinarga / Brinera (Brinzolamide Opthalmic Suspension 1%)- 5ml||1 Vial|1|Brinzolamide Micronized Sterile|51.00 mg / vial|

UDIN00482959AM24

Case No.	39 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000949AM24
RA File Number	09AX04001044 AM23
Licence No and Date	0911005057/18/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Propionaldehyde<br>1.65 kg.<br>2<br>Sodium cyanide<br>1.176 kg.<br>S-(+)-2-2-AMINOBUTANAMIDE<br>HYDROCHLORIDE (CARBOXYAMIDE-<br>FUNCTION COMPOUNDS; AMIDE-<br>FUNCTION COMPOUNDS OF CARBONIC<br>ACID - ACYCLIC AMIDES (INCLUDING<br>ACYCLIC CARBAMATES) AND THEIR<br>DERIVATIVES; SALTS THEREOF : OTHER.)<br>1 kg.<br>3<br>L-Tartaric acid<br>0.875 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ACYCLIC CARBAMATES) AND THEIR DERIVATIVES; SALTS THEREOF : OTHER.) 1 kg. 3 L-Tartaric acid 0.875 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	40 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000955AM24
RA File Number	03AX04000342 AM24
Licence No and<br>Date	0311023698/18/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNC/3/MEET/Oct/202122/9 dated 15/10/2021against advance authorizationNo.<br>0310838954 dated 16/10/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details

UDIN00482959AM24

given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BUDESONIDE	1 kg	1	16 ALPHA HYDROXY PREDNISOLONE	0.972 kg.

d by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BUDESONIDE	1 kg	1	16 ALPHA HYDROXY PREDNISOLONE	0.972 kg.

Case No.	Case No.	41 / NC/3/MEET/Jan/202324/21	41 / NC/3/MEET/Jan/202324/21	41 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000956AM24
RA File Number		04AX04000143 AM24
Licence No and<br>Date		0411005437/18/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNC/3/MEET/Jan/202324/20 dated 18/01/2024against advance authorization<br>No. 0411005354 dated 08/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>ISOBUTYL ACETOPHENONE<br>1.110 kg.<br>2<br>SODIUM METAL<br>0.235 kg.<br>3<br>MONOCHLORO ACETIC ACID<br>0.919 kg.<br>4<br>ISO PROPYL ALCOHOL<br>0.50 kg.<br>IBUPROFEN<br>1 kg.<br>5<br>SODIUM DICHROMATE<br>0.630 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	**Sl.

HOL 0.50 kg. IBUPROFEN 1 kg. 5 SODIUM DICHROMATE 0.630 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||IBUPROFEN||1 kg.|1|ISOBUTYL ACETOPHENONE|1.110 kg.| |||||2|SODIUM METAL|0.235 kg.| |||||3|MONOCHLORO ACETIC ACID|0.919 kg.| |||||4|ISO PROPYL ALCOHOL|0.50 kg.| |||||5|SODIUM DICHROMATE|0.630 kg.| |||||as per above decision of NC.|||

UDIN00482959AM24

Case No.	Case No.	42 / NC/3/MEET/Jan/202324/21	42 / NC/3/MEET/Jan/202324/21	42 / NC/3/MEET/Jan/202324/21	42 / NC/3/MEET/Jan/202324/21	42 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000957AM24
RA File Number		04AX04000142 AM24
Licence No and<br>Date		0411005438/18/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNC/3/MEET/Jan/202324/20 dated 18/01/2024against advance authorization<br>No. 0411005354 dated 08/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 ISOBUTYL ACETOPHENONE 1.110 kg. 2 SODIUM METAL 0.235 kg. 3 MONOCHLORO ACETIC ACID 0.919 kg. 4 ISO PROPYL ALCOHOL 0.50 kg. IBUPROFEN 1 kg. 5 SODIUM DICHROMATE 0.630 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||IBUPROFEN||1 kg.|1|ISOBUTYL ACETOPHENONE|1.110 kg.| |||||2|SODIUM METAL|0.235 kg.| |||||3|MONOCHLORO ACETIC ACID|0.919 kg.| |||||4|ISO PROPYL ALCOHOL|0.50 kg.| |||||5|SODIUM DICHROMATE|0.630 kg.| |||||as per above decision of NC.|||

Case No.<br>	43 / NC/3/MEET/Jan/202324/21
Case Status<br>	Case Approved
Party Name<br>	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number<br>	HQRNORM APPLY 00000959AM24
RA File Number<br>	03AX04000603 AM24
Licence No and<br>Date<br>	0311023701/18/05/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided

UDIN00482959AM24

by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-

est of firm for review of ad-hoc norms and on the basis of information provided||

UDIN00482959AM24

by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-

Sl. No	Export Product<br>	Export Product<br>	Quantity
1	Medical Ointment cream Gel(Clotrimazole and Betamethasone Dipropionate Cream<br>USP 1% 0.05% 15 Gm (Tot wt 2941.16 Kgs Poly 66.18 Kgs, white petro 441.17 Kgs,<br>Min oil 176.47, cetyl 148.23, Stearyl 63.48Kgs, beta1.88 Kgs, Clotri 29.41 Kgs, Benzyl<br>29.41Kgs, Tube 196077 Nos))<br>		1 Number
2	Name: Medical ointment cream, Gel(Clotrimazole and Betamethasone Dipropionate<br>Cream USP 1% 0.05% 45 Gm (Tot wt 2941.11 Kgs Poly 66.17 Kgs, white petro 441.17<br>Kgs, Min oil176.47, cetyl 148.23, Stearyl 63.48Kgs, beta 1.88 Kgs, Clotri 29.41 Kgs,<br>Benzyl 29.41 Kgs, Tube 65358 Nos))<br>		1 Number

S. No	Import Product	Quantity allowed.
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

i. 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.
ii. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.
iii. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No. 44 / NC/3/MEET/Jan/202324/21

25 This document has been digitally signed by Raman Kumar, Deputy DGFT on 14-02-2024 17:40:35.

UDIN00482959AM24

Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000963AM24
RA File Number	34AX04000010 AM24
Licence No and<br>Date	3411003731/18/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance<br>authorizationNo. 3411001750 dated 04/02/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Propionaldehyde 0.947 kg. 2 1-Pentanol / N Amyl Alcohol 0.709 kg. Undecavertol (Kakdinol)((4-Methyl-3-decen- 5- ol)) 1 kg. 3 Magnesium Turning 0.182 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	45 / NC/3/MEET/Jan/202324/21	45 / NC/3/MEET/Jan/202324/21	45 / NC/3/MEET/Jan/202324/21	45 / NC/3/MEET/Jan/202324/21	45 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000978AM24
RA File Number		09AX04000132 AM24
Licence No and Date		0911005072/19/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>(R)-3-AMINO-1-BUTANOL<br>0.395 kg.<br>Dolutegravir Sodium<br>1 kg.<br>1<br>2<br>2,4-DIFLUOROBENZYLAMINE<br>0.426 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

ed.** (R)-3-AMINO-1-BUTANOL 0.395 kg. Dolutegravir Sodium 1 kg. 1 2 2,4-DIFLUOROBENZYLAMINE 0.426 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Dolutegravir Sodium||1 kg.|1 2|(R)-3-AMINO-1-BUTANOL|0.395 kg.| ||||||2,4-DIFLUOROBENZYLAMINE|0.426 kg.|

UDIN00482959AM24

Case No.	46 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00000989AM24
RA File Number	05AX04000389 AM24
Licence No and<br>Date	0511018912/19/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance<br>authorizationNo. 0311026693 dated 29/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Amantadine HCL Tablet 100mg<br>1 Number<br>1<br>Amantadine Hydrochloride<br>102 mg/tablet<br>RA concerned may take further necessary action as per above decision of NC.

* Qty. allowed. Amantadine HCL Tablet 100mg 1 Number 1 Amantadine Hydrochloride 102 mg/tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	47 / NC/3/MEET/Jan/202324/21	47 / NC/3/MEET/Jan/202324/21	47 / NC/3/MEET/Jan/202324/21	47 / NC/3/MEET/Jan/202324/21	47 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00000995AM24
RA File Number		03AX04000744 AM24
Licence No and<br>Date		0311023755/20/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 3/82-ALC4/2019 dated 05/07/2019against advance authorizationNo.<br>0310826001 dated 28/12/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00482959AM24

2, 6-Dichloro Benzoyl chloride 1 kg. 1 2,6-Dichloro Benzaldehyde 0.927 kg.

owed.**||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00482959AM24

2, 6-Dichloro Benzoyl chloride 1 kg. 1 2,6-Dichloro Benzaldehyde 0.927 kg.

Case No.	48 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001008AM24
RA File Number	03AX04000694 AM24
Licence No and<br>Date	0311023767/22/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case alongwith relevant documents from the firm.

Case No.<br>49 / NC/3/MEET/Jan/202324/21
Case Status<br>Case Approved
Party Name<br>AQUA VITOE LABORATORIES
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number<br>HQRNORM APPLY 00001013AM24
RA File Number<br>30AX04000068 AM24
Licence No and<br>Date<br>3011003557/22/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision		for same export
product/import product in meetingNC/3/MEET/Jun/202223/5 dated 08/07/2022against advance		authorizationNo.
0811001842 dated 25/06/2021, it was decided to fix ad-hoc norms under	Para 4.07 of HBP Vol.

t in meetingNC/3/MEET/Jun/202223/5 dated 08/07/2022against advance||||authorizationNo.|| |0811001842 dated 25/06/2021, it was decided to fix ad-hoc norms under|||Para 4.07 of HBP Vol. I as per details||| |given below or as applied by the firm, whichever is less:-|||||| |Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.|| |Ceftazidime for Injection U.S.P 1.0 gm|1 Number|1|Ceftazidime|1100.00 mg|| |RA concerned may take further necessary action as per above decision of NC.||||||

UDIN00482959AM24

Case No.	50 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001033AM24
RA File Number	03AX04000403 AM24
Licence No and<br>Date	0311023793/23/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNC/3/MEET/Mar/202223/22 dated 24/03/2023against advance authorization<br>No. 0311019737 dated 03/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. LIOTHRONINE SODIUM 5 MCG TABLETS 1 Number 1 Liothyronine sodium 5.10 MCG per 5 MCG Tablet LIOTHRONINE SODIUM 10 MCG TABLETS 1 Number 2 Liothyronine sodium 10.20 MCG per 10 MCG Tablet LIOTHRONINE SODIUM 20 MCG TABLETS 1 Number 3 Liothyronine sodium 20.40 MCG per 20 MCG Tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	51 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	HINDYS LAB PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001037AM24
RA File Number	09AX04001157 AM23
Licence No and<br>Date	0911005091/23/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No. 52 / NC/3/MEET/Jan/202324/21

UDIN00482959AM24

and Date|0911005091/23/05/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No. 52 / NC/3/MEET/Jan/202324/21

UDIN00482959AM24

Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001038AM24
RA File Number	03AX04000751 AM24
Licence No and<br>Date	0311023797/23/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Jun/202324/6 dated 14/06/2023against advance authorization<br>No. 0311021683 dated 24/02/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>BRIMONIDINE TARTRATE EYE<br>DROPS 5ML ( IOBRIM EYE DROPS<br>5ML) ((EACH VIAL CONTAINS<br>BRIMONIDINE L TARTRATE 0.01<br>GM NET WT OF BULK DRUG IS<br>0.910 KGS))<br>1 Vial<br>1<br>BRIMONIDINE L-TARTRATE<br>10.2 mg / vial<br>RA concerned may take further necessary action as per above decision of NC.

ARTRATE 0.01 GM NET WT OF BULK DRUG IS 0.910 KGS)) 1 Vial 1 BRIMONIDINE L-TARTRATE 10.2 mg / vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	53 / NC/3/MEET/Jan/202324/21	53 / NC/3/MEET/Jan/202324/21	53 / NC/3/MEET/Jan/202324/21	53 / NC/3/MEET/Jan/202324/21	53 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00001039AM24
RA File Number		09AX04001152 AM23
Licence No and Date		0911005092/23/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Sep/202324/13 dated 14/09/2023against advance<br>authorizationNo. 0911005377 dated 11/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>ADENINE<br>0.85 kg.<br>( R)-9-[2-phosphonomethoxy)propyl]<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	( R)-9-[2-phosphonomethoxy)propyl]		1 kg.	1	ADENINE	0.85 kg.

UDIN00482959AM24

oxy)propyl] 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||( R)-9-[2-phosphonomethoxy)propyl]||1 kg.|1|ADENINE|0.85 kg.|

UDIN00482959AM24

2	N,N-DIMETHYLFORMAMIDE	2.00 kg.
3	(R)-1,2-PROPYLENE<br>CARBONATE	0.79 kg.
4	N-METHYL-2-PYRROLIDONE	0.21 kg.
5	Diethyl Para Toluene Sulfonyl Oxy<br>Methyl Phosphonate	<br>1.00 kg.
6	Magnesium Tert. Butoxide	1.00 kg.

R)-1,2-PROPYLENE CARBONATE|0.79 kg.| ||||4|N-METHYL-2-PYRROLIDONE|0.21 kg.| ||||5|Diethyl Para Toluene Sulfonyl Oxy Methyl Phosphonate| 1.00 kg.| ||||6|Magnesium Tert. Butoxide|1.00 kg.|

Case No.	54 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001041AM24
RA File Number	04AX04000154 AM24
Licence No and Date	0411005457/23/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CIPROFLOXACIN TABLETS<br>USP 500<br>mg(CIPROFLOXACIN<br>TABLETS USP 500 mg<br>(10000x100x10`s)-<br>10000000 Nos - 5000 KGS)<br>1 Number<br>1<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>500 mg / tablet<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 55 / NC/3/MEET/Jan/202324/21

UDIN00482959AM24

ROFLOXACIN HYDROCHLORIDE USP 500 mg / tablet RA concerned may take further necessary action as per above decision of NC.||

Case No. 55 / NC/3/MEET/Jan/202324/21

UDIN00482959AM24

Case Status	Case Approved
Party Name	SHARP MINT LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001045AM24
RA File Number	05AX04000477 AM24
Licence No and<br>Date	0511018941/23/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance<br>authorizationNo. 0511020129dated31/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Menthol Crystal<br>1 kg.<br>1<br>L-Menthol<br>1.02 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	56 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001048AM24
RA File Number	08AX04000163 AM24
Licence No and<br>Date	0811008261/23/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00001048AM24| |RA File Number|08AX04000163 AM24| |Licence No and Date|0811008261/23/05/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	57 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	ABHILASH LIFE SCIENCES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001074AM24
RA File Number	32AX04000094 AM24
Licence No and<br>Date	3211004934/24/05/2023
Norms Committee Decision:

UDIN00482959AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. 12/82-ALC4/2018 dated 12/12/2018 against advance authorization No. 0810142890 dated 22/06/2018 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Nitrofurantoin 50mg Capsules	1 Number	1	Nitrofurantoin Macrocrystals	51 mg / Capsule
Nitrofurantoin 100mg Capsules	1 Number	2	Nitrofurantoin Macrocrystals	102 mg / Capsule

--|---|---|---|---| |Nitrofurantoin 50mg Capsules|1 Number|1|Nitrofurantoin Macrocrystals|51 mg / Capsule| |Nitrofurantoin 100mg Capsules|1 Number|2|Nitrofurantoin Macrocrystals|102 mg / Capsule|

Case No.	58 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	HUMAN PHARMA LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001075AM24
RA File Number	08AX04000092 AM24
Licence No and<br>Date	0811008267/24/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance authorization<br>No. 0511002362 dated 30/04/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>DEXAMETHASONE SODIUM PHOSPHATE 1 kg.<br>1<br>16 Alpha-Methyl Epoxide (8-DM) 0.811 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	59 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	HUMAN PHARMA LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024

UDIN00482959AM24

an/202324/21| |---|---| |Case Status|Case Approved| |Party Name|HUMAN PHARMA LABS PRIVATE LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024|

UDIN00482959AM24

HQ File Number	HQRNORM APPLY 00001076AM24
RA File Number	08AX04000093 AM24
Licence No and<br>Date	0811008268/24/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>MOMETASONE FUROATE<br>1 kg.<br>1<br>16 Alpha-Methyl Epoxide (8-DM)<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	60 / NC/3/MEET/Jan/202324/21	60 / NC/3/MEET/Jan/202324/21	60 / NC/3/MEET/Jan/202324/21	60 / NC/3/MEET/Jan/202324/21	60 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00001078AM24
RA File Number		09AX04000108 AM24
Licence No and Date		0911005106/24/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting**No.

005106/24/05/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo. NC/3/MEET/Aug/202122/7 dated 13/08/2021against advance authorization No. 0910066753dated16/10/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No.Import Items Qty. allowed. 1 2-AZABICYCLO(2.2.1.)HEPT-5- ENE-3-ONE (VINCELACTAM) 1.337 kg. 2 L (+)TARTARIC ACID 0.85 kg. 3 SODIUM BORO HYDRIDE 0.214 kg. 4 THIONYL CHLORIDE 0.40 kg. (1S,4R)-4-AMINO-2-CYCLOPENTEN-1- METHANOL HYDROCHLORIDE (Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: Other ) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||(1S,4R)-4-AMINO-2-CYCLOPENTEN-1- METHANOL HYDROCHLORIDE (Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: Other )||1 kg.|1|2-AZABICYCLO(2.2.1.)HEPT-5- ENE-3-ONE (VINCELACTAM)|1.337 kg.| |||||2|L (+)TARTARIC ACID|0.85 kg.| |||||3|SODIUM BORO HYDRIDE|0.214 kg.| |||||4|THIONYL CHLORIDE|0.40 kg.|

UDIN00482959AM24

	5	METHANOL	2.00	kg.
	6	Triethylamine	0.60	kg.

ARTARIC ACID|0.85 kg.| |||||3|SODIUM BORO HYDRIDE|0.214 kg.| |||||4|THIONYL CHLORIDE|0.40 kg.|

UDIN00482959AM24

	5	METHANOL	2.00	kg.
	6	Triethylamine	0.60	kg.

Case No.	Case No.	61 / NC/3/MEET/Jan/202324/21	61 / NC/3/MEET/Jan/202324/21	61 / NC/3/MEET/Jan/202324/21	61 / NC/3/MEET/Jan/202324/21	61 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00001081AM24
RA File Number		09AX04000106 AM24
Licence No and<br>Date		0911005107/24/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo. 0911003371 dated 20/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Malonic acid 4.46 kg. 2 L (+) Tartaric acid 2.41 kg. 3 2,2,6,6-tetramethyl piparidine-1-oxyl 0.27 kg. 4 Thionyl Chloride 3.81 kg. (S)-TERT-BUTYL-3-OXO-1- PHENYLPROPYLCARBAMATE (Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: ) 1 kg. 5 Di Tert.Butyl Di Carbonate 1.57 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||(S)-TERT-BUTYL-3-OXO-1- PHENYLPROPYLCARBAMATE (Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: )||1 kg.|1|Malonic acid|4.46 kg.| |||||2|L (+) Tartaric acid|2.41 kg.| |||||3|2,2,6,6-tetramethyl piparidine-1-oxyl|0.27 kg.| |||||4|Thionyl Chloride|3.81 kg.| |||||5|Di Tert.Butyl Di Carbonate|1.57 kg.| |||||above decision of NC.|||

Case No.	62 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved

UDIN00482959AM24

loride|3.81 kg.| |||||5|Di Tert.Butyl Di Carbonate|1.57 kg.| |||||above decision of NC.|||

Case No.	62 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved

UDIN00482959AM24

Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00001082AM24
RA File Number	09AX04000107 AM24
Licence No and<br>Date	0911005108/24/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue			from the earlier decision for				same export
product/import product in meetingNo. NC/3/MEET/Aug/202324/11					dated 22/08/2023against advance
authorizationNo.	0911003396 dated 25/07/2022, it was decided	to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is		less:-
Export Product		Qty.		Sl.	No.	Import Items	Qty. allowed.
3-(3-ISOPROPYL-5-METHYL-4H-1,2,4-TRIAZOL-4-		1 kg.			1	Nortropinone.HCl	1.88 kg.
YL)EXO-8-AZA-BICYCLO[3.2.1] OCTANE
(Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: )					2	Tetra Hydro Furan	3.32 kg.
					3	ACETONITRILE	3.77 kg.
RA concerned may take further necessary action as per above decision of NC.

te, Cimetidine, Oxyclozanide, Famotidine: )|||||2|Tetra Hydro Furan|3.32 kg.|| ||||||3|ACETONITRILE|3.77 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||||||

Case No.	63 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	EMCURE PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00005336AM24
RA File Number	31AX04000151 AM24
Licence No and<br>Date	3111002604/31/08/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	64 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	RIDDHI PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00005518AM24

UDIN00482959AM24

RA File Number	34AX04000422 AM24
Licence No and
Date	3411004096/08/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.6/82-ALC4/2018 dated 26/07/2018against advance authorizationNo.<br>3410043042 dated 20/03/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.


Case No.		65 / NC/3/MEET/Jan/202324/21

Case Status		Case Deferred

Party Name		DELTA FINOCHEM PRIVATE LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024

HQ File Number		HQRNORM APPLY 00005619AM24

RA File Number		03AX04002566 AM24

Licence No and<br>Date		0311027073/13/09/2023

Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>To give complete chemistry of reactant and product indicating molecular weight of each chemical and<br>yield of the reaction.<br>1.<br>The value of by-product if any, with evidence.<br>2.<br>Stoichiometric material balance of the reaction.<br>3.
	<br>The value of by-pr<br>2.<br>Stoichiometric mat<br>3.		<br>oduct if any<br>erial balan	, with eviden<br>ce of the reac	ce.<br>tion.


Cas	e No.	66 / NC/	3/MEET/Ja	n/202324/21
Cas	e Status	Case De	ferred

| oduct if any erial balan|, with eviden ce of the reac|ce. tion.|| |||||||| |||||||| |Cas|e No.|66 / NC/|3/MEET/Ja|n/202324/21||| |Cas|e Status|Case De|ferred|||| |Par|ty Name|KAVAL|IFE PRIVA|TE LIMITED||| |Me and||||||| ||eting Number Date|NC/ 3/ MEET/ Jan/||202324/ 21 and 24/01/2024||| |HQ|File Number|HQRNORM APPLY||00005806AM24|||

Case No.	66 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	KAVALIFE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00005806AM24

UDIN00482959AM24

RA File Number<br>07AX04000908 AM24
Licence No and<br>Date<br>0711009260/21/09/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
Justification for 36% wastage.<br>1.
Commercial value of by-product obtained<br>2.
What kind of process loss envisaged.<br>3.
Production/consumption data duly certified by GST for last one year.<br>4.

tage.** 1.| |Commercial value of by-product obtained 2.| |What kind of process loss envisaged. 3.| |Production/consumption data duly certified by GST for last one year. 4.|

Case No.	67 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00005810AM24
RA File Number	05AX04001798 AM24
Licence No and<br>Date	0511021104/22/09/2023
Norms Committee Decision:
The Committee considered the case as per agenda		and taking cue from			the earlier decision for	same export
product/import product in meetingNo. NC/3/MEET/Nov/202324/16				dated 17/11/2023against advance
authorizationNo.	0511013171 dated 13/06/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.		Import Items	Qty. allowed.
Tobramycin Inhalation Solution, 300mg/ 5ml		<br>1 Number	1		TOBRAMYCIN USP	306 mg.
(Having net content of 99.14 kg of Bulk drug)
RA concerned may take further necessary action as per above decision			of NC.

ion, 300mg/ 5ml|| 1 Number|1||TOBRAMYCIN USP|306 mg.|| |(Having net content of 99.14 kg of Bulk drug)|||||||| |RA concerned may take further necessary action as per above decision|||of NC.|||||

Case No.	68 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00005878AM24
RA File Number	05AX04001755 AM24

UDIN00482959AM24

Licence No and Date 0511021168/26/09/2023

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Dec/202324/19 dated 05/01/2024 against advance authorization No. 0511017012 dated 25/01/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
TELMISARTAN	1 kg.	1	2-n-propyl-4-methyl-6-(1-	0.621 kg.
USP/BP/EP/JP/IP(POWDER)			methylbenzimidazol-2-yl)
		2	2-Cyano-4-Methyl Biphenyl (OTBN)	0.650 kg.
		3	Acetic Acid	0.90 kg.
		4	Toluene	1.71 kg.
		5	N-Butanol	1.34 kg.
		6	Methanol	1.25 kg.

P/EP/JP/IP(POWDER)|||methylbenzimidazol-2-yl)|| |||2|2-Cyano-4-Methyl Biphenyl (OTBN)|0.650 kg.| |||3|Acetic Acid|0.90 kg.| |||4|Toluene|1.71 kg.| |||5|N-Butanol|1.34 kg.| |||6|Methanol|1.25 kg.|

Case No.	Case No.	69 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ	File Number	HQRNORM APPLY 00005900AM24
RA File Number		05AX04001893 AM24
Licence No and<br>Date		0511021195/27/09/2023
Norms Committee Decision:
The Committee		considered the case as per agenda and taking cue from the earlier decision for same export
product/import		product in meetingNo.NC/3/MEET/Jan/202122/13 dated 21/01/2022against advance
authorizationNo.0511004139 dated 16/08/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:-
	Export Product<br>Qty.<br>Sl. No.		Import Items	Qty. allowed.

UDIN00482959AM24

|||| |as per details given below or as applied by the firm, whichever is less:-|||||| ||Export Product Qty. Sl. No.||Import Items|Qty. allowed.||

UDIN00482959AM24

1<br>CITRIC ACID<br>0.726 kg.<br>2<br>DENATURED ETHYL ALCOHOL<br>0.526 kg.<br>TRI ETHYL CITRATE<br>(TEC)(TRI ETHYL CITRATE<br>(TEC) (PACKED IN 400 NOS.<br>OF HM-HDPE DRUMS MADE<br>OF HDPE GRANULES<br>(3,400.000 KGS. WITHOUT<br>WASTAGE)) (EACH DRUM<br>SHALL WEIGHT 8.5 KG AND<br>STORAGE CAPACITY<br>250.000 KGS.))<br>1 kg.<br>3<br>HDPE GRANULES (TOTAL<br>WEIGHT = 3,570.000 KGS.)<br>Relevant, as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC.	TRI ETHYL CITRATE<br>(TEC)(TRI ETHYL CITRATE<br>(TEC) (PACKED IN 400 NOS.<br>OF HM-HDPE DRUMS MADE<br>OF HDPE GRANULES<br>(3,400.000 KGS. WITHOUT<br>WASTAGE)) (EACH DRUM<br>SHALL WEIGHT 8.5 KG AND<br>STORAGE CAPACITY<br>250.000 KGS.))	1 kg.	1	CITRIC ACID	0.726 kg.
			2	DENATURED ETHYL ALCOHOL	0.526 kg.
			3	HDPE GRANULES (TOTAL<br>WEIGHT = 3,570.000 KGS.)	Relevant, as per<br>packing policy

Case No.	70 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00005955AM24
RA File Number	34AX04000512 AM24
Licence No and<br>Date	3411004188/29/09/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005955AM24| |RA File Number|34AX04000512 AM24| |Licence No and Date|3411004188/29/09/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	71 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	MEGHMANI DYES AND INTERMEDIATES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00005963AM24
RA File Number	08AX04001166 AM24
Licence No and<br>Date	0811009505/02/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	72 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024

UDIN00482959AM24

and Date
HQ File Number	HQRNORM APPLY 00005974AM24
RA File Number	03AX04002789 AM24
Licence No and<br>Date	0311027510/03/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	73 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00005992AM24
RA File Number	03AX04002781 AM24
Licence No and<br>Date	0311027528/03/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005992AM24| |RA File Number|03AX04002781 AM24| |Licence No and Date|0311027528/03/10/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	74 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00005997AM24
RA File Number	03AX04002790 AM24
Licence No and<br>Date	0311027534/03/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	75 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	INDIA GLYCOLS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006006AM24
RA File Number	05AX04001846 AM24
Licence No and<br>Date	0511021178/03/10/2023
Norms Committee Decision:

41 This document has been digitally signed by Raman Kumar, Deputy DGFT on 14-02-2024 17:40:35.

UDIN00482959AM24

The case is under consideration for want of comments of TE.

Case No.	76 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006014AM24
RA File Number	03AX04002949 AM24
Licence No and<br>Date	0311027570/03/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	77 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006018AM24
RA File Number	05AX04001916 AM24
Licence No and<br>Date	0511021302/03/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	78 / NC/3/MEET/Jan/202324/21	78 / NC/3/MEET/Jan/202324/21	78 / NC/3/MEET/Jan/202324/21	78 / NC/3/MEET/Jan/202324/21	78 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		ROSSARI BIOTECH LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00006029AM24
RA File Number		03AX04002962 AM24
Licence No and<br>Date		0311027600/04/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

|Licence No and Date||0311027600/04/10/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00482959AM24

1	MOR	PHOLINE	0.440 kg.
2	FORM	ALDEHYDE	0.1517 kg.
3	MON	O CARBOXYLIC ACID	0.25 kg.


Case No.			79 / NC/3/MEET/Jan/202324/21

Case Status			Case Approved

Party Name			GLOBAL CALCIUM PRIVATE LIMITED

Meeting Number<br>and Date			NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024

HQ File Number			HQRNORM APPLY 00006126AM24

RA File Number			07AX04001033 AM24

Licence No and<br>Date			0711009399/10/10/2023

umber|||HQRNORM APPLY 00006126AM24||||||||||| ||||||||||||||| |RA File Number|||07AX04001033 AM24||||||||||| ||||||||||||||| |Licence No and Date|||0711009399/10/10/2023||||||||||| ||||||||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decisio product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against ad N0711004862dtd 08/08/2022it didd t fi dh d P 407 f HBP|||||||||||n for same export vance authorization l I dtil||| |o. ae, was ece o x a-oc norms uner ara . o o. as per eas iven below or as alied b the firm whichever is less:-|||||||||||||| |g pp||||y ,|||||||||| ||||||||||||||| ||Export Product||||Qty.||Sl. No.|||Import Items||Qty. allowed.|| ||||||||||||||| ||Nifuroxazide||||1 kg.||1|||5-Nitro-2-furohydrazide||0.634 kg.|| ||||||||||||||| ||||||||||||||| ||||||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||||| ||||||||||||||| |Case No.|||80 / NC/3/MEET/Jan/202324/21||||||||||| |Cas||e Status|Case Approved||||||||||| |Par||ty Name|GRANULES INDIA LIMITED||||||||||| |Me and||eting Number Date|NC/ 3/ MEET/ Jan/ 202324/ 2|||1 and 24/0||1/2024|||||| |HQ||File Number|HQRNORM APPLY 000061|||44AM24|||||||| |RA|||||||||||||| |||File Number|09AX04000605 AM24||||||||||| |Lic Dat||ence No and e|0911005927/10/10/2023||||||||||| |No||ms Committee Decision:|||||||||||| |||||||||||||||

|44AM24|||||||| |RA|||||||||||||| |||File Number|09AX04000605 AM24||||||||||| |Lic Dat||ence No and e|0911005927/10/10/2023||||||||||| |No||ms Committee Decision:|||||||||||| |||||||||||||||

Case No.	80 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006144AM24
RA File Number	09AX04000605 AM24
Licence No and<br>Date	0911005927/10/10/2023
Norms Committee Decision:

UDIN00482959AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Jun/202324/8 dated 30/06/2023 against advance authorization No. 0911005029 dated 15/05/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Methocarbamol	1 kg.	1	Guaifenesin	1.050 kg.
		2	Sodium Methoxide Powder (SMO)	0.005 kg.
		3	Dimethyl Carbonate	0.500 kg.
		4	Ammonium Chloride	0.015 kg.
		5	Ammonia Gas	0.250 kg.
		6	Toluene	0.300 kg.
		7	Methanol	0.700 kg.
		8	Activated carbom	0.005 kg.

(SMO)|0.005 kg.| |||3|Dimethyl Carbonate|0.500 kg.| |||4|Ammonium Chloride|0.015 kg.| |||5|Ammonia Gas|0.250 kg.| |||6|Toluene|0.300 kg.| |||7|Methanol|0.700 kg.| |||8|Activated carbom|0.005 kg.|

Case No.	81 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	ANNORA PHARMA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006180AM24
RA File Number	09AX04000953 AM23
Licence No and Date	0911005908/11/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization<br>No. 0911004105 dated 13/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-

UDIN00482959AM24

1004105 dated 13/12/2022**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00482959AM24

Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>SAPROPTERIN DIHYDROCHLORIDE<br>POWDER FOR ORAL SOLUTION 100 mg<br>/Packet (SAPROPTERIN<br>DIHYDROCHLORIDE<br>POWDER<br>FOR<br>ORAL SOLUTION 100 mg /Packet)<br>1 Number<br>1<br>SAPROPTERIN<br>DIHYDROCHLORIDE<br>102.00 mg.<br>SAPROPTERIN DIHYDROCHLORIDE<br>POWDER FOR ORAL SOLUTION 500<br>mg/Packet (SAPROPTERIN<br>DIHYDROCHLORIDE POWDER FOR<br>ORAL SOLUTION 500 mg/Packet)<br>1 Number<br>2<br>SAPROPTERIN<br>DIHYDROCHLORIDE<br>510.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	SAPROPTERIN DIHYDROCHLORIDE<br>POWDER FOR ORAL SOLUTION 100 mg<br>/Packet (SAPROPTERIN<br>DIHYDROCHLORIDE<br>POWDER<br>FOR<br>ORAL SOLUTION 100 mg /Packet)	<br>1 Number	1	SAPROPTERIN<br>DIHYDROCHLORIDE	102.00 mg.
	SAPROPTERIN DIHYDROCHLORIDE<br>POWDER FOR ORAL SOLUTION 500<br>mg/Packet (SAPROPTERIN<br>DIHYDROCHLORIDE POWDER FOR<br>ORAL SOLUTION 500 mg/Packet)	1 Number	2	SAPROPTERIN<br>DIHYDROCHLORIDE	510.00 mg.

Case No.	82 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	BULI CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006193AM24
RA File Number	03AX04003098 AM24
Licence No and<br>Date	0311027841/12/10/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>The percentage of Hexane in export item.<br>1.<br>To give complete chemistry of reactant and product indicating molecular weight of each chemical and<br>yield of the reaction.<br>2.<br>The value of by-product, if any, with evidence.<br>3.<br>Stoichiometric Material balance of the reaction.<br>4.

Case No.	83 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024

UDIN00482959AM24

HQ File Number	HQRNORM APPLY 00006214AM24
RA File Number	03AX04003139 AM24
Licence No and<br>Date	0311027854/12/10/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

AM24| |---|---| |RA File Number|03AX04003139 AM24| |Licence No and Date|0311027854/12/10/2023| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|

Case No.<br>84 / NC/3/MEET/Jan/202324/21	Case No.<br>84 / NC/3/MEET/Jan/202324/21
Case Status<br>Case Approved
Party Name<br>TADIMETY AROMATICS	PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202324/	21 and 24/01/2024
HQ File Number<br>HQRNORM APPLY 00006217AM24
RA File Number<br>07AX04001062 AM24
Licence No and<br>Date<br>0711009454/12/10/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
PHENYL ETHYL ISO BUTYRATE (2-	1 kg.	1	PHENYL ETHYL ALCOHOL	0.66 kg.
phenylethyl 2-methylpropanoate –
CAS No.103-48-0)		2	ISO BUTYRIC ACID	0.52 kg.
RA concerned may take further necessary action as per above decision of NC.

ETHYL ALCOHOL|0.66 kg.|| |phenylethyl 2-methylpropanoate –|||||| |CAS No.103-48-0)||2|ISO BUTYRIC ACID|0.52 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	85 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	AROCHEMA INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006224AM24
RA File Number	26AX04000053 AM24
Licence No and<br>Date	2611001171/13/10/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Jul/202324/9 dated 28/07/2023against advance authorization

UDIN00482959AM24

No.2611000615 dated 13/06/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
AMBRETTOLIDE VEG	1 kg.	1	7-OCTENAL	1.999 kg.
		2	INHERENT UC 12 ME	2.69 kg.
		3	ULTRACAT?	0.000089 kg.
		4	SNATCHCAT	0.000104 kg.
		5	GREEN CAT	Not imported

ed.**| |---|---|---|---|---| |AMBRETTOLIDE VEG|1 kg.|1|7-OCTENAL|1.999 kg.| |||2|INHERENT UC 12 ME|2.69 kg.| |||3|ULTRACAT?|0.000089 kg.| |||4|SNATCHCAT|0.000104 kg.| |||5|GREEN CAT|Not imported|

Case No.	86 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	AARTI INDUSTRIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006252AM24
RA File Number	03AX04003081 AM24
Licence No and<br>Date	0311027889/14/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	87 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006279AM24
RA File Number	05AX04002118 AM24
Licence No and<br>Date	0511021548/16/10/2023
Norms Committee Decision:

UDIN00482959AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Nov/202324/16 dated 17/11/2023 against advance authorization No. 0511013171 dated 13/06/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

dvance authorization No. 0511013171 dated 13/06/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Tobramycin Inhalation Solution, 300mg/<br>5ml(Having net content of 98.82 kg of Bulk<br>drug (filling volume 5.4ml in each<br>number))	1 Number	1	TOBRAMYCIN USP	306 mg.

Case No.	88 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006316AM24
RA File Number	09AX04000661 AM24
Licence No and<br>Date	0911006014/17/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization<br>No. 0311020485 dated 04/01/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

01/2023**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Colistimethate sodium powder for preparation of solution for inhalation1000000 Units (Each vial contains: Colistimethate Sodium 1000000 U (corresponds to approximately 80 mg)) 120,000 Numbers 1 Colistimethate Sodium 9.419 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00482959AM24

Case No.	89 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006397AM24
RA File Number	03AX04002697 AM24
Licence No and<br>Date	0311028091/20/10/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

PPLY 00006397AM24| |RA File Number|03AX04002697 AM24| |Licence No and Date|0311028091/20/10/2023| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Cas	e No.	89 / NC/3/MEET/Jan/202324/21
Cas	e Status	Case Deferred
Par	ty Name	RUMIT LIFE CARE
Meeting Number<br>and Date
		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00006397AM24
RA File Number		03AX04002697 AM24

Licence No and<br>		0311028091/20/10/2023
Date

Norms Committee		Decision:
The case is under		consideration for want of comments of TE.


Case No.		90 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number		NC/ 3/ MEET/ J/ 202324/ 21 d 24/01/2024
and Date		an an
HQ File Number		HQRNORM APPLY 00006422AM24
RA File Number		09AX04000604 AM24
Licence No and<br>Date		0911005926/25/10/2023

|| |and Date|||an an|||||||||||| |HQ File Number|||HQRNORM APPLY 00006422AM24|||||||||||| |RA File Number|||09AX04000604 AM24|||||||||||| |Licence No and Date|||0911005926/25/10/2023|||||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization No. 0911005029 dated 15/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Guaifenesin 1.050 kg. 2 Sodium Methoxide Powder (SMO) 0.005 kg. Methocarbamol 1 kg.||ms Committee Decision: e Committee considered the c||||ase as per agenda and taking cue from the earlier decision for same export||||||||| |||oduct/import product i . 0911005029 dated en below or as applie||n meeting 15/05/202 d by the fi||No. NC/3/ 3, it was dec rm, whichev||MEET/Jun/202324/8 dated 30/06/2023against adva ided to fix ad-hoc norms under Para 4.07 of HBP V er is less:-||||||nce authorization ol. I as per details| |||||||||||||||| |||Export Product|||Qty.||Sl. N|o.|Import Items|||||**Qty.

x ad-hoc norms under Para 4.07 of HBP V er is less:-||||||nce authorization ol. I as per details| |||||||||||||||| |||Export Product|||Qty.||Sl. N|o.|Import Items|||||Qty. allowed.| |||||||||||||||| ||Methocarbamol|Methocarbamol|||1 kg.||1||Guaifenesin|||||1.050 kg.| |||||||||||||||| ||||||||2||Sodium Methoxide Powder (SMO)||||0.005 kg.|| |||||||||||||||| ||||||||3||Dimethyl Carbonate||||0.500 kg.|| |||||||||||||||| ||||||||4||Ai Chlid||||0015 k|| ||||||||||mmonum ore||||. g.|| ||||||||5||Ammonia Gas||||0.250 kg.|| |||||||||||||||| |||||||||||||||| ||||||||6||Toluene||||0.300 kg.|| |||||||||||||||| |||||||||||||||| ||||||||||||||||

UDIN00482959AM24

	7	Methanol	0.700	kg.
	8	Activated carbom	0.005	kg.

Case No.	91 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00006564AM24
RA File Number	09AX04000635 AM24
Licence No and<br>Date	0911006117/31/10/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Get the license amended to show content of API in the export product as per DML.

fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Get the license amended to show content of API in the export product as per DML.||

Case No.	Case No.	92 / NC/3/MEET/Jan/202324/21	92 / NC/3/MEET/Jan/202324/21	92 / NC/3/MEET/Jan/202324/21	92 / NC/3/MEET/Jan/202324/21	92 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00006584AM24
RA File Number		03AX04003489 AM24
Licence No and<br>Date		0311028387/01/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>IRBESARTAN DC GRANULES 50 %<br>((Net Content : 2224.52 Kgs))<br>1 kg.<br>1<br>IRBESARTAN<br>0.505 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	IRBESARTAN DC GRANULES 50 %<br>((Net Content : 2224.52 Kgs))		1 kg.	1	IRBESARTAN	0.505 kg.

UDIN00482959AM24

Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||IRBESARTAN DC GRANULES 50 % ((Net Content : 2224.52 Kgs))||1 kg.|1|IRBESARTAN|0.505 kg.|

UDIN00482959AM24

RA	concerned may take further necessary	concerned may take further necessary	action as per a	action as per a	bove de	cision of NC.	cision of NC.	cision of NC.


Cas	e No.	93 / NC/3/MEET/Jan/20	2324/21
Cas	e Status	Case Approved
Par	ty Name	MANKIND PHARMA	LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Jan/ 202	324/ 21 and 24		/01/2024
HQ	File Number	HQRNORM APPLY 00	006707AM24

RA	File Number	05AX04002383 AM24
Lic<br>Dat	ence No and<br>e	0511021940/07/11/2023

Nor<br>T<br>V<br>RA	ms Committee Decision:<br>he Committee considered the case as p<br>ol. I as per details given below or as ap		er agenda and<br>plied by the fi		it was d	ecided to fix ad-hoc norms under Para			4.07 of HBP
					rm, whic	hever is less:-
	Export Product			Q
					ty.	Sl. No.	Import Items	Q	**ty.

the fi||it was d||ecided to fix ad-hoc norms under Para|||4.07 of HBP| ||||||rm, whic||hever is less:-|||| ||Export Product|||Q||||||| ||||||ty.||Sl. No.|Import Items|Q|ty. allowed.| ||Atropine Sulfate Ophthalmic Solution 1% 2 ml(Having net content of 0.60 k Bulk drug (filling volume 2.32 ml in each number))||USP, g of|1 Nu|mber||1|ATROPINE SULPHATE||20.40 mg.| |||||||||||| |||||||||||| ||Atropine Sulfate Ophthalmic Solution 1% 5 ml(Having net content of 2.40 k Blk d (filli l 561||USP, g of|1 Nu||||||| ||||||mber||2|ATROPINE SULPHATE||51.00 mg.| ||u rug ng voume . ml in each number))|||||||||| |||||||||||| ||Atropine Sulfate Ophthalmic Solution 1% 15 ml(Having net content of 1.80 Bulk drug (filling volume 15.91 ml in number))||USP, kg of each|1 Nu|mber||3|ATROPINE SULPHATE||153.0 mg.| |||||||||||| ||concerned may take further necessary||action as per a|||||||| ||||||bove de||cision of NC.|||| |||||||||||| |||||||||||| |Cas|e No.|94 / NC/3/MEET/Jan/20|2324/21|||||||| |Cas|e Status|Case Approved||||||||| |Par|ty Name|GLOBAL CALCIUM P|RIVATE LIM||ITED|||||| |||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024|||||||||

Case No.	94 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024

UDIN00482959AM24

T/Jan/202324/21| |---|---| |Case Status|Case Approved| |Party Name|GLOBAL CALCIUM PRIVATE LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024|

UDIN00482959AM24

HQ File Number<br>HQRNORM APPLY 00006817AM24	HQ File Number<br>HQRNORM APPLY 00006817AM24
RA File Number<br>07AX04001248 AM24
Licence No and<br>Date<br>0711009682/11/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue			from the earlier decision for same export
product/import product in meetingNo. NC/3/MEET/Nov/202324/16 dated 17/11/2023				against advance
authorizationNo. 0711004347 dated 17/06/2022, it was decided to fix			ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:-
Export Product	Qty.	Sl. No.	Import Items		Qty. allowed.
MAGNESIUM ASPARTATE (BP /	1 kg.	1	L-ASPARTIC ACID		1.05 kg.
DIHYDRATE Eur.Ph) / MAGNESIUM L-
ASPARTATE HYDROCHLORIDE
TRIHYDRATE
RA concerned may take further necessary action as per above		decision of NC.

RTIC ACID||1.05 kg.|| |DIHYDRATE Eur.Ph) / MAGNESIUM L-||||||| |ASPARTATE HYDROCHLORIDE||||||| |TRIHYDRATE||||||| |RA concerned may take further necessary action as per above||decision of NC.|||||

Case No.<br>95 / NC/3/MEET/Jan/202324/21
Case Status<br>Case Approved
Party Name<br>AARTI PHARMALABS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number<br>HQRNORM APPLY 00006860AM24
RA File Number<br>03AX04003645 AM24
Licence No and<br>Date<br>0311028738/16/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo. NC/3/MEET/Oct/202122/9 dated 15/10/2021against advance authorization
No. 0310838954 dated 16/10/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.<br>Import Items	Qty. allowed.
BUDESONIDE<br>1 kg.<br>1<br>16 ALPHA HYDROXY PREDNISOLONE	0.972 kg.
RA concerned may take further necessary action as per above decision of NC.

UDIN00482959AM24

|Qty. allowed.|| |BUDESONIDE 1 kg. 1 16 ALPHA HYDROXY PREDNISOLONE|0.972 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||

UDIN00482959AM24

Case No.<br>96 / NC/3/MEET/Jan/202324/21
Case Status<br>Case Deferred
Party Name<br>BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number<br>HQRNORM APPLY 00007101AM24
RA File Number<br>34AX04000494 AM24
Licence No and<br>Date<br>3411004386/29/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
To indicate Molecular weight of each reactant and the product.<br>1.
Yield of the reaction with justification.<br>2.
The value of by-product, if any, with evidence.<br>3.
Stoichiometric Material balance of the reaction.<br>4.

Case No.	97 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007141AM24
RA File Number	03AX04003919 AM24
Licence No and<br>Date	0311029038/01/12/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Y 00007141AM24| |RA File Number|03AX04003919 AM24| |Licence No and Date|0311029038/01/12/2023| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|

Case No.		98 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00007150AM24
RA File Number		03AX04003944 AM24
Licence No and<br>Date		0311029049/01/12/2023
Norms Committee Decision:
The Committee	considered the case as per agenda and taking cue from the earlier decision for same export
product/import	product in meetingNo. NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance

53 This document has been digitally signed by Raman Kumar, Deputy DGFT on 14-02-2024 17:40:35.

UDIN00482959AM24

authorization No. 3111001324 dated 02/05/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

M24

authorization No. 3111001324 dated 02/05/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
TYLODOX GOLD WSP (Pack size 1<br>Kgs Jar) Each gram contains:(Tylosin<br>Tartrate BP (Vet) 100 mg, Doxycycline<br>Hyclate BP 200 mg, Net Wt Tylosin<br>Tartrate BP (Vet) 210.00 Kgs Net Wt<br>Doxycycline Hyclate BP 420.000 Kgs)	<br> <br>1 Number	1	Tylosin Tartrate BP/USP /EP	0.101 kg.
		2	Doxycycline Hyclate BP/EP/USP	0.202 kg.
TYLODOX GOLD WSP (Pack size 100<br>Gms sachet) Each gram contains:<br>(Tylosin Tartrate BP (Vet) 100 mg,<br>Doxycycline Hyclate BP 200 mg, Net Wt<br>Tylosin Tartrate BP (Vet) 260.50 Kgs Net<br>Wt Doxycycline Hyclate BP 521.00 Kgs)	1 Number	3	Tylosin Tartrate BP/USP /EP	10.1 gm.
		4	Doxycycline Hyclate BP/EP/USP	20.2 gm.
NEODOX -GOLD WSP ( pack Size 100<br>Gms Sachet) Each gram contains :<br>(Doxycycline Hyclate BP 100 mg,<br>Neomycin Sulfate BP 100 mg, Net Wt<br>Doxycycline Hyclate BP 50.00 Kgs)	1 Number	5	Doxycycline Hyclate BP/EP/USP	10.1 gm.

Case No.	Case No.	99 / NC/3/MEET/Jan/202324/21	99 / NC/3/MEET/Jan/202324/21	99 / NC/3/MEET/Jan/202324/21	99 / NC/3/MEET/Jan/202324/21	99 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		RUMIT LIFE CARE
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00007188AM24
RA File Number		03AX04003955 AM24
Licence No and<br>Date		0311029102/04/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Case No.	Case No.	99 / NC/3/MEET/Jan/202324/21	99 / NC/3/MEET/Jan/202324/21	99 / NC/3/MEET/Jan/202324/21	99 / NC/3/MEET/Jan/202324/21	99 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		RUMIT LIFE CARE
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00007188AM24
RA File Number		03AX04003955 AM24
Licence No and<br>Date		0311029102/04/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00482959AM24

Betamethasone Dipropionate	1	kg.	1	Betamethasone	0.868	kg.
				IP/BP/EP/USP
IP/BP/EP/USP

Import Items*|Qty. allowed.|

UDIN00482959AM24

Betamethasone Dipropionate	1	kg.	1	Betamethasone	0.868	kg.
				IP/BP/EP/USP
IP/BP/EP/USP

Case No.	100 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007214AM24
RA File Number	03AX04003979 AM24
Licence No and Date	0311029131/05/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Sep/202223/14 dated 27/09/2023against advance<br>authorizationNo. 0311026076 dated 07/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>HEXAFLUOROISOPROPYL<br>METHYLETHER(HFMOP)<br>1 kg.<br>1<br>HEXA FLUOROISOPROPANOL<br>0.970 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Qty. allowed. HEXAFLUOROISOPROPYL METHYLETHER(HFMOP) 1 kg. 1 HEXA FLUOROISOPROPANOL 0.970 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	101 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007306AM24
RA File Number	09AX04000802 AM24
Licence No and<br>Date	0911006353/11/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202223/6 dated 09/09/2022against advance<br>authorizationNo.2611000439 dated 28/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

UDIN00482959AM24

I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
RIFAXIMIN (Ph. Eur)	1 kg.	1	4-O-Carboxymethyl-1-Deoxy-1,4-<br>Dihydro-4-Hydroxy-1-Oxorifamycin-γ-<br>Lactone ((Rifamycin-O)	1.50 kg.

**|Import Items|Qty. allowed.| |---|---|---|---|---| |RIFAXIMIN (Ph. Eur)|1 kg.|1|4-O-Carboxymethyl-1-Deoxy-1,4- Dihydro-4-Hydroxy-1-Oxorifamycin-γ- Lactone ((Rifamycin-O)|1.50 kg.|

Case No.	102 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007347AM24
RA File Number	05AX04002833 AM24
Licence No and<br>Date	0511022620/12/12/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	103 / NC/3/MEET/Jan/202324/21	103 / NC/3/MEET/Jan/202324/21	103 / NC/3/MEET/Jan/202324/21	103 / NC/3/MEET/Jan/202324/21	103 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00007391AM24
RA File Number		05AX04002880 AM24
Licence No and<br>Date		0511022658/13/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance<br>authorizationNo.0511022658 dated 13/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

12/2023**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 ADIPIC ACID 0.35 kg. DI-ISO DECYL ADIPATE (DIDA)(DI-ISO 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DI-ISO DECYL ADIPATE (DIDA)(DI-ISO||1 kg.|1|ADIPIC ACID|0.35 kg.|

UDIN00482959AM24

2<br>ISO DECANOL<br>0.768 kg.<br>DECYL ADIPATE (DIDA) (PACKED IN 477<br>NOS. OF HM-HDPE DRUMS MADE OF<br>HDPE GRANULES (4,054.500 KGS.<br>WITHOUT WASTAGE)) (EACH DRUM<br>SHALL WEIGHT 8.5 KG AND STORAGE<br>CAPACITY 210.000 KGS.))<br>3<br>HDPE GRANULES<br>(TOTAL WEIGHT =<br>4,257.225 KGS.)<br>Relevant, as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC.	DECYL ADIPATE (DIDA) (PACKED IN 477<br>NOS. OF HM-HDPE DRUMS MADE OF<br>HDPE GRANULES (4,054.500 KGS.<br>WITHOUT WASTAGE)) (EACH DRUM<br>SHALL WEIGHT 8.5 KG AND STORAGE<br>CAPACITY 210.000 KGS.))		2<br>3	ISO DECANOL	0.768 kg.
				HDPE GRANULES<br>(TOTAL WEIGHT =<br>4,257.225 KGS.)	Relevant, as per<br>packing policy

8.5 KG AND STORAGE CAPACITY 210.000 KGS.))||2 3|ISO DECANOL|0.768 kg.| |---|---|---|---|---|---| |||||HDPE GRANULES (TOTAL WEIGHT = 4,257.225 KGS.)|Relevant, as per packing policy|

Case No.	Case No.	104 / NC/3/MEET/Jan/202324/21	104 / NC/3/MEET/Jan/202324/21	104 / NC/3/MEET/Jan/202324/21	104 / NC/3/MEET/Jan/202324/21	104 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00007395AM24
RA File Number		03AX04004138 AM24
Licence No and<br>Date		0311029329/14/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance authorization<br>No.0311026365 dated 16/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Atorvastatin Calcium<br>Propylene Glycol Solvate USP<br>11.415 mg.<br>2<br>Microcrystalline Cellulose<br>(MCC) NF (Avicel PH 102)<br>64.578 mg.<br>3<br>Calcium Acetate<br>18.049 mg.<br>Atorvastatin Calcium Tablets USP<br>10mg((Net Content of Import Sr. No. 1<br>is 308.205 kgs, Sr. No. 2 is 1743.606<br>kg, Sr.No. 3 is 487.323 kg, Sr. No.

mg. 3 Calcium Acetate 18.049 mg. Atorvastatin Calcium Tablets USP 10mg((Net Content of Import Sr. No. 1 is 308.205 kgs, Sr. No. 2 is 1743.606 kg, Sr.No. 3 is 487.323 kg, Sr. No. 4 is 303000 Nos.)) 1 Number Tablet 4 Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent) Relevant, as per packing policy. 5 Atorvastatin Calcium Propylene Glycol Solvate USP 22.830 mg. Atorvastatin Calcium Tablets USP 20 mg ( (Net Content of Import Sr. No. 1 1 Number Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Atorvastatin Calcium Tablets USP 10mg((Net Content of Import Sr. No. 1 is 308.205 kgs, Sr. No. 2 is 1743.606 kg, Sr.No. 3 is 487.323 kg, Sr. No. 4 is 303000 Nos.))||1 Number Tablet|1|Atorvastatin Calcium Propylene Glycol Solvate USP|11.415 mg.| |||||2|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)|64.578 mg.| |||||3|Calcium Acetate|18.049 mg.| |||||4|Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent)|Relevant, as per packing policy.| ||Atorvastatin Calcium Tablets USP 20 mg ( (Net Content of Import Sr. No. 1||1 Number Tablet|5|Atorvastatin Calcium Propylene Glycol Solvate USP|22.830 mg.|

nt, as per packing policy.| ||Atorvastatin Calcium Tablets USP 20 mg ( (Net Content of Import Sr. No. 1||1 Number Tablet|5|Atorvastatin Calcium Propylene Glycol Solvate USP|22.830 mg.|

Case No.	Case No.	104 / NC/3/MEET/Jan/202324/21	104 / NC/3/MEET/Jan/202324/21	104 / NC/3/MEET/Jan/202324/21	104 / NC/3/MEET/Jan/202324/21	104 / NC/3/MEET/Jan/202324/21
Case Status		Case Approved
Party Name		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number		HQRNORM APPLY 00007395AM24
RA File Number		03AX04004138 AM24
Licence No and<br>Date		0311029329/14/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance authorization<br>No.0311026365 dated 16/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Atorvastatin Calcium<br>Propylene Glycol Solvate USP<br>11.415 mg.<br>2<br>Microcrystalline Cellulose<br>(MCC) NF (Avicel PH 102)<br>64.578 mg.<br>3<br>Calcium Acetate<br>18.049 mg.<br>Atorvastatin Calcium Tablets USP<br>10mg((Net Content of Import Sr. No. 1<br>is 308.205 kgs, Sr. No. 2 is 1743.606<br>kg, Sr.No. 3 is 487.323 kg, Sr. No.

UDIN00482959AM24

icy.| ||Atorvastatin Calcium Tablets USP 20 mg ( (Net Content of Import Sr. No. 1||1 Number Tablet|5|Atorvastatin Calcium Propylene Glycol Solvate USP|22.830 mg.|

UDIN00482959AM24

|6 Microcrystalline Cellulose (MCC) NF (Avicel PH 102) 129.427 mg. 7 Calcium Acetate 36.090 mg. is 205.470 kgs, Sr. No. 2 is 1164.843 kg, Sr. No. 3 is 324.810 kg, Sr. No. 4 is 101000 Nos.)) 8 Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent) Relevant, as per packing policy 9 Atorvastatin Calcium Propylene Glycol Solvate USP 45.595 mg. 10 Microcrystalline Cellulose (MCC) NF (Avicel PH 102) 258.08 mg 11 Calcium Acetate 71.963 mg. Atorvastatin Calcium Tablets USP 40mg ((Net Content of Import Sr. No. 1 is 3857.337 kgs, Sr. No. 2 is 21833.568 kg, Sr. No. 3 is 6088.070 kg, Sr. No. 4 is 949400 Nos.)) 1 Number Tablet 12 Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent) Relevant, as per packing policy 13 Atorvastatin Calcium Propylene Glycol Solvate USP 91.20 mg 14 Microcrystalline Cellulose (MCC) NF (Avicel PH 102) 518.206 mg. 15 Calcium Acetate 144.929 mg. Atorvastatin Calcium Tablets USP 80mg ((Net Content of Import Sr. No. 1 is 4104.000 kgs, Sr. No. 2 is 23319.720 kg, Sr. No. 3 is 6521.805 kg, Sr. No.

is 205.470 kgs, Sr. No. 2 is 1164.843<br>kg, Sr. No. 3 is 324.810 kg, Sr. No. 4 is<br>101000 Nos.))	6	Microcrystalline Cellulose<br>(MCC) NF (Avicel PH 102)	129.427 mg.
	7	Calcium Acetate	36.090 mg.
	8	Silica Gel Dessicants -<br>Packaged Activated Carbon<br>(Strippax Sorbent)	Relevant, as per<br>packing policy
Atorvastatin Calcium Tablets USP<br>40mg ((Net Content of Import Sr. No. 1<br>is 3857.337 kgs, Sr. No. 2 is 21833.568<br>kg, Sr. No. 3 is 6088.070 kg, Sr. No.

t)|Relevant, as per packing policy| ||Atorvastatin Calcium Tablets USP 40mg ((Net Content of Import Sr. No. 1 is 3857.337 kgs, Sr. No. 2 is 21833.568 kg, Sr. No. 3 is 6088.070 kg, Sr. No. 4 is 949400 Nos.))|1 Number Tablet|9|Atorvastatin Calcium Propylene Glycol Solvate USP|45.595 mg.| ||||10|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)|258.08 mg| ||||11|Calcium Acetate|71.963 mg.| ||||12|Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent)|Relevant, as per packing policy| ||Atorvastatin Calcium Tablets USP 80mg ((Net Content of Import Sr. No. 1 is 4104.000 kgs, Sr. No. 2 is 23319.720 kg, Sr. No. 3 is 6521.805 kg, Sr. No. 4 is 505000 Nos.))|1 Number Tablet|13|Atorvastatin Calcium Propylene Glycol Solvate USP|91.20 mg| ||||14|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)|518.206 mg.| ||||15|Calcium Acetate|144.929 mg.| ||||16|Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent)|Relevant, as per packing policy.|

Note: The above norms are valid only for subject to fulfilment of following conditions:-

i. Export Product being Patented Medicine, be filed with USFDA as an NDA (New Drug Application)
ii. Export to USA and Europe only.
iii. Firm holding Certificate of Manufacturing Exclusivity.

Case No.	105 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred

UDIN00482959AM24

SA and Europe only.**

iii. Firm holding Certificate of Manufacturing Exclusivity.

Case No.	105 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred

UDIN00482959AM24

Party Name	ANNORA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007438AM24
RA File Number	09AX04000806 AM24
Licence No and<br>Date	0911006354/18/12/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	106 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007758AM24
RA File Number	09AX04000803 AM24
Licence No and<br>Date	0911006488/04/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jul/202324/9 dated 28/07/2023against advance authorization<br>No.0911001659 dated 30/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Heparin sodium Solution for intravenous and subcutaneous administration 5000 IU / ml - (25000 IU/ 5 ml) 1 Number 1 Heparin Sodium 137.50 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	107 / NC/3/MEET/Jan/202324/21
Case Status	Case Deferred
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007813AM24
RA File Number	03AX04004498 AM24
Licence No and<br>Date	0311029998/08/01/2024

UDIN00482959AM24

Norms Committee Decision:

The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:-

Commercial value of 30% Isomerized Bromo Compounds obtained during manufacturing.

Case No.	108 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007842AM24
RA File Number	09AX04000903 AM24
Licence No and<br>Date	0911006536/09/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202223/6 dated 09/09/2022against advance<br>authorizationNo.2611000439 dated 28/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>RIFAXIMIN (Ph. Eur)<br>1 kg.<br>1<br>4-O-Carboxymethyl-1-Deoxy-1,4-Dihydro-<br>4-Hydroxy-1-Oxorifamycin-γ-Lactone<br>((Rifamycin-O)<br>1.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.

1 4-O-Carboxymethyl-1-Deoxy-1,4-Dihydro- 4-Hydroxy-1-Oxorifamycin-γ-Lactone ((Rifamycin-O) 1.50 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	109 / NC/3/MEET/Jan/202324/21
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202324/ 21 and 24/01/2024
HQ File Number	HQRNORM APPLY 00007955AM24
RA File Number	03AX04004423 AM24
Licence No and<br>Date	0311030155/13/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00482959AM24

product/import product in meeting No. NC/3/MEET/Sep/202324/3 dated 27/09/2023 against advance authorization No.0311025822 dated 28/07/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

advance authorization No.0311025822 dated 28/07/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

.0311025822 dated 28/07/2023, it was decided to fix ad-<br>en below or as applied by the firm, whichever is less:-	hoc norms un	der Para	4.07 of HBP Vol.	I as per details
Export Product	Qty.	Sl. No.	Import Items	Qty.
Bempedoic Acid and Ezetimibe Fixed Dose<br>Combination Tablets ((Each Tablet content Bempedoic<br>Acid 180mg and Ezetimibe 10mg) (Net content of<br>Bempedoic Acid 11700.000 kgs and Ezetimibe<br>650.000 kgs in total Export Qty) (AA for Free of cost<br>material as per Para 4.11 of HBP & Para 4.19 of FTP )<br>)	1 Number	1	Bempedoic Acid	189.90 mg.
		2	Ezetimibe	10.55 mg.
Note:The above norms are valid only for subject to fulfilment of following conditions:-<br>Export Product being Patented Medicine, be filed with USFDA as an NDA (New Drug Application)<br>1.<br>Export to USA and Europe only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 8047 --apply.