IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

UDIN00469236AM25

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/Sep/202425/9 DATED: 10/10/2024

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.
IV. RAs shall ensure compliance of SION, General Notes and Chapter Notes wherever applicable.
V. RAs shall also ensure that authorisation is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard full compliance of the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21 and Para 4.51 of HBP shall be made.

tee or as per wastages claimed in the application, whichever is less. In this regard full compliance of the provisions of Para 4.12 of FTP, Para 4.16, Para 4.21 and Para 4.51 of HBP shall be made.

Meeting No. NC/3/MEET/Sep/202425/9 dated 10/10/2024 of Norms Committee - III for the year 2024-25 was held on 10/10/2024 under the Chairmanship of Shri Rakesh Kumar,Additional 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 2023.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	Shri Rakesh Kumar, Addl. DGFT	DGFT(HQ)

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25

2	Shri Raman Kumar,Deputy DGFT	DGFT(HQ)
3	Shri Dinesh Narain Mathur, Technical Expert	Consultant (Pharma)
4	Shri Shaish Kumar, Technical Expert	Consultant (Chemical)
5	Shri Nand Lal, Technical Expert	Consultant (Chemical)
6	Shri Uttam Dey Sarkar, ASO	DGFT (HQ)

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25

Case Details and Decision(s):


Case Details and Decision			(s):

Case No.		1 / NC/3/	MEET/Sep/202425/9

Case Status		Case Ap	roved

Party Name		AMOLI	ORGANICS PRIVATE LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number		HQRNORM REVIW00009045AM24
RA	File Number	039404000337 AM12
Lic<br>Dat	ence No and<br>e	0310646104/03/08/2011

Nor<br>De<br>Pa	ms Committee Decision:<br>cision:The Committee considered the c<br>407 f HBP Vl I dtil i				ase as pe<br>bl		r agenda<br>	and it was decided to fix ad<br>id b th fi hih i		-hoc norms under<br>l
	ra . o o. as per eas gv				n eow		r as app	e y e rm, wcever		s ess:-
	Export Product			Qty.		Sl	No		Imort Items	Qt allowed
							. .		p	y. .
	Levetiracetam Micronized			1 k		1			Levetiracetam	100 k
	<br>(Not less than 90% pass<br>through 40 mesh)			g.						. g.
RA concerned may take further necessary action as per above decision of NC.

Micronized|||1 k||1|||Levetiracetam|100 k| || (Not less than 90% pass through 40 mesh)|||g.||||||. g.| |RA concerned may take further necessary action as per above decision of NC.|||||||||||



Case No.		2 / NC	3/MEET/Sep/202425/9

Case Status		Case	eferred

Party Name		SALV	CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>		NC/ 3/	MEET/ Sep/ 202425/ 9 and 10/10/2024
and Date

HQ File Number		HQRN	ORM REVIW00009259AM24

RA File Number		03950	000262 AM13

Licence No and<br>Date		0310705888/22/08/2012
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Justification of low yield i.e. 52.01% to 58.9% with published literature, if any.<br>1.<br>Percentage losses in purification stage.<br>2.<br>Certified copy of Production/Consumption data.<br>3.
	Justification of low yield i.e. 52.01%<br>1.<br>Percentage losses in purification sta<br>2.<br>Certified copy of Production/Consu<br>3.			to 58.9% w<br>ge.<br>mption data	ith pub<br>.	lished literature, if any.

This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25

ge. mption data|ith pub .**|lished literature, if any.||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25

Case No.	3 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00000261AM24
RA File Number	039404000617 AM17
Licence No and<br>Date	0310808312/06/10/2016
Norms Committee	Decision:
Decision:The	Committee considered the case as per agenda and it was decided to call the firm for
attending Personal Hearing<br>before Norms Committee to explain its case along with relevant documents.

Case No.<br>4 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Deferred
Party Name<br>CIPLA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM REVIW00000263AM24
RA File Number<br>039404001181 AM17
Licence No and<br>Date<br>0310812323/03/04/2017
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to call the firm for attending
Personal Hearing<br>before Norms Committee to explain its case along with relevant documents.

Case No.	5 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00000262AM24
RA File Number	039404000295 AM18
Licence No and	0310814908/31/07/2017

4 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25

Date

Norms Committee Decision:

Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case along with relevant documents.

Case No.<br>6 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Deferred
Party Name<br>CIPLA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM REVIW00000265AM24
RA File Number<br>039404000822 AM18
Licence No and<br>Date<br>0310818765/30/01/2018
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to call the firm for attending
Personal Hearing<br> before Norms Committee to explain its case along with relevant documents.

Committee considered the case as per agenda and it was decided to call the firm for attending| |Personal Hearing before Norms Committee to explain its case along with relevant documents.|

Case No.	7 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	SHREE BANKEY BEHARI LAL FLAVORS
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00006890AM24
RA File Number	052404000067 AM19
Licence No and<br>Date	0510406412/10/05/2018
Norms Committee Decision:
Decision:The case is under consideration and CLA, Delhi was requested vide DGFT (HQ) letter No.
01/82/0007/AM-25/DES-III/31 dated 11/06/2024 to audit firm and submit production/consumption data for
the year 2018-19	as sought by TE within fifteen days of receipt of said letter, however, no such response
received from CLA, Delhi even after repeated reminders. Therefore, it was decided to send a D.O. letter to
ADG, CLA, New Delhi in this regard.

UDIN00469236AM25

ever, no such response| |received from CLA, Delhi even after repeated reminders. Therefore, it was decided to send a D.O. letter to|| |ADG, CLA, New Delhi in this regard.||

UDIN00469236AM25

Case No.<br>8 / NC/3/MEET/Sep/202425/9	Case No.<br>8 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>CROPNOSYS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/	9	and 10/10/2024
HQ File Number<br>HQRNORM REVIW00001803AM25
RA File Number<br>039404000527 AM19
Licence No and<br>Date<br>0310823957/24/09/2018
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to revise 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.
2-Amino-3-Chloro-5-Trifluoromethyl		1 kg.	1	2,3-Dichloro-5-trifluoromethyl	1.20 kg.
Pyridine Minimum 98% [F1]				Pyridine [DCTF]
RA concerned may take further necessary action as per above decision of NC.

fluoromethyl||1 kg.|1|2,3-Dichloro-5-trifluoromethyl|1.20 kg.|| |Pyridine Minimum 98% [F1]||||Pyridine [DCTF]||| |RA concerned may take further necessary action as per above decision of NC.|||||||

Case No.<br>9 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Deferred
Party Name<br>CIPLA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM REVIW00007594AM24
RA File Number<br>039404001019 AM19
Licence No and<br>Date<br>0310827414/01/03/2019
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to call the firm for attending
Personal Hearing<br>before Norms Committee to explain its case along with relevant documents.

UDIN00469236AM25

Case No.	10 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	VDH ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00008896AM24
RA File Number	052404000721 AM19
Licence No and<br>Date	0510410010/20/03/2019
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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.

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 META - CRESOL 0.9098 kg. MENTHONE 1 kg. 2 ISO PROPYL ALCOHOL 1.000 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	Case No.	11 / NC/3/MEET/Sep/202425/9	11 / NC/3/MEET/Sep/202425/9	11 / NC/3/MEET/Sep/202425/9	11 / NC/3/MEET/Sep/202425/9
Case Status			Case Approved
Party Name			CONCORD BIOTECH LIMITED
Meeting Number and Date			NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number			HQRNORM REVIW00008666AM24
RA File Number			082404000101 AM20
Licence No and Date			0810145581/27/06/2019
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl.<br>Qty.<br>Export Product<br>Qty.<br>Import Items
	Export Product	Qty.		Sl.	Import Items	Qty.

UDIN00469236AM25

m, whichever is less:- Sl. Qty. Export Product Qty. Import Items||||||| ||Export Product|Qty.||Sl.|Import Items|Qty.|

UDIN00469236AM25

No.<br>allowed.<br>Everolimus<br>(Powder Foam)<br>5 kg.<br>1<br>(3S,6R,7E,9R,10R,14S,15E,17E,19E,21S,23S,<br>26R,27R,34aS)- 9, 10, 12, 13, 14, 21, 22, 23, 24, 25,<br>26,27,32,33,34,34 a- Hexadecahydro<br>50.0 kg.<br>RA concerned may take further necessary action as per above decision of NC.			No.		allowed.
	Everolimus<br>(Powder Foam)	5 kg.	1	(3S,6R,7E,9R,10R,14S,15E,17E,19E,21S,23S,<br>26R,27R,34aS)- 9, 10, 12, 13, 14, 21, 22, 23, 24, 25,<br>26,27,32,33,34,34 a- Hexadecahydro	50.0 kg.

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

Case No.	12 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00008637AM24
RA File Number	039404000497 AM20
Licence No and<br>Date	0310831894/27/09/2019
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

r|039404000497 AM20| |Licence No and Date|0310831894/27/09/2019| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	13 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00008636AM24
RA File Number	039404000496 AM20
Licence No and<br>Date	0310831890/27/09/2019
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

UDIN00469236AM25

Case No.	14 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00000048AM25
RA File Number	318304000087 AM20
Licence No and<br>Date	3110067548/30/09/2019
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Difference in two types of export item DONOVA-BP838 and DONOVA-BP818 with its<br>chemical names and end use.<br>1.<br>Calculation of requirement of import items for both types of export item separately with<br>justification of different norms.<br>2.

with its** chemical names and end use. 1. Calculation of requirement of import items for both types of export item separately with justification of different norms. 2.||

Case No.	15 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00009300AM24
RA File Number	052404000670 AM20
Licence No and<br>Date	0510413367/17/01/2020
Norms Committee Decision:<br>Decision:The committee considered the request of firm for review/fixation of ad-hoc norms and as per the<br>advise of the TE, it was decided to call for following information/documents from the firm:-<br>Quantity and value of By-product “Dipentene”

Case No. 16 / NC/3/MEET/Sep/202425/9

9 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25

Case Status	Case Deferred
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00009301AM24
RA File Number	052404000729 AM20
Licence No and<br>Date	0510413656/19/02/2020
Norms Committee Decision:<br>Decision:The committee considered the request of firm for review/fixation of ad-hoc norms and as per<br>the advise of the TE, it was decided to call for following information/documents from the firm:-<br>Quantity and value of By-product “Dipentene”

review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Quantity and value of By-product “Dipentene”||

Case No.	Case No.	17 / NC/3/MEET/Sep/202425/9	17 / NC/3/MEET/Sep/202425/9	17 / NC/3/MEET/Sep/202425/9	17 / NC/3/MEET/Sep/202425/9	17 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number		HQRNORM REVIW00005893AM24
RA File Number		039504000017 AM21
Licence No and Date		0310835789/21/04/2020
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>MPL15723-DICYCLOVERINE<br>HYDROCHLORIDE-20<br>MG<br>TABLETS<br>1 Number<br>1<br>DICYCLOMINE HCL<br>20.40 mg.<br>MPL15716-DICYCLOVERINE<br>HYDROCHLORIDE-10<br>MG<br>TABLETS<br>1 Number<br>2<br>DICYCLOMINE HCL<br>10.20 mg.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty. allowed.
	MPL15723-DICYCLOVERINE<br>HYDROCHLORIDE-20<br>MG<br>TABLETS		1 Number	1	DICYCLOMINE HCL	20.40 mg.
	MPL15716-DICYCLOVERINE<br>HYDROCHLORIDE-10<br>MG<br>TABLETS		1 Number	2	DICYCLOMINE HCL	10.20 mg.

UDIN00469236AM25

E-20 MG TABLETS||1 Number|1|DICYCLOMINE HCL|20.40 mg.| ||MPL15716-DICYCLOVERINE HYDROCHLORIDE-10 MG TABLETS||1 Number|2|DICYCLOMINE HCL|10.20 mg.| ||||||||

UDIN00469236AM25

Case No.	18 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00009299AM24
RA File Number	052404000071 AM21
Licence No and<br>Date	0510414288/29/05/2020
Norms Committee Decision:<br>Decision:The committee considered the request of firm for review/fixation of ad-hoc norms and as per<br>the advise of the TE, it was decided to call for following information/documents from the firm:-<br>Quantity and value of By-product “Dipentene”

Case No.	19 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00000095AM24
RA File Number	522404000013 AM21
Licence No and<br>Date	5210043424/08/06/2020
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for<br>attendingPersonal Hearing<br>before Norms Committee to explain its case along with relevant documents<br>from the firm:

Case No.	20 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved

UDIN00469236AM25

efore Norms Committee to explain its case along with relevant documents from the firm:||

Case No.	20 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved

UDIN00469236AM25

Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00005894AM24
RA File Number	039504000137 AM21
Licence No and Date	0310836741/18/06/2020
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>MPL56212-CLINDAMYCIN<br>150MG HARD CAPSULES<br>1 Number<br>1<br>CLINDAMYCIN<br>HYDROCHLORIDE-<br>RA000907<br>176.21 mg.<br>MPL56213-CLINDAMYCIN<br>150MG HARD CAPSULES<br>1 Number<br>2<br>CLINDAMYCIN<br>HYDROCHLORIDE-<br>RA000907<br>176.21 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	21 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	KOSHA CHEMTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00000014AM25
RA File Number	039404000306 AM21
Licence No and<br>Date	0310837580/10/08/2020
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

UDIN00469236AM25

|Licence No and Date|0310837580/10/08/2020| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

UDIN00469236AM25

Case No.	22 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00004138AM23
RA File Number	092404000365 AM21
Licence No and<br>Date	0910069368/22/10/2020
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	23 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	MAC-CHEM PRODUCTS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00005491AM24
RA File Number	NA
Licence No and<br>Date	0311000185/17/12/2020
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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>Methyl<br>Prednisolone<br>Sodium<br>Succinate for Injection (Lyophilised<br>sterile Bulk)<br>1 kg.<br>1<br>6a-Methyl-11b,17a-dihydroxy-<br>1,4-pregnadiene-3,20-dione<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00469236AM25

k) 1 kg. 1 6a-Methyl-11b,17a-dihydroxy- 1,4-pregnadiene-3,20-dione 1.00 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00469236AM25

Case No.	24 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00000254AM24
RA File Number	03AA04011698 AM21
Licence No and<br>Date	0311000235/21/12/2020
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for<br>attending Personal Hearing<br>before Norms Committee to explain its case along with relevant documents<br>from the firm:

Case No.	25 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00008364AM24
RA File Number	05AA04025954 AM21
Licence No and<br>Date	0511001043/02/02/2021
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was observed that the firm has not<br>given the relevant details of both export items, therefore, it was decided to call the firm for attending<br>Personal Hearing<br>before Norms Committee to explain its case along with following information /<br>documents :-<br>Drug Manufacturing Licence (DML)<br>1.<br>Master-Batch Formula.<br>2.<br>Certificate of Analysis (CoA) of import item.<br>3.

ase along with following information / documents :- Drug Manufacturing Licence (DML) 1. Master-Batch Formula. 2. Certificate of Analysis (CoA) of import item. 3.||

Case No.	26 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	MAHIMA LIFESCIENCES PRIVATE LIMITED

14 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00000099AM25
RA File Number	05AA04029372 AM21
Licence No and<br>Date	0511001191/09/02/2021
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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>PREDNISOLONE MICRONISED<br>190 kg.<br>1<br>PREDNISOLONE<br>190 kg.<br>RA concerned may take further necessary action as per above decision of NC.

o.** Import Items Qty. allowed. PREDNISOLONE MICRONISED 190 kg. 1 PREDNISOLONE 190 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	27 / NC/3/MEET/Sep/202425/9	27 / NC/3/MEET/Sep/202425/9	27 / NC/3/MEET/Sep/202425/9	27 / NC/3/MEET/Sep/202425/9	27 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		CUTCH OIL AND ALLIED INDUSTRIES 1949 PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number		HQRNORM REVIW00000966AM24
RA File Number		02AA04007136 AM22
Licence No and Date		0211000893/05/07/2021
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>QUATERNARY AMMONIUM<br>SALT<br>REFINED<br>CLAY(SMECTONE<br>CLAY (ODF POWDER)<br>1 kg.<br>1<br>0.447 kg.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
	REFINED<br>CLAY(SMECTONE<br>CLAY (ODF POWDER)		1 kg.	1	QUATERNARY AMMONIUM<br>SALT	<br>0.447 kg.

||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||REFINED CLAY(SMECTONE CLAY (ODF POWDER)||1 kg.|1|QUATERNARY AMMONIUM SALT| 0.447 kg.|

Case No.	Case No.	27 / NC/3/MEET/Sep/202425/9	27 / NC/3/MEET/Sep/202425/9	27 / NC/3/MEET/Sep/202425/9	27 / NC/3/MEET/Sep/202425/9	27 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		CUTCH OIL AND ALLIED INDUSTRIES 1949 PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number		HQRNORM REVIW00000966AM24
RA File Number		02AA04007136 AM22
Licence No and Date		0211000893/05/07/2021
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>QUATERNARY AMMONIUM<br>SALT<br>REFINED<br>CLAY(SMECTONE<br>CLAY (ODF POWDER)<br>1 kg.<br>1<br>0.447 kg.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
	REFINED<br>CLAY(SMECTONE<br>CLAY (ODF POWDER)		1 kg.	1	QUATERNARY AMMONIUM<br>SALT	<br>0.447 kg.

UDIN00469236AM25

(Activity 75+1% as per CoA)

Import Items**|Qty. allowed.| ||REFINED CLAY(SMECTONE CLAY (ODF POWDER)||1 kg.|1|QUATERNARY AMMONIUM SALT| 0.447 kg.|

UDIN00469236AM25

(Activity 75+1% as per CoA)

Case No.	28 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	CUTCH OIL AND ALLIED INDUSTRIES 1949 PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00000967AM24
RA File Number	02AA04015335 AM22
Licence No and<br>Date	0211001003/28/07/2021
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>REFINED<br>CLAY<br>(SMECTONE<br>CLAY (ODF POWDER)<br>1 kg.<br>1<br>QUATERNARY AMMONIUM<br>SALT<br>(Activity 75+1% as per CoA)<br>0.447 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	29 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024

UDIN00469236AM25

NC/3/MEET/Sep/202425/9| |---|---| |Case Status|Case Deferred| |Party Name|KOPRAN RESEARCH LABORATORIES LIMITED| |Meeting Number|NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024|

UDIN00469236AM25

and Date
HQ File Number<br>HQRNORM APPLY 00192148AM22
RA File Number<br>03AA04091496 AM22
Licence No and<br>Date<br>0311007180/23/09/2021
Norms Committee Decision:
Decision:The Committee considered the request of firm for fixation of ad-hoc norms and it was observed
that during the Personal Hearing held on 16/05/2024, the firm was advised to furnish the following
information/documents, however, the same is still not received from the firm. Therefore, it was decided
that the firm may be given last chance to furnish the following documents:
Complete batch chemical reaction showing description of export and import item along with<br>i.
percentage yield on molar basis.
Certificate of Analysis (CoA) of import item to explain the complete description of import item<br>ii.
No.1.

i. Complete batch chemical reaction showing description of export and import item along with percentage yield on molar basis.
ii. Certificate of Analysis (CoA) of import item to explain the complete description of import item No.1.

description of export and import item along with percentage yield on molar basis.**

ii. Certificate of Analysis (CoA) of import item to explain the complete description of import item No.1.

Case No.	Case No.	30 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ	File Number	HQRNORM REVIW00001036AM25
RA File Number		56AA04005794 AM22
Licence No and<br>Date		5611000556/12/10/2021
Norms Committee		Decision:
Decision:The Committee considered the case as			per agenda	and it was decided to revise 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.
	Soya Lecithin Liquid Food Grade<br>1 kg.		1	Soya Lecithin Liquid	1.00 kg.
	(Non GMO)
RA	concerned may take further necessary action as		above decision of NC.

UDIN00469236AM25

a Lecithin Liquid Food Grade 1 kg.|||1|Soya Lecithin Liquid|1.00 kg.|| ||(Non GMO)||||||| |RA|concerned may take further necessary action as|||above decision of NC.||||

UDIN00469236AM25

Case No.<br>31 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Deferred
Party Name<br>ANANTA MEDICARE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM REVIW00008200AM24
RA File Number<br>05AA040108247 AM22
Licence No and<br>Date<br>0511006681/07/12/2021
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was observed that the firm has not
furnished the proper justification for enhancement of ad-hoc norms as earlier ad-hoc norms were fixed
based on the Annexure to Appendix-4E.Hence, the committee has decided to call the firm for attending
Personal Hearing<br>before Norms Committee to explain its case along with following information /
documents:-
Drug Manufacturing Licence with approved composition.<br>I.
Master-Batch Formula for each export.<br>II.
Certificate of Analysis of import item.<br>III.

Case No.<br>32 / NC/3/MEET/Sep/202425/9	Case No.<br>32 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>SUMAR BIOTECH LLP
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ	File Number<br>HQRNORM REVIW00000315AM25
RA File Number<br>08AX04000034 AM22
Licence No and<br>Date<br>0811003488/20/12/2021
Norms Committee Decision:
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<br>Qty.<br>Sl.	Import Items	Qty. allowed.
	No.

UDIN00469236AM25

Fosfomycin Calcium EP 1 kg. 1 Fosfomycin Phenethylamine 1.635 kg.

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

UDIN00469236AM25

Fosfomycin Calcium EP 1 kg. 1 Fosfomycin Phenethylamine 1.635 kg.

Case No.<br>33 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Deferred
Party Name<br>ANANTA MEDICARE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM REVIW00008265AM24
RA File Number<br>05AX04000189 AM22
Licence No and<br>Date<br>0511007079/21/12/2021
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was observed that the firm has not
furnish the proper justification for enhancement of ad-hoc norms as earlier ad-hoc norms were fixed
based on the Annexure to Appendix-4E. Hence, the committee has decided to call the firm for attending
Personal Hearing<br>before Norms Committee to explain its case along with following information /
documents from the firm:-
Drug Manufacturing Licence with approved composition.<br>I.
Master-Batch Formula for each export.<br>II.
Certificate of Analysis of import item.<br>III.

Case No.	34 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00293146AM22
RA File Number	34AX04000029 AM22
Licence No and<br>Date	3411001569/21/12/2021
Norms Committee Decision:

UDIN00469236AM25

and 10/10/2024| |HQ File Number|HQRNORM APPLY 00293146AM22| |RA File Number|34AX04000029 AM22| |Licence No and Date|3411001569/21/12/2021| |Norms Committee Decision:||

UDIN00469236AM25

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.
SORBIC ACID 50(ENCAPSULATED SORBIC	300 MT	1	SORBIC ACID	150.0 MT
ACID 50 WITH VEGETABLE FAT)
SORBIC ACID 85(ENCAPSULATED SORBIC	300 MT	2	SORBIC ACID	255.0 MT
ACID 85 WITH VEGETABLE FAT)

Case No.	35 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00005946AM24
RA File Number	05AX04000321 AM22
Licence No and<br>Date	0511007823/11/01/2022
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and as per the advise of Department of Bio-
Technology, it was decided to call the firm for attendingPersonal Hearing		<br>before Norms Committee to
explain its case along with relevant documents from the firm.

Case No.	36 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	GANGWAL HEALTHCARE PRIVATE LIMITED
Meeting Number
<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024

UDIN00469236AM25

202425/9| |---|---| |Case Status|Case Deferred| |Party Name|GANGWAL HEALTHCARE PRIVATE LIMITED| |Meeting Number|| | and Date|NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024|

UDIN00469236AM25

HQ File Number	HQRNORM APPLY 00356909AM22
RA File Number	03AX04001205 AM22
Licence No and<br>Date	0311011422/16/02/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was observed that the firm has given<br>CoA of many formulations which are not shown in Advance Authorisation. It is difficult to formulate a<br>view on the final norms. Therefore, it was decided to call the firm for attendingPersonal Hearing<br>before<br>Norms Committee to explain its case alongwith following documents:<br>Export description is vogue and does not indicate percentage DHA in export.<br>1.<br>Import item No.1 is confusing as it does not indicate percentage Assay.<br>2.<br>Whether import and export are Oil Powder. If so, please get the license amended as per 1 to 3<br>above.<br>3.

Whether import and export are Oil Powder. If so, please get the license amended as per 1 to 3 above.

il Powder. If so, please get the license amended as per 1 to 3** above. 3.||

Whether import and export are Oil Powder. If so, please get the license amended as per 1 to 3 above.

Case No.	37 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	GUPTA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00009287AM24
RA File Number	05AX04001230 AM22
Licence No and<br>Date	0511010862/10/03/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. 10/82-ALC4/2019 dated 29/11/2019against advance<br>authorizationNo. 0510403552 dated 01/08/2017, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP 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>CARVACROL<br>1 kg.<br>1<br>D-LIMONENE<br>(1 methyl-4-(1-methylenyel)-cyclobexene)<br>1.48 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00469236AM25

VACROL 1 kg. 1 D-LIMONENE (1 methyl-4-(1-methylenyel)-cyclobexene) 1.48 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00469236AM25

Case No.	38 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	GUPTA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00009288AM24
RA File Number	05AX04001267 AM22
Licence No and<br>Date	0511010970/14/03/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. 10/82-ALC4/2019 dated 29/11/2019against advance<br>authorizationNo. 0510403552 dated 01/08/2017, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP 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>CARVACROL<br>1 kg.<br>1<br>D-LIMONENE<br>(1 methyl-4-(1-methylenyel)-cyclobexene)<br>1.48 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	39 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	PROEC ENERGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00005029AM24
RA File Number	05AX04001262 AM22
Licence No and<br>Date	0511010975/14/03/2022
Norms Committee Decision:

UDIN00469236AM25

9 and 10/10/2024| |HQ File Number|HQRNORM REVIW00005029AM24| |RA File Number|05AX04001262 AM22| |Licence No and Date|0511010975/14/03/2022| |Norms Committee Decision:||

UDIN00469236AM25

Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:-

I. Stoichiometric balance between import and export on molar basis.
II. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.

o	Decision:The committee considered the re<br>f the TE, it was decided to call for followi<br>	Decision:The committee considered the re<br>f the TE, it was decided to call for followi<br>	Decision:The committee considered the re<br>f the TE, it was decided to call for followi<br>	Decision:The committee considered the re<br>f the TE, it was decided to call for followi<br>	quest of firm<br>ng informatio<br>	quest of firm<br>ng informatio<br>	quest of firm<br>ng informatio<br>	for fixat<br>n/docum<br>	ion of ad-hoc norms and<br>ents from the firm:-<br>	as per the advice	as per the advice
	Stoichiometric balance between im<br>I.<br>Complete chemical reactions with<br>along with stage wise percentage y<br>II.				port and exp<br>molecular an<br>ields on mola			ort on m<br>d struct<br>r basis.	olar basis.<br>ural formula and molec	ular weights

wise percentage y** II.||||port and exp molecular an ields on mola|||ort on m d struct r basis.|olar basis. ural formula and molec|ular weights|| ||||||||||||| ||||||||||||| |C|ase No.||40 / NC/3/MEET/Sep/202425||/9||||||| ||||||||||||| |C|ase Status||Case Approved||||||||| |P|arty Name||STERILE INDIA PRIVATE||LIMITED||||||| |M a|eeting Number nd Date||NC/ 3/ MEET/ Sep/ 202425/||9 and 10/10/20|||24|||| ||||||||||||| |H|Q File Number||HQRNORM APPLY 000017||20AM23||||||| |R|A File Number||33AX04000021 AM23||||||||| |L D|icence No and ate||3311000772/28/06/2022||||||||| |Norms Committee Decision: **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. Meropenem Sodium Sterile (Meropenem for injection ) 1 kg. 1 4-Nitrobenzyl (5S,6S)-3-(((3S,5S)-5- ((Dimethylamino) Carbonyl)- 1(((4nitrobenzyl) oxy) Carbonyl) pyrrolidinyl) sulfanyl]-6-((1R)-1- hydroxyethyl)-4-methyl-7-oxo-1- azabicyclo (3.2.0) hept2-ene-2- 0.8457 kg.|orms Committee Decision: **Decision:**The Committee considered the c Para 4.07 of HBP Vol.

]-6-((1R)-1- hydroxyethyl)-4-methyl-7-oxo-1- azabicyclo (3.2.0) hept2-ene-2- 0.8457 kg.|orms Committee Decision: **Decision:**The Committee considered the c Para 4.07 of HBP Vol. I as per details give Export Product Qty. Meropenem Sodium Sterile f ii 1 kg.||||ase as per ag n below or as||||||| |||||||||enda and applied|it was decided to fix ad- by the firm, whichever is|hoc norms under less:-|| |||Export Product||Qty.||**Sl. No. **|I||||| |||||||||mport It|ems||Qty. allowed.| |||Meropenem Sodium Sterile f ii||1 kg.||1|4 (|-Nitrobe (Dimeth|nzyl (5S,6S)-3-(((3S,5S ylamino) Carbon|)-5- yl)-|0.8457 kg.| |||(Meropenem or njecton )|||||1(((4nitrobenzyl) oxy) Carbonyl) pyrrolidinyl) sulfanyl]-6-((1R)-1- hydroxyethyl)-4-methyl-7-oxo-1- azabicyclo (3.2.0) hept2-ene-2-||||| ||||||||carboxylate||||| ||||||||||||| ||||||||||||| |RA concerned m|||ay take further necessary action as per above decision of NC.||||||||| ||||||||||||| ||||||||||||| |||||||||||||

UDIN00469236AM25

oxylate||||| ||||||||||||| ||||||||||||| |RA concerned m|||ay take further necessary action as per above decision of NC.||||||||| ||||||||||||| ||||||||||||| |||||||||||||

UDIN00469236AM25

Case No.<br>41 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Deferred
Party Name<br>GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00002221AM23
RA File Number<br>07AX04000559 AM23
Licence No and<br>Date<br>0711004755/23/07/2022
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice
of the TE, it was decided to call for following information/documents from the firm:-
To give chemistry of the reaction indicating molecular weight of both reactant and product.<br>i.
Yield of the reaction with end use of the export item.<br>ii.

Case No.	42 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00006414AM24
RA File Number	09AX04000207 AM23
Licence No and<br>Date	0911003443/05/08/2022
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

umber|09AX04000207 AM23| |Licence No and Date|0911003443/05/08/2022| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	43 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00002944AM23
RA File Number	07AX04000812 AM23
Licence No and	0711005159/05/09/2022

24 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25

Date

Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.1/NC/3/MEET/Dec/202223/15dated 29/12/2022 against advance authorization No. 0711004348 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:-

dvance authorization No. 0711004348 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:-

Date

Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.1/NC/3/MEET/Dec/202223/15dated 29/12/2022against advance authorizationNo. 0711004348 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 LACTATE GLUCONATE 1 kg. 1 GLUCONO DELTA LACTONE 0.755 kg. ZINC GLUCONATE (Eur.Ph/USP) 1 kg. 2 GLUCONO DELTA LACTONE 0.945 kg. MAGNESIUM GLUCONATE (Eur.Ph/USP) 1 kg. 3 GLUCONO DELTA LACTONE 0.945 kg. 4 GLUCONO DELTA LACTONE 0.930 kg. POTASSIUM GLUCONATE (USP) 1 kg. 8 POTASSIUM CARBONATE GRANULAR Deleted. FERROUS GLUCONATE (BP/EP/USP) 1 kg. 5 GLUCONO DELTA LACTONE 0.887 kg. MANGANESE GLUCONATE (Eur.Ph/USP) 1 kg. 6 GLUCONO DELTA LACTONE 0.945 kg. CALCIUM MAGNESIUM LACTATE GLUCONATE 1 kg. 7 GLUCONO DELTA LACTONE 0.831 kg. RA concerned may take further necessary action as per above decision of NC.

UDIN00469236AM25

ALCIUM MAGNESIUM LACTATE GLUCONATE 1 kg. 7 GLUCONO DELTA LACTONE 0.831 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00469236AM25

Case No.	Case No.	44 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ	File Number	HQRNORM REVIW00001037AM25
RA File Number		56AX04000172 AM23
Licence No and<br>Date		5611001168/15/09/2022
Norms Committee		Decision:
Decision:The Committee considered the case as per agenda				and it was decided to revise 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.
	Soya Lecithin Liquid Food Grade<br>1 kg.		1	Soya Lecithin Liquid	1.00 kg.
	(Non GMO)
RA	concerned may take further necessary action as per above decision of NC.

Qty. allowed.**|| ||Soya Lecithin Liquid Food Grade 1 kg.||1|Soya Lecithin Liquid|1.00 kg.|| ||(Non GMO)|||||| |RA|concerned may take further necessary action as per above decision of NC.||||||

Case No.<br>45 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Deferred
Party Name<br>KAVALIFE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00003326AM23
RA File Number<br>07AX04000884 AM23
Licence No and<br>Date<br>0711005312/23/09/2022
Norms Committee Decision:
Decision:The firm was called for Personal Hearing on 08.08.2024 through Video Conference but the firm
could not appear before Norms Committee. It was decided to grant one more opportunity to the firm for
Personal Haring<br>with relevant documents.

UDIN00469236AM25

Case No.<br>46 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Deferred
Party Name<br>BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00003358AM23
RA File Number<br>03AX04002988 AM23
Licence No and<br>Date<br>0311018145/25/09/2022
Norms Committee Decision:
Decision:The Committee considered the request of firm for fixation of ad-hoc norms and it was observed
that during the Personal Hearing held on 05/03/2024, the firm informed that they are getting many
intermediates manufactured by their supporting manufacturer, details for which was not given.

ved| |that during the Personal Hearing held on 05/03/2024, the firm informed that they are getting many| |intermediates manufactured by their supporting manufacturer, details for which was not given. The firm| |also could not explain the confusion raised by committee in the yields claim in the process. Keeping the| |above issued in mind the firm stated that they would come with revised application and revised license.| |However, the firm still not submitted the same. Therefore, it was decided that the firm may be given last| |chance to furnish the revised application and license.|

Case No.	47 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	VASISTA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004049AM23
RA File Number	09AX04000675 AM23
Licence No and<br>Date	0911003903/03/11/2022
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise
of the TE, it was	decided to call for following information/documents from the firm:-
Item of import is a solvent, please indicate total quantity used in the process to manufacturing<br>1.
1 kg. of export and recovery of Tetra Hydro Furan duly certified byChartered Chemical
Engineer.

Item of import is a solvent, please indicate total quantity used in the process to manufacturing 1 kg. of export and recovery of Tetra Hydro Furan duly certified byChartered Chemical Engineer.

Item of import is a solvent, please indicate total quantity used in the process to manufacturing 1 kg. of export and recovery of Tetra Hydro Furan duly certified byChartered Chemical Engineer.

27 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25


C	ase No.	48 / NC/3/MEET/Sep/202	425/9
C	ase Status	Case Deferred
P
	arty Name	AURORE LIFE SCIENC	S PRIVATE L	IMITED
M<br>an	eeting Number<br>d Date	NC/ 3/ MEET/ Sep/ 20242	5/ 9 and 10/10/	2024
H	Q File Number	HQRNORM APPLY 0000	4071AM23
R	A File Number	09AX04000645 AM23
Licence No and<br>Date		0911003906/04/11/2022
Norms Committee Decision:<br>
Decision:The case is under consideration and TE was requested to expedite his comments.



Case No		49 / NC/3/MEET/Sep/202425/9
.
Case Status		Case Approved

Party Name		AMARA LABS PRIVATE LIMITED
Mi Nb
eetng umer<br>and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024

HQ File Number		HQRNORM APPLY 00004072AM23

RA File Number		09AX04000646 AM23
Li N d
cence o an<br>Date		0911003907/04/11/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>

|||| |cence o an Date||0911003907/04/11/2022||||| |Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for ||||||| |same export product/import item in meetingNo.NC/3/MEET/Dec/202324/19 dated 05/01/2024against advance authorizationNo.0911001711dated 13/10/2021, 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:-||||||| |||||||| |||||||| ||Et Pd|t|Qt|Sl N|It It|Qt lld| ||xpor ro|uc|y.|. o.|mpor ems|y. aowe.| ||DEFERIPRO|NE|1 kg.|1|Maltol|1.26 kg.| |||||||| |||||||| |||||||| |RA concerned m||ay take further necessary action as per above decision of NC.||||| ||||||||

UDIN00469236AM25


Case No.		50 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		BILAT IGREIA LIMITED
	y Name	JUN N
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Sep/	202425/ 9 and 10/10/2	024
HQ	File Number	HQRNORM APPLY	00004212AM23
RA	File Number	05AX04002149 AM	23
Lic<br>Dat	ence No and<br>e	0511015679/09/11/2	022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Apr/202425/1 dated 10/04/2024against<br>advance authorization**No.

d the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo. NC/3/MEET/Apr/202425/1 dated 10/04/2024against advance authorizationNo. 0311008816 dated 24/11/2021, 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:-|ms Committee Decision:||||||||||| ||||||||||||| ||Export Product|||Qty.||Sl. No.||Import Items||Qty. allowed.|| ||||||||||||| ||||||||||||| ||Propionic An|hydride||1 kg.||1||Propionic Acid||1.15 kg.|| ||||||||||||| |||||||2||Acetic Acid Glacial||0.543 kg.|| ||||||||||||| ||||||||||||| |**Note:**Norms C||ommittee also decided to make Standard Input Output Norms (SION) for the above export|||||||||| | products based|| on ad-hoc norms.|||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||| ||||||||||||| |Cas|e No.|51 / NC/3/MEET/Sep/2024|||25/9||||||| |Cas|e Status|Case Approved|||||||||| |Par|||||||||||| ||y Name|VACHICHEM INTERNA|||TIONAL|RIVATE LI||ITED|||| |Me and|eting Number Date|NC/ 3/ MEET/ Sep/ 20242|||5/ 9 and 1|0/10/2024|||||| |HQ|File Number|HQRNORM APPLY 0000|||4219AM2|3|||||| |RA|File Number|07AX04001122 AM23|||||||||| |Lic Dat|||||||||||| ||ence No and e|0711005637/09/11/2022|||||||||| |Nor|ms Committee Decision:|||||||||||

r|HQRNORM APPLY 0000|||4219AM2|3|||||| |RA|File Number|07AX04001122 AM23|||||||||| |Lic Dat|||||||||||| ||ence No and e|0711005637/09/11/2022|||||||||| |Nor|ms Committee Decision:|||||||||||

Case No.	51 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	VACHICHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004219AM23
RA File Number	07AX04001122 AM23
Licence No and<br>Date	0711005637/09/11/2022
Norms Committee Decision:

UDIN00469236AM25

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Apr/202324/1 dated 28/04/2023 against advance authorization No. 0711006018 dated 26/12/2022, 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:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
6-(2-PROPENY)-ERGOLINE-8-	1 kg.	1	LYSERGOL (9,10 DIDEHYDRO 6	2.98 kg.
CARBOXYLIC ACID CAS NO			METHYLERGOLINE -8B-
81409-74-7			METHANOL CAS NO 602-85-7)

-|---|---|---| |||||allowed.| |6-(2-PROPENY)-ERGOLINE-8-|1 kg.|1|LYSERGOL (9,10 DIDEHYDRO 6|2.98 kg.| |CARBOXYLIC ACID CAS NO|||METHYLERGOLINE -8B-|| |81409-74-7|||METHANOL CAS NO 602-85-7)||

Case No.<br>52 / NC/3/MEET/Sep/202425/9	Case No.<br>52 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>RAJASTHAN ANTIBIOTICS	LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00004250AM23
RA File Number<br>05AX04002186 AM23
Licence No and<br>Date<br>0511015716/09/11/2022
Norms Committee Decision:
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<br>Qty.	Sl. No.	Import Items	Qty.
			allowed.
Imipenem and Cilastatin for<br>1 kg.	1	Cilastatin Acid	0.489 kg.
injection USP(Sterile Bulk)
	2	Imipenem Monohydrate Non Sterile	0.576 kg.
RA concerned may take further necessary action as per above decision of NC.

UDIN00469236AM25

kg.|| |injection USP(Sterile Bulk)||||| ||2|Imipenem Monohydrate Non Sterile|0.576 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

UDIN00469236AM25


Case No.		53 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number and Date
	eting Number and Date	N	/ 3/ MEET/ Sep			/ 202425/ 9 an		d 10/10/2024
HQ	File Number	H	QRNORM REVI			W00008380A		M24
RA	File Number	09	AX04000689 A			M23

Lic	ence No and Date	09	11003913/09/11			/2022
Nor<br>De<br>Pa<br>	ms Committee Decision:<br>cision:The Committee c<br>ra 4.07 of HBP Vol. I as		onsidered the c<br>per details give
						ase as per ag<br>n below or a		enda and it was decided to fix ad-<br>s applied by the firm, whichever i	hoc norms under<br>s less:-

	Export Product			Qty.		Sl. No.	I	mport Items	Qty. allowed.

	BENZOPHENONE-3			1 kg.		1	R	ESORCINOL	0.60 kg.

					2		BENZOTRICHLORIDE		1.07 kg.

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

|BENZOPHENONE-3|||1 kg.||1|R|ESORCINOL|0.60 kg.| ||||||||||| ||||||2||BENZOTRICHLORIDE||1.07 kg.| ||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||



C N			54 / NC/3/MEET/S/202425/9
ase o.			ep
C Stt			C Ad
ase aus			ase pprove
Party Name			ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED

Meeting Number an<br>Dt		d	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
ae
HQ Fil Nb			HQRNORM APPLY 00004258AM23
e umer
RA File Number			03AX04003990 AM23

Licence No and Date			0311019120/10/11/2022
Norms Committee Decision:<br>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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product			Qty.	Sl. No.	Import Items	Qty. allowed.
		<br>
	PARACETA<br>	MOL<br>COATED<br>		1 kg.	1	PARACETAMOL EP	0.9018 kg.
	GRANULES	(89.29%)

UDIN00469236AM25

No.**|Import Items|Qty. allowed.| ||| |||||| ||PARACETA |MOL COATED ||1 kg.|1|PARACETAMOL EP|0.9018 kg.| ||GRANULES|(89.29%)|||||| ||||||||| |||||||||

UDIN00469236AM25

Case No.	55 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004409AM23
RA File Number	03AX04003954 AM23
Licence No and<br>Date	0311019281/17/11/2022
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and it has been
observed that composition of export item in DML is not readable. Hence, it was decided that the firm may
be advised to give clear copy of DML.

Case No.<br>56 / NC/3/MEET/Sep/202425/9	Case No.<br>56 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>ENVEE DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00004428AM23
RA File Number<br>34AX04000741 AM23
Licence No and<br>Date<br>3411003006/17/11/2022
Norms Committee Decision:
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.

ate 3411003006/17/11/2022||||| |Norms Committee Decision:||||| |**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.|Import Items|Qty.|| ||No.||allowed.|| |DEXAMETHASONE 1 kg.|1|16 ALFA METHYL EXOXIDE 8DM|0.811 kg.|| |(IP/ BP/ USP)||||| ||||||

UDIN00469236AM25

Case No.	57 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004437AM23
RA File Number	03AX04003955 AM23
Licence No and<br>Date	0311019320/18/11/2022
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and it has been<br>observed that composition of export item in DML is not readable. Hence, it was decided that the firm may<br>be advised to give clear copy of DML

m for fixation of ad-hoc norms and it has been observed that composition of export item in DML is not readable. Hence, it was decided that the firm may be advised to give clear copy of DML||

Case No.	Case No.	58 / NC/3/MEET/Sep/202425/9	58 / NC/3/MEET/Sep/202425/9	58 / NC/3/MEET/Sep/202425/9	58 / NC/3/MEET/Sep/202425/9	58 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		BIOLOGICAL E. LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number		HQRNORM APPLY 00004512AM23
RA File Number		09AX04000684 AM23
Licence No and<br>Date		0911003996/21/11/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per comments of Deptt. of Bio-Technology, it was<br>decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>HEPARIN SODIUM BP/USP<br>100 kg.<br>1<br>HEPARIN SODIUM CRUDE<br>(BOVINE ORIGIN)<br>114 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	HEPARIN SODIUM BP/USP		100 kg.	1	HEPARIN SODIUM CRUDE<br>(BOVINE ORIGIN)	114 kg.

UDIN00469236AM25

Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||HEPARIN SODIUM BP/USP||100 kg.|1|HEPARIN SODIUM CRUDE (BOVINE ORIGIN)|114 kg.| ||||||||

UDIN00469236AM25

RA	concerned may take further necessary acti	concerned may take further necessary acti	concerned may take further necessary acti	concerned may take further necessary acti	on as per	on as per	above de


Cas	e No.		59 / NC/3/MEET/Sep/20		2425/9
Cas	e Status		Case Approved
Par	ty Name		AUROBINDO PHARM		A LTD
Meeting Number and<br>Date	eting Number and<br>e		NC/ 3/ MEET/ Sep/ 2024		25/ 9 and 1		0/10/2024

HQ File Number			HQRNORM APPLY 00004509AM23
RA File Number			09AX04000587 AM23
Licence No and Date			0911003994/21/11/2022

Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	E P					Sl<br>	I I	lld
	xport ro	uct		Qty.		.<br>N<br>	mport tems	**Qty.

ven below or as applied by the firm, whichever is less:-||||||||||||||| ||E P|||||Sl ||I I|||||lld|| ||xport ro|uct||Qty.||. N ||mport tems|||||Qty. aowe.|| |||||||o.||||||||| ||Clavamox Dr|ops 62.50 mg/mL|| 1008000||1 ||Amoxicillin Trihydrate|||||885.00 kg.|| ||- 15 mL Bott|le(Amoxicillin/||Numbers||||||||||| |||||||||||||||| ||Clavulanic A|cid 50/12.5||||2 ||Pti Cllt diltd|||||45930 k|| ||mg/mL (Eac |h mL contains |||| ||oassum avuanae ue with Silicon Dioxide (Syloid)(1:1)|||||. g.|| |RA|Amoxicillin Trihydrate equivalent to Amoxicillin 50 mg and Clavulanate potassium syloid Blend 1:1 equivalent to Clavulanic acid 12.5mg))||| ||||||||||| ||concerned may take further necessary action as per above decision of NC.|||||||||||||| |||||||||||||||| |||||||||||||||| |Cas|e No.||60 / NC/3/MEET/Sep/20242||||5/9|||||||| |Cas|e Status||Case Approved|||||||||||| |Par|ty Name||PUNISKA HEALTHCARE||||PRIVATE LIM||ITED|||||| |Me Dat|eting Number and e||NC/ 3/ MEET/ Sep/ 202425/||||9 and 10/10/20||24|||||| |HQ|File Number||HQRNORM APPLY 000045||||22AM23|||||||| ||||||||||||||||

Case No.	60 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004522AM23

UDIN00469236AM25

UDIN00469236AM25

RA File Number<br>08AX04001395 AM23
Licence No and Date<br>0811006510/22/11/2022
Norms Committee Decision:
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<br>Qty.<br>Sl. No. Import Items	Qty. allowed.
Levoleucovorin Injection 175<br>6900<br>1<br>CALCIUM LEVOFOLINATE	1.35 kg.
mg/17.5 mL (10 mg/mL)<br>Numbers<br>CONFORMING TO EP
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>61 / NC/3/MEET/Sep/202425/9	Case No.<br>61 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>AUROBINDO PHARMA LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00004555AM23
RA File Number<br>09AX04000691 AM23
Licence No and<br>Date<br>0911004009/23/11/2022
Norms Committee Decision:
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.

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.|| |Acebutolol Tablets 200|1 Number|1|Acebutolol Hydrochloride|221.698 mg|| |mg([Each film coated tablet|||Ph.Eur||| |contains Acebutolol|||||| |Hydrochloride Ph.Eur equivalent|||||| |toAcebutolol 200mg])|||||| |Acebutolol Tablets 400|1 Number|2|Acebutolol Hydrochloride|443.396 mg|| |mg([Each film coated tablet|||Ph.Eur||| |contains Acebutolol|||||| |Hydrochloride Ph.Eur equivalent||||||

UDIN00469236AM25

toAcebutolol 400mg])

Case No.<br>62 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00004575AM23
RA File Number<br>31AX04000236 AM23
Licence No and Date<br>3111001838/24/11/2022
Norms Committee Decision:
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<br>Qty.<br>**Sl.

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.|| |1 METFORMIN HYDROCHLORIDE 1 kg.|DICYANDIAMIDE (DCDA)|0.484 kg.|| |DIRECT COMPRESSIBLE|WHITE POWDER||| |GRANULES 86.66% W/W WHITE|||| |GRANULESPOWDER 2|SODIUM STARCH|0.034 kg.|| ||GLYCOLATE WHITE||| ||POWDER||| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	63 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	NICHINO INDIA PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004577AM23
RA File Number	09AX04000753 AM23
Licence No and Date	0911004012/24/11/2022
Norms Committee Decision:

UDIN00469236AM25

ion:** 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.	Import Items	Qty.
		No.		allowed.
SOD {N-(1,1-DIMETHYL-2-	1 kg.	1	Phthaloyl dichloride (PDC) -	0.469 kg.
METHYLSULFINYLETHY)-N-{2-			98% min.
METHYL-4-{1,2,2,2- TETRAFLUORO-1-
{TRIFLUOROMETHYL)ETHYL]PHENYL		2	2-methyl-1-methylthio-	0.309 kg.
PHTHALAMI(NA)			propan-2-amine (SAA) -
			95% min.
		3	2-Methyl-4-	0.5645 kg.
			heptafluoroisopropyl aniline
			[RFA]-96% min.

Case No.<br>64 / NC/3/MEET/Sep/202425/9	Case No.<br>64 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>VIRCHOW DRUGS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00004590AM23
RA File Number<br>09AX04000666 AM23
Licence No and Date<br>0911004017/24/11/2022
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo. NC/3/MEET/Apr/202324/1dated28/04/2023against
advance authorizationNo. 0711006018dated	26/12/2022,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:-
Export Product<br>Qty.<br>Sl. No.	Import Items	**Qty.

ix 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 TELMISARTAN 1 kg.|2-N-PROPYL-4-METHYL-6-(1-|0.621 kg|| ||METHYLBENZIMIDAZOLE-2-YL)||| ||BENZIMIDAZOLE|||

UDIN00469236AM25

2	2-CYANO-4-METHYLBIPHENYL(OTBN)	0.630 kg.
3	Acetone	0.20 kg.
4	Sodium Hydroxide Flakes	0.60 kg.
5	n-Butanol	0.80 kg.
6	Methanol	2.80 kg.
7	Acetic Acid	0.89 kg.
8	Potassium Hydroxide Flakes (KOH flakes)	0.185 kg.
9	Methylene Chloride	0.50 kg.

droxide Flakes|0.60 kg.| ||||5|n-Butanol|0.80 kg.| ||||6|Methanol|2.80 kg.| ||||7|Acetic Acid|0.89 kg.| ||||8|Potassium Hydroxide Flakes (KOH flakes)|0.185 kg.| ||||9|Methylene Chloride|0.50 kg.|

Case No.	Case No.	65 / NC/3/MEET/Sep/202425/9	65 / NC/3/MEET/Sep/202425/9	65 / NC/3/MEET/Sep/202425/9	65 / NC/3/MEET/Sep/202425/9	65 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		NICHINO INDIA PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number		HQRNORM APPLY 00004625AM23
RA File Number		09AX04000754 AM23
Licence No and Date		0911004025/28/11/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>PHTHALOYI DICHLORIDE<br>(PDC)<br>0.469 kg.<br>SOD {N-(1,1-DIMETHYL-2-<br>METHYLSULFINYLETHY)-N?{2-<br>1 kg.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
	SOD {N-(1,1-DIMETHYL-2-<br>METHYLSULFINYLETHY)-N?{2-		1 kg.	1	PHTHALOYI DICHLORIDE<br>(PDC)	0.469 kg.

UDIN00469236AM25

y.**|Sl. No.|Import Items|Qty. allowed.| ||SOD {N-(1,1-DIMETHYL-2- METHYLSULFINYLETHY)-N?{2-||1 kg.|1|PHTHALOYI DICHLORIDE (PDC)|0.469 kg.|

UDIN00469236AM25

2<br>2. 2-METHYL-1-<br>METHYLTHIO-PROPAN-2-<br>AMINE (SAA)<br>0.309 kg.<br>METHYL-4-{1,2,2,2-TETRAFLUORO-1-<br>{TRIFLUOROMETHYL)ETHYL]PHENYL<br>PHTHALAMID(NA)<br>3<br>2-METHYL-4-<br>HEPTAFLUOROISOPROPYL<br>ANILINE((RFA) 96% MIN<br>0.5645 kg.<br>RA concerned may take further necessary action as per above decision of NC.	METHYL-4-{1,2,2,2-TETRAFLUORO-1-<br>{TRIFLUOROMETHYL)ETHYL]PHENYL<br>PHTHALAMID(NA)		2	2. 2-METHYL-1-<br>METHYLTHIO-PROPAN-2-<br>AMINE (SAA)	0.309 kg.
			3	2-METHYL-4-<br>HEPTAFLUOROISOPROPYL<br>ANILINE((RFA) 96% MIN	0.5645 kg.

Case No.	66 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004648AM23
RA File Number	09AX04000768 AM23
Licence No and<br>Date	0911004035/28/11/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|09AX04000768 AM23| |Licence No and Date|0911004035/28/11/2022| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	67 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004687AM23
RA File Number	09AX04000763 AM23
Licence No and<br>Date	0911004042/29/11/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

UDIN00469236AM25

Case No.	68 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004728AM23
RA File Number	03AX04004201 AM23
Licence No and Date	0311019658/01/12/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Dec/202324/17dated20/12/2023against<br>advance authorizationNo. 0311017046 dated 10/08/2022,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP 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.

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 2N-PROPYL-4-METHYL-6-(1-METHYL- BENZIMIDAZOL-2-YL)BENZIMIDAZOLE 0.621 kg. 2 4-METHYL-2-BIPHENYL CARBOXYLIC ACID METHYL ESTER 0.60 kg. 3 METHANOL 3.69 kg. 4 METHYLENE CHLORIDE 2.20 kg. TELMISARTAN 1 kg. 5 ACETIC ACID GLACIAL 0.90 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	69 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00004798AM23

UDIN00469236AM25

RA File Number<br>03AX04004191 AM23
Licence No and<br>Date<br>0311019737/03/12/2022
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo. NC/3/MEET/Jan/202324/21dated24/01/2024against
advance authorizationNo. 0311023793 dated 23/05/2023,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<br>Qty.<br>Sl. No.	Import Items	**Qty.

x 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 1 Number 1|Liothyronine sodium|5.10 MCG per 5 MCG|| |MCG TABLETS||Tablet|| |LIOTHYRONINE SODIUM 1 Number 2|Liothyronine sodium|10.20 MCG per 10 MCG|| |10 MCG TABLETS||Tablet|| |LIOTHYRONINE SODIUM 1 Number 3|Liothyronine sodium|20.40 MCG per 20 MCG|| |20 MCG TABLETS||Tablet|| |RA concerned may take further necessary action as per|above decision of NC.|||

Case No.<br>70 / NC/3/MEET/Sep/202425/9	Case No.<br>70 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ	File Number<br>HQRNORM APPLY 00004828AM23
RA File Number<br>09AX04000798 AM23
Licence No and<br>Date<br>0911004095/06/12/2022
Norms Committee Decision:
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<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.

UDIN00469236AM25

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.||

UDIN00469236AM25

1	Dihydronopol	0.60 kg.,
2	2-bromo-4,5-dimethoxy benzyl bromide	1.00 kg.
3	Acetone	1.00 kg.
4	Toulene	0.90 kg.

Case No.	71 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00006136AM24
RA File Number	52AX04001711 AM23
Licence No and<br>Date	5211003710/07/12/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Hearing<br>before Norms Committee to explain its case along with relevant documents from the firm.		Personal

e case as per agenda and it was decided to call the firm for attending Hearing before Norms Committee to explain its case along with relevant documents from the firm.||Personal| ||||

Case No.	72 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM REVIW00006412AM24
RA File Number	09AX04000649 AM23
Licence No and<br>Date	0911004131/08/12/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for attending		Personal

UDIN00469236AM25

Hearing before Norms Committee to explain its case alongwith relevant documents from the firm.

<br>	<br>
Hearing<br>before No		rms Committee to explain its case alongwith relevant documents from the firm.


Case No.			73 / NC/3/MEET/Sep/202425/9
Case Status			Case Approved
Par	ty Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED
Me	eting Number and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ	File Number		HQRNORM AP	PLY 000049	43AM23
RA	File Number		03AX04004593	AM23
Lic	nce No and Date		0311019936/12/	2/2022

Sep/ 202425/ 9 and 10/10/2024|||||||| |HQ||File Number||HQRNORM AP||PLY 000049|43AM23||||| |RA||File Number||03AX04004593||AM23|||||| |Lic||nce No and Date||0311019936/12/||2/2022|||||| ||||||||||||| |Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo. NC/3/MEET/Apr/202425/2dated30/04/2024against advance authorization No. 0311024276 dated 06/06/2023,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:- ||ms Committee Decision: cision:The Committee considered the duct/imort item in meetinNo NC||||case as per a 3/MEET/A|genda and t r/202425/||aking cue from the earlier decisi 2dated30/04/2024aainst adv|on for same export ance authorization|| ||||||||||||| ||Export Product||||Qty.||Sl. No.|Import Items|||**Qty.

king cue from the earlier decisi 2dated30/04/2024aainst adv|on for same export ance authorization|| ||||||||||||| ||Export Product||||Qty.||Sl. No.|Import Items|||Qty. allowed.| ||Carbamazepine Extended-Release Tablets USP 100 mg.(Each tablet ||||1 Number||1|Carbamazepine|||102.00 mg.| ||||||||||||| ||contains (i) Carb ||amazepine 100 mg. ||||2|Cellulose Acetate (CA-320S) Eastman|||29.20 mg.| ||(ii) CelluloseAc Eastman 3504||tate (CA-320S) - (iii) Eastman (TM||||||||| ||. Cellulose Acetat||g. e (CA 398-10NF/EP)-||||||||| || 5.28 mg Net con 262.80Kg (iii) 3|| tent (i) 750 Kg (ii) 9.60 Kg.)||||3|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|||4.40 mg.| ||||||||||||| ||Cbi||ddRl||1 Nb||4|Cbi|||20400| ||aramazepne Tablets USP 200 contains (i) Carb||xtene-eease mg.(Each tablet amazeine 200 m||umer|||aramazepne|||. mg.| ||||||||||||| ||p g. (ii) CelluloseAcetate(CA-320S)- Eastman35.04mg. (iii)Eastman(TMCelluloseAcetate (CA398-10NF/EP)-5.28mg Ni530k ii9286Kiii||||||5|Cellulose Acetate (CA-320S) Eastman|||29.20 mg.| ||||||||6|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|||4.40 mg.| ||etcontent()g ().g() 13.99 Kg.)||||||||||| ||Carbamazepine Extended-Release ||||1 Number||7|Carbamazepine|||408.00 mg.| ||Tablets USP 40 ti i C||mg.(Each tablet i 400||||||||| ||||||||||||| ||conans () ar (ii) CelluloseAc||amazepne mg. tate(CA-320S)-||||8|Cellulose Acetate (CA-320S) Eastman|||29.20 mg.| || ~~Eastman26.28m~~|| g.||||||||| |||||||||||||

| ||||||||||||| ||conans () ar (ii) CelluloseAc||amazepne mg. tate(CA-320S)-||||8|Cellulose Acetate (CA-320S) Eastman|||29.20 mg.| || ~~Eastman26.28m~~|| g.||||||||| |||||||||||||

43 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-11-2024 11:09:20.

UDIN00469236AM25

(iii)Eastman(TMCellulose<br>Acetate(CA398-10NF/EP)-3.96mg<br>Netcontent(i)660 Kg.(ii)43.36Kg(ii)<br>6.53 Kg.)<br>9<br>EASTMAN (TM) CELLULOSE<br>ACETATE (CA 398-10NF/EP)<br>4.40 mg.<br>RA concerned may take further necessary action as per above decision of NC.	(iii)Eastman(TMCellulose<br>Acetate(CA398-10NF/EP)-3.96mg<br>Netcontent(i)660 Kg.(ii)43.36Kg(ii)<br>6.53 Kg.)		9	EASTMAN (TM) CELLULOSE<br>ACETATE (CA 398-10NF/EP)	4.40 mg.

Case No.	74 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005018AM23
RA File Number	09AX04000828 AM23
Licence No and<br>Date	0911004164/15/12/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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.

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 Dihydronopol 0.60 kg., 2 2-bromo-4,5-dimethoxy benzyl bromide 1.00 kg. 3 Acetone 1.00 kg. Pinaverium Bromide 1 kg. 4 Toulene 0.90 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	75 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved

UDIN00469236AM25

Part	y Name	PUNISKA HEA	PUNISKA HEA	LTHCARE PRI	LTHCARE PRI	VATE LIM	ITED
Me	eting Number and Date	NC/ 3/ MEET/ S		ep/ 202425/ 9 an		d 10/10/20	24
HQ	File Number	HQRNORM AP		PLY 00005247A		M23
RA	File Number	08AX04001457		AM23
Licence No and Date
		0811006828/23/12/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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>DEXAMETHASONE<br>SODIUM PHOSPHATE<br>INJECTION, USP 10<br>MG/ML,1 ML<br>1 Number<br>1<br>DEXAMETHASONE SODIUM<br>PHOSPHATE<br>11.76 mg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.		Sl. No.	Import Items		**Qty.

ETHASONE SODIUM PHOSPHATE 11.76 mg RA concerned may take further necessary action as per above decision of NC.|||||||||| ||Export Product||Qty.||Sl. No.|Import Items|||Qty. allowed.| ||DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 10 MG/ML,1 ML||1 Number||1|DEXAMETHASONE SODIUM PHOSPHATE|||11.76 mg|

Case No.	Case No.	76 / NC/3/MEET/Sep/202425/9	76 / NC/3/MEET/Sep/202425/9	76 / NC/3/MEET/Sep/202425/9	76 / NC/3/MEET/Sep/202425/9	76 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number		HQRNORM APPLY 00005300AM23
RA File Number		09AX04000869 AM23
Licence No and<br>Date		0911004207/26/12/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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>Dihydronopol<br>0.60 kg.,<br>2<br>2-bromo-4,5-dimethoxy benzyl bromide<br>1.00 kg.<br>Pinaverium Bromide<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Pinaverium Bromide		1 kg.	1	Dihydronopol	0.60 kg.,
				2	2-bromo-4,5-dimethoxy benzyl bromide	1.00 kg.

UDIN00469236AM25

	3	Acetone	1.00	kg.
	4	Toulene	0.90	kg.

verium Bromide||1 kg.|1|Dihydronopol|0.60 kg.,| |||||2|2-bromo-4,5-dimethoxy benzyl bromide|1.00 kg.|

UDIN00469236AM25

	3	Acetone	1.00	kg.
	4	Toulene	0.90	kg.

Case No.	Case No.	77 / NC/3/MEET/Sep/202425/9	77 / NC/3/MEET/Sep/202425/9	77 / NC/3/MEET/Sep/202425/9	77 / NC/3/MEET/Sep/202425/9	77 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024

HQ File Number		HQRNORM APPLY 00005317AM23

RA File Number		07AX04001362 AM23

Licence No and<br>Date		0711006024/27/12/2022

Norms Committee		Decision:

Decision:The C<br>same export pro		ommittee considered the case as per agenda and taking cue from the earlier decision for<br>duct/import item in meetingNo. NC/3/MEET/Jun/202425/6dated01/07/2024against
advance authorizationNo. 0711008971 dated 16/08/2023,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP 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>ASCORBIC ACID DC 97<br>63.087 mg.<br>FERROUS FORTE TABLETS<br>1 Number
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

Sl. No. Import Items Qty. allowed. 1 ASCORBIC ACID DC 97 63.087 mg. FERROUS FORTE TABLETS 1 Number||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||FERROUS FORTE TABLETS||1 Number|1|ASCORBIC ACID DC 97|63.087 mg.| ||(Vitamin C (as Ascorbic Acid) - 71mg (248.500 KGS) +Iron (From Ferrous Bisglycinate || ||Percentage -SF. I.H|| |||||2|IRON BISGLYCINATE|122.400 mg.| ||Chelate- 126m |g (441.000 KGS | |||| ||With Other E Mil|sential Vitamins f Tb3500000||||| ||neras (No o|as-))||||| |RA concerned m||||||| |||ay take further necessary action as||per above decision of NC.||| |||||||| |||||||| |||||||| |||||||| |Case No.||78 / NC/3/MEET/Sep/202425/9|||||

Case No. 78 / NC/3/MEET/Sep/202425/9

UDIN00469236AM25

Case Status<br>Case Approved
Party Name<br>CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00005335AM23
RA File Number<br>31AX04000284 AM23
Licence No and<br>Date<br>3111001917/27/12/2022
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo. NC/3/MEET/Jun/202425/5dated	14/06/2024against
advance authorizationNo. 3111001703 dated 20/09/2022,it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol.

em in meetingNo. NC/3/MEET/Jun/202425/5dated|14/06/2024against||| |advance authorization**No. 3111001703 dated 20/09/2022,**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.|| |CYANAMIDE 50% SOLUTION 1 kg. 1 CALCIUM CYANAMIDE||1.913 kg.|| |(Purity 63% as per CoA)|||| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.<br>79 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>SRF LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00005387AM23
RA File Number<br>05AX04002796 AM23
Licence No and<br>Date<br>0511016607/28/12/2022
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo. NC/3/MEET/Jul/202425/7dated06/08/2024against
advance authorizationNo. 0511013648 dated 07/07/2022,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<br>Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00469236AM25

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.||

UDIN00469236AM25

PBA - (4-CHLORO 2-FLUORO 3-	PBA - (4-CHLORO 2-FLUORO 3-	PBA - (4-CHLORO 2-FLUORO 3-	1	2-Fluorophenol	0.83 kg.
METHOXY	PHENYL)	BORONIC
ACID)			2	Toluene (Bulk)	0.12 kg.
			3	Lithium Metal	0.100 kg.
			4	Monoglyme (1, 2	0.80 kg.
				DIMETHOXYETHANE)
			5	Mixed Hexanes	0.29 kg.
			6	Trimethyl borate	0.79 kg.

Case No.	Case No.	80 / NC/3/MEET/Sep/202425/9	80 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		MEDREICH LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ	File Number	HQRNORM APPLY 00005381AM23
RA File Number		07AX04001433 AM23
Licence No and Date		0711006048/28/12/2022
Norms Committee Decision:
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.<br>Sl. No. Import Items	Qty. allowed.
	ATORVASTATIN	10MG	1<br>ATORVASTATIN CALCIUM<br>1 Number	11.059 mg.
	TABLETS		TRIHYDRATE
			2<br>D MANNITOL	40.00 mg.
RA	concerned may take further necessary action as per above decision of NC.

UDIN00469236AM25

CALCIUM 1 Number|11.059 mg.|| ||TABLETS||TRIHYDRATE||| ||||2 D MANNITOL|40.00 mg.|| |RA|concerned may take further necessary action as per above decision of NC.|||||

UDIN00469236AM25

Case No.	81 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005401AM23
RA File Number	34AX04000903 AM23
Licence No and<br>Date	3411003211/29/12/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	82 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005442AM23
RA File Number	05AX04002802 AM23
Licence No and<br>Date	0511016635/30/12/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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>Imipenem Monohydrate<br>(Non Sterile)<br>0.576 kg.<br>Imipenem and Cilastatin for injection<br>(1:1).<br>1 kg.<br>2<br>Cilastatin Acid<br>0.489kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00469236AM25

ipenem and Cilastatin for injection (1:1). 1 kg. 2 Cilastatin Acid 0.489kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00469236AM25




Case No.		83 / NC/3/MEET/Sep/202425/9

Case Status		Case Approved
Party Name		MAYA BIOTECH PRIVATE LIMITED

Meeting Number<br>		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
and Date

HQ File Number		HQRNORM APPLY 00005487AM23
RA File Number		30AX04000416 AM23

Licence No and<br>Date		3011002973/03/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/May/2024/25/4 dated 06/06/2024against<br>advance authorizationNo. 3011002150 dated 23/05/2022, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP 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.

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 Urokinase (purified) 1043.46 mg. 2 Mannitol 0.5% 128.52 gm. 3 Sodium Chloride (50 mg/vial) 128.52 gm. Injection Urokinase (Each vial contains 500000 IU of Urokinase) 1000 Vials 4 Sodium Hydroxide 3.06 gm. RA concerned may take further necessary action as per above decision of NC.|||||||||| ||Export Product||||Qty.||Sl. No.|Import Items|Qty. allowed.| ||Injection Urokinase (Each vial contains 5 Urokinase)||00000 IU|of| 1000 V|ials|1|Urokinase (purified)|1043.46 mg.| ||||||||||| ||||||||2|Mannitol 0.5%|128.52 gm.| ||||||||||| ||||||||3|Sodium Chloride (50 mg/vial)|128.52 gm.| ||||||||4|Sodium Hydroxide|3.06 gm.| ||concerned may take further neces|||sary action as per above decision of NC.|||||| |||||||||||

Case No.	84 / NC/3/MEET/Sep/202425/9	84 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred

Party Name	AURO	BINDO PHARMA LTD

Meeting Number
<br>and Date	NC/ 3/	MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRN	ORM APPLY 00005526AM23
RA File Number	09AX	04000891 AM23

UDIN00469236AM25

RMA LTD| |||| |Meeting Number||| | and Date|NC/ 3/|MEET/ Sep/ 202425/ 9 and 10/10/2024| |HQ File Number|HQRN|ORM APPLY 00005526AM23| |RA File Number|09AX|04000891 AM23|

UDIN00469236AM25

Licence No and 0911004257/04/01/2023 Date Norms Committee Decision: Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Detailed calculation showing net requirement of import item and wastage applied thereon.

Case No.	Case No.	85 / NC/3/MEET/Sep/202425/9	85 / NC/3/MEET/Sep/202425/9	85 / NC/3/MEET/Sep/202425/9	85 / NC/3/MEET/Sep/202425/9	85 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		RAKSHIT DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number		HQRNORM APPLY 00005513AM23
RA File Number		09AX04000866 AM23
Licence No and<br>Date		0911004255/04/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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.

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 Aloe Emodine 95 1.05 kg. 2 Di Methyl Acetamide 1.23 kg. 3 Di Methyl Formamide 0.93 kg. Diacerein(solid) 1 kg. 4 Methanol 1.70 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Diacerein(solid)||1 kg.|1|Aloe Emodine 95|1.05 kg.| |||||2|Di Methyl Acetamide|1.23 kg.| |||||3|Di Methyl Formamide|0.93 kg.| |||||4|Methanol|1.70 kg.| |||||as per above decision of NC.|||

Case No.	86 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved

UDIN00469236AM25

Party Name	MICRO LABS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005545AM23
RA File Number	07AX04001477 AM23
Licence No and Date	0711006102/05/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

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. DICLOXACILLIN CAPSULES 250MG (64.50 KG) 1 Number 1 DICLOXACILLIN SODIUM 267.5 mg/ 250 mg Capsule DICLOXACILLIN CAPSULES 500MG (2129.990 KG) 1 Number 2 DICLOXACILLIN SODIUM 535.0 mg/ 500 mg Capsule RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	87 / NC/3/MEET/Sep/202425/9	87 / NC/3/MEET/Sep/202425/9	87 / NC/3/MEET/Sep/202425/9
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number		HQRNORM APPLY 00005588AM23
RA File Number		05AX04002947 AM23
Licence No and Date		0511016763/06/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>For export item No. 1<br>a.<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>7(Alpha)-(2-Hydroxy-3,3-<br>Dimethyl-2-Butyl)-6,<br>14-Endo-<br>Ethano-6,<br>7,<br>8,<br>14-<br>BuprenorphineHydrochloride<br>1 kg.<br>1<br>1.955 kg.
	Export Product		Qty.	**Sl. No.

r>7(Alpha)-(2-Hydroxy-3,3- Dimethyl-2-Butyl)-6, 14-Endo- Ethano-6, 7, 8, 14- BuprenorphineHydrochloride 1 kg. 1 1.955 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||BuprenorphineHydrochloride||1 kg.|1|7(Alpha)-(2-Hydroxy-3,3- Dimethyl-2-Butyl)-6, 14-Endo- Ethano-6, 7, 8, 14-|1.955 kg.|

UDIN00469236AM25

	Tetrahydronorthebaine
2	Cyclopropyl methanol	1.60 kg.
3	Methane Sulfonyl Chloride	2.50 kg.
4	Lithium Bromide	2.00 kg.
5	Thiophenol	2.50 kg.
6	Dimethyl Formamide	4.00 kg.
7	Triethyl Amine	4.80 kg.
8	Toluene	20.50 kg.
9	Methanol	5.50 kg.
10	Activated Carbon / Eno Carbon	0.200 kg.
11	Acetone		50.	g.<br>

b. For export item No. 2&3
i. Norms for 1 Number Tablet.

Norms for 1 Number Tablet.<br>i.
Bulk Drug	Quantity in mg.
	Export item no.1	Export item no.2
Buprenorphine Hydrochloride	2.04 mg.	8.16 mg.
Naloxone Hydrochloride	0.51 mg.	2.04 mg.

ii. Raw Material proposed for 1 kg. Buprenorphine Hydrochloride

Export Product Qty. Sl. No. Import Items Qty. allowed.

UDIN00469236AM25

oxone Hydrochloride|0.51 mg.|2.04 mg.|

ii. Raw Material proposed for 1 kg. Buprenorphine Hydrochloride

Export Product Qty. Sl. No. Import Items Qty. allowed.

UDIN00469236AM25

1	7(Alpha)-(2-Hydroxy-3,3-<br>Dimethyl-2-Butyl)-6,<br>14-Endo-<br>Ethano-6,<br>7,<br>8,<br>14-<br>Tetrahydronorthebaine	1.955 kg.
2	Cyclopropyl methanol	1.60 kg.
3	Methane Sulfonyl Chloride	2.50 kg.
4	Lithium Bromide	2.00 kg.
5	Thiophenol	2.50 kg.
6	Dimethyl Formamide	4.00 kg.
7	Triethyl Amine	4.80 kg.
8	Toluene	20.50 kg.
9	Methanol	5.50 kg.
10	Activated Carbon / Eno Carbon	0.200 kg.
11	Acetone	4.50 kg.

Note: RA may work out the import entitlement of all inputs as per (i) & (ii) above on pro-rata basis.

hanol|5.50 kg.| ||||10|Activated Carbon / Eno Carbon|0.200 kg.| ||||11|Acetone|4.50 kg.|

Note: RA may work out the import entitlement of all inputs as per (i) & (ii) above on pro-rata basis.

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

Case No.	88 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005679AM23
RA File Number	08AX04001685 AM23

UDIN00469236AM25

Licence No and 0811006983/11/01/2023 Date Norms Committee Decision:

Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
Magnesium Sulfate In Water for	<br>1 Number	1	Magnesium sulfate heptahydrate	2.00 gm.
Injection (0.325 mEq
Mg++/mL) 40 mg/mL 2g Total
Magnesium Sulfate In Water for	<br>1 Number	2	Magnesium sulfate heptahydrate	2.897 gm.
Injection (0.325 mEq
Mg++/mL) 40 mg/mL 4g Total

.325 mEq||||| |Mg++/mL) 40 mg/mL 2g Total||||| |Magnesium Sulfate In Water for| 1 Number|2|Magnesium sulfate heptahydrate|2.897 gm.| |Injection (0.325 mEq||||| |Mg++/mL) 40 mg/mL 4g Total|||||

Case No.<br>89 / NC/3/MEET/Sep/202425/9	Case No.<br>89 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00005687AM23
RA File Number<br>31AX04000281 AM23
Licence No and Date<br>3111001952/12/01/2023
Norms Committee Decision:
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.	Import Items		Qty.
		No.		allowed.
METFORMIN	1 kg.	1	DICYANDIAMIDE ( DCDA)	0.484 kg.
HYDROCHLORIDE DIRECT			WHITE POWDER
COMPRESSIBLE GRANULES
86.66% W/W WHITE<br>GRANULES		2	SODIUM STARCH	0.034 kg.

lowed.**||| |METFORMIN|1 kg.|1|DICYANDIAMIDE ( DCDA)|0.484 kg.||| |HYDROCHLORIDE DIRECT|||WHITE POWDER|||| |COMPRESSIBLE GRANULES||||||| |86.66% W/W WHITE GRANULES||2|SODIUM STARCH|0.034 kg.|||

Case No.<br>89 / NC/3/MEET/Sep/202425/9	Case No.<br>89 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00005687AM23
RA File Number<br>31AX04000281 AM23
Licence No and Date<br>3111001952/12/01/2023
Norms Committee Decision:
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.	Import Items		Qty.
		No.		allowed.
METFORMIN	1 kg.	1	DICYANDIAMIDE ( DCDA)	0.484 kg.
HYDROCHLORIDE DIRECT			WHITE POWDER
COMPRESSIBLE GRANULES
86.66% W/W WHITE<br>GRANULES		2	SODIUM STARCH	0.034 kg.

UDIN00469236AM25

POWDER

GLYCOLATE WHITE POWDER

g.||| |HYDROCHLORIDE DIRECT|||WHITE POWDER|||| |COMPRESSIBLE GRANULES||||||| |86.66% W/W WHITE GRANULES||2|SODIUM STARCH|0.034 kg.|||

UDIN00469236AM25

POWDER

GLYCOLATE WHITE POWDER

Case No.<br>90 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Deferred
Party Name<br>MICRO LABS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM REVIW00004701AM24
RA File Number<br>07AX04001546 AM23
Licence No and<br>Date<br>0711006197/16/01/2023
Norms Committee Decision:
Decision:The committee considered the request of firm for review of ad-hoc norms and as per the advice
of the TE, it was decided to call for following information/documents from the firm:-
Copy of Drug Manufacturing Licence (DML).<br>1.
Copy of Certificate of Analysis (CoA) of import item item from Foreign Supplier.<br>2.

Case No.	91 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005762AM23
RA File Number	08AX04001684 AM23
Licence No and<br>Date	0811007029/16/01/2023
Norms Committee Decision:
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:-

UDIN00469236AM25

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:-||

UDIN00469236AM25

Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Esmolol Hydrochloride in Sodium<br>Chloride Injection 2,500 mg/250 mL (10<br>mg/mL)<br>1 Number<br>1<br>ESMOLOL<br>2625 mg<br>Esmolol Hydrochloride in Sodium<br>Chloride Injection [DOUBLE<br>STRENGTH] 2,000 mg/100 mL (20<br>mg/mL)<br>1 Number<br>2<br>ESMOLOL<br>2100 mg<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	Esmolol Hydrochloride in Sodium<br>Chloride Injection 2,500 mg/250 mL (10<br>mg/mL)	1 Number	1	ESMOLOL	2625 mg
	Esmolol Hydrochloride in Sodium<br>Chloride Injection [DOUBLE<br>STRENGTH] 2,000 mg/100 mL (20<br>mg/mL)	1 Number	2	ESMOLOL	2100 mg

on 2,500 mg/250 mL (10 mg/mL)|1 Number|1|ESMOLOL|2625 mg| ||Esmolol Hydrochloride in Sodium Chloride Injection [DOUBLE STRENGTH] 2,000 mg/100 mL (20 mg/mL)|1 Number|2|ESMOLOL|2100 mg|

Case No.	92 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	PRACHI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005760AM23
RA File Number	03AX04005177 AM23
Licence No and Date	0311020750/16/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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.<br>allowed.<br>THIAMINE HYDROCHLORIDE<br>1 kg.<br>1<br>THIAMINE MONONITRATE<br>0.922 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00469236AM25

allowed. THIAMINE HYDROCHLORIDE 1 kg. 1 THIAMINE MONONITRATE 0.922 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00469236AM25

Case No.	93 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005769AM23
RA File Number	08AX04001660 AM23
Licence No and Date	0811007032/17/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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.<br>allowed.<br>Dexmedetomidine Hydrochloride in<br>0.9% Sodium Chloride Injection 200<br>mcg per 50 mL (4 mcg/mL)(ACTIVE<br>PHARMA INGREDIENT)<br>1 Number<br>1<br>DEXMEDETOMIDINE<br>210 mcg.<br>Dexmedetomidine Hydrochloride in<br>0.9% Sodium Chloride Injection 400<br>mcg per 100 mL (4 mcg/mL)(ACTIVE<br>PHARMA INGREDIENT)<br>1 Number<br>2<br>DEXMEDETOMIDINE<br>420 mcg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	94 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005768AM23
RA File Number	05AX04003041 AM23

UDIN00469236AM25

UDIN00469236AM25

Licence No and Date

0511016882/17/01/2023

Norms Committee Decision: **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. Formoterol Fumarate Inhalation Solution 20 mcg/2 mL (0.02 mg/2 mL), 6500000 Numbers 1 FORMOTEROL FUMARATE DIHYDRATE USP 136.50 gm. RA concerned may take further necessary action as per above decision of NC.

Case No.	95 / NC/3/MEET/Sep/202425/9
Case Status	Case Approved
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005804AM23
RA File Number	05AX04002999 AM23
Licence No and<br>Date	0511016918/18/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP 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.

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. Linalyl Acetate Refined 98 +/-2% 1 kg. 1 Linalyl Acetate 9352.6 gm RA concerned may take further necessary action as per above decision of NC.||

UDIN00469236AM25

Case No.	96 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	MICROTROL STERILISATION SERVICES PVT.LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005834AM23
RA File Number	07AX04001525 AM23
Licence No and<br>Date	0711006236/19/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for<br>attendingPersonal Hearing<br>before Norms Committee to explain its case along with following<br>information / documents from the firm:<br>Copy of DML for each export item.<br>1.<br>CoA of import item from foreign supplier.<br>2.<br>Copy of CoA of the export item.<br>3.

owing information / documents from the firm: Copy of DML for each export item. 1. CoA of import item from foreign supplier. 2. Copy of CoA of the export item. 3.||

Case No.	97 / NC/3/MEET/Sep/202425/9
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005825AM23
RA File Number	05AX04003069 AM23
Licence No and<br>Date	0511016941/19/01/2023
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>To give proper chemical reaction starting clearly from import items asked for, in the license,<br>giving molecular weight and name of the chemicals and also yield of the reaction.<br>1.<br>Function/application of each raw material asked for, in the process indicating raw materials,<br>catalyst solvent/diluents etc., as the case may be giving Stoichiometric material balance on<br>molar basis.<br>2.<br>The value of by-product, if any and with end use of export item.<br>3.

To give proper chemical reaction starting clearly from import items asked for, in the license, giving molecular weight and name of the chemicals and also yield of the reaction.

** 3.||

To give proper chemical reaction starting clearly from import items asked for, in the license, giving molecular weight and name of the chemicals and also yield of the reaction.
Function/application of each raw material asked for, in the process indicating raw materials, catalyst solvent/diluents etc., as the case may be giving Stoichiometric material balance on molar basis.

UDIN00469236AM25

Case No.	98 / NC/3/MEET/Sep/202425/9
Case Status	Case Rejected
Party Name	LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00005820AM23
RA File Number	07AX04001513 AM23
Licence No and<br>Date	0711006229/19/01/2023
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was observed that quantity of import item
is disproportionately high (12 gm. per tablet) for a tablet of 400 mg. Hence, the Committee decided to
rejectthe case.

e as per agenda and it was observed that quantity of import item|| |is disproportionately high (12 gm. per tablet) for a tablet of 400 mg. Hence, the Committee decided to|| |rejectthe case.||

Case No.<br>99 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00005814AM23
RA File Number<br>03AX04005159 AM23
Licence No and<br>Date<br>0311020797/19/01/2023
Norms Committee Decision:
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<br>Qty.<br>Sl. No.Import Items		Qty. allowed.
1<br>Fenofibrate Bulk Granulate<br>1 Kg.	Fenofibrate Micronized IH/Ph.Eur	0.3155 kg.
2	Hypromellose (2910, 3 cps) Ph. Eur	0.0625 kg.

Qty. Sl. No.Import Items||Qty. allowed.|| |1 Fenofibrate Bulk Granulate 1 Kg.|Fenofibrate Micronized IH/Ph.Eur|0.3155 kg.|| |2|Hypromellose (2910, 3 cps) Ph. Eur|0.0625 kg.||

Case No.<br>99 / NC/3/MEET/Sep/202425/9
Case Status<br>Case Approved
Party Name<br>ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number<br>HQRNORM APPLY 00005814AM23
RA File Number<br>03AX04005159 AM23
Licence No and<br>Date<br>0311020797/19/01/2023
Norms Committee Decision:
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<br>Qty.<br>Sl. No.Import Items		Qty. allowed.
1<br>Fenofibrate Bulk Granulate<br>1 Kg.	Fenofibrate Micronized IH/Ph.Eur	0.3155 kg.
2	Hypromellose (2910, 3 cps) Ph. Eur	0.0625 kg.

UDIN00469236AM25

3	Docusate Sodium Ph.Eur	0.0062 kg.
4	Sucrose Ph.Eur	0.3124 kg.
5	Sodium LaurilSulfatePh.Eur	0.0216 kg.
6	Lactose Monohydrate Ph.Eur	0.2804 kg.

3	Docusate Sodium Ph.Eur	0.0062 kg.
4	Sucrose Ph.Eur	0.3124 kg.
5	Sodium LaurilSulfatePh.Eur	0.0216 kg.
6	Lactose Monohydrate Ph.Eur	0.2804 kg.

Case No.	100 / NC/3/MEET/Sep/202425/9
Case Status	Case Withdrawn
Party Name	LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202425/ 9 and 10/10/2024
HQ File Number	HQRNORM APPLY 00000961AM24
RA File Number	NA
Licence No and<br>Date	0711006229/19/01/2023
Norms Committee Decision:<br>Decision:The committee considered the request of the firm and observed that the firm has filed dual<br>application on same license number as mentioned at case No.98, therefore, the committee has decided to<br>withdrawthe application of the firm.

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 8065 --apply.