IN FORCE Advance Authorisation

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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/Feb/202324/23 DATED: 19/02/2024

Please Note

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

Meeting No. NC/3/MEET/Feb/202324/23 dated 19/02/2024 of Norms Committee - III for the year 2023-24 was held on 19/02/2024 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

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

The following members were present in the meeting:-

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

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00004450AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along with relevant documents from the firm.		Personal Hearing

Case No.	2 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	GREEN PINE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006239AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Reason for applying the export of item Beta Pinene under para 4.06 of HBP Vol.1.<br>1.<br>Chemistry of the reaction, giving molecular weight of each of reactant and product in reaction with yield.<br>2.<br>**3.

ng the export of item Beta Pinene under para 4.06 of HBP Vol.1.** 1. Chemistry of the reaction, giving molecular weight of each of reactant and product in reaction with yield. 2. 3. The value of By-product, if any and to give indigenous item to use in the process and accordingly to fill Annexure to Appendix-4E.||| |||| |Case No.|3 / NC/3/MEET/Feb/202324/23|| |Case Status|Case Rejected|| |Party Name|NAVIN FLUORINE INTERNATIONAL LIMITED|| |Meeting Number and Date|NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024|| |HQ File Number|HQRNORM APPLY 00006413AM24|| |RA File Number|NA|| |Licence No and Date|NA|| |Norms Committee Decision:|||

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

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The committee considered the request of firm and it was observed that the firm neither submitted their application in the Head of (Review of norms) nor paid composition fees of Rs.5000/-. Therefore, the committee decided to withdraw the application of the firm and advised to submit their application in the Head of review of Norms on DGFT Back Office Portal.

n fees of Rs.5000/-. Therefore, the committee decided to withdraw the application of the firm and advised to submit their application in the Head of review of Norms on DGFT Back Office Portal.

Case No.	4 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007797AM24
RA File Number	NA
Licence No and Date	0910067796/null
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>CARBOBENZYLOXY L VALINE CBZ L<br>VALINE<br>1.1824 kg.<br>2<br>N DICYCLOHEXYL CARBODIIMIDE DCC<br>1.061 kg.<br>3<br>4 DIMETHYLAMINO PYRIDINE DMAP<br>0.028 kg.<br>VALACYCLOVIR<br>HYDROCHLORIDE<br>MONOHYDRATE(SOLID)<br>1 kg.<br>4<br>ACYCLOVIR<br>0.758 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	5 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006953AM24
RA File Number	092404000017 AM14
Licence No and<br>Date	0910055800/19/04/2013
Norms Committee Decision:

/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024| |HQ File Number|HQRNORM REVIW00006953AM24| |RA File Number|092404000017 AM14| |Licence No and Date|0910055800/19/04/2013| |Norms Committee Decision:||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

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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.
TRAZODONE<br>HYDROCHLORIDE	1 kg.	1	CRUDE<br>TRAZODONE<br>HYDROCHLORIDE<br>(TRN-3)(Purity 99.89%)	<br>1.01 kg.

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

Case No.	Case No.	6 / NC/3/MEET/Feb/202324/23	6 / NC/3/MEET/Feb/202324/23	6 / NC/3/MEET/Feb/202324/23	6 / NC/3/MEET/Feb/202324/23	6 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00008424AM24
RA File Number		092404000287 AM14
Licence No and<br>Date		0910057785/01/10/2013
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms 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>Export Product<br>Qty.<br>**Sl.

-hoc norms 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 N-PROPYL BROMIDE 2.19 kg. DIVALPROEX SODIUM 1 kg. 2 DIETHYL MALONATE. 1.42 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||DIVALPROEX SODIUM||1 kg.|1|N-PROPYL BROMIDE|2.19 kg.| |||||2|DIETHYL MALONATE.|1.42 kg.| |||||as per above decision of NC.|||

Case No.	7 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024

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and Date
HQ File Number	HQRNORM REVIW00006955AM24
RA File Number	092404000139 AM15
Licence No and<br>Date	0910060467/17/06/2014
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>TRAZODONE<br>HYDROCHLORIDE<br>1 kg.<br>1<br>CRUDE<br>TRAZODONE<br>HYDROCHLORIDE<br>(TRN-3)(Purity 99.89%)<br>1.01 kg.<br>RA concerned may take further necessary action as per above decision of NC.

AZODONE HYDROCHLORIDE 1 kg. 1 CRUDE TRAZODONE HYDROCHLORIDE (TRN-3)(Purity 99.89%) 1.01 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	8 / NC/3/MEET/Feb/202324/23	8 / NC/3/MEET/Feb/202324/23	8 / NC/3/MEET/Feb/202324/23	8 / NC/3/MEET/Feb/202324/23	8 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00008333AM24
RA File Number		092404000060 AM16
Licence No and<br>Date		0910061998/08/05/2015
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.0910061955 dated 01/05/2015; it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Cytidine,N-benzoyl-2-deoxy-2-fluoro-2-methyl-3,5-<br>dibenzoate,(2r)<br>Not required.<br>2<br>( 2-deoxy-2-fluoro-2-C-methyluridine)<br>0.87 kg.<br>SOFOSBUVIR<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

hyl-3,5- dibenzoate,(2r) Not required. 2 ( 2-deoxy-2-fluoro-2-C-methyluridine) 0.87 kg. SOFOSBUVIR 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||SOFOSBUVIR||1 kg.|1|Cytidine,N-benzoyl-2-deoxy-2-fluoro-2-methyl-3,5- dibenzoate,(2r)|Not required.| |||||2|( 2-deoxy-2-fluoro-2-C-methyluridine)|0.87 kg.|

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3	N-[(S)-(2,3,4,5,6-Pentafluorophenoxy)	Not required.
	phenoxyphosphinyl]-L-alanine 1-methylethyl ester
4	L-Alanine isopropyl ester hydrochloride	1.80 kg.
5	Phenyl dichlorophosphate	1.58 kg.
6	Pentafluorophenol	1.16 kg.

Note: The above norms are for regularization and closure purpose only.

Case No.	9 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	HERBOCHEM
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008147AM24
RA File Number	092404000148 AM16
Licence No and<br>Date	0910062238/23/06/2015
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Extract Ipecacuanha<br>(Ipecac Conc.8% alkaloid)<br>1 kg.<br>1<br>Ipecacuanha (Ipecac) Roots (Dry Roots) containing<br>minimum 2 % Alkaloids<br>3.636 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 10 / NC/3/MEET/Feb/202324/23

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s) containing minimum 2 % Alkaloids 3.636 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 10 / NC/3/MEET/Feb/202324/23

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Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008351AM24
RA File Number	092404000328 AM16
Licence No and<br>Date	0910062593/11/09/2015
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.0910061955 dated 01/05/2015; it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Cytidine,N-benzoyl-2-deoxy-2-fluoro-2-methyl-3,5-<br>dibenzoate,(2r)<br>Not required.<br>2<br>( 2-deoxy-2-fluoro-2-C-methyluridine)<br>0.87 kg.<br>3<br>N-[(S)-(2,3,4,5,6-Pentafluorophenoxy)<br>phenoxyphosphinyl]-L-alanine 1-methylethyl ester<br>Not required.<br>4<br>L-Alanine isopropyl ester hydrochloride<br>1.80 kg.<br>5<br>Phenyl dichlorophosphate<br>1.58 kg.<br>SOFOSBUVIR<br>1 kg.<br>6<br>Pentafluorophenol<br>1.16 kg.<br>Note: The above norms are for regularization and closure purpose only.<br>RA concerned may take further necessary action as per above decision of NC.

br>6 Pentafluorophenol 1.16 kg. Note: The above norms are for regularization and closure purpose only. RA concerned may take further necessary action as per above decision of NC.||

Case No.	11 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024

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HQ File Number	HQRNORM REVIW00007759AM24
RA File Number	039404000497 AM16
Licence No and<br>Date	0310799433/14/10/2015
Norms Committee Decision:
This case was earlier approved in NC-3 meeting No. NC/3/MEET/Dec/202324/18 held on 29/12/2023 and minutes of
meeting has been uploaded on the Portal of DGFT.

Case No.	12 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007896AM24
RA File Number	072404000347 AM16
Licence No and<br>Date	0710109255/12/01/2016
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

IW00007896AM24| |RA File Number|072404000347 AM16| |Licence No and Date|0710109255/12/01/2016| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|

Case No.	13 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008070AM24
RA File Number	092404000143 AM17
Licence No and<br>Date	0910063875/30/06/2016
Norms Committee Decision:
The Committee	considered the case as per agenda and taking cue from the written comments of Department of
Pharmaceuticals	vide their O.M. No.35011/138/2016-PI (Norms) dated August, 2016 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.<br>Import Items		Qty. allowed.
1<br>2-deoxy-2-fluoro-2-C-methyluridine<br>SOFOSBUVIR IH<br>1 kg.		0.87 kg.
	2<br>N-[(S)-(2,3,4,5,6-Pentafluorophenoxy)	1.92 kg.
	phenoxyphosphinyl]-L-alanine 1-methylethyl
	ester

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-2-C-methyluridine SOFOSBUVIR IH 1 kg.||0.87 kg.|| ||2 N-[(S)-(2,3,4,5,6-Pentafluorophenoxy)|1.92 kg.|| ||phenoxyphosphinyl]-L-alanine 1-methylethyl||| ||ester|||

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Case No.	14 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007908AM24
RA File Number	072404000160 AM17
Licence No and<br>Date	0710110226/08/08/2016
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	15 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007894AM24
RA File Number	072404000182 AM17
Licence No and<br>Date	0710110335/30/08/2016
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	16 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007903AM24
RA File Number	072404000273 AM17
Licence No and<br>Date	0710110770/09/12/2016
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	17 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred

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

Case No.	17 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred

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Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007898AM24
RA File Number	072404000374 AM17
Licence No and<br>Date	0710111126/14/02/2017
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	18 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00005925AM24
RA File Number	NA
Licence No and<br>Date	0910065335/08/08/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along with relevant documents from the firm.		Personal Hearing

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

Case No.	19 / NC/3/MEET/Feb/202324/23
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007802AM24
RA File Number	092404000309 AM18
Licence No and<br>Date	0910065528/29/09/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

Case No.	20 / NC/3/MEET/Feb/202324/23
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007800AM24

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RA File Number	092404000459 AM18
Licence No and<br>Date	0910065758/19/12/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

rms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.||

Case No.	21 / NC/3/MEET/Feb/202324/23
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number
<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007799AM24
RA File Number	092404000036 AM19
Licence No and<br>Date	0910066244/18/05/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

Case No.	Case No.	22 / NC/3/MEET/Feb/202324/23	22 / NC/3/MEET/Feb/202324/23
Case Status		Case Deferred
Party Name		CIPLA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00007594AM24
RA File Number		039404001019 AM19
Licence No and<br>Date		0310827414/01/03/2019
Norms Committee Decision:
The commit<br>	tee considered the request of firm for review of ad-ho<br>		c norms and it was observed that there are four export<br>
items after<br>followin in	amendment. However, imports are shown only for ex<br>formation/documents from the firm:-		port item No.1.

br>||c norms and it was observed that there are four export | |items after followin in|amendment. However, imports are shown only for ex formation/documents from the firm:-||port item No.1. Therefore, it was decided to call for| |g|||| |Cop 1. I 2|y of Amended Advance Authorisation. t lid f h t it tl||| |mp . Dru 3.|ors appe or eac expor em separaey. g Manufacturing License (DML) for each export item||.| | 4. Mas| ter Batch Formula for each export items.||| ||||| ||||| |Case No.||23 / NC/3/MEET/Feb/202324/23|| |Case Status||Case Approved|| |Party Name||SRF LIMITED||

Case No.	23 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SRF LIMITED

11 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

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Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00000752AM24
RA File Number		052404000438 AM19
Licence No and<br>Date		0510410372/25/04/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol.

510410372/25/04/2019||||| |Norms Committee Decision: The Committee considered the request of firm for fixation of ad-hoc norms 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 ETHYLENE DI CHLORIDE1.105kg. 2 ACID GRADE FLUORSPAR 2.121 kg. 3 EMPTY CANS (340 GRAM) Relevant as per packing policy 1,1,1,2-TETRAFLUOROETHANE-R-134a (340 gram can) 1kg 4 CAPS FOR EMPTY CANS/ TINPLATE VALVE 1/2" Relevant as per packing policy RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product ||Qty.|Sl. No.|Import Items |Qty. allowed.| ||1,1,1,2-TETRAFLUOROETHANE-R-134a (340 gram can) || 1kg|1 |ETHYLENE DI CHLORIDE|1.105kg.| |||||2 |ACID GRADE FLUORSPAR |2.121 kg.| |||||3 |EMPTY CANS (340 GRAM) |Relevant as per packing policy| |||||4 |CAPS FOR EMPTY CANS/ TINPLATE VALVE 1/2" |Relevant as per packing policy| |||||decision of NC.|||

EMPTY CANS (340 GRAM) |Relevant as per packing policy| |||||4 |CAPS FOR EMPTY CANS/ TINPLATE VALVE 1/2" |Relevant as per packing policy| |||||decision of NC.|||

Case No.	24 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006818AM24
RA File Number	082404000005 AM20
Licence No and<br>Date	0810145144/01/05/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance authorization<br>No.0811001850dated25/06/2021; it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-

UDIN00501924AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Indoline	1 kg.	1	O-CHLOROBENZYL CYANIDE	2.20 kg.
		2	TOLUENE	1.00 kg.

UDIN00501924AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Indoline	1 kg.	1	O-CHLOROBENZYL CYANIDE	2.20 kg.
		2	TOLUENE	1.00 kg.

Case No.	25 / NC/3/MEET/Feb/202324/23
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007801AM24
RA File Number	092404000269 AM20
Licence No and<br>Date	0910067906/20/08/2019
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not
provided any technical justification / information for enhancement. Hence, it was decided torejectthe case
maintaining thestatus quo.

Case No.	26 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007586AM24
RA File Number	039404000509 AM20
Licence No and<br>Date	0310831946/01/10/2019
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	27 / NC/3/MEET/Feb/202324/23
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024

UDIN00501924AM24

3/MEET/Feb/202324/23| |---|---| |Case Status|Case Rejected| |Party Name|SRINI PHARMACEUTICALS PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024|

UDIN00501924AM24

and Date
HQ File Number	HQRNORM REVIW00007803AM24
RA File Number	092404000593 AM20
Licence No and<br>Date	0910068522/27/02/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

Case No.	28 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SHREE BANKEY BEHARI LAL FLAVORS
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006894AM24
RA File Number	052404000005 AM21
Licence No and Date	0510414033/20/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>META - CRESOL ABOVE 98.5%<br>PURE<br>1.20 kg.<br>2<br>ISO PROPYL ALCOHOL<br>0.89 kg.<br>L-MENTHOL /MENTHOL(LAVEO)/<br>MENTHOL(L)/LIQUID MENTHOL<br>1 kg.<br>3<br>ARROWZYME/LIPASE AMANO IME 0.010 kg.<br>RA concerned may take further necessary action as per above decision of NC.

g. L-MENTHOL /MENTHOL(LAVEO)/ MENTHOL(L)/LIQUID MENTHOL 1 kg. 3 ARROWZYME/LIPASE AMANO IME 0.010 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	29 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006628AM24

UDIN00501924AM24

RA File Number	092404000024 AM21
Licence No and<br>Date	0910068681/28/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents from the firm:		Personal Hearing

Case No.	30 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SHREE BANKEY BEHARI LAL FLAVORS
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006895AM24
RA File Number	052404000039 AM21
Licence No and Date	0510414144/11/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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 META - CRESOL ABOVE 98.5% PURE 1.20 kg. 2 ISO PROPYL ALCOHOL 0.89 kg. L-MENTHOL /MENTHOL(LAVEO)/ MENTHOL(L)/LIQUID MENTHOL 1 kg. 3 ARROWZYME/LIPASE AMANO IME 0.010 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	31 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008021AM24
RA File Number	522404000003 AM21
Licence No and Date	5210043427/09/06/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms

UDIN00501924AM24

under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

fixation of ad-hoc norms and it was decided to fix ad-hoc norms||

UDIN00501924AM24

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.
ETHERS, ALCOHOL PEROXIDES,<br>ETHER PEROXIDES, KETONE<br>PEROXIDES, EPOXIDES WITH A<br>THREE- MEMBERED RING, ACETALS<br>AND(HEMIACETALS AND THEIR<br>HALOGENATED, SULPHONATED,<br>NITRATED OR NITROSATED<br>DERIVATIVES :AROMATIC ETHERS<br>AND THEIR HALOGENATED,<br>SULPHONATED, NITRATED OR<br>NITROSATED DERIVATES :<br>ANISOLE AND THEIR DERIVATIVES:2-<br>METHOXY-6-CHLOROTOLUENE.)	1 kg.	1	2,6 DICHLOROTOLUENE	1.42 kg.
		2	TETRAHYDROFURAN	0.64 kg.
		3	DIMETHYLSULFOXIDE	0.66 kg.

Case No.	Case No.	32 / NC/3/MEET/Feb/202324/23	32 / NC/3/MEET/Feb/202324/23	32 / NC/3/MEET/Feb/202324/23	32 / NC/3/MEET/Feb/202324/23	32 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		AETHER INDUSTRIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00008025AM24
RA File Number		522404000017 AM21
Licence No and Date		5210043441/16/06/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms 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>Export Product<br>Qty.<br>**Sl. No.

norms 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 2-CHLOROBENZONITRILE 1.235 kg. 2 PARA CHLOROTOLUENE 1.34 kg. 4=BROMOMETHYL-2-CYANOBIP HENYL 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||4=BROMOMETHYL-2-CYANOBIP HENYL||1 kg.|1 2|2-CHLOROBENZONITRILE|1.235 kg.| ||||||PARA CHLOROTOLUENE|1.34 kg.|

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3 TETRAHYDROFURAN 1.00 kg.

Case No.	33 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008022AM24
RA File Number	522404000018 AM21
Licence No and<br>Date	5210043446/23/06/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1-(2-(2-HYDROXYETHOXY)<br>ETHYL)<br>PIPERAZINE, CAS NO.13349-82-1<br>1 kg.<br>1<br>PIPERAZINE ANHYDROUS<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

1-(2-(2-HYDROXYETHOXY) ETHYL) PIPERAZINE, CAS NO.13349-82-1 1 kg. 1 PIPERAZINE ANHYDROUS 1.00 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	34 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007655AM24
RA File Number	039404000198 AM21
Licence No and<br>Date	0310837494/29/07/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the written comments of Department of<br>Chemicals & Petrochemicals vide their U.O. No.14010/32/2013-Ch.II dated 15/04/2015 and decision for same

UDIN00501924AM24

export product/import product in meeting No.1/82-ALC4/2015 dated 15/04/2015 against advance authorization No.0310788806 dated 05/09/2014 , 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.
SODIUM SACCHARIN<br>(PURE DENTAL GRADE)	1 kg.	1	SODIUM SACCHARIN	1.02 kg.

hichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
SODIUM SACCHARIN<br>(PURE DENTAL GRADE)	1 kg.	1	SODIUM SACCHARIN	1.02 kg.

Case No.	35 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	KOSHA CHEMTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007382AM24
RA File Number	039404000306 AM21
Licence No and<br>Date	0310837580/10/08/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>SODIUM<br>META<br>BISULPHITE<br>(SMBS)<br>0.893 kg.<br>2<br>FORMYL<br>BENZENE<br>SULPHONIC<br>ACID<br>1 kg.<br>2<br>ORTHO CHLORO BENZALDEHYDE 0.90 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	36 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024

UDIN00501924AM24

Case No.	36 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024

UDIN00501924AM24

and Date
HQ File Number	HQRNORM REVIW00007634AM24
RA File Number	039404000356 AM21
Licence No and<br>Date	0310837963/28/08/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the written comments of Department of<br>Chemicals & Petrochemicals vide their U.O. No.14010/32/2013-Ch.II dated 15/04/2015 and decision for same<br>export product/import product in meetingNo.1/82-ALC4/2015dated15/04/2015against advance authorization<br>No.0310788806dated05/09/2014, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>SODIUM SACCHARIN<br>(PURE DENTAL GRADE)<br>1 kg.<br>1<br>SODIUM SACCHARIN<br>1.02 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ems** Qty. allowed. SODIUM SACCHARIN (PURE DENTAL GRADE) 1 kg. 1 SODIUM SACCHARIN 1.02 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	37 / NC/3/MEET/Feb/202324/23	37 / NC/3/MEET/Feb/202324/23	37 / NC/3/MEET/Feb/202324/23	37 / NC/3/MEET/Feb/202324/23	37 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00007267AM23
RA File Number		052404000395 AM21
Licence No and<br>Date		0510415782/09/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>DIFLUORO METHANE<br>SULPHONYL CHLORIDE<br>1 kg.<br>1<br>BENZYL DIFLUOROMETHYL SULPHIDE<br>1.516 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	DIFLUORO METHANE<br>SULPHONYL CHLORIDE		1 kg.	1	BENZYL DIFLUOROMETHYL SULPHIDE	1.516 kg.

UDIN00501924AM24

rt Product**||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DIFLUORO METHANE SULPHONYL CHLORIDE||1 kg.|1|BENZYL DIFLUOROMETHYL SULPHIDE|1.516 kg.|

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Case No.	38 / NC/3/MEET/Feb/202324/23
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007804AM24
RA File Number	09AA04002915 AM21
Licence No and<br>Date	0911000179/12/01/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

Case No.	39 / NC/3/MEET/Feb/202324/23
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007805AM24
RA File Number	09AA04002915 AM21
Licence No and<br>Date	0911000179/12/01/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

rms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.||

Case No.	40 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008364AM24
RA File Number	05AA04025954 AM21
Licence No and<br>Date	0511001043/02/02/2021
Norms Committee Decision:

20 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

UDIN00501924AM24

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

Case No.	Case No.	41 / NC/3/MEET/Feb/202324/23	41 / NC/3/MEET/Feb/202324/23	41 / NC/3/MEET/Feb/202324/23	41 / NC/3/MEET/Feb/202324/23	41 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00006922AM24
RA File Number		31AA04006051 AM21
Licence No and Date		3111000148/09/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Sep/202324/13dated14/09/2023against advance authorization<br>No. 3111000201 dated 08/03/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>MONOETHANOLAMINE<br>1.06 kg.<br>ETHYLENE DI AMINE<br>(ORGANIC CHEMICAL)<br>1 kg<br>2<br>AMMONIA ANHYDROUS<br>0.294 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	ETHYLENE DI AMINE<br>(ORGANIC CHEMICAL)		1 kg	1	MONOETHANOLAMINE	1.06 kg.
				2	AMMONIA ANHYDROUS	0.294 kg.
				as per above decision of NC.

*Sl. No.**|Import Items|Qty. allowed.| ||ETHYLENE DI AMINE (ORGANIC CHEMICAL)||1 kg|1|MONOETHANOLAMINE|1.06 kg.| |||||2|AMMONIA ANHYDROUS|0.294 kg.| |||||as per above decision of NC.|||

Case No.	42 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	LARK LABORATORIES (INDIA) LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008143AM24
RA File Number	05AA04036527 AM21
Licence No and<br>Date	0511001512/02/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Mar/202324/24 dated 13/04/2023against advance<br>authorizationNo.0511007234 dated 25/06/2021; it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-

UDIN00501924AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
SITAGLIPTIN TABLETS BP 100 MG<br>(NET CONTENT SITAGLIPTIN<br>PHOSPHATE MONOHYDRATE BP-<br>73.68 KGS) (EACH FILM COATED<br>TABLET CONTAINS: SITAGLIPTIN<br>PHOSPHATE MONOHYDRATE BP<br>EQUIVALENT TO SITAGLIPTIN 100<br>MG)	1 Number	1	SITAGLIPTIN PHOSPHATE<br>MONOHYDRATE BP	131.05 mg.

Case No.	43 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008140AM24
RA File Number	03AA04029725 AM21
Licence No and<br>Date	0311002554/16/03/2021
Norms Committee Decision:<br>Explain use of Aluminum Tri-2-Butoxide and DI N-Butyl Amine in chemical reaction and their end use.<br>1.<br>Stoichiometric reaction indicate use of both raw material.<br>2.

Case No.	44 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00005927AM24
RA File Number	NA
Licence No and Date	0911000512/18/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00501924AM24

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:-||

UDIN00501924AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>AMINO ACETONITRILE HCL<br>0.803 kg.<br>RACTOPAMINE HCL<br>(for Veternery use))<br>1 kg<br>2<br>4 HYDROXY BENZALDEHYDE<br>0.753 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	RACTOPAMINE HCL<br>(for Veternery use))	1 kg	1	AMINO ACETONITRILE HCL	0.803 kg.
			2	4 HYDROXY BENZALDEHYDE	0.753 kg.

Case No.	Case No.	45 / NC/3/MEET/Feb/202324/23	45 / NC/3/MEET/Feb/202324/23	45 / NC/3/MEET/Feb/202324/23	45 / NC/3/MEET/Feb/202324/23	45 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		REYAANSH HEALTHCARE
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00007729AM24
RA File Number		03AA04021445 AM21
Licence No and<br>Date		0311002623/19/03/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms 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>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. SELAMECTIN 6% SPOT ON 0.25 ML TUBE(EACH ML CONTAINS SELAMECTIN 60 MG) 11,000 Numbers 1 SELAMECTIN 168.305 gm. SELAMECTIN 6% SPOT ON 0.50 ML TUBE(EACH ML CONTAINS SELAMECTIN 60 MG) 47,000 Numbers 2 SELAMECTIN 1438.153 gm. SELAMECTIN 6% SPOT ON 0.75 ML TUBE(EACH ML CONTAINS SELAMECTIN 60 MG) 92000 Numbers 3 SELAMECTIN 4222.735 gm. SELAMECTIN 6% SPOT ON 1 ML TUBE(EACH ML CONTAINS SELAMECTIN 60 MG) 50,000 Numbers 4 SELAMECTIN 3060.149 gm.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||SELAMECTIN 6% SPOT ON 0.25 ML TUBE(EACH ML CONTAINS SELAMECTIN 60 MG)|| 11,000 Numbers|1|SELAMECTIN|168.305 gm.| ||SELAMECTIN 6% SPOT ON 0.50 ML TUBE(EACH ML CONTAINS SELAMECTIN 60 MG)|| 47,000 Numbers|2|SELAMECTIN|1438.153 gm.| ||SELAMECTIN 6% SPOT ON 0.75 ML TUBE(EACH ML CONTAINS SELAMECTIN 60 MG)|| 92000 Numbers|3|SELAMECTIN|4222.735 gm.| ||SELAMECTIN 6% SPOT ON 1 ML TUBE(EACH ML CONTAINS SELAMECTIN 60 MG)|| 50,000 Numbers|4|SELAMECTIN|3060.149 gm.|

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000 Numbers|3|SELAMECTIN|4222.735 gm.| ||SELAMECTIN 6% SPOT ON 1 ML TUBE(EACH ML CONTAINS SELAMECTIN 60 MG)|| 50,000 Numbers|4|SELAMECTIN|3060.149 gm.|

UDIN00501924AM24

SELAMECTIN 6% SPOT ON 2 ML<br>TUBE(EACH<br>ML<br>CONTAINS<br>SELAMECTIN 60 MG)<br>30,000 Numbers<br>5<br>SELAMECTIN<br>3671.932 gm.<br>SELAMECTIN 6% SPOT ON 4 ML<br>TUBE(EACH<br>ML<br>CONTAINS<br>SELAMECTIN 60 MG)<br>2000 Numbers<br>6<br>SELAMECTIN<br>489.605 gm.<br>RA concerned may take further necessary action as per above decision of NC.	SELAMECTIN 6% SPOT ON 2 ML<br>TUBE(EACH<br>ML<br>CONTAINS<br>SELAMECTIN 60 MG)	<br> <br>30,000 Numbers	5	SELAMECTIN	3671.932 gm.
	SELAMECTIN 6% SPOT ON 4 ML<br>TUBE(EACH<br>ML<br>CONTAINS<br>SELAMECTIN 60 MG)	<br> <br>2000 Numbers	6	SELAMECTIN	489.605 gm.

Case No.	Case No.	46 / NC/3/MEET/Feb/202324/23	46 / NC/3/MEET/Feb/202324/23	46 / NC/3/MEET/Feb/202324/23	46 / NC/3/MEET/Feb/202324/23	46 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00007375AM24
RA File Number		05AA04009888 AM22
Licence No and<br>Date		0511002414/04/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Dec/202324/17dated20/12/2023against advance authorization<br>**No.

ase as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo. NC/3/MEET/Dec/202324/17dated20/12/2023against advance authorization No. 0511015244dated11/10/2022, 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. 1 7(Alpha)-(2-Hydroxy-3,3-Dimethyl- 2-Butyl)-6,14-Endo-Ethano-6,7,8,14- Tetrahydronorthebaine 20-t-butyl- dihydro-northevinol 1.955 kg. 4 Cyclopropyl Methanol 1.60 kg. 7 Mehtane Sulfonyl Chloride 2.50 kg. 10 Lithium Bromide 2.00 kg. 13 Thiophenol 2.50 kg. Buprenorphine Hydrochloride ((Bulk Drug/ Pharmacopeal Grade)) 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Buprenorphine Hydrochloride ((Bulk Drug/ Pharmacopeal Grade))||1 kg.|1|7(Alpha)-(2-Hydroxy-3,3-Dimethyl- 2-Butyl)-6,14-Endo-Ethano-6,7,8,14- Tetrahydronorthebaine 20-t-butyl- dihydro-northevinol|1.955 kg.| |||||4|Cyclopropyl Methanol|1.60 kg.| |||||7|Mehtane Sulfonyl Chloride|2.50 kg.| |||||10|Lithium Bromide|2.00 kg.| |||||13|Thiophenol|2.50 kg.|

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ydro-northevinol|1.955 kg.| |||||4|Cyclopropyl Methanol|1.60 kg.| |||||7|Mehtane Sulfonyl Chloride|2.50 kg.| |||||10|Lithium Bromide|2.00 kg.| |||||13|Thiophenol|2.50 kg.|

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	16	Dimethyl Formamide	4.00 kg.
	19	Triethyl Amine	4.80 kg.
	22	Toluene	20.50 kg.
	25	Methanol	5.50 kg.
	28	Activated Carbon / Eno Carbon	0.200 kg.
	31	Acetone	4.50 kg.
Buprenorphine Hydrochloride Tablets 2<br>Mg ((Each Tablets Contains 2mg<br>Buprenorphine HCL ) Bulk Drug Qty.<br>20.4 kg)	As per SION A-412
Buprenorphine Hydrochloride Tablets 8<br>Mg( (Each Tablets Contains 8mg<br>Buprenorphine HCL ) Bulk Drug Qty.<br>81.6 Kg.)	As per SION A-412

Bulk Drug Qty. 20.4 kg)||As per SION A-412||| ||Buprenorphine Hydrochloride Tablets 8 Mg( (Each Tablets Contains 8mg Buprenorphine HCL ) Bulk Drug Qty. 81.6 Kg.)||As per SION A-412|||

Case No.	47 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007692AM24
RA File Number	03AA04009329 AM22
Licence No and<br>Date	0311003661/08/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the written comments of Department of<br>Chemicals & Petrochemicals vide their U.O. No.14010/32/2013-Ch.II dated 15/04/2015 and decision for same<br>export product/import product in meetingNo.1/82-ALC4/2015dated15/04/2015against advance authorization<br>No.0310788806dated05/09/2014, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-

UDIN00501924AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
SODIUM SACCHARIN<br>(PURE DENTAL GRADE)	1 kg.	1	SODIUM SACCHARIN	1.02 kg.

UDIN00501924AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
SODIUM SACCHARIN<br>(PURE DENTAL GRADE)	1 kg.	1	SODIUM SACCHARIN	1.02 kg.

Case No.	48 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007661AM24
RA File Number	34AA04004352 AM22
Licence No and<br>Date	3411000801/06/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.3410046524 dated 05/11/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Gamma Nonalactone (Aldehyde C18)<br>1 kg.<br>1<br>N-Hexanol<br>1.36 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	49 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007920AM24
RA File Number	05AA04070230 AM22

UDIN00501924AM24

Licence No and 0511004557/06/09/2021 Date Norms Committee Decision:

UDIN00501924AM24

Licence No and 0511004557/06/09/2021 Date Norms Committee Decision:

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

Case No.	50 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007959AM24
RA File Number	05AA04076110 AM22
Licence No and<br>Date	0511004515/06/09/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>ETHYLENE DI CHLORIDE1.105kg.<br>2<br>ACID GRADE<br>FLUORSPAR<br>2.121 kg.<br>3<br>EMPTY CANS<br>SUPERTECH 340G<br>Relevant as per<br>packing policy<br> HFC-134a<br>(HYDROFLUOROCARBAN<br>1,1,1,2-TETRAFLUOROETHANE)<br>1kg<br>4<br>CAPS FOR EMPTY CANS /<br>TINPLATE CAP 1/2 Inch<br>Relevant as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	51 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008056AM24

UDIN00501924AM24

UDIN00501924AM24

RA File Number	05AA04076999 AM22
Licence No and<br>Date	0511004742/15/09/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	52 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008200AM24
RA File Number	05AA040108247 AM22
Licence No and<br>Date	0511006681/07/12/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	53 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008265AM24
RA File Number	05AX04000189 AM22
Licence No and<br>Date	0511007079/21/12/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00008265AM24| |RA File Number|05AX04000189 AM22| |Licence No and Date|0511007079/21/12/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	54 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006821AM24
RA File Number	038504000145 AM21
Licence No and<br>Date	0311010587/17/01/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

28 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

UDIN00501924AM24

Case No.	55 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006625AM24
RA File Number	03AX04001369 AM22
Licence No and<br>Date	0311011710/23/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the written comments of Department of<br>Chemicals & Petrochemicals vide their U.O. No.14010/32/2013-Ch.II dated 15/04/2015 and decision for same<br>export product/import product in meetingNo.1/82-ALC4/2015dated15/04/2015against advance authorization<br>No.0310788806dated05/09/2014, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

/import product in meetingNo.1/82-ALC4/2015dated15/04/2015against advance authorization No.0310788806dated05/09/2014, 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. SODIUM SACCHARIN (PURE DENTAL GRADE) 1 kg. 1 SODIUM SACCHARIN 1.02 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	56 / NC/3/MEET/Feb/202324/23
Case Status<br>	Case Approved
Party Name<br>	KusuMa PharMa
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number<br>	HQRNORM REVIW00007433AM24
RA File Number<br>	03AX04001369 AM22
Licence No and<br>Date<br>	0311011710/23/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the written comments of Department of<br>Chemicals & Petrochemicals vide their U.O. No.14010/32/2013-Ch.II dated 15/04/2015 and decision for same<br>export product/import product in meetingNo.1/82-ALC4/2015dated15/04/2015against advance authorization<br>No.0310788806dated05/09/2014, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-

UDIN00501924AM24

88806dated05/09/2014**, 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:-||

UDIN00501924AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>SODIUM SACCHARIN<br>(PURE DENTAL GRADE)<br>1 kg.<br>1<br>SODIUM SACCHARIN<br>1.02 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product<br>SODIUM SACCHARIN<br>(PURE DENTAL GRADE)	Qty.	Sl. No.	Import Items	Qty. allowed.
		1 kg.	1	SODIUM SACCHARIN	1.02 kg.

Case No.	57 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006822AM24
RA File Number	03AX04000957 AM22
Licence No and<br>Date	0311011997/28/02/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00006822AM24| |RA File Number|03AX04000957 AM22| |Licence No and Date|0311011997/28/02/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	58 / NC/3/MEET/Feb/202324/23	58 / NC/3/MEET/Feb/202324/23	58 / NC/3/MEET/Feb/202324/23	58 / NC/3/MEET/Feb/202324/23	58 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00008294AM24
RA File Number		03AX04001604 AM22
Licence No and<br>Date		0311013055/17/03/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as<br>under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00501924AM24

Ciprofloxacin	Hydrochloride	<br>1	kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.294 kg.
BP/EP/USP					5Fluorobenzoyl) Acrylate
				2	Piperazine Anhydrous	0.390 kg.

loxacin	Hydrochloride	<br>1	kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.294 kg.
BP/EP/USP					5Fluorobenzoyl) Acrylate
				2	Piperazine Anhydrous	0.390 kg.

Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms.

Case No.	Case No.	59 / NC/3/MEET/Feb/202324/23	59 / NC/3/MEET/Feb/202324/23	59 / NC/3/MEET/Feb/202324/23	59 / NC/3/MEET/Feb/202324/23	59 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00008340AM24
RA File Number		03AX04001595 AM22
Licence No and<br>Date		0311013059/17/03/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as<br>under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg. Ciprofloxacin Hydrochloride BP/EP/USP 1 kg. 2 Piperazine Anhydrous 0.390 kg. Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Ciprofloxacin Hydrochloride BP/EP/USP|| 1 kg.|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg.| |||||2|Piperazine Anhydrous|0.390 kg.| ||Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis||||||

UDIN00501924AM24

of these norms.

Case No.	60 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008341AM24
RA File Number	03AX04001592 AM22
Licence No and<br>Date	0311013060/17/03/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as<br>under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.294 kg.<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP<br>1 kg.<br>2<br>Piperazine Anhydrous<br>0.390 kg.<br>Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis<br>of these norms.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	61 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED

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e further necessary action as per above decision of NC.||

Case No.	61 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED

UDIN00501924AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008342AM24
RA File Number	03AX04001843 AM22
Licence No and<br>Date	0311013348/25/03/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as<br>under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.294 kg.<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP<br>1 kg.<br>2<br>Piperazine Anhydrous<br>0.390 kg.<br>Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis<br>of these norms.<br>RA concerned may take further necessary action as per above decision of NC.

orms are only for regularization purpose and no repeat license will be issued on the basis** of these norms. RA concerned may take further necessary action as per above decision of NC.||

Case No.	62 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008343AM24
RA File Number	03AX04001856 AM22
Licence No and<br>Date	0311013341/25/03/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar

UDIN00501924AM24

Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:

The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP	<br>1 kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.294 kg.
		2	Piperazine Anhydrous	0.390 kg.

Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms.

Case No.	Case No.	63 / NC/3/MEET/Feb/202324/23	63 / NC/3/MEET/Feb/202324/23	63 / NC/3/MEET/Feb/202324/23	63 / NC/3/MEET/Feb/202324/23	63 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00008344AM24
RA File Number		03AX04001844 AM22
Licence No and<br>Date		0311013405/28/03/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as<br>under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00501924AM24

Ciprofloxacin	Hydrochloride	<br>1	kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.294 kg.
BP/EP/USP					5Fluorobenzoyl) Acrylate
				2	Piperazine Anhydrous	0.390 kg.

loxacin	Hydrochloride	<br>1	kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.294 kg.
BP/EP/USP					5Fluorobenzoyl) Acrylate
				2	Piperazine Anhydrous	0.390 kg.

Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms.

Case No.	64 / NC/3/MEET/Feb/202324/23	64 / NC/3/MEET/Feb/202324/23	64 / NC/3/MEET/Feb/202324/23	64 / NC/3/MEET/Feb/202324/23	64 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006448AM24
RA File Number	03AX04000062 AM23
Licence No and<br>Date	0311013759/11/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202122/16 dated 08/04/2022against advance<br>authorizationNo.0311008243dated03/11/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

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:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 PHENOL 0.557 kg. 2 ISODECYL ALCOHOL OR 2 PROPYL HEPTANOL 0.419 kg. DIPHENYL ISODECYL PHOSPHITE ((DPDP)) 1 kg. 3 YELLOW PHOSPHORUS 0.087 kg. RA concerned may take further necessary action as per above decision of NC.|||||| |||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||| 1 kg.|1|PHENOL|0.557 kg.| ||||2|ISODECYL ALCOHOL OR 2 PROPYL HEPTANOL|0.419 kg.| ||||3|YELLOW PHOSPHORUS|0.087 kg.| ||||decision of NC.|||

UDIN00501924AM24

Case No.	65 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008345AM24
RA File Number	03AX04000017 AM23
Licence No and<br>Date	0311013787/11/04/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as<br>under:-<br>Export Product<br>Qty.<br>**Sl. No.

items in their licenses: The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg. Ciprofloxacin Hydrochloride BP/EP/USP 1 kg. 2 Piperazine Anhydrous 0.390 kg. Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms. RA concerned may take further necessary action as per above decision of NC.||

Case No.	66 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008363AM24
RA File Number	03AX04000191 AM23
Licence No and<br>Date	0311014067/22/04/2022

UDIN00501924AM24

Norms Committee Decision:

As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:

The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as under:-

int DGFT to ascertain the exact wastage of import items in their licenses:

The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Ciprofloxacin Hydrochloride -<br>USP	<br>1 kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.294 kg.
		2	Piperazine Anhydrous	0.390 kg.

Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms.

Case No.	67 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008346AM24
RA File Number	03AX04000196 AM23
Licence No and<br>Date	0311014132/25/04/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as<br>under:-

UDIN00501924AM24

wastage of import items in their licenses: The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as under:-||

UDIN00501924AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Ciprofloxacin Hydrochloride	1 kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.294 kg.
		2	Piperazine Anhydrous	0.390 kg.

Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms.

Case No.	68 / NC/3/MEET/Feb/202324/23
Case Status	Case Rejected
Party Name	KOSHA CHEMTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007455AM24
RA File Number	03AX04000276 AM23
Licence No and<br>Date	0311014758/17/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.

Committee Decision: The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence, the Committee decided torejectthe case.||

Case No.	69 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008347AM24
RA File Number	03AX04000640 AM23
Licence No and<br>Date	0311014736/17/05/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar

UDIN00501924AM24

Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:

The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Ciprofloxacin<br>Hydrochloride<br>IP/BP/USP	<br>1 kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-<br>5Fluorobenzoyl) Acrylate	1.294 kg.
		2	Piperazine Anhydrous	0.390 kg.

Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms.

Case No.	Case No.	70 / NC/3/MEET/Feb/202324/23	70 / NC/3/MEET/Feb/202324/23	70 / NC/3/MEET/Feb/202324/23	70 / NC/3/MEET/Feb/202324/23	70 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00008348AM24
RA File Number		03AX04000697 AM23
Licence No and<br>Date		0311014994/25/05/2022
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04/02/2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Joint DGFT to ascertain the exact wastage of import items in their licenses:<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as<br>under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00501924AM24

Ciprofloxacin	Hydrochloride	<br>1	kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.294 kg.
BP/EP/USP					5Fluorobenzoyl) Acrylate
				2	Piperazine Anhydrous	0.390 kg.

loxacin	Hydrochloride	<br>1	kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.294 kg.
BP/EP/USP					5Fluorobenzoyl) Acrylate
				2	Piperazine Anhydrous	0.390 kg.

Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms.

Case No.	71 / NC/3/MEET/Feb/202324/23	71 / NC/3/MEET/Feb/202324/23	71 / NC/3/MEET/Feb/202324/23	71 / NC/3/MEET/Feb/202324/23	71 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00000608AM24
RA File Number	05AX04000553 AM23
Licence No and<br>Date	0511012820/26/05/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms 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>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>ETHYLENE DI CHLORIDE1.105kg.<br>2<br>ACID GRADE<br>FLUORSPAR<br>2.121 kg.<br>3<br>EMPTY CANS<br>(340 GRAM)<br>Relevant as per<br>packing policy<br>HFC-134a<br>(HYDROFLUOROCARBAN<br>1,1,1,2-TETRAFLUOROETHANE)<br>1kg<br>4<br>CAPS FOR EMPTY CANS/<br>TINPLATE VALVE 1/2"<br>Relevant as per<br>packing policy
		Qty.	Sl. No.	Import Items<br>	**Qty.

DROFLUOROCARBAN 1,1,1,2-TETRAFLUOROETHANE) 1kg 4 CAPS FOR EMPTY CANS/ TINPLATE VALVE 1/2" Relevant as per packing policy|||||| |||Qty.|Sl. No.|Import Items |Qty. allowed.| ||| 1kg|1 |ETHYLENE DI CHLORIDE|1.105kg.| ||||2 |ACID GRADE FLUORSPAR |2.121 kg.| ||||3 |EMPTY CANS (340 GRAM) |Relevant as per packing policy| ||||4 |CAPS FOR EMPTY CANS/ TINPLATE VALVE 1/2" |Relevant as per packing policy|

UDIN00501924AM24

Case No.	72 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00004512AM24
RA File Number	03AX04000506 AM23
Licence No and<br>Date	0311015097/30/05/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>ISOBUTYL ACETATE<br>Indigenously source<br>2<br>REFINED GLYCERINE ( GLYCEROL )<br>0.444 kg.<br>3<br>ACETIC ACID<br>0.74 kg.<br>4<br>ACETIC ANHYDRIDE<br>0.06 kg.<br>TRIACETIN<br>1 kg.<br>5<br>MARLON AS 3<br>Indigenously source<br>RA concerned may take further necessary action as per above decision of NC.

D 0.74 kg. 4 ACETIC ANHYDRIDE 0.06 kg. TRIACETIN 1 kg. 5 MARLON AS 3 Indigenously source RA concerned may take further necessary action as per above decision of NC.||

Case No.	73 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008349AM24
RA File Number	03AX04000874 AM23
Licence No and	0311015096/30/05/2022

UDIN00501924AM24

Date

Norms Committee Decision:

The Committee examined the Factory Visit Report and after deliberation, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Ciprofloxacin HCL	1 kg.	1	Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-	1.294 kg.
			5Fluorobenzoyl) Acrylate
		2	Piperazine Anhydrous	0.390 kg.

Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms.

||5Fluorobenzoyl) Acrylate|| |||2|Piperazine Anhydrous|0.390 kg.|

Note: The above norms are only for regularization purpose and no repeat license will be issued on the basis of these norms.

Case No.	74 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007230AM24
RA File Number	31AX04000064 AM23
Licence No and Date	3111001476/24/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo. NC/3/MEET/Sep/202324/13dated14/09/2023against advance authorization
No. 3111000201 dated 08/03/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.		Import Items	Qty. allowed.

UDIN00501924AM24

ETHYLENE DI AMINE	1 kg	1	MONOETHANOLAMINE	1.06 kg.
(ORGANIC CHEMICAL)
		2	AMMONIA ANHYDROUS	0.294 kg.

mport Items**|Qty. allowed.||

UDIN00501924AM24

ETHYLENE DI AMINE	1 kg	1	MONOETHANOLAMINE	1.06 kg.
(ORGANIC CHEMICAL)
		2	AMMONIA ANHYDROUS	0.294 kg.

Case No.	Case No.	75 / NC/3/MEET/Feb/202324/23	75 / NC/3/MEET/Feb/202324/23	75 / NC/3/MEET/Feb/202324/23	75 / NC/3/MEET/Feb/202324/23	75 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00006037AM24
RA File Number		NA
Licence No and<br>Date		0711004432/28/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance<br>authorizationNo.0711003901 dated 19/05/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Cyanocobala min inj.

7 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. Cyanocobala min inj. 1mL(2mL Vial - filled with 1mg of Cyanocobalamin as bulk drug mixed in water for injection and filled in 2mL Vial and capped with 13mm chlorobutyle Rubber Stopper) 681818.18 Numbers 1 V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS) Relevant, as per Packing Policy Furosemide Injection 10mg/mL - 4mL Vial(4mL Vial - filled with 40mg of furosemide as bulk drug mixed in water for injection and filled in 4mL Vial and capped with 13mm chlorobutyle Rubber Stopper) 1863636.36 Numbers 2 V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS) Relevant, as per Packing Policy Prochlorperazine Edisylate Injection USP 10mg/2mL(2mL Vial - Prochlorperazine Edisylate Injection USP 10mg/2mL and capped with 13mm 181818.18 Numbers 3 V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS) Relevant, as per Packing Policy||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Cyanocobala min inj.

(13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS) Relevant, as per Packing Policy||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Cyanocobala min inj. 1mL(2mL Vial - filled with 1mg of Cyanocobalamin as bulk drug mixed in water for injection and filled in 2mL Vial and capped with 13mm chlorobutyle Rubber Stopper)||681818.18 Numbers|1|V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS)|Relevant, as per Packing Policy| ||Furosemide Injection 10mg/mL - 4mL Vial(4mL Vial - filled with 40mg of furosemide as bulk drug mixed in water for injection and filled in 4mL Vial and capped with 13mm chlorobutyle Rubber Stopper)||1863636.36 Numbers|2|V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS)|Relevant, as per Packing Policy| ||Prochlorperazine Edisylate Injection USP 10mg/2mL(2mL Vial - Prochlorperazine Edisylate Injection USP 10mg/2mL and capped with 13mm||181818.18 Numbers|3|V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS)|Relevant, as per Packing Policy|

njection USP 10mg/2mL and capped with 13mm||181818.18 Numbers|3|V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS)|Relevant, as per Packing Policy|

Case No.	Case No.	75 / NC/3/MEET/Feb/202324/23	75 / NC/3/MEET/Feb/202324/23	75 / NC/3/MEET/Feb/202324/23	75 / NC/3/MEET/Feb/202324/23	75 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00006037AM24
RA File Number		NA
Licence No and<br>Date		0711004432/28/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance<br>authorizationNo.0711003901 dated 19/05/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Cyanocobala min inj.

UDIN00501924AM24

chlorobutyle Rubber Stopper)

br>Numbers|3|V-35 4432/50/GREY Westar? RS SIL 1 (13mm Chlorobutyl R/S V-35 4432/50 Grey - RFS)|Relevant, as per Packing Policy|

UDIN00501924AM24

chlorobutyle Rubber Stopper)

Case No.	76 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006557AM24
RA File Number	NA
Licence No and<br>Date	0711004447/28/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance<br>authorizationNo.0711004447dated28/06/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>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. Sodium Bicarbonate Injection 84mg/mL - 50mL Vial(Sodium Bicarbonate as bulk drug filled in 50mL Vial and capped with 20mm Bromobutyl Grey Rubber Stopper) 363636.0 Numbers 1 S-127 4432/50/Grey Westar RS SIL 1 (20mm Grey Chlorobutyl Rubber Stopper- RFS) Relevant, as per packing policy Sodium Bicarbonate Injection 84mg/mL - 50mL Vial (Sodium Bicarbonate Injection 84mg/mL -50mL Vial) 90909.0 Numbers 2 S-127 4432/50/Grey Westar RS SIL 1 (20mm Grey Chlorobutyl Rubber Stopper- RFS) Relevant, as per packing policy RA concerned may take further necessary action as per above decision of NC.||

Case No.	77 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024

UDIN00501924AM24

/202324/23| |---|---| |Case Status|Case Approved| |Party Name|BALAJI SPECIALITY CHEMICALS LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024|

UDIN00501924AM24

HQ File Number	HQRNORM REVIW00007086AM24
RA File Number	31AX04000054 AM23
Licence No and Date	3111001493/04/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Sep/202324/13dated14/09/2023against advance authorization<br>No. 3111000201 dated 08/03/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>MONOETHANOLAMINE<br>1.06 kg.<br>ETHYLENE DI AMINE<br>(ORGANIC CHEMICAL)<br>1 kg<br>2<br>AMMONIA ANHYDROUS<br>0.294 kg.<br>RA concerned may take further necessary action as per above decision of NC.

OETHANOLAMINE 1.06 kg. ETHYLENE DI AMINE (ORGANIC CHEMICAL) 1 kg 2 AMMONIA ANHYDROUS 0.294 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	78 / NC/3/MEET/Feb/202324/23
Case Status	Case Rejected
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007981AM24
RA File Number	03AX04001943 AM23
Licence No and<br>Date	0311016208/08/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms andit was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

Case No.	79 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	APEX DRUG HOUSE
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007290AM24
RA File Number	03AX04002053 AM23
Licence No and<br>Date	0311016315/13/07/2022

UDIN00501924AM24

Norms Committee Decision:

The Committee considered the request of firm for fixation of ad-hoc norms 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.
Benzocaine & Dequalinium Chloride<br>Lozenges (Benzocaine Dequalinium<br>Chloride Lozenges (ELIDOL DUO<br>(Raspberry Flavour) Each Lozenge<br>contains Benzocaine BP 10 mg,<br>Dequalinium Chloride 0.25 mg Net<br>Content: 1) Dequalinium Chloride BP<br>- 518.518 GRAMS 2) Benzocaine BP<br>- Kgs (Indigenous): 31.111 KGS)	2074072<br>Numbers	1	Dequalinium Chloride BP	528.90 gm.

Case No.	80 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00002187AM23
RA File Number	09AX04000313 AM23
Licence No and<br>Date	0911003379/21/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Get the Advance Authorisation amended to show actual export item.

Case No.	81 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007146AM24
RA File Number	31AX04000115 AM23

UDIN00501924AM24

Licence No and Date

3111001583/22/07/2022

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo. NC/3/MEET/Jan/202324/13dated18/01/2024against advance authorization No. 3111002080dated10/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CYANAMIDE 50% SOLUTION 1 kg. 1 CALCIUM CYANAMIDE (Purity 63% as per CoA) 1.913 kg. RA concerned may take further necessary action as per above decision of NC.

ty. allowed.** CYANAMIDE 50% SOLUTION 1 kg. 1 CALCIUM CYANAMIDE (Purity 63% as per CoA) 1.913 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	82 / NC/3/MEET/Feb/202324/23	82 / NC/3/MEET/Feb/202324/23	82 / NC/3/MEET/Feb/202324/23	82 / NC/3/MEET/Feb/202324/23	82 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM REVIW00006819AM24
RA File Number		08AX04000679 AM23
Licence No and<br>Date		0811005628/26/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance authorization<br>No.0811001850dated25/06/2021; it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>O-CHLOROBENZYL CYANIDE<br>2.20 kg.<br>Indoline<br>1 kg.<br>2<br>TOLUENE<br>1.00 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Indoline		1 kg.	1	O-CHLOROBENZYL CYANIDE	2.20 kg.
				2	TOLUENE	1.00 kg.

UDIN00501924AM24

|||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Indoline||1 kg.|1|O-CHLOROBENZYL CYANIDE|2.20 kg.| |||||2|TOLUENE|1.00 kg.| ||||||||

UDIN00501924AM24

Case No.	83 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008151AM24
RA File Number	03AX04002952 AM23
Licence No and<br>Date	0311017587/08/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along with relevant documents from the firm.		Personal Hearing

Case No.	84 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008055AM24
RA File Number	05AX04001704 AM23
Licence No and<br>Date	0511014859/16/09/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00008055AM24| |RA File Number|05AX04001704 AM23| |Licence No and Date|0511014859/16/09/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	85 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00003901AM23
RA File Number	03AX04003806 AM23
Licence No and<br>Date	0311018798/22/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

48 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

UDIN00501924AM24

Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>1<br>NONYL PHENOL<br>1.066 kg.<br>TRIS NONYL PHENYL PHOSPHITE((TNPP))<br>1 kg.<br>2<br>YELLOW PHOSPHORUS<br>0.0506 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	TRIS NONYL PHENYL PHOSPHITE((TNPP))	1 kg.	1	NONYL PHENOL	1.066 kg.
			2	YELLOW PHOSPHORUS	0.0506 kg.

*Qty.**|**Sl. No. **|Import Items|Qty. allowed.| |---|---|---|---|---|---| ||TRIS NONYL PHENYL PHOSPHITE((TNPP))|1 kg.|1|NONYL PHENOL|1.066 kg.| ||||2|YELLOW PHOSPHORUS|0.0506 kg.|

Case No.	86 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00003910AM23
RA File Number	30AX04000299 AM23
Licence No and<br>Date	3011002731/25/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor<br>obtaining their comments.

Case No.	Case No.	87 / NC/3/MEET/Feb/202324/23	87 / NC/3/MEET/Feb/202324/23	87 / NC/3/MEET/Feb/202324/23	87 / NC/3/MEET/Feb/202324/23	87 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		SUNSHIELD CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00003993AM23
RA File Number		03AX04003805 AM23
Licence No and<br>Date		0311018972/01/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

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 DI-PHENYLAMINE 0.470 kg. SDPA 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||SDPA||1 kg.|1|DI-PHENYLAMINE|0.470 kg.|

Case No.	Case No.	87 / NC/3/MEET/Feb/202324/23	87 / NC/3/MEET/Feb/202324/23	87 / NC/3/MEET/Feb/202324/23	87 / NC/3/MEET/Feb/202324/23	87 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		SUNSHIELD CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00003993AM23
RA File Number		03AX04003805 AM23
Licence No and<br>Date		0311018972/01/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>DI-PHENYLAMINE<br>0.470 kg.<br>SDPA<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	SDPA		1 kg.	1	DI-PHENYLAMINE	0.470 kg.

UDIN00501924AM24

(STYRENATED DI-PHENYLAMINE) 2 STYRENE MONOMER 0.529 kg.

rt Product**||Qty.|Sl. No.|Import Items|Qty. allowed.| ||SDPA||1 kg.|1|DI-PHENYLAMINE|0.470 kg.|

UDIN00501924AM24

(STYRENATED DI-PHENYLAMINE) 2 STYRENE MONOMER 0.529 kg.

Case No.	88 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007919AM24
RA File Number	05AX04002217 AM23
Licence No and<br>Date	0511015715/09/11/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	89 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008380AM24
RA File Number	09AX04000689 AM23
Licence No and<br>Date	0911003913/09/11/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Percentage yield at every stage of reaction.<br>1.

Case No.	90 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007116AM24
RA File Number	31AX04000250 AM23
Licence No and Date	3111001849/29/11/2022
Norms Committee Decision:

UDIN00501924AM24

/ 23 and 19/02/2024| |HQ File Number|HQRNORM REVIW00007116AM24| |RA File Number|31AX04000250 AM23| |Licence No and Date|3111001849/29/11/2022| |Norms Committee Decision:||

UDIN00501924AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Sep/202324/13 dated 14/09/2023 against advance authorization No. 3111000201 dated 08/03/2021 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
ETHYLENE DI AMINE	1 kg	1	MONOETHANOLAMINE	1.06 kg.
(ORGANIC CHEMICAL)
		2	AMMONIA ANHYDROUS	0.294 kg.

Case No.	91 / NC/3/MEET/Feb/202324/23	91 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/	23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007528AM24
RA File Number	34AX04000871 AM23
Licence No and<br>Date	3411003177/23/12/2022
Norms Committee Decision:
The Committee considered the case as per		agenda and taking cue from the earlier decision	for same export
product/import product in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024against advance authorization

ase as per|||agenda and taking cue from the earlier decision|||for same export|| |product/import product in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024against advance authorization|||||||| |No. 3411003731dated18/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details|||||||| |given below or as|applied by the firm, whichever is less:-||||||| |Export Product|||Qty.|**Sl. No. **|Import Items|Qty. allowed.|| |Undecavertol|(Kakdinol)((4-Methyl-3-||1 kg.|1|Propionaldehyde|0.947 kg.|| |decen- 5-ol) )|||||||| |||||2|1-Pentanol / N Amyl Alcohol|0.709 kg.|| |||||3|Magnesium Turning|0.182 kg.||

UDIN00501924AM24

Case No.	92 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008388AM24
RA File Number	03AX04004899 AM23
Licence No and<br>Date	0311020446/03/01/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case along with relevant documents from the firm.

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

Case No.<br>93 / NC/3/MEET/Feb/202324/23
Case Status<br>Case Approved
Party Name<br>MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number<br>HQRNORM APPLY 00006560AM24
RA File Number<br>NA
Licence No and<br>Date<br>0711006109/06/01/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision		for same export
product/import product in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023		against advance
authorizationNo.0711006109dated06/01/2023,it was decided to fix	ad-hoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
Rocuronium Bromide Injection<br>318182.0<br>1	S-127 4432/50/GREY	Relevant, as per
5mg/ml - 5mL Vial(Rocuroniu m<br>Numbers	Westar? RS SIL 1 (20mm	packing policy
Bromide Injection 5mg/ml - 5mL	Grey Chlorobutyl Rubber
Vial)	Stopper - RFS)
Rocuronium Bromide Injection<br>227273.0<br>2	S-127 4432/50/GREY	Relevant, as per
5mg/ml - 5mL Vial (Rocuronium<br>Numbers	Westar? RS SIL 1 (20mm	packing policy

r||| |Vial)|Stopper - RFS)||| |Rocuronium Bromide Injection 227273.0 2|S-127 4432/50/GREY|Relevant, as per|| |5mg/ml - 5mL Vial (Rocuronium Numbers|Westar? RS SIL 1 (20mm|packing policy||

Case No.<br>93 / NC/3/MEET/Feb/202324/23
Case Status<br>Case Approved
Party Name<br>MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number<br>HQRNORM APPLY 00006560AM24
RA File Number<br>NA
Licence No and<br>Date<br>0711006109/06/01/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision		for same export
product/import product in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023		against advance
authorizationNo.0711006109dated06/01/2023,it was decided to fix	ad-hoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
Rocuronium Bromide Injection<br>318182.0<br>1	S-127 4432/50/GREY	Relevant, as per
5mg/ml - 5mL Vial(Rocuroniu m<br>Numbers	Westar? RS SIL 1 (20mm	packing policy
Bromide Injection 5mg/ml - 5mL	Grey Chlorobutyl Rubber
Vial)	Stopper - RFS)
Rocuronium Bromide Injection<br>227273.0<br>2	S-127 4432/50/GREY	Relevant, as per
5mg/ml - 5mL Vial (Rocuronium<br>Numbers	Westar? RS SIL 1 (20mm	packing policy

UDIN00501924AM24

)||| |Rocuronium Bromide Injection 227273.0 2|S-127 4432/50/GREY|Relevant, as per|| |5mg/ml - 5mL Vial (Rocuronium Numbers|Westar? RS SIL 1 (20mm|packing policy||

UDIN00501924AM24

Bromide Injection 5mg/ml-5mL<br>Vial - Filled with 50mg of<br>Rocuronium Bromide USP 10 mg<br>as bulk drug filled in 5mL vial and<br>capped with 20mm Bromobutyl<br>Grey Rubber Stopper)<br>Grey Chlorobutyl Rubber<br>Stopper - RFS)<br>RA concerned may take further necessary action as per above decision of NC.	Bromide Injection 5mg/ml-5mL<br>Vial - Filled with 50mg of<br>Rocuronium Bromide USP 10 mg<br>as bulk drug filled in 5mL vial and<br>capped with 20mm Bromobutyl<br>Grey Rubber Stopper)			Grey Chlorobutyl Rubber<br>Stopper - RFS)

Case No.	94 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008389AM24
RA File Number	03AX04005022 AM23
Licence No and<br>Date	0311020561/09/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along with relevant documents from the firm.		Personal Hearing

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

Case No.	Case No.	95 / NC/3/MEET/Feb/202324/23	95 / NC/3/MEET/Feb/202324/23	95 / NC/3/MEET/Feb/202324/23	95 / NC/3/MEET/Feb/202324/23	95 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00006995AM23
RA File Number		NA
Licence No and Date		0911004487/17/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>ORTHO PHENYLENEDIAMINE<br>0.55 kg.<br>SALISOL HS (PBSA) / Ensulizole (2-<br>Phenylbenzimidazole-5- sulfonic acid)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	SALISOL HS (PBSA) / Ensulizole (2-<br>Phenylbenzimidazole-5- sulfonic acid)		<br>1 kg.	1	ORTHO PHENYLENEDIAMINE	0.55 kg.

UDIN00501924AM24

2 BENZALDEHYDE 0.545 kg.

llowed.**| ||SALISOL HS (PBSA) / Ensulizole (2- Phenylbenzimidazole-5- sulfonic acid)|| 1 kg.|1|ORTHO PHENYLENEDIAMINE|0.55 kg.| ||||||||

UDIN00501924AM24

2 BENZALDEHYDE 0.545 kg.

Case No.	96 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00008390AM24
RA File Number	03AX04005710 AM23
Licence No and<br>Date	0311021583/24/02/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case along with relevant documents from the firm.

Case No.	97 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006563AM24
RA File Number	08AX04001977 AM23
Licence No and<br>Date	0811007532/10/03/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>i.
stage wise percentage yields on molar basis.
ii. Justification for requirement of raw material.

tions with molecular and structural formula and molecular weights along with** i.|| |stage wise percentage yields on molar basis.|| |ii. Justification for requirement of raw material.||

i. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.

Case No.	98 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007449AM24
RA File Number	03AX04005815 AM23

UDIN00501924AM24

Licence No and 0311022080/11/03/2023 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the written comments of Department of Chemicals & Petrochemicals vide their U.O. No.14010/32/2013-Ch.II dated 15/04/2015 and decision for same export product/import product in meeting No.1/82-ALC4/2015 dated 15/04/2015 against advance authorization No.0310788806 dated 05/09/2014 , 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.
SODIUM SACCHARIN<br>(PURE DENTAL GRADE)	1 kg.	1	SODIUM SACCHARIN	1.02 kg.

hichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
SODIUM SACCHARIN<br>(PURE DENTAL GRADE)	1 kg.	1	SODIUM SACCHARIN	1.02 kg.

Case No.	99 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006561AM24
RA File Number	04AX04001126 AM23
Licence No and<br>Date	0411005084/21/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Get the Advance Authorisation amended with correct description of export and import product from<br>concerned RA.<br>i.

Case No.	100 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00007548AM24
RA File Number	03AX04001130 AM24
Licence No and<br>Date	0311024614/16/06/2023

UDIN00501924AM24

Norms Committee Decision:

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

Case No.	101 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AROCHEMA INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006496AM24
RA File Number	26AX04000031 AM24
Licence No and<br>Date	2611001006/30/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance authorization<br>No. 2611000716dated23/09/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>SCLAREOL<br>2.0458 kg.<br>ORCANOX<br>1 kg.<br>2<br>TRET AMYL ALCOHOL<br>2.64 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ems** Qty. allowed. 1 SCLAREOL 2.0458 kg. ORCANOX 1 kg. 2 TRET AMYL ALCOHOL 2.64 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	102 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM REVIW00006559AM24
RA File Number	04AX04000303 AM24
Licence No and<br>Date	0411005642/04/07/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>i.

UDIN00501924AM24

Get the Advance Authorisation amended with correct description of export and import product from concerned RA.

|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product **from concerned

ed with correct description of export and import product** from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.|Get the Advance Authorisation amended with correct description of export and import product from concerned RA.| |---|---|---|---|---|---|---|---|---|---|---|---| ||||||||||||| |C|ase No.||103 / NC/3/MEET|/Feb/202324||/23|||||| |C|||||||||||| ||ase Status||Case Approved||||||||| |P|arty Name||AROCHEMA IN|GREDIENTS||PRIVATE LI||MITED|||| |M an|eeting Number d Date||NC/ 3/ MEET/ Fe|b/ 202324/ 2|||||||| |||||||3 and 19/02/20||24|||| |H|Q File Number||HQRNORM REV|IW00006497||AM24|||||| |R|A File Number||26AX04000043 A|M24|||||||| |L D|icence No and ate||2611001013/06/07|/2023|||||||| |||||||||||||

||||3 and 19/02/20||24|||| |H|Q File Number||HQRNORM REV|IW00006497||AM24|||||| |R|A File Number||26AX04000043 A|M24|||||||| |L D|icence No and ate||2611001013/06/07|/2023|||||||| ||||||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance authorization No. 2611000716dated23/09/2022, 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:-|orms Committee Decision: he Committee considered the ca roduct/import product in meetingN No. 2611000716dated23/09/2022,|||se as per a o.NC/3/ME it was decid|||||||| |||||||genda and ta ET/Dec/2023 ed to fix ad-ho||ing cue from the earlier deci 24/17 dated 20/12/2023against c norms under Para 4.07 of HB||ion for same export advance authorization P Vol. I as per details|| ||||||||||||| |||Export Product|||Qty.||**Sl. No. **||Import Items||**Qty.

inst c norms under Para 4.07 of HB||ion for same export advance authorization P Vol. I as per details|| ||||||||||||| |||Export Product|||Qty.||**Sl. No. **||Import Items||Qty. allowed.| ||||||||||||| ||||||||||||| |||ORCANOX|||1 kg.||1||SCLAREOL||2.0458 kg.| ||||||||||||| ||||||||2||TRET AMYL ALCOHOL||2.64 kg.| ||||||||||||| ||||||||||||| ||||||||||||| |RA concerned may|||take further necessary action as per above decision of NC.||||||||| ||||||||||||| ||||||||||||| |Case No.|||104 / NC/3/MEET/Feb/202324/23||||||||| |Case Status|||Case Approved||||||||| |Party Name|||NAPROD LIFE SCIENCES PRIVATE LIMITED||||||||| |Meeting Number|||||||||||| |and Date|||NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024||||||||| |HQ File Number|||HQRNORM APPLY 00005757AM24||||||||| |RA File Number|||03AX04002815 AM24||||||||| |Licence No and|||||||||||| |Date|||0311027227/20/09/2023||||||||| |Norms Committee|||Decision:||||||||| |The Committee c Vl I di|||onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP i bl lid b h fi hih i l||||||||| |o. as per etas gven eow or as appe y te rm, wcever s ess:-||||||||||||

Norms Committee Decision:

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

Stoichiometric balance with molar weight and to arrive at the quantity of raw material asked. 2. Justification for 44% yield.

3.Production/Consumption data certified by GST.

Case No.	123 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00005898AM24
RA File Number	03AX04002915 AM24
Licence No and<br>Date	0311027464/27/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Clobetasol Propionate IP/BP/EP/USP<br>1 kg.<br>1<br>Betamethasone IP/BP/EP/USP<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	124 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00005902AM24
RA File Number	07AX04000839 AM24
Licence No and<br>Date	0711009310/27/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import items in meetingNo. NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance authorization

UDIN00501924AM24

taking cue from the earlier decision for same export product/import items in meetingNo. NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance authorization||

UDIN00501924AM24

No. 0711005403 dated 03/10/2022, 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.
AMITRIPTYLINE HYDROCHLORIDE<br>(IP/BP/EP/USP)	1 kg.	1	1 BROMO 3 CHLORO<br>PROPANE	0.720 kg.
		2	TETRA HYDRO FURAN	0.530 kg.
		3	SODIUM BOROHYDRIDE	Not allowed as not<br>shown in the<br>process reaction.
		4	ACETONE
		5	METHANOL
		6	TOLUENE

Case No.	Case No.	125 / NC/3/MEET/Feb/202324/23	125 / NC/3/MEET/Feb/202324/23	125 / NC/3/MEET/Feb/202324/23	125 / NC/3/MEET/Feb/202324/23	125 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00005907AM24
RA File Number		07AX04000981 AM24
Licence No and Date		0711009320/27/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import items in meetingNo. NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance authorization<br>No. 0711000843 dated 06/04/2021,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

ms in meetingNo. NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance authorization No. **0711000843 dated 06/04/2021,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No.Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Case No.	Case No.	125 / NC/3/MEET/Feb/202324/23	125 / NC/3/MEET/Feb/202324/23	125 / NC/3/MEET/Feb/202324/23	125 / NC/3/MEET/Feb/202324/23	125 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00005907AM24
RA File Number		07AX04000981 AM24
Licence No and Date		0711009320/27/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import items in meetingNo. NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance authorization<br>No. 0711000843 dated 06/04/2021,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00501924AM24

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

UDIN00501924AM24

1	DOXYLAMINE SUCCINATE USP<br>/Ph. Eur Grade	255.0 kg.
2	CAFFEINE BP/Ph. Eur	1530.0 kg.
3	CODEINE PHOSPHATE<br>BP/USP/EP/PH.EUR	510.0 kg.
4	COLOUR QUINOLINE YELLOW<br>CI 47005 (SPECTRACOL)	100.0 kg.

255.0 kg.| |---|---|---|---|---|---| ||||2|CAFFEINE BP/Ph. Eur|1530.0 kg.| ||||3|CODEINE PHOSPHATE BP/USP/EP/PH.EUR|510.0 kg.| ||||4|COLOUR QUINOLINE YELLOW CI 47005 (SPECTRACOL)|100.0 kg.|

Case No.	Case No.	126 / NC/3/MEET/Feb/202324/23	126 / NC/3/MEET/Feb/202324/23	126 / NC/3/MEET/Feb/202324/23	126 / NC/3/MEET/Feb/202324/23	126 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00005917AM24
RA File Number		07AX04000983 AM24
Licence No and<br>Date		0711009327/27/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import items in meetingNo. NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance authorization<br>No. 0711000843 dated 06/04/2021,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>DOXYLAMINE SUCCINATE USP<br>/Ph. Eur Grade<br>255.0 kg.<br>2<br>CAFFEINE BP/Ph.

he firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 DOXYLAMINE SUCCINATE USP /Ph. Eur Grade 255.0 kg. 2 CAFFEINE BP/Ph. Eur 1530.0 kg. 3 CODEINE PHOSPHATE BP/USP/EP/PH.EUR 510.0 kg. ACURATE TABLETS ((Paracetamol 450mg + Doxylamine Succinate 5mg + Caffeine 30mg + Codeine Phosphate 10mg + Color Quinoline Yellow 2Mg) (Para -22500.000+Doxy- 250.000+Caffeine-1500.000 + Codeine-500.000 + Colour- 100.000Kgs) Total KGS- ~~24850000 (No of Tablets -~~ 50000000 Numbers||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ACURATE TABLETS ((Paracetamol 450mg + Doxylamine Succinate 5mg + Caffeine 30mg + Codeine Phosphate 10mg + Color Quinoline Yellow 2Mg) (Para -22500.000+Doxy- 250.000+Caffeine-1500.000 + Codeine-500.000 + Colour- 100.000Kgs) Total KGS- ~~24850000 (No of Tablets -~~|| 50000000 Numbers|1|DOXYLAMINE SUCCINATE USP /Ph. Eur Grade|255.0 kg.| |||||2|CAFFEINE BP/Ph. Eur|1530.0 kg.| |||||3|CODEINE PHOSPHATE BP/USP/EP/PH.EUR|510.0 kg.| ||~~. .~~||||||

UDIN00501924AM24

50000000))		4	COLOUR QUINOLINE YELLOW	100.0 kg.
			CI 47005 (SPECTRACOL)

|3|CODEINE PHOSPHATE BP/USP/EP/PH.EUR|510.0 kg.| ||~~. .~~||||||

UDIN00501924AM24

50000000))		4	COLOUR QUINOLINE YELLOW	100.0 kg.
			CI 47005 (SPECTRACOL)

Case No.	Case No.	127 / NC/3/MEET/Feb/202324/23	127 / NC/3/MEET/Feb/202324/23	127 / NC/3/MEET/Feb/202324/23	127 / NC/3/MEET/Feb/202324/23	127 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		CITO CHEM INDUSTRIES PVT.LTD.
Meeting Number<br>d Dt		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
an ae
HQ File Number		HQRNORM APPLY 00005923AM24
RA File Number		56AX04000305 AM24
Licence No and<br>Date		5611002219/27/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import items in meetingNo. NC/3/MEET/Jul/202122/4 dated 15/07/2021against advance authorization<br>No. 0311001323 dated 28/01/2021,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Clobatasol Propionate<br>1000 kg.<br>1<br>Betamethasone<br>1000 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

Sl. No.** Import Items Qty. allowed. Clobatasol Propionate 1000 kg. 1 Betamethasone 1000 kg.||||||||| ||Export Product|||Qty.||Sl. No.|Import Items|Qty. allowed.| ||Clobatasol Propionate|||1000 kg.||1|Betamethasone|1000 kg.| |||||||||| |RA concern||ed may take further necessary action as per above dec|||ision of NC.|||| |||||||||| |||||||||| |||||||||| |Case No.|||128 / NC/3/MEET/Feb/202324/23|||||| |C S|||C Ad|||||| |ase tatus|||ase pprove|||||| |Part Name|||USV PRIVATE LIMITED|||||| |y||||||||| |Meeting Nu and Date||mber|NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024|||||| |HQ File Nu||mber|HQRNORM APPLY 00005996AM24|||||| |RA File Number|||03AX04003005 AM24|||||| |Licence No and Date|||0311027533/03/10/2023||||||

Case No.	128 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00005996AM24
RA File Number	03AX04003005 AM24
Licence No and<br>Date	0311027533/03/10/2023

UDIN00501924AM24

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import items in meeting No. NC/3/MEET/Jul/202122/4 dated 15/07/2021 against advance authorization No. 0311004820 dated 22/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Doxycycline Hyclate DR Tablets USP 100 mg ,	990000	1	Doxycycline Hyclate	114.247 kg.
100 S US((9,900 Bottles X 100 Per Bottles =	Tablets		USP
9,90,000 Tablets) (Total Weight of Export
Product = 99.000 Kgs) (Net Content weight of
Import Product = 120.582 kgs))

Case No.	129 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006000AM24
RA File Number	08AX04001244 AM24
Licence No and<br>Date	0811009510/03/10/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it has been observed that the strength of the
second export item not mentioned in the application, it was decided that firm was asked to clarify the second export item in
line with DML.

nd it has been observed that the strength of the|| |second export item not mentioned in the application, it was decided that firm was asked to clarify the second export item in|| |line with DML.||

Case No.	130 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006002AM24
RA File Number	08AX04001243 AM24
Licence No and<br>Date	0811009509/03/10/2023

UDIN00501924AM24

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import items in meeting No. NC/3/MEET/Oct/202324/15 dated 13/10/2023 against advance authorization No. 0811003993 dated 08/02/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-


Export Product	Qty.		S	l. No.	Im	port Items	Qty. allowed.

Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL (10 mL)<br>(Phenylephrine Hydrochloride<br>Injection USP 10 mg/mL (10 mL))	1 Num	ber		1	PH	ENYLEPHRINE HCL USP	110.00 mg

,

Case No.<br>131 / NC/3/MEET/Feb/202324/23
Case Status<br>Case Approved
Party Name<br>ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number<br>HQRNORM APPLY 00006019AM24
RA File Number<br>34AX04000513 AM24
Licence No and<br>Date<br>3411004189/03/10/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision			for same export
product/import items in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization
No. 3411003649 dated 29/04/2023,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization|||||| |No. **3411003649 dated 29/04/2023,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details|||||| |given below or as applied by the firm, whichever is less:-|||||| |Export Product Qty.|**Sl. No. **|Import Items||Qty. allowed.|| |Tretinoin Cream USP 0.1% - 20gm Tube 40000 Number|1|Tretinoin USP||816 gm.|| |(Tretinoin Cream USP 0.1% - 20gm Tube|||||| |( net content of active ingredients 800.00 gm ))||||||

UDIN00501924AM24

Tretinoin Cream USP 0.1% - 45 gm Tube	50000 Number	2	Tretinoin USP	2295 gm.
(Tretinoin Cream USP 0.1% - 45 gm Tube ( net
content of active ingredients 2250.00 gm ))

|Tretinoin Cream USP 0.1% - 45 gm Tube (Tretinoin Cream USP 0.1% - 45 gm Tube ( net content of active ingredients 2250.00 gm )) 50000 Number 2 Tretinoin USP 2295 gm. RA concerned may take further necessary action as per above decision of NC.|Tretinoin Cream USP 0.1% - 45 gm Tube (Tretinoin Cream USP 0.1% - 45 gm Tube ( net content of active ingredients 2250.00 gm )) 50000 Number 2 Tretinoin USP 2295 gm. RA concerned may take further necessary action as per above decision of NC.|Tretinoin Cream USP 0.1% - 45 gm Tube (Tretinoin Cream USP 01% - 45 m Tube ( net|Tretinoin Cream USP 0.1% - 45 gm Tube (Tretinoin Cream USP 01% - 45 m Tube ( net|Tretinoin Cream USP 0.1% - 45 gm Tube (Tretinoin Cream USP 01% - 45 m Tube ( net|50000 Number|50000 Number|50000 Numb

inoin Cream USP 0.1% - 45 gm Tube (Tretinoin Cream USP 01% - 45 m Tube ( net|Tretinoin Cream USP 0.1% - 45 gm Tube (Tretinoin Cream USP 01% - 45 m Tube ( net|50000 Number|50000 Number|50000 Number|2|2|Tretinoin USP|2295 gm.|2295 gm.| |---|---|---|---|---|---|---|---|---|---|---|---|---| ||. g content of active ingredients 2250.00 gm|. g content of active ingredients 2250.00 gm|| ))||||||||| |||||||||||||| ||A concerned may take further necessary act|||ion as per abo||ve decisio|n of NC.|||||| |||||||||||||| |C|ase No.||132 / NC/3/MEET/Feb/202|324/23||||||||| |C||||||||||||| ||ase Status||Case Approved|||||||||| |P|arty Name||PIRAMAL PHARMA LIM|ITED||||||||| |Meeting Number and Date|eeting Number d Date||NC/ 3/ MEET/ Feb/ 20232|4/ 23 and 19/0||2/2024||||||| |||||||||||||| |HQ File Number|||HQRNORM APPLY 00006030AM24|||||||||| |RA File Number|||03AX04002969 AM24|||||||||| |Licence No and Dt|||0311027604/04/10/2023|||||||||| |ae||||||||||||| |N Ci Dii||||||||||||| |orms ommttee|||ecson:|||||||||| |The Committee|||considered the case as per agenda and taking cue from the earlier decision for same export|||||||||| |product/import ite |||ms in meetingNo. NC/3/MEET/Jan/202324/21 dated 24/01/2024against advance authorization |||||||||| |No. 0311030155 given below or as|||**dated 13/01/2024,**it was decided to fix ad-hoc no applied by the firm, whichever is less:-||||rms under Para 4.07 of HBP Vol. I as per details|||||| |||||||||||||| |||||||||||||| |||Export P|roduct||Qty.||Sl. No.||Import Items||**Qty.

ed by the firm, whichever is less:-||||rms under Para 4.07 of HBP Vol. I as per details|||||| |||||||||||||| |||||||||||||| |||Export P|roduct||Qty.||Sl. No.||Import Items||Qty. allowed.|| |||||||||||||| |||Bempedoic Acid & Ezetimibe Fixed Dose Combination Tablets (Each Tablet content Bempedoic Acid 180 mg & Ezetimibe 10 mg ((Net content of Bempedoic Acid 162.000 kgs & Ezetimibe 9.000 kgs in total Export Qty) (AA for Free of cost material as per Para 4.11 of HBP & Para 4.19 of FTP & RBI Master Circular C-26 -|||1 Number||1||Bempedoic Acid||189.90 mg.|| ||||||||2||Ezetimibe||10.55 mg.|| |||Disallowing remittances for material being||||||||||| |||supplied free c|ost))|||||||||| |||||||||||||| |||||||||||||| |||Note: The abo|ve norms are valid only for subject to fulfilment of following conditions:-|||||||||| |||||||||||||| |||E 1|dt bi Pttd Mdii b fild ith USFDA NDA N D Aliti|||||||||| |||xpor . Export 2|prouc eng aene ecne, e e w as an (ew rug ppcaon). to USA and Europe only|||||||||| ||| . Firm h 3.|. olding Certificate of Manufacturing Exclusivity.|||||||||| ||||||||||||||

UDIN00501924AM24

rug ppcaon). to USA and Europe only|||||||||| ||| . Firm h 3.|.** olding Certificate of Manufacturing Exclusivity.|||||||||| ||||||||||||||

UDIN00501924AM24

Case No.	133 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006031AM24
RA File Number	03AX04002475 AM24
Licence No and<br>Date	0311027606/04/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along with relevant documents from the firm.		Personal Hearing

Case No.	134 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006047AM24
RA File Number	08AX04001273 AM24
Licence No and<br>Date	0811009529/05/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import items in meetingNo. NC/3/MEET/Oct/202324/15 dated 13/10/2023against advance authorization<br>No. 0811003993 dated 08/02/2022,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

/02/2022,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Phenylephrine Hydrochloride Injection USP, 10 mg/mL (1 mL) 1 Number 1 PHENYLEPHRINE HCL USP 11.00 mg RA concerned may take further necessary action as per above decision of NC.||

UDIN00501924AM24

Case No.	Case No.	135 / NC/3/MEET/Feb/202324/23	135 / NC/3/MEET/Feb/202324/23	135 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ	File Number	HQRNORM APPLY 0000		6054AM24
RA	File Number	31AX04000170 AM24

Lic<br>Da	ence No and<br>te	3111002689	/05/10/2023
No<br>T<br>pr<br>N<br>gi	rms Committee Decision:<br>he Committee considered t<br>oduct/import items in meetin<br>o. 0311001608 dated 03/08/<br>ven below or as applied by th		he case as pe<br>g**No.

pr N gi|rms Committee Decision: he Committee considered t oduct/import items in meetin o. 0311001608 dated 03/08/ ven below or as applied by th||he case as pe gNo. NC/3/ **2022,**it was d e firm, which|r agend MEET/ ecided t||a and taking cue from the earlier decisio Mar/202223/24 dated 13/04/2023against ad o fix ad-hoc norms under Para 4.07 of HBP|||n for same export vance authorization Vol. I as per details|| |||||ever is l||ess:-||||| ||Export Product|||||Qty.|Sl. No.|Import Items||Qty. allowed.| |||||||||||| ||TYLODOX - GOLD WSP ( Jar)(Each gram contains: Ty (Vet) 100 mg, Doxycycline||Pack size 1 K losin Tartrate Hyclate BP 20|gs|1|Number|1|Tylosin Tartrate||0.101 kg.| |||||BP 0 mg)||||BP/USP /EP||| ||||||||2|Doxycycline Hyclat|e|0.202 kg.| |||||||||BP/EP/USP||| ||TYLODOX - GOLD WSP ( sachet)(Each gram contains: BP (Vet) 100 mg, Doxycycl mg)||Pack size 100 Tylosin Tartr ine Hyclate B|||||||| |||||Gms ate P 200|1|Number|3|Tylosin Tartrate BP/USP /EP||10.1 gm| |||||||||||| ||||||||4|Doxycycline Hyclat BP/EP/USP|e|20.2 gm| |||||||||||| ||GENTADOX GOLD 100 / Kgs Jar)(Each gram powder Doxycycline Hyclate BP 20 Sulphate USP 100mg)||200 ( pack Siz contains: 0mg, Gentam|e 1 cin|1|Number|5|Doxycycline Hyclat BP/EP/USP|e|0.202 kg.| ||||||||||||

s Jar)(Each gram powder Doxycycline Hyclate BP 20 Sulphate USP 100mg)||200 ( pack Siz contains: 0mg, Gentam|e 1 cin|1|Number|5|Doxycycline Hyclat BP/EP/USP|e|0.202 kg.| |||||||||||| ||GENTADOX GOLD 100 /2 Gms Sachet)(Each gram po Doxycycline Hyclate BP 20 Sulphate USP 100mg)||00 ( pack Siz wder contains: 0mg, Gentam|100|1|Number|6|Doxccline Hclat|e|202 m| ||||| ycin||||yy y BP/EP/USP||. g| |||||||||||| ||NEODOX - GOLD WSP ( p Jar)(Each gram contains: Do||ack Size 1 Kg xycycline Hy|||||||| |||||s clate|1|Number|7|Doxycycline Hyclat BP/EP/USP|e|0.101 kg.|

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BP 100 mg Neomycin Sulfate BP 100 mg)<br>NEODOX - GOLD WSP ( pack Size 100 Gms<br>Sachet) (Each gram contains: Doxycycline<br>Hyclate BP 100 mg Neomycin Sulfate BP 100<br>mg)<br>1 Number<br>8<br>Doxycycline Hyclate<br>BP/EP/USP<br>10.1 gm<br>RA concerned may take further necessary action as per above decision of NC.	BP 100 mg Neomycin Sulfate BP 100 mg)
	NEODOX - GOLD WSP ( pack Size 100 Gms<br>Sachet) (Each gram contains: Doxycycline<br>Hyclate BP 100 mg Neomycin Sulfate BP 100<br>mg)	1 Number	8	Doxycycline Hyclate<br>BP/EP/USP	10.1 gm

-|---| ||NEODOX - GOLD WSP ( pack Size 100 Gms Sachet) (Each gram contains: Doxycycline Hyclate BP 100 mg Neomycin Sulfate BP 100 mg)|1 Number|8|Doxycycline Hyclate BP/EP/USP|10.1 gm|

Case No.	136 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006096AM24
RA File Number	05AX04002038 AM24
Licence No and<br>Date	0511021399/09/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	137 / NC/3/MEET/Feb/202324/23	137 / NC/3/MEET/Feb/202324/23	137 / NC/3/MEET/Feb/202324/23	137 / NC/3/MEET/Feb/202324/23	137 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006109AM24
RA File Number	08AX04001276 AM24
Licence No and<br>Date	0811009604/09/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import items in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>No. 0811007571 dated 15/03/2023,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

/03/2023,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.|||||| |||Qty.|Sl. No.|Import Items|Qty. allowed.|

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|BISOPROLOL FUMARATE TABLETS 1.25 MG (EACH FILM COATED TABLET CONTAINS: BISOPROLOL FUMARATE USP 1.25 MG NET CONTENT OF BISOPROLOL FUMARATE SHOULD NOT BE LESS THAN 1.125 KG IN EXPORT ITEM.) 1 Number 1 BISOPROLOL FUMARATE USP 1.275 mg/1.25 mg tablet BISOPROLOL FUMARATE TABLETS 2.5 MG (EACH FILM COATED TABLET CONTAINS: BISOPROLOL FUMARATE USP 2.5 MG NET CONTENT OF BISOPROLOL FUMARATE SHOULD NOT BE LESS THAN 3.00 KG IN EXPORT ITEM.) 1 Number 2 BISOPROLOL FUMARATE USP 2.55 mg/2.5 mg tablet BISOPROLOL FUMARATE TABLETS 5 MG (EACH FILM COATED TABLET CONTAINS: BISOPROLOL FUMARATE USP 5 MG NET CONTENT OF BISOPROLOL FUMARATE SHOULD NOT BE LESS THAN 13.500 KG IN EXPORT ITEM.) 1 Number 3 BISOPROLOL FUMARATE USP 5.10 mg/5 mg tablet BISOPROLOL FUMARATE TABLETS 10 MG (EACH FILM COATED TABLET CONTAINS: BISOPROLOL FUMARATE USP 10 MG NET CONTENT OF BISOPROLOL FUMARATE SHOULD NOT BE LESS THAN 30.000 KG IN EXPORT ITEM.) 1 Number 4 BISOPROLOL FUMARATE USP 10.20 mg/10 mg tablet RA concerned may take further necessary action as per above decision of NC.|BISOPROLOL<

BISOPROLOL<br>FUMARATE<br>TABLETS 1.25 MG (EACH FILM<br>COATED TABLET CONTAINS:<br>BISOPROLOL FUMARATE USP<br>1.25 MG NET CONTENT OF<br>BISOPROLOL<br>FUMARATE<br>SHOULD NOT BE LESS THAN<br>1.125 KG IN EXPORT ITEM.)	<br> <br> <br> <br> <br> <br> <br>1 Number	1	BISOPROLOL FUMARATE USP	1.275 mg/1.25 mg<br>tablet
BISOPROLOL<br>FUMARATE<br>TABLETS 2.5 MG (EACH FILM<br>COATED TABLET CONTAINS:<br>BISOPROLOL FUMARATE USP<br>2.5<br>MG<br>NET<br>CONTENT<br>OF<br>BISOPROLOL<br>FUMARATE<br>SHOULD NOT BE LESS THAN<br>3.00 KG IN EXPORT ITEM.)	<br> <br> <br> <br> <br> <br> <br>1 Number	2	BISOPROLOL FUMARATE USP	2.55 mg/2.5 mg<br>tablet
BISOPROLOL<br>FUMARATE<br>TABLETS 5 MG (EACH FILM<br>COATED TABLET CONTAINS:<br>BISOPROLOL FUMARATE USP 5<br>MG<br>NET<br>CONTENT<br>OF<br>BISOPROLOL<br>FUMARATE<br>SHOULD NOT BE LESS THAN<br>13.500 KG IN EXPORT ITEM.)	<br> <br> <br> <br> <br> <br> <br>1 Number	3	BISOPROLOL FUMARATE USP	5.10 mg/5 mg<br>tablet
BISOPROLOL<br>FUMARATE<br>TABLETS 10 MG (EACH FILM<br>COATED TABLET CONTAINS:<br>BISOPROLOL FUMARATE USP<br>10<br>MG<br>NET<br>CONTENT<br>OF<br>BISOPROLOL<br>FUMARATE<br>SHOULD NOT BE LESS THAN<br>30.000 KG IN EXPORT ITEM.)	<br> <br> <br> <br> <br> <br> <br>1 Number	4	BISOPROLOL FUMARATE USP	10.20 mg/10 mg<br>tablet

Case No.	138 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006119AM24
RA File Number	03AX04003131 AM24

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Licence No and 0311027738/09/10/2023 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Sep/202324/14 dated 27/09/2023 against advance authorization No.0311026446 dated 18/08/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
OCTYLATED DIPHENYLAMINE	1 kg.	1	DIPHENYLAMINE	0.50 kg.
(OCD FLAKES/POWDER)
		2	DI ISOBUTYLENE	0.64 kg.
		3	ACTIVATED CLAY	0.10 kg.

ort Items**|Qty. allowed.| |---|---|---|---|---| |OCTYLATED DIPHENYLAMINE|1 kg.|1|DIPHENYLAMINE|0.50 kg.| |(OCD FLAKES/POWDER)||||| |||2|DI ISOBUTYLENE|0.64 kg.| |||3|ACTIVATED CLAY|0.10 kg.|

Case No.	139 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	CHEMIKER PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006178AM24
RA File Number	50AX04000062 AM24
Licence No and<br>Date	5011001072/11/10/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	140 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006182AM24
RA File Number	08AX04001270 AM24
Licence No and<br>Date	0811009637/11/10/2023

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Norms Committee Decision:

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

Case No.	141 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006184AM24
RA File Number	52AX04001763 AM23
Licence No and Date	5211005979/12/10/2023
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1-(2-(2-HYDROXYETHOXY)ETHYL)<br>PIPERAZINE<br>1 kg.<br>1<br>PIPERAZINE ANHYDROUS<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	142 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006189AM24
RA File Number	09AX04000621 AM24
Licence No and<br>Date	0911005970/12/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	143 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024

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|143 / NC/3/MEET/Feb/202324/23| |---|---| |Case Status|Case Deferred| |Party Name|TORRENT PHARMACEUTICALS LTD| |Meeting Number|NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024|

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and Date
HQ File Number	HQRNORM APPLY 00006200AM24
RA File Number	08AX04001277 AM24
Licence No and<br>Date	0811009642/12/10/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

and Date
HQ File Number	HQRNORM APPLY 00006200AM24
RA File Number	08AX04001277 AM24
Licence No and<br>Date	0811009642/12/10/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.



Case No.	144 /	NC/3/MEET/Feb/202324/23

Case Status	Case A	pproved
Party Name	J B CH	EMICALS AND PHARMACEUTICALS LIMITED
Meeting Number	NC/ 3/	MEET/ Feb/ 202324/ 23 and 19/02/2024
and Date

HQ File Number	HQRN	ORM APPLY 00006202AM24

RA File Number	03AX04003026 AM24
Licence No and<br>Date	0311027846/12/10/2023

ate|||||||||||| ||||||||||||| |HQ File Number||HQRN|ORM APPLY 00006202AM24||||||||| ||||||||||||| |RA File Number||03AX04003026 AM24|||||||||| |Licence No and Date||0311027846/12/10/2023|||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance authorizationNo.0311026848 dated 04/09/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 29.70 mg. 2 SENTRY POLYOX WSR N80 FP NF 178.10 mg GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG.(Each tablet contains (i) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 29.70 mg (ii) Sentry Polyox WSR N80 FP NF- 178.10 mg (iii) Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 820.16 Kgs (ii) 4918.18 1 Number|||||||||||| ||uctmport prouct n meetng thorizationNo.0311026848 dated 04 per details given below or as applied b|||o. /09/2023, it w y the firm, wh||ep as decide ichever i||aea d to fix ad-hoc norms under Para 4.0 s less:-||ganst avance 7 of HBP Vol. I|| ||||||||||||| ||Export Product||||Qt|y.||**Sl. No. **|Import Items||**Qty.

br>ichever i||aea d to fix ad-hoc norms under Para 4.0 s less:-||ganst avance 7 of HBP Vol. I|| ||||||||||||| ||Export Product||||Qt|y.||**Sl. No. **|Import Items||Qty. allowed.| ||GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG.(Each tablet contai (i) Eastman (TM Cellulose Acetate (C||| ns A|1 Numb|er||1|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)||29.70 mg.| || 398- 10NF/EP)- 29.70 mg (ii) Sentry Polyox WSR N80 FP NF- 178.10 mg (iii) Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 820.16 Kgs (ii) 4918.18||||||||||| ||||||||2||SENTRY POLYOX WSR N80 FP NF||178.10 mg| ||Kgs (iii) 2761.47 Kgs.)||||||||||| ||||||||||||| ||||||||3||SENTRY POLYOX WSR||100.00 mg| ||||||||||303 NF||| ||||||||||||| ||||||||||||| ||GLIPIZIDE E TABLETS 5 M|XTENDED RELEASE G.(Each tablet contains|||1 Number||4||EASTMAN (TM) CELLULOSE ACETATE||20.40 mg| || (i) Eastman (T| M Cellulose Acetate (CA|||||||(CA 398-10NF/EP)||| ||398- 10NF/EP|)- 20.40 mg (ii) Sentry|||||||||| ||||||||||||| ||Polyox WSR N Sentry Polyox |80 FP NF- 89.05 mg (iii) WSR 303 NF- 50 mg. |||||5||SENTRY POLYOX WSR N80 FP NF||89.05 mg| ||Net content (i) 430.05 Kgs (ii) 1877.27|||||||||||

83 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

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SR N80 FP NF||89.05 mg| ||Net content (i) 430.05 Kgs (ii) 1877.27|||||||||||

83 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

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Kgs (iii) 1054.06 Kgs.)		6	SENTRY POLYOX WSR<br>303 NF	50.00 mg
GLIPIZIDE EXTENDED RELEASE<br>TABLETS 2.5 MG.(Each tablet contains<br>(i) Eastman (TM Cellulose Acetate (CA<br>398- 10NF/EP)- 20.40 mg (ii) Sentry<br>Polyox WSR N80 FP NF- 89.05 mg (iii)<br>Sentry Polyox WSR 303 NF- 50 mg. Net<br>content (i) 231.08 Kgs (ii) 1008.71 Kgs<br>(iii) 566.37 Kgs.)	1 Number	7	EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)	20.40 mg
		8	SENTRY POLYOX WSR<br>N80 FP NF	89.05 mg
		9	SENTRY POLYOX WSR<br>303 NF	50.00 mg

.71 Kgs (iii) 566.37 Kgs.)|1 Number|7|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|20.40 mg| ||||8|SENTRY POLYOX WSR N80 FP NF|89.05 mg| ||||9|SENTRY POLYOX WSR 303 NF|50.00 mg|

Case No.	145 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006208AM24
RA File Number	34AX04000546 AM24
Licence No and<br>Date	3411004225/12/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	146 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006250AM24
RA File Number	08AX04001324 AM24
Licence No and<br>Date	0811009657/13/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No. 147 / NC/3/MEET/Feb/202324/23

UDIN00501924AM24

and Date|0811009657/13/10/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No. 147 / NC/3/MEET/Feb/202324/23

UDIN00501924AM24

Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00006262AM24
RA File Number		03AX04003185 AM24
Licence No and<br>Date		0311027906/16/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. 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>1<br>ORTHO TERTIARY BUTYL PHENOL<br>0.79 kg.<br>Coeur Amber Eternis (Ambercore)<br>1 kg.<br>2<br>1,2 Epoxy butane<br>0.379 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	Coeur Amber Eternis (Ambercore)		1 kg.	1	ORTHO TERTIARY BUTYL PHENOL	0.79 kg.
				2	1,2 Epoxy butane	0.379 kg.
				per above decision of NC.

**|Import Items|Qty. allowed.| ||Coeur Amber Eternis (Ambercore)||1 kg.|1|ORTHO TERTIARY BUTYL PHENOL|0.79 kg.| |||||2|1,2 Epoxy butane|0.379 kg.| |||||per above decision of NC.|||

Case No.	148 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006295AM24
RA File Number	03AX04003186 AM24
Licence No and<br>Date	0311027939/17/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	149 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006301AM24
RA File Number	03AX04003276 AM24

UDIN00501924AM24

Licence No and Date

0311027949/17/10/2023

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. OFLOXACIN OPHTHALMIC SOL 0.3% 5.0ML (OFLOXACIN EYE DROPS 5 ML)((EACH VIAL CONTAINS OFLOXACIN 0.015 GM NET WT OF BULK DRUG IS 28.080 KGS)) 1 Number 1 OFLOXACIN 15.30 mg OFLOXACIN OPHTHALMIC SOL 0.3% 10.0ML (OFLOXACIN EYE DROPS 10 ML)((EACH VIAL CONTAINS OFLOXACIN 0.03 GM NET WT OF BULK DRUG IS 7.440 KGS)) 1 Number 2 OFLOXACIN 30.60 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	150 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	PRASHI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006329AM24
RA File Number	03AX04003293 AM24
Licence No and<br>Date	0311028015/18/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	151 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006330AM24

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UDIN00501924AM24

RA File Number

08AX04001178 AM24

Licence No and Date

0811009695/18/10/2023

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance authorizationNo.0810146231 dated 25/09/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop 5 mL. 90,000 Numbers 1 Metamizole Magnesium 143.654 kg. Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop 15 mL. 13,00,000 Numbers Metamizole Magnesium 6142.50 kg. RA concerned may take further necessary action as per above decision of NC.

Pargeverine Hydrochloride 6mg Oral Drop 15 mL. 13,00,000 Numbers Metamizole Magnesium 6142.50 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	152 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006333AM24
RA File Number	08AX04001249 AM24
Licence No and<br>Date	0811009697/18/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	153 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006334AM24
RA File Number	08AX04001262 AM24

UDIN00501924AM24

Licence No and 0811009700/18/10/2023 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No.	154 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006335AM24
RA File Number	05AX04002187 AM24
Licence No and<br>Date	0511021614/18/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00006335AM24| |RA File Number|05AX04002187 AM24| |Licence No and Date|0511021614/18/10/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	155 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006356AM24
RA File Number	30AX04000323 AM24
Licence No and<br>Date	3011004322/19/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	156 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006363AM24
RA File Number	03AX04003340 AM24
Licence No and<br>Date	0311028059/19/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance<br>authorizationNo.0311026446 dated 18/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I

88 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

UDIN00501924AM24

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

I||

88 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

UDIN00501924AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
OCTYLATED DIPHENYLAMINE<br>(OCD FLAKES/POWDER)	1 kg.	1	DIPHENYLAMINE	0.50 kg.
		2	DI ISOBUTYLENE	0.64 kg.
		3	ACTIVATED CLAY	0.10 kg.

Case No.	157 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	INTIGREAT CONSULTING SERVICES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006403AM24
RA File Number	03AX04003028 AM24
Licence No and<br>Date	0311028103/23/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	158 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	SANDOZ PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006418AM24
RA File Number	03AX04003201 AM24
Licence No and<br>Date	0311028115/23/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	159 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred

UDIN00501924AM24

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

Case No.	159 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred

UDIN00501924AM24

Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006420AM24
RA File Number	03AX04003262 AM24
Licence No and<br>Date	0311028121/23/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along with relevant documents from the firm:		Personal Hearing

Case No.	160 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	FREESIA CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006426AM24
RA File Number	03AX04002817 AM24
Licence No and<br>Date	0311028138/25/10/2023
Norms Committee Decision:<br>RA concerned may take further necessary action as per above decision of NC.<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance<br>authorizationNo. 0311016342 dated 14/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

Case No.	161 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	NEXUS PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006434AM24
RA File Number	08AX04001338 AM24
Licence No and	0811009742/25/10/2023

UDIN00501924AM24

Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. 10/82-ALC4/2018 dated 16/10/2018 against advance authorization No.0810136408 dated 02.11.2015 , 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.
Prednisolone Sodium Phosphate BP	1 kg.	1	Prednisolone IP	0.839 kg.

firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Prednisolone Sodium Phosphate BP	1 kg.	1	Prednisolone IP	0.839 kg.

Case No.	162 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006452AM24
RA File Number	09AX04000686 AM24
Licence No and<br>Date	0911006081/26/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202324/20 dated 18/01/2024against advance<br>authorizationNo.0911004999dated09/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>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>Valganciclovir HCl<br>1 kg.<br>1<br>Ganciclovir<br>1.75 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00501924AM24

tems** Qty. allowed. Valganciclovir HCl 1 kg. 1 Ganciclovir 1.75 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00501924AM24

Case No.	163 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006454AM24
RA File Number	03AX04003224 AM24
Licence No and<br>Date	0311028189/26/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	164 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006457AM24
RA File Number	07AX04001166 AM24
Licence No and<br>Date	0711009545/26/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.0711005078 dated 23/08/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. PREMIX OF NIFUROXAZIDE (1GM OF PREMIX CONTAINS 0.552 GMS OF NIFUROXAZIDE) NET CONTENT 2980.80KGS) 5400 kg. 1 NIFUROXAZIDE BP/EP 3010.61 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	165 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	MICRO LABS LIMITED

UDIN00501924AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006458AM24
RA File Number	07AX04001167 AM24
Licence No and<br>Date	0711009546/26/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance<br>authorizationNo.0711004100 dated 26/05/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>DICLOXACILLIN<br>CAPSULES<br>500MG (1500.00KG))<br>3,000,000<br>Numbers<br>1<br>DICLOXACILLIN SODIUM E.P.<br>1605 kg.<br>RA concerned may take further necessary action as per above decision of NC.

CLOXACILLIN CAPSULES 500MG (1500.00KG)) 3,000,000 Numbers 1 DICLOXACILLIN SODIUM E.P. 1605 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	166 / NC/3/MEET/Feb/202324/23	166 / NC/3/MEET/Feb/202324/23	166 / NC/3/MEET/Feb/202324/23	166 / NC/3/MEET/Feb/202324/23	166 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00006462AM24
RA File Number		03AX04003436 AM24
Licence No and<br>Date		0311028216/26/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. 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>HYDRAZINE HYDRATE 80% (H.H)<br>0.134 kg.<br>2<br>CARBON DISULPHIDE<br>0.3502 kg.<br>2,5-bis-( Tert-Nonyldithio)-1,3,4,-<br>thiadizole ( YALUB DM -113) (2,5-<br>bis-( Tert-Nonyldithio)-1,3,4,-<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	2,5-bis-( Tert-Nonyldithio)-1,3,4,-<br>thiadizole ( YALUB DM -113) (2,5-<br>bis-( Tert-Nonyldithio)-1,3,4,-		1 kg.	1	HYDRAZINE HYDRATE 80% (H.H)	0.134 kg.
				2	CARBON DISULPHIDE	0.3502 kg.

| ||2,5-bis-( Tert-Nonyldithio)-1,3,4,- thiadizole ( YALUB DM -113) (2,5- bis-( Tert-Nonyldithio)-1,3,4,-||1 kg.|1|HYDRAZINE HYDRATE 80% (H.H)|0.134 kg.| |||||2|CARBON DISULPHIDE|0.3502 kg.|

Case No.	Case No.	166 / NC/3/MEET/Feb/202324/23	166 / NC/3/MEET/Feb/202324/23	166 / NC/3/MEET/Feb/202324/23	166 / NC/3/MEET/Feb/202324/23	166 / NC/3/MEET/Feb/202324/23
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number		HQRNORM APPLY 00006462AM24
RA File Number		03AX04003436 AM24
Licence No and<br>Date		0311028216/26/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. 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>HYDRAZINE HYDRATE 80% (H.H)<br>0.134 kg.<br>2<br>CARBON DISULPHIDE<br>0.3502 kg.<br>2,5-bis-( Tert-Nonyldithio)-1,3,4,-<br>thiadizole ( YALUB DM -113) (2,5-<br>bis-( Tert-Nonyldithio)-1,3,4,-<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	2,5-bis-( Tert-Nonyldithio)-1,3,4,-<br>thiadizole ( YALUB DM -113) (2,5-<br>bis-( Tert-Nonyldithio)-1,3,4,-		1 kg.	1	HYDRAZINE HYDRATE 80% (H.H)	0.134 kg.
				2	CARBON DISULPHIDE	0.3502 kg.

UDIN00501924AM24

ithio)-1,3,4,- thiadizole ( YALUB DM -113) (2,5- bis-( Tert-Nonyldithio)-1,3,4,-||1 kg.|1|HYDRAZINE HYDRATE 80% (H.H)|0.134 kg.| |||||2|CARBON DISULPHIDE|0.3502 kg.|

UDIN00501924AM24

thiadizole	(YALUB DM -113))		3	TERT -NONYL MERCAPTAN	0.700 kg.
				(S-MERCAPTAN)

Case No.	167 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006470AM24
RA File Number	07AX04001168 AM24
Licence No and<br>Date	0711009558/27/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	168 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006479AM24
RA File Number	03AX04003049 AM24
Licence No and<br>Date	0311028247/27/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along with relevant documents from the firm:		Personal Hearing

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

Case No.	169 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006481AM24
RA File Number	03AX04003424 AM24
Licence No and Date	0311028257/27/10/2023
Norms Committee Decision:

UDIN00501924AM24

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.
DOXYLEB CAPSULE (DOXYCYCLINE<br>HYCLATE CAPSULE BP) 100MG (IN<br>PACKING OF 10x10s, 10x100s & 1000s.<br>QTY CONSUMED OF EXEMPT<br>MATERIAL DOXYCYCLINE HYCLATE<br>BP-115.400MG/CAPSULE)	1 Number	1	DOXYCYCLINE<br>HYCLATE BP	115.40 mg / capsule

Case No.	170 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006486AM24
RA File Number	03AX04003432 AM24
Licence No and Date	0311028267/27/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202324/21dated 24/01/2024against advance authorization<br>No.0311023542 dated 12/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>CHLORAMPHENICOL EYE DROPS<br>10 ML ( CLOROGEN , CLORAH AND<br>VANMYCETIN EYE DROPS 10 ML)<br>(EACH VIAL CONTAINS<br>CHLORAMPHENICOL MICRONIZED<br>0.050GM)<br>1 Number<br>1<br>CHLORAMPHENICOL<br>MICRONIZED<br>51.00 mg/vial<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00501924AM24

MICRONIZED 0.050GM) 1 Number 1 CHLORAMPHENICOL MICRONIZED 51.00 mg/vial RA concerned may take further necessary action as per above decision of NC.||

UDIN00501924AM24

Case No.	171 / NC/3/MEET/Feb/202324/23
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006503AM24
RA File Number	03AX04003414 AM24
Licence No and Date	0311028288/30/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202324/21dated 24/01/2024against advance authorization<br>No.0311029131 dated 05/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>HEXAFLUOROISOPROPYL<br>METHYLETHER(HFMOP)<br>1 kg.<br>1<br>HEXA FLUOROISOPROPANOL<br>0.970 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No.	172 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006520AM24
RA File Number	09AX04000671 AM24
Licence No and<br>Date	0911006113/30/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	173 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	PANACEA BIOTEC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006537AM24
RA File Number	05AX04002270 AM24

UDIN00501924AM24

Licence No and 0511021818/31/10/2023 Date Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case to Department of BioTechnology for obtaining their comments.

Case No.	174 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006566AM24
RA File Number	09AX04000607 AM24
Licence No and<br>Date	0911006121/31/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00006566AM24| |RA File Number|09AX04000607 AM24| |Licence No and Date|0911006121/31/10/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	175 / NC/3/MEET/Feb/202324/23
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202324/ 23 and 19/02/2024
HQ File Number	HQRNORM APPLY 00006567AM24
RA File Number	08AX04001381 AM24
Licence No and<br>Date	0811009826/31/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

97 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-02-2024 16:06:42.

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