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/Apr/202425/2 DATED: 30/04/2024

Please Note

I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in
II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.
III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.
IV. RAs shall also ensure compliance of SION, General Notes and Chapter Notes wherever applicable.
V. RAs shall ensure that authorization is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard full compliance of the provision of Para 4.12 of FTP, Para 4.16; Para 4.21 and Para 4.51 of HBP shall be made.

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

Meeting No. NC/3/MEET/Apr/202425/2 dated 30/04/2024 of Norms Committee - III for the year 2024-25 was held on 30/04/2024 under the Chairmanship of Shri Rakesh Kumar,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2023.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	Shri Raman Kumar, Deputy DGFT	DGFT(HQ)
2	Shri Dinesh Narain Mathur, Technical Expert	Consultant (Pharma)

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

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3	Shri Shaish Kumar, Technical Expert	Consultant (Chemical)
4	Shri Nand Lal, Technical Expert	Consultant (Chemical)
5	Shri Uttam Dey Sarkar, ASO	DGFT (HQ)

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	018305001161AM21
RA File Number	052304000251 AM21
Licence No and<br>Date	0510415659/27/10/2020
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. 0511000078 dated 09/12/2020, 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>1<br>Platinum (Sponge Powder)<br>0.85 kg.<br>Oxaliplatin (Assay (By HPLC on<br>dried basis) 98% to 102%)<br>1 kg.<br>2<br>(1R,2R)-(-)-1,2-Diamino cyclo<br>hexane.<br>0.49 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ssay (By HPLC on dried basis) 98% to 102%) 1 kg. 2 (1R,2R)-(-)-1,2-Diamino cyclo hexane. 0.49 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	2 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM REVIW00007068AM24
RA File Number	05AX04001017 AM23
Licence No and<br>Date	0511013648/07/07/2022
Norms Committee Decision:<br> The Committee considered the case as per agenda and it has been observed that the firm has not furnished the past<br>production/consumption of raw material certified by GST Authorities as sought by TE. Therefore, it was decided that

This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

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a team from CLA, New Delhi will audit the production and consumption data of the firm and submit the report to DGFT HQ withinfifteen days of uploding of Minutes of Meeting on DGFT website.

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a team from CLA, New Delhi will audit the production and consumption data of the firm and submit the report to DGFT HQ withinfifteen days of uploding of Minutes of Meeting on DGFT website.

Case No.	Case No.	3 / NC/3/MEET/Apr/202425/2	3 / NC/3/MEET/Apr/202425/2	3 / NC/3/MEET/Apr/202425/2	3 / NC/3/MEET/Apr/202425/2	3 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM REVIW00007056AM24
RA File Number		05AX04001011 AM23
Licence No and<br>Date		0511013749/13/07/2022
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>DIMETHYL FORMAMIDE<br>0.950 kg.<br>2<br>Sodium Methoxide Powder<br>0.670 kg.<br>3<br>ACETONITRILE<br>0.520 kg.<br>4<br>TRI ETHYL AMINE (TEA)<br>0.350 kg.<br>5<br>TOLUENE<br>0.315 kg.<br>6<br>MIXED HEXANES<br>0.236 kg.<br>7<br>N-BUTANOL<br>0.010 kg.<br>3-DIFLUOROMETHYL-1-METHYL-1H-<br>PYRAZOLE-4-CARBOXYLIC ACID<br>1 kg.<br>8<br>Hydrazine Hydrate (100%)<br>0.668 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

010 kg. 3-DIFLUOROMETHYL-1-METHYL-1H- PYRAZOLE-4-CARBOXYLIC ACID 1 kg. 8 Hydrazine Hydrate (100%) 0.668 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||3-DIFLUOROMETHYL-1-METHYL-1H- PYRAZOLE-4-CARBOXYLIC ACID||1 kg.|1|DIMETHYL FORMAMIDE|0.950 kg.| |||||2|Sodium Methoxide Powder|0.670 kg.| |||||3|ACETONITRILE|0.520 kg.| |||||4|TRI ETHYL AMINE (TEA)|0.350 kg.| |||||5|TOLUENE|0.315 kg.| |||||6|MIXED HEXANES|0.236 kg.| |||||7|N-BUTANOL|0.010 kg.| |||||8|Hydrazine Hydrate (100%)|0.668 kg.| ||||||||

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

Case No.	4 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM REVIW00008055AM24
RA File Number	05AX04001704 AM23
Licence No and Date	0511014859/16/09/2022
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>METHOXY-AA TECH.

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 METHOXY-AA TECH. 12 [GB] 0.820 kg. 2 TOLUENE 0.270 kg. 3 TRI ETHYL AMINE (TEA) 0.140 kg. 4 Potassium Carbonate - Powder 0.020 kg. 5 ETHYL VINYL ETHER 0.330 kg. 6 ACETIC ACID 0.030 kg. 3-PYRIDINECARBOXYLIC ACID, 2- [(2METHOXYETHOXY) METHYL]-6- (TRIFLUOROMETHYL)-ETHYL ESTER 1 kg. 7 ORTHOXYLENE 0.140 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.		5 / NC/3/MEET/Apr/202425/2

Case Status		Case Approved
Party Name		BELCHEM INDUSTRIES (INDIA) PVT LTD

Meeting Number an<br>	d	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
Date

HQ File Number		HQRNORM APPLY 00003172AM23
RA File Number		03AX04003088 AM23

Licence No and Date		0311017943/16/09/2022
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/Oct/202223/11 dated 31/10/2022against advance
authorizationNo. 0310838842 dated 13/10/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

meetingNo.NC/3/MEET/Oct/202223/11 dated 31/10/2022against advance|||||||| |authorizationNo. 0310838842 dated 13/10/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|||||||| ||Et|dt||Qt|Sl N|It It|Qt lld| ||xpor|rouc||y.|. o.|mpor ems|y. aowe.| ||||||||| ||1,3 DIMETHY DIMETHYL |LOL-5,5- ||1 kg.|1|5,5 DIMETHYL HYDANTOIN ASSAY 99% |0.382 kg.| ||HYDANTOIN |((DMDM ||||MIN COLOUR PURE WHITE|| ||HYDANTOI ASSAY 55%|52%-55%) MAX|||||| || BELGUARD| DMDMH)|||||| |RA concerned may take further necessary action as per above decision of NC.|||||||| ||||||||| |Case No.||6 / NC/3/MEET/Apr/202425/2|||||| |Case Status||Case Approved|||||| ||||||||| |Party Name||SRF LIMITED|||||| |Meeting Number and Date||NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024|||||| |HQ File Number||HQRNORM REVIW00007058AM24|||||| |RA File Number||05AX04002096 AM23|||||| ||||||||| |Licence No and|||||||| | Date||0511015534/31/10/2022|||||| |||||||||

Case No.	6 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM REVIW00007058AM24
RA File Number	05AX04002096 AM23
Licence No and<br>Date	0511015534/31/10/2022

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Norms Committee Decision:

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Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DIFLUORO METHANE SULPHONYL<br>CHLORIDE	<br>32,000 kg.	1	BENZYL<br>DIFLUOROMETHYL<br>SULPHIDE	3577.6 kg.
		2	BENZYL MERCAPTAN	39125.0 kg.
		3	OPEN HEAD DRUM 210<br>LITER WITH<br>COMPOSITE 117 LITER<br>DRUM INSIDE (MULLER<br>SWITZERLAND)	<br>Relevant, as per<br>packing policy<br>and General<br>Notes.

Case No.	Case No.	7 / NC/3/MEET/Apr/202425/2	7 / NC/3/MEET/Apr/202425/2	7 / NC/3/MEET/Apr/202425/2	7 / NC/3/MEET/Apr/202425/2	7 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM REVIW00007919AM24
RA File Number		05AX04002217 AM23
Licence No and<br>Date		0511015715/09/11/2022
Norms Committee Decision:<br>The 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.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

Case No.	Case No.	7 / NC/3/MEET/Apr/202425/2	7 / NC/3/MEET/Apr/202425/2	7 / NC/3/MEET/Apr/202425/2	7 / NC/3/MEET/Apr/202425/2	7 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM REVIW00007919AM24
RA File Number		05AX04002217 AM23
Licence No and<br>Date		0511015715/09/11/2022
Norms Committee Decision:<br>The 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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

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1	HYDRAZINE HYDRATE<br>(80%)	0.56 kg.
2	ACETIC ANHYDRIDE	1.90 kg.
3	Potassium Carbonate -<br>Powder	0.94 kg.
4	2,2'-Dichlorodiethyl ether<br>(DCEE)	1.50 kg.
5	DIMETHYL SULFOXIDE<br>(DMSO)	1.30 kg.
6	CAUSTIC POTASH LYE<br>(POTASSIUM HYDROXIDE<br>95 PERCENT)	<br>0.72 kg.
7	N-PENTANOL	0.10 kg.

Case No.	8 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00005387AM23
RA File Number	05AX04002796 AM23
Licence No and<br>Date	0511016607/28/12/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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ile Number|05AX04002796 AM23| |Licence No and Date|0511016607/28/12/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

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Ca	se No.	9 / NC/3/MEET/Apr/202425/2	9 / NC/3/MEET/Apr/202425/2
Ca	se Status	Case Approved
Pa	rty Name	COHANCE LIFESCIENCES LIM		ITED
M<br>an	i Nb
	etng umer<br>d Date	NC/ 3/ MEET/ Apr/ 202425/ 2 an		d 30/04/2024
H	Q File Number	HQRNORM APPLY 00005417A		M23
RA	File Number	09AX04000884 AM23
Li<br>Da	cence No and<br>te	0911004233/29/12/2022
No<br>T<br>pr<br>a<br>as<br>R	rms Committee Decision:<br>he Committee considered the case as per agen<br>oduct/import product in meetingNo.NC/3/<br>uthorizationNo. 0911003424 dated 01/08/2022, i<br>			da and taking cue f<br>MEET/Jan/202324/2<br>t was decided to fix a<br>			rom the earlier decision f<br>0 dated 18/01/2024ag<br>d-hoc norms under Para 4.0	or same export<br>ainst advance<br>7 of HBP Vol. I
	per details given below or as applied by the firm,<br>Export Product<br>Qty.			whichever is less:-
			Qty.		Sl. No.	Impor	t Items	**Qty.

st advance 7 of HBP Vol. I| ||per details given below or as applied by the firm, Export Product Qty.|||whichever is less:-||||| ||||Qty.||Sl. No.|Impor|t Items|Qty. allowed.| ||||||||60 % -LACTOSE 200 G osorbide Mononitrate 60 % and Lactose 40 %)|50.90 mg.| ||Isosorbide Mononitrate Extended-Relesed Tablets USP 30-MG(Each Extended-Released Tablets Contains : Diluted ISMN (40 Percent Diluted With Lactose|| 1 Number||1|IS5MN 40% (Is||| ||Monohydate ) USP Equivelent to ISMN 30Mg.|||||||| ||||||||NC.|| ||A concerned may take further necessary action as|||per above decision of||||| |||||||||| |||||||||| |Ca|se No. |10 / NC/3/MEET/Apr/202425/2||||||| |Ca| |||||||| ||se Status |Case Approved||||||| |Pa|rty Name |COHANCE LIFESCIENCES LIM||ITED||||| |M an|eeting Number d Date |NC/ 3/ MEET/ Apr/ 202425/ 2 and||30/04/2024||||| |H|File Number |HQRNORM APPLY 00005432A||M23||||| || |||||||| |RA|File Number |09AX04000883 AM23||||||| |Li Da|cence No and te |0911004235/30/12/2022||||||| |No|rms Committee Decision:||||||||

Case No.	10 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	COHANCE LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00005432AM23
RA File Number	09AX04000883 AM23
Licence No and<br>Date	0911004235/30/12/2022
Norms Committee Decision:

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2 and 30/04/2024| |HQ File Number|HQRNORM APPLY 00005432AM23| |RA File Number|09AX04000883 AM23| |Licence No and Date|0911004235/30/12/2022| |Norms Committee Decision:||

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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/Jan/202324/20 dated 18/01/2024 against advance authorization No. 0911003424 dated 01/08/2022 , 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.
Isosorbide Mononitrate	1 Number	1	IS5MN 60%-LACTOSE 200 G 40%	203.60 mg.
Extended-Relesed Tablets USP			(Isosorbide Mononitrate 60% and
120-MG(Each Extended			Lactose 40%)
Released Tablets Contains :
Diluted ISMN (40% Diluted
With Lactose Monohydate )
USP Equivelent to ISMN
120Mg .

trate 60% and|| |120-MG(Each Extended|||Lactose 40%)|| |Released Tablets Contains :||||| |Diluted ISMN (40% Diluted||||| |With Lactose Monohydate )||||| |USP Equivelent to ISMN||||| |120Mg .|||||

Case No.<br>11 / NC/3/MEET/Apr/202425/2	Case No.<br>11 / NC/3/MEET/Apr/202425/2
Case Status<br>Case Approved
Party Name<br>ANUH PHARMA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number<br>HQRNORM APPLY 00006763AM23
RA File Number<br>03AX04005850 AM23
Licence No and<br>Date<br>0311021914/06/03/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07		of HBP
Vol. I as per details given below or as applied by	the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
		allowed.
Deflazacort IP/BP/EP<br>1 kg.<br>1	11 B, 16B)-HYDROXY 2-METHLY-5H-PREGNA-	1.00 kg.

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1.4DIENO (17.16D) OXAzole-3.0-dione (D5)

Items**||Qty.|| ||||allowed.|| |Deflazacort IP/BP/EP 1 kg. 1|11 B, 16B)-HYDROXY 2-METHLY-5H-PREGNA-||1.00 kg.||

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1.4DIENO (17.16D) OXAzole-3.0-dione (D5)

Case No.	Case No.	12 / NC/3/MEET/Apr/202425/2	12 / NC/3/MEET/Apr/202425/2	12 / NC/3/MEET/Apr/202425/2	12 / NC/3/MEET/Apr/202425/2	12 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		JUBILANT GENERICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001227AM24
RA File Number		05AX04000591 AM24
Licence No and<br>Date		0511019120/01/06/2023
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:-

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


	Levetiracetam	500 mg tablets	1 Tablet	1	Levetiracetam	510 mg/tablet

	Levetiracetam	1000 mg tablets	1 Tablet	2	Levetiracetam	1020 mg/tablet



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

Case No.	13 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number
and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001233AM24

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Deferred| |Party Name|ENCUBE ETHICALS PRIVATE LIMITED| |Meeting Number|| |and Date|NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024| |HQ File Number|HQRNORM APPLY 00001233AM24|

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RA File Number	03AX04000925 AM24
Licence No and<br>Date	0311024109/01/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Copy of Export Orders showing the product is exported to US.

Case No.	Case No.	14 / NC/3/MEET/Apr/202425/2	14 / NC/3/MEET/Apr/202425/2	14 / NC/3/MEET/Apr/202425/2	14 / NC/3/MEET/Apr/202425/2	14 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001234AM24
RA File Number		09AX04000845 AM23
Licence No and<br>Date		0911005139/01/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it w<br>Vol. I as per details given below or as applied by the firm,<br>Export Product<br>Qty.<br>GCLE(7-PHENYLACETAMIDEO-3-<br>CHLOROMETHYL<br>CEPHALOSPORANIC ACID PARA<br>METHOXY BENZYL ESTER) (WHITE<br>CRYSTALLINE)<br>1 kg.				as decided to fix ad-hoc norms under Para 4.07 of HBP<br>whichever is less:-
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

OXY BENZYL ESTER) (WHITE CRYSTALLINE) 1 kg.||||as decided to fix ad-hoc norms under Para 4.07 of HBP whichever is less:-||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||GCLE(7-PHENYLACETAMIDEO-3- CHLOROMETHYL CEPHALOSPORANIC ACID PARA METHOXY BENZYL ESTER) (WHITE CRYSTALLINE)|| 1 kg.|1|PENICILLIN G POTASSIUM FIRST CRYSTAL|1.3125 kg.| |||||2|ACETONE|1.971 kg.| |||||3|METHYLENE CHLORIDE MDC|3.29 kg.| |||||4|2 MERCAPTO BENZO THIAZOLE MBT|0.511 kg.|

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5 METHANOL 1.971 kg.

Case No.	15 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	VINYL PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001243AM24
RA File Number	05AX04000373 AM24
Licence No and<br>Date	0511019135/01/06/2023
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/202324/19 dated 05/01/2024against advance<br>authorizationNo. 0511016621 dated 29/12/2022, 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.<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 Phthalic Anhydride 0.400 kg. PVC Plasticizer (Phthalic, Non-Polymeric) 1 kg. 2 2 Ethyl Hexanol 0.700 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	16 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024

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and Date
HQ File Number	HQRNORM APPLY 00001244AM24
RA File Number	34AX04000140 AM24
Licence No and<br>Date	3411003769/01/06/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it
was decided to call for following information/documents from the firm:-
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.

er Annexure to Appendix 4E for chemical products.** iii.|| |Stoichiometric balance between import and export on molar basis. iv.|| |Details of indigenous input with quantity. v.||

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

Case No.	17 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001246AM24
RA File Number	09AX04000952 AM23
Licence No and<br>Date	0911005147/01/06/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it
was decided to call for following information/documents from the firm:-
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Production / consumption data for the last three years duly certified by CA.<br>iv.

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

Case No.	18 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED

rmula and molecular weights along with stage wise percentage yields on molar basis.**

Case No.	18 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED

14 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001247AM24
RA File Number	09AX04000097 AM24
Licence No and<br>Date	0911005137/01/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>5-Hydroxy-1,3-oxathiolane-2-<br>carboxylicacid(1R,2S,5R)<br>menthyl ester<br>1.00 kg.<br>2<br>Dimethyl formamide<br>0.2632 kg.<br>3<br>Triphosgene<br>0.421 kg.<br>4<br>Cytosine<br>0.375 kg.<br>(2R-cis)-5-(4-amino-1,2-dihydro-2-oxo-<br>1-pyrimidinyl)-1,3-oxathiolane-2-<br>carboxylic acid(2S,5R)-methyl<br>ester.(Other heterocyclic compounds)<br>1 kg.<br>5<br>Hexamethyl disilazane<br>0.660 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ylic acid(2S,5R)-methyl ester.(Other heterocyclic compounds) 1 kg. 5 Hexamethyl disilazane 0.660 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	19 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001248AM24
RA File Number	09AX04000181 AM24
Licence No and<br>Date	0911005153/01/06/2023
Norms Committee Decision:

UDIN00220736AM25

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.
Bivalirudin for Injection 250mg /Vial	1 Number	1	Bivalirudin	275 mg / vial

Case No.	Case No.	20 / NC/3/MEET/Apr/202425/2	20 / NC/3/MEET/Apr/202425/2	20 / NC/3/MEET/Apr/202425/2	20 / NC/3/MEET/Apr/202425/2	20 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001270AM24
RA File Number		34AX04000147 AM24
Licence No and<br>Date		3411003773/02/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

|Licence No and Date||3411003773/02/06/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2-Methyl-3-butene-2- ol 0.616 kg. 2 Tri Methyl Ortho formate 0.71 kg. POMELO ACETAL((6,6-Dimethoxy- 2,5,5-trimethylhex- 2-ene)) 1 kg. 3 Iso Butyraldehyde 1.105 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||POMELO ACETAL((6,6-Dimethoxy- 2,5,5-trimethylhex- 2-ene))||1 kg.|1|2-Methyl-3-butene-2- ol|0.616 kg.| |||||2|Tri Methyl Ortho formate|0.71 kg.| |||||3|Iso Butyraldehyde|1.105 kg.| ||||||||

UDIN00220736AM25

Case No.	21 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001257AM24
RA File Number	03AX04000921 AM24
Licence No and<br>Date	0311024140/02/06/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it
was decided to call for following information/documents from the firm:-
Copy of Export Orders showing the product is exported to US.

of ad-hoc norms and as per the advise of the TE, it|| |was decided to call for following information/documents from the firm:-|| |Copy of Export Orders showing the product is exported to US.||

Case No.	22 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001260AM24
RA File Number	03AX04000922 AM24
Licence No and<br>Date	0311024145/02/06/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it
was decided to call for following information/documents from the firm:-
Complete chemical reactions, Molecular weight and percentage yield on molar basis.<br>1.
Production/Consumption data for the last three years duly certified by CA.<br>2.

17 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

UDIN00220736AM25

ction/Consumption data for the last three years duly certified by CA.** 2.||

17 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

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Case No.	23 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ A/ 202425/ 2 d 30/04/2024
and Date	pr an
HQ File Number	HQRNORM APPLY 00001261AM24
RA File Number	03AX04000895 AM24
Licence No and<br>Date	0311024147/02/06/2023
Norms Committee	Decision:
The committee co	sidered the reuest of firm for review/fixation of ad-hoc norms and as er the advise of the TE it
<br>was decided to cal	q p ,<br>l for following information/documents from the firm:-
Complete chemical reactions, Molecular weight and percentage yield on molar basis.

Case No.	24 / NC	/3/MEET/Apr/202425/2
Case Status	Case A	pproved
Party Name	ALEM	BIC PHARMACEUTICALS LIMITED
Meeting Number	NC/ 3/	MEET/ Apr/ 202425/ 2 and 30/04/2024
and Date
HQ File Number	HQRN	ORM APPLY 00001267AM24
RA File Number	34AX0	4000158 AM24
Licence No and<br>Date	3411003772/02/06/2023
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.

ence No and Date||3411003772/02/06/2023||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Glycopyrrolate injection USP 0.2 mg - 1 ml 1 Number 1 Glycopyrrolate USP 0.22 mg. Glycopyrrolate injection USP 0.2 mg - 2 ml 1 Number 2 Glycopyrrolate USP 0.44 mg.||||||||||| |||||||||||| ||Export Product|||||Qty.|**Sl. No. **|Import Items||Qty. allowed.| |||||||||||| ||Glycopyrrolate injection USP 0.2 mg - 1 ml||||1|Number|1|Glycopyrrolate USP||0.22 mg.| ||Glycopyrrolate injection USP 0.2 mg - 2 ml||||1|Number|2|Glycopyrrolate USP||0.44 mg.| ||||||||||||

UDIN00220736AM25

Glycopyrrolate injection USP 0.2 mg- 5 ml<br>1 Number<br>3<br>Glycopyrrolate USP<br>1.10 mg.<br>Glycopyrrolate injection USP 0.2 mg - 20 ml<br>1 Number<br>4<br>Glycopyrrolate USP<br>4.20 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Glycopyrrolate injection USP 0.2 mg- 5 ml	1 Number	3	Glycopyrrolate USP	1.10 mg.
	Glycopyrrolate injection USP 0.2 mg - 20 ml	1 Number	4	Glycopyrrolate USP	4.20 mg.

.	Glycopyrrolate injection USP 0.2 mg- 5 ml	1 Number	3	Glycopyrrolate USP	1.10 mg.
	Glycopyrrolate injection USP 0.2 mg - 20 ml	1 Number	4	Glycopyrrolate USP	4.20 mg.

Case No.	25 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001271AM24
RA File Number	34AX04000149 AM24
Licence No and<br>Date	3411003774/02/06/2023
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/Nov/202324/16 dated 17/11/2023against advance<br>authorizationNo. 3411001553 dated 17/12/2021, 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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>PHENOXYETHYL ISOBUTYRATE<br>(Phenoxy) ethyl 2-methylpropanoate)<br>1 kg.<br>1<br>ISOBUTYRIC ACID<br>0.5633 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00220736AM25

RATE (Phenoxy) ethyl 2-methylpropanoate) 1 kg. 1 ISOBUTYRIC ACID 0.5633 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	Case No.	26 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		BEST VALUE CHEM PRIVATE LIMITED
Meeting Number
and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001273AM24
RA File Number		34AX04000150 AM24
Licence No and<br>Date		3411003775/02/06/2023
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/Nov/202324/14 dated 09/11/2023against advance<br>authorizationNo. 3411000984 dated 17/08/2021, 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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Ethyl Heptenone<br>1.145 kg.<br>Limbunile(3,7-Dimethyl-2(3), 6-nonadienonitrile))<br>1 kg.<br>2<br>Cyano Acetic acid<br>1.75 kg.
	horization**No.

port Items** Qty. allowed. 1 Ethyl Heptenone 1.145 kg. Limbunile(3,7-Dimethyl-2(3), 6-nonadienonitrile)) 1 kg. 2 Cyano Acetic acid 1.75 kg.||||||||||| ||horizationNo. 3411000984 dat per details given below or as app||ed 17/08/20 lied by the f|21, it was dec irm, whicheve||ided to fix ad-hoc norms unde r is less:-|||r Para 4.07 of HBP Vol. I|| |||||||||||| ||Export Product|||||ty|Sl No|Impor|Items|Qty allowed| ||||||.||. .|||. .| ||Limbunile(3,7-Dimethyl-2(3), 6-nonadienonitrile))||||1 kg.||1|Ethyl Heptenone||1.145 kg.| ||||||||2|Cyano Acetic acid||1.75 kg.| |||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||




C N	27 / N	C/3/MEET/A/202425/2
ase o.		pr
Case Status	Case	Deferred

Party Name	AAR	I PHARMALABS LIMITED

Meeting Number<br>d D	NC/ 3	/ MEET/ Apr/ 202425/ 2 and 30/04/2024
an ate
H Fil Nb	HR	ORM APPLY 00001283AM24
Q e umer	Q
RA File Number	03AX04000485 AM24
Licence No and<br>Date	0311024202/05/06/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

UDIN00220736AM25

r|03AX04000485 AM24|| |Licence No and Date|0311024202/05/06/2023|| |Norms Committee Decision: The case is under consideration for want of comments of TE.||| ||||

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Case No.	28 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001296AM24
RA File Number	05AX04000632 AM24
Licence No and<br>Date	0511019178/05/06/2023
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>Budesonide Suspension For Inhalation , 0.125 mg / ml (2<br>ml Ampoule)<br>8700000<br>Numbers<br>1<br>Budesonide<br>2.284 kg.<br>Budesonide Suspension For Inhalation , 0.25 mg / ml (2<br>ml Ampoule)<br>10800000<br>Numbers<br>2<br>Budesonide<br>5.670 kg.<br>Budesonide Suspension For Inhalation , 0.5 mg / ml (2 ml<br>Ampoule)<br>2400000<br>Numbers<br>3<br>Budesonide<br>2.52 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	29 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001297AM24
RA File Number	34AX04000152 AM24

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Licence No and<br>Date	3411003779/05/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Aldehyde C10 (Capric Aldehyde)<br>1 kg.<br>1<br>Fatty Alcohol C10 (98% purity)<br>1.40 kg.<br>RA concerned may take further necessary action as per above decision of NC and also check the percentage content of<br>item at the time of export.

Licence No and Date

3411003779/05/06/2023

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Aldehyde C10 (Capric Aldehyde) 1 kg. 1 Fatty Alcohol C10 (98% purity) 1.40 kg. RA concerned may take further necessary action as per above decision of NC and also check the percentage content of item at the time of export.

Case No.	30 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001300AM24
RA File Number	03AX04000899 AM24
Licence No and<br>Date	0311024234/05/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>E.D.T.A. DI SODIUM (PURE/AR)<br>1 kg.<br>1<br>EDTA ACID<br>0.80 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Import Items Qty. allowed. E.D.T.A. DI SODIUM (PURE/AR) 1 kg. 1 EDTA ACID 0.80 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	31 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	AURA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001303AM24
RA File Number	03AX04000739 AM24
Licence No and<br>Date	0311024240/05/06/2023
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/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo. 0311009243 dated 07/12/2021, 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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ARGYROL 1% /SILVER<br>VITELLINATE NASAL DROPS 1%<br>weight by volume<br>1 Number<br>1<br>SILVER VITELLINATE102.00 mg /10 ml. Vial<br>RA concerned may take further necessary action as per above decision of NC.

VER VITELLINATE NASAL DROPS 1% weight by volume 1 Number 1 SILVER VITELLINATE102.00 mg /10 ml. Vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	32 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001348AM24
RA File Number	08AX04000333 AM24
Licence No and<br>Date	0811008323/06/06/2023
Norms Committee Decision:

UDIN00220736AM25

The Committee considered the case as per agenda and it has been observed that the export item is new type of drug delivery system and there is no standard wastage. For such export, wastage applied by the firm is 127.22% for import item No. (1) and 126.73% for import item No. (2) which appears to be very high. Therefore, it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case along with relevant documents, i.e. PPT, Plant Operation Video etc.

ry high. Therefore, it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case along with relevant documents, i.e. PPT, Plant Operation Video etc.

Case No.	33 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	INTIGREAT CONSULTING SERVICES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001324AM24
RA File Number	03AX04000737 AM24
Licence No and<br>Date	0311024265/06/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>No specific import item is given. Please get the specific import item endorsed in the License.<br>1.<br>Copy of Drug Manufacturing License (DML) with approved composition.<br>2.<br>Copy of Master Batch Formula.<br>3.<br>Why 5% overages is required in the export. Any such approval from Drug Authorities?<br>4.

Case No.	34 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	SHILPA PHARMA LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001330AM24
RA File Number	07AX04000315 AM24
Licence No and<br>Date	0711007735/06/06/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

24 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

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

24 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

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Case No.		35 / NC/3/MEET/Apr/202425/2

Case Status		Case Approved
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED

Meeting Number<br>		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
and Date

HQ File Number		HQRNORM APPLY 00001340AM24
RA File Number		03AX04000962 AM24

Licence No and<br>Date		0311024276/06/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Carbamazepine<br>102.00 mg.<br>2<br>Cellulose Acetate (CA 320S)<br>Eastman<br>29.20 mg.<br>Carbamazepine Extended-Release Tablets<br>USP 100 mg.(Each tablet contains (i)<br>Carbamazepine 100 mg. (ii) Cellulose<br>Acetate (CA-320S) -Eastman 35.04mg.<br>(iii) Eastman (TM Cellulose Acetate (CA<br>398-10NF/EP)- 5.28 mg.<br>1 Number<br>3<br>EASTMAN (TM)<br>4.40 mg.
	l. I as per details given below or as appli		ed by the firm		, whichever		is less:-

	Export Product			Qty.		**Sl.

. 1 Number 3 EASTMAN (TM) 4.40 mg.||||||||||| ||l. I as per details given below or as appli||ed by the firm||, whichever||is less:-|||| |||||||||||| ||Export Product|||Qty.||Sl. N|o.|Import Items||Qty. allowed.| ||Carbamazepine Extended-Release Tabl USP 100 mg.(Each tablet contains (i) Carbamazepine 100 mg. (ii) Cellulose||ets |1 Number||1||Carbamazepine||102.00 mg.| ||||||||||| | ||Acetate (CA-320S) -Eastman 35.04mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 5.28 mg.|||||2||Cellulose Acetate (CA 320S Eastman||) 29.20 mg.| |||||||3||EASTMAN (TM)||4.40 mg.| |||||||||CELLULOSE ACETATE (CA 398-10NF/EP)||| ||Carbamazepine Extended-Release Tablets|||1 Number||4||Carbamazepine||204.00 mg.| ||USP 200 mg.( |Each tablet contains (i) ||||||||| |||||||||||| ||Carbamazepin |e 200 mg. (ii) Cellulose ||||5||Cellulose Acetate (CA 320S||) 2920 mg| ||Acetate (CA-3 iii E|20S) -Eastman 35.04mg. TM Clll A CA|||||| Eastman|| . .| ||() astman ( 398-10NF/EP)|euose cetate ( - 5.28 mg.||||||||| |||||||||||| |||||||6||EASTMAN (TM) ||4.40 mg.| |||||||||CELLULOSE ACETATE (CA 398-10NF/EP)||| |||||||||||| |||||||||||| ||Carbamazepine Extended-Release Tablets|||1 Number||7||Carbamazepine||408.00 mg.| ||||||||||||

UDIN00220736AM25

|||||||||CELLULOSE ACETATE (CA 398-10NF/EP)||| |||||||||||| |||||||||||| ||Carbamazepine Extended-Release Tablets|||1 Number||7||Carbamazepine||408.00 mg.| ||||||||||||

UDIN00220736AM25

USP 400 mg.(Each tablet contains (i)	8	Cellulose Acetate (CA-320S)	<br>29.20 mg.
Carbamazepine 400 mg. (ii) Cellulose		Eastman
Acetate (CA-320S) -Eastman 26.28mg.
(iii) Eastman (TM Cellulose Acetate (CA
398-10NF/EP)- 3.96 mg.	9	EASTMAN (TM)<br>CELLULOSE ACETATE	4.40 mg.
		(CA 398-10NF/EP)

Case No.	36 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	LOZEN PHARMA PRIVATE LIMITED

Meeting Number<br>d D	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
an ate
H Fil Nb	HRNORM APPLY 00001379AM24
Q e umer	Q
RA Fil Nb	03AX04001008 AM24
e umer
Licence No and<br>D	0311024330/07/06/2023
ate
N Ci	ii
orms ommttee	ecson:
The committee co<br>decided to call for	nsidered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>following information/documents from the firm:-
Approved composition of each export item from Drug Licensing Authority.<br>1.<br> <br>
Copy of Master-Batch Formula for each export item.<br>2.<br>Chemical description / Catalogue for import item No. (4).<br>3.

export item from Drug Licensing Authority.** 1. || |Copy of Master-Batch Formula for each export item. 2. Chemical description / Catalogue for import item No. (4). 3.||




Case No.	3	7 / NC/3/MEET/Apr/202425/2

Case Status	C	ase Approved

Party Name	Y	ASHO INDUSTRIES LIMITED

Meeting Number and
<br>Date	N	C/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001382AM24
RA File Number	03AX04001033 AM24
Licence No and Date	0311024333/07/06/2023
Norms Committee Decision:

UDIN00220736AM25

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/Apr/202425/2 dated 30/04/2024 against advance authorization No. 0311024333 dated 07/06/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
YAPOX CL 30/10 "HYDROQUINONE BIS"	1 kg.	1	HYDROQUINONE	0.735 kg.
(2 HYDROXY ETHYL ETHER)
		2	ETHYLENE CARBONATE	1.232 kg.

Import Items*|Qty. allowed.| |---|---|---|---|---|---| |YAPOX CL 30/10 "HYDROQUINONE BIS"|1 kg.|1||HYDROQUINONE|0.735 kg.| |(2 HYDROXY ETHYL ETHER)|||||| |||2||ETHYLENE CARBONATE|1.232 kg.|

Case No.<br>38 / NC/3/MEET/Apr/202425/2
Case Status<br>Case Approved
Party Name<br>YASHO INDUSTRIES LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number<br>HQRNORM APPLY 00001384AM24
RA File Number<br>03AX04001034 AM24
Licence No and Date<br>0311024337/07/06/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Mar/202324/26 dated 22/03/2024		against advance
authorizationNo. 0311030426 dated 24/01/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever	is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>OCTYLATED DIPHENYLAMINE<br>1 kg.	DIPHENYLAMINE	0.405 kg.
2<br>(OCD FLAKES/POWDER)	DI ISOBUTYLENE	0.622 kg.

UDIN00220736AM25

3 ACTIVATED CLAY 0.100 kg.

s**|Qty. allowed.|| |1 OCTYLATED DIPHENYLAMINE 1 kg.|DIPHENYLAMINE|0.405 kg.|| |2 (OCD FLAKES/POWDER)|DI ISOBUTYLENE|0.622 kg.||

UDIN00220736AM25

3 ACTIVATED CLAY 0.100 kg.

Case No.	Case No.	39 / NC/3/MEET/Apr/202425/2	39 / NC/3/MEET/Apr/202425/2	39 / NC/3/MEET/Apr/202425/2	39 / NC/3/MEET/Apr/202425/2	39 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number
and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001424AM24
RA File Number		05AX04000664 AM24
Licence No and
Date		0511019264/09/06/2023
Norms Committee<br>		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/202324/26 dated 22/03/2024against advance<br>authorizationNo. 0511016407 dated 15/12/2022, 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.<br>Import Items<br>Qty. allowed.<br>1<br>PURE TERA PHTHALIC ACID<br>0.447 kg.<br>DI OCTYL TERA PHTHALATE<br>(DOTP)<br>1 kg.<br>2<br>2 ETHYL HEXANOL<br>0.680 kg.

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

THALIC ACID 0.447 kg. DI OCTYL TERA PHTHALATE (DOTP) 1 kg. 2 2 ETHYL HEXANOL 0.680 kg.|||||||||| ||||||||||| ||Export Product|||Qty.||Sl. No.||Import Items|Qty. allowed.| ||||||||||| ||DI OCTYL TERA PHTHALAT (DOTP)||E|1 kg.||1||PURE TERA PHTHALIC ACID|0.447 kg.| ||||||||||| |||||||2|2 ETHYL HEXANOL||0.680 kg.| ||||||||||| |RA concerned may take further necessary action as||||||per above decision of NC.||||




Case No.	40 / NC/	3/MEET/Apr/202425/2

Case Status	Case De	ferred

Party Name	ENCUB	E ETHICALS PRIVATE LIMITED

Meeting Number	NC/ 3/ M	EET/ Apr/ 202425/ 2 and 30/04/2024

UDIN00220736AM25

and Date
HQ File Number	HQRNORM APPLY 00001425AM24
RA File Number	03AX04000550 AM24
Licence No and<br>Date	0311024389/09/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Copy of Export Orders showing the product is exported to US.

of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Copy of Export Orders showing the product is exported to US.||

Case No.	41 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001432AM24
RA File Number	08AX04000386 AM24
Licence No and<br>Date	0811008360/09/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CLOZAPINE TABLETS 25 MG<br>(ZIPROC 25 MG)<br>1 Number<br>1<br>CLOZAPINE BP<br>25.50 mg/Tablet<br>CLOZAPINE TABLETS 100 MG<br>(ZIPROC 100 MG)<br>1 Number<br>2<br>CLOZAPINE BP<br>102.00 mg/Tablet<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00220736AM25

INE TABLETS 100 MG (ZIPROC 100 MG) 1 Number 2 CLOZAPINE BP 102.00 mg/Tablet RA concerned may take further necessary action as per above decision of NC.||

UDIN00220736AM25

Case No.	42 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001433AM24
RA File Number	05AX04000661 AM24
Licence No and<br>Date	0511019270/09/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Kombinil-DUO Eye/Ear Drops 5ml Vial<br>2777778<br>Vials<br>1<br>Dexamethasone Micronised<br>PH EUR USP JP<br>14.167 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	43 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001437AM24
RA File Number	03AX04000985 AM24
Licence No and<br>Date	0311024401/09/06/2023
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:-

ommittee 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:-||

UDIN00220736AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Mometasone Furoate & Azelastine	1 Number	1	Azelastine Hydrochloride BP	0.02142 gm
HCL Nasal Spray (150MD) /
(DIRNELID AZ) 150 MDI / Momate
AZ NASAL SPRAY 150 MDI((Each
Spray Delivers 140mcg of Azelastine
HCL)
Mometasone Furoate & Azelastine	1 Number	2	Azelastine Hydrochloride BP	0.02142 gm.
HCL Nasal Spray (150MD) /
(DIRNELID AZ) 150 MDI / Momate
AZ NASAL SPRAY 150 MDI((Each
Spray Delivers 140mcg of Azelastine
HCL)
Mometasone Furoate & Azelastine	1 Number	3	Azelastine Hydrochloride BP	0.01071 gm.
HCL Nasal Spray (75MD) /
(DIRNELID AZ) 75 MDI / Momate
AZ NASAL SPRAY 75 MDI((Each
Spray Delivers 140mcg of Azelastine
HCL)

|Azelastine Hydrochloride BP|0.01071 gm.| |HCL Nasal Spray (75MD) /||||| |(DIRNELID AZ) 75 MDI / Momate||||| |AZ NASAL SPRAY 75 MDI((Each||||| |Spray Delivers 140mcg of Azelastine||||| |HCL)|||||

Case No.	44 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001454AM24
RA File Number	34AX04000148 AM24
Licence No and Date	3411003799/09/06/2023
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/May/202324/5 dated 08/06/2023against advance
authorizationNo. 3411000701 dated 08/06/2021, 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:-

UDIN00220736AM25

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Dicyclopentadiene<br>0.705 kg.<br>VERDYL ISOBUTYRATE((3a,4,5,6,7a-<br>hexahydro-4,7-methano-1H-inden-5-yl<br>isobutyrate))<br>1 kg.<br>2<br>Iso butyric Acid<br>0.493 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	VERDYL ISOBUTYRATE((3a,4,5,6,7a-<br>hexahydro-4,7-methano-1H-inden-5-yl<br>isobutyrate))	1 kg.	1	Dicyclopentadiene	0.705 kg.
			2	Iso butyric Acid	0.493 kg.

wed.**| |---|---|---|---|---|---| ||VERDYL ISOBUTYRATE((3a,4,5,6,7a- hexahydro-4,7-methano-1H-inden-5-yl isobutyrate))|1 kg.|1|Dicyclopentadiene|0.705 kg.| ||||2|Iso butyric Acid|0.493 kg.|

Case No.	45 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	UNIMAX LABORATORIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001505AM24
RA File Number	05AX04000673 AM24
Licence No and<br>Date	0511019298/12/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Copy of Drug Manufacturing License (DML) showing approved composition of each export item.<br>1.<br>Certificate of Analysis (CoA) for import item No.3 and 4 from foreign supplier showing actual potency.<br>2.

Case No.	46 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001486AM24
RA File Number	05AX04000711 AM24
Licence No and<br>Date	0511019290/12/06/2023
Norms Committee Decision:

UDIN00220736AM25

and 30/04/2024| |HQ File Number|HQRNORM APPLY 00001486AM24| |RA File Number|05AX04000711 AM24| |Licence No and Date|0511019290/12/06/2023| |Norms Committee Decision:||

UDIN00220736AM25

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. 0510404862 dated 12/12/2017 , 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.
PVC PLASTICIZER (DINP)	1 kg.	1	PHTHALIC ANHYDRIDE	0.372 kg.
		2	ISO NONANOL	0.726 kg.

Case No.	47 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001573AM24
RA File Number	03AX04001075 AM24
Licence No and<br>Date	0311024511/13/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Copy of Master-Batch Formula for each export item.<br>1.<br>Certificate of Analysis (CoA) of import item.<br>2.

Case No.	48 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED

Certificate of Analysis (CoA) of import item.** 2.||

Case No.	48 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED

UDIN00220736AM25

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001530AM24
RA File Number		03AX04001109 AM24
Licence No and<br>Date		0311024473/13/06/2023
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/Jun/202324/8 dated 30/06/2023against advance authorization<br>No. 0311022762 dated 12/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Benzydamine Hydrochloride<br>3.06 gm<br>2<br>Cetylpyridinium Chloride<br>1.356 gm<br>Benzydamine Hydrochloride And<br>Cetylpyridinium Chloride Anti-<br>Inflammatory And Antiseptic<br>Lozenges Sugar Free and(all other<br>flavours.

.06 gm 2 Cetylpyridinium Chloride 1.356 gm Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M – 2586 mg. 1000 Numbers 3 Isomalt ST-M 2586.00 gm 4 Benzydamine Hydrochloride 3.06 gm Benzydamine Hydrochloride, 2,4- Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST- M- 2586mg. 1000 Numbers 5 Isomalt ST-M 2586.00 gm 6 Benzydamine Hydrochloride 3.06 gm Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free.(Each lozenge contains (i) Benzydamine Hydrochloride- 3mg (ii) Isomalt ST-M - 2586mg. 1000 Numbers 7 Isomalt ST-M 2586.00 gm 8 Cetylpyridinium Chloride 1.356 gm Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. 1000 Numbers 9 Isomalt ST-M 2586.00 gm||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(all other flavours.

y.**|Sl. No.|Import Items|Qty. allowed.| ||Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M – 2586 mg.||1000 Numbers|1|Benzydamine Hydrochloride|3.06 gm| |||||2|Cetylpyridinium Chloride|1.356 gm| |||||3|Isomalt ST-M|2586.00 gm| ||Benzydamine Hydrochloride, 2,4- Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST- M- 2586mg.|| 1000 Numbers|4|Benzydamine Hydrochloride|3.06 gm| |||||5|Isomalt ST-M|2586.00 gm| ||Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free.(Each lozenge contains (i) Benzydamine Hydrochloride- 3mg (ii) Isomalt ST-M - 2586mg.||1000 Numbers|6|Benzydamine Hydrochloride|3.06 gm| |||||7|Isomalt ST-M|2586.00 gm| ||Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg.||1000 Numbers|8|Cetylpyridinium Chloride|1.356 gm| |||||9|Isomalt ST-M|2586.00 gm|

UDIN00220736AM25

contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg.||1000 Numbers|8|Cetylpyridinium Chloride|1.356 gm| |||||9|Isomalt ST-M|2586.00 gm|

UDIN00220736AM25

10<br>Cetylpyridinium Chloride<br>1.02 gm<br>Cetylpyridinium Chloride And<br>Benzydamine Hydrochloride<br>Antiseptic Lozenges Sugar<br>Free.(Each lozenge contains (i)<br>Cetylpyridinium Chloride- 1 mg (ii)<br>lsomalt ST-M - 2586mg.<br>1000<br>Numbers<br>11<br>Isomalt ST-M<br>2586.00 gm<br>RA concerned may take further necessary action as per above decision of NC.	Cetylpyridinium Chloride And<br>Benzydamine Hydrochloride<br>Antiseptic Lozenges Sugar<br>Free.(Each lozenge contains (i)<br>Cetylpyridinium Chloride- 1 mg (ii)<br>lsomalt ST-M - 2586mg.	1000<br>Numbers	10	Cetylpyridinium Chloride	1.02 gm
			11	Isomalt ST-M	2586.00 gm

Case No.	49 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001546AM24
RA File Number	03AX04001142 AM24
Licence No and<br>Date	0311024489/13/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix-4E.

n of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Complete technical details as per Annexure to Appendix-4E.||

Case No.	50 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001555AM24
RA File Number	03AX04001141 AM24
Licence No and<br>Date	0311024501/13/06/2023
Norms Committee Decision:

UDIN00220736AM25

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

Complete technical details as per Annexure to Appendix-4E.

Case No.	51 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001556AM24
RA File Number	03AX04001157 AM24
Licence No and<br>Date	0311024502/13/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix-4E.

Case No.	52 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001557AM24
RA File Number	03AX04001137 AM24
Licence No and<br>Date	0311024503/13/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-

UDIN00220736AM25

Complete technical details as per Annexure to Appendix-4E.

Case No.	53 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001558AM24
RA File Number	03AX04001150 AM24
Licence No and<br>Date	0311024504/13/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix-4E.

Case No.	54 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001562AM24
RA File Number	03AX04001138 AM24
Licence No and<br>Date	0311024507/13/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix-4E.

37 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

UDIN00220736AM25

the firm:- Complete technical details as per Annexure to Appendix-4E.||

37 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

UDIN00220736AM25

Case No.	55 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001564AM24
RA File Number	03AX04001139 AM24
Licence No and<br>Date	0311024508/13/06/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was
decided to call for	following information/documents from the firm:-
Complete technical details as per Annexure to Appendix-4E.

Case No.	56 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001565AM24
RA File Number	03AX04001169 AM24
Licence No and<br>Date	0311024509/13/06/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was
decided to call for	following information/documents from the firm:-
Complete technical details as per Annexure to Appendix-4E.

Case No.	57 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	CHEMIKER PHARMACEUTICALS PRIVATE LIMITED

Complete technical details as per Annexure to Appendix-4E.**||

Case No.	57 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	CHEMIKER PHARMACEUTICALS PRIVATE LIMITED

38 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

UDIN00220736AM25

Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number<br>HQRNORM APPLY 00001572AM24
RA File Number<br>50AX04000015 AM24
Licence No and<br>Date<br>5011000916/13/06/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was
decided to call for following information/documents from the firm:-
Complete technical details as per Annexure to Appendix-4E.

Case No.	58 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001574AM24
RA File Number	03AX04001083 AM24
Licence No and<br>Date	0311024513/13/06/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was
decided to call for	following information/documents from the firm:-
Copy of Master-Batch Formula for each export item.

r fixation of ad-hoc norms and as per the advise of the TE, it was|| |decided to call for|following information/documents from the firm:-| |Copy of Master-Batch Formula for each export item.||

Case No.	59 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred

Party Name	ENCUBE ETHICALS PRIVATE LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001580AM24
RA File Number	03AX04001140 AM24

Licence No and
<br>Date	0311024530/14/06/2023

39 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

UDIN00220736AM25

Norms Committee Decision:

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

Copy of Export Orders showing the product is exported to US.

Case No.	60 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001586AM24
RA File Number	03AX04001174 AM24
Licence No and<br>Date	0311024536/14/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix-4E.

Case No.	61 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001587AM24
RA File Number	03AX04001170 AM24
Licence No and<br>Date	0311024537/14/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-

40 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

UDIN00220736AM25

Complete technical details as per Annexure to Appendix-4E.

Case No.	62 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001594AM24
RA File Number	03AX04001153 AM24
Licence No and<br>Date	0311024542/14/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Complete chemistry with Molecular weight and percentage of yield on molar basis.<br>i.<br>End-use of export product.<br>ii.

Case No.	63 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001595AM24
RA File Number	03AX04001154 AM24
Licence No and<br>Date	0311024543/14/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix-4E.

41 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

UDIN00220736AM25

the firm:- Complete technical details as per Annexure to Appendix-4E.||

41 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

UDIN00220736AM25

Case No.	64 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001629AM24
RA File Number	03AX04001202 AM24
Licence No and<br>Date	0311024559/15/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Complete chemistry with molecular weight and percentage yield on molar basis.<br>i.<br>End use of export product.<br>ii.

Case No.	65 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001634AM24
RA File Number	34AX04000189 AM24
Licence No and<br>Date	3411003805/15/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Copy of Master-Batch Formula for each export items, showing net content of inputs in the export items.

Case No.	66 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved

r>Copy of Master-Batch Formula for each export items, showing net content of inputs in the export items.||

Case No.	66 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved

UDIN00220736AM25

Party Name	Party Name	PIRAMAL PHARMA LIMITED	PIRAMAL PHARMA LIMITED	PIRAMAL PHARMA LIMITED	PIRAMAL PHARMA LIMITED	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001659AM24
RA File Number		03AX04001231 AM24
Licence No and		0311024593/15/06/2023
Date

Norms Committee<br>The Committee		Decision:<br>onsidered the case as er aenda and takin cue from the earlier decision for same exort
<br>product/import p		p g g p<br>roduct in meetingNo.NC/3/MEET/Mar/202324/26 dated 22/03/2024against advance
<br>authorizationNo.		<br>0311031086 dated 12/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as	per details give	n below or as applied by the firm, whichever is less:-

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

	Atorvastatin Calcium Tablets<br>USP 10mg.		1 Number<br>Tablet	1	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	<br>11.4415 mg.

				2	Microcrystalline Cellulose (MCC)	<br>64578 mg
					<br>NF (Avicel PH 102)	<br>.

USP 10mg.||1 Number Tablet|1|Atorvastatin Calcium Propylene Glycol Solvate USP| 11.4415 mg.| |||||||| |||||2|Microcrystalline Cellulose (MCC)| 64578 mg| |||||| NF (Avicel PH 102)| . .| |||||||| |||||3|Calcium Acetate|18.049 mg.| |||||||| |||||||| |||||4|Silica Gel Dessicants - Packaged| Relevant, as per| ||||||Activated Carbon (Strippax Sorbent)| packing policy and General Notes.| |||||||| ||Atorvastatin Calcium Tablets USP 20 mg.||1 Number Tablet|5|Atorvastatin Calcium Propylene Glycol Solvate USP| 22.830 mg.| |||||||| |||||6|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)| 129.427 mg.| |||||7|Cli Att|36090| ||||||acum ceae|. mg.| |||||||| |||||8|Silica Gel Dessicants - Packaged Activated Carbon (Strippax | Relevant, as per packing policy and | ||||||Sorbent)|General Notes.| |||||||| |||||||| ||Atorvastatin C USP 40mg.|alcium Tablets|1 Number Tablet|9|Atorvastatin Calcium Propylene Glycol Solvate USP| 45.595 mg.| ||||||||

UDIN00220736AM25

l Notes.| |||||||| |||||||| ||Atorvastatin C USP 40mg.|alcium Tablets|1 Number Tablet|9|Atorvastatin Calcium Propylene Glycol Solvate USP| 45.595 mg.| ||||||||

UDIN00220736AM25

10<br>Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)<br>258.08 mg.<br>11<br>Calcium Acetate<br>71.963 mg.<br>12<br>Silica Gel Dessicants - Packaged<br>Activated<br>Carbon<br>(Strippax<br>Sorbent)<br>Relevant, as per<br>packing policy and<br>General Notes.<br>13<br>Atorvastatin Calcium Propylene<br>Glycol Solvate USP<br>91.20 mg.<br>14<br>Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)<br>518.206 mg.<br>15<br>Calcium Acetate<br>144.929 mg.<br>Atorvastatin Calcium Tablets<br>USP 80mg.<br>1 Number<br>Tablet<br>16<br>Silica Gel Dessicants - Packaged<br>Activated<br>Carbon<br>(Strippax<br>Sorbent)<br>Relevant, as per<br>packing policy and<br>General Notes.<br>Note: The above norms are valid only for subject to fulfillment of following conditions:-<br>Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application).<br>1.<br>Export to USA only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.<br>RA concerned may take further necessary action as per above decision of NC.			10	Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102)	<br>258.08 mg.
			11	Calcium Acetate	71.963 mg.
			12	Silica Gel Dessicants - Packaged<br>Activated<br>Carbon<br>(Strippax<br>Sorbent)	<br> <br>Relevant, as per<br>packing policy and<br>General Notes.

|---|---| ||||11|Calcium Acetate|71.963 mg.| ||||12|Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent)| Relevant, as per packing policy and General Notes.| ||Atorvastatin Calcium Tablets USP 80mg.|1 Number Tablet|13|Atorvastatin Calcium Propylene Glycol Solvate USP| 91.20 mg.| ||||14|Microcrystalline Cellulose (MCC) NF (Avicel PH 102)| 518.206 mg.| ||||15|Calcium Acetate|144.929 mg.| ||||16|Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent)| Relevant, as per packing policy and General Notes.|

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

Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application). 2. Export to USA only.
Firm holding Certificate of Manufacturing Exclusivity.

Case No.	67 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001722AM24
RA File Number	08AX04000457 AM24
Licence No and<br>Date	0811008434/16/06/2023

UDIN00220736AM25

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/Mar/202324/26 dated 22/03/2024 against advance authorization No. 0811010634 dated 01/02/2024 , 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.
Tranexamic<br>Acid<br>in<br>0.7%<br>Sodium Chloride Injection 1,000<br>mg per 100 mL (10 mg/mL)	<br> <br>1 Number	1	Tranexamic acid	1.05 gm/100 ml Vial

Case No.	68 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ARCH PROTECTION CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001705AM24
RA File Number	03AX04001182 AM24
Licence No and<br>Date	0311024600/16/06/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	69 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	VINYL PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001723AM24
RA File Number	05AX04000743 AM24
Licence No and	0511019402/16/06/2023

UDIN00220736AM25

Date

Norms Committee Decision:

UDIN00220736AM25

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/Dec/202324/19 dated 05/01/2024 against advance authorization No. 0511016621 dated 29/12/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
PVC PLASTICIZER<br>(PLASTICIZER, NON-POLLYMERIC)	1 kg.	1	PHTHALIC ANHYDRIDE	0.400 kg.
		2	2 ETHYL HEXANOL	0.700 kg.

Case No.	70 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	CONNEX PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001735AM24
RA File Number	26AX04000033 AM24
Licence No and<br>Date	2611000980/16/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Stage wise and overall yield of the reaction.<br>1.<br>Complete justification of low yield of the reaction.<br>2.<br>Stoichiometric material balance on molar basis.<br>3.

Case No. 71 / NC/3/MEET/Apr/202425/2

the reaction.** 1. Complete justification of low yield of the reaction. 2. Stoichiometric material balance on molar basis. 3.||

Case No. 71 / NC/3/MEET/Apr/202425/2

UDIN00220736AM25

Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001884AM24
RA File Number	07AX04000372 AM24
Licence No and Date	0711008298/19/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>AZELASTINE<br>HYDROCHLORIDE EYE<br>DROPS SOLUTION 0.05%<br>weight by volume.<br>1 Number<br>1<br>AZELASTINE<br>HYDROCHLORIDE Ph.Eur<br>5.10 mg /10 ml vial<br>RA concerned may take further necessary action as per above decision of NC.

S SOLUTION 0.05% weight by volume. 1 Number 1 AZELASTINE HYDROCHLORIDE Ph.Eur 5.10 mg /10 ml vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	72 / NC/3/MEET/Apr/202425/2	72 / NC/3/MEET/Apr/202425/2	72 / NC/3/MEET/Apr/202425/2	72 / NC/3/MEET/Apr/202425/2	72 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001885AM24
RA File Number		07AX04000378 AM24
Licence No and<br>Date		0711008301/19/06/2023
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/Sep/202223/8 dated 23/09/2022against advance authorization<br>No. 0711001517 dated 20/07/2021, 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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

Case No.	Case No.	72 / NC/3/MEET/Apr/202425/2	72 / NC/3/MEET/Apr/202425/2	72 / NC/3/MEET/Apr/202425/2	72 / NC/3/MEET/Apr/202425/2	72 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001885AM24
RA File Number		07AX04000378 AM24
Licence No and<br>Date		0711008301/19/06/2023
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/Sep/202223/8 dated 23/09/2022against advance authorization<br>No. 0711001517 dated 20/07/2021, 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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00220736AM25

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

UDIN00220736AM25

1<br>3<br>METHYL<br>BENZYL<br>CHLORIDE<br>0.391 kg.<br>2<br>TOLUENE<br>Not shown in<br>process<br>MECLIZINE<br>HYDROCHLORIDE<br>(IP/USP/BP)<br>1 kg.<br>3<br>ACETONE<br>1.65 kg.<br>RA concerned may take further necessary action as per above decision of NC.	MECLIZINE<br>HYDROCHLORIDE<br>(IP/USP/BP)	1 kg.	1	3<br>METHYL<br>BENZYL<br>CHLORIDE	<br>0.391 kg.
			2	TOLUENE	Not shown in<br>process
			3	ACETONE	1.65 kg.

Case No.	73 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001886AM24
RA File Number	07AX04000371 AM24
Licence No and<br>Date	0711008304/19/06/2023
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/Mar/202324/26 dated 22/03/2024against advance<br>authorizationNo. 0811010831 dated 21/02/2024, 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. TRANEXAMIC ACID INJECTION SOLUTION 1000MG/10ML 1 Number 1 TRANEXAMIC ACID USP 1.05 gm/100 ml Vial RA concerned may take further necessary action as per above decision of NC.||

UDIN00220736AM25

Case No.	74 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001889AM24
RA File Number	03AX04001069 AM24
Licence No and<br>Date	0311024666/19/06/2023
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>NAPROLAT-CARBOPLATIN BP 10<br>MG/ML INJ.( 1x45ML) 450 MG.<br>1 Number<br>Vial<br>1<br>Carboplatin IP/ BP/ USP<br>472.50 mg. /45 ml.<br>Injection.<br>RA concerned may take further necessary action as per above decision of NC.

MG/ML INJ.( 1x45ML) 450 MG. 1 Number Vial 1 Carboplatin IP/ BP/ USP 472.50 mg. /45 ml. Injection. RA concerned may take further necessary action as per above decision of NC.||

Case No.	75 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001892AM24
RA File Number	09AX04000025 AM24
Licence No and Date	0911005223/19/06/2023
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/Mar/202324/26 dated 22/03/2024against advance<br>authorizationNo. 0911006753 dated 14/02/2024, 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:-

UDIN00220736AM25

753** dated 14/02/2024, 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:-||

UDIN00220736AM25

Qty.	Sl. No	. Import Items	Qty. allowed.
1 kg.	1	PENICILLIN G POTASSIUM FIRST<br>CRYSTAL	<br> 1.3125 kg.
	2	ACETONE	1.971 kg.
	3	METHYLENE CHLORIDE MDC	3.29 kg.
	4	2 MERCAPTO BENZO THIAZOLE<br>MBT	<br>0.511 kg.
	5	METHANOL	1.971 kg.

ILLIN G POTASSIUM FIRST CRYSTAL| 1.3125 kg.| ||||2|ACETONE|1.971 kg.| ||||3|METHYLENE CHLORIDE MDC|3.29 kg.| ||||4|2 MERCAPTO BENZO THIAZOLE MBT| 0.511 kg.| ||||5|METHANOL|1.971 kg.|

Case No.	Case No.	76 / NC/3/MEET/Apr/202425/2	76 / NC/3/MEET/Apr/202425/2	76 / NC/3/MEET/Apr/202425/2	76 / NC/3/MEET/Apr/202425/2	76 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001905AM24
RA File Number		03AX04001262 AM24
Licence No and<br>Date		0311024672/19/06/2023
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>Clindamycin Phosphate Foam 1%, 100<br>gm<br>13889<br>Numbers<br>1<br>Clindamycin Phosphate USP<br>14.17 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Clindamycin Phosphate Foam 1%, 100<br>gm		13889<br>Numbers	1	Clindamycin Phosphate USP	14.17 kg.

14.17 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Clindamycin Phosphate Foam 1%, 100 gm||13889 Numbers|1|Clindamycin Phosphate USP|14.17 kg.|

Case No.	Case No.	76 / NC/3/MEET/Apr/202425/2	76 / NC/3/MEET/Apr/202425/2	76 / NC/3/MEET/Apr/202425/2	76 / NC/3/MEET/Apr/202425/2	76 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00001905AM24
RA File Number		03AX04001262 AM24
Licence No and<br>Date		0311024672/19/06/2023
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>Clindamycin Phosphate Foam 1%, 100<br>gm<br>13889<br>Numbers<br>1<br>Clindamycin Phosphate USP<br>14.17 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Clindamycin Phosphate Foam 1%, 100<br>gm		13889<br>Numbers	1	Clindamycin Phosphate USP	14.17 kg.

UDIN00220736AM25

Clindamycin Phosphate Foam 1%,	13889	2	Clindamycin Phosphate USP	7.08 kg.
	Numbers
50 gm

bers|1|Clindamycin Phosphate USP|14.17 kg.|

UDIN00220736AM25

Clindamycin Phosphate Foam 1%,	13889	2	Clindamycin Phosphate USP	7.08 kg.
	Numbers
50 gm

	Clindamycin Phosphate Foam 1%,	Clindamycin Phosphate Foam 1%,	Clindamycin Phosphate Foam 1%,
	50 gm



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





Case No.			77 / NC/3/MEET/Apr/202425/2
Case Status			Case Approved

Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number			HQRNORM APPLY 00001954AM24
RA Fil Nmbr			03AX04001227 AM24
e ue
Licence No and Da		te	0311024688/20/06/2023

Norms Committee		Decision:

The Committee<br>product/import pr		considered the case as per agenda and taking cue from the earlier decision for same export<br>oduct in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization
**No.

dered the case as per agenda and taking cue from the earlier decision for same export oduct in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization|||||||||||| |No. 0311022762 |||dated 12/04/2023, it was decided to f |||||ix ad-hoc norms under Para 4.07 of HBP Vol. I as per details ||||||| |given below or as|||applied by the firm, whichever is less|||||:-||||||| |||||||||||||||| |||Export Product|||Qty.||||**Sl. No. **||Import Items||Qty. allowed.|| |||Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic|||1000 Number||||1||Benzydamine Hydrochloride||3.06 gm.|| |||||||||||||||| ||| Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Bdi Hdhlid3|||||||2||C|etylpyridinium Chloride||1.356 gm.| |||||||||||||||| |||enzyamne yrocore-mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg.|||||||3||I|somalt ST-M||2586.00 gm.| |||||||||||||||| |||Benzydamine Hydrochloride, 2,4-Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each|||10||00 Number|||||||| ||||||||||4||B|enzydamine Hydrochloride||3.06 gm.| ||||||||||5||I|somalt ST-M||2586.00 gm.| ||||||||||||||||

UDIN00220736AM25

Bacterial Lozenges Sugar Free. Each|||10||00 Number|||||||| ||||||||||4||B|enzydamine Hydrochloride||3.06 gm.| ||||||||||5||I|somalt ST-M||2586.00 gm.| ||||||||||||||||

UDIN00220736AM25

lozenge contains (i)<br>Benzydamine Hydrochloride -<br>3mg (ii) Isomalt ST-M-<br>2586mg.<br>6<br>Benzydamine Hydrochloride<br>3.06 gm.<br>Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar<br>Free.(Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride- 3mg (ii) Isomalt<br>ST-M - 2586mg.<br>1000 Number<br>7<br>Isomalt ST-M<br>2586.00 gm<br>8<br>Cetylpyridinium Chloride<br>1.356 gm<br>Cetylpyridinium Chloride And<br>Bromhexine Hydrochloride<br>Antiseptic Lozenges Sugar Free<br>and all other flavours.(Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium<br>Chloride<br>-<br>1.33mg (ii) lsomalt ST-M - 2586<br>mg.<br>1000 Number<br>9<br>Isomalt ST-M<br>2586.00 gm<br>10<br>Cetylpyridinium Chloride<br>1.02 gm.<br>Cetylpyridinium Chloride And<br>Benzydamine Hydrochloride<br>Antiseptic Lozenges Sugar<br>Free.(Each lozenge contains (i)<br>Cetylpyridinium Chloride- 1 mg<br>(ii) lsomalt ST-M - 2586mg.<br>1000 Number<br>11<br>Isomalt ST-M<br>2586.00 gm<br>RA concerned may take further necessary action as per above decision of NC.	lozenge contains (i)<br>Benzydamine Hydrochloride -<br>3mg (ii) Isomalt ST-M-<br>2586mg.
	Benzydamine Hydrochloride Anti-<br>Inflammatory Lozenges Sugar<br>Free.(Each lozenge contains (i)<br>Benzydamine<br>Hydrochloride- 3mg (ii) Isomalt<br>ST-M - 2586mg.	1000 Number	6	Benzydamine Hydrochloride	3.06 gm.

ochloride Anti- Inflammatory Lozenges Sugar Free.(Each lozenge contains (i) Benzydamine Hydrochloride- 3mg (ii) Isomalt ST-M - 2586mg.|1000 Number|6|Benzydamine Hydrochloride|3.06 gm.| ||||7|Isomalt ST-M|2586.00 gm| ||Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg.|1000 Number|8|Cetylpyridinium Chloride|1.356 gm| ||||9|Isomalt ST-M|2586.00 gm| ||Cetylpyridinium Chloride And Benzydamine Hydrochloride Antiseptic Lozenges Sugar Free.(Each lozenge contains (i) Cetylpyridinium Chloride- 1 mg (ii) lsomalt ST-M - 2586mg.|1000 Number|10|Cetylpyridinium Chloride|1.02 gm.| ||||11|Isomalt ST-M|2586.00 gm|

Case No.	78 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00001953AM24
RA File Number	03AX04001254 AM24
Licence No and Date	0311024687/20/06/2023

UDIN00220736AM25

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/Jun/202324/8 dated 30/06/2023 against advance authorization No. 0311022762 dated 12/04/2023 , 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:-

|Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization No. 0311022762 dated 12/04/2023, 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. 1 Benzydamine Hydrochloride 3.06 gm. 2 Cetylpyridinium Chloride 1.356 gm. Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. 1000 Number 3 Isomalt ST-M 2586.00 gm. 4 Benzydamine Hydrochloride 3.06 gm. Benzydamine Hydrochloride, 2,4-Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free.

mine Hydrochloride 3.06 gm. Benzydamine Hydrochloride, 2,4-Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. 1000 Number 5 Isomalt ST-M 2586.00 gm. 6 Benzydamine Hydrochloride 3.06 gm. Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free.(Each lozenge contains (i) Benzydamine Hydrochloride- 3mg (ii) Isomalt ST-M - 2586mg. 1000 Number 7 Isomalt ST-M 2586.00 gm 8 Cetylpyridinium Chloride 1.356 gm Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. 1000 Number 9 Isomalt ST-M 2586.00 gm|Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization No. 0311022762 dated 12/04/2023, 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.

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 Benzydamine Hydrochloride 3.06 gm. 2 Cetylpyridinium Chloride 1.356 gm. Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. 1000 Number 3 Isomalt ST-M 2586.00 gm. 4 Benzydamine Hydrochloride 3.06 gm. Benzydamine Hydrochloride, 2,4-Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. 1000 Number 5 Isomalt ST-M 2586.00 gm. 6 Benzydamine Hydrochloride 3.06 gm. Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free.(Each lozenge contains (i) Benzydamine Hydrochloride- 3mg (ii) Isomalt ST-M - 2586mg. 1000 Number 7 Isomalt ST-M 2586.00 gm 8 Cetylpyridinium Chloride 1.356 gm Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. 1000 Number 9 Isomalt ST-M 2586.00 gm|Norms

ree and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. 1000 Number 9 Isomalt ST-M 2586.00 gm|Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization No. 0311022762 dated 12/04/2023, 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. 1 Benzydamine Hydrochloride 3.06 gm. 2 Cetylpyridinium Chloride 1.356 gm. Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. 1000 Number 3 Isomalt ST-M 2586.00 gm. 4 Benzydamine Hydrochloride 3.06 gm. Benzydamine Hydrochloride, 2,4-Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free.

gar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. 1000 Number 9 Isomalt ST-M 2586.00 gm| |---|---|---|---|---|---| ||Export Product|Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg.|1000 Number|1|Benzydamine Hydrochloride|3.06 gm.| ||||2|Cetylpyridinium Chloride|1.356 gm.| ||||3|Isomalt ST-M|2586.00 gm.| ||Benzydamine Hydrochloride, 2,4-Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg.|1000 Number|4|Benzydamine Hydrochloride|3.06 gm.| ||||5|Isomalt ST-M|2586.00 gm.| ||Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free.(Each lozenge contains (i) Benzydamine Hydrochloride- 3mg (ii) Isomalt ST-M - 2586mg.|1000 Number|6|Benzydamine Hydrochloride|3.06 gm.| ||||7|Isomalt ST-M|2586.00 gm| ||Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg.|1000 Number|8|Cetylpyridinium Chloride|1.356 gm|

Sugar Free and all other flavours.(Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg.|1000 Number|8|Cetylpyridinium Chloride|1.356 gm| ||||9|Isomalt ST-M|2586.00 gm|

UDIN00220736AM25

Cetylpyridinium Chloride And	10	Cetylpyridinium Chloride	1.02 gm.
Benzydamine Hydrochloride
Antiseptic Lozenges Sugar<br>Free.(Each lozenge contains (i)	11	Isomalt ST-M	2586.00 gm
Cetylpyridinium Chloride- 1 mg
(ii) lsomalt ST-M - 2586mg.

Case No.	79 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00002051AM24
RA File Number	08AX04000505 AM24
Licence No and<br>Date	0811008459/22/06/2023
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>IMIPENEM AND CILASTATIN FOR<br>INJECTION USP/BP/IP/CEP/EP/ChP<br>500MG<br>1 Number<br>1<br>Sterile Mixture of Imipenem<br>and Cilastatin for Injection<br>1.102 gm.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00220736AM25

1 Number 1 Sterile Mixture of Imipenem and Cilastatin for Injection 1.102 gm. RA concerned may take further necessary action as per above decision of NC.||

UDIN00220736AM25

Case No.	Case No.	80 / NC/3/MEET/Apr/202425/2	80 / NC/3/MEET/Apr/202425/2	80 / NC/3/MEET/Apr/202425/2	80 / NC/3/MEET/Apr/202425/2	80 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		CITO CHEM INDUSTRIES PVT.LTD.
Meeting Number		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
and Date
HQ File Number		HQRNORM APPLY 00002066AM24
RA File Number		56AX04000189 AM24
Licence No and<br>		5611001972/22/06/2023
Date

Norms Committee		Decision:
The Committee c		onsidered the case as per agenda and taking cue from the earlier decision for same export
product/import p<br>authorizationNo.		roduct in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance<br>0811008785 dated 18/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as	per details give	n below or as applied by the firm, whichever is less:-



Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Clobatasol Propionate<br>1 kg.<br>1<br>Betamethasone<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Clobatasol Propionate		1 kg.	1	Betamethasone	1.00 kg.

may take further necessary action as per above decision of NC.|Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Clobatasol Propionate||1 kg.|1|Betamethasone|1.00 kg.|

Case No.	Case No.		81 / NC/3/MEET/Apr/202425/2	81 / NC/3/MEET/Apr/202425/2	81 / NC/3/MEET/Apr/202425/2	81 / NC/3/MEET/Apr/202425/2	81 / NC/3/MEET/Apr/202425/2

Case Status			Case Approved

Party Name			MICRO LABS LIMITED

Meeting Number an<br>Date		d	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024

HQ File Number			HQRNORM APPLY 00002068AM24

RA File Number			07AX04000426 AM24

Licence No and Da		te	0711008352/22/06/2023
Norms Committee		Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

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

UDIN00220736AM25

BROMOCRIPTIN TABLETS 2.5MG<br>[Each Tablet contains Bromocriptin<br>Mesylate equivalent to Bromocriptin<br>2.5 mg.]<br>1 Number<br>1<br>BROMOCRIPTIN<br>MESYLATE BP/EP/IP/USP<br>2.924 mg.<br>RA concerned may take further necessary action as per above decision of NC.	BROMOCRIPTIN TABLETS 2.5MG<br>[Each Tablet contains Bromocriptin<br>Mesylate equivalent to Bromocriptin<br>2.5 mg.]	1 Number	1<br> <br>	BROMOCRIPTIN<br>MESYLATE BP/EP/IP/USP	2.924 mg.

BLETS 2.5MG [Each Tablet contains Bromocriptin Mesylate equivalent to Bromocriptin 2.5 mg.]|1 Number|1 |BROMOCRIPTIN MESYLATE BP/EP/IP/USP|2.924 mg.| |---|---|---|---|---|---|

Case No.	Case No.	82 / NC/3/MEET/Apr/202425/2	82 / NC/3/MEET/Apr/202425/2	82 / NC/3/MEET/Apr/202425/2	82 / NC/3/MEET/Apr/202425/2	82 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00002077AM24
RA File Number		34AX04000200 AM24
Licence No and<br>Date		0311024778/22/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Lidocaine USP<br>152.80 kg.<br>Lidocaine and Prilocaine Cream USP 2.5% and<br>2.5% 5 gm Tube<br>1200000<br>Numbers<br>2<br>Prilocaine Base USP<br>152.80 kg.<br>3<br>Lidocaine USP<br>363.30 kg.<br>Lidocaine and Prilocaine Cream USP 2.5% and<br>2.5% 30 gm tube<br>475000<br>Numbers<br>4<br>Prilocaine Base USP<br>363.30 kg.<br>Lidocaine Ointment USP 5% 30 gm tube<br>5000<br>Numbers<br>5<br>Lidocaine USP<br>7.64 kg.<br>Lidocaine Ointment USP 5% 35.44 gm tube<br>5000<br>Numbers<br>6<br>Lidocaine USP<br>9.01 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

Lidocaine USP 7.64 kg. Lidocaine Ointment USP 5% 35.44 gm tube 5000 Numbers 6 Lidocaine USP 9.01 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 5 gm Tube||1200000 Numbers|1|Lidocaine USP|152.80 kg.| |||||2|Prilocaine Base USP|152.80 kg.| ||Lidocaine and Prilocaine Cream USP 2.5% and 2.5% 30 gm tube||475000 Numbers|3|Lidocaine USP|363.30 kg.| |||||4|Prilocaine Base USP|363.30 kg.| ||Lidocaine Ointment USP 5% 30 gm tube||5000 Numbers|5|Lidocaine USP|7.64 kg.| ||Lidocaine Ointment USP 5% 35.44 gm tube||5000 Numbers|6|Lidocaine USP|9.01 kg.|

UDIN00220736AM25

Lidocaine Ointment USP 5% 50 gm Jar<br>5000<br>Numbers<br>7<br>Lidocaine USP<br>12.74 kg.<br>RA concerned may take further necessary action as per above decision of NC.	5000<br>Numbers	7	Lidocaine USP	12.74 kg.

Case No.	83 / NC/3/MEET/Apr/202425/2	83 / NC/3/MEET/Apr/202425/2	83 / NC/3/MEET/Apr/202425/2	83 / NC/3/MEET/Apr/202425/2	83 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	ALKEM LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00002078AM24
RA File Number	03AX04001302 AM24
Licence No and<br>Date	0311024779/22/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

|Licence No and Date|0311024779/22/06/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Venlafaxine Hydrochloride Extended Release Tablets 37.5 mg(Each extended release tablet contains: Venlafaxine Hydrochloride equivalent to venlafaxine 37.5mg. 1 Number 1 Venlafaxine Hydrochloride USP 43.127 mg. Venlafaxine Hydrochloride Extended Release Tablets 75 mg(Each extended release tablet contains: Venlafaxine Hydrochloride equivalent to venlafaxine 75 mg. 1 Number 2 Venlafaxine Hydrochloride USP 84.00 mg. Venlafaxine Hydrochloride Extended Release Tablets 150 mg(Each extended release tablet contains: Venlafaxine Hydrochloride equivalent to venlafaxine 150 mg. 1 Number 3 Venlafaxine Hydrochloride USP 166.50 mg. Venlafaxine Hydrochloride Extended Release Venlafaxine Hydrochloride 1 Number 4 247.50 mg.|||||| |||Qty.|Sl. No.|Import Items|Qty. allowed.| ||| 1 Number|1|Venlafaxine Hydrochloride USP| 43.127 mg.| ||| 1 Number|2|Venlafaxine Hydrochloride USP| 84.00 mg.| ||| 1 Number|3|Venlafaxine Hydrochloride USP| 166.50 mg.| |||1 Number|4|Venlafaxine Hydrochloride| 247.50 mg.|

UDIN00220736AM25

|Venlafaxine Hydrochloride USP| 84.00 mg.| ||| 1 Number|3|Venlafaxine Hydrochloride USP| 166.50 mg.| |||1 Number|4|Venlafaxine Hydrochloride| 247.50 mg.|

UDIN00220736AM25

Tablets 225 mg(Each extended release tablet			USP
contains: Venlafaxine Hydrochloride equivalent
to venlafaxine 225mg.

Case No.	84 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00002087AM24
RA File Number	03AX04001180 AM24
Licence No and<br>Date	0311024787/22/06/2023
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>Betamethasone Dipropionate IP/BP/EP/USP<br>1 kg.<br>1<br>Betamethasone IP/BP/EP/USP<br>0.868 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	85 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00002100AM24

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UDIN00220736AM25

RA File Number

03AX04001224 AM24

Licence No and Date

0311024798/22/06/2023

Norms Committee Decision: The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Complete chemical reactions with Molecular and Structural Formula and Molecular weight along with stage wise percentage yields on molar basis. 1. Material Balance (Stoichiometric Balance details) for the entire manufacturing process. 2.

Case No.	86 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00002099AM24
RA File Number	05AX04000823 AM24
Licence No and<br>Date	0511019494/22/06/2023
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/Sep/202425/13 dated 14/09/2023against advance<br>authorizationNo. 0510404862 dated 12/12/2017, 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.

12/12/2017**, 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 PHTHALIC ANHYDRIDE 0.372 kg. PVC PLASTICIZER (PHTHALIC, NON POLYMERIC) (DINP) 1 kg. 2 ISO NONANOL 0.726 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00220736AM25

Case No.<br>87 / NC/3/MEET/Apr/202425/2
Case Status<br>Case Approved
Party Name<br>GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number<br>HQRNORM APPLY 00002158AM24
RA File Number<br>07AX04000433 AM24
Licence No and<br>Date<br>0711008370/23/06/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking	cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024		against advance
authorizationNo. 0711009399 dated 10/10/2023, 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.
Nifuroxazide<br>1 kg.<br>1	5-Nitro-2-furohydrazide	0.634
RA concerned may take further necessary action as per above decision of NC.

.** Sl. No.|Import Items|Qty. allowed.|| |Nifuroxazide 1 kg. 1|5-Nitro-2-furohydrazide|0.634|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	88 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00002558AM24
RA File Number	07AX04000359 AM24
Licence No and<br>Date	0711008395/26/06/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it
was decided to call for following information/documents from the firm:-

UDIN00220736AM25

Step wise manufacturing process.
Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
Material balance (Stoichiometric Balance details) for the entire manufacturing process.
Justification for low yield along with published literature.
Past production / consumption data for last two years duly certified by GST.
Authentic technical literature/catalogue in support of percentage yield claimed in the entire manufacturing process.

oduction / consumption data for last two years duly certified by GST.**

Authentic technical literature/catalogue in support of percentage yield claimed in the entire manufacturing process.

Case No.	89 / NC/3/MEET/Apr/202425/2
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00002491AM24
RA File Number	03AX04001286 AM24
Licence No and<br>Date	0311024864/26/06/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it
was decided to call for following information/documents from the firm:-
Copy of Export Orders showing the product is exported to US.

Case No.	Case No.	90 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		HARMAN FINOCHEM LIMITED
Meeting Number an	d Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number		HQRNORM APPLY 00004844AM24
RA File Number		03AX04001874 AM24
Licence No and Da	te	0311026010/04/08/2023
Norms Committee	Decision:

The Committee<br>dt/it	onsidered the case as per agenda and taking cue from the earlier decision for same export<br>dt i tiNNC/3/MEET/Fb/202324/24dtd 05/03/2024it d
proucmpor<br>authorizationNo.<br>as per details give	rouc n meengo.e aeagans avance<br>0311014263 dated 29/04/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

|proucmpor authorizationNo. as per details give|rouc n meengo.e aeagans avance 0311014263 dated 29/04/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I n below or as applied by the firm whichever is less:-|| |,|||

61 This document has been digitally signed by Raman Kumar, Deputy DGFT on 27-05-2024 12:56:01.

UDIN00220736AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Sacubitril+Calcium<br>(Sacubitril Calcium)	1 kg.	1	2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA)	1.237 kg.

Case No.	91 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00004845AM24
RA File Number	03AX04001880 AM24
Licence No and<br>Date	0311026011/04/08/2023
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/Feb/202324/24 dated 05/03/2024against advance authorization<br>No.0311014263 dated 29/04/2022, 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.<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. Sacubitril+Calcium (Sacubitril Calcium) 1 kg. 1 2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert- butoxycarbonyl) amino)-2-methylpentanoic acid (BMPA) 1.237 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00220736AM25

Case No.	92 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00005165AM24
RA File Number	03AX04002258 AM24
Licence No and<br>Date	0311026486/22/08/2023
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/Feb/202324/24 dated 05/03/2024against advance authorization<br>No.0311014263 dated 29/04/2022, 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.<br>Import Items<br>Qty. allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl) amino)-2-methylpentanoic acid<br>(BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC.

br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert- butoxycarbonyl) amino)-2-methylpentanoic acid (BMPA) 1.237 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	93 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00005192AM24
RA File Number	03AX04002292 AM24
Licence No and<br>Date	0311026535/23/08/2023
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/Feb/202324/24 dated 05/03/2024against advance authorization

UDIN00220736AM25

No.0311014263 dated 29/04/2022 , 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.
Sacubitril+Calcium	1 kg.	1	2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-	1.237 kg.
			butoxycarbonyl) amino)-2-methylpentanoic acid
(Sacubitril Calcium)			(BMPA)

owed.**| |---|---|---|---|---| |Sacubitril+Calcium|1 kg.|1|2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-|1.237 kg.| ||||butoxycarbonyl) amino)-2-methylpentanoic acid|| |(Sacubitril Calcium)|||(BMPA)||

Case No.<br>94 / NC/3/MEET/Apr/202425/2	Case No.<br>94 / NC/3/MEET/Apr/202425/2
Case Status<br>Case Approved
Party Name<br>HARMAN FINOCHEM	LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number<br>HQRNORM APPLY 00005188AM24
RA File Number<br>03AX04002257 AM24
Licence No and<br>Date<br>0311026528/23/08/2023
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/Feb/202324/24 dated 05/03/2024against advance authorization
No.0311014263 dated 29/04/2022, it was	decided to fix ad-hoc norms under Para 4.07 of HBP Vol.	I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.<br>Import Items	Qty. allowed.
Sacubitril+Calcium<br>1 kg.	1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-	1.237 kg.
	butoxycarbonyl) amino)-2-methylpentanoic acid
(Sacubitril Calcium)	(BMPA)
RA concerned may take further necessary action as per above decision of NC.

UDIN00220736AM25

g.|| |||butoxycarbonyl) amino)-2-methylpentanoic acid||| |(Sacubitril Calcium)||(BMPA)||| |RA concerned may take further necessary action as per above decision of NC.|||||

UDIN00220736AM25

Case No.	95 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00005187AM24
RA File Number	03AX04002259 AM24
Licence No and<br>Date	0311026527/23/08/2023
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/Feb/202324/24 dated 05/03/2024against advance authorization<br>No.0311014263 dated 29/04/2022, 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.<br>Import Items<br>Qty. allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl) amino)-2-methylpentanoic acid<br>(BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC.

br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert- butoxycarbonyl) amino)-2-methylpentanoic acid (BMPA) 1.237 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	96 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00005776AM24
RA File Number	03AX04002663 AM24
Licence No and<br>Date	0311027253/21/09/2023
Norms Committee Decision:

UDIN00220736AM25

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/Feb/202324/24 dated 05/03/2024 against advance authorization No.0311014263 dated 29/04/2022 , 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.
Sacubitril+Calcium	1 kg.	1	2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-	1.237 kg.
			butoxycarbonyl) amino)-2-methylpentanoic acid
(Sacubitril Calcium)			(BMPA)

owed.**| |---|---|---|---|---| |Sacubitril+Calcium|1 kg.|1|2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-|1.237 kg.| ||||butoxycarbonyl) amino)-2-methylpentanoic acid|| |(Sacubitril Calcium)|||(BMPA)||

Case No.	Case No.	97 / NC/3/MEET/Apr/202425/2	97 / NC/3/MEET/Apr/202425/2	97 / NC/3/MEET/Apr/202425/2	97 / NC/3/MEET/Apr/202425/2	97 / NC/3/MEET/Apr/202425/2
Case Status		Case Aroved
		pp
Part Name		HARMAN FINOCHEM LIMITED
y
Meetin Number
g<br>and Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024

HQ File Number		HQRNORM APPLY 00005777AM24
RA File Number		03AX04002664 AM24

Licence No and
<br>Date		0311027255/21/09/2023

Norms Committee		Decision:
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/Feb/202324/24 dated 05/03/2024against advance authorization<br>No.0311014263 dated 29/04/2022, 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:-

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

	Sacubitril	Calcium	1 kg.	1	2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>btbl i2thlti id	1.237 kg.
	(Sacubitril	Calcium)			uoxycarony) amno)--meypenanoc ac<br>(BMPA)

UDIN00220736AM25

,1 -biphenyl]-4-yl)-4-(tert- btbl i2thlti id||1.237 kg.| ||(Sacubitril|Calcium)|||uoxycarony) amno)--meypenanoc ac (BMPA)||| ||||||||| ||||||||| ||||||||| |||||||||

UDIN00220736AM25

Case No.<br>98 / NC/3/MEET/Apr/202425/2	Case No.<br>98 / NC/3/MEET/Apr/202425/2
Case Status<br>Case Approved
Party Name<br>HARMAN FINOCHEM	LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number<br>HQRNORM APPLY 00005775AM24
RA File Number<br>03AX04002665 AM24
Licence No and<br>Date<br>0311027252/21/09/2023
Norms Committee Decision:
The Committee considered the case as	per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Feb/202324/24 dated 05/03/2024against advance authorization
No.0311014263 dated 29/04/2022, it was	decided to fix ad-hoc norms under Para 4.07 of HBP Vol.	I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.<br>Import Items	Qty. allowed.
Sacubitril+Calcium<br>1 kg.	1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-	1.237 kg.
	butoxycarbonyl) amino)-2-methylpentanoic acid
(Sacubitril Calcium)	(BMPA)
RA concerned may take further necessary action as per above decision of NC.

l]-4-yl)-4-(tert-|1.237 kg.|| |||butoxycarbonyl) amino)-2-methylpentanoic acid||| |(Sacubitril Calcium)||(BMPA)||| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	99 / NC/3/MEET/Apr/202425/2
Case Status	Case Approved
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ File Number	HQRNORM APPLY 00006420AM24
RA File Number	03AX04003262 AM24
Licence No and<br>Date	0311028121/23/10/2023

UDIN00220736AM25

Norms Committee Decision:

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Sacubitril+Calcium	1 kg.	1	2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-	1.237 kg.
			butoxycarbonyl) amino)-2-methylpentanoic acid
(Sacubitril Calcium)			(BMPA)

Case No.	Case No.	100 / NC/3/MEET/Apr/202425/2	100 / NC/3/MEET/Apr/202425/2
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Apr/ 202425/ 2 and 30/04/2024
HQ	File Number	HQRNORM APPLY 00008643AM24
RA File Number		05AX04003613 AM24
Licence No and Date		0511024042/19/02/2024
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/Apr/202425/1 dated 10/04/2024against advance authorization
No.0510415972 dated		24/11/2020, it was decided to fix ad-hoc norms		under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
	Export	Product<br>Qty.	**Sl.

**, 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.|| ||HFC-134a (HYDROFLUOROCARBAN 1 kg.||1|TCE (TRICHLORO ETHYLENE)||2.116 kg.|| ||1,1,1,2-TETRAFLUOROETHANE)||2|ACID GRADE FLUORSPAR||1.065 kg.||

UDIN00220736AM25

3<br>EMPTY CANS 340 G<br>Relevant, as per<br>Packing Policy<br>and General<br>Notes<br>4<br>CAPS FOR EMPTY CANS /<br>TINPLATE CAP 1/2 inch<br>Relevant, as per<br>Packing Policy<br>and General<br>Notes<br>RA concerned may take further necessary action as per above decision of NC.			3	EMPTY CANS 340 G	Relevant, as per<br>Packing Policy<br>and General<br>Notes
			4	CAPS FOR EMPTY CANS /<br>TINPLATE CAP 1/2 inch	Relevant, as per<br>Packing Policy<br>and General<br>Notes

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