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/Dec/202425/12 DATED: 10/12/2024

Please Note

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

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

Meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 of Norms Committee - III for the year 2024-25 was held on 10/12/2024 under the Chairmanship of Shri Rakesh Kumar,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2023.

The following members were present in the meeting:-

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

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-01-2025 14:40:40.

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

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-01-2025 14:40:40.

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Case Details and Decision(s):

Case No.	Case No.	1 / NC/3/MEET/Dec/202425/12	1 / NC/3/MEET/Dec/202425/12	1 / NC/3/MEET/Dec/202425/12	1 / NC/3/MEET/Dec/202425/12	1 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		STRIDES ALATHUR PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00093217AM21
RA File Number		09AA04004604 AM21
Licence No and<br>Date		0911000444/26/02/2021
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Memantine Hydrochloride USP<br>5.10 mg.<br>2<br>Silicified Microcrystalline<br>Cellulose (Prosolv SMCC 90)<br>197.00 mg.<br>3<br>Croscarmellose Sodium (Ac Di<br>Sol)<br>3.00 mg.<br>4<br>Colloidal Silicon dioxide<br>( Aerosil-200)<br>1.50 mg<br>Memantine Hydrochloride<br>Tablets USP 5Mg- 60's<br>1 Number<br>5<br>Magnesium Stearate<br>(Mallinckrodt 2257)<br>1.50 mg.<br>6<br>Memantine Hydrochloride USP<br>5.10 mg.<br>7<br>Silicified Microcrystalline<br>Cellulose (Prosolv SMCC 90)<br>197.00 mg.<br>8<br>Croscarmellose Sodium (Ac Di<br>Sol)<br>3.00 mg.<br>Memantine Hydrochloride<br>Tablets USP 5Mg- 500's<br>1 Number
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

mg. 8 Croscarmellose Sodium (Ac Di Sol) 3.00 mg. Memantine Hydrochloride Tablets USP 5Mg- 500's 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Memantine Hydrochloride Tablets USP 5Mg- 60's|| 1 Number|1|Memantine Hydrochloride USP|5.10 mg.| |||||2|Silicified Microcrystalline Cellulose (Prosolv SMCC 90)|197.00 mg.| |||||3|Croscarmellose Sodium (Ac Di Sol)|3.00 mg.| |||||4|Colloidal Silicon dioxide ( Aerosil-200)|1.50 mg| |||||5|Magnesium Stearate (Mallinckrodt 2257)|1.50 mg.| ||Memantine Hydrochloride Tablets USP 5Mg- 500's|| 1 Number|6|Memantine Hydrochloride USP|5.10 mg.| |||||7|Silicified Microcrystalline Cellulose (Prosolv SMCC 90)|197.00 mg.| |||||8|Croscarmellose Sodium (Ac Di Sol)|3.00 mg.|

This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-01-2025 14:40:40.

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|9 Colloidal Silicon dioxide ( Aerosil-200) 1.50 mg. 10 Magnesium Stearate (Mallinckrodt 2257) 1.50 mg. 11 Memantine Hydrochloride USP 10.20 mg. 12 Silicified Microcrystalline Cellulose (Prosolv SMCC 90) 192.00 mg. 13 Croscarmellose Sodium (Ac Di Sol) 3.00 mg. 14 Colloidal Silicon dioxide ( Aerosil-200) 1.50 mg. Memantine Hydrochloride Tablets USP -10Mg-60's 1 Number 15 Magnesium Stearate (Mallinckrodt 2257) 1.50 mg. 16 Memantine Hydrochloride USP 10.20 mg. 17 Silicified Microcrystalline Cellulose (Prosolv SMCC 90) 192.00 mg. 18 Croscarmellose Sodium (A

		9	Colloidal Silicon dioxide<br>( Aerosil-200)	1.50 mg.
		10	Magnesium Stearate<br>(Mallinckrodt 2257)	1.50 mg.
Memantine Hydrochloride<br>Tablets USP -10Mg-60's	<br>1 Number	11	Memantine Hydrochloride USP	10.20 mg.
		12	Silicified Microcrystalline<br>Cellulose (Prosolv SMCC 90)	192.00 mg.
		13	Croscarmellose Sodium (Ac Di<br>Sol)	3.00 mg.
		14	Colloidal Silicon dioxide<br>( Aerosil-200)	1.50 mg.
		15	Magnesium Stearate<br>(Mallinckrodt 2257)	1.50 mg.
Memantine Hydrochloride<br>Tablets USP -10Mg-500's	<br>1 Number	16	Memantine Hydrochloride USP	10.20 mg.
		17	Silicified Microcrystalline<br>Cellulose (Prosolv SMCC 90)	192.00 mg.
		18	Croscarmellose Sodium (Ac Di<br>Sol)	3.00 mg.
		19	Colloidal Silicon dioxide<br>( Aerosil-200)	1.50 mg.
		20	Magnesium Stearate<br>(Mallinckrodt 2257)	1.50 mg.

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

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dioxide ( Aerosil-200)|1.50 mg.| ||||20|Magnesium Stearate (Mallinckrodt 2257)|1.50 mg.|

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

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Case No.	Case No.	2 / NC/3/MEET/Dec/202425/12	2 / NC/3/MEET/Dec/202425/12	2 / NC/3/MEET/Dec/202425/12	2 / NC/3/MEET/Dec/202425/12	2 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00003358AM23
RA File Number		03AX04002988 AM23
Licence No and Date		0311018145/25/09/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Tetrahydrofuran<br>0.56 kg.<br>2<br>Lithium Metal<br>0.075 kg.<br>3<br>n-Heptane<br>0.89 kg.<br>4<br>Ethyl Isobutyrate<br>0.374 kg.<br>5<br>1 Bromo-5-chloropentane<br>0.60 kg.<br>6<br>Methyl-ethyl-ketone<br>0.52 kg.<br>7<br>N, N Dimethylacetamide<br>0.84 kg.<br>8<br>Sodium t-pentoxide<br>0.31 kg.<br>9<br>Iodine<br>0.45 kg.<br>diethyl<br>2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate<br>1 kg.<br>10<br>Tosmic<br>0.28 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

nedioate 1 kg. 10 Tosmic 0.28 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|0.56 kg.| |||||2|Lithium Metal|0.075 kg.| |||||3|n-Heptane|0.89 kg.| |||||4|Ethyl Isobutyrate|0.374 kg.| |||||5|1 Bromo-5-chloropentane|0.60 kg.| |||||6|Methyl-ethyl-ketone|0.52 kg.| |||||7|N, N Dimethylacetamide|0.84 kg.| |||||8|Sodium t-pentoxide|0.31 kg.| |||||9|Iodine|0.45 kg.| |||||10|Tosmic|0.28 kg.| |||||as per above decision of NC.|||

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Case No.	Case No.	3 /	NC/3/MEET/Dec/202425/12
Case Status		Ca	se Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00006770AM23
RA	File Number	03AX04005861 AM23
Lic	ence No and Date	0311021934/06/03/2023
Nor<br>De<br>Pa	ms Committee Decision:<br>cision:The Committee considered th<br>ra 4.07 of HBP Vol.

e Number|03AX04005861 AM23|||||||||| |Lic|ence No and Date|0311021934/06/03/2023|||||||||| |Nor De Pa|ms Committee Decision: **cision:**The Committee considered th ra 4.07 of HBP Vol. I as per details gi|||e case as ven belo||per agen w or as a||da and it was decided to fix ad-h plied by the firm whichever is le|||oc norms under ss:-| |||||||||,|||| ||Export Product||||Qty.||Sl. N|**o. **|Import Items||Qty. allowed.| ||||||||||||| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||||1 kg.||1||Tetrahydrofuran||0.56 kg.| ||||||||||||| ||||||||2||N-Heptane||0.89 kg.| ||||||||||||| ||||||||3||Ethyl Isobutyrate||0.374 kg.| ||||||||||||| ||||||||4||1 Bromo-5-chloropentane||0.60 kg.| ||||||||||||| ||||||||5||N, N Dimethylacetamide|0.84 kg.|| ||||||||6||Sodium t-pentoxide|0.31 kg.|| ||||||||||||| ||||||||7||Tosmic|0.28 kg.|| ||||||||||||| ||||||||||||| |RA concerned may tak||e further necessary action as per above decision of NC.|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |Case No.||4 / NC/3/MEET/Dec/202425/12|||||||||| |Case Status||Case Approved|||||||||| |Party Name||OC SPECIALITIES PRIVATE LIMITED|||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024|||||||||| |HQ File Number||HQRNORM APPLY 00001097AM24|||||||||| |RA File Number||03AX04000687 AM24|||||||||| |Licence No and Date||0311023887/25/05/2023||||||||||

T/ Dec/ 202425/ 12 and 10/12/2024|||||||||| |HQ File Number||HQRNORM APPLY 00001097AM24|||||||||| |RA File Number||03AX04000687 AM24|||||||||| |Licence No and Date||0311023887/25/05/2023||||||||||

Case No.	4 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001097AM24
RA File Number	03AX04000687 AM24
Licence No and Date	0311023887/25/05/2023

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Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
N-METHYL-2-OXO-2-	40000 kg.	1	ETHYL PHENYL GLYOXYLATE	72000 kg.
PHENYLACETAMIDE
			( OXOBENZENE ACETATE)

Qty.|**Sl. No. **|Import Items|Qty. allowed.| |---|---|---|---|---| |N-METHYL-2-OXO-2-|40000 kg.|1|ETHYL PHENYL GLYOXYLATE|72000 kg.| |PHENYLACETAMIDE||||| ||||( OXOBENZENE ACETATE)||

Case No.<br>5 / NC/3/MEET/Dec/202425/12
Case Status<br>Case Approved
Party Name<br>BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number<br>HQRNORM APPLY 00007460AM24
RA File Number<br>03AX04004237 AM24
Licence No and Date<br>0311029470/19/12/2023
Norms Committee Decision:
Decision:The Committee considered the case as per	agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate (CION-4)<br>1 kg.	1<br>2	Tetrahydrofuran<br>Lithium Metal	0.56 kg.<br>0.075 kg.
	3	n-Heptane	0.89 kg.
	4	Ethyl Isobutyrate	0.374 kg.
	5	1 Bromo-5-chloropentane	0.60 kg.

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) 1 kg.|1 2|Tetrahydrofuran Lithium Metal|0.56 kg. 0.075 kg.|| ||3|n-Heptane|0.89 kg.|| ||4|Ethyl Isobutyrate|0.374 kg.|| ||5|1 Bromo-5-chloropentane|0.60 kg.||

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6	Methyl-ethyl-ketone	0.52 kg.
7	N, N Dimethylacetamide	0.84 kg.
8	Sodium t-pentoxide	0.31 kg.
9	Iodine	0.45 kg.
10	Tosmic	0.28 kg.

Case No.	Case No.	6 / NC/3/MEET/Dec/202425/12	6 / NC/3/MEET/Dec/202425/12	6 / NC/3/MEET/Dec/202425/12	6 / NC/3/MEET/Dec/202425/12	6 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00008057AM24
RA File Number		03AX04004728 AM24
Licence No and Date		0311030291/19/01/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Tetrahydrofuran 0.56 kg. 2 Lithium Metal 0.075 kg. 3 n-Heptane 0.89 kg. 4 Ethyl Isobutyrate 0.374 kg. 5 1 Bromo-5-chloropentane 0.60 kg. 1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|0.56 kg.| |||||2|Lithium Metal|0.075 kg.| |||||3|n-Heptane|0.89 kg.| |||||4|Ethyl Isobutyrate|0.374 kg.| |||||5|1 Bromo-5-chloropentane|0.60 kg.|

Case No.	Case No.	6 / NC/3/MEET/Dec/202425/12	6 / NC/3/MEET/Dec/202425/12	6 / NC/3/MEET/Dec/202425/12	6 / NC/3/MEET/Dec/202425/12	6 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00008057AM24
RA File Number		03AX04004728 AM24
Licence No and Date		0311030291/19/01/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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6	Methyl-ethyl-ketone	0.52 kg.
7	N, N Dimethylacetamide	0.84 kg.
8	Sodium t-pentoxide	0.31 kg.
9	Iodine	0.45 kg.
10	Tosmic	0.28 kg.

6	Methyl-ethyl-ketone	0.52 kg.
7	N, N Dimethylacetamide	0.84 kg.
8	Sodium t-pentoxide	0.31 kg.
9	Iodine	0.45 kg.
10	Tosmic	0.28 kg.

Case No.	7 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00008154AM24
RA File Number	03AX04004736 AM24
Licence No and Date	0311030436/25/01/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>N N Diisopropylethyl Amine<br>100000 kg.<br>1<br>Di IsoPropylAmine<br>100000 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	8 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	DCM SHRIRAM INDUSTRIES LIMITED

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necessary action as per above decision of NC.||

Case No.	8 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	DCM SHRIRAM INDUSTRIES LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00009276AM24
RA File Number	05AX04003886 AM24
Licence No and<br>Date	0511024653/22/03/2024
Norms Committee Decision:
Decision:The Committee considered the case as per			agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
D (-) Para Hydroxy Phenyl Glycine		<br>1 kg.	1	Glyoxylic Acid (50%)	2.044 kg.
Methyl Ester
			2	Phenol	1.298 kg.
			3	Sulfamic Acid	1.34 kg.
			4	Acetone	0.18 kg.
			5	Activated Carbon	0.035 kg.
RA concerned may take further necessary		action as per above decision of NC.

||2|Phenol|1.298 kg.|| ||||3|Sulfamic Acid|1.34 kg.|| ||||4|Acetone|0.18 kg.|| ||||5|Activated Carbon|0.035 kg.|| |RA concerned may take further necessary||action as per above decision of NC.|||||

Case No.	9 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 12	and 10/12/2024
HQ File Number	HQRNORM APPLY 00000349AM25
RA File Number	03AX04000120 AM25
Licence No and Date	0311033250/22/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol.	I as per details given below or as applied by the firm, whichever is				less:-
Export Product<br>Qty.			Sl. No.	Import Items	Qty. allowed.

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1	Tetrahydrofuran	0.56 kg.
2	N-Heptane	0.89 kg.
3	Ethyl Isobutyrate	0.374 kg.
4	1 Bromo-5-chloropentane	0.60 kg.

tetramethyl-8- oxopentadecanedioate|1 kg.|1|Tetrahydrofuran|0.56 kg.| |---|---|---|---|---|---| ||||2|N-Heptane|0.89 kg.| ||||3|Ethyl Isobutyrate|0.374 kg.| ||||4|1 Bromo-5-chloropentane|0.60 kg.| ||||5|N, N Dimethylacetamide|0.84 kg.| ||||6|Sodium t-pentoxide|0.31 kg.| ||||7|Tosmic|0.28 kg.|

Case No.	Case No.	10 / NC/3/MEET/Dec/202425/12	10 / NC/3/MEET/Dec/202425/12	10 / NC/3/MEET/Dec/202425/12	10 / NC/3/MEET/Dec/202425/12	10 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00000348AM25
RA File Number		03AX04000076 AM25
Licence No and Date		0311033249/22/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Tetrahydrofuran<br>0.56 kg.<br>2<br>N-Heptane<br>0.89 kg.<br>3<br>Ethyl Isobutyrate<br>0.374 kg.<br>1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate		1 kg.	1	Tetrahydrofuran	0.56 kg.
				2	N-Heptane	0.89 kg.
				3	Ethyl Isobutyrate	0.374 kg.

Import Items*|Qty. allowed.| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|0.56 kg.| |||||2|N-Heptane|0.89 kg.| |||||3|Ethyl Isobutyrate|0.374 kg.|

Case No.	Case No.	10 / NC/3/MEET/Dec/202425/12	10 / NC/3/MEET/Dec/202425/12	10 / NC/3/MEET/Dec/202425/12	10 / NC/3/MEET/Dec/202425/12	10 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00000348AM25
RA File Number		03AX04000076 AM25
Licence No and Date		0311033249/22/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Tetrahydrofuran<br>0.56 kg.<br>2<br>N-Heptane<br>0.89 kg.<br>3<br>Ethyl Isobutyrate<br>0.374 kg.<br>1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate		1 kg.	1	Tetrahydrofuran	0.56 kg.
				2	N-Heptane	0.89 kg.
				3	Ethyl Isobutyrate	0.374 kg.

UDIN00521586AM25

lowed.**| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|0.56 kg.| |||||2|N-Heptane|0.89 kg.| |||||3|Ethyl Isobutyrate|0.374 kg.|

UDIN00521586AM25

4	1 Bromo-5-chloropentane	0.60 kg.
5	N, N Dimethylacetamide	0.84 kg.
6	Sodium t-pentoxide	0.31 kg.
7	Tosmic	0.28 kg.

Case No.	11 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00000951AM25
RA File Number	03AX04000876 AM25
Licence No and<br>Date	0311034159/28/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Calcitonin Salmon Injection USP<br>400 I.U./2ml (200 I.U./ml)(Each ml<br>contains : Calcitonin Salmon USP<br>200 I.U. Phenol USP 5mg)<br>1 Number<br>1<br>Calcitonin Salmon USP<br>0.0734 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	12 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred

nin Salmon USP 0.0734 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	12 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred

UDIN00521586AM25

Par	ty Name	APTRA SYNTHESIS PRIVATE L	IMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 12 an	d 10/12/2024
HQ	File Number	HQRNORM APPLY 00000952AM	25

RA	File Number	26AX04000006 AM25
Lic<br>Dat	ence No and<br>e	2611001464/28/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it appears that export item is non-existing<br>and no norms can be fixed for such export. Hence, it was decided to call the firm for attendingPersonal<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents:	ms Committee Decision:<br>





Case No.	13 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved

Party Name	FDC LIMITED

Meeting Number<br>	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
and Date
HQ File Number	HQRNORM APPLY 00000954AM25

RA File Number	03AX04000939 AM25
Licence No and<br>Date	0311034175/28/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. GENTAMICIN EYE/EAR DROPS 5 ML((EACH VIAL CONTAINS GENTAMICIN SULPHATE 0.015 GM NET WT OF BULK DRUG IS 10.391 KGS)) 692750 Vials 1 GENTAMICIN SULPHATE 12.725 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00521586AM25

Case No.		14 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number an	d
Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00000957AM25
RA File Number		08AX04000294 AM25
Licence No and Date		0811011676/28/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 (R)-3-[(tert-butoxycarbonyl)amino-4 -(2,4,5-trifluorophenyl)]butanoic acid 0.953 kg. 2 3-(trifluoromethyl)-5,6,7,8-tetrahydro [124] triazolo [43-a]pyrazine 0.686 kg. SITAGLIPTIN FREE BASE API (BULK DRUG) 1 kg.|||||||||||| ||||||||||||| ||Export Product|||Q|ty.|Sl|. No.|Impo|rt Items||Qty. allowed.| ||||||||||||| ||SITAGLIPTIN FREE BASE|||1|kg.||1|(R)-3-|[(tert-butoxycarbonyl)amino|-4|0.953 kg.| ||API (BULK DRUG)|||||||-(2,4,5-trifluorophenyl)]butanoic acid|||| |||||||2||3-(trifluoromethyl)-5,6,7,8-tetrahydro [124] triazolo [43-a]pyrazine||| 0.686 kg.| |||||||||,, , hdrochloride|||| |||||||||y|||| ||||||||||||| |||||||3||O-(Benzotriazol-1-yl)-N,N,N',N'- |||0.936 kg.| |||||||||tetramethyluronium Tetrafluoroborate (TBTU)|||| ||||||||||||| ||||||||||||| |||||||4||ISOPROPYL ALCOHOL|||6.80 kg.| ||||||||||||| ||||||||||||| |5 METHANOL 5.25 kg. RA concerned may take further necessary action as per above decision of NC.||||||5||METHANOL|||5.25 kg.| |||||||||||||

ALCOHOL|||6.80 kg.| ||||||||||||| ||||||||||||| |5 METHANOL 5.25 kg. RA concerned may take further necessary action as per above decision of NC.||||||5||METHANOL|||5.25 kg.| |||||||||||||




Case No.	15 / NC/3/MEET/Dec/202425/12

Case Status	Case Deferred
Party Name	MANIPAL NATURAL PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
and Date

HQ File Number	HQRNORM APPLY 00000966AM25
RA File Number	07AX04000258 AM25
Licence No and	0711011405/28/05/2024

UDIN00521586AM25

Date

Norms Committee Decision:

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

Complete Certificate of Analysis (CoA) of import items from supplier indicating mesh size.

2. Specification of export indicating mesh size.

Case No.	16 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00000994AM25
RA File Number	03AX04000906 AM25
Licence No and Date	0311034224/29/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/May/202425/4 dated 06/06/2024against<br>advance authorization**No.

se as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo. NC/3/MEET/May/202425/4 dated 06/06/2024against advance authorizationNo. 0311023871 dated 25/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. AMANTADINE HYDROCHLORIDE 100 MG CAPSULES (DINETREL100 MG) 1 Number Capsule 1 AMANTADINE HYDROCHLORIDE 102 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	17 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00000977AM25
RA File Number	08AX04000298 AM25

UDIN00521586AM25

UDIN00521586AM25

Licence No and<br>Date	0811011681/29/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Loteprednol Etabonate Sterile<br>Micronized<br>25.50 mg.<br>Loteprednol Etabonate &<br>Tobramycin Ophthalmic<br>suspension 0.5%/ 0.3% - 5 ML<br>1 Number<br>2<br>Tobramycin USP<br>15.30 mg.<br>3<br>Loteprednol Etabonate Sterile<br>Micronized<br>51.00 mg.<br>Loteprednol Etabonate &<br>Tobramycin Ophthalmic<br>suspension 0.5%/ 0.3% - 10 ML<br>1 Number<br>4<br>Tobramycin USP<br>30.60 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Licence No and Date

0811011681/29/05/2024

Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Loteprednol Etabonate Sterile Micronized 25.50 mg. Loteprednol Etabonate & Tobramycin Ophthalmic suspension 0.5%/ 0.3% - 5 ML 1 Number 2 Tobramycin USP 15.30 mg. 3 Loteprednol Etabonate Sterile Micronized 51.00 mg. Loteprednol Etabonate & Tobramycin Ophthalmic suspension 0.5%/ 0.3% - 10 ML 1 Number 4 Tobramycin USP 30.60 mg. RA concerned may take further necessary action as per above decision of NC.

abonate & Tobramycin Ophthalmic suspension 0.5%/ 0.3% - 10 ML 1 Number 4 Tobramycin USP 30.60 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	18 / NC/3/MEET/Dec/202425/12	18 / NC/3/MEET/Dec/202425/12	18 / NC/3/MEET/Dec/202425/12	18 / NC/3/MEET/Dec/202425/12	18 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00000978AM25
RA File Number		03AX04000881 AM25
Licence No and<br>Date		0311034209/29/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Lactic Acid<br>0.295 kg.<br>Sodium Stearyl Lactylate (Fatty Acid Ester)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Sodium Stearyl Lactylate (Fatty Acid Ester)		1 kg.	1	Lactic Acid	0.295 kg.

UDIN00521586AM25

2 Stearic Acid 0.765 kg.

oduct**||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Sodium Stearyl Lactylate (Fatty Acid Ester)||1 kg.|1|Lactic Acid|0.295 kg.|

UDIN00521586AM25

2 Stearic Acid 0.765 kg.

Case No.	19 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	AGIO PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00000990AM25
RA File Number	03AX04000815 AM25
Licence No and<br>Date	0311034218/29/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Copy of Drug Manufacturing Licence (DML).<br>1.<br>Import quantity against each export product pack size.<br>2.

Case No.	Case No.	20 / NC/3/MEET/Dec/202425/12	20 / NC/3/MEET/Dec/202425/12	20 / NC/3/MEET/Dec/202425/12	20 / NC/3/MEET/Dec/202425/12	20 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		SAGA LIFESCIENCES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00000999AM25
RA File Number		08AX04000285 AM25
Licence No and Date		0811011704/29/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol.

o and Date||0811011704/29/05/2024||||| |Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. LYSINE CLONIXINATE (125MG) 500000 CLONIXINATE 1 63.75 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||LYSINE CLONIXINATE (125MG)||500000|1|CLONIXINATE|63.75 kg.|

UDIN00521586AM25

AND PROPINOX<br>HYDROCHLORIDE (10MG)<br>TABLETS (CONTENTS OF<br>CLONIXINATE LYSINE 62.50 KGS)<br>Numbers<br>LYSINE<br>RA concerned may take further necessary action as per above decision of NC.	AND PROPINOX<br>HYDROCHLORIDE (10MG)<br>TABLETS (CONTENTS OF<br>CLONIXINATE LYSINE 62.50 KGS)	Numbers		LYSINE

Case No.	21 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	GULBRANDSEN INDUSTRIES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001000AM25
RA File Number	34AX04000145 AM25
Licence No and<br>Date	3411004994/29/05/2024

|Meeting Number and Date|NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024| |HQ File Number|HQRNORM APPLY 00001000AM25| |RA File Number|34AX04000145 AM25| |Licence No and Date|3411004994/29/05/2024| |Norms Committee Decision: **Decision:**The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Chemical reaction indicating molecular weight of Reactant and Products. 1. Step wise and overall yield of the reaction. 2. End use of export item and a copy of minutes, if approved in the past by Norms Committee. 3.||

Case No.	22 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	SAI RAM CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001002AM25
RA File Number	26AX04000011 AM25
Licence No and<br>Date	2611001466/29/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under

UDIN00521586AM25

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.
(4R-CIS)-1,1-Dimethylethyl-6-(2-	1 kg.	1	(4R,Cis)-1,1-Dimethylethyl-6-	1.01 kg.
Aminomethyl-2,2- Dimetyl-13-			Cyanomethyl-2,2-Dimethyl-1,3-
Dioxane-4-Acetate (Amino Ketal)			Dioxane-4-Acetate

CIS)-1,1-Dimethylethyl-6-(2-|1 kg.|1|(4R,Cis)-1,1-Dimethylethyl-6-|1.01 kg.| |Aminomethyl-2,2- Dimetyl-13-|||Cyanomethyl-2,2-Dimethyl-1,3-|| |Dioxane-4-Acetate (Amino Ketal)|||Dioxane-4-Acetate||

Case No.	23 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and	10/12/2024
HQ File Number	HQRNORM APPLY 00001017AM25
RA File Number	03AX04000988 AM25
Licence No and<br>Date	0311034260/30/05/2024
Norms Committee Decision:
Decision:The Committee considered the case as		per agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
(4R-Cis)-1,1-dimethylethyl 6-{2[2-(4-		1 kg.	1	Diisopropyl Amine	0.50 kg.
fluorophenyl)-5-(1-methylethyl)-3-phenyl-
4[(phenylamino) carbonyl](]-1H-pyrrol-
1-yl] ethyl}-2,2-dimethyl-1,3-dioxan-4-
acetate (ATV-1))

UDIN00521586AM25

henyl)-5-(1-methylethyl)-3-phenyl-||||||| |4[(phenylamino) carbonyl](]-1H-pyrrol-||||||| |1-yl] ethyl}-2,2-dimethyl-1,3-dioxan-4-||||||| |acetate (ATV-1))||||||| ||||||||

UDIN00521586AM25

Case No.	24 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001018AM25
RA File Number	03AX04000989 AM25
Licence No and<br>Date	0311034261/30/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>(4R-Cis)-1,1-dimethylethyl 6-{2-[2-(4-<br>fluorophenyl)-5-(1-isopropyl)-3-phenyl-<br>0.6259 kg.<br>Atorvastatin Calcium<br>1 kg.<br>2<br>METHANOL<br>4.285 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	25 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001028AM25
RA File Number	03AX04000079 AM25
Licence No and<br>Date	0311034279/31/05/2024

UDIN00521586AM25

Norms Committee Decision:

UDIN00521586AM25

Norms Committee Decision:

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

Manufacturing process giving chemical reaction indicating molecular weight of Reactant and Products and import of item S03 is in solid or liquid form.

Step wise and overall yield of the reaction with justification.

Specific requirement of import item 1 i.e Ethyl alcohol or Denatured Ethyl alcohol.
A copy of Minutes, if approved in the past by Norms Committee.

Case No.	26 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001066AM25
RA File Number	05AX04000713 AM25
Licence No and<br>Date	0511025847/03/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Tobramycin Inhalation Solution, 300mg/ 4ml(Having net content of 49.26 kg of Bulk drug (filling volume 4.35ml in each number)) 151000 Numbers 1 TOBRAMYCIN USP 47.565 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00521586AM25

Case No.	27 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001061AM25
RA File Number	05AX04000712 AM25
Licence No and<br>Date	0511025839/03/06/2024
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<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Nitroglycerin Sublingual Tablets<br>USP, 0.3mg<br>1 Number<br>1<br>DILUTED<br>NITROGLYCERIN USP<br>(2% W/W)<br>15.30 mg.<br>Nitroglycerin Sublingual Tablets<br>USP, 0.4mg<br>1 Number<br>2<br>DILUTED<br>NITROGLYCERIN USP<br>(2% W/W)<br>20.40 mg.<br>Nitroglycerin Sublingual Tablets<br>USP, 0.6mg<br>1 Number<br>3<br>DILUTED<br>NITROGLYCERIN USP<br>(2% W/W)<br>30.60 mg.<br>RA concerned may take further necessary action as per above decision of NC.

glycerin Sublingual Tablets USP, 0.6mg 1 Number 3 DILUTED NITROGLYCERIN USP (2% W/W) 30.60 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	28 / NC/3/MEET/Dec/202425/12
Case Status<br>	Case Approved
Party Name<br>	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number<br>	HQRNORM APPLY 00001058AM25
RA File Number<br>	08AX04000327 AM25
Licence No and<br>	0811011729/03/06/2024

UDIN00521586AM25

Date Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/May/202425/4 dated 06/06/2024 against advance authorization No. 0811008290 dated 25/05/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
CAPTOPRIL TABLETS USP -25 MG	1 Number	1	CAPTOPRIL USP	25.50 mg.
(ANGIOPRIL 25 MG)((each uncoated
tablet contains USP 25mg.

|Import Items|Qty. allowed.| |---|---|---|---|---| |CAPTOPRIL TABLETS USP -25 MG|1 Number|1|CAPTOPRIL USP|25.50 mg.| |(ANGIOPRIL 25 MG)((each uncoated||||| |tablet contains USP 25mg.|||||


Case No.		29 / NC/3/M	EET/Dec/202425/12
Case Status		Case Appro	ved
Party Name		STERILE I	NDIA PRIVATE LIMITED
Meeting Number		NC/ 3/ ME	T/ Dec/ 202425/ 12 and 10/12/2024
and Date
HQ File Number		HQRNORM	APPLY 00001126AM25
RA File Number		05AX04000637 AM25
Licence No and<br>Date		0511025895/05/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against<br>advance authorizationNo. 0511017736 dated 14/03/2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.
	me export prouctmport tem n<br>vance authorizationNo. 051101773<br>07 of HBP Vol. I as per details give			eetngo.<br>6 dated 14/0<br>n below or as		<br>3/2023, i<br>applied b		Jun ae <br>t was decided to fix ad-hoc nor<br>y the firm, whichever is less:-	aganst<br>ms under Para

	Export Product				Qty.		Sl.	**No.

3/2023*, i applied b||Jun ae t was decided to fix ad-hoc nor y the firm, whichever is less:-||aganst ms under Para| |||||||||||| ||Export Product||||Qty.||Sl.|**No. **|Import Items|Qty. allowed.| ||||||||||||

UDIN00521586AM25

Deferoxamine Mesylate Lyophilized	1	kg.	1	Deferoxamine Mesylate	1.02 kg.
Sterile				USP (Non-Sterile)

Case No.	30 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	DR.ACHARYA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001119AM25
RA File Number	03AX04000976 AM25
Licence No and<br>Date	0311034156/05/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>3-Methoxy-2-methylbenzoyl chloride<br>(MMBC)(CAS No.: 24487-91-0)<br>1 kg.<br>1<br>3-Methoxy-o-toluic Acid<br>(MOTA)<br>0.95 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	31 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	CLARIANT INDIA PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024

UDIN00521586AM25

1 / NC/3/MEET/Dec/202425/12| |---|---| |Case Status|Case Deferred| |Party Name|CLARIANT INDIA PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024|

UDIN00521586AM25

and Date
HQ File Number	HQRNORM APPLY 00001120AM25
RA File Number	03AX04001111 AM25
Licence No and<br>Date	0311034385/05/06/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>The norms for the export item was approved through raw material Hydroxyl Amine<br>Hydrochloride and other chemicals, therefore, difference in the present item of import<br>Hydroxyl ammonium sulfate.<br>1.<br>Stoichiometric material balance of the reaction on molar basis.<br>2.<br>The commercial value of by-products obtained during reaction.<br>3.<br>Overall yield of reaction with justification for the low yield.<br>4.

The norms for the export item was approved through raw material Hydroxyl Amine Hydrochloride and other chemicals, therefore, difference in the present item of import Hydroxyl ammonium sulfate.

The norms for the export item was approved through raw material Hydroxyl Amine Hydrochloride and other chemicals, therefore, difference in the present item of import Hydroxyl ammonium sulfate.

Case No.	32 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001122AM25
RA File Number	05AX04000723 AM25
Licence No and<br>Date	0511025891/05/06/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Export product is not matching with chemistry given for stage 3(DP06).<br>1.<br>Percentage yield on molar basis for each step.<br>2.<br>Recovery of solvent at each stage.<br>3.

Case No.	33 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred

UDIN00521586AM25

Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001123AM25
RA File Number	05AX04000722 AM25
Licence No and<br>Date	0511025892/05/06/2024
Norms Committee Decision:<br>Decision:The case is under consideration and TE was requested to expedite his comments.

er|05AX04000722 AM25| |Licence No and Date|0511025892/05/06/2024| |Norms Committee Decision: Decision:The case is under consideration and TE was requested to expedite his comments.||

Case No.	34 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	AASTRID LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001124AM25
RA File Number	03AX04001065 AM25
Licence No and<br>Date	0311034388/05/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>2-(dimethyl amino)-2-methylpropan-1-ol<br>[80% solution][DMAMP 80%]<br>1 kg.<br>1<br>2-amino-2-methyl-1-<br>propanol ( AMP)<br>0.716 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	35 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	MICRO LABS LIMITED

UDIN00521586AM25

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

Case No.	35 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	MICRO LABS LIMITED

UDIN00521586AM25

Me<br>Dat	eting Number and<br>e	eting Number and<br>e	NC/ 3/ ME	ET/ Dec/ 20242	ET/ Dec/ 20242	5/ 12 an	5/ 12 an	d 10/12/2024	d 10/12/2024	d 10/12/2024
HQ File Number	File Number		HQRNOR	M APPLY 0000		1148AM		25

RA File Number			07AX04000379 AM25
Licence No and Date			0711011477/06/06/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export pro		duct/import item in meetingNo. NC/3/MEET/Apr/202324/1 dated 28/04/2023against
advance authori		zationNo. 0711006198 dated 16/01/2023, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vo		l. I as per details given below or as applied by the firm, whichever is less:-



	Export P	roduct			Qty.		Sl.<br>		Import Items	**Qty.

iven below or as applied by the firm, whichever is less:-||||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| ||Export P|roduct|||Qty.|||Sl. |||Import Items||Qty. allowed.|| |||||||||No.||||||| |||||||||||||||| |RA|AMOXICILLIN 250 MG + FLUCLOXACILLIN 250 MG CAPSULES - 1999.985 KGS)|||| 1 Number Capsule|||1|||AMOXICILLIN TRIHYDRATE BP/EP/IP/USP||292.68 mg/Capsule|| |||||||||2|||FLUCLOXACILLIN SODIUM BP/EP/IP/USP||277.47 mg/Capsule|| ||AMOXICILLIN||||1 Number|||3|||AMOXICILLIN||3012.83 mg/Bottle|| ||125 MG + FLUCLOXACILLIN 125 MG /5ML ORAL||||Bo|ttle|||||TRI|HYDRATE BP/EP/IP/USP||| |||||||||||||||| ||SUSPENSION 100ML BOTTLES - 350.00 KGS)|||||||4|||FLU BP/E|CLOXACILLIN SODIUM P/IP/USP|2856|.33 mg/Bottle| |||||||||||||||| ||concerned may take further necess|||||ary action||as p|er abov|||e decision of NC.||| |||||||||||||||| |||||||||||||||| |Cas|e No.|36 / NC/3/MEET/Dec/2||||02425/12||||||||| |Cas|e Status|Case Approved||||||||||||| |Par|ty Name|MICRO LABS LIMITE||||D||||||||| |Me and|eting Number|NC/ 3/ MEET/ Dec/ 202||||425/ 12 and 10|||12/2024|||||| ||Date|||||||||||||| |HQ|File Number|HQRNORM APPLY 00001149AM25||||||||||||| |RA File Number||07AX04000378 AM25||||||||||||| |Licence No and||0711011478/06/06/2024||||||||||||| |Date|||||||||||||||

|Date|||||||||||||| |HQ|File Number|HQRNORM APPLY 00001149AM25||||||||||||| |RA File Number||07AX04000378 AM25||||||||||||| |Licence No and||0711011478/06/06/2024||||||||||||| |Date|||||||||||||||

Case No.	36 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001149AM25
RA File Number	07AX04000378 AM25
Licence No and<br>Date	0711011478/06/06/2024

UDIN00521586AM25

Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Jun/202425/6 dated 01/07/2024 against advance authorization No. 0811009157 dated 21/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
TRANEXAMIC ACID<br>INJECTION SOLUTION<br>1000MG/10ML (196.50 KGS)	1 Number	1	TRANEXAMIC ACID<br>USP	1.05 gm/100 ml Vial

Case No.	Case No.	37 / NC/3/MEET/Dec/202425/12	37 / NC/3/MEET/Dec/202425/12	37 / NC/3/MEET/Dec/202425/12	37 / NC/3/MEET/Dec/202425/12	37 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001150AM25
RA File Number		07AX04000380 AM25
Licence No and<br>Date		0711011479/06/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Sep/202425/9 dated 10/10/2024against<br>advance authorizationNo. 0711006102 dated 05/01/2023,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

ort item in meetingNo. NC/3/MEET/Sep/202425/9 dated 10/10/2024against advance authorization**No. 0711006102 dated 05/01/2023,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. DICLOXACILLIN CAPSULES 250MG (65.003 KGS)) 1 Number 1 DICLOXACILLIN SODIUM E.P 267.5 mg/250 mg Capsule||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DICLOXACILLIN CAPSULES 250MG (65.003 KGS))||1 Number|1|DICLOXACILLIN SODIUM E.P|267.5 mg/250 mg Capsule|

UDIN00521586AM25

DICLOXACILLIN CAPSULES	1 Number	2	DICLOXACILLIN SODIUM E.P	535.0 mg/500 mg
500MG (1629.995 KGS))				Capsule

Case No.	38 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	ANNORA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001157AM25
RA File Number	09AX04000088 AM25
Licence No and<br>Date	0911007356/06/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Sucralfate Oral Suspension 1 g / 10 ML 420 ML (Composition : Each 10 mL of Suspension Contains, Sucralfate USP 1g) 106973 Numbers 1 Sucralfate USP 4717.51 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	39 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024

UDIN00521586AM25

and Date
HQ File Number	HQRNORM APPLY 00001164AM25
RA File Number	09AX04000161 AM25
Licence No and<br>Date	0911007369/06/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Cefepime for Injection 1 Gram<br>(Each vial contains Sterile<br>mixture of Cefepime<br>Hydrochloride USP Equivalent<br>to Cefepime 1 gram and L-<br>Arginine for pH adjustment (as a<br>buffer)<br>1 Number<br>1<br>Sterile Cefepime with Arginine<br>1.8975 gm<br>RA concerned may take further necessary action as per above decision of NC.

d L- Arginine for pH adjustment (as a buffer) 1 Number 1 Sterile Cefepime with Arginine 1.8975 gm RA concerned may take further necessary action as per above decision of NC.||

Case No.	40 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001166AM25
RA File Number	08AX04000371 AM25
Licence No and<br>Date	0811011769/07/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Feb/202324/23 dated 19/02/2024against<br>advance authorizationNo. 0811009604 dated 09/10/2023,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00521586AM25

1009604 dated 09/10/2023,**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:-||

UDIN00521586AM25


Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BISOPROLOL FUMARATE<br>TABLETS 1.25 MG(EACH<br>FILM COATED TABLET<br>CONTAINS: BISOPROLOL<br>FUMARATE USP 1.25 MG<br>NET CONTENT OF<br>BISOPROLOL FUMARATE<br>SHOULD NOT BE LESS<br>THAN 5.530 KG IN<br>EXPORT<br>ITEM.)	1 Number<br>Tablet	1	BISOPROLOL FUMARATE<br>USP	1.275 mg/1.25 mg<br>Tablet
BISOPROLOL FUMARATE<br>TABLETS 2.5 MG(EACH<br>FILM COATED TABLET<br>CONTAINS: BISOPROLOL<br>FUMARATE USP 2.5 MG<br>NET CONTENT OF<br>BISOPROLOL FUMARATE<br>SHOULD NOT BE LESS<br>THAN 14.978 KG IN<br>EXPORT<br>ITEM.)	1 Number<br>Tablet	2	BISOPROLOL FUMARATE<br>USP	2.55 mg/2.5 mg Tablet
BISOPROLOL FUMARATE<br>TABLETS 5 MG(EACH FILM<br>COATED TABLET<br>CONTAINS: BISOPROLOL<br>FUMARATE USP 5 MG NET<br>CONTENT OF BISOPROLOL<br>FUMARATE SHOULD NOT BE<br>LESS THAN 29.850 KG IN<br>EXPORT ITEM.)	<br>1 Number<br>Tablet	3	BISOPROLOL FUMARATE<br>USP	5.10 mg/5 mg Tablet
BISOPROLOL FUMARATE<br>TABLETS 10 MG(EACH FILM<br>COATED TABLET<br>CONTAINS: BISOPROLOL<br>FUMARATE USP 10 MG NET<br>CONTENT OF BISOPROLOL<br>FUMARATE SHOULD NOT BE	<br>1 Number<br>Tablet	4	BISOPROLOL FUMARATE<br>USP	10.20 mg/10 mg Tablet

UDIN00521586AM25

LESS THAN 43.970 KG IN EXPORT ITEM.)

UDIN00521586AM25

LESS THAN 43.970 KG IN EXPORT ITEM.)

Case No.	41 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001174AM25
RA File Number	03AX04001084 AM25
Licence No and Date	0311034440/07/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Nov/202425/10 dated 22/11/2024against<br>advance authorizationNo. 0311033608 dated 06/05/2024,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>ROSUVASTATIN TABLET<br>BP / USP 10 MG.((Each<br>Tablet contains Rosuvastatin<br>Calcium 10.400 mg) Eq. to<br>Rosuvastatin 10 mg.<br>52500000<br>Numbers<br>1<br>Tert-butyl 2-((4R,6S)-6-((E)-2-(4-<br>(4-fluorophenyl)-6-isopropyl-2-(N-<br>methylmethylsulfonamido)<br>pyrimidin-5-yl)vinyl)-2,2-dimethyl-<br>1,3-dioxan-4-yl)acetate<br>556.92 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00521586AM25

lfonamido) pyrimidin-5-yl)vinyl)-2,2-dimethyl- 1,3-dioxan-4-yl)acetate 556.92 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00521586AM25

Case No.	42 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001197AM25
RA File Number	07AX04000407 AM25
Licence No and Date	0711011510/08/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Apr/202425/2 dated 30/04/2024against<br>advance authorizationNo. 0711008298 dated 19/06/2023,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>AZELASTINE<br>HYDROCHLORIDER 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.

OPS 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.	43 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001242AM25
RA File Number	05AX04000783 AM25
Licence No and<br>Date	0511026035/11/06/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-

UDIN00521586AM25

1. Manufacturing process in detail.

Complete chemistry with Stoichiometric balance molecular weight and percentage of yield.

Case No.	44 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001241AM25
RA File Number	07AX04000435 AM25
Licence No and Date	0711011543/11/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. 2/82-ALC4/2020 dated 10/07/2020against advance<br>authorizationNo. 0310826799 dated 04/02/2019,it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>BROMOCRIPTINE<br>TABLETS 2.5mg<br>1 Number<br>1<br>BROMOCRIPTINE<br>MESILATE BP/EP/IP/USP<br>2.927 mg/Tablet.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	45 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	ALCHEMIE FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001248AM25
RA File Number	03AX04001154 AM25

UDIN00521586AM25

Licence No and 0311034547/12/06/2024 Date Norms Committee Decision:

UDIN00521586AM25

Licence No and 0311034547/12/06/2024 Date Norms Committee Decision:

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

Stoichiometric material balance of the reaction on molar basis.
Stage wise yield of the reaction indicating overall yield with justification for the low yield.

Case No.	Case No.	46 / NC/3/MEET/Dec/202425/12
Cas	e Status	Case Approved
Par	ty Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED

Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ	File Number	HQRNORM APPLY 00001250AM25
RA	File Number	08AX04000413 AM25
Lic<br>Dat	ence No and<br>e	0811011789/12/06/2024
Nor<br>De<br>sa<br>ad<br>4.<br> <br> <br> <br>RA	ms Committee Decision:<br>cision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>me export product/import item in meetingNo. NC/3/MEET/Nov/202425/10 dated 22/11/2024against<br>vance authorization**No.

red the case as per agenda and taking cue from the earlier decision for me export product/import item in meetingNo. NC/3/MEET/Nov/202425/10 dated 22/11/2024against vance authorizationNo. 0811010830 **dated 21/02/2024,**it was decided to fix ad-hoc norms under Para 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.||| || |Cupric Chloride Injection USP, 0.4 mg/mL (10 mL)||1 Number|1|Copper (II) chloride dihydrate GMP|11.77 mg.||| |||concerned may take further necessary action as per above decision of NC.|||||||| |||||||||||

Case No. 47 / NC/3/MEET/Dec/202425/12

UDIN00521586AM25

Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001254AM25
RA File Number	08AX04000339 AM25
Licence No and<br>Date	0811011790/12/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Calcium Gluconate Injection, USP 1,000 mg per 10 mL (100 mg per mL) 1 Number 1 CALCIUM GLUCONATE MONOHYDRATE USP 1081.0 mg. Calcium Gluconate Injection, USP 5,000 mg per 50 mL (100 mg per mL) 1 Number 2 CALCIUM GLUCONATE MONOHYDRATE USP 5145.0 mg. Calcium Gluconate Injection, USP 10,000 mg per 100 mL (100 mg per mL) 1 Number 3 CALCIUM GLUCONATE MONOHYDRATE USP 10290.0 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	48 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001267AM25
RA File Number	03AX04001124 AM25
Licence No and Date	0311034554/12/06/2024
Norms Committee Decision:

UDIN00521586AM25

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate	1 kg.	1	Tetrahydrofuran	0.56 kg.
		2	N-Heptane	0.89 kg.
		3	Ethyl Isobutyrate	0.374 kg.
		4	1 Bromo-5-chloropentane	0.60 kg.
		5	N, N Dimethylacetamide	0.84 kg.
		6	Sodium t-pentoxide	0.31 kg.
		7	Tosmic	0.28 kg.

Case No.	49 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001269AM25
RA File Number	08AX04000373 AM25
Licence No and<br>Date	0811011805/12/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Feb/202324/23 dated 19/02/2024against

UDIN00521586AM25

advance authorization No. 0811009604 dated 09/10/2023, 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:-

dvance authorization No. 0811009604 dated 09/10/2023, 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	Qty.	Sl. No.	Import Items	Qty. allowed.
BISOPROLOL FUMARATE<br>TABLETS 5 MG (Bisoprolol<br>Galenika 5 mg)(Each film<br>coated tablet contains<br>Bisprolol<br>Fumarate EP 5 mg and<br>Excipients. Net content of<br>Bisoprolol Fumarate should<br>not be less than 65.000 Kg in<br>export item.)	1 Number<br>Tablet	1	BISPROLOL FUMARATE EP	5.10 mg/5 mg<br>Tablet
BISOPROLOL FUMARATE<br>10 MG TABLETS (Bisoprolol<br>Galenika 10 mg)(Each film<br>coated tablet contains<br>Bisprolol<br>Fumarate EP 10 mg and<br>Excipients. Net content of<br>Bisoprolol Fumarate should<br>not be less than 24.000 Kg in<br>export item.)	<br>1 Number<br>Tablet	2	BISPROLOL FUMARATE EP	10.20 mg/10 mg<br>Tablet

Case No.	50 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001270AM25
RA File Number	08AX04000356 AM25
Licence No and Date	0811011806/12/06/2024

UDIN00521586AM25

Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/May/202425/4 dated 06/06/2024 against advance authorization No. 0811010967 dated 04/03/2024, 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.
PROPAFENONE TABLETS<br>150MG (PROPRAFENON<br>150 HEUMANN)(EACH<br>FILM COATED TABLET<br>CONTAINS:<br>PROPAFENONE<br>HYDROCHLORIDE PH.<br>EUR. 150 MG	1 Number	1	PROPAFENONE<br>HYDROCHLORIDE EP	153 mg/Tablet
PROPAFENONE TABLETS<br>300MG (PROPRAFENON<br>300 HEUMANN)(EACH<br>FILM COATED TABLET<br>CONTAINS:<br>PROPAFENONE<br>HYDROCHLORIDE PH.<br>EUR. 300 MG	1 Number	2	PROPAFENONE<br>HYDROCHLORIDE EP	306 mg/Tablet

Case No.	51 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001279AM25
RA File Number	05AX04000655 AM25
Licence No and<br>Date	0511026076/13/06/2024

UDIN00521586AM25

Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Mar/202324/26 dated 22/03/2024 against advance authorization No. 0511023989 dated 15/02/2024, 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.
Ceftriaxone Sodium Sterile	1 kg.	1	Ceftriaxone Sodium<br>(Non Sterile)	1.04 kg.

Case No.	52 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001316AM25
RA File Number	52AX04000061 AM25
Licence No and<br>Date	5211008490/13/06/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Complete Chemistry indicating molecular weight of both reactant and products with yield and<br>justification, including Hydrazine Hydrate 64% to Semicarbazide HCL.<br>I.<br>Production consumption data (including Hydrazine Hydrate 64% to Semicarbazide HCL) for<br>the last three years duly certified by Chartered Accountant.<br>II.

micarbazide HCL.** I. Production consumption data (including Hydrazine Hydrate 64% to Semicarbazide HCL) for the last three years duly certified by Chartered Accountant. II.||

I. Complete Chemistry indicating molecular weight of both reactant and products with yield and justification, including Hydrazine Hydrate 64% to Semicarbazide HCL.
II. Production consumption data (including Hydrazine Hydrate 64% to Semicarbazide HCL) for the last three years duly certified by Chartered Accountant.

UDIN00521586AM25

Case No.	53 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001314AM25
RA File Number	04AX04000189 AM25
Licence No and<br>Date	0411007575/13/06/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>The commercial value of by-product formed during manufacturing export item with providing<br>sales invoice.<br>1.<br>Stage wise and overall yield of the reaction with calculation of requirement of imported raw<br>materials.<br>2.<br>Current production/consumption data duly certified by Chartered Accountant.<br>3.

d overall yield of the reaction with calculation of requirement of imported raw** materials. 2. Current production/consumption data duly certified by Chartered Accountant. 3.||

Case No.	Case No.	54 / NC/3/MEET/Dec/202425/12	54 / NC/3/MEET/Dec/202425/12	54 / NC/3/MEET/Dec/202425/12	54 / NC/3/MEET/Dec/202425/12	54 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001311AM25
RA File Number		03AX04001155 AM25
Licence No and<br>Date		0311034601/13/06/2024
Norms Committee Decision:<br>Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty. allowed.

UDIN00521586AM25

DMA Chloride-Lan 40000 kg. 1 2-Chloro Benzyl Chloride 44000 kg.

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

UDIN00521586AM25

DMA Chloride-Lan 40000 kg. 1 2-Chloro Benzyl Chloride 44000 kg.

Case No.	55 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001276AM25
RA File Number	03AX04000955 AM25
Licence No and Date	0311034567/13/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Sep/202324/13 dated 14/09/2023against<br>advance authorizationNo. 0311025247 dated 10/07/2023,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>FAROPENEM SODIUM<br>1 kg.<br>1<br>(3R,4R)-4-ACETOXY-3-[(R)-1-(T-<br>BUTYLDIMETHYLSILYLOXY)ETHYL]-<br>2-AZITIDINONE;4-AA(AOSA)<br>1.20 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	56 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001292AM25

UDIN00521586AM25

UDIN00521586AM25

RA File Number

03AX04001135 AM25

Licence No and Date

0311034573/13/06/2024

Norms Committee Decision: **Decision:**The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Chemical name of export item and to indicate difference in norms approved in the past for the export item (Ambercore) and other names. 1. Chemistry indicating molecular weight of reactants and products with yield. 2. End use of export item. 3.

Case No.	57 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001293AM25
RA File Number	03AX04001186 AM25
Licence No and<br>Date	0311034574/13/06/2024

|Meeting Number and Date|NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024| |HQ File Number|HQRNORM APPLY 00001293AM25| |RA File Number|03AX04001186 AM25| |Licence No and Date|0311034574/13/06/2024| |Norms Committee Decision: **Decision:**The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Manufacturing process using methanol as input giving chemistry indicating molecular weight of reactants and product with yield and justification. 1. Stoichiometric material balance of the item of export on molar basis. 2. End use of export item. 3.||

Case No.	58 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	LINCOLN PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024

43 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-01-2025 14:40:40.

UDIN00521586AM25

HQ File Number	HQRNORM APPLY 00001296AM25
RA File Number	08AX04000313 AM25
Licence No and<br>Date	0811011811/13/06/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|08AX04000313 AM25| |Licence No and Date|0811011811/13/06/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	Case No.	59 / NC/3/MEET/Dec/202425/12	59 / NC/3/MEET/Dec/202425/12	59 / NC/3/MEET/Dec/202425/12	59 / NC/3/MEET/Dec/202425/12	59 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001308AM25
RA File Number		03AX04001160 AM25
Licence No and Date		0311034428/13/06/2024
Norms Committee Decision:<br>Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>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. MOXILEB KID TABLET (AMOXICILLIN TABLET 125MG)((EACH TABLET CONTAINING AMOXICILLIN TRIHYDRATE EQUIVALENT TO 125MG OF AMOXICILLIN) NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE BP (COMPACTED) 71.751 KGS (EXCL 2% WASTAGE)) 500000 Tablets 1 AMOXICILLIN TRIHYDRATE BP COMPACTED 73.16 kg MOXILEB-250 CAPSULE. ( AMOXICILLIN CAPSULES 4200000 Capsules 2 AMOXICILLIN TRIHYDRATE BP COMPACTED 1229.085 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||MOXILEB KID TABLET (AMOXICILLIN TABLET 125MG)((EACH TABLET CONTAINING AMOXICILLIN TRIHYDRATE EQUIVALENT TO 125MG OF AMOXICILLIN) NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE BP (COMPACTED) 71.751 KGS (EXCL 2% WASTAGE))|| 500000 Tablets|1|AMOXICILLIN TRIHYDRATE BP COMPACTED|73.16 kg| ||MOXILEB-250 CAPSULE. ( AMOXICILLIN CAPSULES||4200000 Capsules|2|AMOXICILLIN TRIHYDRATE BP COMPACTED|1229.085 kg.|

UDIN00521586AM25

LIN TRIHYDRATE BP COMPACTED|73.16 kg| ||MOXILEB-250 CAPSULE. ( AMOXICILLIN CAPSULES||4200000 Capsules|2|AMOXICILLIN TRIHYDRATE BP COMPACTED|1229.085 kg.|

UDIN00521586AM25

250MG)((EACH CAPSULE CONTAINING AMOXICILLIN TRIHYDRATE EQUIVALENT TO 250MG OF AMOXICILLIN). NET CONTENT OF IMPORT/ EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE BP (COMPACTED) - 1205.400 KGS (EXCLUDING 2% WASTAGE)) MOXILEB-500 CAPSULE. 6315000 3 AMOXICILLIN 3696.036 kg. Capsules TRIHYDRATE BP ( AMOXICILLIN CAPSULES COMPACTED 500MG)((EACH CAPSULE CONTAINING AMOXICILLIN TRIHYDRATE EQUIVALENT TO 500 MG OF AMOXICILLIN). NET CONTENT OF IMPORT /EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE BP (COMPACTED) - 3624.810 KGS (EACLUDING 2% WASTAGE))

Case No.	60 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001309AM25
RA File Number	03AX04001212 AM25
Licence No and<br>Date	0311034498/13/06/2024
Norms Committee Decision:

UDIN00521586AM25

Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	61 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	SUPRIYA LIFESCIENCE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001310AM25
RA File Number	03AX04001271 AM25
Licence No and Date	0311034600/13/06/2024
Norms Committee Decision:<br>Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>VITAMIN B2 OR RIBOFLAVIN<br>1.17 kg.<br>2<br>PYRIDINE<br>2.00 kg.<br>3<br>ACETONITRILE<br>1.73 kg.<br>RIBOFLAVIN<br>SODIUM<br>PHOSPHATE HYDRATE EP<br>11.2<br>1 kg<br>4<br>PHOSPHORUS OXYCHLORIDE<br>2.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	62 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024

UDIN00521586AM25

and Date
HQ File Number	HQRNORM APPLY 00001312AM25
RA File Number	03AX04001280 AM25
Licence No and<br>Date	0311034602/13/06/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

r|03AX04001280 AM25| |Licence No and Date|0311034602/13/06/2024| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	63 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001344AM25
RA File Number	02AX04000161 AM25
Licence No and<br>Date	0211006735/14/06/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.		Import Items	Qty. allowed.
Calcium Orotate(~)<br>1 kg.<br>1		Orotic Acid	0.95 kg.
RA concerned may take further necessary action as per above decision of NC.

Case No.	64 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001318AM25

UDIN00521586AM25

UDIN00521586AM25

RA File Number

03AX04001192 AM25

Licence No and Date

0311034620/14/06/2024

Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Tetrahydrofuran 0.56 kg. 2 N-Heptane 0.89 kg. 3 Ethyl Isobutyrate 0.374 kg. 4 1 Bromo-5-chloropentane 0.60 kg. 5 N, N Dimethylacetamide 0.84 kg. 6 Sodium t-pentoxide 0.31 kg. 1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate 1 kg. 7 Tosmic 0.28 kg. RA concerned may take further necessary action as per above decision of NC.

Case No.	65 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001322AM25
RA File Number	08AX04000399 AM25
Licence No and<br>Date	0811011827/14/06/2024
Norms Committee Decision:

UDIN00521586AM25

and 10/12/2024| |HQ File Number|HQRNORM APPLY 00001322AM25| |RA File Number|08AX04000399 AM25| |Licence No and Date|0811011827/14/06/2024| |Norms Committee Decision:||

UDIN00521586AM25

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Sep/202425/9 dated 10/10/2024 against advance authorization No. 0811006983 dated 11/01/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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

Sulfate Heptahydrate phEur, USP|2.00 gm| |Magnesium Sulfate In Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL 4g Total|1 Number|2|Magnesium Sulfate Heptahydrate phEur, USP|2.897 gm|

Case No.	Case No.	66 / NC/3/MEET/Dec/202425/12	66 / NC/3/MEET/Dec/202425/12	66 / NC/3/MEET/Dec/202425/12	66 / NC/3/MEET/Dec/202425/12	66 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		SANOFI INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001337AM25
RA File Number		03AX04001301 AM25
Licence No and<br>Date		0311034648/14/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Ramipril<br>PC<br>Granules((Net<br>7000 kg.<br>1<br>Ramipril<br>6009.50 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Ramipril<br>PC<br>Granules((Net		7000 kg.	1	Ramipril	6009.50 kg.

UDIN00521586AM25

content: each 1 gm of Ramipril 850 mg, Total net content Ramipril 5950 kg))

ems**|Qty. allowed.| ||Ramipril PC Granules((Net||7000 kg.|1|Ramipril|6009.50 kg.|

UDIN00521586AM25

content: each 1 gm of Ramipril 850 mg, Total net content Ramipril 5950 kg))

Case No.	67 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001341AM25
RA File Number	02AX04000159 AM25
Licence No and<br>Date	0211006732/14/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Calcium Levulinate(~)<br>1 kg.<br>1<br>Levulinic Acid<br>0.8 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	68 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001342AM25

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RA File Number

02AX04000158 AM25

Licence No and Date

0211006733/14/06/2024

Case No.	69 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001343AM25
RA File Number	02AX04000160 AM25
Licence No and<br>Date	0211006734/14/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Magnesium Pidolate(~)<br>1 kg.<br>1<br>L-Pyroclumatic Acid<br>0.968 kg.<br>RA concerned may take further necessary action as per above decision of NC.

mport Items** Qty. allowed. Magnesium Pidolate(~) 1 kg. 1 L-Pyroclumatic Acid 0.968 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	Case No.	70 / NC/3/MEET/Dec/202425/12	70 / NC/3/MEET/Dec/202425/12	70 / NC/3/MEET/Dec/202425/12	70 / NC/3/MEET/Dec/202425/12	70 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001379AM25
RA File Number		09AX04000169 AM25
Licence No and<br>Date		0911007440/18/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : Orisantin 200mg/25mg Caps(Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : (Orisantin 200mg/25mg depotkapseli, kova/kapsel med modifierad frisattning, hard) Pack Size : 100s (Consist of 1080.08 Kgs of Dipyridamole - Ph Eur )) 1 Number 1 Dipyridamole 204 mg/200 mg Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : Diprasorin 200/25mgCaps100s (Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : (Diprasorin 200mg/25 mg hardkapsel med modifieradfrisattning/ hardkapsel med modifisertfr) Pack Size : 100s (Consist of 800.00 Kgs of Dipyridamole - Ph Eur )) 1 Number 2 Dipyridamole 204 mg/200 mg Dipyridamole Modified Release capsules 1 Number 3 Dipyridamole 204 mg/200 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

Dipyridamole 204 mg/200 mg Dipyridamole Modified Release capsules 1 Number 3 Dipyridamole 204 mg/200 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : Orisantin 200mg/25mg Caps(Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : (Orisantin 200mg/25mg depotkapseli, kova/kapsel med modifierad frisattning, hard) Pack Size : 100s (Consist of 1080.08 Kgs of Dipyridamole - Ph Eur ))|| 1 Number|1|Dipyridamole|204 mg/200 mg| ||Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : Diprasorin 200/25mgCaps100s (Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : (Diprasorin 200mg/25 mg hardkapsel med modifieradfrisattning/ hardkapsel med modifisertfr) Pack Size : 100s (Consist of 800.00 Kgs of Dipyridamole - Ph Eur ))|| 1 Number|2|Dipyridamole|204 mg/200 mg| ||Dipyridamole Modified Release capsules||1 Number|3|Dipyridamole|204 mg/200 mg|

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200 mg Pack Size : 60s Consist of 319.97 Kgs of Dipyridamole - Ph Eur )(Dipyridamole Modified Release capsules 200 mg Pack Size : 60s Consist of 319.97 Kgs of Dipyridamole - Ph Eur ))

521586AM25

200 mg Pack Size : 60s Consist of 319.97 Kgs of Dipyridamole - Ph Eur )(Dipyridamole Modified Release capsules 200 mg Pack Size : 60s Consist of 319.97 Kgs of Dipyridamole - Ph Eur ))

Case No.	71 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001396AM25
RA File Number	09AX04000130 AM25
Licence No and<br>Date	0911007445/18/06/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	72 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001408AM25
RA File Number	03AX04001311 AM25
Licence No and<br>Date	0311034718/19/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Jun/202425/9 dated 14/06/2024against<br>advance authorizationNo. 0311007268 dated 28/09/2021,it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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007268 dated 28/09/2021,**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:-||

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Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BRIMONIDINE TARTRATE EYE<br>DROPS 5 ML (IOBRIM EYE<br>DROPS 5 ML & IOBRAM EYE<br>DROPS 5 ML)((EACH VIAL<br>CONTAINS BRIMONIDINE L<br>TARTRATE 0.01 GM NET WT OF<br>BULK DRUG IS 460 Grams ))	1 Number	1	BRIMONIDINE L<br>TARTRATE	10.2 mg.

Case No.	Case No.	73 / NC/3/MEET/Dec/202425/12	73 / NC/3/MEET/Dec/202425/12	73 / NC/3/MEET/Dec/202425/12	73 / NC/3/MEET/Dec/202425/12	73 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001424AM25
RA File Number		08AX04000355 AM25
Licence No and<br>Date		0811011866/19/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Aug/202425/8 dated 28/08/2024against<br>advance authorizationNo. 0811011226 dated 04/04/2024,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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. Opipramol Dihydrochloride Tablets 50 MG (OPIPRAMOL HEUMANN 50 MG)(Each film coated tablet contains: Opipramol Dihydrochloride 50 mg Excipients.q.s. Net content of active 1 Number 1 Opipramol Dihydrochloride 51 mg/Tablet||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Opipramol Dihydrochloride Tablets 50 MG (OPIPRAMOL HEUMANN 50 MG)(Each film coated tablet contains: Opipramol Dihydrochloride 50 mg Excipients.q.s. Net content of active||1 Number|1|Opipramol Dihydrochloride|51 mg/Tablet|

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|ingredient Opipramol Dihydrochloride should not be less than 100.00 kgs in export product.) Opipramol Dihydrochloride Tablets 100 MG (OPIPRAMOL HEUMANN 100 MG)(Each film coated tablet contains:Opipramol Dihydrochloride 100 mg Excipients. q.s.

100.00 kgs in<br>export product.)<br>Opipramol Dihydrochloride Tablets<br>100 MG (OPIPRAMOL HEUMANN<br>100 MG)(Each film coated tablet<br>contains:Opipramol Dihydrochloride<br>100 mg Excipients. q.s. Net content of<br>active ingredient Opipramol<br>Dihydrochloride should not be less<br>than 100.00 kgs in export product.)<br>1 Number<br>2<br>Opipramol Dihydrochloride<br>102 mg/Tablet<br>RA concerned may take further necessary action as per above decision of NC.	ingredient Opipramol Dihydrochloride<br>should not be less than 100.00 kgs in<br>export product.)
	Opipramol Dihydrochloride Tablets<br>100 MG (OPIPRAMOL HEUMANN<br>100 MG)(Each film coated tablet<br>contains:Opipramol Dihydrochloride<br>100 mg Excipients. q.s. Net content of<br>active ingredient Opipramol<br>Dihydrochloride should not be less<br>than 100.00 kgs in export product.)	1 Number	2	Opipramol Dihydrochloride	102 mg/Tablet

Case No.	74 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001440AM25
RA File Number	03AX04001349 AM25
Licence No and<br>Date	0311034767/20/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. METHYL-2-CHLORO PROPIONATE 200000 kg. 1 PROPIONIC ACID 200000 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	75 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001490AM25
RA File Number	03AX04001450 AM25
Licence No and<br>Date	0311034819/21/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for<br>attending Personal Hearing<br>before Norms Committee to explain its case along with relevant documents.

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

Case No.	76 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	AGGARWWAL EXPORTS
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001484AM25
RA File Number	05AX04000858 AM25
Licence No and<br>Date	0511026193/21/06/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per<br>the advice of the TE, it was decided to call for following information/documents from the firm:-<br>Chemistry indicating molecular weight of reactants and products with yield and<br>justification.<br>1.<br>End use of export item.<br>2.<br>Stoichiometric material balance on molar basis.<br>3.

Case No. 77 / NC/3/MEET/Dec/202425/12

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erial balance on molar basis.** 3.||

Case No. 77 / NC/3/MEET/Dec/202425/12

56 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-01-2025 14:40:40.

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Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001486AM25
RA File Number	05AX04000757 AM25
Licence No and<br>Date	0511026265/21/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Brinzolamide Ophthalmic<br>Suspension, 1% w/v 5ml<br>( Sterile Eye Drops)((Each ml<br>contains Brinzolamide equivalent<br>to Brinzolamide Micronized<br>Sterile 10 mg (Equivalent to<br>4500 Gm of Bulk Drug))<br>1 Number<br>1<br>Brinzolamide<br>(Micronized and Sterile)<br>51.00 mg/Vial<br>RA concerned may take further necessary action as per above decision of NC.

uivalent to 4500 Gm of Bulk Drug)) 1 Number 1 Brinzolamide (Micronized and Sterile) 51.00 mg/Vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	78 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	STERIL-GENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001488AM25
RA File Number	04AX04001003 AM24
Licence No and<br>Date	0411007616/21/06/2024
Norms Committee Decision:<br>Decision:The case is under consideration and TE was requested to expedite his comments.

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Case No.	79 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001489AM25
RA File Number	03AX04001452 AM25
Licence No and<br>Date	0311034818/21/06/2024
Norms Committee Decision:<br>Decision:The case is under consideration and TE was requested to expedite his comments.

Case No.	80 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001491AM25
RA File Number	03AX04001449 AM25
Licence No and<br>Date	0311034820/21/06/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|03AX04001449 AM25| |Licence No and Date|0311034820/21/06/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	81 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	GULBRANDSEN INDUSTRIES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001492AM25
RA File Number	34AX04000146 AM25
Licence No and<br>Date	3411005088/21/06/2024
Norms Committee Decision:

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

Chemical reaction indicating molecular weight of Reactant and Products.
Step wise and overall yield of the reaction.
End use of export item and copy of minutes, if approved in the past by the Norms Committee.

lecular weight of Reactant and Products.**

Step wise and overall yield of the reaction.
End use of export item and copy of minutes, if approved in the past by the Norms Committee.

Case No.	82 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001493AM25
RA File Number	03AX04001447 AM25
Licence No and<br>Date	0311034821/21/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for<br>attendingPersonal Hearing<br>before Norms Committee to explain its case along with relevant<br>information / documents from the firm:

Case No.	83 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001494AM25
RA File Number	03AX04001441 AM25
Licence No and<br>Date	0311034822/21/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for<br>attendingPersonal Hearing<br>before Norms Committee to explain its case along with relevant<br>information / documents from the firm:

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xplain its case along with relevant information / documents from the firm:||

59 This document has been digitally signed by Raman Kumar, Deputy DGFT on 06-01-2025 14:40:40.

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Case No.	Case No.	84 / NC/3/MEET/Dec/202425/12	84 / NC/3/MEET/Dec/202425/12	84 / NC/3/MEET/Dec/202425/12	84 / NC/3/MEET/Dec/202425/12	84 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001520AM25
RA File Number		03AX04001368 AM25
Licence No and Date		0311034864/24/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Apr/202425/2 dated 30/04/2024against<br>advance authorizationNo. 0311024276 dated 06/06/2023,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Carbamazepine<br>102.00 mg<br>2<br>Cellulose Acetate (CA 320S)<br>Eastman<br>29.20 mg<br>Carbamazepine Extended-<br>Release Tablets USP 100<br>mg.(Each tablet contains (i)<br>Carbamazepine 100 mg. (ii)<br>Cellulose Acetate (CA-320S)<br>-Eastman 35.04mg. (iii)<br>Eastman (TM Cellulose<br>Acetate (CA 398-10NF/EP)-<br>5.28 mg.

blets USP 100 mg.(Each tablet contains (i) Carbamazepine 100 mg. (ii) Cellulose Acetate (CA-320S) -Eastman 35.04mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 5.28 mg. Net content (i) 223.220 Kg (ii) 78.216 Kg (iii) 11.786 Kg.) 1 Number 3 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 4.40 mg. 4 Carbamazepine 204.00 mg. 5 Cellulose Acetate (CA 320S) Eastman 29.20 mg. Carbamazepine Extended- Release Tablets USP 200 mg.(Each tablet contains (i) Carbamazepine 200 mg. (ii) Cellulose Acetate (CA-320S) -Eastman 35.04mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 5.28 mg. Net content (i) 467.300 kg (ii) 81.871 Kg (iii) 1 Number 6 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 4.40 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Carbamazepine Extended- Release Tablets USP 100 mg.(Each tablet contains (i) Carbamazepine 100 mg. (ii) Cellulose Acetate (CA-320S) -Eastman 35.04mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 5.28 mg. Net content (i) 223.220 Kg (ii) 78.216 Kg (iii) 11.786 Kg.)||1 Number|1|Carbamazepine|102.00 mg| |||||2|Cellulose Acetate (CA 320S) Eastman|29.20 mg| |||||3|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|4.40 mg.| ||Carbamazepine Extended- Release Tablets USP 200 mg.(Each tablet contains (i) Carbamazepine 200 mg. (ii) Cellulose Acetate (CA-320S) -Eastman 35.04mg.

TE (CA 398-10NF/EP)|4.40 mg.| ||Carbamazepine Extended- Release Tablets USP 200 mg.(Each tablet contains (i) Carbamazepine 200 mg. (ii) Cellulose Acetate (CA-320S) -Eastman 35.04mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 5.28 mg. Net content (i) 467.300 kg (ii) 81.871 Kg (iii)||1 Number|4|Carbamazepine|204.00 mg.| |||||5|Cellulose Acetate (CA 320S) Eastman|29.20 mg.| |||||6|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|4.40 mg.|

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12.337 Kg.)<br>7<br>Carbamazepine<br>408.00 mg.<br>8<br>Cellulose Acetate (CA 320S)<br>Eastman<br>29.20 mg.<br>Carbamazepine Extended-Release<br>Tablets USP 400 mg.(Each tablet<br>contains (i) Carbamazepine 400<br>mg. (ii) Cellulose Acetate (CA-<br>320S) -Eastman 26.28mg. (iii)<br>Eastman (TM Cellulose Acetate<br>(CA 398-10NF/EP)- 3.96 mg. Net<br>content (i) 223.240 Kg. (ii) 14.667<br>Kg (iii) 2.210 Kg.)<br>1 Number<br>9<br>EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)<br>4.40 mg.<br>RA concerned may take further necessary action as per above decision of NC.	12.337 Kg.)
	Carbamazepine Extended-Release<br>Tablets USP 400 mg.(Each tablet<br>contains (i) Carbamazepine 400<br>mg. (ii) Cellulose Acetate (CA-<br>320S) -Eastman 26.28mg. (iii)<br>Eastman (TM Cellulose Acetate<br>(CA 398-10NF/EP)- 3.96 mg. Net<br>content (i) 223.240 Kg.

let contains (i) Carbamazepine 400 mg. (ii) Cellulose Acetate (CA- 320S) -Eastman 26.28mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 3.96 mg. Net content (i) 223.240 Kg. (ii) 14.667 Kg (iii) 2.210 Kg.)| 1 Number|7|Carbamazepine|408.00 mg.| ||||8|Cellulose Acetate (CA 320S) Eastman|29.20 mg.| ||||9|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|4.40 mg.|

Case No.	85 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001507AM25
RA File Number	09AX04000202 AM25
Licence No and<br>Date	0911007468/24/06/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	86 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001508AM25
RA File Number	03AX04001364 AM25
Licence No and<br>Date	0311034851/24/06/2024

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Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance authorization No. 0311032850 dated 05/04/2024, 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.
Idezar 300 mg Tablets 28 S (Irbesartan<br>Tablets 300 Mg 28 S )((25,000 Boxes X<br>28 Tablets per Boxes = 7,00,000 Tablets)<br>(Total Weight of Export Product =<br>210.000 Kgs) (Net Content weight of<br>Import Product = 226.863 kgs))	<br> <br>1 Number	1	Irbesartan Ph. Eur	306 mg.
Idezar 150 mg Tablets 28 S (Irbesartan<br>Tablets 150 Mg 28 S )((45,525 Boxes X<br>28 Tablets per Boxes = 12,74,700 Tablets)<br>(Total Weight of Export Product =<br>191.205 Kgs) (Net Content weight of<br>Import Product = 206.559 kgs))	1 Number	2	Irbesartan Ph. Eur	153 mg.

Case No.	87 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001526AM25
RA File Number	03AX04001213 AM25
Licence No and<br>Date	0311034871/25/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under

UDIN00521586AM25

nd Date|0311034871/25/06/2024| |Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under||

UDIN00521586AM25

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.
GENTAMICIN EYE/EAR DROPS 5<br>ML (BACTIGEN EYE/EAR DROPS<br>5 ML)((EACH VIAL CONTAINS<br>GENTAMICIN SULPHATE 0.015<br>GM NET WT OF BULK DRUG IS<br>9.390 KGS))	626000 Vial	1	GENTAMICIN<br>SULPHATE	9.578 kg.
GENTAMICIN EYE/EAR DROPS<br>10 ML (BACTIGEN EYE/EAR<br>DROPS 10 ML)((EACH VIAL<br>CONTAINS GENTAMICIN<br>SULPHATE 0.030 GM NET WT OF<br>BULK DRUG IS 0.300 KGS))	10000 Vial	2	GENTAMICIN<br>SULPHATE	0.306 kg.

Case No.	Case No.	88 / NC/3/MEET/Dec/202425/12	88 / NC/3/MEET/Dec/202425/12	88 / NC/3/MEET/Dec/202425/12	88 / NC/3/MEET/Dec/202425/12	88 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001539AM25
RA File Number		07AX04000414 AM25
Licence No and Date		0711011646/25/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol.

o and Date||0711011646/25/06/2024||||| |Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00521586AM25

1<br>ASCORBIC ACID DC 97<br>Percentage SF I.H<br>283.892 kg.<br>FERROUS FORTE TABLETS((Each<br>Tab contains 71mg Equivalent to<br>60mg of Ascorbic Acid and 26mg<br>Equivalent to 24mg of Iron<br>Bisglycinate) (Ascorbic-283.892<br>KGS) (Iron -550.800 KGS) (No of<br>Tabs-4500000))<br>834 kg.<br>2<br>IRON BISGLYCINATE<br>550.8 kg.<br>RA concerned may take further necessary action as per above decision of NC.	FERROUS FORTE TABLETS((Each<br>Tab contains 71mg Equivalent to<br>60mg of Ascorbic Acid and 26mg<br>Equivalent to 24mg of Iron<br>Bisglycinate) (Ascorbic-283.892<br>KGS) (Iron -550.800 KGS) (No of<br>Tabs-4500000))	834 kg.	1	ASCORBIC ACID DC 97<br>Percentage SF I.H	283.892 kg.
			2	IRON BISGLYCINATE	550.8 kg.

(Ascorbic-283.892 KGS) (Iron -550.800 KGS) (No of Tabs-4500000))|834 kg.|1|ASCORBIC ACID DC 97 Percentage SF I.H|283.892 kg.| |---|---|---|---|---|---| ||||2|IRON BISGLYCINATE|550.8 kg.|

Case No.	89 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001565AM25
RA File Number	05AX04000957 AM25
Licence No and<br>Date	0511026325/26/06/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE<br>of Deptt. of Bio-Technology, it was decided to call for following information/documents from the firm:-<br>Copy of received and issued quantity of albumin from the store and its actual consumption with<br>reconciliation duly signed by store manager/head.

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

Copy of received and issued quantity of albumin from the store and its actual consumption with reconciliation duly signed by store manager/head.

Case No.	90 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001557AM25
RA File Number	08AX04000459 AM25
Licence No and<br>Date	0811011943/26/06/2024
Norms Committee Decision:

UDIN00521586AM25

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No. NC/3/MEET/May/202425/4 dated 06/06/2024 against advance authorization No. 0811010987 dated 12/03/2024, 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:-

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<br>EXTENDED RELEASE TABLETS<br>USP 60 MG(EACH FILM COATED<br>EXTENDED RELEASE TABLETS<br>CONTAINS: DILUTED<br>ISOSORBIDE MONONITRATE<br>(50% DILUTED WITH LACTOSE<br>MONOHYDRATE) USP<br>EQUIVALENT TO ISOSORBIDE<br>MONONITRATE 60MG	1 Number	1	Isosorbide Mononitrate<br>50 percent Assay.<br>Diluted ISMN (50%<br>diluted with lactose<br>monohydrate) USP	<br>122.40 mg.
ISOSORBIDE MONONITRATE<br>EXTENDED RELEASE TABLETS<br>USP 120 MG(EACH FILM COATED<br>EXTENDED RELEASE TABLETS<br>CONTAINS: DILUTED<br>ISOSORBIDE MONONITRATE<br>(50% DILUTED WITH LACTOSE<br>MONOHYDRATE) USP<br>EQUIVALENT TO ISOSORBIDE<br>MONONITRATE 120MG	1 Number	2	Isosorbide Mononitrate<br>50 percent Assay.<br>Diluted ISMN (50%<br>diluted with lactose<br>monohydrate) USP	<br>244.80 mg

Case No.	91 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024

UDIN00521586AM25

HQ File Number	HQRNORM APPLY 00001606AM25
RA File Number	03AX04001454 AM25
Licence No and<br>Date	0311034979/27/06/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|03AX04001454 AM25| |Licence No and Date|0311034979/27/06/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	Case No.	92 / NC/3/MEET/Dec/202425/12	92 / NC/3/MEET/Dec/202425/12	92 / NC/3/MEET/Dec/202425/12	92 / NC/3/MEET/Dec/202425/12	92 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001603AM25
RA File Number		05AX04001007 AM25
Licence No and<br>Date		0511026356/27/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Mar/202223/26 dated 22/03/2024against<br>advance authorizationNo. 0511023881 dated 09/02/2024,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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. Atropine Sulfate Ophthalmic Solution USP, 1% 2 ml(Having net content of 3.27 kg of Bulk drug (filling volume 2.32 ml in each number)) 1 Number 1 ATROPINE SULPHATE 20.40 mg. Atropine Sulfate Ophthalmic Solution USP, 1% 5 ml(Having net content of 5.61 kg of Bulk drug (filling volume 5.61 ml in each number)) 1 Number 2 ATROPINE SULPHATE 51.00 mg. Atropine Sulfate Ophthalmic Solution USP, 1% 15 ml(Having net content of 4.77 1 Number 3 ATROPINE SULPHATE 153.0 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Atropine Sulfate Ophthalmic Solution USP, 1% 2 ml(Having net content of 3.27 kg of Bulk drug (filling volume 2.32 ml in each number))||1 Number|1|ATROPINE SULPHATE|20.40 mg.| ||Atropine Sulfate Ophthalmic Solution USP, 1% 5 ml(Having net content of 5.61 kg of Bulk drug (filling volume 5.61 ml in each number))||1 Number|2|ATROPINE SULPHATE|51.00 mg.| ||Atropine Sulfate Ophthalmic Solution USP, 1% 15 ml(Having net content of 4.77|| 1 Number|3|ATROPINE SULPHATE|153.0 mg.|

UDIN00521586AM25

kg of Bulk drug (filling volume 15.91 ml in each number))

phthalmic Solution USP, 1% 15 ml(Having net content of 4.77|| 1 Number|3|ATROPINE SULPHATE|153.0 mg.|

UDIN00521586AM25

kg of Bulk drug (filling volume 15.91 ml in each number))

Case No.	93 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001600AM25
RA File Number	05AX04000773 AM25
Licence No and<br>Date	0511026344/27/06/2024
Norms Committee Decision:<br>Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>NEPAFENAC<br>(MICRONIZED)<br>969 gm.<br>Nepafenac Ophthalmic<br>Suspension, 0.1% w/v<br>NEPALACT Sterile Eye<br>Drops, 5ml((Each ml contains<br>Nepafenac 1.0 mg<br>(Equivalent to 950.000 Gram<br>of Bulk Drug))<br>190000<br>Numbers<br>2<br>1 LITRE POLYELITE EL<br>POWDER TRANSFER<br>STERILE FULL FLAT<br>FERRULE BAG 4S01ELIR<br>DRAWING NO. SFFB1IR<br>HOSOKAWA (EXPO)<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.

UDIN00521586AM25

SFFB1IR HOSOKAWA (EXPO) Relevant, as per Packing Policy and General Notes. RA concerned may take further necessary action as per above decision of NC.||

UDIN00521586AM25

Case No.	Case No.	94 / NC/3/MEET/Dec/202425/12	94 / NC/3/MEET/Dec/202425/12	94 / NC/3/MEET/Dec/202425/12	94 / NC/3/MEET/Dec/202425/12	94 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001588AM25
RA File Number		31AX04000060 AM25
Licence No and<br>Date		3111003614/27/06/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2,6 Xylenol<br>1.02 kg.<br>2<br>Paraformaldehyde<br>0.13 kg.<br>3<br>Methanol<br>0.10 kg.<br>4<br>Epichlorohydrine<br>0.60 kg.<br>5<br>Sodium Hydroxide<br>0.228 kg.<br>6<br>Toluene<br>0.20 kg.<br>DNOVO BP 818 DGE<br>(Tetra Methyl Bisphenol F Diglycidyl<br>Ether)<br>1 kg.<br>7<br>Catalyst (Katalco-71.5)<br>0.004 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

7 Catalyst (Katalco-71.5) 0.004 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DNOVO BP 818 DGE (Tetra Methyl Bisphenol F Diglycidyl Ether)||1 kg.|1|2,6 Xylenol|1.02 kg.| |||||2|Paraformaldehyde|0.13 kg.| |||||3|Methanol|0.10 kg.| |||||4|Epichlorohydrine|0.60 kg.| |||||5|Sodium Hydroxide|0.228 kg.| |||||6|Toluene|0.20 kg.| |||||7|Catalyst (Katalco-71.5)|0.004 kg.| |||||above decision of NC.|||

Case No. 95 / NC/3/MEET/Dec/202425/12

UDIN00521586AM25

Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		UNIMAX LABORATORIES
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001659AM25
RA File Number		05AX04000808 AM25
Licence No and<br>Date		0511026070/01/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Mar/202223/26 dated 22/03/2024against<br>advance authorizationNo. 0511023881 dated 09/02/2024,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Azithromycin Tablets 250 mg USP ((Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)) 1 Number 1 Azithromycin Dihydrate USP 267.24 mg/Tablet Azithromycin Tablets 500 mg USP ((Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)) 1 Number 2 Azithromycin Dihydrate USP 534.48 mg/Tablet Azithromycin 250 mg & Lactic Acid Bacillus 60 Million Spores Tablets ((Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin and Lactic Acid Bacillus)) 1 Number 3 Azithromycin Dihydrate USP 267.24 mg/Tablet Azithromycin 500 mg & Lactic Acid Bacillus 60 Million Spores Tablets((Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin and Lactic Acid Bacillus)) 1 Number 4 Azithromycin Dihydrate USP 534.48 mg/Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Azithromycin Tablets 250 mg USP ((Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin))||1 Number|1|Azithromycin Dihydrate USP|267.24 mg/Tablet| ||Azithromycin Tablets 500 mg USP ((Each tablet contains : Azithromycin USP (As Dihydrate) Eq.

te) Eq. to Anhydrous Azithromycin))||1 Number|1|Azithromycin Dihydrate USP|267.24 mg/Tablet| ||Azithromycin Tablets 500 mg USP ((Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin))||1 Number|2|Azithromycin Dihydrate USP|534.48 mg/Tablet| ||Azithromycin 250 mg & Lactic Acid Bacillus 60 Million Spores Tablets ((Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin and Lactic Acid Bacillus))||1 Number|3|Azithromycin Dihydrate USP|267.24 mg/Tablet| ||Azithromycin 500 mg & Lactic Acid Bacillus 60 Million Spores Tablets((Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin and Lactic Acid Bacillus))||1 Number|4|Azithromycin Dihydrate USP|534.48 mg/Tablet|

UDIN00521586AM25

Ampicillin Capsules BP, 500 mg	1 Number	5	Ampicillin	585.282 mg./Capsule
((Each Capsules contains Ampicillin			Trihydrate BP
BP (As Trihydrate))

DIN00521586AM25

Ampicillin Capsules BP, 500 mg	1 Number	5	Ampicillin	585.282 mg./Capsule
((Each Capsules contains Ampicillin			Trihydrate BP
BP (As Trihydrate))

Case No.	Case No.	96 / NC/3/MEET/Dec/202425/12	96 / NC/3/MEET/Dec/202425/12	96 / NC/3/MEET/Dec/202425/12	96 / NC/3/MEET/Dec/202425/12	96 / NC/3/MEET/Dec/202425/12
Case Status		Case Approved
Party Name		BIODEAL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number		HQRNORM APPLY 00001661AM25
RA File Number		05AX04000889 AM25
Licence No and<br>Date		0511026379/01/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Sep/202324/14 dated 27/09/2024against<br>advance authorizationNo. 0511019975 dated 24/07/2023,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>NASAL SPRAY(MADE FROM<br>100 MCL SNAP ON PUMP WITH<br>ACTUATOR AND PROTECTION<br>CAP (BONA) BDL SPFN, PROD.<br>CODE CAP045, BONA REF NO.<br>BONA4P20892)<br>384000<br>Pieces<br>1<br>NASAL<br>ADAPTOR<br>NASAL SPRAY(MADE FROM<br>50 MCL SNAP ON PUMP WITH<br>ACTUATOR AND PROTECTION<br>CAP (BONA)<br>BDL SPFN, PROD.

CODE CAP045, BONA REF NO. BONA4P20892) 384000 Pieces 1 NASAL ADAPTOR NASAL SPRAY(MADE FROM 50 MCL SNAP ON PUMP WITH ACTUATOR AND PROTECTION CAP (BONA) BDL SPFN, PROD. CODE 192000 Pieces 2 NASAL ADAPTOR Relevant on Net to Net basis with accountability||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||NASAL SPRAY(MADE FROM 100 MCL SNAP ON PUMP WITH ACTUATOR AND PROTECTION CAP (BONA) BDL SPFN, PROD. CODE CAP045, BONA REF NO. BONA4P20892)|| 384000 Pieces|1|NASAL ADAPTOR|Relevant on Net to Net basis with accountability| ||NASAL SPRAY(MADE FROM 50 MCL SNAP ON PUMP WITH ACTUATOR AND PROTECTION CAP (BONA) BDL SPFN, PROD. CODE|| 192000 Pieces|2|NASAL ADAPTOR||

UDIN00521586AM25

CAP046, BONA REF NO. BONA4P20892)

Case No.	97 / NC/3/MEET/Dec/202425/12
Case Status	Case Approved
Party Name	KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001673AM25
RA File Number	03AX04001534 AM25
Licence No and<br>Date	0311035090/01/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Mar/202324/25dated11.03.2024against<br>advance authorizationNo. 0311029148 dated 16.12.2023,it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

tingNo. NC/3/MEET/Mar/202324/25dated11.03.2024against advance authorizationNo. 0311029148 **dated 16.12.2023,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Isobornyl Cyclohexanol 1 kg. 1 Gum Turpentine Oil 1.582 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	98 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024

UDIN00521586AM25

HQ File Number	HQRNORM APPLY 00001683AM25
RA File Number	52AX04000062 AM25
Licence No and<br>Date	5211008717/02/07/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	99 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001694AM25
RA File Number	52AX04000072 AM25
Licence No and<br>Date	5211008732/03/07/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|52AX04000072 AM25| |Licence No and Date|5211008732/03/07/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	100 / NC/3/MEET/Dec/202425/12
Case Status	Case Deferred
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 12 and 10/12/2024
HQ File Number	HQRNORM APPLY 00001713AM25
RA File Number	05AX04001073 AM25
Licence No and<br>Date	0511026456/03/07/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

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