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/Jun/202425/6 DATED: 01/07/2024

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 regards, full compliance of provisions of Para 4.12 of FTP, Para 4.16; Para 4.21 and Para 4.51 of HBP shall be made

mittee or as per wastages claimed in the application, whichever is less. In this regards, full compliance of 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/Jun/202425/6 dated 01/07/2024 of Norms Committee - III for the year 2024-25 was held on 01/07/2024 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 12-08-2024 12:47:02.

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

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00001088AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms and it has been observed<br>that the purchase orders submitted by the firm were not signed by anyone. Therefore, the Committee has<br>decided to seek clarification from the firm with the following information/documents:<br>Drug Manufacturing Licence (DML) showing approved composition.<br>1.<br>Master Batch Formula showing net content of all inputs.<br>2.

Case No.	2 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00001160AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms and it has been observed that<br>the purchase orders submitted by the firm were not signed by anyone, and it is not possible to know whether<br>these purchase orders were formally accepted by both parties. Therefore, the Committee has decided to<br>seek the clarification in this regard from the firm.

s not possible to know whether these purchase orders were formally accepted by both parties. Therefore, the Committee has decided to seek the clarification in this regard from the firm.||

Case No.	3 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

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and Date
HQ File Number	HQRNORM APPLY 00006267AM23
RA File Number	09AX04000893 AM23
Licence No and<br>Date	0911004453/13/02/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	Case No.	4 / NC/3/MEET/Jun/202425/6	4 / NC/3/MEET/Jun/202425/6	4 / NC/3/MEET/Jun/202425/6	4 / NC/3/MEET/Jun/202425/6	4 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		ANDHRA ORGANICS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00006448AM23
RA File Number		09AX04001032 AM23
Licence No and Date		0911004503/20/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2-N-PROPYL-4-METHYL-6-(1- METHYLBENZIMIDAZOLE-2-YL) BENZIMIDAZOLE 0.621 kg 2 2-CYANO-4- METHYLBIPHENYL(OTBN) 0.630 kg 3 Acetone 0.20 kg 4 Sodium Hydroxide Flakes 0.60 kg 5 n-Butanol 0.80 kg 6 Methanol 2.80 kg TELMISARTAN (TELMISARTAN) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TELMISARTAN (TELMISARTAN)||1 kg.|1|2-N-PROPYL-4-METHYL-6-(1- METHYLBENZIMIDAZOLE-2-YL) BENZIMIDAZOLE|0.621 kg| |||||2|2-CYANO-4- METHYLBIPHENYL(OTBN)|0.630 kg| |||||3|Acetone|0.20 kg| |||||4|Sodium Hydroxide Flakes|0.60 kg| |||||5|n-Butanol|0.80 kg| |||||6|Methanol|2.80 kg|

Case No.	Case No.	4 / NC/3/MEET/Jun/202425/6	4 / NC/3/MEET/Jun/202425/6	4 / NC/3/MEET/Jun/202425/6	4 / NC/3/MEET/Jun/202425/6	4 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		ANDHRA ORGANICS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00006448AM23
RA File Number		09AX04001032 AM23
Licence No and Date		0911004503/20/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

|| |Licence No and Date||0911004503/20/02/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2-N-PROPYL-4-METHYL-6-(1- METHYLBENZIMIDAZOLE-2-YL) BENZIMIDAZOLE 0.621 kg 2 2-CYANO-4- METHYLBIPHENYL(OTBN) 0.630 kg 3 Acetone 0.20 kg 4 Sodium Hydroxide Flakes 0.60 kg 5 n-Butanol 0.80 kg 6 Methanol 2.80 kg TELMISARTAN (TELMISARTAN) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TELMISARTAN (TELMISARTAN)||1 kg.|1|2-N-PROPYL-4-METHYL-6-(1- METHYLBENZIMIDAZOLE-2-YL) BENZIMIDAZOLE|0.621 kg| |||||2|2-CYANO-4- METHYLBIPHENYL(OTBN)|0.630 kg| |||||3|Acetone|0.20 kg| |||||4|Sodium Hydroxide Flakes|0.60 kg| |||||5|n-Butanol|0.80 kg| |||||6|Methanol|2.80 kg|

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7<br>Acetic Acid<br>0.89 kg<br>8<br>Potassium Hydroxide Flakes (KOH<br>flakes)<br>0.185 kg<br>9<br>Methylene Chloride<br>0.50 kg<br>RA concerned may take further necessary action as per above decision of NC.			7	Acetic Acid	0.89 kg
			8	Potassium Hydroxide Flakes (KOH<br>flakes)	0.185 kg
			9	Methylene Chloride	0.50 kg

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

|---|---|---|---|---|---| ||||8|Potassium Hydroxide Flakes (KOH flakes)|0.185 kg| ||||9|Methylene Chloride|0.50 kg|

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

Case No.	Case No.	5 / NC/3/MEET/Jun/202425/6	5 / NC/3/MEET/Jun/202425/6	5 / NC/3/MEET/Jun/202425/6	5 / NC/3/MEET/Jun/202425/6	5 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00006487AM23
RA File Number		09AX04001024 AM23
Licence No and<br>Date		0911004510/21/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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>1<br>Ethyl Trifluoro Acetate<br>1.71 kg<br>2<br>2,4,5-Tri fluoro phenyl acetic acid<br>0.86 kg<br>3<br>(R)-Phenyl ethyl amine<br>0.57 kg<br>4<br>Sodium borohydride<br>0.16 kg<br>5<br>Acetonitrile<br>1.14 kg<br>Sitagliptin<br>hydrochloride<br>(Pharmaceutical<br>product)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

orohydride 0.16 kg 5 Acetonitrile 1.14 kg Sitagliptin hydrochloride (Pharmaceutical product) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Sitagliptin hydrochloride (Pharmaceutical product)||1 kg.|1|Ethyl Trifluoro Acetate|1.71 kg| |||||2|2,4,5-Tri fluoro phenyl acetic acid|0.86 kg| |||||3|(R)-Phenyl ethyl amine|0.57 kg| |||||4|Sodium borohydride|0.16 kg| |||||5|Acetonitrile|1.14 kg|

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6<br>Methylene dichloride<br>9.30 kg<br>7<br>Isopropyl alcohol<br>4.52 kg<br>8<br>Methanol<br>4.29 kg<br>RA concerned may take further necessary action as per above decision of NC.			6	Methylene dichloride	9.30 kg
			7	Isopropyl alcohol	4.52 kg
			8	Methanol	4.29 kg

Case No.	6 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00006770AM23
RA File Number	03AX04005861 AM23
Licence No and<br>Date	0311021934/06/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was observed during the<br>Personal Hearing held on 05/03/2024 that they are getting many intermediates manufactured by their<br>supporting manufacturetr and details of for which was not given and the firm also could not explain the<br>confusion raised by the Committee in the yields claim in the process. The Committee has advised to<br>furnish the revised application.

which was not given and the firm also could not explain the confusion raised by the Committee in the yields claim in the process. The Committee has advised to furnish the revised application. However, the same still not received from the firm. Therefore, it was decided that the firm may be again advised to furnish the following documents as sought earlier: Revised Annexure to Appendix-4E 1. Revised Production/Consumption for the last three years certified by CA. 2.||

Case No.	7 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

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HQ File Number	HQ File Number	HQRNORM APPLY 00006807AM23	HQRNORM APPLY 00006807AM23	HQRNORM APPLY 00006807AM23	HQRNORM APPLY 00006807AM23	HQRNORM APPLY 00006807AM23
RA File Number		09AX04001097 AM23
Licence No and<br>Date		0911004646/08/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 DIHYDRONOPOL 0.66 kg 2 TOLUENE 1.915 kg 3 SODAMIDE 0.19 kg 4-(2-(2-(6,6-dimethylbicyclo [3.1.1] heptan-2-yl)ethoxy)ethyl) morpholine (intermediate) 1 kg. 4 METHANOL 0.56 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4-(2-(2-(6,6-dimethylbicyclo [3.1.1] heptan-2-yl)ethoxy)ethyl) morpholine (intermediate)|| 1 kg.|1|DIHYDRONOPOL|0.66 kg| |||||2|TOLUENE|1.915 kg| |||||3|SODAMIDE|0.19 kg| |||||4|METHANOL|0.56 kg| |||||per above decision of NC.|||

Case No.	8 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00000093AM24
RA File Number	03AX04000048 AM24
Licence No and<br>Date	0311022711/11/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and 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:-

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Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
ETHYL ISOBUTYRATE	1 kg.	1	ISOBUTYRIC ACID	0.948 kg

ever is less:-||

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Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
ETHYL ISOBUTYRATE	1 kg.	1	ISOBUTYRIC ACID	0.948 kg

Case No.	9 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00000292AM24
RA File Number	03AX04000045 AM24
Licence No and<br>Date	0311022935/19/04/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	10 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00000325AM24
RA File Number	03AX04000169 AM24
Licence No and<br>Date	0311022998/21/04/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

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0169 AM24| |Licence No and Date|0311022998/21/04/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

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Case No.	Case No.	11 / NC/3/MEET/Jun/202425/6	11 / NC/3/MEET/Jun/202425/6	11 / NC/3/MEET/Jun/202425/6	11 / NC/3/MEET/Jun/202425/6	11 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM REVIW00004946AM24
RA File Number		03AX04000416 AM24
Licence No and Date		0311023239/01/05/2023
Norms Committee Decisio		n:

The Committee consi<br>		ered the case as per agenda and it was decided to revise 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:-
Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>HYDROQUINONE<br>0.66 kg<br>YAPOX CL 30/10<br>"HYDROQUINONE BIS"(2<br>HYDROXY ETHYL ETHER)<br>1 kg.<br>2<br>ETHYLENE<br>CARBONATE<br>1.05 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

2 ETHYLENE CARBONATE 1.05 kg RA concerned may take further necessary action as per above decision of NC.|||||||||| |||Export Product||Qty.|Sl. No.||Import Items|Qty. allowed.|| |||YAPOX CL 30/10||1 kg.|1||HYDROQUINONE|0.66 kg|| |||"HYDROQUINONE BIS"(2 HYDROXY ETHYL ETHER)|||||||| ||||||2||ETHYLENE||1.05 kg| ||A concerned may take further necessary||||||CARBONATE||| |||||action as|per abo|ve decision of NC.|||| ||||||||||| |||||||||||

Case No.	12 / NC/3/MEET/Jun/202425/6	12 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD

Meeting Number<br>and Date	NC/ 3/ MEE	T/ Jun/ 202425/ 6 and 01/07/2024

HQ File Number	HQRNORM	APPLY 00002509AM24

RA File Number	08AX040005	10 AM24

Licence No and
<br>Date	0811008516/	26/06/2023

Norms Committee Decision:

The Committee considered the case as per agenda and 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:-

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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:-||| ||||

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Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Nystatin Cream USP,<br>100000 units/gm,<br>15gm (15gm<br>Tube)(Each gram<br>Contains: 100,000 USP<br>Nystatin Units in an<br>aqueous, cream base.<br>30000<br>Numbers<br>1<br>Nystatin (Nystatin Micronized)<br>7.37 kg<br>Nystatin Cream USP,<br>100000 units/gm,<br>30gm (30gm Tube)<br>(Each gram Contains:<br>100,000 USP Nystatin<br>Units in<br>anaqueous, cream base.<br>620000<br>Numbers<br>2<br>Nystatin (Nystatin Micronized)<br>304.53 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Nystatin Cream USP,<br>100000 units/gm,<br>15gm (15gm<br>Tube)(Each gram<br>Contains: 100,000 USP<br>Nystatin Units in an<br>aqueous, cream base.	<br>30000<br>Numbers	1	Nystatin (Nystatin Micronized)	7.37 kg
	Nystatin Cream USP,<br>100000 units/gm,<br>30gm (30gm Tube)<br>(Each gram Contains:<br>100,000 USP Nystatin<br>Units in<br>anaqueous, cream base.	620000<br>Numbers	2	Nystatin (Nystatin Micronized)	304.53 kg

Case No.	Case No.	13 / NC/3/MEET/Jun/202425/6	13 / NC/3/MEET/Jun/202425/6	13 / NC/3/MEET/Jun/202425/6	13 / NC/3/MEET/Jun/202425/6	13 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00002572AM24
RA File Number		08AX04000392 AM24
Licence No and Date		0811008526/26/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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>MYCOPHENOLATE<br>MYCOPHENOLATE MOFETIL EP /<br>1 Number<br>1<br>255.00 mg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	MYCOPHENOLATE		1 Number	1	MYCOPHENOLATE MOFETIL EP /	<br>255.00 mg

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1 255.00 mg||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||MYCOPHENOLATE||1 Number|1|MYCOPHENOLATE MOFETIL EP /| 255.00 mg|

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MOFETIL CAPSULES<br>250MG (EACH HARD<br>GELATIN CAPSULE<br>CONTAINS:<br>MYCOPHENOLATE<br>MOFETIL<br>PH.<br>EUR.<br>250MG)<br>BP / IP / USP / PH. EUR.<br>MYCOPHENOLATE<br>MOFETIL TABLETS<br>500MG(EACH FILM<br>COATED TABLET<br>CONTAINS:<br>MYCOPHENOLATE<br>MOFETIL PH. EUR.<br>500MG)<br>1 Number<br>2<br>MYCOPHENOLATE MOFETIL EP /<br>BP / IP / USP / PH. EUR.<br>510.00 mg<br>RA concerned may take further necessary action as per above decision of NC.	MOFETIL CAPSULES<br>250MG (EACH HARD<br>GELATIN CAPSULE<br>CONTAINS:<br>MYCOPHENOLATE<br>MOFETIL<br>PH.<br>EUR.<br>250MG)			BP / IP / USP / PH. EUR.
	MYCOPHENOLATE<br>MOFETIL TABLETS<br>500MG(EACH FILM<br>COATED TABLET<br>CONTAINS:<br>MYCOPHENOLATE<br>MOFETIL PH. EUR.<br>500MG)	1 Number	2	MYCOPHENOLATE MOFETIL EP /<br>BP / IP / USP / PH. EUR.	<br>510.00 mg

Case No.	Case No.	14 / NC/3/MEET/Jun/202425/6	14 / NC/3/MEET/Jun/202425/6	14 / NC/3/MEET/Jun/202425/6	14 / NC/3/MEET/Jun/202425/6	14 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00002683AM24
RA File Number		08AX04000542 AM24
Licence No and Date		0811008532/27/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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>INDAPAMIDESR1.5MG TABLETS<br>(INDAPAMIDEHEUMANN1.5MG)<br>1 Number<br>1<br>INDAPAMIDE EP<br>1.53 mg /<br>Tablet
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	INDAPAMIDESR1.5MG TABLETS<br>(INDAPAMIDEHEUMANN1.5MG)		1 Number	1	INDAPAMIDE EP	1.53 mg /<br>Tablet

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Product**||Qty.|Sl. No.|Import Items|Qty. allowed.| ||INDAPAMIDESR1.5MG TABLETS (INDAPAMIDEHEUMANN1.5MG)||1 Number|1|INDAPAMIDE EP|1.53 mg / Tablet|

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(EACH FILM COATED SUSTAINED<br>RELEASE TABLET CONTAINS:<br>INDAPAMIDE PH. EUR. 1.5MG.<br>INDAPAMIDE HEMIHYDRATE<br>TABLETS 2.5 MG (INDAPAMIDE<br>HEMIHYDRATE 2.5 MG<br>EQUIVALENT TO INDAPAMIDE 2.44<br>MG) (EACH FILM COATED TABLET<br>CONTAINS : INDAPAMIDE<br>HEMIHYDRATE PH. EUR. 2.5 MG<br>EQUIVALENT TO INDAPAMIDE 2.44<br>MG<br>1 Number<br>2<br>INDAPAMIDE EP<br>2.55 mg /<br>Tablet<br>RA concerned may take further necessary action as per above decision of NC.	(EACH FILM COATED SUSTAINED<br>RELEASE TABLET CONTAINS:<br>INDAPAMIDE PH. EUR. 1.5MG.
	INDAPAMIDE HEMIHYDRATE<br>TABLETS 2.5 MG (INDAPAMIDE<br>HEMIHYDRATE 2.5 MG<br>EQUIVALENT TO INDAPAMIDE 2.44<br>MG) (EACH FILM COATED TABLET<br>CONTAINS : INDAPAMIDE<br>HEMIHYDRATE PH. EUR. 2.5 MG<br>EQUIVALENT TO INDAPAMIDE 2.44<br>MG	1 Number	2	INDAPAMIDE EP	2.55 mg /<br>Tablet

Case No.	Case No.	15 / NC/3/MEET/Jun/202425/6	15 / NC/3/MEET/Jun/202425/6	15 / NC/3/MEET/Jun/202425/6	15 / NC/3/MEET/Jun/202425/6	15 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00002734AM24
RA File Number		34AX04000232 AM24
Licence No and<br>Date		3411003838/27/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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>Dorzolamide Hydrochloride and<br>Timolol Maleate Ophthalmic<br>Solution, USP 2% & 0.5% - 10<br>ML(Dorzolamide<br>1 Number<br>1<br>Timolol Maleate USP<br>69.67 mg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Dorzolamide Hydrochloride and<br>Timolol Maleate Ophthalmic<br>Solution, USP 2% & 0.5% - 10<br>ML(Dorzolamide		1 Number	1	Timolol Maleate USP	69.67 mg

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*Qty. allowed.**| ||Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP 2% & 0.5% - 10 ML(Dorzolamide||1 Number|1|Timolol Maleate USP|69.67 mg|

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Hydrochloride<br>and<br>Timolol<br>Maleate Ophthalmic Solution, USP<br>2% & 0.5% - 10 ML.	<br>
Brimonidine Tartrate and Timolol<br>Maleate Ophthalmic solution 0.2%<br>& 0.5% - 5 ML	1 Number	2	Timolol Maleate USP	34.68 mg
Brimonidine Tartrate and Timolol<br>Maleate Ophthalmic solution 0.2%<br>& 0.5% -10 ML	1 Number	3	Timolol Maleate USP	69.36 mg
Brimonidine Tartrate and Timolol<br>Maleate Ophthalmic solution 0.2%<br>& 0.5% - 15 ML	1 Number	4	Timolol Maleate USP	104.04 mg

ution 0.2% & 0.5% -10 ML|1 Number|3|Timolol Maleate USP|69.36 mg| ||Brimonidine Tartrate and Timolol Maleate Ophthalmic solution 0.2% & 0.5% - 15 ML|1 Number|4|Timolol Maleate USP|104.04 mg| ||Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% - 5 ML|1 Number|5|Timolol Maleate USP|34.68 mg| ||Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% - 5 ML|1 Number|6|Timolol Maleate USP|17.34 mg|

Case No.	16 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00002856AM24
RA File Number	03AX04001411 AM24
Licence No and<br>Date	0311024954/28/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para

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

Sl. No	Export Product<br>	Quantity
1	Medical Cream, Ointment, Gel (Mycospor 1% Cream 10 Gm (Tot Wt: 1000Kgs.<br>Net Cont: Bifonazole JP 10 Kgs, Octyldodecanol JP 135 Kgs, Sorbitan<br>Monostearate JP 20 Kgs, Aluminium Tubes 100,000 Nos))<br>	1 Number

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

Case No.	Case No.	17 / NC/3/MEET/Jun/202425/6	17 / NC/3/MEET/Jun/202425/6	17 / NC/3/MEET/Jun/202425/6	17 / NC/3/MEET/Jun/202425/6	17 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		TERBOL LABORATORIES PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00002865AM24
RA File Number		07AX04000446 AM24
Licence No and Date		0711008410/28/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

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NIFUROXAZIDE CAPSULES<br>200MG - "ENTEROCOLIN<br>200MG"(NIFUROXAZIDE<br>CAPSULES 200MG -<br>"ENTEROCOLIN 200MG" 475500<br>NOS)<br>1 Number<br>Capsules<br>1<br>NIFUROXAZIDE BP<br>204 mg/Capsules<br>RA concerned may take further necessary action as per above decision of NC.	NIFUROXAZIDE CAPSULES<br>200MG - "ENTEROCOLIN<br>200MG"(NIFUROXAZIDE<br>CAPSULES 200MG -<br>"ENTEROCOLIN 200MG" 475500<br>NOS)	<br>1 Number<br>Capsules	1	NIFUROXAZIDE BP	204 mg/Capsules

Case No.	18 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	LINCOLN PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00002874AM24
RA File Number	08AX04000490 AM24
Licence No and Date	0811008569/28/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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>ALENDRONATE SODIUM<br>TABLETS USP 70 MG<br>(ALENDRONATE SODIUM<br>TABLETS USP 70 MG<br>(PACKING1x4<br>= 4 NOS IN EACH PACK.)<br>1 Number<br>1<br>SODIUM<br>ALENDRONATE<br>TRIHYDRATE<br>93.19 mg<br>RA concerned may take further necessary action as per above decision of NC.

70 MG (PACKING1x4 = 4 NOS IN EACH PACK.) 1 Number 1 SODIUM ALENDRONATE TRIHYDRATE 93.19 mg RA concerned may take further necessary action as per above decision of NC.||

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Case No.	19 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00002880AM24
RA File Number	03AX04001433 AM24
Licence No and Date	0311024964/28/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202324/20 dated 18/01/2024against advance<br>authorizationNo.0311016485 dated 21.07.2022, 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>1<br>2 Fluro Aniline<br>0.66 kg<br>2<br>Ethyl chloroformate<br>0.55 kg<br>3<br>Ethyl 3 amino -4,4,4<br>triflurocrotonate<br>0.66 kg<br>4<br>Potassium carbonate<br>0.31 kg<br>3-(4-CHLORO-2-FLUORO-<br>5-MERCAPTO-PHENYL)-1-<br>METHYL-6-<br>TRIFLOUOROMETHYL-1H-<br>PYRIMIDINE-<br>2,4-DIONE<br>TECHNICAL<br>(PDSH)<br>1 Kg<br>5<br>Dimethyl Formamide<br>Deleted (not given in<br>production/consumption<br>data & also not a main<br>reactant)<br>RA concerned may take further necessary action as per above decision of NC.

r>5 Dimethyl Formamide Deleted (not given in production/consumption data & also not a main reactant) RA concerned may take further necessary action as per above decision of NC.||

Case No.	20 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved

UDIN00350282AM25

Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00003111AM24
RA File Number	09AX04000258 AM24
Licence No and Date	0911005298/30/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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>2-CHLORO-5-<br>METHYLPYRIDINE-4-AMINE<br>1 Kg<br>1<br>2 CHLORO 5<br>METHYLPYRIDINE<br>1.80 kg<br>RA concerned may take further necessary action as per above decision of NC.

Qty. allowed. 2-CHLORO-5- METHYLPYRIDINE-4-AMINE 1 Kg 1 2 CHLORO 5 METHYLPYRIDINE 1.80 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	21 / NC/3/MEET/Jun/202425/6	21 / NC/3/MEET/Jun/202425/6	21 / NC/3/MEET/Jun/202425/6	21 / NC/3/MEET/Jun/202425/6	21 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		BROOKS STERISCIENCE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00003176AM24
RA File Number		34AX04000101 AM24
Licence No and<br>Date		3411003857/30/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202324/26 dated 22/03/2024against advance<br>authorizationNo.0811010864 dated 26.02.2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Meropenem for Injection USP<br>Sterile Meropenem with<br>1.29 gm/1 gm<br>1 Number<br>1
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Meropenem for Injection USP		<br>1 Number	1	Sterile Meropenem with	1.29 gm/1 gm

UDIN00350282AM25

1||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Meropenem for Injection USP|| 1 Number|1|Sterile Meropenem with|1.29 gm/1 gm|

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1000 mg			Sodium Carbonate USP	Injection
Meropenem for Injection USP	<br>1 Number	2	Sterile Meropenem with	0.645 gm/500 mg
500 mg			Sodium Carbonate USP	Injection

Case No.	Case No.	22 / NC/3/MEET/Jun/202425/6	22 / NC/3/MEET/Jun/202425/6	22 / NC/3/MEET/Jun/202425/6	22 / NC/3/MEET/Jun/202425/6	22 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00003181AM24
RA File Number		08AX04000522 AM24
Licence No and Date		0811008584/30/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo. NC/3/MEET/Mar/202324/26 dated 22/03/2024against advance authorization<br>No.0811010864 dated 26.02.2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>MITOXANTRONE<br>CONCENTRATE FOR SOLUTION<br>FOR INFUSION 2MG/ML, 5ML<br>VIAL<br>1 Number<br>1<br>MITOXANTRONE<br>HYDROCHLORIDE EP / BP /<br>IP / USP / PH.

. No. Import Items** Qty. allowed. MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUSION 2MG/ML, 5ML VIAL 1 Number 1 MITOXANTRONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR. (Water + Residual Solvent NLT 3.56%) 13.27 mg MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUISON 2MG/ML, 10 ML VIAL 1 Number 2 MITOXANTRONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR. (Water + Residual Solvent NLT 3.56%) 26.54 mg MITOXANTRONE MITOXANTRONE 1 Number 3 38.01 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUSION 2MG/ML, 5ML VIAL||1 Number|1|MITOXANTRONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR. (Water + Residual Solvent NLT 3.56%)| 13.27 mg| ||MITOXANTRONE CONCENTRATE FOR SOLUTION FOR INFUISON 2MG/ML, 10 ML VIAL||1 Number|2|MITOXANTRONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR. (Water + Residual Solvent NLT 3.56%)| 26.54 mg| ||MITOXANTRONE||1 Number|3|MITOXANTRONE|38.01 mg|

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CONCENTRATE FOR SOLUTION<br>FOR INFUSION 2MG/ML, 15 ML<br>VIAL<br>HYDROCHLORIDE EP / BP /<br>IP / USP / PH. EUR.<br>(Water + Residual Solvent NLT<br>3.56%)<br>RA concerned may take further necessary action as per above decision of NC.	CONCENTRATE FOR SOLUTION<br>FOR INFUSION 2MG/ML, 15 ML<br>VIAL			HYDROCHLORIDE EP / BP /<br>IP / USP / PH. EUR.<br>(Water + Residual Solvent NLT<br>3.56%)

ision of NC.	CONCENTRATE FOR SOLUTION<br>FOR INFUSION 2MG/ML, 15 ML<br>VIAL			HYDROCHLORIDE EP / BP /<br>IP / USP / PH. EUR.<br>(Water + Residual Solvent NLT<br>3.56%)

Case No.	23 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00003729AM24
RA File Number	03AX04001457 AM24
Licence No and<br>Date	0311025050/03/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo. NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance<br>authorizationNo.0311026873 dated 04/09/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Agomelatine Citric Acid Co-Crystal<br>1 Kg<br>1<br>(7-METHOXY 1 NAPHTHYL)<br>ACETONITRILE<br>0.60 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	24 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED

UDIN00350282AM25

urther necessary action as per above decision of NC.||

Case No.	24 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED

UDIN00350282AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00003730AM24
RA File Number	03AX04001458 AM24
Licence No and<br>Date	0311025051/03/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Naftidrofuryl Hydrogen Oxalate<br>1868 Kg<br>1<br>Naftidrofuryl Hydrogen Oxalate Seed<br>18 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	25 / NC/3/MEET/Jun/202425/6	25 / NC/3/MEET/Jun/202425/6	25 / NC/3/MEET/Jun/202425/6	25 / NC/3/MEET/Jun/202425/6	25 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00003736AM24
RA File Number		03AX04001505 AM24
Licence No and<br>Date		0311025060/03/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

|Licence No and Date||0311025060/03/07/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Doxorubicin Hydrochloride for Inj. BP 50 MG 1 Number 1 Doxorubicin Hydrochloride IP/BP 52.00 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxorubicin Hydrochloride for Inj. BP 50 MG|| 1 Number|1|Doxorubicin Hydrochloride IP/BP|52.00 mg|

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Case No.	Case No.	26 / NC/3/MEET/Jun/202425/6	26 / NC/3/MEET/Jun/202425/6	26 / NC/3/MEET/Jun/202425/6	26 / NC/3/MEET/Jun/202425/6	26 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		KLJ PLASTICIZERS LIMITED.
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00003758AM24
RA File Number		05AX04000871 AM24
Licence No and Date		0511019606/03/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 PHTHALIC ANHYDRIDE 0.472 kg 2 CYCLOHEXANOL 0.639 kg DI CYCLO HEXYL PHTHALATE (DCHP) (DI CYCLO HEXYL PHTHALATE (DCHP) (PACKED IN 909 NOS. OF HM-HDPE DRUMS MADE OF HDPE GRANULES 1 Kg 3 HDPE GRANULES As per packing policy and General Notes. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||DI CYCLO HEXYL PHTHALATE (DCHP) (DI CYCLO HEXYL PHTHALATE (DCHP) (PACKED IN 909 NOS. OF HM-HDPE DRUMS MADE OF HDPE GRANULES||1 Kg|1|PHTHALIC ANHYDRIDE|0.472 kg| |||||2|CYCLOHEXANOL|0.639 kg| |||||3|HDPE GRANULES|As per packing policy and General Notes.| |||||action as per above decision of NC.|||

Case No.	27 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00003937AM24
RA File Number	05AX04000876 AM24

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Licence No and 0511019620/04/07/2023 Date Norms Committee Decision:

UDIN00350282AM25

Licence No and 0511019620/04/07/2023 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Apr/202425/2 dated 30/04/2024 against advance authorization No.0511019120 datesd 01.06.2023 it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Levetiracetam 500 mg tablets	1 Tablet	1	Levetiracetam	510 mg/tablet
Levetiracetam 1000 mg tablets	1 Tablet	2	Levetiracetam	1020 mg/tablet

Case No.	28 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004115AM24
RA File Number	52AX04000093 AM24
Licence No and<br>Date	5211005099/05/07/2023

| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024| |HQ File Number|HQRNORM APPLY 00004115AM24| |RA File Number|52AX04000093 AM24| |Licence No and Date|5211005099/05/07/2023| |Norms Committee Decision: The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- To give justification for low yield of formation of intermediate Semicarbazide HCL from Hydrazine Hydrate 64%. 1. Calculation for the requirement of all the raw materials based on yield of the reaction separately at each stage. 2.||

UDIN00350282AM25

Case No.	29 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004117AM24
RA File Number	08AX04000578 AM24
Licence No and<br>Date	0811008606/05/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and 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.<br>VINORELBINE CONCENTRATE FOR<br>SOLUTION FOR INFUSION 10MG/ML,<br>1ML VIAL(EACH ML CONTAINS:<br>VINORELBINE TARTRATE PH.EUR<br>EQ. TO VINORELBINE 10 MG)<br>1 Vial<br>1<br>VINORELBINE TARTRATE EP<br>/ BP / IP / USP / PH.

RATE FOR SOLUTION FOR INFUSION 10MG/ML, 1ML VIAL(EACH ML CONTAINS: VINORELBINE TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG) 1 Vial 1 VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR 13.80 mg VINORELBINE CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML, 5ML VIAL(EACH ML CONTAINS: VINORELBINE TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG) 1 Vial 2 VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR 69.00 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	30 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004222AM24

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RA File Number	09AX04000297 AM24
Licence No and<br>Date	0911005327/06/07/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

umber	09AX04000297 AM24
Licence No and<br>Date	0911005327/06/07/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	31 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	BULI CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004235AM24
RA File Number	03AX04001475 AM24
Licence No and<br>Date	0311025181/06/07/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>To indicate the exact percentage of Hexane in export item, because the requirement of raw<br>materials will be different in different concentration.<br>1.<br>Complete chemical reaction of reactant and product indicating molecular weight of each<br>chemical and yield of the reaction and accordingly calculate the requirement.<br>2.<br>The commercial value of by-product Lithium Chloride, supported by invoices.<br>3.<br>Stoichiometric material balance of the reaction.<br>4.<br>To indicate indigenous items in Annexure to Appendixt-4E.<br>5.

f by-product Lithium Chloride, supported by invoices.** 3. Stoichiometric material balance of the reaction. 4. To indicate indigenous items in Annexure to Appendixt-4E. 5.||

Case No.	32 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004244AM24
RA File Number	09AX04000203 AM24
Licence No and<br>Date	0911005339/06/07/2023
Norms Committee Decision:

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

Exact specification of export product whether 15% or 23 % or 30%

Case No.	33 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004246AM24
RA File Number	34AX04000258 AM24
Licence No and<br>Date	3411003871/06/07/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master-Batch formula showing net content of inputs in the export item.

as per the advise of the TE, it was decided to call for following information/documents from the firm:- Copy of Master-Batch formula showing net content of inputs in the export item.||

Case No.	34 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	VISWAAT CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004250AM24
RA File Number	03AX04001561 AM24
Licence No and<br>Date	0311025198/06/07/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-

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Step wise manufacturing process.
i.
ii. Complete chemical reactions with molecular and structural formula and molecular weight alongwith stage wise percentage yield on molar basis.
iii. All technical details as per annexure to appendix 4E for chemical products.
iv. Stichometric balance between import and export on molar basis.
v. Details of indigenous input with quantity.

ical details as per annexure to appendix 4E for chemical products.**

iv. Stichometric balance between import and export on molar basis.
v. Details of indigenous input with quantity.

Case No.	Case No.	35 / NC/3/MEET/Jun/202425/6	35 / NC/3/MEET/Jun/202425/6	35 / NC/3/MEET/Jun/202425/6	35 / NC/3/MEET/Jun/202425/6	35 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00004286AM24
RA File Number		09AX04000315 AM24
Licence No and<br>Date		0911005356/07/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Phytonadione USP 97% assay<br>1.134 mg<br>2<br>HYPAK BSCF1MLL W4023<br>FLUR DAIKYO LID Stoppers<br>Relevant as per<br>packing policy and<br>General Notes.<br>Phytonadione Injectable<br>Emulsion USP 1 mg/0.5ML<br>1 Number<br>3<br>HYPAK SCF1MLL 27GA1/2IN-<br>5B P136 RNS4800 Syringe<br>Barrel<br>Relevant as per<br>packing policy and<br>General Notes.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

as per packing policy and General Notes. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Phytonadione Injectable Emulsion USP 1 mg/0.5ML||1 Number|1|Phytonadione USP 97% assay|1.134 mg| |||||2|HYPAK BSCF1MLL W4023 FLUR DAIKYO LID Stoppers|Relevant as per packing policy and General Notes.| |||||3|HYPAK SCF1MLL 27GA1/2IN- 5B P136 RNS4800 Syringe Barrel|Relevant as per packing policy and General Notes.| |||||as per above decision of NC.|||

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Case No.	36 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004299AM24
RA File Number	03AX04001599 AM24
Licence No and<br>Date	0311025255/10/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Doxorubicin Hydrochloride for Inj. BP<br>50 MG<br>1 Vial<br>1<br>Doxorubicin Hydrochloride IP/BP<br>55 mg/vial<br>RA concerned may take further necessary action as per above decision of NC.

* Doxorubicin Hydrochloride for Inj. BP 50 MG 1 Vial 1 Doxorubicin Hydrochloride IP/BP 55 mg/vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	37 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004401AM24
RA File Number	34AX04000275 AM24
Licence No and<br>Date	3411003884/13/07/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	38 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred

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Party Name	SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004404AM24
RA File Number	31AX04000095 AM24
Licence No and<br>Date	3111002460/13/07/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of DML for Export item.<br>1.<br>Copy of Master-Batch formula.<br>2.

nd as per the advise of the TE, it was decided to call for following information/documents from the firm:- Copy of DML for Export item. 1. Copy of Master-Batch formula. 2.||

Case No.	39 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004433AM24
RA File Number	03AX04001604 AM24
Licence No and<br>Date	0311025397/14/07/2023
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms and it has been observed<br>that the purchase orders submitted by the firm were not signed by anyone, and it is not possible to know<br>whether these purchase orders were formally accepted by both parties. Therefore, the Committee has<br>decided to seek the clarification in this regard from the firm.

Case No.	40 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004440AM24
RA File Number	03AX04001669 AM24
Licence No and Date	0311025403/14/07/2023
Norms Committee Decision:

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AM24| |Licence No and Date|0311025403/14/07/2023| |Norms Committee Decision:||

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The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Dec/202324/19 dated 05/01/2024 against advance authorization No.0311019551 dated 28/11/2022 it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
OLMESARTAN<br>MEDOXOMIL	1 Kg	1	4-(1-HYDROXY-1-METHYL ETHYL)-2-PROPYL-1H-<br>IMIDAZOLE 5-CARBOXYLIC ACID ETHYL ESTER	0.70 kg
		2	5-(4-BROMOMETHYL) (1,-<br>BROMOMETHYLIPHENYL)-2YL TRIPHENYL-1-H<br>TETRAZOLE; 5-(4-BROMOMETHYL BIPHENYL-2-<br>YL)-1-TRITYL-1H-TET	1.35 kg
		3	4-CHLOROMETHYL-5-METHYL 1,3-DIOXOLEN-2-<br>ONE	0.426 kg
		4	ACETIC ACID GLACIAL	0.60 kg
		5	ACETONE	3.00 kg
		6	METHANOL	2.60 kg
		7	TOLUENE	1.00 kg

Case No.	41 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004443AM24
RA File Number	03AX04001084 AM24

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Licence No and 0311025417/14/07/2023 Date Norms Committee Decision:

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

AX04001084 AM24|

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Licence No and 0311025417/14/07/2023 Date Norms Committee Decision:

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

Case No.	42 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	BROOKS STERISCIENCE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004445AM24
RA File Number	34AX04000271 AM24
Licence No and<br>Date	3411003892/14/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202324/26 dated 22/03/2024against advance<br>authorizationNo.0811010864 dated 26/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Meropenem for Injection USP<br>1000 mg<br>1 Number<br>1<br>Sterile Meropenem with<br>Sodium Carbonate USP<br>1.29 gm/1 gm<br>Injection<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	43 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004448AM24

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RA File Number	07AX04000507 AM24
Licence No and<br>Date	0711008721/14/07/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Export quantity to be given in Numbers in the Advance Authorization.

Case No.	44 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004482AM24
RA File Number	34AX04000293 AM24
Licence No and<br>Date	3411003888/18/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and 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>Betahistine Dihydrochloride<br>1 Kg<br>1<br>Pyridine 2 Ethanol<br>0.852 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	45 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

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5 / NC/3/MEET/Jun/202425/6| |---|---| |Case Status|Case Approved| |Party Name|SOHAN HEALTHCARE PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024|

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and Date
HQ File Number	HQRNORM APPLY 00004538AM24
RA File Number	31AX04000105 AM24
Licence No and<br>Date	3111002491/20/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>METFORMIN HYDROCHLORIDE<br>DIRECT COMPRESSIBLE<br>GRANULES 95% W/W<br>WHITE GRANULES POWDER<br>1 Kg<br>1<br>DICYANDIAMIDE<br>( DCDA) WHITE POWDER<br>0.530 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	46 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ELPPE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004593AM24
RA File Number	03AX04001792 AM24
Licence No and<br>Date	0311025670/24/07/2023

| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024| |HQ File Number|HQRNORM APPLY 00004593AM24| |RA File Number|03AX04001792 AM24| |Licence No and Date|0311025670/24/07/2023| |Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Chemical reaction of the process, indicating molecular weight of both reactants & products with stage wise and overall yield of the reaction. 1. End use of Export item. 2. Production of the export item vis-à-vis consumption of the raw materials for the last three 3.||

UDIN00350282AM25

years duly certified by CA.

Case No.	47 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004622AM24
RA File Number	05AX04001146 AM24
Licence No and<br>Date	0511020026/25/07/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage Yield of Reaction.

Case No.	48 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004626AM24
RA File Number	52AX04000117 AM24
Licence No and<br>Date	5211005254/25/07/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Name of the Bulk drug produced from the export item i.e a drug intermediate.<br>1.<br>Norms applied for Import item no.1 does not match with the yield given.<br>2.<br>Requirement and Recovery of Import iten no. 2 and no. 3 and their sale value if not recovered<br>with documentary evidence.<br>3.

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d their sale value if not recovered** with documentary evidence. 3.||

33 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

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Case No.	49 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004640AM24
RA File Number	03AX04001848 AM24
Licence No and<br>Date	0311025745/25/07/2023
Norms Committee Decision:
The case is under consideration and TE was requested to expedite their comments.

Case No.<br>50 / NC/3/MEET/Jun/202425/6
Case Status<br>Case Approved
Party Name<br>PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number<br>HQRNORM APPLY 00004654AM24
RA File Number<br>08AX04000710 AM24
Licence No and<br>Date<br>0811008720/26/07/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	**Qty.

ix ad-hoc norms under Para 4.07 of HBP||||| |Vol. I as per details given below or as applied by the firm, whichever is less:-||||| |Export Product Qty.|**Sl. No. **|Import Items|Qty. allowed.|| |Calcium Gluconate in Sodium Chloride 1 Number|1|CALCIUM GLUCONATE|1029.00 mg|| |Injection, 20 mg/mL||MONOHYDRATE USP||| |(1000 mg/50 mL)||||| |Calcium Gluconate in Sodium Chloride 1 Number|2|CALCIUM GLUCONATE|2058.00 mg|| |Injection, 20 mg/mL||MONOHYDRATE USP|||

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(2000 mg/100 mL)

Case No.	51 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004659AM24
RA File Number	03AX04001873 AM24
Licence No and<br>Date	0311025786/27/07/2023
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms and it has been observed that<br>the purchase orders submitted by the firm were not signed by anyone, and it is not possible to know whether<br>these purchase orders were formally accepted by both parties. Therefore, the Committee has decided to<br>seek the clarification in this regard from the firm.

s not possible to know whether these purchase orders were formally accepted by both parties. Therefore, the Committee has decided to seek the clarification in this regard from the firm.||

Case No.	52 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004677AM24
RA File Number	34AX04000343 AM24
Licence No and<br>Date	3411003955/27/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00350282AM25

|Export Product Qty. Sl. No. Import Items Qty. allowed. Metronidazole Gel Usp 1% 55 gm pump(Metronidazole Gel Usp 1% 55 gm pump 50000 Numbers 1 Metronidazole (Micronized) USP 28.05 kg Metronidazole Gel Usp 1% 60 gm tube(Metronidazole Gel Usp 1% 60 gm tube 120000 Numbers 2 Metronidazole (Micronized) USP 73.44 kg RA concerned may take further necessary action as per above decision of NC.|Export Product|Qty.|Sl. No.|Import Items|**Qty.

rs<br>2<br>Metronidazole<br>(Micronized) USP<br>73.44 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Metronidazole Gel Usp 1% 55 gm<br>pump(Metronidazole Gel Usp 1% 55<br>gm pump	50000 Numbers	1	Metronidazole<br>(Micronized) USP	28.05 kg
	Metronidazole Gel Usp 1% 60 gm<br>tube(Metronidazole Gel Usp 1% 60<br>gm tube	120000<br>Numbers	2	Metronidazole<br>(Micronized) USP	73.44 kg

Case No.	53 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004700AM24
RA File Number	09AX04000394 AM24
Licence No and<br>Date	0911005507/28/07/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments.

Case No.	54 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	KELVIN NATURAL MINT PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004732AM24
RA File Number	05AX04001031 AM24
Licence No and<br>Date	0511019800/31/07/2023
Norms Committee Decision:

UDIN00350282AM25

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

N00350282AM25

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

Percentage composition of Export product. 2. COA of import item from foreign supplier.

Case No.	55 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	NIFTY LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004736AM24
RA File Number	09AX04000399 AM24
Licence No and<br>Date	0911005517/31/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo. NC/3/MEET/Jan/202324/20 dated 18/01/2024against advance authorization<br>No.0911003436 dated 03.08.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Thiophenol<br>0.59 kg<br>2<br>Hydrazien Hydrate 64%<br>0.688 kg<br>N-[dibenzo [b,f] [1,4] thiazepin -11-YL]<br>piperazine Hydrochloride(BULK DRUG)<br>1 Kg<br>3<br>Poly Phosphoric Acid 117%<br>4.03 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 56 / NC/3/MEET/Jun/202425/6

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r>1 Kg 3 Poly Phosphoric Acid 117% 4.03 kg RA concerned may take further necessary action as per above decision of NC.||

Case No. 56 / NC/3/MEET/Jun/202425/6

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Case Status	Case Approved
Party Name	LECILITE INGREDIENTS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004750AM24
RA File Number	50AX04000034 AM24
Licence No and Date	5011000972/31/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202324/26 dated 22/03/2024against advance<br>authorizationNo.5011001267 dated 31.01.2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>SUNFLOWER<br>LECITHIN<br>POWDER/GRANULES<br>1 MT<br>1<br>SUNFLOWER LECITHIN<br>Liquid (Crude)<br>1.40 MT<br>RA concerned may take further necessary action as per above decision of NC.

owed.** SUNFLOWER LECITHIN POWDER/GRANULES 1 MT 1 SUNFLOWER LECITHIN Liquid (Crude) 1.40 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	57 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004751AM24
RA File Number	03AX04001897 AM24
Licence No and<br>Date	0311025909/31/07/2023
Norms Committee Decision:<br> The committee considered the request of the firm for fixation of ad-hoc norms and it has been observed that<br>the purchase orders submitted by the firm were not signed by anyone, and it is not possible to know whether<br>these purchase orders were formally accepted by both parties. Therefore, the Committee has decided to<br>seek the clarification in this regard from the firm.

UDIN00350282AM25

ether these purchase orders were formally accepted by both parties. Therefore, the Committee has decided to seek the clarification in this regard from the firm.||

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Case No.	Case No.	58 / NC/3/MEET/Jun/202425/6	58 / NC/3/MEET/Jun/202425/6	58 / NC/3/MEET/Jun/202425/6	58 / NC/3/MEET/Jun/202425/6	58 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00004779AM24
RA File Number		08AX04000819 AM24
Licence No and Date		0811008977/01/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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. CANDESARTAN CILEXETIL 2 MG TABLETS 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg CANDESARTAN CILEXETIL 4 MG TABLETS 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg CANDESARTAN CILEXETIL 8 MG TABLETS 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL 16 MG TABLETS 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg CANDESARTAN CILEXETIL 32 MG TABLETS 1 Number 5 CANDESARTAN CILEXETIL PH.EUR 32.64 mg CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 8MG+12.5MG 1 Number 6 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 16MG+12.5MG 1 Number 7 CANDESARTAN CILEXETIL PH.EUR 16.32 mg CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 32MG+12.5MG 1 Number 8 CANDESARTAN CILEXETIL PH.EUR 32.64 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

N CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 32MG+12.5MG 1 Number 8 CANDESARTAN CILEXETIL PH.EUR 32.64 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CANDESARTAN CILEXETIL 2 MG TABLETS|| 1 Number|1|CANDESARTAN CILEXETIL PH.EUR| 2.04 mg| ||CANDESARTAN CILEXETIL 4 MG TABLETS||1 Number|2|CANDESARTAN CILEXETIL PH.EUR| 4.08 mg| ||CANDESARTAN CILEXETIL 8 MG TABLETS||1 Number|3|CANDESARTAN CILEXETIL PH.EUR| 8.16 mg| ||CANDESARTAN CILEXETIL 16 MG TABLETS||1 Number|4|CANDESARTAN CILEXETIL PH.EUR| 16.32 mg| ||CANDESARTAN CILEXETIL 32 MG TABLETS||1 Number|5|CANDESARTAN CILEXETIL PH.EUR| 32.64 mg| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 8MG+12.5MG||1 Number|6|CANDESARTAN CILEXETIL PH.EUR| 8.16 mg| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 16MG+12.5MG||1 Number|7|CANDESARTAN CILEXETIL PH.EUR| 16.32 mg| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 32MG+12.5MG||1 Number|8|CANDESARTAN CILEXETIL PH.EUR| 32.64 mg|

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CANDESARTAN CILEXETIL AND	1 Number	9	CANDESARTAN CILEXETIL	<br>32.64 mg
HYDROCHLOROTHIAZIDE			PH.EUR
TABLETS 32MG+25MG

R| 32.64 mg|

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CANDESARTAN CILEXETIL AND	1 Number	9	CANDESARTAN CILEXETIL	<br>32.64 mg
HYDROCHLOROTHIAZIDE			PH.EUR
TABLETS 32MG+25MG

	CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE	1 Number	1 Number	9	CANDESARTAN CILEXETIL<br>PH.EUR	<br>32.64 mg
TABLETS 32MG+25MG<br>RA concerned may take further necessary action as per above decision of NC.	TABLETS 32MG+25MG




Case No.		59 / NC/3/M	EET/Jun/202425/6
Case Status		Case Approv	ed
Party Name		MEDREICH	LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00004788AM24
RA File Number		07AX04000660 AM24
Lic<br>Dat	ence No and<br>e	0711008872/02/08/2023
Nor<br>T<br>V<br>RA	ms Committee Decision:<br>he Committee considered the case as			per agenda	and it wa		s decided to fix ad-hoc norms under Pa		ra 4.07 of HBP
	<br>ol. I as per details given below or as ap			<br>plied by t	<br>he firm, w		<br>hichever is less:-
	Export Product			Qty.
						Sl.	No.	Import Items	**Qty.

l. I as per details given below or as ap|||| plied by t|| he firm, w||| hichever is less:-||||| ||Export Product||||Qty.|||||||||| |||||||||Sl.||No.||Import Items||Qty. allowed.| ||Rebamipide 100mg Tablets|||1 N|umber Tab|||||||||| ||||||||let|||1||Rebamipide JP||102.00 mg| |||||||||||||||| |||||||||||2||Ethyl Alcohol 200 Proof||0.19 ml| ||concerned may take further necessary||||action as|||||||||| ||||||||er above|||decision of NC.||||| |||||||||||||||| ||||||||||||||||

Case No.	60 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
and Date
HQ File Number	HQRNORM APPLY 00004796AM24

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RA File Number	34AX04000209 AM24
Licence No and<br>Date	3411003978/02/08/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments.

ber	34AX04000209 AM24
Licence No and<br>Date	3411003978/02/08/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments.

Case No.	61 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004798AM24
RA File Number	34AX04000210 AM24
Licence No and<br>Date	3411003980/02/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance<br>authorizationNo.3411002472 dated 01/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Methyl Heptenone<br>1.50 kg<br>2<br>Methyl Mono Chloro<br>Acetate<br>1.72 kg<br>MELONAL<br>(2,6-dimethylhept-5-enal)<br>(Clear colorless liquid)<br>1 Kg<br>3<br>Sodium Methoxide<br>0.8711 kg<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00350282AM25

thylhept-5-enal) (Clear colorless liquid) 1 Kg 3 Sodium Methoxide 0.8711 kg RA concerned may take further necessary action as per above decision of NC.||

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Cas	e No.		62 / NC/3/MEET/Jun/202425/6
Cas	e Status		Case Deferred
Par	ty Name		DEV BHOOMI ENTERPRISES
Me<br>and	eting Num<br>	ber	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2	024
	Date
HQ	File Num	ber	HQRNORM APPLY 00004815AM24
RA	File Num	ber	05AX04001219 AM24
Lic<br>Dat	nce No	nd
	<br>e		0511020221/03/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage composition of Export product.<br>1.<br>COA of import item from foreign supplier.<br>2.	ms Com<br>	mittee Decision:<br>			c norms<br>the firm	and as per the<br>:-	advise of the
	e comm<br>, it was<br> <br>	ittee considered the request of firm for fix<br>decided to call for following information/do<br>		ation of ad-ho<br>cuments from

d as per the :-|advise of the| ||e comm , it was |ittee considered the request of firm for fix decided to call for following information/do ||ation of ad-ho cuments from||||

Case No.	Case No.	63 / NC/	3/MEET/Jun/202425/6	3/MEET/Jun/202425/6	3/MEET/Jun/202425/6	3/MEET/Jun/202425/6	3/MEET/Jun/202425/6
Case Status		Case De	ferred
Party Name		VINCIT	LABS PRIVATE LIMITED
Meeting Number		NC/ 3/	EET/ Jun/ 202425/ 6 and 01/07/2024
and Date
HQ File Number		HQRNO	RM APPLY 00004827AM24
RA File Number		05AX04	001062 AM24
Licence No and<br>Date		0511020229/03/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Complete chemical reactions with molecular weight alongwith stage wise percentage yield on<br>molar basis.<br>1.
	Complete chemical r<br>molar basis.<br>1.			eactions wi	th molecu	lar weight alongwith stage wise pe	rcentage yield on



Cas	e No.	64 / NC/3/MEET/Jun/2024			25/6
Cas	e Status	Case Deferred
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED

Complete chemical reactions with molecular weight alongwith stage wise percentage yield on molar basis.

Case No.	64 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED

weight alongwith stage wise percentage yield on molar basis.**

Case No.	64 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED

42 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004860AM24
RA File Number	03AX04001676 AM24
Licence No and<br>Date	0311026031/04/08/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of
the TE, it was decided to call for following information/documents from the firm:-
Copy of DML for Export item.<br>I.
Copy of Master-Batch formula.<br>II.

Case No.	65 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004867AM24
RA File Number	09AX04000370 AM24
Licence No and<br>Date	0911005577/04/08/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the
TE, it was decided to call for following information/documents from the firm:-
Copy of DML for Export item.<br>1.
Copy of Master-Batch Formula.<br>2.
Technical justification of 23% wastage claimed in 4E.<br>3.

llowing information/documents from the firm:-|| |Copy of DML for Export item. 1.|| |Copy of Master-Batch Formula. 2.|| |Technical justification of 23% wastage claimed in 4E. 3.|| |Documented description of import item and description given in Bill of entry. 4.||

Case No.	66 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

43 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

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HQ File Number	HQRNORM APPLY 00004930AM24
RA File Number	09AX04000371 AM24
Licence No and<br>Date	0911005594/08/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along with relevant documents.		Personal Hearing

Case No.	67 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	S KANT HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004943AM24
RA File Number	03AX04002077 AM24
Licence No and<br>Date	0311026147/09/08/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|03AX04002077 AM24| |Licence No and Date|0311026147/09/08/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	68 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004944AM24
RA File Number	07AX04000704 AM24
Licence No and<br>Date	0711008930/09/08/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No. 69 / NC/3/MEET/Jun/202425/6

44 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

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Cas	e Status	Case Approved
Par	ty Name	SWISS PARENTERAL	S LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Jun/ 202	425/ 6 and 01/0	7/2024
HQ	File Number	HQRNORM APPLY 00	004949AM24

RA	File Number	08AX04000854 AM24
Lic<br>Dat	ence No and<br>e	0811009060/09/08/202	3

25/ 6 and 01/0||7/2024||||| |HQ|File Number|HQRNORM APPLY 00|||004949AM24||||||| ||||||||||||| |RA|File Number|08AX04000854 AM24|||||||||| |Lic Dat|ence No and e|0811009060/09/08/202|||3||||||| |Nor Th pr au as|ms Committee Decision: e Committee considered the case as oduct/import product in meetingN thorizationNo.0811010864 dated 26/0 per details given below or as applied b||||per agenda a o. NC/3/ME 2/2024, it was y the firm, whic||nd taking ET/Mar/20 decided to||cue from the earlier decisio 2324/26 dated 22/03/2024 fix ad-hoc norms under Para||n for same export against advance 4.07 of HBP Vol. I| ||||||||hever is les||s:-||| ||Export Product||||Qty||Sl No|I|port Items|Q|ty allowed| |||||.||. .||||. .|| ||MEROPENEM FOR INJECTION 500MG (Meropenem 500mg |||1 Number||1||STERILE MIXTURE OF MEROPENEM AND ||0.645 gm/500 mg Injection|| ||Powder for Solution for Injection or Infusion.Each vial contains Active Pharmaceutical Ingredients Meropenem Trihydrate Eqv. to Meropenem Anhydrous 500mg|||||||SODIUM CARBONATE|||| ||Excipients: An|hydrous Sodium|||||||||| ||Cbt 1|4 Eilt t|||||||||| ||aronae 451mg of So|mg, quvaen o dium)|||||||||| ||.||||||||||| ||||||||||||| ||MEROPENE |M FOR INJECTION ||1 Number||2||STERILE MIXTURE OF ||1.29 gm/1 gm || ||1gm (Meropen |em 1.0 GM Powder ||||||MEROPENEM AND ||Injection|| ||for Solution fo Infusion.

||MEROPENE |M FOR INJECTION ||1 Number||2||STERILE MIXTURE OF ||1.29 gm/1 gm || ||1gm (Meropen |em 1.0 GM Powder ||||||MEROPENEM AND ||Injection|| ||for Solution fo Infusion. Each Phti|r Injection or vial contains Active l Idit||||||SODIUM CARBONATE|||| |armaceuca ngreens Meropenem Trihydrate Eqv.to Meropenem Anhydrous 1000 mg Excipients: Anhydrous Sodium Carbonate 208mg, Equivalent to 90.2mg of Sodium) RA concerned may take further necessary action as per above decision of NC.|armaceuca ngreens Meropenem Trihydrate Eqv.to Meropenem Anhydrous 1000 mg Excipients: Anhydrous Sodium Carbonate 208mg, Equivalent to 90.2mg of Sodium)|| .to 0 mg ium ||||||||| |||||||||||||

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Case No.	70 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004957AM24
RA File Number	03AX04002106 AM24
Licence No and<br>Date	0311026174/09/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee with sampel of export and import items such as import item (i) BOP Infusion, (ii) BOP
Injection, (iii) SSC Infusion and (iv) SSC Injection.

ndingPersonal Hearing|| |before Norms Committee with sampel of export and import items such as import item (i) BOP Infusion, (ii) BOP|| |Injection, (iii) SSC Infusion and (iv) SSC Injection.||

Case No.	71 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004971AM24
RA File Number	03AX04002029 AM24
Licence No and<br>Date	0311026195/10/08/2023
Norms Committee Decision:
The committee	considered the request of the firm for fixation of ad-hoc norms and it has been observed
that the purchase orders submitted by the firm were not signed by anyone, and it is not possible to know
whether these purchase orders were formally accepted by both parties. Therefore, the Committee has
decided to seek the clarification in this regard from the firm.

Case No.	72 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004972AM24
RA File Number	03AX04002023 AM24

46 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

UDIN00350282AM25

Licence No and 0311026196/10/08/2023 Date Norms Committee Decision: The case is under consideration and TE was requested to expedite their comments.

on 12-08-2024 12:47:02.

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Licence No and 0311026196/10/08/2023 Date Norms Committee Decision: The case is under consideration and TE was requested to expedite their comments.

Case No.	73 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	BULI CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004985AM24
RA File Number	03AX04002061 AM24
Licence No and<br>Date	0311026225/10/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>To indicate the exact percentage of Hexane in export item, because the requirement of raw<br>materials will be different in different concentration.<br>1.<br>Complete chemical reaction of reactant and product indicating molecular weight of each<br>chemical and yield of the reaction and accordingly calculate the requirement.<br>2.<br>The commercial value of by-product Lithium Chloride, supported by invoices.<br>3.<br>Stoichiometric material balance of the reaction.<br>4.<br>To indicate indigenous items in Annexure to Appendix-4E.<br>5.

of by-product Lithium Chloride, supported by invoices.** 3. Stoichiometric material balance of the reaction. 4. To indicate indigenous items in Annexure to Appendix-4E. 5.||

Case No.	74 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	BROOKS STERISCIENCE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00004995AM24
RA File Number	34AX04000179 AM24
Licence No and<br>Date	3411004010/10/08/2023
Norms Committee Decision:

47 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

UDIN00350282AM25

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Mar/202324/26 dated 22/03/2024 against advance authorization No.0811010864 dated 26/02/2024 , 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.
Meropenem for Injection USP	<br>1 Number	2	Meropenem with Sodium	1.29 gm/1 gm
1000 mg			Carbonate USP	Injection

|Qty.|Sl. No.|Import Items|Qty. allowed.| |---|---|---|---|---| |Meropenem for Injection USP| 1 Number|2|Meropenem with Sodium|1.29 gm/1 gm| |1000 mg|||Carbonate USP|Injection|

Case No.		75 / NC/3/MEET/Jun/202425/6
Case Status		Case Deferred
Party Name		ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00005011AM24
RA File Number		32AX04000274 AM24
Licence No and<br>Date		3211005388/11/08/2023
Norms Committee	Decision:
The committee	considered the request of firm for fixation of ad-hoc norms and as per the advise of the
TE, it was decided to call for following information/documents from the firm:-
Stoichiometric balance in the chemical reaction given at step 4 is not correct.<br>1.
Commercial value of by-products formed in the manufacturing process.<br>2.
Calculation for the requirement of the imported raw material based on yield with justification<br>3.
of asking	high quantity of raw material Glycerine.

Case No.	76 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
PartyName	TORRENT PHARMACEUTICALS LTD

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ng**|high quantity of raw material Glycerine.||

Case No.	76 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
PartyName	TORRENT PHARMACEUTICALS LTD

UDIN00350282AM25

Me<br>Dat	eting Number and<br>e	NC/ 3	/ MEET/ J	un/ 202425/ 6	and 01/07/2024	and 01/07/2024	and 01/07/2024
HQ	File Number	HQR	NORM AP	PLY 0000507	3AM24

RA	File Number	08AX	04000916	AM24
Lic	ence No and Date	08110	09102/16/	08/2023
Nor<br>Th<br>pr<br>au<br>as	ms Committee Decision:<br>e Committee considered t<br>oduct/import product in<br>thorizationNo.0811010469<br>per details given below or a		he case a<br>meeting<br>dated 09/<br>s applied b
				s per agenda<br>No. NC/3/M<br>	and taking cue from the earlier deci<br>EET/Mar/202324/26 dated 22/03/20<br>			sion for same export<br>24against advance<br>
				01/2024, it w<br>y the firm, w	as decided to fix ad-hoc norms under Pa<br>hichever is less:-			ra 4.07 of HBP Vol. I


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

y the firm, w|as decided to fix ad-hoc norms under Pa hichever is less:-|||ra 4.07 of HBP Vol. I|| |||||||||||| |||||||||||| ||Export Product||||Qty.||Sl. No.|Import Items||Qty. allowed.| ||Opipramol Dihydrochloride Tablets 50 MG (OPIPRAMOL HEUMANN|||| 1 Number||1|Opipramol Dihydrochloride||51 mg/Tablet| ||50 MG) (Each film coated tablet contains: Opipramol Dihydrochloride 50 mg Excipients. q.s.Colors: Titanium DioxideandYellow OxideofIron.|||| |||||| |||||||||||| |||||||||||| ||Opipramol Di Tblt 100 M|ydrochloride G|||1 Number||2|Opipramol Dihydrochloride||102 mg/Tablet| ||aes (OPIPRAMOL 100 MG) (Eac| HEUMANN h film coated||||||||| || tablet contains| : Opipramol||||||||| || Dihydrochlori| de 100 mg||||||||| ||Excipients. q.s Titanium Diox|. Colors: ide and Yellow||||||||| ||Oxide of Iron. Net content of active ingredient Opipramol Dihydrochloride should not be less than 235.000 kgs in|||| |||||| ||export product.)|||||||||| |||||||||||| |RA concerned may||take further necessary action as per above decision of NC.||||||||| |||||||||||| |||||||||||| |||||||||||| |||||||||||| |||||||||||| |Case No||77 / NC/3/MEET/Jun/202425/6||||||||| |.||||||||||| |Case Status||Case Deferred||||||||| ||||||||||||

Case No.	77 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred

UDIN00350282AM25

/MEET/Jun/202425/6||||||||| |.||||||||||| |Case Status||Case Deferred||||||||| ||||||||||||

Case No.	77 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred

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Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005075AM24
RA File Number	08AX04000894 AM24
Licence No and<br>Date	0811009108/16/08/2023
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Party Name	Party Name	ATUL LIMITED
Meeting Number
and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00005075AM24
RA File Number		08AX04000894 AM24
Licence No and<br>		0811009108/16/08/2023
Date
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.




Case No.		78 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		PIL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00005085AM24
RA File Number		05AX04001384 AM24
Licence No and<br>Date		0511020419/16/08/2023
Nor<br>T<br>V	ms Committee Decision:<br>

ile Number||HQRNORM APPLY 00005085AM24||||||||| |RA File Number||05AX04001384 AM24||||||||| |Licence No and Date||0511020419/16/08/2023||||||||| |Nor T V|ms Committee Decision: |||||||||| ||he Committee considered the case as per ag ol. I as per details given below or as applied||enda and it wa by the firm, w||s decide hichever||d to fix ad-hoc norms under Pa is less:-|||ra 4.07 of HBP| |||||||||||| ||Export Product|||Qty.||Sl. N|**o. **|Import Items||Qty. allowed.| ||MOXIPIL CV 156 (100 ML)(CO-|||1 Number||1||Amoxycillin Trihydrate||2625.0 mg| ||AMOXICLAV ORAL SUSPENSION BP 156.25 MG/5ML, AMOXYCILLIN AND POTASSIUM CLAVULANATE BP 125/31.25 MG)|||||||BP/USP Plain||| |||||||||||| ||MOXIPIL CV 228.5 (100 ML)(CO- AMOXICLAV ORAL SUSPENSION BP 2285 MG/5ML AMOXYCILLIN AND|||1 Number||2||Amoxycillin Trihydrate BP/USP Plain|4200.0 mg|| ||. POTASSIUM|, CLAVULANATE BP||||||||| ||200/28.5MG)|||||||||| |||||||||||| |||||||||||| ||MOXIPIL CV|312 (100 ML)(CO-||1 Number||3||Amoxycillin Trihydrate|5250.0 mg||

UDIN00350282AM25

POTASSIUM|, CLAVULANATE BP||||||||| ||200/28.5MG)|||||||||| |||||||||||| |||||||||||| ||MOXIPIL CV|312 (100 ML)(CO-||1 Number||3||Amoxycillin Trihydrate|5250.0 mg||

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AMOXICLAV ORAL SUSPENSION BP<br>312.5 MG/5ML, AMOXYCILLIN AND<br>POTASSIUM CLAVULANATE BP<br>250/62.5MG)<br>BP/USP Plain<br>MOXIPIL CV 457 (100 ML)(CO-<br>AMOXICLAV ORAL SUSPENSION BP<br>457 MG/5ML, AMOXYCILLIN AND<br>POTASSIUM CLAVULANATE BP<br>400/57MG)<br>1 Number<br>4<br>Amoxycillin Trihydrate<br>BP/USP Plain<br>8400.0 mg<br>MOXIPIL125 (100 ML)(AMOXICILLIN<br>FOR ORAL SUSPENSION USP 125<br>MG/5ML)<br>1 Number<br>5<br>Amoxycillin Trihydrate<br>BP/USP Plain<br>2625.0 mg<br>MIXCLAV DS (60ML)(CO-AMOXICLAV<br>250 MG/62.5MG PER 5ML POWDER<br>FOR SUSPENSION,<br>AMOXYCILLIN AND POTASSIUM<br>CLAVULANATE BP 250/62.5MG)<br>1 Number<br>6<br>Amoxycillin Trihydrate<br>BP/USP Plain<br>3150.0 mg<br>FAXICLAV DS (60ML)(CO-<br>AMOXICLAV 250 MG/62.5MG PER 5ML<br>POWDER FOR SUSPENSION,<br>AMOXYCILLIN AND POTASSIUM<br>CLAVULANATE BP 250/62.5MG)<br>1 Number<br>7<br>Amoxycillin Trihydrate<br>BP/USP Plain<br>3150.0 mg<br>MOXIPIL 250 (100 ML)(AMOXICILLIN<br>FOR ORAL SUSPENSION USP 250<br>MG/5ML)<br>1 Number<br>8<br>Amoxycillin Trihydrate<br>BP/USP Plain<br>5250.0 mg<br>RA concerned may take further necessary action as per above decision of NC.	AMOXICLAV ORAL SUSPENSION BP<br>312.5 MG/5ML, AMOXYCILLIN AND<br>POTASSIUM CLAVULANATE BP<br>250/62.5MG)			BP/USP Plain

AMOXICLAV ORAL SUSPENSION BP<br>312.5 MG/5ML, AMOXYCILLIN AND<br>POTASSIUM CLAVULANATE BP<br>250/62.5MG)			BP/USP Plain
MOXIPIL CV 457 (100 ML)(CO-<br>AMOXICLAV ORAL SUSPENSION BP<br>457 MG/5ML, AMOXYCILLIN AND<br>POTASSIUM CLAVULANATE BP<br>400/57MG)	1 Number	4	Amoxycillin Trihydrate<br>BP/USP Plain	8400.0 mg
MOXIPIL125 (100 ML)(AMOXICILLIN<br>FOR ORAL SUSPENSION USP 125<br>MG/5ML)	1 Number	5	Amoxycillin Trihydrate<br>BP/USP Plain	2625.0 mg
MIXCLAV DS (60ML)(CO-AMOXICLAV<br>250 MG/62.5MG PER 5ML POWDER<br>FOR SUSPENSION,<br>AMOXYCILLIN AND POTASSIUM<br>CLAVULANATE BP 250/62.5MG)	1 Number	6	Amoxycillin Trihydrate<br>BP/USP Plain	3150.0 mg
FAXICLAV DS (60ML)(CO-<br>AMOXICLAV 250 MG/62.5MG PER 5ML<br>POWDER FOR SUSPENSION,<br>AMOXYCILLIN AND POTASSIUM<br>CLAVULANATE BP 250/62.5MG)	1 Number	7	Amoxycillin Trihydrate<br>BP/USP Plain	3150.0 mg
MOXIPIL 250 (100 ML)(AMOXICILLIN<br>FOR ORAL SUSPENSION USP 250<br>MG/5ML)	1 Number	8	Amoxycillin Trihydrate<br>BP/USP Plain	5250.0 mg

Case No.	79 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ADCOCK INGRAM LIMITED
Meeting Number	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

UDIN00350282AM25

Case No.	79 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ADCOCK INGRAM LIMITED
Meeting Number	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

UDIN00350282AM25

and Date
HQ File Number	HQRNORM APPLY 00005087AM24
RA File Number	07AX04000732 AM24
Licence No and<br>Date	0711008971/16/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/May/202425/4 dated 06/06/2024against advance<br>authorizationNo.0711007675 dated 29/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>ASCORBIC ACID DC 97<br>Percentage SF. I.H<br>63.087 mg<br>FERROUS FORTE TABLETS (Vitamin<br>C (as Ascorbic Acid) -71mg (248.500<br>KGS) +Iron (From Ferrous Bisglycinate<br>Chelate- 126mg (441.000 KGS) With<br>Other Essential Vitamins & Minerals (No<br>of Tabs-3500000))<br>1 Number<br>2<br>IRON BISGLYCINATE<br>122.400 mg<br>RA concerned may take further necessary action as per above decision of NC.

br>Other Essential Vitamins & Minerals (No of Tabs-3500000)) 1 Number 2 IRON BISGLYCINATE 122.400 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	80 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005088AM24
RA File Number	09AX04000448 AM24
Licence No and<br>Date	0911005633/16/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202324/26 dated 22/03/2024against advance<br>authorizationNo.0911006637 dated 24/01/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-

UDIN00350282AM25

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>CARBIDOPA<br>12.75 mg<br>CARBIDOPA 12.5MG<br>LEVODOPA 50MG TABLETS<br>1 Number<br>2<br>LEVODOPA<br>51.00 mg<br>RA concerned may take further necessary action as per above decision of NC	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	CARBIDOPA 12.5MG<br>LEVODOPA 50MG TABLETS	1 Number	1	CARBIDOPA	12.75 mg
			2	LEVODOPA	51.00 mg

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

--|---|---|---|---| ||CARBIDOPA 12.5MG LEVODOPA 50MG TABLETS|1 Number|1|CARBIDOPA|12.75 mg| ||||2|LEVODOPA|51.00 mg|

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

Case No.	81 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005109AM24
RA File Number	03AX04001779 AM24
Licence No and<br>Date	0311025949/18/08/2023
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms and it has been observed<br>that the purchase orders submitted by the firm were not signed by anyone, and it is not possible to know<br>whether these purchase orders were formally accepted by both parties. Therefore, the Committee has<br>decided to seek the clarification in this regard from the firm.

Case No.	82 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005137AM24
RA File Number	52AX04000128 AM24
Licence No and<br>Date	5211005508/21/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the

UDIN00350282AM25

TE, it was decided to call for following information/documents from the firm:-

Name of the Bulk drug produced from the export item i.e a drug intermediate.

he||

UDIN00350282AM25

TE, it was decided to call for following information/documents from the firm:-

Name of the Bulk drug produced from the export item i.e a drug intermediate.
Norms applied for Import item no.1 does not match with the yield given.
Requirement and Recovery of Import iten no. 2 and no. 3 and their sale value if not recovered with documentary evidence.

Case No.	83 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005146AM24
RA File Number	08AX04000944 AM24
Licence No and<br>Date	0811009157/21/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Apr/202425/2 dated 30/04/2024against advance authorization<br>No.0811008434 dated 16/06/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Tranexamic Acid in 0.7% Sodium<br>Chloride Injection 1,000 mg per 100<br>mL (10 mg/mL)<br>1 Number<br>1<br>Tranexamic acid<br>1.05 gm/100 ml Vial<br>RA concerned may take further necessary action as per above decision of NC

m Chloride Injection 1,000 mg per 100 mL (10 mg/mL) 1 Number 1 Tranexamic acid 1.05 gm/100 ml Vial RA concerned may take further necessary action as per above decision of NC||

Case No.	84 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED

UDIN00350282AM25

Meeting Number and<br>Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005152AM24
RA File Number	05AX04001449 AM24
Licence No and Date	0511020498/21/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization<br>No.0511016259 dated 08/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ACETAZOLAMIDE TABLETS<br>USP 125 MG<br>1 Number<br>1<br>ACETAZOLAMIDE USP<br>127.50 mg<br>ACETAZOLAMIDE TABLETS<br>USP 250 MG<br>1 Number<br>2<br>ACETAZOLAMIDE USP<br>255.00 mg<br>RA concerned may take further necessary action as per above decision of NC

AZOLAMIDE USP 127.50 mg ACETAZOLAMIDE TABLETS USP 250 MG 1 Number 2 ACETAZOLAMIDE USP 255.00 mg RA concerned may take further necessary action as per above decision of NC||

Case No.	Case No.	85 / NC/3/MEET/Jun/202425/6	85 / NC/3/MEET/Jun/202425/6	85 / NC/3/MEET/Jun/202425/6	85 / NC/3/MEET/Jun/202425/6	85 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00005153AM24
RA File Number		05AX04001447 AM24
Licence No and<br>Date		0511020506/21/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00350282AM25

Fenofibrate Tablets USP,	54 mg	20000000 Tablets	1	FENOFIBRATE USP	1101.6 kg
Fenofibrate Tablets USP,	160 mg	10128000 Tablets	2	FENOFIBRATE USP	1652.89 kg

50282AM25

Fenofibrate Tablets USP,	54 mg	20000000 Tablets	1	FENOFIBRATE USP	1101.6 kg
Fenofibrate Tablets USP,	160 mg	10128000 Tablets	2	FENOFIBRATE USP	1652.89 kg

Case No.	86 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005154AM24
RA File Number	05AX04001448 AM24
Licence No and<br>Date	0511020507/21/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of DML for Export item.<br>1.<br>Copy of Master-Batch formula.<br>2.

Case No.	87 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	SHARP MINT LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005169AM24
RA File Number	05AX04001349 AM24
Licence No and<br>Date	0511020338/22/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the

UDIN00350282AM25

TE, it was decided to call for following information/documents from the firm:-

i. Step wise manufacturing process.
ii. Complete chemical reactions with molecular and structural formula and molecular weight alongwith stage wise percentage yield on molar basis.
i. Step wise manufacturing process.
ii. Complete chemical reactions with molecular and structural formula and molecular weight alongwith stage wise percentage yield on molar basis.
iii. All technical details as per annexure to appendix 4E for chemical products. iv. Stichometric balance between import and export on molar basis.
v. Details of indigenous input with quantity.

Case No.	88 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005202AM24
RA File Number	34AX04000404 AM24
Licence No and<br>Date	3411004043/23/08/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments.

Case No.	89 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	SPAR PHARMA LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005203AM24
RA File Number	09AX04000344 AM24
Licence No and<br>Date	0911005672/23/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo. NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization<br>No.0511016259 dated 08/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-

authorization No.0511016259 dated 08/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

57 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

UDIN00350282AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
4-FLUORO-a-2-METHYL-1-OXOPROPYL)-g-<br>OXO-N-B-DIPHENYL BENZENE<br>BUTANEAMIDE (DIKETONE,<br>INTERMEDIATE FOR ATORVASTATIN / DKT-<br>3(SOLID)	1 Kg	1	ANILINE OIL	0.47 kg
		2	FLUOROBENZENE	0.52 kg
		3	ACETONE	0.50 kg

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

Case No.	90 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005258AM24
RA File Number	03AX04002280 AM24
Licence No and<br>Date	0311026646/28/08/2023
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms and it has been observed<br>that the purchase orders submitted by the firm were not signed by anyone, and it is not possible to know<br>whether these purchase orders were formally accepted by both parties. Therefore, the Committee has<br>decided to seek the clarification in this regard from the firm.

s not possible to know whether these purchase orders were formally accepted by both parties. Therefore, the Committee has decided to seek the clarification in this regard from the firm.||

Case No.	91 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005263AM24

UDIN00350282AM25

RA File Number	08AX04001023 AM24
Licence No and<br>Date	0811009216/28/08/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments.

Case No.	92 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005281AM24
RA File Number	08AX04000923 AM24
Licence No and<br>Date	0811009151/29/08/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments.

A File Number|08AX04000923 AM24| |Licence No and Date|0811009151/29/08/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite their comments.||

Case No.	93 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	DEV BHOOMI ENTERPRISES
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005292AM24
RA File Number	05AX04001460 AM24
Licence No and<br>Date	0511020678/29/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage composition of Export product.<br>1.<br>COA of import item from foreign supplier.<br>2.

59 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

UDIN00350282AM25

Case No.	94 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	PARAGON FINE AND SPECIALITY CHEMICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005306AM24
RA File Number	08AX04000985 AM24
Licence No and<br>Date	0811009232/29/08/2023

| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024| |HQ File Number|HQRNORM APPLY 00005306AM24| |RA File Number|08AX04000985 AM24| |Licence No and Date|0811009232/29/08/2023| |Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Complete chemical reactions with molecular and structural formula and molecular weight alongwith stage wise percentage yield on molar basis.|| |||

Case No.	Case No.	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		EMCURE PHARMACEUTICALS LIMITED
Meeting Number		NC/ 3/ MEET/ Jn/ 202425/ 6 nd 01/07/2024
and Date		u a
HQ File Number		HQRNORM APPLY 00005336AM24
RA File Number		31AX04000151 AM24
Licence No and		3111002604/31/08/2023
Date
Norms Committee		Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<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. Benazepril Hydrochloride Tablets USP 5 mg(EACH FILM COATED TABLET CONTAIN : Benazepril Hydrochloride USP 5 MG 1 Number 1 BENAZEPRIL HYDROCHLORIDE USP 5.10 mg/Tablet|||||||||| ||||||||||| ||Export Product|||Qt|y.|Sl. No.|Import Items||Qty. allowed.| ||Benazeril Hdrochloride Tablets||USP 5|1|umber|1|BENAZEPRIL||510 m/Tablet| ||p y mg(EACH FILM COATED TAB CONTAIN : Benazepril Hydrochl USP 5 MG|| LET oride|||| HYDROCHLORIDE USP||. g| |||||||||||

Case No.	Case No.	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6	95 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		EMCURE PHARMACEUTICALS LIMITED
Meeting Number		NC/ 3/ MEET/ Jn/ 202425/ 6 nd 01/07/2024
and Date		u a
HQ File Number		HQRNORM APPLY 00005336AM24
RA File Number		31AX04000151 AM24
Licence No and		3111002604/31/08/2023
Date
Norms Committee		Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

111002604/31/08/2023|||||||| |Date|||||||||| |Norms Committee||Decision:|||||||| |The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Benazepril Hydrochloride Tablets USP 5 mg(EACH FILM COATED TABLET CONTAIN : Benazepril Hydrochloride USP 5 MG 1 Number 1 BENAZEPRIL HYDROCHLORIDE USP 5.10 mg/Tablet|||||||||| ||||||||||| ||Export Product|||Qt|y.|Sl. No.|Import Items||Qty. allowed.| ||Benazeril Hdrochloride Tablets||USP 5|1|umber|1|BENAZEPRIL||510 m/Tablet| ||p y mg(EACH FILM COATED TAB CONTAIN : Benazepril Hydrochl USP 5 MG|| LET oride|||| HYDROCHLORIDE USP||. g| |||||||||||

UDIN00350282AM25

Benazepril Hydrochloride Tablets<br>mg(EACH FILM COATED TAB<br>CONTAIN : Benazepril Hydrochl<br>USP 5 MG	USP 5<br>LET<br>oride<br>	1	Number	2	BENAZEPRIL<br>HYDROCHLORIDE USP	5.10 mg/Tablet

Benazepril Hydrochloride Tablets<br>10 mg(EACH FILM COATED T	USP<br>ABLET<br>	1	Number	3	BENAZEPRIL<br>HYDROCHLORIDE USP	10.20 mg/Tablet
<br>CONTAIN : Benazepril Hydrochloride<br>USP 10 MG
Benazeril Hdrochloride Tablets USP<br>		1 Number		4	BENAZEPRIL	1020 m/Tablet

BENAZEPRIL HYDROCHLORIDE USP|||10.20 mg/Tablet| || CONTAIN : Benazepril Hydrochloride USP 10 MG||||||||||| ||Benazeril Hdrochloride Tablets USP |||1 Number|||4|BENAZEPRIL|||1020 m/Tablet| ||p y 10 mg(EACH FILM COATED TABLET CONTAIN : Benazepril Hydrochloride USP 10 MG ||||||| HYDROCHLORIDE USP|||. g| ||||||||||||| ||||||||||||| ||Benazepril Hy|drochloride Tablets USP ||1 Number|||5|BENAZEPRIL|||20.40 mg/Tablet| ||20 mg(EACH |FILM COATED TABLET ||||||HYDROCHLORIDE USP|||| ||CONTAIN : B Hdrochloride|enazepril USP 20 MG|||||||||| ||y||||||||||| ||| |||||||||| ||Benazepril Hy 20 mg(EACH |drochloride Tablets USP FILM COATED TABLET ||1 Number|||6|BENAZEPRIL HYDROCHLORIDE USP|||20.40 mg/Tablet| |CONTAIN : Benazepril Hydrochloride USP 20 MG Benazepril Hydrochloride Tablets USP 40 mg(EACH FILM COATED TABLET CONTAIN : Benazepril Hydrochloride USP 40 MG 1 Number 7 BENAZEPRIL HYDROCHLORIDE USP 40.80 mg/Tablet Benazepril Hydrochloride Tablets USP 40 mg(EACH FILM COATED TABLET CONTAIN : Benazepril Hydrochloride USP 40 MG 1 Number 8 BENAZEPRIL HYDROCHLORIDE USP 40.80 mg/Tablet RA concerned may take further necessary action as per above decision of NC.|CONTAIN : Benazepril Hydrochloride USP 20 MG||||||||||| ||Benazepril Hydrochloride Tablets USP 40 mg(EACH FILM COATED TABLET |||1 Number|||7|BENAZEPRIL HYDROCHLORIDE USP|||40.80 mg/Tablet| ||CONTAIN : Benazepril Hydrochloride USP 40 MG||||||||||| |||||||||||||

ride Tablets USP 40 mg(EACH FILM COATED TABLET |||1 Number|||7|BENAZEPRIL HYDROCHLORIDE USP|||40.80 mg/Tablet| ||CONTAIN : Benazepril Hydrochloride USP 40 MG||||||||||| ||||||||||||| ||Benazepril Hydrochloride Tablets USP 40 mg(EACH FILM COATED TABLET CONTAIN : Benazepril Hydrochloride USP 40 MG |||1 Number|||8| |BENAZEPRIL HYDROCHLORIDE USP||40.80 mg/Tablet| ||||||||||||| ||||||||||||| |||||||||||||

UDIN00350282AM25




Case No.	96 / NC/3/MEET/Jun/202425/6

Case Status	Case Deferred
Pt N	MANNITAB PHARMA SPECIALITIES PRIVATE LIMITED
ary ame
Mti Nb
eeng umer<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

HQ File Number	HQRNORM APPLY 00005338AM24
RA Fil Nb	31AX04000075 AM24
e umer
Licence No and<br>Date	3111002606/31/08/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments.

Case No.	Case No.	97 / NC/3/MEET/Jun/202425/6	97 / NC/3/MEET/Jun/202425/6	97 / NC/3/MEET/Jun/202425/6	97 / NC/3/MEET/Jun/202425/6	97 / NC/3/MEET/Jun/202425/6
Case Status		Case Deferred
Party Name		CHEMPLAST SANMAR LIMITED

Meeting Number
<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00005348AM24
RA File Number		04AX04000283 AM24
Licence No and
Date		0411005945/31/08/2023
Norms Committee		Decision:

and 01/07/2024||||| |HQ File Number||HQRNORM APPLY 00005348AM24||||| |RA File Number||04AX04000283 AM24||||| |Licence No and||||||| |Date||0411005945/31/08/2023||||| |Norms Committee||Decision:||||| |The committee||considered the request of firm for fixation of ad-hoc norms and as per the advise of the||||| |TE, it was decided to call for following information/documents from the firm:- Commercial value of by-products formed in the manufacturing export item with providing sales invoice. 1. Stage wise and overall yield of the reaction with calculation of requirement of imported raw materials. 2. Current production/consumption data duly certified by CA. 3.||||||| || materials. Current product 3.|| ion/consu| mption da| ta duly certified by CA.|| |||||||| |||||||| |||||||| |Cas|N|98 / NC|3/MEET/J|/202425/6||| ||e o.|u||||| |Cas|e Status|Case Deferred||||| |Par|ty Name|INNOVARE LABS||PRIVATE LIMITED|||

Case No.	98 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED

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---|---| |Case Status|Case Deferred| |Party Name|INNOVARE LABS PRIVATE LIMITED|

62 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005353AM24

RA File Number	26AX04000049 AM24
Licence No and<br>Date	2611001116/31/08/2023
Norms Committee Decision:

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

Reason fo<br>1.	r not giving chemical name of export item in application and to indicate its end use.
Full form<br>2.	of WOAH and do not use abbreviations in technical details.
Highlight<br>as raw ma<br>3.	the imported items in chemical reaction and to indicate separately whether it is used<br>terial, catalyst, solvent, purifier etc., as the case may be.
Justification for low yield at each stage, giving overall yield of the reaction.<br>4.<br>The commercial value of by-product formed in the process.<br>5.

tc., as the case may be.**| |Justification for low yield at each stage, giving overall yield of the reaction. 4. The commercial value of by-product formed in the process. 5.|| |||

Case No.	99 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved

Party Name	NEOGEN CHEMICALS LIMITED
Mi b
eetng Numer<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

HQ File Number	HQRNORM APPLY 00005389AM24

RA File Number	03AX04002443 AM24
i d
Lcence No an<br>Date	0311026825/01/09/2023

Norms Committee	Decision:
<br>The Committee	<br>considered the case as per agenda and it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ETHYL ISOBUTYRATE<br>1 kg.<br>1<br>ISOBUTYRIC ACID<br>0.948 kg<br>RA concerned may take further necessary action as per above decision of NC
.

UDIN00350282AM25

br>Qty. allowed. ETHYL ISOBUTYRATE 1 kg. 1 ISOBUTYRIC ACID 0.948 kg RA concerned may take further necessary action as per above decision of NC|| |.||

UDIN00350282AM25

Case No.	100 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	FARBE FIRMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005427AM24
RA File Number	34AX04000424 AM24
Licence No and<br>Date	3411004082/04/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Propofol Injection BP 10mg/ml (1% w/v) 20 ml<br>Vial. Total 202450 Injections<br>40 Kg<br>1<br>Propofol BP<br>42.515 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	101 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	STANEX DRUGS AND CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005456AM24
RA File Number	09AX04000507 AM24
Licence No and<br>Date	0911005765/05/09/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

UDIN00350282AM25

507 AM24| |Licence No and Date|0911005765/05/09/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

UDIN00350282AM25

Case No.	102 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005462AM24
RA File Number	08AX04001060 AM24
Licence No and<br>Date	0811009279/05/09/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of DML for Export item.<br>I.

Case No.	103 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005504AM24
RA File Number	34AX04000414 AM24
Licence No and<br>Date	3411004086/08/09/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite their comments.

Case No.	104 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

65 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

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IMITED| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024|

65 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-08-2024 12:47:02.

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HQ File Number	HQRNORM APPLY 00005505AM24	HQRNORM APPLY 00005505AM24
RA File Number	34AX04000427 AM24
Licence No and<br>Date	3411004087/08/09/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
Clindamycin Phosphate Gel USP 1 %		1 Number	1	Clindamycin Phosphate USP	0.306 gm/Tube
- 30 gm tube(Clindamycin Phosphate
Gel USP 1 % - 30 gm tube
Clindamycin Phosphate Gel USP 1 %		1 Number	2	Clindamycin Phosphate USP	0.612 gm/Tube
- 60 gm tube(Clindamycin Phosphate
Gel USP 1 % - 60 gm tube
RA concerned may take further necessary action as per above decision of NC.

amycin Phosphate USP|0.612 gm/Tube|| |- 60 gm tube(Clindamycin Phosphate||||||| |Gel USP 1 % - 60 gm tube||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||

Case No.<br>105 / NC/3/MEET/Jun/202425/6	Case No.<br>105 / NC/3/MEET/Jun/202425/6	Case No.<br>105 / NC/3/MEET/Jun/202425/6
Case Status<br>Case Approved
Party Name<br>NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202425/ 6		and 01/07/2024
HQ	File Number<br>HQRNORM APPLY 00005523AM24
RA	File Number<br>03AX04002548 AM24
Licence No and<br>Date<br>0311026958/08/09/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00350282AM25

Fluorouracil INJ BP	500 MG/10 ML	1 Vial	1	Fluorouracil IP/BP	538 mg/vial
Fluorouracil INJ BP	1000 MG/20 ML	1 Vial	2	Fluorouracil IP/BP	1050 mg/vial

DIN00350282AM25

Fluorouracil INJ BP	500 MG/10 ML	1 Vial	1	Fluorouracil IP/BP	538 mg/vial
Fluorouracil INJ BP	1000 MG/20 ML	1 Vial	2	Fluorouracil IP/BP	1050 mg/vial


	Fluorouracil INJ BP 50		0 MG/10 ML		1 Vial		1	Fluorouracil IP/BP	538 mg/vial


	Fluorouracil INJ BP 10		00 MG/20 ML		1 Vial		2	Fluorouracil IP/BP	1050 mg/vial
RA concerned may take further necessary action as per above decision of NC.


Cas	e No.	106 / NC/3/MEET/Jun/2		02425/6
Cas
	e Status	Case Approved
Par	ty Name	MANGALAM DRUGS		AND OR		GANICS	LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Jun/ 202		425/ 6 an
						01/07/2	24
HQ	File Number	HQRNORM APPLY 00		005529A		M24
RA	File Number	03AX04002585 AM24

Lic<br>Dat	ence No and<br>e	0311026961/08/09/2023
Nor<br>Th<br>pr<br>au<br>as	ms Committee Decision:<br>e Committee considered the case as<br>oduct/import product in meetingN<br>thorizationNo.0311024825 dated 23/0<br>per details given below or as applied by			per age<br>o. NC/<br>6/2023, i<br>the firm		nda and	taking cue from the earlier decision f			or same export
						3/MEET<br>t was dec<br>whichev	/Nov/202324/16 dated 17/11/2023a<br>ided to fix ad-hoc norms under Para 4.07<br>er is less:-			gainst advance<br>of HBP Vol.

on f|||||or same export| ||||||||3/MEET t was dec whichev||/Nov/202324/16 dated 17/11/2023a ided to fix ad-hoc norms under Para 4.07 er is less:-|||||gainst advance of HBP Vol. I| |||||||||||||||| ||Export Product||||Qty.|||Sl.|No.|Import Items||Qty.||allowed.| ||Chloroquine Phosphate (CQP)|||1 Kg||||1||NOVALDIAMINE||0.411 kg||| |||||||||||||||| |RA concerned may take further necessary action as per above decision of NC|||||||||||||||



Case No.	107 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	DEV BHOOMI ENTERPRISES

Meeting Number	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

UDIN00350282AM25

and Date
HQ File Number	HQRNORM APPLY 00005544AM24
RA File Number	05AX04001629 AM24
Licence No and<br>Date	0511020833/11/09/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage composition of Export product.<br>1.<br>COA of import item from foreign supplier.<br>2.

r>TE, it was decided to call for following information/documents from the firm:- Percentage composition of Export product. 1. COA of import item from foreign supplier. 2.|| |||

Case No.	108 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005546AM24
RA File Number	03AX04002544 AM24
Licence No and<br>Date	0311026992/11/09/2023
Norms Committee Decision:
The committee	considered the request of the firm for fixation of ad-hoc norms and it has been observed
that the purchase orders submitted by the firm were not signed by anyone, and it is not possible to know
whether these purchase orders were formally accepted by both parties. Therefore, the Committee has
decided to seek the clarification in this regard from the firm.

Case No.	109 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	ALCHEMIE FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005547AM24
RA File Number	03AX04002513 AM24
Licence No and<br>Date	0311026994/11/09/2023
Norms Committee Decision:

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

Case No.	110 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	MAXMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005549AM24
RA File Number	05AX04001595 AM24
Licence No and<br>Date	0511020841/11/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Amoxicillin Trihydrate 500mg<br>580.94 mg<br>Amoxicillin and Potassium<br>Clavulanate 625MG Tablet ((Each<br>Tablet contains Amoxicillin 500mg<br>&Potassium Clavulanate equivalent<br>to Clavunic Acid 125mg))<br>1 Number<br>2<br>DILUTED CLAVULANATE<br>(1:1)<br>303.773 mg<br>Amoxicillin Capsule 500mg ((Each<br>Capsule<br>Contains<br>Amoxicillin<br>500mg))<br>1 Number<br>3<br>AMOXICILLIN TRIHYDRATE<br>500mg<br>580.94 mg<br>Amoxicillin Tablet 500mg ((Each<br>Tablet Contains Amoxicillin 500mg))<br>1Number<br>4<br>AMOXICILLIN TRIHYDRATE<br>500mg<br>575.00 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 111 / NC/3/MEET/Jun/202425/6

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4 AMOXICILLIN TRIHYDRATE 500mg 575.00 mg RA concerned may take further necessary action as per above decision of NC.||

Case No. 111 / NC/3/MEET/Jun/202425/6

UDIN00350282AM25

Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005581AM24
RA File Number	09AX04000504 AM24
Licence No and<br>Date	0911005783/11/09/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	112 / NC/3/MEET/Jun/202425/6
Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005583AM24
RA File Number	09AX04000512 AM24
Licence No and<br>Date	0911005784/11/09/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

RA File Number|09AX04000512 AM24| |Licence No and Date|0911005784/11/09/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	113 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005607AM24
RA File Number	34AX04000462 AM24
Licence No and<br>Date	3411004113/12/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo. NC/3/MEET/May/202425/4 dated 06/06/2024against advance authorization<br>No.3411003766 dated 31/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-

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UDIN00350282AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Fluorouracil Injection USP 2.5 gm 50 ML	1 Number	1	Fluorouracil USP	2.60 gm
Fluorouracil Injection USP 5 gm 100 ML	1 Number	2	Fluorouracil USP	5.20 gm

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

50 ML|1 Number|1|Fluorouracil USP|2.60 gm| |Fluorouracil Injection USP 5 gm 100 ML|1 Number|2|Fluorouracil USP|5.20 gm|

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

Case No.	Case No.	Case No.	114 / NC/3/MEET/Jun/202425/6	114 / NC/3/MEET/Jun/202425/6	114 / NC/3/MEET/Jun/202425/6
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number			HQRNORM APPLY 00005618AM24
RA File Number			03AX04002659 AM24
Licence No and<br>Date			0311027072/13/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Clobetasol Propionate Foam 0.05percent 50gm(( Net.<br>wt. of Net. wt. of Clobetasol Propionate USP<br>(Micronized) is 1.00 Kgs.))<br>40000<br>Number<br>2<br>Clobetasol Propionate Foam 0.05percent 100gm((Net.<br>wt. of Clobetasol Propionate USP (Micronized) is 2.00<br>Kgs.))<br>40000<br>Number<br>3<br>Clobetasol Propionate Cream USP 0.05percent (Pack<br>Size 15gm)((Net Weight of Clobetasol Propionate USP<br>(Micronized) 0.300 Kgs))<br>40000<br>Number<br>1<br>Clobetasol<br>Propionate<br>USP<br>(Micronized)<br>19.93 kg
	Sl. No.	Export product		Qty.	Sl.

((Net Weight of Clobetasol Propionate USP (Micronized) 0.300 Kgs)) 40000 Number 1 Clobetasol Propionate USP (Micronized) 19.93 kg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Clobetasol Propionate Foam 0.05percent 50gm(( Net. wt. of Net. wt. of Clobetasol Propionate USP (Micronized) is 1.00 Kgs.))||40000 Number|1|Clobetasol Propionate USP (Micronized)| 19.93 kg| ||2|Clobetasol Propionate Foam 0.05percent 100gm((Net. wt. of Clobetasol Propionate USP (Micronized) is 2.00 Kgs.))|| 40000 Number|||| ||3|Clobetasol Propionate Cream USP 0.05percent (Pack Size 15gm)((Net Weight of Clobetasol Propionate USP (Micronized) 0.300 Kgs))||40000 Number||||

UDIN00350282AM25

4	Clobetasol Propionate Cream USP 0.05percent (Pack<br>size 30gm)((Net Weight of Clobetasol Propionate USP<br>(Micronized) 0.600 Kgs))	40000<br>Number
5	Clobetasol Propionate Cream USP 0.05percent (Pack<br>size 45 gm)((Net Weight of Clobetasol Propionate USP<br>(Micronized) 0.900 Kgs))	<br>40000<br>Number
6	Clobetasol Propionate Cream USP 0.05percent (Pack<br>size 60gm)((Net Weight of Clobetasol Propionate USP<br>(Micronized) 1.200 Kgs))	40000<br>Number
7	Clobetasol Propionate Ointment USP 0.05percent<br>(Pack size 15gm)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.300 Kgs))	40000<br>Number

onized) 1.200 Kgs))|40000 Number|||| ||7|Clobetasol Propionate Ointment USP 0.05percent (Pack size 15gm)((Net Weight of Clobetasol Propionate USP (Micronized) 0.300 Kgs))|40000 Number|||| ||8|Clobetasol Propionate Ointment USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol Propionate USP (Micronized) 0.600 Kgs))|40000 Number|||| ||9|Clobetasol Propionate Ointment USP 0.05percent (Pack size 45gm)((Net Weight of Clobetasol Propionate USP (Micronized) 0.900 Kgs))|40000 Number|||| ||10|Clobetasol Propionate Ointment USP 0.05percent (Pack size 60gm)((Net Weight of Clobetasol Propionate USP (Micronized) 1.200 Kgs))|40000 Number|||| ||11|Clobetasol Propionate Spray 0.05percent (Pack size 59ml)((Net Weight of Clobetasol Propionate USP (Micronized) 1.180 Kgs))|40000 Number|||| ||12|Clobetasol Propionate Spray 0.05percent (Pack size 125ml)((Net Weight of Clobetasol Propionate USP (Micronized) 2.500 Kgs))|40000 Number|||| ||13|Clobetasol Prop. Top Sol USP, 0.05percent 25ml((Net Weight of Clobetasol Propionate USP (Micronized) 0.500 Kgs))|40000 Number|||| ||14|Clobetasol Prop. Top Sol USP, 0.05percent 50ml((Net Weight of Clobetasol Propionate USP (Micronized) 1.000 Kgs))|40000 Number|||| ||15|Clobetasol Pro Shampoo, 0.05 percent 118ml((Net|40000||||

UDIN00350282AM25

0.05percent 50ml((Net Weight of Clobetasol Propionate USP (Micronized) 1.000 Kgs))|40000 Number|||| ||15|Clobetasol Pro Shampoo, 0.05 percent 118ml((Net|40000||||

UDIN00350282AM25

Weight of Clobetasol Propionate USP (Micronized)<br>2.360 Kgs))<br>Number<br>16<br>Clobetasol Propionate Foam 0.05percent 100gm<br>(Emulsion Formulation)(( Net. wt. of Clobetasol<br>Propionate USP (Micronized) is 2.000 Kgs.))<br>40000<br>Number<br>17<br>Clobetasol Propionate Foam 0.05percent 50gm<br>(Emulsion Formulation)(( Net. wt. of Clobetasol<br>Propionate USP (Micronized) is 1.000 Kgs.))<br>40000<br>Number<br>RA concerned may take further necessary action as per above decision of NC.		Weight of Clobetasol Propionate USP (Micronized)<br>2.360 Kgs))	<br>Number
	16	Clobetasol Propionate Foam 0.05percent 100gm<br>(Emulsion Formulation)(( Net. wt. of Clobetasol<br>Propionate USP (Micronized) is 2.000 Kgs.))	40000<br>Number
	17	Clobetasol Propionate Foam 0.05percent 50gm<br>(Emulsion Formulation)(( Net. wt. of Clobetasol<br>Propionate USP (Micronized) is 1.000 Kgs.))	40000<br>Number

0 Kgs.))|40000 Number|||| ||17|Clobetasol Propionate Foam 0.05percent 50gm (Emulsion Formulation)(( Net. wt. of Clobetasol Propionate USP (Micronized) is 1.000 Kgs.))|40000 Number||||

Case No.	Case No.	115 / NC/3/MEET/Jun/202425/6	115 / NC/3/MEET/Jun/202425/6	115 / NC/3/MEET/Jun/202425/6	115 / NC/3/MEET/Jun/202425/6	115 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00005619AM24
RA File Number		03AX04002566 AM24
Licence No and<br>Date		0311027073/13/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Veratraldehyde<br>0.596 kg.<br>2<br>Sodium borohydride<br>0.06 kg.<br>3<br>Liquid Bromine<br>0.69 kg.<br>4<br>Chloroform<br>2.1 kg.<br>2-Bromo-4,5-dimethoxy benzyl bromide<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	2-Bromo-4,5-dimethoxy benzyl bromide		1 kg.	1	Veratraldehyde	0.596 kg.
				2	Sodium borohydride	0.06 kg.
				3	Liquid Bromine	0.69 kg.
				4	Chloroform	2.1 kg.

Items**|Qty. allowed.| ||2-Bromo-4,5-dimethoxy benzyl bromide||1 kg.|1|Veratraldehyde|0.596 kg.| |||||2|Sodium borohydride|0.06 kg.| |||||3|Liquid Bromine|0.69 kg.| |||||4|Chloroform|2.1 kg.|

Case No.	Case No.	115 / NC/3/MEET/Jun/202425/6	115 / NC/3/MEET/Jun/202425/6	115 / NC/3/MEET/Jun/202425/6	115 / NC/3/MEET/Jun/202425/6	115 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00005619AM24
RA File Number		03AX04002566 AM24
Licence No and<br>Date		0311027073/13/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Veratraldehyde<br>0.596 kg.<br>2<br>Sodium borohydride<br>0.06 kg.<br>3<br>Liquid Bromine<br>0.69 kg.<br>4<br>Chloroform<br>2.1 kg.<br>2-Bromo-4,5-dimethoxy benzyl bromide<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	2-Bromo-4,5-dimethoxy benzyl bromide		1 kg.	1	Veratraldehyde	0.596 kg.
				2	Sodium borohydride	0.06 kg.
				3	Liquid Bromine	0.69 kg.
				4	Chloroform	2.1 kg.

UDIN00350282AM25

5 Methyl Tert. Butyl Ether 0.84 kg.

de||1 kg.|1|Veratraldehyde|0.596 kg.| |||||2|Sodium borohydride|0.06 kg.| |||||3|Liquid Bromine|0.69 kg.| |||||4|Chloroform|2.1 kg.|

UDIN00350282AM25

5 Methyl Tert. Butyl Ether 0.84 kg.

Case No.	116 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	STERLING SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005632AM24
RA File Number	03AX04002593 AM24
Licence No and<br>Date	0311027082/13/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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>2-Ethylhexyl Thioglycolate (EHTG)<br>1 Kg<br>1<br>2-ETHYL HEXANOL<br>0.684 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	117 / NC/3/MEET/Jun/202425/6
Case Status	Case Approved
Party Name	MAXMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number	HQRNORM APPLY 00005644AM24

UDIN00350282AM25

UDIN00350282AM25

RA File Number	RA File Number	05AX04001722 AM24	05AX04001722 AM24	05AX04001722 AM24	05AX04001722 AM24	05AX04001722 AM24
Licence No and<br>Date		0511020940/13/09/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-


	Export Produ	ct	Qty.	Sl. No.	Import Items	Qty. allowed.


	Amoxicillin an<br>625MG Tbl	d Potassium Clavulanate<br>((Eh Tblt ti	1 Number	1	Amoxicillin Trihydrate<br>500	580.94 mg
	ae<br>Amoxicillin 5	ac ae conans<br>00mg &Potassium			mg
	<br>Clavulanate eq	<br>uivalent to Clavunic Acid
	<br>125mg))			2	DILUTED<br>CLAVULANATE (1:1)	303.773 mg

	Amoxicillin Capsule 500mg((Each Capsule<br>Contains Amoxicillin 500mg))		<br>1 Number	3	AMOXICILLIN<br>TRIHYDRATE 500mg	580.94 mg
	Amoxicillin Tablet 500mg((Each Tablet<br>Contains Amoxicillin 500mg))		<br>1Number	4	AMOXICILLIN<br>TRIHYDRATE 500mg	575.00 mg

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

g((Each Tablet Contains Amoxicillin 500mg))|| 1Number|4|AMOXICILLIN TRIHYDRATE 500mg|575.00 mg| |||||||| |RA concerned may take further necessary action as per above||||decision of NC.|||



Case No	118 / NC/3/MEET/Jun/202425/6
.
Case Status	Case Deferred

Party Name	ENCUBE ETHICALS PRIVATE LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024

HQ File Number	HQRNORM APPLY 00005691AM24

RA File Number	03AX04002669 AM24

Licence No and<br>Date	0311027142/14/09/2023
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms and it has been observed<br>that the purchase orders submitted by the firm were not signed by anyone, and it is not possible to know<br>whether these purchase orders were formally accepted by both parties. Therefore, the Committee has

UDIN00350282AM25

decided to seek the clarification in this regard from the firm.

ether these purchase orders were formally accepted by both parties. Therefore, the Committee has|| |||

UDIN00350282AM25

decided to seek the clarification in this regard from the firm.

Case No.	Case No.	119 / NC/3/MEET/Jun/202425/6	119 / NC/3/MEET/Jun/202425/6	119 / NC/3/MEET/Jun/202425/6	119 / NC/3/MEET/Jun/202425/6	119 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		ABRYL LABORATORIES PRIVATE LIMITED
Meeting Number
and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00005699AM24
RA File Number		30AX04000242 AM24
Licence No and
Date		3011004161/15/09/2023
Norms Committee		Decision:
The Committee c<br>Vl I d		onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>il i bl lid b h fi hih i l
o. as per etas gven eow or as appe y te rm, wcever s ess:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Phentolamine Mesilate Injection<br>10mg/ml, 1 ml vial<br>1 Number<br>1<br>Phentolamine Mesylate<br>11 mg/ml
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Phentolamine Mesilate Injection<br>10mg/ml, 1 ml vial		1 Number	1	Phentolamine Mesylate	11 mg/ml

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

**| ||Phentolamine Mesilate Injection 10mg/ml, 1 ml vial||1 Number|1|Phentolamine Mesylate|11 mg/ml| |||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||





Case No.	120 / NC/3/MEET/Jun/202425/6
C S	C Dfd
ase tatus	ase eerre
	AA A
Party Name	WEXFORD LBORTORIES PRIVTE LIMITED
Mi b
eetng Numer<br>and Date	NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
H Fil b	HRORM APPLY 000051AM24
Q e Numer	QN 79
RA File Number	07AX04000904 AM24
Licence No and<br>Date	0711009215/15/09/2023
Norms Committee Decision:

UDIN00350282AM25

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

Case No.	Case No.	121 / NC/3/MEET/Jun/202425/6	121 / NC/3/MEET/Jun/202425/6	121 / NC/3/MEET/Jun/202425/6	121 / NC/3/MEET/Jun/202425/6	121 / NC/3/MEET/Jun/202425/6
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202425/ 6 and 01/07/2024
HQ File Number		HQRNORM APPLY 00005750AM24
RA File Number		08AX04001120 AM24
Licence No and Date		0811009407/19/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>CANDESARTAN CILEXETIL 2 MG<br>TABLETS<br>1 Number<br>1<br>CANDESARTAN CILEXETIL<br>PH.EUR<br>2.04 mg<br>CANDESARTAN CILEXETIL 4<br>MG TABLETS<br>1 Number<br>2<br>CANDESARTAN CILEXETIL<br>PH.EUR<br>4.08 mg<br>CANDESARTAN CILEXETIL 8<br>MG TABLETS<br>1 Number<br>3<br>CANDESARTAN CILEXETIL<br>PH.EUR<br>8.16 mg<br>CANDESARTAN CILEXETIL 16<br>MG TABLETS<br>1 Number<br>4<br>CANDESARTAN CILEXETIL<br>PH.EUR<br>16.32 mg<br>CANDESARTAN CILEXETIL 32<br>MG TABLETS<br>1 Number<br>5<br>CANDESARTAN CILEXETIL<br>PH.EUR<br>32.64 mg<br>CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE<br>TABLETS 8MG+12.5MG<br>1 Number<br>6<br>CANDESARTAN CILEXETIL<br>PH.EUR<br>8.16 mg<br>CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE<br>TAB

4 mg CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 8MG+12.5MG 1 Number 6 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 16MG+12.5MG 1 Number 7 CANDESARTAN CILEXETIL PH.EUR 16.32 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CANDESARTAN CILEXETIL 2 MG TABLETS|| 1 Number|1|CANDESARTAN CILEXETIL PH.EUR| 2.04 mg| ||CANDESARTAN CILEXETIL 4 MG TABLETS||1 Number|2|CANDESARTAN CILEXETIL PH.EUR| 4.08 mg| ||CANDESARTAN CILEXETIL 8 MG TABLETS||1 Number|3|CANDESARTAN CILEXETIL PH.EUR| 8.16 mg| ||CANDESARTAN CILEXETIL 16 MG TABLETS||1 Number|4|CANDESARTAN CILEXETIL PH.EUR| 16.32 mg| ||CANDESARTAN CILEXETIL 32 MG TABLETS||1 Number|5|CANDESARTAN CILEXETIL PH.EUR| 32.64 mg| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 8MG+12.5MG||1 Number|6|CANDESARTAN CILEXETIL PH.EUR| 8.16 mg| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 16MG+12.5MG||1 Number|7|CANDESARTAN CILEXETIL PH.EUR| 16.32 mg|

UDIN00350282AM25

SARTAN CILEXETIL PH.EUR| 8.16 mg| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS 16MG+12.5MG||1 Number|7|CANDESARTAN CILEXETIL PH.EUR| 16.32 mg|

UDIN00350282AM25

CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE<br>TABLETS 32MG+12.5MG<br>1 Number<br>8<br>CANDESARTAN CILEXETIL<br>PH.EUR<br>32.64 mg<br>CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE<br>TABLETS 32MG+25MG<br>1 Number<br>9<br>CANDESARTAN CILEXETIL<br>PH.EUR<br>32.64 mg<br>RA concerned may take further necessary action as per above decision of NC.	CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE<br>TABLETS 32MG+12.5MG	1 Number	8	CANDESARTAN CILEXETIL<br>PH.EUR	<br>32.64 mg
	CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZIDE<br>TABLETS 32MG+25MG	1 Number	9	CANDESARTAN CILEXETIL<br>PH.EUR	<br>32.64 mg

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