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/Aug/202425/8 DATED: 28/08/2024

Please Note

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

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

Meeting No. NC/3/MEET/Aug/202425/8 dated 28/08/2024 of Norms Committee - III for the year 2024-25 was held on 28/08/2024 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)

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

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

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Case Details and Decision(s):

Cas	Cas	e Details and Decision(s):	e Details and Decision(s):
Case No.
		1 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
and Date
HQ File Number		HQRNORM APPLY 00001088AM25
RA File Number		NA
Licence No and<br>		NA
Date

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



	Export Produ	ct	Qty.	Sl.<br>No.	Import Items		Qty. allowed.

	FLUOCINONIDE<br>TOPICAL<br>SOLUTION<br>0.05% 60 ML Tot Wt. 17100<br>Kgs		<br> <br>1 Number	1	Fluocinonide Micronized USP		30.6 mg
				2	Ethyl Alcohol USP Ethanol 96 %		17.35 gm
				3	DI- I	sopropyl Adipate in House	3.9	9 gm

				4	2 OZ<br>Oval	.

1 Number||1||Fluocinonide Micronized USP||30.6 mg|| |||||||2||Ethyl Alcohol USP Ethanol 96 %||17.35 gm|| |||||||3||DI- I|sopropyl Adipate in House|3.9|9 gm| ||||||||||||| |||||||4||2 OZ Oval|. White HDPE Bottle Drug Plastic Bottle|Rel Pac and|evant as per king Policy Genral Notes| |||||||5||Whit|e PP Dropper Tip Cap|Rel|evant as per| ||||||||||| Packing Policy and Genral Notes|| |||||||6||20 MM Natural LLDPE Dropper Tip 0.020 NEEDLE||Relevant as per Packing Policy and Genral N|| |||||||||||otes|| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |||||||||||||

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

Case No.	Case No.	Case No.	2 / NC/3/MEET/Aug/202425/8	2 / NC/3/MEET/Aug/202425/8
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number			HQRNORM APPLY 00001160AM25
RA File Number			NA
Licence No and<br>Date			NA
Norms Committee Decision:<br>Decision:The Committee considered the request of firm in details and also discussed report of factory<br>visit.

|RA File Number|||NA|| |Licence No and Date|||NA|| |Norms Committee Decision: **Decision:**The Committee considered the request of firm in details and also discussed report of factory visit. The committee found that in the above mention case export product is in form of Gel not a cream/Ointments and accordingly decided to fix the ad-hoc norms as under :- Sl. No Export Product Quantity (i) Medical Creams & Ointments(Testosterone Gel 1.62% 88G Tot Wt. 61600Kgs (Net Wt. Testo 997.92Kgs, Ethyl 45276Kgs, Iso 616Kgs, Carbo 616Kgs, Sodi 246Kgs, Bottle 700000Nos, Cap 700000Nos)) 1 Number (ii) Creams & Ointments(Testosterone Gel 1%, ?88gm Tot Wt. 5280Kgs ( Net Wt . Testo 52.80Kgs, Ethyl 3832.22Kgs, Iso 26.4, Carbo 47.52Kgs, Sod 10.03Kgs, Bottle 60000Nos, Cap 60000Nos)) 1 Number (iii) Medical Creams & Ointments(Testosterone Gel 1%, 5g Sachet Tow Wt. 18000 Kgs (Net Cont Testo 180Kgs, Ethyl 13064.4Kgs, Iso 90Kgs, Carbo 162Kgs, Sod 34.20Kgs)) 1 Number (iv) Medical Creams & Ointments(Testosterone Gel 1%, 2.5g Sachet Tot Wt. 3450 Kgs (Net Wt. Testo 34.50Kgs, Ethyl 2504.01Kgs, Iso 17.25Kgs, Carbo 31.05Kgs, Sod 6.56Kgs)) 1 Number||||| ||Sl. No|Export Product||Quantity| ||(i)|Medical Creams & Ointments(Testosterone Gel 1.62% 88G Tot Wt. 61600Kgs (Net Wt. Testo 997.92Kgs, Ethyl 45276Kgs, Iso 616Kgs, Carbo 616Kgs, Sodi 246Kgs, Bottle 700000Nos, Cap 700000Nos))||1 Number| ||(ii)|Creams & Ointments(Testosterone Gel 1%, ?88gm Tot Wt.

600Kgs (Net Wt. Testo 997.92Kgs, Ethyl 45276Kgs, Iso 616Kgs, Carbo 616Kgs, Sodi 246Kgs, Bottle 700000Nos, Cap 700000Nos))||1 Number| ||(ii)|Creams & Ointments(Testosterone Gel 1%, ?88gm Tot Wt. 5280Kgs ( Net Wt . Testo 52.80Kgs, Ethyl 3832.22Kgs, Iso 26.4, Carbo 47.52Kgs, Sod 10.03Kgs, Bottle 60000Nos, Cap 60000Nos))||1 Number| ||(iii)|Medical Creams & Ointments(Testosterone Gel 1%, 5g Sachet Tow Wt. 18000 Kgs (Net Cont Testo 180Kgs, Ethyl 13064.4Kgs, Iso 90Kgs, Carbo 162Kgs, Sod 34.20Kgs))||1 Number| ||(iv)|Medical Creams & Ointments(Testosterone Gel 1%, 2.5g Sachet Tot Wt. 3450 Kgs (Net Wt. Testo 34.50Kgs, Ethyl 2504.01Kgs, Iso 17.25Kgs, Carbo 31.05Kgs, Sod 6.56Kgs))||1 Number| ||||||

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Sl. No.	Import Items	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.

Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	3 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	KRUNAL INDUSTRIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00301989AM22
RA File Number	08AX04000162 AM22
Licence No and<br>Date	0811003592/30/12/2021
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Justificatio for low yield.<br>1.<br>Production/consumtion data for the year 2021-2022 duly certified by Auditor of the firm.<br>2.

Case No.	4 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred

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Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00002548AM23
RA File Number	03AX04002511 AM23
Licence No and<br>Date	0311017048/10/08/2022
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Please get the Advance Authorisation amended to show content of API in export in line with DML.

se of the TE, it was decided to call for following information/documents from the firm:- Please get the Advance Authorisation amended to show content of API in export in line with DML.||

Case No.	5 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003366AM23
RA File Number	03AX04003250 AM23
Licence No and<br>Date	0311018155/25/09/2022
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Please get the Advance Authorisation amended to show content of API in export in line with<br>DML.<br>1.

Case No.	6 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024

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IES LTD| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024|

6 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

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HQ File Number	HQRNORM APPLY 00003417AM23
RA File Number	09AX04000478 AM23
Licence No and<br>Date	0911003707/27/09/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Daptomycin for Injection 350mg/vial<br>(Consist of 52.50 Kgs Daptomycin)<br>1 Number<br>1<br>Daptomycin<br>385.0 mg.<br>Daptomycin for Injection 500mg/vial<br>(Consist of 150.00Kgs Daptomycin)<br>1 Number<br>2<br>Daptomycin<br>550.0 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	7 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003479AM23
RA File Number	08AX04000835 AM23
Licence No and<br>Date	0811006153/30/09/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	8 / NC/3/MEET/Aug/202425/8
Case Status	Case Rejected
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED

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E was requested to expedite his comments.**||

Case No.	8 / NC/3/MEET/Aug/202425/8
Case Status	Case Rejected
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED

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Meeting Number	NC/ 3/ MEET/ Au/ 202425/ 8 and 28/08/2024
and Date	g
HQ File Number	HQRNORM APPLY 00003514AM23
RA File Number	03AX04003421 AM23
Licence No and<br>Date	0311018336/03/10/2022
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm and it has been observed by the committee that input Galaxmusk Pure<br>(Perfumery Compound) as applied by the firm comes under para 4.11(b) of FTP, 2023, and the said para<br>states that “For export of perfumes, perfumery compounds and various feed ingredients containing vitamins,<br>no authorisation shall be issued by Regional Authority under para 4.07 of HBP and applicants shall be<br>required to apply under para 4.06 of HBP to the Norms Committee”

taining vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP and applicants shall be required to apply under para 4.06 of HBP to the Norms Committee”|| |||

Case No.	Case No.	Case No.	9 / NC/3/MEET/Aug/202425/8	9 / NC/3/MEET/Aug/202425/8	9 / NC/3/MEET/Aug/202425/8	9 / NC/3/MEET/Aug/202425/8	9 / NC/3/MEET/Aug/202425/8	9 / NC/3/MEET/Aug/202425/8	9 / NC/3/MEET/Aug/202425/8	9 / NC/3/MEET/Aug/202425/8

Case Status			Case Approved

Party Name			CIPLA LIMITED

Meeting Number
<br>and Date			NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number			HQRNORM APPLY 00003540AM23

RA File Number			03AX04003155 AM23

Licence No and
Date			0311018363/05/10/2022
Norms Committee			Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Amoxycillin Trihydrate 196.875 kg. 2 CLAVULANATE POTASSIUM WITH SILICON DIOXIDE 1:1 116.30 kg. SILICONE Not covered in Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 62.5mg (Pack Size 75ml) (Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin 250 mg, Clavulanate Potassium USP equivalent to Clavulanic Acid 62.50mg) 50000 Numbers 3||||||||||| ||E|xport Product||||Qty.|Sl. No.|Import Items|Qty. allowed.|| ||Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 62.5mg (Pack Size 75ml) (Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin 250 mg, Clavulanate Potassium USP equivalent to Clavulanic Acid 62.50mg)|||||||||| |||moxicillin and Clavu or Oral Suspension U||lanate Po SP 250mg|tassium /|50000 Numbers|1|Amoxycillin Trihydrate|1|96.875 kg.| |||||||||||| |||2.5mg (Pack Size 75m ontains: Amoxycillin quivalent to Amoxicil lavulanate Potassium ||l) (Each Trihydrat lin 250 m USP equ |5ml e USP g, ivalent||2|CLAVULANATE POTASSIUM WITH SILICON DIOXIDE 1:1|1|16.30 kg.| |||||||||||| ||||||||3|SILICONE|Not covered in|| ||||||||||||

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equ |5ml e USP g, ivalent||2|CLAVULANATE POTASSIUM WITH SILICON DIOXIDE 1:1|1|16.30 kg.| |||||||||||| ||||||||3|SILICONE|Not covered in|| ||||||||||||

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						DIOXIDE(SYLOID<br>244FP)	SION	SION

					4	115CC HDPE	Relevant as per
						BOTTLES 75 ML	<br>Packing Policy
						(250/62.5)	<br>& General
							Notes.

					5	28-400 WHITE CLIC<br>	Relevant as per<br>
						LOC CAP WITH<br>PRINTED FSM-1	Packing Policy<br>& General<br>
							Notes.
					6	Cap 28/400 WHT CRC<br>W/FS M-I WITH<br>INDUCTION<br>SEALING	Relevant as per<br>Packing Policy<br>& General<br>Notes.
Amoxicillin and Clavulanate Potassium<br>for Oral Suspension USP 250mg /<br>62.5mg (Pack Size 100ml)(Each 5ml<br>contains: Amoxycillin Trihydrate USP<br>equivalent to Amoxicillin 250mg,<br>Clavulanate Potassium USP equivalent<br>to Clavulanic Acid 62.50mg)
	moxicillin and Clavu<br>or Oral Suspension U<br>2.5mg (Pack Size 100	lanate Po<br>SP 250mg<br>ml)(Each	tassium<br>/<br>5ml	75000<br>Numbers	7	Amoxycillin Trihydrate	3	93.75 kg.

	<br>ontains: Amoxycillin<br>quivalent to Amoxicil<br>lavulanate Potassium<br>o Clavulanic Acid 62.	<br>Trihydrat<br>lin 250m<br>USP equ<br>50mg)	<br>e USP<br>g,<br>ivalent		8	CLAVULANATE<br>POTASSIUM WITH<br>SILICON DIOXIDE<br>1:1	2	32.60 kg.

					9	SILICONE<br>DIOXIDE(SYLOID<br>244FP)	Not covered in<br>SION

g)| e USP g, ivalent||8|CLAVULANATE POTASSIUM WITH SILICON DIOXIDE 1:1|2|32.60 kg.| |||||||||||| ||||||||9|SILICONE DIOXIDE(SYLOID 244FP)|Not covered in SION|| |||||||||||| ||||||||10|115CC HDPE BOTTLES 100 ML 250/625|Relevant as per Packing Policy & Gl|| |||||||||(.)|enera Notes|| ||||||||||.|| |||||||||||| ||||||||11|28-400 WHITE CLIC LOC CAP WITH|Relevant as per Packing Policy|| |||||||||PRINTED FSM-1|& General|| ||||||||||Notes.|| |||||||||||| ||||||||12|Ca 28/400 WHT CRC|Relevant as er|| |||||||||p W/FS M-I WITH|p Packing Policy|| ||||||||||||

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|INDUCTION SEALING & General Notes. 13 Amoxycillin Trihydrate 196.875 kg. 14 CLAVULANATE POTASSIUM WITH SILICON DIOXIDE 1:1 116.30 kg. 15 SILICONE DIOXIDE(SYLOID 244FP) Not covered in SION 16 115 CC HDPE BOTTLES 150 ML (250/62.5) Relevant as per Packing Policy & General Notes. 17 28-400 WHITE CLIC LOC CAP WITH PRINTED FSM-1 Relevant as per Packing Policy & General Notes. Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg /62.5mg (Pack Size 150ml)(Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin 250mg, Clavulanate Potassium USP equivalent to Clavulanic Acid 62.50mg) 25000 Numbers 18 Cap 28/400 WHT CRC W/FS M-I WITH INDUCTION SEALING Relevant as per Packing Policy & General Notes. RA concerned may take further necessary action as per above decision of NC.||||I

			INDUCTION<br>SEALING	& General<br>Notes.
Amoxicillin and Clavulanate Potassium<br>for Oral Suspension USP 250mg<br>/62.5mg (Pack Size 150ml)(Each 5ml<br>contains: Amoxycillin Trihydrate USP<br>equivalent to Amoxicillin 250mg,<br>Clavulanate Potassium USP equivalent<br>to Clavulanic Acid 62.50mg)	25000<br>Numbers	13	Amoxycillin Trihydrate	196.875 kg.
		14	CLAVULANATE<br>POTASSIUM WITH<br>SILICON DIOXIDE<br>1:1	116.30 kg.
		15	SILICONE<br>DIOXIDE(SYLOID<br>244FP)	Not covered in<br>SION
		16	115 CC HDPE<br>BOTTLES 150 ML<br>(250/62.5)	Relevant as per<br>Packing Policy<br>& General<br>Notes.
		17	28-400 WHITE CLIC<br>LOC CAP WITH<br>PRINTED FSM-1	Relevant as per<br>Packing Policy<br>& General<br>Notes.
		18	Cap 28/400 WHT CRC<br>W/FS M-I WITH<br>INDUCTION<br>SEALING	Relevant as per<br>Packing Policy<br>& General<br>Notes.

Case No.	10 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	CORAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003543AM23

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RA File Number	05AX04001818 AM23
Licence No and<br>Date	0511015160/06/10/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

04001818 AM23| |---|---| |Licence No and Date|0511015160/06/10/2022| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	11 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003555AM23
RA File Number	52AX04001659 AM23
Licence No and Date	5211003386/06/10/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jun/202425/5 dated 14/06/2024against<br>advance authorizationNo. 5211001047 dated 26/07/2021, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2 6 DICHLOROTOLUENE<br>1.90 kg.<br>2<br>TETRAHYDROFURAN<br>2.00 kg.<br>3<br>MAGNESIUM TURNINGS<br>0.60 kg.<br>BIFENTHRIN ALCOHOL<br>1 kg.<br>4<br>n HEPTANE<br>1.77 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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AGNESIUM TURNINGS 0.60 kg. BIFENTHRIN ALCOHOL 1 kg. 4 n HEPTANE 1.77 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	12 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003610AM23
RA File Number	34AX04000652 AM23
Licence No and<br>Date	3411002874/10/10/2022
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	Case No.	12 / NC/3/MEET/Aug/202425/8	12 / NC/3/MEET/Aug/202425/8	12 / NC/3/MEET/Aug/202425/8	12 / NC/3/MEET/Aug/202425/8	12 / NC/3/MEET/Aug/202425/8
Case Status		Case Deferred
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00003610AM23
RA File Number		34AX04000652 AM23
Licence No and<br>Date		3411002874/10/10/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.
	ecision: The case is under consid		eration a	nd TE wa	s requested to expedite his comm	ents.


Cas	e No.	13 / NC/3/MEET/Aug/	202425/8
Cas	e Status	Case Approved
Par	ty Name	ENCEE AROMATICS	PRIVATE	LIMITED
Me<br>and

expedite his comm**||ents.| ||||||||| ||||||||| |Cas|e No.|13 / NC/3/MEET/Aug/|202425/8||||| |Cas|e Status|Case Approved|||||| |Par|ty Name|ENCEE AROMATICS|PRIVATE|LIMITED|||| |Me and|||||||| ||eting Number Date|NC/ 3/ MEET/ Aug/ 20|2425/ 8 an|d 28/08/202|4||| |HQ|File Number|HQRNORM APPLY 0|0003616A|M23|||| |RA|File Number|32AX04000290 AM23|||||| |Lic Dat|ence No and e|3211003763/11/10/202|2||||| |Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Mar/202324/26 dated 22.03.2024 against advance authorizationNo.3211006285 dated 07.02.2024, 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. 1 Triethyl Orthoformate 2.400 kg. Enamber / Kephalis / Tetrambrone 1 kg. 2 Mesityl Oxide 2.700 kg. RA concerned may take further necessary action as per above decision of NC.|ms Committee Decision: ecision:The Committee considere ame export product/import produ ||d the cas ct in me ||||| |||||e as per ag etingNo. |enda and taking cue from the earl NC/3/MEET/Mar/202324/26 dat ||ier decision for ed 22.03.2024 | ||gainst advance authorizationNo.3 nder Para 4.07 of HBP Vol.

ngNo. |enda and taking cue from the earl NC/3/MEET/Mar/202324/26 dat ||ier decision for ed 22.03.2024 | ||gainst advance authorizationNo.3 nder Para 4.07 of HBP Vol. I as per||2110062 details g|85 dated iven below|07.02.2024, it was decided to fix or as applied by the firm, whiche||ad-hoc norms ver is less:-| ||||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Q|ty. allowed.| ||||||||| ||Enamber / Kephalis / Tetrambrone|| 1 kg.|1 2|Triethyl Orthoformate||2.400 kg.| ||||||Mesityl Oxide||2.700 kg.| ||||||||| |||||||||

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Case No.	14 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	LIVEALTH BIOPHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003619AM23
RA File Number	03AX04003335 AM23
Licence No and<br>Date	0311018491/11/10/2022
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Copy of Drug Manufacturing Licence (DML) showing approved composition.<br>1.<br>COA of Import Items.<br>2.<br>Ratio of 1 kg. Activity and 1 kg. Net with documentary evidence.<br>3.

r>Copy of Drug Manufacturing Licence (DML) showing approved composition. 1. COA of Import Items. 2. Ratio of 1 kg. Activity and 1 kg. Net with documentary evidence. 3.||

Case No.	15 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003629AM23
RA File Number	34AX04000662 AM23
Licence No and<br>Date	3411002884/11/10/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	16 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED

13 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

UDIN00451692AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003643AM23
RA File Number	09AX04000594 AM23
Licence No and<br>Date	0911003780/11/10/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Dihydronopol 0.60 kg. 2 2-bromo-4,5-dimethoxy benzyl bromide 1.00 kg. 3 Acetone 1.00 kg. Pinaverium Bromide 1 kg. 4 Toulene 0.90 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	17 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003663AM23
RA File Number	09AX04000574 AM23
Licence No and<br>Date	0911003782/12/10/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00451692AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Teriparatide Injection 600 mcg/2.4<br>ml.((Each Ml contains Teriparatide -<br>250 mcg))	<br>1 Number	1	Teriparatide	660 mcg/injection

*|Import Items|Qty. allowed.| |---|---|---|---|---| |Teriparatide Injection 600 mcg/2.4 ml.((Each Ml contains Teriparatide - 250 mcg))| 1 Number|1|Teriparatide|660 mcg/injection|

Case No.	18 / NC/3/MEET/Aug/202425/8
Case Status	Case Withdrawn
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003691AM23
RA File Number	09AX04000567 AM23
Licence No and<br>Date	0911003791/13/10/2022
Norms Committee Decision:<br>Decision:The firm vide letter dated 09/06/2023 has informed that they have surrendered their above license<br>to RA. Therefore, the Committee decided toclosethe application of the firm.

Case No.	19 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003701AM23
RA File Number	09AX04000630 AM23
Licence No and<br>Date	0911003795/13/10/2022
Norms Committee Decision:

UDIN00451692AM25

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.
Tetanus Antitoxin I.H.S / B.P<br>1500 IU, Plus [overage of 150<br>IU in addition] in PFS / vials /<br>Ampoule	100000 Vials	1	Tetanus Antitoxin 2500<br>IU ml	68 Liter

d.**| |---|---|---|---|---| |Tetanus Antitoxin I.H.S / B.P 1500 IU, Plus [overage of 150 IU in addition] in PFS / vials / Ampoule|100000 Vials|1|Tetanus Antitoxin 2500 IU ml|68 Liter|

Case No.	Case No.	20 / NC/3/MEET/Aug/202425/8	20 / NC/3/MEET/Aug/202425/8	20 / NC/3/MEET/Aug/202425/8	20 / NC/3/MEET/Aug/202425/8	20 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00003761AM23
RA File Number		03AX04003660 AM23
Licence No and<br>Date		0311018607/17/10/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>ALPHA PINENE<br>1.04 kg<br>CAMPHOR USP (AB08005)<br>1 kg<br>2<br>Acetic Acid<br>0.10 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	CAMPHOR USP (AB08005)		1 kg	1	ALPHA PINENE	1.04 kg
				2	Acetic Acid	0.10 kg

UDIN00451692AM25

||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CAMPHOR USP (AB08005)||1 kg|1|ALPHA PINENE|1.04 kg| |||||2|Acetic Acid|0.10 kg| ||||||||

UDIN00451692AM25

Case No.	Case No.	21 / NC/3/MEET/Aug/202425/8	21 / NC/3/MEET/Aug/202425/8	21 / NC/3/MEET/Aug/202425/8	21 / NC/3/MEET/Aug/202425/8	21 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		MEDREICH LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00003824AM23
RA File Number		07AX04001015 AM23
Licence No and Date		0711005482/19/10/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>ATORVASTATIN CALCIUM<br>TRIHYDRATE<br>11.059 mg.<br>ATORVASTATIN<br>10MG<br>TABLETS [904.241 KG])<br>1 Number<br>2<br>D MANNITOL<br>40.0 mg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items<br>	Qty. allowed.
	ATORVASTATIN<br>10MG<br>TABLETS [904.241 KG])		<br>1 Number	1	ATORVASTATIN CALCIUM<br>TRIHYDRATE	11.059 mg.
				2	D MANNITOL	40.0 mg
	RA concerned may take further necessary action as per above decision of NC.

ABLETS [904.241 KG])|| 1 Number|1|ATORVASTATIN CALCIUM TRIHYDRATE|11.059 mg.| |||||2|D MANNITOL|40.0 mg| ||RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	22 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003910AM23
RA File Number	30AX04000299 AM23
Licence No and<br>Date	3011002731/25/10/2022

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Norms Committee Decision:

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Injection Urokinase	1000 Vials	1	Urokinase (purified)	1043.46 mg.
		2	Mannitol 0.5%	128.52 gm.
		3	Sodium Chloride (50 mg/vial)	128.52 gm.
		4	Sodium Hydroxide	3.06 gm.

Case No.	23 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00003925AM23
RA File Number	09AX04000647 AM23
Licence No and<br>Date	0911003881/27/10/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|09AX04000647 AM23| |Licence No and Date|0911003881/27/10/2022| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	24 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	NECTAR LIFE SCIENCES LIMITED
Meeting Number	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024

UDIN00451692AM25

and Date
HQ File Number	HQRNORM APPLY 00003987AM23
RA File Number	302404000100 AM20
Licence No and<br>Date	3011002766/01/11/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	25 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00004014AM23
RA File Number	05AX04002182 AM23
Licence No and<br>Date	0511015566/01/11/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Sep/202324/13 dated 14/09/2023against<br>advance authorizationNo. 0511019795 dated 18.07.2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

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. Mydrimax Eye Drops 5 ml. (Tropicamide 0.8%) 1 Number 1 Tropicamide 40.8 mg / 5ml Vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	26 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED

UDIN00451692AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000289AM25
RA File Number	NA
Licence No and<br>Date	0511017371/17/02/2023
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the
TE, it was decided to call for following information/documents from the firm:-
Details submitted is for export of Pine Oil not for Terpenyl Acetate.<br>1.
Complete technical details as per Annexure to Appendix-4E.

llowing information/documents from the firm:-|| |Details submitted is for export of Pine Oil not for Terpenyl Acetate. 1.|| |Complete technical details as per Annexure to Appendix-4E.||

Case No.<br>27 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00009143AM24
RA File Number<br>09AX04001120 AM24
Licence No and Date<br>0911006926/15/03/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Jul/202425/7 dated 06.08.2024against
advance authorizationNo. 0911003379 dated 21.07.2022, it was decided to fix ad-hoc		norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>(1S,4R)-4-([(2-AMINO-6-CHLORO-5-<br>1 Kg.	VINCELACTAM	0.92 kg.
FORMAMIDO-4- PYRIMIDINYL)
AMINO]-2-CYCLOPENTENE-1-
METHANOL)<br>2	N 2 AMINO 4 6	0.764 kg
	DICHLORO 5
	PYRIMDINYL

S,4R)-4-([(2-AMINO-6-CHLORO-5- 1 Kg.|VINCELACTAM|0.92 kg.|| |FORMAMIDO-4- PYRIMIDINYL)|||| |AMINO]-2-CYCLOPENTENE-1-|||| |METHANOL) 2|N 2 AMINO 4 6|0.764 kg|| ||DICHLORO 5||| ||PYRIMDINYL|||

Case No.<br>27 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00009143AM24
RA File Number<br>09AX04001120 AM24
Licence No and Date<br>0911006926/15/03/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Jul/202425/7 dated 06.08.2024against
advance authorizationNo. 0911003379 dated 21.07.2022, it was decided to fix ad-hoc		norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>(1S,4R)-4-([(2-AMINO-6-CHLORO-5-<br>1 Kg.	VINCELACTAM	0.92 kg.
FORMAMIDO-4- PYRIMIDINYL)
AMINO]-2-CYCLOPENTENE-1-
METHANOL)<br>2	N 2 AMINO 4 6	0.764 kg
	DICHLORO 5
	PYRIMDINYL

UDIN00451692AM25

RO-5- 1 Kg.|VINCELACTAM|0.92 kg.|| |FORMAMIDO-4- PYRIMIDINYL)|||| |AMINO]-2-CYCLOPENTENE-1-|||| |METHANOL) 2|N 2 AMINO 4 6|0.764 kg|| ||DICHLORO 5||| ||PYRIMDINYL|||

UDIN00451692AM25

	FORMAMIDE
3	SODIUM BORO<br>HYDRIDE	0.226 kg.
4	L TARTARIC ACID	0.519 kg.
5	D TARTARIC ACID	0.76 kg.

Case No.	Case No.	28 / NC/3/MEET/Aug/202425/8	28 / NC/3/MEET/Aug/202425/8	28 / NC/3/MEET/Aug/202425/8	28 / NC/3/MEET/Aug/202425/8	28 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00009151AM24
RA File Number		03AX04005709 AM24
Licence No and<br>Date		0311032228/15/03/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Sep/202324/13 dated 14.09.2023against<br>advance authorizationNo. 0311025074 dated 03.07.2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

07.2023**, 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. Co-codamol 8/500 tablets (Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg) (Each Tablet contains Codeine Phosphate Hemihydrate 8mg and Paracetamol 500 mg (Net Wt.Codeine Phosphate Hemihydrate 640.00 KGS)) 1 Number 1 Codeine Phosphate Hemihydrate 8.16 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Co-codamol 8/500 tablets (Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg) (Each Tablet contains Codeine Phosphate Hemihydrate 8mg and Paracetamol 500 mg (Net Wt.Codeine Phosphate Hemihydrate 640.00 KGS))||1 Number|1|Codeine Phosphate Hemihydrate|8.16 mg.|

UDIN00451692AM25

|Co-codamol 15/500 tablets (Codeine Phosphate Hemihydrate 15mg and Paracetamol 500mg) (Each Tablet contains Codeine Phosphate Hemihydrate 15mg and Paracetamol 500mg (Net Wt.Codeine Phosphate Hemihydrate 2400.00 KGS)) 1 Number 2 Codeine Phosphate Hemihydrate 15.30 mg. Co-codamol 30/500 tablets (Codeine Phosphate Hemihydrate 30mg and Paracetamol 500mg)(Each Tablet contains Codeine Phosphate Hemihydrate 30mg and Paracetamol 500mg (Net Wt.Codeine Phosphate Hemihydrate 7980.00 KGS)) 1 Number 3 Codeine Phosphate Hemihydrate 30.60 mg. RA concerned may take further necessary action as per

<br>Paracetamol 500mg (Net Wt.Codeine<br>Phosphate Hemihydrate 7980.00 KGS))<br>1 Number<br>3<br>Codeine Phosphate<br>Hemihydrate<br>30.60 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Co-codamol 15/500 tablets (Codeine<br>Phosphate Hemihydrate 15mg and<br>Paracetamol 500mg) (Each Tablet contains<br>Codeine Phosphate Hemihydrate 15mg and<br>Paracetamol 500mg (Net Wt.Codeine<br>Phosphate Hemihydrate 2400.00 KGS))	1 Number	2	Codeine Phosphate<br>Hemihydrate	15.30 mg.
	Co-codamol 30/500 tablets (Codeine<br>Phosphate Hemihydrate 30mg and<br>Paracetamol 500mg)(Each Tablet contains<br>Codeine Phosphate Hemihydrate 30mg and<br>Paracetamol 500mg (Net Wt.Codeine<br>Phosphate Hemihydrate 7980.00 KGS))	1 Number	3	Codeine Phosphate<br>Hemihydrate	30.60 mg.

Case No.	29 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009169AM24
RA File Number	03AX04005784 AM24
Licence No and<br>Date	0311032244/16/03/2024

| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024| |HQ File Number|HQRNORM APPLY 00009169AM24| |RA File Number|03AX04005784 AM24| |Licence No and Date|0311032244/16/03/2024| |Norms Committee Decision: **Decision:**The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Step wise manufacturing process. I. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis. II. Complete technical details as per Annexure to Appendix 4E for chemical products. III. Stoichiometric balance between import and export on molar basis. IV. Details of indigenous input with quantity. V. Certificate of Analysis (CoA) of import product. VI.||

UDIN00451692AM25

between import and export on molar basis.** IV. Details of indigenous input with quantity. V. Certificate of Analysis (CoA) of import product. VI.||

UDIN00451692AM25

Case No.	Case No.	30 / NC/3/MEET/Aug/202425/8	30 / NC/3/MEET/Aug/202425/8	30 / NC/3/MEET/Aug/202425/8	30 / NC/3/MEET/Aug/202425/8	30 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		RECKITT BENCKISER (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00009195AM24
RA File Number		05AX04003835 AM24
Licence No and<br>Date		0511024563/18/03/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

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 SACCHARIN BASE 55Ox 4.50 mg DISPRIN REGUALAR (ASPIRIN PH.EUR 300MG) ACETYL SALICYLIC ACID 300 mg Tablet (ASPIRIN) 1 Number Tablet 2 CALCIUM CARBONATE EP 90.00 mg 3 SACCHARIN BASE 55Ox 7.50 mg DISPRIN EXTRA (ASPIRIN PH.EUR 500MG) ACETYL SALICYLIC ACID 500 mg Tablet (ASPIRIN) 1 Number Tablet 4 CALCIUM CARBONATE EP 150.00 mg 5 SACCHARIN BASE 55Ox 1.00 mg DISPRIN DIRECTS/MELTS (ASPIRIN PH.EUR 300MG) ACETYL SALICYLIC ACID 300 mg Tablet (ASPIRIN) 1 Number Tablet 6 GLYCINE EP 133.30 mg 7 SACCHARIN BASE 55Ox 0.334 mg DISPRIN CARDIOCARE (ASPIRIN BP 100MG) ACETYL SALICYLIC ACID 100 mg Tablet (ASPIRIN) 1 Number Tablet||||||| ||Export Product||Qty.|**Sl. No.

r>SACCHARIN BASE 55Ox 0.334 mg DISPRIN CARDIOCARE (ASPIRIN BP 100MG) ACETYL SALICYLIC ACID 100 mg Tablet (ASPIRIN) 1 Number Tablet||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DISPRIN REGUALAR (ASPIRIN PH.EUR 300MG) ACETYL SALICYLIC ACID 300 mg Tablet (ASPIRIN)|| 1 Number Tablet|1|SACCHARIN BASE 55Ox|4.50 mg| |||||2|CALCIUM CARBONATE EP|90.00 mg| ||DISPRIN EXTRA (ASPIRIN PH.EUR 500MG) ACETYL SALICYLIC ACID 500 mg Tablet (ASPIRIN)|| 1 Number Tablet|3|SACCHARIN BASE 55Ox|7.50 mg| |||||4|CALCIUM CARBONATE EP|150.00 mg| ||DISPRIN DIRECTS/MELTS (ASPIRIN PH.EUR 300MG) ACETYL SALICYLIC ACID 300 mg Tablet (ASPIRIN)|| 1 Number Tablet|5|SACCHARIN BASE 55Ox|1.00 mg| |||||6|GLYCINE EP|133.30 mg| ||DISPRIN CARDIOCARE (ASPIRIN BP 100MG) ACETYL SALICYLIC ACID 100 mg Tablet (ASPIRIN)|| 1 Number Tablet|7|SACCHARIN BASE 55Ox|0.334 mg| ||||||||

23 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

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8 GLYCINE EP 44.40 mg

Tablet|7|SACCHARIN BASE 55Ox|0.334 mg| ||||||||

23 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

UDIN00451692AM25

8 GLYCINE EP 44.40 mg

Case No.	Case No.	31 / NC/3/MEET/Aug/202425/8	31 / NC/3/MEET/Aug/202425/8	31 / NC/3/MEET/Aug/202425/8	31 / NC/3/MEET/Aug/202425/8	31 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00009202AM24
RA File Number		05AX04003994 AM24
Licence No and Date		0511024586/19/03/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

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. Progesterone Capsules 100mg((Each capsules contains 100 mg of Progesterone) (Equivalent to 300.000 Kg of bulk drug)) 3000000 Numbers 1 PROGESTERONE (MICRONIZED) 306 kg Progesterone Capsules 200mg((Each capsules contains 200 mg of Progesterone) (Equivalent to 600.000 Kg of bulk drug)) 3000000 Numbers 2 PROGESTERONE (MICRONIZED) 612 kg Progesterone Capsules 300mg((Each capsules contains 300 mg of Progesterone) (Equivalent to 900.000 Kg of bulk drug)) 3000000Numbers 3 PROGESTERONE (MICRONIZED) 918 kg Progesterone Capsules 400mg ((Each 3000000 PROGESTERONE 4 1224 kg||||||| ||Export Product||Qty.|**Sl. No.

k drug)) 3000000Numbers 3 PROGESTERONE (MICRONIZED) 918 kg Progesterone Capsules 400mg ((Each 3000000 PROGESTERONE 4 1224 kg||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Progesterone Capsules 100mg((Each capsules contains 100 mg of Progesterone) (Equivalent to 300.000 Kg of bulk drug))||3000000 Numbers|1|PROGESTERONE (MICRONIZED)|306 kg| ||Progesterone Capsules 200mg((Each capsules contains 200 mg of Progesterone) (Equivalent to 600.000 Kg of bulk drug))||3000000 Numbers|2|PROGESTERONE (MICRONIZED)|612 kg| ||Progesterone Capsules 300mg((Each capsules contains 300 mg of Progesterone) (Equivalent to 900.000 Kg of bulk drug))||3000000Numbers|3|PROGESTERONE (MICRONIZED)|918 kg| ||Progesterone Capsules 400mg ((Each||3000000|4|PROGESTERONE|1224 kg|

UDIN00451692AM25

|capsules contains 400 mg of Progesterone) (Equivalent to 1200.000 Kg of bulk drug)) Numbers (MICRONIZED) Progesterone Gel 4% w/w( (Each Injectable Applicator Gel contain 45mg of Progesterone Gel ) (Equivalent to 67.500 Kg of bulk drug)) 1500000Numbers 5 PROGESTERONE (MICRONIZED) 74.25 kg Progesterone Gel 8% w/w( (Each Injectable Applicator Gel contain 90mg of Progesterone Gel) (Equivalent to 135.000 Kg of bulk drug) (Pharmaceutical Formulations / Standard Grade) (Equivalent to total 3202.500 Kg of bulk drug)) 1500000Numbers 6 PROGESTERONE (MICRONIZED) 148.5 kg

capsules<br>contains<br>4<br>Progesterone)<br>(Equ<br>1200.000 Kg of bulk dr	00<br>mg<br>ivalent<br>ug))	<br>of<br>to	Nu	mbers		(MICRONIZED)

Progesterone Gel 4% w<br>Injectable Applicator G<br>45mg of Progesterone G<br>(Equivalent to 67.500 K<br>drug))	/w( (Eac<br>el contain<br>el )<br>g of bulk
		h<br>	150	0000Numbers	5	PROGESTERONE<br>(MICRONIZED)	74.25 kg


Progesterone Gel 8% w<br>Injectable Applicator G<br>90mg of Progesterone G<br>(Equivalent to 135.000<br>drug) (Pharmaceutical F<br>Standard Grade) (Equiv<br>3202.500 Kg of bulk dr	/w( (Each<br>el contain<br>el)<br>Kg of bul<br>ormulati<br>alent to t<br>ug))		150	0000Numbers	6	PROGESTERONE	148.5 kg
		<br> <br>				(MICRONIZED)
		k<br>ons /<br>otal

el) Kg of bul ormulati alent to t ug))||150|0000Numbers|6|PROGESTERONE|148.5 kg| ||||| ||||(MICRONIZED)|| |||||k ons / otal|||||| ||||||||||| ||||||||||| |||||||||||


Case No.		32 / NC/3/MEE	T/Aug/202425/8
Case Status		Case Deferred
Party Name		SALVI CHEMI	CAL INDUSTRIES LIMITED
Meeting Number<br>		NC/ 3/ MEET/	Aug/ 202425/ 8 and 28/08/2024
and Date

HQ File Number		HQRNORM A	PPLY 00009206AM24

RA File Number		03AX04005785 AM24
Licence No and<br>Date		0311032328/19/03/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br> <br>
	cision:The committee considered the request<br>the TE, it was decided to call for following inf			of firm<br>ormati	for f<br>on/do	ixation of ad-hoc norms and as pe<br>cuments from the firm:-	r the advise
	Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecula<br>stage wise percentage yields on molar basis.<br>ii.<br> <br>			r and<br>	struct<br>	ural formula and molecular weigh<br>	ts along with

plete chemical reactions with molecula** stage wise percentage yields on molar basis. ii. |||r and |struct |ural formula and molecular weigh |ts along with| |Complete technical details as per Annexure to Appendix 4E for chemical products. iii.||||||||

UDIN00451692AM25

iv. Stoichiometric balance between import and export on molar basis.
v. Details of indigenous input with quantity.
vi. Certificate of Analysis (CoA) of import product.

Case No.	33 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009209AM24
RA File Number	03AX04005812 AM24
Licence No and<br>Date	0311032330/19/03/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	34 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009219AM24
RA File Number	03AX04005814 AM24
Licence No and<br>Date	0311032351/20/03/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|03AX04005814 AM24| |Licence No and Date|0311032351/20/03/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	35 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024

26 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

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HQ File Number	HQRNORM APPLY 00009247AM24
RA File Number	03AX04005861 AM24
Licence No and<br>Date	0311032405/21/03/2024
Norms Committee Decision:
The Committee	considered the case as per agenda and it was decided to call the firm for attending
Personal Hearing on next meetingthrough Video Conference before Norms Committee to explain its
case alongwith following clarification / documents from the firm:
1. How the content of import item is more than content of export product, please clarify.

rms Committee to explain its|| |case alongwith following clarification / documents from the firm:|| |1. How the content of import item is more than content of export product, please clarify.||

Case No.<br>36 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00009262AM24
RA File Number<br>03AX04005888 AM24
Licence No and<br>Date<br>0311032428/21/03/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/May/202425/4 dated 06.06.2024against
advance authorizationNo. 0311032129 dated 13.03.2024, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
HALQUNOL BP 80<br>1 kg.<br>1	8 HYDROXY QUINOLINE	0.77 kg.
RA concerned may take further necessary action as per above decision of NC.

Case No.	37 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved

UDIN00451692AM25

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

Case No.	37 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved

UDIN00451692AM25

Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009269AM24
RA File Number	07AX04002026 AM24
Licence No and<br>Date	0711010859/21/03/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jun/202425/6 dated 01.07.2024against<br>advance authorizationNo. 0711008872 dated 02.08.2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>REBAMIPIDE JP<br>102.00 mg<br>REBAMIPIDE 100 MG TABLETS<br>[5392.157 KG]<br>1 Number<br>Tablet<br>2<br>Ethyl Alcohol 200<br>Proof<br>0.19 ml<br>RA concerned may take further necessary action as per above decision of NC.

g REBAMIPIDE 100 MG TABLETS [5392.157 KG] 1 Number Tablet 2 Ethyl Alcohol 200 Proof 0.19 ml RA concerned may take further necessary action as per above decision of NC.||

Case No.	38 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	DCM SHRIRAM INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009276AM24
RA File Number	05AX04003886 AM24
Licence No and<br>Date	0511024653/22/03/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise<br>of the TE, it was decided to call for following information/documents from the firm:-

UDIN00451692AM25

Reasons for low yield in stage one (48.37%) and stage 2 (85.9%) and yield for thired stage have not been given.
To indicate overall yield of the reaction and value of the by product, if any.
Stoichiometric Material balance of the reaction.

) and yield for thired stage have not been given.**

To indicate overall yield of the reaction and value of the by product, if any.
Stoichiometric Material balance of the reaction.

Case No.<br>39 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00009277AM24
RA File Number<br>03AX04005811 AM24
Licence No and<br>Date<br>0311032452/22/03/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Jun/202425/6 dated 01/07/2024against
advance authorizationNo.0311022711 dated 11/04/2023, it was decided to fix ad-hoc		norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
ETHYL ISOBUTYRATE<br>1 kg.<br>1	ISOBUTYRIC ACID	0.948 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	40 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	AVA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQFile Number	HQRNORM APPLY 00009279AM24

UDIN00451692AM25

UDIN00451692AM25

RA File Number

03AX04005818 AM24

Licence No and Date

0311032462/22/03/2024

Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Jan/202324/21 dated 24.01.2024against advance authorizationNo.0311023611 dated 16.05.2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. zinc diammonium edta (liquid)- zinc content 9% (? 1) 1 kg 1 ethylenediamine tetra acitic acid 0.422 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	41 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009329AM24
RA File Number	03AX04005978 AM24
Licence No and<br>Date	0311032511/26/03/2024
Norms Committee Decision:<br>Decision:The committee considered the case as per agenda and it was decided to fix ad-hoc norms as per<br>SION A-2005and RA Mumbai is to explain why Advance Authorization is not issued as per SION A-2005.

ommittee considered the case as per agenda and it was decided to fix ad-hoc norms as per SION A-2005and RA Mumbai is to explain why Advance Authorization is not issued as per SION A-2005.||

Case No.	42 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024

UDIN00451692AM25

and Date
HQ File Number<br>HQRNORM APPLY 00009334AM24
RA File Number<br>03AX04005534 AM24
Licence No and<br>Date<br>0311032537/26/03/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Mar/202324/26 dated 22.03.2024against
advance authorizationNo.0311031566 dated 28.02.2024, 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<br>Qty.	Sl. No.	Import Items	Qty. allowed.
Oxcarbazepine USP/BP/EP/IH<br>1 kg.	1	10-Methoxy Iminostilbene	1.10 kg.
RA concerned may take further necessary action as per above decision of NC.

**|Import Items|Qty. allowed.|| |Oxcarbazepine USP/BP/EP/IH 1 kg.|1|10-Methoxy Iminostilbene|1.10 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.<br>43 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00009337AM24
RA File Number<br>08AX04002293 AM24
Licence No and<br>Date<br>0811011114/27/03/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Mar/202324/26 dated 22.03.2024against
advance authorizationNo.0811010634 dated 01.02.2024, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.<br>Import Items	Qty. allowed.

UDIN00451692AM25

Tranexamic Acid in 0.7% Sodium	1 Number	1	Tranexamic acid	1.05 gm/100ml
Chloride Injection 1,000 mg per			(Injectable grade, US	Vial
100 mL (10 mg/mL)			FDA approved)

Tranexamic Acid in 0.7% Sodium	1 Number	1	Tranexamic acid	1.05 gm/100ml
Chloride Injection 1,000 mg per			(Injectable grade, US	Vial
100 mL (10 mg/mL)			FDA approved)

Case No.	44 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009338AM24
RA File Number	08AX04002294 AM24
Licence No and<br>Date	0811011115/27/03/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	45 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009339AM24
RA File Number	08AX04002292 AM24
Licence No and<br>Date	0811011116/27/03/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Mar/202324/26 dated 22.03.2024against
advance authorizationNo.0811010634 dated 01.02.2024, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00451692AM25

634** dated 01.02.2024, it was decided to fix ad-hoc norms under Para|| |4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00451692AM25

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<br>100 mL (10 mg/mL)<br>1 Number<br>1<br>Tranexamic acid<br>(Injectable grade, US<br>FDA approved)<br>1.05 gm/100ml<br>Vial<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Tranexamic Acid in 0.7% Sodium<br>Chloride Injection 1,000 mg per<br>100 mL (10 mg/mL)	1 Number	1	Tranexamic acid<br>(Injectable grade, US<br>FDA approved)	1.05 gm/100ml<br>Vial

Case No.	46 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009343AM24
RA File Number	03AX04006008 AM24
Licence No and<br>Date	0311032549/27/03/2024
Norms Committee Decision:<br>Decision:The committee considered the case as per agenda and it was decided to fix ad-hoc norms as per<br>SION A-3574and RA Mumbai is to explain why Advance Authorization is not issued as per SION A-<br>3574.

ttee considered the case as per agenda and it was decided to fix ad-hoc norms as per SION A-3574and RA Mumbai is to explain why Advance Authorization is not issued as per SION A- 3574.||

Case No.	47 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009354AM24
RA File Number	03AX04006015 AM24
Licence No and<br>Date	0311032562/27/03/2024
Norms Committee Decision:

UDIN00451692AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BENZYL BROMIDE	1 kg.	1	BENZYL ALCOHOL	0.7015 kg.
		2	HYDROBROMIC ACID 48%	1.12 kg.

less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BENZYL BROMIDE	1 kg.	1	BENZYL ALCOHOL	0.7015 kg.
		2	HYDROBROMIC ACID 48%	1.12 kg.

Case No.	Case No.	48 / NC/3/MEET/Aug/202425/8	48 / NC/3/MEET/Aug/202425/8	48 / NC/3/MEET/Aug/202425/8	48 / NC/3/MEET/Aug/202425/8	48 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		NIFTY LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00009357AM24
RA File Number		09AX04001147 AM24
Licence No and<br>Date		0911006991/27/03/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Thiophenol<br>0.554 kg<br>2<br>Hydrazien Hydrate 64%<br>0.823 kg.<br>QUETIAPINE FUMARATE<br>(BULK DRUG)<br>1 kg.<br>3<br>Poly Phosphoric Acid 117%<br>3.78 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	QUETIAPINE FUMARATE<br>(BULK DRUG)		1 kg.	1	Thiophenol	0.554 kg
				2	Hydrazien Hydrate 64%	0.823 kg.
				3	Poly Phosphoric Acid 117%	3.78 kg.

UDIN00451692AM25

*|Qty. allowed.| ||QUETIAPINE FUMARATE (BULK DRUG)||1 kg.|1|Thiophenol|0.554 kg| |||||2|Hydrazien Hydrate 64%|0.823 kg.| |||||3|Poly Phosphoric Acid 117%|3.78 kg.|

UDIN00451692AM25

Case No.	49 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009358AM24
RA File Number	03AX04006024 AM24
Licence No and<br>Date	0311032573/27/03/2024
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm and it has been observed by the committee that input AMBROZANE<br>AB22005 (Perfumery Compound) as applied by the firm comes under para 4.11(b) of FTP, 2023, and the<br>said para states that “For export of perfumes, perfumery compounds and various feed ingredients<br>containing vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP and<br>applicants shall be required to apply under para 4.06 of HBP to the Norms Committee” and also it was<br>decided to call for following information/documents from the firm:-<br>Step wise manufacturing process.<br>I.<br>Complete chemical reactions with molecular and structural formula and molecular<br>weights along with stage wise percentage yields on molar basis.<br>II.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>III.<br>**Stoichiometric balance between import and export on molar

ercentage yields on molar basis.** II. Complete technical details as per Annexure to Appendix 4E for chemical products. III. Stoichiometric balance between import and export on molar basis. IV. Details of indigenous input with quantity. V. Certificate of Analysis (CoA) of import product. VI.||

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

Case No.	50 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009360AM24

35 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

UDIN00451692AM25

RA File Number	03AX04006006 AM24
Licence No and<br>Date	0311032575/27/03/2024
Norms Committee Decision:
Decision:Th	mmitt nidrd th rt f firm fr fitin f dh nrm nd r th di
e c<br>of the TE it was	ee cosee e eques o o xao o a-oc os a as pe e avse<br>decided to call for followin information/documents from the firm:-
,	g
<br>
Certificat<br>1.<br> <br>	e of Analysis (CoA) of export item.<br>
Calculatio<br><br>2.	n of the requirement raw materials based on chemical reaction and yield of the
reaction.<br>Stoichiom<br>3.	etric material balance of the reaction.

alculatio** 2.|n of the requirement raw materials based on chemical reaction and yield of the| |reaction. Stoichiom 3.|etric material balance of the reaction.| ||| |||

Case No.	51 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number
and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009370AM24
RA File Number	05AX04004025 AM24
Licence No and
Date	0511024728/28/03/2024
Norms Committee	Decision:
Decision:The<br>	Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Tobramycin Inhalation / Nebuliser<br>Solution 300mg / 5ml((Each ml contains<br>Tobramycin 60mg) (Equivalent to<br>403.200 Kg of Bulk Drug))<br>1344000.0<br>Numbers<br>1<br>Tobramycin<br>423.36 kg<br>RA concerned may take further necessary action as per above decision of NC.

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o 403.200 Kg of Bulk Drug)) 1344000.0 Numbers 1 Tobramycin 423.36 kg RA concerned may take further necessary action as per above decision of NC.|| |||

UDIN00451692AM25

Case No.	52 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00009394AM24
RA File Number	03AX04006080 AM24
Licence No and<br>Date	0311032677/31/03/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jun/202425/5 dated 14.06.2024against<br>HQ File No.HQRNORMAPPLY00008586AM24it 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>4,6 Dichloro 5-Methoxy Pyrimidine<br>(DCMP)<br>0.78 kg.<br>2<br>SULFANILAMIDE<br>0.90 kg.<br>3<br>Diethyl oxalate<br>Not shown in<br>process.<br>SULFADOXINE<br>1 kg<br>4<br>DIMETHYL FORMAMIDE (DMF)<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	53 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	INDOCO REMEDIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024

UDIN00451692AM25

NC/3/MEET/Aug/202425/8| |---|---| |Case Status|Case Approved| |Party Name|INDOCO REMEDIES LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024|

UDIN00451692AM25

HQ File Number	HQ File Number	HQRNORM APPLY 00000009AM25	HQRNORM APPLY 00000009AM25	HQRNORM APPLY 00000009AM25	HQRNORM APPLY 00000009AM25	HQRNORM APPLY 00000009AM25
RA File Number		03AX04006036 AM24
Licence No and Date<br>		0311032713/01/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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

der 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.|| ||||||||||||| ||Brimonidine|Tartrate /Timolol|||1 Number||1||Timolol Maleate|25.50 mg.|| ||ophthalmic s|olution 0.2%/0.5% (5 ml|||||||||| || Bottle)((Each| ml Contains :|||||||||| ||Brimonidine Timolol Mal|Tartrate 2mg and eate 6.8 mg equivalent to|||||2||BOTTLE|Relevant as per Packing Policy & || ||Timolol 5mg|) (Each 5 ml Bottle||||||||General Notes.|| ||Contains : Br|imonidine Tartrate 10mg|||||||||| ||||||||||||| ||and Timolol of Timolol M|Maleate 34 mg ) - Net wt aleate 6.800 kgs)|||||3||CAP|Relevant as per Packing Policy &|| ||||||||||| General Notes.|| ||||||||4||DROPPER|Relevant as per Packing Policy &|| |||||||||||| General Notes.| ||||||||||||| ||Brimonidine Tartrate /Timolol ophthalmic solution 0.2%/0.5% Bottle )((Each ml Contains : Brimonidine Tartrate 2mg and Timolol Maleate 6.8mg equivale Timolol 5mg) (Each 10 ml Bottl Contains :Brimonidine Tartrate and Timolol Maleate 68 mg ) -N of Timolol Maleate 10.200 kgs)|||(10 ml nt to e 20mg et wt| 1 N|umber||5|Timolol Maleate||51.00 mg.| ||||||||||||| |||||||||6|BOTTLE||Relevant as per Packing Policy & | ||||||||||||General Notes.| ||||||||||||| |||||||||7|CAP||Relevant as per Packing Policy & General Notes.| ||||||||||||| ||||||||8||DROPPER|Relevant as per|| ||||||||||| Packing Policy & General Notes.|| |||||||||||||

||||||||||| |||||||||7|CAP||Relevant as per Packing Policy & General Notes.| ||||||||||||| ||||||||8||DROPPER|Relevant as per|| ||||||||||| Packing Policy & General Notes.|| ||||||||||||| ||Brimonidine Tartra||e /Timolol||1 Number||9||Timolol Maleate|76.50 mg.|| ||||||||||||| |||||||||||||

UDIN00451692AM25


ophthalmic solution<br>	0.2%/0.5% (15 ml<br>			10		BOTTLE	Relevant as per<br>
Bottle )((Each ml C<br>	ontains :<br>						Packing Policy &<br>
Brimonidine Tartrat	e 2mg						General Notes.
and Timolol Maleat	e 68mg equivalent

.<br>to Timolol 5mg) (Each 15 ml Contains<br>:Brimonidine Tartrate 30mg and<br>Timolol Maleate 102 mg ) – Net wt of<br>Timolol Maleate 5.100 kgs)		<br>		11		CAP	Relevant as per<br>Packing Policy &<br>General Notes.

					12	DROPPER	R<br>Pa<br>G	elevant as per<br>cking Policy &<br>eneral Notes.

Dorzolamide Hydrochloride -<br>Timolol Maleate Ophthalmic<br>		1 Numb	er		13	Timolol Maleate		25.50 mg.

Solution USP (5 ml Bottle)((Each<br>ml Contains:Dorzolamide<br>Hydrochloride 22.3mg equivalent<br>to Dorzolamide 20mg and Timolol					14	BOTTLE	R<br>Pa<br>G	elevant as per<br>cking Policy &<br>eneral Notes.
<br>Maleate 6.8mg equivalent to<br>Timolol 5mg) (Each 5ml Contains:
				15		CAP	Relevant as per

l||||||||14|BOTTLE|R Pa G|elevant as per cking Policy & eneral Notes.| || Maleate 6.8mg equivalent to Timolol 5mg) (Each 5ml Contains:|||||||||||| |||||||||15||CAP|Relevant as per|| ||Dorzolamide Hydrochloride 111.50mg &Timolol Maleate 34 mg) Net wt of Timolol Maleate 6.800 kgs)||||||||||Packing Policy & General Notes.|| |||||||||16||DROPPER|Relevant as per|| |||||||||||| Packing Policy &|| |||||||||||| General Notes.|| |||||||||||||| |||||||||||||| ||Dorzolamide Hydrochl Till Ml Oh||oride - li||1 Number|||17||Timolol Maleate|51.00 mg.|| ||moo aeate pt Slti USP (10 l B||amc ttl)((Eh|||||||||| |||||||||||||| ||ouon m ml Contain: Dorzolami||eac de|||||18||BOTTLE|Relevant as per|| || Hydrochloride 22.3mg equivalent to Dorzolamide 20mg and Timolol Maleate 6.8mg equivalent to Timolol 5mg) (Each 10ml Contains:||||||||||Packing Policy & General Notes.|| |||||||||19||CAP|Relevant as per Packing Policy & General Notes|| ||Dorzolamide Hydrochloride 223 mg &Timolol Maleate 68 mg) Net f Till Ml 6800 k|||||||||||.| |||||||||20||DROPPER|R|elevant as er| ||wt o moo aeate . gs)|||||||||| Pa G|p cking Policy & eneral Notes.| ||||||||||||||

UDIN00451692AM25

et f Till Ml 6800 k|||||||||||.| |||||||||20||DROPPER|R|elevant as er| ||wt o moo aeate . gs)|||||||||| Pa G|p cking Policy & eneral Notes.| ||||||||||||||

UDIN00451692AM25

Case No.<br>54 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and	28/08/2024
HQ File Number<br>HQRNORM APPLY 00000010AM25
RA File Number<br>09AX04001031 AM24
Licence No and<br>Date<br>0911007011/01/04/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision			for same export
product/import item in meetingNo.NC/3/MEET/Jan/202324/21 dated 24.01.2024against advance
Authorization No.0911006353 dated 11.12.2023it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the		firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
RIFAXIMIN(Ph. Eur)<br>1 kg.	1	4-O-Carboxymethyl-1-Deoxy-	1.50 kg.
		1,4-Dihydro-4-Hydroxy-1-
		Oxorifamycin-γ-Lactone
RA concerned may take further necessary action	as per above decision of NC.

r) 1 kg.||1|4-O-Carboxymethyl-1-Deoxy-|1.50 kg.|| ||||1,4-Dihydro-4-Hydroxy-1-||| ||||Oxorifamycin-γ-Lactone||| |RA concerned may take further necessary action||as per above decision of NC.||||

Case No.	55 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000011AM25
RA File Number	09AX04001077 AM24
Licence No and Date	0911007013/01/04/2024
Norms Committee Decision:

UDIN00451692AM25

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Aug/202324/11 dated 22.08.2023 against advance Authorization No. 0911003559 dated 30.08.2022 it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Empagliflozin-IH	1 kg.	1	(1S)-1,5-Anhydro-1-(4-Chloro-3-{4-	1.30 kg.
			[(3S)- Tetra hydrofuran-3-
			yloxy]Benzyl}Phenyl)-D-Glucitol

port Items**|Qty. allowed.| |---|---|---|---|---| |Empagliflozin-IH|1 kg.|1|(1S)-1,5-Anhydro-1-(4-Chloro-3-{4-|1.30 kg.| ||||[(3S)- Tetra hydrofuran-3-|| ||||yloxy]Benzyl}Phenyl)-D-Glucitol||

Case No.	56 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000028AM25
RA File Number	30AX04000590 AM24
Licence No and<br>Date	3011005003/02/04/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	Case No.	57 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number an	d Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00000043AM25
RA File Number		03AX04006083 AM24
Licence No and Da	te	0311032759/02/04/2024
Norms Committee	Decision:

UDIN00451692AM25

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202425/4 dated 06.06.2024 against advance Authorization No. 0311023981 dated 26.05.2023 it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

advance Authorization No. 0311023981 dated 26.05.2023 it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
LUMEFANTRINE	1 kg.	1	FLUORENE	0.90 kg.
		2	DIMETHYL FORMAMIDE (DMF)	0.50 kg.
		3	DI N BUTYLAMINE (N-DBA)	0.060 kg.
		4	4-CHLOROBENZALDEHYDE	0.3476 kg.
		5	SODIUM BOROHYDRIDE	0.555 kg.

Case No.	58 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000050AM25
RA File Number	08AX04000003 AM25
Licence No and<br>Date	0811011199/02/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00451692AM25

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:-||

UDIN00451692AM25

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL (5 mL)<br>1 Number<br>1<br>Phenylephrine HCl<br>USP/Ph.Eur<br>55 mg / Vial<br>Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL(10 mL)<br>1 Number<br>2<br>Phenylephrine HCl<br>USP/Ph.Eur<br>110 mg / Vial<br>RA concerned may take further necessary action as per above decision of NC	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL (5 mL)	1 Number	1	Phenylephrine HCl<br>USP/Ph.Eur	55 mg / Vial
	Phenylephrine Hydrochloride<br>Injection USP, 10 mg/mL(10 mL)	1 Number	2	Phenylephrine HCl<br>USP/Ph.Eur	110 mg / Vial

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

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

Case No.	59 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000061AM25
RA File Number	05AX04004115 AM24
Licence No and<br>Date	0511024832/03/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Fluorometholone Acetate 0.1% &<br>Tobramycin 0.3% ophthalmic<br>suspension - 5ml (Each ml contains 3<br>mg of Tobramycin)<br>1 Number<br>1<br>Tobramycin USP IP<br>15.75 mg<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00451692AM25

(Each ml contains 3 mg of Tobramycin) 1 Number 1 Tobramycin USP IP 15.75 mg RA concerned may take further necessary action as per above decision of NC.||

UDIN00451692AM25


Cas	e No.	60 / NC/3/MEET/Aug/202425/8
Cas	e Status	Case Deferred
Par	ty Name	LAURUS SYNTHESIS PRIVATE	LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and	28/08/2024
HQ	File Number	HQRNORM APPLY 00000065AM	25

RA	File Number	09AX04001116 AM24
Lic<br>Dat	ence No and<br>e	0911007027/03/04/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.	ms Committee Decision:<br>ecision: The case is under consideration an		d TE was re	ested to	exedite his comm	ents

Case No.	61 / NC/3/MEET/Aug/202425/8	61 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED

Meeting Number
<br>and Date	NC/ 3/	MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRN	ORM APPLY 00000066AM25
RA File Number	09AX0	4001075 AM24
Licence No and
Date	09110	7031/03/04/2024

202425/ 8 and 28/08/2024||||||||| |HQ File Number||HQRN|ORM APPLY 00000066AM25||||||||| |RA File Number||09AX0|4001075 AM24||||||||| |Licence No and|||||||||||| |Date||09110|7031/03/04/2024||||||||| |Norms Committee Decisio|||n:||||||||| ||||||||||||| |Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202324/11 dated 22.08.2023against advance Authorization No.0911003559 dated 30.08.2022it 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. Empagliflozin-IH 1 kg. 1 (3R,4S,5S,6R)-2-(4-Chloro-3-(4-(((S)- Tetra hydro furan-3-yl)oxy) Benzyl) Phenyl)-6-(Hydroxyl Methyl)-2- Methoxytetra 1.525 kg.|||||||||||| ||Export Product|||Qty.|Sl.|**No. **|Imp|ort Ite|ms||Qty. allowed.| ||||||||||||| ||Empagliflozin-IH|||1 kg.|1||(3R Tetr Phe|,4S,5S,6 a hydro nyl)-6-(|R)-2-(4-Chloro-3-(4-(((S)- furan-3-yl)oxy) Benzyl) Hydroxyl Methyl)-2-||1.525 kg.| |||||||| Methoxytetra||||| ||||||||||||| |||||||||||||

UDIN00451692AM25

a hydro nyl)-6-(|R)-2-(4-Chloro-3-(4-(((S)- furan-3-yl)oxy) Benzyl) Hydroxyl Methyl)-2-||1.525 kg.| |||||||| Methoxytetra||||| ||||||||||||| |||||||||||||

UDIN00451692AM25

Case No.	62 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	PLASTIBLENDS INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000067AM25
RA File Number	03AX04006127 AM24
Licence No and<br>Date	0311032797/03/04/2024
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise
of the TE, it was	decided to call for following information/documents from the firm:-
Please explain the use of BOPP (which is a film) in manufacturing of Additive Masterbatch.

Case No.<br>63 / NC/3/MEET/Aug/202425/8	Case No.<br>63 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00000076AM25
RA File Number<br>03AX04006163 AM24
Licence No and Date<br>0311032812/04/04/2024
Norms Committee Decision:
	Decision:The Committee considered the request of firm in details and also discussed report of factory
	visit. The committee found that in the above mention case export product is in form	of Gel not a
	cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-
	Sl.

factory||| ||visit. The committee found that in the above mention case export product is in form|of Gel not a|| ||cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-||| ||Sl. No. Export Product|Quantity||

UDIN00451692AM25

1	Medical Creams and Ointments(ADAPALENE GEL 0.3% 45GM Tube	Wt:	1 Number
	7499.97 Kgs (Net Cont: Adapal22.50Kgs, Edetate7.50Kgs, Poloxamer15Kgs,
	Carbomer82.5Kgs,<br>Methy15Kgs,<br>Propel300Kgs,<br>sodium	Hy
	26.25Kgs,Hydrocl37.50Kgs,Tubes166666Nos))
2	Medical Creams and Ointments(ADAPALENE GEL 0.3% 45GM Pump		1 Number
	Wt:<br>750.06Kgs<br>(Net<br>Cont:<br>Adapal2.25Kgs,<br>Edetate0.75Kgs,
	Poloxamer1.50Kgs, Carbomer8.25Kgs, Methyl1.50Kgs, Propel30Kgs,
	sodium Hy 2.63Kgs, Hydrocl3.75Kgs,Pump body16668Nos Pump Engine
	16668Nos))

Sl. No.	Import Items<br>Quantity allowed.
1	Relevant Bulk Drugs<br>Net content in the export product plus 2% wastage.
2	Relevant Excipients<br>Net content in the export product plus 2% wastage.
3	Relevant Packaging Material<br>Relevant as per Packing Policy & Genral Notes.

Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	64 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000084AM25
RA File Number	08AX04002289 AM24
Licence No and<br>Date	0811011217/04/04/2024
Norms Committee Decision:

46 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

UDIN00451692AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
TRETINOIN CREAM USP 0.1%	<br>505500	1	TRETINOIN USP	10312.20 gm.
20 GRAM (EACH GRAM	Numbers
CONTAIN 1.10 MG OF<br>TRETINOIN USP) ((NET		2	ALUMINIUM TUBES<br>FOR TRETINOIN	Relevant as per<br>Packing Policy
CONTENT OF ACTIVE			CREAM USP 0.1% 20	and Genral
INGREDIENT : TRETINOIN			GRAM	Notes
USP - 11121.000 GRAMS))
TRETINOIN CREAM USP	639000	3	TRETINOIN USP	29330.10 gm.
0.1% 45 GRAM (EACH GRAM	Numbers
CONTAIN 1.10 MG OF<br>TRETINOIN USP)((NET		4	ALUMINIUM TUBES<br>FOR TRETINOIN	Relevant as per<br>Packing Policy
CONTENT OF ACTIVE			CREAM USP 0.1% 45	and Genral
INGREDIENT : TRETINOIN			GRAM	Notes
USP - 31630.500 GRAMS))

((NET||4|ALUMINIUM TUBES FOR TRETINOIN|Relevant as per Packing Policy| |CONTENT OF ACTIVE|||CREAM USP 0.1% 45|and Genral| |INGREDIENT : TRETINOIN|||GRAM|Notes| |USP - 31630.500 GRAMS))|||||

Case No.	65 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000093AM25
RA File Number	08AX04002290 AM24
Licence No and<br>Date	0811011225/04/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for

UDIN00451692AM25

same export product/import item in meeting No.NC/3/MEET/Mar/202324/25 dated 11.03.2024 against advance Authorization No. 0811009842 dated 02.11.2023 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:-

advance Authorization No. 0811009842 dated 02.11.2023 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.
Metamizole Sodium,<br>Pitofenone Hydrochloride<br>&Fenpiverinium Bromide<br>Tablets. (Spasmalin Tablets<br>500mg).(Each coated tablet<br>contains 500 MG of<br>Metamizole Sodium B P mg<br>Excipients...as per q.s.	25000000<br>Numbers	1	Metamizole Sodium B. P.	12750 kg.
Metamizole Sodium,<br>Pitofenone Hydrochloride<br>&Fenpiverinium Bromide<br>Tablets. (Spasmalin Tablets<br>500mg).(Each coated tablet<br>contains 500 MG of<br>Metamizole Sodium B P mg<br>Excipients...as per q.s.	13635000<br>Numbers	2	Metamizole Sodium B. P.	6953.85 kg.

Case No.	66 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number and<br>Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000095AM25
RA File Number	08AX04002339 AM24
Licence No and Date	0811011226/04/04/2024
Norms Committee Decision:

UDIN00451692AM25

/ 8 and 28/08/2024| |HQ File Number|HQRNORM APPLY 00000095AM25| |RA File Number|08AX04002339 AM24| |Licence No and Date|0811011226/04/04/2024| |Norms Committee Decision:||

UDIN00451692AM25

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jun/202425/6 dated 01.07.2024 against advance Authorization No. 0811009102 dated 16.08.2023 it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

D<br>sa<br>ad<br>4.	ecision:The Committee consid<br>me export product/import item<br>vance Authorization No.0811<br>07 of HBP Vol. I as per details	ecision:The Committee consid<br>me export product/import item<br>vance Authorization No.0811<br>07 of HBP Vol. I as per details	ered the<br>in mee<br>009102 d<br>given be	ered the<br>in mee<br>009102 d<br>given be	case a<br>tingNo	s per agenda and taking cue from the e<br>.NC/3/MEET/Jun/202425/6 dated 0	s per agenda and taking cue from the e<br>.NC/3/MEET/Jun/202425/6 dated 0	s per agenda and taking cue from the e<br>.NC/3/MEET/Jun/202425/6 dated 0	s per agenda and taking cue from the e<br>.NC/3/MEET/Jun/202425/6 dated 0	arlier decision for<br>1.07.2024against
					ated 1<br>low or	6.08.2023it was decided to fix ad-hoc<br>as applied by the firm, whichever is less				norms under Para<br>:-

|---|---|---|---|---|---|---|---|---|---|---| ||||||ated 1 low or|6.08.2023it was decided to fix ad-hoc as applied by the firm, whichever is less||||norms under Para :-| |||||||||||| ||Export Product|||||||||| ||||||Qty|.|Sl. No.|Import Items||Qty. allowed.| |||||||||||| ||Opipramol Dihydrochloride Tablets 50 MG (OPIPRAMOL HEUMANN 50 MG) (Each film coated tablet contains: Opipramol|||1 Number|||1|Opipramol Dihydrochloride|51 mg/Tablet|| ||Dihydrochloride 50 mg Excipients q.s.|||||||||| |||||||||||| |||||||||||| ||Opipramol D|ihydrochloride Tablets||1 Number|||2|Opipramol|102mg/Tablet|| ||100 MG (OP|IPRAMOL||||||Dihydrochloride||| ||HEUMANN coated tablet|100 MG) (Each film contains: Opipramol||||||||| ||Dihydrochlor|ide 100 mg||||||||| ||Excipients.q.|s.||||||||| |||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||| ||||||||||||

Case No.	67 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000096AM25
RA File Number	08AX04000006 AM25
Licence No and Date	0811011227/04/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for

UDIN00451692AM25

o and Date|0811011227/04/04/2024| |Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and taking cue from the earlier decision for||

UDIN00451692AM25

same export product/import item in meeting No.NC/3/MEET/Jun/202425/6 dated 01.07.2024 against advance Authorization No. 0811008977 dated 01.08.2023 it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

|same export product/import item in meetingNo.NC/3/MEET/Jun/202425/6 dated 01.07.2024against advance Authorization No.0811008977 dated 01.08.2023it 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. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 0.180 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 1.440 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH.

HAN 1.440 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 5.760 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 399.226 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg|same export product/import item in meetingNo.NC/3/MEET/Jun/202425/6 dated 01.07.2024against advance Authorization No.0811008977 dated 01.08.2023it 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. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 0.180 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH.

HAN 0.180 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 1.440 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 5.760 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 399.226 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg|same export product/import item in meetingNo.NC/3/MEET/Jun/202425/6 dated 01.07.2024against advance Authorization No.0811008977 dated 01.08.2023it 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. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH.

ss:- Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 0.180 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 1.440 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 5.760 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 399.226 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg|same export product/import item in meetingNo.NC/3/MEET/Jun/202425/6 dated 01.07.2024against advance Authorization No.0811008977 dated 01.08.2023it 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.

1.08.2023it 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. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 0.180 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 1.440 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 5.760 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 399.226 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg|same export product/import item in meetingNo.NC/3/MEET/Jun/202425/6** dated 01.07.2024against advance Authorization No.0811008977 dated 01.08.2023it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

t item in meetingNo.NC/3/MEET/Jun/202425/6 dated 01.07.2024against advance Authorization No.0811008977 dated 01.08.2023it 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. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 0.180 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 1.440 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 5.760 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH.

AN 5.760 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 399.226 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg|same export product/import item in meetingNo.NC/3/MEET/Jun/202425/6 dated 01.07.2024against advance Authorization No.0811008977 dated 01.08.2023it 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. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 0.180 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 1.440 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH.

HAN 1.440 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 5.760 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 399.226 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 0.180 KG IN EXPORT ITEM)|1 Number|1|CANDESARTAN CILEXETIL PH.EUR|2.04 mg| ||CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 1.440 KG IN EXPORT ITEM)|1 Number|2|CANDESARTAN CILEXETIL PH.EUR|4.08 mg| ||CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH.

OT BE LESS THAN 1.440 KG IN EXPORT ITEM)|1 Number|2|CANDESARTAN CILEXETIL PH.EUR|4.08 mg| ||CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 5.760 KG IN EXPORT ITEM)|1 Number|3|CANDESARTAN CILEXETIL PH.EUR|8.16 mg| ||CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 399.226| 1 Number|4|CANDESARTAN CILEXETIL PH.EUR|16.32 mg|

UDIN00451692AM25

KG IN EXPORT ITEM)
CANDESARTAN CILEXETIL 32 MG<br>TABLETS(EACH UNCOATED<br>TABLET CONTAINS :<br>CANDESARTAN CILEXETIL PH. EUR<br>32 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN 14.400<br>KG IN EXPORT ITEM)	1 Number	5	CANDESARTAN<br>CILEXETIL PH.EUR	32.64 mg
CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E<br>TABLETS 8 MG +12.5 MG(EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN CILEXETIL PH. EUR<br>8 MG AND<br>HYDROCHLOROTHIAZIDE PH. EUR.<br>12.5 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN 2.520<br>KG IN EXPORT ITEM)	1 Number	6	CANDESARTAN<br>CILEXETIL PH.EUR	8.16 mg
CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E<br>TABLETS 16 MG +12.5 MG(EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN CILEXETIL PH. EUR<br>16 MG AND<br>HYDROCHLOROTHIAZIDE PH.

PH.EUR|8.16 mg| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 16 MG +12.5 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 16 MG AND HYDROCHLOROTHIAZIDE PH. EUR. 12.5 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 46.800 KG IN EXPORT ITEM)|1 Number|7|CANDESARTAN CILEXETIL PH.EUR|16.32 mg| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 32 MG +12.5 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH. EUR. 12.5 MG NET CONTENT OF|1 Number|8|CANDESARTAN CILEXETIL PH.EUR|32.64 mg|

UDIN00451692AM25

CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN 11.520<br>KG IN EXPORT ITEM)<br>CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E<br>TABLETS 32 MG +25 MG(EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN CILEXETIL PH.<br>EUR 32 MG AND<br>HYDROCHLOROTHIAZIDE PH<br>EUR. 25 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN<br>11.520 KG IN EXPORT ITEM)<br>1 Number<br>9<br>CANDESARTAN<br>CILEXETIL PH.EUR<br>32.64 mg<br>RA concerned may take further necessary action as per above decision of NC.	CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN 11.520<br>KG IN EXPORT ITEM)
	CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E<br>TABLETS 32 MG +25 MG(EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN CILEXETIL PH.<br>EUR 32 MG AND<br>HYDROCHLOROTHIAZIDE PH<br>EUR.

-|---|---| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 32 MG +25 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH EUR. 25 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 11.520 KG IN EXPORT ITEM)|1 Number|9|CANDESARTAN CILEXETIL PH.EUR|32.64 mg|

Case No.	Case No.	68 / NC/3/MEET/Aug/202425/8	68 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00000101AM25
RA File Number		03AX04006141 AM24
Licence No and<br>Date		0311032832/05/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the request of firm in details and also discussed report of factory<br>visit. The committee found that in the above mention case export product is in form of Gel not a<br>cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-<br>Sl. No.<br>Export Product<br>Quantity<br>MEDICAL CREAM AND OINTMENT(Testosterone Gel 1%,88gm Pump Pack Tot Wt<br>5280Kg (Net Cont. TestosteroneUSP-52.80 kg, Ethanol 96% -<br>1<br>1 Number
	Export Product		Quantity
	MEDICAL CREAM AND OINTMENT(Testosterone Gel 1%,88gm Pump Pack Tot Wt<br>5280Kg (Net Cont. TestosteroneUSP-52.80 kg, Ethanol 96% -		1 Number

6% - 1 1 Number|||| ||Export Product||Quantity| ||MEDICAL CREAM AND OINTMENT(Testosterone Gel 1%,88gm Pump Pack Tot Wt 5280Kg (Net Cont. TestosteroneUSP-52.80 kg, Ethanol 96% -||1 Number|

Case No.	Case No.	68 / NC/3/MEET/Aug/202425/8	68 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00000101AM25
RA File Number		03AX04006141 AM24
Licence No and<br>Date		0311032832/05/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the request of firm in details and also discussed report of factory<br>visit. The committee found that in the above mention case export product is in form of Gel not a<br>cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-<br>Sl. No.<br>Export Product<br>Quantity<br>MEDICAL CREAM AND OINTMENT(Testosterone Gel 1%,88gm Pump Pack Tot Wt<br>5280Kg (Net Cont. TestosteroneUSP-52.80 kg, Ethanol 96% -<br>1<br>1 Number
	Export Product		Quantity
	MEDICAL CREAM AND OINTMENT(Testosterone Gel 1%,88gm Pump Pack Tot Wt<br>5280Kg (Net Cont. TestosteroneUSP-52.80 kg, Ethanol 96% -		1 Number

UDIN00451692AM25

||Export Product||Quantity| ||MEDICAL CREAM AND OINTMENT(Testosterone Gel 1%,88gm Pump Pack Tot Wt 5280Kg (Net Cont. TestosteroneUSP-52.80 kg, Ethanol 96% -||1 Number|

UDIN00451692AM25

	3832.22kg,IsopropylMyristateNF-26.40kg,Carbopol980 NF -47.52kg, Sodium Hydroxide
	NF- 10.03kg,WHITE COLORS OF BAG BOTTLE 112mL-60000nos, SP943+PUMP
	60000nos))
2	MEDICAL CREAM AND OINTMENT(Testosterone Gel 1%, 5g Sachet Tot Wt	1 Number
	7350Kg(Testosterone USP-73.5kg,Ethanol 96 %-5334.63kg,Isopropyl Myristate NF -
	36.75kg,Carbopol 980 NF-66.15kg,Sodium Hydroxide NF-13.97kg))
3	MEDICAL CREAM AND OINTMENT(Testosterone Gel 1%, 2.5g Sachet Tot Wt	1 Number
	1425Kg(Testosterone USP14.25kg, Ethanol 96 %- 1034.27 kg, Isopropyl Myristate NF-
	7.13kg,Carbopol 980 NF-12.83kg, Sodium Hydroxide NF 2.71kg))

Sl. No.	Import Items	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 & General Notes

Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	69 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000102AM25
RA File Number	03AX04006162 AM24
Licence No and<br>Date	0311032839/05/04/2024

53 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

UDIN00451692AM25

Norms Committee Decision:

Sl. No.	Export Product	Quantity
1	Medical Creams & Ointments(Fluocinolone Acetonide Topical Solution USP	1 Number
	0.01 % (60 ML) Tot Wt: 24000Kgs (Net Cont: Fluocinolone 2.40Kgs, 2 Oz.
	White HDPE 400000Nos, White PP dropper 400000Nos, 20MM Natural LLDPE
	400000Nos))

Sl. No.	Import Items	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 & General Notes

Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	70 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	LIVMORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000105AM25
RA File Number	34AX04000777 AM24
Licence No and	3411004764/05/04/2024

54 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

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Date

Norms Committee Decision:

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

Complete chemical description of import item with CoA from Foreign Supplier.

Case No.	71 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	LIVMORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000106AM25
RA File Number	34AX04000776 AM24
Licence No and<br>Date	3411004765/05/04/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for review/fixation of ad-hoc norms and as per<br>the advise of the TE, it was decided to call for following information/documents from the firm:-<br>Complete chemical description of import item with CoA from Foreign Supplier.

and as per the advise of the TE, it was decided to call for following information/documents from the firm:- Complete chemical description of import item with CoA from Foreign Supplier.||

Case No.	72 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000108AM25
RA File Number	03AX04000029 AM25
Licence No and<br>Date	0311032850/05/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

55 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

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Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Idezar 150 mg Tablets 28 S (Irbesartan<br>Tablets 150 Mg 28 S )((15,175 Boxes X<br>28 Tablets per Boxes = 4,24,900<br>Tablets) (Total Weight of Export<br>Product = 63.735 Kgs)	<br>1 Number	1	Irbesartan Ph. Eur.	153 mg
Idezar 300 mg Tablets 28 S (Irbesartan<br>Tablets 300 Mg 28 S )((37,800 Boxes X<br>28 Tablets per Boxes = 10,58,400<br>Tablets) (Total Weight of Export<br>Product = 317.520 Kgs)	<br>1 Number	2	Irbesartan Ph. Eur.	306 mg

Case No.	73 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000145AM25
RA File Number	03AX04000009 AM25
Licence No and<br>Date	0311032889/08/04/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	74 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024

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and Date
HQ File Number	HQRNORM APPLY 00000155AM25
RA File Number	08AX04000014 AM25
Licence No and<br>Date	0811011244/08/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.Import Items<br>**Qty.

d 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. PIPERACILLIN TAZOBACTAM 4.5gm (PIPERACILLIN AND TAZOBACTAM FOR INJECTION USP 4.5 GM)) 1 Number Vial 1 Piperacillin Sodium and Tazobactam Sodium for Injection (8:1) (Bulk Sterile Mixture) USP 4.80 gm/ Vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	75 / NC/3/MEET/Aug/202425/8	75 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00000171AM25
RA File Number		03AX04006114 AM24
Licence No and<br>Date		0311032906/10/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl. No.<br>Export Product<br>Quantity
	Export Product		Quantity

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Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Sl. No. Export Product Quantity|||| ||Export Product||Quantity|

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1<br>2<br>3<br>4<br>5<br>6<br>7<br>8<br>9<br>10	Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 10 Gm tube Tot<br>Wt. 8775 Kgs (Net Cont: Clotri 87.75Kgs, Octy 1184.63Kgs,Cetyl<br>263.25Kgs,Ceto 877.50Kgs, Emp tubes 877500Nos))	1 Number
	Medical Creams & Ointments(Clotrimazole 1 Percentage Vaginal cream 35Gm<br>Tube with 6 Applicator Tot Wt. 6999.65Kgs (Net Cont. Clotri 70Kgs, Octy<br>944.95Kgs,Cetyl 209.99Kgs, Ceto 699.97Kgs, Emp tubes 199990Nos, Appli<br>1199940 Nos))	1 Number
	Medical Creams & Ointments(Clotrimazole1 Percentage Cream 100 Gm Tube<br>Tot Wt. 3000Kgs (Net Cont: Clotri 30Kgs, Octy 405Kgs,Cetyl 90Kgs,Ceto<br>300Kgs, Emp tubes 30000Nos))	1 Number
	Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 20Gm.Tube Tot<br>Wt. 39200Kgs (Net Cont: Clotri 392Kgs, Octy 5292Kgs,Cetyl 1176Kgs,Ceto<br>3920Kgs, Emp tubes 1960000Nos))	1 Number
	Medical Creams & Ointments(Clotrimazole 1 PercentageCream 50 Gm-Tube Tot<br>Wt. 21700Kgs (Net Cont: Clotri 217Kgs, Octy 2929.50Kgs,Cetyl 651Kgs,Ceto<br>2170Kgs, Emp tubes 434000Nos))	1 Number
	Medical Creams & Ointments(Clotrimazole 2 Percentage Vaginal Cream 20<br>Gm.Tube with 3 Applicator Tot Wt. 4000Kgs (Net Cont.

45000 Numbers 2 Fluorouracil USP 225.0 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 78 / NC/3/MEET/Aug/202425/8

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Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000191AM25
RA File Number	05AX04000086 AM25
Licence No and<br>Date	0511024958/10/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Mar/202324/26 dated 22.03.2024against<br>advance Authorization No.0511023326 dated 17.01.2024it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Moxifloxacin<br>Hydrochloride<br>1030.04 gm.<br>Moxifloxacin HCL and<br>Dexamethasone Sodium Phosphate<br>Eye Drops 0.5%w/v, 0.1% w/v,<br>5ml((Each ml contain Moxifloxacin<br>Base 5mg. equi. to Moxifloxacin<br>HCL 5.45mg. & Dexamethasone<br>Phosphate 1mg equi. to<br>Dexamethasone Sodium Phosphate<br>1.1mg (Equi.to 981.000gm<br>Moxifloxacin HCL and 198.000gm<br>Dexamethasone Sodium Phosphate<br>Bulk Drug))<br>36000<br>Numbers<br>2<br>Dexamethasone<br>Sodium Phosphate<br>207.90 gm.<br>RA concerned may take further necessary action as per above decision of NC.

thasone Sodium Phosphate Bulk Drug)) 36000 Numbers 2 Dexamethasone Sodium Phosphate 207.90 gm. RA concerned may take further necessary action as per above decision of NC.||

Case No.	79 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	STERLING SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000209AM25
RA File Number	03AX04000077 AM25

UDIN00451692AM25

Licence No and 0311032963/12/04/2024 Date Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jun/202425/6 dated 01/07/2024 against advance authorization No. 0311027082 dated 13/09/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
2-Ethylhexyl Thioglycolate (EHTG)	1 kg.	1	2-ETHYL HEXANOL	0.684 kg.

rm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
2-Ethylhexyl Thioglycolate (EHTG)	1 kg.	1	2-ETHYL HEXANOL	0.684 kg.

Case No.	Case No.	80 / NC/3/MEET/Aug/202425/8	80 / NC/3/MEET/Aug/202425/8	80 / NC/3/MEET/Aug/202425/8	80 / NC/3/MEET/Aug/202425/8	80 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00000213AM25
RA File Number		07AX04002122 AM24
Licence No and Date		0711011047/12/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Aug/202324/11 dated 22.08.2023against<br>advance authorizationNo. 0711005078 dated 23.08.2022, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>PREMIX OF NIFUROXAZIDE<br>(Each gm of Premix contains<br>Nifuroxazide 0.552 gm)<br>12600 kg.<br>1<br>NIFUROXAZIDE BP/EP<br>7024.752 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	PREMIX OF NIFUROXAZIDE<br>(Each gm of Premix contains<br>Nifuroxazide 0.552 gm)		12600 kg.	1	NIFUROXAZIDE BP/EP	7024.752 kg.

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No. **|Import Items|Qty. allowed.| ||PREMIX OF NIFUROXAZIDE (Each gm of Premix contains Nifuroxazide 0.552 gm)||12600 kg.|1|NIFUROXAZIDE BP/EP|7024.752 kg.|

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Case No.	81 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000215AM25
RA File Number	07AX04000009 AM25
Licence No and Date	0711011049/12/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/May/202425/4 dated 06.06.2024against<br>advance authorizationNo. 0711010708 dated 07.03.2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>DIRECT COMPRESSION<br>GRANULES OF<br>PHLOROGLUCINOL 160MG ODT<br>PREMIX(DIRECT COMPRESSION<br>GRANULES<br>OF<br>PHLOROGLUCINOL 160MG ODT<br>PREMIX<br>(Each<br>450mg<br>Premix<br>Contains<br>160mg<br>Phloroglucinol)<br>contents 625.778kgs)<br>1 kg.<br>1<br>PHLOROGLUCINOL<br>DIHYDRATE Ph.Eur<br>0.359 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00451692AM25

) contents 625.778kgs) 1 kg. 1 PHLOROGLUCINOL DIHYDRATE Ph.Eur 0.359 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	82 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000234AM25
RA File Number	03AX04000127 AM25
Licence No and<br>Date	0311033003/15/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Vibegron (Gemtesa)Tablets 75 mg<br>1 Number<br>1<br>Vibegron<br>76.50 mg/ Tablet<br>Vibegron (Gemtesa)Tablets 75 mg<br>1 Number<br>2<br>Vibegron<br>76.50 mg/ Tablet<br>RA concerned may take further necessary action as per above decision of NC.

br>Vibegron 76.50 mg/ Tablet Vibegron (Gemtesa)Tablets 75 mg 1 Number 2 Vibegron 76.50 mg/ Tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	83 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000260AM25
RA File Number	03AX04000132 AM25
Licence No and<br>Date	0311033059/16/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00451692AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Flormax 20% / Florfenicol Oral Solution<br>200mg/ml((Pack size 1000ML), Each ml<br>contains: Florfenicol 200mg,	1 Number	1	Florfenicol	0.204 kg

Items**|Qty. allowed.| |---|---|---|---|---| |Flormax 20% / Florfenicol Oral Solution 200mg/ml((Pack size 1000ML), Each ml contains: Florfenicol 200mg,|1 Number|1|Florfenicol|0.204 kg|

Case No.	Case No.	84 / NC/3/MEET/Aug/202425/8	84 / NC/3/MEET/Aug/202425/8	84 / NC/3/MEET/Aug/202425/8	84 / NC/3/MEET/Aug/202425/8	84 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00000262AM25
RA File Number		03AX04000157 AM25
Licence No and<br>Date		0311033083/16/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>3, 4 - Dichloro toluene (3,4-<br>DCT)<br>1.047 kg.<br>2<br>Sodium Cyanide<br>0.2812 kg.<br>3, 4 - Dichloro Phenyl Acetic Acid<br>1 kg.<br>3<br>Sodium Hydroxide Flakes<br>0.2886 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	3, 4 - Dichloro Phenyl Acetic Acid		1 kg.	1	3, 4 - Dichloro toluene (3,4-<br>DCT)	1.047 kg.
				2	Sodium Cyanide	0.2812 kg.
				3	Sodium Hydroxide Flakes	0.2886 kg.

UDIN00451692AM25

|3, 4 - Dichloro Phenyl Acetic Acid||1 kg.|1|3, 4 - Dichloro toluene (3,4- DCT)|1.047 kg.| |||||2|Sodium Cyanide|0.2812 kg.| |||||3|Sodium Hydroxide Flakes|0.2886 kg.|

UDIN00451692AM25

Case No.<br>85 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>ENALTEC LABS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00000263AM25
RA File Number<br>03AX04000180 AM25
Licence No and<br>Date<br>0311033084/16/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Mar/202324/26 dated 22.03.2024against
advance authorizationNo. 0311031566 dated 28.02.2024, 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<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
Oxcarbazepine USP<br>1 kg.<br>1	10-Methoxy Iminostilbene	1.10 kg.
RA concerned may take further necessary action as per	above decision of NC.

Case No.	86 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000268AM25
RA File Number	09AX04001014 AM24
Licence No and<br>Date	0911007079/16/04/2024

UDIN00451692AM25

Norms Committee Decision:

Master batch formula (MBF) showing net content of import item in export.

Case No.	Case No.	87 / NC/3/MEET/Aug/202425/8	87 / NC/3/MEET/Aug/202425/8	87 / NC/3/MEET/Aug/202425/8	87 / NC/3/MEET/Aug/202425/8	87 / NC/3/MEET/Aug/202425/8	87 / NC/3/MEET/Aug/202425/8	87 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved

Party Name		INDI	GLYCOLS LIMITED
i
Meetng Number<br>and Date		NC/ 3/	MEET/ Aug/ 202425/ 8 and 28/08/2024

HQ File Number		HQRN	ORM APPLY 00000272AM25

RA File Number		05AX	04000114 AM25
i
Lcence No and<br>Date		05110	25004/16/04/2024

Norms Committee Decisio			n:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meeting No.NC/3/MEET/Aug/202122/7 dated 13.08.2021against<br>advance authorization No.0510408634 dated 26.11.2018, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Denatured Ethyl Alcohol<br>1.123 kg<br>2<br>Silver Catalyst ( Activity<br>29-30%)<br>0.000284 kg<br>Mono Ethylene Glycol (MEG)<br>1 Kg<br>3<br>Ali Cl<br>0000362 k

	Export Product			Qty.	Sl. No.	Import Items	Q	ty.

Silver Catalyst ( Activity 29-30%) 0.000284 kg Mono Ethylene Glycol (MEG) 1 Kg 3 Ali Cl 0000362 k||||||||||| |||||||||||| ||Export Product|||||Qty.|Sl. No.|Import Items|Q|ty. allowed.| |||||||||||| ||Mono Ethylene Gly|||col (MEG|)|1 Kg|1|Denatured Ethyl Alcohol|1.|123 kg| |||||||||||| ||||||||2|Silver Catalyst ( Activity 29-30%)|0.000284 kg|| ||||||||3|Ali Cl|0000362 k|| |RA nrnd m tk frthr nr tin||||||||umna atayst|. g|| ||||||||r b diin f NC|||| |cocee||y ae ue ecessay aco as pe aove ecso o .||||||||| |||||||||||| |||||||||||| ||||||||||||

UDIN00451692AM25




Case No.		88 / NC/3/MEET/Aug/202425/8

Case Status		Case Approved
Pt N		ENCUBE ETHICALS PRIVATE LIMITED
ary ame
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ	File Number	HQRNORM APPLY 00000276AM25
RA	File Number	03AX04000156 A	M25
Lic<br>Dat	ence No and<br>	0311033116/16/0	4/2024
	e
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less as<br>the export item is a solution:-<br>Sl.

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 as the export item is a solution:- Sl. No. Export Product Quantity 1 Medical Creams & Ointments(Clobetasol Propionate Topical Solution USP, 0.05%, 25ml Tot Wt: 2700Kgs (Net Cont: Clobetasol Propionate USP 1.35Kgs, LDPE Dropper tip FOR OVAL BOTTLE 108000Nos)) 1 Number|ms Committee Decision **ecision:**The Comm ||||: ittee con |sidered |the case as per agenda and it was decided to fix ad- |||hoc norms | ||nder Para 4.07 of HB e export item is a sol||||P Vol. I ution:-|as per d|etails given below or as applied by the firm, whichev|||er is less as| |||||||||||| ||. No.|Export Product|||||||Q|uantity| |||||||||||| |||Medical Creams & Ointments(Clobetasol Propionate Topical Solution USP, 0.05%, 25ml Tot Wt: 2700Kgs (Net Cont: Clobetasol Propionate USP 1.35Kgs, LDPE Dropper tip FOR OVAL BOTTLE 108000Nos))|||||||1 Number|| |||||||||||| |2||Medical Creams & Ointments(Clobetasol Propionate Topical Solution USP, 0.05%, 50ml Tot Wt: 17400Kgs (Net Cont: Clobetasol Propionate USP 8.7Kgs, LDPE Dropper tip FOR OVAL BOTTLE 348000Nos))|||||||1 Number|| |||||||||||| |||||||||||| |||||||||||| |||||||||||| |Sl.

0.05%, 50ml Tot Wt: 17400Kgs (Net Cont: Clobetasol Propionate USP 8.7Kgs, LDPE Dropper tip FOR OVAL BOTTLE 348000Nos))|||||||1 Number|| |||||||||||| |||||||||||| |||||||||||| |||||||||||| |Sl. No.|||Imp|ort Items||||Quantity allowed.||| |||||||||||| |1|||Rel|evant Bulk Drugs||||Net content in the export product plus 2% wastage.||| |2||||||||||| ||||Rel|evant Excipients||||Net content in the export product plus 2% wastage.||| | 3 Relevant Packaging Material Relevant as per Packing Policy & General Notes. Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.||||||||||| ||||Relevant Packaging Material|||||Relevant as per Packing Policy & General Notes.||| ||||||||||||

68 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

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Case No.	89 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000277AM25
RA File Number	03AX04000189 AM25
Licence No and Date	0311033115/16/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

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. PILOCARPINE HYDROCHLORIDE 5MG FILM COATED TABLETS((NET CONTENT OF PILOCARPINE HYDROCHLORIDE IN TOTAL EXPORT QTY 3.749 KGS)) 1 Number 1 Pilocarpine Hydrochloride Milled (Ph. Eur) 5.10 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	90 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000299AM25
RA File Number	05AX04004117 AM24
Licence No and<br>Date	0511024955/18/04/2024

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Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Mar/202324/26 dated 22.03.2024 against advance authorization No. 0511023621 dated 02.02.2024 , 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.
Brinex / Brinex-M / Brinarga /	1 Vial	1	Brinzolamide Micronized	51.00 mg/ Vial
Brinera (Brinzolamide Opthalmic			Sterile
Suspension 1%)- 5ml (Each ml
contains 10 mg of Brinzolami

Case No.<br>91 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>GRANULES INDIA LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00000301AM25
RA File Number<br>09AX04000017 AM25
Licence No and Date<br>0911007083/18/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>METOPROLOL SUCCINATE<br>1 kg.	4 2 Methoxyethylphenol	0.694 kg.
2	Epichloro Hydrine	0.6179 kg.

:-|||| |Export Product Qty. **Sl. No. **|Import Items|Qty. allowed.|| |1 METOPROLOL SUCCINATE 1 kg.|4 2 Methoxyethylphenol|0.694 kg.|| |2|Epichloro Hydrine|0.6179 kg.||

Case No.<br>91 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>GRANULES INDIA LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00000301AM25
RA File Number<br>09AX04000017 AM25
Licence No and Date<br>0911007083/18/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>METOPROLOL SUCCINATE<br>1 kg.	4 2 Methoxyethylphenol	0.694 kg.
2	Epichloro Hydrine	0.6179 kg.

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Qty. **Sl. No. **|Import Items|Qty. allowed.|| |1 METOPROLOL SUCCINATE 1 kg.|4 2 Methoxyethylphenol|0.694 kg.|| |2|Epichloro Hydrine|0.6179 kg.||

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Case No.	92 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000306AM25
RA File Number	08AX04000057 AM25
Licence No and<br>Date	0811011317/18/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Dec/202324/19 dated 05.01.2024against<br>advance authorizationNo. 3411003310 dated 28.01.2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>MINOXIDIL TOPICAL AEROSOL<br>5% ( FOAM) 60 Gm CAN<br>(MINOXIDIL TOPICAL AEROSOL<br>5% ( FOAM) 60 Gm CAN<br>1 Number<br>1<br>MINOXIDIL USP<br>3.06 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	93 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQFile Number	HQRNORM APPLY 00000312AM25

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RA File Number<br>05AX04000176 AM25	RA File Number<br>05AX04000176 AM25
Licence No and<br>Date<br>0511025034/18/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per		agenda and it was decided to fix ad-hoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Formoterol Fumarate Inhalation	4100000.0	1	FORMOTEROL	86.10 gm.
Solution 20 mcg/2 mL (0.02	Numbers		FUMARATE
mg/2 mL),(Having net content of			DIHYDRATE USP
92.25 gm of Bulk drug
(filling volume 2.25 ml in each
number))
RA concerned may take further necessary action as per above decision of NC.

content of|||DIHYDRATE USP||| |92.25 gm of Bulk drug|||||| |(filling volume 2.25 ml in each|||||| |number))|||||| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.<br>94 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00000326AM25
RA File Number<br>05AX04000127 AM25
Licence No and Date<br>0511025055/19/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Jun/202324/8 dated 30.06.2023against
advance authorizationNo. 0511018638 dated 04.05.2023, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.

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I as per details given below or as applied by the firm, whichever is less:-|||| |Export Product Qty. **Sl. No. **|Import Items|Qty. allowed.|| |||||

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RA concerned may take further necessary action as per above decision of NC.<br>1<br>DORZOLAMIDE<br>HYDROCHLORIDE<br>14.051 kg.<br>Dorzolamide and Timolol<br>Ophthalmic Solution, 2.0%w/v +<br>0.5%w/v, 5ml Sterile Eye<br>Drops((Each ml contains<br>Dorzolamide Hydrochloride<br>equivalent to Dorzolamide 20 mg<br>(Equivalent to 12.000Kg of Bulk<br>Drug), and Timolol Maleate<br>equivalent to Timolol 5.0 mg<br>(Equivalent to 3.000 Kg. of Bulk<br>Drug))<br>120000<br>Numbers<br>2<br>TIMOLOL MALEATE<br>4.284 kg.	Dorzolamide and Timolol<br>Ophthalmic Solution, 2.0%w/v +<br>0.5%w/v, 5ml Sterile Eye<br>Drops((Each ml contains<br>Dorzolamide Hydrochloride<br>equivalent to Dorzolamide 20 mg<br>(Equivalent to 12.000Kg of Bulk<br>Drug), and Timolol Maleate<br>equivalent to Timolol 5.0 mg<br>(Equivalent to 3.000 Kg. of Bulk<br>Drug))	<br>120000<br>Numbers	1	DORZOLAMIDE<br>HYDROCHLORIDE	14.051 kg.
			2	TIMOLOL MALEATE	4.284 kg.

ivalent to Timolol 5.0 mg (Equivalent to 3.000 Kg. of Bulk Drug))| 120000 Numbers|1|DORZOLAMIDE HYDROCHLORIDE|14.051 kg.| |---|---|---|---|---|---| ||||2|TIMOLOL MALEATE|4.284 kg.|

Case No.	95 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	SYNERGIA SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000333AM25
RA File Number	03AX04000023 AM25
Licence No and<br>Date	0311033222/19/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for<br>attendingPersonal Hearing<br>before Norms Committee to explain its case along with relevant documents<br>from the firm:

Case No.	96 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	VINCIT LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000334AM25
RA File Number	05AX04004078 AM24
Licence No and	0511025080/19/04/2024

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Date Norms Committee Decision:

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

M24| |Licence No and|0511025080/19/04/2024|

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Date Norms Committee Decision:

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

Case No.	97 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000348AM25
RA File Number	03AX04000076 AM25
Licence No and<br>Date	0311033249/22/04/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	98 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000349AM25
RA File Number	03AX04000120 AM25
Licence No and<br>Date	0311033250/22/04/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.




Case No		99 / NC/3/MEET/Au/202425/8
.		g
Case Status		Case Approved

Party Name		CALYX CHEMICALS AND PHARMACEUTICALS LIMITED

Meeting Number a<br>Date	d	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024

74 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

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eeting Number a Date|d|NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024| |||| ||||

74 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

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HQ File Number	HQRNORM APPLY 00000355AM25
RA File Number	03AX04000287 AM25
Licence No and Date	0311033255/22/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Mar/202324/25 dated 11.03.2024against<br>advance authorizationNo. 0311029157 dated 06.12.2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>AZITHROMYCIN DIHYDRATE<br>1 kg.<br>1<br>AZITHROMYCIN AMINE<br>0.9434 kg.<br>RA concerned may take further necessary action as per above decision of NC.

No. Import Items** Qty. allowed. AZITHROMYCIN DIHYDRATE 1 kg. 1 AZITHROMYCIN AMINE 0.9434 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	100 / NC/3/MEET/Aug/202425/8	100 / NC/3/MEET/Aug/202425/8	100 / NC/3/MEET/Aug/202425/8	100 / NC/3/MEET/Aug/202425/8	100 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00000372AM25
RA File Number		03AX04006123 AM24
Licence No and<br>Date		0311033283/23/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Nov/202324/16 dated 17.11.2023against<br>advance authorizationNo. 0311024400 dated 09.06.2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Fenofibrate Micronized IH/Ph.Eur<br>0.3155 kg.<br>Fenofibrate Bulk Granulate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Fenofibrate Bulk Granulate		1 kg.	1	Fenofibrate Micronized IH/Ph.Eur	0.3155 kg.

te Bulk Granulate 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Fenofibrate Bulk Granulate||1 kg.|1|Fenofibrate Micronized IH/Ph.Eur|0.3155 kg.|

Case No.	Case No.	100 / NC/3/MEET/Aug/202425/8	100 / NC/3/MEET/Aug/202425/8	100 / NC/3/MEET/Aug/202425/8	100 / NC/3/MEET/Aug/202425/8	100 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00000372AM25
RA File Number		03AX04006123 AM24
Licence No and<br>Date		0311033283/23/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Nov/202324/16 dated 17.11.2023against<br>advance authorizationNo. 0311024400 dated 09.06.2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Fenofibrate Micronized IH/Ph.Eur<br>0.3155 kg.<br>Fenofibrate Bulk Granulate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Fenofibrate Bulk Granulate		1 kg.	1	Fenofibrate Micronized IH/Ph.Eur	0.3155 kg.

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.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Fenofibrate Bulk Granulate||1 kg.|1|Fenofibrate Micronized IH/Ph.Eur|0.3155 kg.|

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2	Hypromellose (2910, 3 cps) Ph. Eur	0.0625 kg.
3	Docusate Sodium Ph.Eur	0.0062 kg.
4	Sucrose Ph.Eur	0.3124 kg.
5	Sodium Lauril Sulfate Ph.Eur	0.0216 kg.
6	Lactose Monohydrate Ph.Eur	0.2804 kg.

Case No.	101 / NC/3/MEET/Aug/202425/8	101 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000386AM25
RA File Number	05AX04000226 AM25
Licence No and Date	0511025124/23/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms
under Para 4.07 of HBP	Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.		Sl. No.	Import Items	Qty.
				allowed.
PROPARACAINE	320000.0	1	PROPARACAINE	24.48 kg.
HYDROCHLORIDE	<br>Numbers		HYDROCHLORIDE USP
OPHTHALMIC SOLUTION USP
0.5%,15ML(HAVING NET
CONTENT OF 25.47	KG OF
PROPARACAINE
HYDROCHLORIDE	USP)

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br>Numbers||HYDROCHLORIDE USP||| |OPHTHALMIC SOLUTION USP||||||| |0.5%,15ML(HAVING NET||||||| |CONTENT OF 25.47||KG OF||||| |PROPARACAINE||||||| |HYDROCHLORIDE||USP)|||||

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Case No.	Case No.	102 / NC/3/MEET/Aug/202425/8	102 / NC/3/MEET/Aug/202425/8	102 / NC/3/MEET/Aug/202425/8	102 / NC/3/MEET/Aug/202425/8	102 / NC/3/MEET/Aug/202425/8
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number		HQRNORM APPLY 00000387AM25
RA File Number		08AX04000059 AM25
Licence No and<br>Date		0811011334/23/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jun/202425/5 dated 14.06.2024against<br>advance authorizationNo. 3410046549 dated 13.11.2020, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube(Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube net content of active ingredients 6.136 kgs.) 1 Number 1 Nystatin USP 238.65 mg. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube(Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube net content of active ingredients 12.273 kgs.) 1 Number 2 Nystatin USP 477.30 mg. Nystatin and Triamcinolone Acetonide 1 Number 3 Nystatin USP 954.61 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube(Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube net content of active ingredients 6.136 kgs.)||1 Number|1|Nystatin USP|238.65 mg.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube(Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM;

ystatin USP|238.65 mg.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube(Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube net content of active ingredients 12.273 kgs.)|| 1 Number|2|Nystatin USP|477.30 mg.| ||Nystatin and Triamcinolone Acetonide||1 Number|3|Nystatin USP|954.61 mg.|

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Ointment USP, 1,00,000 UNITS / GM; 0.1%<br>- 60 gm(Nystatin and Triamcinolone<br>Acetonide Ointment USP, 1,00,000 UNITS /<br>GM; 0.1% - 60 gm tube net content of active<br>ingredients 25.545 kgs.)

Nystatin and Triamcinolone Acetonide<br>Cream USP, 1,00,000 UNITS / GM; 0.1% -<br>15 bNi d Tiil	1 Num	ber		4	Nystatin USP	2	38.65 mg
gm tue(ystatn an ramcnoone<br>Acetonide Cream USP, 1,00,000 UNITS /<br>GM; 0.1% - 15 gm tube net content of active<br>ingredients 6.818 kgs.)

Nystatin and Triamcinolone Acetonide<br>Cream USP, 1,00,000 UNITS / GM; 0.1% -<br>30 gm tube(Nystatin and Triamcinolone	1 Number		5		Nystatin USP	477.30 mg.
Acetonide Cream USP, 1,00,000 UNITS /<br>GM;

and Triamcinolone Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube(Nystatin and Triamcinolone|||1 Number||5||Nystatin USP|477.30 mg.|| ||Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube net content of active ingredients 13.636 kgs.)|||||||||| |||||||||||| ||Nstatin and|Triamcinolone Acetonide||1 Number||6||Nstatin USP|95461 m|| ||y Cream USP| 100000 UNITS / GM; 01% -||||||y|. g|| ||, 60 gm tube(N|,, . ystatin and Triamcinolone||||||||| || Acetonide Cr| eam USP, 1,00,000 UNITS /||||||||| ||GM; 0.1% - 6|0 gm tube net content of active||||||||| ||ingredients 2|7.273 kgs.)||||||||| |||||||||||| |||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||| |||||||||||| |Case No||103 / NC/3/MEET/Au/202425/8||||||||| |.||g||||||||| |Case Status||Case Approved||||||||| |Party Name||ALEMBIC PHARMACEUTICALS LIMITED||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024||||||||| |||||||||||| |HQ File Number||HQRNORM APPLY 00000395AM25||||||||| |||||||||||| |RA File Number||08AX04000093 AM25||||||||| ||||||||||||

Case No.	103 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000395AM25
RA File Number	08AX04000093 AM25

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Licence No and 0811011347/23/04/2024 Date Norms Committee Decision:

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Licence No and 0811011347/23/04/2024 Date Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jun/202324/8 dated 30.06.2023 against advance authorization No. 3411003468 dated 14.03.2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Fulvestrant Injection 250 mg / 5	One 5 ml. Prefilled	1	Fulvestrant USP	269.349 mg/Vial
ML (50mg/ML)	Syringe

Case No.<br>104 / NC/3/MEET/Aug/202425/8	Case No.<br>104 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/	8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00000407AM25
RA File Number<br>03AX04000192 AM25
Licence No and<br>Date<br>0311033314/24/04/2024
Norms Committee Decision:
Decision:The Committee considered the case		as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Aug/202324/11 dated			22.08.2023against
advance authorization**No.

agenda and taking cue from the earlier decision for|||||| |same export product/import item in meetingNo.NC/3/MEET/Aug/202324/11 dated|||||22.08.2023against||| |advance authorizationNo. 0311020392 dated||02.01.2023, it was decided to fix ad-hoc norms under Para|||||| |4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|||||||| |Export Product||Qty.|**Sl. No. **|Import Items||Qty. allowed.|| |NAS-5((2-DIAZO-1-NAPTHOL-5-||99900 kg.|1|Tobias Acid||161638.0 kg.|| |SULFONIC ACID, SODIUM SALT))||||||||

UDIN00451692AM25

Case No.	105 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000408AM25
RA File Number	03AX04000290 AM25
Licence No and<br>Date	0311033317/24/04/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	106 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000410AM25
RA File Number	52AX04000014 AM25
Licence No and<br>Date	5211007960/24/04/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|52AX04000014 AM25| |Licence No and Date|5211007960/24/04/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	107 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000411AM25

80 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

UDIN00451692AM25

RA File Number	RA File Number	03AX04000307 AM25
Licence No and Date		0311033331/24/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and					taking cue from the	earlier decision for
same export product/import item in meeting			No.NC/3/MEET/May/202425/4 dated			06.06.2024against
advance authorizationNo. 0311031952 dated 11.03.2024, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl. No.	Import Items		**Qty.

orms under Para|||||||||| |4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|||||||||| ||Export Product|||Qty.|**Sl. No. **|Import Items||Qty. allowed.|| ||DOXYLEB CAPSULE||1|Number|1|DOXYCYCLINE||115.40 mg.|| ||(DOXYCYCLINE HYCLATE|||||HYCLATE BP|||| ||CAPSULE BP) 100MG(IN PACKING||||||||| ||OF 10 X10's , 10 X 100's,||||||||| ||1000's QTY CONSUMED OF||||||||| ||EXEMPT MATERIAL||||||||| ||DOXYCYLINE HYCLATE BP-||||||||| ||115.400MG/CAPSULE)||||||||| |RA|concerned may take|further necessary action as per above decision of NC.||||||||

Case No.	108 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000416AM25
RA File Number	34AX04000913 AM24
Licence No and<br>Date	3411004851/24/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00451692AM25

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:-||

UDIN00451692AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Acitretin Capsules USP 10<br>mg(Acitretin Capsules USP 10<br>mg (Net content of active<br>ingredients 2.50 kgs ))	1 Number	1	Acitretin USP	10.2 mg/ Capsule
Acitretin Capsules USP 17.5<br>mg(Acitretin Capsules USP 17.5<br>mg (Net content of active<br>ingredients 6.125 kgs ))	1 Number	2	Acitretin USP	17.85 mg/ Capsule
Acitretin Capsules USP 25<br>mg(Acitretin Capsules USP 25<br>mg (Net content of active<br>ingredients 10.00 kgs ))	1 Number	3	Acitretin USP	25.50 mg/ Capsule

2|Acitretin USP|17.85 mg/ Capsule| ||Acitretin Capsules USP 25 mg(Acitretin Capsules USP 25 mg (Net content of active ingredients 10.00 kgs ))|1 Number|3|Acitretin USP|25.50 mg/ Capsule|

Case No.	109 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	CONNEX PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000436AM25
RA File Number	26AX04000084 AM24
Licence No and<br>Date	2611001430/25/04/2024
Norms Committee Decision:<br>Decision: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>Stoichiometric material balance of the reaction.<br>1.<br>Stage wise yield of the reaction, giving justification for overall low yield.<br>2.

UDIN00451692AM25

Case No.	110 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000437AM25
RA File Number	03AX04000385 AM25
Licence No and<br>Date	0311033377/26/04/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

umber|03AX04000385 AM25| |Licence No and Date|0311033377/26/04/2024| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.<br>111 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and	28/08/2024
HQ File Number<br>HQRNORM APPLY 00000441AM25
RA File Number<br>08AX04000115 AM25
Licence No and<br>Date<br>0811011386/26/04/2024
Norms Committee Decision:
Decision:The Committee considered the request of firm for review of ad-hoc norms and on			the basis of
information provided by the firm, it was decided to revise ad-hoc norms as under:-
Sl.<br>Export Product	Qty.	Import Items	Qty.
			allowed.
No.
1<br>Clobetasol Propionate Cream USP 0.05% 15	60000.0	CLOBETASOL PROPIONATE USP	<br>16238.40 gms.
gm(Clobetasol Propionate Cream USP 0.05%	<br>Numbers	(MICRONIZED)
15 gm ( net content of active
ingredients 450.00 gm. ))
Clobetasol Propionate Cream USP 0.05% 30<br>2	40000.0

UDIN00451692AM25

Cream USP 0.05%| Numbers|(MICRONIZED)||| |15 gm ( net content of active||||| |ingredients 450.00 gm. ))||||| |Clobetasol Propionate Cream USP 0.05% 30 2|40000.0||||

UDIN00451692AM25

	gm(Clobetasol Propionate Cream USP 0.05%<br>30 gm ( net content of active<br>ingredients 600.00 gm. ))	<br>Numbers
3<br>	Clobetasol Propionate Cream USP 0.05% 45<br>gm(Clobetasol Propionate Cream USP 0.05%<br>45 gm ( net content of active<br>ingredients 1012.50 gm. ))	<br>45000.0<br>Numbers
4<br>	Clobetasol Propionate Cream USP 0.05% 60<br>gm(Clobetasol Propionate Cream USP 0.05%<br>60 gm ( net content of active<br>ingredients 1650.00 gm. ))	<br>55000.0<br>Numbers
5<br>	Clobetasol Propionate Topical Solution USP<br>0.05% 25ml(Clobetasol Propionate Topical<br>Solution USP 0.05% 25ml ( net<br>content of active ingredients 625.00 gm. ))	50000.0<br>Numbers
6<br>	Clobetasol Propionate Topical Solution USP<br>0.05% 50 ml(Clobetasol Propionate Topical<br>Solution USP 0.05% 50 ml (<br>net content of active ingredients 875.00 gm.

))|50000.0 Numbers||| ||6 |Clobetasol Propionate Topical Solution USP 0.05% 50 ml(Clobetasol Propionate Topical Solution USP 0.05% 50 ml ( net content of active ingredients 875.00 gm. ))|35000.0 Numbers||| ||7 |Clobetasol Propionate Shampoo, 0.05% 118 ml(Clobetasol Propionate Shampoo, 0.05% 118 ml ( net content of active ingredients 3540.00 gm.))|60000.0 Numbers||| ||8 |Clobetasol Propionate Spray, 0.05% - 59 ml(Clobetasol Propionate Spray, 0.05% - 59 ml ( net content of active ingredients 442.50 gm.))|15000.0 Numbers||| ||9 |Clobetasol Propionate Spray, 0.05% - 125 ml(Clobetasol Propionate Spray, 0.05% - 125 ml ( net content of active ingredients 625.00 gm.))| 10000.0 Numbers||| ||10|Clobetasol Propionate Ointment USP 0.05% 15 gm(Clobetasol Propionate Ointment USP 0.05% 15 gm ( net content of|60000.0 Numbers|||

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|active ingredients 450.00 gm. )) 11 Clobetasol Propionate Ointment USP 0.05% 30 gm(Clobetasol Propionate OintmentUSP 0.05% 30 gm ( net content of active ingredients 675.00 gm. )) 45000.0 Numbers 12 Clobetasol Propionate Ointment USP 0.05% 45 gm(Clobetasol Propionate Ointment USP 0.05% 45 gm ( net content of active ingredients 675.00 gm. )) 30000.0 Numbers 13 Clobetasol Propionate Ointment USP 0.05% 60 gm(Clobetasol Propionate Ointment USP 0.05% 60 gm ( net content of active ingredients 1800.00 gm.

	active ingredients 450.00 gm. ))
11<br>	Clobetasol Propionate Ointment USP 0.05%<br>30 gm(Clobetasol Propionate OintmentUSP<br>0.05% 30 gm ( net content of<br>active ingredients 675.00 gm. ))	45000.0<br>Numbers
12<br>	Clobetasol Propionate Ointment USP 0.05%<br>45 gm(Clobetasol Propionate Ointment USP<br>0.05% 45 gm ( net content of<br>active ingredients 675.00 gm. ))	30000.0<br>Numbers
13<br>	Clobetasol Propionate Ointment USP 0.05%<br>60 gm(Clobetasol Propionate Ointment USP<br>0.05% 60 gm ( net content of<br>active ingredients 1800.00 gm. ))	60000.0<br>Numbers
14<br>	Clobetasol Propionate Foam USP 0.05%<br>50gm.(Clobetasol Propionate Foam USP<br>0.05% 50gm. ( net content of active<br>ingredients 1000.00 gm. ))	40000.0<br>Numbers
15<br>	Clobetasol Propionate Foam USP 0.05% 100<br>gm.(Clobetasol Propionate Foam USP 0.05%<br>100 gm.

USP 0.05% 50gm. ( net content of active ingredients 1000.00 gm. ))|40000.0 Numbers||| ||15 |Clobetasol Propionate Foam USP 0.05% 100 gm.(Clobetasol Propionate Foam USP 0.05% 100 gm. ( net content of active ingredients 1500.00 gm. ))|30000.0 Numbers|||

Case No.	112 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000450AM25
RA File Number	34AX04000063 AM25

UDIN00451692AM25

Licence No and 3411004867/26/04/2024 Date Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Apr/202425/2 dated 30/04/2024 against advance authorization No. 3411003779 dated 05/06/2023 , 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.
ALDEHYDE C10	1 kg.	1	FATTY ALCOHOL C10	1.40 kg.
(CAPRIC ALDEHYDE)			(98% purity)

RA concerned may take further necessary action as per above decision of NC and also check the percentage content of item at the time of export.

C10|1.40 kg.| |(CAPRIC ALDEHYDE)|||(98% purity)||

RA concerned may take further necessary action as per above decision of NC and also check the percentage content of item at the time of export.

Case No.<br>113 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00000451AM25
RA File Number<br>03AX04000434 AM25
Licence No and<br>Date<br>0311033398/26/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda		and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Mar/202223/22 dated 24.03.2023against
advance authorizationNo. 0311018753 dated 20.10.2022, it		was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00451692AM25

ORLISTAT PELLETS 50 % 1 kg. 1 ORLISTAT USP 0.505 kg.

he firm, whichever is less:-||||| |Export Product Qty.|**Sl. No. **|Import Items|Qty. allowed.||

UDIN00451692AM25

ORLISTAT PELLETS 50 % 1 kg. 1 ORLISTAT USP 0.505 kg.

Case No.	114 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000455AM25
RA File Number	03AX04000337 AM25
Licence No and<br>Date	0311033405/28/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.3/82-ALC4/2018 dated 05/06/2018against advance<br>authorizationNo. 0310815936 dated 25/09/2017, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>1<br>N-BUTYRIC ACID<br>0.701 kg.<br>ETHYL-2-BROMOBUTYRATE<br>1 kg.<br>2<br>LIQUID BROMINE<br>1.276 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	115 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved

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

Case No.	115 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved

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Party Name<br>KOPRAN RESEARCH LABORATORIES LIMITED	Party Name<br>KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00000457AM25
RA File Number<br>03AX04000436 AM25
Licence No and<br>Date<br>0311033409/29/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Mar/202324/25 dated 11.03.2024against
advance authorizationNo. 0311029157 dated 06.12.2023, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
AZITHROMYCIN DIHYDRATE<br>1 kg.<br>1	AZITHROMYCIN AMINE	0.9434 kg.
RA concerned may take further necessary action as per above decision of NC.

. No. **|Import Items|Qty. allowed.|| |AZITHROMYCIN DIHYDRATE 1 kg. 1|AZITHROMYCIN AMINE|0.9434 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	116 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000458AM25
RA File Number	03AX04000426 AM25
Licence No and<br>Date	0311033410/29/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Mar/202324/25 dated 11.03.2024against
advance authorizationNo. 0311029157 dated 06.12.2023, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00451692AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
AZITHROMYCIN DIHYDRATE	1 kg.	1	AZITHROMYCIN AMINE	0.9434 kg.

s:-||

UDIN00451692AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
AZITHROMYCIN DIHYDRATE	1 kg.	1	AZITHROMYCIN AMINE	0.9434 kg.


Case No.			117 / NC/3/MEET/Aug/202425/8

Case Status			Case Approved

Party Name			KOPRAN RESEARCH LABORATORIES LIMITED

Meeting Number an<br>Date		d	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024

HQ File Number			HQRNORM APPLY 00000465AM25

RA File Number			03AX04000400 AM25

Licence No and Da		te	0311033430/29/04/2024
Norms Committee		Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>1<br>MAP (METHYL VINYL<br>PHOSPHATE:CAS NO. 189188-38-3)<br>(4R-5S-6S-3-DIPHENYLOXY<br>500 kg.<br>DORIPENEM STERILE<br>200 kg.
	Export Product			Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	DORIPENEM STERILE			200 kg.	1	MAP (METHYL VINYL<br>PHOSPHATE:CAS NO. 189188-38-3)<br>(4R-5S-6S-3-DIPHENYLOXY	500 kg.
						<br>PHOSPHORYLOX-6-<br>1R-HYDROXYETHYL-4-METHYL-7-<br>OXO-1 AZABICYCLO 3 2 0


					2	DORIPENEM SIDE CHAIN (4-	49235 kg
						<br>NITROBENZYL (2S4S)-4-	.

NYLOXY|500 kg.| ||||||| PHOSPHORYLOX-6- 1R-HYDROXYETHYL-4-METHYL-7- OXO-1 AZABICYCLO 3 2 0|| ||||||||| ||||||||| ||||||2|DORIPENEM SIDE CHAIN (4-|49235 kg| ||||||| NITROBENZYL (2S4S)-4-|. .| |||||||, ACETYLTHIO-2-[ (N-SULFAMOYLN- ( TERT-|| ||||||||| |||||||BUTOXYCARBONYL)|| |||||||AMINO)PYRROLIDINE-1-|| |||||||||

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CARBOXYLAT

Case No.<br>118 / NC/3/MEET/Aug/202425/8
Case Status<br>Case Approved
Party Name<br>GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number<br>HQRNORM APPLY 00000466AM25
RA File Number<br>03AX04000437 AM25
Licence No and<br>Date<br>0311033432/29/04/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms
under Para 4.07 of HBP Vol. I as per details given below	or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
AZELAIC ACID GEL 15 percent (Pack<br>130750	1	Azelaic Acid	1000.24 kg.
Size 50 Grams) (Net Wt. of Azelaic Acid
is 980.63 Kgs.)<br>Numbers
RA concerned may take further necessary action as per above decision		of NC.

Case No.	119 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	SIGNATURE PHYTOCHEMICAL INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000467AM25

UDIN00451692AM25

UDIN00451692AM25

RA File Number<br>03AX04000380 AM25
Licence No and<br>Date<br>0311033435/29/04/2024
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advise
of the TE, it was decided to call for following information/documents from the firm:-
Copy of Drug Manufacturing Licence (DML) showing approved composition.<br>1.

Case No.	120 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000476AM25
RA File Number	08AX04000132 AM25
Licence No and<br>Date	0811011403/29/04/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	121 / NC/3/MEET/Aug/202425/8
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
and Date
HQ File Number	HQRNORM APPLY 00000484AM25
RA File Number	09AX04001160 AM24
Licence No and	0911007159/30/04/2024
Date
Norms Committee	Decision:
Decision:The Co<br>BiThl	mmittee considered the case as per agenda and it was decided to refer the case toDeptt. of<br>f btii thi t
o-ecnoogyor oanng er commens.

ecision:| |Decision:The Co BiThl|mmittee considered the case as per agenda and it was decided to refer the case toDeptt. of f btii thi t| |o-ecnoogyor oanng er commens.|| |||

Decision: The Committee considered the case as per agenda and it was decided to refer the case to Deptt. of Bio-Technology for obtaining their comments.

91 This document has been digitally signed by Raman Kumar, Deputy DGFT on 01-11-2024 15:42:41.

UDIN00451692AM25

Case No.	122 / NC/3/MEET/Aug/202425/8
Case Status	Case Approved
Party Name	INDO AMINES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Aug/ 202425/ 8 and 28/08/2024
HQ File Number	HQRNORM APPLY 00000487AM25
RA File Number	03AX04000301 AM25
Licence No and Date	0311033470/30/04/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>DI N BUTYL AMINE<br>0.788 kg.<br>DI BUTYL AMINO PROPYL<br>AMINE OR IAL DBAPA<br>1 kg.<br>2<br>ACRYLONITRILE<br>0.324 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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