IN FORCE Advance Authorisation

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली

VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Feb/202425/17 DATED: 25/02/2025

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/Feb/202425/17 dated 25/02/2025 of Norms Committee - III for the year 2024-25 was held on 25/02/2025 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 (Pharma)	Consultant
4	Shri Shaish Kumar, Technical Expert (Chemical)	Consultant
5	Shri Nand Lal, Technical Expert (Chemical)	Consultant

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Case Details and Decision(s):

Case Details and Decision(s):	Case Details and Decision(s):	Case Details and Decision(s):	Case Details and Decision(s):	Case Details and Decision(s):	Case Details and Decision(s):	Case Details and Decision(s):	Case Details and Decision(s):
Case No.		1 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		MEGHMAI IDSTRIES LIMITED
	y Name	N	NU
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/	Feb/ 202425	/ 17 and 25/02/		2025
HQ	File Number	HQRNORM R	EVIW00003	609AM25
RA	File Number	082404000293	AM17
Lic<br>Dat	ence No and<br>e	0810139050/2	2/11/2016

Nor<br>Th<br>pr<br>N<br>pe	ms Committee Decision:<br>e Committee considered th<br>oduct/import item in meeti<br>o.0810140258 dated 08/05<br>r details given below or as		e case as pe<br>ngNo.15/8<br>/2019, it w<br>applied by t	d d		ki f h li di	f
				r agena an<br>2-ALC4/2018<br>as decided to		ang cue rom te earer ecs<br> dated 22/03/2019against adv<br>fix ad-hoc norms under Para 4.0	on or same export<br>ance authorization<br>7 of HBP Vol. I as
				he firm, which		ever is less:-

	Export Product		Qty.	Sl. No.	Imp	ort Items	**Qty.

Para 4.0||on or same export ance authorization 7 of HBP Vol. I as| ||||||he firm, which||ever is less:-||| ||||||||||| ||Export Product||Qty.||Sl. No.|Imp|ort Items||Qty. allowed.| ||||||||||| ||BROMOKETAL||1 kg.||1|2,4 D|ichloro Aceteophenone||0.160 kg.| ||||||||||| ||||||2|1,2 P|entandiol||0.385 kg.| ||||||||||| |||||3||Cychlohexane||0.0625 kg.|| ||||||||||| ||||||||||| ||||||||||| |RA concerned m||ay take further necessary action as per above decision of NC.|||||||| ||||||||||| ||||||||||| ||||||||||| |Case No.||2 / NC/3/MEET/Feb/202425/17|||||||| ||||||||||| |Case Status||Case Deferred|||||||| |Party Name||SHREE BANKEY BEHARI LAL FLAVORS|||||||| ||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025|||||||| |HQ File Number||HQRNORM REVIW00006890AM24|||||||| |RA|File Number|052404000067 AM19|||||||| |Lic Dat|ence No and e|0510406412/1|0/05/2018||||||| |Nor|ms Committee Decision:||||||||| |||||||||||

Case No.	2 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	SHREE BANKEY BEHARI LAL FLAVORS
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00006890AM24
RA File Number	052404000067 AM19
Licence No and<br>Date	0510406412/10/05/2018
Norms Committee Decision:

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9| |Licence No and Date|0510406412/10/05/2018| |Norms Committee Decision:||

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The case is under consideration and CLA, Delhi was requested vide DGFT (HQ) letter dated 11/06/2024 to audit firm and submit prodiction/consumption data for the year 2018-2019 as sought by Technical Expertto be submitted within fifteen days of receipt of said letter, however, no such response received from CLA, Delhi. A D.O. letter dated 22/10/2024 in this regard was sent to the CLA with the request to expedite the matter. The response from CLA, Delhi, is still awaited.The Committee decided to remind CLA to expedite the matter.

Case No.	3 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	CROPNOSYS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00004564AM25
RA File Number	039404000527 AM19
Licence No and<br>Date	0310823957/24/09/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>FLUAZINAM Tech.<br>98% Min.<br>1 kg<br>1<br>2,3-Dichloro-5-trifluoromethyl Pyridine<br>[DCTF]<br>0.60 kg.<br>RA concerned may take further necessary action as per above decision of NC.

wed.** FLUAZINAM Tech. 98% Min. 1 kg 1 2,3-Dichloro-5-trifluoromethyl Pyridine [DCTF] 0.60 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	4 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00002022AM25

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RA File Number	052304000507 AM19
Licence No and<br>Date	0510409676/15/02/2019
Norms Committee Decision:<br>The representative of the firm had attended the Personal Hearing and explained the case. The Committee<br>heard the explanation of the Representative of the firm, and after due deliberation,it was decided to seek<br>information from the authorization holder to furnish the details of previous licenses wherein ad-hoc norms<br>were fixed.

Case No.	5 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00003664AM25
RA File Number	292404000010 AM20
Licence No and Date	2910025424/19/08/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<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. DIHYDROMYRCENOL 1 kg. 1 DIHYDROMYRCENE (91% Purity) 1.13 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	6 / NC/3/MEET/Feb/202425/17
Case Status	Case Rejected
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00008636AM24

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RA File Number	039404000496 AM20
Licence No and<br>Date	0310831890/27/09/2019
Norms Committee Decision:<br>The Committee considered the case as per the agenda, and it hasbeen observed that the ad-hoc norms were<br>fixed earlier based on the comparative data from other firms, therefore, the Committee did not find any<br>cogent reason to review the norms and decided to maintain the status quo.

norms were fixed earlier based on the comparative data from other firms, therefore, the Committee did not find any cogent reason to review the norms and decided to maintain the status quo.||

Case No.	7 / NC/3/MEET/Feb/202425/17
Case Status	Case Rejected
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00008637AM24
RA File Number	039404000497 AM20
Licence No and<br>Date	0310831894/27/09/2019
Norms Committee Decision:<br>The Committee considered the case as per the agenda, and it hasbeen observed that the earlier ad-hoc norms<br>were fixed based on the comparative data from other firms, therefore, the Committee the Committee did not<br>find any cogent reason to review the norms and decided to maintain the status quo.

Case No.	8 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00000095AM24
RA File Number	522404000013 AM21
Licence No and<br>Date	5210043424/08/06/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-

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tion provided by the firm, it was decided to revise ad-hoc norms as under:-||

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Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
4-HYDROXY COUMARIN	1 kg.	1	Acetyl Salicylic Acid	1.85 kg.
(by Acetyl Salicylic Acid route)			(For Industrial Use)
		2	Ethyl Aceto Acetate	1.60 kg.

Note: The above ad-hoc norms fixed for one time basis.

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

Case No.	9 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	KOSHA CHEMTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00000014AM25
RA File Number	039404000306 AM21
Licence No and<br>Date	0310837580/10/08/2020
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Production/Consumption data for the last two years duly certified by Auditor of the Company.

Case No.	10 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025

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C/3/MEET/Feb/202425/17| |---|---| |Case Status|Case Approved| |Party Name|AURORE LIFE SCIENCES PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025|

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and Date
HQ File Number	HQRNORM REVIW00004138AM23
RA File Number	092404000365 AM21
Licence No and<br>Date	0910069368/22/10/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2,2,2-Trifluoroethanol<br>1.42 kg.<br>2<br>Dimethyl formamide<br>1.50 kg.<br>3<br>Toluene<br>1.00 kg.<br>4<br>Acetic Acid<br>0.61 kg.<br>5<br>Sodium Nitrite<br>1.05 kg.<br>2,5-Bis-(2,2,2-Trifluoroethoxy) Benzoic Acid<br>1 kg.<br>6<br>Hydrogen Peroxide<br>0.70 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	11 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00008364AM24
RA File Number	05AA04025954 AM21
Licence No and<br>Date	0511001043/02/02/2021
Norms Committee Decision:

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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:-

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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:-

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
CEFTAZIDIME POWDER FOR<br>SOLUTION FOR INJECTION,<br>WEIGHT 1 GMS<br>/VIAL(CEFTAZIDIME WITH<br>SODIUM<br>CARBONATE<br>USP<br>FOR INJECTION)	67000 Vials	1	CEFTAZIDIME WITH SODIUM<br>CARBONATE USP	84 kg.
CEFTAZIDIME POWDER FOR<br>SOLUTION FOR INJECTION,<br>WEIGHT 2 GMS/<br>VIAL(CEFTAZIDIME WITH<br>SODIUM<br>CARBONATE<br>USP<br>FOR INJECTION)	29000 Vials	2	CEFTAZIDIME WITH SODIUM<br>CARBONATE USP	36 kg.
CEFEPIME POWDER FOR<br>SOLUTION FOR INJECTION,<br>WEIGHT 1 GMS/<br>VIAL(CEFEPIME HCL+L-<br>ARGININE STERILE USP FOR<br>INJECTION)	101000 Vials	3	CEFEPIME HCL+L-ARGININE<br>STERILE USP	126 kg.
CEFEPIME POWDER FOR<br>SOLUTION FOR INJECTION ,<br>WEIGHT 2 GMS/ VIAL<br>(CEFEPIME HCL+L-ARGININE<br>STERILE USP FOR INJECTION)	43000 Vials	4	CEFEPIME HCL+L-ARGININE<br>STERILE USP	54 kg.

Case No.	12 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved

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Case No.	12 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved

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Party Name	PROEC ENERGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00005029AM24
RA File Number	05AX04001262 AM22
Licence No and<br>Date	0511010975/14/03/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Polyetheramine<br>0.2436 kg.<br>2<br>Diethylenetriamine<br>0.2515 kg.<br>Polyamine Shale Inhibitor<br>1 kg.<br>3<br>Ethyleneamines Product Mixture /<br>Higher Polyethylene Polyamines<br>0.0488 kg.<br>Note: The above ad-hoc norms fixed for one time basis.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	13 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00002011AM23
RA File Number	52AX04001578 AM23
Licence No and<br>Date	5211002817/13/07/2022
Norms Committee Decision:

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and 25/02/2025| |HQ File Number|HQRNORM APPLY 00002011AM23| |RA File Number|52AX04001578 AM23| |Licence No and Date|5211002817/13/07/2022| |Norms Committee Decision:||

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The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
7-ETHYL TRYPTOPHOL	1 kg.	1	2,3-Dihydrofuran	1.2 kg.
		2	2-Ethyl Aniline	1.9 kg.
		3	Methylene Chloride	5.0 kg.
		4	Methanol	3.0 kg.

Note: The above ad-hoc norms fixed for one time basis.

Case No.	14 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00002221AM23
RA File Number	07AX04000559 AM23
Licence No and<br>Date	0711004755/23/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Dec/202425/13 dated 07/01/2025against advance<br>authorizationNo.0711006773 dated 16/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Calcium Dobesilate Monohydrate BP/<br>Calcium Dobesilate Monohydrate<br>Eur.Ph / Calcium Dobesilate<br>1 kg.<br>1<br>HYDROQUINONE<br>0.631 kg.<br>Etamsylate / Etamsylate EP<br>1 kg.<br>2<br>HYDROQUINONE<br>0.527 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Calcium Dobesilate Monohydrate BP/<br>Calcium Dobesilate Monohydrate<br>Eur.Ph / Calcium Dobesilate	1 kg.	1	HYDROQUINONE	0.631 kg.
	Etamsylate / Etamsylate EP	1 kg.	2	HYDROQUINONE	0.527 kg.

||Calcium Dobesilate Monohydrate BP/ Calcium Dobesilate Monohydrate Eur.Ph / Calcium Dobesilate|1 kg.|1|HYDROQUINONE|0.631 kg.| ||Etamsylate / Etamsylate EP|1 kg.|2|HYDROQUINONE|0.527 kg.|

Case No.	15 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00006414AM24
RA File Number	09AX04000207 AM23
Licence No and<br>Date	0911003443/05/08/2022
The representative of the firm had attended the Personal Hearing and explained the case. The Committee<br>heard the explanation of the Representative of the firm, and after due deliberation,it was decided to seek<br>information from the authorization holder to furnish the details of previous licenses wherein ad-hoc norms<br>were fixed.

Case No.	16 / NC/3/MEET/Feb/202425/17
Case Status	Case Rejected
Party Name	KAVALIFE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00003326AM23
RA File Number	07AX04000884 AM23
Licence No and<br>Date	0711005312/23/09/2022
Norms Committee Decision:

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The committee considered the application of the firm and it has been observed that various opportunities were given to firm but the firm has not appeared for personal hearing before committee to explain their case, therefore, the committee decided to reject the application of the firm.

s opportunities were given to firm but the firm has not appeared for personal hearing before committee to explain their case, therefore, the committee decided to reject the application of the firm.

Case No.	17 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004071AM23
RA File Number	09AX04000645 AM23
Licence No and<br>Date	0911003906/04/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Propionic Anhydride<br>2.64 kg.<br>Sulindac<br>(Pharamaceutical product)<br>1 kg.<br>2<br>4-Fluoro benzaldehyde<br>2.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	18 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004648AM23
RA File Number	09AX04000768 AM23
Licence No and Date	0911004035/28/11/2022

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Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
2R3R4R5S6S)2(acetoxymethyl)<br>6(4chloro-3 (4(S)<br>tetrahydrofuran3yl)oxy)benzyl)<br>phenyl)tetrahydro2H-pyran3,4,5triyl<br>Triacetate (Drug intermidiate)	1 kg.	1	Fluorobenzene	1.60 kg.
		2	(S)-Ethyl 4-chloro-3-<br>hydroxybutanoate	2.81 kg.
		3	Potassium tert-butoxide	1.19 kg.
		4	Triethyl Silane	1.00 kg.
		5	n-butyl lithium 15% in Hexane	2.98 kg.
		6	Trimethylsilyl chloride	3.71 kg.
		7	Dimethylamino pyridine	0.53 kg.
		8	N-methylmorpholine (NMM)	2.65 kg.
		9	Sodium borohydride	0.62 kg.

Case No.	19 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004687AM23
RA File Number	09AX04000763 AM23

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Licence No and<br>Date	0911004042/29/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Fluorobenzene<br>2.40 kg.<br>2<br>(S)-3-hydroxy tetrahydrofuran<br>1.80 kg.<br>3<br>Potassium tert-butoxide<br>1.80 kg.<br>4<br>Triethyl Silane<br>2.70 kg.<br>5<br>n-butyl lithium 15% in Hexane<br>4.00 kg.<br>6<br>Trimethylsilyl chloride<br>5.60 kg.<br>7<br>Dimethylamino pyridine<br>0.80 kg.<br>Emphagliflozin<br>(Pharmaceutical product)<br>1 kg.<br>8<br>N-methylmorpholine (NMM)<br>4.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Licence No and Date

0911004042/29/11/2022

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Fluorobenzene 2.40 kg. 2 (S)-3-hydroxy tetrahydrofuran 1.80 kg. 3 Potassium tert-butoxide 1.80 kg. 4 Triethyl Silane 2.70 kg. 5 n-butyl lithium 15% in Hexane 4.00 kg. 6 Trimethylsilyl chloride 5.60 kg. 7 Dimethylamino pyridine 0.80 kg. Emphagliflozin (Pharmaceutical product) 1 kg. 8 N-methylmorpholine (NMM) 4.00 kg. RA concerned may take further necessary action as per above decision of NC.

Case No.	20 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005401AM23
RA File Number	34AX04000903 AM23
Licence No and	3411003211/29/12/2022

UDIN00710749AM25

Date Norms Committee Decision:

UDIN00710749AM25

Date 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 meeting No. NC/3/MEET/Dec/2425/13 dated 07/01/2025 against advance authorization No. 3411002061 dated 31/03/2022 , 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:-

Date	Date
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo. NC/3/MEET/Dec/2425/13 dated 07/01/2025against advance authorizationNo.<br>3411002061 dated 31/03/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Chlorthalidone (Micronized) 25.50 mg. 2 Microcrystalline Cellulose (Avicel PH 101) 37.45 mg. 3 Pregelatinized corn starch (Lycatab PGS) 5.00 mg. 4 Sodium Starch Glycolate (Type A) (EXPLOTAB) 1.50 mg. Chlorthalidone Tabs USP 25 mg 1 Number 5 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 0.30 mg. 6 Chlorthalidone (Micronized) 51.00 mg. 7 Microcrystalline Cellulose (Avicel PH 101) 74.90 mg. 8 Pregelatinized corn starch (Lycatab PGS) 10.00 mg. 9 Sodium Starch Glycolate (Type A) (EXPLOTAB) 3.00 mg. Chlorthalidone Tabs USP 50 mg 1 Number 10 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 0.60 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

g. Chlorthalidone Tabs USP 50 mg 1 Number 10 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 0.60 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Chlorthalidone Tabs USP 25 mg||1 Number|1|Chlorthalidone (Micronized)|25.50 mg.| |||||2|Microcrystalline Cellulose (Avicel PH 101)|37.45 mg.| |||||3|Pregelatinized corn starch (Lycatab PGS)|5.00 mg.| |||||4|Sodium Starch Glycolate (Type A) (EXPLOTAB)|1.50 mg.| |||||5|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|0.30 mg.| ||Chlorthalidone Tabs USP 50 mg||1 Number|6|Chlorthalidone (Micronized)|51.00 mg.| |||||7|Microcrystalline Cellulose (Avicel PH 101)|74.90 mg.| |||||8|Pregelatinized corn starch (Lycatab PGS)|10.00 mg.| |||||9|Sodium Starch Glycolate (Type A) (EXPLOTAB)|3.00 mg.| |||||10|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|0.60 mg.|

UDIN00710749AM25

Case No.<br>Case Status	21 / NC/3/MEET/Feb/202425/17<br>Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005526AM23
RA File Number	09AX04000891 AM23
Licence No and<br>Date	0911004257/04/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. ATORVASTATIN Tablets 10mg ( ( Each Tablet contains Atorvastatin Calcium (Propylene glycol solvate) equivalent to Atorvastatin 10mg)) 1 Number 1 Atorvastatin Calcium (Propylene Glycol Solvate ) 11.24 mg. ATORVASTATIN Tablets 20mg(( Each Tablet contains Atorvastatin Calcium (Propylene glycol solvate) equivalent to Atorvastatin 20mg) ) 1 Number 2 Atorvastatin Calcium (Propylene Glycol Solvate ) 22.48 mg. ATORVASTATIN Tablets 40mg( ( Each Tablet contains Atorvastatin Calcium (Propylene glycol solvate) equivalent to Atorvastatin 40mg)) 1 Number 3 Atorvastatin Calcium (Propylene Glycol Solvate ) 44.96 mg.||

UDIN00710749AM25

Case No.	22 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00004701AM24
RA File Number	07AX04001546 AM23
Licence No and Date	0711006197/16/01/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

eview of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. DOXYCYCLINE 100MG DISPERSIBLE TABLETS (equivalent to anhydrous doxycycline 100mg) USP/IP (600.00 KG) 1 Number 1 DOXYCYCLINE MONOHYDRATE U.S.P/B.P. (Potency 93%) 109.68 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	23 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005825AM23
RA File Number	05AX04003069 AM23

UDIN00710749AM25

Licence No and 0511016941/19/01/2023 Date Norms Committee Decision:

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

To give proper Chemical reaction starting clearly from import items asked for, in the licence, giving molecular weight and name of the chemicals and also yield of the reaction.
Function/application of each raw material asked for in the process indicating raw material, catalyst solvent/diluents, etc., as the case may be, giving stoichiometric material balance on a molar basis.
Value of by-product, if any and with End use of export item.

icating raw material, catalyst solvent/diluents, etc., as the case may be, giving stoichiometric material balance on a molar basis.

Value of by-product, if any and with End use of export item.

Case No.	Case No.	24 / NC/3/MEET/Feb/202425/17	24 / NC/3/MEET/Feb/202425/17	24 / NC/3/MEET/Feb/202425/17	24 / NC/3/MEET/Feb/202425/17	24 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00001573AM24
RA File Number		03AX04001075 AM24
Licence No and Date		0311024511/13/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ASHOXY 20% LA / OXYVET 20% LA<br>(OXYTETRACYCLINE INJECTABLE<br>SOLUTION 20% LONG ACTING) Pack<br>50ML vial((EACH VIAL CONTAINS<br>19ML 2-pyrrolidone) (Nett Wt. of<br>EXEMPTED MATERIAL IS 646.15 KGS)<br>(32700 NOS))<br>32700<br>Numbers<br>1<br>2 PYRROLIDONE<br>678.46 kg.<br>ASHOXY 20% LA / OXYVET 20% LA<br>(OXYTETRACYCLINE INJECTABLE<br>SOLUTION 20% LONG ACTING) Pack<br>24000<br>Numbers<br>2<br>2 PYRROLIDONE<br>995.9 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

0% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack 24000 Numbers 2 2 PYRROLIDONE 995.9 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack 50ML vial((EACH VIAL CONTAINS 19ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 646.15 KGS) (32700 NOS))||32700 Numbers|1|2 PYRROLIDONE|678.46 kg.| ||ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack||24000 Numbers|2|2 PYRROLIDONE|995.9 kg.|

Case No.	Case No.	24 / NC/3/MEET/Feb/202425/17	24 / NC/3/MEET/Feb/202425/17	24 / NC/3/MEET/Feb/202425/17	24 / NC/3/MEET/Feb/202425/17	24 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00001573AM24
RA File Number		03AX04001075 AM24
Licence No and Date		0311024511/13/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ASHOXY 20% LA / OXYVET 20% LA<br>(OXYTETRACYCLINE INJECTABLE<br>SOLUTION 20% LONG ACTING) Pack<br>50ML vial((EACH VIAL CONTAINS<br>19ML 2-pyrrolidone) (Nett Wt.

Import Items** Qty. allowed. ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack 50ML vial((EACH VIAL CONTAINS 19ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 646.15 KGS) (32700 NOS)) 32700 Numbers 1 2 PYRROLIDONE 678.46 kg. ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack 24000 Numbers 2 2 PYRROLIDONE 995.9 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack 50ML vial((EACH VIAL CONTAINS 19ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 646.15 KGS) (32700 NOS))||32700 Numbers|1|2 PYRROLIDONE|678.46 kg.| ||ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack||24000 Numbers|2|2 PYRROLIDONE|995.9 kg.|

UDIN00710749AM25

s|1|2 PYRROLIDONE|678.46 kg.| ||ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack||24000 Numbers|2|2 PYRROLIDONE|995.9 kg.|

UDIN00710749AM25

100ML vial((EACH VIAL CONTAINS<br>38ML 2-pyrrolidone) (Nett Wt. of<br>EXEMPTED MATERIAL IS 948.48 KGS)<br>(24000 NOS))<br>ASHOXY 20% LA / OXYVET 20% LA<br>(OXYTETRACYCLINE INJECTABLE<br>SOLUTION 20% LONG ACTING) Pack<br>250ML vial((EACH VIAL CONTAINS<br>95ML 2-pyrrolidone) (Nett Wt. of<br>EXEMPTED MATERIAL IS 691.60 KGS)<br>(7000 NOS))<br>7000<br>Numbers<br>3<br>2 PYRROLIDONE<br>726.18 kg.<br>RA concerned may take further necessary action as per above decision of NC.	100ML vial((EACH VIAL CONTAINS<br>38ML 2-pyrrolidone) (Nett Wt. of<br>EXEMPTED MATERIAL IS 948.48 KGS)<br>(24000 NOS))
	ASHOXY 20% LA / OXYVET 20% LA<br>(OXYTETRACYCLINE INJECTABLE<br>SOLUTION 20% LONG ACTING) Pack<br>250ML vial((EACH VIAL CONTAINS<br>95ML 2-pyrrolidone) (Nett Wt. of<br>EXEMPTED MATERIAL IS 691.60 KGS)<br>(7000 NOS))	7000<br>Numbers	3	2 PYRROLIDONE	726.18 kg.

Case No.	Case No.	25 / NC/3/MEET/Feb/202425/17	25 / NC/3/MEET/Feb/202425/17	25 / NC/3/MEET/Feb/202425/17	25 / NC/3/MEET/Feb/202425/17	25 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00001574AM24
RA File Number		03AX04001083 AM24
Licence No and<br>Date		0311024513/13/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Jan/202425/15 dated 28/01/2025 against advance<br>authorization No. 0311023767 dated 22/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Ashoxy 5% (Oxytetracycline<br>Hydrochloride Injection 50mg) 50ml<br>vial((Net content of exempted material is<br>1 Number<br>1<br>PROPYLENE GLYCOL<br>39.52 gm/Vial
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

ride Injection 50mg) 50ml vial((Net content of exempted material is 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial((Net content of exempted material is|| 1 Number|1|PROPYLENE GLYCOL|39.52 gm/Vial|

Case No.	Case No.	25 / NC/3/MEET/Feb/202425/17	25 / NC/3/MEET/Feb/202425/17	25 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00001574AM24
RA File Number		03AX04001083 AM24
Licence No and<br>Date		0311024513/13/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Jan/202425/15 dated 28/01/2025 against advance<br>authorization No. 0311023767 dated 22/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Ashoxy 5% (Oxytetracycline<br>Hydrochloride Injection 50mg) 50ml<br>vial((Net content of exempted material is<br>1 Number<br>1<br>PROPYLENE GLYCOL<br>39.52 gm/Vial
	Export Product		Qty.	**Sl. No.

xytetracycline Hydrochloride Injection 50mg) 50ml vial((Net content of exempted material is 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial((Net content of exempted material is|| 1 Number|1|PROPYLENE GLYCOL|39.52 gm/Vial|

UDIN00710749AM25

447.20 kgs) (10000 NOS))
Ashoxy 5% (Oxytetracycline<br>Hydrochloride Injection 50mg) 100ml<br>vial((Net content of exempted material is<br>1252.16 kgs) (14000 NOS))	<br>1 Number	2	PROPYLENE GLYCOL	79.04 gm/Vial
Ashoxy 5% (Oxytetracycline<br>Hydrochloride Injection 50mg) 250ml<br>vial((Net content of exempted material is<br>603.72 kgs) (2700 NOS))	<br>1 Number	3	PROPYLENE GLYCOL	197.60 gm/Vial
Ashoxy 5% (Oxytetracycline<br>Hydrochloride Injection 50mg) 500ml<br>vial((Net content of exempted material is<br>894.40 kgs) (2000 NOS))	<br>1 Number	4	PROPYLENE GLYCOL	395.20 gm/Vial
Ashoxy 10% (Oxytetracycline Injection<br>100mg) 50ml vial((Net content of<br>exempted material is 426.40 kgs) (10000<br>NOS))	1 Number	5	PROPYLENE GLYCOL	35.256 gm/Vial
Ashoxy 10% (Oxytetracycline Injection<br>100mg) 100ml vial((Net content of<br>exempted material is 1705.60 kgs)<br>(20000 NOS))	1 Number	6	PROPYLENE GLYCOL	70.512 gm/Vial
Ashoxy 10% (Oxytetracycline Injection<br>100mg) 250ml vial((Net content of<br>exempted material is 1066.00 kgs) (5000<br>NOS))	1 Number	7	PROPYLENE GLYCOL	176.28 gm/Vial

ENE GLYCOL|70.512 gm/Vial| ||Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial((Net content of exempted material is 1066.00 kgs) (5000 NOS))|1 Number|7|PROPYLENE GLYCOL|176.28 gm/Vial| ||PAN Ashoxy 3% (Oxytetracycline Injection 30mg) 100ml vial((Net content of exempted material is 852.80 kgs) (10000 NOS))|1 Number|8|PROPYLENE GLYCOL|70.512 gm/Vial| ||Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 50ml vial((Net content of exempted material is 93.60 kgs) (10000 NOS))|1 Number|9|PROPYLENE GLYCOL|9.00 gm/Vial| ||Ashoxy 20% LA (Oxytetracycline|1 Number|10|PROPYLENE GLYCOL|18.00 gm/Vial|

UDIN00710749AM25

Dihydrate Injection eq Oxytetracycline<br>200mg) 100ml vial((Net content of<br>exempted material is 187.20 kgs) (10000<br>NOS))
Ashoxy 20% LA (Oxytetracycline<br>Dihydrate Injection eq Oxytetracycline<br>200mg) 250ml vial((Net content of<br>exempted material is 468.00 kgs) (10000<br>NOS))	1 Number	11	PROPYLENE GLYCOL	45.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg Injection)<br>10ml viaL((Net content of exempted<br>material is 101.92 kgs) (10000 NOS))	<br> <br>1 Number	12	PROPYLENE GLYCOL	10.40 gm/Vial
Ashiver 1% (Ivermectin 10 Mg Injection)<br>50ml vial((Net content of exempted<br>material is 509.60 kgs) (10000 NOS))	<br> <br>1 Number	13	PROPYLENE GLYCOL	52.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg Injection)<br>100ml vial((Net content of exempted<br>material is 2038.40 kgs) (20000 NOS))	<br> <br>1 Number	14	PROPYLENE GLYCOL	104.00 gm/Vial

E GLYCOL|52.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 100ml vial((Net content of exempted material is 2038.40 kgs) (20000 NOS))| 1 Number|14|PROPYLENE GLYCOL|104.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 250ml vial((Net content of exempted material is 1274.00 kgs) (5000 NOS))| 1 Number|15|PROPYLENE GLYCOL|260.00 gm/Vial| ||Ashiver 1% (Ivermectin 10 Mg Injection) 500ml vial((Net content of exempted material is 1017.12 kgs) (2000 NOS))| 1 Number|16|PROPYLENE GLYCOL|520.00 gm/Vial| ||Ashiver Forte (Ivermectin 10mg and Clorsulon 100mg Injection) 50ml viaL((Net content of exempted material is 512.72 kgs) (10000 NOS))|1 Number|17|PROPYLENE GLYCOL|50.96 gm/Vial| ||Ashiver Forte (Ivermectin 10mg and Clorsulon 100mg Injection) 100ml vial((Net content of exempted material is 1029.60 kgs) (10000 NOS))| 1 Number|18|PROPYLENE GLYCOL|101.92 gm/Vial| ||Ashienro 10% (Enrofloxacin Injection 100mg) 50ml vial((Net content of exempted material is 52.00 kgs) (10000| 1 Number|19|PROPYLENE GLYCOL|5.20 gm/Vial|

UDIN00710749AM25

UDIN00710749AM25

|NOS)) Ashienro 10% (Enrofloxacin Injection 100mg) 100ml vial((Net content of exempted material is 104.00 kgs) (10000 NOS)) 1 Number 20 PROPYLENE GLYCOL 10.40 gm/Vial Ashienro 10% (Enrofloxacin Injection 100mg) 250ml vial((Net content of exempted material is 260.00 kgs) (10000 NOS)) 1 Number 21 PROPYLENE GLYCOL 26.00 gm/Vial Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial((Net content of exempted material is 104.00 kgs) (10000 NOS)) 1 Number 22 PROPYLENE GLYCOL Not matching with Master-Batch Formula Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial((Net content of exempted material is 208.00 kgs) (10000 NOS)) 1 Number 23 PROPYLENE GLYCOL 20.80 gm/Vial Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial((Net content of exempted material is 520.00 kgs) (10000 NOS)) 1 Number 24 PROPYLENE GLYCOL Not matching with Master-Batch Formula Ashityl 5% (Tylosin Tartrate injection eq to Tylosin 50mg) 50ml vial((Net content of exempted material is 104.00 kgs) (10000 NOS)) 1 Number 25 PROPYLENE GLYCOL 10.40 gm/Vial Ashital 10% (Closantel 10% Inj) 100ml vial((Net content of exempted material is 551.20 kgs) (10000 NOS)) 1 Number 26 PROPYLENE GLYCOL 55.12 g

NOS))
Ashienro 10% (Enrofloxacin Injection<br>100mg) 100ml vial((Net content of<br>exempted material is 104.00 kgs) (10000<br>NOS))	1 Number	20	PROPYLENE GLYCOL	10.40 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 250ml vial((Net content of<br>exempted material is 260.00 kgs) (10000<br>NOS))	1 Number	21	PROPYLENE GLYCOL	26.00 gm/Vial
Ashityl 20% (Tylosin Tartrate injection<br>eq to Tylosin 200mg) 100ml vial((Net<br>content of exempted material is 104.00<br>kgs) (10000 NOS))	1 Number	22	PROPYLENE GLYCOL	Not matching with<br>Master-Batch<br>Formula
Ashityl 20% (Tylosin Tartrate injection<br>eq to Tylosin 200mg) 100ml vial((Net<br>content of exempted material is 208.00<br>kgs) (10000 NOS))	1 Number	23	PROPYLENE GLYCOL	20.80 gm/Vial
Ashityl 20% (Tylosin Tartrate injection<br>eq to Tylosin 200mg) 100ml vial((Net<br>content of exempted material is 520.00<br>kgs) (10000 NOS))	1 Number	24	PROPYLENE GLYCOL	Not matching with<br>Master-Batch<br>Formula
Ashityl 5% (Tylosin Tartrate injection eq<br>to Tylosin 50mg) 50ml vial((Net content<br>of exempted material is 104.00 kgs)<br>(10000 NOS))	<br>1 Number	25	PROPYLENE GLYCOL	10.40 gm/Vial

Formula| ||Ashityl 5% (Tylosin Tartrate injection eq to Tylosin 50mg) 50ml vial((Net content of exempted material is 104.00 kgs) (10000 NOS))| 1 Number|25|PROPYLENE GLYCOL|10.40 gm/Vial| ||Ashital 10% (Closantel 10% Inj) 100ml vial((Net content of exempted material is 551.20 kgs) (10000 NOS))| 1 Number|26|PROPYLENE GLYCOL|55.12 gm/Vial|

Case No. 26 / NC/3/MEET/Feb/202425/17

UDIN00710749AM25

Case Status	Case Status	Case Status	Case Status	Case Approved	Case Approved	Case Approved
Party Name				ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date				NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number				HQRNORM APPLY 00001580AM24
RA File Number				03AX04001140 AM24
Licence No and<br>Date				0311024530/14/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of factory visit. The<br>committee found that in the above mention case export product is in form of Gel not a cream/Ointments<br>and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity<br>(i)<br>Medical Creams &Ointments(Clobetasol Propionate Cream 0.05% 15 Gm tube<br>Tot Wt: 450 Kgs (Net Cont: Clob0.23 Kg, Arlacel 20.25Kg, White Wax 4.5Kg))<br>1 Number<br>(ii)<br>Medical Creams &Ointments(Clobetasol Propionate Cream 0.05% 30 Gm tube<br>Tot Wt: 120Kgs (Net Cont: Clob0.06Kg, Arlacel 5.40Kg, White Wax 1.20Kgs))<br>1 Number<br>(iii)<br>Medical Creams &Ointments(Clobetasol Propionate Cream 0.05%

tasol Propionate Cream 0.05% 30 Gm tube Tot Wt: 120Kgs (Net Cont: Clob0.06Kg, Arlacel 5.40Kg, White Wax 1.20Kgs)) 1 Number (iii) Medical Creams &Ointments(Clobetasol Propionate Cream 0.05% 45 Gm tube Tot Wt: 1125 Kgs (Net Cont: Clob0.58 Kg, Arlacel 50.63Kg, White Wax 11.25Kgs)) 1 Number (iv) Medical Creams &Ointments(Clobetasol Propionate Cream 0.05% 60 Gm tube Tot Wt: 18000Kgs (Net Cont: Clob9.33 Kgs, Arlacel 810.01Kgs, White Wax 180Kgs)) 1 Number 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.||||||| ||Sl. No||Export Product|||Quantity| ||(i)||Medical Creams &Ointments(Clobetasol Propionate Cream 0.05% 15 Gm tube Tot Wt: 450 Kgs (Net Cont: Clob0.23 Kg, Arlacel 20.25Kg, White Wax 4.5Kg))|||1 Number| ||(ii)||Medical Creams &Ointments(Clobetasol Propionate Cream 0.05% 30 Gm tube Tot Wt: 120Kgs (Net Cont: Clob0.06Kg, Arlacel 5.40Kg, White Wax 1.20Kgs))|||1 Number| ||(iii)||Medical Creams &Ointments(Clobetasol Propionate Cream 0.05% 45 Gm tube Tot Wt: 1125 Kgs (Net Cont: Clob0.58 Kg, Arlacel 50.63Kg, White Wax 11.25Kgs))|||1 Number| ||(iv)||Medical Creams &Ointments(Clobetasol Propionate Cream 0.05% 60 Gm tube Tot Wt: 18000Kgs (Net Cont: Clob9.33 Kgs, Arlacel 810.01Kgs, White Wax 180Kgs))|||1 Number| |||||||| |||Sl. No.|Import Items||Quantity allowed.||

onate Cream 0.05% 60 Gm tube Tot Wt: 18000Kgs (Net Cont: Clob9.33 Kgs, Arlacel 810.01Kgs, White Wax 180Kgs))|||1 Number| |||||||| |||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.||

24 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

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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.	Case No.	27 / NC/3/MEET/Feb/202425/17	27 / NC/3/MEET/Feb/202425/17	27 / NC/3/MEET/Feb/202425/17	27 / NC/3/MEET/Feb/202425/17	27 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00001634AM24
RA File Number		34AX04000189 AM24
Licence No and Date		3411003805/15/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

eview of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Doxycycline Monohydrate USP 82.26 mg 2 Microcrystalline Cellulose (Avicel PH 301) 88.874 mg. 3 Sodium Starch Glycolate (Type A) (EXPLOTAB) 12.75 mg. 4 Povidone (Kollidon30 LP) 6.00 mg. Microcrystalline Cellulose DOXYCYCLINE CAPS. USP 75 MG(DOXYCYCLINE CAPS. USP 75 MG (Net content of active ingredients 82.50 kgs )) 1 Number 5 15.00 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DOXYCYCLINE CAPS. USP 75 MG(DOXYCYCLINE CAPS. USP 75 MG (Net content of active ingredients 82.50 kgs ))|| 1 Number|1|Doxycycline Monohydrate USP|82.26 mg| |||||2|Microcrystalline Cellulose (Avicel PH 301)|88.874 mg.| |||||3|Sodium Starch Glycolate (Type A) (EXPLOTAB)|12.75 mg.| |||||4|Povidone (Kollidon30 LP)|6.00 mg.| |||||5|Microcrystalline Cellulose|15.00 mg.|

ine Cellulose (Avicel PH 301)|88.874 mg.| |||||3|Sodium Starch Glycolate (Type A) (EXPLOTAB)|12.75 mg.| |||||4|Povidone (Kollidon30 LP)|6.00 mg.| |||||5|Microcrystalline Cellulose|15.00 mg.|

Case No.	Case No.	27 / NC/3/MEET/Feb/202425/17	27 / NC/3/MEET/Feb/202425/17	27 / NC/3/MEET/Feb/202425/17	27 / NC/3/MEET/Feb/202425/17	27 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00001634AM24
RA File Number		34AX04000189 AM24
Licence No and Date		3411003805/15/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Doxycycline Monohydrate<br>USP<br>82.26 mg<br>2<br>Microcrystalline Cellulose<br>(Avicel PH 301)<br>88.874 mg.<br>3<br>Sodium Starch Glycolate<br>(Type A) (EXPLOTAB)<br>12.75 mg.<br>4<br>Povidone (Kollidon30 LP)<br>6.00 mg.<br>Microcrystalline Cellulose<br>DOXYCYCLINE CAPS. USP 75<br>MG(DOXYCYCLINE CAPS.<br>USP 75 MG (Net content of<br>active ingredients<br>82.50 kgs ))<br>1 Number<br>5<br>15.00 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	DOXYCYCLINE CAPS.

SP 75 MG (Net content of active ingredients 82.50 kgs )) 1 Number 5 15.00 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DOXYCYCLINE CAPS. USP 75 MG(DOXYCYCLINE CAPS. USP 75 MG (Net content of active ingredients 82.50 kgs ))|| 1 Number|1|Doxycycline Monohydrate USP|82.26 mg| |||||2|Microcrystalline Cellulose (Avicel PH 301)|88.874 mg.| |||||3|Sodium Starch Glycolate (Type A) (EXPLOTAB)|12.75 mg.| |||||4|Povidone (Kollidon30 LP)|6.00 mg.| |||||5|Microcrystalline Cellulose|15.00 mg.|

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		(Avicel PH 200 LM)
	6	Colloidal Silicon Dioxide<br>(Aerosil 200 Pharma)	1.088 mg.
	7	Magnesium Stearate<br>(Vegetable Source)	2.25 mg.
DOXYCYCLINE CAPS.

			(Avicel PH 200 LM)
		6	Colloidal Silicon Dioxide<br>(Aerosil 200 Pharma)	1.088 mg.
		7	Magnesium Stearate<br>(Vegetable Source)	2.25 mg.
DOXYCYCLINE CAPS. USP<br>100 MG(DOXYCYCLINE<br>CAPS. USP 100 MG (Net<br>content of active ingredients<br>160.00 kgs ))	1 Number	8	Doxycycline Monohydrate<br>USP	109.68 mg.
		9	Microcrystalline Cellulose<br>(Avicel PH 301)	118.498 mg.
		10	Sodium Starch Glycolate<br>(Type A) (EXPLOTAB)	17.00 mg.
		11	Povidone (Kollidon30 LP)	8.00 mg.
		12	Microcrystalline Cellulose<br>(Avicel PH 200 LM)	20.00 mg.
		13	Colloidal Silicon Dioxide<br>(Aerosil 200 Pharma)	1.45 mg.
		14	Magnesium Stearate<br>(Vegetable Source)	3.00 mg.

Case No.	28 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	ARCH PROTECTION CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQFile Number	HQRNORM APPLY 00001705AM24

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RA File Number

03AX04001182 AM24

Licence No and Date

0311024600/16/06/2023

Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Certificate of Analysis (CoA) of import item from Foreign Supplierand export item and to indicate the difference between the two. 1. Name of the Solvent and other indigenous items used in the process. 2. Justification of 16% wastage (on out basis). 3.

t item and to indicate the difference between the two. 1. Name of the Solvent and other indigenous items used in the process. 2. Justification of 16% wastage (on out basis). 3.||

Case No.	29 / NC/3/MEET/Feb/202425/17
Case Status	Case Rejected
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00007548AM24
RA File Number	03AX04001130 AM24
Licence No and<br>Date	0311024614/16/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided to reject<br>the case maintaining the status quo.

Case No.	30 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00001889AM24
RA File Number	03AX04001069 AM24
Licence No and<br>Date	0311024666/19/06/2023
Norms Committee Decision:

27 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

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The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

UDIN00710749AM25

The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
NAPROLAT-CARBOPLATIN BP<br>10 MG/ML INJ. ( 1x45ML ) 450<br>MG.<br>	<br> <br>1 Number Vial	1	Carboplatin IP/ BP/ USP	472.50 mg/45<br>ml. Injection

Case No.	Case No.	31 / NC/3/MEET/Feb/202425/17	31 / NC/3/MEET/Feb/202425/17	31 / NC/3/MEET/Feb/202425/17	31 / NC/3/MEET/Feb/202425/17	31 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM REVIW00001053AM25
RA File Number		09AX04000025 AM24
Licence No and Date		0911005223/19/06/2023
Norms Committee Decision:<br>The representative of the firm had attended the Personal Hearing through Video Concerence and<br>explained the case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>**Sl. No.

e case. The Committee heard the explanation of Representative of the firm and after due deliberation it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 PENICILLIN G POTASSIUM FIRST CRYSTAL 1.375 kg. 2 ACETONE 1.971 kg. 3 METHYLENE CHLORIDE MDC 3.29 kg. GCLE (7-PHENYLACETAMIDEO- 3- CHLOROMETHYL CEPHALOSPORANIC ACID PARA METHOXY BENZYL ESTER) (WHITE RYSTALLINE) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||GCLE (7-PHENYLACETAMIDEO- 3- CHLOROMETHYL CEPHALOSPORANIC ACID PARA METHOXY BENZYL ESTER) (WHITE RYSTALLINE)||1 kg.|1|PENICILLIN G POTASSIUM FIRST CRYSTAL|1.375 kg.| |||||2|ACETONE|1.971 kg.| |||||3|METHYLENE CHLORIDE MDC|3.29 kg.|

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4<br>2 MERCAPTO BENZO<br>THIAZOLE MBT<br>0.511 kg.<br>5<br>METHANOL<br>1.971 kg.<br>RA concerned may take further necessary action as per above decision of NC.			4	2 MERCAPTO BENZO<br>THIAZOLE MBT	0.511 kg.
			5	METHANOL	1.971 kg.

NOL<br>1.971 kg.<br>RA concerned may take further necessary action as per above decision of NC.			4	2 MERCAPTO BENZO<br>THIAZOLE MBT	0.511 kg.
			5	METHANOL	1.971 kg.

Case No.	Case No.	Case No.	32 / NC/3/MEET/Feb/202425/17	32 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number			HQRNORM APPLY 00002491AM24
RA File Number			03AX04001286 AM24
Licence No and<br>Date			0311024864/26/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of factory visit. The<br>committee found that in the above mention case export product is in form of Gel not a cream/Ointments<br>and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity<br>(i)<br>Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 15Gm Tot<br>Wt: 6000 Kgs (Net ContClobetasol3.11Kgs, Sorbitan 30Kgs, White Petrolatum<br>5667Kgs))<br>1 Number<br>(ii)<br>Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 30Gm Tot<br>Wt: 4500 Kgs (Net ContClobetasol2.33Kgs, Sorbitan 22.5Kgs, White Petrolatum<br>4250.25Kgs))<br>1 Number<br>Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 45Gm Tot<br>Wt: 6750Kgs (Net ContClobetasol3.50Kgs, Sorbitan 33.75Kgs, White<br>(iii)<br>1 Number
	Sl.<br>No	Export Product		Quantity

ments(Clobetasol Propionate Ointment 0.05% 45Gm Tot Wt: 6750Kgs (Net ContClobetasol3.50Kgs, Sorbitan 33.75Kgs, White (iii) 1 Number||||| ||Sl. No|Export Product||Quantity| ||(i)|Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 15Gm Tot Wt: 6000 Kgs (Net ContClobetasol3.11Kgs, Sorbitan 30Kgs, White Petrolatum 5667Kgs))||1 Number| ||(ii)|Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 30Gm Tot Wt: 4500 Kgs (Net ContClobetasol2.33Kgs, Sorbitan 22.5Kgs, White Petrolatum 4250.25Kgs))||1 Number| ||(iii)|Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 45Gm Tot Wt: 6750Kgs (Net ContClobetasol3.50Kgs, Sorbitan 33.75Kgs, White||1 Number|

Case No.	Case No.	Case No.	32 / NC/3/MEET/Feb/202425/17	32 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number			HQRNORM APPLY 00002491AM24
RA File Number			03AX04001286 AM24
Licence No and<br>Date			0311024864/26/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of factory visit.

03AX04001286 AM24|| |Licence No and Date|||0311024864/26/06/2023|| |Norms Committee 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(Clobetasol Propionate Ointment 0.05% 15Gm Tot Wt: 6000 Kgs (Net ContClobetasol3.11Kgs, Sorbitan 30Kgs, White Petrolatum 5667Kgs)) 1 Number (ii) Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 30Gm Tot Wt: 4500 Kgs (Net ContClobetasol2.33Kgs, Sorbitan 22.5Kgs, White Petrolatum 4250.25Kgs)) 1 Number Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 45Gm Tot Wt: 6750Kgs (Net ContClobetasol3.50Kgs, Sorbitan 33.75Kgs, White (iii) 1 Number||||| ||Sl. No|Export Product||Quantity| ||(i)|Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 15Gm Tot Wt: 6000 Kgs (Net ContClobetasol3.11Kgs, Sorbitan 30Kgs, White Petrolatum 5667Kgs))||1 Number| ||(ii)|Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 30Gm Tot Wt: 4500 Kgs (Net ContClobetasol2.33Kgs, Sorbitan 22.5Kgs, White Petrolatum 4250.25Kgs))||1 Number| ||(iii)|Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 45Gm Tot Wt: 6750Kgs (Net ContClobetasol3.50Kgs, Sorbitan 33.75Kgs, White||1 Number|

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)||1 Number| ||(iii)|Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 45Gm Tot Wt: 6750Kgs (Net ContClobetasol3.50Kgs, Sorbitan 33.75Kgs, White||1 Number|

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	Petrolatum 6375.38))
(iv)	Medical Creams &Ointments(Clobetasol Propionate Ointment 0.05% 60Gm Tot	1 Number
	Wt: 25200Kgs (Net ContClobetasol 13.05Kgs, Sorbitan 126Kgs, White
	Petrolatum 23801.40Kgs))

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.	33 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00006559AM24
RA File Number	04AX04000303 AM24
Licence No and<br>Date	0411005642/04/07/2023
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-

30 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

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mation provided by the firm, it was decided to revise ad-hoc norms as under:-||

30 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

UDIN00710749AM25

Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>IBUPROFEN<br>0.683 kg.<br>IBUPROFEN LYSINE (LYSINATE)<br>(CHEMICAL<br>AND<br>ALLIED<br>PRODUCT)<br>1 kg.<br>2<br>DL LYSINATE 50%<br>0.970 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	IBUPROFEN LYSINE (LYSINATE)<br>(CHEMICAL<br>AND<br>ALLIED<br>PRODUCT)	<br> <br>1 kg.	1	IBUPROFEN	0.683 kg.
			2	DL LYSINATE 50%	0.970 kg.

Case No.	34 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004115AM24
RA File Number	52AX04000093 AM24
Licence No and Date	5211005099/05/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 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.

per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Hydrazine Hydrate 64% (RM for mfg of SEMICARBAZIDE HCL for further mfg of TPO) 2.40 kg. 1,2,4 - TRIAZOLO (4,3-a) PYRIDIN -3 (2H) - ONE - 98% MIN.(TPO) 1 kg. 2 2-CHLORO PYRIDINE 1.14 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	35 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004222AM24
RA File Number	09AX04000297 AM24
Licence No and<br>Date	0911005327/06/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2,3,4,5-Tetra fluoro benzoyl Chloride<br>2.60 kg.<br>2<br>Ethyl 3-(N,N-dimethyl amino) acrylate<br>2.11 kg.<br>3<br>Toluene<br>9.21 kg.<br>4<br>N-Methyl Piperazine<br>1.03 kg.<br>MARBOFLOXACIN<br>(PHARMACEUTICAL<br>PRODUCT)<br>1 kg.<br>5<br>Dimethyl Sulfoxide<br>1.33 kg.<br>RA concerned may take further necessary action as per above decision of NC.

erazine 1.03 kg. MARBOFLOXACIN (PHARMACEUTICAL PRODUCT) 1 kg. 5 Dimethyl Sulfoxide 1.33 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	36 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025

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HQ File Number	HQ File Number	HQRNORM APPLY 00004246AM24	HQRNORM APPLY 00004246AM24	HQRNORM APPLY 00004246AM24	HQRNORM APPLY 00004246AM24	HQRNORM APPLY 00004246AM24
RA File Number		34AX04000258 AM24
Licence No and<br>Date		3411003871/06/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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 Acitretin USP 10.2 mg 2 Microcrystalline cellulose (Avicel PH 102) 54.6 mg. 3 Colloidal silicon dioxide (Aerosil 200 Pharma) 0.30 mg. Acitretin Capsules USP 10 mg (Net content of active ingredients 1.000 kgs ) 1 Number 4 Magnesium stearate (Ligamed MF- 2-V) 0.60 mg. 5 Acitretin USP 17.85 mg. 6 Microcrystalline cellulose (Avicel PH 102) 95.55 mg. 7 Colloidal silicon dioxide (Aerosil 200 Pharma) 0.70 mg. Acitretin Capsules USP 17.5 mg (Net content of active ingredients 1.75 kgs ) 1 Number 8 Magnesium stearate (Ligamed MF- 2-V) 1.00 mg. 9 Acitretin USP 25.50 mg. 10 Microcrystalline cellulose (Avicel PH 102) 136.50 mg. Colloidal silicon dioxide (Aerosil Acitretin Capsules USP 25 mg (Net content of active ingredients 2.50 kgs ) 1 Number 11 1.00 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

il Acitretin Capsules USP 25 mg (Net content of active ingredients 2.50 kgs ) 1 Number 11 1.00 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Acitretin Capsules USP 10 mg (Net content of active ingredients 1.000 kgs )|| 1 Number|1|Acitretin USP|10.2 mg| |||||2|Microcrystalline cellulose (Avicel PH 102)|54.6 mg.| |||||3|Colloidal silicon dioxide (Aerosil 200 Pharma)|0.30 mg.| |||||4|Magnesium stearate (Ligamed MF- 2-V)|0.60 mg.| ||Acitretin Capsules USP 17.5 mg (Net content of active ingredients 1.75 kgs )|| 1 Number|5|Acitretin USP|17.85 mg.| |||||6|Microcrystalline cellulose (Avicel PH 102)|95.55 mg.| |||||7|Colloidal silicon dioxide (Aerosil 200 Pharma)|0.70 mg.| |||||8|Magnesium stearate (Ligamed MF- 2-V)|1.00 mg.| ||Acitretin Capsules USP 25 mg (Net content of active ingredients 2.50 kgs )|| 1 Number|9|Acitretin USP|25.50 mg.| |||||10|Microcrystalline cellulose (Avicel PH 102)|136.50 mg.| |||||11|Colloidal silicon dioxide (Aerosil|1.00 mg.|

UDIN00710749AM25

200 Pharma)<br>12<br>Magnesium stearate (Ligamed MF-<br>2-V)<br>1.40 mg.<br>RA concerned may take further necessary action as per above decision of NC.				200 Pharma)
			12	Magnesium stearate (Ligamed MF-<br>2-V)	1.40 mg.

2-V)<br>1.40 mg.<br>RA concerned may take further necessary action as per above decision of NC.				200 Pharma)
			12	Magnesium stearate (Ligamed MF-<br>2-V)	1.40 mg.

Case No.	37 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	VISWAAT CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004250AM24
RA File Number	03AX04001561 AM24
Licence No and<br>Date	0311025198/06/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>AMMONIA GAS<br>15.3 MT<br>VICASOL MV 06<br>[POLY-ISOPROPANOL AMINES]<br>750 MT<br>2<br>PROPYLENE OXIDE<br>749.7 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	38 / NC/3/MEET/Feb/202425/17
Case Status	Case Rejected

UDIN00710749AM25

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

Case No.	38 / NC/3/MEET/Feb/202425/17
Case Status	Case Rejected

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Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00001706AM25
RA File Number	03AX04001312 AM24
Licence No and<br>Date	0311025237/07/07/2023
Norms Committee Decision:<br>The committee considered the application of the firm and it has been observed that the firm has not<br>appeared for personal hearing before committee to explain their case, therefore, the committee decided to<br>reject the application of the firm.

Case No.	Case No.	39 / NC/3/MEET/Feb/202425/17	39 / NC/3/MEET/Feb/202425/17	39 / NC/3/MEET/Feb/202425/17	39 / NC/3/MEET/Feb/202425/17	39 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00004401AM24
RA File Number		34AX04000275 AM24
Licence No and<br>Date		3411003884/13/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Dec/202425/13dated 07/01/2025 against advance<br>authorization No.3411005187 dated 22/07/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

t/import item in meeting No.NC/3/MEET/Dec/202425/13dated 07/01/2025 against advance authorization No.3411005187 dated 22/07/2024, 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. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube (net content of active ingredients 23.86 kgs. ) 1 Number 1 Nystatin USP 238.65 mg. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30 1 Number 2 Nystatin USP 477.30 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 (net content of active ingredients 23.86 kgs. )|| 1 Number|1|Nystatin USP|238.65 mg.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30|| 1 Number|2|Nystatin USP|477.30 mg.|

UDIN00710749AM25

in USP|238.65 mg.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30|| 1 Number|2|Nystatin USP|477.30 mg.|

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gm tube (net content of active<br>ingredients 34.09 kgs.)<br>Nystatin<br>and<br>Triamcinolone<br>Acetonide<br>Ointment<br>USP,<br>1,00,000 UNITS / GM; 0.1% - 60<br>gm<br>(net<br>content<br>of<br>active<br>ingredients 40.90 kgs.)<br>1 Number<br>3<br>Nystatin USP<br>954.61 mg.<br>Nystatin<br>and<br>Triamcinolone<br>Acetonide Cream USP, 1,00,000<br>UNITS / GM; 0.1% - 15 gm tube<br>(net content of active ingredients<br>23.86 kgs.)<br>1 Number<br>4<br>Nystatin USP<br>238.65 mg.<br>Nystatin<br>and<br>Triamcinolone<br>Acetonide Cream USP, 1,00,000<br>UNITS / GM; 0.1% - 30 gm tube<br>(net content of active ingredients<br>34.09 kgs.)<br>1 Number<br>5<br>Nystatin USP<br>477.30 mg.<br>Nystatin<br>and<br>Triamcinolone<br>Acetonide Cream USP, 1,00,000<br>UNITS / GM; 0.1% - 60 gm tube<br>(net content of active ingredients<br>40.90 kgs.)<br>1 Number<br>6<br>Nystatin USP<br>954.61 mg.<br>RA concerned may take further necessary action as per above decision of NC.	gm tube (net content of active<br>ingredients 34.09 kgs.)
	Nystatin<br>and<br>Triamcinolone<br>Acetonide<br>Ointment<br>USP,<br>1,00,000 UNITS / GM; 0.1% - 60<br>gm<br>(net<br>content<br>of<br>active<br>ingredients 40.90 kgs.)	<br> <br> <br> <br>1 Number	3	Nystatin USP	954.61 mg.
	Nystatin<br>and<br>Triamcinolone<br>Acetonide Cream USP, 1,00,000<br>UNITS / GM;

br>(net content of active ingredients 40.90 kgs.)| 1 Number|3|Nystatin USP|954.61 mg.| ||Nystatin and Triamcinolone Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 15 gm tube (net content of active ingredients 23.86 kgs.)| 1 Number|4|Nystatin USP|238.65 mg.| ||Nystatin and Triamcinolone Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube (net content of active ingredients 34.09 kgs.)| 1 Number|5|Nystatin USP|477.30 mg.| ||Nystatin and Triamcinolone Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 60 gm tube (net content of active ingredients 40.90 kgs.)| 1 Number|6|Nystatin USP|954.61 mg.|

Case No.	40 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004404AM24
RA File Number	31AX04000095 AM24

UDIN00710749AM25

Licence No and Date 3111002460/13/07/2023 Norms Committee Decision:

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

ion:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
METFORMIN<br>HYDROCHLORIDE DIRECT<br>COMPRESSIBLE GRANULES<br>86.66% W/W WHITE<br>GRANULES POWDER	1 kg.	1	DICYANDIAMIDE ( DCDA)<br>WHITE POWDER	0.484 kg.
		2	SODIUM STARCH GLYCOLATE<br>WHITE POWDER	0.034 kg.

Case No.	Case No.	Case No.	41 / NC/3/MEET/Feb/202425/17	41 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number			HQRNORM APPLY 00004433AM24
RA File Number			03AX04001604 AM24
Licence No and<br>Date			0311025397/14/07/2023
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of factory visit. The<br>committee found that in the above mention case export product is in form of Gel not a cream/Ointments<br>and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity<br>Medical Cream Ointment Gel(Metronidazole Topical Vaginal Gel 0.75% 70<br>(i)<br>1 Number
	Sl.<br>No	Export Product		Quantity
	(i)	Medical Cream Ointment Gel(Metronidazole Topical Vaginal Gel 0.75% 70		<br>1 Number

UDIN00710749AM25

70 (i) 1 Number||||| ||Sl. No|Export Product||Quantity| ||(i)|Medical Cream Ointment Gel(Metronidazole Topical Vaginal Gel 0.75% 70|| 1 Number|

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Gms Tube Wt:15000.02 Kgs NetWt:(Carbopol 300 Kgs, Edetate 7.5Kgs, Propylene 450Kgs,Sodium Hyd 37.5 Kgs, Propyl 12 Kgs,Methyl par12Kgs, Applicator 214286Nos))

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.	Case No.	42 / NC/3/MEET/Feb/202425/17	42 / NC/3/MEET/Feb/202425/17	42 / NC/3/MEET/Feb/202425/17	42 / NC/3/MEET/Feb/202425/17	42 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00004443AM24
RA File Number		03AX04001084 AM24
Licence No and<br>Date		0311025417/14/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl.

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

UDIN00710749AM25

TYLOSIN BOLUS 200MG (EACH<br>BOLUS CONTAINS TYLOSIN 200MG)<br>(nett content of exempt material is 0.900<br>kgs) (4500 NOS))	4500 Numbers	1	TYLOSIN TARTRATE	0.918 kg.
TYLOSIN INJECTION 5%-50 ML (EACH<br>ML CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN BASE 50MG) (nett<br>content of exempt material is 10 kgs) (4000<br>NOS))	<br>4000 Numbers	2	TYLOSIN TARTRATE	12.22 kg.
TYLOSIN INJECTION 5%-100 ML<br>(EACH ML CONTAINS TYLOSIN<br>TARTRATE EQ. TO TYLOSIN BASE<br>50MG) (nett content of exempt material is<br>15 kgs) (3000 nos))	3000 Numbers	3	TYLOSIN TARTRATE	18.33 kg.
TYLOSIN TARTRATE INJECTION 20%-<br>50 ML (EACH ML CONTAINS<br>TYLOSIN TARTRATE EQ. TO<br>TYLOSIN 200MG) (nett content of exempt<br>material is 75 kgs) (7500 nos))	<br>7500 Numbers	4	TYLOSIN TARTRATE	91.65 kg.
TYLOSIN TARTRATE INJECTION 20%-<br>100 ML (EACH ML CONTAINS<br>TYLOSIN TARTRATE EQ.

200MG) (nett content of exempt material is 75 kgs) (7500 nos))| 7500 Numbers|4|TYLOSIN TARTRATE|91.65 kg.| ||TYLOSIN TARTRATE INJECTION 20%- 100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) (nett content of exempt material is 150kgs) (7500 NOS))| 7500 Numbers|5|TYLOSIN TARTRATE|183.30 kg.| ||TYLOSIN TARTRATE POWDER 100%- 100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) (nett content of exempt material is 10 kgs) (100 NOS))|100 Numbers|6|TYLOSIN TARTRATE|10.10 kg.| ||TYLOSIN TARTRATE POWDER 100% - 500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) (nett content of exempt material is 7.5 kgs) (15 NOS))|15 Numbers|7|TYLOSIN TARTRATE|7.575 kg.| ||TYLOSIN TARTRATE POWDER 100% - 1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) (nett content of exempt material is 50 kgs) (50|50 Numbers|8|TYLOSIN TARTRATE|50.5 kg.|

UDIN00710749AM25

	NOS))	NOS))
	TYLOSIN TARTRATE POWDER 20%-		2500 Numbers	9	TYLOSIN TARTRATE	2.939 kg.
	5GM (EACH G	RAM CONTAINS
	TYLOSIN TAR	TRATE EQ. TO
	TYLOSIN 20%)<br>	(nett content of exempt<br>
	material is 2.5kg	s) (2500 NOS))

	TYLOSIN TAR	TRATE POWDER 20% -	2820 Numbers	10	TYLOSIN TARTRATE	66.305 kg.
	100GM (EACH	GRAM CONTAINS
	TYLOSIN TAR<br>TYLOSIN 20%)<br>	TRATE EQ. TO<br>(nett content of exempt<br>
material is 56.40 kgs) (2820 NOS))<br>TYLOSIN TARTRATE POWDER 20% -<br>500GM (EACH GRAM CONTAINS<br>TYLOSIN TARTRATE EQ.

N TAR TYLOSIN 20%) ||TRATE EQ. TO (nett content of exempt ||||||| |material is 56.40 kgs) (2820 NOS)) TYLOSIN TARTRATE POWDER 20% - 500GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 5kgs) (50 NOS)) 50 Numbers TYLOSIN TARTRATE POWDER 20% - 1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 10 kgs) (50 NOS)) 50 Numbers TYLOSIN TARTRATE POWDER 99% - 100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) (nett content of exempt material is 1.980 kgs) (20 NOS)) 20 Numbers TYLOSIN TARTRATE POWDER 99% - 500GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) (nett content of exempt material is 4.950 kgs) (10 NOS)) 10 Numbers TYLOSIN TARTRATE POWDER 99% - 1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) (nett content of exempt material is 24.75 kgs) (25 NOS)) 25 Numbers|material is 56.40 kgs) (2820 NOS))||||||||| ||TYLOSIN TARTRATE POWDER 20% - 500GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) (nett content of exempt material is 5kgs) (50 NOS))||||50 Numbers||11|TYLOSIN TARTRATE|5.878 kg.| ||| aterial is 5kgs) (50 NOS))|||||||| ||T 1 T T m||||||||| |||YLOSIN TARTRATE POWDER 20% KG JAR (EACH GRAM CONTAINS YLOSIN TARTRATE EQ.

0 Numbers||11|TYLOSIN TARTRATE|5.878 kg.| ||| aterial is 5kgs) (50 NOS))|||||||| ||T 1 T T m||||||||| |||YLOSIN TARTRATE POWDER 20% KG JAR (EACH GRAM CONTAINS YLOSIN TARTRATE EQ. TO YLOSIN 20%) (nett content of exempt aterial is 10 kgs) (50 NOS))||- |50 Nu|mbers|12|TYLOSIN TARTRATE|11.756 kg.| ||||||||||| ||T 1 C ( k|YLOSIN TARTRATE POWDER 99% 00GM SACHET (EACH GRAM ONTAINS TYLOSIN TARTRATE 99 nett content of exempt material is 1.980 gs) (20 NOS))||- %) |20 Nu|b|13|TYLOSIN TARTRATE|200 k| |||||||ers|||. g.| ||||||||||| ||T 5 C ( k|YLOSIN TARTRATE POWDER 99% 00GM SACHET (EACH GRAM ONTAINS TYLOSIN TARTRATE 99 nett content of exempt material is 4.950 gs) (10 NOS))||- %) |10 Nu|mbers|14|TYLOSIN TARTRATE|5.00 kg.| ||||||||||| ||||||||||| ||T 1 T o|YLOSIN TARTRATE POWDER 99%||-|25 Nu|mbers|15|TYLOSIN TARTRATE|25.00 kg.| |||KG JAR (EACH GRAM CONTAINS YLOSIN TARTRATE 99%) (nett cont f exempt material is 24.75 kgs) (25 NO||ent S))|||||| ||||||||||| ||||||||||| |||||||||||

UDIN00710749AM25

5.00 kg.| |||KG JAR (EACH GRAM CONTAINS YLOSIN TARTRATE 99%) (nett cont f exempt material is 24.75 kgs) (25 NO||ent S))|||||| ||||||||||| ||||||||||| |||||||||||

UDIN00710749AM25

Case No.	Case No.	43 / NC/3/MEET/Feb/202425/17	43 / NC/3/MEET/Feb/202425/17	43 / NC/3/MEET/Feb/202425/17	43 / NC/3/MEET/Feb/202425/17	43 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ELPPE CHEMICALS PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00004593AM24
RA File Number		03AX04001792 AM24
Licence No and Date		0311025670/24/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>1<br>HYDRXYLAMINE<br>OSULPHONIC ACID<br>0.720 kg.<br>2-(METHYLTHIO)-3-<br>NITROPYRAZOLO{1,5-a} PYRIDINE<br>1 kg.<br>2<br>1 1 BIS METHYLTHIO 2<br>NITROETHYLENE<br>1.053 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product<br>		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	2-(METHYLTHIO)-3-<br>NITROPYRAZOLO{1,5-a} PYRIDINE<br>		1 kg.	1	HYDRXYLAMINE<br>OSULPHONIC ACID	0.720 kg.
				2	1 1 BIS METHYLTHIO 2<br>NITROETHYLENE	1.053 kg.
				above decision of NC.

| ||2-(METHYLTHIO)-3- NITROPYRAZOLO{1,5-a} PYRIDINE ||1 kg.|1|HYDRXYLAMINE OSULPHONIC ACID|0.720 kg.| |||||2|1 1 BIS METHYLTHIO 2 NITROETHYLENE|1.053 kg.| |||||above decision of NC.|||

Case No.	44 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004626AM24
RA File Number	52AX04000117 AM24
Licence No and	5211005254/25/07/2023

UDIN00710749AM25

Date

Norms Committee Decision:

The Committee considered the case as per agenda, and it was decided to call the firm to attenda Personal Hearing before the Norms Committee to explain its case along with relevant information/documents from the firm.

Case No.	Case No.	45 / NC/3/MEET/Feb/202425/17	45 / NC/3/MEET/Feb/202425/17	45 / NC/3/MEET/Feb/202425/17	45 / NC/3/MEET/Feb/202425/17	45 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00004640AM24
RA File Number		03AX04001848 AM24
Licence No and Date		0311025745/25/07/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ASHOXY 20% LA / OXYVET 20% LA<br>(OXYTETRACYCLINE INJECTABLE<br>SOLUTION 20% LONG ACTING) Pack<br>50ML vial((EACH VIAL CONTAINS<br>19ML 2-pyrrolidone) (Nett Wt. of<br>EXEMPTED MATERIAL IS 296.40 KGS)<br>(15000 NOS))<br>15000<br>Numbers<br>1<br>2 PYRROLIDONE<br>311.22 Kg.<br>ASHOXY 20% LA / OXYVET 20% LA<br>(OXYTETRACYCLINE INJECTABLE<br>SOLUTION 20% LONG ACTING) Pack<br>100ML vial((EACH VIAL CONTAINS<br>38ML 2-pyrrolidone) (Nett Wt.

r>1 2 PYRROLIDONE 311.22 Kg. ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack 100ML vial((EACH VIAL CONTAINS 38ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 474.24 KGS) (12000 NOS)) 12000 Numbers 2 2 PYRROLIDONE 497.95 kg. ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE 2050 Numbers 3 2 PYRROLIDONE 212.67 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack 50ML vial((EACH VIAL CONTAINS 19ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 296.40 KGS) (15000 NOS))||15000 Numbers|1|2 PYRROLIDONE|311.22 Kg.| ||ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE SOLUTION 20% LONG ACTING) Pack 100ML vial((EACH VIAL CONTAINS 38ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 474.24 KGS) (12000 NOS))||12000 Numbers|2|2 PYRROLIDONE|497.95 kg.| ||ASHOXY 20% LA / OXYVET 20% LA (OXYTETRACYCLINE INJECTABLE||2050 Numbers|3|2 PYRROLIDONE|212.67 kg.|

UDIN00710749AM25

SOLUTION 20% LONG ACTING) Pack 250ML vial((EACH VIAL CONTAINS 95ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 202.54 KGS) (2050 NOS))

|3|2 PYRROLIDONE|212.67 kg.|

UDIN00710749AM25

SOLUTION 20% LONG ACTING) Pack 250ML vial((EACH VIAL CONTAINS 95ML 2-pyrrolidone) (Nett Wt. of EXEMPTED MATERIAL IS 202.54 KGS) (2050 NOS))

Case No.	Case No.	Case No.	46 / NC/3/MEET/Feb/202425/17	46 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number			HQRNORM APPLY 00004659AM24
RA File Number			03AX04001873 AM24
Licence No and<br>Date			0311025786/27/07/2023
Norms Committee Decision:<br>The Committee considered the request of the firm in detailand also discussed the report of the factory<br>visit. The committee found that in the above-mentioned case export product is in the form of Gel, not a<br>cream/ointment, and accordingly decided to fix the ad-hoc norms as under:-<br>Sl.<br>No<br>Export Product<br>Quantity<br>(i)<br>Medical Creams &Ointments(Miconazole Nitrate 2 % Antifungal Cream 0.5 Oz / 14 Gm<br>Tot Wt: 1190 Kgs (Net Cont: Benzoic 2.386Kgs, Pegoxyl 238.083Kgs, Oleoyl<br>35.786Kgs, Miconazole 24.681Kgs))<br>1 Number<br>(ii)<br>Medical Creams &Ointments(Miconazole Nitrate 2 % Antifungal Cream 1 Oz / 28 Gm<br>Tot Wt: 2100Kgs (Net Cont: Benzoic 4.20 Kgs, Pegoxyl 420.15Kgs, Oleoyl 63.15Kgs,<br>Miconazole 43.55Kgs))<br>1 Number<br>Medical Creams &Ointments(Miconazole Nitrate 2 % Antifungal Cream 1.5 Oz / 42.5<br>Gm Tot Wt: 3612.50Kgs (Net Cont: Benzoic 7.23 Kgs, Pegoxyl 722.75 Kgs, Oleoyl<br>(iii)<br>1 Number

1 Number Medical Creams &Ointments(Miconazole Nitrate 2 % Antifungal Cream 1.5 Oz / 42.5 Gm Tot Wt: 3612.50Kgs (Net Cont: Benzoic 7.23 Kgs, Pegoxyl 722.75 Kgs, Oleoyl (iii) 1 Number||||| ||Sl. No|Export Product||Quantity| ||(i)|Medical Creams &Ointments(Miconazole Nitrate 2 % Antifungal Cream 0.5 Oz / 14 Gm Tot Wt: 1190 Kgs (Net Cont: Benzoic 2.386Kgs, Pegoxyl 238.083Kgs, Oleoyl 35.786Kgs, Miconazole 24.681Kgs))||1 Number| ||(ii)|Medical Creams &Ointments(Miconazole Nitrate 2 % Antifungal Cream 1 Oz / 28 Gm Tot Wt: 2100Kgs (Net Cont: Benzoic 4.20 Kgs, Pegoxyl 420.15Kgs, Oleoyl 63.15Kgs, Miconazole 43.55Kgs))||1 Number| ||(iii)|Medical Creams &Ointments(Miconazole Nitrate 2 % Antifungal Cream 1.5 Oz / 42.5 Gm Tot Wt: 3612.50Kgs (Net Cont: Benzoic 7.23 Kgs, Pegoxyl 722.75 Kgs, Oleoyl||1 Number|

UDIN00710749AM25

	108.64 Kgs, Miconazole 74.92Kgs))
(iv)	Medical Creams &Ointments(Miconazole Nitrate 2 % Vaginal Cream USP 1.59 Oz / 45	1 Number
	Gm with 1 Applicator Pack Tot Wt: 13500Kgs (Net Cont: Benzoic 27Kgs, Pegoxyl
	2700.95Kgs, Oleoyl 405.97 Kgs, Miconazole 279.99 Kgs, Plas App 300000 Nos))
(v)	Medical Creams &Ointments(Miconazole Nitrate 2 % Vaginal Cream USP 1.59 Oz / 45	1 Number
	Gm with 7 Applicator Pack Tot Wt: 31500 Kgs (Net Cont: Benzoic 63 Kgs, Pegoxyl
	6302.21 Kgs, Oleoyl 947.27 Kgs, Miconazole 653.31 Kgs, Plas App 700000 Nos))

Cream USP 1.59 Oz / 45|1 Number| ||Gm with 7 Applicator Pack Tot Wt: 31500 Kgs (Net Cont: Benzoic 63 Kgs, Pegoxyl|| ||6302.21 Kgs, Oleoyl 947.27 Kgs, Miconazole 653.31 Kgs, Plas App 700000 Nos))||

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 the Packing Policy and General<br>Notes.

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

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

Case No.	47 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004700AM24
RA File Number	09AX04000394 AM24
Licence No and Date	0911005507/28/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para

44 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

UDIN00710749AM25

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

ment has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

UDIN00710749AM25

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.
4-(2-(2-(6,6-Dimethylbicyclo[3.1.1]heptan-2-<br>yl)ethoxy)ethyl)morpholin (Intermediate of<br>Pinaverium Bromide)	1 kg.	1	DihydroNopol	0.66 kg.
		2	Toulene	1.915 kg.
		3	Sodamide	0.19 kg.
		4	Methanol	0.56 kg.

Case No.	48 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	KELVIN NATURAL MINT PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004732AM24
RA File Number	05AX04001031 AM24
Licence No and<br>Date	0511019800/31/07/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that export is changed to<br>Cornmint Oil and Menthol Crystal and Menthol Crystal is made from mother liquor and wastage is there<br>which have not been shown in the process, therefore it was decided to call the firm for attending Personal<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents from the<br>firm.

Case No.	49 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved

UDIN00710749AM25

mittee to explain its case along with relevant information / documents from the firm.||

Case No.	49 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved

UDIN00710749AM25

Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004751AM24
RA File Number	03AX04001897 AM24
Licence No and<br>Date	0311025909/31/07/2023
Norms Committee Decision:<br>The Committee considered the request of firm in detailand also discussed report of factory visit. The<br>committee found that in the above-mentioned case, the 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.<br>No<br>Export Product<br>Quantity<br>(i)<br>Medical Creams and Ointments(FLUOCINONIDE TOPICAL SOLUTION<br>0.05% 60 ML Tot Wt. 15390 Kgs (Net Cont: Fluocin 8.43 Kgs, Ethyl 4614.06<br>Kgs, Isopropyl 1000.36 Kgs, Bottle 270000Nos, Cap 270000 Nos, Needle<br>270000Nos))<br>1 Number<br>**Sl.

OPICAL SOLUTION 0.05% 60 ML Tot Wt. 15390 Kgs (Net Cont: Fluocin 8.43 Kgs, Ethyl 4614.06 Kgs, Isopropyl 1000.36 Kgs, Bottle 270000Nos, Cap 270000 Nos, Needle 270000Nos)) 1 Number 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. RA concerned may take further necessary action as per above decision of NC.||

46 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

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Case No.	50 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004796AM24
RA File Number	34AX04000209 AM24
Licence No and<br>Date	3411003978/02/08/2023

|Meeting Number and Date|NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025| |HQ File Number|HQRNORM APPLY 00004796AM24| |RA File Number|34AX04000209 AM24| |Licence No and Date|3411003978/02/08/2023| |Norms Committee Decision: The committee considered the request of firm for the fixation of ad-hoc norms, and as per the advice of the TE, it was decided to call for the following information/documents from the firm:- To give a balanced chemical reaction indicating molecular weight of both reactant and products without using abbreviation. 1. Stoichiometric material balance on molar basis, indicating yield of the reaction with justification. 2. End use of export product. 3.||

To give a balanced chemical reaction indicating molecular weight of both reactant and products without using abbreviation.

Case No.	Case No.	51 / NC/3/MEET/Feb/202425/17	51 / NC/3/MEET/Feb/202425/17	51 / NC/3/MEET/Feb/202425/17	51 / NC/3/MEET/Feb/202425/17	51 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		VINCIT LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00004827AM24
RA File Number		05AX04001062 AM24
Licence No and<br>Date		0511020229/03/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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.

per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 LEVOFLOXACIN Q ACID 0.856 kg. LEVOFLOXACIN HEMIHYDRATE 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||LEVOFLOXACIN HEMIHYDRATE||1 kg.|1|LEVOFLOXACIN Q ACID|0.856 kg.|

UDIN00710749AM25

2 N METHYL PIPERAZINE 0.432 kg.

Case No.	52 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004867AM24
RA File Number	09AX04000370 AM24
Licence No and<br>Date	0911005577/04/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda, and it was decided to call the firm to attendPersonal<br>Hearing<br>before the Norms Committee to explain its case along with relevant information/documents from<br>the firm:

ase as per agenda, and it was decided to call the firm to attendPersonal Hearing before the Norms Committee to explain its case along with relevant information/documents from the firm:|||

Case No.	Case No.	53 / NC/3/MEET/Feb/202425/17	53 / NC/3/MEET/Feb/202425/17	53 / NC/3/MEET/Feb/202425/17	53 / NC/3/MEET/Feb/202425/17	53 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		DAFFODIL PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00004908AM24
RA File Number		08AX04000865 AM24
Licence No and<br>Date		0811009026/07/08/2023
Norms Committee Decision:<br>The Committee considered the request of firm for the fixation of ad-hoc norms, and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00710749AM25

SODIUM CITRATE 1 kg. 1 CITRIC ACID MONOHYDRATE 0.740 kg.

Note: NC also decided to make Standard Input Output Norms (SION) for the above export products based on ad-hoc norms.

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

te: NC also decided to make Standard Input Output Norms (SION) for the above export products based on ad-hoc norms.

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

	SODIUM CITRATE	SODIUM CITRATE	SODIUM CITRATE	1 kg.	1	CITRIC ACID MONOHYDRATE



Note: NC also d		ecided to make Standard Inut Outut Norms (SION) for the above exort roducts based
<br>on ad-hoc norms		p p p p<br>.


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


Case No.			54 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Par	ty Name		VIRCHOW PETROC		HEMICAL PRIVATE LIMITED
Me<br>Dat	eting Number and<br>		NC/ 3/ MEET/ Feb/ 2		02425/ 17 and 25/02/2025
	e
HQ	File Number		HQRNORM	APPLY	00004930	AM24
RA	File Number		09AX04000	371 AM2	4

Lic	ence No and Date		0911005594	/08/08/20	23
Norms Committee Decision:<br>The Committee considered the case as<br>4.07 of HBP Vol.

e Number||09AX04000||371 AM2||4||||||| |||||||||||||||| |Lic||ence No and Date||0911005594||/08/08/20||23||||||| |Norms Committee Decision: The Committee considered the case as 4.07 of HBP Vol. I as per details given b Export Product GCLE(7-PHENYLACETAMIDEO- 3- CHLOROMETHYL CEPHALOSPORANIC ACID PARA METHOXY BENZYL ESTER) (WHITE CRYSTALLINE POWDER)||ms Committee Decision: he Committee considered the .07 of HBP Vol. I as per details||||case as given b||||||||| |||||||||per agen elow or a||da and it was decided to fix ad-hoc norm s applied by the firm, whichever is less:-|||s under Para|| |||||||||||||||| |||Export Product||||||||||||| |||||||||Qty.||Sl. No.|Import Items|||Qty. allowed.| |||||||||||||||| ||GCLE(7-PHENYLACETAMIDEO- 3- CHLOROMETHYL CEPHALOSPORANIC ACID PARA METHOXY BENZYL ESTER) (WHITE CRYSTALLINE POWDER)|CLE(7-PHENYLACETAMID HLOROMETHYL EPHALOSPORANIC ACID P ETHOXY BENZYL ESTER)||||EO- 3- ARA ||1 kg.||1|PENICILLIN G POTASSIU M||| 1.375 kg.| ||||||||||||FIRST CRYSTAL|||| |||||||||||||||| |||||||||||2|ACETONE|||1.971 kg.| |||||||||||3|METHYLENE CHLORIDE MDC||| 3.29 kg.| |||||||||||||||| |||||||||||4|2 MERCAPTO BENZO THIAZOLE MBT||| 0.511 kg.| |||||||||||||||| |||||||||||||||| ||||||||||||||||

UDIN00710749AM25

5 METHANOL 1.971 kg.

3.29 kg.| |||||||||||||||| |||||||||||4|2 MERCAPTO BENZO THIAZOLE MBT||| 0.511 kg.| |||||||||||||||| |||||||||||||||| ||||||||||||||||

UDIN00710749AM25

5 METHANOL 1.971 kg.


							5			METHANOL			1.971 kg.



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


Case No.			55 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Pa	rty Name		S KANT HEALTHCARE LIMITED
M	eeting Number and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
H	Q File Number		HQRNORM APPLY 0000			4943AM24
RA	File Number		03AX04002077 AM24
Li	cence No and Date		0311026147/09/08/2023
No<br> <br>4	rms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
						enda and<br>r as appli		it was deci<br>ed by the fi			ded to fix ad-hoc norms<br>rm, whichever is less:-			under Para

	Export Item			Qty	S.No.				Import item			**Qty.

and r as appli||it was deci ed by the fi|||ded to fix ad-hoc norms rm, whichever is less:-|||under Para| ||||||||||||||||| ||Export Item|||Qty||S.No.||||Import item|||Qty. allowed||| ||ARTEMETHER 20 MG & LUMEFANTRINE 120 MG TABLETS|||1 Number Tablet||1||||ARTEMETHER|||20.4 mg/Tablet||| |||||||2||||LUMEFANTRINE|||122.4 mg/Tablet||| ||||||||||||||||| ||||||||||||||||| ||ARTEMETH|ER 20 MG &||1 Nb||1||||ARTEMETHER|||204 /Tblt||| || LUMEFANT| RINE 120 MG||umer Tablet|||||||||. mgae||| || DISPERSIBL| E TABLETS||||2||||LUMEFANTRINE|||122.4 mg/Tablet||| ||||||||||||||||| ||||||||||||||||| ||ARTEMETH|ER 40 MG &||1 Nb||1||||ARTEMETHER|||408 /Tblt||| || LUMEFANT TABLETS| RINE 240 MG||umer Tablet|||||||||. mgae||| ||||||||||||||||| |||||||2||||LUMEFANTRINE|||244.8 mg/Tablet||| ||ARTEMETHER 80 MG & LUMEFANTRINE 480 MG TABLETS|||1 Number Tablet||1||||ARTEMETHER|||81.6 mg./Tablet||| |||||||2||||LUMEFANTRINE|||489.60 mg./Tablet||| |||||||||||||||||

4.8 mg/Tablet||| ||ARTEMETHER 80 MG & LUMEFANTRINE 480 MG TABLETS|||1 Number Tablet||1||||ARTEMETHER|||81.6 mg./Tablet||| |||||||2||||LUMEFANTRINE|||489.60 mg./Tablet||| |||||||||||||||||


							5			METHANOL			1.971 kg.



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


Case No.			55 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Pa	rty Name		S KANT HEALTHCARE LIMITED
M	eeting Number and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
H	Q File Number		HQRNORM APPLY 0000			4943AM24
RA	File Number		03AX04002077 AM24
Li	cence No and Date		0311026147/09/08/2023
No<br> <br>4	rms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
						enda and<br>r as appli		it was deci<br>ed by the fi			ded to fix ad-hoc norms<br>rm, whichever is less:-			under Para

	Export Item			Qty	S.No.				Import item			**Qty.

UDIN00710749AM25

Norms Proposed for 1 kg of ARTEMETHER	Norms Proposed for 1 kg of ARTEMETHER	Norms Proposed for 1 kg of ARTEMETHER	Norms Proposed for 1 kg of ARTEMETHER	Norms Proposed for 1 kg of ARTEMETHER
Export Item	Qty	S.No.	Import item	Qty. allowed
ARTEMETHER	1Kg	1	Artemisinin	1.04 Kg
		2	Sodium Borohydride	0.188 Kg

oposed for 1 kg of ARTEMETHER**| |---|---|---|---|---| |Export Item|Qty|S.No.|Import item|Qty. allowed| |ARTEMETHER|1Kg|1|Artemisinin|1.04 Kg| |||2|Sodium Borohydride|0.188 Kg|

Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE
Export Item	Qty	S.No.	Import item	Qty. allowed
LUMEFANTRINE	1Kg	1	2, 7 DICHLORO A<br>DIBUTYLAMINO METHYL<br>9 HFLUORENE-4-<br>METHANOL DBA 99<br>PERCENT MIN	0.86896 kg
		2	4-chlorobenzaldehide	0.3476 Kg

Case No.	56 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025

UDIN00710749AM25

and Date
HQ File Number	HQRNORM APPLY 00004944AM24
RA File Number	07AX04000704 AM24
Licence No and<br>Date	0711008930/09/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Firm has given two steps reaction whereas the yields claimed for three step.<br>1.<br>It appears, the chemistry given is incomplete.<br>2.<br>Firm may be advised to furnish complete and balanced chemical reactions for entire process with<br>molecuare weight and percentage yield on molar basis.<br>3.

istry given is incomplete. 2. Firm may be advised to furnish complete and balanced chemical reactions for entire process with molecuare weight and percentage yield on molar basis. 3.||

Case No.	57 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004957AM24
RA File Number	03AX04002106 AM24
Licence No and<br>Date	0311026174/09/08/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	58 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004971AM24
RA File Number	03AX04002029 AM24
Licence No and<br>Date	0311026195/10/08/2023
Norms Committee Decision:

52 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

UDIN00710749AM25

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 :-

cussed 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.<br>No	Export Product	Quantity
(i)	Medical Cream and Onitments(Lidocaine and Prilocaine Cream USP, 2.5% ,<br>2.5%, 30g Tot Wt. 12000 Kgs (Net Cont. Lidocaine 300Kgs, Prilocaine 300Kgs,<br>Carbopol 120Kgs, PEG-60 228Kgs & Tubes 400000 Nos))	<br> <br>1 Number

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.	59 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00004972AM24
RA File Number	03AX04002023 AM24

53 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

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Licence No and 0311026196/10/08/2023 Date Norms Committee Decision:

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

tee Decision:

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

Complete and balanced chemical reactions with molecular weight weight and percentage yield on molar basis.
Material balance for entire process.

Central Insecticide Board (CIB) Registration.

Case No.	Case No.	60 / NC/3/MEET/Feb/202425/17	60 / NC/3/MEET/Feb/202425/17	60 / NC/3/MEET/Feb/202425/17	60 / NC/3/MEET/Feb/202425/17	60 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		BULI CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00004985AM24
RA File Number		03AX04002061 AM24
Licence No and<br>Date		0311026225/10/08/2023
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>LITHIUM METAL<br>0.0406 kg.<br>2<br>BUTYL CHLORIDE<br>0.270 kg.<br>N-BUTYL LITHIUM IN HEXANE<br>(n-butyl Lithium) 15%<br>1 kg.<br>3<br>HEXANE<br>1.760 kg.<br>1<br>LITHIUM METAL<br>0.0650 kg.<br>2<br>BUTYL CHLORIDE<br>0.432 kg.<br>N-BUTYL LITHIUM IN HEXANE<br>(n-butyl Lithium) 24%<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

ITHIUM METAL 0.0650 kg. 2 BUTYL CHLORIDE 0.432 kg. N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 24% 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 15%||1 kg.|1|LITHIUM METAL|0.0406 kg.| |||||2|BUTYL CHLORIDE|0.270 kg.| |||||3|HEXANE|1.760 kg.| ||N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 24%||1 kg.|1|LITHIUM METAL|0.0650 kg.| |||||2|BUTYL CHLORIDE|0.432 kg.|

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		3	HEXANE	1.574 kg.
N-BUTYL LITHIUM IN HEXANE<br>(n-butyl Lithium) 30%	1 kg.	1	LITHIUM METAL	0.0812 kg.
		2	BUTYL CHLORIDE	0.540 kg.
		3	HEXANE	1.450 kg.

		3	HEXANE	1.574 kg.
N-BUTYL LITHIUM IN HEXANE<br>(n-butyl Lithium) 30%	1 kg.	1	LITHIUM METAL	0.0812 kg.
		2	BUTYL CHLORIDE	0.540 kg.
		3	HEXANE	1.450 kg.

Case No.	61 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005011AM24
RA File Number	32AX04000274 AM24
Licence No and<br>Date	3211005388/11/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Secondary Butyl Quinoline<br>1 kg.<br>1<br>Glycerine<br>2.650 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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ty.** allowed. Secondary Butyl Quinoline 1 kg. 1 Glycerine 2.650 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	62 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005075AM24
RA File Number	08AX04000894 AM24
Licence No and<br>Date	0811009108/16/08/2023
Norms Committee Decision:<br>The committee considered the request of firm for the fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for the following information/documents from the firm:-<br>To submit Certificate of Analysis (CoA) report of export and composition of export item.<br>1.<br>If the process involves a chemical reaction then to submit chemistry indicating molecular weight of<br>reactant and products.<br>2.<br>Indigenous items to use in the process and to fill accordingly in Annexure to Appendix-4E table and<br>also material balance.<br>3.

icating molecular weight of reactant and products. 2. Indigenous items to use in the process and to fill accordingly in Annexure to Appendix-4E table and also material balance. 3.||

Case No.<br>	Case No.<br>	Case No.<br>	63 / NC/3/MEET/Feb/202425/17	63 / NC/3/MEET/Feb/202425/17
Case Status<br>			Case Approved
Party Name<br>			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>			NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number<br>			HQRNORM APPLY 00005109AM24
RA File Number<br>			03AX04001779 AM24
Licence No and<br>Date<br>			0311025949/18/08/2023
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of the factory visit. The<br>committee found that in the above mention case export product is in the form of Gel not a<br>cream/Ointments, and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity
	Sl.<br>No	Export Product		Quantity

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cordingly decided to fix the ad-hoc norms as under :- Sl. No Export Product Quantity||||| ||Sl. No|Export Product||Quantity|

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(	i)	Medical Creams &Ointme<br>140Kgs ( Net Cont: Bacitr	nts(Bacitracin Zi<br>acin1.18 Kgs))	nc Ointme	nt 0.5 OZ /14 GM Tube Tot W	t:	1 Number
(	ii)	Medical Creams &Ointme<br>32002 Kgs ( Net Cont: Ba	nts(Bacitracin Zi<br>citracin 270.74Kg	nc Ointme<br>s))	nt 1 OZ / 28 GM Tube Tot Wt	:	1 Number
(
	iii)	Medical Creams &Ointme<br>1001Kgs ( Net Cont: Baci	nts(Double Antib<br>tracin 8.47Kgs, P	iotic Oint<br>olymixin1.	ment 0.5 OZ / 14 GM Tube To<br>83Kgs))	t Wt:	1 Number
(	iv)	Medical Creams &Ointme<br>280Kgs ( Net Cont: Bacitr	nts(Double Antib<br>acin 2.37Kgs, Po
				iotic Oint<br>lymixin0.5	ment 1 OZ / 28 GM tube Tot<br>1Kgs))	t:	1 Number
(	v)	Medical Creams &Ointme	nts(Triple Antibi	otic Ointm	ent 0.5 OZ / 14 Gm Tube Tot	Wt:	1 Number
		1173.032Kgs ( Net Cont:	Baci 7.51Kgs, Pol	y 1.00Kgs	, Neo 8.21Kgs))
(	vi)	Medical Creams &Ointme<br>4159.40 Kgs ( Net Cont: B	nts(Triple Antibi<br>aci35.19Kgs, Pol	otic Ointm<br>y 7.63Kgs	ent 1 OZ / 28 Gm Tube Tot W<br>, Neo 29.11Kgs))	t:	1 Number
(	vii)	Medical Creams &Ointme	nts(Triple MS An	tibiotic O	intment 0.5 OZ / 14 Gm		1 Number
		<br>TubeTotWt: 140Kgs ( Net	<br>Cont: Baci1.18K	<br>gs, Poly 0	<br>.26Kgs, Neo 0.98Kgs))

Number| ||(|vii)|Medical Creams &Ointme||nts(Triple MS An|tibiotic O|intment 0.5 OZ / 14 Gm||1 Number| |||| TubeTotWt: 140Kgs ( Net|| Cont: Baci1.18K| gs, Poly 0| .26Kgs, Neo 0.98Kgs))||| ||(|viii)|Medical Creams &Ointme Wt: 280Kgs ( Net Cont: B||nts(Triple MS An aci2.37Kgs, Poly|tibiotic O 0.51Kgs,|intment 1 OZ / 28 Gm Tube T Neo 1.96Kgs))|ot|1 Number| ||(|ix)|Medical Creams &Ointme||nts(Triple MS A|tibiotic O|ntment 2 OZ / 56 Gm Tube T|ot|1 Number| |||| Wt: 6384Kgs ( Net Cont:|| Baci54.01Kgs, Po| ly 11.68K| gs, Neo 44.68Kgs))||| ||(|x)|Medical Creams &Ointme 14 GM Tube Tot Wt: 140 Pramo1.43Kgs))||nts(Triple Antibi Kgs (Net Cont: B|otic Ointm aci 1.18Kg|ent W/ Pramoxine HCL 0.2 O s, Poly 0.26Kgs, Neo 0.98Kg|Z / s,|1 Number| ||(xi)||||||||| ||||Medical Creams &Ointments(Triple Antibiotic Ointment W/ Pramoxine HCL 1 OZ / 28 GM Tube Tot Wt: 11103.85 Kgs ( Net Cont: Baci 93.94Kgs, Poly 20.32Kgs, Neo 77.70Kgs, Pramo113.26Kgs))||||||1 Number| ||(xii)||Medical Creams &Ointments(Triple Antibiotic Ointment W/ Pramoxine HCL 2 OZ / 56 GM Tube Tot Wt: 560 Kgs ( Net Cont: Baci 4.74Kgs, Poly 1.02Kgs, Neo 3.92Kgs, Pramo5.71Kgs))||||||1 Number| ||||||||||| ||||||||||| ||||||||||| ||||||||||| |||||||||||

UDIN00710749AM25

r>GM Tube Tot Wt: 560 Kgs ( Net Cont: Baci 4.74Kgs, Poly 1.02Kgs, Neo 3.92Kgs, Pramo5.71Kgs))||||||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.	64 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005126AM24
RA File Number	03AX04002247 AM24
Licence No and Date	0311026446/18/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for			same export
product/import item	in meeting No.NC/3/MEET/Apr/202425/2dated 30/04/2024 against advance
authorization No.0311024337 dated 07/06/2023, it was		decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product	Qty.	**Sl.

d 07/06/2023, it was||decided to fix ad-hoc norms under Para 4.07 of|||| |HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|||||| |Export Product|Qty.|Sl. No.|Import Items|Qty.|| |||||allowed.|| |OCTYLATED DIPHENYLAMINE 1 kg.||1|DIPHENYLAMINE|0.405 kg.|| |(OCD FLAKES/POWDER)|||||| |||2|DI ISOBUTYLENE|0.622 kg.||

Case No.	64 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005126AM24
RA File Number	03AX04002247 AM24
Licence No and Date	0311026446/18/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for				same export
product/import item	in meeting No.NC/3/MEET/Apr/202425/2dated 30/04/2024 against advance
authorization No.0311024337 dated 07/06/2023, it was		decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
OCTYLATED DIPHENYLAMINE<br>1 kg.		1	DIPHENYLAMINE	0.405 kg.
(OCD FLAKES/POWDER)
		2	DI ISOBUTYLENE	0.622 kg.

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3 ACTIVATED CLAY 0.100 kg.

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

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3 ACTIVATED CLAY 0.100 kg.

Case No.	65 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005137AM24
RA File Number	52AX04000128 AM24
Licence No and<br>Date	5211005508/21/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents<br>firm:		Personal<br>from the

Case No.	Case No.	66 / NC/3/MEET/Feb/202425/17	66 / NC/3/MEET/Feb/202425/17	66 / NC/3/MEET/Feb/202425/17	66 / NC/3/MEET/Feb/202425/17	66 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		SHARP MINT LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00005169AM24
RA File Number		05AX04001349 AM24
Licence No and<br>Date		0511020338/22/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

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

Case No.	Case No.	66 / NC/3/MEET/Feb/202425/17	66 / NC/3/MEET/Feb/202425/17	66 / NC/3/MEET/Feb/202425/17	66 / NC/3/MEET/Feb/202425/17	66 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		SHARP MINT LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00005169AM24
RA File Number		05AX04001349 AM24
Licence No and<br>Date		0511020338/22/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00710749AM25

Menthol Crystals 84706 kg. 1 Menthol Laevo Dist 86400 kg.

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

UDIN00710749AM25

Menthol Crystals 84706 kg. 1 Menthol Laevo Dist 86400 kg.

Case No.	Case No.	67 / NC/3/MEET/Feb/202425/17	67 / NC/3/MEET/Feb/202425/17	67 / NC/3/MEET/Feb/202425/17	67 / NC/3/MEET/Feb/202425/17	67 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00005202AM24
RA File Number		34AX04000404 AM24
Licence No and<br>Date		3411004043/23/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Jan/202425/15dated28/01/2025against advance authorization No.<br>3411002884dated 11/10/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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 Guanfacine Hydrochloride 1.171 mg. 2 Methacrylic Acid and Ethyl Acrylate Copolymer (Eudragit L 100-55) 55.00 mg. 3 Hypromellose (Methocel K15M Premium CR Grade) 55.00 mg. 4 Microcrystalline Cellulose (Avicel PH 102) 10.00 mg. 5 Lactose Monohydrate (Flowlac100) 46.35 mg. Guanfacine Extended-Release Tablets USP 1 mg (Net content of active ingredients 3.900 kgs ) 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Guanfacine Extended-Release Tablets USP 1 mg (Net content of active ingredients 3.900 kgs )|| 1 Number|1|Guanfacine Hydrochloride|1.171 mg.| |||||2|Methacrylic Acid and Ethyl Acrylate Copolymer (Eudragit L 100-55)|55.00 mg.| |||||3|Hypromellose (Methocel K15M Premium CR Grade)|55.00 mg.| |||||4|Microcrystalline Cellulose (Avicel PH 102)|10.00 mg.| |||||5|Lactose Monohydrate (Flowlac100)|46.35 mg.|

UDIN00710749AM25

romellose (Methocel K15M Premium CR Grade)|55.00 mg.| |||||4|Microcrystalline Cellulose (Avicel PH 102)|10.00 mg.| |||||5|Lactose Monohydrate (Flowlac100)|46.35 mg.|

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		6	Magnesium stearate	1.00 mg.
Guanfacine Extended-Release Tablets<br>USP 2 mg (Net content of active<br>ingredients 7.800 kgs )	<br>1 Number	7	Guanfacine Hydrochloride	2.342 mg.
		8	Methacrylic Acid and Ethyl<br>Acrylate Copolymer (Eudragit L<br>100-55)	55.00 mg.
		9	Hypromellose (Methocel K15M<br>Premium CR Grade)	55.00 mg.
		10	Microcrystalline Cellulose (Avicel<br>PH 102)	10.00 mg.
		11	Lactose Monohydrate (Flowlac100)	45.20 mg.
		12	Magnesium stearate	1.00 mg.
Guanfacine Extended-Release Tablets<br>USP 3 mg (Net content of active<br>ingredients 7.50 kgs )	<br>1 Number	13	Guanfacine Hydrochloride	3.513 mg.
		14	Methacrylic Acid and Ethyl<br>Acrylate Copolymer (Eudragit L<br>100-55)	55.00 mg.
		15	Hypromellose (Methocel K15M<br>Premium CR Grade)	55.00 mg.
		16	Microcrystalline Cellulose (Avicel<br>PH 102)	10.00 mg.
		17	Lactose Monohydrate (Flowlac100)	43.56 mg.
		18	Magnesium stearate	1.00 mg.
Guanfacine Extended-Release Tablets<br>USP 4 mg (Net content of active<br>ingredients 9.60 kgs )	<br>1 Number	19	Guanfacine Hydrochloride	4.684 mg.
		20	Methacrylic Acid and Ethyl<br>Acrylate Copolymer (Eudragit L<br>100-55)	55.00 mg.

UDIN00710749AM25

ive ingredients 9.60 kgs )| 1 Number|19|Guanfacine Hydrochloride|4.684 mg.| ||||20|Methacrylic Acid and Ethyl Acrylate Copolymer (Eudragit L 100-55)|55.00 mg.|

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21	Hypromellose (Methocel K15M<br>Premium CR Grade)	55.00 mg.
22	Microcrystalline Cellulose (Avicel<br>PH 102)	10.00 mg.
23	Lactose Monohydrate (Flowlac100)	42.40 mg.
24	Magnesium stearate	1.00 mg.

Case No.	Case No.	Case No.	68 / NC/3/MEET/Feb/202425/17	68 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number			HQRNORM APPLY 00005258AM24
RA File Number			03AX04002280 AM24
Licence No and<br>Date			0311026646/28/08/2023
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of factory visit.

03AX04002280 AM24|| |Licence No and Date|||0311026646/28/08/2023|| |Norms Committee 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 CREAM AND OINTMENT(Clindamycin BPO 1.2/2.5% Gel, 50g (Pump) Tot Wt. 1750 Kg (Net ContHydrous 43.75 Kg, Clinda 21 kg, Polo 0.7 Kg, Piston 35000Nos, Engine 35000Nos)) 1 Number||||| ||Sl. No|Export Product||Quantity| ||(i)|MEDICAL CREAM AND OINTMENT(Clindamycin BPO 1.2/2.5% Gel, 50g (Pump) Tot Wt. 1750 Kg (Net ContHydrous 43.75 Kg, Clinda 21 kg, Polo 0.7 Kg, Piston 35000Nos, Engine 35000Nos))||1 Number| ||||||

UDIN00710749AM25

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.

rial|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.	Case No.	69 / NC/3/MEET/Feb/202425/17	69 / NC/3/MEET/Feb/202425/17	69 / NC/3/MEET/Feb/202425/17	69 / NC/3/MEET/Feb/202425/17	69 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00005263AM24
RA File Number		08AX04001023 AM24
Licence No and<br>Date		0811009216/28/08/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Magnesium Sulfate in Water for<br>Injection 2G/50 mL (40 mg/mL)<br>1 Number<br>1<br>Magnesium Sulfate<br>Heptahydrate PhEur, USP<br>2.00 gm.<br>Magnesium Sulfate in Water for<br>Magnesium Sulfate<br>1 Number<br>2<br>4.00 gm.
	Export Product<br>		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	Magnesium Sulfate in Water for<br>Injection 2G/50 mL (40 mg/mL)<br>		1 Number	1	Magnesium Sulfate<br>Heptahydrate PhEur, USP	2.00 gm.
	Magnesium Sulfate in Water for<br>		1 Number	2	Magnesium Sulfate	4.00 gm.

UDIN00710749AM25

ion 2G/50 mL (40 mg/mL) ||1 Number|1|Magnesium Sulfate Heptahydrate PhEur, USP|2.00 gm.| ||Magnesium Sulfate in Water for ||1 Number|2|Magnesium Sulfate|4.00 gm.|

UDIN00710749AM25

Injection 4G/100 mL (40 mg/mL) Heptahydrate PhEur, USP

R	Injection 4G/100 mL (40 mg/mL)<br>A concerned may take further necessary ac	Injection 4G/100 mL (40 mg/mL)			eptahydrate PhEur, USP
			tion as per a	bove dec	ision of NC.


C	ase No.	70 / NC/3/MEET/Feb/202425/	17
C	ase Status	Case Approved
P	arty Name	PUNISKA HEALTHCARE PR	IVATE LIM	TED

M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Feb/ 202425/ 1	7 and 25/02/2	025
H	Q File Number	HQRNORM APPLY 0000528	1AM24
R	A File Number	08AX04000923 AM24
L<br>D	icence No and<br>ate	0811009151/29/08/2023
N<br>R	orms Committee Decision:<br>The Committee considered the case as per		agenda and i
				t was de	cided to fix ad-hoc norms un	der Para
	4.07 of HBP Vol.

2023|||||||||||| |N R|orms Committee Decision: The Committee considered the case as per|||||agenda and i||||||||| ||||||||||t was de||cided to fix ad-hoc norms un|||der Para| ||4.07 of HBP Vol. I as per details given belo Export Product Qty. Calcium Gluconate Injection, 100mg/ml, 10mL 1 Number Calcium Gluconate Injection, 100mg/ml, 50mL 1 Number Calcium Gluconate Injection, 100mg/ml, 100 mL 1 Number A concerned may take further necessary ac|||||w or as app|||lied by t||he firm, whichever is less:-|||| |||Export Product ||Qty.|||Sl. No.||Import||Items|Qty||. allowed.| |||Calcium Gluconate Injection, 100mg/ml, 10mL ||1 Number|||1 |||||||| ||||||||||CALCIU MONOH||M GLUCONATE YDRATE USP|108||1.00 mg.| |||Calcium Gluconate Injection, 100mg/ml, 50mL ||1 Number|||2 ||CALCIU||M GLUCONATE|514||5.00 mg.| ||||||||||MONOH||YDRATE USP|||| |||Calcium Gluconate Injection, 100mg/ml, 100 mL ||1 Number|||3 ||CALCIU||M GLUCONATE|102||9000 mg| |||||||||| MONOH|| YDRATE USP|,||.| |||||||tion as per a||||||||| ||||||||||bove dec||ision of NC.|||| |||||||||||||||| ||||||||||||||||

UDIN00710749AM25

U||M GLUCONATE|102||9000 mg| |||||||||| MONOH|| YDRATE USP|,||.| |||||||tion as per a||||||||| ||||||||||bove dec||ision of NC.|||| |||||||||||||||| ||||||||||||||||

UDIN00710749AM25

Case No.		71 / NC/3/MEET/Feb/202425/17
Case Status		Case Deferred
Party Name		MANNITAB PHARMA SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00005338AM24
RA File Number		31AX04000075 AM24
Licence No and<br>Date		3111002606/31/08/2023
Norms Committee	Decision:
The committee	considered the request of firm for fixation of ad-hoc norms and as per the advice of the
TE, it was decided to call for following information/documents from the firm:-
Microne size of	import item and export product.

Case No.	72 / NC/3/MEET/Feb/202425/17	72 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005348AM24
RA File Number	04AX04000283 AM24
Licence No and<br>Date	0411005945/31/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.	Import Items	**Qty.

x ad-hoc norms under Para||||||| |4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||||||| |Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|| |(4R)-2-oxooxazolidine-4-carboxylic||1 kg.|1|D-Serine ((R)-2-amino-3-|1.073 kg.|| |acid (COX)||||hydroxypropanoic acid)||| ||||2|Potassium methoxide 32% in|2.240 kg.|| |||||methanol|||

Case No.	72 / NC/3/MEET/Feb/202425/17	72 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005348AM24
RA File Number	04AX04000283 AM24
Licence No and<br>Date	0411005945/31/08/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
(4R)-2-oxooxazolidine-4-carboxylic		1 kg.	1	D-Serine ((R)-2-amino-3-	1.073 kg.
acid (COX)				hydroxypropanoic acid)
			2	Potassium methoxide 32% in	2.240 kg.
				methanol

UDIN00710749AM25

zolidine-4-carboxylic||1 kg.|1|D-Serine ((R)-2-amino-3-|1.073 kg.|| |acid (COX)||||hydroxypropanoic acid)||| ||||2|Potassium methoxide 32% in|2.240 kg.|| |||||methanol|||

UDIN00710749AM25

Case No.	73 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	STANEX DRUGS AND CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005456AM24
RA File Number	09AX04000507 AM24
Licence No and<br>Date	0911005765/05/09/2023
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Case No.<br>74 / NC/3/MEET/Feb/202425/17
Case Status<br>Case Approved
Party Name<br>MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number<br>HQRNORM APPLY 00005462AM24
RA File Number<br>08AX04001060 AM24
Licence No and<br>Date<br>0811009279/05/09/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was			decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items		Qty. allowed.
Cefoxitin 1 gm (1 vial = 1gm)<br>1 Number	1		Cefoxitin Sodium	1.081 gm.

UDIN00710749AM25

|||| |Export Product Qty.|**Sl. No. **|Import Items||Qty. allowed.|| |Cefoxitin 1 gm (1 vial = 1gm) 1 Number|1||Cefoxitin Sodium|1.081 gm.|| |||||||

UDIN00710749AM25

Case No.	75 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005504AM24
RA File Number	34AX04000414 AM24
Licence No and<br>Date	3411004086/08/09/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master-Batch Formula showing net content of all inputs in the export.<br>1.<br>Wastage claimed.<br>2.

Case No.	Case No.	Case No.	76 / NC/3/MEET/Feb/202425/17	76 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number			HQRNORM APPLY 00005546AM24
RA File Number			03AX04002544 AM24
Licence No and<br>Date			0311026992/11/09/2023
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of factory visit.

03AX04002544 AM24|| |Licence No and Date|||0311026992/11/09/2023|| |Norms Committee 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||||| ||Sl. No|Export Product||Quantity|

Case No.	Case No.	Case No.	76 / NC/3/MEET/Feb/202425/17	76 / NC/3/MEET/Feb/202425/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number			HQRNORM APPLY 00005546AM24
RA File Number			03AX04002544 AM24
Licence No and<br>Date			0311026992/11/09/2023
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of factory visit. The<br>committee found that in the above mention case export product is in form of Gel not a cream/Ointments<br>and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity
	Sl.<br>No	Export Product		Quantity

UDIN00710749AM25

cordingly decided to fix the ad-hoc norms as under :- Sl. No Export Product Quantity||||| ||Sl. No|Export Product||Quantity|

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|(i) MEDICAL CREAM AND OINTMENT(TESTOSTERONE GEL 1.62% - 88G (TOT WT 17600 kgs Cont.Testoerone USP 285.12 kgs, Ethanol 96% 12936.00kgs, Isopropyl MyristateNF 176kgs, Carbopol 980NF 176kgs, Sodium Hydroxide NF70.40 kgs,WHITCOSOFBAG BOTTLE 100 mL200000 nos, SP943+PU200000nos) 1 Number 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. RA concerned may take further necessary action as per above decision of NC.|(i)|(i)|MEDICAL CREAM AND OINTMENT(TESTOSTERONE GEL 1.62% - 88G (TOT WT 17600 kgs Cont.Testoerone USP 285.12 kgs, Ethanol 96% 12936.00kgs, Isopropyl MyristateNF 176kgs, Carbopol 980NF 176kgs, Sodium Hydroxide NF70.40 kgs,WHITCOSOFBAG BOTTLE 100 mL200000 nos, SP943+PU200000nos)|MEDICAL CREAM AND OINTMENT(TESTOSTERONE GEL 1.62% - 88G (TOT WT 17600 kgs Cont.Testoerone USP 285.12 kgs, Ethanol 96% 12936.00kgs, Isopropyl MyristateNF 176kgs, Carbopol 980NF 176kgs, Sodium Hydroxide NF70.40 kgs,WHITCOSOFBAG BOTTLE 100 mL200000 nos, SP943+

00 kgs Cont.Testoerone USP 285.12 kgs, Ethanol 96% 12936.00kgs, Isopropyl MyristateNF 176kgs, Carbopol 980NF 176kgs, Sodium Hydroxide NF70.40 kgs,WHITCOSOFBAG BOTTLE 100 mL200000 nos, SP943+PU200000nos)|MEDICAL CREAM AND OINTMENT(TESTOSTERONE GEL 1.62% - 88G (TOT WT 17600 kgs Cont.Testoerone USP 285.12 kgs, Ethanol 96% 12936.00kgs, Isopropyl MyristateNF 176kgs, Carbopol 980NF 176kgs, Sodium Hydroxide NF70.40 kgs,WHITCOSOFBAG BOTTLE 100 mL200000 nos, SP943+PU200000nos)| 1 Number| |---|---|---|---|---|---|---| |||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.

ial|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.	Case No.	77 / NC/3/MEET/Feb/202425/17	77 / NC/3/MEET/Feb/202425/17	77 / NC/3/MEET/Feb/202425/17	77 / NC/3/MEET/Feb/202425/17	77 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		ALCHEMIE FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00005547AM24
RA File Number		03AX04002513 AM24
Licence No and<br>Date		0311026994/11/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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>METATOLUIDINE<br>0.691 kg.<br>N,N,<br>DI<br>ETHYL<br>META<br>TOLUIDINE (DEMT)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	N,N,<br>DI<br>ETHYL<br>META<br>TOLUIDINE (DEMT)		<br>1 kg.	1	METATOLUIDINE	0.691 kg.

UDIN00710749AM25

	2	ETHANOL			0.594	kg.
		(Denatured	Ethyl	Alcohol)

ETHYL META TOLUIDINE (DEMT)|| 1 kg.|1|METATOLUIDINE|0.691 kg.| ||||||||

UDIN00710749AM25

	2	ETHANOL			0.594	kg.
		(Denatured	Ethyl	Alcohol)

Case No.	Case No.	78 / NC/3/MEET/Feb/202425/17	78 / NC/3/MEET/Feb/202425/17	78 / NC/3/MEET/Feb/202425/17	78 / NC/3/MEET/Feb/202425/17	78 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00005581AM24
RA File Number		09AX04000504 AM24
Licence No and<br>Date		0911005783/11/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>5-(2-Fluorophenyl)-1H-pyrrole-3-<br>carbaldehyde<br>0.757 kg.<br>2<br>Pyridine 3 sulfonyl chloride<br>0.856 kg.<br>3<br>Tetrahydrofuran<br>3.29 kg.<br>4<br>Methylene Di Chloride<br>3.80 kg.<br>5<br>Sodium Borohydrate<br>0.22 kg.<br>Vonoprazan Fumarate<br>1 kg.<br>6<br>Potassium Carbonate<br>0.66 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

e 3.80 kg. 5 Sodium Borohydrate 0.22 kg. Vonoprazan Fumarate 1 kg. 6 Potassium Carbonate 0.66 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Vonoprazan Fumarate||1 kg.|1|5-(2-Fluorophenyl)-1H-pyrrole-3- carbaldehyde|0.757 kg.| |||||2|Pyridine 3 sulfonyl chloride|0.856 kg.| |||||3|Tetrahydrofuran|3.29 kg.| |||||4|Methylene Di Chloride|3.80 kg.| |||||5|Sodium Borohydrate|0.22 kg.| |||||6|Potassium Carbonate|0.66 kg.|

UDIN00710749AM25

Case No.	79 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005583AM24
RA File Number	09AX04000512 AM24
Licence No and<br>Date	0911005784/11/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>5-(2-Fluorophenyl)-1H-pyrrole-3-<br>carbaldehyde<br>0.757 kg.<br>2<br>Pyridine 3 sulfonyl chloride<br>0.856 kg.<br>3<br>Tetrahydrofuran<br>3.29 kg.<br>4<br>Methylene Di Chloride<br>3.80 kg.<br>5<br>Sodium Borohydrate<br>0.22 kg.<br>Vonoprazan Fumarate<br>1 kg.<br>6<br>Potassium Carbonate<br>0.66 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00710749AM25

ydrate 0.22 kg. Vonoprazan Fumarate 1 kg. 6 Potassium Carbonate 0.66 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00710749AM25

Case No.	80 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005691AM24
RA File Number	03AX04002669 AM24
Licence No and<br>Date	0311027142/14/09/2023
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of factory visit. The<br>committee found that in the above mention case export product is in form of Gel not a cream/Ointments<br>and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity<br>(i)<br>Medical Cream & Onitment (Mesalamine Rectal Suspension, USP Enema<br>4.0g/60ml (Tot Wt: 25880.4 Kgs (Net Cont: Mesalamine 1812.66 Kgs,<br>POTASSIUM METABISULFITE NF 125.29, POTASSIUM ACETATE 109.29<br>kgs LDPE Bottle 424200 Nos, Enema Applictor 424200 Nos.))<br>1 Number<br>**Sl.

ot Wt: 25880.4 Kgs (Net Cont: Mesalamine 1812.66 Kgs, POTASSIUM METABISULFITE NF 125.29, POTASSIUM ACETATE 109.29 kgs LDPE Bottle 424200 Nos, Enema Applictor 424200 Nos.)) 1 Number 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. RA concerned may take further necessary action as per above decision of NC.||

UDIN00710749AM25

Case No.	81 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005719AM24
RA File Number	07AX04000904 AM24
Licence No and<br>Date	0711009215/15/09/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|07AX04000904 AM24| |Licence No and Date|0711009215/15/09/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	82 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005805AM24
RA File Number	34AX04000495 AM24
Licence No and<br>Date	3411004147/21/09/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Jun/202425/6 dated 01/07/2024 against advance<br>authorization No.3411003888 dated 18/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>BetahistineDihydrochloride<br>1 kg.<br>1<br>Pyridine 2 Ethanol<br>0.852 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00710749AM25

allowed.** BetahistineDihydrochloride 1 kg. 1 Pyridine 2 Ethanol 0.852 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00710749AM25

Case No.	83 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005822AM24
RA File Number	03AX04002768 AM24
Licence No and<br>Date	0311027333/22/09/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	84 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005845AM24
RA File Number	05AX04001599 AM24
Licence No and<br>Date	0511021137/25/09/2023
Norms Committee Decision:<br>The case is under consideration, and TE was requested to expedite his comments.

Case No.	85 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005955AM24
RA File Number	34AX04000512 AM24
Licence No and<br>Date	3411004188/29/09/2023
Norms Committee Decision:

73 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

UDIN00710749AM25

24| |Licence No and Date|3411004188/29/09/2023| |Norms Committee Decision:||

73 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

UDIN00710749AM25

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

Case No.	86 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	MEGHMANI DYES AND INTERMEDIATES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005963AM24
RA File Number	08AX04001166 AM24
Licence No and<br>Date	0811009505/02/10/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage yield on molar basis.<br>1.<br>Quantity recovered and sale-value of Ferric Chloride a by-product in the process.<br>2.

Case No.	Case No.	87 / NC/3/MEET/Feb/202425/17	87 / NC/3/MEET/Feb/202425/17	87 / NC/3/MEET/Feb/202425/17	87 / NC/3/MEET/Feb/202425/17	87 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00005974AM24
RA File Number		03AX04002789 AM24
Licence No and<br>Date		0311027510/03/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

|Licence No and Date||0311027510/03/10/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Case No.	Case No.	87 / NC/3/MEET/Feb/202425/17	87 / NC/3/MEET/Feb/202425/17	87 / NC/3/MEET/Feb/202425/17	87 / NC/3/MEET/Feb/202425/17	87 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00005974AM24
RA File Number		03AX04002789 AM24
Licence No and<br>Date		0311027510/03/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00710749AM25

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

UDIN00710749AM25

1	L Acid	0.856 kg.
2	N Methyl Piperazine	0.432 kg.
3	Methanol	0.366 kg.
4	Caustic Soda Flakes	0.190 kg.

Case No.	88 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00005992AM24
RA File Number	03AX04002781 AM24
Licence No and<br>Date	0311027528/03/10/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Whether export item is active-ingredient or it’s intermediate?<br>I.<br>Complete chemistry with molecular weightand percentage yield on molar basis.<br>II.<br>Material balance showing requirement and recovery of solvent.<br>III.<br>Justification for appling import item No. 5 & 6 separately.<br>IV.

r weightand percentage yield on molar basis. II. Material balance showing requirement and recovery of solvent. III. Justification for appling import item No. 5 & 6 separately. IV.||

Case No.	89 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025

UDIN00710749AM25

HQ File Number	HQRNORM APPLY 00005997AM24
RA File Number	03AX04002790 AM24
Licence No and<br>Date	0311027534/03/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>L-Acid<br>0.856 kg.<br>2<br>N, Methyl Piperazine<br>0.432 kg.<br>3<br>Methanol<br>0.366 kg.<br>Levofloxacin USP<br>1 kg.<br>4<br>Caustic Soda Flakes<br>1.190 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	90 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006000AM24
RA File Number	08AX04001244 AM24
Licence No and<br>Date	0811009510/03/10/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

UDIN00710749AM25

4001244 AM24| |Licence No and Date|0811009510/03/10/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

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Case No.	91 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	INDIA GLYCOLS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006006AM24
RA File Number	05AX04001846 AM24
Licence No and<br>Date	0511021178/03/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Dec/202324/19 dated 05/01/2024 against advance<br>authorization No.0511016572dated 27/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Denatured Ethyl Alcohol<br>1.123 kg.<br>2<br>Silver Catalyst<br>(Activity 17% to 18%)<br>0.000228 kg.<br>Mono Ethylene Glycol (MEG)<br>1 kg.<br>3<br>Alumina Catalyst<br>0.000362 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ctivity 17% to 18%) 0.000228 kg. Mono Ethylene Glycol (MEG) 1 kg. 3 Alumina Catalyst 0.000362 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	92 / NC/3/MEET/Feb/202425/17
Case Status<br>	Case Approved
Party Name<br>	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number<br>	HQRNORM APPLY 00006014AM24
RA File Number<br>	03AX04002949 AM24
Licence No and<br>Date<br>	0311027570/03/10/2023
Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Clotrimazole USP / BP / EP / IH	1 kg.	1	Ortho Chloro Phenyl Diphenyl<br>Chloromethane	1.03 kg.
		2	Imidazole	0.310 kg.

*|**Sl. No. **|Import Items|Qty. allowed.| |---|---|---|---|---| |Clotrimazole USP / BP / EP / IH|1 kg.|1|Ortho Chloro Phenyl Diphenyl Chloromethane|1.03 kg.| |||2|Imidazole|0.310 kg.|

Case No.	Case No.	93 / NC/3/MEET/Feb/202425/17	93 / NC/3/MEET/Feb/202425/17	93 / NC/3/MEET/Feb/202425/17	93 / NC/3/MEET/Feb/202425/17	93 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00006018AM24
RA File Number		05AX04001916 AM24
Licence No and<br>Date		0511021302/03/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance<br>authorization No.0511025839 dated 03/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Nitroglycerin Sublingual Tablets<br>USP, 0.3mg<br>1 Number<br>1<br>DILUTED<br>NITROGLYCERIN<br>USP (2% W/W)<br>15.30 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Nitroglycerin Sublingual Tablets<br>USP, 0.3mg		<br>1 Number	1	DILUTED<br>NITROGLYCERIN<br>USP (2% W/W)	15.30 mg.

||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Nitroglycerin Sublingual Tablets USP, 0.3mg|| 1 Number|1|DILUTED NITROGLYCERIN USP (2% W/W)|15.30 mg.|

Case No.	Case No.	93 / NC/3/MEET/Feb/202425/17	93 / NC/3/MEET/Feb/202425/17	93 / NC/3/MEET/Feb/202425/17	93 / NC/3/MEET/Feb/202425/17	93 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00006018AM24
RA File Number		05AX04001916 AM24
Licence No and<br>Date		0511021302/03/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance<br>authorization No.0511025839 dated 03/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Nitroglycerin Sublingual Tablets<br>USP, 0.3mg<br>1 Number<br>1<br>DILUTED<br>NITROGLYCERIN<br>USP (2% W/W)<br>15.30 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Nitroglycerin Sublingual Tablets<br>USP, 0.3mg		<br>1 Number	1	DILUTED<br>NITROGLYCERIN<br>USP (2% W/W)	15.30 mg.

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ty.**|**Sl. No. **|Import Items|Qty. allowed.| ||Nitroglycerin Sublingual Tablets USP, 0.3mg|| 1 Number|1|DILUTED NITROGLYCERIN USP (2% W/W)|15.30 mg.|

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Nitroglycerin Sublingual Tablets<br>USP, 0.4mg<br>1 Number<br>2<br>DILUTED<br>NITROGLYCERIN<br>USP (2% W/W)<br>20.40 mg.<br>Nitroglycerin Sublingual Tablets<br>USP, 0.6mg<br>1 Number<br>3<br>DILUTED<br>NITROGLYCERIN<br>USP (2% W/W)<br>30.60 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Nitroglycerin Sublingual Tablets<br>USP, 0.4mg	<br>1 Number	2	DILUTED<br>NITROGLYCERIN<br>USP (2% W/W)	20.40 mg.
	Nitroglycerin Sublingual Tablets<br>USP, 0.6mg	<br>1 Number	3	DILUTED<br>NITROGLYCERIN<br>USP (2% W/W)	30.60 mg.

Case No.	94 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00008930AM24
RA File Number	03AX04003005 AM24
Licence No and<br>Date	0311027533/03/10/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

24| |RA File Number|03AX04003005 AM24| |Licence No and Date|0311027533/03/10/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	95 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006096AM24
RA File Number	05AX04002038 AM24
Licence No and Date	0511021399/09/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00710749AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
ALPHADOL CAPSULES ((EACH SOFT<br>GELATIN<br>CAPSULE<br>CONTAINS:<br>ALFACALCIDOL 0.25 MCG.))	<br> <br>1 Number	1	ALFACALCIDIOL	0.255 mcg.
ALPHADOL-CA CAPSULES ((EACH<br>SOFT GELATIN CAPSULE CONTAINS:<br>ALFACALCIDOL 0.25 MCG &<br>CALCIUM CARBONATE 500MG<br>EQUIVALENT TO ELEMENTAL<br>CALCIUM 200 MG.))	1 Number	2	ALFACALCIDIOL	0.255 mcg.
ALPHADOL<br>1<br>MCG((EACH<br>SOFT<br>GELATIN<br>CAPSULE<br>CONTAINS:<br>ALFACALCIDOL 1.00 MCG.))	<br> <br>1 Number	3	ALFACALCIDIOL	1.02 mcg.

Case No.	96 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	CHEMIKER PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006178AM24
RA File Number	50AX04000062 AM24
Licence No and<br>Date	5011001072/11/10/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No. 97 / NC/3/MEET/Feb/202425/17

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Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006182AM24
RA File Number	08AX04001270 AM24
Licence No and<br>Date	0811009637/11/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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. Co-Careldopa Tablets 250MG+25MG ( TIDOMET / TIDOMET FORTE, Levodopa 250 Mg +Carbidopa 25 mgTablets) (Each uncoated tablet contains Levodopa BP250 Mg NET CONTENT OF ACTIVE INGREDIENT LEVODOPA SHOULD NOT BE LESS THAN 10200.000 KGS.) 1 Number 1 LEVODOPA BP 255.0 mg. Levodopa and Carbidopa controlled release tablets, 200Mg + 50Mg (TIDOMET CR Levodopa BP 200MG and carbidopa50MG tablet(Each uncoated tablet contains Levodopa BP 200mg NET CONTENT OF ACTIVE INGREDIENT LEVODOPA SHOULD NOT BE LESS THAN 29.002 KGS.) 1 Number 2 LEVODOPA BP 204.0 mg. Co-Careldopa Tablets 100Mg + 25 Mg (TIDOMET / TIDOMET PLUS Levodopa 100 Mg and Carbidopa 25 MgTablets) (Each uncoated tablet contains LevodopaBP 100 Mg NET CONTENT OF ACTIVE INGREDIENT LEVODOPA SHOULD NOT BE LESS THAN 30.000 KGS.) 1 Number 3 LEVODOPA BP 102.0 mg. RA concerned may take further necessary action as per above decision of NC.||

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ODOPA SHOULD NOT BE LESS THAN 30.000 KGS.) 1 Number 3 LEVODOPA BP 102.0 mg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	98 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006189AM24
RA File Number	09AX04000621 AM24
Licence No and<br>Date	0911005970/12/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Ethyl-2-(3-cyano-4-isobutoxyphenyl)-4-<br>methyl-1,3-thiazole-5-carboxylate<br>1.00 kg.<br>FEBUXOSTAT<br>1 kg.<br>2<br>Methanol<br>2.92 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	99 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	BULI CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006193AM24
RA File Number	03AX04003098 AM24
Licence No and<br>Date	0311027841/12/10/2023
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of

UDIN00710749AM25

Licence No and Date|0311027841/12/10/2023| |Norms Committee Decision: The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of||

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information provided by the firm, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
N-BUTYL LITHIUM IN HEXANE<br>(n-butyl Lithium) 15%	1 kg.	1	LITHIUM METAL	0.0406 kg.
		2	BUTYL CHLORIDE	0.270 kg.
		3	HEXANE	1.760 kg.
N-BUTYL LITHIUM IN HEXANE<br>(n-butyl Lithium) 24%	1 kg.	1	LITHIUM METAL	0.0650 kg.
		2	BUTYL CHLORIDE	0.432 kg.
		3	HEXANE	1.574 kg.
N-BUTYL LITHIUM IN HEXANE<br>(n-butyl Lithium) 30%	1 kg.	1	LITHIUM METAL	0.0812 kg.
		2	BUTYL CHLORIDE	0.540 kg.
		3	HEXANE	1.450 kg.

Case No.	100 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006200AM24
RA File Number	08AX04001277 AM24
Licence No and<br>Date	0811009642/12/10/2023
Norms Committee Decision:

UDIN00710749AM25

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:-

AM25

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.
Co-Careldopa Tablets 100Mg + 25 Mg (TIDOMET<br>/ TIEDOMET PLUS Levodopa 100 Mg<br>+Carbidopa 25 MgTablets)(Each uncoated tablet<br>contains Levodopa BP 100Mg NET CONTENT<br>OF ACTIVEINGREDIENT LEVODOPA<br>SHOULD NOT BE LESS THAN 60.000 KGS.)	<br>1 Number	1	LEVODOPA BP	102.00 mg.
Levodopa and Carbidopa controlled release tablets<br>200Mg+50Mg (TIDOMETCR Levodopa BP200<br>Mg and carbidopa50MG tablet (Each uncoated<br>tablet contains Levodopa BP 200 Mg NET<br>CONTENT OF ACTIVE INGREDIENT<br>LEVODOPA SHOULD NOT BE LESS THAN<br>2.500 KGS.)	1 Number	2	LEVODOPA BP	204.00 mg.
Co-Careldopa Tablets 250MG+25MG ( TIDOMET<br>/ TIDOMET FORTE, Levodopa 250 Mg<br>+Carbidopa 25 mgTablets) (Each uncoated tablet<br>contains Levodopa BP250 Mg NET CONTENT<br>OF ACTIVE INGREDIENT LEVODOPA<br>SHOULD NOT BE LESS THAN 275.000 KGS.)	<br>1 Number	3	LEVODOPA BP	255.00 mg.

Case No.	101 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006208AM24
RA File Number	34AX04000546 AM24
Licence No and<br>Date	3411004225/12/10/2023
Norms Committee Decision:

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and 25/02/2025| |HQ File Number|HQRNORM APPLY 00006208AM24| |RA File Number|34AX04000546 AM24| |Licence No and Date|3411004225/12/10/2023| |Norms Committee Decision:||

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Diclofenac Sodium Topical Solution 2% 112<br>gm (Diclofenac Sodium Topical Solution 2%<br>112 gm (Net content of active ingredients<br>156.80 kgs ))	1 Number	1	Diclofenac Sodium<br>USP	2.2838 gm.
Diclofenac Sodium Topical Gel 3 % 100<br>gm(Diclofenac Sodium Topical Gel 3 % 100<br>gm (Net content of active ingredients 360.000<br>kgs ))	1 Number	2	Diclofenac Sodium<br>USP	3.06 gm.

Case No.	Case No.	102 / NC/3/MEET/Feb/202425/17	102 / NC/3/MEET/Feb/202425/17	102 / NC/3/MEET/Feb/202425/17	102 / NC/3/MEET/Feb/202425/17	102 / NC/3/MEET/Feb/202425/17
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number		HQRNORM APPLY 00006214AM24
RA File Number		03AX04003139 AM24
Licence No and<br>Date		0311027854/12/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

|Licence No and Date||0311027854/12/10/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 L-Acid 0.856 kg. Levofloxacin USP 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Levofloxacin USP||1 kg.|1|L-Acid|0.856 kg.|

UDIN00710749AM25

2<br>N, Methyl Piperazine<br>0.432 kg.<br>3<br>Methanol<br>0.366 kg.<br>4<br>Caustic Soda Flakes<br>1.190 kg.<br>RA concerned may take further necessary action as per above decision of NC.			2	N, Methyl Piperazine	0.432 kg.
			3	Methanol	0.366 kg.
			4	Caustic Soda Flakes	1.190 kg.

Case No.	103 / NC/3/MEET/Feb/202425/17
Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM APPLY 00006250AM24
RA File Number	08AX04001324 AM24
Licence No and Date	0811009657/13/10/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Dexmedetomidine Inj 4mcg/mL (400mcg/100ml) 1 Number 1 DEXMEDETOMIDINE 420.00 mcg. Dexmedetomidine Inj 4mcg/mL (200mcg/50ml) 1 Number 2 DEXMEDETOMIDINE 210.00 mcg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00710749AM25

Case No.	104 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00000628AM25
RA File Number	03AX04003995 AM24
Licence No and<br>Date	0311029148/06/12/2023
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Dipentene is also produced which has got commercial value.<br>1.<br>Low Boiler and High Boiler commercial value<br>2.<br>Production/Consumption data duly certified by Auditor of the Company.<br>3.

pentene is also produced which has got commercial value. 1. Low Boiler and High Boiler commercial value 2. Production/Consumption data duly certified by Auditor of the Company. 3.||

Case No.	105 / NC/3/MEET/Feb/202425/17
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202425/ 17 and 25/02/2025
HQ File Number	HQRNORM REVIW00000622AM25
RA File Number	34AX04000854 AM24
Licence No and<br>Date	3411004626/16/02/2024
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and as per the advice of the TE,<br>it was decided to call for following information/documents from the firm:-<br>Production / Consumption data duly certified by Auditor of the Company.

87 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

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88 This document has been digitally signed by Raman Kumar, Deputy DGFT on 28-03-2025 11:52:56.

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