IN FORCE Advance Authorisation

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग

Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Dec/202425/13 DATED: 07/01/2025

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.

Meeting No. NC/3/MEET/Dec/202425/13 dated 07/01/2025 of Norms Committee - III for the year 2024-25 was held on 07/01/2025 under the Chairmanship of 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	UTTAM SARKAR,Assistant Section Officer	DGFT(HQ)
2	Raman Kumar,Deputy DGFT	DGFT(HQ)
3	NAND Lal,Technical Consultant	DPIIT
4	SHAISH KUMAR,Technical Consultant	DGFT
5	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00000293AM25
RA File Number	NA
Licence No and Date	NA
Norms Committee Decision:<br> Decision:The Committee considered the request of firm for fixation of ad-hoc norms to enable them to<br>obtain Advance Authorization from concerned RA and it was decided to fix ad-hoc norms as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>62/0- Dihydromyrcenol<br>81400 kg.<br>1<br>Dihydromyrcene<br>110000 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	2 / NC/3/MEET/Dec/202425/13	2 / NC/3/MEET/Dec/202425/13	2 / NC/3/MEET/Dec/202425/13	2 / NC/3/MEET/Dec/202425/13	2 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		BIOLOGICAL E.

NC/3/MEET/Dec/202425/13|2 / NC/3/MEET/Dec/202425/13|2 / NC/3/MEET/Dec/202425/13|2 / NC/3/MEET/Dec/202425/13| |---|---|---|---|---|---|---| |Case Status||Case Approved||||| |Party Name||BIOLOGICAL E. LIMITED||||| |Meeting Number and Date||NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025||||| |HQ File Number||HQRNORM APPLY 00007891AM24||||| |RA File Number||NA||||| |Licence No and Date||NA||||| |Norms Committee Decision: **Decision:**The Committee considered the request of firm for fixation of ad-hoc norms to enable them to obtain Advance Authorization from concerned RA and it was decided to fix ad-hoc norms 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.|

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

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1	YEAST EXTRACT	135.09 kg.
2	HYPEP	268.75 kg.
3	ALUMINIUM<br>CHLORIDE HEXA<br>HYDRATE 6	30.33 kg.
4	CAPTO Q	2 Liters
5	Phenyl SEPHAROSE<br>HP RESIN	8 Liters
6	50L ALLEGRO BAG	10 Numbers
7	HEAT MARKER<br>VACCINE VIAL<br>MONITOR (VVM<br>Labels)	1010,000<br>Numbers
8	GLASS VIALS	10,20,000<br>Numbers
9	SHIPPING<br>INDICATORS (Q<br>TAGS)	660 Numbers
10	RUBBER STOPPERS	10,20,000<br>Numbers
11	FILTERS & FILTER<br>AIDS	21 Numbers

0 Numbers| ||||8|GLASS VIALS|10,20,000 Numbers| ||||9|SHIPPING INDICATORS (Q TAGS)|660 Numbers| ||||10|RUBBER STOPPERS|10,20,000 Numbers| ||||11|FILTERS & FILTER AIDS|21 Numbers|

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

Case No.	3 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	NECTAR LIFE SCIENCES LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00001482AM25
RA File Number	222404000083 AM14
Licence No and<br>Date	2210015019/15/07/2014
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Personal Hearing<br>before Norms Committee to explain its case along with following information /<br>documents from the firm:<br>Drug Manufacturing License<br>1.<br>Annexure to Appendix-4E<br>2.

Case No.	4 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00007896AM24
RA File Number	072404000347 AM16
Licence No and<br>Date	0710109255/12/01/2016
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|072404000347 AM16| |Licence No and Date|0710109255/12/01/2016| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	5 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00000261AM24
RA File Number	039404000617 AM17
Licence No and<br>Date	0310808312/06/10/2016
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	6 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025

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HQ File Number	HQRNORM REVIW00000263AM24
RA File Number	039404001181 AM17
Licence No and<br>Date	0310812323/03/04/2017
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|039404001181 AM17| |Licence No and Date|0310812323/03/04/2017| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	7 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00000262AM24
RA File Number	039404000295 AM18
Licence No and<br>Date	0310814908/31/07/2017
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	8 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00000265AM24
RA File Number	039404000822 AM18
Licence No and<br>Date	0310818765/30/01/2018
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|039404000822 AM18| |Licence No and Date|0310818765/30/01/2018| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	9 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	PALADIN PAINTS & CHEMICALS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00001511AM25
RA File Number	039504000456 AM19
Licence No and Date	0310823254/24/08/2018
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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|Export Product Qty. Sl. No. Import Items Qty. allowed. 8 ETHYLENEDIAMINE(EDA) 12.326 kg 14 PARAFORMALDEHYDE 7.706 kg 22 BISPHENOL - A 6.219 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 28 GY – 250 (unmodified Expoxy Resin) 9.483 kg 9 ETHYLENEDIAMINE(EDA) 8.890 kg 15 PARAFORMALDEHYDE 6.935 kg 23 BISPHENOL - A 5.96 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 29 GY – 250 (unmodified Expoxy Resin) 8.99 kg 1 DIETHYLENE TRRIAMINE (DETA) 25.663kg 16 PARAFORMALDEHYDE 11.60 kg PPA-7124

AMINE FUNCTION COMPOUND) 100 kg. 29 GY – 250 (unmodified Expoxy Resin) 8.99 kg 1 DIETHYLENE TRRIAMINE (DETA) 25.663kg 16 PARAFORMALDEHYDE 11.60 kg PPA-7124 (PHENALKAMIDE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 30 GY – 250 (unmodified Expoxy Resin) 10.33 kg 2 DIETHYLENE TRRIAMINE (DETA) 8.0 kg 10 ETHYLENEDIAMINE(EDA) 13.0 kg 17 PARAFORMALDEHYDE 9.706 kg PPA-7558 LITE (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg.|Export Product Qty. Sl. No. Import Items Qty. allowed. 8 ETHYLENEDIAMINE(EDA) 12.326 kg 14 PARAFORMALDEHYDE 7.706 kg 22 BISPHENOL - A 6.219 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 28 GY – 250 (unmodified Expoxy Resin) 9.483 kg 9 ETHYLENEDIAMINE(EDA) 8.890 kg 15 PARAFORMALDEHYDE 6.935 kg 23 BISPHENOL - A 5.96 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 29 GY – 250 (unmodified Expoxy Resin) 8.99 kg 1 DIETHYLENE TRRIAMINE (DETA) 25.663kg 16 PARAFORMALDEHYDE 11.60 kg PPA-7124 (PHENALKAMIDE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 30 GY – 250 (unmodified Expoxy Resin) 10.33 kg 2 DIETHYLENE TRRIAMINE (DETA) 8.0 kg 10 ETHYLENEDIAMINE(EDA) 13.0 kg 17 PARAFORMALDEHYDE 9.706 kg PPA-7558 LITE (PHENALKAMINE EPOXY<br

Expoxy Resin) 10.33 kg 2 DIETHYLENE TRRIAMINE (DETA) 8.0 kg 10 ETHYLENEDIAMINE(EDA) 13.0 kg 17 PARAFORMALDEHYDE 9.706 kg PPA-7558 LITE (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg.|Export Product Qty. Sl. No. Import Items Qty. allowed. 8 ETHYLENEDIAMINE(EDA) 12.326 kg 14 PARAFORMALDEHYDE 7.706 kg 22 BISPHENOL - A 6.219 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 28 GY – 250 (unmodified Expoxy Resin) 9.483 kg 9 ETHYLENEDIAMINE(EDA) 8.890 kg 15 PARAFORMALDEHYDE 6.935 kg 23 BISPHENOL - A 5.96 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 29 GY – 250 (unmodified Expoxy Resin) 8.99 kg 1 DIETHYLENE TRRIAMINE (DETA) 25.663kg 16 PARAFORMALDEHYDE 11.60 kg PPA-7124 (PHENALKAMIDE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 30 GY – 250 (unmodified Expoxy Resin) 10.33 kg 2 DIETHYLENE TRRIAMINE (DETA) 8.0 kg 10 ETHYLENEDIAMINE(EDA) 13.0 kg 17 PARAFORMALDEHYDE 9.706 kg PPA-7558 LITE (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg.|Export Product Qty. Sl. No. Import Items **Qty.

17 PARAFORMALDEHYDE 9.706 kg PPA-7558 LITE (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg.|Export Product Qty. Sl. No. Import Items Qty. allowed. 8 ETHYLENEDIAMINE(EDA) 12.326 kg 14 PARAFORMALDEHYDE 7.706 kg 22 BISPHENOL - A 6.219 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 28 GY – 250 (unmodified Expoxy Resin) 9.483 kg 9 ETHYLENEDIAMINE(EDA) 8.890 kg 15 PARAFORMALDEHYDE 6.935 kg 23 BISPHENOL - A 5.96 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 29 GY – 250 (unmodified Expoxy Resin) 8.99 kg 1 DIETHYLENE TRRIAMINE (DETA) 25.663kg 16 PARAFORMALDEHYDE 11.60 kg PPA-7124 (PHENALKAMIDE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 30 GY – 250 (unmodified Expoxy Resin) 10.33 kg 2 DIETHYLENE TRRIAMINE (DETA) 8.0 kg 10 ETHYLENEDIAMINE(EDA) 13.0 kg 17 PARAFORMALDEHYDE 9.706 kg PPA-7558 LITE (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg.|Export Product Qty. Sl. No. Import Items **Qty.

17 PARAFORMALDEHYDE 9.706 kg PPA-7558 LITE (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg.|Export Product Qty. Sl. No. Import Items Qty. allowed. 8 ETHYLENEDIAMINE(EDA) 12.326 kg 14 PARAFORMALDEHYDE 7.706 kg 22 BISPHENOL - A 6.219 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 28 GY – 250 (unmodified Expoxy Resin) 9.483 kg 9 ETHYLENEDIAMINE(EDA) 8.890 kg 15 PARAFORMALDEHYDE 6.935 kg 23 BISPHENOL - A 5.96 kg PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 29 GY – 250 (unmodified Expoxy Resin) 8.99 kg 1 DIETHYLENE TRRIAMINE (DETA) 25.663kg 16 PARAFORMALDEHYDE 11.60 kg PPA-7124 (PHENALKAMIDE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg. 30 GY – 250 (unmodified Expoxy Resin) 10.33 kg 2 DIETHYLENE TRRIAMINE (DETA) 8.0 kg 10 ETHYLENEDIAMINE(EDA) 13.0 kg 17 PARAFORMALDEHYDE 9.706 kg PPA-7558 LITE (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg.| |---|---|---|---|---|---| ||Export Product|Qty.|**Sl. No. **|Import Items|**Qty.

9.706 kg PPA-7558 LITE (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND) 100 kg.| |---|---|---|---|---|---| ||Export Product|Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND)| 100 kg.|8|ETHYLENEDIAMINE(EDA)|12.326 kg| ||||14|PARAFORMALDEHYDE|7.706 kg| ||||22|BISPHENOL - A|6.219 kg| ||||28|GY – 250 (unmodified Expoxy Resin)|9.483 kg| ||PPA-7169 (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND)| 100 kg.|9|ETHYLENEDIAMINE(EDA)|8.890 kg| ||||15|PARAFORMALDEHYDE|6.935 kg| ||||23|BISPHENOL - A|5.96 kg| ||||29|GY – 250 (unmodified Expoxy Resin)|8.99 kg| ||PPA-7124 (PHENALKAMIDE EPOXY HARDENER) (AMINE FUNCTION COMPOUND)| 100 kg.|1|DIETHYLENE TRRIAMINE (DETA)| 25.663kg| ||||16|PARAFORMALDEHYDE|11.60 kg| ||||30|GY – 250 (unmodified Expoxy Resin)|10.33 kg| ||PPA-7558 LITE (PHENALKAMINE EPOXY HARDENER) (AMINE FUNCTION COMPOUND)| 100 kg.|2|DIETHYLENE TRRIAMINE (DETA)| 8.0 kg| ||||10|ETHYLENEDIAMINE(EDA)|13.0 kg| ||||17|PARAFORMALDEHYDE|9.706 kg|

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NER) (AMINE FUNCTION COMPOUND)| 100 kg.|2|DIETHYLENE TRRIAMINE (DETA)| 8.0 kg| ||||10|ETHYLENEDIAMINE(EDA)|13.0 kg| ||||17|PARAFORMALDEHYDE|9.706 kg|

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		24	BISPHENOL - A	5.98 kg
		31	GY – 250<br>(unmodified Expoxy Resin)	1.29 kg
PPA-7566 LITE (PHENALKAMINE<br>EPOXY<br>HARDENER)<br>(AMINE<br>FUNCTION COMPOUND)	<br> <br>100 kg.	3	DIETHYLENE<br>TRRIAMINE<br>(DETA)	<br>7.406 kg
		7	META-XYLENEDIAMINE<br>(MXDA)	4.36 kg
		11	ETHYLENEDIAMINE(EDA)	8.872 kg
		18	PARAFORMALDEHYDE	9.367 kg
		25	BISPHENOL - A	4.960 kg
		32	GY – 250<br>(unmodified Expoxy Resin)	1.61 kg
PPA-7040 LITE (PHENALKAMINE<br>EPOXY<br>HARDENER)<br>(AMINE<br>FUNCTION COMPOUND)	<br> <br>100 kg.	4	DIETHYLENE<br>TRRIAMINE<br>(DETA)	<br>36.487 kg
		19	PARAFORMALDEHYDE	14.98 kg
PPA-7553<br>(PHENALKAMINE<br>EPOXY<br>HARDENER)<br>(AMINE<br>FUNCTION COMPOUND)	<br> <br>100 kg.	5	DIETHYLENE<br>TRRIAMINE<br>(DETA)	<br>7.203 kg
		12	ETHYLENEDIAMINE(EDA)	15.666 kg
		20	PARAFORMALDEHYDE	14.199 kg
		26	BISPHENOL - A	3.635 kg
		30	GY – 250<br>(unmodified Expoxy Resin)	3.000 kg
PPA-7062<br>I<br>(PHENALKAMINE	<br>100 kg.	6	DIETHYLENE<br>TRRIAMINE	<br>6.605 kg

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| ||||26|BISPHENOL - A|3.635 kg| ||||30|GY – 250 (unmodified Expoxy Resin)|3.000 kg| ||PPA-7062 I (PHENALKAMINE| 100 kg.|6|DIETHYLENE TRRIAMINE| 6.605 kg|

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	(DETA)
13	ETHYLENEDIAMINE(EDA)	5.549 kg
21	PARAFORMALDEHYDE	9.111 kg
27	BISPHENOL - A	5.229 kg
34	GY – 250<br>(unmodified Expoxy Resin)	4.221 kg

Case No.	10 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00002022AM25
RA File Number	052304000507 AM19
Licence No and<br>Date	0510409676/15/02/2019
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Personal Hearing<br>before Norms Committee to explain its case along with relevant information / documents<br>from the firm.

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

Case No.	11 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00007594AM24
RA File Number	039404001019 AM19
Licence No and<br>Date	0310827414/01/03/2019
Norms Committee Decision:

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

Case No.	12 / NC/3/MEET/Dec/202425/13
Case Status	Case Rejected
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00002204AM23
RA File Number	052304000048 AM20
Licence No and<br>Date	0510410475/03/05/2019
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for review of ad-hoc norms and it was observed<br>that the firm has not provided any technical justification / information for enhancement. Hence, it was<br>decided torejectthe case maintaining thestatus quo.

Case No.	Case No.	13 / NC/3/MEET/Dec/202425/13	13 / NC/3/MEET/Dec/202425/13	13 / NC/3/MEET/Dec/202425/13	13 / NC/3/MEET/Dec/202425/13	13 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM REVIW00002357AM25
RA File Number		092404000172 AM20
Licence No and<br>Date		0910067749/03/07/2019
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jun/202425/5 dated 14/06/2024against<br>advance authorizationNo.0910067749 dated 03/07/2019, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

m in meetingNo.NC/3/MEET/Jun/202425/5 dated 14/06/2024against advance authorizationNo.0910067749 dated 03/07/2019, 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. (1R,2R)-2-amino-6-(4-nitrophenyl)-1- phenylhex-5-yn-1-ol hydrochloride of Aminoalcohol 1 kg. 1 KRED LYOPHILIZED ENZYME POWDER 0.014 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||(1R,2R)-2-amino-6-(4-nitrophenyl)-1- phenylhex-5-yn-1-ol hydrochloride of Aminoalcohol|| 1 kg.|1|KRED LYOPHILIZED ENZYME POWDER|0.014 kg.| ||||||||

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Case No.	14 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00000048AM25
RA File Number	318304000087 AM20
Licence No and<br>Date	3110067548/30/09/2019

| |Meeting Number and Date|NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025| |HQ File Number|HQRNORM REVIW00000048AM25| |RA File Number|318304000087 AM20| |Licence No and Date|3110067548/30/09/2019| |Norms Committee Decision: **Decision:**The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Reason for submitting revised GST certificate for production/consumption data. 1. To give complete calculation with step wise yield of reaction and justification for enhanced quantity of import items which were approved earlier by Norms Committee. 2. Production/consumption data for the last three years duly certificate by Chartered Accountant. 3.||

Case No.	Case No.	15 / NC/3/MEET/Dec/202425/13	15 / NC/3/MEET/Dec/202425/13	15 / NC/3/MEET/Dec/202425/13	15 / NC/3/MEET/Dec/202425/13	15 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM REVIW00002927AM25
RA File Number		039404000688 AM20
Licence No and Date		0310833118/02/12/2019

and Date||NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025||||| |HQ File Number||HQRNORM REVIW00002927AM25||||| |RA File Number||039404000688 AM20||||| |Licence No and Date||0310833118/02/12/2019||||| |Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance authorizationNo.0310838377 dated 21/09/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. SODIUM CROMOGLICATE EYE DROPS 13.5 ML 1 Vial 1 SODIUM CROMOGLYCATE 0.2835 gm/13.5 ml pack||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||SODIUM CROMOGLICATE EYE DROPS 13.5 ML|| 1 Vial|1|SODIUM CROMOGLYCATE|0.2835 gm/13.5 ml pack|

UDIN00557092AM25

*||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||SODIUM CROMOGLICATE EYE DROPS 13.5 ML|| 1 Vial|1|SODIUM CROMOGLYCATE|0.2835 gm/13.5 ml pack|

UDIN00557092AM25

Case No.	Case No.	16 / NC/3/MEET/Dec/202425/13	16 / NC/3/MEET/Dec/202425/13	16 / NC/3/MEET/Dec/202425/13	16 / NC/3/MEET/Dec/202425/13	16 / NC/3/MEET/Dec/202425/13
C Stt		C Ad
ase aus		ase pprove
Pt N		DIPS BIOSCIENCE PRIVATE LIMITED
ary ame
Mti Nb
eeng umer<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025

HQ File Number		HQRNORM REVIW00003330AM25
RA Fil Nb		039404000788 AM20
e umer
Li N d
cence o an<br>Date		0310833754/27/12/2019

Norms Committee		Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Vii B12 BP<br>101<br>A f 236 Eh h 236<br>1 Nb
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	A f 236 Eh h 236		1 Nb	1	Vii B12 BP	101
	grozen orte .gm. ac sacet .<br>gm contains - (a) Diminazene Diaceturate<br>BP Vet 10.5 gm,((b) Vitamin B12 BP<br>10.0 mg, (c) Vitamin B6 BP 50.0 mg, (d)<br>Exciients (Phenazone BP) 1304 m		umer		tamn	.

zen orte .gm. ac sacet . gm contains - (a) Diminazene Diaceturate BP Vet 10.5 gm,((b) Vitamin B12 BP 10.0 mg, (c) Vitamin B6 BP 50.0 mg, (d) Exciients (Phenazone BP) 1304 m|||umer||tamn|. mg.|| |||||||2|Phenazone BP|12.436 gm.|| |||p (30000 Boxe||. g s Box of 10 Sachets = Total|||||| ||| 300000 Sach||, ets))|||||| ||||||||||| |||Vetozen plus||23.6gm. Each sachet 23.6|1 Number|3|Vitamin B12 BP|10.1 mg.|| |||gm contains ||- (a) Diminazene Diaceturate |||||| ||||||||||| |||BP Vet 10.5 ||gm,((b) Vitamin B12 BP ||4|Phenazone BP|12.436 gm.|| |||10.0 mg (c) E 13.09 gm (30||xcipients (Phenazone BP) 000 Boxes, Box of 10|||||| |||Sachets = Total 300000 Sachets))|||||||| |||Appyvet 23.6gm. Each sachet 23.6 gm contains - (a) Diminazene Diaceturate BP Vet 10.5 gm,((b) Vitamin B12 BP 10.0 mg, (c) Excipients (Phenazone BP) 13.09 m (30000 Boxes Box of 10 Sachets =|||1 Number|5|Vitamin B12 BP|10.1 mg.|| |||||||6|Phenazone BP|12.436 gm.|| |||g Total 3|, 00000 Sachets))|||||||

mg, (c) Excipients (Phenazone BP) 13.09 m (30000 Boxes Box of 10 Sachets =|||1 Number|5|Vitamin B12 BP|10.1 mg.|| |||||||6|Phenazone BP|12.436 gm.|| |||g Total 3|, 00000 Sachets))|||||||

Case No.	Case No.	16 / NC/3/MEET/Dec/202425/13	16 / NC/3/MEET/Dec/202425/13	16 / NC/3/MEET/Dec/202425/13	16 / NC/3/MEET/Dec/202425/13	16 / NC/3/MEET/Dec/202425/13
C Stt		C Ad
ase aus		ase pprove
Pt N		DIPS BIOSCIENCE PRIVATE LIMITED
ary ame
Mti Nb
eeng umer<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025

HQ File Number		HQRNORM REVIW00003330AM25
RA Fil Nb		039404000788 AM20
e umer
Li N d
cence o an<br>Date		0310833754/27/12/2019

Norms Committee		Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Vii B12 BP<br>101<br>A f 236 Eh h 236<br>1 Nb
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	A f 236 Eh h 236		1 Nb	1	Vii B12 BP	101
	grozen orte .gm. ac sacet .<br>gm contains - (a) Diminazene Diaceturate<br>BP Vet 10.5 gm,((b) Vitamin B12 BP<br>10.0 mg, (c) Vitamin B6 BP 50.0 mg, (d)<br>Exciients (Phenazone BP) 1304 m		umer		tamn	.

UDIN00557092AM25

azone BP) 13.09 m (30000 Boxes Box of 10 Sachets =|||1 Number|5|Vitamin B12 BP|10.1 mg.|| |||||||6|Phenazone BP|12.436 gm.|| |||g Total 3|, 00000 Sachets))|||||||

UDIN00557092AM25

Fomiz<br>contai	en Plus. Each Sachet 23.6 gm<br>ns - (a) Diminazene Diaceturate BP	en Plus. Each Sachet 23.6 gm<br>ns - (a) Diminazene Diaceturate BP	1 Number	1 Number	7	Vitamin B12 BP		10.1 mg.
<br>Vet 10<br>mg, (c<br>Excipi<br>(20000<br>	<br>.5 gm,((b) Vitamin B12 BP 10.0<br>) Vitamin B6 BP 50 mg (d)<br>ents (Phenazone BP) 13.04 gm<br>Boxes, Box of 10 Sachets = Total<br>				8	Phenazone BP		12.436 gm.
200000 Sachets))

Trypano Fo<br>Contains - (<br>Vet 105 g		rt. Each Sachet 23.6 gm<br>a) Diminazene Diaceturate BP<br>((b) Vitamin B12 BP 10mg	<br>1 Nu	mber	9	Vitamin B12 BP	10.1 mg.

.<br>(c) Vitamin<br>(Phenazone		, ,<br>B6 BP 50 mg, (d) Excipients<br>BP) 13.04 gm (20000 Boxes,			10	Phenazone BP	12.436 gm.
Box of 10 S<br>Sachets))		achets = Total 200000
Synozen Pl<br>Contains - (		us. Each Sachet 23.6 gm<br>a) Diminazene Diaceturate BP	<br>1 Nu	mber	11	Vitamin B12 BP	10.1 mg.
<br>Vet 10.5 gm,((b) Vitamin B12 BP 10 mg<br>(c) Vitamin B6 BP 50 mg, (d) Excipients<br>(Phenazone BP) 13.04 gm (20000 Boxes,<br>Box of 10 Sachets = Total 200000<br>Sachets))					12	Phenazone BP	12.436 gm.
Thryptazene Forte.

2 BP 10 mg (c) Vitamin B6 BP 50 mg, (d) Excipients (Phenazone BP) 13.04 gm (20000 Boxes, Box of 10 Sachets = Total 200000 Sachets))||||||12|Phenazone BP|12.436 gm.|| |||Thryptazene Forte. Each Sachet 23.6 gm i Dii Dil BP||||1 Number||13|Vitamin B12 BP|10.1 mg.|| |||contans - (a) mnazene aceturae Vet 10.5 gm,((b) Vitamin B12 BP 10.0 mg, (c) Vitamin B6 BP 50 mg, (d) Excipients (Phenazone BP) 13.04 gm (23920 Boxes Box of 10 Sachets = Total|||||||||| |||||||||14|Phenazone BP|12.436 gm.|| ||| 239200 Sach|||, ets))||||||| ||||||||||||| ||||||||||||| |RA concerned m|||||ay take further necessary action as per above decision of NC||||||| ||||||.||||||| ||||||||||||| |Case No.|||||17 / NC/3/MEET/Dec/202425/13||||||| |Case Status|||||Case Rejected||||||| |Party Name|||||REFLUX PHARMACEUTICALS||||||| |Meeting Number and Date|||||NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025||||||| |HQ File Number|||||HQRNORM REVIW00001943AM25||||||| |RA File Number|||||039504000931 AM20||||||| |Licence No and|||||0310833815/01/01/2020|||||||

Case No.	17 / NC/3/MEET/Dec/202425/13
Case Status	Case Rejected
Party Name	REFLUX PHARMACEUTICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00001943AM25
RA File Number	039504000931 AM20
Licence No and	0310833815/01/01/2020

UDIN00557092AM25

Date

Norms Committee Decision:

Decision: The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided to reject the case maintaining the status quo.

Date	Date
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for review of ad-hoc norms and it was observed<br>
that the firm has<br>didd		not provided any technical justification / information for enhancement. Hence, it was<br> h iii h
ece toreject		te case mantanng testatus quo.


Case No.		18 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved

Party Name		STRIDES ALATHUR PRIVATE LIMITED

Meeting Number
<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		018305000750AM20

RA File Number		092404000575 AM20
Licence No and<br>Date		0910068524/28/02/2020
Nor<br>De<br>sa<br>ad<br>4.	ms Committee Decision:<br>cision:The Committee considered the case as		per agenda and taking cue from the earlier decision for

910068524/28/02/2020|||||||| |Nor De sa ad 4.|ms Committee Decision: cision:The Committee considered the case as||||per agenda and taking cue from the earlier decision for||||| ||me export product/import item in me vance authorizationNo.0911000444 7 f HBP Vl I dil i|||etingNo. dated 26 bl|NC/3/M /02/202 li|EET/Dec/202425/12 dated 1 1, it was decided to fix ad-hoc d b h fi hih i l||0/12/2024against norms under Para || ||o o. as per etas gven|||eow or|s app|y te rm, wcever s es||:-|| ||Export Product||Qty|.|||||| ||||||Sl. No|**. **|Import Items||Qty. allowed.| ||||||||||| ||Memantine Hydrochloride Tablets USP 5Mg - 60s|| 1 Number||1||Memantine Hydrochloride USP||5.10 mg.| ||||||||||| ||||||5||Silicified Microcrystalline Cellulose ||197.00 mg.| ||||||||(Prosolv SMCC 90)||| ||||||||||| ||||||||||| ||||||9||Croscarmellose Sodium||3.00 mg.| ||||||||(Ac Di Sol)||| ||||||||||| ||||||||||| ||||||13||Colloidal Silicon dioxide||1.50 mg.| ||||||||( Aerosil-200)||| ||||||||||| ||||||17||Magnesium Stearate||1.50 mg.|

UDIN00557092AM25

||||||||(Ac Di Sol)||| ||||||||||| ||||||||||| ||||||13||Colloidal Silicon dioxide||1.50 mg.| ||||||||( Aerosil-200)||| ||||||||||| ||||||17||Magnesium Stearate||1.50 mg.|

UDIN00557092AM25

			(Mallinckrodt 2257)
Memantine<br>Hydrochloride<br>Tablets USP 5Mg - 500s	<br>1 Number	2	Memantine Hydrochloride<br>USP	5.10 mg.
		6	Silicified Microcrystalline<br>Cellulose<br>(Prosolv SMCC 90)	197.00 mg.
		10	Croscarmellose Sodium<br>(Ac Di Sol)	3.00 mg.
		14	Colloidal Silicon dioxide<br>( Aerosil-200)	1.50 mg.
		18	Magnesium Stearate<br>(Mallinckrodt 2257)	1.50 mg.
Memantine<br>Hydrochloride<br>Tablets USP 10Mg - 60s	<br>1 Number	3	Memantine Hydrochloride<br>USP	10.20 mg.
		7	Silicified Microcrystalline<br>Cellulose<br>(Prosolv SMCC 90)	192.00 mg.
		11	Croscarmellose Sodium<br>(Ac Di Sol)	3.00 mg.
		15	Colloidal Silicon dioxide<br>( Aerosil-200)	1.50 mg.
		19	Magnesium Stearate<br>(Mallinckrodt 2257)	1.50 mg.
Memantine<br>Hydrochloride<br>Tablets USP 10Mg - 500s	<br>1 Number	4	Memantine Hydrochloride<br>USP	10.20 mg.

UDIN00557092AM25

||||19|Magnesium Stearate (Mallinckrodt 2257)|1.50 mg.| ||Memantine Hydrochloride Tablets USP 10Mg - 500s| 1 Number|4|Memantine Hydrochloride USP|10.20 mg.|

UDIN00557092AM25

8	Silicified Microcrystalline<br>Cellulose<br>(Prosolv SMCC 90)	192.00 mg.
12	Croscarmellose Sodium<br>(Ac Di Sol)	3.00 mg.
16	Colloidal Silicon dioxide<br>( Aerosil-200)	1.50 mg.
20	Magnesium Stearate<br>(Mallinckrodt 2257)	1.50 mg.

Case No.	Case No.	19 / NC/3/MEET/Dec/202425/13	19 / NC/3/MEET/Dec/202425/13	19 / NC/3/MEET/Dec/202425/13	19 / NC/3/MEET/Dec/202425/13	19 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		DELTA FINOCHEM PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM REVIW00003546AM23
RA File Number		039404000112 AM21
Licence No and Date		0310836419/29/05/2020
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol.

o and Date||0310836419/29/05/2020||||| |Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Liqiud Bromine 1.1226 kg. 2 Hexamine 1.010 kg. 4 Bromobenzaldehyde 1 kg. 3 Isopropanol (synonyms Iso Propyl Alcohol) 0.433 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4 Bromobenzaldehyde||1 kg.|1|Liqiud Bromine|1.1226 kg.| |||||2|Hexamine|1.010 kg.| |||||3|Isopropanol (synonyms Iso Propyl Alcohol)|0.433 kg.|

UDIN00557092AM25

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

Cas	e No.	20 / NC/3/MEE	T/Dec/202	425/13
Cas
	e Status	Case Deferred
Par	ty Name	AMI ORGANIC	S LIMIT	ED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ D	ec/ 2024
				5/ 13 and 0	/01/2025

/ NC/3/MEE|T/Dec/202|425/13||| |Cas||||||| ||e Status|Case Deferred||||| |Par|ty Name|AMI ORGANIC|S LIMIT|ED||| |Me and|eting Number Date|NC/ 3/ MEET/ D|ec/ 2024|||| |||||5/ 13 and 0|/01/2025|| |HQ|File Number|HQRNORM RE|VIW0000|0095AM24||| |RA|File Number|522404000013|AM21|||| |||||||| |Lic Dat|ence No and e|5210043424/08/|06/2020|||| |Norms Committee Decision: Decision:The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing before Norms Committee to explain its case along with relevant information / documents from the firm:|ms Committee Decision: **cision:**The Committee con||sidered t|he case as|per agenda and it was decided|to call the firm for| ||||||||

Case No.	Case No.	21 / NC/3/MEET/Dec/202425/13	21 / NC/3/MEET/Dec/202425/13	21 / NC/3/MEET/Dec/202425/13	21 / NC/3/MEET/Dec/202425/13	21 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Part Name		SYNTHO CHIRALS PRIVATE LIMITED
y
Meeting Number
<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025

HQ File Number		HQRNORM REVIW00002342AM25

RA File Number		092404000185 AM21
Licence No and
<br>Date		0910068991/22/07/2020

Norms Committee		Decision:
Decision:The C		ommittee 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:-<br>Export Product<br>Qty.<br>**Sl.

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. allowed. (1R2R)-2-amino-6-(4-nitrophenyl)- 1 kg 1 CDX-034 LYOPHILIZED 00154 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||(1R2R)-2-amino-6-(4-nitrophenyl)-||1 kg|1|CDX-034 LYOPHILIZED| 00154 kg| ||, 1-phenylhex-5-yn-1-ol hydrochloride||.|| ENZYME POWDER| . .| |||||||| |||||||| |RA concerned m||ay take further necessary action as per above decision of NC.||||| ||||||||

UDIN00557092AM25

Case No.	22 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00000254AM24
RA File Number	03AA04011698 AM21
Licence No and<br>Date	0311000235/21/12/2020
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|03AA04011698 AM21| |Licence No and Date|0311000235/21/12/2020| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	23 / NC/3/MEET/Dec/202425/13
Case Status	Case Rejected
Party Name	REFLUX PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00001944AM25
RA File Number	NA
Licence No and<br>Date	0311001445/03/02/2021
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for review of ad-hoc norms and it was observed<br>that the firm has not provided any technical justification / information for enhancement. Hence, it was<br>decided torejectthe case maintaining thestatus quo.

Case No.	Case No.	24 / NC/3/MEET/Dec/202425/13	24 / NC/3/MEET/Dec/202425/13	24 / NC/3/MEET/Dec/202425/13	24 / NC/3/MEET/Dec/202425/13	24 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM REVIW00002353AM25
RA File Number		09AA04007265 AM22
Licence No and<br>Date		0911001194/12/07/2021
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>**Sl.

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

UDIN00557092AM25

(1R,2R)-2-amino-6-(4-	1 kg.	1	CDX-034	LYOPHILIZED	0.0154 kg.
nitrophenyl)-1-phenylhex-5-			ENZYME	POWDER
yn-1-ol hydrochloride

Case No.	25 / NC/3/MEET/Dec/202425/13
Case Status	Case Rejected
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00193597AM22
RA File Number	03AA04097753 AM22
Licence No and<br>Date	0311007198/25/09/2021
Norms Committee Decision:
Decision:The firm has informed that they have surrendered their above license to RA. Therefore, the
Committee decided toclosethe application of the firm.

Case No.	26 / NC/3/MEET/Dec/202425/13
Case Status	Case Rejected
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00008200AM24
RA File Number	05AA040108247 AM22
Licence No and<br>Date	0511006681/07/12/2021
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was observed that the firm still has not
furnished its reply. Hence, the Committee decided torejectthe case.

ision:|| |Decision:The Committee considered the case as per agenda and it was observed that the firm still has not|| |furnished its reply. Hence, the Committee decided torejectthe case.||

Case No.	27 / NC/3/MEET/Dec/202425/13
Case Status	Case Rejected
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00008265AM24
RA File Number	05AX04000189 AM22
Licence No and	0511007079/21/12/2021

UDIN00557092AM25

Date

Norms Committee Decision:

Decision: The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence, the Committee decided to reject the case.

Date	Date
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was observed that the firm still has not<br>furnished its reply. Hence, the Committee decided torejectthe case.

Case No.		28 / NC/3/MEET/D/202425/13
	e o.		c
Cas	e Status	Case Approved
Par	ty Name	GLOBAL CALCIU	M PRIVATE LI		MITED
Me<br>Dat	eting Number and<br>e	NC/ 3/ MEET/ Dec/	202425/ 13 and		07/01/2025
HQ	File Number	HQRNORM APPL	Y 00299344AM2		2
RA	File Number	07AA04038998 AM	22
Lic	ence No and Date	0711002737/28/12/	2021
Nor<br>D<br>Pa<br>RA
	ms Committee Decision:<br>ecision:The Committee considered th<br>ra 4.07 of HBP Vol. I as per details gi		e case as per ag<br>ven below or a		enda and<br>s applied		it was decided to fix ad<br>by the firm, whichever	-hoc norms under<br>is less:-
	Export Product		Qty.	S<br>N	l.<br>o.	Im	port Items		**Qty.

nda and s applied||it was decided to fix ad by the firm, whichever|-hoc norms under is less:-|| ||Export Product||||Qty.|S N|l. o.|Im|port Items||Qty. allowed.| ||Calcium Dobesilate Monohydrate||||1 kg.||1|HY|DROQUINONE||0.631 kg.| ||BP/ Calcium Dobesilate Monohydrate Eur.Ph / Calcium Dobesilate||||||||||| ||Etamsylate||||1 kg.||2|HY|DROQUINONE||0.527 kg.| ||||||||||||| ||concerned may take further necessary||||action as per||above dec||ision of NC.||| ||||||||||||| |Cas|e No.|29 / NC/3/MEET/Dec/202|||425/13||||||| |Cas|e Status|Case Deferred|||||||||| |Par|ty Name|KRUNAL INDUSTRIES|||PRIVATE LIMI||TED||||| |Me and|eting Number Date|NC/ 3/ MEET/ Dec/ 20242|||5/ 13 and 07/01/||2025||||| |HQ File Number|||||||||||| |||HQRNORM APPLY 00301989AM22|||||||||| |RA File Number||08AX04000162 AM22|||||||||| |Licence No and Date||0811003592/30/12/2021|||||||||| ||||||||||||| |Norms Committee Decision:||||||||||||

Case No.	29 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	KRUNAL INDUSTRIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00301989AM22
RA File Number	08AX04000162 AM22
Licence No and<br>Date	0811003592/30/12/2021
Norms Committee Decision:

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and 07/01/2025| |HQ File Number|HQRNORM APPLY 00301989AM22| |RA File Number|08AX04000162 AM22| |Licence No and Date|0811003592/30/12/2021| |Norms Committee Decision:||

UDIN00557092AM25

Decision: The committee considered the request of firm for fixation of ad-hoc norms and it has been observed that the firm has still not furnished the information/documents as sought by Committee earlier in the meeting held on 28.08.2024. Therefore, the Committee has decided to give last chance to the firm to furnish the following information/documents:-

1. Justification for low yield.

Production / Consumption data for the year 2021-22 duly certified by the Auditor of the firm.

Case No.	30 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00005946AM24
RA File Number	05AX04000321 AM22
Licence No and<br>Date	0511007823/11/01/2022
Norms Committee Decision:<br>Decision: The committee considered the request of firm for fixation of ad-hoc norms and it has been<br>observed that the firm still not furnished the information/documents as sought by Deptt. of Bio-Technology<br>during personal hearing held on 11.11.2024. Therefore, the committee decided to give one more chance to<br>the firm to furnish the reply to Deptt. of Bio-Technnology under intimation to the Committee.

Case No.	31 / NC/3/MEET/Dec/202425/13
Case Status	Case Rejected
Party Name	GANGWAL HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00356909AM22
RA File Number	03AX04001205 AM22
Licence No and<br>Date	0311011422/16/02/2022
Norms Committee Decision:<br>Decision:The firm has informed that they have surrendered their above license to RA. Therefore, the<br>Committee decided toclosethe application of the firm.

Norms Committee Decision: Decision:The firm has informed that they have surrendered their above license to RA. Therefore, the Committee decided toclosethe application of the firm.||

Case No.	32 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025

20 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

UDIN00557092AM25

HQ File Number	HQ File Number	HQRNORM APPLY 00409480AM22	HQRNORM APPLY 00409480AM22	HQRNORM APPLY 00409480AM22	HQRNORM APPLY 00409480AM22	HQRNORM APPLY 00409480AM22
RA File Number		34AX04000458 AM22
Licence No and<br>Date		3411002061/31/03/2022
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.<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. Colloidal Silicon Dioxide Chlorthalidone Tabs USP 50 mg 1 Number 10 0.60 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

A) (EXPLOTAB) 3.00 mg. Colloidal Silicon Dioxide Chlorthalidone Tabs USP 50 mg 1 Number 10 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|0.60 mg.|

UDIN00557092AM25

(Aerosil 200 Pharma)

Case No.	33 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001090AM23
RA File Number	09AX04000132 AM23
Licence No and<br>Date	0911003083/31/05/2022
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and it has been<br>observed that the firm has not furnished complete reply of DL.

Norms Committee Decision: **Decision:**The committee considered the request of firm for fixation of ad-hoc norms and it has been observed that the firm has not furnished complete reply of DL. Therefore it was decided to call for following information/documents from the firm:- Percentage Yield at every stage not given I. Stichometric balance on molar basis not given to justify the quantity of import asked for. II.||

Case No.	Case No.	34 / NC/3/MEET/Dec/202425/13	34 / NC/3/MEET/Dec/202425/13	34 / NC/3/MEET/Dec/202425/13	34 / NC/3/MEET/Dec/202425/13	34 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		NASENSE LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00001297AM23
RA File Number		09AX04000213 AM23
Licence No and<br>Date		0911003160/09/06/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>4-Cyanopyridine<br>1.0 kg.<br>4 Dimethyl Aminopyridine<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	4 Dimethyl Aminopyridine		1 kg.	1	4-Cyanopyridine	1.0 kg.

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==> picture [464 x 211] intentionally omitted <==

*Qty.**|Sl. No.|Import Items|Qty. allowed.| ||4 Dimethyl Aminopyridine||1 kg.|1|4-Cyanopyridine|1.0 kg.|

UDIN00557092AM25

==> picture [464 x 211] intentionally omitted <==

----- Start of picture text ----- 2 Cp.HCl (33 percent) 1.07 kg, 3 Acrylic Acid 0.694 kg. 4 Dimethylamine 40 0.08 percent Solution 5 Caustic Soda Flakes Not allowed as fully recovered 6 Toluene 1.15 kg. ----- End of picture text -----

Case No.	35 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001347AM23
RA File Number	05AX04000669 AM23
Licence No and<br>Date	0511013173/13/06/2022
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>To give a balanced chemical rection indicating molecular weight of all the reactants and<br>product with stage wise yield of the reaction.<br>1.<br>To indicate where AluminoSilicate catalyst, Denatured Ethyl alcohol and methanol are used in<br>the chemical reaction giving their application/use.<br>2.<br>Calculation of the requirement of all the chemicals with justification of low yield.<br>3.

ohol and methanol are used in** the chemical reaction giving their application/use. 2. Calculation of the requirement of all the chemicals with justification of low yield. 3.||

Case No.	36 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001993AM23

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RA File Number	34AX04000353 AM23
Licence No and<br>Date	3411002522/12/07/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	37 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002011AM23
RA File Number	52AX04001578 AM23
Licence No and<br>Date	5211002817/13/07/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call the firm for<br>attendingPersonal Hearing<br>before Norms Committee to explain its case along with relevant information<br>/ documents from the firm:

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

Case No.	Case No.	38 / NC/3/MEET/Dec/202425/13	38 / NC/3/MEET/Dec/202425/13	38 / NC/3/MEET/Dec/202425/13	38 / NC/3/MEET/Dec/202425/13	38 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00002019AM23
RA File Number		09AX04000338 AM23
Licence No and Date		0911003340/13/07/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Guanine<br>0.80 kg.<br>2<br>Dioxolane Diacetate<br>1.30 kg.<br>3<br>Acetic anhydride<br>2.30 kg.<br>Valaciclovir HCl<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Valaciclovir HCl		1 kg.	1	Guanine	0.80 kg.
				2	Dioxolane Diacetate	1.30 kg.
				3	Acetic anhydride	2.30 kg.

||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Valaciclovir HCl||1 kg.|1|Guanine|0.80 kg.| |||||2|Dioxolane Diacetate|1.30 kg.| |||||3|Acetic anhydride|2.30 kg.|

Case No.	Case No.	38 / NC/3/MEET/Dec/202425/13	38 / NC/3/MEET/Dec/202425/13	38 / NC/3/MEET/Dec/202425/13	38 / NC/3/MEET/Dec/202425/13	38 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00002019AM23
RA File Number		09AX04000338 AM23
Licence No and Date		0911003340/13/07/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Guanine<br>0.80 kg.<br>2<br>Dioxolane Diacetate<br>1.30 kg.<br>3<br>Acetic anhydride<br>2.30 kg.<br>Valaciclovir HCl<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Valaciclovir HCl		1 kg.	1	Guanine	0.80 kg.
				2	Dioxolane Diacetate	1.30 kg.
				3	Acetic anhydride	2.30 kg.

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Qty.**|Sl. No.|Import Items|Qty. allowed.| ||Valaciclovir HCl||1 kg.|1|Guanine|0.80 kg.| |||||2|Dioxolane Diacetate|1.30 kg.| |||||3|Acetic anhydride|2.30 kg.|

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4	Acetone	0.69 kg.
5	Aqueous Dimethyl Amine	1.64 kg.
6	Acetic Acid	0.47 kg.
7	CBZ - L - Valine	1.112 kg.
8	Dimethyl carbonyl chloride	0.98 kg.
9	Dimethylaminopyridine	0.028 kg.
10	Dimethyl formamide	1.92 kg.
11	methanol	4.82 kg.
12	Isopropanol	2.55 kg.

Case No.	39 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002358AM23
RA File Number	34AX04000398 AM23
Licence No and<br>Date	3411002586/29/07/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|34AX04000398 AM23| |Licence No and Date|3411002586/29/07/2022| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	40 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002124AM25

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RA File Number

Licence No and Date

0511014073/02/08/2022

Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Desmopressin Acetate Nasal Solution 0.01% (Nasal Spray) 5ml/Vial, Each ml contains 0.1mg (Equivalent to qty Desmopressin Acetate 500.000 Gm) 1 Number 1 Desmopressin Acetate 510 gm. RA concerned may take further necessary action as per above decision of NC.

mg (Equivalent to qty Desmopressin Acetate 500.000 Gm) 1 Number 1 Desmopressin Acetate 510 gm. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	41 / NC/3/MEET/Dec/202425/13	41 / NC/3/MEET/Dec/202425/13	41 / NC/3/MEET/Dec/202425/13	41 / NC/3/MEET/Dec/202425/13	41 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00002474AM23
RA File Number		34AX04000434 AM23
Licence No and<br>Date		3411002610/04/08/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>1<br>Midodrine Hydrochloride<br>USP (Micronized)<br>2.55 mg.<br>Midodrine HCL Tabs USP 2.5 mg 1 Number
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty. allowed.
	Midodrine HCL Tabs USP 2.5 mg		1 Number	1	Midodrine Hydrochloride<br>USP (Micronized)	2.55 mg.

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roduct**||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Midodrine HCL Tabs USP 2.5 mg||1 Number|1|Midodrine Hydrochloride USP (Micronized)|2.55 mg.|

UDIN00557092AM25

		2	Microcrystalline Cellulose<br>(Avicel PH 102)	74.50 mg.
		3	Crospovidone (Type-A)<br>(Polyplasdone) XL	8.00 mg.
		4	Hydroxypropyl cellulose<br>(KLUCEL LF PHARM)	1.50 mg.
		5	Colloidal Silicon dioxide<br>(Aerosil 200 Pharma)	2.00 mg.
		6	Magnesium Stearate	1.50 mg.
Midodrine HCL Tabs USP 5 mg	1 Number	7	Midodrine Hydrochloride<br>USP (Micronized)	5.10 mg.
		8	Microcrystalline Cellulose<br>(Avicel PH 102)	149.00 mg.
		9	Crospovidone (Type-A)<br>(Polyplasdone) XL	16.00 mg.
		10	Hydroxypropyl cellulose<br>(KLUCEL LF PHARM)	3.00 mg.
		11	Colloidal Silicon dioxide<br>(Aerosil 200 Pharma)	4.00 mg.
		12	Magnesium Stearate	3.00 mg.
Midodrine HCL Tabs USP 10 mg	1 Number	13	Midodrine Hydrochloride<br>USP (Micronized)	10.20 mg.
		14	Microcrystalline Cellulose<br>(Avicel PH 102)	298.00 mg.
		15	Crospovidone (Type-A)<br>(Polyplasdone) XL	32.00 mg.

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16	Hydroxypropyl cellulose	6.00 mg.
	(KLUCEL LF PHARM)
17	Colloidal Silicon dioxide	8.00 mg.
	(Aerosil 200 Pharma)
18	Magnesium Stearate	6.00 mg.

00557092AM25

16	Hydroxypropyl cellulose	6.00 mg.
	(KLUCEL LF PHARM)
17	Colloidal Silicon dioxide	8.00 mg.
	(Aerosil 200 Pharma)
18	Magnesium Stearate	6.00 mg.

					16	16	Hydroxypropyl cellulose<br>KLUCEL LF PHARM	6.00 mg.
							( )

					17		Colloidal Silicon dioxide	8.00 mg.
							(Aerosil 200 Pharma)

					18		Manesium Stearate	600 m
							g	. g.

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

Cas	e No.	42 / NC/3/MEET/Dec/20		2425/13
Cas	e Status	Case App	roved
Par	ty Name	ALPHAM	ED FORMUL	ATIONS PR		IVATE LIMITED
Me<br>Dat	i Nb d
	tng umer an<br>e	NC/ 3/ M	EET/ Dec/ 202	425/ 13 and		07/01/2025
HQ	File Number	HQRNO	RM APPLY 00	002477AM2		3
RA	File Number	09AX040	00348 AM23
Lic	ence No and Date	09110034	42/04/08/2022
Nor<br>D<br>sa<br>ad<br>4.	ms Committee Decision:<br>ecision:The Committee con<br>me export product/import it<br>vance authorizationNo.091<br>07 of HBP Vol.

034|42/04/08/2022|||||||||||| |Nor D sa ad 4.|ms Committee Decision: ecision:The Committee con me export product/import it vance authorizationNo.091 07 of HBP Vol. I as per detai|||sidered the c em in meetin 0068698 date ls given belo|||||||||||| ||||||||ase as per a gNo.NC/3 d 29/04/20 |||genda and taking cue from the ea /MEET/Jan/202021/4 dated 12/ 20, it was decided to fix ad-hoc n |||rlier decision for 02/2021against orms under Para ||| ||||||||w or as app|||lied by the firm, whichever is less:|||-||| ||Export Product||||Qty.|||Sl||N|It It|||Qt lld|| |||||||||.||o.|mpor ems|||y. aowe.|| ||BOLT ENERGY EFFERVESCENT TABLE|||TS|1 Num||ber|1|||Glucuronolactone|||51.00 mg|| || ((Each Tablet Contains - Glucuronolactone 50 mg, Ascorbic Acid 300 mg,Caff 50mg ))||| eine|Tablet||||||||||| |||||||||2|||Ascorbic Acid (Crystalline)|||306.0 mg.|| ||||||||||||||||| |||||||||3|||Caffeine Anhydrous|||51.00 mg.|| ||||||||||||||||| |||||||||4|||Sodium Polyphosphate|||50.00 mg.|| |||||||||5|||Sodium Hydrogen Carbonate|||950.00 mg.|| |||||||||||||||||

UDIN00557092AM25

	6	Gin Fizz Micron Flavour	30.00 mg.
	7	Macrogol 6000	135.00 mg.
	8	Monosodium Fumarate	2000.00 mg.

Carbonate|||950.00 mg.|| |||||||||||||||||

UDIN00557092AM25

	6	Gin Fizz Micron Flavour	30.00 mg.
	7	Macrogol 6000	135.00 mg.
	8	Monosodium Fumarate	2000.00 mg.

Case No.<br>43 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00002548AM23
RA File Number<br>03AX04002511 AM23
Licence No and<br>Date<br>0311017048/10/08/2022
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
SECNIDAZOLE PELLETS<br>1 kg.	1	SECNIDAZOLE IH	0.478 kg.
(Secnidazole taste masked pellets)
(each gm contains 473.5 mg a.i.)
RA concerned may take further necessary action as per above decision of NC.

Case No.	44 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	GUJARAT FLUOROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002598AM23
RA File Number	34AX04000342 AM23

UDIN00557092AM25

UDIN00557092AM25

Licence No and<br>Date
Norms Committee Decision:
Decision:The Committee considered the case as per		agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given	below or as applied by the firm, whichever is less:-
Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
R142B (1-Chloro 1,1-Difluoroethane)	1 kg.	1	1-1-Dichloroethene	1.00 kg.
			(Vinylidene Chloride)
		2	Fluorspar	Deleted
		3	Tintetrachloride	Deleted
Note: The above ad-norms were fixed only for this license.
RA concerned may take further necessary action as per above decision of NC.

Case No.	45 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002645AM23
RA File Number	03AX04002727 AM23
Licence No and<br>Date	0311017254/16/08/2022
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

umber|03AX04002727 AM23| |Licence No and Date|0311017254/16/08/2022| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	46 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002801AM23

UDIN00557092AM25

RA File Number

09AX04000470 AM23

Licence No and Date

0911003541/26/08/2022

Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Chloroform 1.90 kg. 2 Toluene 2.06 kg. 3 N-(Triphenylmethyl)-5-(4- Bromomethylbiphenyl-2-yl-) Tetrazole 1.02 kg. 4 Dimethyl Sulfoxide 0.46 kg. 2butyl16dihydro- NN,4trimethyl6oxo- 1[[2[1(triphenylmethyl)-1H- tetrazol-5-yl] [1,1biphenyl]4yl]methyl]5- Pyrimidineacetamide (Drug intermediate) 1 kg. 5 Lithium hydride 0.0166 kg. RA concerned may take further necessary action as per above decision of NC.

biphenyl]4yl]methyl]5- Pyrimidineacetamide (Drug intermediate) 1 kg. 5 Lithium hydride 0.0166 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	47 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002813AM23
RA File Number	07AX04000768 AM23
Licence No and Date	0711005110/26/08/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from earlier decision for same<br>export product / import item in Meeting No. NC/3/MEET/Jun/202324/6 dated 14/06/2024against<br>advance authorization No.0711006656 dated 07/03/2023, it was decided to fix adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

UDIN00557092AM25

11006656 dated 07/03/2023**, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:||

UDIN00557092AM25

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
MAGNESIUM CITRATE (USP/<br>NONAHYDRATE Eur.Ph/<br>ANHYDROUS Eur.Ph/<br>DODECAHYDRATE<br>Eur.Ph)	1 kg.<br>	1	CITRIC ACID	1.001 kg.
		2	MAGNESIUM CARBONATE	0.730 kg.
CALCIUM CITRATE(USP)	1 kg.	3	CITRIC ACID	0.816 kg.
		4	CALCIUM CARBONATE	0.660 kg.
ZINC CITRATE(USP)	1 kg.	5	CITRIC ACID	0.880 kg.
POTASSIUM<br>CITRATE<br>(BP/Eur.Ph/ USP)	1 kg.	6	CITRIC ACID	0.859 kg.
		7	POTASSIUM CARBONATE<br>GRANULAR	Deleted

ARBONATE|0.660 kg.| ||ZINC CITRATE(USP)|1 kg.|5|CITRIC ACID|0.880 kg.| ||POTASSIUM CITRATE (BP/Eur.Ph/ USP)|1 kg.|6|CITRIC ACID|0.859 kg.| ||||7|POTASSIUM CARBONATE GRANULAR|Deleted|

Case No.	Case No.	48 / NC/3/MEET/Dec/202425/13	48 / NC/3/MEET/Dec/202425/13	48 / NC/3/MEET/Dec/202425/13	48 / NC/3/MEET/Dec/202425/13	48 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		GODAVARI BIOREFINERIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00002842AM23
RA File Number		03AX04002739 AM23
Licence No and<br>Date		0311017558/29/08/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl.<br>Export Product<br>Qty.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl.	Import Items	Qty. allowed.

UDIN00557092AM25

			No.
3-METHYL-3-PENTEN-2-ONE	1	kg.	1	Methyl Ethyl Ketone	0.864 kg.
			2	DENATURE ETHYL	0.626 kg.
				ALCOHOL

ty. allowed.**|

UDIN00557092AM25

			No.
3-METHYL-3-PENTEN-2-ONE	1	kg.	1	Methyl Ethyl Ketone	0.864 kg.
			2	DENATURE ETHYL	0.626 kg.
				ALCOHOL

Case No.	49 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002919AM23
RA File Number	34AX04000543 AM23
Licence No and<br>Date	3411002729/02/09/2022
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	50 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	INTIGREAT CONSULTING SERVICES LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00003056AM23
RA File Number	03AX04002543 AM23
Licence No and<br>Date	0311017790/12/09/2022
Norms Committee Decision:
The case is under consideration and TE was requested to expedite his comments.

Case No.	51 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00003118AM23

UDIN00557092AM25

RA File Number	09AX04000498 AM23
Licence No and<br>Date	0911003623/14/09/2022
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

04000498 AM23| |---|---| |Licence No and Date|0911003623/14/09/2022| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	52 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00003251AM23
RA File Number	34AX04000590 AM23
Licence No and<br>Date	3411002800/21/09/2022
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	53 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00006256AM24
RA File Number	08AX04000971 AM23
Licence No and<br>Date	0811006083/22/09/2022
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	54 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	KAVALIFE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00003326AM23
RA File Number	07AX04000884 AM23
Licence No and<br>Date	0711005312/23/09/2022
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to call the firm for attending

AM23| |Licence No and Date|0711005312/23/09/2022| |Norms Committee Decision:|| |**Decision:**The Committee considered the case as per agenda and it was decided to call the firm for attending||

34 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

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Personal Hearing before Norms Committee to explain its case along with relevant information / documents from the firm:

Case No.	55 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	ALIVUS LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00003339AM23
RA File Number	03AX04003267 AM23
Licence No and<br>Date	0311018114/24/09/2022
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	56 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00003366AM23
RA File Number	03AX04003250 AM23
Licence No and<br>Date	0311018155/25/09/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<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. FENOFIBRATE PELLETS (Each gm of Pellets contains 662.5 mg Fenofibrate) 3595 kg. 1 FENOFIBRATE 2013.2 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00557092AM25

Case No.<br>57 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>MICRO LABS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00006048AM23
RA File Number<br>07AX04001667 AM23
Licence No and<br>Date<br>0711006347/02/02/2023
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the			earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Nov/202425/10 dated			22/11/2024against
advance authorizationNo.0711011361 dated 24/05/2024	, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
RAMELTEON 8 MG TABLETS<br>1 Number Tablet	1	RAMELTEON	8.16 mg/Tablet
RA concerned may take further necessary action as per above decision of NC.

**|Import Items|Qty. allowed.|| |RAMELTEON 8 MG TABLETS 1 Number Tablet||1|RAMELTEON|8.16 mg/Tablet|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	58 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	SYNERGIA SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00006312AM23
RA File Number	03AX04005369 AM23
Licence No and<br>Date	0311021429/14/02/2023
Norms Committee Decision:
After going through the application filed at the time of issuance of authorisation, the committee observed
that the firm wants to import two alternate inputs in the same quantity for the same export product. As per
the FTP/HBP provisions, the Advance authorisation scheme doesn’t provide for two substitute/alternate
inputs. Therefore, the Committee decided to call for the following information/documents from the firm:-
Clarification regarding the unusable quantity of Alpha picoline and why it cannot be used and<br>I.

I. Clarification regarding the unusable quantity of Alpha picoline and why it cannot be used and

UDIN00557092AM25

also the yield of 50.4% in first stage.

II. GST certified data for production/consumption quantity of export made from raw material 2- Ethanol Pyridine and Secondary Butyl Chloroformate.

also the yield of 50.4% in first stage.*

II. GST certified data for production/consumption quantity of export made from raw material 2- Ethanol Pyridine and Secondary Butyl Chloroformate.

Case No.	59 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	AZAKEM LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00000910AM24
RA File Number	09AX04000127 AM24
Licence No and<br>Date	0911005042/17/05/2023
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	60 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	VASISTA PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001152AM24
RA File Number	26AX04000028 AM24
Licence No and<br>Date	2611000961/26/05/2023
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

umber|26AX04000028 AM24| |Licence No and Date|2611000961/26/05/2023| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	61 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002558AM24
RA File Number	07AX04000359 AM24
Licence No and<br>Date	0711008395/26/06/2023
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

37 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

UDIN00557092AM25

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>MAGNOLIAL (2,4-dimethyl-4,4a,5,9b-<br>tetrahydroindeno[1,2-d][1,3]dioxine<br>CAS NO.27606-09-3)<br>1 kg.<br>1<br>INDENE<br>(92-94% purity)<br>1.12 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	MAGNOLIAL (2,4-dimethyl-4,4a,5,9b-<br>tetrahydroindeno[1,2-d][1,3]dioxine<br>CAS NO.27606-09-3)	1 kg.	1	INDENE<br>(92-94% purity)	1.12 kg.

*|Qty. allowed.| |---|---|---|---|---|---| ||MAGNOLIAL (2,4-dimethyl-4,4a,5,9b- tetrahydroindeno[1,2-d][1,3]dioxine CAS NO.27606-09-3)|1 kg.|1|INDENE (92-94% purity)|1.12 kg.|

Case No.	62 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00004244AM24
RA File Number	09AX04000203 AM24
Licence No and<br>Date	0911005339/06/07/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>N-Butyl Chloride<br>0.6 kg.<br>2<br>Lithium Metal<br>0.09 kg.<br>N Butyl Lithium 15% /23% /30% w/w in<br>Hexane (100% Active basis)<br>1 kg.<br>3<br>n-Hexane<br>0.84 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	63 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	GITANJALI CHEMICALS PRIVATE LIMITED

UDIN00557092AM25

ary action as per above decision of NC.||

Case No.	63 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	GITANJALI CHEMICALS PRIVATE LIMITED

UDIN00557092AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00004784AM24
RA File Number	03AX04001927 AM24
Licence No and<br>Date	0311025944/02/08/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>4-BROMO ANISOLE<br>1 kg.<br>1<br>ANISOLE<br>0.728 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	64 / NC/3/MEET/Dec/202425/13
Case Status	Case Rejected
Party Name	SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM REVIW00003678AM25
RA File Number	09AX04000551 AM24
Licence No and<br>Date	0911005810/20/09/2023
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for review of ad-hoc norms and it was observed<br>that the firm has not provided any technical justification / information for enhancement. Hence, it was<br>decided torejectthe case maintaining thestatus quo.

rms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided torejectthe case maintaining thestatus quo.||

Case No.	65 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	PRASOL CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00008287AM24
RA File Number	03AX04004987 AM24
Licence No and<br>Date	0311030614/01/02/2024
Norms Committee Decision:

UDIN00557092AM25

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

Manufacturing process staring from Acetone.
Molecular weight and percentage of yield at every stage of reaction.
Stichiomatric balance for chemical reaction.

Case No.	66 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	YELLOWSTONE FINE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00008613AM24
RA File Number	03AX04005249 AM24
Licence No and<br>Date	0311031269/16/02/2024
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:-
Molecular weigh of export product.<br>1.

t 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:-|| |Molecular weigh of export product. 1.|| |Yield at every stage of reaction. 2.|| |Stichiometric balance with percentage of yield on molar basis to arrive at the quantity of raw 3.|| |material asked.||

Case No.	Case No.	67 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ	File Number	HQRNORM APPLY 00008718AM24
RA File Number		03AX04005330 AM24
Licence No and<br>Date		0311031439/23/02/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product<br>Qty.		Sl.	Import Items	Qty.
			No.		allowed.

UDIN00557092AM25

YODANOL	1	Benzaldehyde	0.790 kg.
(a,y-dimethyl-benzenepentanol)
	2	N-HEPTANE	0.029 kg.
	3	Camphor sulfonic acid	0.005 kg.
	4	SYNPERONIC T/1301-LQ-(CQ)	0.08 kg.
	5	Primol 352	0.09 kg.

-|---|---|---|---|---| |(a,y-dimethyl-benzenepentanol)|||||| ||||2|N-HEPTANE|0.029 kg.| ||||3|Camphor sulfonic acid|0.005 kg.| ||||4|SYNPERONIC T/1301-LQ-(CQ)|0.08 kg.| ||||5|Primol 352|0.09 kg.|

Case No.	68 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	SYNERGIA SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00000333AM25
RA File Number	03AX04000023 AM25
Licence No and<br>Date	0311033222/19/04/2024
Norms Committee Decision:
After going through the application filed at the time of issuance of authorisation, the committee observed
that the firm wants to import two alternate inputs in the same quantity for the same export product. As per
the FTP/HBP provisions, the Advance authorisation scheme doesn’t provide for two substitute/alternate
inputs. Therefore, the Committee decided to call for the following information/documents from the firm:-
Clarification regarding the unusable quantity of Alpha picoline and why it cannot be used and<br>I.
also the yield of 50.4% in first stage.
GST certified data for production/consumption quantity of export made from raw material 2-<br>II.
Ethanol Pyridine and Secondary Butyl Chloroformate.

I. Clarification regarding the unusable quantity of Alpha picoline and why it cannot be used and also the yield of 50.4% in first stage.

nol Pyridine and Secondary Butyl Chloroformate.**||

I. Clarification regarding the unusable quantity of Alpha picoline and why it cannot be used and also the yield of 50.4% in first stage.

Case No.	69 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001762AM25
RA File Number	03AX04001633 AM25
Licence No and	0311035236/05/07/2024

UDIN00557092AM25

Date Norms Committee Decision:

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

Copy of Master Batch Formula.

Case No.<br>70 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Deferred
Party Name<br>CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001763AM25
RA File Number<br>31AX04000098 AM25
Licence No and<br>Date<br>3111003647/05/07/2024
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice
of the TE, it was decided to call for following information/documents from the firm:-
Justification for low yield of reaction for the items acetone, Ammonia and hydrogen peroxide.<br>1.
The function of Methylene Dichloride in the reaction and its recovery details in the process.<br>2.
Stoichiometric material balance on molar basis.<br>3.
The commercial value of by-product Caustic soda lye.<br>4.

Case No.	71 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001769AM25
RA File Number	07AX04000561 AM25
Licence No and<br>Date	0711011739/05/07/2024
Norms Committee Decision:
Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the
TE, it was decided to call for following information/documents from the firm:-
Whether the item of export will be convered under Vitamin category?<br>1.

ms and as per the advice of the|| |TE, it was decided to call for following information/documents from the firm:-|| |Whether the item of export will be convered under Vitamin category? 1.||

42 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

UDIN00557092AM25

2. Whether the import item ‘Orotic Acid’ is a vitamin?

Case No.	72 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	COHANCE LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001770AM25
RA File Number	09AX04000214 AM25
Licence No and<br>Date	0911007551/05/07/2024
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the
TE, it was decided to call for following information/documents from the firm:-
Composition of import item<br>1.
Certificate of Analysis (CoA) from Foreign Supplier.<br>2.
Copy of Drumg Manufacturing License (DML).<br>3.
Wastage applied.<br>4.

Case No.<br>73 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001796AM25
RA File Number<br>03AX04001674 AM25
Licence No and<br>Date<br>0311035257/07/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Sep/202324/13 dated 14/09/2023against
advance authorizationNo.0311025115 dated 04/07/2023, it was decided to fix ad-hoc			norms under Para
4.07 of HBP Vol.

eetingNo.NC/3/MEET/Sep/202324/13 dated 14/09/2023against||||| |advance authorizationNo.0311025115 dated 04/07/2023, it was decided to fix ad-hoc|||norms under Para|| |4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||||| |Export Product Qty.|Sl. No.|Import Items|Qty. allowed.|| |Colesevelam Hydrochloride for oral 41000|1|Colesevelam|4843.12 kg.|| |suspension 3.75GM Packs||Hydrochloride|||

UDIN00557092AM25

(Per Pack 30 Pouches)

Case No.	Case No.	Case No.	Case No.	Case No.	74 / NC/3/MEET/Dec/202425/13	74 / NC/3/MEET/Dec/202425/13	74 / NC/3/MEET/Dec/202425/13
Case Status					Case Approved
Party Name					ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date					NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number					HQRNORM APPLY 00001797AM25
RA File Number					03AX04001664 AM25
Licence No and<br>Date					0311035262/08/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the request of firm in details and also discussed report of factory<br>visit. The committee found that in the above mention case export product is in form of Gel not a<br>cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity<br>(i)<br>Medical Ointment cream lotion(Lidocaine and Prilocaine Cream USP, 2.5% ,<br>2.5%,30g Tot Wt. 19500 Kgs (Net Cont.

orms as under :- Sl. No Export Product Quantity (i) Medical Ointment cream lotion(Lidocaine and Prilocaine Cream USP, 2.5% , 2.5%,30g Tot Wt. 19500 Kgs (Net Cont. Lidocaine 487.50 Kgs, Prilocaine 487.50 Kgs, Carbopol 195 Kgs, PEG-60 370.50 Kgs tubes 65000 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.|||||||| ||Sl. No||Export Product||||Quantity| ||(i)||Medical Ointment cream lotion(Lidocaine and Prilocaine Cream USP, 2.5% , 2.5%,30g Tot Wt. 19500 Kgs (Net Cont. Lidocaine 487.50 Kgs, Prilocaine 487.50 Kgs, Carbopol 195 Kgs, PEG-60 370.50 Kgs tubes 65000 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.|| |||||||||

UDIN00557092AM25

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

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

elevant Bulk Drugs and Excipients) in** export to the RA concerned for redemption.|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.|||||||||| ||||||||||| |Case No.||75 / NC/3/MEET/Dec/202425/13|||||||| |Case Status||Case Approved|||||||| |Party Name||ABRYL LABORATORIES PRIVATE LIMITED|||||||| |Meeting Number|||||||||| | and Date||NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025|||||||| |HQ File Number||HQRNORM APPLY 00001806AM25|||||||| |RA File Number||30AX04000117 AM25|||||||| |Licence No and|||||||||| |Date||3011005434/08/07/2024|||||||| |Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Dexketoprofen 50mg/2ml solution for Injection (Ampoules) (Dexketoprofen 50mg/2ml equivalent to 73.80 mg of Dexketoprofen trometamol) 1 Number 1 Dexketoprofen Trometamol 55.00 mg.|||||||||| ||||||||||| ||Export Product||||ty.||**Sl.

Dexketoprofen 50mg/2ml equivalent to 73.80 mg of Dexketoprofen trometamol) 1 Number 1 Dexketoprofen Trometamol 55.00 mg.|||||||||| ||||||||||| ||Export Product||||ty.||Sl. No.|Import Items|Qty.| |||||||||| allowed.| ||Dexketoprofen 50mg/2m for Injection (Ampoules) (Dexketoprofen 50mg/2m ||l solution l | 1|Number||1|Dexketoprofen Trometamol|5500 mg| ||||||||||. .| ||equivalent to 73.80 mg of Dexketoprofen trometamol)||||||||| ||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||

Case No	76 / NC/3/MEET/Dec/202425/13
.
Case Status	Case Aroved
	pp
Part Name	DRACHARYA LABORATORIES PRIVATE LIMITED
y	.
Meetin Number
g<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001817AM25

RA File Number	03AX04001681 AM25

Licence No and
<br>Date	0311035296/08/07/2024

UDIN00557092AM25

Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance authorization No.0311034156 dated 05/06/2024 , 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.
3-Methoxy-2-methylbenzoyl	chloride	<br>1 kg.	1	3-Methoxy-o-toluic Acid	0.95 kg.
(MMBC)(CAS NO.24487-91-0)				(MOTA)

Case No.<br>77 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Deferred
Party Name<br>AMI ORGANICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001818AM25
RA File Number<br>52AX04000090 AM25
Licence No and<br>Date<br>5211008811/08/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to call the firm for attending
Personal Hearing<br>before Norms Committee to explain its case along with relevant information / documents
from the firm.

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

Case No.	78 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001820AM25
RA File Number	52AX04000089 AM25
Licence No and<br>Date	5211008812/08/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to call the firm for attending

UDIN00557092AM25

Personal Hearing before Norms Committee to explain its case along with relevant information / documents from the firm.

Case No.<br>79 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Deferred
Party Name<br>TIDE INDUSTRIES
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001846AM25
RA File Number<br>34AX04000273 AM25
Licence No and<br>Date<br>3411005128/09/07/2024
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice
of the TE, it was decided to call for following information/documents from the firm:-
Complete chemical reactions with molecular and structural formula and molecular weights<br>I.
along with stage wise percentage yields on molar basis.
Stoichiometric balance between import and export on molar basis.<br>II.

ar and structural formula and molecular weights** I.| |along with stage wise percentage yields on molar basis.| |Stoichiometric balance between import and export on molar basis. II.|

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

Case No.<br>80 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>USV PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001858AM25
RA File Number<br>03AX04001750 AM25
Licence No and<br>Date<br>0311035328/10/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda	and taking cue from the earlier decision for
same export product/import item in meetingNo.5/82-ALC4/2020 dated 09/10/2020against advance
authorizationNo.0310835571 dated 20/03/2020, it was decided to fix ad-hoc		norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
Felodipine ER Tablets 2.5 mg<br>1 Number<br>1	Felodipine	2.55 mg/2.5 mg Tablet
100's((6,000 Bottles X 100

Export Product Qty. Sl. No.|Import Items|Qty. allowed.|| |Felodipine ER Tablets 2.5 mg 1 Number 1|Felodipine|2.55 mg/2.5 mg Tablet|| |100's((6,000 Bottles X 100||||

Case No.<br>80 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>USV PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001858AM25
RA File Number<br>03AX04001750 AM25
Licence No and<br>Date<br>0311035328/10/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda	and taking cue from the earlier decision for
same export product/import item in meetingNo.5/82-ALC4/2020 dated 09/10/2020against advance
authorizationNo.0310835571 dated 20/03/2020, it was decided to fix ad-hoc		norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
Felodipine ER Tablets 2.5 mg<br>1 Number<br>1	Felodipine	2.55 mg/2.5 mg Tablet
100's((6,000 Bottles X 100

UDIN00557092AM25

ty.** Sl. No.|Import Items|Qty. allowed.|| |Felodipine ER Tablets 2.5 mg 1 Number 1|Felodipine|2.55 mg/2.5 mg Tablet|| |100's((6,000 Bottles X 100||||

UDIN00557092AM25

Tablets Per Bottles = 6,00,000<br>Tablets) (Total Weight of Export<br>Product = 1.500 Kgs)<br>Tablet<br>Felodipine ER Tablets 5.0 mg<br>100's((15,000 Bottles X 100<br>Tablets Per Bottles = 15,00,000<br>Tablets) (Total Weight of<br>Export Product = 7.500 Kgs)<br>1 Number<br>Tablet<br>2<br>Felodipine<br>5.10 mg/5 mg Tablet<br>Felodipine ER Tablets 10 mg<br>100's((37,500 Bottles X 100<br>Tablets Per Bottles = 37,50,000<br>Tablets) (Total Weight of<br>Export Product = 37.500 Kgs)<br>1 Number<br>Tablet<br>3<br>Felodipine<br>10.20 mg/10 mg Tablet<br>RA concerned may take further necessary action as per above decision of NC.	Tablets Per Bottles = 6,00,000<br>Tablets) (Total Weight of Export<br>Product = 1.500 Kgs)	Tablet
	Felodipine ER Tablets 5.0 mg<br>100's((15,000 Bottles X 100<br>Tablets Per Bottles = 15,00,000<br>Tablets) (Total Weight of<br>Export Product = 7.500 Kgs)	1 Number<br>Tablet	2	Felodipine	5.10 mg/5 mg Tablet
	Felodipine ER Tablets 10 mg<br>100's((37,500 Bottles X 100<br>Tablets Per Bottles = 37,50,000<br>Tablets) (Total Weight of<br>Export Product = 37.500 Kgs)	1 Number<br>Tablet	3	Felodipine	10.20 mg/10 mg Tablet

Case No.	Case No.	81 / NC/3/MEET/Dec/202425/13	81 / NC/3/MEET/Dec/202425/13	81 / NC/3/MEET/Dec/202425/13	81 / NC/3/MEET/Dec/202425/13	81 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00001869AM25
RA File Number		03AX04001782 AM25
Licence No and Date		0311035355/10/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>TRIMETHYLOLPROPANE<br>TRIMETHACRYLATE<br>(TMPTMA 70)<br>30000 kg.<br>1<br>TRIMETHYLOLPROPANE<br>TRIMETHACRYLATE<br>(TMPTMA)<br>21030 kg.
	Export Product<br>		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	TRIMETHYLOLPROPANE<br>TRIMETHACRYLATE<br>(TMPTMA 70)<br>		30000 kg.	1	TRIMETHYLOLPROPANE<br>TRIMETHACRYLATE<br>(TMPTMA)	21030 kg.

UDIN00557092AM25

(Minimum 70% active content)

ed.**| ||TRIMETHYLOLPROPANE TRIMETHACRYLATE (TMPTMA 70) ||30000 kg.|1|TRIMETHYLOLPROPANE TRIMETHACRYLATE (TMPTMA)|21030 kg.|

UDIN00557092AM25

(Minimum 70% active content)

Case No.	82 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001870AM25
RA File Number	09AX04000225 AM25
Licence No and<br>Date	0911007569/10/07/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.<br>83 / NC/3/MEET/Dec/202425/13	Case No.<br>83 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ	File Number<br>HQRNORM APPLY 00001871AM25
RA File Number<br>03AX04001699 AM25
Licence No and<br>Date<br>0311035363/10/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
	1<br>Fenofibrate 48mg tablets<br>1 Number	Fenofibrate Micronized IH/Ph Eur	48.96 mg.
	2	Sucrose PH.Eur (exepient)	145.57 mg.

UDIN00557092AM25

ort Items**|Qty. allowed.|| ||1 Fenofibrate 48mg tablets 1 Number|Fenofibrate Micronized IH/Ph Eur|48.96 mg.|| ||2|Sucrose PH.Eur (exepient)|145.57 mg.|| ||||||

UDIN00557092AM25


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



Case No.			84 / NC/3/MEET/Dec/202425/13
			Ad
Case Status			Case pprove
Party Name			SRF LIMITED
Meeting Number and Date			NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number			HQRNORM APPLY 00001896AM25
RA File Number			05AX04000950 AM25
Licence No and Date			0511026636/12/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br> <br><br> <br> <br>

	Export Product			Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
	3-PYRIDINECARBOXYLIC ACID,			1 kg.	1	METHOXY-AA TECH. 12 [GB]	0.790 kg.
	<br>2-[(2METHOX	<br>YETHOXY)
	<br>METHYL]-6-
	(TRIFLUORO	METHYL)-ETHYL			2	TOLUENE	0.239 kg.
	ESTER
					3	TRI ETHYL AMINE (TEA)	0.140 kg.


					4	TRICHLOROACETYL<br>CHLORIDE [TCAC]	0.945 kg.

					5	ETHYL VINYL ETHER	0.314 kg.
					6	ACETIC ACID	0.030 kg.
					7	ORTHOXYLENE	0.140 kg.

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

|| ||||||5|ETHYL VINYL ETHER|0.314 kg.| ||||||6|ACETIC ACID|0.030 kg.| ||||||7|ORTHOXYLENE|0.140 kg.| ||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||

Case No.	85 / NC/3/MEET/Dec/202425/13

Case Status	Case Approved

Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED

UDIN00557092AM25

Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001907AM25
RA File Number<br>03AX04001823 AM25
Licence No and<br>Date<br>0311035444/12/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No. Import Items	Qty. allowed.
1<br>Fenofibrate Micronized IH/Ph Eur<br>Fenofibrate 48mg tablets<br>1 Number	48.96 mg.
2<br>Sucrose PH.Eur (exepient)	145.57 mg.
RA concerned may take further necessary action as per above decision of NC.

icronized IH/Ph Eur Fenofibrate 48mg tablets 1 Number|48.96 mg.|| |2 Sucrose PH.Eur (exepient)|145.57 mg.|| |RA concerned may take further necessary action as per above decision of NC.|||

Case No.<br>86 / NC/3/MEET/Dec/202425/13	Case No.<br>86 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001913AM25
RA File Number<br>03AX04001799 AM25
Licence No and<br>Date<br>0311035447/12/07/2024
Norms Committee Decision:
Decision:The Committee considered the case		as per agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product	Qty.	Sl.	Import Items	Qty. allowed.
		No.
Fenofibrate 145mg tablets	1 Number	1	Fenofibrate Micronized IH/Ph Eur	147.90 mg.

UDIN00557092AM25

2 Sucrose PH.Eur (exepient) 146.45 mg.

rt Items**|Qty. allowed.|| |||No.|||| |Fenofibrate 145mg tablets|1 Number|1|Fenofibrate Micronized IH/Ph Eur|147.90 mg.||

UDIN00557092AM25

2 Sucrose PH.Eur (exepient) 146.45 mg.

Case No.	87 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001929AM25
RA File Number	08AX04000588 AM25
Licence No and<br>Date	0811012112/15/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Dec/202425/12 dated 10/12/2024against<br>advance authorizationNo.0811011790 dated 12/06/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Calcium<br>Gluconate<br>Injection,<br>USP 1,000 mg per 10 mL<br>(100 mg per mL)<br>1 Number<br>1<br>CALCIUM GLUCONATE<br>MONOHYDRATE USP<br>1081.0 mg.<br>Calcium Gluconate Injection,<br>USP 5,000 mg per 50 mL<br>(100 mg per mL)<br>1 Number<br>2<br>CALCIUM GLUCONATE<br>MONOHYDRATE USP<br>5145.0 mg.<br>Calcium Gluconate Injection,<br>USP 10,000 mg per 100 mL (100<br>mg per mL)<br>1 Number<br>3<br>CALCIUM GLUCONATE<br>MONOHYDRATE USP<br>10290.0 mg.<br>RA concerned may take further necessary action as per above decision of NC.

SP 10,000 mg per 100 mL (100 mg per mL) 1 Number 3 CALCIUM GLUCONATE MONOHYDRATE USP 10290.0 mg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00557092AM25

Case No.	Case No.	88 / NC/3/MEET/Dec/202425/13	88 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		VINEET LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00001932AM25
RA File Number		09AX04000247 AM25
Licence No and<br>Date
	ate	0911007585/15/07	/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>N-Butyl Chloride<br>0.6 kg.<br>N Butyl Lithium 30% w/w in Hexane<br>1 kg.	orms Committee Decision:
	Decision:The Committee consid<br>Para 4.07 of HBP Vol.

Qty. allowed. 1 N-Butyl Chloride 0.6 kg. N Butyl Lithium 30% w/w in Hexane 1 kg.|orms Committee Decision:|||||||||||||| ||**Decision:**The Committee consid Para 4.07 of HBP Vol. I as per de|||ered the case a tails given bel||s per ag ow or a|||enda and it was decided to f s applied by the firm, which|||ix ad-hoc norms under ever is less:-||| |||Export Product|||||Qty.|||Sl. No.|Import Items|||Qty. allowed.| |||N Butyl Lithium 30% w/w in Hexane|||||1 kg.|||1|N-Butyl Chloride|||0.6 kg.| ||| Solution||||||||||||| |||||||||||2|Lithium Metal|||0.09 kg.| |||||||||||||||| |||||||||||3|n-Hexane|||0.84 kg.| |||||||||||||||| |||||||||||||||| |RA concerned m|||ay take further necessary action as per above decision of NC.|||||||||||| |||||||||||||||| |||||||||||||||| |Case No.|||89 / NC/3/MEET/Dec/202425/13|||||||||||| |Case Status|||Case Approved|||||||||||| |Party Name|||SENTISS PHARMA PRIVATE LIMITED|||||||||||| |Meeting Number and Date|||NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025|||||||||||| |HQ File Number|||HQRNORM APPLY 00001938AM25|||||||||||| |RA File Number|||05AX04001174 AM25|||||||||||| |Licence No and Date|||0511026672/15/07/2024|||||||||||| |N s a 4|orms Committee Decision:|||||||||||||| ||Decision:The Committee consid ame export product/import item|||ered the case in meeting|as per No.NC/|||agenda and taking cue from th 3/MEET/Jun/202324/6 dated|||||e earlier decision for 14/06/2024against|| || dvance authorizationNo.051101 .07 of HBP Vol.

|as per No.NC/|||agenda and taking cue from th 3/MEET/Jun/202324/6 dated|||||e earlier decision for 14/06/2024against|| || dvance authorizationNo.051101 .07 of HBP Vol. I as per details||| 7659 dated given below| 07/03/2 or as ap||| 023, it was decided to fix ad-h plied by the firm, whichever is l||||| oc norms under Para ess:-|| ||||||||||||||||

Case No.	89 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001938AM25
RA File Number	05AX04001174 AM25
Licence No and<br>Date	0511026672/15/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Jun/202324/6 dated 14/06/2024against
advance authorizationNo.0511017659 dated 07/03/2023, it was decided to fix ad-hoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00557092AM25

Export	Product		Qty.	Sl. No.	Import Items	Qty. allowed.
TOBRISS	(TOBRAMYCIN	<br>0.3	<br>1 Number	1	Tobramycin Sulphate	19.057 mg.
PERCENT)	EYE DROPS 5 ML	VIAL	Vial

**|Sl. No.|Import Items|Qty. allowed.| |---|---|---|---|---|---|---| |TOBRISS|(TOBRAMYCIN| 0.3| 1 Number|1|Tobramycin Sulphate|19.057 mg.| |PERCENT)|EYE DROPS 5 ML|VIAL|Vial||||


Case No.	90 / NC/3/MEET/Dec/202425/13

Case Status	Case Approved

Party Name	SENTISS PHARMA PRIVATE LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025

HQ File Number	HQRNORM APPLY 00001939AM25

RA File Number	05AX04001182 AM25

Licence No and<br>Date	0511026673/15/07/2024

Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.6/82-ALC4/2019 dated 16/08/2019against advance<br>authorizationNo.0510411169 dated 05/07/2019, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>DANCIL EYE & EAR DROPS .3% 5 ML<br>VIAL (Each ml of Dancil contains 3mg of<br>Ofloxacin)<br>1 pack<br>1<br>Ofloxacin<br>0.0153 gm/5 ml.<br>pack<br>RA concerned may take further necessary action as per above decision of NC.

br>VIAL (Each ml of Dancil contains 3mg of Ofloxacin) 1 pack 1 Ofloxacin 0.0153 gm/5 ml. pack RA concerned may take further necessary action as per above decision of NC.|| |||

Case No.	91 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Pt N	SENTISS PHARMA PRIVATE LIMITED
ary ame
Mti Nb
eeng umer<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025

HQ File Number	HQRNORM APPLY 00001940AM25

RA File Number	05AX04001170 AM25

UDIN00557092AM25

Licence No and 0511026674/15/07/2024 Date Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance authorization No.0511024955 dated 18/04/2024 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Brinex / Brinex-M / Brinarga /	<br>1 Vial	1	Brinzolamide Micronized	51.00 mg/Vial
Brinera (Brinzolamide Opthalmic			Sterile
Suspension 1%)- 5ml (Each ml
contains 10 mg of Brinzolamide)

x / Brinex-M / Brinarga /| 1 Vial|1|Brinzolamide Micronized|51.00 mg/Vial| |Brinera (Brinzolamide Opthalmic|||Sterile|| |Suspension 1%)- 5ml (Each ml||||| |contains 10 mg of Brinzolamide)|||||

Case No.<br>92 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001941AM25
RA File Number<br>05AX04001181 AM25
Licence No and<br>Date<br>0511026676/15/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Mar/202324/26 dated 22/03/2024against
advance authorizationNo.0511023042 dated 03/01/2024, it was decided to fix ad-hoc			norms under Para
4.07 of HBP Vol. I as per details given below or as	applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
Cyclomed Eye Drops 1% 5ml (Each<br>1 Pack	1	Cyclopentolate HCL USP	51.00 mg.
ml contains 10 mg of Cyclopentolate
Hydochloride)

ty.**|Sl. No.|Import Items|Qty. allowed.|| |Cyclomed Eye Drops 1% 5ml (Each 1 Pack|1|Cyclopentolate HCL USP|51.00 mg.|| |ml contains 10 mg of Cyclopentolate||||| |Hydochloride)|||||

Case No.<br>92 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001941AM25
RA File Number<br>05AX04001181 AM25
Licence No and<br>Date<br>0511026676/15/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for
same export product/import item in meetingNo.NC/3/MEET/Mar/202324/26 dated 22/03/2024against
advance authorizationNo.0511023042 dated 03/01/2024, it was decided to fix ad-hoc			norms under Para
4.07 of HBP Vol. I as per details given below or as	applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
Cyclomed Eye Drops 1% 5ml (Each<br>1 Pack	1	Cyclopentolate HCL USP	51.00 mg.
ml contains 10 mg of Cyclopentolate
Hydochloride)

UDIN00557092AM25

Items**|Qty. allowed.|| |Cyclomed Eye Drops 1% 5ml (Each 1 Pack|1|Cyclopentolate HCL USP|51.00 mg.|| |ml contains 10 mg of Cyclopentolate||||| |Hydochloride)|||||

UDIN00557092AM25

Case No.	93 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001942AM25
RA File Number	03AX04001857 AM25
Licence No and<br>Date	0311035506/15/07/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	94 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001953AM25
RA File Number	03AX04001667 AM25
Licence No and<br>Date	0311035539/16/07/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

umber|03AX04001667 AM25| |Licence No and Date|0311035539/16/07/2024| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.		95 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00001959AM25
RA File Number		03AX04001864 AM25
Licence No and<br>Date		0311035562/16/07/2024
Norms Committee Decision:
Decision:The	Committee considered the request of firm in details and also discussed report of factory
visit. The committee found that in the above mention case export product is in form of Gel not a
cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-

56 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

UDIN00557092AM25

Sl.	Export Product	Quantity
No
(i)	Medical Creams & Ointments(Mycospor 1% Cream 10 Gm (Tot Wt: 6000Kgs.	1 Number
	Net Cont:Bifonazole JP 60 Kgs,Octyldodecanol JP 810 Kgs, Sorbitan
	Monostearate JP 120 Kgs, Aluminium Tubes 600,000 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 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.	96 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001961AM25
RA File Number	03AX04001867 AM25
Licence No and<br>Date	0311035566/16/07/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No. 97 / NC/3/MEET/Dec/202425/13

57 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

UDIN00557092AM25

Case Status<br>Case Deferred
Party Name<br>DINAKARA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number<br>HQRNORM APPLY 00001982AM25
RA File Number<br>09AX04000270 AM25
Licence No and<br>Date<br>0911007602/18/07/2024
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice
of the TE, it was decided to call for following information/documents from the firm:-
To give complete chemical reaction (without using abbreviation) indicating molecular weight of<br>1.
reactant and products and calculation of requirement of chemicals.
To give stage wise yield of the reaction with justification and Stoichiometric material balance<br>2.
on molar basis.

reactant and products and calculation of requirement of chemicals.**| |To give stage wise yield of the reaction with justification and Stoichiometric material balance 2.| |on molar basis.| |Function of mineral oil in the process and current production/consumption data. 3.|

Case No.	98 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00001994AM25
RA File Number	03AX04001885 AM25
Licence No and<br>Date	0311035597/18/07/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	99 / NC/3/MEET/Dec/202425/13

Case Status	Case Approved

Party Name	MANKIND PHARMA LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025

HQ File Number	HQRNORM APPLY 00002019AM25

RA File Number	05AX04001273 AM25

Licence No and<br>Date	0511026754/19/07/2024

Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Dec/202425/12 dated 10/12/2024against

58 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

UDIN00557092AM25

/import item in meetingNo.NC/3/MEET/Dec/202425/12 dated 10/12/2024against||

58 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

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advance authorization No.0511025839 dated 03/06/2024 , 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.
Nitroglycerin<br>Sublingual<br>Tablets USP, 0.3mg	<br>1 Number	1	DILUTED NITROGLYCERIN USP<br>(2% W/W)	15.30 mg.
Nitroglycerin<br>Sublingual<br>Tablets USP, 0.4mg	<br>1 Number	2	DILUTED NITROGLYCERIN USP<br>(2% W/W)	20.40 mg.
Nitroglycerin<br>Sublingual<br>Tablets USP, 0.6mg	<br>1 Number	3	DILUTED NITROGLYCERIN USP<br>(2% W/W)	30.60 mg.

Case No.	100 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002025AM25
RA File Number	09AX04000240 AM25
Licence No and<br>Date	0911007615/19/07/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|09AX04000240 AM25| |Licence No and Date|0911007615/19/07/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	101 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002026AM25
RA File Number	09AX04000239 AM25
Licence No and<br>Date	0911007616/19/07/2024
Norms Committee Decision:

UDIN00557092AM25

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

Case No.	Case No.	102 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		INDOCO REMEDIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ	File Number	HQRNORM APPLY 00002039AM25
RA File Number		03AX04001938 AM25
Licence No and Date		0311035673/22/07/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting
No.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo. 0311032713 dated 01/04/2024, it was decided to fix ad-hoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl.<br>Import<br>Qty.
				No.<br>Items<br>allowed.
	Brimonidine Tartrate /Timolol ophthalmic solution 0.2%/0.5% (5 ml Bottle) ((Each ml Contains : Brimonidine		1	1 Timolol<br>25.50 mg.
	Tartrate 2mgand Timolol Maleate 6.8 mg equivalent to Timolol 5mg) (Each 5 ml Bottle Contains :Brimonidine		Number	Maleate
	Tartrate 10mg and Timolol Maleate 34 mg )			2 BOTTLE<br>Relevant,<br>as per<br>Packing<br>Policy &<br>General<br>Notes.<br>3 CAP<br>Relevant,<br>as per<br>Packing<br>Policy &<br>General<br>Notes.<br>4 DROPPER Relevant,<br>as per<br>Packing<br>Policy &<br>General<br>Notes.

UDIN00557092AM25

eneral Notes. 3 CAP Relevant, as per Packing Policy & General Notes. 4 DROPPER Relevant, as per Packing Policy & General Notes.|

UDIN00557092AM25

BrimonidineTartrate/Timololophthalmicsolution0.2%/0.5%(10mlBottle)((EachmlContains:BrimonidineTartrate2mgand 1 Timolol Maleate 6.8mg equivalent to Timolol 5mg) (Each 10 ml Bottle Contains :Brimonidine Tartrate 20mg and Number Timolol Maleate 68 mg )

Brimonidine Tartrate /Timolol ophthalmic solution 0.2%/0.5% (15 ml Bottle )((Each ml Contains : Brimonidine Tartrate 2mg and Timolol Maleate 6.8mg equivalent to Timolol 5mg) (Each 15 ml Contains :Brimonidine Tartrate 30mg and Timolol Maleate 102 mg )

1 Number

UDIN00557092AM25


	DorzolamideHydrochloride-<br>TimololMaleateOphthalmicSolutionUSP(5mlBottle)((EachmlContains:DorzolamideHydrochloride 22.3mg equivalent<br>to Dorzolamide 20mg and Timolol Maleate 6.8mg equivalent to Timolol 5mg) (Each 5ml Contains: Dorzolamide<br>Hydrochloride 111.50mg & Timolol Maleate 34 mg)	1<br>Number
	DorzolamideHydrochloride-<br>TimololMaleateOphthalmicSolutionUSP(10mlBottle)((EachmlContain:DorzolamideHydrochloride 22.3mg equivalent<br>to Dorzolamide 20mg and Timolol Maleate 6.8mg equivalent to Timolol 5mg) (Each 10ml Contains: Dorzolamide<br>Hydrochloride 223 mg & Timolol Maleate 68 mg)	1<br>Number

UDIN00557092AM25

br>to Dorzolamide 20mg and Timolol Maleate 6.8mg equivalent to Timolol 5mg) (Each 10ml Contains: Dorzolamide Hydrochloride 223 mg & Timolol Maleate 68 mg)|1 Number|

UDIN00557092AM25

RA


	concerned may take further necessary action		as per ab	ove decisi	on of NC.

Cas	e No.	103 / NC/3/MEET/Dec/20242	5/13
Cas	e Status	Case Approved

Part	y Name	INDOCO REMEDIES LIMIT	ED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Dec/ 202425/	13 and 07
				01/2025
HQ	File Number	HQRNORM APPLY 0000204	0AM25
RA	File Number	03AX04001939 AM25

Lic<br>Dat	ence No and<br>e	0311035674/22/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against<br>advance authorizationNo. 0311023932 dated 25/05/2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol.

eetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against advance authorizationNo. 0311023932 dated 25/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- |ms Committee Decision: cision:The Committee considered the c me export product/import item in meetin vance authorizationNo. 0311023932 dat |||ase as p gNo.N ed 25/0 |er agenda|and taking cue from the ea||rlier decision for||| |||||| C/3/MEE 5/2023, it | T/Jan/202324/20 dated 18 was decided to fix ad-hoc n || /01/2024against orms under Para ||| |||||||||||| ||Export Product||Qty.||Sl. No.|Import Items|Qty. allowed.|||| ||Ketotifen Fumarate ophthalmic solution 0.035% (5ml Bottle)||1 Number||1|Ketotifen Fumarate|1.785 mg.|||| ||(Each ml. Co|ntains: Ketotifen|||2|Bttl|Rlt|||| ||(0.025%) An|tihistamine||||oe|eevan, as per Packin Polic &|||| ||(Equivalent t|o Ketotifen|||||g y General Notes|||| ||Fumarate0.0 bottle of 5ml|35%) =1.750mg per .) (i.e.1.75mg./5ml)|||||.|||| |||||||||||| ||Net Weight i|n Export|||3|Cap|Relevant, as per|||| ||Productsis:10|01.000|||||Packing Policy &|||| ||GRAMS)||||||General Notes.|||| |||||||||||| ||||||4|Dropper|Relevant, as per Packing Policy & General Notes.||||

UDIN00557092AM25

| ||Productsis:10|01.000|||||Packing Policy &|||| ||GRAMS)||||||General Notes.|||| |||||||||||| ||||||4|Dropper|Relevant, as per Packing Policy & General Notes.||||

UDIN00557092AM25

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

C	ase No.	104 / NC/3/MEET	/Dec/202425/1	3
C	ase Status	Case Approved
P
	arty Name	ALEMBIC PHAR	MACEUTICA	LS LIMI	TED
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ De	c/ 202425/ 13 a	nd 07/01	/2025
H	Q File Number	HQRNORM APP	LY 00002042A	M25

| ||arty Name||ALEMBIC PHAR||MACEUTICA||LS LIMI||TED|||| |M a|eeting Number nd Date||NC/ 3/ MEET/ De||c/ 202425/ 13 a||nd 07/01||/2025|||| |H|Q File Number||HQRNORM APP||LY 00002042A||M25|||||| |R|A File Number||08AX04000418 A||M25|||||||| |L D|icence No and ate||0811012178/22/0||7/2024|||||||| |Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Jun/202324/6 dated 01/07/2024against advance authorizationNo. 3411003955 dated 27/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Metronidazole Gel Usp 1% 55 gm pump 40,000 Numbers 1 Metronidazole (Micronized) USP 22.44 kg. Metronidazole Gel USP 1% 60 gm tube 70,000 Numbers 2 Metronidazole (Micronized) USP 42.84 kg. Note: NC also decided to make Standard Input Output Norms (SION) for the above export products based on ad-hoc norms.|orms Committee Decision: Decision:The Committee consi ame export product/import ite dvance authorizationNo. 3411 .07 of HBP Vol.

xport** products based on ad-hoc norms.|orms Committee Decision: Decision:The Committee consi ame export product/import ite dvance authorizationNo. 3411 .07 of HBP Vol. I as per details||||dered the case m in meeting 003955 dated given below||as per No.NC/ 27/07/2 or as ap||agenda and taking cue from the e 3/MEET/Jun/202324/6 dated 0 023, it was decided to fix ad-hoc plied by the firm, whichever is less|||arlier decision for 1/07/2024against norms under Para :-| |||||||||||||| |||Export Product||||Qty.||S|l. No.|Import Items|Qt|y. allowed.| |||Metronidazole Gel Usp 1% gm pump|||55|40,000 Number|s||1|Metronidazole (Micronized) USP|22|.44 kg.| |||Metronidazole Gel USP 1% gm tube|||60|70,000 Number|s||2|Metronidazole (Micronized) USP|42|.84 kg.| |||||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||||| |||||||||||||| |||||||||||||| |Case No.|||105 / N|C/3/MEET/Dec/202425/13||||||||| |||||||||||||| |Case Status|||Case A|pproved||||||||| |||||||||||||| |Party Name|||AARTI|DRUGS LIMITED||||||||| |||||||||||||| |Meeting Number |||NC/ 3/|MEET/ Dec/ 202425/ 13 and 07/01/2025||||||||| |and Date||||||||||||| |||||||||||||| |HQ File Number|||HQRN|RM APPLY 00002046AM25||||||||| ||||||||||||||

|||||||||||||| |Meeting Number |||NC/ 3/|MEET/ Dec/ 202425/ 13 and 07/01/2025||||||||| |and Date||||||||||||| |||||||||||||| |HQ File Number|||HQRN|RM APPLY 00002046AM25||||||||| ||||||||||||||

Case No.	105 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002046AM25

UDIN00557092AM25

RA File Number	RA File Number	03AX04001493 AM25	03AX04001493 AM25	03AX04001493 AM25	03AX04001493 AM25	03AX04001493 AM25	03AX04001493 AM25	03AX04001493 AM25
Licence No and<br>Date		0311035695/22/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Ethyl 3 Cyclopropylamino-2(2,4<br>Dichloro-5Fluorobenzoyl) Acrylate<br>1.240 kg.<br>Ciprofloxacin Hydrochloride<br>BP/EP/USP<br>1 kg.<br>2<br>Piperazine (68%)<br>0.574 kg.<br>RA concerned may take further necessary action as per above decision of NC.

	Export Product		Qty.	Sl.	No.	Impo	rt Items	**Qty.

%) 0.574 kg. RA concerned may take further necessary action as per above decision of NC.|||||||||||| ||||||||||||| |||Export Product|||Qty.|Sl.|No.|Impo|rt Items||Qty. allowed.| ||||||||||||| |||Ciprofloxacin Hydrochloride BP/EP/USP|||1 kg.||1|Ethyl Dichl|3 Cyclopropylamino-2(2,4 oro-5Fluorobenzoyl) Acrylate||1.240 kg.| ||||||||2|Piper|azine (68%)||0.574 kg.| ||||||||||||| ||A concerned may take further n|||ecessary actio|||n as per abo||ve decision of NC.||| ||||||||||||| |C|ase No.||106 / NC/3/MEET|/Dec/202425/1|||3||||| |C|ase Status||Case Deferred||||||||| |P|arty Name||ALEMBIC PHAR|MACEUTICA|||LS LIMITED||||| |M a|eeting Number nd Date||NC/ 3/ MEET/ De|c/ 202425/ 13 a|||nd 07/01/202||5||| |H|Q File Number||HQRNORM APP|LY 00002051A|||M25||||| |R|A File Number||34AX04000849 A|M24|||||||| |Licence No and Date|||3411005190/22/07/2024||||||||| |Norms Committee Decision: |||||||||||| |Decision: The case is under consideration and TE was requested to expedite his comments.||||||||||||

Case No.	106 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002051AM25
RA File Number	34AX04000849 AM24
Licence No and<br>Date	3411005190/22/07/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

umber|34AX04000849 AM24| |Licence No and Date|3411005190/22/07/2024| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	107 / NC/3/MEET/Dec/202425/13
Case Status	Case Aroved
	pp
Party Name	ALEMBIC PHARMACEUTICALS LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025

HQ File Number	HQRNORM APPLY 00002052AM25
RA File Number	34AX04000306 AM25

Licence No and
<br>Date	3411005187/22/07/2024

Norms Committee	Decision:

UDIN00557092AM25

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance authorization No. 0811011334 dated 23/04/2024 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

dvance authorization No. 0811011334 dated 23/04/2024 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

|Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo. 0811011334 dated 23/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 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 gm tube (net content of active ingredients 34.09 kgs.) 1 Number 2 Nystatin USP 477.30 mg. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 60 gm (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;

gm (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 1 Number 6 Nystatin USP 954.61 mg.|Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo. 0811011334 dated 23/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube (net content of active ingredients 23.86 kgs.

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 gm tube (net content of active ingredients 34.09 kgs.) 1 Number 2 Nystatin USP 477.30 mg. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 60 gm (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 1 Number 6 Nystatin USP 954.61 mg.|Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo. 0811011334 dated 23/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo. 0811011334 dated 23/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 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 gm tube (net content of active ingredients 34.09 kgs.) 1 Number 2 Nystatin USP 477.30 mg. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 60 gm (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;

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 1 Number 6 Nystatin USP 954.61 mg.|Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo. 0811011334 dated 23/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube (net content of active ingredients 23.86 kgs.

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 gm tube (net content of active ingredients 34.09 kgs.) 1 Number 2 Nystatin USP 477.30 mg. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 60 gm (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 1 Number 6 Nystatin USP 954.61 mg.| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube (net content of active ingredients 23.86 kgs.

*|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 gm tube (net content of active ingredients 34.09 kgs.)| 1 Number|2|Nystatin USP|477.30 mg.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 60 gm (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| 1 Number|6|Nystatin USP|954.61 mg.|

UDIN00557092AM25

UNITS / GM; 0.1% - 60 gm tube (net content of active ingredients 40.90 kgs.)

UDIN00557092AM25

UNITS / GM; 0.1% - 60 gm tube (net content of active ingredients 40.90 kgs.)

Case No.	108 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002058AM25
RA File Number	08AX04000652 AM25
Licence No and<br>Date	0811012185/22/07/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	109 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002060AM25
RA File Number	05AX04001134 AM25
Licence No and<br>Date	0511026794/22/07/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	110 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002066AM25
RA File Number	03AX04001974 AM25
Licence No and<br>Date	0311035722/23/07/2024
Norms Committee Decision:

UDIN00557092AM25

and 07/01/2025| |HQ File Number|HQRNORM APPLY 00002066AM25| |RA File Number|03AX04001974 AM25| |Licence No and Date|0311035722/23/07/2024| |Norms Committee Decision:||

UDIN00557092AM25

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

Case No.	111 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002069AM25
RA File Number	03AX04001934 AM25
Licence No and<br>Date	0311035731/23/07/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Full chemical name with details of the export item.<br>1.<br>Chemical reaction of the reactant and products indicating molecular weight and yield of the<br>reaction with justification.<br>2.<br>Stoichiometric material balance on molar basis indicating endues of export item<br>3.

and products indicating molecular weight and yield of the** reaction with justification. 2. Stoichiometric material balance on molar basis indicating endues of export item 3.||

Case No.	Case No.	112 / NC/3/MEET/Dec/202425/13	112 / NC/3/MEET/Dec/202425/13	112 / NC/3/MEET/Dec/202425/13	112 / NC/3/MEET/Dec/202425/13	112 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00002077AM25
RA File Number		08AX04000609 AM25
Licence No and<br>Date		0811012189/23/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>APROTININ INJECTION<br>1 Number Vial<br>1<br>APROTININ<br>15.4 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	APROTININ INJECTION		1 Number Vial	1	APROTININ	15.4 mg.

TION 1 Number Vial 1 APROTININ 15.4 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||APROTININ INJECTION||1 Number Vial|1|APROTININ|15.4 mg.|

Case No.	Case No.	112 / NC/3/MEET/Dec/202425/13	112 / NC/3/MEET/Dec/202425/13	112 / NC/3/MEET/Dec/202425/13	112 / NC/3/MEET/Dec/202425/13	112 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00002077AM25
RA File Number		08AX04000609 AM25
Licence No and<br>Date		0811012189/23/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>APROTININ INJECTION<br>1 Number Vial<br>1<br>APROTININ<br>15.4 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	APROTININ INJECTION		1 Number Vial	1	APROTININ	15.4 mg.

UDIN00557092AM25

(100000 KIU, 10ML AMP)

||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||APROTININ INJECTION||1 Number Vial|1|APROTININ|15.4 mg.|

UDIN00557092AM25

(100000 KIU, 10ML AMP)

Case No.	113 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002099AM25
RA File Number	02AX04000242 AM25
Licence No and<br>Date	0211006960/23/07/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for review/fixation of ad-hoc norms and as per<br>the advice of the TE, it was decided to call for following information/documents from the firm:-<br>Complete chemical reactions with molecular and structural formula and molecular weights along<br>with stage wise percentage yields on molar basis.

Case No.	114 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	MEONE HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002100AM25
RA File Number	04AX04000340 AM25
Licence No and<br>Date	0411007845/23/07/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|04AX04000340 AM25| |Licence No and Date|0411007845/23/07/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	115 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002111AM25
RA File Number	07AX04000649 AM25

69 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

UDIN00557092AM25

Licence No and Date 0711011876/24/07/2024

Norms Committee Decision:

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

Export Product	Qty.	Sl.<br>No.	Import Items	Qty. allowed.
Calcium Dobesilate Monohydrate<br>BP/ Calcium Dobesilate<br>Monohydrate Eur.Ph / Calcium<br>Dobesilate	1 kg.	1	HYDROQUINONE	0.631 kg.
Etamsylate	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|1 kg.|2|HYDROQUINONE|0.527 kg.|

Case No.	Case No.	116 / NC/3/MEET/Dec/202425/13	116 / NC/3/MEET/Dec/202425/13	116 / NC/3/MEET/Dec/202425/13	116 / NC/3/MEET/Dec/202425/13	116 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00002123AM25
RA File Number		08AX04000639 AM25
Licence No and Date		0811012198/24/07/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against<br>advance authorizationNo. 0811011227 dated 04/04/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CANDESARTAN CILEXETIL 2 MG<br>TABLETS (EACH UNCOATED<br>TABLET CONTAINS :<br>CANDESARTAN CILEXETIL PH.<br>EUR 2 MG NET CONTENT OF<br>1 Number<br>1<br>CANDESARTAN<br>CILEXETIL PH.EUR<br>2.04 mg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

INS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CANDESARTAN CILEXETIL 2 MG TABLETS (EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF||1 Number|1|CANDESARTAN CILEXETIL PH.EUR|2.04 mg.|

UDIN00557092AM25

CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN 0.180<br>KG IN EXPORT ITEM)
CANDESARTAN CILEXETIL 4 MG<br>TABLETS (EACH UNCOATED<br>TABLET CONTAINS :<br>CANDESARTAN CILEXETIL PH.<br>EUR 4 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN 1.440<br>KG IN EXPORT ITEM)	<br>1 Number	2	CANDESARTAN<br>CILEXETIL PH.EUR	4.08 mg.
CANDESARTAN CILEXETIL 8 MG<br>TABLETS<br>(EACH<br>UNCOATED<br>TABLET<br>CONTAINS<br>:<br>CANDESARTAN<br>CILEXETIL<br>PH.<br>EUR 8 MG NET CONTENT OF<br>CANDESARTAN<br>CILEXETIL<br>SHOULD NOT BE LESS THAN 5.760<br>KG IN EXPORT ITEM)	<br> <br> <br> <br> <br> <br> <br>1 Number	3	CANDESARTAN<br>CILEXETIL PH.EUR	8.16 mg.
CANDESARTAN CILEXETIL 16 MG<br>TABLETS (EACH UNCOATED<br>TABLET CONTAINS :<br>CANDESARTAN CILEXETIL PH.<br>EUR 16 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN<br>399.226 KG IN EXPORT ITEM)	1 Number	4	CANDESARTAN<br>CILEXETIL PH.EUR	16.32 mg.

AINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 399.226 KG IN EXPORT ITEM)|1 Number|4|CANDESARTAN CILEXETIL PH.EUR|16.32 mg.| ||CANDESARTAN CILEXETIL 32 MG TABLETS (EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 32 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 14.400 KG IN EXPORT ITEM)|1 Number|5|CANDESARTAN CILEXETIL PH.EUR|32.64 mg.| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 8 MG +12.5 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 8 MG AND HYDROCHLOROTHIAZIDE PH.|1 Number|6|CANDESARTAN CILEXETIL PH.EUR|8.16 mg.|

UDIN00557092AM25

|EUR. 12.5 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 2.520 KG IN EXPORT ITEM) CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 16 MG +12.5 MG (EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 16 MG AND HYDROCHLOROTHIAZIDE PH. EUR. 12.5 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 46.800 KG IN EXPORT ITEM) 1 Number 7 CANDESARTAN CILEXETIL PH.EUR 16.32 mg. CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 32 MG +12.5 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH. EUR.

CILEXETIL AND<br>HYDROCHLOROTHIAZID<br>E<br>TABLETS 32 MG +12.5 MG(EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN<br>CILEXETIL<br>PH.<br>EUR<br>32<br>MG<br>AND<br>HYDROCHLOROTHIAZIDE<br>PH.<br>EUR. 12.5 MG NET CONTENT OF<br>CANDESARTAN<br>CILEXETIL<br>SHOULD NOT BE LESS THAN<br>11.520 KG IN EXPORT ITEM)<br>1 Number<br>8<br>CANDESARTAN<br>CILEXETIL PH.EUR<br>32.64 mg.<br>CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID<br>E<br>TABLETS 32 MG +25 MG(EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN<br>CILEXETIL<br>PH.<br>EUR<br>32<br>MG<br>AND<br>HYDROCHLOROTHIAZIDE<br>PH<br>EUR. 25 MG NET CONTENT OF<br>CANDESARTAN<br>CILEXETIL<br>SHOULD NOT BE LESS THAN<br>11.520 KG IN EXPORT ITEM)<br>1 Number<br>9<br>CANDESARTAN<br>CILEXETIL PH.EUR<br>32.64 mg.<br>RA concerned may take further necessary action as per above decision of NC.	EUR. 12.5 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN 2.520<br>KG IN EXPORT ITEM)
	CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E<br>TABLETS 16 MG +12.5 MG (EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN CILEXETIL PH.<br>EUR 16 MG AND<br>HYDROCHLOROTHIAZIDE PH.<br>EUR. 12.5 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL<br>SHOULD NOT BE LESS THAN<br>46.800 KG IN EXPORT ITEM)	1 Number	7	CANDESARTAN<br>CILEXETIL PH.EUR	16.32 mg.
	CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID<br>E<br>TABLETS 32 MG +12.5 MG(EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN<br>CILEXETIL<br>PH.<br>EUR<br>32<br>MG<br>AND<br>HYDROCHLOROTHIAZIDE<br>PH.<br>EUR.

CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 32 MG +12.5 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH. EUR. 12.5 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 11.520 KG IN EXPORT ITEM)| 1 Number|8|CANDESARTAN CILEXETIL PH.EUR|32.64 mg.| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 32 MG +25 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH EUR. 25 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 11.520 KG IN EXPORT ITEM)| 1 Number|9|CANDESARTAN CILEXETIL PH.EUR|32.64 mg.|

Case No.	117 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred

UDIN00557092AM25

Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002125AM25
RA File Number	08AX04000637 AM25
Licence No and<br>Date	0811012200/24/07/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

umber|08AX04000637 AM25| |Licence No and Date|0811012200/24/07/2024| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	118 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	UNION PARK CHEMICALS BOMBAY PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00002859AM25
RA File Number	03AX04002739 AM25
Licence No and<br>Date	0311036906/05/09/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.<br>119 / NC/3/MEET/Dec/202425/13	Case No.<br>119 / NC/3/MEET/Dec/202425/13
Case Status<br>Case Approved
Party Name<br>POLLOMI PHARMACEUTICAL PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ	File Number<br>HQRNORM APPLY 00003074AM25
RA File Number<br>52AX04000164 AM25
Licence No and Date<br>5211009880/17/09/2024
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product<br>Qty.<br>Sl.	Import Items	Qty. allowed.
	No.
	PROMESTRIENE 10 MG<br>1 Number<br>1	PROMESTRIENE IH API	10.2 mg/Capsule
	SOFT GELATINE
	VAGINAL CAPSULE

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*|Import Items|Qty. allowed.|| ||No.|||| ||PROMESTRIENE 10 MG 1 Number 1|PROMESTRIENE IH API|10.2 mg/Capsule|| ||SOFT GELATINE|||| ||VAGINAL CAPSULE||||

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Case No.	120 / NC/3/MEET/Dec/202425/13
Case Status	Case Approved
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00003405AM25
RA File Number	03AX04003124 AM25
Licence No and<br>Date	0311037569/01/10/2024
Norms Committee Decision:<br>Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Fatty Acid Distillate<br>/Deoderised Distillate<br>9,21,250 kg.<br>2<br>Acetone<br>44,000 kg.<br>Natural Refined Phytosterol 95%<br>60000 kg.<br>3<br>N Heptane<br>94,050 kg.<br>4<br>Fatty Acid Distillate<br>/Deoderised Distillate<br>9,21,250 kg.<br>5<br>Acetone<br>44,000 kg.<br>Natural Mixed Tocopherol 50%<br>38500 kg.<br>6<br>N Heptane<br>94,050 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	121 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred

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

Case No.	121 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred

UDIN00557092AM25

Part	y Name	SAGA LIFESCIENCES L	IMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Dec/ 20242	5/ 13 and 07/01/2	025
HQ	File Number	HQRNORM APPLY 0000	3526AM25
RA File Number	File Number	08AX04001122 AM25

Licence No and<br>Date		0811012864/08/10/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	122 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00003684AM25
RA File Number	03AX04003549 AM25
Licence No and<br>Date	0311037997/16/10/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	123 / NC/3/MEET/Dec/202425/13
Case Status	Case Deferred
Party Name	PARADISE HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number	HQRNORM APPLY 00003965AM25
RA File Number	34AX04000658 AM25
Licence No and<br>Date	3411005628/30/10/2024
Norms Committee Decision:
Decision: The case is under consideration and TE was requested to expedite his comments.

umber|34AX04000658 AM25| |Licence No and Date|3411005628/30/10/2024| |Norms Committee Decision:|| |Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	Case No.	124 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		SAGA LIFESCIENCES LIMITED

Meeting Number a	d
<br>Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00004083AM25
RA File Number		08AX04001348 AM25
Licence No and Da	te	0811013194/12/11/2024

Norms Committee	Decision:

75 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

UDIN00557092AM25

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/202425/12 dated 10/12/2024 against advance authorization No0811011704 dated 29/05/2024 , 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.
LYSINE<br>CLONIXINATE<br>(125MG)<br>AND<br>PROPINOX<br>HYDROCHLORIDE<br>(10MG)<br>TABLETS<br>(CONTENTS<br>OF<br>LYSINE<br>CLONIXINATE<br>62.50KGS)	<br> <br> <br> <br> <br>500000<br>Numbers	1	LYSINE CLONIXINATE	63.75 kg.

Case No.	Case No.	125 / NC/3/MEET/Dec/202425/13	125 / NC/3/MEET/Dec/202425/13	125 / NC/3/MEET/Dec/202425/13	125 / NC/3/MEET/Dec/202425/13	125 / NC/3/MEET/Dec/202425/13
Case Status		Case Approved
Party Name		BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202425/ 13 and 07/01/2025
HQ File Number		HQRNORM APPLY 00004499AM25
RA File Number		03AX04004313 AM25
Licence No and<br>Date		0311039223/02/12/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>TAMOXIFEN TABLETS / BP - 20 MG<br>1 Number<br>1<br>TAMOXIFEN<br>CITRATE BP<br>30.4 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	TAMOXIFEN TABLETS / BP - 20 MG		1 Number	1	TAMOXIFEN<br>CITRATE BP	30.4 mg.

UDIN00557092AM25

77 This document has been digitally signed by Raman Kumar, Deputy DGFT on 04-02-2025 17:22:20.

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